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ENVIRONMENTAL IMPACT ASSESSMENT

REPORT
&
ENVIRONMENTAL MANAGEMENT PLAN
OF

M/s. ARCHIMEDIS
LABORATORIES PVT. LTD.
LOCATED AT

Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet


(M), Krishna District, Andhra Pradesh.
FOR

PROPOSED BULK DRUGS AND INTERMEDIATES


MANUFACTURING UNIT

Proposal for

ENVIRONMENTAL CLEARANCE
Industry falls under 5(f) ‘A’ Category as per the EIA Notification, 2006.

Baseline Period – March – 2018 to May - 2018

Project Proponent
Mr. Maddireddy Venkateswara Reddy,
Managing Director,
5-163/1, 2nd floor,
Malleswari Nilayam, Chintalkunta,
LB Nagar Post, Hyderabad

Prepared by:
Rightsource Industrial Solutions Pvt. Ltd
Plot No: 203, H.No:5-36/203, Prashanthi Nagar, IDA,
Kukatpally, Hyderabad – 500072. Ph: 040-23070602,
23075699. 40126589. Email: info@rightsource.co.in.
NABET Accreditation No: NABET/EIA/1518/SA 038
UNDERTAKING BY PROJECT
AUTHORITIES
DISCLOSURE OF CONSULTANTS
ENGAGED
Annexure

Declaration by Experts contributing to the EIA of Archimedis Laboratories Pvt. Ltd ., Sy No:
108 & 109, Jayanthipuram (V) Jaggayyapet Mandai, Krishna District, Andhra Pradesh.
I, hereby, certify that I was a part of the EIA team in the following capacity that developed the
above EIA.

EIA coordinator:
Name: Yarlagadda V. Prasad
Signature: ;(-!'------.;o:r.-1
Period of involvement: Feb 2018 -Till date
Contact information: Rightsource Industrial Solutions Pvt. Ltd.
Plot No: 203, H.No:5-36/203, Prashanthi Nagar, IDA,
Kukatpally, Hyderabad - 500072. Ph: 040-23070602, 23075699.
info@rightsource.co.in , eiaemp@riqhtsource.co .in

Functional Area Experts:

Name of
s. Functional
the
Involvement
Signature
No. areas (period and task-)
expertls
Period: Feb 2018 -Till date
Task: Selecting ambient air monitoring sites
1 AP
Yarlagadda based on IMD data, Review of the
V. Prasad meteorological data, Process emissions and
AAQ data, suggesting air pollution control
fl~
measures.
Period: Feb 2018 - Till date

9
Task: Identification of water monitoring sites,
P.S.N.
2 WP estimating water requirement, Suggesting ,.,_
Murthy
Recycling of water, waste water treatment
methods & disposal schemes.

~~
Period: Feb 2018 - Till date
Task: lnventorization of Hazardous waste,
P .S.N.
3 SHW* Solid wastes, etc., suggesting treatment
Murthy
options viz., landfill, incineration, recycling,
and stabilization.

4 SE
Setti VR
Bhaskara
Rao
Period: Feb 2018 -Till date
Task: Generating primary SE data, livestock
inventory and impacts, conducted focused
group discussions, taken public opinion on

DECLARATION OF ASSOCIATION IN THE EIA
the project. Identified villages wise amenities
and needs
Period: Feb 2018 - Till date
Task: Collected secondary data from foresU
agricultural/ fisheries department, generation
G. Raja of primary flora and fauna data from study
5 EB Reddy area & core area, ground truthing for
ecological assessment, development of
status report, suggested species for
greenbelt development.
Period: March 2018 -Till date
Task: Measurement of ground water levels
from the existing wells present in and around
E. V. project site, observation of surface water
6 HG Naresh bodies, establishing groundwater flow
Kumar direction and its gradient and evaluation of
rainfall data and suggesting suitable depth
for secured land fill base, and identification
of development of monitoring wells.
Period: March 2018 -Till date
Task: Observations made towards the
E. V. Identification of country rock, development of
7 GEO Naresh porosity, thickness and extent of weathered
Kumar formations, area seismicity and evaluation of
soil permeability for suggesting suitable civil
structures.
Period: Feb 2018- Till date
Task: Meteorological & Air Pollution
P. Praveen
8 AQ dispersion studies, suggesting environmental
Kumar
management plan for air pollution control
measures
Period: Feb 2018 - Till date
Yarlagadda Task: Monitoring of noise I vibration levels
9 NV v. Prasad using instrument, processing and analysis of
Data for suggesting suitable noise mitigating
measures
Period: March 2018 -Till date
Task: Collection of GPS readings from the
project site and prepared layout, preparation
Dr. Y.
of TOPO map through SOl 1 :50,000 scale
10 LU Ram a
TOPO sheet. Collections of ground through
Mohan
data from the field. Preparation of LU map
through Satellite imagery, SOl, Google map
& Ground through data.
Period: Feb 2018 - Till date
P . Praveen
11 RH Task: Identification of Hazards and
Kumar
Hazardous substances from process &

DECLARATION OF ASSOCIATION IN THE EIA


warehouse, storage tanks .Risks and
consequence analysis using software and
lethality damages, DMP and EPP for onsite
& offsite were provided

Functional Involvement
S.No. Name of the F AAs Signature
Areas Period

1 AP,AQ Y. Prathyusha Feb 2018- Till date R l..l~ho.

2 LU G. Sandeep Feb 2018- Till date



Functional Name of the Team Involvement
S.No. Signature
Areas Members Period

1 sc G. Raja Reddy Feb 2018 -Till date


~

Declaration by the Head of the accredited consultant organization/ authorized person


I, Yarlagadda V . Prasad, hereby, confirm that the above mentioned experts prepared the EIA of
Archimedis Laboratories Pvt. Ltd., Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet Mandai,
Krishna District, Andhra Pradesh. I also confirm that the consultant organization shall be fully
accountable for any mis-leading information mentioned in this statement.

Signature: ~'
Name: Yarlagadda V. Prasad
Designation: Managing Director
Name of the EIA consultant organization: Rightsource Industrial Solutions Pvt. Ltd.
NABET Certificate No. & Issue Date: NABET Accreditation No: NABET/EIA/1821/RA 0100

DECLARATION OF ASSOCIATION IN THE EIA


COPY OF
TERMS OF REFERENCE [TOR]
No.IA-J-11011/9/2018-IA-II(I)
Goverment of India
Minister of Enviroment,Forest and Climate Change
Impact Assessment Division
***

Indira Paryavaran Bhavan,


Vayu Wing,3rd Floor,Aliganj,
Jor Bagh Road,New Delhi-110003
05 Feb 2018

To,

M/s ARCHIMEDIS LABORATORIES PRIVATE LIMITED


5-163/1, 2 nd Floor, Malleswari Nilayam, Chintalkunta, LB Nagar Post Hyderabada,
Rangareddi-500074
Telangana

Tel.No.040-23070602; Email:archimedismlpl@gmail.com

Sir/Madam,

This has reference to the proposal submitted in the Ministry of Environment, Forest
and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA
study for the purpose of obtaining Environmental Clearance in accordance with the provisions of
the EIA Notification, 2006. For this purpose, the proponent had submitted online information in the
prescribed format (Form-1 ) along with a Pre-feasibility Report. The details of the proposal are
given below:

1. Proposal No.: IA/AP/IND2/72028/2018

2. Name of the Proposal: Archimedis laboratories Private Limited

3. Category of the Proposal: Industrial Projects - 2

4. Project/Activity applied for: 5(f) Synthetic organic chemicals industry (dyes


& dye intermediates; bulk

5. Date of submission for TOR: 03 Jan 2018

In this regard, under the provisions of the EIA Notification 2006 as amended, the Standard TOR
for the purpose of preparing environment impact assessment report and environment
management plan for obtaining prior environment clearance is prescribed with public consultation
as follows:
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/
ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

5(f):STANDARD TERMS OF REFERENCE FOR CONDUCTING


ENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETIC
ORGANIC CHEMICALS INDUSTRY (DYES & DYE
INTERMEDIATES; BULK DRUGS AND INTERMEDIATES
EXCLUDING DRUG FORMULATIONS; SYNTHETIC RUBBERS;
BASIC ORGANIC CHEMICALS, OTHER SYNTHETIC ORGANIC
CHEMICALS AND CHEMICAL INTERMEDIATES) AND
INFORMATION TO BE INCLUDED IN EIA/EMP REPORT
A. STANDARD TERMS OF REFERENCE
1) Executive Summary
2) Introduction
i. Details of the EIA Consultant including NABET accreditation
ii. Information about the project proponent
iii. Importance and benefits of the project
3) Project Description
i. Cost of project and time of completion.
ii. Products with capacities for the proposed project.
iii. If expansion project, details of existing products with capacities and whether adequate land
is available for expansion, reference of earlier EC if any.
iv. List of raw materials required and their source along with mode of transportation.
v. Other chemicals and materials required with quantities and storage capacities
vi. Details of Emission, effluents, hazardous waste generation and their management.
vii. Requirement of water, power, with source of supply, status of approval, water balance diagram,
man-power requirement (regular and contract)
viii. Process description along with major equipments and machineries, process flow sheet
(quantative) from raw material to products to be provided
ix. Hazard identification and details of proposed safety systems.
x. Expansion/modernization proposals:
c. Copy of all the Environmental Clearance(s) including Amendments thereto obtained for
the project from MOEF/SEIAA shall be attached as an Annexure. A certified copy of the
latest Monitoring Report of the Regional Office of the Ministry of Environment and Forests
as per circular dated 30th May, 2012 on the status of compliance of conditions stipulated
in all the existing environmental clearances including Amendments shall be provided. In
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR
PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

addition, status of compliance of Consent to Operate for the ongoing Iexisting operation
of the project from SPCB shall be attached with the EIA-EMP report.
d. In case the existing project has not obtained environmental clearance, reasons for not
taking EC under the provisions of the EIA Notification 1994 and/or EIA Notification
2006 shall be provided. Copies of Consent to Establish/No Objection Certificate and
Consent to Operate (in case of units operating prior to EIA Notification 2006, CTE and
CTO of FY 2005-2006) obtained from the SPCB shall be submitted. Further, compliance
report to the conditions of consents from the SPCB shall be submitted.
4) Site Details
i. Location of the project site covering village, Taluka/Tehsil, District and State, Justification
for selecting the site, whether other sites were considered.
ii. A toposheet of the study area of radius of 10km and site location on 1:50,000/1:25,000 scale
on an A3/A2 sheet. (including all eco-sensitive areas and environmentally sensitive places)
iii. Details w.r.t. option analysis for selection of site
iv. Co-ordinates (lat-long) of all four corners of the site.
v. Google map-Earth downloaded of the project site.
vi. Layout maps indicating existing unit as well as proposed unit indicating storage area, plant
area, greenbelt area, utilities etc. If located within an Industrial area/Estate/Complex, layout
of Industrial Area indicating location of unit within the Industrial area/Estate.
vii. Photographs of the proposed and existing (if applicable) plant site. If existing, show
photographs of plantation/greenbelt, in particular.
viii. Landuse break-up of total land of the project site (identified and acquired), government/
private - agricultural, forest, wasteland, water bodies, settlements, etc shall be included. (not
required for industrial area)
ix. A list of major industries with name and type within study area (10km radius) shall be
incorporated. Land use details of the study area
x. Geological features and Geo-hydrological status of the study area shall be included.
xi. Details of Drainage of the project upto 5km radius of study area. If the site is within 1 km
radius of any major river, peak and lean season river discharge as well as flood occurrence
frequency based on peak rainfall data of the past 30 years. Details of Flood Level of the
project site and maximum Flood Level of the river shall also be provided. (mega green field
projects)
xii. Status of acquisition of land. If acquisition is not complete, stage of the acquisition process
and expected time of complete possession of the land.
xiii. R&R details in respect of land in line with state Government policy.
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/
ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

5) Forest and wildlife related issues (if applicable):


i. Permission and approval for the use of forest land (forestry clearance), if any, and
recommendations of the State Forest Department. (if applicable)
ii. Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineating
the forestland (in case of projects involving forest land more than 40 ha)
iii. Status of Application submitted for obtaining the stage I forestry clearance along with latest
status shall be submitted.
iv. The projects to be located within 10 km of the National Parks, Sanctuaries, Biosphere Reserves,
Migratory Corridors of Wild Animals, the project proponent shall submit the map duly
authenticated by Chief Wildlife Warden showing these features vis-à-vis the project location
and the recommendations or comments of the Chief Wildlife Warden-thereon.
v. Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the State
Government for conservation of Schedule I fauna, if any exists in the study area.
vi. Copy of application submitted for clearance under the Wildlife (Protection) Act, 1972, to the
Standing Committee of the National Board for Wildlife.
6) Environmental Status
i. Determination of atmospheric inversion level at the project site and site-specific micro-
meteorological data using temperature, relative humidity, hourly wind speed and direction
and rainfall.
ii. AAQ data (except monsoon) at 8 locations for PM10, PM2.5, SO2, NOX, CO and other
parameters relevant to the project shall be collected. The monitoring stations shall be based
CPCB guidelines and take into account the pre-dominant wind direction, population zone
and sensitive receptors including reserved forests.
iii. Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in the
NAQQM Notification of Nov. 2009 along with - min., max., average and 98% values for
each of the AAQ parameters from data of all AAQ stations should be provided as an annexure
to the EIA Report.
iv. Surface water quality of nearby River (100m upstream and downstream of discharge point)
and other surface drains at eight locations as per CPCB/MoEF&CC guidelines.
v. Whether the site falls near to polluted stretch of river identified by the CPCB/MoEF&CC, if
yes give details.
vi. Ground water monitoring at minimum at 8 locations shall be included.
vii. Noise levels monitoring at 8 locations within the study area.
viii. Soil Characteristic as per CPCB guidelines.
ix. Traffic study of the area, type of vehicles, frequency of vehicles for transportation of materials,
additional traffic due to proposed project, parking arrangement etc.
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR
PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

x. Detailed description of flora and fauna (terrestrial and aquatic) existing in the study area
shall be given with special reference to rare, endemic and endangered species. If Schedule-
I fauna are found within the study area, a Wildlife Conservation Plan shall be prepared and
furnished.
xi. Socio-economic status of the study area.
7) Impact and Environment Management Plan
i. Assessment of ground level concentration of pollutants from the stack emission based on
site-specific meteorological features. In case the project is located on a hilly terrain, the
AQIP Modelling shall be done using inputs of the specific terrain characteristics for
determining the potential impacts of the project on the AAQ. Cumulative impact of all sources
of emissions (including transportation) on the AAQ of the area shall be assessed. Details of
the model used and the input data used for modelling shall also be provided. The air quality
contours shall be plotted on a location map showing the location of project site, habitation
nearby, sensitive receptors, if any.
ii. Water Quality modelling - in case of discharge in water body
iii. Impact of the transport of the raw materials and end products on the surrounding environment
hall be assessed and provided. In this regard, options for transport of raw materials and
finished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-
cum-rail transport shall be examined.
iv. A note on treatment of wastewater from different plant operations, extent recycled and reused
for different purposes shall be included. Complete scheme of effluent treatment. Characteristics
of untreated and treated effluent to meet the prescribed standards of discharge under E(P)
Rules.
v. Details of stack emission and action plan for control of emissions to meet standards.
vi. Measures for fugitive emission control
vii. Details of hazardous waste generation and their storage, utilization and management. Copies
of MOU regarding utilization of solid and hazardous waste in cement plant shall also be
included. EMP shall include the concept of waste-minimization, recycle/reuse/recover
techniques, Energy conservation, and natural resource conservation.
viii. Proper utilization of fly ash shall be ensured as per Fly Ash Notification, 2009. A detailed
plan of action shall be provided.
ix. Action plan for the green belt development plan in 33 % area i.e. land with not less than
1,500 trees per ha. Giving details of species, width of plantation, planning schedule etc. shall
be included. The green belt shall be around the project boundary and a scheme for greening
of the roads used for the project shall also be incorporated.
x. Action plan for rainwater harvesting measures at plant site shall be submitted to harvest
rainwater from the roof tops and storm water drains to recharge the ground water and also to
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/
ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

use for the various activities at the project site to conserve fresh water and reduce the water
requirement from other sources.
xi. Total capital cost and recurring cost/annum for environmental pollution control measures
shall be included.
xii. Action plan for post-project environmental monitoring shall be submitted.
xiii. Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency Management
Plan including Risk Assessment and damage control. Disaster management plan should be
linked with District Disaster Management Plan.
8) Occupational health
i. Plan and fund allocation to ensure the occupational health & safety of all contract and casual
workers
ii. Details of exposure specific health status evaluation of worker. If the workers' health is being
evaluated by pre designed format, chest x rays, Audiometry, Spirometry, Vision testing (Far
& Near vision, colour vision and any other ocular defect) ECG, during pre placement and
periodical examinations give the details of the same. Details regarding last month analyzed
data of above mentioned parameters as per age, sex, duration of exposure and department
wise.
iii. Details of existing Occupational & Safety Hazards. What are the exposure levels of hazards
and whether they are within Permissible Exposure level (PEL). If these are not within PEL,
what measures the company has adopted to keep them within PEL so that health of the workers
can be preserved,
iv. Annual report of heath status of workers with special reference to Occupational Health and
Safety.
9) Corporate Environment Policy
i. Does the company have a well laid down Environment Policy approved by its Board of
Directors? If so, it may be detailed in the EIA report.
ii. Does the Environment Policy prescribe for standard operating process / procedures to bring
into focus any infringement / deviation / violation of the environmental or forest norms /
conditions? If so, it may be detailed in the EIA.
iii. What is the hierarchical system or Administrative order of the company to deal with the
environmental issues and for ensuring compliance with the environmental clearance
conditions? Details of this system may be given.
iv. Does the company have system of reporting of non compliances / violations of environmental
norms to the Board of Directors of the company and / or shareholders or stakeholders at
large? This reporting mechanism shall be detailed in the EIA report
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR
PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

10) Details regarding infrastructure facilities such as sanitation, fuel, restroom etc. to be provided to the
labour force during construction as well as to the casual workers including truck drivers during
operation phase.
11) Enterprise Social Commitment (ESC)
i. Adequate funds (at least 2.5 % of the project cost) shall be earmarked towards the Enterprise
Social Commitment based on Public Hearing issues and item-wise details along with time
bound action plan shall be included. Socio-economic development activities need to be
elaborated upon.
12) Any litigation pending against the project and/or any direction/order passed by any Court of Law
against the project, if so, details thereof shall also be included. Has the unit received any notice
under the Section 5 of Environment (Protection) Act, 1986 or relevant Sections of Air and Water
Acts? If so, details thereof and compliance/ATR to the notice(s) and present status of the case.
13) 'A tabular chart with index for point wise compliance of above TOR.

B. SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETIC


ORGANIC CHEMICALS INDUSTRY (DYES & DYE INTERMEDIATES;
BULK DRUGS AND INTERMEDIATES EXCLUDING DRUG
FORMULATIONS; SYNTHETIC RUBBERS; BASIC ORGANIC
CHEMICALS, OTHER SYNTHETIC ORGANIC CHEMICALS AND
CHEMICAL INTERMEDIATES)
1. Detailsonsolvents to be used,measuresfor solventrecovery and for emissions control.
2. Details of process emissions from the proposed unit and its arrangement to control.
3. Ambient air quality data should include VOC, otherprocess-specificpollutants* like NH3*, chlorine*,
HCl*, HBr*, H2S*, HF*,etc.,(*-asapplicable)
4. Work zone monitoring arrangements for hazardous chemicals.
5. Detailed effluent treatment scheme including ssegregation of effluent streams for units adopting
'Zero' liquid discharge.
6. Action plan for odour control to be submitted.
7. A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearly
that they co-process organic solid/hazardous waste generated.
8. Authorization/Membership for the disposal of liquid effluent in CETP and solid/hazardous waste in
TSDF, if any.
9. Action plan for utilization of MEE/dryers salts.
10. Material Safety Data Sheet for all the Chemicals are being used/will be used.
11. Authorization/Membership for the disposal of solid/hazardous waste in TSDF.
STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/
ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

12. Details of incinerator if to be installed.


13. Risk assessment for storage and handling of hazardous chemicals/solvents. Action plan for handling
& safety system to be incorporated.
14. Arrangements for ensuring health and safety of workers engaged in handling of toxic materials.

***
TOR COMPLIANCE
TOR Compliance Archimedis Laboratories Pvt Ltd

ToR COMPLIANCE
S. No Standard Terms of Reference Chapters Page Nos
1. Executive Summary Enclosed in EIA Report
2. Introduction
1. Details of the EIA Consultant including NABET
Enclosed as Enclosure - VI
accreditation
2. Information about the project proponent Chapter - I 1
3. Importance and benefits of the project Chapter - VIII 430-433
3 Project Description
Chapter - I 2
I. 1. Cost of project and time of completion
Chapter - II 17-18
2. Products with capacities for the proposed
II. Chapter - II 16-17
project.
3. If expansion project, details of existing products
with capacities and whether adequate land is
III. It is a Greenfield project
available for expansion, reference of earlier EC
if any.
4. List of raw materials required and their source
IV. Chapter - II 226-239
along with mode of transportation.
5. Other chemicals and materials required with
V. Chapter - VII 371
quantities and storage capacities.
6. Details of Emission, effluents, hazardous waste
VI Chapter - X 438-451
generating and their management
7. Requirement of water, power, with source of
supply, status of approval, water balance Chapter - II 209-210
VII.
diagram, man-power requirement (regular and Chapter - VIII 430
contract)
8. Process description along with major
equipments and machineries, process flow
VIII. Chapter - II 19-204
sheet (quantities) from raw material to products
to be provided.
9. Hazard identification and details of proposed
IX. Chapter - VII 359-370
safety systems.
X. Expansion/modernization proposals
a. Copy of all Environmental Clearance (s)
including Amendments thereto obtained for the
project from MOEF/SEIAA shall be attached as
an Annexure. A certified copy of the latest It is a Greenfield Project
Monitoring report of the Regional Office of the
X.
Ministry of Environment and Forests as per
circular dated 30th May, 2012 on the status of
compliance of conditions stipulated in all the
existing environmental clearances including
Amendments shall be provided In addition,
status of compliance of consent to operate for

Prepared By Rightsource Industrial Solutions Pvt. Ltd Page I


TOR Compliance Archimedis Laboratories Pvt Ltd

S. No Standard Terms of Reference Chapters Page Nos


the ongoing existing operation of the project
from SPCB shall be attached with the EIA-EMP
report.

d. In case the existing project has not obtained


environmental clearance, reasons for not taking
EC under the provisions of the EIA Notification
2006 shall be provided. Copies of Consent to
Establish /No Objection Certificate and Consent
to Operate (in case of units operating prior to
EIA Notification 2006, CTE and CTO of FY
2005-2006) obtained from the SPCB shall be
submitted. Further, compliance report to the
conditions of consents from the SPCB shall be
submitted
Site Details
i. Location of the project site covering village, Chapter - II 9-10
Taluka /Tehsil, District and State, Justification Chapter - I 4
for selecting the site, whether other sites were
considered.

ii. A toposheet of the study area of radius of 10


KMs and site location on 1:50,000/1:25,000 Chapter - II 14
scale on an A3/A2 sheet. (including all eco-
sensitive areas and environmentally sensitive
places)

iii. Details w.r.t. option analysis for selection of site Site is suitable for
Industrial
Establishment &
4
no need of
alternative site
analysis.

iv. Co-ordinates (lat-long) of all four corners of the Chapter - II 14


site.
v. Google map –Earth downloaded of the project Chapter - II 12
site
vi. Layout maps indicating existing unit as well as
proposed unit indicating storage area, plant Chapter - II 15
area, greenbelt area, utilities etc. If located
within an Industrial area/Estate /Complex, layout
of Industrial Area indicating location of unit
within the Industrial area/Estate.
vii. Photographs of the proposed and existing (if Chapter - II 13

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TOR Compliance Archimedis Laboratories Pvt Ltd

S. No Standard Terms of Reference Chapters Page Nos


applicable) plant site. If existing, show
photographs of plantation /greenbelt, in
particular.
viii. Landuse break up of total land of the project site
(identified and acquired), government/ private- Chapter - II 9
agricultural, forest, wasteland, water bodies,
settlement, etc shall be included. (not required
for industrial area)
ix. A list of major industries with name and type Chapter - I 5
within study area (10KMs radius) shall be
incorporated. Land use details of the study area
x. Geological features and Geo-hydrological status
of the study area shall be included.
xi. Details of Drainage of the project upto 5km Chapter - III 248
radius of study area. If the site is within 1 km
radius of any major river, peak and lean season
river discharge as well as flood occurrence
frequency based on peak rainfall data of thee
past 30 years, Details of Flood Level of the
project site and maximum Flood level of the river
shall also be provided. (mega green field
projects)
xii. Status of acquisition of land. If acquisition is not Proposed land for
complete, stage of the acquisition process and unit was acquired
expected time of complete possession of the by Proponent
land.
The proposed unit
xiii. R&R details in respect of land in line with state is established in
Government policy. 11.62 Acres, so
R&R is applicable

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TOR Compliance Archimedis Laboratories Pvt Ltd

S. No Standard Terms of Reference Chapters Page Nos

Forest and wildlife related issues


(if applicable)
i. i. Permission and approval for the use of forest
land (forestry clearance), if any, and
recommendations of the State Forest The project area is non- forest
Department (if applicable) land.

ii. Landuse map base on High resolution satellite Land use map based on
imagery (GPS) of the proposed site delineating satellite imaginary of the
the forestland (in case of projects involving proposed site is presented in
forest land more than 40 ha) chapter - III, Page no: 294-295

iii. Status of Application submitted for obtaining Not applicable


the stage I forestry clearance along with latest
status shall be submitted.

5
iv. The projects to be located within 10KMs of
the National Parks, Sanctuaries, Biosphere There are no National parks,
Reserves, Migratory Corridors of Wild Animals, Sanctuaries, Biosphere
the project proponent shall submit the map duly Reserves, Migratory corridors of
authenticated by chief wildlife warden showing Wild Animals, within the 10 Km
these features vis-à-vis the project location and buffer zone
the recommendations or comments of the Chief
Wildlife Warden –there on.

v. Wildlife Conservation plan duly authenticated Not Applicable


by the chief wildlife warden of the state
government for conservation of schedule 1
fauna, if any exists in the study area.

vi. Copy of application submitted for clearance Not Applicable


under the wildlife (Protection) Act, 1972, to be
standing committee of the national board for
wildlife.

6 Environmental Status
i. i) Determination of atmospheric inversion level
at the project site and site-specific micro- Chapter - III 249- 252
meteorological data using temperature, relative
humidity, hourly wind speed and direction and
rainfall.

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ii) AAQ data (except monsoon) at 8 locations for


PM10, PM2.5, SO2, NOX, CO and other Chapter - III 254-255
parameters relevant to the project shall be
collected. The monitoring stations shall be
based CPCB guidelines and take into account
the pre-dominant wind direction, population zone
and sensitive receptors including reserved
forests.
ii. iii) Raw data of all AAQ measurement for 12 Chapter - III 259-267
weeks of al stations as per frequency given in
the NAQQM Notification of Nov.2009 along with
–min., max., average and 98% values for each
of the AAQ parameters from data of all AAQ
stations should be provided as an annexure to
the EIA Report.
iii.
iv. iv) Surface water quality of nearby River (100m Chapter - III 269-270
upstream and downstream of discharge point
and other surface drains at eight locations as
per CPCB / MoEF&CC guidelines.

V) Whether the site falls near to polluted stretch


of river identified by the CPCB/MoEFCC, if yes Not Applicable
give details.

Vi) Ground water monitoring at minimum at 8 Chapter - III 269-270


locations shall be included

vii) Noise levels monitoring at 8 locations within Chapter - III 277-278


the study area.

Viii) Soil characteristic as per CPCB guidelines. Chapter - III 283-284

ix) Traffic study of the area, type of vehicles, Chapter - III 280-282
frequency of vehicles for transportation of
materials, additional traffic due to proposed
project, parking arrangement etc.
x) Detailed description of flora and fauna Chapter - III 296-307
(terrestrial and aquatic) existing in the study
area shall be given with special reference to
rare, endemic and endangered species. If
Schedule-I fauna are found within the study
area, a wildlife conservation plan shall be
prepared and furnished.

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xi) Socio-economic status of the study area. Chapter - III 307-311
7 Impact and Environment Management Plan
i. i) Assessment of ground level concentration of Chapter - IV 326-329
pollutants from the stack emission based on site
–specific meteorological features. In case the
project is located on a hilly terrain, the AQIP
Modelling shall be done using inputs of the
specific terrain characteristics for determining
the potential impacts of the project on the AAQ.
Cumulative impact of all sources of emissions
(including transportation) on the AAQ of the area
shall be assessed. Details of the model used
and the input data used for modeling shall also
be provided. The air quality contours shall be
plotted on a location map showing the location
of project site, habitation nearby, sensitive
receptors, if any.
ii.
iii. ii) Water Quality modeling –in case of discharge The proposed unit
in water body is will employ ZLD
system

iii) Impact of the transport of the raw materials


and end products on the surrounding Chapter - X 439
environment hall be assessed and provided. In
this regard, options for transport of raw materials
and finished products and wastes (large
quantities) by rail or rail-cum road transport or
conveyor- cum –rail transport shall be examined.

iv) A note on treatment of wastewater from


different plant operations, extent recycled and
reused for different purposes shall be included. Chapter - X 440-449
Complete scheme of effluent treatment,
Characteristics of untreated and treated effluent
to meet the prescribed standards of discharge
under E (P) Rules.

v) Details of stack emission and action plan for Chapter - X 438


control of emissions to meet standards

VI) Measures for fugitive emission control Chapter - X 460-463

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VII) Details of hazardous waste generation and Chapter - X 465
their storage, utilization and management.
Copies of MOU regarding utilization of solid and
hazardous waste in cement plant shall also be
included. EMP shall include the concept of
waste – minimization, recycle/reuse/ recover
techniques, Energy conservation, and natural
resource conservation.

VIII) Proper utilization of fly ash shall be ensured Chapter - X 465


as per fly ash notification, 2009. A detailed plan Chapter - IV 336
of action shall be provided.

IX) Acton plan for the green belt development Chapter - X 455-456
plan in 33% area i.e. land with not less than
1,500 trees per ha. Giving details of species,
width of plantation, planning schedule etc. shall
be included. The green belt shall be around the
project boundary and a scheme for greening of
the roads used for the project shall also be
incorporated.

X) Action plan for rainwater harvesting Chapter - X 466-467


measures at plant site shall be submitted to
harvest rainwater from the roof tops and storm
water drains to recharge the ground water and
also to use for the various activities at the
project site to conserve fresh water and reduce
the water requirement from other sources.

XI) Total capital cost and recurring cost /annum Chapter - X 468
for environmental pollution control measures
shall be included.
XII) Action plan for post –project environment Chapter - VI 347-350
monitoring shall be submitted. Chapter - X 456-458

XIII) Onsite and offsite Disaster (natural and


Man –made) Preparedness and Emergency Chapter - VII 413-429
Management Plan including Risk Assessment
and damage control. Disaster management plan
should be linked with District Disaster
Management Plan.
Occupational health
8 i. Plan and fund allocation to ensure the Chapter - VII 404-405
occupational health & safety of all contract and

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casual workers
ii. Details of exposure specific health status
evaluation of workers’ health is being evaluated
by pre designed format, chest x rays,
Audiometry, Spirometry, Vision testing (Far &
Near vision, colour vision and any other ocular
defect) EGG, during pre placement and
periodical examinations give the details of the
same details regarding last month analyzed data
of above mentioned parameters as per age, sex,
duration of exposure and department wise.
Details of existing Occupational & safety
Hazards. What are the exposure levels of
hazards and whether they are within permissible
Exposure level (PEL) If these are not within
PEL, what measures the company has adopted
to keep them within PEL so that health of the
workers. Can be preserved,
Annual report of heath status of workers with
special reference to Occupational Health and
safety.
Corporate Environment Policy
i. Does the company have a well laid down
Environment Policy approved by its Board of
Directors? If so, it may be detailed in the EIA
report. Chapter -VI 344-345

ii. Does the Environment Policy prescribe for


standard operation process / procedures to bring
into focus any infringement / deviation / violation
of the environmental or forest norms/
conditions? If so, it may be detailed in the EIA. - -
9
iii. What is the hierarchical system or
Administrative order of the company to deal with
the environmental issues and for ensuring - -
compliance with the environmental clearance
conditions? Details of this system may be given
iv. Does the company have system of
reporting of non compliance /violations of - -
environmental norms to the Board of Directors of
the company and / or shareholders or
stakeholders at large? This reporting
mechanism shall be detailed in the EIA report.
10 Details regarding infrastructure facilities such as The proposed unit will provide

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sanitation, fuel, restroom etc. to be provided to all the facilities for construction
the labour force during construction as well as to labour during construction
the casual workers including truck drivers during phase and as well as the casual
operation phase. workers including truck drivers
during operation phase
Enterprise Social Commitment(ESC)
Chapter - VIII
1. Adequate funds (at least 2.5% of the project
The fund allocated
cost) shall be earmarked towards the Enterprise
for Enterprise Social
social commitment based on public hearing 431 - 432
11 Commitment will be
issues and item –wise details along with time
utilized as
bound action plan shall be included socio-
suggested during
economic development activities need to be
Public Hearing
elaborated upon.
Any litigation pending against the project and /
or any direction/ order passed by any Court or
law against the project, if so, details thereof shall
also be included. Has the unit received any
No Litigations against proposed
12 notice under the section 5 of environment
project
(protection) Act 1986 or relevant sections of air
and water acts? If so, details thereof and
compliance /ATR to the notice (s) and present
status of the case.
A tabular chart with index for point wise Enclosed along with EIA & EMP
13
compliance of above TOR. Report
A Specific ToR
Details on solvents to be used, measures for
1 Chapter - X 460-463
solvent recovery and for emissions control.
Details of process emissions from the proposed
2 Chapter - X 459-460
unit and its arrangement to control
Ambient air quality data should include VOC,
3 Chapter - III 93-100
etc.,
Work zone monitoring arrangements for
4 Chapter - VII 380-383
hazardous chemicals
Detailed effluent treatment scheme including
5 segregation of effluent streams for units NA NA
adopting zero liquid discharge
6 Action plan for odour control to be submitted; - -
A copy of the Memorandum of Understanding
Yet to make MOU with Cement
signed with cement manufactures indicating
7 Industries as it is a Greenfield
clearly that they co-process organic
Project
solid/hazardous waste generated.
Authorization / Membership for the disposal of Yet to take Membership of
8 liquid effluent I CETP and solid/ hazardous TSDS as it is a Proposed
waste in TSDF, If any. Project
9 Action plan for utilization of MEE/dryers salts. Chapter -X 465

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MSDS for all the chemicals will
Material safety data sheet for all the chemicals
10 be used and kept in plant for
are being used/ will be used.
reference.
Authorization/ Membership for the disposal of Yet to take Membership of
11 solid/hazardous waste in TSDF are being used TSDF as it is a Proposed
/will be used Project
No proposal for installation of
12 Details of incinerator if to be installed
Incinerator
Risk assessment for storage and hazardous
13 chemicals/solvents, Action plan for handling & Chapter - VII 380-383
safety system to be incorporated.
Arrangements for ensuring health and safety of
14 Chapter - VII 404-406
workers engaged in handling of toxic materials.

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LIST OF CONTENTS
[INDEX]
Index of EIA Report Archimedis Laboratories Pvt. Ltd

LIST OF CONTENTS

CHAPTER - I INTRODUCTION
S. No Description Page No
1.1 Purpose of the Project 1
1.2 Identification of project & Project proponent 1
1.1.1 Identification of Project 1
1.1.2 About the Promoters 1
1.3 Objective and Scope of the Study 2
1.4 Brief Description of the Project 2
1.4.1 Nature of the Project 2
1.4.2 Size of the Project 2
1.4.3 Location of the Project 4
Project and its Importance to the Country &
1.4.4 5
Region.
1.5 Scope of Study. 6
1.5.1 Environmental Impact Assessment 6
1.5.2 Socio-Economic Assessment 6
1.5.3 Regulatory Framework 6
1.5.4 Regulatory Scoping 6
1.6 Legal Policy and Institutional Frameworks 7-8

CHA PTER - II PROJECT DESCRIPTION


S. No Description Page No
2.1 Type of the project 9
2.2 Need For The Project 9
2.3 Location 9
2.4 Size and Magnitude of Operation 16
2.5 Proposed schedule for approval and implementation 17
2.6 Technology and process description 18
2.6.1 Manufacturing process of the Products 19-204
2.7 Pollution Load 204
Details of Process Emissions and its mitigation
2.8 207
measures
2.9 Proposed Water Consumption Details 208
2.10 Expected Waste Water Generation Details 210
2.11 Waste Water Characteristics 214
2.12 Hazardous & Solid Waste Generation Details 214
2.13 Power(Energy) requirement 216
2.14 Utilities 216
2.15 Proposed Boilers & DG sets 216
2.16 Details Of Proposed Solvents Input, Recovery & Loss 218
2.17 List Of The Raw Materials Product Wise 226-239
Environmental aspects, impacts and mitigation
2.18 239-242
measures of proposed industry
Assessment of new & untested technology for risk of
2.19 242
technological failure

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CHAPTER - III DESCRIPTION OF THE ENVIRONMENT


S. No Description Page No
3.0 Introduction 243
3.1 Study Area 243
3.1.2 Study Period 243
3.2 Geological & Hydro geological Environment 243-244
3.2.1 Geomorphology and soil types 244
3.2.2 Geology 245
3.2.3 Hydrogeology 245
3.2.4 Ground water Conditions 245
3.2.5 Drainage Pattern of Study Area 245-246
3.2.6 Drainage Map 247
3.3 Micrometeorology And Climate 249-250
3.4 Air Environment 253
3.4.1 National Ambient Air Quality Standards (NAAQS) 256-257
3.4.2 Ambient Air Quality Data (AAQ) 257-258
3.5 Water Environment 268
3.5.1 Methodology For Water Quality Monitoring 268
3.6 Noise Environment 276
3.6.1 Noise Monitoring Stations 276-277
3.6.2 Traffic Study 280
3.7 Soil Environment 283
3.8 Land Use Pattern 287
3.8.1 Data Used 287
3.8.2 Land use / Land Cover Map 288
3.8.2.1 Basic concepts of land use 289
3.8.2.2 Methodology for land use / land cover mapping 289-291
3.9 Ecological Environment 296
3.9.1 Detailed Description of Flora and Fauna 296
3.9.2 Vegetation and Flora of the Buffer zone 298
Terrestrial fauna of the Core area and the Buffer
3.9.3 301
zone
3.9.3.1 Methodology for Mammals study 302
3.9.3.2 Methodology for Herpeto-fauna 302
3.9.3.3 Methodology for Birds in Study Area 302
3.9.4 Aquatic flora and fauna 305
3.9.5 RET and Schedule I Fauna 307
3.10 Socio Economic Study 307
3.10.1 Methodology Adopted for the Study 307
3.10.2 Distribution of Population in the study area 308
3.10.3 Literacy & Illiteracy Rate 309
3.10.4 Occupational Structure 310
3.10.5 Civic Amenities Available In The Study Area 312
Corporate Social Responsibility of the Project
3.10.6 313
Proponent

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CHAPTER - IV ANTICIPATED ENVIRONMENTAL IMPACTS


& MITIGATION MEASURES
S. No Description Page No
4.1 Introduction 314
Investigated Environmental Impacts Due To Proposed
4.2 314
Project
4.3 Construction Phase 315
4.3.1 Impact on Land Use 315
4.3.2 Impact on Land / Soil Environment 315
4.3.3 Impact on Topography 315
4.3.4 Impact on Air Quality 316
4.3.5 Impact on Water Environment 316
4.3.6 Impact on Noise Levels 317
4.3.7 Impact on Ecology 317
4.3.8 Impact on Socio-Economic Environment 317
Mitigative measures of impacts during construction
4.4 319-321
phase
4.5 Prediction of Impacts During Operational Phase 321
4.6 Air Environment 322
4.6.1 Source of Air Pollution 322
4.6.2 Prediction of Impacts on Air Environment 324-332
4.7 Water Environment 332
4.8 Noise Environment 334
4.9 Impact on Land Use 334
4.9 Land/Soil Environment 334
4.10 Impact of Solid Waste 336
4.11 Impacts on Ecology 337
4.12 Impacts on Socio- Economy 339
4.13 Impacts on Hydrology and Geology 339

CHAPTER - V ANALYSIS OF ALTERNATIVES


(TECHNOLOGY & SITE)
Page
S. No Description
No
5.0 Analysis Of Alternatives 340
5.1 Site Selection Criteria 340
5.2 Selection Of Process Technology 341

CHAPTER - VI ENVIRONMENTAL MONITORING PROGRAM


S. No Description Page No
6.1 Introduction 343
6.2 Environmental Management System 343-344
6.3 Environmental Management Cell Responsibilities 344-345
6.4 Environmental Monitoring and Reporting Procedure 346
6.4.1 Objectives of Monitoring 346
Monitoring Schedule for Construction and Operation
6.4.2 346-347
Phases.

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6.5 Location of Monitoring Stations 350


6.6 Monitoring and Data Analysis 351
6.6.1 Air Quality Monitoring and Data Analysis 351
Water and Waste Water Quality Monitoring and
6.6.2 351-352
Data Analysis.
6.6.3 Noise Levels 352
6.6.4 Soil Quality 352
6.7 Reporting Schedule of the Monitoring Data 353
6.8 Environmental Laboratory 353
6.8.1 Air Quality and Meteorology 353
6.9 Occupational Safety and Health aspects 354

CHAPTER -VII ADDITIONAL STUDIES, RISK ASSESSMENT


& DISASTER MANAGEMENT REPORT

S. No Description Page No
7.1. Additional Studies 355
7.1.1 Scope of this Study 355
7.1.2 Methodology 355
7.2 Introduction to Risk Assessment 356
7.2.1 Objectives of Risk Assessment 356
7.2.2 Identification of Hazards 357-358
7.3 Solvents/Chemicals 371
7.4 Potential Hazards of solvents and chemicals 372-380
Safe practices [handling, storage, transportation
7.5 380
and unloading of chemicals]
7.5.1 Measures to avoid Evaporation 380-381
7.5.2 Safety Systems 381
7.5.3 Transportation /unloading 381-382
7.5.4 Spill Control 382
7.5.5 Effect and Consequence Analysis 383
7.6 Inventory 383
7.7 Loss of Containment 383-385
7.8 Damage Criteria 385
7.9 Damages to human life due to heat radiation 388
7.10 Incidents Impact 390
7.11 Maximum credible loss accident scenarios 390-391
7.12 Risk Analysis 391
7.13 Risk Modeling Scenarios 391
7.14 Occupational Health 404-406
7.14.1 Sampling Devices 406-407
Chemical exposure limits & emp for the
7.15 407-409
occupational safety & health hazards
Treatment of workers affected by accidental
7.16 410-412
spillage of chemicals
7.17 Predictive and preventive maintenance 412-413
7.18 Onsite emergency plan 413

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7.19 Structure of emergency management system 413-414


Emergency Management system-Roles &
7.20 414
Responsibilities
7.20.1 Site Main Controller (SMC) 414-415
7.21 Incident Controller/Deputy Incident Controller 415
7.22 Key Personnel’s 415-416
7.23 Essential workers 416-417
7.24 Other Elements of DMP 417
7.24.1 Assembly Point 417
7.24.2 Emergency Control Center 417-418
7.24.3 Fire Services 418-419
7.24.4 Medical Services 419
7.24.5 Security Services 419
7.24.6 Mutual Aid 420
7.25 Emergency Response 420-421
7.26 Emergency Capabilities 421
7.27 Emergency Handling Procedures 421-422
Mitigation of Environmental Impact during Fire
7.28 423
Emergency
7.28.1 Raising the Alarm 423-424
7.29 Declaring Major Emergency 424
7.30 Transport and evacuation arrangements 424
7.31 Plant Operations 424-425
7.32 Telephone Messages 425
7.33 Mock Drill 425-426
7.34 Offsite emergency plan 426
7.35 Role of the factory management 428
7.35.1 Role of Local Authority 428
7.35.2 Role of Fire Authority 428
7.35.3 Role of Police 428
7.35.4 Role of Health Authorities 428
7.35.5 Role of the Mutual aid agencies 428
7.35.6 Role of the Factory Inspectorate 429

CHAPTER - VIII PROJECT BENEFITS


S. No Description Page No
8.1 Employment Potential 430
8.2 Corporate Social Responsibility (CSR) & CER 430
8.3 Direct revenue earning to the National and State 433
exchequer
8.4 Improvements in the Physical Infrastructure 433
8.5 Improvements in the Social Infrastructure 433
8.6 Other Tangible Benefits 433

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CHAPTER - IX ENVIRONMENTAL COST BENEFIT ANALYSIS


S. No Description Page No
9.1 Cost benefit analysis 434

CHAPTER - X ENVIRONMENTAL MANAGEMENT PLAN


S. No Description Page No
10.1 Introduction 435
10.2 Pre-Project Environmental Management Plan 437
10.2.1 Site Preparation 437
10.2.2 Sanitation 437
10.2.3 Noise 437
10.2.4 Construction Equipment And Waste 437
10.2.5 Site Security 437
10.3 Environmental Management During Operation 438
10.3.1 Air Quality 438
10.3.1.1 Air Pollution Control / Management 438
A Stack Design 438
B Fugitive Emission from Solvents 438
C Expected Process Emission and Mitigation Measures 439
D Storage and Transportation of Raw Materials 439
E Storage and Transportation of Solvents 439
10.3.2 Noise Pollution 439
10.3.3 Water Quality 440
10.3.3.1 Details of ZLD system 445
10.3.3.2 The technical details of the systems are as follows 446
10.3.3.3 MEE plant configuration 446
10.3.3.4 Process description (Part - A) 446
10.3.3.5 Process description (Part - B) 447
10.3.3.6 Process description (Part - C) 448
10.4 Hazardous/ Solid Waste Management 450
10.5 EB [Ecology & Biodiversity 451
10.6 SE [Socio-Economic Aspects 451
10.7 HG [Hydrogeology, Ground Water & Water Conservation] 452
10.8 GEO [Geology] 453
10.9 SC [Soil Conservation] 453
10.10 RH [Risk & Hazards Management] 453
10.11 Greenbelt Development 454
10.11.1 Objective 454
10.11.2 Action Plan 455
10.12 Post Project Monitoring 456
10.12.1 Air Pollution Monitoring 457
10.12.2 Waste Water Monitoring 457
10.12.3 Ground Water Monitoring 457
10.12.4 Hazardous / Solid Waste Monitoring 457
10.13 Management of Public Interests 458
10.13.1 Objective 458

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10.13.2 Preference To Local Population 458


10.13.3 Health Camps 459
10.13.4 Public Amenities 459
10.13.5 Public Relations 459
10.14 Water Requirement 459
10.15 Process Emission Control System 459
10.16 Fugitive Emissions 460
10.17 Solvent Management Plan 460
10.18 Emissions – Utilities 463
10.19 Wastewater Loads 464
10.20 Stage wise Effluent Characteristics 465
10.21 Hazardous & Solid Waste details 465
10.22 Proposed Roof Water Harvesting 466
10.23 Investment 468
10.23.1 Budget allocation 468
10.24 Mitigation Plan 469
10.25 Socio-Economic development activities 470
Waste Minimization / Resource Conservation
10.26 470
5 r concept (Recycle / Refuse / Reduce / Reuse / Reform)
10.27 Conclusion 472

CHAPTER - XI SUMMARY & CONCLUSION


(THIS WILL CONSTITUETE THE
SUMMARY OF THE EIA REPORT)

S. No Description Page No
11.1 Salient features of the project 473
11.2 Conclusions 474

LIST OF TABLES
CHAPTER - I INTRODUCTION
Table No Description Page No
1.1 Proposed Products and Quantities 3
1.2 Proposed By-Products and Quantities 4
1.3 Project location and Compliance of site 4-5
1.4 Applicability of legal policies to the project 7-8

CHAPTER - II PROJECT DESCRIPTION


Table No Description Page No
2.1 Land use details 9
2.2 List of proposed products and Capacities 16-17
2.3 List of proposed By-Products and Capacities 17
Consolidated Pollution Load Of All Products In Per
2.4 205-206
Day Quantities
2.5 Process Emission details and Its Mitigation 207

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measures
2.6 Process Emission Details Product wise 207-208
2.7 Proposed water consumption details 209
Proposed water consumption in process product
2.8 209-210
wise
2.9 Expected Effluent Generation details 210
2.10 Expected HTDS & LTDS effluent details 210-211
Expected Waste water generation in Kg per day
2.11 212-213
Product wise
Expected Hazardous/Solid Waste Generation,
2.12 214-215
Disposal Details
2.13 Solid waste generation per day Product wise 215-216
2.14 Details Of Utilities 216
2.15 Emission characteristic details of proposed Boiler 217
2.16 Stack Emission Details for Thermic Fluid Heater 217
2.17 Stack Emission details of proposed DG Set 217
Details Of Proposed Solvent Input, Recovery &
2.18 218-225
Loss [Product Wise]

CHAPTER - III DESCRIPTION OF THE ENVIRONMENT


Table No Description Page No
Showing drainage density based criteria by smith and
3.1 247
strahler
Showing drainage density based criteria proposed by Long
3.2 247
Bein
Showing Drainage Density Based Criteria Proposed by
3.3 247
Horton
3.4 Frequency distribution wind directions and wind speed 251
3.5 Ambient air quality sampling locations 254
3.6 National ambient air quality standards 256-257
The maximum ,minimum & 98th percentile values for all the
3.7 259
sampling locations
3.8 Ambient air quality, station : Project Site A1 260
3.9 Ambient air quality station : Jayanthipuram (A2) 261
3.10 Ambient air quality station : Dhramavarappadu tanda (A3) 262
3.11 Ambient air quality station : Bhimavaram (A4) 263
3.12 Ambient air quality station : Gauravaram (A5) 264
3.13 Ambient air quality station : Pochampalli (A6) 265
3.14 Ambient air quality station : Vedadri tanda (A7) 266
3.15 Ambient air quality station : Ravirala A8) 267
3.16 Ground water and Surface sampling locations 269
3.17 Ground water quality in the study area 270
3.18 Surface water quality the study area 272-274
3.19 Noise monitoring locations 277
3.20 Ambient noise levels within study area 279
3.21 Traffic Study 281-282
3.22 Soil sampling locations 283
3.23 Soil sampling analysis results 285

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3.24 Standard Soil Classification 286-287


3.25 Showing the Details of Sources & the Maps Prepared 287
3.26 Showing the Topographic Maps 287
3.27 Satellite Data of National Remote Sensing Center 288
3.28 Land Use / Land Cover Statistics of the Study Area 293
3.29 Sampling locations for flora and fauna study in study area 297
3.30 List of plants found in the project area 297-298
List of Trees, shrubs and perennial climbers Found the
3.31 299-301
Buffer Zone
3.32 List of mammals observed in study area 303
3.33 List of reptiles and amphibians observed in study area 303
3.34 List of butterflies observed in study area 303-304
List of birds either spotted or reported from the areas in and
3.35 304-305
around the project site
3.36 Aquatic ecological locations in study area 306
3.37 Check list of fishes found in Krishna River 306
3.38 List of aquatic flora species recorded in study area 306-307
3.39 Population Distribution 308
Distribution of Literacy Rate and Illiteracy Rate in the Study
3.40 311
Area
3.41 Occupational Structure in Study Area 311

CHAPTER - IV ANTICIPATED ENVIRONMENTAL IMPACTS


& MITIGATION MEASURES
Table No Description Page No
Summary – Identification Of Impacts During Construction
4.1 318
Phase
4.2 Mitigation Measures During Construction Phase 319-321
4.3 Emission Details from Proposed Boiler Stack 322
4.4 Emission Details from DG Set Stack 323
Predicted 24-Hourly Short Term Incremental
4.5 326
Concentrations
4.6 Resultant Concentrations Due to Incremental GLC's 326
4.7 Process Emission details and mitigation measures 330
4.8 Hazardous & Solid Waste Disposal Details 337

CHAPTER - V ANALYSIS OF ALTERNATIVES (TECHNOLOGY & SITE)


Table No Description Page No
5.1 Site Description 340-341

CHAPTER - VI ENVIRONMENTAL MONITORING PROGRAM

Table No Description Page No


Post Project Environmental Monitoring schedule
6.1 347
details
Environmental Monitoring Plan during Operation
6.2 348-350
Phase
6.3 Details of Post Project Monitoring Locations 350
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CHAPTER -VII ADDITIONAL STUDIES, RISK ASSESSMENT


& DISASTER MANAGEMENT REPORT
Table No Description Page No
Area Wise Identified Hazards, Precautions proposed With
7.1 359-370
Mitigation Measures.
7.2 Solvent/ Chemicals 371
7.3 Severity Categories and Criteria 386
Heat flux Intensity and exposure time-Damage criteria for
7.4 389
people
7.5 Damage due to overpressures 390
7.6 Chemical exposure limits 407

CHAPTER - X ENVIRONMENTAL MANAGEMENT PLAN


Table No Description Page No
10.1 List of Plants identified for Greenbelt 455
10.2 The details of the Monitoring Program 457-458
10.3 Proposed Water consumption details 459
10.4 Characteristics Details of proposed Boiler 463
10.5 Stack Emission Details for Thermic Fluid Heater 464
10.6 Stack Emission Details of proposed DG set 464
10.7 Effluent generation details 464
10.8 HTDs & LTDs effluent details 465
10.9 Hazardous / Solid waste generation, disposal Details 465-466
10.10 Available rain water (annual)for Harvesting 467
10.11 Proposed Budget for Environmental Management plan 468-469

LIST OF FIGURES
CHAPTER - II PROJECT DISCRIPTION
Figure No Description Page No
2.1 Location map 10
2.2 Google Earth Map Surrounding Of Project Area 11
2.3 Google Earth Map Showing Project Site 12
2.4 Latest photographs of Proposed site 13
2.5 Topomap showing 10km radius 14
2.6 Site plan details 15

CHAPTER - III DESCRIPTION OF THE ENVIRONMENT


Figure No Description Page No
Showing Drainage Map Of The Project Study
3.1 248
Area
Windrose Diagram Period: March 2018 – May
3.2 252
2018
3.3 Ambient Air Quality Sampling Locations Map 255
3.4 Ground & Surface Water Sampling Locations Map 270
3.5 Noise Sampling Locations Map 278

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Index of EIA Report Archimedis Laboratories Pvt. Ltd

3.6 Soil Sampling Locations Map 284


Pie Diagram Showing Land Use The In Study
3.7 293
Area
3.8 Satellite Image Of The Study Area 294
3.9 Land Use / Land Cover Map Of The Study Area 295
Diagram Showing Total Population Distribution in
3.10 309
the Study Area
The Diagram Showing Literates and Illiterates in
3.11 310
Study Area
The Diagram Showing Occupational Structure in
3.12 311
Study Area

CHAPTER - IV ANTICIPATED ENVIRONMENTAL IMPACTS


& MITIGATION MEASURES
Figure No Description Page No
4.1 Short term 24 hourly incremental GLCs of SPM 327
4.2 Short term 24 hourly incremental GLCs of SO2 328
4.3 Short term 24 hourly incremental GLCs of NOx 329

CHAPTER - VI ENVIRONMENTAL MONITORING PROGRAM


Figure No Description Page No
Organisational Structure of Environment Health
6.1 345
& Safety

CHAPTER - X ENVIRONMENTAL MANAGEMENT PLAN


Figure No Description Page No
10.1 Flow chart of EMP 436
Schematic diagram of Proposed waste water
10.2 442
treatment – ZLD System
10.3 Flow chart for effluent treatment HTDS 443
10.4 Flow chart for effluent treatment LTDS 444
10.5 Flow chart for effluent treatment 445
10.6 Schematic diagram of MEE system 449
Schematic diagram Emissions Control
10.7 460
Scrubbing System
10.8 Roof water harvesting Structure 467
10.9 5 R concept 471

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EXECUTIVE SUMMARY OF
EIA REPORT
EXECUTIVE SUMMARY OF

EIA REPORT
OF

ARCHIMEDIS LABORATORIES PVT. LTD

For

Proposed Bulk Drugs & Intermediates


Manufacturing Unit

AT

Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet (M),


Krishna District, Andhra Pradesh.

PREPARED BY

Rightsource Industrial Solutions Pvt. Ltd


Plot No: 203, H.No:5-36/203, Prashanthi Nagar,
IDA, Kukatpally, Hyderabad – 500072.
Ph: 040-65873137, 23070602, 23075699, 40126589.
Fax: 040-23070602. Mail: info@rightsource.co.in
NABET Accreditation No. NABET/EIA/1518/SA 038
Executive Summary of EIA Report Archimedis Laboratories Pvt. Ltd.

1. INTRODUCTION
Archimedis Laboratories Pvt. Ltd proposed to establish a Bulk Drugs &
Intermediates manufacturing unit at Sy No: 108 & 109, Jayanthipuram (V)
Jaggayyapet (M), Krishna District, Andhra Pradesh.
The proposed project cost is about Rs. 30.0 Crores, which includes construction of
the buildings, equipment, machinery and greenbelt development.
The project proposal was appraised by the Expert Appraisal Committee (EAC) and
has issued Standard Terms of Reference vide F. No: J-11011/9144/2018-IA II (I)
Dated on 5th Feb 2018, to carryout EIA Study. The Environmental monitoring and
analysis was carried out during the period of March – 2018 to May– 2018 The
Environmental Public Hearing was conducted on 27/10/2018 in Jayanthipuram
village, Jaggayyapet Mandal, Krishna District, Andhra Pradesh. The Public Hearing
paper ads, PH Minutes and its compliance Report are enclosed as enclosures.

1.1. PROJECT DESCRIPTION


The salient features of the unit are furnished below.

TABLE-1: SALIENT FEATURES OF THE PROJECT


Project location Details
Latitude: 16°50'51.19" North
Latitude & Longitude
Longitude: 80°08'11.93" East
Annual Max Temp is 47.1 0C
Climatic Conditions Annual Min Temp is 9.3 0C
Normal Annual Rainfall is 982 mm
(Source: IMD Climatological Normals, 1981 - 2010)
Land acquired for the plant 11.62 Acres (47024.47 Sq.m)
Land use Industrial use
Nearest Habitation Jayanthipuram Village 1.80 km (WNW)
Major urban Settlements Vijayawada - 58 km (SE)
Nearest Highway National Highway No.65 – 4.45 km (N)
Nearest Railway station Motumuri Railway Station – 22.7 km (NE)
Nearest Airport Vijayawada Airport - 77 km (SE)
VBC Fertilizers & Chemicals Ltd
Amoda Iron & Steel Ltd
The Ramco Cements
Mine of VSP
Major Industries near the plant site
Jaggayapeta Industrial Estate
CKS Laboratories Pvt Ltd
Mylan Laboratories Limited
RA Chem Pharma Pvt Ltd
National Parks None within 10 km radius
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Wild life sanctuary None


Palleru River – 3.30 km (W)
Krishna River – 3.30 km (SSW)
Nagarjuna Sagar Left bank Canal- 2.50 km (E)
Chillakallu Major canal - 2.10 km (WNW)
Gauravaram Cheruvu – 5.40 km (E)
Water Bodies within 10 km radius Pochampalli Cheruvu – 3.38 km (ESE)
Konakachi Cheruvu – 5.51 km (ESE)
Nawabpeta Cheruvu – 9.53 km (ESE)
Water body near Jaggayyapet – 5.54 km (NW)
Tank Near Chillakallu – 4.57 km (N)
Tank near Shermohammedpet – 8.55 km (NNW)
Jaggayyapeta Extension R.F – 0.52 km (S),
0.39 km (N) of Project Site
Kuntimadi R.F- 5.12 km (SSW)
Reserve Forest within 10 km radius
Ginjupalle R.F- 5.60 km (SSW)
Venkatayapalem R.F- 7.80 km (SSW)
Budavada R.F- 4.68 km (W)

2.0 PROCESS DESCRIPTION


The manufacturing process of Bulk Drugs & Intermediates consists of chemical
synthesis extending to stages of processing involving different type of chemical
reactions. Total production capacity of proposal will be 115 TPM. (Given in Table -2).
The unit will take adequate control measures for storage and handling of Raw
materials and cylinders with in factory premises.

TABLE- 2: PROPOSED PRODUCTS AND QUANTITIES


Quantity Therapeutic
S No Product name CAS NO
in TPM category
1 Itraconazole 4 84625-61-6 Anti fungal
2 Lansprazole 1 103577-45-3 Anti ulcerative
3 Pentaprazole Sodium 9 138786-67-1 Antiulcerative
4 Duloxetine Hydrochloride 2 136434-34-9 Antidepressant
5 Sumatriptan Succinate 1 103628-48-4 Anti migraine
6 Almotriptan Malate 1 181183-52-8 Anti migraine
7 Zolmitriptan 1 139264-17-8 Anti migraine
8 Ketorolac tromethamine 5 74103-07-4 Analgesic
9 Rosuvastatin 4 147098-20-2 Antilipemic
10 Mesalamine (or) Mesalazine 4 89-57-6 Anti-inflammatory
11 Imatinib Mesylate 2 220127-57-1 Anti neoplastic
12 Celecoxib 4 169590-42-5 Arthritis
13 Sitagliptin Phosphate Monohydrate 2 654671-77-9 Hypoglycemic
14 Dabigatran 2 211915-06-9 Anticoagulant

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Quantity Therapeutic
S No Product name CAS NO
in TPM category
15 Velpatasvir 2 1377049-84-7 Antiviral
16 Emtricitabine 4 143491-57-0 Antiretroviral
17 Olmesartan medoxomil 4 144689-63-4 Anti hypertensive
18 Pregabalin 4 148553-50-8 Anticonvulsant
2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-
Drug
19 piperazinyl ) -2-(1-methyl propyl )-3H-1,2,4- 10 -
intermediate
Triazole-3-one(Itraconazole intermediate)
Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-1,2,4-
Drug
20 Triazole -1-yl Methyl ]-1,3 Dioxalane -4 yl 4 -
intermediate
Methanol(Itraconazole intermediate)
Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-
Triazole -1-yl methyl]-1,3 Dioxalane-4yl Drug
21 5 -
Methyl ] Methane Sulfonate (Itraconazole intermediate
intermediate)
2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-
pyridinyl ] 5methylthio -1H- Drug
22 5 -
benzimidazole(Lansoprazole Sulfide intermediate
Intermediate )
Pentaprazole chloro compound (2- Drug
23 10 72830-09-02
Chloromethyl-3,4-Dimethoxy-Pyridine) intermediate
(S)-(-)-3-(Dimethyl amino )-1-(2-Thienyl)-1- Drug
24 10 13233-44-5
praponal intermediate
4-Chloro-1 hydroxy butane sulphonic acid Drug
25 5 54322-20-2
sodium salt intermediate
Drug
26 4-Chloro Butyralde Diethyl acetal 5 6139-83-9
intermediate
Drug
27 4-Dimethyl amino butytalde diethyl acetal 5 1116-77-4
intermediate
Total 115

2.1 RESOURCE REQUIREMENT & INFRASTRUCTURE FACILITIES


A) Land Use Details:
The proposed unit is in an area of 11.62 Acres (47024.47 SQM), the usage details
are given table 3.
TABLE- 3: PROPOSED LAND USE DETAILS
S. No. DESCRIPTION AREA IN SQM AREA IN ACRES AREA IN %
1 Total Built up Area 11536.00 2.85 24.5
2 Green Belt Area 17287.11 4.27 36.8
3 Roads & Open Area 18201.36 4.50 38.7
TOTAL 47024.47 11.62 100
 36.8 % of Land is allotted For Green Belt Development

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B) Proposed Water Consumption Details


TABLE- 4: PROPOSED WATER CONSUMPTION DETAILS
Water
S.No Purpose
input KLD
1 Process 59
2 Washings 10
3 Boiler make up 71
4 Cooling towers make up 104
5 Scrubbing system 5
6 Domestic 4
7 Gardening 6
Total 259

The fresh water of 175 KLD will be met from Ground Water source.
Recovered water 84 KLD from ZLD system is reused.
The permission to draw ground water for industrial and drinking water purpose was
obtained for 269 KLD from AP Ground Water & Water Audit Department and the
same has been enclosed.

C) Energy Requirement
Power requirement of proposed project will be made available through Andhra
Pradesh Southern Power Distribution Corporation Limited [APSPDCL]. The power
requirement of project will be 2000 KVA.

D) Utilities:
For generation of Steam, the industry proposed to install 8 TPH & 4 TPH coal fired
boilers. The coal requirement will be met from government allocation or from local
authorized sources.
The unit is proposing a 500 KVA & 1000 KVA DG set, for usage during the power
failures.
The emission details are presented in table No.6, 7 & 8.

TABLE- 5: DETAILS OF UTILITIES

S. No Description Capacity

1 Coal fired boiler 8 TPH & 4 TPH


Thermic Fluid
2 200000 kcal/hr
Heater

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500 KVA & 1000


3 D.G. Set
KVA
2x200 TR, 250 TR
4 Cooling Towers
& 300 TR
Electricity supply
5 2000 KVA
from APSPDCL.
Fuel
6 Coal 48 TPD
7 Diesel 300 Liters/Day

TABLE- 6: EMISSION CHARACTERISTIC DETAILS OF PROPOSED BOILER

Particulars 8.0 TPH Coal fired 4.0 TPH Coal fired


Units
Boiler Boiler
Indian Coal with CV Indian Coal with CV
Type of Fuel -- of 4000 kcal/kg to of 4000 kcal/kg to
5000 kcal/kg 5000 kcal/kg
Coal Consumption TPD 32 16
Ash Content % 35 35
Sulphur Content % 0.4 0.4
No. of Stacks No 1 1
Height of stack M 34 30
Diameter of Stack M 0.50 0.40
o
Temperature of Flue Gas C 200 180
Velocity of Flue Gas m/s 16 14
Particulate Matter gm/sec 0.26 0.13
Sulphur dioxide emission gm/sec 2.95 1.48
Oxides of Nitrogen emission gm/sec 9.70 4.86
Note: 5 TPH Coal fired Boiler is kept as standby.

TABLE- 7: Stack Emission Details for Thermic Fluid Heater


2,00,000 kcal/hr.
Particulars Units
Thermic fluid heater
Thermo pack Boiler Capacity Kcal/hr. 2,00,000
Type of Fuel -- Diesel
Stack Temperature Before o
C 200
Air preheater
o
Stack Temperature After Air preheater C 130
Stack Height m 15
Fuel Consumption per Day TPD 0.57
Diameter m 0.3

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TABLE- 8: STACK EMISSION DETAILS OF PROPOSED DG SET


Emission Emission Emission Stack Flue Gas Stack Flue gas
Capacity
of SPM in Of SO2 in of NOx dia. Temp. in Height Velocity
In KVA
mg/Nm3 mg/Nm3 in mg/Nm3 in m O
C in m in m/sec.
500 KVA
80 150 180 0.30 220 10 16
(Proposed)
1000 KVA
120 170 200 0.35 280 10 18
(Proposed)

E) Pollution Control Equipment:


i) Cyclone separator: The denser particles which are carried away by boiler flue
gases will get separated in the cyclone separator and collected in the bottom of the
cyclone separator at a definite interval.
ii) Bag Filter: The boiler flue gases from cyclone separator enter into pack of bag
filters, where particulate matter will be separated leaving as cake on bags surface.
They are cleared by shaking or vibrating by pulse jet causing the filter cake to be
loosened and to fall in the Hopper.
iii) Boiler Stack: The adequate stacks of height 34 mtrs & 30 mtrs will be provided
for pollutants (SO2, NOx, PM & CO) dispersed in a very large area so that ground
level concentration is within CPCB permissible limits.
iv) Scrubbers: Two scrubbers of 2-Stage are proposed to scrub the HCl & SO2. The
packing media in the scrubber is 25mm poly propylene rings.

3. BASELINE ENVIRONMENTAL STATUS


3.1 Study Area Included In Environmental Setting
Studies were carried out in about 10 km radius area from the site with respect to
meteorology, flora, fauna, land and socio-economies of the area. Further sampling
and analysis of air quality, water quality, noise level and soil quality were carried out.
The air quality, water quality, noise level and soil quality in the study area is
evaluated based on this physical sampling and analysis.
The base line data were monitored during the study period of March 2018 – May
2018. The study team conducted site surveys and field experiments for gathering the
information on air quality, water quality, noise quality and soil quality.

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3.2 CLIMATE OF THE STUDY AREA


A. Temperature:
During the study period the minimum and maximum temperatures were recorded as
22.1°C and 45.2°C respectively.

B. Relative Humidity:
During study period at project site during study period, the relative humidity was
recorded as 79.1%

C. Wind Pattern during Study Period


Dispersion of different air pollutants released into the atmosphere has significant
impacts on neighborhood air environment. The dispersion/dilution of the released
pollutant over a large area will result in considerable reduction of the concentration of
a pollutant. The dispersion in turn depends on the weather conditions like the wind
speed, wind direction, temperature, relative humidity, mixing height, cloud cover and
also the rainfall in the area.
Wind speed and direction data recorded during the study period is useful in
identifying the influence of meteorology on the air quality of the area. Wind roses on
sixteen sector basis have been drawn. Wind directions and wind speed frequency
observed during study period is given in Table 3.5 and wind rose diagrams are given
in Figure 3.7
The following observations can be made from the collected data;
 Calm period is observed to be 16.9 % during the time of monitoring.
 The predominant wind direction is S & SSW.
 Other than predominant wind directions wind was blowing in ESE direction.
 Average wind speed 3.7 m/s.
 Mostly the wind speeds are observed to be in the range of 5.7 – 8.8 m/sec,
0.5 – 2.1 m/Sec, 3.6 - 5.7 m/Sec, with frequency of distribution percentages
ranges from 27.5, 21.1, & 16.2.

D. Rainfall
No rainfall during the Study Period at the Project Site. Average annual rainfall is 982
mm. (Source: IMD Climatatological Normals, Nandigama 1981 - 2010)

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3.3 SAMPLING LOCATION DETAILS


Total eight locations were selected for Base line status. Air, Water & Noise results
are presented in Table 10, 11 & 12 respectively.

3.4 AMBIENT AIR QUALITY


The ambient air monitoring was carried out for 24 hours a day, twice a week for 12
week per location in the study area. Ambient Air Quality Monitoring (AAQM) was
carried out at eight locations during period of March 2018 – May 2018.

1. Particulate Matter (PM10)


The maximum and minimum concentrations for PM10 were recorded in the study
area showed 98th percentile values in the range of 55.46 – 68.88 μg/ m3. The
maximum concentration 68.88 μg/ m3 were recorded at sampling locations at
Dhramavarappadu Tanda. The concentrations of PM10 are well below the CPCB
standard of 100 μg/ m3.

2. Particulate Matter (PM2.5)


The CPCB Standard for concentration of PM2.5 is 60 μg/ m3. The maximum and
minimum 98th percentile concentrations for Particulate Matter (PM2.5) monitored
in the study area were 18.02 – 28.92 μg/m3 respectively. Highest value of 28.92
μg/ m3 was at Dhramavarappadu Tanda. The concentration of PM2.5 is well
below the prescribed limit of 60 μg/ m3

3. Sulphur Dioxide (SO2)


98th percentile value of Sulphur dioxide in the study area from the monitored data
was in the range of 11.44 – 15.15 μg/ m3. Maximum value of Sulpur dioxide of
15.15 μg/ m3 obtained at Dhramavarappadu Tanda. The concentration of SO2 is
well below the prescribed limit of 80 μg/ m3

4. Oxides of Nitrogen (NOx)


Ambient air quality status monitored for oxides of nitrogen in the study area were
in the range with 98th percentile values between 17.10 – 22.33 μg/ m3. A
maximum value of 22.33 μg/ m3 was prevailing at the time of sampling at
Bhimavaram. The concentration of NOX is well below the prescribed limit of 80
μg/ m3

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5. Carbon Monoxide (CO)


The maximum and minimum 98th percentile concentrations for Carbon Monoxide
(CO) monitored in the study area were 0.34 – 0.74 mg/m3 respectively. Highest
value of 0.74 mg/ m3 was at the Dhramavarappadu Tanda. The concentration of
CO is well below the prescribed limit of 2 mg/ m3

6. Ammonia (NH3)
The maximum and minimum 98th percentile concentrations for Ammonia (NH3)
monitored in the study area were 12.91 – 32.75 μg/m3 respectively. Highest value
of 32.75 μg/ m3 was at Dhramavarappadu Tanda. The concentration of NH3 is
well below the prescribed limit of 400 μg/ m3

7. Volatile Organic Compounds (VOCs)


Volatile Organic Compounds (VOCs) concentration in study area was found to be
Below Detectable Limit of 1 ppm.

The ambient air quality monitoring results indicates that the overall air quality in the
study area is within permissible standards prescribed by NAAQ Standards.

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TABLE- 9: THE MAXIMUM, MINIMUM & 98TH PERCENTILE VALUES FOR ALL THE
SAMPLING LOCATIONS

3 3 3 3 3 3
PM 10(µg/M ) PM 2.5(µg/M ) SO2(µg/M ) NOX(µg/M ) CO (mg/M ) NH3 (µg/M )
Code Name of Sampling
th th th th th th
Location Min Max 98 Min Max 98 Min Max 98 Min Max 98 Min Max 98 Min Max 98

A1 Project Site 53.69 62.35 61.68 18.62 22.60 22.17 10.50 14.31 13.93 13.78 21.93 20.84 0.22 0.41 0.40 20.98 30.25 29.97
A2 Jayanthipuram 56.51 61.44 60.93 17.05 21.31 20.97 11.21 16.30 15.07 15.42 22.51 20.79 0.42 0.67 0.65 20.49 27.63 27.61
Dhramavarappadu
A3 59.89 70.15 68.88 18.07 30.59 28.92 11.29 15.19 15.15 15.93 19.46 19.45 0.45 0.76 0.74 28.35 32.87 32.75
Tanda
A4 Bhimavaram 56.29 64.29 62.46 19.42 25.18 25.18 12.37 15.06 15.04 15.49 23.19 22.33 0.24 0.45 0.44 18.29 22.46 22.33

A5 Gauravaram 58.09 60.31 60.24 18.09 21.47 21.45 11.04 14.83 14.26 15.89 20.18 19.94 0.24 0.41 0.40 12.58 15.73 15.59
A6 Pochampalli 55.19 60.39 60.34 17.42 24.87 24.85 10.34 13.84 13.74 14.25 19.27 19.00 0.23 0.39 0.38 10.23 13.31 12.91
A7 Vedadri Tanda 49.30 55.73 55.46 14.52 18.06 18.02 10.08 12.89 12.85 15.24 17.39 17.36 0.20 0.34 0.34 12.38 15.09 15.05
A8 Ravirala 48.23 59.68 58.13 15.00 19.63 19.10 9.58 11.49 11.44 13.82 17.25 17.10 0.19 0.35 0.35 10.48 14.00 13.97
NAAQ Standards’ 100 60 80 80 2 400

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3.5 WATER QUALITY


Water sampling and subsequent analysis was carried out to determine both the
groundwater and surface water quality of the study area.
Ground water & Surface water samples were collected at 8 locations in the study
area. These samples were analyzed for physical and chemical parameters to
ascertain the Baseline status in the existing surface water and ground water bodies.

TABLE-10: WATER ANALYSIS RESULTS


Ground water Surface water
S. No Parameters
Min Max Min Max
1 pH 7.32 8.37 7.54 8.51
2 Total dissolved solids (mg/l) 467.5 983.4 401 905
3 Total hardness (mg/l) 295 670 210 455
4 Chlorides (mg/l) 94.2 310 34 148
5 Fluoride (mg/l) <0.5 <0.5 <0.5 <0.5
6 Sulphates (mg/l) 25 96 2.5 64.2

 Ground water samples collected was analyzed as per the Standard methods
and the water quality of the study area is found to be above the acceptable
limits of IS-10500, for parameters TDS, Total hardness, Total Alkalinity,
Calcium, Magnesium and Chloride.

3.6 NOISE ENVIRONMENT


Noise level monitoring was carried out at eight locations during the period of March
2018 – May 2018.

Daytime Noise Levels (Lday)


Industrial Zone: The day time noise level at the Project site was 55.0 dB(A), which
is well below the permissible limits of 75 dB(A).
Commercial Zone: The daytime noise levels in all the commercial locations were
observed to be in the range of 59.5 dB (A) to 62.3 dB(A). The noise levels at all the
locations were below the permissible limits of 65 dB(A).
Residential Zone: The daytime noise levels in all the residential locations were
observed to be in the range of 46.5 dB (A) to 53.2 dB(A). The noise levels at all the
locations were below the permissible limits of 55 dB(A).

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Night time Noise Levels (Lnight)


Industrial Zone: The night time noise level in the Project site was observed be 43.8
dB(A), which is well below the permissible limits of 70 dB (A).
Commercial Zone: The night time noise levels in all the commercial locations were
observed to be in the range of 46.2 dB (A) to 52.1 dB(A). The noise levels at all the
locations were below the permissible limits of 55 dB(A).
Residential Zone: The nighttime noise levels in all the residential locations were
observed to be in the range of 38.9 dB(A) to 42.6 dB(A). The noise levels were
below the permissible limits of 45 dB(A) in nighttime at all the locations.

TABLE-11: NOISE LEVELS OF THE STUDY AREA


Day Time CPCB Night Time CPCB
Category of
Name of the in Leq Standard in Leq Standard
S.No Area/zone
Location dB (A) Day Time dB (A) Night time
1. Project site Industrial 55.0 75dB (A) 43.8 70dB (A)
2. Jayanthipuram Residential 53.2 55dB (A) 40.4 45dB (A)
3. Chillakallu Commercial 62.3 65dB (A) 52.1 55dB (A)
4. Bhimavaram Residential 50.6 55dB (A) 42.6 45dB (A)

5. Konakanchi Residential 48.7 55dB (A) 39.2 45dB (A)

6. Vedadri Tanda Residential 50.0 55dB (A) 38.9 45dB (A)

7. Mukteswarapuram Residential 46.5 55dB (A) 39.1 45dB (A)

8. Jaggayyapeta Commercial 59.5 65dB (A) 46.2 55dB (A)

3.7 SOIL ENVIRONMENT


On data obtained, the soil quality at around the site is appropriate and normal in
terms of soil contaminants.

3.8 LAND USE/ LAND COVER OF THE STUDY AREA


Land use / Land cover map is prepared by visual interpretation of high-resolution
satellite data (Satellite Imagery Acquisition: 11-Nov-2016) and with the help of
Survey of India Topographic maps on 1: 50,000 scale. Two seasons’ data (Rabi year
2017) is used for the delineation of different units. The units are confirmed by the
ground truth/field visits.

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TABLE-12: LAND USE / LAND COVER OF THE STUDY AREA


Area in Area in
S. No LANDUSE
SQ.KM Percentage (%)
1 Built Up Land 22.3 7.1
2 Water Bodies 23.2 7.4
3 Forest 36.4 11.6
4 Crop Land 172.1 54.8
5 Waste Lands 60.0 19.1
Total 314 100

3.9 DEMOGRAPHIC AND SOCIO-ECONOMIC PROFILE


 The total population of the study area is 2,04,510 in which male and female
population constitutes about 49.75 % and 50.25 % in the study area
respectively.
 The literate male and female in the study area are 68,273 and 55,524 which
implies that the percentage of literacy rate is 67.06% with male and 54.06%
with female respectively.
 In the study area the main and marginal workers are 86,663 (42.3%) and
13,633 (6.7%) respectively of the total population while the remaining
1,04,214 (51.0%) constitutes non-workers
All the Villages, in the study area, are electrified – both for Domestic Purpose and
common facilities like, Street Lights, Public Water Pumping, etc. and also are
provided with Domestic Water.

4.0 IDENTIFICATION, PREDICTION & MITIGATION MEASURES


4.1 Expected Air Environment
A. PROCESS EMISSIONS DETAILS
The Predicted Process emissions are O2, CO2, (CH3)2NH, HF, CH4, H2, NH3 & HCl
which are liberated from manufacturing process of proposed products.

TABLE-13: PROCESS EMISSION DETAILS


Quantity
S. No Name of the Gas Treatment Method
in Kg/Day
1 Carbon dioxide 270 Dispersed into the atmosphere
2 Oxygen 224 Dispersed into the atmosphere
3 Ammonia 9 Scrubbed by using Chilled water media
4 Hydrogen chloride 426 Scrubbed by using Chilled water media
5 Sulfur dioxide 312 Scrubbed by using C.S.Lye Solution

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6 Dimethylamine 8 Scrubbed by using chilled water media


7 Hydrogen fluoride 5 Scrubbed by using C.S.Lye Solution
Diffused by using Nitrogen through
8 Hydrogen 35
Flame arrestor
9 Methane 15 Dispersed into the atmosphere

4.2 PROPOSED PROCESS EMISSION CONTROL SYSTEM


Scrubbers with 300 mm (Diameter) X 3 meters (Height) & 300mm (Diameter) X 3
meters (Height) capacities will be installed for control of process emissions. The
Schematic diagram of emission control system is given below.

FIGURE-1: SCHEMATIC DIAGRAM OF PROPOSED EMISSION CONTROL


SYSTEM

B. EMISSIONS FROM BOILER


The Particulate matter generated from 8 TPH &4 TPH Boilers will be controlled by
using cyclone separator followed by bag filters. The sulphur dioxide (SO2) and
oxides of nitrogen (NOX) from boiler will be dispersed in to atmosphere by providing
adequate stacks of height 34 mtrs & 30 mtrs for effective dispersion and dilution.
The predicted ground level concentrations when added to Baseline scenario, the
overall scenario levels of PM, SO2 and NOX are well within the permissible limits as
specified by NAAQ Standards.

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TABLE 14: RESULTANT CONCENTRATIONS DUE TO


INCREMENTAL GLC's
Maximum Baseline Incremental Resultant NAAQ
Pollutant Concentration Concentrations due to Concentration Standards
(μg/m3) Proposed Project (μg/m3) (μg/m3) (μg/m3)
PM 68.88 0.759 69.639 100
SO2 15.15 4.694 19.844 80
NOx 22.33 9.47 31.80 80

4.3 Expected Effluent Water Details


The waste water generation will be 105.8 KLD which is from process, floor & reactor
washes, cooling tower blow down, boiler blow down, scrubber, DM plant and
domestic usage. The effluent generation and its HTDS & LTDS effluent details are
given below.

TABLE-15: EXPECTED EFFLUENT GENERATION DETAILS


Effluent
S.No. Purpose
Details KLD
1 Process 66
2 Washings 10
3 Boiler Blow down 10
4 Cooling towers Blow down 12
5 Scrubbing system 5.00
6 Domestic 2.80
Total 105.8

TABLE-16: EXPECTED HTDS & LTDS EFFLUENT GENERATION DETAILS


HTDS LTDS Effluent
S. No Purpose Disposal Method
In KLD In KLD In KLD
HTDS Effluent sent to
1 Process 47 19 66
MEESystem.MEE
Condensate sent to
2 Washings 0 10 10 Biological treatment.
LTDS Effluents along
with Domestic sewage
3 Boiler Blow down 0 10 10 sent to ETP, treated
effluent sent to RO
followed by MEE &
Cooling towers
4 0 12 12 ATFD.
bleed off
RO Permeate and MEE

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Condensate water
5 Scrubbing system 5 0 5.00 recovered for reuse
MEE Salts collected and
6 Domestic 0 2.8 2.80 disposed to TSDF.

Total 52 53.8 105.8

Effluent Treatment / Disposal: Zero Liquid Discharge (ZLD) concept consisting of


steam stripper, MEE system, ATFD, Biological Treatment and RO will be installed to
treat the effluents generated from plant and to reuse the treated water.
The MEE System with 85 KLD Capacity & RO system with 100 KLD Capacity will be
installed for treatment of effluents generated from plant operations.

4.4 Noise Environment


The main sources of noise pollution in the plant operations are Boiler, Reactors, DG
Set, compressors and other Noise generating units. Vehicular movements during
operation phase for loading / unloading of raw materials and finished products and
transporting activity may also increases the noise levels.
All the noise generating equipments like motors, gear boxes and compressors will be
regularly maintained with lubricating material to avoid noise generation. DG set will
be provided with acoustic enclosures. A thick greenbelt will be developed along the
periphery of the plant boundaries to minimize the noise pollution from the source.

4.5 Land Environment


The plant activities are unlikely to alter the land-use pattern in the project site. The
unit will take adequate measures for storage, handling and disposal of hazardous
waste. Hence, there will be no significant adverse impact on land environment.

4.6 Ecological Environment


Detailed flora and fauna studies were carried in the study area. As per baseline
studies, there are no endangered, threatened & protected plants and animal species
were recorded in the study area. Hence, no significant adverse impact is envisaged
on ecology.

4.7 Expected Hazardous and Solid Waste Details


The Hazardous / Solid waste generated and disposal methods from proposed project
are given below.

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TABLE- 17: EXPECTED HAZARDOUS/SOLID WASTE GENERATION, DISPOSAL


DETAILS
Name of the
S. No Quantity Disposal Method
Hazardous Waste
1 Organic Solid Waste 3757 Kg/Day
2 Spent Carbon 108 Kg/Day
3 Solvent distillation residue 1174 Kg/Day
Sent to Cement Industries
Organic Evaporate liquid from
4 1040 Kg/Day
MEE stripper
5 Mixed Solvents 3933 Kg/Day
6 ETP Sludge 1000 Kg/Day
7 Inorganic solid waste 366 Kg/Day Sent to TSDF
8 MEE Salts 4954 Kg/Day
1000 SPCB Authorized Agencies
9 Used Oils
Ltrs/Annum for Reprocessing/Recycling
After Detoxification sent back
1000
10 Detoxified Containers to suppliers/sent to outside
No’s/Month
Parties
Send back to suppliers for
11 Used Lead Acid Batteries 9 No’s/Year
buyback of New Batteries
Solid Waste Details
16800
12 Ash from boiler Sent to Brick Manufacturers
Kg/Day

4.8. Risk Assessment and Disaster Management Plan


The Risk assessment studies have been conducted for identification of hazards, to
calculate damage distances and to spell out risk mitigation measures. The details
are discussed in detail in Chapter – 7 of EIA Report.

5.0 ENVIRONMENTAL MANAGEMENT PLAN


5.1 ENVIRONMENT MANAGEMENT PLAN FOR CONSTRUCTION PHASE
Adequate and effective environment protection measures will be planned and
designed to minimize the impacts due to activities related to pre-construction
(preparatory phase) of the project, machinery installation and commissioning stages
and end with the induction of manpower and start up. The impacts identified during
the construction phase are mainly due to site preparation, foundation work, material
handling, and construction of buildings and installation of the machinery.
All possible care will be taken to reduce the noise levels due to construction activity.
Also, noise prone activities shall be restricted to the extent possible during night
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particularly during the period of 10 PM to 6 AM in order to have minimum


environmental impact.

5.2 ENVIRONMENT MANAGEMENT PLAN FOR OPERATIONAL PHASE


A) Air Pollution Management
 The industry will take measures for reduction of fugitive emissions emanating
out of process reactions by providing vent condensers.
 Good ventilation will be provided to reduce the workroom concentrations.
 Fugitive emissions will be reduced by providing vent condensers to the all the
reactors.
 Adequate stacks of height of 34 Mtrs & 30 Mtrs will be provided to the 8 TPH
& 4 TPH coal fired boilers.
 Stack monitoring facilities for the periodic monitoring of the stack to verify the
compliance of the stipulated norms. Apart from this Cyclone Separator, Bag
filters will be provided to the boiler.
 In order to minimize the air pollution, unit will develop greenbelt in and around
its premises.

B) Water Pollution Management


 Effluent generated in the plant will be treated in Proposed ZLD system.
 The industry is proposing to install a MEE System with 85 KLD capacity,
Biological Treatment system of 110 KLD and RO system with 100 KLD
capacities for treatment of 105.8 KLD effluents generated from plant
operations.
 Total Water requirement is 259 KLD out of which 84 KLD recycled water
recovered from ZLD system. The fresh water of 175 KLD will be met from
Ground Water source.
 Unit is proposed to recharge ground water through roof water harvesting pits
in the project area and rain water harvesting pits outside plant area wherever
possible to balance the water table.
 Use of high-pressure hoses for cleaning the floor and process equipment to
reduce the amount of wastewater generated during washings.

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C) Noise Pollution Management


 Noise suppression measures such as enclosures, buffers and / or protective
measures will be provided, if required.
 Extensive oiling, lubrication and preventive maintenance will be carried out for
the machineries and equipments to reduce noise generation.
 Greenbelt Development.

D) Hazardous & Solid Waste Management


To reduce the quantity of solid / hazardous waste generation as well as possible
contamination of land (soil) due to spillages / leaks from the plant operations,
following Mitigation measures are proposed:

 There will not be any leakages / spillage from the raw-materials storage.

 The generated Hazardous waste will be stored on floor with suitable packing
and this dedicated area will be covered with the roof.

 The records on quantity of hazardous waste generation and disposal will be


maintained for each category and possibilities will be explored for
minimization and reuse.

E) Green Belt
Greenbelt will be developed in an area of 4.27 Acres (17287.11 Sq.m). The industry
will spend 5 Lakhs as capital cost for planting of samplings. Lists of plants suitable
for greenbelt as per the local agro climatic conditions are given in the EIA Report.

F) Solvent Recovery
Solvents will be recovered upto 95% using distillation column and necessary cooling
condensers.

5.3 ENVIRONMENT MANAGEMENT CELL


Archimedis Laboratories Pvt. Ltd. will have a dedicated Environmental
Management Cell with experienced staff to look after the proper environmental
management of the plant including operation & maintenance of all pollution control
facilities.

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5.4 ENVIRONMENT MONITORING PROGRAM


Regular monitoring of environmental parameters is of immense importance to
assess the status of environment during project operation. The regular monitoring
will be carried out with the MoEF&CC Registration / NABL Accredited Laboratory.

6. PROPOSED ROOF WATER HARVESTING


Roof top rainwater harvesting is one of the appropriate options for augmenting
ground water recharge/ storage in this industry.
The following table gives expected quantity of rain water harvesting using buildings
Roof top.

TABLE- 18: AVAILABLE RAINWATER (ANNUAL) FOR HARVESTING


Rainfall Runoff Total Rainwater
Description Area (m2)
(m/Annum) coefficient (m3/Annum)
Roof Area 11536 0.98 0.8 9044.224
3
Total available rainwater (in m /annum) 9044

FIGURE-2: PROPOSED ROOF WATER HARVESTING STRUCTURE

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7. EMP BUDGET
The unit has proposed for 110 Lakhs as capital cost and 20 Lakhs as recurring cost
for environment pollution control measures.

TABLE- 19: PROPOSED BUDGET FOR ENVIRONMENTAL MANAGEMENT


PLAN [EMP]
Proposed Recurring
S. No Particulars Capital Cost Cost
(Rs. Lakhs) (Rs. Lakhs)
Pollution Control Equipment
1 (Scrubbers, Cyclone separator, Bag filter, 30.0 2.0
Sampling port arrangements etc.,)
ZLD System
2 70.0 12.0
(MEE, RO, ETP system)
Rain Water Harvesting
3 (Roof top water collection pit and Roof top water 3.0 0.5
towards the rain water harvesting pit)
Green Belt Development
4 5.0 2.0
(Plantation and Maintenance)
Health & Safety
5 2.0 1.0
(PPEs, Medical Surveillances Expenses etc.,)
Environmental Monitoring
6 (Air, Water, Noise, VOCs, Boiler Stack flue 0.0 2.5
gases, DG sets stack monitoring expenses etc.,)
Total 110.0 20.0

8.0 SOCIO-ECONOMIC DEVELOPMENT


It is predicted that socio-economic impact due to this project will positively increase
the chance of more employment opportunities for local people. There are no
Resettlement and Rehabilitation issues involved in this project. The project
infrastructures will be of use to people of the area. The revenue of the village will be
definitely increased due to the proposed project.

9.0 PROJECT BENEFITS


Proposed project will result in considerable growth and upliftment of local community
in the nearby villages by providing the employment. The project will generate direct
and indirect employment to the nearby villages and the unavailable technical
persons will be recruited from outside.

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10.0 CONCLUSION
Archimedis laboratories Pvt. Ltd. has committed to implement all the pollution
control measures to protect the surrounding environment – adapting Zero-Liquid-
Discharge System for all its Effluents, by controlling process emissions and Safe-
Disposal of all Solid Wastes – generated either as process wastes or packing
wastes.
The project can definitely improve the regional, state and national economy.
Industrial growth is an indication of all-round Socio-Economic Development – by
generating local Employment and Business Opportunities. The implementation of
this project will definitely improve the physical and social infrastructure of the
surrounding area.

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CHAPTER -I

INTRODUCTION
EIA Report Archimedis Laboratories Pvt. Ltd.

CHAPTER- I
INTRODUCTION

1.1 PURPOSE OF THE REPORT


As per the EIA Notification dated 14th September 2006 and its amendments from time to
time, the project falls under 5(f) “A” category and require Environmental Clearance. The
industry engaged the services of Rightsource Industrial Solutions Pvt. Ltd, Hyderabad to
prepare and submit the necessary documents. The consulting firm has submitted an
application in prescribed FORM-I along with necessary enclosures for obtaining Terms of
Reference to IA – II Division, MoEF&CC GOI, New Delhi. The project proposal was
appraised by the Expert Appraisal Committee (EAC) and has given Standard Terms of
Reference vide F. No: J-11011/9/2018-IA II (I) Dated on 05th Feb 2018, to carryout EIA
Study. The Environmental monitoring and analysis were carried out during the period of
March – 2018 to May – 2018. The Environmental Public Hearing was conducted on
27/10/2018 in Jayanthipuram village, Jaggayyapet Mandal, Krishna District, Andhra
Pradesh. The Public Hearing paper ads, PH Minutes and its compliance Report are
enclosed as enclosures.

1.2 IDENTIFICATION OF PROJECT & PROJECT PROPONENT


1.1.1 IDENTIFICATION OF THE PROJECT
Archimedis Laboratories Pvt. Ltd. was incorporated on 24th Dec, 2004. Its registered
office is at 5-163/1, 2nd floor, Malleswari Nilayam, Chintalkunta, LB Nagar Post, Hyderabad
– 500074. Industry proposed to set up a new Bulk Drugs & Intermediates Manufacturing
Unit at Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet (M), Krishna District, Andhra
Pradesh.

1.1.2 ABOUT THE PROMOTERS


Mr. Maddireddy Venkateswara Reddy is the Managing Director of the company. He has
done Master of Technology and has 15 years of manufacturing experience in Bulk Drugs
and Drug Intermediates and overall 27 years of Industrial experience.
Mr. Maddireddy Kesava Reddy is the Director of the company having bachelors of
Engineering. He worked as a Govt. Civil Engineer for 28 years and has 12 years of
manufacturing experience of Bulk Drugs and Intermediates.

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1.3 OBJECTIVE OF THE STUDY


The objective of the study is to carry out Environmental Impact Assessment (EIA) for the
proposed project to meet the Environmental compliances laid down by the Ministry of
Environment, Forest and Climate Change (MoEF&CC) Government of India. Ministry
issued a circular making it mandatory to obtain Environment Clearance for 65 categories of
industries. Bulk Drugs & Intermediates is one of them, occupying 5th place.
The study would include the description of project setting, appraisal of project activities and
assessment of adverse impacts related to the location, design, construction and operation
of the project. Environmental Management Plan (EMP) will be prepared that includes
mitigation measures, including evaluation of alternatives to reduce or mitigate/eliminate the
impacts that likely to cause most significant environmental burdens. As per the above
notification the industry seeks Environment Clearance from MoEF&CC, GOI, New Delhi,
Preparation of Environmental Impact Assessment Report (EIA) based on one season
(Three Months) data, which would be used as management planning tool for better
Environmental Management by suggesting control measures to avoid pollution problems
arising out of the project. The report will include a detailed Environmental Management
Plan (EMP). The study will be carried out incorporating all the details and requirements of
State Pollution Control (SPCB) and Ministry of Ministry of Environment, Forest and Climatic
Change as per their requirements.

1.4 BRIEF DESRIPTION OF THE PROJECT


1.4.1 NATURE OF THE PROJECT
Archimedis Laboratories Pvt. Ltd proposed to establish a Bulk Drugs & Intermediates
manufacturing unit. The proposed project falls under 5(f) “A” category of Synthetic Organic
Chemicals Industry of EIA Notification-2006 and its amendment thereof and requires
Environmental Clearance.

1.4.2 SIZE OF THE PROJECT


The industry proposed to establish the unit in an area of 11.62 Acres (47024.47 SQM). The
proposed project cost is about Rs. 30 Crores, which includes construction of the buildings,
equipment, machinery and greenbelt development.
Archimedis Laboratories Pvt. Ltd to produce below mention products with Manufacturing
Capacity of 115 TPM. The list of products is shown in Table 1.1.

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Table 1.1: Proposed Products and Quantities


Quantity Therapeutic
S No Product name CAS NO
in TPM category
1 Itraconazole 4 84625-61-6 Anti fungal
2 Lansprazole 1 103577-45-3 Anti ulcerative
3 Pentaprazole Sodium 9 138786-67-1 Antiulcerative
4 Duloxetine Hydrochloride 2 136434-34-9 Antidepressant
5 Sumatriptan Succinate 1 103628-48-4 Anti migraine
6 Almotriptan Malate 1 181183-52-8 Anti migraine
7 Zolmitriptan 1 139264-17-8 Anti migraine
8 Ketorolac tromethamine 5 74103-07-4 Analgesic
9 Rosuvastatin 4 147098-20-2 Antilipemic
10 Mesalamine (or) Mesalazine 4 89-57-6 Anti-inflammatory
11 Imatinib Mesylate 2 220127-57-1 Anti neoplastic
12 Celecoxib 4 169590-42-5 Arthritis
13 Sitagliptin Phosphate Monohydrate 2 654671-77-9 Hypoglycemic
14 Dabigatran 2 211915-06-9 Anticoagulant
15 Velpatasvir 2 1377049-84-7 Antiviral
16 Emtricitabine 4 143491-57-0 Antiretroviral
17 Olmesartan medoxomil 4 144689-63-4 Anti hypertensive
18 Pregabalin 4 148553-50-8 Anticonvulsant
2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-
piperazinyl ) -2-(1-methyl propyl )-3H-
19 10 - Drug intermediate
1,2,4-Triazole-3-one(Itraconazole
intermediate)
Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-
20 1,2,4-Triazole -1-yl Methyl ]-1,3 Dioxalane 4 - Drug intermediate
-4 yl Methanol(Itraconazole intermediate)
Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-
Triazole -1-yl methyl]-1,3 Dioxalane-4yl
21 5 - Drug intermediate
Methyl ] Methane Sulfonate (Itraconazole
intermediate)
2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-
pyridinyl ] 5methylthio -1H-
22 5 - Drug intermediate
benzimidazole(Lansoprazole Sulfide
Intermediate )
Pentaprazole chloro compound (2-
23 10 72830-09-02 Drug intermediate
Chloromethyl-3,4-Dimethoxy-Pyridine)
(S)-(-)-3-(Dimethyl amino )-1-(2-Thienyl)-
24 10 13233-44-5 Drug intermediate
1-praponal
4-Chloro-1 hydroxy butane sulphonic acid
25 5 54322-20-2 Drug intermediate
sodium salt
26 4-Chloro Butyralde Diethyl acetal 5 6139-83-9 Drug intermediate
27 4-Dimethyl amino butytalde diethyl acetal 5 1116-77-4 Drug intermediate
Total 115

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Table 1.2: Proposed By-Products and Quantities


Quantity
S. No Name of the Product Name of the By-Product
in Kg/Day
Lansprazole
2[4-(2,2,2-Tri Fluoro Ethoxy)-3-
1 Methyl Pyridinyl]Methyl Thio]-1h-
Benzimidazole Ammonium sulphate 698.00
Zolmitriptan
Imitinib mesylate
Lansprazole
2 2[4-(2,2,2-Tri Fluoro Ethoxy)-3- Acetic acid (70%) 414.00
Methyl Pyridinyl]Methyl Thio]-1h-
Benzimidazole
Dabigartan
Velpatasvir
2, 4-Di Hydro-4-[4-[4-(4hydroxy
3 Phenyl)-1-Piperazinyl]-2-(1- Hydrobromic acid (20%) 4552.00
Methylpropyl)-3h-1, 2, 4-Triazole-3-
One (Itraconazole Intermediate)
Olmesartan Medoxomil
Pentaprazole chlorocompound Potassium carbonate 167
4 (2-Chloromethyl-3,4-Dimethoxy-
Phosphoric acid 472
Pyridine)
5 Emtricitabine L-Menthol 105.00

1.4.3 LOCATION OF THE PROJECT


Archimedis Laboratories Pvt. Ltd proposed to set up a new Bulk Drugs & Intermediates
Manufacturing Unit at Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet Mandal, Krishna
District, Andhra Pradesh.

TABLE 1.3: PROJECT LOCATION AND COMPLIANCE OF SITE.


Project location Details
Latitude: 16°50'51.19"N
Latitude & Longitude
Longitude: 80°08'11.93"E
Annual Max Temp is 47.10C
Annual Min Temp is 9.3 0C
Climatic Conditions Normal Annual Rainfall is 982 mm
(Source: IMD Climatalogical Normals, Nandigama 1981
- 2010)
Land acquired for the plant 11.62 Acres (47024.47 Sq.m)
Land use Industrial use
Nearest Habitation Jayanthipuram Village 1.80 km (WNW)
Major urban Settlements Vijayawada - 58 km (SE)
Nearest Highway National Highway No.65 – 4.45 km (N)

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Nearest Railway station Motumuri Railway Station – 22.6 km (NE)


Nearest Airport Vijayawada Airport - 77 km (SE)
VBC Fertilizers & Chemicals Ltd
Amoda Iron & Steel Ltd
The Ramco Cements
Mine of VSP
Major Industries near the plant site
Jaggayapeta Industrial Estate
CKS Laboratories Pvt Ltd
Mylan Laboratories Limited
RA Chem Pharma Pvt Ltd
National Parks None within 10 km radius
Wild life sanctuary None
Historical Places Buddhist Stupa near Jaggayyapet - 5.17 km (NW)
Palleru River – 3.30 km (W)
Krishna River – 3.30 km (SSW)
Nagarjuna Sagar Left bank Canal- 2.50 km (E)
Chillakallu Major canal - 2.10 km (WNW)
Gauravaram Cheruvu – 5.40 km (E)
Water Bodies within 10 km radius Pochampalli Cheruvu – 3.38 km (ESE)
Konakachi Cheruvu – 5.51 km (ESE)
Nawabpeta Cheruvu – 9.53 km (ESE)
Water body near Jaggayyapet – 5.54 km (NW)
Tank Near Chillakallu – 4.57 km (N)
Tank near Shermohammedpet – 8.55 km (NNW)
Jaggayyapeta Extension R.F – 0.52 km (S),
0.39 km (N) of Project Site
Kuntimadi R.F- 5.12 km (SSW)
Reserve Forest within 10 km radius
Ginjupalle R.F- 5.60 km (SSW)
Venkatayapalem R.F- 7.80 km (SSW)
Budavada R.F- 4.68 km (W)

1.4.4 PROJECT AND ITS IMPORTANCE TO THE COUNTRY, REGION


Archimedis Laboratories Pvt. Ltd. is a Greenfield project intended to start a
manufacturing unit of Bulk Drugs & Intermediates.
 Availability of the well-connected road and railway network for easy transportation of
the construction equipments and materials, Raw materials and finished products.
 Easy availability of skilled and unskilled labor for construction of Plant and its
operation.
India’s pharmaceutical sector accounts for about 2.4 per cent of the global pharmaceutical
industry in terms of value and 10 per cent in terms of volume. India accounted for about 20
per cent of the global exports in generics. In FY16, India exported pharmaceutical products
worth USD$16.89 billion, with the number expected to reach USD$40 billion by 2020.
India’s healthcare sector, one of the fastest growing sectors, is expected to advance at a
CAGR of 17 per cent to reach USD$250 billion by 20. The generics market stood at

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USD$26.1 billion in 2016 from USD$21 billion in 2015. India’s generics market has shown
an immense potential for future growth.

1.5 SCOPE OF STUDY


1.5.1 ENVIRONMENTAL IMPACT ASSESSMENT
 To assess the impact of the project on Land use, Ambient Air Quality, Water
Quality, Noise levels, Ecology & Biodiversity, Hydrology & Geology, and Socio-
economic status of area.
 To prepare Environmental Management Plan (EMP) for mitigating adverse
impacts due to proposed project.
 Collection and testing of water sources and soil.
 To prepare environmental monitoring plan for operational phase.
 Greenbelt development.

1.5.2 SOCIO-ECONOMIC ASSESSMENT


This Study Report covers Population, Gender Ratio, Rural & Semi-Urban Demographic
Distribution, Literacy Rate and Social Amenities available in the study Area like, Transport,
Sanitation, Drinking Water, Medical & Health Facilities, Employment Rate and other
Developmental Indices of Villages falling within the 10 km radius of the Proposed Project
site.

1.5.3 REGULATORY FRAMEWORK


The MoEF&CC, CPCB and SPCBs together form the regulatory and administrative core of
the sector. Legislation for environmental protection in India for chemical industry is mainly
EIA Notification- 2006, Water (Prevention & Control of Pollution) Act -1974, Air (Prevention
& Control of Pollution) Act, 1981, Water (Prevention and Control of Pollution) Cess Act,
1977 Hazardous Waste (Management, Handling and Transboundary Movement) Rules,
2016, amended time to time etc are major Act/rules/notification applicable to industry.

1.5.4 REGULATORY SCOPING


 Obtaining Consent for Establishment & Consent for Operation from State
Pollution control board.

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1.6 LEGAL POLICY AND INSTITUTIONAL FRAMEWORKS


The principal environmental regulatory authority is the Ministry of Environment, Forest and
Climatic Change (MoEF&CC), New Delhi which formulates environmental policies and
accords environmental clearances for different projects. Table 1.2 highlights the relevant
environmental legislations applicable to this project.

TABLE 1.4: APPLICABILITY OF LEGAL POLICIES TO THE PROJECT


Applicability
coordinating
S. No Legal frame work Objectives of the policy to the
authority
project
Environmental Legality
Prohibits the discharge of
Water (Prevention pollutants into water bodies
1 and Control of CPCB beyond a given standard, and Applicable
pollution) Act, 1974 lays down penalties for non-
compliance
Water (Prevention
Provides for a levy and collection
and Control of
2 SPCB of a cess on water consumed by Applicable
Pollution) Cess Act,
industries and local authorities
1977
Air (Prevention and
Provides means for the control
3 Control of Pollution) CPCB Applicable
and abatement of air pollution.
Act, 1981
Defined the procedures for
The Air(Prevention
conducting meetings of the
and Control of
4 CPCB boards, the powers of the Applicable
Pollution) Rules,
presiding officers, decision-
1982
making etc
An act to provide for public
liability insurance for the purpose
of providing immediate relief to
Public Liability Director of the persons affected by accident
5 Applicable
Insurance Act, 1991 Factories occurring while handling any
hazardous substance and for
matters connected herewith or
incidental thereto
Environment Ministry of
Ensure that appropriate
(Protection) Act, 1986 Environment,
measures are taken to conserve
(EPA) followed by Forest and
6 and protect the Environment Applicable
amendment in Climatic
before commencement of
May1994 (Schedule- Change
operations.
I) (MoEF&CC)
Environmental Impact Under its ambit, 32 types of
Assessment industries are liable to opt for
7 MoEF&CC Applicable
Notification no. S.O. Environmental clearance from
1533 MoEF&CC by providing adequate

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EIA report
Lay down the procedures for
The Environment
setting standards of emission or
8 (Protection) Rules, CPCB Applicable
discharge of environmental
1986
pollutants
The Hazardous Procedure for inventory, control,
Wastes management handling and disposal of
(Management and hazardous waste. Provide for
9 SPCB Applicable
Handling) Rules, setting up of disposal sites/landfill
1989 and amended in sites design, operation and
2000 closure
Solid Waste
Procedure for management and
10 Management Rules, SPCB Applicable
handling of solid wastes
2016
Batteries
(Management and To ensure that the used batteries
11 Handling) SPCB are collected back as per the Applicable
Amendment Rules, schedule against new batteries
2010
Procedure to recovery/and/or
E- Waste
reuse of useful material from
12 (Management Rules), SPCB Applicable
waste electrical and electronic
2016
equipment

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CHAPTER -II

PROJECT DESCRIPTION
EIA Report Archimedis Laboratories Pvt. Ltd.

CHAPTER-II
PROJECT DESCRIPTION

2.1 TYPE OF THE PROJECT


Archimedis Laboratories Pvt. Ltd. is a Greenfield project, which proposed to
establish a Bulk Drugs & Intermediates manufacturing unit.

2.2 NEED FOR THE PROJECT


India’s healthcare sector, one of the fastest growing sectors, is expected to advance
at a compounded annual growth rate (CAGR) of 17 per cent to reach USD$250
billion by 2020. The generics market stood at USD$26.1 billion in 2016 from USD$21
billion in 2015. India’s generics market has shown an immense potential for future
growth. Hence, the proponent has decided to set up a Bulk drugs industry in this
location keeping in view of Low cost manpower, Semi–skilled and un-skilled labor
availability.

2.3 LOCATION
The proposed site is located at Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet
(M), Krishna District, Andhra Pradesh. It has good connectivity and infrastructure
availability. National Highway No.65 is at a distance of 4.45 km (N); the proposed
site is located about 5.7 km from Jaggayyapet. The Nearest Railway Station
Motumuri is at distance of 22.7 km (NE). Vijayawada Airport is about 224 km from
the project site.
The industry proposes to establish unit in an area of 11.62 Acres (47024.47 SQM).
The co-ordinates of the Project site are Latitude: 16°50'51.19"N, Longitude:
76°50'36.3" East. The land usage details are given in Table 2.1.

TABLE 2.1: LAND USE DETAILS


S. No. DESCRIPTION AREA IN SQM AREA IN ACRES AREA IN %
1 Total Built up Area 11536.00 2.85 24.5
2 Green Belt Area 17287.11 4.27 36.8
3 Roads & Open Area 18201.36 4.50 38.7
TOTAL 47024.47 11.62 100
36.8% of Land Allotted For Green Belt Development

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FIGURE 2.1: LOCATION MAP

ARCHIMEDIS LABORATORIES PVT


LTD

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FIGURE 2.2: GOOGLE EARTH MAP SURROUNDING OF PROJECT AREA

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EIA Report Archimedis Laboratories Pvt. Ltd.

FIGURE 2.3: GOOGLE EARTH MAP SHOWING PROJECT SITE

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FIGURE 2.4: LATEST PHOTOGRAPHS OF PROJECT SITE

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FIGURE 2.5: TOPO MAP SHOWING 10KM RADIUS

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FIGURE 2.6: SITE PLAN

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2.4 SIZE AND MAGNITUDE OF OPERATION


Total production capacity of proposal is 115 TPM.

TABLE 2.2: List Of Proposed Products And Capacities


Quantity in Therapeutic
S No Product name CAS No
Kg/Month category
(S)-(-)-3-(Dimethyl amino )-1-(2-Thienyl)- Drug
1 10000 13233-44-5
1-praponal intermediate
2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-
piperazinyl ) -2-(1-methyl propyl )-3H- Drug
2 10000 -
1,2,4-Triazole-3-one(Itraconazole intermediate
intermediate)
2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-
pyridinyl ] 5methylthio -1H- Drug
3 5000 -
benzimidazole(Lansoprazole Sulfide intermediate
Intermediate )
Drug
4 4-Chloro Butyralde Diethyl acetal 5000 6139-83-9
intermediate
4-Chloro-1 hydroxy butane sulphonic Drug
5 5000 54322-20-2
acid sodium salt intermediate
Drug
6 4-Dimethyl amino butytalde diethyl acetal 5000 1116-77-4
intermediate
7 Almotriptan Malate 1000 181183-52-8 Anti migraine
8 Celecoxib 4000 169590-42-5 Arthritis
Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-
1,2,4-Triazole -1-yl Methyl ]-1,3 Drug
9 4000 -
Dioxalane -4 yl Methanol(Itraconazole intermediate
intermediate)
Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-
Triazole -1-yl methyl]-1,3 Dioxalane-4yl Drug
10 5000 -
Methyl ] Methane Sulfonate (Itraconazole intermediate
intermediate)
11 Dabigatran 2000 211915-06-9 Anticoagulant
12 Duloxetine Hydrochloride 2000 136434-34-9 Antidepressant
13 Emtricitabine 4000 143491-57-0 Antiretroviral
14 Imatinib Mesylate 2000 220127-57-1 Anti neoplastic
15 Itraconazole 4000 84625-61-6 Anti fungal
16 Ketorolac tromethamine 5000 74103-07-4 Analgesic
17 Lansprazole 1000 103577-45-3 Anti ulcerative
Anti-
18 Mesalamine (or) Mesalazine 4000 89-57-6
inflammatory
Anti
19 Olmesartan medoxomil 4000 144689-63-4
hypertensive
Pentaprazole chloro compound (2- Drug
20 10000 72830-09-02
Chloromethyl-3,4-Dimethoxy-Pyridine) intermediate
21 Pentaprazole Sodium 9000 138786-67-1 Antiulcerative

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22 Pregabalin 4000 148553-50-8 Anticonvulsant


23 Rosuvastatin 4000 147098-20-2 Antilipemic
24 Sitagliptin Phosphate Monohydrate 2000 654671-77-9 Hypoglycemic
25 Sumatriptan Succinate 1000 103628-48-4 Anti migraine
1377049-84-
26 Velpatasvir 2000 Antiviral
7
27 Zolmitriptan 1000 139264-17-8 Anti migraine
Total 115000

Table 2.3: Proposed By-Products and Quantities


Quantity
S. No Name of the Product Name of the By-Product
in Kg/Day
Lansprazole
2[4-(2,2,2-Tri Fluoro Ethoxy)-3-
1 Methyl Pyridinyl]Methyl Thio]-1h-
Benzimidazole Ammonium sulphate 698.00
Zolmitriptan
Imitinib mesylate
Lansprazole
2 2[4-(2,2,2-Tri Fluoro Ethoxy)-3- Acetic acid (70%) 414.00
Methyl Pyridinyl]Methyl Thio]-1h-
Benzimidazole
Dabigartan
Velpatasvir
2, 4-Di Hydro-4-[4-[4-(4hydroxy
3 Phenyl)-1-Piperazinyl]-2-(1- Hydrobromic acid (20%) 4552.00
Methylpropyl)-3h-1, 2, 4-Triazole-3-
One (Itraconazole Intermediate)
Olmesartan Medoxomil
Pentaprazole chlorocompound Potassium carbonate 167
4 (2-Chloromethyl-3,4-Dimethoxy-
Phosphoric acid 472
Pyridine)
5 Emtricitabine L-Menthol 105.00

The required raw materials & solvents will be procured indigenously. In case any raw
material is un-available the same will be imported. The proponent is committed to
manufacture products as per current Good Manufacturing Practices.

2.5 PROPOSED SCHEDULE FOR APPROVAL AND IMPLEMENTATION


The industry intends to obtain approval within one year and to implement the
recommendations. The industry proposes to implement the recommendations of the
Authorities from construction stage. The MoEF&CC has given Terms of Reference

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vide F. No: J-11011/9/2018-IA II (I) Dated on 05th Feb 2018, to carryout EIA Study.
The Environmental monitoring and analysis were carried out during the period of
March – 2018 to May – 2018. The Environmental Public Hearing was conducted on
27/10/2018 in Jayanthipuram village, Jaggayyapet Mandal, Krishna District, Andhra
Pradesh. The Public Hearing paper ads, PH Minutes and its compliance Report are
enclosed as enclosures.
The proponent after receiving the EC will approach SPCB to get CFE/CFO and other
statutory approvals from respective authorities for plant operations.

2.6 TECHNOLOGY AND PROCESS DESCRIPTION


The manufacturing process of Bulk Drug Intermediates consists of chemical
synthesis extending to stages of processing involving different types of chemical
reactions. The unit will take adequate control measures for storage and handling of
Raw materials, solvents and gas cylinders within factory premises. The proponent is
having proven technology to manufacture the proposed products.

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2.6.1 MANUFACTURING PROCESS OF THE PRODUCTS


1. (S)-(-)-3-(DIMETHYLAMINO)-1-(2-THIENYL)-1-PROPANOL

Process description:

Stage-1
2-Acetylthiophene reacts with Dimethylamine hydrochloride and Formaldehyde in
presence of Isopropylalcohol to give Stage-1Product

Stage-2
Step-A
Stage-1 product undergoes reduction with Sodium borohydride inpresence of Water,
Methanol and n-Hexane to give Step-A Product

Step-B
Step-A Product undergoes resolution with (S)-(+)-Mandelic acid in presence of
Methanol and n-Hexane to give Stage-2Product

Stage-3
Stage-2Product undergoes Hydrolysis with Sodium hydroxide and Hydrochloric acid
in presence of methanol, Toluene & Petroleum ether to give (S)-(-)-3-
(Dimethylamino)-1-(2-Thienyl)-1-Propanol product

Route of synthesis:
Stage-1

S H
N H
O + Cl CH2O Isopropyl alcohol
+
2-Acetyl thiophene Dimethyl amine Para
C6H6OS Hydrochloride formaldehyde
C2H8ClN
126.18 30.03
81.54

H3C

N
S CH3
. HCl
O
+ H2O
3-Dimethylamino-1-thiophen-2-yl-propan-
1-one;Hydrochloride 18.02

C9H14ClNOS
219.73

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Stage-2
Step-A
H3C

N
S CH3 n-Hexane
. HCl Methanol
O + NaBH4 + 3 H2O

3-Dimethylamino-1-thiophen-2-yl-propan- 37.83 54.06


1-one;Hydrochloride
C9H14ClNOS
219.73
H3C
N
S CH3

OH + NaCl + H3BO3 + 3H2


3-Dimethylamino-1-thiophen-
2-yl-propan-1-ol 58.44 61.83 6.05
C9H15NOS
185.29
Step-B
H3C O
N OH
S CH3
+
2 OH Acetone
OH
3-Dimethylamino-1-thiophen- (S)-(+)-mandelic acid
2-yl-propan-1-ol
C8H8O3
C9H15NOS
185.29 X 2=370.40 152.15

HO
H3C H3C
HO
N N
S CH3 O CH3
S
OH +
OH
3-Dimethylamino-1-thiophen- Isomer
2-yl-propan-1-ol Mandalate salt C9H15NOS

C17H23NO4S 185.29

337.43

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Stage-3
HO
H 3C
HO
N
S CH3 O Methanol , Toluene &
OH Petroleum ether
+ NaOH + HCl
3-Dimethylamino-1-thiophen-
2-yl-propan-1-ol Mandalate salt 40.00 36.46

C17H23NO4S

337.43

H3C HO
N HO
S CH3

OH + O NaCl + H 2O
+
(S)-(-)-3-(DIMETHYLAMINO)-1 Mandelic acid 58.44 18.02
-(2-THIENYL)-1-PROPANOL C8H8O3
C9H15NOS 152.15
185.29

FLOW CHART:

2-Acetylthiophene
Dimethylamine hydrochloride
Formaldehyde
Isopropyl alcohol Recovery
Isopropyl alcohol stage-1 Effluent Water
Water

Stage-1
Sodium borohydride Methanol Recovery
S-(+) -mandelic acid n-Hexane Recovery
Methanol Acetone Recovery
stage-2
n-Hexane Effluent Water
Acetone
Water
Stage-3
Sodium hydroxide Toluene recovery
Hydrochloric acid stage-3 Methanol Recovery
Toluene Petroleum ether Recovery
Methanol
Petroleum ether
Water

(S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol

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Material Balance:
Material Balance of (S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol
Stage-1
Batch Size:100.00Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
2-Acetylthiophene 152.00 Stage-1 260.00
Dimethylamine hydrochloride 98.50 Isopropyl alcohol Recovery 95.00
Formaldehyde 37.00 Isopropyl alcohol Loss 2.00
Isopropyl alcohol 100.00 Effluent Water 321.70
(Water-300,
Generated water-21.70,)
Water 300.00 Organic Residue 8.80
Process residue-5.8
Distillation Residue-3
(IPA)
Total 687.50 Total 687.50

Material Balance of (S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol


Stage-2
Batch Size:100.00Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-1 260.00 Stage-2 190.00
Sodium borohydride 45.00 Mixed Solvents 494.00
(n-Hexane +Methanol )Recovery
S-(+) –mandelic acid 87.00 Methanol Loss 13.00
Methanol 260.00 n-Hexane loss 13.00
n-Hexane 260.00 Acetone Recovery 190.00
Acetone 200.00 Acetone loss 4.00
Water 300.00 Effluent Water 378.19
(Water-236
Sodium chloride-69.13,
Boric acid-73.06)
Process emission 7.15
(Hydrogen)
Isomer Recovery/Reuse 107.00
Organic Residue 15.66
Process residue-9.66
Distillation Residue-6
(Acetone)
Total 1412 Total 1412

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Material Balance of (S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol


Stage-3
Batch Size:100.00Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-3 190.00 (S)-(-)-3-(Dimethylamino)-1-(2- 100.00
Thienyl)-1-Propanol
Sodium hydroxide 23.00 Toluene recovery 190.00
Hydrochloric acid 21.00 Toluene loss 4.00
Toluene 200.00 Methanol Recovery 190.00
Methanol 200.00 Methanol loss 4.00
Petroleum ether 200.00 Petroleum ether Recovery 190.00
Water 300.00 Petroleum ether loss 4.00
Mandelic acid Recovery /Reuse 85.00
Effluent Water 349.14
(Water-300,Sodium chloride-33,
Generated Water-10.14,
Toluene-6)
Organic Residue 17.86
Process residue-5.86
Distillation Residue-12
(Methanol-6, Petroleum Ether-6)
Total 1134 Total 1134

2. 2, 4 –DIHYDRO-4-(4-[4-(4-HYDOXY PHENYL)-1-PIPERZINYL]-2-(1-
METHYLPROPYL)-3H-1, 2, 4-TRIAZOLE -3-ONE
(Itraconazole intermediate)
Process Description
Stage-1
Step-A

1-(4-methoxy-phenyl)-4-(4-nitro-phenyl)-piperazine under goes Hydrogenation with


Hydrogen in presence of Palladium Carbon and Di methyl formamide to give Step-
A product

Step-B

Step-A product reacts with Phenyl chloroformate in presence of Pyridine and Di


methyl foramamide to give Step-B product

Step-c

Step –B reacts with hydrazine hydrate in presence of Acetic acid in presence of Di


Methyl formamide to give step –C product

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Step-D

Step-c product reacts with Formamidine and Acetic acid in presence of Di Methyl
formamide to give Stage-1 product

Stage-2

Stage-1 product reacts with 2-Bromo butane in presence Potassium hydroxide,


Dimethyl sulfoxide and Acetone to give stage-2 product

Stage-3

Stage-2 product reacts with Hydro bromic acid in presence of Acetic Acid
,Chloroform Sodium carbonate , Methanol and water to give 2,4 –DIHYDRO-4-(4-
[4-(4-Hydoxy phenyl)-1-Piperzinyl]-2-(1- methylpropyl)-3H-1,2,4-Triazole -3-one
(Itraconazole intermediate)

Route of synthesis
Stage-1
Step-A
Palladium carbon,
H3CO N N NO2 + H2 Dimethylformamide
H3CO N N NH2
+ O2
1-(4-Methoxy-phenyl)-4-
2.02 1-(4-Methoxy-phenyl)-4-
(4-nitro-phenyl)-piperazine 32.00
(4-amino-phenyl)-piperazine
C17H19N3O3 C17H21N3O
313.36
283.37

Step-B
COOCl
Dimethylformamide
H3CO N N NH2 + Pyridine

1-(4-Methoxy-phenyl)-4- phenyl
(4-amino-phenyl) chloroformate
-piperazine
C17H21N3O C7H5ClO2
283.37 156.57

H3CO N N NHCOO + HCl

{1-4[4-(4-Methoxy-phenyl)-piperazinyl]- 36.46
phenyl}phenyl carbonate
C24H25N3O3
403.48

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Step-C

H3CO N N NHCOO Dimethylformamide


+ NH2-NH2.H2O

{1-4[4-(4-Methoxy-phenyl)-piperazinyl]- Hydrazine
phenyl}phenyl carbonate Hydrate
C24H25N3O3 N2H6O
403.48 50.06
OH

H3CO N N NHCONH NH2 + + H2O

{1-4[4-(4-Methoxy-phenyl)-piperazinyl]- Phenol 18.02


phenyl}Hydrazinecarboximide
C6H6O
C18H23N5O2
94.11
341.41
Step-D

Dimethyl
H3CO N N NHCONHNH2 + H2N NH + 2CH COOH formamide
3
Water
1,3-Dimethyl-7-{2-[(1-phenyl-2-propanyl)amino]ethyl} Formamidine 120.10
-3,7-dihydro-1H-purine-2,6-dione CH4N2
C18H23N5O2 44.07
341.41
O
NH
H3CO N N N 2CH3COONH4
+
N
Ammonium acetate
2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-piperazinyl ) -
2-(1-methyl propyl )-3H-1,2,4-Triazole-3-one 154.16
C19H21N5O2
351.40

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Stage-2
O
NH Acetone
H3CO N N N Br
+ Dimethyl sulfoxide
N + KOH
2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-piperazinyl ) -
2-(1-methyl propyl )-3H-1,2,4- 2-Bromobutane 56.11 Water
Triazole-3-one
C19H21N5O2 C4H9Br
351.40 137.02

O
CH3
N
H3CO N N N C2H5
N + KBr + H2O

4-{4[4-(4-Methoxy-phenyl)-piperazinyl]- 119.00 18.02


phenyl}2,4-Dihydro2-(1-methyl propyl )-3H-1,2,4-
Triazole-3-one
C23H29N5O2
407.51

Stage-3
O
CH3
N
H3CO N N N C2H5 Acetic acid
N + 2 HBr + Na2CO3
Chloroform
4-{4[4-(4-Methoxy-phenyl)-piperazinyl]- Methanol, Water
161.82 105.99
phenyl}2,4-Dihydro2-(1-methyl propyl )-3H-1,2,4-
Triazole-3-one
C23H29N5O2
407.51

O
CH3
N
HO N N N C2H5 + 2 NaBr +
N CO2 + CH3OH

2, 4-Di hydro-4-[4-[4-(4Hydroxy phenyl)-1-piperazinyl 205.79 44.01


32.03
]-2-(1-Methylpropyl)-3h-1, 2, 4-triazole-3-one
C22H27N5O2
393.48

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Flow chart:
1-(4-Methoxy-phenyl)-4-
(4-nitro-phenyl)-piperazine
Hydrogen
Palladium on carbon
Dimethylformamide
Phenyl chloroformate
Formamidine Dimethylformamide Recovery
Hydrazine hydrate Palladium on carbon Recovery
Acetic acid stage-1 Effluent water
Water
Stage-1
2-Bromo butane
Dimethylsulfoxide Dimethylsulfoxide Recovery
Acetone stage-2 Acetone Recovery
Potassium hydroxide Effluent water
Water

Stage-2
Sodium carbonate Acetic acid Recovery
Hydrobromic acid Chloroform Recovery
stage-3 Methanol Recovery
Acetic acid
Chloroform Effluent water
Methanol
Water

2, 4-di hydro-4-[4-[4-(4hydroxy phenyl)-1-piperazinyl]


-2-(1-methylpropyl)-3h-1, 2, 4-triazole-3-one

Material Balance

Material Balance of 2, 4-di hydro-4-[4-[4-(4hydroxy phenyl)-1-piperazinyl]-2-(1-methylpropyl)-


3h-1, 2, 4-triazole-3-one (Itraconazole Intermediate)
Stage-1
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
1-(4-Methoxy-phenyl)-4- (4-nitro- 185.00 Stage-1 140.00
phenyl)-piperazine
Hydrogen 1.20 Dimethylformamide Recovery 285.00
Palladium on carbon 10.00 Dimethylformamide Loss 6.00
Dimethylformamide 300.00 Palladium on carbon Recovery 10.00
Phenyl chloroformate 87.00 Effluent water 730.45

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Formamidine 20.00 (water-610, Phenol-43.85


Generated Water-8.40,
Ammonium acetate-68.2 )
Hydrazine hydrate 24.00 Process emission 39.07
(Oxygen-18.88
Hydrogen chloride-20.19)
Acetic acid 54.00 Organic Residue 80.68
Water 610.00 Process residue-71.68
Distillation residue -9
(Dimethylformamide -9)
Total 1291.2 Total 1291.2

Material Balance of 2, 4-di hydro-4-[4-[4-(4hydroxy phenyl)-1-piperazinyl]-2-(1-methylpropyl)-


3h-1, 2, 4-triazole-3-one (Itraconazole Intermediate)
Stage-2
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 140.00 Stage-2 126.00
2-Bromo butane 55.00 Dimethylsulfoxide Recovery 190.00
Dimethylsulfoxide 200.00 Dimethylsulfoxide loss 4.00
Acetone 200.00 Acetone Recovery 190.00
Potassium hydroxide 23.00 Acetone Loss 4.00
Water 600.00 Effluent water 654.57
(water-600, Generated Water-
7.17 Potassium bromide-47.4 )
Organic Residue 49.43
Process residue-37.43
Distillation residue -12
(Acetone-6, Dimethylsulfoxide-
6)
Total 1218 Total 1218

Material Balance of 2, 4-di hydro-4-[4-[4-(4hydroxy phenyl)-1-piperazinyl]-2-(1-methylpropyl)-


3h-1, 2, 4-triazole-3-one (Itraconazole Intermediate)
Stage-3
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-2 126.00 2, 4-di hydro-4-[4-[4-(4hydroxy 100.00
phenyl)-1-piperazinyl]-2-(1-
methylpropyl)-3h-1, 2, 4-triazole-
3-one
Sodium carbonate 42.00 Acetic acid Recovery 392.00
Hydrobromic acid 750.00 Acetic acid loss 9.00
Acetic acid 412.00 Chloroform Recovery 1045.00

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Chloroform 1100.00 Chloroform loss 55.00


Methanol 300.00 Methanol Recovery 285.00
Water 2239.00 Methanol loss 6.00
(By-Product 1350.00
Hydrobromic acid )
Effluent water 1673.90
(water-1600.38, Sodium 0
bromide-63.62
Methanol-9.9 )
Process emission 13.60
(Carbon dioxide)
Organic Residue 39.50
Process residue-19.5
Distillation residue -20
(Acetic acid-11 Methanol-9)
Total 4969 Total 4969

3. 2-[3-METHYL-4-(2, 2, 2-TRIFLUOROETHOXY) METHYLTHIO-1H-


BENZIMIDAZOLE

Process Description

Stage-1

2, 3 –Lutidine reacts with Hydrogen Peroxide in presence of Acetic acid to give


stage-1 product

Stage-2

Stage-1 product reacts with Sulphuric acid, nitric acid and Ammonia to give stage-2
product

Stage-3

Stage-2 product reacts with trifuloro ethanol, Potassium carbonate ,Acetic anhydride
in presence of Tetra –n-butyl Ammonium bromide (TBAB),Sodium hydroxide ,
Methyl isobutyl ketone (MIBK),Isopropyl alcohol, Toluene and Acetone to give
stage-3 product

Stage-4

Stage-3 product reacts with Thionyl chloride in presence of DiChloro methane,


Acetone and Methanol to give stage-4 product

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Stage-5

Stage-4 Product reacts with 2-mercapto benimidazole in presence of Sodium


hydroxide and Acetone to give product 2-[3-methyl-4-(2, 2, 2-trifluoroethoxy)
methylthio-1h-benzimidazole

Route of Synthesis:

Stage-1
CH3
CH3

Aceticacid N+ CH3
N CH3 + H2O2 H2O
O - +
2,3-Dimethyl-4-nitro
2,3-Lutidine 34.00 18.02
-pyridine
C7H9N N-oxide
107.16 C7H9NO
123.15

Stage-2

Methanol NO2
CH3 Sodium hydroxide CH3
methylenedichloride
+ H2SO4 + HNO3 + 2 NH3
N+ CH3 Water N CH3
O- O
2,3-Dimethyl-4-nitro 98.08 63.00 34.06
-pyridine 2,3-Dimethyl-
4-nitro-pyridine-N-Oxide
N-oxide
C7H9NO C7H8N2O3
123.15 168.15

+ (NH4)2SO4 + H2O
Ammonium sulphate 18.02
132.12

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Stage-3
NO2
CH3

N CH3
O CF3CH2OH + K2CO3 + (CH3CO)2O
+ + NaoH + HCl

138.21 Acetic
4-Nitro-2,3-Dimethyl Trifluoro 40.00 36.46
anhydride
pyridine-N-Oxide ethanol
102.09
C7H8N2O3 100.04

168.15
Tetra-n-butyl
ammonium bromide(TBAB)
Methylisobutyl
Water ketone(MIBK)
Isopropyl alcohol
Toluene
Acetone
OCH2CF3

CH3
. HCl

N CH2OH + KHCO3 + KNO2 + CH3COONa + CH3COOH


2-Hydroxy methyl-3-methyl Potassium
Potassium 82.03 60.05
pyridine hydrochloride bicarbonate
nitrite
C9H11ClF3NO2 100.12
85.10
257.64
Stage-4
OCH2CF3

CH3 OCH2CF3
. HCl Methylenedichloride
Acetone CH3
CH2OH methanol . HCl
N + SOCl2
N CH2Cl
2-Hydroxy methyl-3-methyl 118.97
pyridine hydrochloride 2-Chloromethyl-3-methyl-
4-(2,2,2-trifluoro-ethoxy)-pyridine
C9H11ClF3NO2 hydrochloride
257.64 C9H10Cl2F3NO
276.08

+ SO2 + HCl

64.06 36.46

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Stage-5

OCH2CF3
Water
CH3 H Acetone,
. HCl N
methylene di chloride
HS
N CH2Cl + + 2NaOH
N
2-Chloromethyl-3-methyl- 2-Mercapto 79.99
4-(2,2,2-trifluoro-ethoxy)-pyridine benimidazole
hydrochloride
C9H10Cl2F3NO C7H6N2S
150.22
276.08

H
N
N
S
N

H3C O
F
F F + 2NaCl + 2H2O
2-[3-Methyl-4-(2,2,2-trifluoro-ethoxy)- 116.88 36.02
pyridin-2-ylmethylsulfanyl]-
1H-benzoimidazole
C16H14F3N3OS
353.36

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FLOW CHART:
2,3-Lutidine
Hydrogen peroxide (50%)
Acetic acid stage-1 Acetic acid recovery
Water Effluent water

Stage-1
Sulphuric acid
Nitric acid Methanol Recovery
Ammonia Methylene di chloride recovery
stage-2
Sodium hydroxide Effluent water
Methanol
Methylene di chloride
Water
Stage-2
Trifluoroethanol
Potassium carbonate
Acetic anhydride Isopropyl alcohol Recovery
Sodium hydroxide Methyl isobutyl ketone recovery
stage-3 Toluene Recovery
Hydrochloric acid
Acetone Recovery
Tetra-n-butyl Effluent water
ammonium bromide(TBAB)
Methyl isobutyl ketone
Isopropyl alcohol
Toluene
Acetone
Water

Stage-3
Thionyl chloride Methylene dichloride Recovery
Methylene dichloride Methanol Recovery
stage-4
Methanol Acetone Recovery
Acetone Effluent water
Water

Stage-5
2-Mercaptobanzimidazole Acetone Recovery
Sodium hydroxide stage-5
Effluent water
Acetone
Water

2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl


Pyridinyl]Methyl Thio]-1h-Benzimidazole

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Material Balance:
Material Balance of 2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-
Benzimidazole
Stage-1
Batch Size: 500Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
2,3-Lutidine 400.00 Stage-1(With Acetic acid) 645.00
Hydrogen peroxide (50%) 360.00 (By Product 495.00
Acetic acid + Water)
Acetic acid 380.00
Total 1140 Total 1140

Material Balance of 2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-


Benzimidazole
Stage-2
Batch Size: 500Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1(With Acetic acid) 645.00 Stage-2 375.00
Sulphuric acid 1390.00 Methanol Recovery 741.00
Nitric acid 740.00 Methanol Loss 16.00
Ammonia 700.00 Methylene di chloride recovery 1520.00
Sodium hydroxide 25.00 Methylene di chloride loss 32.00
Methanol 780.00 Effluent water 1200.00
Methylene di chloride 1600.00 (Generatedwater-1175, Sodium 0
hydroxide-25)
Water 3000.00 By-Product 1850.00
(Ammonium sulphate)
Ammonium sulphate Water 200.00
Distillation loss
Generated Ammonium sulphate 2800.00
water distillation for water reuse
Organic Residue 146.00
Process residue-75
Distillation residue -71
( Methanol-23,
Methylene dichloride-48)
Total 8880 Total 8880

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Material Balance of 2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-


Benzimidazole
Stage-3
Batch Size: 500Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-2 375.000 Stage-3 393.00
Trifluoroethanol 223.00 Isopropyl alcohol Recovery 570.00
Potassium carbonate 309.00 Isopropyl alcohol Loss 12.00
Acetic anhydride 750.00 Methyl isobutyl ketone recovery 570.00
Sodium hydroxide 90.00 Methyl isobutyl ketone loss 30.00
Hydrochloric acid 82.00 Toluene Recovery 570.00
Tetra-n-butylammonium 10.00 Toluene loss 12.00
bromide(TBAB)
Methyl isobutyl ketone 600.00 Acetone Recovery 570.00
Isopropyl alcohol 600.00 Acetone loss 12.00
Toluene 600.00 By product 500.00
(Acetic acid )
Acetone 600.00 Effluent water 1424.03
Water 800.00 (water-800, Potassium 0
bicarbonate-223.30, Potassium
nitrite-189.8, Sodium acetate-
182.93 , Toluene-18, TBAB-10)
Organic Residue 375.97
Process residue-339.97
Distillation residue -36
(Isopropyl alcohol-18, Acetone-
18 )
Total 5039 Total 5039

Material Balance of 2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-


Benzimidazole
Stage-4
Batch Size: 500Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-3 393.00 Stage-4 393.00
Thionyl chloride 182.00 Methylene dichloride Recovery 1425.00
Methylene dichloride 1500.00 Methylene dichloride Loss 30.00
Methanol 1000.00 Methanol Recovery 950.00
Acetone 1000.00 Methanol Loss 20.00
Water 1000.00 Acetone Recovery 950.00
Acetone Loss 20.00
Effluent water 1000.00
(water-1000) 0

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Process emission 153.30


(Sulphur dioxide-97.70
Hydrogen chloride-55.60
Organic Residue 133.70
Process residue-28.7
Distillation residue -105
(Methanol-30, Methylene
dichloride -45, Acetone-30)
Total 5075 Total 5075

Material Balance of 2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-


Benzimidazole
Stage-5
Batch Size: 500Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-4 393.00 2[4-(2,2,2-Tri Fluoro Ethoxy)-3- 500.00
Methyl Pyridinyl]Methyl Thio]-1h-
Benzimidazole
2-Mercaptobanzimidazole 214.00 Acetone Recovery 1900.00
Sodium hydroxide 114.00 Acetone Loss 40.00
Acetone 2000.00 Effluent water 1717.47
Water 1500.00 (water-1500,Sodium chloride- 0
166.3 Generated Water -51.17
Organic Residue 63.53
Process residue-3.53
Distillation residue -60
( Acetone-60)
Total 4221 Total 4221

4. 4-CHLOROBUTYRALDEHYDE DIETHYL ACETAL

Process description:

Stage-1

Tetrahydrofuran reacts with Hydrochloric acid and Sodium hydroxide in presence of


Water to give stage-1 product

Stage-2

Stage-1 product reacts with Sodium hypo chlorite in presence of Methylene


dichloride,TEMPO , Potassium bromide, Sodium thiosulphate , Sodium bicarbonate&
Water to give Stage-2 Product.

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Stage-3
Stage-2 product reacts with Triethylorthoformate and water in presence of Para
toluene sulfonic acid , Methylene dichloride and Sodium carbonate to give 4-
Chlorobutyraldehyde Diethyl Acetal

Route of synthesis:
Stage-1

Water Cl
HO
O + 2 HCl + NaOH + 2 NaCl
Tetrahydro-furan 72.92 40.00 4-Chloro-butanol
116.89
C4H8O C4H9OCl
72.11 108.57 + H2O

18.02
Stage-2
TEMPO, Potassium bromide,
Cl Sodium bicarbonate,Sodium thiosulphate,
HO + NaOCl Sodium chloride, Methylene dichloride & Water

4-Chloro-butanol
Sodium
C4H9OCl hypochlorite
108.57
74.44 O

Cl
H + NaCl + H 2O
4-Chloro-butyraldehyde 58.44
C4H7OCl 18.02
106.55
Stage-3
O O Paratoluenesoulphonic acid,
O Sodium carbonate,
Cl O Methylene dichloride
H + + H2O
4-Chloro-butyraldehyde Triethyl orthoformate 18.02
C4H7OCl
C7H16O3
106.55
148.20

H3C O
Cl
O

CH3 + C2H5OH + CO2 + H2


4-Chlorobutyraldehyde Diethyl Acetal
C8H17ClO2 46.07 44.01 2.02
180.67

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Flow chart:

Tetra hydrofuran
Sodium hydroxide
Hydrochloric acid Stage-1 Effluent water
Water

Stage-1
Sodium hypochlorite
Sodium bicarbonate
Sodium thiosulphate MDC Recovery
Potassium bromide Mixed Solvent s
Sodium chloride Stage-2 (Methanol+Toluene)Recovery
MDC Effluent water
TEMPO
Methanol
Toluene
Water

Stage-2
Triethylorthoformate
Sodium carbonate MDC Recovery
Stage-3
MDC Effluent water
Para toluene sulfonic acid
Water

4-Chlorobutyraldehyde Diethyl Acetal

Material balance:

Material Balance of 4-Chlorobutyraldehyde Diethyl Acetal


Stage-1
Batch Size:100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Tetra hydrofuran 47.00 Stage-1 66.00
Sodium hydroxide 26.10 Effluent water 549.84
(Water-500, Sodium chloride-
38.10, Generated water-11.74
Hydrochloric acid 47.60 Organic Residue 4.860
Water 500.0
Total 620.70 Total 620.70

Material Balance of 4-Chlorobutyraldehyde Diethyl Acetal


Stage-2
Batch Size:100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 66.00 Stage-2 61.00
Sodium hypochlorite 45.25 MDC Recovery 380.00

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Sodium bicarbonate 50.00 MDC Loss 8.00


Sodium thiosulphate 3.25 Mixed Solvent s 980.00
(Methanol+Toluene)Recovery
Potassium bromide 5.00 Toluene loss 10.00
Sodium chloride 3.25 Methanol loss 10.00
MDC 400.00 Effluent water 369.75
(Water-300,
Sodium chloride-35.55
Generated water-10.95, Sodium
thio sulphate-3.25, TEMPO-20)
TEMPO 20.00 Inorganic solid waste 58.25
(Sodium chloride-3.25, Sodium
bicarbonate-50, Potassium
bromide-5)
Methanol 500.00 Organic Residue 15.75
Process residue-3.75
Distillation Residue-12
(MDC)
Toluene 500.00
Water 300.00
Total 1892.75 Total 1892.75

Material Balance of 4-Chlorobutyraldehyde Diethyl Acetal


Stage-3
Batch Size:100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-2 61.00 4-Chlorobutyraldehyde Diethyl 100.00
Acetal
Triethylorthoformate 84.85 MDC Recovery 380.00
Sodium carbonate 5.00 MDC Loss 8.00
MDC 400.00 Effluent water 326.05
(Water-289.65 Ethanol-26.4,
Para toluene sulfonic acid-5,
Sodium carbonate-5)
Para toluene sulfonic acid 5.00 Process emission 26.34
(Carbon dioxide-25.19,
Hydrogen-1.15)
Water 300.00 Organic Residue 15.46
Process residue-3.46
Distillation Residue-12
(MDC)
Total 855.85 Total 855.85

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5. 4-CHLORO 1-HYDROXY BUTANE SULPHONIC ACID SODIUM SALT

Process description:

Stage-1

Tetrahydrofuran reacts with Hydrochloric acid and Sodium hydroxide in presence of Water to
give stage-1 product

Stage-2

Stage-1 product reacts with Sodium hypo chlorite in presence of Methylene dichloride,
TEMPO, Potassium bromide, Sodium thiosulphate, Sodium chloride, Water and Sodium
bicarbonate to give Stage-2 Product.

Stage-3

Stage-2 Product reacts with Sodium met bisulphate and Hydrochloric acid in presence of
methanol and Methylenedichoride to give 4-Chloro 1-Hydroxy Butane Sulphonic Acid
Sodium Salt

Route of Synthesis

Stage-1

Water Cl
HO
O + 2 HCl + NaOH + 2 NaCl
Tetrahydro-furan 72.92 40.00 4-Chloro-butanol
116.89
C4H8O C4H9OCl
72.11 108.57 + H2O

18.02
Stage-2

TEMPO, Potassium bromide,


Cl Sodium bicarbonate,Sodium thiosulphate,
HO + NaOCl Sodium chloride, Methylene dichloride & Water

4-Chloro-butanol
Sodium
C4H9OCl hypochlorite
108.57
74.44 O

Cl
H + NaCl + H 2O
4-Chloro-butyraldehyde 58.44
C4H7OCl 18.02
106.55

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Stage-3
O
Water
Cl Methylenedichloride
H + Na2S2O5 + HCl Methanol
4-Chloro-butyraldehyde sodium 36.46
C4H7OCl metabisulfite
106.55 190.11

- O
O
+
Na S
Cl
O
OH
+ NaCl + SO2
4-Chloro-1-Hydroxy Butane Sulphonic
Acid Sodium Salt 58.44 64.06
C4H8O4SNaCl
210.61
Flow chart:

Tetra hydrofuran
Sodium hydroxide
Hydrochloric acid Stage-1 Effluent water
Water

Stage-1
Sodium hypochlorite
Sodium bicarbonate
MDC MDC Recovery
(2,2,6,6-Tetramethylpiperidin-1-yl) Stage-2 Effluent water
oxyl or (2,2,6,6-tetramethylpiperidin-1
-yl)oxidanyl,(TEMPO)
Potassium bromide
Sodium thio sulphate
Sodium chloride
Water

Stage-2
Hydrochloric acid MDC Recovery
Sodium metabisulphate Stage-3 Methanol Recovery
MDC Effluent water
Methanol
Water

4-Chloro 1-Hydroxy Butane


Sulphonic Acid Sodium Salt

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Material balance:

Material Balance Of 4-Chloro 1-Hydroxy Butane Sulphonic Acid Sodium Salt


Stage-1
Batch Size:100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Tetra hydrofuran 40.00 Stage-1 57.00
Sodium hydroxide 22.20 Effluent water 342.40
(Water-300, Sodium chloride-
32.41, Generated water-9.99
Hydrochloric acid 40.50 Organic Residue 3.30
Water 300.00
Total 402.7 Total 402.7

Material Balance Of 4-Chloro 1-Hydroxy Butane Sulphonic Acid Sodium Salt


Stage-2
Batch Size:100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 57.00 Stage-2 53.00
Sodium hypochlorite 39.10 MDC Recovery 380.00
Sodium bicarbonate 50.00 MDC Loss 8.00
MDC 400.00 Effluent water 363.40
(Water-300, Sodium chloride-
30.7 Generated water-9.45,
Sodium thio sulphate-3.25
TEMPO-20)
(2,2,6,6-Tetramethylpiperidin-1- 20.00 Inorganic solid waste 58.25
yl)oxyl or (2,2,6,6- (Sodium chloride-3.25, Sodium
tetramethylpiperidin-1- bicarbonate-50, Potassium
yl)oxidanyl,(TEMPO) bromide-5)
Potassium bromide 5.00 Organic Residue 14.95
Process residue-2.95
Distillation Residue-12
(MDC)
Sodium thio sulphate 3.25
Sodium chloride 3.25
Water 300.00
Total 877.6 Total 877.6

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Material Balance Of 4-Chloro 1-Hydroxy Butane Sulphonic Acid Sodium Salt


Stage-3
Batch Size:100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-2 53.00 4-Chloro 1-Hydroxy Butane 100.00
Sulphonic Acid Sodium Salt
Hydrochloric acid 18.15 MDC Recovery 380.00
Sodium metabisulphate 94.60 MDC Loss 8.00
MDC 400.00 Methanol Recovery 190.00
Methanol 200.00 Methanol loss 4.0
Water 300.00 Effluent water 329.10
(Water-300 Sodium chloride-
29.1)
Process emission 31.86
(Sulphur dioxide)
Organic Residue 22.79
Process residue-4.79
Distillation Residue-18
(MDC-12, Methanol,-6)
Total 1065.75 Total 1065.75

6. 4- DIMETHYLAMINOBUTYRALDEHYDE DIETHYL ACETAL

Process Description

Stage-1

1-Bromo -3-chloro –propane reacts with Dimethyl amine in presence of Sodium


hydroxide, water and Cyclohexane to give stage-1 product

Stage-2

Stage-1 product reacts with Triethyl orthoformate in presence of Magnesium, Iodine,


Hydrochloric acid and Cyclohexane to give 4-Dimethylamino butyraldehyde Diethyl
acetal product.

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Route of Synthesis:

Stage- 1

H Water
N
Cl Br + HC cyclohexane
3 CH3 + NaOH
1-Bromo-3-chloro-propane
Dimethyl-amine
C3H6BrCl C2H7N 40.00
157.44 45.08

CH3
Cl N

CH3 + NaBr + H2O


3-Dimethylamino,1-Chloropropone 102.89
18.02
C5H12NCl
121.61

Stage-2
CH3 O
Cl N O Iodine
CH3 O Mg Cyclohexane
+ +
3-Dimethylamino,1- Triethyl orthoformate
Chloropropone 24.31
C7H16O3
C5H12NCl 148.20
121.61
O CH3
N
O CH3
+ MgCl(C2H5O)
4- Dimethylaminobutyraldehyde
104.82
Diethyl Acetal
C10H23NO2
189.30

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Flow chart:
1-Bromo-3-chloro-propane
Dimethylamine
Sodium hydroxide Cyclo hexane Recovery
Cyclo hexane Stage-1 Effluent water
Water

Stage-1
Triethylorthoformate
Magnesium Cyclo hexane Recovery
Hydrochloric acid Stage-2
Effluent water
Iodine
Cyclo hexane
Water
4- Dimethylaminobutyraldehyde Diethyl Acetal

Material Balance:
Material Balance Of 4- Dimethylaminobutyraldehyde Diethyl Acetal
Stage-1
Batch Size:100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
1-Bromo-3-chloro-propane 93.00 Stage-1 68.00
Dimethylamine 26.70 Cyclo hexane Recovery 285.00
Sodium hydroxide 23.65 Cyclo hexane loss 6.00
Cyclo hexane 300.00 Effluent water 375.45
(Water-300, Sodium bromide-
60.80, Generated water-10.65,
Cyclo hexane-4)
Water 300.00 Organic Residue 8.90
Process residue-3.9
Distillation Residue-5
(Cyclohexane)
Total 743.35 Total 743.35

Material Balance Of 4- Dimethylaminobutyraldehyde Diethyl Acetal


Stage-2
Batch Size:100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 68.00 4- Dimethylaminobutyraldehyde 100.00
Diethyl Acetal
Triethylorthoformate 81.50 Cyclo hexane Recovery 285.00

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Magnesium 14.00 Cyclo hexane loss 6.00


Iodine 20.00 Effluent water 378.61
(Water-300, Iodine-20,
Magnesium salt of Ethnocide-
58.61 )
Cyclohexane 300.00 Organic Residue 13.89
Process residue-4.89
Distillation Residue-9
(Cyclohexane)
Water 300.00
Total 783.5 Total 783.5

7. ALOMOTRIPTAN MALATE

Process Description

Stage-1

(4- Nitro –phenyl)-Methane sulfonyl Chloride reacts in presence of Chloroform and


Methanol to stage-1 product Process Description

Stage-2

Stage-1 Product under goes hydrogenation with hydrogen gas in presence of Raney
nickel, Di methyl formamide and Di Isopropyl ether to give stage-2 product

Stage-3

Stage-2 reacts with Sodium Nitrite and Stannous chloride in presence of liquid
Ammonia, water, Hydrochloric acid, Di chloro methane, Methanol and, Isopropyl
Alcohol to give stage -3 product

Stage-4

Stage-3 product reacts with 4- Chloro -1,1-dimethoxy –butane in presence of Di


chloro methane , methanol , Hydrochloric acid and water to give stage -4 product

Stage-5

Stage-4 product reacts with Sodium boro hydride and Formaldehyde in presence of
Di chloro methane, Ethyl acetate and Oxalic acid to given Stgae-5 product

Stage-6

Stgae-5 product under goes Salt formation with Malic acid in presence of Methanol
and Ethyl acetate to give Almotriptan malate product

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Route of Synthesis:

Stage-1
O
S O
Cl S N
O
O

N
Methanol
NO2 H Chloroform
+ NO2 + HCl
(4-Nitro-phenyl)-methane Pyrrolidine
1-(4-Nitro-phenylmethane 36.46
sulfonyl chloride C4H9N sulfonyl)-pyrrolidine
C7H6ClNO4S C11H14N2O4S
71.12
235.64
270.30

Stage -2
O
O
S N
S N
O
O

Raney Nickel
Dimethylformamide,
NO2 Diisopropylether
+ H2 NH2
1-(4-Nitro-phenylmethane 2.02 O2
4-(Pyrrolidine-1-sulfonyl
sulfonyl)-pyrrolidine methyl)-phenylamine 32.00
C11H14N2O4S
C11H16N2O2S
270.30 240.32

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Stage-3
O
S N
O

HCl+Water
Dichloromethane,
NH2 Methanol & Isopropylalcohol
+ NaNO2 + SnCl2 + 2 NH4OH
4-(Pyrrolidine-1-sulfonyl
methyl)-phenylamine 69.00 189.62 70.09
C11H16N2O2S
O
240.32 S N
O

HN NH2 . HCl + (NH4)2SnO3 + NaCl + 0.5 O2


[4-(Pyrrolidine-1-sulfonylmethyl)- Ammonium Stannate 58.44 16.00
phenyl]-hydrazine
Hydrochloride 202.79
C11H18ClN3O2S
291.80
Stage-4

O
S N
O
Disodiumorthophosphate
O
Dichloromethane,
O Cl Methanol, HCl+Water
HN NH2 . HCl +
[4-(Pyrrolidine-1-sulfonylmethyl)- 4-Chloro-1,1-
phenyl]-hydrazine dimethoxy-butane
Hydrochloride C6H13ClO2
C11H18ClN3O2S 152.62
291.80

N
O
S
O
NH2

N
H 2 CH3OH 2 HCl
+ +
2-[5-(Pyrrolidine-1-sulfonylmethyl) 64.08 72.92
-1H-indol-3-yl]-ethylamine
C15H21N3O2S
307.41

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Stage-5

N
O
S
O
NH2

N Dichloromethane, Methanol,
H NaBH4 + 2 H2C O Ethyl acetate & Oxalic acid
+
2-[5-(Pyrrolidine-1-sulfonylmethyl) 37.83 Formaldehyde
-1H-indol-3-yl]-ethylamine
CH2O
C15H21N3O2S
2 X30.03=60.06
307.41

N N(CH3)2
S
O O N
H + NaBO2 + 2 H2
Almotriptan
Sodium meta 4.02
C17H25N3O2S borate
335.46 65.80
Stage-6

N N(CH3)2 O
S
OH
O O HO
N +
H OH O
Methanol,
Almotriptan Malic acid Ethyl acetate
C17H25N3O2S C4H6O5
335.46 158.28

N N(CH3)2 O
S
OH
O O HO
N .
H OH O

Almotriptan malate

C21H31N3O7S

469.55

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Flow Chart:
(4-Nitro-phenyl)-methane
sulfonyl chloride
Pyrrolidine Chloroform Recovery
Chloroform Stage-1 Methanol Recovery
Methanol Effluent water
Water
Stage-1
Hydrogen Diisopropylether Recovery
Raney nickel Dimethyl formamide Recovery
Dimethyl formamide Stage-2 Effluent water
Diisopropylether
Water

Stage-2
Sodium nitrite
Ammonium hydroxide Isopropyl alcohol Recovery
Tin(II) chloride Methanol Recovery
Hydrochloric acid Stage-3 Dichloromethane Recovery
Dichloromethane Effluent water
Methanol
Isopropyl alcohol
Water

Stage-3
4-Chloro-1,1-dimethoxy
-butane
Methanol Recovery
Disodium orthophosphate
Stage-4 Dichloromethane Recovery
Hydrochloric acid
Effluent water
Dichloromethane
Methanol
Water

Stage-4
Sodium borohydride
Formaldehyde
Methanol Recovery
Ethyl acetate
Dichloromethane Recovery
Oxalic acid Stage-5 Ethyl acetate Recovery
Dichloromethane
Effluent water
Methanol
Water

Stage-5 Methanol Recovery


Malic acid Ethyl acetate Recovery
Ethyl acetate Stage-6
Effluent water
Methanol
Water

ALMOTRIPTAN MALATE

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Material Balance:

Material balance of Almotriptan Malate


Stage-1
Batch Size:100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
(4-Nitro-phenyl)-methane 73.00 Stage-1 79.00
sulfonyl chloride
Pyrrolidine 22.00 Chloroform Recovery 190.00
Chloroform 200.00 Chloroform Loss 10.00
Methanol 200.00 Methanol Recovery 190.00
Water 200.00 Methanol Loss 4.00
Effluent water 200.00
(Water-200)
Process emission 11.29
(Hydrogen chloride)
Organic Residue 10.71
Process residue-4.71
Distillation Residue-6
(Methanol-6)
Total 695 Total 695

Material balance of Almotriptan Malate


Stage-2
Batch Size:100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-1 79.00 Stage-2 66.00
Hydrogen 0.60 Diisopropylether Recovery 190.00
Raney nickel 10.00 Diisopropylether Loss 10.00
Dimethyl formamide 200.00 Dimethyl formamide Recovery 190.00
Diisopropylether 200.00 Dimethyl formamide Loss 4.00
Water 200.00 Effluent water 200.00
(Water-200)
Spent Raney Nickel recovery 10.00
/Reuse
Process emission 9.34
(Oxygen)
Organic Residue 10.26
Process residue-4.26
Distillation Residue-6
(Dimethyl formamide -6)
Total 689.6 Total 689.6

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Material balance of Almotriptan Malate


Stage-3 Batch Size:100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-2 66.00 Stage-3 76.00
Sodium nitrite 19.00 Isopropyl alcohol Recovery 190.00
Ammonium hydroxide 52.00 Isopropyl alcohol Loss 4.00
Tin(II) chloride 20.00 Methanol Recovery 190.00
Hydrochloric acid 20.00 Methanol Loss 4.00
Dichloromethane 200.00 Dichloromethane Recovery 190.00
Methanol 200.00 Dichloromethane loss 4.00
Isopropyl alcohol 200.00 Effluent water 242.05
200.00 (Water-200, Isopropyl alcohol-6
Sodium chloride-16.05,
Water Hydrochloric acid -20)
Inorganic solid waste 55.70
(Ammonium stannate)
Process emission 4.38
(Oxygen)
Organic Residue 16.87
Process residue-4.87
Distillation Residue-12
(Methanol -6,Dichloromethane-6 )
Total 977 Total 977

Material balance of Almotriptan Malate


Stage-4
Batch Size:100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-3 76.00 Stage-4 75.00
4-Chloro-1,1-dimethoxy- 40.00 Methanol Recovery 190.00
butane
Disodium orthophosphate 20.00 Methanol Loss 4.00
Hydrochloric acid 20.00 Dichloromethane Recovery 190.00
Dichloromethane 200.00 Dichloromethane loss 4.00
Methanol 200.00 Effluent water 256.70
200.00 (Water-200,
Methanol-16.7,
Hydrochloric acid -20,
Water Disodium orthophosphate-20)
Process emission 18.98
(hydrogen chloride)
Organic Residue 17.32
Process residue-5.32
Distillation Residue-12
(Methanol -6,Dichloromethane-6 )
Total 756 Total 756

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Material balance of Almotriptan Malate


Stage-5
Batch Size:100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-4 75.00 Stage-5 76.00
Sodium borohydride 10.00 Methanol Recovery 190.00
Formaldehyde 15.00 Methanol Loss 4.00
Ethyl acetate 200.00 Dichloromethane Recovery 190.00
Oxalic acid 20.00 Dichloromethane loss 4.00
Dichloromethane 200.00 Ethyl acetate Recovery 190.00
Methanol 200.00 Ethyl acetate loss 4.00
Water 200.00 Effluent water 242.05
(Water-200,
Sodium meta borate-16.05,
Oxalic acid-20, Ethyl acetate--6)
Process emission 0.97
(hydrogen)
Organic Residue 18.98
Process residue-6.98
Distillation Residue-12
(Methanol -6,Dichloromethane-6 )
Total 920 Total 920

Material balance of Almotriptan Malate


Stage-6
Batch Size:100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-5 76.00 Almotriptan Malate 100.00
Malic acid 36.00 Methanol Recovery 190.00
Ethyl acetate 200.00 Methanol Loss 4.00
Methanol 200.00 Ethyl acetate Recovery 190.00
Water 200.00 Ethyl acetate loss 4.00
Effluent water 206.00
(Water-200,
Ethyl acetate--6)
Organic Residue 18.00
Process residue-12
Distillation Residue-6
(Methanol -6)
Total 712 Total 712

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8. CELECOXIB

Process Description

Stage-1

Trifluro acetic acid reacts with Methanol in presence of Methanol to give stage-1
product

Stage-2

Stage -1 reacts with 4-Methyl Acetophenone in presence of Sodium methoxide,


Hydrochloric acid and Methanol to give stage-2 product

Stage-3

4-Aminobenzene sulphonamide reacts with Sodium nitrite, Hydrochloric acid and


Sodium metabisulfite in presence of Sodium hydrochloride and Methanol to give
stage-3 product

Stage-4

Stage-3 product reacts with 4, 4, 4, - Trifluoro 1-p-tolyl butane-1, 3-dione in presence


of Methanol to give Celecoxib product

Stage-5

Celecoxib Crude under goes Purification in Methanol and Toluene to give Celecoxib
product

Route of Synthesis:

Stage-1

F3C OH F3C O
CH3
Methanol
O + CH3OH O + H2O
Trifluro Acetic Acid Methanol Trifluoro-acetic acid 18.00
C2HF3O2 32.04 methyl ester
114.00 C3H3F3O2
128.00

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Stage-2
O
F3C O
CH3 CH3
Methanol
O + H3C + CH3ONa + HCl
Trifluoro-acetic acid 4-Methyl Acetophenone 54.00 36.50
methyl ester
C9H10O
C3H3F3O2
134.00
128.00

O O

CF3

+ 2CH3OH + NaCl
H3C

4,4,4-Trifluoro-1-p-tolyl-butane-1,3-dione 64.00 58.50


C11H9F3O2
230.18

Stage-3
O O

S
H2N

NH2 + NaNO2 Methanol


+ 2HCl + 2NaOH + Na2S2O5
4-Aminobenzene sulfonamide 69.00 Sodium
72.92 80.00
C6H8N2O2S metabisulfite
172.00 190.00

O O

S
H 2N
NH2.HCl
+ NaCl + 2 Na2SO4 + H 2O
NH

4-Sulfonamido Phenyl Hydrazine HCl 58.50 142.04X2=284.08 18.02

C6H10ClN3O2S
223.68

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Stage-4

O O
O O
S
H2N
NH2.HCl CF3
N
H + H3C

4-Sulfonamido Phenyl Hydrazine HCl 4,4,4-Trifluoro-1-p-tolyl-butane-1,3-dione


(Stage-3) (Stage-2)
C6H10ClN3O2S C11H9F3O2
223.68
230.18

Methanol

O O
S
H 2N

N N
CF3

+ 2H2O + HCl
H3C

Celecoxib Crude 36.03 36.46


C17H14F3N3O2S
381.37
Stage-5
O O
S O O
H 2N S
H2N
N
N
CF3 N N
Toluene CF3
Methanol
H3C
H3C

Celecoxib Crude Celecoxib


C17H14F3N3O2S C17H14F3N3O2S
381.37 381.37

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Flow Chart:
Trifluoro acetic acid
Methanol Methanol Recovery
Water Stage-1 Effluent water
Stage-1
4-methyl acetophenone
Sodium methoxide
Hydrochloric acid
Stage-2 Methanol Recovery
Methanol
Effluent water
Water

4-amino benzene sulfonamide


Sodium nitrite
Methanol Recovery
Hydrochloric acid Stage-3 Effluent water
Sodium chloride
Sodiummeta bi sulphate
Methanol
Water
Stage-3 Methanol Recovery
4,4,4,-Trifluooro-1-p Stage-4
Effluent water
-toly-utane -1,3-dione
Methanol
Water
Toluene Recovery
Stage-4
Methanol Recovery
Toluene Stage-5 Effluent water
Methanol
Water

Celecoxib

Material Balance:

Material balance of Celecoxib


Stage-1
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Trifluoro acetic acid 36.00 Stage-1 38.00
Methanol 210.20 Methanol Recovery 190.00
Water 200.00 Methanol Loss 4.00
Effluent water 205.70
(Water-200
Generated water-5.7)

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Organic Residue 8.50


Process residue -2.5
Distillation Residue-6
(Methanol)
Total 446.2 Total 446.2

Material balance of Celecoxib


Stage-2
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-1 38.00 Stage-2 66.00
4-methyl acetophenone 39.80 Methanol Recovery 190.00
Sodium methoxide 16.05 Methanol Loss 4.00
Hydrochloric acid 10.85 Effluent water 236.40
Methanol 200.00 (Water-200, Methanol-19,
Sodium chloride-17.4)
Water 200.00 Organic Residue 8.30
Process residue -2.30
Distillation Residue-6
(Methanol)
Total 504.7 Total 504.7

Material balance of Celecoxib


Stage-3
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
4-amino benzene sulfonamide 51.00 Stage-3 64.00
Sodium nitrite 20.50 Methanol Recovery 190.00
Hydrochloric acid 21.65 Methanol Loss 4.00
Sodium chloride 23.75 Effluent water 307.15
Sodiummeta bi sulphate 56.60 (Water-200, Generated Water-
5.55, Sodium chloriode-17.35,
Sodium sulphate-84.25)
Methanol 200.00 Organic Residue 8.35
Water 200.00 Process residue -2.35
Distillation Residue-6
(Methanol)
Total 573.5 Total 573.5

Material balance of Celecoxib


Stage-4
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg

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Stage-3 64.00 Stage-4 105.00


Stage-2 66.00 Methanol Recovery 190.00
Methanol 200.00 Methanol Loss 4.00
Water 200.00 Effluent water 210.30
(Water-200, Generated Water-
10.30)
Process emission 10.45
(Hydrogen chloride)
Organic Residue 10.25
Process residue – 4.25
Distillation Residue-6
(Methanol)
Total 530.00 Total 530.00

Material balance of Celecoxib


Stage-5
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-4 105.00 Celecoxib 100.00
Toluene 200.00 Toluene Recovery 190.00
Methanol 200.00 Toluene loss 4.00
Water 300.00 Methanol Recovery 190.00
Methanol Loss 4.00
Effluent water 300.00
(Water-300)
Organic Residue 17.00
Process residue – 5
Distillation Residue-12
(Toluene -6, Methnol-6)
Total 805.00 Total 805.00

9. CIS -2-[2, 4-DI CHLORO PHENYL] -2-[1H-1, 2,4-TRIAZOLE -1-YL METHYL


]-1,3 DIOXALANE -4 YL METHANOL

Process description:

Stage-1

Cis Bromo benzoate undergoes condensation with 1,2,4 triazole in presence of


Potassium carbonate, Sodium hydroxide, Dimethyl sulfoxide Toluene & methanol to
give Cis -2-[2, 4-Di Chloro Phenyl] -2-[1h-1, 2,4-Triazole -1-Yl Methyl ]-1,3
Dioxalane -4 Yl Methanol product

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Route of Synthesis:
Stage-1
Br
O
OOCC6H5
H
O N
N 1/2 K2CO3 + NaOH
Cl Cl + N +

Potassium Sodium
Cis-bromo benzoate 1,2,4-Triazole carbonate hydroxide
C18H15BrCl2O4 C2H3N3 69.0 40.0
446.12 69.1

Dimethylsulfoxide
Water Toluene,
Methanol

N
N
N
O COONa

HO O
+ + KBr + 1/2 CO2 + 1/2 H2O
Cl Cl
Sodium 119.0 22.0 9.01
Cis -2-[2,4-Di Chloro Phenyl] -2-
[1h-1,2,4-Triazole -1-Yl Methyl ]- benzoate
1,3 Dioxalane -4 Yl Methanol C7H5NaO2
C13H13Cl2N3O3 144.10
330.17

Flow chart:

Cis bromo benzoate


1,2,4-Trazole
Potassium carbonate
Sodium hydroxide Toluene Recovery
Dimethylsulfoxide Methanol Recovery
Toluene Stage-1
Dimethylsulfoxide Recovery
Methanol
Water

Cis -2-[2,4-Di Chloro Phenyl] -2-[1h-1,2,4-Triazole -1-Yl Methyl ]-1,3 Dioxalane -4 Yl Methanol

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Material balance:

Material Balance of Cis -2-[2,4-Di Chloro Phenyl] -2-[1h-1,2,4-Triazole -1-Yl Methyl ]-1,3
Dioxalane -4 Yl Methanol
Stage-1
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Cis bromo benzoate 159.00 Cis -2-[2,4-Di Chloro Phenyl] -2- 100.00
[1h-1,2,4-Triazole -1-Yl Methyl ]-
1,3 Dioxalane -4 Yl Methanol
1,2,4-Trazole 24.50 Toluene Recovery 190.00
Potassium carbonate 24.50 Toluene Loss 4.00
Sodium hydroxide 15.00 Methanol Recovery 190.00
Dimethylsulfoxide 200.00 Methanol Loss 4.00

Toluene 200.00 Dimethylsulfoxide Recovery 190.00


Methanol 200.00 Dimethylsulfoxide Loss 4.00
Water 200.00 Effluent water 302.82
(Water-200,generated water-
3.18, Sodium benzoate-51.35,
Potassium bromide-42.29,
Toluene-6)
Process emission 7.79
(Carbon dioxide )
Organic Residue 30.39
(Process residue-18.39
Distillation Residue-12
(Methanol-6, DMSO-6)
Total 1023 Total 1023

10. CIS -2-[2, 4-DI CHLORO PHENYL]-2-[1H-1, 2, 4-TRIAZOLE -1-YL


METHYL]-1, 3 DIOXALANE-4YL METHYL] METHANE SULFONATE

Process description:

Stage-1

Cis Bromo benzoate undergoes condensation with 1,2,4 triazole in presence of


Potassium carbonate, Sodium hydroxide, Dimethyl sulfoxide Toluene & methanol to
give Stage-1 product

Stage-2

Stage-1 product react with Methane sulfonyl chloride in presence of Triethyl amine ,
Dicholoro methane ,methanol & Water to give Cis -2-[2, 4-Di Chloro Phenyl]-2-[1h-
1,2,4-Triazole -1-Yl Methyl]-1,3 Dioxalane-4yl Methyl ] Methane Sulfonate product

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Route of Synthesis:
Stage-1
Br
O
OOCC6H5
H
O N
N 1/2 K2CO3 + NaOH
Cl Cl + N +

Potassium Sodium
Cis-bromo benzoate 1,2,4-Triazole carbonate hydroxide
C18H15BrCl2O4 C2H3N3 69.0 40.0
446.12 69.1

Dimethylsulfoxide
Water Toluene,
Methanol

N
N
N
O COONa

HO O
+ + KBr + 1/2 CO2 + 1/2 H2O
Cl Cl
Sodium 119.0 22.0 9.01
Cis -2-[2,4-Di Chloro Phenyl] -2-
[1h-1,2,4-Triazole -1-Yl Methyl ]- benzoate
1,3 Dioxalane -4 Yl Methanol C7H5NaO2
C13H13Cl2N3O3 144.10
330.17

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Stage-2
N
N
N
O
HO
Dichloromethane
O
Methanol
+ CH3SO2Cl + (C2H5)3N
Cl Cl Water
[2-(2,4-Dichloro-phenyl)-2-[1,2,4]triazol Methane sulfonyl Triethyl amine
-1-ylmethyl-[1,3]dioxolan-4-yl]-methanol chloride 101.19
C13H13Cl2N3O3 114.55
330.17
N
N
N
O
O3SH3C
O
+ (C2H5)3N.HCl
Cl Cl
Triethyl amine hydrochloride
Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-
Triazole -1-yl methyl]-1,3 Dioxalane- 137.65
4yl Methyl ] Methane Sulfonate
C14H15Cl2N3O5S

408.26

Flow chart;
Cis bromo benzoate
1,2,4-Trazole
Potassium carbonate
Sodium hydroxide Toluene Recovery
Dimethylsulfoxide Methanol Recovery
Toluene Stage-1
Dimethylsulfoxide Recovery
Methanol
Water
Stage-1
Methane sulfonyl chloride Dichloromethane Recovery
Triethylamine Methanol Recovery
Stage-2
Dichloromethane Effluent water
Methanol
Water

Cis -2-[2,4-Di Chloro Phenyl]-2-[1h-1,2,4-Triazole -1-Yl Methyl]-1,3 Dioxalane-4yl Methyl ]


Methane Sulfonate

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Material balance:
Material Balance of Cis -2-[2,4-Di Chloro Phenyl]-2-[1h-1,2,4-Triazole -1-Yl Methyl]-1,3
Dioxalane-4yl Methyl ] Methane Sulfonate
Stage-1
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Cis bromo benzoate 137.00 Stage-1 86.00
1,2,4-Trazole 22.00 Toluene Recovery 190.00
Potassium carbonate 22.00 Toluene Loss 4.00
Sodium hydroxide 13.00 Methanol Recovery 190.00
Dimethylsulfoxide 200.00 Methanol Loss 4.00

Toluene 200.00 Dimethylsulfoxide Recovery 190.00


Methanol 200.00 Dimethylsulfoxide Loss 4.00
Water 200.00 Effluent water 289.55
(Water-200,generated water-
2.75, Sodium benzoate-44.25
Potassium bromide-36.55,
Toluene-6)
Process emission 6.75
(Carbon dioxide )
Organic Residue 29.70
(Process residue-17.7
Distillation Residue-12
(Methanol-6, DMSO-6)
Total 994 Total 994

Material Balance of Cis -2-[2,4-Di Chloro Phenyl]-2-[1h-1,2,4-Triazole -1-Yl Methyl]-1,3


Dioxalane-4yl Methyl ] Methane Sulfonate
Stage-2
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 86.00 Cis -2-[2,4-Di Chloro Phenyl]-2- 100.00
[1h-1,2,4-Triazole -1-Yl Methyl]-
1,3 Dioxalane-4yl Methyl ]
Methane Sulfonate
Methane sulfonyl chloride 30.00 Dichloromethane Recovery 190.00
Triethylamine 27.00 Dichloromethane Loss 4.00
Dichloromethane 200.00 Methanol Recovery 190.00
Methanol 200.00 Methanol Loss 4.00
Water 200.00 Effluent water 235.85
(Water-200,Triethylamine
hydrochloride-35.85)

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Organic Residue 19.15


(Process residue-7.15
Distillation Residue-12
(Methanol-6, Dichloromethane -
6)
Total 743 Total 743

11. DABIGARTAN

Process Description
Stage-1
Pyridin-2-ylamine reacts with Ethyl acrylate, Ammonia and Hydrochloric acid in
presence of n-Hexane to give stage-1 product
Stage-2
Step-A
4-Chloro -3-nitro benzoic acid reacts with Methyl amine in presence of Isopropyl
Alcohol and Acetic to give step –A product
Step-B
Step-A product reacts with thinly chloride in presence of Methanol to give step-B of
stage of state-2 product
Stage-3
Stage-2 and Stage-1 condensed in presence of Tri ethyl amine, Toluene and Ethanol
to give stage-3product
Stage-4
Stage-3 product undergoes reduction with Iron powder in presence of Ammonium
formate, Toluene, Ethanol, Tetra hydro furan to give stage-3 product
Stage-5
4-Amino benzonitrile reacts with 2- Bromo acetic acid in presence of water to give
stage-5 product
Stage-6
Stage-4 product reacts with stage -5 products in presence of DiChloro methane and
ethyl acetate to give stage-6 product
Stage-7
Stage-6 product reacts with Ammonium carbonate in presence of Ethanol and
Isopropyl Alcohol give stage-7 product

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Stage-8
Stage-7 product reacts with Hexylchloroformate in presence of potassium carbonate
and Tetra hydro furan to give Dibgatran product

Route of Synthesis:

Stage-1

N NH2 + O NH3 HCl n-Hexane


+ +
Pyridin-2-ylamine Ethyl acrylate 17.03 36.46
C5H6N2
C5H8O2
94.11
100.12
O

N N O
H + NH4Cl
3-(Pyridin-2-ylamino)-
propionic acid ethyl ester 53.49

C10H14N2O2

194.23

Stage-2

Step-A

O O
O2N O2N
OH OH
Acetic acid ,
H 2N N
Cl + Isopropylalcohol H
+ HCl
Methyl Amine Water 4-Methylamino-3-nitro
4-Chloro-3-nitro- 36.46
benzoic acid CH5N -benzoic acid
C7H4ClNO4 C8H8N2O4
31.06
201.56 196.16

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Step-B

O O
O2N O2N
Cl
OH

N N HCl
Methanol H +
H + SOCl2
4-Methylamino-3-nitro- 36.46
4-Methylamino-3-nitro 118.97 benzoyl chloride
-benzoic acid C8H7ClN2O3
C8H8N2O4
214.61 + SO2
196.16
64.06

Stage-3
O
O2N O
Cl
N N Toluene , Ethanol
N N O
H + H +
4-Methylamino-3-nitro- 3-(Pyridin-2-ylamino)- Triethylamine
benzoyl chloride propionic acid ethyl ester
C8H7ClN2O3 C6H15N
C10H14N2O2
214.61 101.19
194.23

O O
O 2N
N O

N N N
H . HCl
+

3-[(4-Methylamino-3-nitro-benzoyl)-pyridin Triethylamine
-2-yl-amino]-propionic acid ethyl ester hydrochloride
C18H20N4O5 C6H16NCl
372.38 137.65

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Stage-4
O O
O 2N
N O
Ammonium formate Toluene , Ethanol
N N ,Tetrahydrofuran & Water
H Fe
+

3-[(4-Methylamino-3-nitro-benzoyl)-pyridin 55.84
-2-yl-amino]-propionic acid ethyl ester
C18H20N4O5
O O
372.38
H 2N
N O

N N
H Fe + O2
+

3-[(3-Amino-4-methylamino-benzoyl)-pyridin-2-yl- 55.84 32.00


amino]-propionic acid ethyl ester
C18H22N4O3
342.39

Stage-5
O

N NH2 + Br Water
OH

4-Amino benzonitrile 2-bromoacetic acid


C7H6N2 C2H3BrO2
118.14 138.95
O
H
N N
OH + HBr
(4-Cyano-phenylamino)-acetic acid 80.91
C9H8N2O2

176.17

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STAGE-6
O O
H2N
N O

N N O
H H
N N
+ OH
3-[(3-Amino-4-methylamino-benzoyl)-pyridin-2-yl- (4-Cyano-phenylamino)-acetic acid
amino]-propionic acid ethyl ester
C18H22N4O3 C9H8N2O2
342.39 176.17

Dichloromethane, Ethyl acetate

O O
N
N O
N
N NH N
+ 2 H2 O
3-({2-[(4-Cyano-phenylamino)-methyl]-1-methyl-1H-benzoimidazole-
5-carbonyl}-pyridin-2-yl-amino)-propionic acid ethyl ester 36.03

C27H26N6O3

482.53

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STAgE-7

N N O

O N
Ethano, IPA
N HN CN + (NH4)2CO3

Ethyl 3-(2-((4-cyanophenylamino) Ammonium


methyl)-1-methyl-N-(pyridin-2-yl)- carbonate
1H-benzo[d]imidazole-5- 96.09
carboxamido)propanoate
C27H26N6O3
Mol. Wt.: 482.53

N N O

O N
NH2
N HN
NH + CO2 + NH3 H2O
+
Ethyl 3-(2-((4-amidinophenylamino) 18.0
44.0 17.03
methyl)-1-methyl-N-(pyridin-2-
yl)-1H-benzo[d]imidazole-5-
carboxamido)propanoate
C27H29N7O3
Mol. Wt.: 499.56

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Stage-8

O
N N O
O N
NH2 Cl O
N HN
NH O + K2CO3
+
3-({2-[(4-Carbamimidoyl-phenylamino)- Hexyl chloroformate 138.21
methyl]-1-methyl-1H-benzoimidazole-5- C7H13Cl O2
carbonyl}-pyridin-2-yl-amino)-propionic acid
ethyl ester 164.63
C27H29N7O3
499.56

THF

N N O
N O
O
N
N HN O
NH2

+ KCl + CHKO2
Dabigatran
74.55 Potassium
C34H41N7O5
formate
627.73 84.12

+ 0.5 O2
16.00

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Flow chart:
(pyridine-2-ylamine
Ethyl acrylate
Ammonia n-Hexane Recovery
Hydrochloric acid Effluent water
Stage-1
n-Hexane
Water
4-chloro-3-nitro-benzoic acid
Methyl amine Acetic acid Recovery
Acetic acid Isopropyl alcohol Recovery
Isopropyl alcohol Stage-2 Methanol Recovery
Thionyl chloride Effluent water
Methanol
Water

Stage-1
Stage-2 Toluene Recovery
Triethylamine Ethanol Recovery
Toluene Stage-3 Effluent water
Ethanol
Water

Stage-3
Iron Toluene Recovery
Ammonium formate Ethanol Recovery
Toluene Stage-4 Tetra hydrofuran Recovery
Ethanol Effluent water
Tetra hydrofuran
Water

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4-amino benzonitrile
2-bromoacetic acid Stage-5 Effluent water
Water

Stage-4
Stage-5
Dichloromethane Recovery
Dichloromethane
Stage-6 Ethyl acetate Recovery
Ethyl acetate
Effluent water
Water

Stage-6
Ammonium carbonate Ethanol Recovery
Ethanol Stage-7 Isopropyl alcohol Recovery
Isopropyl alcohol Effluent water
Water

Stage-7
Hexyl chloro formate Tetrahydrofuran Recovery
Potassium carbonate Stage-8 Effluent water
Tetrahydrofuran
Water

Dabigartan

Material balance:

Material balance of Dabigartan


Stage-1
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
(pyridine-2-ylamine 23.00 Stage-1 45.00
Ethyl acrylate 25.00 n-Hexane Recovery 190.00
Ammonia 5.00 n-Hexane loss 4.00
Hydrochloric acid 9.00 Effluent water 313.10
n-Hexane 200.00 (Water-300
Ammonium chloride-13.10)
Water 300.00 Organic Residue 9.90
Process residue -3.9
Distillation Residue-6
(n-Hexane )
Total 562 Total 562

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Material balance of Dabigartan


Stage-2
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
4-chloro-3-nitro-benzoic acid 55.00 Stage-2 49.00
Methyl amine 9.00 Acetic acid Recovery 190.00
Acetic acid 200.00 Acetic acid loss 4.00
Isopropyl alcohol 200.00 Isopropyl alcohol Recovery 190.00
Thionyl chloride 31.00 Isopropyl alcohol loss 4.00
Methanol 200.00 Methanol Recovery 190.00
Water 300.00 Methanol loss 4.00
Effluent water 306.00
(Water-300
Isopropyl alcohol -6)
Process emission 35.29
(Hydrogen chloride-19.04
Sulphur dioxide-16.25,
Organic Residue 22.71
Process residue -10.71
Distillation Residue-12
(Methanol-6, Acetic acid-6 )
Total 995 Total 995

Material balance of Dabigartan


Stage-3
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-1 45.00 Stage-3 78.00
Stage-2 49.00 Toluene Recovery 190.00
Triethylamine 24.00 Toluene loss 4.00
Toluene 200.00 Ethanol Recovery 190.00
Ethanol 200.00 Ethanol loss 4.00
Water 300.00 Effluent water 337.45
(Water-300
Toluene -6, Triethylamine
hydrochloride-31.45)
Organic Residue 14.55
Process residue -8.55
Distillation Residue-6
(Ethanol -6)
Total 818 Total 818

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Material balance of Dabigartan


Stage-4
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-3 78.00 Stage-4 68.00
Iron 12.00 Toluene Recovery 190.00
Ammonium formate 20.00 Toluene loss 4.00
Toluene 200.00 Ethanol Recovery 190.00
Ethanol 200.00 Ethanol loss 4.00
Tetra hydrofuran 200.00 Tetra hydrofuran Recovery 190.00
Water 300.00 Tetra hydrofuran loss 4.00
Effluent water 337.70
(Water-300
Toluene -6, Iron -11.70,
Ammonium formate-20)
Process emission 6.70
(oxygen)
Organic Residue 15.6
Process residue -3.6
Distillation Residue-12
(Ethanol -6, Tetra hydrofuran-6)
Total 1010 Total 1010

Material balance of Dabigartan


Stage-5
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
4-amino benzonitrile 25.00 Stage-5 35.00
2-bromoacetic acid 30.00 Effluent water 300.00
Water 300.00 (Water-300)
Byproduct 17.15
(Hydrobromic acid)
Organic Residue 2.85
Total 355 Total 355

Material balance of Dabigartan


Stage-6
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-4 68.00 Stage-6 89.00
Stage-5 35.00 Dichloromethane Recovery 190.00
Dichloromethane 200.00 Dichloromethane loss 4.00
Ethyl acetate 200.00 Ethyl acetate Recovery 190.00

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Water 300.00 Ethyl acetate loss 4.00


Effluent water 313.15
(Water-300
Ethyl acetate -6, Generated
water -7.15
Organic Residue 12.85
Process residue -6.85
Distillation Residue-6
(Dichloromethane -6)
Total 803 Total 803

Material balance of Dabigartan


Stage-7
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-6 89.00 Stage-7 87.00
Ammonium carbonate 18.00 Ethanol Recovery 190.00
Ethanol 200 Ethanol loss 4.00
Isopropyl alcohol 200.00 Isopropyl alcohol Recovery 190.00
Water 300.00 Isopropyl alcohol loss 4.00
Effluent water 303.25
(Water-300
Generated water -3.35)
Process emission 11.23
(Carbon dioxide-8.10, Ammonia-
3.13),
Organic Residue 17.52
Process residue -5.52
Distillation Residue-12
(ethanol-6, Isopropyl alcohol-6 )
Total 807 Total 807

Material balance of Dabigartan


Stage-8
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-7 87.00 Dabigartan 100.00
Hexyl chloro formate 29.00 Tetrahydrofuran Recovery 190.00
Potassium carbonate 25.00 Tetrahydrofuran loss 4.00
Tetrahydrofuran 200.00 Effluent water 327.63
Water 300.00 (Water-300 , Potassium formate-
14.65, potassium chloride-12.98)
Process emission 2.78
(Oxygen)
Organic Residue 16.59

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Process residue -10.59


Distillation Residue-6
(THF )
Total 641 Total 641

12. DULOXETIN HYDROCHLORIDE

Process Description

Stage-1
(S)-3-Dimethyl amino -1-thiophen -2-yl-propan-1-ol reacts with in presence of DMSO
and Potassium hydroxide to give stage -1 product
Stage-2
Stage-1 product reacts with oxalic acid, Phenyl chloro formate and Sodium
hydroxide in presence of Di isopropyl ethyl amine to give stage-2 product
Stage-3
Stage-2 product reacts with Hydrochloric acid in presence of Ethyl acetate to give
stage-3 product
Stage-4
Stage-3 product undergoes purification in Ethyl acetate and Methanol to give
Duloxetin Hydrochloride product
Route of synthesis
Stage-1
OH
F
S CH3
N DMSO, Potassium hydroxide,
CH3 + toluene & Water
(S)-3-Dimethylamino-1-thiophen 1-fluoro
-2-yl-propan-1-ol naphthalene
C9H15NSO C10H7F
185.29 145.15

O
S CH3
N
CH3 + HF

(S)-N,N-Dimethyl-[3-(naphthalen 20.01
-1-yloxy)-3-thiophen-2-yl)-
propan-1-amine
C19H21NSO
311.44

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Stage-2

O
O OH
S CH3 O diisopropyl
N ethylamine
CH3 + + NaOH
HO O + Cl O
(S)-N,N-Dimethyl-[3-(naphthalen Oxalicacid Phenylchloro Water
40.00
-1-yloxy)-3-thiophen-2-yl)- C2H2O4 formate
propan-1-amine 90.03 C7H5ClO2
C19H21NOS 156.57
311.44

O O OH O O
S
NH
CH3 . HO O
+ + NaCl + O2
(S)-N-N-Dimethyl-[3-(naphthalen-1-yloxy) Methyl benzoate 58.44 32.00
-3-thiophen-2-yl-propan-1-oxalate] C8H8O2
C20H21NSO5 136.15
387.45

Stage-3

O O OH
O O OH
S Ethyl
NH S
acetate HN . HCl + HO O
CH3 . HO O + HCl
CH3
(S)-N-N-Dimethyl-[3-(naphthalen-1-yloxy) 36.46 Oxalic acid
Duloxetin hydrochloride
-3-thiophen-2-yl-propan-1-oxalate] Crude C2H2O4
C20H21NSO5 C18H20ClNOS 90.03
387.45 338.88

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Stage-4

O O
S S
NH . HCl Ethylacetate HN . HCl
CH3 Methanol CH3
Duloxetin hydrochloride Crude Duloxetin hydrochloride pure
C18H20ClNOS C18H20ClNOS
338.88 338.88

Flow chart:
(S)-3-Dimethylamino-
1-thiophen -2-yl-propan-1-ol
1-fluoronaphthalene
Toluene Recovery
Potassium hydroxide
DMSO Recovery
DMSO Stage-1 Effluent water
Toluene
Water
Stage-1
Oxalic acid
Phenyl chloro formate Diisopropyl ethylamine Recovery
Sodium hydroxide Stage-2 Effluent water
Diisopropyl ethylamine
Water

Stage-2
Hydrochloric acid
Ethyl acetate Ethyl acetate Recovery
Stage-3 Effluent water
Water

Stage-3 Methanol Recovery


Methanol Stage-4 Ethyl acetate Recover
Ethyl acetate

Duloxetin Hydrochloride

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Material Balance:

Material balance of Duloxetin Hydrochloride


Stage-1
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
(S)-3-Dimethylamino-1- 74.00 Stage-1 118.00
thiophen -2-yl-propan-1-ol
1-fluoronaphthalene 58.00 Toluene Recovery 190.00
Potassium hydroxide 10.00 Toluene loss 4.00
DMSO 200.00 DMSO Recovery 190.00
Toluene 200.00 DMSO loss 4.00
Water 300.00 Effluent water 316.00
(Water-300
DMSO-6,
Potassium hydroxide-10)
Process emission 7.98
(Hydrogen Fluoride)
Organic Residue 12.02
Process residue -6.02
Distillation Residue-6
(Toluene)
Total 842 Total 842

Material balance of Duloxetin Hydrochloride


Stage-2
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-1 118.00 Stage-2 135.00
Oxalic acid 35.00 Diisopropyl ethylamine Recovery 190.00
Phenyl chloro formate 60.00 Diisopropyl ethylamine loss 4.00
Sodium hydroxide 16.00 Effluent water 373.75
Diisopropyl ethylamine 200.00 (Water-300
Methyl benzoate -51.60, Sodium
chloride-22.15)
Water 300.00 Process emission 12.11
(Oxygen)
Organic Residue 14.14
Process residue -8.14
Distillation Residue-6
(Diisopropyl ethylamine)
Total 729 Total 729

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Material balance of Duloxetin Hydrochloride


Stage-3
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-2 135.00 Stage-3 106.00
Hydrochloric acid 13.00 Ethyl acetate Recovery 190.00
Ethyl acetate 200.00 Ethyl acetate loss 4.00
Water 300.00 Effluent water 334.40
(Water-300
Oxalic acid-31.40, Ethyl acetate-
3)
Organic Residue 13.60
Process residue -10.60
Distillation Residue-3
(Ethyl acetate)
Total 648 Total 648

Material balance of Duloxetin Hydrochloride


Stage-4
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-3 106.00 Duloxetin Hydrochloride 100.00
Methanol 200.00 Methanol Recovery 190.00
Ethyl acetate 200.00 Methanol loss 4.00
Ethyl acetate Recovery 190.00
Ethyl acetate loss 4.00
Organic Residue 18.00
Process residue -6
Distillation Residue-12
(Ethyl acetate-6, Methanol-6)
Total 506 Total 506

13. EMTRICITABINE

Process Description:
Stage-1
5-(4-Amino-5-fluoro-2-oxo-2H-pyrimidin-1-yl)-[1,3]Oxa thiolane-2-carboxylic acid-2-
isopropyl-5-methyl cyclo hexyl ester undergoes reduction with Sodium borohydride
in presence of Ethanol , Toluene and Isopropyl alcohol to give stage -1 product.
Stage-2
Stage-1 undergoes neutralization with Tri ethylamine in the presence of Methanol
and MDC to give stage -2 product.

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Stage-3
Stage-2 undergoes purification in Isopropyl alcohol and activated carbon to give
Emtricitabine.

Route of synthesis:
Stage-1:
NH2
F
CH3 N

O O N
O
O
S Ethanol
H3C CH3 Toluene, IPA
+ NaBH4 + 4 H2O + HCl
5-(4-Amino-5-fluoro-2-oxo-2H-pyrimidin-1-yl)
37.83 4X18=72.0 36.46
-[1,3]oxathiolane-2-carboxylic acid 2-isopropyl
-5-methyl-cyclohexyl ester
C18H26FN3O4S

399.48
NH2
F CH3
N

O N
O Cl
HO H OH

S H3C CH3
+ + H3BO3 + NaCl + 2 H2
4-Amino-5-fluoro-1-(2-hydroxy
Menthol Boric acid 58.44 4.00
methyl-[1,3]oxathiolan-5-yl)-1H-pyrimidin-2-one
C10 H20O 61.83
C8H11ClFN3O3S 156.26
283.70

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Stage-2:
NH2 NH2

F F
N N

O N O N
O Methanol O
+ (C2H5)3N
HO Cl MDC HO
H
S
S

4-Amino-5-fluoro-1-(2-hydroxy Triethyl amine 4-Amino-5-fluoro-1-(2-hydroxymethyl-


methyl-[1,3]oxathiolan-5-yl)-1H- [1,3]oxathiolan-5-yl)-1H-pyrimidin-2-one
pyrimidin-2-one C6H15N
C8H10FN3O3S
C8H11ClFN3O3S 101.19
247.25
283.70
+ (C2H5)3N.HCl

Triethyl amine
Hydrochloride
137.65
Stage-3:
NH2
NH2
F
F N
N

Purification O N
O N O
O IPA
HO
HO
S
S

Emtricitabine(Crude) Emtricitabine(Pure)

C8H10FN3O3S C8H10FN3O3S

247.25 247.25

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Flow chart:
5-(4-Amino-5-fluoro-2-oxo-2H-
pyrimidin-1-yl)-[1,3]Oxa thiolane-
2-carboxylic acid-2-isopropyl-5
-methyl cyclo hexyl ester
IPA.HCl (25%)
Dipotassium hydrogen phosphate
Sodium Hydroxide
Ethanol
Sodium borohydride
Toluene
Activated carbon Isopropyl alcohol Recovery
Isopropyl alcohol Toluene Recovery
Stage-1 Ethanol Recovery
Hydrochloric Acid
Water Effluent Water

Stage-1
Tri ethylamine
Activated carbon Methanol Recovery
Methanol Stage-2 MDC Recovery
MDC
Hyflow

Stage-2
IPA Recovery
Isopropyl alcohol Stage-3 Spent Carbon & Hyflow
Activated carbon
Hyflow

EMTRICITABINE

Material Balance:

Material Balance Of Emtricitabine


Stage-1
Batch Size:100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
5-(4-Amino-5-fluoro-2-oxo-2H- 200.00 Stage-1 130.00
pyrimidin-1-yl)-[1,3]Oxa
thiolane-2-carboxylic acid-2-
isopropyl-5-methyl cyclo hexyl
ester
IPA.HCl (25%) 73.20 Isopropyl alcohol Recovery 145.90
Dipotassium hydrogen 10.00 Isopropyl alcohol Loss 2.00
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phosphate
Sodium Hydroxide 11.00 Toluene Recovery 95.00
Ethanol 200.00 Toluene Loss 2.00
Sodium borohydride 19.00 Ethanol Recovery 190.00
Toluene 100.00 Ethanol Loss 4.00
Activated carbon 13.00 Effluent Water 1069.78
Isopropyl alcohol 100.00 (Water-982,
Sodium borate-32.9,
Dipotassium hydrogen
phosphate-10
Sodium chloride-32.02,
Generated water-9.86,
Toluene-3,)
Hydrochloric Acid 20.00 Spent Carbon 13.00
Water 1000.00 By-Product 78.23
(L-Menthol )
Process Emission 2.00
(Hydrogen) 0
Organic residue 14.29
Process residue-5.29
Distillation Resideu-9
(Ethanol-6
IPA-3)
Total 1746.20 Total 1746.20

Material Balance Of Emtricitabine


Stage-2
Batch Size: 100.0 Kg/Day
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 130.00 Stage-2 105.00
Tri ethylamine 47.00 Methanol Recovery 95.00
Activated carbon 5.00 Methanol Loss 2.00
Methanol 100.00 MDC Recovery 95.00
MDC 100.00 MDC Loss 2.00
Hyflow 5.00 Spent Carbon & Hyflow 10.00
Organic Residue 78.00
(Process residue-72
(Triethylamine-63.93,
Organioc impurities-8.07)
Distillation Residue-6
(MDC-3,Methanol-3
Total 387 Total 387

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Material Balance Of Emtricitabine


Stage-3
Batch Size:100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-2 105.00 Emtricitabine 100.00
Isopropyl alcohol 100.00 IPA Recovery 95.00
Activated carbon 5.00 IPA Loss 2.00
Hyflow 5.00 Spent Carbon & Hyflow 10.00
Organic Residue 8.00
Process Residue-5
Distillation Residue-3
(IPA-3)
Total 215.00 Total 215.00

14. IMATINIB MESYLATE

Process Description:

Stage-1

O-Toluidine undergoes nitration with Nitric acid in presence of Sulphuric acid and
IPA to give Stage-1 product

Further Spent Nitration MLs (H2SO4) neutralization with ammonia gas to give
Ammonia sulphate as by product

Stage-2

Stage-1 product reacts with cyanamide in the presence of nitric acid and n-Butanol ,
IPE & Methanol to give stage-2 product.

Stage-3

Stage-2 product undergoes Condensation with 2-Dimethylamino-1-(3-pyridyl)-2-


propen-1-one in the presence of n-Butanol, Methanol & 2-Propanol to give stage-3
as product.

Stage-4

Stage-3 product undergoes reduction with Tin (II) chloride in presence of Chloroform
& Ethyl acetate to give stage-4 product.

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Stage-5

Stage-4 product undergoes condensation with 4-(4-methyl piperazino methyl)


benzoyl chloride in presence of Chloroform, DMF & Ethyl acetate to give stage-5 as
product.

Stage-6

Stage-5 product undergoes Condensation with Methane sulfonic acid in presence


of Methanol to give Imatinib Mesylate as product.

Route of synthesis:

Stage-1:
CH3
NH2

IPA
+ HNO3 + 2 NH3
+ H2SO4
O-Toluidine Nitric acid 98.08 34.06
C7H9N
63.01
107.15
CH3
NH2

NO2 (NH4)2SO4 + H 2O
+
5-Nitro Toluidine 132.14 18.00
C7H8N2O2
160.21

Stage-2:
CH3 NH
CH3 H
N HNO3
NH2
NH2
N-Butanol,
Methanol & IPE NO2
NO2 + NH2CN + HNO3

5-Nitro Toluidine Cyanamide 2-Methyl-5-nitro-phenyl-


63.01
C7H8N2O2 42.03 guanidine Nitrate
C8H11N5O5
152.15
257.20

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Stage-3:
CH3
N
CH3

CH3 NH O
H
N HNO3
NH2

N
NO2 + n-Butanol, Methanol
+ NaOH
2-Methyl-5-nitro- 3-Dimethylamino-1-pyridin 40.0
phenyl-guanidine -3-yl-propenone
Nitrate C10H12N2O
C8H11N5O5
176.21
257.20

CH3
H
N N

NO2
H
N
N H 3C CH3 + 2H2O + NaNO3
+
(2-Methyl-5-nitro-phenyl)-(4-pyridin- Dimethyl amine 36.02 84.99
3-yl-pyrimidin-2-yl)-amine C2H7N
C16H13N5O2
45.08
307.31
Stage-4:

CH3 CH3
H H
N N N N

N N

Palladium on Carbon NH2


NO2 Tin(II) chloride,
Chloroform & Ethylacetate
3H2 N
N +
(N-(5-Amino-2-Methyl
(2-Methyl-5-nitro-phenyl)-(4-pyridin- Hydrogen phenyl)-4-
3-yl-pyrimidin-2-yl)-amine 3X2=6.00 (3-Pyridyl)-2-pyrimidine
C16H13N5O2 Amine
C16H15N5
307.30
277.32

+ 2H2O
2X18=36.00

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Stage-5:
Step-A:
H2C N N CH3 H 2C N N CH3

2HCl 2HCl

COOH COCl
+ SOCl2 Dimethylformamide
4-(4-Methyl-piperazin-1-ylmethyl)- 4-(4-Methyl-piperazin-1-ylmethyl)-
118.97
benzoic acid Dihydrochloride benzoyl chloride Dihydrochloride
C13H20Cl2N2O2
C13H19Cl3N2O
307.22
325.66

+ SO2 + HCl

64.06 36.45
Step-B
CH3
H N N CH3
N N

N
2 HCl
NH2
Chloroform, DMF &
N + COCl Ethylaceate

(N-(5-Amino-2-Methyl phenyl)-4- 4-(4-Methyl-piperazin-1-ylmethyl)-


(3-Pyridyl)-2-pyrimidine Amine benzoyl chloride Hydrochloride
C16H15N5 C13H17ClN2O.2HCl
277.32 325.66

HN N N
CH3

HN
CH3
O N
N
+ 3 HCl

4-(4-Methyl-piperazin-1-ylmethyl)-N-[4-methyl 109.38
-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-phenyl]-
benzamide(Imatinib)
C29H31N7O

493.60

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Stage-6:
N

HN N N
CH3

OH
HN
CH3 O S O
O N
N CH3 Methanol
+

4-(4-Methyl-piperazin-1-ylmethyl)-N-[4-methyl Methane Sulphonic acid


-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-phenyl]- CH4O3S
benzamide(Imatinib)
96.10
C29H31N7O
493.60

HN N N
CH3

OH
HN
CH3 O S O
O N
N CH3

Imatinib Methane Sulfonate


C29H31N7O.CH4O3S
589.71

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Flow Chart:
O-Toludine
Nitric acid
Sulfuric acid
IPA Stage-1 IPA Recovery
Water Effluent water

Stage-1
Nitric acid
Cyanamide
N-Butanol N-Butanol Recovery
Methanol IPE Recovery
IPE Stage-2 Methanol Recovery
Water Effluent water
Stage-2
3-dimethylamino-1-
(pyridyl0-2-propan-1- N-Butanol Recovery
one Methanol Recovery
Sodium hydroxide Stage-3 2-Propanol Recovery
N-Butanol Effluent water
Methanol
2-Propanol
Water
Stage-3
Stannous chloride Chloroform Recovery
Hydrogen Ethyl acetate Recovery
Chloroform Stage-4 Spent Palladium on carbon
Ethyl acetate Recovery
Palladium on carbon Effluent water
Water
Stage-4
4-(4-methylpiperazine
mono methyl)benzoic Chloroform Recovery
acid di HCl DMF Recovery
Stage-5
Thionyl chloride Ethyl acetate Recovery
Chloroform Effluent water
DMF
Ethyl acetate
Water
Stage-5 Stage-6 Methanol Recovery
Methane sulfonic acid
Methanol

IMATINIB MESYLATE

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Material Balance:

Material Balance of Imatinib mesylate


Stage-1
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
O-Toludine 31.00 Stage-1 42.00
Nitric acid 18.25 IPA Recovery 285.00
Sulfuric acid 28.50 IPA Loss 6.00
Ammonia 10.00 Effluent water 405.20
IPA 300.00 (Water-400, Generated Water-
5.2)
Water 400.00 By products 38.50
(Ammonium sulphate)
Organic residue 11.05
Process residue-2.05
Distillation Residue-9
(IPA)
Total 787.75 Total 787.75

Material Balance of Imatinib mesylate


Stage-2
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 42.00 Stage-2 69.00
Nitric acid 17.40 N-Butanol Recovery 285.00
Cyanamide 11.60 N-Butanol Loss 6.00
N-Butanol 300.00 IPE Recovery 190.00
Methanol 300.00 IPE Loss 10.00
IPE 200.00 Methanol Recovery 285.00
Water 300.00 Methanol Loss 6.00
Effluent water 300.00
(Water-300)
Organic residue 20.00
(Process residue-2
Distillation Residue-18
(Methanol-9, n-Butanol-9)
Total 1171.00 Total 1171

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Material Balance of Imatinib mesylate


Stage-3
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-2 69.00 Stage-3 80.00
3-dimethylamino-1-(pyridyl0-2- 47.30 N-Butanol Recovery 190.00
propan-1-one
Sodium hydroxide 10.75 N-Butanol Loss 10.00
N-Butanol 200.00 Methanol Recovery 190.00
Methanol 200.00 Methanol Loss 4.00
2-Propanol 200.00 2-Propanol Recovery 190.00
Water 300.00 2-Propanol Loss 10.00
Effluent water 332.80
(Water-300, Generated Water-
9.70, Sodium nittate-22.8)
Process emission 12.08
(Dimethylamine)
Organic residue- 8.17
(Process residue-2.17
Distillation Residue-6
(Methanol)
Total 1027.05 Total 1027.05

Material Balance of Imatinib mesylate


Stage-4
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-3 80.00 Stage-4 70.00
Tin(II) chloride 10.00 Chloroform Recovery 190.00
Hydrogen 1.56 Chloroform Loss 4.00
Chloroform 200.00 Ethyl acetate Recovery 285.00
Ethyl acetate 300.00 Ethyl acetate Loss 6.00
Palladium on carbon 10.00 Spent Palladium on carbon 10.00
Recovery
Water 400.00 Effluent water 423.40
(Water-400, Generated Water-
9.40, Ethyl acetate-4, Stannous
chloride-10 )
Organic Residue 13.16
(Process residue-2.16
Distillation Residue-11
(Chloroform -6,Ethyl acetate-5)
Total 1001.56 Total 1001.56

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Material Balance of Imatinib mesylate


Stage-5
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-4 70.00 Stage-5 87.00
4-(4-methylpiperazine mono 57.00 Chloroform Recovery 190.00
methyl)benzoic acid di HCl
Thionyl chloride 22.10 Chloroform Loss 4.00
Chloroform 200.00 DMF Recovery 285.00
DMF 300.00 DMF Loss 6.00
Ethyl acetate 300.00 Ethyl acetate Recovery 285.00
Water 300.00 Ethyl acetate Loss 6.00
Effluent water 309.00
(Water-300,Ethyl acetate-9)
Process Emission 38.45
(Sulphur dioxide-11.88,
Hydrogen chloride-26.57)
Organic residue 38.65
(Process Residue-23.65
Distillation Residue-15
(Chloroform-6, DMF-9)
Total 1249.1 Total 1249.1

Material Balance of Imatinib mesylate


Stage-6
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-5 87.00 Imatinib mesylate 100.00
Methane sulfonic acid 16.95 Methanol Recovery 285.00
Methanol 300.00 Methanol Loss 6.00
Organic residue 12.95
(Process residue-3.95
Distillation Residue-9
(Methanol)
Total 403.95 Total 403.95

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15. ITRCONAZOLE

Process Description
Stage-1
1-[2,(2,4-Dichloro-phenyl)-4-ethyl-[1,3] dioxolan-2-ylmethyl]-1H-[1,2,4] triazole reacts
with 2-{4-(4-hydroxy –phenyl)-piperazin -1-yl ]-4-isobutyl-2,4-di hydro-[1,2,4] triazol-
3-one in presence of sodium hydroxide , Toluene and Methanol to give
Itraconazole product

Route of Synthesis
Stage-1
N
N
N
O
O3SH3C O CH3 Touene,
O N
+ HO N N N CH3 + NaOH Methanol
Cl Cl N
1-[2-(2,4-Dichloro-phenyl)-4-ethy MDC, Water
2-{4-[4-(4-Hydroxy-phenyl)-piperazin- 40.00
l-[1,3]dioxolan 1-yl]-phenyl}-4-isobutyl-2,4-dihydro
-2-ylmethyl]-1H-[1,2,4]triazole; -[1,2,4]triazol-3-one
C14H15Cl2N3O5S C22H27N5O2
408.26 393.48

Cl Cl O CH3
N + CH3O2SONa + H2O
O O N N N CH3
N
NO Methane sulfonate 18.02
N ITRACONAZOLE
N Sodium
C35H38Cl2N8O4
705.63 118.09
Flowchart:
1-[2-(2,4-Dichloro-phenyl)-4-ethy l-
[1,3]dioxolan -2-ylmethyl]-1H-[1,2,4]triazole
2-{4-[4-(4-Hydroxy-phenyl)-piperazin-
1-yl]-phenyl}-4-isobutyl-2,4-dihydro
-[1,2,4]triazol-3-one
Sodium hydroxide Toluene Recovery
Toluene Methanol Recovery
Methanol Dichloro methane Recovery
Stage-1
Effluent Water
Dichloro methane
Water

Itraconazole

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Material Balance:

Material Balance of Itraconazole


Stage-1
Batch Size:100.00Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
1-[2-(2,4-Dichloro-phenyl)-4- 65.00 Itraconazole 100.00
ethy l-[1,3]dioxolan -2-
ylmethyl]-1H-[1,2,4]triazole
2-{4-[4-(4-Hydroxy-phenyl)- 63.00 Toluene Recovery 190.00
piperazin- 1-yl]-phenyl}-4-
isobutyl-2,4-dihydro -
[1,2,4]triazol-3-one
Sodium hydroxide 7.00 Toluene loss 4.00
Toluene 200.00 Methanol Recovery 190.00
Methanol 200.00 Methanol Loss 4.00
Dichloro methane 200.00 Dichloro methane Recovery 190.00
Water 500.00 Dichloro methane loss 4.00
Effluent Water 527.70
(Water-500,
Generated Water-2.9
Sodium Methane Sulfonate-
18.80, Toluene-6
Organic residue 25.30
Process residue-13.3
Distillation Residue-12
(Methanol-6,
Dichloro methane -6)
Total 1235 Total 1235

16. KETORLAC TROMETHAMINE

Process Description

Stage-1

Step-A

Benzoyl chloride reacts with Morpholine in presence of Sodium hydroxide and


Toluene to give step-A product

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Step-B
Step-A product reacts with pyrrole and phosphorus oxy chloride in presence of
Sodium hydroxide and water to give stage-1 product
Stage-2
Di ethyl malonate reacts with Ethyl chloroforate in presence of Magnesium oxide,
Hydrochloric acid, Toluene and water to give stage-2 product
Stage-3
Stage-1 product reacts with stage-2 product in presence of Potassium
permanngate, Manganesactate, Acetic acid and acetic anhydride to give stage-3
product
Stage-4
Stage-3 product reacts with Dichloro ethane in presence of water, Tetra-n-butyl
ammonium bromide (TBAB) and Ethylene Dichloride (EDC) to give stage -4 products
Stage-5
Stage-4 product undergoes hydrolysis with Sodium hydroxide, water and
Hydrochloric acid in presence of Ethyl acetate to give Ketorolac product
Stage-6
Ketorolac Crude reacts with Tromethamine in presence of Acetone and Ethyl acetate
to give Ketorolac Tromethamine

Route of synthesis
Stage-1
Step-A

O
Cl O N
HN Toluene
O + + NaOH O + NaCl
Morpholine 40.00 Water Morpholin-4-yl- 58.44
Benzoyl chloride
phenyl-methanone
C7H5ClO C4H9NO
C11H13NO2
140.57 87.12 + H2O
191.23
18.02

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Step-B

O O
H
N N
N Water
O + H + POCl3 + 3 NaOH
Morpholin-4-yl- Pyrrole 153.33 119.99 Phenyl-(1H-pyrrol-2-yl)
phenyl-methanone
C4H5N -methanone
C11H13NO2 C11H9NO
191.23 67.09
171.20

O
+ 3 NaCl + H3PO4
HN
Morpholine 175.33 97.99
C4H9NO
87.12

Stage -2
O O
O

O O + MgO + O Cl Toluene , Water


+ HCl
Diethyl malonate 40.30 Ethylchloroformate 36.46
C7H12O4 C3H5ClO2
160.17
108.52
O O
O O

O O

+ MgCl2 + H2 O
Triethyl methane tricarboxylate 95.21 18.02
C10H16O6
232.23

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Stage-3
O O
O O O
H
N
O O
Manganesactate,Potassium per mamganate , Acetic
+ acid & Acetic anhydride
Phenyl-(1H-pyrrol-2-yl) 2-Ethoxycarbonyl-malonic water
-methanone acid diethyl ester
C11H9NO C10H16O6
171.20 232.23 O O O
H O
N
O
O
O
+ H2
2-(5-Benzoyl-1H-pyrrol-2-yl)-2-
ethoxycarbonyl-malonic acid diethyl ester 2.02
C21H23NO7
401.41

Stage-4

O O O
H O
N
O
O Cl
O
+ Cl H2O TBAB, EDC
+
2-(5-Benzoyl-1H-pyrrol-2-yl)-2- Dichloroethane
ethoxycarbonyl-malonic acid diethyl ester 18.02 Water
C21H23NO7 C2H4Cl2

401.41 98.96
O
O
N
O
O
O
+ 2 HCl + C2H5OH + CO2
5-Benzoyl-2,3-dihydro-pyrrolizine-1,
72.92 46.07 44.01
1-dicarboxylic acid diethyl ester
C20H21NO5

355.38

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Stage-5

O
O
N
O
O
O Ethyl acetate
+ NaOH + HCl + H2O
5-Benzoyl-2,3-dihydro-pyrrolizine-1, Water
40.00 36.46
1-dicarboxylic acid diethyl ester 18.02
C20H21NO5
355.38
O
N

H O
OH
O + O + NaCl + C2H5OH + 0.5 O2
Ketorolac Formic acid ethyl ester 58.44 46.07
16.00
C15H13NO3 C3H6O2
255.27 74.08

Stage-6
O
N
HO
OH
OH
O HO NH2
+ Ethyl acetate
Ketorolac Acetone
Tromethamine
C15H13NO3
C4H11NO3
255.27 O
121.14 N HO
OH
OH
O HO NH2
.

Ketorolac Tromethamine
C19H24N2O6

376.40

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Flow chart:
Benzoyl chloride
Morpholine
Sodium hydroxide
Toluene
Pyrrole Toluene Recovery
Phosphoryl chloride Stage-1 Effluent water
Water

Diethylmalonate
Magnesium oxide
Ethylchloroformate Toluene Recovery
Hydrochloric acid Stage-2 Effluent water
Toluene
Water

Stage-1
Stage-2
Manganese acetate
Acetic acid Recovery
potassium permanganate
Stage-3 Effluent water
Acetic acid
Acetic anhydride
Water

Stage-3
Dichloroethane (EDC) EDC Recovery
TBAB Stage-4
Effluent water
Water

Stage-4
Sodium hydroxide
Hydrochloric acid Ethyl acetate Recovery
Stage-5 Effluent water
Ethyl acetate
Water

Stage-5 Ethyl acetate Recovery


Tromethamine Stage-6 Acetone Recovery
Acetone
Ethyl acetate

Ketorolac Tromethamine

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Material Balance

Material Balance of Ketorolac Tromethamine


Stage-1
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Benzoyl chloride 71.00 Stage-1 73.00
Morpholine 44.00 Toluene Recovery 190.00
Sodium hydroxide 77.30 Toluene Loss 4.00
Toluene 200.00 Effluent water 713.12
Pyrrole 32.00 (water-500,Sodium chloride-
112.94, Generated water-9.10,
Toluene-3, Phosphoric acid-
46.63, Morpholine-41.45)
Phosphoryl chloride 73.00 Organic Residue 17.18
Water 500.00 Process residue-14.18
Distillation residue -3
(Toluene -3)
Total 997.3 Total 997.3

Material Balance of Ketorolac Tromethamine


Stage-2
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Diethylmalonate 71.00 Stage-2 99.00
Magnesium oxide 18.00 Toluene Recovery 190.00
Ethylchloroformate 48.00 Toluene Loss 4.00
Hydrochloric acid 16.20 Effluent water 550.20
Toluene 200.00 (water-500, Magnesium
chloride-42.20, Generated
Water-8)
Water 500.00 Organic Residue 10.00
Process residue-4
Distillation residue -6
(Toluene -6)
Total 853.2 Total 853.2

Material Balance of Ketorolac Tromethamine


Stage-3
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 73.00 Stage-3 152.00
Stage-2 99.00 Acetic acid Recovery 190.00
Manganese acetate 10.00 Acetic acid Loss 4.00

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potassium permanganate 10.00 Effluent water 754.00


Acetic acid 200.00 (water-500,
Manganese acetate -10,
potassium permanganate -10,
Acetic anhydride-234)
Acetic anhydride 234.00 Process emission 0.86
(Hydrogen)
Water 500.00 Organic Residue 25.14
Process residue-19.14
Distillation residue -6
(Acetic acid -6)
Total 1126 Total 1126

Material Balance of Ketorolac Tromethamine


Stage-4
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-3 152.00 Stage-4 118.00
Dichloroethane (EDC) 238.00 EDC Recovery 190.00
TBAB 10.00 EDC Loss 4.00
Water 500.00 Effluent water 527.45
(water-500,
TBAB-10, Ethanol-17.45)
Process emission 44.27
(Hydrogenchloride-27.61
Carbon dioxide-16.66)
Organic Residue 16.28
Process residue-10.28
Distillation residue -6
(EDC)
Total 900 Total 900

Material Balance of Ketorolac Tromethamine


Stage-5
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-4 118.00 Stage-5 76.00
Sodium hydroxide 13.50 Ethyl acetate Recovery 190.00
Hydrochloric acid 12.00 Ethyl acetate Loss 4.00
Ethyl acetate 200.00 Effluent water 562.40
Water 500.00 (water-500,
Sodium chloride-19.5, Ethanol-
15.30, Formic acid ethyl ester-
24.6, Ethyl acetate -3)

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Process emission 5.31


(Oxygen)
Organic Residue 5.79
Process residue-2.79
Distillation residue -3
(Ethyl acetate)
Total 843.5 Total 843.5

Material Balance of Ketorolac Tromethamine


Stage-6
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-5 76.00 Ketorolac Tromethamine 100.00
Tromethamine 36.00 Ethyl acetate Recovery 190.00
Acetone 200.00 Ethyl acetate Loss 4.00
Ethyl acetate 200.00 Acetone Recovery 190.00
Acetone Loss 4.00
Organic Residue 24.00
Process residue-12
Distillation residue -12
(Ethyl acetate-6, Acetone-6)
Total 512 Total 512

17. LANSPRAZOLE
Process Description
Stage-1
2, 3 –Lutidine reacts with Hydrogen Peroxide in presence of Acetic acid to give
stage-1 product
Stage-2

Stage-1 product reacts with Sulphuric acid, nitric acid and Ammonia to give stage-2
product

Stage-3

Stage-2 product reacts with trifuloro ethanol, Potassium carbonate ,Acetic anhydride
in presence of Tetra –n-butyl Ammonium bromide (TBAB),Sodium hydroxide ,
Methyl isobutyl ketone (MIBK),Isopropyl alcohol, Toluene and Acetone to give
stage-3 product

Stage-4
Stage-3 product reacts with Thionyl chloride in presence of DiChloro methane,
Acetone and Methanol to give stage-4 product

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Stage-5

Stage-4 Product reacts with 2-mercapto benimidazole in presence of Sodium


hydroxide and Acetone to give Stage-5 product

Stage-6

Stage-5 Product reacts with Sodium hypochlorite in presence of Ammonium sulphate


and Acetone to give Lansprazole product

Route of Synthesis:
Stage-1

CH3
CH3

Aceticacid N+ CH3
N CH3 + H2O2 H2O
O- +
2,3-Dimethyl-4-nitro
2,3-Lutidine 34.00 18.02
-pyridine
C7H9N N-oxide
107.16 C7H9NO
123.15

Stage-2
Methanol NO2
CH3 Sodium hydroxide CH3
methylenedichloride
+ H2SO4 + HNO3 + 2 NH3
N+ CH3 Water N CH3
O- O
2,3-Dimethyl-4-nitro 98.08 63.00 34.06
2,3-Dimethyl-
-pyridine
4-nitro-pyridine-N-
N-oxide
Oxide
C7H9NO C7H8N2O3
123.15 168.15

+ (NH4)2SO4 + H 2O
Ammonium sulphate 18.02
132.12

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Stage-3
NO2
CH3

N CH3
O CF3CH2OH + K2CO3 + (CH3CO)2O
+ + NaoH + HCl

138.21 Acetic
4-Nitro-2,3-Dimethyl Trifluoro 40.00 36.46
anhydride
pyridine-N-Oxide ethanol
102.09
C7H8N2O3 100.04

168.15
Tetra-n-butyl
ammonium bromide(TBAB)
Methylisobutyl
Water ketone(MIBK)
Isopropyl alcohol
Toluene
Acetone
OCH2CF3

CH3
. HCl

N CH2OH + KHCO3 + KNO2 + CH3COONa + CH3COOH


2-Hydroxy methyl-3-methyl Potassium
Potassium 82.03 60.05
pyridine hydrochloride bicarbonate
nitrite
C9H11ClF3NO2 100.12
85.10
257.64

Stage-4
OCH2CF3

CH3 OCH2CF3
. HCl Methylenedichloride
Acetone CH3
CH2OH methanol . HCl
N + SOCl2
N CH2Cl
2-Hydroxy methyl-3-methyl 118.97
pyridine hydrochloride 2-Chloromethyl-3-methyl-
4-(2,2,2-trifluoro-ethoxy)-pyridine
C9H11ClF3NO2 hydrochloride
257.64 C9H10Cl2F3NO
276.08

+ SO2 + HCl

64.06 36.46

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Stage-5
OCH2CF3
CH3 H
. HCl N
Acetone
CH2Cl HS
N + + 2NaOH
N
2-Chloromethyl-3-methyl- 2-Mercapto 79.99
4-(2,2,2-trifluoro-ethoxy)-pyridine benimidazole
hydrochloride
C9H10Cl2F3NO C7H6N2S
150.22
276.08

H
N
N
S
N

H3C O
F
F F + 2NaCl + 2H2O
2-[3-Methyl-4-(2,2,2-trifluoro-ethoxy)- 116.88 36.02
pyridin-2-ylmethylsulfanyl]-
1H-benzoimidazole
C16H14F3N3OS
353.36

Stage-6
H
N
N
S
N

O Acetone
H3C water
F
F F Ammonium Sulphate
+ NaOCl
2-[3-Methyl-4-(2,2,2-trifluoro-ethoxy)- Sodium
pyridin-2-ylmethylsulfanyl]- hypochlorite
1H-benzoimidazole
C16H14F3N3OS 74.44
353.36

H
N O
S N
N

H3C O
F +
F F NaCl

Lansprazole 58.44
C16H14F3N3O2S
369.36

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Flow chart:

2,3-Lutidine By-products
Hydrogen peroxide (50%) Stage-1 (Acetic acid+Generated Water)
Acetic acid

Stage-1
Sulphuric acid
Nitric acid Methanol Recovery
Ammonia Methylene di chloride recovery
Stage-2
Sodium hydroxide Effluent water
Methanol
Methylene di chloride
Water
Stage-2
Trifluoroethanol
Potassium carbonate
Acetic anhydride
Sodium hydroxide Isopropyl alcohol Recovery
Hydrochloric acid Methyl isobutyl ketone recovery
Tetra-n-butylammonium Toluene Recovery
Stage-3
bromide(TBAB) Acetone Recovery
Methyl isobutyl ketone Effluent water
Isopropyl alcohol
Toluene
Acetone
Water

Stage-3 Methylene dichloride Recovery


Thionyl chloride Methanol Recovery
Methylene dichloride Stage-4 Acetone Recovery
Methanol Effluent water
Acetone
Water

Stage-4 Acetone Recovery


2-Mercaptobanzimidazole Stage-5
Effluent water
Sodium hydroxide
Acetone
Water
Stage-5
Sodium hypo chlorite Acetone Recovery
Acetone Stage-6 Effluent water
Ammonium sulphate
Water

Lansprazole

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Material Balance:

Material Balance of Lansprazole


Stage-1
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
2,3-Lutidine 47.00 Stage-1 51.00
Hydrogen peroxide (50%) 30.00 By-products 222.90
(Acetic acid+ Water)
Acetic acid 200.00 Organic Residue 3.10
Process Residue-3.10

Total 277.00 Total 277.00

Material Balance of Lansprazole


Stage-2
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 51.00 Stage-2 63.00
Sulphuric acid 41.00 Methanol Recovery 190.00
Nitric acid 27.00 Methanol Loss 4.00
Ammonia 15.00 Methylene di chloride recovery 285.00
Sodium hydroxide 5.00 Methylene di chloride loss 6.00
Methanol 200.00 Effluent water 512.50
Methylene di chloride 300.00 (water-500, Generatedwater-
7.50, Sodium hydroxide-5)
Water 500.00 By-Product 55.00
(Ammonium sulphate)
Organic Residue 23.50
Process residue-8.5
Distillation residue -15
( Methanol-6, Methylene
dichloride-9)
Total 1139 Total 1139

Material Balance of Lansprazole


Stage-3
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-2 63.00 Stage-3 88.00
Trifluoroethanol 38.00 Isopropyl alcohol Recovery 190.00
Potassium carbonate 52.00 Isopropyl alcohol Loss 4.00
Acetic anhydride 39.00 Methyl isobutyl ketone recovery 190.00

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Sodium hydroxide 15.00 Methyl isobutyl ketone loss 10.00


Hydrochloric acid 14.00 Toluene Recovery 190.00
Tetra-n-butylammonium 10.00 Toluene loss 4.00
bromide(TBAB)
Methyl isobutyl ketone 200.00 Acetone Recovery 190.00
Isopropyl alcohol 200.00 Acetone loss 4.00
Toluene 200.00 By product 22.50
(Acetic acid)
Acetone 200.00 Effluent water 616.20
Water 500.00 (water-500, Potassium
bicarbonate-37.55, Potassium
nitrite-31.90,Sodium acetate-
30.75 , Toluene-6, TBAB-10)
Organic Residue 22.30
Process residue-10.3
Distillation residue -12
(Isopropyl alcohol-6, Acetone-6 )
Total 1531 Total 1531

Material Balance of Lansprazole


Stage-4
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-3 88.00 Stage-4 89.00
Thionyl chloride 41.00 Methylene dichloride Recovery 190.00
Methylene dichloride 200.00 Methylene dichloride Loss 4.00
Methanol 200.00 Methanol Recovery 190.00
Acetone 200.00 Methanol Loss 4.00
Water 500.00 Acetone Recovery 190.00
Acetone Loss 4.00
Effluent water 500.00
(water-500)
Process emission 34.27
(Sulphur dioxide-21.82
Hydrogen chloride-12.45)
Organic Residue 23.73
Process residue-5.73
Distillation residue -18
(Methanol-6, Methylene
dichloride -6, Acetone-6)
Total 1229 Total 1229

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Material Balance of Lansprazole


Stage-5
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-4 89.00 Stage-5 104.00
2-Mercaptobanzimidazole 49.00 Acetone Recovery 285.00
Sodium hydroxide 26.00 Acetone Loss 6.00
Acetone 300.00 Effluent water 549.30
Water 500.00 (water-500,Sodium chloride-37.7
Generated Water -11.6)
Organic Residue 19.70
Process residue-10.7
Distillation residue -9
( Acetone-9)
Total 964 Total 964

Material Balance of Lansprazole


Stage-6
Batch Size: 100Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-5 104.00 Lansprazole 100.00
Sodium hypo chlorite 22.00 Acetone Recovery 190.00
Acetone 200.00 Acetone Loss 4.00
Ammonium sulphate 25.00 Effluent water 542.00
Water 500.00 (water-500,Sodium chloride-17,
Ammonium sulphate-25)
Organic Residue 15.00
Process residue-9
Distillation residue -6
( Acetone)
Total 851 Total 842

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18. MESALAMINE

Process Description

Stage-1

2-Chloro benza ldehyde under goes nitration with Nitric acid in presence of
Sulphuric acid and water to give stage -1 product

Stage-2

Stage-1 reacts with Potassium permanganate and water in presence of Acetone to


give stage-2 product

Stage-3

Stage-2 undergoes Hydrolysis with Potassium hydroxide in presence of Acetone and


Ethyl acetate to give stage-3 product

Stage-4

Stage-3 product undergoes Hydrogenation with Hydrogen in presence of Raney


nickel and Methanol to give Mesalamine product

Route of synthesis:
Stage-1
Cl O

Cl O

H2SO4 + HNO3 Water NO2 + SO2 + 0.5 O2


+
63.01 2-Chloro-5-nitro- 64.06 16.00
2-Chloro-benzaldehyde 98.08
benzaldehyde
C7H5ClO C7H4ClNO3
+ 2 H2O
140.57 185.56
36.03

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Stage-2
Cl O
Cl O
OH

NO2 + H2
NO2 + H2O + Acetone
2 KMnO4 2-Chloro-5-nitro-
2-Chloro-5-nitro- 2.02
18.02 potassium benzoic acid
benzaldehyde C7H4ClNO4
permanganate
C7H4ClNO3
316.07 201.56
185.56
+ K2MnO4 + MnO2 + O2
potassium 86.94
manganate 32.00
197.13

Stage-3
Cl O OH O

OH OH

NO2 KOH Acetone & Ethyl acetate NO2 + KCl


+
2-Chloro-5-nitro- 56.11 2-Hydroxy-5-nitro- 74.55
benzoic acid benzoic acid
C7H4ClNO4 C7H5NO5
201.56 183.12

Stage-4

OH O OH O

OH OH

Raney Nickel,
NO2 Methanol O2
+ H2 NH2 +
2-Hydroxy-5-nitro- 2.02 Mesalamine 36.00
benzoic acid
C7H7NO3
C7H5NO5
153.14
183.12

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Flowchart:
2-chloro-benzaldehyde
Sulphuric acid
Nitric acid Stage-1 Effluent water
Water

Stage-1
Potassium
permanganate Acetone Recovery
Acetone Stage-2 Effluent water
Water

Stage-2
Potassium hydroxide Acetone Recovery
Acetone Stage-3 Ethyl acetate Recovery
Ethyl acetate Effluent water
Water

Stage-3
Raney Nickel Methanol Recovery
Hydrogen Stage-4 Raney nickel Recovery/Reuse
Methanol

Mesalamine

Material Balance:

Material Balance of Mesalamine


Stage-1
Batch Size:100kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
2-chloro-benzaldehyde 138.00 Stage-1 164.00
Sulphuric acid 96.50 Effluent Water 335.40
Nitric acid 62.00 (Water-300, Generated
Water -35.40)
Water 300.00 Process Emission 78.58
(Oxygen-15.70, Sulphur
dioxide-62.88))
Organic Residue 18.52
Total 596.5 Total 596.5

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Material Balance of Mesalamine


Stage-2
Batch Size:100kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 164.00 Stage-2 160.00
Potassium permanganate 279.50 Acetone Recovery 190.00
Acetone 200.00 Acetone loss 4.00
Water 300.00 Effluent Water 535.10
(Water-284,Potassium
manganate-174.25,
Manganese dioxide-76.85)
Process Emission 28.27
(Oxygen-28.27
Organic Residue 26.13
Process Residue-20.13
Distillation Residue-6
(Acetone)
Total 943.5 Total 943.5

Material Balance of Mesalamine


Stage-3
Batch Size:100kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-2 160.00 Stage-3 133.00
Potassium hydroxide 45.00 Acetone Recovery 190.00
Acetone 200.00 Acetone loss 4.00
Ethyl acetate 200.00 Ethyl acetate Recovery 190.00
Water 300.00 Ethyl acetate loss 4.00
Effluent water 365.20
(Water-300,Potassium
Chloride-59.20, Ethyl
acetate-6)
Organic Residue 18.80
Process Residue-12.8
Distillation Residue-6
(Acetone, )
Total 905 Total 905

Material Balance of Mesalamine


Stage-4
Batch Size:100kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-3 133.00 Mesalamine 100.00
Raney Nickel 10.00 Methanol Recovery 190.00

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Hydrogen 1.50 Methanol loss 4.00


Methanol 200.00 Raney nickel 10.00
Recovery/Reuse
Process emission 26.13
(Oxygen
Organic Residue 14.37
Process Residue-8.37
Distillation Residue-6
(Methanol)
Total 344.5 Total 344.5

19. OLEMESARTAN MEDOXOMIL

Process Description
Stage-1
Diamino maleonitrile reacts with Tri methyl orthobutarate in presence of Acetonitrile
to give stage-1 product
Stage-2
Stage-1 product reacts with Hydrochloric acid in presence of water to give stage-2
product
Stage-3
Step-A
Stage-2 product reacts undergoes Thionyl chloride in presence of Ethyl Acetate to
give step-a product
Step-B
Step-A product under goes Esterification with ethanol in presence of n-Hexane to
give stage-3 product
Stage-4
Stage-3 product reacts with Methyl magnesium chloride, water and Hydrochloric acid
in presence of Toluene, Di isopropyl ether and Acetone to give stage-4 product
Stage-5
Stage-4 product reacts with 4-[2-(Trityltetrazole)-5yl) phenyl] benzyl bromide (5-(4-
bromo methyl-biphenyl-2-yl)-2-trityl-2, 5-dihydro-1H-tetrazole in presence of Ethyl
acetate to give stage-5 product
Stage-6
Stage-5 product reacts with Lithium hydroxide mono hydrate in presence of Dioxane,
Ethyl acetate to give stage-6 product

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Stage-7
Stage-6 reacts with 4-Chloromethyl-5-methyl-[1,3]dioxol-2-one in presence of Ethyl
acetate and Di methyl acetamide to give stage-7 product
Stage-8
Stage-7 product reacts with water in presence of Acetic acid and Toluene to give
Olmesartan medoxomil

Route of Synthesis:

Stage-1
OCH3 NC
NC CN
C2H5 OCH3 N

OCH3 NC
H2N NH2 + Acetonitrile N CH3
H
DiaminoMaleonitrile Tri methyl orthobutarate 2-Propyl-1H-imidazole-4,5-
C4H4N4 (1,1,1-Trimethoxy-butane) dicarbonitrile
C7H16O3 C8H8N4
120.20
148.20 160.18

+ 3 CH3OH

96.13
Stage-2
NC
N

NC CH3
N Water
H + HCl + 4 H 2O
2-Propyl-1H-imidazole-4,5- 72.06
36.46
dicarbonitrile
C8H8N4 O

160.18 HO
HO N

N CH3
H
O + NH4Cl + NH3
2-Propyl-1H-imidazole-
53.49 17.03
4,5-dicarboxylic acid
C8H10N2O4
198.18

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Stage-3
Step-A
O

HO
HO N

N CH3
H Ethyl acetate
O + SOCl2
2-Propyl-1H-imidazole- 118.97
4,5-dicarboxylic acid O
C8H10N2O4
Cl
198.18
Cl N

N CH3
H
O + SO2 + H2O
2-Propyl-1H-imidazole-4,5 64.06 18.02
-dicarbonyl dichloride
C8H8Cl2N2O2
235.07
Step-B
O

Cl
Cl N

N CH3
H
n-Hexane
O + 2 C2H5OH
O
2-Propyl-1H-imidazole-4,5 92.14
-dicarbonyl dichloride
C2H5O
C8H8Cl2N2O2 N
C2H5O
235.07
N CH3
H
O + 2 HCl
2-Propyl-1H-imidazole-4,5- 72.92
dicarboxylic acid diethyl ester
C12H18N2O4

254.28

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Stage-4
O

C2H5O
C2H5O N

N CH3 Toluene ,
H Di isopropyl ether & Acetone
O + CH3MgCl + H2O + HCl
2-Propyl-1H-imidazole-4,5- 74.79 18.02
dicarboxylic acid diethyl ester 36.46

C12H18N2O4
CH3
254.28 HO
H 3C
C2H5O N

CH3
N
H
O + CH3OH + MgCl2 + 0.5 O
2
5-(1-Hydroxy-1-methyl-ethyl)-2-propyl- 32.04 95.21 16.00
3H-imidazole-4-carboxylic acid ethyl ester
C12H20N2O3
240.30

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Stage-5
Br

CH3 Ph Ph
HO Ph
H 3C N
N N
C2H5O N
N
N CH3 Ethyl acetate,
H
Sodium sulphate
O +
5-(1-Hydroxy-1-methyl-ethyl)-2-propyl- 4-[2-(TRITYLTETRAZOLE)-5YL)PHENYL]
3H-imidazole-4-carboxylic acid ethyl ester BENZYL BROMIDE
C12H20N2O3 (5-(4'-Bromomethyl-biphenyl-2-yl)-2-
trityl-2,5-dihydro-1H-tetrazole)
240.30
C33H25BrN4

557.48
CH3
HO
H 3C
C2H5O N

N CH3
O
Ph Ph
Ph

N N
N
N

+ HBr

5-(1-Hydroxy-1-methyl-ethyl)-2-propyl- 80.91
3-[2'-(2-trityl-2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-
3H-imidazole-4-carboxylic acid ethyl ester
C45H44N6O3

716.87

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Stage-6
CH3
HO
H3C
C2H5O N

N CH3
O
Ph Ph
Ph

N N
N
N

+ LiOH .H2O H 2O HCl


+ +
5-(1-Hydroxy-1-methyl-ethyl)-2-propyl- Lithium hydroxide 18.02 36.46
3-[2'-(2-trityl-2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]- monohydrate
3H-imidazole-4-carboxylic acid ethyl ester 41.96
C45H44N6O3

716.87 Dioxan, Ethyl acetate,


Sodium sulphate

CH3
HO
H3C
HO N

N CH3
O
Ph Ph
Ph

N N
N . 2 H2O
N

+ C2H5OH + LiCl
5-(1-Hydroxy-1-methyl-ethyl)-2-propyl-3-[2'-(2-trityl- 46.07 42.39
2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3H-
imidazole-4-carboxylic acid hydrate
C43H44N6O5
724.85

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Stage-7
CH3
HO
H3C
HO N

N CH3
O
Ph Ph
Ph
O
N N
N . 2 H 2O
O O
N
Ethyl acetate,
Cl Dimethylacetamide
+ H3C
5-(1-Hydroxy-1-methyl-ethyl)-2-propyl-3-[2'-(2-trityl- 4-Chloromethyl-5-methyl
2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3H- -[1,3]dioxol-2-one
imidazole-4-carboxylic acid hydrate C5H5ClO3
C43H44N6O5 148.54
724.85

O CH3
HO
O O H3C
N
O
H3C N CH3
O
Ph Ph
Ph
N N
N
N

+ 2 H2O + HCl

5-(1-Hydroxy-1-methyl-ethyl)-2-propyl- 36.03 36.46


3-[2'-(2-trityl-2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-
3H-imidazole-4-carboxylic acid 5-methyl-2-oxo-
[1,3]dioxol-4-ylmethyl ester
C48H44N6O6
800.90

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Stage-8

O CH3
HO
O O H3C
N
O
H3C N CH3
O
Ph Ph
Ph
N N
N
N

+ H 2O Acetic acid,Toluene
5-(1-Hydroxy-1-methyl-ethyl)-2-propyl-
18.02
3-[2'-(2-trityl-2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-
3H-imidazole-4-carboxylic acid 5-methyl-2-oxo-
[1,3]dioxol-4-ylmethyl ester
C48H44N6O6
800.90
O
HO CH3
O O H3C
N
O
H3C N CH3
O

HN N Ph Ph
N Ph
N
+ OH

Olmesartan Medoxomil Triphenyl-methanol


C29H30N6O6 C19H16O
558.59 260.33

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Flow chart:
DiaminoMaleonitrile
Trimethyl ortho butyrate
Stage-1 Acetonitrile Recovery
Acetonitrile

Stage-1
Hydrochloric acid Stage-2 Effluent water
Water
Stage-2
Thionyl chloride
Ethyl acetate
Ethanol Ethyl acetate Recovery
n-hexane Stage-3 n-hexane Recovery
Water Effluent water

Stage-3
Methyl magnesium chloride
Hydrochloric acid Toluene Recovery
Toluene Diisopropyl ether Recovery
Diisopropyl ether Stage-4 Acetone Recovery
Acetone Effluent water
Water
Stage-4
4-[2-(trityltetrazole)-5yl)
phenyl] benzyl bromide
Ethyl acetate Recovery
Sodium sulphate Stage-5 Effluent water
Ethyl acetate
Water
Stage-5
Lithium hydroxide Ethyl acetate Recovery
mono hydrate Dioxane Recovery
Hydrochloric acid Stage-6
Effluent water
Ethyl acetate
Dioxane
Sodium sulphate
Water

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Stage-6
4-Chloromethyl-5-methyl-
[1,3]diooxol-2-one
Ethyl acetate Ethyl acetate Recovery
Dimethylacetamide Dimethylacetamide Recovery
Stage-7 Effluent water
Water

Stage-7
Acetic acid Toluene Recovery
Toluene Stage-8 Effluent water
Water

Olmesartan Medoxomil

Material Balance:
Material Balance of Olmesartan Medoxomil
Stage-1
Batch Size:100.00Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
DiaminoMaleonitrile 41.00 Stage-1 51.00
Trimethyl ortho butyrate 51.00 Acetonitrile Recovery 190.00
Acetonitrile 200.00 Acetonitrile Loss 4.00
Generated Methanol 32.80
Organic Residue 14.20
Process residue-8.20
Distillation Residue-6
(Acetonitrile)
Total 292 Total 292

Material Balance of Olmesartan Medoxomil


Stage-2
Batch Size:100.00Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-1 51.00 Stage-2 58.00
Hydrochloric acid 12.00 Effluent water 294.05
(Water-277,
Ammonium chloride-17.05)
Water 300.00 Process emission 5.42
(Ammonia)
Organic Residue 5.53

Total 363 Total 363

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Material Balance of Olmesartan Medoxomil


Stage-3
Batch Size:100.00Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-2 58.00 Stage-3 64.00
Thionyl chloride 35.00 Ethyl acetate Recovery 190.00
Ethyl acetate 200.00 Ethyl acetate loss 4.00
Ethanol 26.00 n-hexane Recovery 190.00
n-hexane 200.00 n-hexane loss 4.00
Water 300.00 Effluent water 305.30
(Water-300,
Generated water-5.30)
Process emission 38.90
(Sulphur dioxide-18.74,
Hydrochloric acid-20.16))
Organic Residue 22.80
Process residue-10.8
Distillation Residue-
(Ethyl acetate-6, N-Hexane-6)
Total 819 Total 819

Material Balance of Olmesartan Medoxomil


Stage-4
Batch Size:100.00Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-3 64.00 Stage-4 55.00
Methyl magnesium chloride 19.00 Toluene Recovery 190.00
Hydrochloric acid 10.00 Toluene loss 4.00
Toluene 200.00 Diisopropyl ether Recovery 190.00
Diisopropyl ether 200.00 Diisopropyl ether loss 4.00
Acetone 200.00 Acetone Recovery 190.00
Water 300.00 Acetone loss 4.00
Effluent water 333.06
(Water-295
Methanol-8.10, Magnesium
chloride-23.96, Toluene-6)
Process emission 4.02
(Oxygen)
Organic Residue 18.92
Process residue-6.92
Distillation Residue-12
(Acetone -6, Diisopropyl ether -6)
Total 993 Total 993

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Material Balance of Olmesartan Medoxomil


Stage-5
Batch Size:100.00Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-4 55.00 Stage-5 155.00
4-[2-(trityltetrazole)-5yl)phenyl] 128.00 Ethyl acetate Recovery 190.00
benzyl bromide((5-(4'-
Bromomethyl-Biphenyl-2-
Yl)-2- Trityl-2,5-Dihydro-1H-
Tetrazole))
Sodium sulphate 75.00 Ethyl acetate loss 4.00
Ethyl acetate 200.00 Effluent water 300.00
(Water-300)
Water 300.00 By product 18.55
(Hydrobromic acid)
Inorganic solid waste 75.00
(Sodium sulphate)
Organic Residue 15.45
Process residue-9.45
Distillation Residue-6
(Ethyl acetate)
Total 758 Total 758

Material Balance of Olmesartan Medoxomil


Stage-6
Batch Size:100.00Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-5 155.00 Stage-6 144.00
Lithium hydroxide mono 10.00 Ethyl acetate Recovery 190.00
hydrate
Hydrochloric acid 8.00 Ethyl acetate loss 4.00
Ethyl acetate 200.00 Dioxane Recovery 190.00
Dioxane 200.00 Dioxane loss 4.00
Sodium sulphate 75.00 Effluent water 321.15
(Water-296,Ethyl acetate-6,
Ethanol-9.95, Lithium chloride-
9.20)
Water 300.00 Inorganic solid waste 75.00
(Sodium sulphate)
Organic Residue 19.85
Process residue-13.85
Distillation Residue-6
(Dioxane)
Total 948 Total 948

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Material Balance of Olmesartan Medoxomil


Stage-7
Batch Size:100.00Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-6 144.00 Stage-7 151.00
4-Chloromethyl-5-methyl- 30.00 Ethyl acetate Recovery 190.00
[1,3]diooxol-2-one
Ethyl acetate 200.00 Ethyl acetate loss 4.00
Dimethylacetamide 200.00 Dimethylacetamide Recovery 190.00
Water 300.00 Dimethylacetamide loss 4.00
Effluent water 313.15
(Water-300,Ethyl acetate-6,
Generated water -7.15)
Process emission 7.29
(Hydrogen chloride)
Organic Residue 14.56
Process residue-8.56
Distillation Residue-6
(Dimethylacetamide)
Total 874 Total 874

Material Balance of Olmesartan Medoxomil


Stage-8
Batch Size:100.00Kg
Name of the input Quantity Name of the out put Quantity
in Kg In Kg
Stage-7 151.00 Olmesartan Medoxomil 100.00
Acetic acid 200.00 Acetic acid Recovery 190.00
Toluene 200.00 Acetic acid loss 4.00
Water 300.00 Toluene Recovery 190.00
Toluene loss 4.00
Effluent water 351.10
(Water-296, Toluene -6,
Triphenylmethanol-49.10)
Organic Residue 11.90
Process residue-5.9
Distillation Residue-6
(Acetic acid)
Total 851 Total 851

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20. PENTAPRAZOLE CHLORO COMPOUND


(2-CHLOROMETHYL-3, 4-DIMETHOXY-PYRIDINE)
Process Description
Stage-1:
Maltol undergoes Methylation with Dimethyl sulphate in presence of Potassium
carbonate IPA , Acetone and Toluene to give Stage-1product.
Stage-2:
Stage-1 product reacts with Ammonium in presence of Toluene to give Stage-2
product.
Stage-3:
Stage-2 product. reacts with Phosphorous oxy chloride in presence of MDC to give
Stage-3 product.
Stage-4
Stage-3 product undergoes oxidation with Hydrogen peroxide in presence of
Methanol and MDC to give Stage-4 product.
Stage-5
Stage-4 product reacts with Sodium Methoxide in presence of Methanol to give
stage-5 product.
Stage-6
Step-A:
Stage-5 product undergoes Acetylation with Acetic anhydride in presence of MDC to
give Step-A product.
Step-B:
Step-A product undergoes Hydrolysis with Sodium Hydroxide in presence of
Methanol to give Stage-6 product.

Stage-7

Stage-6 product undergoes condensation with Hydrochloric acid in presence of


Methanol and MDC to give Pentaprazole Chloro Compound (2-Chloromethyl-3, 4-
Dimethoxy-Pyridine) product.

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Route of Synthesis:

Stage-1
O O
OH OCH3
2 IPA ,
Toluene&Acetone 2
+ (CH3)2SO4 + K2CO3
O CH3 O CH3

Maltol Dimethyl sulphate 138.21 3-Methoxy-2-methyl-pyran-4-one


C6H6O3 C7H8O3
126.13
2X126.11=252.22 2x140.14=280.28

+ K2SO4 + CO2 + H2O

174.26 44.0 18.0

Stage-2
O
O
OCH3
OCH3

O CH3 Water
+ NH3 N CH3
H + H2O
3-Methoxy-2-methyl- 17.03
pyran-4-one 3-Methoxy-2-methyl- 18.0
1H-pyridin-4-one
C7H8O3
C7H9NO2
140.14
139.15
Stage-3
O Cl
OCH3 OCH3

N CH3 water N CH3


H + 2 H2O + POCl3 + H3PO4
4-Chloro-3-methoxy-
3-Methoxy-2-methyl- 153.33 98.00
36.03 2-methyl-pyridine
1H-pyridin-4-one
C7H8ClNO
C7H9NO2 + 2 HCl
157.60
139.15 72.92

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Stage-4
Cl

Cl OCH3

OCH3
N CH3
Acetic acid,
N CH3 Methanol O + H2 O
+ H2O2
4-Chloro-3-methoxy- 4-Chloro-3-methoxy- 18.0
34.01
2-methyl-pyridine 2-methyl-pyridin-1-ol
C7H8ClNO C7H8ClNO

157.60 173.60
Stage-5
Cl OCH3

OCH3 OCH3

N CH3 N CH3

O + NaOH Methanol O
+ CH3OH
4-Chloro-3-methoxy- 40.0
32.0 3,4-Dimethoxy-2-
2-methyl-pyridin-1-ol
methyl-pyridin-1-ol
C7H8ClNO
C8H11NO3
173.60
169.18

+ NaCl + H2O

58.5 18.0
Stage-6
Step-A

OCH3
OCH3 OCH3
OCH3

N CH3
Chloroform N CH2OCOCH3
+ (CH3CO)2O + CH3COOH
O
Acetic acid 3,4-dimethoxy-
3,4-Dimethoxy-2- Acetic anhydride pyridin-2-ylmethyl ester 60.0
methyl-pyridin-1-ol 102.09 C10H13NO4
C8H11NO3
211.21
169.18

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Step-B

OCH3 OCH3

OCH3 OCH3

N CH2OCOCH3 N CH2OH
+ NaOH MDC , Water + CH3COONa

Acetic acid 3,4-dimethoxy- 40.0 (3,4-Dimethoxy-pyridin-


82.03
pyridin-2-ylmethyl ester 2-yl)-methanol
C10H13NO4 C8H11NO3

211.21 169.18

Stage-7

OCH3 OCH3
OCH3 OCH3
. HCl

N CH2OH + SOCl2 MDC,Methanol N CH2Cl + SO2


(3,4-Dimethoxy-pyridin- 118.97 2-Chloromethyl-3,4-dimethoxy- 64.06
2-yl)-methanol pyridineHydrochloride
C8H11NO3 (Pantaprazole chloro compound)
169.18 C8H11Cl2NO2
224.08

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Flow chart:
Maltol
Dimethyl sulphate
Potassium carbonate Mixed Solvents
Stage-1
Toluene (IPA+Toluene )
IPA Recovery
Acetone Acetone Recovery
Water Effluent water

Stage-1
Ammonia Stage-2 Effluent water
Water

Stage-2
Phosphorous oxy chloride
Sodium hydroxide Effluent Water
Stage-3
Water

Stage-3
Hydrogen peroxide
Methanol Acetic acidRecovery
Acetic acid Stage-4 Methanol Recovery
Water Effluent Water

Stage-4
Methanol
Sodium Hydroxide Methanol Recovery
Water Stage-5
Effluent Water

Stage-5
Acetic Anhydride
Chloroform Chloroform Recovery
Sodium hydroxide MDC Recovery
Stage-6
MDC Effluent Water
Water

Stage-6 Methanol Recovery


Hydrochloric acid MDC Recovery
Methanol Stage-7
Effluent water
MDC
Water

Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

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Material Balance:

Material Balance of Pentaprazole chloro compound


(2-Chloromethyl-3,4-Dimethoxy-Pyridine)
Stage-1
Batch Size: 500 Kg
Name of the input Quantity Name of the output Quantity
in Kg in Kg
Maltol 411.00 Stage-1 447.00
Dimethyl sulphate 206.00 Mixed Solvents 980.00
(IPA+Toluene ) Recovery
Potassium carbonate 359.00 Toluene Loss 10.00
Toluene 500.00 IPA loss 10.00
IPA 500.00 Acetone recovery 95.00
Acetone 100.00 Acetone loss 2.00
Water 100.00 Effluent water 266.36
(Water-100, Generated
water -29.36, Potassium
sulphate-137)
By-products 250.00
(Potassium carbonate)
Process Emission 71.69
(Carbon dioxide)
Organic residue- 43.95
(Process residue-40.95
Distillation Residue-3
(Acetone)
Total 2176 Total 2176

Material Balance of Pentaprazole chloro compound


(2-Chloromethyl-3,4-Dimethoxy-Pyridine)
Stage-2
Batch Size: 500Kg
Name of the input Quantity Name of the output Quantity
in Kg in Kg
Stage-1 447.00 Stage-2 432.00
Ammonia 54.50 Effluent water (Water-300, 357.47
Generated water-57.47)
Water 300.00 Organic residue- 12.03
(Process residue-12.03
Total 801.5 Total 801.5

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Material Balance of Pentaprazole chloro compound


(2-Chloromethyl-3,4-Dimethoxy-Pyridine)
Stage-3
Batch Size: 500Kg
Name of the input Quantity Name of the output Quantity
in Kg in Kg
Stage-2 432.00 Stage-3 474.00
Phosphorous oxy chloride 476.00 By product 707.62
(Phosphoric acid Water )
Water 500.00 Process Emission 226.38
(Hydrogen Chloride)
Total 1408 Total 1408

Material Balance of Pentaprazole chloro compound


(2-Chloromethyl-3,4-Dimethoxy-Pyridine)
Stage-4
Batch Size: 500Kg
Name of the input Quantity Name of the output Quantity in Kg
in Kg
Stage-3 474.00 Stage-4 509.00
Hydrogen peroxide (50%) 205.00 Acetic acid Recovery 95.00
Methanol 100.00 Acetic acid Loss 2.00
Acetic acid 100.00 Methanol Recovery 95.00
Water 300.00 Methanol Loss 2.00
Effluent Water 456.63
(Water-300, generated
Waetre-54.13, Water from
Hydrogen peroxide-
102.50)
Organic residue 19.37
Process Residue-13.37
Distillation Residue-6
(Acetic acid -3 Methanol-3
Total 1179 Total 1179

Material Balance of Pentaprazole chloro compound


(2-Chloromethyl-3,4-Dimethoxy-Pyridine)
Stage-5 Batch Size: 500 Kg
Name of the input Quantity Name of the output Quantity in
in Kg Kg
Stage-4 509.00 Stage-5 481.00
Methanol 194.00 Methanol Recovery 95.00
Sodium Hydroxide 117.50 Methanol Loss 2.00
Water 500.00 Effluent Water 724.35
(Water-500,
Sodium Chloride-171.52,
Generated water -52.83)

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Organic Residue 18.15


Process residue-15.15
Distillation Residue-3
(Methanol)
Total 1320.50 Total 1320.50

Material Balance of Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-


Pyridine)
Stage-6 Batch Size: 500Kg
Name of the input Quantity Name of the output Quantity
in Kg in Kg
Stage-5 481.00 Stage-6 461.00
Acetic Anhydride 290.50 Chloroform Recovery 190.00
Chloroform 200.00 Chloroform Loss 10.00
Sodium hydroxide 111.40 MDC Recovery 95.00
MDC 100.00 MDC loss 2.00
Water 200.00 Effluent Water 598.94
(Water-200, Acetic acid-
170.58,Sodium acetate-
228.36)
Organic residue- 25.96
(Process residue-22.96
Distillation Residue-3
(MDC)
Total 1382.90 Total 1382.9

Material Balance of Pentaprazole chloro compound


(2-Chloromethyl-3,4-Dimethoxy-Pyridine)
Stage-7 Batch Size: 500Kg
Name of the input Quantity Name of the output Quantity in Kg
in Kg
Stage-6 461.00 Pentaprazole chloro 500.00
compound (2-
Chloromethyl-3,4-
Dimethoxy-Pyridine)
Hydrochloric acid 99.50 Methanol Recovery 95.00
Methanol 100.00 Methanol Loss 2.00
MDC 100.00 MDC Recovery 95.00
Water 200.00 MDC Loss 2.00
Effluent water 249.10
(Water-200, Generated
water -49.10)
Organic residue 17.40
(Process residue-11.4
Distillation residue-6
(MDC-3 Methanol-3)
Total 960.5 Total 960.5

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21. PANTOPRAZOLE SODIUM

Process Description
Stage-1
2-Chloromethyl -3, 4-dimethoxy pyridine hydrochloride reacts with 5-
Difuloromethoxy-2-mercatobenzimidazole in presence of Acetone, Di chloro
methane and Isopropyl Alcohol to give stage-1 product
Stage-2

Stage-1 product undergoes oxidation with Sodium hydroxide in presence of Acetone


Di chloro methane to give Pantoprazole sodium

Route of Synthesis:
Stage-1:
SH

N NH
Toluene, Acetone ,
OCH3 Isopropylalcohol &
OCH3 Dichloromethane
+ O
HCl F Water
N CH2Cl + 2 NH4OH
F
2-Chloromethyl-3,4- 5-Difluoromethoxy-2- 70.08
dimethoxy-pyridine mercaptobenzimidazole
Hydrochloride C8H6F2N2OS
C8H10ClNO2.HCl
216.21
224.12
OCH3
OCH3
H
N
N CH2 S F
N O
F + 2 NH4Cl + 2 H2O
5-Difluoromethoxy-2-(3,4-dimethoxy-
106.98 36.04
pyridin-2-ylmethylsulfanyl)-
1H-benzoimidazole
C16H15F2N3O3S
367.37

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Stage-2
OCH3
OCH3
H
N
N CH2 S F
N O Acetone
F Dichloromethane
+ NaOCl + NaOH
5-Difluoromethoxy-2-(3,4-dimethoxy-
pyridin-2-ylmethylsulfanyl)- Sodium Sodium
1H-benzoimidazole hypochlorite hydroxide
C16H15F2N3O3S 40.0
74.44
367.37

OCH3
OCH3
O
N
N CH2 S F
N O
Na F
+ NaCl + H2O
58.5 18.0
Pantoprazole sodium
C16H14F2N3NaO4S
405.35
Flow Chart
2-Chloromethyl-3,4-dimethoxy-
pyridine Hydrochloride
5-Difluoromethoxy-2-
mercaptobenzimidazole
Ammonium hydroxide Acetone Recovery
Dichloromethane Dichloromethane Recovery
Acetone Isopropylacohol Recovery
Isopropylacohol Stage-1 Effluent water
Water

Stage-1
Acetone Recovery
Sodium hypochlorite
Dichloromethane Recovery
Sodium hydroxide Stage-2 Effluent water
Dichloromethane
Acetone
Water

Pantoprazole Sodium

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Material Balance:

Material Balance of Pantoprazole Sodium


Stage-1
Batch Size: 100 Kg
Name of the input Quantity Name of the output Quantity
in Kg in Kg
2-Chloromethyl-3,4-dimethoxy- 68.00 Stage-1 99.00
pyridine Hydrochloride
5-Difluoromethoxy-2- 66.00 Acetone Recovery 190.00
mercaptobenzimidazole
Ammonium hydroxide 22.00 Acetone Loss 4.00
MDC 200.00 MDC Recovery 190.00
Acetone 200.00 MDC Loss 4.00
Isopropylacohol 200.00 Isopropylacohol Recovery 190.00
Water 500.00 Isopropylacohol Loss 4.00
Effluent water 543.50
(Water-500,
Generated water-11
Ammonium chloride-32.5
Organic residue 31.50
Process residue-13.50
Distillation residue-18
(MDC-6, Acetone-6,
Isopropyl alcohol-6 )
Total 1256 Total 1256

Material Balance of Pantoprazole Sodium


Stage-2
Batch Size: 100 Kg
Name of the input Quantity Name of the output Quantity
in Kg in Kg
Stage-1 99.00 Pantoprazole Sodium 100.00
Sodium hypochlorite 20.00 Acetone Recovery 190.00
Sodium hydroxide 11.00 Acetone Loss 4.00
Dichloromethane 200.00 Dichloromethane Recovery 190.00
Acetone 200.00 Dichloromethane Loss 4.00
Water 500.00 Effluent water 520.80
(Water-500,
Generated water-5
Sodium chloride-15.80
Organic residue 21.20
Process residue-9.20
Distillation residue-12
(MDC-6, Acetone-6)
Total 1030 Total 1030

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22. PREGABALIN

Process Description

Stage-1

Iso valeraldehyde Reacts with Diethylmalonate in presence of Water to give stage-1


product

Stage-2

Stage-1 reacts with Sodium cyanide and Acetic acid in presence of Ethanol to give
stage-2 product

Stage-3

Stage-2 product undergoes Hydrolysis with Potassium hydroxide in presence of


methanol to give salt formation of stage-3 product

Stage-4

Stage-3 undergoes Hydrogenation with hydrogen in presence of Acetic acid, Raney


nickel and methanol to give stage-4 product

Stage-5

Stage-4 product under goes with tartaric acid in presence of Acetone to give stage-5
product

Stage-6

Stage-5 product reacts undergoes Hydrolysis with Sodium hydroxide in presence


of Toluene ,water and Hydrochloric acid to give stage-6(Pregabalin crude)
Product

Stage-7

Sdtage-6 (Pregabalin crude) product undergoes purification in Acetone, Activated


carbon and Isopropyl Alcohol to give Pregabalin product

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Route of Synthesis:

Stage-1
O O

CH3 H3C O O CH3


O O

O CH3 + H3C O O CH3


H3C CH3
Iso valeraldehyde
Diethylmalonate
C5H10O C7H12O4 2-(3-Methyl-butyl)-malonic acid
diethyl ester
86.13 160.17 C12H20O4
228.28

+ H2O

18.02
Stage-2
O O
O O
H3C O O CH3
H3C O O CH3

NC
H3C CH3
Ethanol H3C CH3
+ NaCN + CH3COOH
2-(3-Methyl-butyl)-malonic acid 2-(1-Cyano-3-methyl-butyl)-
49.01 60.05
diethyl ester malonic acid diethyl ester
C12H20O4
C13H21NO4
228.28
255.31

+ CH3COONa
Sodium acetate
82.03

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Stage-3
O O

H3C O O CH3

NC CH3 CN O

H3C CH3 Methanol H3C O- K+


+ KOH
2-(1-Cyano-3-methyl-butyl)- 56.11 Potassium; 3-cyano-5-
malonic acid diethyl ester methyl-hexanoate
C13H21NO4 C8H12KNO2
193.28
255.31
O
O
+ H3C O CH3
Ethyl methoxyacetate
C5H10O3
118.13
Stage -4
CH3 CN O
Raney Nickel
H3C O- K+ Methanol
+ CH3COOH + 2 H2
Potassium; 3-cyano-5- water
60.05 4.03
methyl-hexanoate
C8H12KNO2 H2N
193.28
CH3 O

H 3C OH + CH3COOK
3-Aminomethyl-5- 98.14
methyl-hexanoic acid
C8H17NO2
159.23

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Stage –5
H 2N
OH O
CH3 O
2 HO
OH
O OH Acetone
H3C OH +
3-Aminomethyl-5- Tartaric acid
methyl-hexanoic acid C4H6O6
C8H17NO2 150.09
2 x 159.23=318.46 H2N
OH O
CH3 O HO
OH
H3C OH . O OH
Isomer
+
3-Aminomethyl-5-methyl-hexanoic acid 159.23
,2,3-dihydroxy-succinic acid
C12H23NO8

309.31
Stage –6
H2N
OH O
CH3 O HO
OH
H 3C OH . O OH Toluene
+ NaOH + HCl

3-Aminomethyl-5-methyl-hexanoic acid 40.00 36.46


,2,3-dihydroxy-succinic acid
C12H23NO8

309.31

H2N OH O
CH3 O HO
OH
O OH + NaCl + H2O
H 3C OH +
Pregabalin Crude Tartaric acid 58.44 18.02
C4H6O6
C8H17NO2
150.09
159.23

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Stage-7
H2N H2N

CH3 O CH3 O
Activated Carbon
Acetone& IPA H3C OH
H 3C OH
Pregabalin
Pregabalin Crude
C8H17NO2 C8H17NO2

159.23 159.23

Flow Chart:

Iso valeraldehyde
Stage-1 Effluent water
Diethylmalonate
Water

Stage-1
Sodium cyanide
Acetic acid Ethanol Recovery
Ethanol Stage-2 Effluent water
Water

Stage-2
Potassium hydroxide
Methanol Methanol Recovery
Water Stage-3 Effluent water

Stage-3
Acetic acid
Hydrogen
Raney Nickel Stage-4 Methanol Recovery
Methanol Effluent water
Water

Stage-4
Tartric acid Acetone Recovery
Acetone Stage-5 Effluent water
Water

Stage-5
Sodium hydroxide
Toluene Recovery
Hydrochloric acid Stage-6 Effluent water
Toluene
Water

Stage-6 Acetone Recovery


Activated carbon Stage-7 IPA Recovery
Acetone
IPA

Pregabalin

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Material Balance:

Material Balance of Pregabalin


Stage-1
Batch Size: 100.0Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Iso valeraldehyde 553.00 Stage-1 1172.00
Diethylmalonate 1028.50 Effluent water 615.70
(Water-500,
Generated water-115.70)
Water 500.00 Organic Residue 293.80
Total 2081.5 Total 2081.5

Material Balance of Pregabalin


Stage-2
Batch Size: 100.0Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 1172.00 Stage-2 1114.00
Sodium cyanide 252.00 Ethanol Recovery 190.00
Acetic acid 309.00 Ethanol loss 4.00
Ethanol 200.00 Effluent water 921.10
(Water-500,
Sodium acetate- 421.10)
Water 500.00 Organic Residue 203.90
Process residue-197.9
Distillation Residue-
(Ethanol-6)
Total 2433 Total 2433

Material Balance of Pregabalin


Stage-3
Batch Size: 100.0Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-2 1114.00 Stage-3 759.00
Potassium hydroxide 245.00 Methanol Recovery 190.00
Methanol 200.00 Methanol loss 4.00
Water 500.00 Effluent water 500.00
(Water-500
Organic residue 606.00
(Process Residue-600
(Ethylmethoxyacetate-
515.35, Organic impurities-
84.65)
Distillation Residue-6

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(Methanol)

Total 2059 Total 2059

Material Balance of Pregabalin


Stage-4
Batch Size: 100.0Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-3 759.00 Stage-4 594.00
Acetic acid 236.00 Methanol Recovery 190.00
Hydrogen 16.00 Methanol loss 4.00
Raney Nickel 10.00 Effluent water 885.35
(Water-500
Potassium acetate-385.35)
Methanol 200.00 Spent Raney nickel 10.00
Recovery/reuse
Water 500.00 Organic residue 37.65
(Process Residue-31.65
Distillation Residue-6
(Methanol)
Total 1721 Total 1721

Material Balance of Pregabalin


Stage-5
Batch Size: 100.0Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-4 594.00 Stage-5 530.00
Tartric acid 280.00 Acetone Recovery 190.00
Acetone 200.00 Acetone loss 4.00
Water 500.00 Effluent water 500.00
(Water-500 )
Isomer Recovery /reuse for 297.00
product
Organic residue 53.00
(Process Residue-47
Distillation Residue-6
(Acetone)
Total 1574 Total 1574

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Material Balance of Pregabalin


Stage-6
Batch Size: 100.0Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-5 530.00 Stage-6 109.00
Sodium hydroxide 69.00 Toluene Recovery 190.00
Hydrochloric acid 63.00 Toluene loss 4.00
Toluene 200.00 Effluent water 631.00
(Water-500 , Sodium
chloride-100.15, Generated
Water-30.85)
Water 500.00 Tartaric acid Recovery 257.15
Organic residue 170.85
(Process Residue-164.85
Distillation Residue-6
(Toluene)

Total 1362 Total 1362

Material Balance of Pregabalin


Stage-7
Batch Size: 100.0Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-6 109.00 Pregabalin 100.00
Activated carbon 30.00 Acetone Recovery 190.00
Acetone 200.00 Acetone loss 4.00
IPA 200.00 IPA Recovery 190.00
IPA loss 4.00
Spent carbon 30.00
Organic residue 21.00
(Process Residue-9
Distillation Residue-12
(IPA-6, Acetone-6)
Total 539 Total 539

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23. ROSUVASTATIN

Process Description

Stage-1

4-Fluoro-Benzadehyde reacts with Methylisobutyrylacetate in presence of Piperadine


& Isopropyl Alcohol to give Stage-1 as product.

Stage-2
Stage-1 product reacts with 2-Methyl iso thio urea and Sodoium hydroxide &
Hydrochloric acid in presence of Water to give stage-2 as product.

Stage-3

Stage-2 product reacts with Manganese dioxide in presence of Dichloromethane


&Water to give Stage-3 product

Stage-4
Stage-3 product reacts with Sodium hypochlorite in presence of TEMPO, Sodium bi
carbonate & Dichloromethane to give Stage-4 as product.

Stage-5

Stage-4 product reacts with Methane amine in presence of Toluene to give Stage-5
as product.

Stage-6
Stage-5 product reacts with Methane sulfonic acid in presence of Toluene to give
Stage-6 as product.

Stage-7
Stage-6 product reacts with Sodium boro hydride in presence of Methanol to give
Stage-7 Product

Stage-8
Stage-7 product reacts with Hydrogen bromide in presence of Sodium bi carbonate
& Water to give Stage-8 as product.

Stage-9
Stage-8 product reacts with Triphenylphosphine in presence of Toluene to give
Sage-9 product.

Stage-10
Step-A
(6-Acetoxy-2,2-dimethyl-[1,3] dioxan-4-yl)-acetic acid tert-butyl ester reacts with
potassium carbonate & hydrochloric acid I presence of Methanol to give Step-A
product

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Step-B
Step-A product reacts with Sodium hypo chlorite in presence of Methanol to give
Stage-10 product
Stgae-11
Stage-10 undergoes condensation with Stage-9 Product in presence of Potassium
carbonate , DMSO , Dichloromethane & Methanol to give Stage-11 product

Stage-12
Stage-11 product undergoes condensation with Dicyclohexylamine in presence of
Water to give Stage-12 Product

Stage-13
Stage-12 Product reacts with Water to give Rosuvastatin product

Route of Synthesis:

Stage-1
O O
O
O
F
O O
Piperadine,
O Iso propylalcohol
F + + H2O
4-Fluoro- methyl isobutyryl 2-(3-Fluoro-benzylidene)-4-methyl-3- 18.02
benzaldehyde acetate oxo-pentanoic acid methyl ester
C7H5FO C7H12O3 C14H15FO3
124.11 144.17 250.27

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Stage-2
O O

NH

F H2N S Water
+ + NaOH + HCl
2-(4-Fluoro-benzylidene)- 2-Methyl-isothiourea 40.00 36.46
4-methyl-3-oxo-pentanoic acid
C2H6N2S
methyl ester
C14H15FO3 90.15
O
250.27
N O

S N

F + NaCl + 2 H O
2
6-(4-Fluoro-phenyl)-4-isopropyl-2- 58.44 36.04
methylsulfanyl-4,5-dihydro-pyrimidine-5-
carboxylic acid methyl ester
C16H19FN2O2S
322.40

Stage-3

N O

S N Water,
Dichloromethane
F + MnO2
6-(4-Fluoro-phenyl)-4-isopropyl-2-
methylsulfanyl-4,5-dihydro-pyrimidine-5- 86.94
carboxylic acid methyl ester O
C16H19FN2O2S
322.40 N O

S N
+ MnO2 + H2
F
86.94 2.02
4-(4-Fluoro-phenyl)-6-isopropyl-
2-methylsulfanyl-pyrimidine-5-carboxylic
acid methyl ester
C16H17FN2O2S
320.38

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Stage-4

N O

S N TEMPO, Sodium bicarbonate,


Dichloromethane
F + 2 NaOCl
4-(4-Fluoro-phenyl)-6-isopropyl-
2-methylsulfanyl-pyrimidine-5-carboxylic 148.88 O
acid methyl ester
C16H17FN2O2S
N O
320.38 O
S N
O
F + 2 NaCl
4-(4-Fluoro-phenyl)-6-isopropyl-2- 116.89
methanesulfonyl-pyrimidine-5-carboxylic
acid methyl ester
C16H17FN2O4S
352.38

Stage-5

O
O
N O
N O
O
N N
S N H
O Toluene F
F + H2N CH3
4-(4-Fluoro-phenyl)-6-isopropyl-2- Methyl amine 4-(4-Fluoro-phenyl)-6-isopropyl-
methanesulfonyl-pyrimidine- 2-methylamino-pyrimidine-5-
31.06 carboxylic acid methyl ester
5-carboxylic acid methyl ester
C16H17FN2O4S C16H18FN3O2

352.38 303.33

CH4 + SO2
64.06
16.04

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Stage-6

N O

N N OH
H
O S O
F + Toluene
4-(4-Fluoro-phenyl)-6-isopropyl- Methane
2-methylamino-pyrimidine-5- sulfonic acid
carboxylic acid methyl ester
CH3SHO3
C16H18FN3O2
96.11 O
303.33

N O
O
S N N
O
F + H2O

4-(4-Fluoro-phenyl)-6-isopropyl-2- 18.02
(methanesulfonyl-methyl-amino)-pyrimidine-
5-carboxylic acid methyl ester
C17H20FN3O4S
381.42

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Stage-7

N O
O
S N N
O
F + NaBH4 H2O
+ Methanol
4-(4-Fluoro-phenyl)-6-isopropyl-2- 37.83 18.02
(methanesulfonyl-methyl-amino)-pyrimidine-
5-carboxylic acid methyl ester
C17H20FN3O4S
381.42

N OH
O
S N N
O
F
+ NaBO2 + CH4 + H2
N-[4-(4-Fluoro-phenyl)-5-hydroxymethyl- 65.80
6-isopropyl-pyrimidin-2-yl]-N-methyl 16.04 2.02
-methanesulfonamide
C16H20FN3O3S
353.41

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Stage-8

N OH
O
S N N
O
Sodium bicarbonate
F + HBr
N-[4-(4-Fluoro-phenyl)-5-hydroxymethyl- 80.91
6-isopropyl-pyrimidin-2-yl]-N-methyl
-methanesulfonamide
C16H20FN3O3S
353.41
N Br
O
S N N
O
F + H2O
N-[5-Bromomethyl-4-(4-fluoro-phenyl)-
6-isopropyl-pyrimidin-2-yl]-N-methyl- 18.02
methanesulfonamide
C16H19BrFN3O2S
416.31

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Stage-9

N Br
O
Ph
S N N
Ph P
O
F + Ph Toluene
N-[5-Bromomethyl-4-(4-fluoro-phenyl)- Triphenylphosphine
6-isopropyl-pyrimidin-2-yl]-N-methyl-
methanesulfonamide C18H15P
C16H19BrFN3O2S
262.29
416.31

N Br
O Ph
S N N Ph P
O
F . Ph

N-[5-Bromomethyl-4-(4-fluoro-phenyl)-
6-isopropyl-pyrimidin-2-yl]-N-methyl-
methanesulfonamide; triphenyl-phosphane
C34H34BrFN3O2PS
678.59

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Stage-10

Step-A

O O O O

O O + K2CO3 Methanol
+ 2 HCl
(6-Acetoxy-2,2-dimethyl-[1,3] 138.21 72.92
dioxan-4-yl)-acetic acid tert-butyl ester
C14H24O6
288.34

O O O
HO
O + 2 KCl + 2 CO2 + H2
(6-Hydroxymethyl-2,2-dimethyl 149.10 88.01 2.02
-[1,3]dioxan-4-yl)-acetic acid tert-butyl ester
C13H24O5
260.33

Step-B

O O O
HO Methanol
O + NaOCl
(6-Hydroxymethyl-2,2-dimethyl 74.44
-[1,3]dioxan-4-yl)-acetic acid tert-butyl ester
C13H24O5
260.33
O O O
H
O

O + NaCl + H2O
(6-Formyl-2,2-dimethyl-[1,3]dioxan-
58.44 18.02
4-yl)-acetic acid tert-butyl ester
C13H22O5

258.31

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Stage-11

N Br
O Ph O O O
S N N Ph P + H
O O
F . Ph
O + K2CO3

N-[5-Bromomethyl-4-(4-fluoro-phenyl)- (6-Formyl-2,2-dimethyl-[1,3]dioxan- 138.20


6-isopropyl-pyrimidin-2-yl]-N-methyl- 4-yl)-acetic acid tert-butyl ester
methanesulfonamide; triphenyl-phosphane C13H22O5 2 HCl
+
C34H34BrFN3O2PS 258.31 72.92
678.59
DMSO, Dichloromethane & Methanol

O O O

O Ph
N
O
S N N Ph P
O
F Ph
+ 2 KCl + CO2 +
(6-{2-[4-(4-Fluoro-phenyl)-6-isopropyl-2- 44.01 Triphenyl
(methanesulfonyl-methyl-amino)-pyrimidin-5-yl] 149.10
phosphine
-vinyl}-2,2-dimethyl-[1,3]dioxan-4-yl)-acetic
C18H15P
acid tert-butyl ester
262.29
C29H40FN3O6S
577.71
+ HBr + 0.5O2 + H2O
80.91 16.00 18.02

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Stage-12

O O O

O
N
O H
S N N N
O
F + + 2 H 2O
(6-{2-[4-(4-Fluoro-phenyl)-6-isopropyl-2- Dicyclohexyl-amine 36.03
(methanesulfonyl-methyl-amino)-pyrimidin-5-yl] C12H23N
-vinyl}-2,2-dimethyl-[1,3]dioxan-4-yl)-acetic acid tert-butyl ester
181.32
C29H40FN3O6S
577.71

OH OH O
N
O
N
O OH

S N N
H3C CH3
O CH3
+
F 2-Methyl-propan-2-ol
7-[4-(4-Fluoro-phenyl)-6-isopropyl-2- C4H10O
(methanesulfonyl-methyl-amino)-pyrimidin-
74.12
5-yl]-3,5-dihydroxy-hept-6-enoic acid Dicyclohexyl-amine
C34H49FN4O6S
660.84 + HO

Propanol
C3H8O
60.10

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Stage-13

OH OH O
N
O
N
O
S N N
O
F
+ H2O
7-[4-(4-Fluoro-phenyl)-6-isopropyl-2-
(methanesulfonyl-methyl-amino)-pyrimidin- 18.02
5-yl]-3,5-dihydroxy-hept-6-enoic acid Dicyclohexyl-amine
C34H49FN4O6S
660.84
OH OH O

OH
N
O HO N
S N N
O
F +

Rosuvastatin
N,N-Dicyclohexyl
C22H28FN3O6S -hydroxylamine
481.54 C12H23NO
197.32

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ROSUVASTATIN CALCIUM
Flow-Chart:

4-Fluoro benzaldehyde
Methyl isobutyryl acetate
Piperidine Isopropyl alcohol Recovery
Isopropyl alcohol Stage-1 Effluent water
Water

Stage-1
2-Methyl iso thio urea
Sodium hydroxide Effluent water
Hydrochloric acid Stage-2
Water

Stage-2
Manganese dioxide
MDC MDC Recovery
Water Stage-3 Effluent water

Stage-3
Sodium hypo chlorite
TEMPO Dichloromethane Recovery
Dichloro methane Stage-4
Effluent water
Water

Stage-4
Methyl Amine Toluene Recovery
Toluene Effluent water
Stage-5
Water

Stage-5
Methane sulfonic acid Toluene Recovery
Toluene Stage-6 Effluent water
Water

Stage-6 Methanol Recovery


Sodium boro hydride Stage-7 Effluent water
Methanol
Water

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Stage-7
Hydrobromic acid
Sodium bicarbonate Stage-8 Effluent water
Water

Stage-8
Triphenylphosphine
Toluene Toluene Recovery
Stage-9
Water Effluent water

(6-Acetoxy-2,2-dimethyl-[1,3]
dioxan-4-yl)-acetic acid
tert-butyl ester
Potassium carbonate Methanol Recovery
Stage-10
Methanol Effluent water
Sodium hypo chlorite
Water
Stage-9
Stage-10 Methanol Recovery
Potassium carbonate Dichloromethane Recovery
Stage-11
DMSO DMSO Recovery
Dichloromethane Effluent water
Methanol
Water

Stage-11
Stage-12 Effluent water
Dicyclohexylamine
Water

Stage-12
Stage-13 Effluent water
Water

Rosuvastatin

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Material Balance:

Material Balance of Rosuvastatin


Stage-1
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
4-Fluoro benzaldehyde 62.00 Stage-1 114.00
Methyl isobutyryl acetate 72.00 Isopropyl alcohol Recovery 190.00
Piperidine 5.00 Isopropyl alcohol Loss 4.00
Isopropyl alcohol 200.00 Effluent water 514.25
Water 500.00 (Water-500
Generated water-9.25,
Piperidine-5)
Organic Residue 16.75
(Process residue-10.75
Distillation Residue-6
(Isopropyl alcohol)
Total 839 Total 839

Material Balance of Rosuvastatin


Stage-2
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 114.00 Stage-2 139.00
2-Methyl iso thio urea 41.00 Effluent water 543.10
Sodium hydroxide 19.00 (Water-500,gen water-16.45,
Sodium chloride-26.65)
Hydrochloric acid 17.0 Organic Residue 8.90
Water 500.00
Total 691 Total 691

Material Balance of Rosuvastatin


Stage-3
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-2 139.00 Stage-3 127.00
Manganese dioxide 10.00 MDC Recovery 190.00
MDC 200.00 MDC Loss 4.00
Water 500.00 Effluent water 510.00
(Water-500, Manganese
dioxide-10)
Process emission 0.86
(Hydrogen)

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Organic Residue 17.14


Process residue-11.14
Distillation Residue-6
(MDC)
Total 849 Total 849

Material Balance of Rosuvastatin


Stage-4
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-3 127.00 Stage-4 131.00
Sodium hypo chlorite 59.00 Dichloro methane Recovery 190.00
TEMPO 5.00 Dichloro methane Loss 4.00
Dichloro methane 200.00 Effluent water 551.35
Water 500.00 (Water-500,Sodium chloride-
46.35, TEMPO-5)
Organic Residue 14.65
Process residue-8.65
Distillation Residue-6
(Dichloro methane)
Total 891 Total 891

Material Balance of Rosuvastatin


Stage-5
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-4 131.00 Stage-5 103.00
Methyl Amine 12.00 Toluene Recovery 190.00
Toluene 200.00 Toluene Loss 4.00
Water 500.00 Effluent waters 500.00
(Water-500)
Process Emissions 29.76
(Methane-5.96, Sulphur
dioxide-23.8))
Organic Residue 16.24
(process residue-10.24
Distillation Residue-6
(Toluene)
Total 843 Total 843

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Material Balance of Rosuvastatin


Stage-6
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-5 103.00 Stage-6 123.00
Methane sulfonic acid 33.00 Toluene Recovery 190.00
Toluene 200.00 Toluene Loss 4.00
Water 500.00 Effluent water 506.15
(Water-500, Generated Water-
6.15)
Organic Residue 12.85
Process residue-6.85
Distillation residue-6
(Toluene)
Total 836 Total 836

Material Balance of Rosuvastatin


Stage-7
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-6 123.00 Stage-7 102.00
Sodium boro hydride 13.00 Methanol Recovery 190.00
Methanol 200.00 Methanol Loss 4.00
Water 500.00 Effluent water 515.38
(Water-494.18, Sodium meta
borate-21.2)
Process emission 5.82
(Hydrogen-0.65, Methane-
5.17)
Organic Residue 18.80
Process residue-12.8
Distillation Residue-6
(Methanol)
Total 836 Total 836

Material Balance of Rosuvastatin


Stage-8
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-7 102.00 Stage-8 108.00

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Hydrobromic acid 24.00 Effluent water 510.20


(Water -500, Generated water-
5.20, Sodium bicarbonate-5)
Sodium bicarbonate 5.00 Organic Residue 12.80
Water 500.00
Total 631 Total 631

Material Balance of Rosuvastatin


Stage-9
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-8 108.00 Stage-9 166.00
Triphenylphosphine 68.00 Toluene Recovery 190.00
Toluene 200.00 Toluene Loss 4.00
Water 500.00 Effluent water 506.00
(water-500
Toluene-6)
Organic Residue 10.00
Total 876 Total 876
Material Balance of Rosuvastatin
Stage-10
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
(6-Acetoxy-2,2-dimethyl-[1,3] 81.00 Stage-10 63.00
dioxan-4-yl)-acetic acid tert-
butyl ester
Potassium carbonate 39.00 Methanol Recovery 190.00
Methanol 200.00 Methanol Loss 4.00
Sodium hypo chlorite 20.00 Effluent water 562.16
Hydrochloric acid 21.00 (Water-500, Potassium
chloride-41.88, Sodium
chloride-15.48, Generated
water-4.80)
Water 500.00 Process emission 25.28
(Carbon dioxide-24.72,
Hydrogen-0.56)
Organic Residue 16.56
(Process residue-10.56
Distillation Residue-6
(Methanol -6)
Total 861 Total 861

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Material Balance of Rosuvastatin


Stage-11
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-9 166.00 Stage-11 132.00
Stage-10 63.00 Methanol Recovery 190.00
Potassium carbonate 34.00 Methanol Loss 4.00
DMSO 200.00 Dichloromethane Recovery 190.00
Dichloromethane 200.00 Dichloromethane Loss 4.00
Methanol 200.00 DMSO Recovery 190.00
Hydrochloric acid 18.00 DMSO Loss 4.00
Water 500.00 Effluent water 610.84
(Water-500,
Potassiumchloride-36.47
Triphenyl phosohine-63.97,
DMSO-6, generated water-4.4)
By-product 19.73
(Hydrogen bromide)
Process emission 14.67
(Carbon dioxide-10.76,
Oxygen-3.91)
Organic Residue 21.76
(Process residue-9.76
Distillation Residue-12
(Dichloromethane-6, Methanol-
6)
Total 1381 Total 1381

Material Balance of Rosuvastatin


Stage-12
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-11 132.00 Stage-12 145.00
Dicyclohexylamine 42.00 Effluent water 522.37
(Water-491.7, 2-Methyl-
propanol-16.95, Propanol-
13.72)
Water 500.00 Organic Residue 6.63
Total 674 Total 674

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Material Balance of Rosuvastatin


Stage-13
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-12 145.00 Rosuvastatin 100.00
Water 500.00 Effluent water 496.00
(Water-496,
Organic Residue 49.00
(N,N-
Dicyclohexylhydroxylamie-
43.3), Organivc impurities-
5.70)
Total 645 Total 645

24. SITAGLIPTIN PHOSPHATE MONOHYDRATE

Process Description

Stage-1

Step-A

(2, 4, 5-Trifluoro-phenyl) acetic acid reacts with Thionyl chloride and Meldrum acid
in presence of Sodium Hydroxide, Methylene dichloride, Methanol and Ethyl acetate
to give Step-A product
Step-B

Step-A product reacts with 3-(Trifluoro methyl) 5, 6, 7, 8-tetra hydro-[1,2,4]triazolo (4,


3-a) pyrazine hydrochloride in presence of Methane sulphonic acid , Sodium
carbonate, Methanol, Toluene and IPA to give Stage-1 product
Stage-2

Stage-1 produc reacts with Hydroxyl-phenyl acetic acid and sodium borohydride in
presence of Toluene, Methylene dichloride and Isopropylalcohol to give stage-2
product

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Stage-3

Stage-2 compound reacts with sodium hydroxide, phosphoric acid and water in
presence of Methylene dichloride and Isopropyl alcohol to give Sitagliptin Phosphate
Monohydrate.

Route of synthesis
Stage-1
Step-A
F F H 3C CH3
O Methylenedichloride Methanol,
O O
Ethyl acetate
F OH + SOCl2 + O O + 2 NaOH
(2,4,5-Trifluoro-phenyl) 118.97 Meldrums acid 80.00
-acetic acid
C6H8O4
C8H5F3O2
144.13
190.12

F F
OH O

F O
CH3
O O
CH3 + SO2 + + 2H2O
2 NaCl
5-[1-Hydroxy-2-(2,4,5-trifluoro-phenyl) 64.06 36.02
2X58.4=116.8
-ethylidene]-2,2-dimethyl-[1,3]
dioxane-4,6-dione
C14H11F3O5
316.23

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Step-B
F F
OH O
N
F O HN
N
CH3 N HCl
O O
CH3 CF3
+ + CH3SO3H + NaHCO3
5-[1-Hydroxy-2-(2,4,5-trifluoro-phenyl) 3-Trifluoromethyl-5,6,7,8-
-ethylidene]-2,2-dimethyl-[1,3] 96.11 84.01
tetrahydro-[1,2,4]triazolo[4,3-a]
dioxane-4,6-dione pyrazine Hydrochloride
C14H11F3O5 C6H8ClF3N4
+ NH3
316.23 228.60
17.03

Methanol, Toluene, IPA

F F
NH2 O

N
F N
N O
N HO
OH

CF3 HO
+ OH + OH
3-Amino-1-(3-trifluoromethyl-5,6-dihydro-8H- Propanetriol Lactic acid
[1,2,4]triazolo[4,3-a]pyrazin-7-yl)-4-(2,4,5-
C3H8O3 C3H6O3
trifluoro-phenyl)-but-2-en-1-one
C16H13F6N5O 92.09 90.08

405.30

+ NaCl + SO2 + O2

58.44 64.06 32.00

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Stage-2
F F
NH2 O

N OH
F N
N OH
N
O
CF3 +
+ NaBH4 + CH3COOH
3-Amino-1-(3-trifluoromethyl-5,6-dihydro-8H- Hydroxy-phenyl-
[1,2,4]triazolo[4,3-a]pyrazin-7-yl)-4-(2,4,5- acetic acid 37.83 60.05
trifluoro-phenyl)-but-2-en-1-one C8H8O3
+ 3 H2O
C16H13F6N5O 152.15
405.30 54.05

Methylene dichloride, Toluene &


Isopropylalcohol

F F
NH2 O

N
F N
N
OH N
OH CF3

O + CH3COONa + H3BO3 + 4 H2

3-Amino-1-(3-trifluoromethyl-5,6-dihydro- 82.03 61.83 8.00


8H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl)-4-
(2,4,5-trifluoro-phenyl)-but-2-en-
1-one Hydroxy phenyl acetate
C24H23F6N5O4
559.46

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Stage-3
F F
NH2 O

F N N
N
OH N
OH CF3 Methylenedichloride, Isopropylalcohol
O
+ NaOH + H3PO4
3-Amino-1-(3-trifluoromethyl-5,6-dihydro- 40.00 98.00
8H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl)-4-
(2,4,5-trifluoro-phenyl)-but-2-en-
1-one Hydroxy phenyl acetate
C24H23F6N5O4 CF3
559.46 N
F
N
N N
NH2 O ONa
F
OH
F
H3PO4 H2O + O

Sitagliptin Phosphate monohydrate Sodium mandelate


C16H20F6N5O6P C8H7NaO3
174.13
523.32

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SITAGLIPTIN PHOSPHATE MONOHYDRATE

Flow Chart
2,4,5-Trifluro phenyl acetic acid
3-(trifluoromethyl)-5,6,7,8-tetrahydro
(1,2,4)triazole(4,3,-a)Pyrazine hydrochloride
Methane sulfonic acid
Thionyl chloride
Meldrum acid
Sodium hydroxide
Sodium bicarbonate Methylene dichloride
Ammonia Recovery
Methylene dichloride Toluene Recovery
Ethyl acetate Ethyl acetate Recovery
Methanol Methanol Recovery
Stage-1
IPA IPA Recovery
Toluene Effluent water
Water

Stage-1
Sodium borohydrate
Hydroxyl phenyl acetic acid Methylene dichloride Recovery
Acetic acid Toluene Recovery
Stage-2 Isopropyl alcohol Recovery
Isopropyl alcohol
Toluene Effluent water
Methylene chloride
Water
Stage-2
Sodium hydroxide Methylene dichloride recovery
Phosphoric acid Isopropyl alcohol Recovery
Stage-3 Sodium mandelate recovery
Methylene chloride
Isopropyl alcohol Effluent water
Water

Sitagliptin Phosphate Monohydrate

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Material Balance

Material balance of Sitagliptin Phosphate Monohydrate


Stage-1
Batch size : 100kg
Name of the input Quantity Name of the out put Quantity
In kg In kg
2,4,5-Trifluro phenyl acetic acid 95.00 Stage-1 180.00
3-(trifluoromethyl)-5,6,7,8- 109.00 Methylene dichloride 95.00
tetrahydro(1,2,4)triazole(4,3,- Recovery
a)Pyrazine hydrochloride
Methane sulfonic acid 46.00 Methylene dichloride 2.00
Loss
Thionyl chloride 60.00 Toluene Recovery 95.00
Meldrum acid 72.00 Toluene Loss 2.00
Sodium hydroxide 40.00 Ethyl acetate Recovery 95.00
Sodium bicarbonate 40.00 Ethyl acetate Loss 2.00
Ammonia 8.00 Methanol Recovery 95.00
Methylene dichloride 100.00 Methanol Loss 2.00
Ethyl acetate 100.00 IPA Recovery 95.00
Methanol 100.00 IPA Loss 2.00
IPA 100.00 Effluent water 996.48
Toluene 100.00 (Water-800, Generated
water-17.99, Sodium
chloride-86.08, Lactic
acid-42.73, Ethyl acetate-
3 Propanetriol-43.68,
Toluene-3)
Water 800.00 Process emission 77.54
(Sulphur dioxide-62.37, 0
Oxygen-15.17)
Organic residue 30.98
Process residue -21.98
Distillation residue- 9
(MDC-3, Methanol-3, IPA-
3)
Total 1770.00 Total 1770.00

Material balance of Sitagliptin Phosphate Monohydrate


Stage-2
Batch size : 100kg
Name of the input Quantity Name of the out put Quantity
In kg In kg
Stage-1 180.00 Stage-2 115.00
Sodium borohydrate 8.50 Methylene dichloride 95.00
Recovery

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Hydroxyl phenyl acetic acid 34.00 Methylene dichloride Loss 2.00


Acetic acid 15.00 Toluene Recovery 95.00
Isopropyl alcohol 100.00 Toluene Loss 2.00
Toluene 100.0 Isopropyl alcohol Recovery 95.00
Methylene chloride 100.00 Isopropyl alcohol Loss 2.00
Water 800.00 Effluent water 822.93
(Water-788, Sodium acetate-
18.21, Boric acid-13.72,
Toluene-3)
Process emission 1.77
(Hydrogen-1.77)
Organic residue 106.80
Process residue-100.8,
(R-Isomer-90, Organic
impuritises-10.8)
Distillation residue - 6
( MDC-3, IPA-3)
Total 1337.50 Total 1337.50

Material balance of Sitagliptin Phosphate Monohydrate


Stage-3
Batch size : 100kg
Name of the input Quantity Name of the out put Quantity
In kg In kg
Stage-2 115.00 Sitagliptin Phosphate 100.00
Monohydrate
Sodium hydroxide 8.50 Methylene dichloride 95.00
Recovery
Phosphoric acid 20.50 Methylene dichloride Loss 2.00
Methylene chloride 100.00 Isopropyl alcohol Recovery 95.00
Isopropyl alcohol 100.00 Isopropyl alcohol Loss 2.00
Water 700.00 Sodium mandelate 35.79
recovery
Effluent water 700.00
(Water-700)
Organic residue 14.21
Process residue -8.21
Distillation residue-6
(MDC-3, IPA-3)
Total 1044.00 Total 1044.00

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25. SUMATRIPTAN SUCCINATE

Process Description

Stage-1

Para nitro benzyl bromide reacts with Sodium sulphite in presence of water to give
stage-1 product

Stage-2

Stage -1 product reacts with Phosphorus oxy chloride and Methyl amine in presence
of water and Toluene to give stage-2 product

Stage-3

Stage-2 undergoes Hydrogenation in presence of Raney nickel, Methanol and


Toluene to give stage-3 product

Stage-4

Stage-3 product reacts with Sodium nitrite and Hydrochloric acid in presence of
water Sodium dithionite, Methanol and Sodium hydroxide to give stage-4 product

Stage-5

Stage-5 reacts with 4-Chloro-1-hydroxy –butane – sodium sulfonic acid in presence


of Disodium hydrogen ortho phosphate, Dichloro methane and Methanol to give
stage-5 product

Stage-6

Stage-5 product reacts with Formaldehyde and Sodium borohydride in presence of


water and Methanol ethyl acetate to give stage-6 product

Stage-7

Stage-6 product with Succinic acid in presence of methanol to give Sumatriptan


succinate

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Route of Synthesis
Stage-1
CH2Br
CH2SO3Na
Water
+ Na2SO3
+ NaBr
NO2
NO2
Para nitro benzyl Sodium Sodium salt of (4-Nitro-phenyl) 102.89
bromide sulphite
C7H6BrNO2 -methanesulfonic acid
126.04
216.03 C7H6NNaO5S
239.18
Stage-2
CH2SO3Na

NO2 + POCl3 Toluene


+ CH3NH2 + 2H2O
Sodium salt of (4-Nitro-phenyl)
153.33 Monomethyl 36.03
-methanesulfonic acid
amine
C7H6NNaO5S 31.06
239.18
CH2SO2NHCH3

NO2 + H3PO4 + 2HCl + NaCl


4-nitro-Methayl benzene 98.00 72.92 58.44
methene sulfonamide
C8H10N2O4S
230.24
Stage-3

CH2SO2NHCH3 CH2SO2NHCH3
raney NickelNi,
Methanol
Toluene
NH2 + O2
NO2 + H2
(4-Amino)-N-methyl 32.00
4-nitro-Methayl benzene 2.02
benzene-
methene sulfonamide
methanesulfonamide
C8H10N2O4S
C8H12N2O2S
230.24 200.26

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Stage-4
CH2SO2NHCH3

Sodium hydroxide
Methanol
water
Sodium dithionite
NH2 + NaNO2 + 2 HCl
(4-Amino)-N-methylbenzene- sodium 72.92
methanesulfonamide nitrite
C8H12N2O2S CH2SO2NHCH3
69.00
200.26

.
HCl + NaCl + O2
NHNH2
4-Hydrazino-N-methyl- 58.44 32.00
benzenemethane
sulfonamide hydrochloride
C8H14N3O2SCl
251.73
Stage-5

O Cl
H Methanol,
H 3C N S H
Disodiumhydrogen
OH
O NH2 Cl orthophosphate,
N Dichloromethane
H + SO3Na
C-(4-Hydrazino-phenyl)-N 4-Chloro-1-hydroxy-butane-1-
-methyl-methanesulfonamide Sodium sulfonic acid
Hydrochloride C4H8ClNaO4S
C8H14ClN3O2S
210.61
251.73

O NH2
H
H 3C N S
O
N + NaCl + HCl + 2 H2O + SO2
H
C-[3-(2-Amino-ethyl)-1H-indol-5-yl] 58.44 36.46 36.03 64.06
-N-methyl-methanesulfonamide
C12H17N3O2S
267.35

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Stage-6

O NH2
H
H3C N S
Methanol
O Ethyl acetae
N
H Water
+ 2 CH2O + NaBH4
C-[3-(2-Amino-ethyl)-1H-indol-5-yl] Formaldehyde 37.83
-N-methyl-methanesulfonamide
60.05
C12H17N3O2S
267.35
O N CH3
H
H3C N S H3C
O
N + NaBO2 + 2H2
H
C-[3-(2-Dimethylamino-ethyl) Sodium 4.03
-1H-indol-5-yl]-N-methyl metaborate
-methanesulfonamide Oxalate
65.80
C14H21N3O2S
295.40
Stage-7

O N CH3
H
H 3C N S COOH
H3C
O
N Methanol
H + COOH
C-[3-(2-Dimethylamino-ethyl)-1H-indol Succinic acid
-5-yl]-N-methyl-methanesulfonamide C4H6O4
C14H21N3O2S 118.09
295.40

O N CH3
H
H3C N S H3C
O COOH
N
H
COOH
Sumatriptan succinate
C18H27N3O6S
413.49

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SUMATRIPTAN SUCCINATE
Flow Chart
Para Nitrobenzyl Bromide
Sodium Sulphite Stage-1 Effluent water
Water

Stage-1
Phosphoryl chloride
Mono methyl amine Toluene Recovery
Toluene Stage-2
Effluent water
Water
Stage-2
Hydrogen
Raney Nickel
Methanol Toluene Recovery
Toluene Stage-3 Methanol Recovery
Water Effluent water

Stage-3
Sodium nitrite
Hydrochloric acid
Sodium dithionate Methanol Recovery
Stage-4
Sodium hydroxide Effluent water
Methanol
Water
Stage-4
4-Chloro-1-hydroxy butane- Methanol recovery
1-sodium sulfonic acid Stage-5 Dichloromethane Recovery
Disodium hydrogen Effluent water
orthophosphate
Dichloromethane
Methanol
Water
Stage-5
Formaldehyde (50%) Methanol Recovery
Sodium borohydride Stage-6 Ethyl acetate Recovery
Methanol Effluent water
Ethyl acetate
Water
Stage-6
Succinic acid Methanol Recovery
Methanol Stage-7 Effluent water
Water

Sumatriptan Succinate

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SUMATRIPTAN SUCCINATE

Material Balance

Material Balance of Sumatriptan Succinate


Stage-1
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Para Nitrobenzyl Bromide 372.00 Stage-1 288.00
Sodium Sulphite 217.00 Effluent water 417.15
(Water-300,
Water 300.00
Sodium bromide-117.15)
Organic Residue 183.85
Total 889.0 Total 889.00

Material Balance of Sumatriptan Succinate


Stage-2
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 288.00 Stage-2 166.00
Phosphoryl chloride 185.00 Toluene Recovery 190.00
Mono methyl amine 38.00 Toluene loss 4.00
Toluene 200.00 Effluent water 444.35
(Water-256,
Water 300.00 Phosphoric acid-118
Sodium chloride-70.35)
Process emission 87.78
(Hydrogen chloride)
Organic Residue 118.87
Process residue-112.87
Distillation Residue-6.00
(Toluene )
Total 1011 Total 1011

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Material Balance of Sumatriptan Succinate


Stage-3
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-2 166.00 Stage-3 115.00
Hydrogen 1.50 Toluene Recovery 190.00
Raney Nickel 10.00 Toluene loss 4.00
Methanol 200.00 Methanol Recovery 190.00
Toluene 200.00 Methanol loss 4.00
Water 300.00 Effluent water 306.00
(Water-300
Toluene-6)
Process emission 23.05
(Oxygen)
Spent Raney Nickel 10.00
Recovery/Reuse
Organic Residue 35.45
Process residue-29.45
Distillation Residue-6.00
(Methanol)
Total 877.5 Total 877.5

Material Balance of Sumatriptan Succinate


Stage-4
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-3 115.00 Stage-4 108.00
Sodium nitrite 40.00 Methanol Recovery 190.00
Hydrochloric acid 42.00 Methanol loss 4.00
Sodium dithionate 15.00 Effluent water 358.55
(Water-300
Sodium hydroxide-10, Sodium
Sodium hydroxide 10.00
chloride-33.55, Sodium
dithionate-15)
Process emission 18.36
Methanol 200.00
(Oxygen)
Organic Residue 43.09
Process residue-37.09
Water 300.00
Distillation Residue-6.00
(Methanol)
Total 722 Total 722

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Material Balance of Sumatriptan Succinate


Stage-5
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-4 108.00 Stage-5 91.00
4-Chloro-1-hydroxy butane-1-sodium Methanol recovery 190.00
91.00
sulfonic acid
Disodium hydrogen orthophosphate 10.00 Methanol loss 4.00
Dichloromethane 200.00 Dichloromethane Recovery 190.00
Methanol 200.00 Dichloromethane Loss 4.00
Water 300.00 Effluent water 350.60
(Water-300,
Generated water-15.50 Sodium
chloride -25.10, Disodium
hydrogen orthophosphate-10)
Process emission 43.54
(Hydrogen chloride-16.07,
Sulphur dioxide-27.47)
Organic Residue 35.86
(Process residue-23.86
Distillation Residue-12
(Dichloromethane-6,
Methanol-6)
Total 909 Total 909

Material Balance of Sumatriptan Succinate


Stage-6
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-5 91.00 Stage-6 80.00
Formaldehyde (50%) 42.00 Methanol Recovery 190.00
Sodium borohydride 13.00 Methanol Loss 4.00
Methanol 200.00 Ethyl acetate Recovery 190.00
Ethyl acetate 200.00 Ethyl acetate Loss 4.00
Water 300.00 Effluent water 349.40
(Water-300
Water from Formaldehyde-21,
Sodium meta borate-22.40,
Ethyl acetate -6)
Process Emissions 1.36
(Hydrogen)

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Organic residue- 27.24


(Process residue-21.24
Distillation Residue-6
(Methanol-6)
Total 846 Total 846

Material Balance of Sumatriptan Succinate


Stage-7
Batch Size: 100.0Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-6 80.00 Sumatriptan Succinate 100.00
Succinic acid 32.00 Methanol Recovery 190.00
Methanol 200.00 Methanol Loss 4.00
Water 300.00 Effluent water 300.00
(Water-300)
Organic Residue 18.00
Process residue-12
Distillation Residue-6
(Methanol)
Total 612 Total 612

26. VELPATASVIR
Process description:
Stage-1
9-Bromo-3-(2-bromo-acetyl)-10,11-dihydro-5H,9H-6-oxa-benzo[a]anthracen-8-one
reacts with 4-Methoxymethyl-pyrrolidine -1,2-dicarboxylic acid 1-tert-butyl ester in
presence of MDC and Water to give Stage-1 product
Stage-2
Stage-1 product reacts with 1-(2-Methoxycarbonylamino-3-methyl -butyryl)-5-methyl-
pyrrolidine- 2-carboxylic acid and Ammonia in presence of THF and Caesium
Carbonate to give Stage-2 product
Stage-3
Stage-2 product reacts with Ammonium acetate in presence fo IPA and Toluene to
give Stage-3 product
Stage-4
Stage-3 product undergoes Dehydrogenation with DDQ in presence of THF and
Methanol to give Stage-4 product

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Stage-5
Stage-4 product reacts with Water in presence of Methanol, Phosphoric acid &
Hydrochloric acid to give Stage-5 product
Stage-6
Stage-5 product reacts with Acetyl amino-phenyl-acetic acid in presence of CDMT
and Methanol to give Velptasvir product.

Route of Synthesis
Stage-1
O O

Br
OH

O CH3
H3C O
N
CH3
Br O
+ CH3
O O + H2O
9-Bromo-3-(2-bromo-acetyl)-10,11 4-Methoxymethyl-pyrrolidine
-dihydro-5H,9H-6-oxa-benzo[a]anthracen-8-one 18.02
-1,2-dicarboxylic acid 1-tert-butyl ester
C19H14Br2O3 C12H21NO5
450.12
259.30

MDC

O
H3C CH3 O Br
O
CH3
O
N
O
H3C O

O O
+ HBr + CH3OH

2-(9-Bromo-8-oxo-8,9,10,11-tetrahydro-5H-6- 80.91 32.04


oxa-benzo[a]anthracene-3-carbonyloxycarbonyl)-4-methoxymethyl
-pyrrolidine-1-carboxylic acid tert-butyl ester
C30H32BrNO8

614.48

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Stage-2
H3C CH3
O O
H3C CH3 O Br
O H3C O
CH3 O N
O H OH
N N
H3C
H3C O O
O
O O + + 2 NH3
2-(9-Bromo-8-oxo-8,9,10,11-tetrahydro-5H-6- 1-(2-Methoxycarbonylamino-3-methyl
34.06
oxa-benzo[a]anthracene-3-carbonyloxycarbonyl)- -butyryl)-5-methyl-pyrrolidine-
4-methoxymethyl 2-carboxylic acid
-pyrrolidine-1-carboxylic acid tert-butyl ester C13H22N2O5
C30H32BrNO8
286.32
614.48

THF, Caesium carbonate

CH3
O
H3C
HN O

H3C N

CH3 O
HN
H3C CH3 O N
O
CH3
O
N
H3C O O

O O + HBr + 3H O
2

80.91
(2s,4s)-1-(TERT-BUTOXYCARBONYL)-4--(METHOXYMETHYL)PYRROLIDINE-2- 54.05
CARBOXYLIC2-(2s, 5s)-1((S)-2-(METHOXYCARBONYL)AMINO)-3-
METHYLBUTANOYL)5-METHYLPYRROLIDINE-2-YL)-1,4,511-
TETRAHYDROISOCHROMENO[4,3,6,7]NAPTHOL [1,2d]IMIAZOLE-9-CARBOXYLIC
ANHYDRIDE

C43H53N5O10
799.91

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Stage-3
CH3
O
H3C
HN O

H3C N

CH3 O
HN
H3C CH3 O N
O
CH3 NH4+
O
N -O
H3C O O
2
+ O
O O
Ammonium acetate
(2s,4s)-1-(TERT-BUTOXYCARBONYL)-4--(METHOXYMETHYL)PYRROLIDINE-2-
CARBOXYLIC2-(2s, 5s)-1((S)-2-(METHOXYCARBONYL)AMINO)-3- C2H7NO2
METHYLBUTANOYL)5-METHYLPYRROLIDINE-2-YL)-1,4,511-
TETRAHYDROISOCHROMENO[4,3,6,7]NAPTHOL [1,2d]IMIAZOLE-9- 77.08 X2=154.16
CARBOXYLIC ANHYDRIDE

C43H53N5O10
799.91
IPA,Toluene

CH3
O
H3C
HN O

H3C N
H3C CH3
O CH3 O
CH3 HN
O O N
N
O
H3C H
N
+ CH3COOH + CH3OH
N

2-(5-{2-[1-(2-Methoxycarbonylamino-3-methyl-butyryl)- 60.05 32.04


5-methyl-pyrrolidin-2-yl]-1,4,5,11-tetrahydro-12-oxa-1,3-diaza-
benzo[a]cyclopenta[h]anthracen-9-yl}-1H-imidazol-
2-yl)-4-methoxymethyl-pyrrolidine-1-carboxylic acid tert-butyl ester
+ 2 H2O+ O2
C44H55N7O7
793.95 36.02 32.00

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Stage-4
CH3
O
H3C
HN O

H3C N
H3C CH3
O CH3 O
CH3 HN
O O N
N
O
H3C H
N 2,3-Dichloro-5,6-dicyano-1,4-
benzoquinone(DDQ), Acetic acid ,
N THF, Methanol
2-(5-{2-[1-(2-Methoxycarbonylamino-3-methyl-butyryl)-
5-methyl-pyrrolidin-2-yl]-1,4,5,11-tetrahydro-12-oxa-1,3-diaza-
benzo[a]cyclopenta[h]anthracen-9-yl}-1H-imidazol-
2-yl)-4-methoxymethyl-pyrrolidine-1-carboxylic acid tert-butyl ester
C44H55N7O7
793.95 CH3
O
H3C
HN O

H3C N
H3C CH3
O CH3 O
CH3 HN
O O N
N
O
H3C H
N
+ H2
N

2-(5-{2-[1-(2-Methoxycarbonylamino-3-methyl-butyryl)- 2.02
5-methyl-pyrrolidin-2-yl]-1,11-dihydro-12-oxa-1,3-
diaza-benzo[a]cyclopenta[h]anthracen-9-yl}-1H-imidazol-2-yl)-4-
methoxymethyl-pyrrolidine-1-carboxylic acid tert-butyl ester

C44H53N7O7
791.93

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Stage-5
CH3
O
H3C
HN O

H3C N
H3C CH3
O CH3 O
CH3 HN
O O N
N
O H
H3C Phospohric acid, Hydrochloric acid
N
&Methanol
N + 2 H 2O

2-(5-{2-[1-(2-Methoxycarbonylamino-3-methyl-butyryl)- 36.03
5-methyl-pyrrolidin-2-yl]-1,11-dihydro-12-oxa-1,3-
diaza-benzo[a]cyclopenta[h]anthracen-9-yl}-1H-imidazol-2-yl)-4-
methoxymethyl-pyrrolidine-1-carboxylic acid tert-butyl ester

C44H53N7O7
791.93

CH3
O
H3C
HN O

H3C N

CH3 O
HN
O N
H3C CH3
NH O
O H CH3
H3C
N O
H
N
Acetic acid tert-butyl ester
+
[1-(2-{9-[2-(4-Methoxymethyl-pyrrolidin-2-yl) C5H10O2
-3H-imidazol-4-yl]-1,4,5,11-tetrahydro-12-oxa-1,3-diaza-
benzo[a]cyclopenta[h]anthracen-2-yl}-5-methyl-pyrrolidine 102.13
-1-carbonyl)-2-methyl-propyl]-carbamic acid methyl ester
C39H47N7O5 + O2

693.83 32.00

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Stage-6
CH3
O
H3C
HN O

H3C N
O
CH3 O
HN H
N CH3
O N HO
NH
O O
H3C H
N

N
+
[1-(2-{9-[2-(4-Methoxymethyl-pyrrolidin-2-yl) Acetylamino-phenyl-acetic acid
-3H-imidazol-4-yl]-1,4,5,11-tetrahydro-12-oxa-1,3-diaza-
benzo[a]cyclopenta[h]anthracen-2-yl}-5-methyl-pyrrolidine C10H11NO3
-1-carbonyl)-2-methyl-propyl]-carbamic acid methyl ester 193.20
C39H47N7O5
693.83

CDMT,
Methanol

CH3
O
H3C
O H3C
O HN O

H3C N
NH
CH3 O
HN
O O N
N
O H
H3C
N
+ 2 H2
N

4.03
Velpatasvir
C49H54N8O8
883.0

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Flow chart:
9-Bromo-3-(2-bromo-acetyl)-10,11 -
dihydro-5H,9H-6-oxa-benzo[a]anthracen-8-one
4-Methoxymethyl-pyrrolidine -1,2-
dicarboxylic acid 1-tert-butyl ester MDC Recovery
MDC Stage-1 Effluent water
Water

Stage-1
1-(2-Methoxycarbonylamino-3-
methyl -butyryl)-5-methyl-pyrrolidine-
2-carboxylic acid
AMMONIA THF Recovery
Stage-2
Caesium carbonate Effluent water
THF
Water
Stage-2
Ammonium acetate IPA Recovery
IPA Stage-3 Toluene Recovery
Toluene Effluent water
Water
Stage-3
DDQ Methanol Recovery
THF Stage-4 THF Recovery
Methanol Effluent water
Water
Stage-4
Phosphoric acid Methanol Recovery
Methanol Stage-5 Effluent water
Water

Stage-5
Acetylamino-phenyl-acetic acid
CDMT(2-Chloro-4,6-dimethoxy- Methanol Recovery
1,3,5-triazine) Stage-5 Effluent water
Methanol
Water

Velpatasvir

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Material balance:

Material Balance of Velpatasvir


Stage-1
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
9-Bromo-3-(2-bromo-acetyl)- 61.00 Stage-1 80.00
10,11 -dihydro-5H,9H-6-oxa-
benzo[a]anthracen-8-one
4-Methoxymethyl-pyrrolidine -1,2- 35.15 MDC Recovery 190.00
dicarboxylic acid 1-tert-butyl ester
MDC 200.00 MDC Loss 4.0
Water 100.00 Effluent water 101.90
(water-97.55, Methanol-4.35 )
By product 10.96
Hydrogen bromide
Organic residue 9.29
Process residue -3.29
Distillation Residue-6
(MDC)
Total 396.15 Total 396.15

Material Balance of Velpatasvir


Stage-2
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 80.00 Stage-2 102.00
1-(2-Methoxycarbonylamino-3- 37.30 THF Recovery 190.00
methyl -butyryl)-5-methyl-
pyrrolidine- 2-carboxylic acid
AMMONIA 4.50 THF Loss 4.0
Caesium carbonate 5.00 Effluent water 112.05
(water-100, generated water-
7.05, Caesium carbonate-5 )
THF 200.00 By product 10.52
(Hydrogen bromide)
Water 100.00 Organic residue 8.23
Process residue -2.23
Distillation Residue-6
(THF)
Total 426.80 Total 426.8

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Material Balance of Velpatasvir


Stage-3
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-2 102.00 Stage-3 98.00
Ammonium acetate 19.70 IPA Recovery 190.00
IPA 200.00 IPA Loss 4.0
Toluene 200.00 Toluene Recovery 190.00
Water 100.00 Toluene loss 4.00
Effluent water 116.35
(water-100, generated water-
4.6, Acetic acid-7.65, Methanol-
4.10)
Process emission 4.08
(Oxygen)
Organic residue 15.27
Process residue -3.27
Distillation Residue-12
(PA-6, Toluene-6)
Total 621.70 Total 621.7

Material Balance of Velpatasvir


Stage-4
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-3 98.00 Stage-4 95.00
DDQ 5.00 Methanol Recovery 285.00
THF 200.00 Methanol Loss 6.00
Methanol 300.00 THF Recovery 190.00
Acetic acid 200.00 THF loss 4.00
Water 100.00 Acetic acid Recovery 190.00
Acetic acid loss 4.00
Effluent water 105.00
(water-100, DDQ -5)
Process emission 0.24
(Hydrogen)
Organic residue 23.76
Process residue -2.76
Distillation Residue-21
(Methanol-9, THF-6, Acetic acid-
6)
Total 903 Total 903

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Material Balance of Velpatasvir


Stage-5
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-4 95.00 Stage-5 81.00
Phosphoric acid 5.00 Methanol Recovery 285.00
Hydrochloric acid 5.00 Methanol Loss 6.00
Methanol 300.00 Effluent water 105.65
(water-95.65, Phosphoric acid -
5, Hydrochloric acid -5)
Water 100.00 Process emission 3.83
(Oxygen)
Organic residue 23.52
Process residue -14.52
(Acetic acid tert butylester-
12.25, Organic imipurities-2.27)
Distillation Residue-9
(Methanol)
Total 505 Total 505

Material Balance of Velpatasvir


Stage-6
Batch Size: 100Kgs
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-5 81.00 Velpatasvir 100.00
Acetylamino-phenyl-acetic acid 22.60 Methanol Recovery 285.00
CDMT(2-Chloro-4,6-dimethoxy- 5.00 Methanol Loss 6.00
1,3,5-triazine)
Methanol 300.00 Effluent water 105.00
(water-100, CDMT(2-Chloro-4,6-
dimethoxy-1,3,5-triazine)-5)
Water 100.00 Process emission 0.46
(Hydrogen)
Organic residue 12.14
(Process residue-3.14
Distillation Residue-9
(Methanol)
Total 508.6 Total 508.6

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27. ZOLMITRIPTAN

Process Description

Stage-1

L-Phenylalanine undergoes nitration with nitric acid in presence of Sulphuric acid,


Ammonia and Sodium hydroxide to give stage-1 product

Stage-2

Stage-2 product reacts with Thionyl chloride and Methanol in presence of Methanol
to give stage-2 product

Stage-3

Stage-2 reacts with Ethyl chloroforamate in presence of Ethyl acetate Sodium


Hydroxide, n-hexane and methanol to give stage-3 product

Stage-4

Stage-3 product reacts with sodium borohydride, sodium Ethyl acetate and n-
Hexane to give stage-4 product

Stage-5

Stage-4 product reacts with Sodium methoxide, Hydrochloric acid ,water in


presence of Ethyl acetate , Methanol , and n-Hexane to give stage-5 product

Stage-6

Stage-5 product undergoes Hydrogenation with Hydrogen gas in presence of Raney


nickel, Methanol, Ethyl acetate and Isopropyl alcohol to give stage-6 product

Stage-7

Stage-6 product reacts with 4, 4 –Diethoxy –butyl –dimethyl amine in presence of


Methanol to give Zolmitriptan

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Route of synthesis:

Stage-1:
O

HO Sodium hydroxide,
methanol
NH2 + HNO3 + H2SO4 + 2 NH3
water
L-Phenylalanine 63.01 98.08 34.06
C9H11NO2
165.18 O

HO
NH2
NO2 + (NH4)2SO4 + H2O
L-Paranitro phenyl
alanine 132.14 18.02
C9H10N2O4
210.18

Stage-2:
O

HO O
NH2
NO2 + SOCl2 + CH3OH OH3C
L-Paranitro phenyl NH2
. HCl
118.97 32.04
alanine NO2
C9H10N2O4
210.18 L-Paranitro phenyl
alanine hydrochloride
C10H12N2O4.HCl
260.67

+ SO2 + HCl
64.06 36.45

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Stage-3
O Ethylacetate
n-hexane
OH3C O
. HCl Methanol
NH2 Sodium sulfate
NO2 + O Cl + 2 NaOH

L-Paranitro phenyl Ethyl 79.99


alanine hydrochloride Chloroformate
C10H12N2O4.HCl C3H5ClO2
260.67 O
108.52
OH3C
O NH
NO2 +
2 NaCl + 2H2O
O
4-Nitrobenzene-S- 116.88 36.03
(Ethyl carbamate)
methyl propanonate
C13H16N2O6
296.28

Stage-4
Sodium bicarbonate
O Ethyl acetate
n-Hexane
OH3C Sodium sulfate
O NH Carbon,Hi-flow
NO2 + NaBH4 + HCl + 3 H2O
O
4-Nitrobenzene-S-
38.03 36.46 54.05
(Ethyl carbamate)
methyl propanonate
C13H16N2O6
296.28
OH
O NH
NO2 + NaCl + H BO + CH OH + 2H
3 3 3 2
O
4-Nitrobenzene-2-S- 58.44 61.83 32.04 4.03
(Ethyl carbamate)-1-
propanol
C12H16N2O5
268.27

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Stage-5
Methanol
Ethyl acetate
n-Hexane
OH Sodiumsulfate
O NH Carbon,Hiflow
NO2 + CH ONa + HCl + H O
3 2
O
4-Nitrobenzene-2-S- 54.02 36.46 18.02
(Ethyl carbamate)-1-
propanol
C12H16N2O5
268.27

HN
O
NO2 + NaCl + C2H5OH + CO2 + 3H2
O
S-(4)-(4-Nitro-benzyl) 58.44 46.07 44.01 6.05
-2-oxazolidinone
C10H10N2O4
222.20

Stage-6:
Raney Ni,
Methanol
Ethyl acetate,
HN
HN Isopropyl alochol O
O Activated carbon NH2 + O2
NO2 + H2 O
O
S-(4)-(4-Nitro-benzyl) 2.02 (S)-4-(4-Amino-benzyl)- 32.00
-2-oxazolidinone oxazolidin-2-one
C10H10N2O4 C10H12N2O2
222.20 192.21

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Stage-7

HN
O Methanol
NH2 + H3C O CH3
O N
water/HCl
CH3 O
(S)-4-(4-Amino-benzyl)- CH3
oxazolidin-2-one (4,4-Diethoxy-butyl)
C10H12N2O2 -dimethyl-amine
192.21 C10H23NO2
189.30

H H
N N
O
O

+ 2C2H5OH + H2
(H3C)2N
Zolmitrptan 92.12 2.00
C16H21N3O2

287.35

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Flow chart:
L-Phenylalanine
Nitric acid
Sulphuric acid
Ammonia Methanol Recovery
Methanol stage-1 Effluent water
Sodium hydroxide
Water

Stage-1
Thionyl chloride Methanol Recovery
Methanol stage-2 Effluent water
Water

Stage-2
Ethyl chloroformate
Hydrochloric acid Ethyl acetate Recovery
Methanol stage-3 n-Hexane Recovery
Sodium sulphate Methanol Recovery
n-Hexane Effluent water
Ethyl acetate
Water
Stage-3
Sodium boro hydride Ethyl acetate Recovery
Hydrochloric acid stage-4 n-Hexane Recovery
Sodium bicarbonate Effluent water
Sodium sulphate
Activated carbon
Hyflow
n-Hexane
Ethyl acetate
Water
Stage-4
Sodium methoxide Ethyl acetate Recovery
Hydrochloric acid stage-5 n-Hexane Recovery
Sodium sulphate Methanol Recovery
Activated carbon Effluent water
Hyflow
Methanol
n-Hexane
Ethyl acetate
Water

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Stage-5
Hydrogen Ethyl acetate Recovery
Raney Nickel stage-6 Isopropyl alcohol Recovery
Ethyl acetate Methanol Recovery
Isopropyl alcohol Effluent water
Activated Carbon
Methanol
Water

Stage-6
(4,4-Diethoxy-butyl) -
dimethyl-amine
Methanol stage-7 Methanol Recovery
Hydrochloric acid Effluent water
Water

Zolmitriptan

Material Balance

Material Balance of Zolmitriptan


Stage-1
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
L-Phenylalanine 132.00 Stage-1 151.00
Nitric acid 51.00 Methanol Recovery 190.00
Sulphuric acid 79.00 Methanol loss 4.00
Ammonia 28.00 Effluent water 524.40
Methanol 200.00 (Water-500, generated water - 0
14.40, Sodium hydroxide-10)
Sodium hydroxide 10.00 By product 105.60
(Ammonium sulphate)
Water 500.00 Organic Residue 25.00
(Process residue-19
Distillation Residue-6
(Methanol-6)
Total 1000 Total 1000

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Material Balance of Zolmitriptan


Stage-2
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-1 151.00 Stage-2 164.00
Thionyl chloride 86.00 Methanol Recovery 190.00
Methanol 223.00 Methanol loss 4.00
Water 500.00 Effluent water 500.00
(Water-500)
Process emission 72.18
(Sulphur dioxide-46, Hydrogen
chloride-26.18
Organic Residue 29.82
(Process residue-23.82
Distillation Residue-6
(Methanol-6)
Total 960 Total 960

Material Balance of Zolmitriptan


Stage-3
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-2 164.00 Stage-3 167.00
Ethyl chloroformate 69.00 Ethyl acetate Recovery 190.00
Hydrochloric acid 51.00 Ethyl acetate Loss 4.00
Methanol 200.00 n-Hexane Recovery 190.00
Sodium sulphate 50.00 n-Hexane loss 4.00
n-Hexane 200.00 Methanol Recovery 190.00
Ethyl acetate 200.00 Methanol loss 4.00
Water 500.00 Effluent water 602.25
(Water-500,Generated Water-
22.70, Sodium chloride-73.55,
Ethyl acetate-6)
Inorganic solid waste 50.00
(Sodium sulphate)
Organic Residue 32.75
(Process residue-20.75
Distillation Residue-12
(n-Hexane -6, Methanol-6)
Total 1434 Total 1434

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Material Balance of Zolmitriptan


Stage-4
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-3 167.00 Stage-4 133.00
Sodium boro hydride 22.00 Ethyl acetate Recovery 190.00
Hydrochloric acid 21.00 Ethyl acetate Loss 4.00
Sodium bicarbonate 20.00 n-Hexane Recovery 190.00
Sodium sulphate 50.00 n-Hexane loss 4.00
Activated carbon 20.00 Effluent water 580.83
Hyflow 5.00 (Water-469 Ethyl acetate-6,
Sodium chloride-32.93, Boric
acid-34.85, Methanol-18.05,
Sodium bicarbonate-20 )
n-Hexane 200.00 Process emission 2.27
(Hydrogen)
Ethyl acetate 200.00 Spent carbon & Hyflow 25.00
Water 500.00 Inorganic solid waste 50.00
(Sodium sulphate)
Organic Residue 25.90
(Process residue-19.9
Distillation Residue-6
(n-Hexane -6)
Total 1205 Total 1205

Material Balance of Zolmitriptan


Stage-5
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-4 133.00 Stage-5 99.00
Sodium methoxide 27.00 Ethyl acetate Recovery 190.00
Hydrochloric acid 18.00 Ethyl acetate Loss 4.00
Sodium sulphate 50.00 n-Hexane Recovery 190.00
Activated carbon 20.00 n-Hexane loss 4.00
Hyflow 5.00 Methanol Recovery 190.00
Methanol 200.00 Methanol loss 4.00
n-Hexane 200.00 Effluent water 548.79
Ethyl acetate 200.00 (Water-491,Ethyl acetate-6,
Sodium chloride-28.96,
Ethanol-22.83, )
Water 500.00 Process emission 24.80
(Carbon dioxide-21.81,
Hydrogen -2.99)
Spent carbon & Hyflow 25.00

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Inorganic solid waste 50.00


(Sodium sulphate)
Organic Residue 23.41
(Process residue-11.41
Distillation Residue-12
(Methanol-6,
n-Hexane -6)
Total 1353 Total 1353

Material Balance of Zolmitriptan


Stage-6
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-5 99.00 Stage-6 75.00
Hydrogen 0.90 Ethyl acetate Recovery 190.00
Raney Nickel 10.00 Ethyl acetate Loss 4.00
Ethyl acetate 200.00 Isopropyl alcohol Recovery 190.00
Isopropyl alcohol 200.00 Isopropyl alcohol loss 4.00
Activated Carbon 20.00 Methanol Recovery 190.00
Methanol 200.00 Methanol loss 4.00
Water 500.00 Effluent water 506.00
(Water-500 Ethyl acetate-6)
Process emission 14.25
(Oxygen)
Spent carbon 20.00
Spent Reney Nickel 10.00
Recovery/Reuse
Organic Residue 22.65
(Process residue-10.65
Distillation Residue-12
(Methanol-6,
Isopropyl alcohol-6)
Total 1229.9 Total 1229.9

Material Balance of Zolmitriptan


Stage-7
Batch Size: 100.0 Kg
Name of the input Quantity Name of the out put Quantity
in Kg in Kg
Stage-6 75.00 Zolmitriptan 100.00

(4,4-Diethoxy-butyl) -dimethyl- 74.00 Methanol Recovery 190.00


amine
Methanol 200.00 Methanol Loss 4.00
Hydrochloric acid 10.00 Effluent water 546.00

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Water 500.00 (Water-500 ,ethanol-36,


Hydrochloric acid-10)
Process emission 0.78
(Hydrogen)
Organic Residue 18.22
(Process residue-12.22
Distillation Residue-6
(Methanol)
Total 859.00 Total 859.00

2.7 POLLUTION LOAD


Pollution load and generation of waste per day from all the proposed products is
given in below table 2.4

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TABLE 2.4: CONSOLIDATED POLLUTION LOAD OF ALL PRODUCTS IN PER DAY QUANTITES
Kg Per Day
Produ In
ction Orga Tota
Production Wate Orga Spe
S. Capac nics l Distill
Product Name Capacity r In nics Total nt
No. ity Water In LTD Org Inorg soli ation Proc Fugitiv
Kg/Month In TDS COD(Mg/L) COD HTDS Efflue
Kg/Da Input S anic anic d Resid ess e
efflu nt Car
y Efflu was ue
ent Efflu bon
ent te
ent
1 (S)-(-)-3-
3000.0 2892. 583.9 107 4569.1 71.0 71.0 23.8
(Dimethylamino)-1-(2- 10000 333.33 20.00 583.97 179297.70 62.60 3496.77 0.00 0.00 70.00 126.67
0 80 7 2.33 0 7 7 3
Thienyl)-1-Propanol
2 2,4- Dihydro-4-(4-4
hydroxy phenyl )-1-
11496. 9419. 406.5 370.0 243 10196. 428. 428. 130.
piperazinyl ) -2-(1- 10000 333.33 370.07 764096.04 586.03 7761.57 0.00 0.00 136.67 280.00
67 83 0 7 4.83 40 70 70 23
methyl propyl )-3H-
1,2,4-Triazole-3-one
3 2-[3-methyl -4-(2,2,2-
trifluoroethoxy)-2- 2100.0 1508. 204.8 333. 1780.5 149. 149. 51.1
5000 166.67 66.98 204.80 46586.10 66.34 1447.17 0.00 0.00 90.67 74.67
pyridinyl ] methylthio - 0 72 0 33 0 07 07 0
1H-benzimidazole
4-Chloro Butyraldehyde 1833.3 1853. 178.1 2076.0 20.1 117. 43.9
5000 166.67 44.00 178.17 282011.96 91.95 2076.07 0.00 97.08 0.00 40.00 60.00
4 Diethyl acetal 3 90 7 7 2 20 0
5 4-Chloro-1 hydroxy
1500.0 1532. 192.4 1724.8 18.4 18.4 53.1
butane sulphonic acid 5000 166.67 0.00 192.43 0.00 0.00 1724.83 0.00 0.00 0.00 50.00 33.33
0 40 3 3 0 0 0
sodium salt
4-Dimethyl amino 1000.0 1017. 232.3 1256.7 14.6 14.6
5000 166.67 6.67 232.35 60904.69 22.87 1256.77 0.00 0.00 0.00 23.33 0.00 20.00
6 butytalde diethyl acetal 0 75 5 7 5 5
400.0 202. 12.7 31.2 14.9
Almotriptan Malate 1000 33.33 400.00 11.57 37.37 37.37 85066.97 20.43 246.93 448.93 18.57 0.00 18.00 19.33
7 0 00 1 8 9
1466.6 1495. 158.6 954. 1679.4 21.8 21.8 13.9
Celecoxib 4000 133.33 25.33 158.67 160744.50 38.00 724.73 0.00 0.00 48.00 32.00
8 7 40 7 67 0 7 7 3
Cis -2-[2,4-Di Chloro
Phenyl] -2-[1H-1,2,4-
270.9 24.5 24.5 10.3
Triazole -1-yl Methyl ]- 4000 133.33 266.67 76.47 56.39 56.39 460251.41 139.37 403.76 0.00 403.76 0.00 0.00 16.00 16.00
1 2 2 9
1,3 Dioxalane -4 yl
9 Methanol
10 Cis -2-[2,4-Di chloro
Phenyl]-2-[1H-1,2,4-
671.2 120.6 41.4 41.4 11.2
Triazole -1-yl methyl]-1,3 5000 166.67 666.67 83.75 120.67 530881.25 153.72 875.67 0.00 875.67 0.00 0.00 40.00 33.33
5 7 2 2 5
Dioxalane-4yl Methyl ]
Methane Sulfonate
1600.0 1607. 815. 1692.2 35.0 35.0 37.3
Dabigartan 2000 66.67 16.00 69.25 69.25 121214.61 39.60 877.25 0.00 0.00 40.00 37.33
11 0 00 00 5 5 5 3

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Duloxetine 600.0 222. 20.5 20.5 13.3


2000 66.67 600.00 61.27 21.43 21.43 237109.22 86.55 459.83 682.70 0.00 0.00 18.00 16.00
12 Hydrochloride 0 87 1 1 9
1333.3 1322. 1426.3 117. 44.0 161.
Emitricitibine 4000 133.33 4.00 99.89 99.89 11703.34 12.52 1426.37 0.00 0.00 24.00 2.67 18.67
13 3 48 7 72 0 72
1133.3 1149. 503. 1180.0 23.9 23.9 33.6
Imatinib Mesylate 2000 66.67 8.67 21.87 21.87 46802.57 15.77 676.13 0.00 0.00 45.33 56.00
14 3 53 93 7 9 9 9
670.5 17.7 17.7
Itraconazole 4000 133.33 666.67 8.00 25.07 25.07 47451.20 25.04 703.60 0.00 703.60 0.00 0.00 16.00 0.00 16.00
15 3 3 3
4166.6 4195. 523.6 459.7 5178.6 103. 103. 84.0
Ketorolac Tromethamine 5000 166.67 459.78 1133938.12 796.95 5178.62 0.00 0.00 0.00 60.00 40.00
16 7 17 7 8 2 98 98 7
839.7 166. 15.7 15.7 11.4
Lansprazole 1000 33.33 833.33 12.25 54.72 54.72 23131.02 14.25 747.50 914.17 0.00 0.00 20.00 18.00
17 0 67 8 8 2
18 1200.0 1225. 413.7 447. 1647.6 79.7 79.7 177.
Mesalamine 4000 133.33 8.00 413.73 39868.57 14.56 1200.40 0.00 0.00 24.00 16.00
0 87 3 20 0 6 6 31
2800.0 2768. 121.5 169 2957.0 92.2 200.0 292. 74.1
Olmesartan Medoxomil 4000 133.33 66.95 66.95 908476.75 310.35 1264.35 0.00 72.00 69.33
19 0 60 3 2.73 8 8 0 28 7
20 Pentaprazole chloro
compound (2- 110 1767.2
10000 333.33 0.00 0.00 0.00 0.00 0.00 0.00 0.00 660.47 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Chloromethyl-3,4- 6.76 3
Dimethoxy-Pyridine)
3000.0 3048. 144.9 3192.9 68.1 68.1
Pantoprazole Sodium 9000 300.00 0.00 144.90 0.00 0.00 3192.90 0.00 0.00 0.00 90.00 0.00 60.00
21 0 00 0 0 0 0
4000.0 4195. 1075. 133.5 456 5404.2 1792 40.0 183
Pregabalin 4000 133.33 133.53 852652.78 771.89 841.33 0.00 56.00 0.00 37.33
22 0 40 27 3 2.87 0 .27 0 2.27
23 8666.6 8704. 369.3 337 9130.4 224. 224. 62.1
Rosuvastatin 4000 133.33 56.89 369.33 154992.07 82.05 5756.37 0.00 0.00 72.00 58.67
7 17 3 4.03 0 16 16 7
Sitagliptin Phosphate 1533.3 1537. 466. 1679.6 87.3 87.3 52.8
2000 66.67 75.75 66.53 66.53 64691.02 61.15 1212.94 0.00 0.00 14.00 12.00
24 Monohydrate 3 33 67 1 3 3 7
697.5 140.5 200. 139. 139. 58.0
Sumatriptan Succinate 1000 33.33 700.00 2.00 140.52 10417.86 3.64 640.01 840.01 0.00 0.00 14.00 10.67
25 0 2 00 96 96 3
26 403.2 145. 19.4 19.4
Velpatasvir 2000 66.67 400.00 10.73 16.67 16.67 236500.61 26.42 285.13 430.63 0.00 0.00 42.00 5.74 28.00
3 50 7 7
1166.6 1165. 111.3 335. 1975.2 39.2 23.3 112. 38.0
Zolmitriptan 1000 33.33 27.61 111.31 101050.32 55.54 1639.96 50.00 20.00 18.67
27 7 70 1 33 9 5 3 58 9
190
3833.3 57530. 5519 2752. 4350. 46777.4 65814. 3679 365.6 107. 415 1160.0 1003 1208.0
Total 115000 4350.36 6559840.69 3497.60 36.7
3 00 3.18 89 36 4 16 .84 5 33 2.83 0 .68 0
2

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Pollution loads have been calculated for each product based on chemical reactions,
material balance and subsequent process operations to get the required quantity.

2.8 Description of Process Emissions and its mitigation measures


The Predicted Process emissions are SO2, O2, CO2, (CH3)2NH, HF, CH4, H2, NH3 &
HCl which will liberate from manufacturing process of proposed products. The
process emissions are based on reactants quantity and chemical reactions between
them in relation with desired product output.
To meet the environmental standards, double stage scrubbers as a single unit is
proposed. The process emissions such as Sulphur dioxide and Hydrogen chloride
will be scrubbed with suitable scrubbing solution as applicable. During plant
operations samples will be collected to check whether process emissions are within
limits.

TABLE-2.5: Process Emission details and mitigation measures


Quantity
S. No Name of the Gas Treatment Method
in Kg/Day
1 Carbon dioxide 270 Dispersed into the atmosphere
2 Oxygen 224 Dispersed into the atmosphere
3 Ammonia 9 Scrubbed by using Chilled water media
4 Hydrogen chloride 426 Scrubbed by using Chilled water media
5 Sulfur dioxide 312 Scrubbed by using C.S.Lye Solution
6 Dimethylamine 8 Scrubbed by using chilled water media
7 Hydrogen fluoride 5 Scrubbed by using C.S.Lye Solution
Diffused by using Nitrogen through
8 Hydrogen 35
Flame arrestor
9 Methane 15 Dispersed into the atmosphere

TABLE-: 2.6 PROCESS EMISSION DETAILS - PRODUCT WISE

Production Production
Process
S.No. Product Name Capacity in Capacity
in kg/day
Kg/Month in Kg/Day
(S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-
1 10000 333.33 23.83
1-Propanol
2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-
2 piperazinyl ) -2-(1-methyl propyl )-3H- 10000 333.33 130.23
1,2,4-Triazole-3-one
2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-
3 5000 166.67 51.10
pyridinyl ] methylthio -1H-benzimidazole
4 4-Chloro Butyraldehyde Diethyl acetal 5000 166.67 43.90

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4-Chloro-1 hydroxy butane sulphonic


5 5000 166.67 53.10
acid sodium salt
4-Dimethyl amino butytalde diethyl
6 5000 166.67 0.00
acetal
7 Almotriptan Malate 1000 33.33 14.99
8 Celecoxib 4000 133.33 13.93
Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-
9 1,2,4-Triazole -1-yl Methyl ]-1,3 4000 133.33 10.39
Dioxalane -4 yl Methanol
Cis -2-[2,4-Di chloro Phenyl]-2-[1H-
1,2,4-Triazole -1-yl methyl]-1,3
10 5000 166.67 11.25
Dioxalane-4yl Methyl ] Methane
Sulfonate
11 Dabigartan 2000 66.67 37.33
12 Duloxetine Hydrochloride 2000 66.67 13.39
13 Emitricitibine 4000 133.33 2.67
14 Imatinib Mesylate 2000 66.67 33.69
15 Itraconazole 4000 133.33 0.00
16 Ketorolac Tromethamine 5000 166.67 84.07
17 Lansprazole 1000 33.33 11.42
18 Mesalamine 4000 133.33 177.31
19 Olmesartan Medoxomil 4000 133.33 74.17
Pentaprazole chloro compound (2-
20 10000 333.33 0.00
Chloromethyl-3,4-Dimethoxy-Pyridine)
21 Pantoprazole Sodium 9000 300.00 0.00
22 Pregabalin 4000 133.33 0.00
23 Rosuvastatin 4000 133.33 62.17
24 Sitagliptin Phosphate Monohydrate 2000 66.67 52.87
25 Sumatriptan Succinate 1000 33.33 58.03
26 Velpatasvir 2000 66.67 5.74
27 Zolmitriptan 1000 33.33 38.09
Total 115000 3833.33 1003.68

2.9 PROPOSED WATER CONSUMPTION DETAILS


The Total water consumption for the proposed project is 259 KLD. Water
consumption details are given in below Table. No. 2.7.

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TABLE- 2.7: Proposed Water Consumption details


Water
S.No Purpose
input KLD
1 Process 59
2 Washings 10
3 Boiler make up 71
4 Cooling towers make up 104
5 Scrubbing system 5
6 Domestic 4
7 Gardening 6
Total 259

The fresh water of 175 KLD will be met from Ground Water source.
Recovered water 84 KLD from ZLD system is reused.
The permission to draw ground water for industrial and drinking water purpose was
obtained for 269 KLD from AP Ground Water & Water Audit Department and the
same has been enclosed.

TABLE- 2.8: PROPOSED WATER CONSUMPTION IN PROCESS


– PRODUCT WISE
Production Production Water
S.No. Product Name Capacity Capacity Input in
Kg/Month Kg/Day kg/day
(S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-
1 10000 333.33 3000.00
Propanol
2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-
2 piperazinyl ) -2-(1-methyl propyl )-3H- 10000 333.33 11496.67
1,2,4-Triazole-3-one
2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-
3 5000 166.67 2100.00
pyridinyl ] methylthio -1H-benzimidazole
4 4-Chloro Butyraldehyde Diethyl acetal 5000 166.67 1833.33
4-Chloro-1 hydroxy butane sulphonic acid
5 5000 166.67 1500.00
sodium salt
6 4-Dimethyl amino butytalde diethyl acetal 5000 166.67 1000.00
7 Almotriptan Malate 1000 33.33 400.00
8 Celecoxib 4000 133.33 1466.67
Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-
9 1,2,4-Triazole -1-yl Methyl ]-1,3 4000 133.33 266.67
Dioxalane -4 yl Methanol
Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-
10 Triazole -1-yl methyl]-1,3 Dioxalane-4yl 5000 166.67 666.67
Methyl ] Methane Sulfonate
11 Dabigartan 2000 66.67 1600.00

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12 Duloxetine Hydrochloride 2000 66.67 600.00


13 Emitricitibine 4000 133.33 1333.33
14 Imatinib Mesylate 2000 66.67 1133.33
15 Itraconazole 4000 133.33 666.67
16 Ketorolac Tromethamine 5000 166.67 4166.67
17 Lansprazole 1000 33.33 833.33
18 Mesalamine 4000 133.33 1200.00
19 Olmesartan Medoxomil 4000 133.33 2800.00
Pentaprazole chloro compound (2-
20 10000 333.33 0.00
Chloromethyl-3,4-Dimethoxy-Pyridine)
21 Pantoprazole Sodium 9000 300.00 3000.00
22 Pregabalin 4000 133.33 4000.00
23 Rosuvastatin 4000 133.33 8666.67
24 Sitagliptin Phosphate Monohydrate 2000 66.67 1533.33
25 Sumatriptan Succinate 1000 33.33 700.00
26 Velpatasvir 2000 66.67 400.00
27 Zolmitriptan 1000 33.33 1166.67
Total 115000 3833.33 57530.00

2.10 EXPECTED WASTE WATER GENERATION DETAILS


TABLE-2.9: Expected Effluent generation details
Effluent
S.No Purpose
Details KLD
1 Process 66
2 Washings 10
3 Boiler Blow down 10
4 Cooling towers Blow down 12
5 Scrubbing system 5.00
6 Domestic 2.80
Total 105.8

TABLE-2.10: Expected HTDS & LTDS EFFLUENT GENERATION


DETAILS
HTDS LTDS Effluent
S. No Purpose Disposal Method
In KLD In KLD In KLD
HTDS Effluent sent to
1 Process 47 19 66 MEESystem.MEE Condensate
sent to Biological treatment.
2 Washings 0 10 10
LTDS Effluents along with
Domestic sewage sent to ETP,
3 Boiler Blow down 0 10 10 treated effluent sent to RO
followed by MEE & ATFD.

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Cooling towers bleed


4 0 12 12 RO Permeate and MEE
off Condensate water recovered for
reuse
5 Scrubbing system 5 0 5.00 MEE Salts collected and disposed
to TSDF.
6 Domestic 0 2.8 2.80
Total 52 53.8 105.8

The generations of process effluent water HTDS & LTDS and its characteristics are
based on reactants quantity and chemical reactions between them in relation with
desired product output.
The Boiler & Cooling towers blow down water will have TDS & COD less than 5000
mg/l and scrubbing solution will have TDS more than 5000 mg/l. Floor washings and
equipment washings will have TDS less than 5000 mg/l

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TABLE- 2.11 WASTEWATER GENERATION IN KGS PER DAY - PRODUCT WISE


Product Kg Per Day
Product
ion In
ion Organic
S.N Capacit Organic
Product Name Capacit Water In s In Total
o. y s In TDS COD(Mg/L) COD HTDS LTDS
y effluent Effluent
Kg/Mon
Kg/Day Effluent
th Effluent
(S)-(-)-3-(Dimethylamino)-1-
1 10000 333.33 2892.80 20.00 583.97 583.97 179297.70 62.60 3496.77 1072.33 4569.10
(2-Thienyl)-1-Propanol
2,4- Dihydro-4-(4-4 hydroxy
phenyl )-1-piperazinyl ) -2-
2 10000 333.33 9419.83 406.50 370.07 370.07 764096.04 586.03 7761.57 2434.83 10196.40
(1-methyl propyl )-3H-1,2,4-
Triazole-3-one
2-[3-methyl -4-(2,2,2-
trifluoroethoxy)-2-pyridinyl ]
3 5000 166.67 1508.72 66.98 204.80 204.80 46586.10 66.34 1447.17 333.33 1780.50
methylthio -1H-
benzimidazole
4-Chloro Butyraldehyde
4 5000 166.67 1853.90 44.00 178.17 178.17 282011.96 91.95 2076.07 0.00 2076.07
Diethyl acetal
4-Chloro-1 hydroxy butane
5 5000 166.67 1532.40 0.00 192.43 192.43 0.00 0.00 1724.83 0.00 1724.83
sulphonic acid sodium salt
4-Dimethyl amino butytalde
6 5000 166.67 1017.75 6.67 232.35 232.35 60904.69 22.87 1256.77 0.00 1256.77
diethyl acetal
7 Almotriptan Malate 1000 33.33 400.00 11.57 37.37 37.37 85066.97 20.43 246.93 202.00 448.93
8 Celecoxib 4000 133.33 1495.40 25.33 158.67 158.67 160744.50 38.00 724.73 954.67 1679.40
Cis -2-[2,4-Di Chloro
Phenyl] -2-[1H-1,2,4-
9 4000 133.33 270.91 76.47 56.39 56.39 460251.41 139.37 403.76 0.00 403.76
Triazole -1-yl Methyl ]-1,3
Dioxalane -4 yl Methanol

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Cis -2-[2,4-Di chloro


Phenyl]-2-[1H-1,2,4-
10 Triazole -1-yl methyl]-1,3 5000 166.67 671.25 83.75 120.67 120.67 530881.25 153.72 875.67 0.00 875.67
Dioxalane-4yl Methyl ]
Methane Sulfonate
11 Dabigartan 2000 66.67 1607.00 16.00 69.25 69.25 121214.61 39.60 877.25 815.00 1692.25
12 Duloxetine Hydrochloride 2000 66.67 600.00 61.27 21.43 21.43 237109.22 86.55 459.83 222.87 682.70
13 Emitricitibine 4000 133.33 1322.48 4.00 99.89 99.89 11703.34 12.52 1426.37 0.00 1426.37
14 Imatinib Mesylate 2000 66.67 1149.53 8.67 21.87 21.87 46802.57 15.77 676.13 503.93 1180.07
15 Itraconazole 4000 133.33 670.53 8.00 25.07 25.07 47451.20 25.04 703.60 0.00 703.60
16 Ketorolac Tromethamine 5000 166.67 4195.17 523.67 459.78 459.78 1133938.12 796.95 5178.62 0.00 5178.62
17 Lansprazole 1000 33.33 839.70 12.25 54.72 54.72 23131.02 14.25 747.50 166.67 914.17
18 Mesalamine 4000 133.33 1225.87 8.00 413.73 413.73 39868.57 14.56 1200.40 447.20 1647.60
19 Olmesartan Medoxomil 4000 133.33 2768.60 121.53 66.95 66.95 908476.75 310.35 1264.35 1692.73 2957.08
Pentaprazole chloro
20 compound (2-Chloromethyl- 10000 333.33 0.00 0.00 0.00 0.00 0.00 0.00 660.47 1106.76 1767.23
3,4-Dimethoxy-Pyridine)
21 Pantoprazole Sodium 9000 300.00 3048.00 0.00 144.90 144.90 0.00 0.00 3192.90 0.00 3192.90
22 Pregabalin 4000 133.33 4195.40 1075.27 133.53 133.53 852652.78 771.89 841.33 4562.87 5404.20
23 Rosuvastatin 4000 133.33 8704.17 56.89 369.33 369.33 154992.07 82.05 5756.37 3374.03 9130.40
Sitagliptin Phosphate
24 2000 66.67 1537.33 75.75 66.53 66.53 64691.02 61.15 1212.94 466.67 1679.61
Monohydrate
25 Sumatriptan Succinate 1000 33.33 697.50 2.00 140.52 140.52 10417.86 3.64 640.01 200.00 840.01
26 Velpatasvir 2000 66.67 403.23 10.73 16.67 16.67 236500.61 26.42 285.13 145.50 430.63
27 Zolmitriptan 1000 33.33 1165.70 27.61 111.31 111.31 101050.32 55.54 1639.96 335.33 1975.29
Total 115000 3833.33 55193.18 2752.89 4350.36 4350.36 6559840.69 3497.60 46777.44 19036.72 65814.16

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2.11 Expected Effluent water characteristics:


Results
S. No Parameters Unit Before After
treatment treatment*
1. pH - 8.5-9.0 7.0-7.5
2. HTDS mg/L 59316.42 <500
3. LTDS mg/L <5000 <500
4. COD mg/L 28977 <250
5. Oil & Grease mg/L 20-25 <10

*We are going to achieve zero discharge.


The effluent water characteristics before treatment are based on calculations. The
effluent water after passing through Stripper, MEE, Biological treatment plant & RO
plant the expected results after treatment are given in the above table.

2.12 HAZARDOUS & SOLID WASTE GENERATION DETAILS


The Hazardous/Solid waste generated and disposal methods from proposed project
are given below.

TABLE- 2.12: EXPECTED HAZARDOUS/SOLID WASTE GENERATION,


DISPOSAL DETAILS
Name of the
S. No Quantity Disposal Method
Hazardous Waste
1 Organic Solid Waste 3757 Kg/Day
2 Spent Carbon 108 Kg/Day
3 Solvent distillation residue 1174 Kg/Day
Sent to Cement Industries
Organic Evaporate liquid from
4 1040 Kg/Day
MEE stripper
5 Mixed Solvents 3933 Kg/Day
6 ETP Sludge 1000 Kg/Day
7 Inorganic solid waste 366 Kg/Day Sent to TSDF
8 MEE Salts 4954 Kg/Day
1000 SPCB Authorized Agencies
9 Used Oils
Ltrs/Annum for Reprocessing/Recycling
After Detoxification sent back
1000
10 Detoxified Containers to suppliers/sent to outside
No’s/Month
Parties
Send back to suppliers for
11 Used Lead Acid Batteries 9 No’s/Year
buyback of New Batteries
Solid Waste Details
16800
12 Ash from boiler Sent to Brick Manufacturers
Kg/Day

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The expected quantities which are given in the above table based on calculations of
each product material balance. The ash from boiler is based on ash percentage in
the coal. The used oils and used lead acid batteries quantities are based on usage of
respective equipment. The container liners & containers are based on various
packing of raw materials.

TABLE- 2.13: SOLID WASTE GENERATION – PRODUCT WISE PER DAY


Producti Kg Per Day
Production
S.N on Total
Product Name Capacity Inorga Spent
o. Capacity Organic solid
Kg/Month nic arbon
Kg/Day waste
(S)-(-)-3-(Dimethylamino)-1-
1 10000 333.33 71.07 0.00 0.00 71.07
(2-Thienyl)-1-Propanol
2,4- Dihydro-4-(4-4 hydroxy
phenyl )-1-piperazinyl ) -2-(1-
2 10000 333.33 428.70 0.00 0.00 428.70
methyl propyl )-3H-1,2,4-
Triazole-3-one
2-[3-methyl -4-(2,2,2-
3 trifluoroethoxy)-2-pyridinyl ] 5000 166.67 149.07 0.00 0.00 149.07
methylthio -1H-benzimidazole
4-Chloro Butyraldehyde
4 5000 166.67 20.12 97.08 0.00 117.20
Diethyl acetal
4-Chloro-1 hydroxy butane
5 5000 166.67 18.40 0.00 0.00 18.40
sulphonic acid sodium salt
4-Dimethyl amino butytalde
6 5000 166.67 14.65 0.00 0.00 14.65
diethyl acetal
7 Almotriptan Malate 1000 33.33 12.71 18.57 0.00 31.28
8 Celecoxib 4000 133.33 21.87 0.00 0.00 21.87
Cis -2-[2,4-Di Chloro Phenyl]
-2-[1H-1,2,4-Triazole -1-yl
9 4000 133.33 24.52 0.00 0.00 24.52
Methyl ]-1,3 Dioxalane -4 yl
Methanol
Cis -2-[2,4-Di chloro Phenyl]-
2-[1H-1,2,4-Triazole -1-yl
10 5000 166.67 41.42 0.00 0.00 41.42
methyl]-1,3 Dioxalane-4yl
Methyl ] Methane Sulfonate
11 Dabigartan 2000 66.67 35.05 0.00 0.00 35.05
12 Duloxetine Hydrochloride 2000 66.67 20.51 0.00 0.00 20.51
13 Emitricitibine 4000 133.33 117.72 0.00 44.00 161.72
14 Imatinib Mesylate 2000 66.67 23.99 0.00 0.00 23.99
15 Itraconazole 4000 133.33 17.73 0.00 0.00 17.73
16 Ketorolac Tromethamine 5000 166.67 103.98 0.00 0.00 103.98
17 Lansprazole 1000 33.33 15.78 0.00 0.00 15.78
18 Mesalamine 4000 133.33 79.76 0.00 0.00 79.76

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19 Olmesartan Medoxomil 4000 133.33 92.28 200.00 0.00 292.28


Pentaprazole chloro
20 compound (2-Chloromethyl- 10000 333.33 0.00 0.00 0.00 0.00
3,4-Dimethoxy-Pyridine)
21 Pantoprazole Sodium 9000 300.00 68.10 0.00 0.00 68.10
22 Pregabalin 4000 133.33 1792.27 0.00 40.00 1832.27
23 Rosuvastatin 4000 133.33 224.16 0.00 0.00 224.16
Sitagliptin Phosphate
24 2000 66.67 87.33 0.00 0.00 87.33
Monohydrate
25 Sumatriptan Succinate 1000 33.33 139.96 0.00 0.00 139.96
26 Velpatasvir 2000 66.67 19.47 0.00 0.00 19.47
27 Zolmitriptan 1000 33.33 39.25 50.00 23.33 112.58
Total 115000 3833.33 3679.84 365.65 107.33 4152.83

2.13 POWER (ENERGY) REQUIREMENT


Power requirement of proposed project will be made available through Andhra
Pradesh Southern Power Distribution Corporation Limited [APSPDCL]. The power
requirement of project will be 2000 KVA.

2.14 UTILITIES
TABLE - 2.14: Details of Utilities

S. No Description Capacity

1 Coal fired boiler 8 TPH & 4 TPH


2 Thermic Fluid Heater 200000 kcal/hr
500 KVA & 1000
3 D.G. Set
KVA
2x200 TR, 250 TR
4 Cooling Towers
& 300 TR
Electricity supply from
5 2000 KVA
APSPDCL.
Fuel
6 Coal 48 TPD
7 Diesel 300 Liters/Day

2.15 PROPOSED BOILER & DG SET


For generation of Steam, the industry proposed to install 8 TPH & 4 TPH coal fired
boilers. The coal requirement will be met from government allocation or from local
authorized sources.

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The unit is proposing a 500 KVA & 1000 KVA DG sets, for usage during the power
failures.

TABLE- 2.15: Emission Characteristic details of proposed Boiler


8.0 TPH Coal fired 4.0 TPH Coal fired
Particulars Units
Boiler Boiler
Indian Coal with CV Indian Coal with CV
Type of Fuel -- of 4000 kcal/kg to of 4000 kcal/kg to
5000 kcal/kg 5000 kcal/kg
Coal Consumption TPD 32 16
Ash Content % 35 35
Sulphur Content % 0.4 0.4
No. of Stacks No 1 1
Height of stack M 34 30
Diameter of Stack M 0.50 0.40
o
Temperature of Flue Gas C 200 180
Velocity of Flue Gas m/s 16 14
Particulate Matter gm/sec 0.26 0.13
Sulphur dioxide emission gm/sec 2.95 1.48
Oxides of Nitrogen emission gm/sec 9.70 4.86

Note: 5 TPH Coal fired Boiler is kept as standby.

TABLE- 2.16: Stack Emission Details for Thermic Fluid Heater


2,00,000 kcal/hr.
Particulars Units
Thermic fluid heater
Thermo pack Boiler Capacity Kcal/hr. 2,00,000
Type of Fuel -- Diesel
Stack Temperature Before o
C 200
Air preheater
Stack Temperature After Air o
C 130
preheater
Stack Height m 15
Fuel Consumption per Day TPD 0.57
Diameter m 0.3

TABLE- 2.17: Stack Emission details of proposed DG Set


Emission Emission Emission Stack Flue Gas Stack Flue gas
Capacity
of SPM in Of SO2 in of NOx dia. Temp. in Height Velocity
In KVA
mg/Nm3 mg/Nm3 in mg/Nm3 in m O
C in m in m/sec.
500 KVA
80 150 180 0.30 220 10 16
(Proposed)
1000 KVA
120 170 200 0.35 280 10 18
(Proposed)

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2.16 DETAILS OF PROPOSED SOLVENTS INPUT, RECOVERY & LOSS


A liquid substance capable of dissolving other substances; "the solvent does not change its state in forming a solution". Details of
solvents are given below in a table 2.18.

TABLE 2.18: DETAILS OF PROPOSED SOLVENT INPUT, RECOVERY & LOSS [PRODUCT WISE]
Solvents details Quantity in Kgs/Day
Productio Solven Solve Solve Solve
S. Solve Solvent
Product Name n capacity Solvent t nt in nt in Solvent Solvent Solvent nt in
No Solvent Name nt in
Kg/Month Input Recov aste Resid Input Recovery Loss waste
Loss Residue
ery water ue water
(S)-(-)-3-
(Dimethylamino)-1-
10000 IPA 100.00 95.0 2.00 0.00 3.00 333.33 316.67 6.67 0.00 10.00
(2-Thienyl)-1-
1 Propanol
Mixed Solvents(n-
Hexane + 520.00 494.0 26.00 0.00 0.00 1733.33 1646.67 86.67 0.00 0.00
Methanol)
Acetone 200.00 190.0 4.00 0.00 6.00 666.67 633.33 13.33 0.00 20.00
Toluene 200.00 190.0 4.00 6.00 0.00 666.67 633.33 13.33 20.00 0.00
Methanol 200.00 190.0 4.00 0.00 6.00 666.67 633.33 13.33 0.00 20.00
Petrolium ether 200.00 190.0 4.00 0.00 6.00 666.67 633.33 13.33 0.00 20.00
4733.33 4496.67 146.67 20.00 70.00
2,4- Dihydro-4-(4-4
hydroxy phenyl )-1-
piperazinyl ) -2-(1-
10000 DMF 300.00 285.00 6.00 0.00 9.00 1000.00 950.00 20.00 0.00 30.00
methyl propyl )-3H-
1,2,4-Triazole-3-
2 one
Dimethylsulfoxide 200.00 190.0 4.00 0.00 6.00 666.67 633.33 13.33 0.00 20.00

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Acetone 200.00 190.0 4.00 0.00 6.00 666.67 633.33 13.33 0.00 20.00
Acetic acid 412.00 392.0 9.00 0.00 11.00 1373.33 1306.67 30.00 0.00 36.67
Chloroform 200.00 190.0 10.00 0.00 0.00 666.67 633.33 33.33 0.00 0.00
Methanol 300.00 285.0 6.00 0.00 9.00 1000.00 950.00 20.00 0.00 30.00
41.00 5373.33 5106.67 130.00 0.00 136.67
2-[3-methyl -4-
(2,2,2-
trifluoroethoxy)-2-
5000 Methanol 1780.00 1691.0 36.00 0.00 53.00 593.33 563.67 12.00 0.00 17.67
pyridinyl ]
methylthio -1H-
3 benzimidazole
Methylenedichlori
3100.00 2945.0 62.00 0.00 93.00 1033.33 981.67 20.67 0.00 31.00
de
Isopropylalcohol 600.00 570.0 12.00 0.00 18.00 200.00 190.00 4.00 0.00 6.00
Methyl
600.00 570.0 30.00 0.00 0.00 200.00 190.00 10.00 0.00 0.00
isobutylketone
Toluene 600.00 570.0 12.00 18.00 0.00 200.00 190.00 4.00 6.00 0.00
Acetone 3600.00 3420.0 72.00 0.00 108.00 1200.00 1140.00 24.00 0.00 36.00
3426.67 3255.33 74.67 6.00 90.67
4-Chloro Butyralde
5000 MDC 800.00 760.0 16.00 0.00 24.00 1333.33 1266.67 26.67 0.00 40.00
4 Diethyl acetal
Mixed
Solvents(Toluene 1000.00 980.0 20.00 0.00 0.00 1666.67 1633.33 33.33 0.00 0.00
+Methanol )
3000.00 2900.00 60.00 0.00 40.00
4-Chloro-1 hydroxy
butane sulphonic 5000 MDC 800.00 760.0 16.00 0.00 24.00 1333.33 1266.67 26.67 0.00 40.00
5 acid sodium salt
METHANOL 200.00 190.0 4.00 0.00 6.00 333.33 316.67 6.67 0.00 10.00
1666.67 1583.33 33.33 0.00 50.00
6 4-Dimethyl amino 5000 Cyclohexane 600.00 570.0 12.00 4.00 14.00 1000.00 950.00 20.00 6.67 23.33

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butytalde diethyl
acetal
1000.00 950.00 20.00 6.67 23.33
7 Almotriptan Malate 1000 Chloroform 200.00 190.0 10.00 0.00 0.00 66.67 63.33 3.33 0.00 0.00
Diisopropyl ether 200.00 190.0 10.00 0.00 0.00 66.67 63.33 3.33 0.00 0.00
Methanol 1000.00 950.0 20.00 0.00 30.00 333.33 316.67 6.67 0.00 10.00
Dimethyl
200.00 190.0 4.00 0.00 6.00 66.67 63.33 1.33 0.00 2.00
formamide
Isopropyl alcohol 200.00 190.0 4.00 6.00 0.00 66.67 63.33 1.33 2.00 0.00
dichloromethane 600.00 570.0 12.00 0.00 18.00 200.00 190.00 4.00 0.00 6.00
Ethyl acetate 400.00 380.0 8.00 12.00 0.00 133.33 126.67 2.67 4.00 0.00
933.33 886.67 22.67 6.00 18.00
8 Celecoxib 4000 Methanol 1000.00 950.0 20.00 0.00 30.00 1333.33 1266.67 26.67 0.00 40.00
Toluene 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
36.00 1600.00 1520.00 32.00 0.00 48.00
Cis -2-[2,4-Di
Chloro Phenyl] -2-
[1H-1,2,4-Triazole -
4000 Dimethylsulfoxide 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
1-yl Methyl ]-1,3
Dioxalane -4 yl
9 Methanol
Toluene 200.00 190.0 4.00 6.00 0.00 266.67 253.33 5.33 8.00 0.00
Methanol 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
800.00 760.00 16.00 8.00 16.00
Cis -2-[2,4-Di
chloro Phenyl]-2-
[1H-1,2,4-Triazole -
5000 Dimethylsulfoxide 200.00 190.0 4.00 0.00 6.00 333.33 316.67 6.67 0.00 10.00
1-yl methyl]-1,3
Dioxalane-4yl
10 Methyl ] Methane

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Sulfonate

Toluene 200.00 190.0 4.00 6.00 0.00 333.33 316.67 6.67 10.00 0.00
Methanol 400.00 380.0 8.00 0.00 12.00 666.67 633.33 13.33 0.00 20.00
Dichloromethane 200.00 190.0 4.00 0.00 6.00 333.33 316.67 6.67 0.00 10.00
1666.67 1583.33 33.33 10.00 40.00
11 Dabigartan 2000 n- hexane 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00
Acetic acid 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00
Methanol 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00
Toluene 400.00 380.0 8.00 12.00 0.00 266.67 253.33 5.33 8.00 0.00
Ethanol 600.00 570.0 16.00 0.00 18.00 400.00 380.00 10.67 0.00 12.00
THF 400.00 380.0 8.00 0.00 12.00 266.67 253.33 5.33 0.00 8.00
Isopropyl alcohol 400.00 380.0 8.00 6.00 6.00 266.67 253.33 5.33 4.00 4.00
MDC 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00
Ethyl acetate 200.00 190.0 4.00 6.00 0.00 133.33 126.67 2.67 4.00 0.00
60.00 1866.67 1773.33 40.00 16.00 40.00
Duloxetine
2000 DMSO 200.00 190.0 4.00 6.00 0.00 133.33 126.67 2.67 4.00 0.00
12 Hydrochloride
Toluene 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00
Diisopropylethyla
200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00
mine
Ethyl acetate 400.00 380.0 8.00 3.00 9.00 266.67 253.33 5.33 2.00 6.00
Methanol 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00
800.00 760.00 16.00 6.00 18.00
13 Emitricitibine 4000 Isopropyl alcohol 100.00 95.0 2.00 0.00 3.00 133.33 126.67 2.67 0.00 4.00
Toluene 100.00 95.0 2.00 0.00 3.00 133.33 126.67 2.67 0.00 4.00
Ethanol 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
Methanol 100.00 95.0 2.00 0.00 3.00 133.33 126.67 2.67 0.00 4.00

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MDC 100.00 95.0 2.00 0.00 3.00 133.33 126.67 2.67 0.00 4.00
800.00 760.00 16.00 0.00 24.00
14 Imatinib Mesylate 2000 IPA 300.00 285.0 6.00 0.00 9.00 200.00 190.00 4.00 0.00 6.00
n-Butanol 500.00 475.0 16.00 0.00 9.00 333.33 316.67 10.67 0.00 6.00
IPE 200.00 190.0 10.00 0.00 0.00 133.33 126.67 6.67 0.00 0.00
Methanol 800.00 760.0 16.00 0.00 24.00 533.33 506.67 10.67 0.00 16.00
2-Propanol 200.00 190.0 10.00 0.00 0.00 133.33 126.67 6.67 0.00 0.00
Chloroform 400.00 380.0 8.00 0.00 12.00 266.67 253.33 5.33 0.00 8.00
Ethyl acetate 300.00 285.0 6.00 4.00 5.00 200.00 190.00 4.00 2.67 3.33
DMF 300.00 285.0 6.00 0.00 9.00 200.00 190.00 4.00 0.00 6.00
Total 2000.00 1900.00 52.00 2.67 45.33
15 Itraconazole 4000 Methanol 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
MDC 200.00 190.0 40.00 0.00 6.00 266.67 253.33 53.33 0.00 8.00
Toluene 200.00 190.0 4.00 6.00 0.00 266.67 253.33 5.33 8.00 0.00
Total 800.00 760.00 64.00 8.00 16.00
16 Ketorolac
5000 Toluene 400.00 380.0 8.00 3.00 9.00 9.00 633.33 13.33 5.00 15.00
Tromethamine
Acetic acid 200.00 190.0 4.00 0.00 6.00 10.00 316.67 6.67 0.00 10.00
EDC 200.00 190.0 4.00 0.00 6.00 11.00 316.67 6.67 0.00 10.00
Ethyl acetate 400.00 380.0 8.00 3.00 9.00 12.00 633.33 13.33 5.00 15.00
Acetone 200.00 190.0 4.00 0.00 6.00 13.00 316.67 6.67 0.00 10.00
Total 55.00 2216.67 46.67 10.00 60.00
17 Lansprazole 1000 Methanol 400.00 380.0 8.00 0.00 12.00 133.33 126.67 2.67 0.00 4.00
MDC 500.00 475.0 10.00 0.00 15.00 166.67 158.33 3.33 0.00 5.00
IPA 200.00 190.0 4.00 0.00 6.00 66.67 63.33 1.33 0.00 2.00
Methylisobutylket
200.00 190.0 10.00 0.00 0.00 66.67 63.33 3.33 0.00 0.00
one
Toluene 200.00 190.0 4.00 6.00 0.00 66.67 63.33 1.33 2.00 0.00

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Acetone 900.00 855.0 18.00 0.00 27.00 300.00 285.00 6.00 0.00 9.00
800.00 760.00 18.00 2.00 20.00
18 Mesalamine 4000 Acetone 400.00 380.0 8.00 0.00 12.00 533.33 506.67 10.67 0.00 16.00
Ethyl acetate 200.00 190.0 4.00 6.00 0.00 266.67 253.33 5.33 8.00 0.00
Methanol 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
Total 1066.67 1013.33 21.33 8.00 24.00
Olmesartan
4000 Acetonitrile 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
19 Medoxomil
Ethyl acetate 800.00 760.0 16.00 12.00 12.00 1066.67 1013.33 21.33 16.00 16.00
n-Hexane 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
Toluene 400.00 380.0 8.00 6.00 6.00 533.33 506.67 10.67 8.00 8.00
Diisopropylamine 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
Dioxane 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
Dimethl
200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
acetamide
Acetic acid 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
Total 54.00 3200.00 3040.00 64.00 24.00 72.00
20 Pentaprazole
chloro compound Mixed
(2-Chloromethyl- 10000 Solvents(IPA 1000.00 980.0 20.00 0.00 0.00 666.67 653.33 13.33 0.00 0.00
3,4-Dimethoxy- +Toluene )
Pyridine)
Chloroform 200.00 190.0 10.00 0.00 0.00 133.33 126.67 6.67 0.00 0.00
Acetone 100.00 95.0 2.00 0.00 3.00 66.67 63.33 1.33 0.00 2.00
Methylenedi
200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00
chloride
Methanol 300.00 285.0 6.00 0.00 9.00 200.00 190.00 4.00 0.00 6.00
Acetic acid 100.00 95.0 2.00 0.00 3.00 66.67 63.33 1.33 0.00 2.00
Total 21.00 1266.67 1223.33 29.33 0.00 14.00

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21 pantoprazole
9000 Acetone 400.00 380.0 8.00 0.00 12.00 1200.00 1140.00 24.00 0.00 36.00
Sodium
MDC 400.00 380.0 8.00 0.00 12.00 1200.00 1140.00 24.00 0.00 36.00
Isopropyl alcohol 200.00 190.0 4.00 0.00 6.00 600.00 570.00 12.00 0.00 18.00
Total 30.00 3000.00 2850.00 60.00 0.00 90.00
22 Pregabalin 4000 Ethanol 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
Methanol 400.00 380.0 8.00 0.00 12.00 533.33 506.67 10.67 0.00 16.00
Acetone 400.00 380.0 8.00 0.00 12.00 533.33 506.67 10.67 0.00 16.00
Toluene 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
IPA 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
Total 1866.67 1773.33 37.33 0.00 56.00
23 Rosuvastatin 4000 Isopropyl alcohol 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
MDC 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00
Methanol 600.00 570.0 12.00 0.00 18.00 800.00 760.00 16.00 0.00 24.00
Dichloro methane 400.00 380.0 8.00 0.00 12.00 533.33 506.67 10.67 0.00 16.00
DMSO 200.00 190.0 4.00 6.00 0.00 266.67 253.33 5.33 8.00 0.00
Toluene 600.00 570.0 12.00 6.00 12.00 800.00 760.00 16.00 8.00 16.00
Total 44.00 54.00 2933.33 2786.67 58.67 16.00 72.00
Sitagliptin
Phosphate 2000 MDC 300.00 285.0 6.00 0.00 9.00 200.00 190.00 4.00 0.00 6.00
24 Monohydrate
Toluene 200.00 190.0 4.00 6.00 0.00 133.33 126.67 2.67 4.00 0.00
Ethyl acetate 100.00 95.0 2.00 3.00 0.00 66.67 63.33 1.33 2.00 0.00
Methanol 100.00 95.0 2.00 0.00 3.00 66.67 63.33 1.33 0.00 2.00
IPA 300.00 285.0 6.00 0.00 9.00 200.00 190.00 4.00 0.00 6.00
21.00 666.67 633.33 13.33 6.00 14.00
Sumatriptan
1000 Toluene 400.00 380.0 8.00 6.00 6.00 133.33 126.67 2.67 2.00 2.00
25 Succinate
Methanol 100.00 950.0 20.00 0.00 30.00 33.33 316.67 6.67 0.00 10.00

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Dichloromethane 200.00 190.0 4.00 0.00 6.00 66.67 63.33 1.33 0.00 2.00
Ethyl acetate 200.00 190.0 4.00 6.00 0.00 66.67 63.33 1.33 2.00 0.00
42.00 300.00 570.00 12.00 4.00 14.00
26 Velpatasvir 2000 MDC 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00
THF 400.00 380.0 8.00 0.00 12.00 266.67 253.33 5.33 0.00 8.00
IPA 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00
Methanol 900.00 855.0 18.00 0.00 27.00 600.00 570.00 12.00 0.00 18.00
Toluene 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00
Acetic Acid 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00
1400.00 1330.00 28.00 0.00 42.00
27 Zolmitriptan 1000 n-Hexane 600.00 570.0 12.00 0.00 18.00 200.00 190.00 4.00 0.00 6.00
Isopropylalcohol 200.00 190.0 4.00 0.00 6.00 66.67 63.33 1.33 0.00 2.00
Methanol 1200.00 1140.0 24.00 0.00 36.00 400.00 380.00 8.00 0.00 12.00
Ethyl acetate 800.00 760.0 16.00 24.00 0.00 0.00 253.33 5.33 8.00 0.00
Total 666.67 886.67 18.67 8.00 20.00
Total 115000 47688.33 48078.67 1164.00 167.33 1174.00

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2.17 LIST OF THE RAW MATERIALS PRODUCT WISE


1. (S)-(-)-3-(DIMETHYLAMINO)-1-(2-THIENYL)-1-PROPANOL
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 2-Acetylthiophene 152 506.67
2 Acetone 200 666.67
Dimethylamine
3 98.5 328.33
hydrochloride
4 Formaldehyde 37.00 123.33
5 Hydrochloric acid 21.00 70.00
6 Isopropyl alcohol 100.00 333.33
7 Methanol 460.00 1533.33
8 n-Hexane 260.00 866.67
9 Petroleum ether 200.00 666.67
10 S-(+) –mandelic acid 87.00 290.00
11 Sodium borohydride 45.00 150.00
12 Sodium hydroxide 23.00 76.67
13 Toluene 200.00 666.67

2. 2,4- DIHYDRO-4-(4-4 HYDROXY PHENYL )-1-PIPERAZINYL ) –


2-(1-METHYL PROPYL)-3H-1,2,4-TRIAZOLE-3-ONE
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1-(4-Methoxy-phenyl)-4-
1 185.00 616.67
(4-nitro-phenyl)-piperazine
2 2-Bromo butane 55.00 183.33
3 Acetic acid 466.00 1553.33
4 Acetone 200.00 666.67
5 Chloroform 1100.00 3666.67
6 Dimethylformamide 300.00 1000.00
7 Dimethylsulfoxide 200.00 666.67
8 Formamidine 20.00 66.67
9 Hydrazine hydrate 24.00 80.00
10 Hydrobromic acid 750.00 2500.00
11 Hydrogen 1.20 4.00
12 Methanol 300.00 1000.00
13 Palladium on carbon 10.00 33.33
14 Phenyl chloroformate 87.00 290.00
15 Potassium hydroxide 23.00 76.67
15 Sodium carbonate 42.00 140.00

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3. 2-[3-METHYL -4-(2,2,2-TRIFLUOROETHOXY)-2-PYRIDINYL ]
4. METHYLTHIO -1H-BENZIMIDAZOLE
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 2,3-Lutidine 400.00 133.33
2 2-Mercaptobanzimidazole 214.00 71.33
3 Acetic acid 380.00 126.67
4 Acetic anhydride 750.00 250.00
5 Acetone 3600.00 1200.00
6 Ammonia 700.00 233.33
7 Hydrochloric acid 82.00 27.33
8 Hydrogen peroxide (50%) 360.00 120.00
9 Isopropyl alcohol 600.00 200.00
10 Methanol 1780.00 593.33
11 Methyl isobutyl ketone 600.00 200.00
12 Methylene di chloride 3100.00 1033.33
13 Nitric acid 740.00 246.67
14 Potassium carbonate 309.00 103.00
15 Sodium hydroxide 229.00 76.33
16 Sulphuric acid 1390.00 463.33
Tetra-n-butylammonium
17 10.00 3.33
bromide(TBAB)
18 Thionyl chloride 182.00 60.67
19 Toluene 600.00 200.00
20 Trifluoroethanol 223.00 74.33

4. 4-CHLORO BUTYRALDEHYDE DIETHYL ACETAL


Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 Tetra hydrofuran 47.00 78.33
2 Hydrochloric acid 47.60 79.33
3 MDC 800.00 1333.33
4 Methanol 500.00 833.33
5 Para toluene sulfonic acid 5.00 8.33
6 Potassium bromide 5.00 8.33
7 Sodium bicarbonate 50.00 83.33
8 Sodium carbonate 5.00 8.33
9 Sodium chloride 3.25 5.42
10 Sodium hydroxide 26.10 43.50
11 Sodium hypochlorite 45.25 75.42
12 Sodium thiosulphate 3.25 5.42
13 TEMPO 20.00 33.33
14 Toluene 500.00 833.33
15 Triethylorthoformate 84.85 141.42

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5. 4-CHLORO 1-HYDROXY BUTANE SULPHONIC ACID SODIUM SALT


Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 Tetra hydrofuran 40.00 66.67
2 Sodium hydroxide 22.20 37.00
3 Hydrochloric acid 40.50 67.50
4 Sodium hypochlorite 39.10 65.17
5 Sodium bicarbonate 50.00 83.33
6 MDC 400.00 666.67
(2,2,6,6-
Tetramethylpiperidin-1-
7 yl)oxyl or (2,2,6,6- 20.00 33.33
tetramethylpiperidin-1-
yl)oxidanyl,(TEMPO)
8 Potassium bromide 5.00 8.33
9 Sodium thio sulphate 3.25 5.42
10 Sodium chloride 3.25 5.42
11 Hydrochloric acid 18.15 30.25
12 Sodium metabisulphate 94.60 157.67
13 MDC 400.00 666.67
14 Methanol 200.00 333.33

6. 4- DIMETHYLAMINOBUTYRALDEHYDE DIETHYL ACETAL


Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1-Bromo-3-chloro-
1 93.00 155.00
propane
2 Cyclo hexane 600.00 1000.00
3 Dimethylamine 26.70 44.50
4 Iodine 20.00 33.33
5 Magnesium 14.00 23.33
6 Sodium hydroxide 23.65 39.42
7 Triethylorthoformate 81.50 135.83

7. ALMOTRIPTAN MALATE
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
(4-Nitro-phenyl)-methane 73.00 24.33
1
sulfonyl chloride
4-Chloro-1,1-dimethoxy- 40.00
2
butane 13.33
3 Ammonium hydroxide 52.00 17.33
4 Chloroform 200.00 66.67
5 Dichloromethane 600.00 200.00
6 Diisopropylether 200.00 66.67
7 Dimethyl formamide 200.00 66.67

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8 Disodium orthophosphate 20.00 6.67


9 Ethyl acetate 400.00 133.33
10 Formaldehyde 15.00 5.00
11 Hydrochloric acid 40.00 13.33
12 Hydrogen 0.60 0.20
13 Isopropyl alcohol 200.00 66.67
14 Malic acid 36.00 12.00
15 Methanol 1000.00 333.33
16 Oxalic acid 20.00 6.67
17 Pyrrolidine 22.00 7.33
18 Raney nickel 10.00 3.33
19 Sodium borohydride 10.00 3.33
20 Sodium nitrite 19.00 6.33
21 Tin(II) chloride 20.00 6.67

8. CELECOXIB
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 Trifluoro acetic acid 36.00 48.00
2 4-amino benzene
51.00 68.00
sulfonamide
3 4-methyl acetophenone 39.80 53.07
4 Hydrochloric acid 32.50 43.33
5 Methanol 1010.00 1346.67
6 Sodium chloride 23.75 31.67
7 Sodium methoxide 16.05 21.40
8 Sodium nitrite 20.50 27.33
9 Sodiummeta bi sulphate 56.60 75.47
10 Toluene 200.00 266.67

9. CIS -2-[2, 4-DI CHLORO PHENYL] -2-[1H-1, 2,4-TRIAZOLE -1-YL METHYL


]-1,3 DIOXALANE -4 YL METHANOL
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 Cis bromo benzoate 159.00 212.00
2 1,2,4-Trazole 24.50 32.67
3 Potassium carbonate 24.50 32.67
4 Sodium hydroxide 15.00 20.00
5 Dimethylsulfoxide 200.00 266.67
6 Toluene 200.00 266.67
7 Methanol 200.00 266.67

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10. CIS -2-[2, 4-DI CHLORO PHENYL]-2-[1H-1, 2, 4-TRIAZOLE -1-YL


METHYL]-1, 3 DIOXALANE-4YL METHYL] METHANE SULFONATE
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 Cis bromo benzoate 137.00 228.33
2 1,2,4-Trazole 22.00 36.67
3 Dichloromethane 200.00 333.33
4 Dimethylsulfoxide 200.00 333.33
5 Methane sulfonyl chloride 30.00 50.00
6 Methanol 400.00 666.67
7 Potassium carbonate 22.00 36.67
8 Sodium hydroxide 13.00 21.67
9 Toluene 200.00 333.33
10 Triethylamine 27.00 45.00

11. DABIGATRAN
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 (pyridine-2-ylamine 23.00 15.33
2 2-bromoacetic acid 30.00 20.00
3 4-amino benzonitrile 25.00 16.67
4-chloro-3-nitro-benzoic
4 55.00 36.67
acid
5 Acetic acid 200.00 133.33
6 Ammonia 5.00 3.33
7 Ammonium carbonate 18.00 12.00
8 Ammonium formate 20.00 13.33
9 Dichloromethane 200.00 133.33
10 Ethanol 400.00 266.67
11 Ethyl acetate 200.00 133.33
12 Ethyl acrylate 25.00 16.67
13 Hexyl chloro formate 29.00 19.33
14 Hydrochloric acid 9.00 6.00
15 Iron 12.00 8.00
16 Isopropyl alcohol 400.00 266.67
17 Methanol 200.00 133.33
18 Methyl amine 9.00 6.00
19 n-Hexane 200.00 133.33
20 Potassium carbonate 25.00 16.67
21 Tetra hydrofuran 400.00 266.67
22 Thionyl chloride 31.00 20.67
23 Toluene 400.00 266.67
24 Triethylamine 24.00 16.00

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12. DULOXETINE HYDROCHLORIDE


Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
(S)-3-Dimethylamino-1-
1 74.00 49.33
thiophen -2-yl-propan-1-ol
2 1-fluoronaphthalene 58.00 38.67
3 Diisopropyl ethylamine 200.00 133.33
4 DMSO 200.00 133.33
5 Ethyl acetate 400.00 266.67
6 Hydrochloric acid 13.00 8.67
7 Methanol 200.00 133.33
8 Oxalic acid 35.00 23.33
9 Phenyl chloro formate 60.00 40.00
10 Potassium hydroxide 10.00 6.67
11 Sodium hydroxide 16.00 10.67
12 Toluene 200.00 133.33

13. EMITRICITABINE
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
5-(4-Amino-5-fluoro-2-
oxo-2H-pyrimidin-1-yl)-
[1,3]Oxa thiolane-2-
1 200.00 266.67
carboxylic acid-2-
isopropyl-5-methyl cyclo
hexyl ester
2 Activated carbon 23.00 30.67
Dipotassium hydrogen
3 10.00 13.33
phosphate
4 Ethanol 200.00 266.67
5 Hydrochloric Acid 20.00 26.67
6 Hyflow 10.00 13.33
7 IPA.HCl (25%) 73.20 97.60
8 Isopropyl alcohol 200.00 266.67
9 MDC 100.00 133.33
10 Methanol 100.00 133.33
11 Sodium borohydride 19.00 25.33
12 Sodium Hydroxide 11.00 14.67
13 Toluene 100.00 133.33
14 Tri ethylamine 47.00 62.67

14. IMATINIB MESYLATE


Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 O-Toludine 31.00 20.67
2 2-Propanol 200.00 133.33
3 3-dimethylamino-1- 47.30 31.53

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(pyridyl0-2-propan-1-one
4-(4-methylpiperazine
4 mono methyl)benzoic acid 57.00 38.00
di HCl
5 Ammonia 10.00 6.67
6 Chloroform 400.00 266.67
7 Chloroform 0.00
8 Cyanamide 11.60 7.73
9 DMF 300.00 200.00
10 Ethyl acetate 600.00 400.00
11 Ethyl acetate 0.00
12 Hydrogen 1.56 1.04
13 IPA 300.00 200.00
14 IPE 200.00 133.33
15 Methane sulfonic acid 16.95 11.30
16 Methanol 800.00 533.33
17 N-Butanol 500.00 333.33
18 Nitric acid 35.65 23.77
19 Palladium on carbon 10.00 6.67
20 Sodium hydroxide 10.75 7.17
21 Sulfuric acid 28.50 19.00
22 Thionyl chloride 22.10 14.73
23 Tin(II) chloride 10.00 6.67

15. ITRACONAZOLE
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1-[2-(2,4-Dichloro-phenyl)-4-ethy l-
1 [1,3]dioxolan -2-ylmethyl]-1H- 65.00 86.67
[1,2,4]triazole
2-{4-[4-(4-Hydroxy-phenyl)-piperazin-
2 1-yl]-phenyl}-4-isobutyl-2,4-dihydro - 63.00 84.00
[1,2,4]triazol-3-one
3 Sodium hydroxide 7.00 9.33
4 Toluene 200.00 266.67
5 Methanol 200.00 266.67
6 Dichloro methane 200.00 266.67

16. KETOROLAC TROMETHAMINE


S. No. Raw Material Consumption/ Consumption/
Batch in Kgs Day in Kgs
1 Benzoyl chloride 71.00 118.33
2 Acetic acid 200.00 333.33
3 Acetic anhydride 234.00 390.00
4 Acetone 200.00 333.33
5 Dichloroethane (EDC) 238.00 396.67
6 Diethylmalonate 71.00 118.33

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7 Ethyl acetate 400.00 666.67


8 Ethylchloroformate 48.00 80.00
9 Hydrochloric acid 28.20 47.00
10 Magnesium oxide 18.00 30.00
11 Manganese acetate 10.00 16.67
12 Morpholine 44.00 73.33
13 Phosphoryl chloride 73.00 121.67
14 potassium permanganate 10.00 16.67
15 Pyrrole 32.00 53.33
16 Sodium hydroxide 90.80 151.33
17 TBAB 10.00 16.67
18 Toluene 400.00 666.67
19 Tromethamine 36.00 60.00

17. LANSOPRAZOLE
S. Raw Material Consumption/ Consumption/
No. Batch in Kgs Day in Kgs
1 2,3-Lutidine 47.00 15.67
2 2-Mercaptobanzimidazole 49.00 16.33
3 Acetic acid 200.00 66.67
4 Acetic anhydride 39.00 13.00
5 Acetone 900.00 300.00
6 Ammonia 15.00 5.00
7 Ammonium sulphate 25.00 8.33
8 Hydrochloric acid 14.00 4.67
9 Hydrogen peroxide (50%) 30.00 10.00
10 Isopropyl alcohol 200.00 66.67
11 Methanol 400.00 133.33
12 Methyl isobutyl ketone 200.00 66.67
13 Methylene di chloride 500.00 166.67
14 Nitric acid 27.00 9.00
15 Potassium carbonate 52.00 17.33
16 Sodium hydroxide 46.00 15.33
17 Sodium hypo chlorite 22.00 7.33
18 Sulphuric acid 41.00 13.67
Tetra-n-butylammonium 10.00
19
bromide(TBAB) 3.33
20 Thionyl chloride 41.00 13.67
21 Toluene 200.00 66.67
22 Trifluoroethanol 38.00 12.67

18. MESALAMINE
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 2-chloro-benzaldehyde 138.00 184.00
2 Acetone 400.00 533.33
3 Ethyl acetate 200.00 266.67

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4 Hydrogen 1.50 2.00


5 Methanol 200.00 266.67
6 Nitric acid 62.00 82.67
7 Potassium hydroxide 45.00 60.00
8 Potassium permanganate 279.50 372.67
9 Raney Nickel 10.00 13.33
10 Sulphuric acid 96.50 128.67

19. OLMESARTAN MEDOXOMIL


Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 DiaminoMaleonitrile 41.00 54.67
2 4-[2-(trityltetrazole)-
5yl)phenyl] benzyl
bromide((5-(4'-
128.00 170.67
Bromomethyl-Biphenyl-
2-Yl)-2- Trityl-2,5-
Dihydro-1H-Tetrazole))
3 4-Chloromethyl-5-methyl-
30.00 40.00
[1,3]diooxol-2-one
4 Acetic acid 200.00 266.67
5 Acetone 200.00 266.67
6 Acetonitrile 200.00 266.67
7 Diisopropyl ether 200.00 266.67
8 Dimethylacetamide 200.00 266.67
9 Dioxane 200.00 266.67
10 Ethanol 26.00 34.67
11 Ethyl acetate 800.00 1066.67
12 Hydrochloric acid 30.00 40.00
13 Lithium hydroxide mono
10.00 13.33
hydrate
14 Methyl magnesium
19.00 25.33
chloride
15 n-hexane 200.00 266.67
16 Sodium sulphate 150.00 200.00
17 Thionyl chloride 35.00 46.67
18 Toluene 400.00 533.33
19 Trimethyl ortho butyrate 51.00 68.00

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20. PENTAPRAZOLE CHLORO COMPOUND


(2-CHLOROMETHYL-3,4-DIMETHOXY-PYRIDINE)
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 Maltol 411.00 274.00
2 Acetic acid 100.00 66.67
3 Acetic Anhydride 290.50 193.67
4 Acetone 100.00 66.67
5 Ammonia 54.50 36.33
6 Chloroform 200.00 133.33
7 Dimethyl sulphate 206.00 137.33
8 Hydrochloric acid 99.50 66.33
9 Hydrogen peroxide (50%) 205.00 136.67
10 IPA 500.00 333.33
11 MDC 200.0 133.33
12 Methanol 394.00 262.67
13 Phosphorous oxy chloride 476.00 317.33
14 Potassium carbonate 359.00 239.33
15 Sodium Hydroxide 228.90 152.60
16 Toluene 500.00 333.33

21. .PANTOPRAZOLE SODIUM


Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 2-Chloromethyl-3,4-
dimethoxy-pyridine 68.00 204.00
Hydrochloride
2 5-Difluoromethoxy-2-
66.00 198.00
mercaptobenzimidazole
3 Acetone 400.00 1200.00
4 Ammonium hydroxide 22.00 66.00
5 Dichloromethane 400.00 1200.00
6 Isopropylacohol 200.00 600.00
7 Sodium hydroxide 11.00 33.00
8 Sodium hypochlorite 20.00 60.00

22. PREGABALIN
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 Iso valeraldehyde 553.00 737.33
2 Acetic acid 545.00 726.67
3 Acetone 400.00 533.33
4 Activated carbon 30.00 40.00
5 Diethylmalonate 1028.50 1371.33
6 Ethanol 200.00 266.67
7 Hydrochloric acid 63.00 84.00

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8 Hydrogen 16.00 21.33


9 IPA 200.00 266.67
10 Methanol 400.00 533.33
11 Potassium hydroxide 245.00 326.67
12 Raney Nickel 10.00 13.33
13 Sodium cyanide 252.00 336.00
14 Sodium hydroxide 69.00 92.00
15 Tartric acid 280.00 373.33
16 Toluene 200.00 266.67

23. ROSUVASTATIN
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 4-Fluoro benzaldehyde 62.00 82.67
2 (6-Acetoxy-2,2-dimethyl-
[1,3] dioxan-4-yl)-acetic 81.00 108.00
acid tert-butyl ester
3 2-Methyl iso thio urea 41.00 54.67
4 Dichloro methane 400.00 533.33
5 Dicyclohexylamine 42.00 56.00
6 DMSO 200.00 266.67
7 Hydrobromic acid 175.44 233.92
8 Isopropyl alcohol 200.00 266.67
9 Manganese dioxide 10.00 13.33
10 MDC 200.00 266.67
11 Methane sulfonic acid 33.00 44.00
12 Methanol 600.00 800.00
13 Methyl Amine 12.00 16.00
14 Methyl isobutyryl acetate 72.00 96.00
15 Piperidine 5.00 6.67
16 Potassium carbonate 65.00 86.67
17 Sodium bicarbonate 5.00 6.67
18 Sodium boro hydride 13.00 17.33
19 Sodium hydroxide 19.00 25.33
20 Sodium hypo chlorite 79.00 105.33
21 TEMPO 5.00 6.67
22 Toluene 600.00 800.00
23 Triphenylphosphine 68.00 90.67

24. SITAGLIPTIN PHOSPHATE MONOHYDRATE


Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 2,4,5-Trifluro phenyl acetic
95.00 63.33
acid
2 3-(trifluoromethyl)-5,6,7,8-
tetrahydro(1,2,4)triazole(4,3,- 109.00 72.67
a)Pyrazine hydrochloride

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3 Acetic acid 15.00 10.00


4 Ammonia 8.00 5.33
5 Ethyl acetate 100.00 66.67
6 Hydroxyl phenyl acetic acid 34.00 22.67
7 Isopropyl alcohol 300.00 200.00
8 Meldrum acid 72.00 48.00
9 Methane sulfonic acid 46.00 30.67
10 Methanol 100.00 66.67
11 Methylene chloride 300.00 200.00
12 Phosphoric acid 20.50 13.67
13 Sodium bicarbonate 40.00 26.67
14 Sodium borohydrate 8.50 5.67
15 Sodium hydroxide 48.50 32.33
16 Thionyl chloride 60.00 40.00
17 Toluene 200.00 133.33

25. SUMATRIPTAN SUCCINATE


Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 Para Nitrobenzyl Bromide 372.00 124.00
2 4-Chloro-1-hydroxy
butane-1-sodium sulfonic 91.00 30.33
acid
3 Dichloromethane 200.00 66.67
4 Disodium hydrogen
10.00 3.33
orthophosphate
5 Ethyl acetate 200.00 66.67
6 Formaldehyde (50%) 42.00 14.00
7 Hydrochloric acid 42.00 14.00
8 Hydrogen 1.50 0.50
9 Methanol 1000.00 333.33
10 Mono methyl amine 38.00 12.67
11 Phosphoryl chloride 185.00 61.67
12 Raney Nickel 10.00 3.33
13 Sodium Sulphite 217.00 72.33
14 Sodium borohydride 13.00 4.33
15 Sodium dithionate 15.00 5.00
16 Sodium hydroxide 10.00 3.33
17 Sodium nitrite 40.00 13.33
18 Succinic acid 32.00 10.67
19 Toluene 400.00 133.33

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26. VELPATASVIR
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 9-Bromo-3-(2-bromo-acetyl)-
10,11 -dihydro-5H,9H-6-oxa- 61.00 40.67
benzo[a]anthracen-8-one
2 1-(2-Methoxycarbonylamino-3-
methyl -butyryl)-5-methyl- 37.30 24.87
pyrrolidine- 2-carboxylic acid
3 4-Methoxymethyl-pyrrolidine -
1,2-dicarboxylic acid 1-tert-butyl 35.15 23.43
ester
4 Acetic acid 200.00 133.33
5 Acetylamino-phenyl-acetic acid 22.60 15.07
6 AMMONIA 4.50 3.00
7 Ammonium acetate 19.70 13.13
8 Caesium carbonate 5.00 3.33
9 CDMT(2-Chloro-4,6-dimethoxy-
5.00 3.33
1,3,5-triazine)
10 DDQ 5.00 3.33
11 Hydrochloric acid 5.00 3.33
12 IPA 200.00 133.33
13 MDC 200.00 133.33
14 Methanol 900.00 600.00
15 Phosphoric acid 5.00 3.33
16 THF 400.00 266.67
17 Toluene 200.00 133.33

27. ZOLMITRIPTAN
Consumption/ Consumption/
S. No. Raw Material
Batch in Kgs Day in Kgs
1 L-Phenylalanine 132.00 44.00
2 (4,4-Diethoxy-butyl) -
74.00 24.67
dimethyl-amine
3 Activated carbon 60.00 20.00
4 Ammonia 28.00 9.33
5 Ethyl acetate 800.00 266.67
6 Ethyl chloroformate 69.00 23.00
7 Hydrochloric acid 100.00 33.33
8 Hydrogen 0.90 0.30
9 Hyflow 10.00 3.33
10 Isopropyl alcohol 200.00 66.67
11 Methanol 623.00 207.67
12 n-Hexane 600.00 200.00
13 Nitric acid 51.00 17.00
14 Raney Nickel 10.00 3.33

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15 Sodium bicarbonate 20.00 6.67


16 Sodium boro hydride 22.00 7.33
17 Sodium hydroxide 10.00 3.33
18 Sodium methoxide 27.00 9.00
19 Sodium sulphate 150.00 50.00
20 Sulphuric acid 79.00 26.33
21 Thionyl chloride 86.00 28.67

2.18 ENVIRONMENTAL ASPECTS, IMPACTS AND MITIGATION MEASURES OF


PROPOSED INDUSTRY
1. Aspect: Process gases such as SO2, HCl Emissions, DG Set emissions & Boiler
emissions into atmosphere.
Impact: Air pollution & Acid precipitation.
Mitigation measures: During production process the released gases will be
passed through double stage scrubber to scrub the gases with miscible liquid.
The scrubber will have polypropylene rings as packing media to increase the
contact surface area between gas and scrubbing solution to increase the
absorption. Gas and scrubbing solution will pass through the scrubber counter
currently.

SO2 gas will be scrubbed with caustic lye solution to convert into sodium
sulphate. In this process the entire SO2 will get scrubbed.
HF gas will be scrubbed with caustic lye solution to convert into convert into
sodium salt.
HCl gas will be scrubbed with chilled water to convert into HCl solution.
(CH3)2NH will be scrubbed with chilled water to convert into dilute solution of
Dimethylamine.
NH3 will be scrubbed with chilled water to convert into ammonium solution.
DG set emissions will be monitored regularly to maintain the emission limits
within the CPCB limits. As per norms the stack height will be provided around 9
mts to have proper dispersion. In case the limits are crossing the combustion
engine will be taken for service.
Boiler flue gases emissions will be monitored regularly to maintain the flue gases
emission limit as per CPCB Standard. The stacks of height 34 m & 30 m will be
provided to have proper dispersion of flue gases.

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2. Aspect: Organic & inorganic impurities from process & inorganic impurities High
TDS water & High COD water from utilities, floor washings entering into water
stream.
Impact; water pollution (contamination of natural resources)
Mitigation measures: The generated High& Low TDS water, floor washings will
be collected in separate streams at generation point and collected in to
respective dedicated tanks. The high TDS water sent through the MEE System to
remove COD and TDS and later passed with Low TDS water through the
Biological treatment plant to remove BOD and finally through the RO plant to get
reusable water quality. This water will be used for Cooling towers and floor
washings etc. This will minimize the fresh water requirement by 175 KLD.
3. Aspect: Noise from DG Set, Boiler & Electric motors more than 75 dB.
Impact: Noise pollution.
Mitigation measure: DG set will have acoustic enclosure and drives will have
proper maintenance to minimize vibrations and internal parts servicing to
minimize the sound pollution.

4. Aspect: Spillages of chemicals during loading /unloading, Effluent water at ETP


Plant, Solvents spillages at storage tanks, spillage of Oils from DG Set & Air
compressor/Refrigeration compressor on to the ground.
Impact: Soil pollution.
Mitigation measure: To avoid any spillage of chemicals the working area of
loading & unloading area is barricaded and the floor will be made with acid proof
tiling with a slope towards a small pit so as to collect the spilled chemicals in the
dedicated pit. This results in avoiding the spillage of chemicals on to the ground.
Effluent water will be transferred through the dedicated pipe lines from plant to
ETP plant .This will eliminate soil contamination with effluent water.
Each solvent storage tank area will have dyke wall and the floor will have cement
concrete with slope towards a pit. Hence spillage of solvent will be avoided on to
ground.
The DG set /Air compressor/refrigeration compressor area will be placed in
Utilities building with cement concrete floor. The filling and draining of Oils from

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respective equipment will be done by trained technical person to avoid any


spillage of oil on to the floor/ground.

5. Aspect: Improper Storage of hazardous waste (organic waste, inorganic waste,


spent carbon) results in leakage/Spillage on to the ground
Impact; Soil pollution
Mitigation measure: The hazardous waste in containers will be stored in
dedicated area as per its category with proper flooring having slope towards a pit
to collect any spilled material. The entire area will be barricaded with a dyke wall
and only authorized personnel will be allowed to do operations in storage area.
This avoids soil pollution.

6. Aspect: Establishment of industry may release gases emissions, effluent water


leakage to surrounding areas.
Impact: 1. Flora & Fauna, Water Bodies, Agriculture & Human habitation.
2. The positive impact is generation of employment to skilled & unskilled
people of nearby villages and economic development.
Mitigation measure: The industry will have dedicated effluent treatment (MEE,
Biological treatment plant, RO system) to achieve Zero Liquid discharge system.
This will eliminate effluent leakage to surrounding area of the plant.

7. Aspect; Improper Storage of Flammable chemicals Methanol, Toluene, Acetone


causing leakage of flammable chemical
Impact: presence of ignition source caches fire, risk to plant personnel due to
thermal radiation, release of CO, CO2, toxic gases in to atmosphere and global
warming.

Mitigation measure: Each solvent storage tank will have dyke to contain entire
contents. This will avoid leakage of solvent to the outside of dyke wall. The tanks
will be monitored regularly for any corrosion at valve joints, valve gland leakages.
The storage tanks will have fire alarm system. In case if it is catches fire, it will be
extinguished with DCP fire extinguishers and fire hydrant water. This will
minimize the thermal radiation and release of CO, CO2 and toxic gases to the
atmosphere.

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8. Aspect: ground water extraction for industry


Impact: Depletion of water resources
Mitigation measure: The industry will conserve rain water by adopting rain water
harvesting system in the plant of11536 m3/annum.

2.19 ASSESSMENT OF NEW & UNTESTED TECHNOLOGY FOR RISK OF


TECHNOLOGICAL FAILURE
No new or untested technology will be used in the proposed project but the
manufacturing process may be altered for better yields after successful lab tests and
R&D.

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CHAPTER -III

DESCRIPTION OF THE
ENVIRONMENT
EIA Report Archimedis Laboratories Pvt. Ltd.

CHAPTER-III
DESCRIPTION OF THE ENVIRONMENT

3.0 INTRODUCTION
Baseline data generation is a part of the Environmental Impact Assessment study, which
helps to evaluate the predicted impacts on the various environmental attributes in the study
area by using scientifically developed and widely accepted environmental impact
assessment methodologies. This further helps in preparing an Environment Management
Plan (EMP) outlining the measures for improving the environmental quality and scope for
future improvements for environmentally sustainable development. The baseline
environmental study also helps to identify the critical environmental attributes, which are
required to be monitored after implementation of the project.
This chapter illustrates the description of the existing environmental status of the study
area with reference to the prominent environmental attributes. The existing environmental
setting is considered to adjudge the baseline conditions which are described with respect
to climate, hydro-geological aspects, atmospheric conditions, water quality, soil quality,
vegetation pattern, ecology, socio-economic profile, landuse, places of archaeological
importance etc.

3.1 STUDY AREA


Archimedis Laboratories Pvt. Ltd. proposed manufacturing unit is located at Sy No: 108
& 109, Jayanthipuram (V) Jaggayyapet (M), Krishna District, Andhra Pradesh.

3.1.2 Study Period


The baseline data was collected for the study area during the period of March – 2018 to
May – 2018.

3.2 Geological & Hydrogeological Environment


Scope and Methodology
In any given environment the occurrence and movement of ground water and its quality
and quantity is chiefly controlled and governed by many factors such as geographical set-
up, climate and rainfall conditions, hydrological features, topography, soil characteristics,
the nature and thickness of underlying rock formations and other related aspects that
prevail in an area. Therefore the study envisages indentifying the existing ground water
conditions comprising both quality and potential within the project site and its

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neighborhood, relating the projected utilization for the production, identifying the likely
impacts on surface and ground water resources and indicating mitigation measures. In
order to accomplish the proposed objective of the study, the scope and methodology
adopted is as follows:
 Collection of the relevant data contained in the EIA and EMP Reports, from the
reports and maps of Central Ground Water Board (CGWB), Geological Survey of
India (GSI) and Indian Meterological Department (IMD) other Institutions and
Departments.
 Identify Inter- related and Inter – dependent key factors that play vital role in the
occurrence of ground water its quality and potential.
 Identify surface water resources in the project site and its catchment area.
 Assess the ground water resource potential in the catchment area of the project
site.

The field investigations were carried out to study surface rock outcrops, geological cross
sections in the road cuttings. Inventory of wells representing the entire watershed area was
carried out. Hydrogeological data of about 10 wells was collected. Water levels were
measured in the Dug wells and bore wells.
Information already available and the data collected during the survey is collated and
analyzed to comprehend the overall ground water situation in the area. An attempt is made
to predict the likely changes that could occur on account of the proposed bulk drugs
manufacturing and certain mitigation measures have been indicated to avoid adverse
effect on the ground water environment.

3.2.1 Geomorphology and Soil Types:


Geomorphologically the district can be broadly divided into 3 distinct units, viz., Pediplain,
Alluvial plains, and Coastal & Deltaic plains. The pediplain area i.e., northern part of the
district consists of an undulated plain with broken ridges. Major part of the district in the
southern part is represented by the alluvial plains forming the Krishna delta. The river
Krishna and its tributaries have contributed to the formation of this alluvial plain. The
predominant soils in the district are black cotton soils/deltaic soils, red loamy soils and
sandy soils. Red clayey soils with sandy loam to clayey loam in texture and occur in the
northern part of the district.

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3.2.2 Geology
The district is underlain by variety of geological formations comprising from the oldest
Archaeans to Recent Alluvium. Hydrogeologically these formations are classified as
consolidated (Hard), semi-consolidated (Soft) and unconsolidated (Soft) formations. The
consolidated formations include crystallines (khondalites, charnockites and granitic
gneisses) and metasediments (Limestones, shales, phyllites and quartzites) of Archaean
and Pre-cambrian periods respectively.

3.2.3 Hydrogeology
The proposed manufacturing unit is located on the ridge portion of the catchment and is
over the run off zone. No major streams are passing through the site. The catchment area
of the proposed site is moderate and recharge conditions are good. However, the buffer
zone of 10 km radius has good catchment and recharge potential with streams and tanks
of considerable storage potential.
All the stream courses are ephemeral in character and carry large volumes of storm flows
during rainy season and remain dry during non - monsoon season. The width of the
streams is narrow and follows the weak planes within the hard rock formations.
A drainage map of the area around the project is shown in Figure 3.1.

3.2.4 Groundwater Conditions:


Groundwater occurs under semi-confined conditions in the fissured zone of the banded
biotite hornblende gneisses. Ten bore wells were inventoried to assess the groundwater
conditions. The depth to water levels was found to be 12-20m. The yield ranges of bore
wells was found to be 50-100 lpm. The quality of water is found to be potable.
As the extent of the proposed site is very small only roof top rainwater harvesting is
suggested for improving the recharge to the groundwater.
The proposed area is categorized as safe by the Groundwater department and scope for
development & stage of groundwater is good. The site is feasible for groundwater
extraction for the proposed Bulk drugs & intermediates manufacturing unit.

3.2.5 Drainage Pattern of Study Area


Dendritic drainage indicates homogenous rocks, the trellis, rectangular and parallel
drainage patterns indicate structural and lithological controls. The coarse drainage texture
indicates highly porous and permeable rock formations; whereas fine drainage texture is

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more common in less pervious formations. Weathering profile controls of ground water and
above all discharge of surface water along the major streams and rivers. Fractured pattern
and other structural features control drainage pattern in hard rocks. Slope / gradient of
area coupled with drainage density decide the weathering profile. These two factors
synthesized with rainfall (of a given area) provide information on the ground water potential
(weathering profile, structural factors) and discharge of surface water along streams.
Weathering profile increases groundwater potential, slope/gradient together with runoff
controls the thickness of weathered zone. Major faults, lineaments sometimes connects
two are more watersheds (Drainage Basins) and act as conduits (Interconnecting channel
ways). Flow of groundwater along these week zones is an established fact. A proper
understanding of the major faults, their influence of groundwater flow has to be understood
from drainage system and its controls. The study of the drainage for the present purpose is
to understand that, to what extent the ground water would be affected by the water
pollutants. Survey of India Topomaps, satellite data of summer season are the main input
data for preparation of drainage map. The drainage map is prepared using Toposheets of
Survey of India on 1:50,000 scale and updated using latest satellite data wherever
deviations and new developments are observed.

Step I: All the rivers its tributaries and drainage network shown on the Toposheets are
captured. The boundaries of all rivers/water bodies with names appearing are captured
from Toposheets. The drainage is drawn from whole to part, i.e., from the rivers to
tributaries to first drains to second order drains to third order drains.
Step II: Based on the post monsoon satellite image extent of water spread and dry parts
are updated. The water bodies which did not exist at the time of survey of Toposheets, if
any are also captured based on satellite imagery. The study area forms part of Mahanadi
river basin the southern of the area from western part, towards East. All these rivers and
rivulets get dry for major part of the year and carry heavy floods during rainy season. The
drainage map of study area has showing in figure 3.1.

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Table 3.1
Showing drainage density based criteria by smith and strahler.
Drainage
Texture Runoff Infiltration Relief Stratum
Density
< 5.0 Coarse (High) High Low High High Impermeable
5.0 - 13.7 Medium Medium Medium Medium Medium Permeable
13.7 - 155.3 Ultra fine (Low) Low High Low Good Permeable

Table 3.2
Showing drainage density based criteria proposed by Long Bein
Drainage Density Areas Runoff
0.55 - 2.09 Steep Impervious Areas High
1.03 Humid Regions High

Table 3.3
Showing Drainage Density Based Criteria Proposed by Horton
Drainage Density Stratum Runoff
0.9 - 1.29 Steep Impervious Areas High
< 0.9 Permeable High Infiltration Areas Low

3.2.6 Drainage Map


This Draingae map consists of all water bodies, rivers, tributaries, perennial & ephemeral
streams, reservoirs, tanks, ponds and the entire drainage network from first order
originating in the area to the last order joining the rivers, tributaries and tanks based on
topography. Understanding the importance of drainage depends on the purpose and the
objective of the project. For the present study purpose the following factors have to be
understood and extracted from the study of the drainage pattern. Drainage network helps
in delineation of watersheds. Drainage density and type of drainage gives information
related to runoff, infiltration relief and permeability.

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FIGURE 3.1 SHOWING DRAINAGE MAP OF THE PROJECT STUDY AREA


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3.3 Micrometeorology and Climate


The meteorological data recorded during the study period is very useful for proper
interpretation of the baseline information as well as for input to prediction models for
air quality dispersion. Historical data on meteorological parameters will also play an
important role in identifying general meteorological regime of the region.
Automatic weather station was installed in the project site at about 10 m above the
ground level. On-site monitoring was undertaken for various meteorological variables
in order to record the site-specific data. Data was recorded every hour continuously
from March – 2018 to May – 2018.
The critical weather elements that influence air pollution are wind speed, wind
direction, temperature, which together determines atmosphere stability. The details
of the temperature, relative humidity and rainfall observed during study period
(March – 2018 to May – 2018) are given below.

A. Temperature:
During the study period the minimum and maximum temperatures were recorded as
22.1°C and 45.2°C respectively.

B. Relative Humidity:
During study period at project site, the relative humidity was recorded as 79.1%

C. Rainfall
No rainfall during the Study Period at the Project Site. Average annual rainfall is 982
mm. (Source: IMD Climatatological Normals, Nandigama 1981 - 2010)

D. Wind pattern
Dispersion of different air pollutants released into the atmosphere has significant
impacts on neighborhood air environment. The dispersion/dilution of the released
pollutant over a large area will result in considerable reduction of the concentration of
a pollutant. The dispersion in turn depends on the weather conditions like the wind
speed, wind direction, temperature, relative humidity, mixing height, cloud cover and
also the rainfall in the area.
Wind speed and direction data recorded during the study period is useful in
identifying the influence of meteorology on the air quality of the area. Wind roses on
sixteen sector basis have been drawn. Wind directions and wind speed frequency

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observed during study period is given in Table 3.4 and wind rose diagrams are
given in Figure 3.2.
The following observations can be made from the collected data;
 Calm period is observed to be 16.9 % during the time of monitoring.
 The predominant wind direction is S & SSW.
 Other than predominant wind directions wind was blowing in ESE direction.
 Average wind speed 3.7 m/s.
 Mostly the wind speeds are observed to be in the range of 5.7 – 8.8 m/sec,
0.5 – 2.1 m/Sec, 3.6 - 5.7 m/Sec, with frequency of distribution percentages
ranges from 27.5, 21.1, & 16.2.

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TABLE 3.4: FREQUENCY DISTRIBUTION WIND DIRECTIONS AND WIND SPEED


Wind Classes (m/s)
S. No Wind Directions
0.5 - 2.1 2.1 - 3.6 3.6 - 5.7 5.7 - 8.8 8.8 - 11.1 >= 11.1 Total (%)
1 N 348.75 - 11.25 0.7 0.2 0.2 0.3 0 0 1.4
2 NNE 11.25 - 33.75 0 0 0 0 0 0 0
3 NE 33.75 - 56.25 0.1 0 0 0 0 0 0.1
4 ENE 56.25 - 78.75 0.7 0.6 1.7 1.5 0 0 4.5
5 E 78.75 - 101.25 1.3 1.2 1.7 1.4 0 0 5.6
6 ESE 101.25 - 123.75 1 1.2 2.2 2.8 1.5 0 8.7
7 SE 123.75 - 146.25 0.7 0.5 0.9 2.3 0.6 0 5
8 SSE 146.25 - 168.75 0.2 0.3 0.8 0.5 0 0 1.8
9 S 168.75 - 191.25 9.8 4.9 2.7 9.1 0.1 0 26.6
10 SSW 191.25 - 213.75 4.1 3.6 4.3 7.4 0.8 0 20.2
11 SW 213.75 - 236.25 0 0 0 0 0 0 0
12 WSW 236.25 - 258.75 0 0 0 0 0 0 0
13 W 258.75 - 281.25 2.2 2.3 1.4 1.7 0.1 0 7.7
14 WNW 281.25 - 303.75 0 0 0 0 0 0 0
15 NW 303.75 - 326.25 0.3 0.4 0.3 0.5 0 0 1.5
16 NNW 326.25 - 348.75 0 0 0 0 0 0 0
Sub-Total 21.1 15.2 16.2 27.5 3.1 0 83.1
Calms 16.9
Missing/Incomplete 0
Total 100

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FIGURE 3.2: WINDROSE DIAGRAM PERIOD: MARCH 2018 – MAY 2018

Source: WRPLOT VIEW - Lakes Environmental Software

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3.4 AIR ENVIRONMENT


The ambient air quality with respect to the study area of 10 km radius around the
plant site forms the baseline information. The various sources of air pollution in the
region are industrial, traffic and rural activities. This will also be useful for assessing
the conformity to standards of the ambient air quality during the plant operation. The
study area represents mostly rural environment.
The baseline status of the ambient air quality has been assessed through a
scientifically designed ambient air quality monitoring network. The design of
monitoring network in the air quality surveillance programme has been based on the
following considerations:

 Meteorological conditions on synoptic scale.


 Topography of the study area.
 Representation of plant site.
 Influence of the existing sources (if any) are to be kept at minimum.
 Inclusion of major distinct villages to collect the baseline status.
 Representation of down wind direction.
 Representation of upwind direction.
 Representation of cross sectional distribution in the down wind direction.

The ambient air quality monitoring was carried out in accordance with National
Ambient Air Quality Standards (NAAQS) of CPCB. Ambient Air Quality Monitoring
(AAQM) was carried out at eight locations for 2 days per week for 12 weeks during
study period and the locations are shown in Figure 3.3. The locations of the different
stations with respect to its distance and direction from project site are shown in
Table 3.5.

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TABLE 3.5: AMBIENT AIR QUALITY SAMPLING LOCATIONS


Distance (km) Direction
S.No. Code Name of Sampling Location
w.r.t Project w.r.t Project
1 A1 Project Site - -
2 A2 Jayanthipuram 1.80 WNW
3 A3 Dhramavarappadu Tanda 2.80 N
4 A4 Bhimavaram 6.70 NE
5 A5 Gauravaram 6.00 ENE
6 A6 Pochampalli 5.11 ESE
7 A7 Vedadri Tanda 3.80 S
8 A8 Ravirala 4.05 SW

The monitoring was carried out for a three month period (March 2018 – May 2018) at
a frequency of twice a week at each station adopting a continuous 24- hour
schedule.
The following parameters were monitored in the study area :
 Particulate Matter (PM10)
 Particulate Matter (PM2.5)
 Sulphur Dioxide (SO2)
 Oxides of Nitrogen (NOx)
 Carbon Monoxide (CO)
 Ammonia (NH3)
 Volitail Organic Compounds (VOC)

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FIGURE 3.3: AMBIENT AIR QUALITY SAMPLING LOCATIONS MAP


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3.4.1. National Ambient Air Quality Standards (NAAQS)


National Ambient Air Quality Standards, 2009 for the notified Industrial, Residential,
Rural and Other Areas as well as Sensitive Areas are presented in table below. The
state has not promulgated separate Ambient Air Quality Standards.

TABLE 3.6: NATIONAL AMBIENT AIR QUALITY STANDARDS


Concentration in Ambient Air
Industrial
Time Ecologically
S. Area Methods of
Pollutant Weighted sensitive area
No Residential, measurement
Average (Notified by
Rural &
Central Govt)
other Areas
Annual * 50 20 -Improved West and
1 Sulphur Dioxide Gaeke method
(SO2) µg/m3 24 hours** 80 80
-Ultraviolet fluorescence
Oxides of Annual * 40 30 -Modified Jocob and
2 Nitrogen as NO2 Hochheise(NaArsenite )
24 hours** 80 80
µg/m3 -Chemiluminescence
Particulate matter Annual * 60 60 -Gravimetric
3 (size Less than -TOEM
24 hours** 100 100
10µm) µg/m3 -Beta attenuation
Particulate matter Annual * 40 40 -Gravimetric
4 (size less than -TOEM
24 hours** 60 60
2.5 µm) µg/m3 -Beta attenuation
8 hours** 100 100 - UV Photometric
5 Ozone µg/m 3 -Chemiluminescence
1 hour** 180 180 -Chemical method
Annual * 0.50 0.50 -AAS/ICP method for
Lead (Pb) sampling on EPM 2000
6 or Equivalent Filter
µg/m3 24 hours** 1.0 1.0
paper -ED -XRF using
Teflon filter paper
Carbon 8 02 02 -Non Dispersive Infra
7 hours** Red (NDIR)
Monooxide mg/m3 1 hour ** 04 04 spectroscopy
Annual * 100 100 -Chemiluminescence
8 Ammonia (NH3)
-Indo-Phenol Blue
µg/m3 24 hours** 400 400
method
-GC based continuous
analyzer
9 Benzene µg/m3 Annual * 05 05 - Adsorption &
desorption followed by
GC analysis
10 Benzo(a) pyrene -Solvent extraction
(BaP)- Particulate Annual * 01 01 followed by GC/HPLC
Phase only ng/m3 extraction
AAS/ICP method for
11 Arsenic ng/m3 Annual * 06 06 sampling on EPM2000
OR Equivalent Filter
paper
12 Nickel ng/m3 Annual * 20 20 -AAS/ICP method for
sampling on EPM2000

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Concentration in Ambient Air


Industrial
Time Ecologically
S. Area Methods of
Pollutant Weighted sensitive area
No Residential, measurement
Average (Notified by
Rural &
Central Govt)
other Areas
OR Equivalent Filter
paper
G.S.No.826 (E) dated 16th November, 2009. Vide letter no. F. No. Q-15017/43/2007-CPW.
*Average Arithmetic mean of minimum 104 measurements in a year taken for a week
24 hourly at uniform interval.
**24 hourly/8 hourly values should meet 98 percent of the time in a year.

3.4.2. Ambient Air Quality Data (AAQ)


The Maximum, Minimum & 98th percentile values for all the sampling are shown in
Table 3.7. The location wise monitored Ambient Air Quality details are presented in
Table 3.8 to Table 3.15.

1. Particulate Matter (PM10)


The maximum and minimum concentrations for PM10 were recorded in the study
area showed 98th percentile values in the range of 55.46 – 68.88 μg/ m3. The
maximum concentration 68.88 μg/ m3 were recorded at sampling locations at
Dhramavarappadu Tanda. The concentrations of PM10 are well below the CPCB
standard of 100 μg/ m3.

2. Particulate Matter (PM2.5)


The CPCB Standard for concentration of PM2.5 is 60 μg/ m3. The maximum and
minimum 98th percentile concentrations for Particulate Matter (PM2.5) monitored
in the study area were 18.02 – 28.92 μg/m3 respectively. Highest value of 28.92
μg/ m3 was at Dhramavarappadu Tanda. The concentration of PM2.5 is well
below the prescribed limit of 60 μg/ m3

3. Sulphur Dioxide (SO2)


98th percentile value of Sulphur dioxide in the study area from the monitored data
was in the range of 11.44 – 15.15 μg/ m3. Maximum value of Sulpur dioxide of
15.15 μg/ m3 obtained at Dhramavarappadu Tanda. The concentration of SO2 is
well below the prescribed limit of 80 μg/ m3

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4. Oxides of Nitrogen (NOx)


Ambient air quality status monitored for oxides of nitrogen in the study area were
in the range with 98th percentile values between 17.10 – 22.33 μg/ m3. A
maximum value of 22.33 μg/ m3 was prevailing at the time of sampling at
Bhimavaram. The concentration of NOX is well below the prescribed limit of 80
μg/ m3

5. Carbon Monoxide (CO)


The maximum and minimum 98th percentile concentrations for Carbon Monoxide
(CO) monitored in the study area were 0.34 – 0.74 mg/m3 respectively. Highest
value of 0.74 mg/ m3 was at the Dhramavarappadu Tanda. The concentration of
CO is well below the prescribed limit of 2 mg/ m3

6. Ammonia (NH3)
The maximum and minimum 98th percentile concentrations for Ammonia (NH3)
monitored in the study area were 12.91 – 32.75 μg/m3 respectively. Highest value
of 32.75 μg/ m3 was at Dhramavarappadu Tanda. The concentration of NH3 is
well below the prescribed limit of 400 μg/ m3

7. Volatile Organic Compounds (VOCs)


Volatile Organic Compounds (VOCs) concentration in study area was found to be
Below Detectable Limit of 1 ppm.

The ambient air quality monitoring results indicates that the overall air quality in the
study area is within permissible standards prescribed by NAAQ Standards.

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TABLE 3.7: THE MAXIMUM, MINIMUM & 98th PERCENTILE VALUES FOR ALL THE
SAMPLING LOCATIONS

3 3 3 3 3 3
PM 10(µg/M ) PM 2.5(µg/M ) SO2(µg/M ) NOX(µg/M ) CO (mg/M ) NH3 (µg/M )
Code Name of Sampling
th th th th th th
Location Min Max 98 Min Max 98 Min Max 98 Min Max 98 Min Max 98 Min Max 98

A1 Project Site 53.69 62.35 61.68 18.62 22.60 22.17 10.50 14.31 13.93 13.78 21.93 20.84 0.22 0.41 0.40 20.98 30.25 29.97
A2 Jayanthipuram 56.51 61.44 60.93 17.05 21.31 20.97 11.21 16.30 15.07 15.42 22.51 20.79 0.42 0.67 0.65 20.49 27.63 27.61
Dhramavarappadu
A3 59.89 70.15 68.88 18.07 30.59 28.92 11.29 15.19 15.15 15.93 19.46 19.45 0.45 0.76 0.74 28.35 32.87 32.75
Tanda
A4 Bhimavaram 56.29 64.29 62.46 19.42 25.18 25.18 12.37 15.06 15.04 15.49 23.19 22.33 0.24 0.45 0.44 18.29 22.46 22.33

A5 Gauravaram 58.09 60.31 60.24 18.09 21.47 21.45 11.04 14.83 14.26 15.89 20.18 19.94 0.24 0.41 0.40 12.58 15.73 15.59
A6 Pochampalli 55.19 60.39 60.34 17.42 24.87 24.85 10.34 13.84 13.74 14.25 19.27 19.00 0.23 0.39 0.38 10.23 13.31 12.91
A7 Vedadri Tanda 49.30 55.73 55.46 14.52 18.06 18.02 10.08 12.89 12.85 15.24 17.39 17.36 0.20 0.34 0.34 12.38 15.09 15.05
A8 Ravirala 48.23 59.68 58.13 15.00 19.63 19.10 9.58 11.49 11.44 13.82 17.25 17.10 0.19 0.35 0.35 10.48 14.00 13.97
NAAQ Standards’ 100 60 80 80 2 400

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TABLE 3.8: AMBIENT AIR QUALITY, STATION: PROJECT SITE (A1)


Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC
02.03.2018 1 53.69 19.78 13.14 19.08 0.32 23.16 BDL
03.03.2018 1 59.42 20.04 11.67 18.22 0.41 20.98 BDL
09.03.2018 2 58.31 18.76 14.31 21.93 0.39 22.45 BDL
10.03.2018 2 57.26 19.43 11.43 19.57 0.35 24.18 BDL
16.03.2018 3 60.30 20.60 12.53 15.22 0.29 23.67 BDL
17.03.2018 3 60.90 21.65 13.20 16.40 0.25 22.49 BDL
21.03.2018 4 59.35 20.44 11.45 14.66 0.31 21.08 BDL
22.03.2018 4 60.10 21.28 10.90 15.20 0.35 22.61 BDL
03.04.2018 5 62.35 19.60 11.42 13.78 0.31 30.25 BDL
04.04.2018 5 59.85 19.46 12.70 15.30 0.27 28.47 BDL
09.04.2018 6 58.30 20.30 11.28 14.84 0.22 29.64 BDL
10.04.2018 6 57.22 20.95 12.30 16.58 0.32 27.15 BDL
16.04.2018 7 56.34 18.62 10.97 16.83 0.22 26.69 BDL
17.04.2018 7 57.22 20.33 10.55 16.95 0.25 24.11 BDL
24.04.2018 8 56.55 20.62 12.41 16.84 0.33 23.35 BDL
25.04.2018 8 57.36 22.60 13.49 17.82 0.25 22.46 BDL
03.05.2018 9 59.62 21.12 12.35 15.44 0.27 21.59 BDL
04.05.2018 9 60.35 19.25 12.39 17.30 0.29 22.37 BDL
10.05.2018 10 58.33 20.12 10.50 16.98 0.31 23.61 BDL
11.05.2018 10 59.74 20.45 12.34 15.40 0.36 22.55 BDL
17.05.2018 11 56.98 19.63 11.69 18.12 0.24 21.48 BDL
18.05.2018 11 56.34 18.77 12.47 16.98 0.25 23.42 BDL
25.05.2018 12 58.62 21.67 11.33 17.83 0.29 24.16 BDL
26.05.2018 12 59.66 20.65 10.60 16.21 0.33 23.79 BDL
Minimum 53.69 18.62 10.50 13.78 0.22 20.98 0.00
Maximum 62.35 22.60 14.31 21.93 0.41 30.25 0.00
Average 58.51 20.25 11.98 16.81 0.30 23.99 0.00
98th Percentile 61.68 22.17 13.93 20.84 0.40 29.97 0.00

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TABLE 3.9: AMBIENT AIR QUALITY, STATION: JAYANTHIPURAM (A2)


Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC
02.03.2018 1 56.69 19.85 12.63 16.85 0.52 25.46 BDL
03.03.2018 1 57.58 19.54 13.45 17.21 0.43 27.59 BDL
09.03.2018 2 59.69 20.03 13.63 17.52 0.62 23.61 BDL
10.03.2018 2 60.33 20.58 12.36 16.25 0.53 27.15 BDL
16.03.2018 3 59.82 19.47 13.54 17.20 0.67 24.39 BDL
17.03.2018 3 61.44 21.31 13.25 17.55 0.54 25.77 BDL
21.03.2018 4 56.51 17.23 13.21 17.54 0.49 24.36 BDL
22.03.2018 4 58.16 19.29 12.54 16.41 0.48 25.10 BDL
03.04.2018 5 58.45 19.04 13.62 17.74 0.51 27.63 BDL
04.04.2018 5 57.29 18.93 13.21 17.65 0.57 26.19 BDL
09.04.2018 6 59.58 19.99 16.30 22.51 0.59 23.41 BDL
10.04.2018 6 60.14 20.55 12.52 16.33 0.54 22.94 BDL
16.04.2018 7 58.29 19.68 12.41 17.28 0.43 23.84 BDL
17.04.2018 7 58.14 19.23 13.28 18.04 0.48 24.65 BDL
24.04.2018 8 57.85 20.04 12.25 16.21 0.50 25.19 BDL
25.04.2018 8 56.82 17.05 13.54 17.85 0.49 24.47 BDL
03.05.2018 9 59.08 20.01 13.24 17.45 0.42 23.19 BDL
04.05.2018 9 58.33 19.71 12.56 17.25 0.47 22.43 BDL
10.05.2018 10 58.25 19.65 13.57 18.54 0.42 23.85 BDL
11.05.2018 10 59.17 20.25 12.45 18.76 0.49 22.67 BDL
17.05.2018 11 58.54 20.22 11.58 16.65 0.52 21.75 BDL
18.05.2018 11 59.63 19.49 13.59 18.21 0.56 22.61 BDL
25.05.2018 12 58.39 18.64 11.21 15.42 0.55 20.49 BDL
26.05.2018 12 57.19 18.06 11.93 16.06 0.59 22.49 BDL
Minimum 56.51 17.05 11.21 15.42 0.42 20.49 0.00
Maximum 61.44 21.31 16.30 22.51 0.67 27.63 0.00
Average 58.56 19.49 12.99 17.44 0.52 24.22 0.00
98th Percentile 60.93 20.97 15.07 20.79 0.65 27.61 0.00

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TABLE 3.10: AMBIENT AIR QUALITY, STATION: DHRAMAVARAPPADU TANDA


(A3)
Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC
06.03.2018 1 63.25 20.18 14.55 17.55 0.59 30.15 BDL
07.03.2018 1 65.18 25.14 15.10 19.43 0.62 29.54 BDL
13.03.2018 2 60.33 20.01 11.29 18.45 0.49 30.68 BDL
14.03.2018 2 62.95 20.91 13.90 17.60 0.45 29.46 BDL
19.03.2018 3 60.48 19.68 15.19 19.21 0.47 30.28 BDL
20.03.2018 3 62.91 19.60 14.25 17.83 0.52 30.17 BDL
26.03.2018 4 67.39 20.47 12.98 16.87 0.51 28.35 BDL
27.03.2018 4 70.15 30.59 12.74 17.31 0.56 30.69 BDL
06.04.2018 5 65.16 24.78 12.01 17.05 0.60 31.41 BDL
07.04.2018 5 64.29 23.46 13.62 18.69 0.62 28.91 BDL
12.04.2018 6 66.52 25.59 11.75 15.93 0.55 28.58 BDL
13.04.2018 6 64.73 23.10 12.35 17.00 0.60 29.37 BDL
19.04.2018 7 65.17 25.33 12.44 17.46 0.49 31.14 BDL
20.04.2018 7 60.25 19.84 13.28 18.63 0.62 32.55 BDL
27.04.2018 8 63.94 22.61 12.74 17.08 0.68 30.19 BDL
28.04.2018 8 64.07 25.15 11.95 16.93 0.71 32.61 BDL
07.05.2018 9 65.37 26.95 12.63 17.56 0.76 30.28 BDL
08.05.2018 9 60.28 18.33 13.28 18.44 0.63 29.13 BDL
14.05.2018 10 59.91 18.07 12.41 17.39 0.58 32.49 BDL
15.05.2018 10 62.31 23.49 13.29 18.24 0.63 32.42 BDL
22.05.2018 11 60.26 20.73 13.24 18.69 0.59 30.66 BDL
23.05.2018 11 59.89 19.68 14.28 19.46 0.54 32.87 BDL
28.05.2018 12 61.05 22.44 13.64 18.33 0.61 30.69 BDL
29.05.2018 12 63.39 24.19 12.88 17.29 0.58 32.25 BDL
Minimum 59.89 18.07 11.29 15.93 0.45 28.35 0.00
Maximum 70.15 30.59 15.19 19.46 0.76 32.87 0.00
Average 63.30 22.51 13.16 17.85 0.58 30.62 0.00
98th Percentile 68.88 28.92 15.15 19.45 0.74 32.75 0.00

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TABLE 3.11: AMBIENT AIR QUALITY, STATION: BHIMAVARAM (A4)


Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC
06.03.2018 1 59.14 20.14 12.89 18.25 0.42 19.54 BDL
07.03.2018 1 57.36 23.61 14.31 19.64 0.39 18.63 BDL
13.03.2018 2 60.25 25.18 13.26 18.31 0.43 20.14 BDL
14.03.2018 2 59.34 22.19 13.87 18.76 0.38 21.08 BDL
19.03.2018 3 57.29 24.39 14.65 19.33 0.39 20.37 BDL
20.03.2018 3 58.44 25.17 13.58 18.07 0.40 19.68 BDL
26.03.2018 4 57.38 24.51 14.26 19.54 0.38 18.33 BDL
27.03.2018 4 58.29 23.67 15.06 20.31 0.36 19.47 BDL
06.04.2018 5 60.31 24.08 13.08 18.63 0.42 18.29 BDL
07.04.2018 5 58.44 21.37 14.65 19.66 0.43 19.33 BDL
12.04.2018 6 59.33 20.68 14.63 19.47 0.41 20.18 BDL
13.04.2018 6 58.49 19.42 14.22 19.63 0.39 21.05 BDL
19.04.2018 7 60.08 24.00 13.97 18.24 0.43 19.64 BDL
20.04.2018 7 59.27 20.69 13.64 21.33 0.33 18.73 BDL
27.04.2018 8 64.29 24.65 15.02 23.19 0.41 20.55 BDL
28.04.2018 8 58.46 24.17 14.87 20.69 0.24 19.63 BDL
07.05.2018 9 57.81 23.61 13.69 18.44 0.37 19.47 BDL
08.05.2018 9 56.29 23.34 14.28 17.22 0.34 20.24 BDL
14.05.2018 10 58.49 24.58 12.37 15.86 0.31 21.06 BDL
15.05.2018 10 59.18 22.69 12.71 16.58 0.38 20.39 BDL
22.05.2018 11 60.24 23.54 13.22 17.24 0.32 22.18 BDL
23.05.2018 11 59.33 22.45 12.68 15.49 0.36 20.12 BDL
28.05.2018 12 57.69 24.18 12.51 16.22 0.38 21.63 BDL
29.05.2018 12 58.06 23.57 13.24 16.27 0.45 22.46 BDL
Minimum 56.29 19.42 12.37 15.49 0.24 18.29 0.00
Maximum 64.29 25.18 15.06 23.19 0.45 22.46 0.00
Average 58.89 23.16 13.78 18.60 0.38 20.09 0.00
98th Percentile 62.46 25.18 15.04 22.33 0.44 22.33 0.00

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TABLE 3.12: AMBIENT AIR QUALITY, STATION: GAURAVARAM (A5)


Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC
02.03.2018 1 58.32 20.15 12.45 17.69 0.33 14.05 BDL
03.03.2018 1 58.96 19.47 13.06 16.29 0.30 15.73 BDL
09.03.2018 2 59.59 20.30 12.63 17.21 0.36 13.27 BDL
10.03.2018 2 58.63 19.85 11.32 17.63 0.32 12.58 BDL
16.03.2018 3 59.81 18.72 12.56 18.63 0.39 14.38 BDL
17.03.2018 3 60.09 20.30 12.95 17.95 0.36 15.42 BDL
21.03.2018 4 58.67 18.09 13.25 18.21 0.32 13.62 BDL
22.03.2018 4 59.51 20.14 13.60 18.54 0.38 14.59 BDL
03.04.2018 5 58.60 19.89 14.83 19.65 0.35 13.41 BDL
04.04.2018 5 59.24 20.33 12.35 18.22 0.32 13.96 BDL
09.04.2018 6 59.85 20.18 13.24 20.18 0.36 14.82 BDL
10.04.2018 6 59.63 19.62 12.63 16.31 0.31 13.49 BDL
16.04.2018 7 58.09 18.46 13.45 17.65 0.35 12.64 BDL
17.04.2018 7 60.31 21.05 13.28 18.21 0.41 13.26 BDL
24.04.2018 8 59.54 19.98 11.04 16.03 0.32 14.09 BDL
25.04.2018 8 58.86 19.43 11.68 15.89 0.35 13.48 BDL
03.05.2018 9 58.96 19.68 12.43 16.94 0.39 12.69 BDL
04.05.2018 9 58.49 18.57 11.28 16.08 0.24 14.57 BDL
10.05.2018 10 58.24 19.65 12.47 16.15 0.33 13.69 BDL
11.05.2018 10 58.20 19.53 12.81 17.59 0.30 14.76 BDL
17.05.2018 11 60.15 21.47 12.64 17.42 0.35 13.28 BDL
18.05.2018 11 59.23 19.27 11.38 16.43 0.33 13.04 BDL
25.05.2018 12 60.14 21.43 12.63 18.04 0.38 14.69 BDL
26.05.2018 12 58.37 18.69 12.36 17.11 0.31 13.54 BDL
Minimum 58.09 18.09 11.04 15.89 0.24 12.58 0.00
Maximum 60.31 21.47 14.83 20.18 0.41 15.73 0.00
Average 59.15 19.76 12.60 17.50 0.34 13.88 0.00
98th Percentile 60.24 21.45 14.26 19.94 0.40 15.59 0.00

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TABLE 3.13: AMBIENT AIR QUALITY, STATION: POCHAMPALLI (A6)


Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC
02.03.2018 1 58.71 19.69 12.95 18.39 0.35 11.01 BDL
03.03.2018 1 60.39 20.32 12.56 17.94 0.27 12.36 BDL
09.03.2018 2 59.26 22.34 11.33 16.23 0.24 10.35 BDL
10.03.2018 2 57.15 21.12 12.18 17.29 0.29 10.64 BDL
16.03.2018 3 58.54 19.86 11.26 17.32 0.30 10.23 BDL
17.03.2018 3 59.10 20.34 10.34 16.39 0.34 10.39 BDL
21.03.2018 4 60.26 21.58 10.52 16.99 0.23 11.22 BDL
22.03.2018 4 58.38 22.56 11.67 18.52 0.25 12.04 BDL
03.04.2018 5 59.22 20.17 12.69 19.27 0.31 12.37 BDL
04.04.2018 5 59.18 19.48 13.62 18.69 0.30 13.31 BDL
09.04.2018 6 57.62 24.36 13.84 18.23 0.29 11.93 BDL
10.04.2018 6 55.19 24.83 12.58 16.47 0.24 12.07 BDL
16.04.2018 7 60.25 24.19 13.24 17.46 0.31 12.26 BDL
17.04.2018 7 60.29 24.87 12.63 16.39 0.27 11.54 BDL
24.04.2018 8 56.21 20.56 13.33 17.42 0.31 12.15 BDL
25.04.2018 8 58.27 17.42 11.23 15.45 0.36 11.26 BDL
03.05.2018 9 58.12 22.32 12.24 16.25 0.32 11.09 BDL
04.05.2018 9 59.23 19.14 12.44 16.52 0.39 12.43 BDL
10.05.2018 10 58.54 21.14 11.51 15.54 0.28 11.58 BDL
11.05.2018 10 58.51 21.21 11.24 15.25 0.32 11.23 BDL
17.05.2018 11 58.74 19.52 12.40 16.15 0.30 12.09 BDL
18.05.2018 11 57.52 19.54 12.98 16.90 0.34 11.27 BDL
25.05.2018 12 59.58 20.12 11.07 14.25 0.36 11.29 BDL
26.05.2018 12 57.44 20.13 11.24 15.30 0.27 12.44 BDL
Minimum 55.19 17.42 10.34 14.25 0.23 10.23 0.00
Maximum 60.39 24.87 13.84 19.27 0.39 13.31 0.00
Average 58.57 21.12 12.13 16.86 0.30 11.61 0.00
98th Percentile 60.34 24.85 13.74 19.00 0.38 12.91 0.00

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TABLE 3.14: AMBIENT AIR QUALITY, STATION: VEDADRI TANDA (A7)


Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC
06.03.2018 1 50.11 17.39 11.25 16.73 0.29 13.62 BDL
07.03.2018 1 52.52 16.35 12.52 16.39 0.31 12.38 BDL
13.03.2018 2 51.15 16.29 10.35 15.84 0.32 13.28 BDL
14.03.2018 2 52.34 17.42 11.39 16.30 0.29 15.09 BDL
19.03.2018 3 53.54 16.35 10.63 15.47 0.33 14.72 BDL
20.03.2018 3 52.85 18.06 10.55 15.68 0.28 14.39 BDL
26.03.2018 4 50.60 17.29 10.21 16.35 0.24 13.08 BDL
27.03.2018 4 50.95 16.35 10.08 15.38 0.30 13.47 BDL
06.04.2018 5 55.73 17.98 10.28 15.89 0.29 14.61 BDL
07.04.2018 5 53.58 17.30 11.42 16.09 0.34 13.08 BDL
12.04.2018 6 52.85 16.49 10.93 15.37 0.32 14.26 BDL
13.04.2018 6 49.55 15.03 11.47 17.33 0.20 14.59 BDL
19.04.2018 7 49.52 14.69 10.68 15.31 0.26 14.31 BDL
20.04.2018 7 53.53 16.88 12.89 17.39 0.31 15.00 BDL
27.04.2018 8 54.34 15.43 12.62 15.36 0.27 14.82 BDL
28.04.2018 8 49.30 14.52 12.80 17.28 0.24 13.79 BDL
07.05.2018 9 52.94 15.23 10.38 15.82 0.28 12.55 BDL
08.05.2018 9 53.55 17.48 10.45 15.85 0.31 14.08 BDL
14.05.2018 10 54.97 16.33 10.92 15.39 0.22 13.27 BDL
15.05.2018 10 55.14 16.46 11.59 16.47 0.27 14.66 BDL
22.05.2018 11 52.80 15.09 11.66 16.09 0.21 13.59 BDL
23.05.2018 11 53.63 16.27 10.63 16.48 0.30 13.44 BDL
28.05.2018 12 51.55 15.92 10.37 15.24 0.32 14.27 BDL
29.05.2018 12 52.49 16.34 11.52 16.35 0.25 13.68 BDL
Minimum 49.30 14.52 10.08 15.24 0.20 12.38 0.00
Maximum 55.73 18.06 12.89 17.39 0.34 15.09 0.00
Average 52.48 16.37 11.15 16.08 0.28 13.92 0.00
98th Percentile 55.46 18.02 12.85 17.36 0.34 15.05 0.00

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TABLE 3.15: AMBIENT AIR QUALITY, STATION: RAVIRALA (A8)


Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC
06.03.2018 1 52.16 16.13 9.94 14.62 0.22 10.48 BDL
07.03.2018 1 51.85 15.69 9.58 13.82 0.19 11.32 BDL
13.03.2018 2 49.32 15.00 10.34 15.60 0.32 12.59 BDL
14.03.2018 2 50.46 16.68 11.27 16.85 0.35 13.48 BDL
19.03.2018 3 53.23 17.93 11.39 17.25 0.25 12.67 BDL
20.03.2018 3 55.85 17.69 10.36 16.87 0.26 13.28 BDL
26.03.2018 4 56.32 19.63 10.24 15.81 0.22 13.64 BDL
27.03.2018 4 50.39 16.21 11.05 16.14 0.22 13.08 BDL
06.04.2018 5 48.23 17.31 10.69 16.08 0.23 12.91 BDL
07.04.2018 5 48.38 17.06 10.03 15.47 0.27 13.26 BDL
12.04.2018 6 49.88 16.48 10.10 15.93 0.22 14.00 BDL
13.04.2018 6 52.39 17.24 11.49 16.21 0.26 13.55 BDL
19.04.2018 7 50.96 15.69 10.39 15.43 0.24 13.49 BDL
20.04.2018 7 55.64 18.47 10.48 15.66 0.31 13.61 BDL
27.04.2018 8 53.52 15.33 10.19 15.07 0.20 13.29 BDL
28.04.2018 8 54.22 15.87 10.31 16.44 0.23 12.52 BDL
07.05.2018 9 56.23 17.22 10.64 16.08 0.25 11.94 BDL
08.05.2018 9 59.68 18.25 10.60 15.73 0.28 12.38 BDL
14.05.2018 10 56.29 17.28 10.79 16.52 0.34 13.94 BDL
15.05.2018 10 52.54 16.04 10.14 15.49 0.25 12.55 BDL
22.05.2018 11 49.37 15.38 11.36 16.83 0.24 11.49 BDL
23.05.2018 11 49.51 15.84 10.28 15.39 0.26 13.40 BDL
28.05.2018 12 51.44 16.02 10.64 15.47 0.31 12.62 BDL
29.05.2018 12 50.33 15.36 11.19 16.92 0.25 13.69 BDL
Minimum 48.23 15.00 9.58 13.82 0.19 10.48 0.00
Maximum 59.68 19.63 11.49 17.25 0.35 14.00 0.00
Average 52.42 16.66 10.56 15.90 0.26 12.88 0.00
98th Percentile 58.13 19.10 11.44 17.10 0.35 13.97 0.00

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3.5 WATER ENVIRONMENT


Water sampling and subsequent analysis were carried out to determine both the
groundwater and surface water quality of the study area.
Selected water quality parameters of ground water resources and surface water
resources within 10 km radius of the study area has been studied for assessing the
quality of water.

3.5.1 Methodology for Water Quality Monitoring


Ground water sources and surface water sources covering 10 km radial distance
were examined for physico-chemical, heavy metals and bacteriological parameters
in order to assess the effect of industrial and other activities on ground water and
surface water. The samples were analyzed as per the procedures specified in
'Standard Methods for the Examination of Water and Wastewater' published by
American Public Health Association (APHA).
Samples for chemical analysis were collected in polyethylene carboys. Samples for
bacteriological analysis were collected in sterilized glass bottles. Selected
physicochemical and bacteriological parameters have been analyzed for projecting
the existing water quality status in the study area. Parameters like pH and
temperature were analyzed at the time of sample collection.
The details of surface and ground water sampling locations are given in Table 3.16
and sampling locations of ground water quality and surface quality monitoring are
shown in Figure 3.4. The physico - chemical characteristics of the ground water
samples and surface water samples are presented in the Tables 3.17 & Tables 3.18.

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TABLE 3.16: GROUND AND SURFACE WATER SAMPLING LOCATIONS


Distance (km) Direction
S.No. Code Name of Sampling Location
w.r.t Project w.r.t Project
Ground Water Sampling Locations
1 GW1 Near Project Site - -
2 GW2 Jayanthipuram 1.80 WNW
3 GW3 Dhramavarappadu Tanda 2.80 N
4 GW4 Bhimavaram 6.70 NE
5 GW5 Pochampalli 5.15 ESE
6 GW6 Vedadri Tanda 4.1 S
7 GW7 Ravirala 4.05 SW
8 GW8 Jaggayyapeta 6.00 NW
Surface Water Sampling Locations
1 SW1 Gauravaram Cheruvu 5.40 ENE
2 SW2 Pochampalli Cheruvu 3.40 SE
3 SW3 Konakanchi Cheruvu 5.50 SE
4 SW4 Krishna River near Vedadri 4.10 SSW
5 SW5 Palleru River 3.45 W
6 SW6 Jaggayyapeta Cheruvu 5.75 NW
Water body near
7 SW7 8.45 NNW
Shermohmammadpeta
8 SW8 Water body near Chillakallu 4.65 N

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FIGURE 3.4: GROUND & SURFACE WATER SAMPLING LOCATIONS MAP


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TABLE 3.17 GROUNDWATER QUALITY IN THE STUDY AREA


IS 10,500 Limits
S. No Parameter Method Unit GW1 GW2 GW3 GW4
Acceptable Permissible
1 pH APHA 22nd Edition 4500 H+ B -- 7.32 8.08 8.13 8.01 6.5-8.5 No Relaxation
2 Color APHA 22nd Edition 2120 B CU <1.0 < 1.0 <1.0 <1.0 5 15
3 Total Dissolved Solids APHA 22nd Edition 2540 C mg/l 467.5 545.2 612 521 500 2000
Total Alkalinity (as
4 APHA 22nd Edition 2320 B mg/l 175 252 142 125 200 600
CaCO3)
Total Hardness (as
5 APHA 22nd Edition 2340 C mg/l 315.0 330.0 295.0 340.0 200 600
CaCO3)
6 Calcium (as Ca ) APHA 22nd Edition 3500 Ca B mg/l 74.6 84.52 58.4 84.2 75 200
7 Magnesium (as Mg) APHA 22nd Edition 3500-Mg B mg/l 25.34 32 31.5 22.5 30 100
8 Sulphate (as SO4) APHA 22nd Edition 4500 SO4 E mg/l 32.40 49.4 52 96 200 400
9 Chloride (as Cl) APHA 22nd Edition 4500 Cl- B mg/l 154 114 185.6 148 250 1000
10 Lead as Pb APHA 22nd Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01 0.01 No Relaxation
11 Cadmium as Cd APHA 22nd Edition 3111B mg/l <0.01 < 0.01 < 0.01 < 0.01 0.003 No Relaxation
12 Total Chromium as Cr APHA 22nd Edition 3111B mg/l <0.05 < 0.05 < 0.05 < 0.05 0.05 No Relaxation
13 Copper as Cu APHA 22nd Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01 0.05 1.5
14 Zinc as Zn APHA 22nd Edition 3111B mg/l < 0.5 < 0.5 < 0.5 < 0.5 5 15
15 Nickel as Ni APHA 22nd Edition 3111B mg/l <0.01 < 0.01 < 0.01 < 0.01 0.02 No Relaxation
16 Fluorides as F APHA 22nd Edition 4500 F- D mg/l < 0.5 < 0.5 < 0.5 < 0.5 1 1.5
17 Aluminium as Al APHA 22nd Edition 3500 Al B mg/l <0.03 < 0.03 < 0.03 < 0.03 0.03 0.2
18 Boron as B APHA 22nd Edition 4500 B B mg/l <0.2 <0.2 <0.2 <0.2 0.5 1
19 Manganese as Mn APHA 22nd Edition 3111B mg/l <0.02 <0.02 < 0.02 < 0.02 0.1 0.3
20 Iron as Fe APHA 22nd Edition 3500 Fe B mg/l < 0.05 < 0.05 < 0.05 < 0.05 0.3 No Relaxation
21 Nitrate Nitrogen APHA 22nd Edition 4500 NO3 B mg/l 2.4 2.32 2.1 2.3 45 No Relaxation
22 Sodium as Na APHA 22nd Edition 3500 Na B mg/l 51 92 96.8 76.4 -- --
23 Potassium as K APHA 22nd Edition 3500 K B mg/l < 5.0 < 5.0 9.5 < 5.0 -- --
24 Odour APHA 22nd Edition 2150 B -- Agreeable Agreeable Agreeable Agreeable -- --
25 Electrical Conductivity APHA 22nd Edition 2510 B μmho/cm 721 840 956 812 -- --
26 Phosphorus as P APHA 22nd Edition 4500 P C mg/l 0.52 1.42 1.35 0.45 -- --

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TABLE 3.17 GROUND WATER QUALITY IN THE STUDY AREA


IS 10,500 Limits
S. No Parameter Method Unit GW5 GW6 GW7 GW8
Acceptable Permissible
No
1 pH APHA 22nd Edition 4500 H+ B -- 7.93 8.37 8.33 8.19 6.5-8.5
Relaxation
2 Color APHA 22nd Edition 2120 B CU <1.0 < 1.0 <1.0 <1.0 5 15
3 Total Dissolved Solids APHA 22nd Edition 2540 C mg/l 936 983.4 512 522 500 2000
Total Alkalinity (as
4 APHA 22nd Edition 2320 B mg/l 120 315 248 115 200 600
CaCO3)
Total Hardness (as
5 APHA 22nd Edition 2340 C mg/l 600.0 670.0 325.0 320.0 200 600
CaCO3)
6 Calcium (as Ca ) APHA 22nd Edition 3500 Ca B mg/l 100.8 96.8 66.2 68.4 75 200
7 Magnesium (as Mg) APHA 22nd Edition 3500-Mg B mg/l 31.4 46.2 24.5 18.46 30 100
8 Sulphate (as SO4) APHA 22nd Edition 4500 SO4 E mg/l 84 78.2 25 41.60 200 400
9 Chloride (as Cl) APHA 22nd Edition 4500 Cl- B mg/l 310 212 94.2 85 250 1000
10 Lead as Pb APHA 22nd Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01 0.01 No Relaxation
11 Cadmium as Cd APHA 22nd Edition 3111B mg/l <0.01 < 0.01 < 0.01 < 0.01 0.003 No Relaxation
12 Total Chromium as Cr APHA 22nd Edition 3111B mg/l <0.05 < 0.05 < 0.05 < 0.05 0.05 No Relaxation
13 Copper as Cu APHA 22nd Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01 0.05 1.5
14 Zinc as Zn APHA 22nd Edition 3111B mg/l < 0.5 < 0.5 < 0.5 < 0.5 5 15
15 Nickel as Ni APHA 22nd Edition 3111B mg/l <0.01 < 0.01 < 0.01 < 0.01 0.02 No Relaxation
16 Fluorides as F APHA 22nd Edition 4500 F- D mg/l < 0.5 < 0.5 < 0.5 < 0.5 1 1.5
17 Aluminium as Al APHA 22nd Edition 3500 Al B mg/l <0.03 < 0.03 < 0.03 < 0.03 0.03 0.2
18 Boron as B APHA 22nd Edition 4500 B B mg/l <0.2 <0.2 <0.2 <0.2 0.5 1
19 Manganese as Mn APHA 22nd Edition 3111B mg/l <0.02 <0.02 < 0.02 < 0.02 0.1 0.3
20 Iron as Fe APHA 22nd Edition 3500 Fe B mg/l < 0.05 < 0.05 < 0.05 < 0.05 0.3 No Relaxation
21 Nitrate Nitrogen APHA 22nd Edition 4500 NO3 B mg/l 2.12 2.19 2.4 2.10 45 No Relaxation
22 Sodium as Na APHA 22nd Edition 3500 Na B mg/l 86.84 86 46.2 38.4 -- --
23 Potassium as K APHA 22nd Edition 3500 K B mg/l < 5.0 < 5.0 < 5.0 < 5.0 -- --
24 Odour APHA 22nd Edition 2150 B -- Agreeable Agreeable Agreeable Agreeable -- --
μmho
25 Electrical Conductivity APHA 22nd Edition 2510 B 1420 1510 784 821 -- --
/cm
26 Phosphorus as P APHA 22nd Edition 4500 P C mg/l 2.56 2.45 0.86 0.38 -- --

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TABLE 3.18 SURFACE WATER QUALITY IN THE STUDY AREA


S. No Parameter Method Unit SW1 SW2 SW3 SW4
nd +
1 pH APHA 22 Edition 4500 H B -- 8.02 8.01 8.20 8.02
nd
2 Color APHA 22 Edition 2120 B CU < 1.0 < 1.0 <1.0 <1.0
nd
3 Turbidity APHA 22 Edition 2130 B NTU 1 1 1 1
nd
4 Total Dissolved Solids APHA 22 Edition 2540 C mg/l 465 502 401 462
nd
5 Total Alkalinity (as CaCO3) APHA 22 Edition 2320 B mg/l 150 115 35 75
nd
6 Total Hardness (as CaCO3) APHA 22 Edition 2340 C mg/l 255 290.0 210.0 195.0
nd
7 Calcium (as Ca ) APHA 22 Edition 3500 Ca B mg/l 36.4 54.2 18.6 21.4
nd
8 Magnesium (as Mg) APHA 22 Edition 3500-Mg B mg/l 18.20 19.2 2.4 11.2
nd
9 Sulphate (as SO4) APHA 22 Edition 4500 SO4 E mg/l 16.4 22.4 2.8 4.2
nd -
10 Chloride (as Cl) APHA 22 Edition 4500 Cl B mg/l 68 72 38.6 34
nd
11 Lead as Pb APHA 22 Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01
nd
12 Cadmium as Cd APHA 22 Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01
nd
13 Total Chromium as Cr APHA 22 Edition 3111B mg/l < 0.05 < 0.05 <0.05 <0.05
nd
14 Copper as Cu APHA 22 Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01
nd
15 Zinc as Zn APHA 22 Edition 3111B mg/l < 0.5 < 0.5 < 0.5 < 0.5
nd
16 Nickel as Ni APHA 22 Edition 3111B mg/l < 0.02 < 0.02 < 0.02 < 0.02
nd -
17 Fluorides as F APHA 22 Edition 4500 F D mg/l < 0.5 < 0.5 < 0.5 < 0.5
nd
18 Aluminium as Al APHA 22 Edition 3500 Al B mg/l < 0.03 < 0.03 < 0.03 < 0.03
nd
19 Boron as B APHA 22 Edition 4500 B B mg/l < 0.2 < 0.2 < 0.2 < 0.2
nd
20 Manganese as Mn APHA 22 Edition 3111B mg/l < 0.02 < 0.02 <0.02 <0.02
nd
21 Iron as Fe APHA 22 Edition 3500 Fe B mg/l < 0.05 < 0.05 < 0.05 < 0.05
nd
22 Nitrate Nitrogen APHA 22 Edition 4500 NO3 B mg/l 0.64 2.5 2.3 2.4
nd
23 Chemical Oxygen Demand APHA 22 Edition 5220 B mg/l 48 54 34 28
o
24 BOD(3day’s at 27 C) IS 3025 (Part – 44) 2009 mg/l 15.6 19.2 14 10.2
nd
25 Sodium as Na APHA 22 Edition 3500 Na B mg/l 20.4 32.4 12 18.2
nd
26 Potassium as K APHA 22 Edition 3500 K B mg/l 1.4 < 5.0 < 5.0 < 5.0
nd
27 Total Suspended Solids APHA 22 Edition 2540 D mg/l 10.5 10.6 10.9 10.3
nd
28 Dissolved Oxygen APHA 22 Edition 4500 O C mg/l 5.2 5.1 5.0 5.2
nd
29 Oil and grease APHA 22 Edition 5520 B mg/l <1.0 <1.0 <1.0 <1.0
nd
30 Electrical Conductivity APHA 22 Edition 2510 B μmho/cm 743 804 640 732
nd
31 Phosphorus as P APHA 22 Edition 4500 P C mg/l 0.24 0.34 0.29 0.24
32 Total Coliform IS 1622 MPN/100 ml 45 48 42 62
33 Feacal Coliforms IS 1622 MPN/100 ml 4 4 11.2 5

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TABLE 3.18 SURFACE WATER QUALITY IN THE STUDY AREA


S. No Parameter Method Unit SW5 SW6 SW7 SW8
nd +
1 pH APHA 22 Edition 4500 H B -- 7.52 8.22 8.51 8.25
nd
2 Color APHA 22 Edition 2120 B CU < 1.0 < 1.0 <1.0 <1.0
nd
3 Turbidity APHA 22 Edition 2130 B NTU 1.0 1.0 1.0 1.0
nd
4 Total Dissolved Solids APHA 22 Edition 2540 C mg/l 510.0 905.0 840.0 620.0
nd
5 Total Alkalinity (as CaCO3) APHA 22 Edition 2320 B mg/l 65 95 115 200
nd
6 Total Hardness (as CaCO3) APHA 22 Edition 2340 C mg/l 210.0 365 455.0 275
nd
7 Calcium (as Ca ) APHA 22 Edition 3500 Ca B mg/l 32 28.2 48.2 54
nd
8 Magnesium (as Mg) APHA 22 Edition 3500-Mg B mg/l 12.4 8.60 38.2 30.2
nd
9 Sulphate (as SO4) APHA 22 Edition 4500 SO4 E mg/l 2.5 24.3 52 64.2
nd -
10 Chloride (as Cl) APHA 22 Edition 4500 Cl B mg/l 62 88.5 148 148
nd
11 Lead as Pb APHA 22 Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01
nd
12 Cadmium as Cd APHA 22 Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01
nd
13 Total Chromium as Cr APHA 22 Edition 3111B mg/l < 0.05 < 0.05 <0.05 <0.05
nd
14 Copper as Cu APHA 22 Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01
nd
15 Zinc as Zn APHA 22 Edition 3111B mg/l < 0.5 < 0.5 < 0.5 < 0.5
nd
16 Nickel as Ni APHA 22 Edition 3111B mg/l < 0.02 < 0.02 < 0.02 < 0.02
nd -
17 Fluorides as F APHA 22 Edition 4500 F D mg/l < 0.5 < 0.5 < 0.5 < 0.5
nd
18 Aluminium as Al APHA 22 Edition 3500 Al B mg/l < 0.03 < 0.03 < 0.03 < 0.03
nd
19 Boron as B APHA 22 Edition 4500 B B mg/l < 0.2 < 0.2 < 0.2 < 0.2
nd
20 Manganese as Mn APHA 22 Edition 3111B mg/l < 0.02 < 0.02 <0.02 <0.02
nd
21 Iron as Fe APHA 22 Edition 3500 Fe B mg/l < 0.05 < 0.05 < 0.05 < 0.05
nd
22 Nitrate Nitrogen APHA 22 Edition 4500 NO3 B mg/l 1.5 2.5 5.4 4.2
nd
23 Chemical Oxygen Demand APHA 22 Edition 5220 B mg/l 28.0 35.0 40.0 74
o
24 BOD(3day’s at 27 C) IS 3025 (Part – 44) 2009 mg/l 9.2 10.9 12.9 11.4
nd
25 Sodium as Na APHA 22 Edition 3500 Na B mg/l 22.2 45 85 74
nd
26 Potassium as K APHA 22 Edition 3500 K B mg/l <5 <5 <5 11.4
nd
27 Total Suspended Solids APHA 22 Edition 2540 D mg/l 9.2 9.6 9.8 9.4
nd
28 Dissolved Oxygen APHA 22 Edition 4500 O C mg/l 5..0 4.9 4.8 5.1
nd
29 Oil and grease APHA 22 Edition 5520 B mg/l <1.0 <1.0 <1.0 <1.0
nd
30 Electrical Conductivity APHA 22 Edition 2510 B μmho/cm 802 1410 1301 960
nd
31 Phosphorus as P APHA 22 Edition 4500 P C mg/l 0.31 0.25 0.20 0.23
32 Total Coliform IS 1622 MPN/100 ml 51 48 56 54
33 Feacal Coliforms IS 1622 MPN/100 ml 8 4 6 5

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A. Summary of Groundwater Samples within 10 Km Radius


pH of the ground water samples collected was in the range between 7.32 –
8.37. All samples are below acceptable limits. Only drinking water samples
have fixed pH limit which is 6.5 -8.5 as per IS 10500-2012.
The acceptable limits for total dissolved solids as per IS: 10500-2012 are 500
mg/l whereas the permissible limits in absence of alternate source are 2000
mg/l, beyond this palatability decreases and may cause gastro intestinal
irritation. Total dissolved solids in the ground water samples were in the range
between 467.5 – 983.4 mg/l. one sample is below acceptable limits, seven
other samples are above acceptable limits but all samples are well below the
permissible limits of 2000 mg/l.
In the ground water samples collected from the study area, the Total hardness
was found to vary between 295 – 670 mg/l. All samples are above acceptable
limits and seven ground water samples for Total hardness are above
acceptable limit but within the permissible limits, while one sample is above the
permissible of 600 mg/l.
The acceptable limit for chloride is 250 mg/l as per IS: 10500 whereas the
permissible limit of the same is 1000 mg/l beyond this limit taste, corrosion and
palatability are affected. The Chlorides concentration was found to vary
between 94.2 – 310 mg/l. Seven samples are below acceptable limits while
one sample is above acceptable limits but within permissible limits.
Fluoride is the other important parameter, which has the acceptable limit of 1
mg/l and permissible limit of 1.5 mg/l. Fluoride concentration in all samples are
found to be below acceptable limits.
The Sulphates concentration was found to vary between 25 – 96 mg/l. All the
samples for Sulphates concentration was found are within acceptable limits of
200 mg/l.
Ground water samples collected from eight locations within 10 km radius from the
plant site & analyzed as per standard methods of water and wastewater analysis
(APHA).
The water quality of the study area is found to be above the acceptable limits of
IS10500, for parameters TDS, Total hardness, Total Alkalinity, Calcium, Magnesium,
Fluorides.

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Summary of Surface Water Samples within 10 km Radius:


 pH of the water samples collected was in the range between 7.54 – 8.51.

 Total dissolved solids in the samples were in the range between 401 – 905
mg/l.

 Total hardness was found to be in the range of 210 – 455 mg/l.

 Chlorides concentration was found to vary between 34 – 148 mg/l.

 Fluoride concentration was <0.5 mg/l.

 Sulphates concentration was found to vary between 2.5 – 64.2 mg/l.

3.6. NOISE ENVIRONMENT


Noise, often defined as unwanted sound, interferes with speech communication,
causes annoyance, distracts from work, and disturbs sleep thus deteriorating quality
of human environment. Noise levels in the study area have therefore been
measured, at selected points, to provide the baseline data to describe the existing
situation.
Measured noise levels displayed as a function of time provides a useful scheme for
describing the acoustical climate of a community. Noise levels records at each
station with a time interval of about one hour are computed for equivalent noise
levels. Equivalent noise level is a single number descriptor for describing time
varying noise levels.

3.6.1 Noise Monitoring Stations


In order to assess the noise levels in the study area, monitoring was carried out at
eight different locations within 10 km radius of the study area. The noise monitoring
locations are shown in figure 3.5 and distances & directions of monitoring location
mentioned in Table 3.19. Noise levels were recorded and computed for equivalent
noise levels for day-equivalent, night-equivalent & day-night equivalent.
Sound Pressure Levels (SPL) measurements were recorded at eight locations. The
readings were taken for every hour for 24-hrs. The day noise levels have been
monitored during 6 am to 10 pm and night noise levels during 10 pm to 6 am at all
the locations covered in the study area.
The noise recording stations and the summary of the minimum, maximum, day -

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equivalent, night - equivalent and day-night equivalent values computed for various
location in the study area is given in Table 3.20.

TABLE 3.19: NOISE MONITORING LOCATIONS


Name of Sampling Distance (km) Direction w.r.t
S No. Code
Location w.r.t Project Project
1. N1 Project Site - -
2. N2 Jayanthipuram 1.80 WNW
3. N3 Chillakallu 4.75 N
4. N4 Bhimavaram 6.70 NE
5. N5 Konakanchi 6.64 SE
6. N6 Vedadri Tanda 3.80 S
7. N7 Mukteswarapuram 7.10 SW
8. N8 Jaggayyapeta 6.00 NW

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FIGURE 3.5: NOISE SAMPLING LOCATIONS MAP

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TABLE 3.20: AMBIENT NOISE LEVELS WITHIN STUDY AREA


Day Time CPCB Night Time CPCB
Name of the Category of
in Leq Standard in Leq Standard
S.No Location Area/zone
dB (A) Day Time dB (A) Night time
1. Project site Industrial 55.0 75dB (A) 43.8 70dB (A)

2. Jayanthipuram Residential 53.2 55dB (A) 40.4 45dB (A)


3. Chillakallu Commercial 62.3 65dB (A) 52.1 55dB (A)
4. Bhimavaram Residential 50.6 55dB (A) 42.6 45dB (A)

5. Konakanchi Residential 48.7 55dB (A) 39.2 45dB (A)

6. Vedadri Tanda Residential 50.0 55dB (A) 38.9 45dB (A)

7. Mukteswarapuram Residential 46.5 55dB (A) 39.1 45dB (A)

8. Jaggayyapeta Commercial 59.5 65dB (A) 46.2 55dB (A)

Daytime Noise Levels (Lday)


Industrial Zone: The day time noise level at the Project site was 55.0 dB(A), which
is well below the permissible limits of 75 dB(A).
Commercial Zone: The daytime noise levels in all the commercial locations were
observed to be in the range of 59.5 dB (A) to 62.3 dB(A). The noise levels at all the
locations were below the permissible limits of 65 dB(A).
Residential Zone: The daytime noise levels in all the residential locations were
observed to be in the range of 46.5 dB (A) to 53.2 dB(A). The noise levels at all the
locations were below the permissible limits of 55 dB(A).

Night time Noise Levels (Lnight)


Industrial Zone: The night time noise level in the Project site was observed be 43.8
dB(A), which is well below the permissible limits of 70 dB (A).
Commercial Zone: The night time noise levels in all the commercial locations were
observed to be in the range of 46.2 dB (A) to 52.1 dB(A). The noise levels at all the
locations were below the permissible limits of 55 dB(A).
Residential Zone: The nighttime noise levels in all the residential locations were
observed to be in the range of 38.9 dB(A) to 42.6 dB(A). The noise levels were
below the permissible limits of 45 dB(A) in nighttime at all the locations.

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3.6.2 TRAFFIC STUDY


Anthropogenic emissions not only contribute to the green house effect but also
participate in the reaction that results in photochemical oxidants. The effect of
photochemical oxidants is well known for forming smog particularly in the urban
areas.Among the anthropogenic sources of pollutants forming the green house
gases, burning of fossil fuels constitute a major source. Highway mobile sources that
contribute significantly to poor quality have been regulated for the past two decades
in countries like India. The absence of regulation in developing countries has caused
a global concern regarding potential environmental damage on a larger scale.
The traffic survey was carried out on the NH-65 (Hyderabad to Vijayawada Road)
which is 4.75 km (N) to the Project site. Vehicular traffic counts were performed on
either side of the studied roads to provide background values of traffic density, and
correlate such data to the levels of air pollution along the road. Vehicular traffic on
these roads included heavy vehicle, light vehicle, three wheelers, and two wheelers.
The additional traffic due to the project would also occur in this time duration only. A
summary of the data is presented in Table 3.21.

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TABLE 3.21: TRAFFIC STUDY AT NH - 65 HYDERABAD – VIJAYAWADA ROAD (To & From)
3 Wheeler Passenger Heavy Total
Two 2 Wheeler Three Passenger Heavy Total
S.No Time @ 1.2 cars @ 1 Vehicles vehicles
Wheelers @ 0.75 PCU Wheeler cars vehicles vehicles
PCU PCU @3.7 PCU PCU
1 06-07 am 178 134 42 40 235 235 340 1258 795 1667
2 07-08 am 245 184 47 51 249 249 387 1432 928 1916
3 08-09 am 298 224 52 78 320 320 368 1362 1038 1983
4 09-10 am 305 229 56 96 340 340 350 1295 1051 1960
5 10-11 am 260 195 60 125 380 380 333 1232 1033 1932
6 11-12 pm 242 182 66 139 355 355 320 1184 983 1860
7 12-01 pm 210 158 72 130 334 334 311 1151 927 1772
8 01-02 pm 200 150 70 106 300 300 302 1117 872 1673
9 02-03 pm 207 155 64 102 289 289 284 1051 844 1597
10 03-04 pm 193 145 60 95 261 261 245 907 759 1407
11 04-05 pm 176 132 53 90 255 255 225 833 709 1310
12 05-06 pm 196 147 50 112 310 310 210 777 766 1346
13 06-07 pm 215 161 46 125 290 290 200 740 751 1316
14 07-08 pm 196 147 45 102 275 275 186 688 702 1212
15 08-09pm 170 128 40 96 260 260 178 659 648 1142
16 09-10pm 165 124 37 68 254 254 360 1332 816 1778
17 10-11pm 155 116 33 52 258 258 440 1628 886 2054
18 11-12pm 125 94 29 46 182 182 550 2035 886 2357
19 12-01am 113 85 25 35 118 118 320 1184 576 1422
20 01-02am 90 68 20 28 90 90 301 1114 501 1299
21 02-03am 75 56 18 19 84 84 293 1084 470 1243
22 03-04am 60 45 25 8 100 100 180 666 365 819
23 04-05am 76 57 33 12 146 146 157 581 412 796
24 05-06am 88 66 38 29 195 195 280 1036 601 1326

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The highest peak observed during 11 am to 10 pm (worst Scenario) PCU/hr 2357


Total width of the Road in meters (Arterial Road) 24
Carrying capacity of the road (the road is 4 lane Divided 2 way road) As per IRC:106-1990 (PCU’s per hour) 3600
Existing V/C Ratio 0.65
LOS=Level of Service (Existing)
V/C LOS Performance
0.0-0.2 A Excellent
0.2-0.4 B Very Good
0.4-0.6 C Good
0.6-0.8 D Fair/Average
0.8-1.0 E Poor
1.0 & above F Very Poor

Note: *As per IRC Guidelines 1990


The traffic survey was carried out on the NH-65 (Hyderabad - Vijayawada Road) which is 4.75 km (N) to the Project site. The
details of the vehicles movement recorded. From the study it is observed that there is no major impact on traffic due to the
proposed project.

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3.7 SOIL ENVIRONMENT


The present study on soil quality establishes the baseline characteristics in the study
area surrounding the project site. The study has been addressed with the following
objectives.
 To determine the base line characteristics
 To determine the soil characteristics of plant site and surrounding areas with
in 10 km radius.
 To determine the impact of industrialization/urbanization on soil
characteristics
 To determine the impacts on soils from agricultural productivity point of view.
The soil samples were collected during study period. Sampling Locations are
detailed in Table 3.22. and Figure 3.6. The analysis results are given in Table 3.23.
Details of Standard Soil Classification are given in table 3.24.
The homogenized soil samples collected at different locations were packed in a
polyethylene plastic bag and sealed. The sealed samples were sent to laboratory for
analysis. The important physical, chemical parameter concentrations were
determined from all samples.

TABLE 3.22: SOIL SAMPLING LOCATIONS


Distance (km) Direction w.r.t
S. No. Code Name of Sampling Location
w.r.t Project Project
1 S1 Project Site - -
2 S2 Jayanthipuram 1.80 WNW
3 S3 Dhramavarappadu Tanda 2.80 N
4 S4 Gauravaram 6.00 ENE
5 S5 Bandipalem 5.66 SE
6 S6 Vedadri Tanda 3.80 S
7 S7 Madipadu 7.25 SE
8 S8 Jaggayyapeta 6.00 NW

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FIGURE 3.6: SOIL SAMPLING LOCATIONS MAP


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TABLE 3.23: SOIL SAMPLING ANALYSIS RESULTS


S.No Parameters Units S1 S2 S3 S4 S5 S6 S7 S8
H
1 P -- 7.05 6.85 6.75 7.15 7.10 7.30 7.09 7.14
2 Electrical Conductivity µ mhos 110 108 124 112 98.6 120 110.5 142
3 Bulk Density g/cc 1.23 1.25 1.35 1.18 1.21 1.26 1.14 1.18
4 Moisture Content % 7.42 8.06 8.95 6.25 6.58 8.25 6.01 6.52
5 Nitrates as N Kg/ha 112 154 172 132 134 146 158 164
Phosphorous as
6 Kg/ha 51 53 48 54 58 51 59 54
P2O5
7 Potassium as K2O Kg/ha 386 345 298 324 336 294 334 314
8 Sodium as Na2O Kg/ha 174.2 156 134 153 192 140 162 201
9 Calcium as Ca mg/ kg 601 612 762 635 864 802 684 685
10 Magnesium as Mg mg/ kg 218 232.7 215.2 155.6 160.5 205.0 205.2 215.2
11 Total Organic Carbon % 0.78 0.84 0.86 0.79 0.74 0.75 0.85 0.72
Silt Sandy Sandy Silt Silt Sandy Sandy Silt
12 Type of Soil --
Loam Loam Loam Loam Loam Loam Loam Loam
a) Sand (%) -- 32 49 50 35 26 48 50 32
b) Silt (%) -- 48 36 40 49 49 36 33 50
c) Clay (%) -- 20 14 10 16 15 14 17 18
13 Copper as Cu mg/ kg 22.14 15.2 16.2 22 15.25 16.52 15.25 20.14
14 Chromium as Cr mg/ kg 33.05 23.2 30.2 28.6 26.52 31.25 29.63 22.15
15 Cadmium as Cd mg/ kg <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5
16 Zinc as Zn mg/ kg 35.02 42.65 42.32 51.36 52.3 38.54 54.0 53.26
17 Lead as Pb mg/ kg 22.11 21.3 30.22 14.38 18.65 16.22 21.65 51.48
18 Nickel as Ni mg/ kg 12.52 14.01 16.25 15.69 12.54 19.23 15.24 16.24
19 Sulphates as SO4 mg/ kg 41.12 38.2 25.3 25.64 42.21 29.56 30.25 28.23
20 Iron as Fe mg/ kg 21.8 21.23 19.6 17.04 19.58 19.4 19.54 20.14

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Physicochemical characteristics of the soil samples obtained from 7 areas in the


buffer zone and one from the project site reveals that all basically Silt loams. It is due
to the fact that the upper soil layers are formed by the deposition of fine sand and silt
carried down by the storm waters from the surrounding areas. They are moderately
productive and they are not prone to water logging.
 It has been observed that the pH of the soil quality ranged from 6.75 to 7.30.
 Percentage of Total Organic Carbon is observed in between 0.72 to 0.86
indicating that On an avg. sufficient in nature.

Table 3.24 :STANDARD SOIL CLASSIFICATION


S.No Soil Test Classification
<4.5 Extremely acidic
4.51- 5.50 Very strongly acidic
5.51-6.00 Moderately acidic
6.01-6.50 Slightly acidic
1 pH 6.51-7.30 Neutral
7.31-7.80 Slightly alkaline
7.81-8.50 Moderately alkaline
8.51-9.00 Strongly alkaline
>9.00 Very strongly alkaline
Salinity Electrical Conductivity Upto 1.00 Average
2 1.01 - 2.00 harmful to germination
(μS/cm) (1ppm = 640 μS/cm)
2.01 - 3.00 Harmful to crops (sensitive to salts)
Upto 0.20: Very less
0.21- 0.40: Less
3 Organic Carbon (%) 0.41- 0.50: Medium,
0.51- 0.80: On an avg. sufficient
0.81 - 1.00: Sufficient
>1.00 : More than sufficient
Upto 50 Very less
51-100 Less
4 Nitrogen (kg/ha) 101-150 Good
151-300 Better
>300 Sufficient
Upto 15 Very less
16-30 Less
5 Phosphorus (kg/ha) 31-50 Medium,
51-65 On an avg. sufficient
66-80 Sufficient
>80 More than sufficient

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S.No Soil Test Classification


0 -120 Very less
120-180 Less
6 Potash (kg/ha) 181-240 Medium
241-300 Average
301-360 Better
>360 More than sufficient
Source: Hand book of Agriculture, ICAR, New Delhi

3.8 LAND USE PATTERN


Remote sensing satellite imageries were collected and interpreted for the 10-km
radius study area for analyzing the Land use pattern of the study area. Based on the
satellite data, Land use/ Land cover maps have been prepared.
Objectives
The objectives of land use studies are:
 To determine the present land use pattern;
 To analyze the impacts on land use due to the proposed project in the study
area; and
 To give recommendations for optimizing the future land use pattern and
associated impacts.

3.8.1 DATA USED


The data is used for the preparation of different maps for the study natural
resources. The data is used by using the application of Remote Sensing and GIS
technologies.

TABLE 3.25: SHOWING THE DETAILS OF SOURCES & THE MAPS PREPARED
S No. Source Maps Prepared
Survey of India’s topographic maps and satellite
1 Drainage map
imageries
2 Satellite imageries Land use / Land cover

TABLE 3.26: SHOWING THE TOPOGRAPHIC MAPS


Sl. No. Topographic Map No. Scale Year of Survey Year of Publication
1. 65D/1 1: 50,000 2010 2011
Source:Survey of India’s Topographic Maps

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TABLE 3.27:SATELLITE DATA OF NATIONAL REMOTE SENSING CENTRE


S.No. Season Sensor path/row Satellite/Sensor Date of Pass
11-November-
1. Rabi 101-61-B IRS RS2 LISS IV FX
2016

3.8.2 LAND USE / LAND COVER MAP


Land use / land cover map is prepared by visual interpretation of high-resolution
satellite data with the help of Survey of India Topographic maps on 1:50,000 scale.
Two seasons’ data (Rabi year 2017) is used for the delineation of different units. The
units are confirmed by the ground truth/field visits.
Level-II classification of National (Natural) Resources Information System (NRIS)
has been followed for the delineation of units.
Land use/ Land cover map of the study area is integrated with village map and
analyzed with the help of GIS to get the village wise findings of the present land use
of the study area, which is given elaborately in the following tables:
Land use refers to man’s activities and various uses, which are carried on land. Land
cover refers to natural vegetation, water bodies, rock/soil, artificial cover and others
resulting due to land transformation. Although land use is generally inferred based
on the cover, yet both the terms land use and land cover are closely related and
interchangeable. Information on the rate and kind of change in the use of land
resources is essential to the proper planning, management and regulation of the use
of such resources.
Knowledge about the existing land use and trends of change is essential if the nation
is to tackle the problems associated with the haphazard and uncontrolled growth. A
systematic framework is needed for updating the land use and land cover maps that
will be timely, relatively inexpensive and appropriate for different needs at national
and state level. The rapidly developing technology of remote sensing offers an
efficient and timely approach to the mapping and collection of basic land use and
land cover data over large area. The satellite imageries are potentially more
amenable to digital processing because the remote sensor output can be obtained in
digital format. Land use data are needed in the analysis of environmental processes
and problems that must be understood if living conditions and standards are to be
improved or maintained at current levels.

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3.8.2.1 Basic Concepts of Land Use


Clawson has given nine major ideas or concepts about land. These are:
 Location or the relation of a specific parcel of land to the poles, the equator,
and the major oceans and landmasses. There is also relationship between
various tracts of land, as well as a political location.
 Activity on the land, for what purpose this piece of land or tract is used.
 Natural qualities of land, including its surface and subsurface characteristics
and its vegetative cover.
 Improvements to and on the land. This is closely related to the activity.
 Intensity of land use or amount of activity per unit area.
 Land tenure, i.e. who owns the land, which uses it.
 Land prices, land market activity and credit as applied to land.
 Interrelations between activities on the land and other economic and social
activities.
 Interrelations in the use between different tracts of land.

3.8.2.2 Methodology for land use / land cover mapping


The land use / land cover map is prepared by adopting the interpretation techniques
of the image in conjunction with collateral data such as Survey of India topographical
maps and census records. Image classification can be done by using visual
interpretation techniques and digital classification using any of the image processing
software. For the present study, ERDAS 9.1 version software is used for
preprocessing, rectification, enhancements and classifying the satellite data for
preparation of land use land cover map for assessing and monitoring the temporal
changes in land use land cover and land developmental activities.

The imagery is interpreted and ground checked for corrections. The final map is
prepared after field check. Flow chart showing the methodology adopted is given in
the different land use / land cover categories in the study area has been carried out
based on the NRSC land use / land cover classification system.

For analysis and interpretation, and preparation of LU / LC map, two types of data
are needed:
1. Basic data 2. Ground data

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1. Basic data includes:


 Fused data of LISS IV
 Toposheets on 1 : 50,000
 Local knowledge
 Area map on any scale to transfer details
 Reports and other literature of the study area

2. Ground data: Ground data is very much essential to verify and to increase the
accuracy of the interpreted classes and also to minimize the field work.
Data analysis: For analysis and interpretation of satellite data, the study can be
divided into three parts:
 Preliminary work
 Field work
 Post field work

A. Preliminary work includes:


 to see the limitation of satellite data
 to lay down the criteria for land use classification to be adopted
 to fix the size of mapping units, which depends upon the scale
 interpretation of different land use/land cover classes
 demarcation of doubtful areas
 preparation of field land use/land cover map

B. Field work:
 Type of ground data to be collected
 Selection of sample area for final classification
 Checking of doubtful areas
 Change in land use/ land cover due to wrong identification, fresh
development, nomenclature.
 General verification

C. Post field work:


 Reinterpretation or analysis or correction of doubtful areas
 Transfer of details on base map

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 Marginal information
 Preparation of final land use/land cover map

A map showing Satelite Imagery Showing in Figure 3.8. A map depicting major land
use/ land cover classes comprising lands under agriculture, fallow land,
open/degraded vegetation; lands falling under water bodies, scrub and lands under
inhabitations is presented at Figure 3.9 and Flow chart for LU/LC mapping
methodology is presented at Flow chart 3.1.
The land use classification within a distance of ten kilometers from the project
location and the areas falling under the respective classifications are presented in
Table 3.28:

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FLOW CHART 3.1 : LU/LC MAPPING METHODOLOGY

Basic data Data source Secondary data

IRS LISS IV FMX

Preparation
Khariff Rabi of base
season season maps

Development of
interpretation keys based
on image characteristics.
Interpretation and mapping of
land use /land cover categories

Ground verification of doubtful areas


Validation and final and modification of thematic details
interpretation key

Transfer of Khariff and Rabi season Final land use/land cover


land use/land cover details on to a map with symbols and
single base map. colours

Area estimation of each


land use/land cover class.

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TABLE 3.28 : LAND USE / LAND COVER STATISTICS OF THE STUDY AREA

S. No. LANDUSE AREA (Sq. km) %

BUILT UP LAND
A. Settlements / Temple 16.328 5.2
1.
B. Industrial area 5.966 1.9
WATERBODIES
A. Tank / River/ Major canal
2. 23.236 7.4
etc.
FOREST
3. A. Scrub forest 36.424 11.6
CROP LAND
A. Single crop 21.038 6.7
B. Double crop 142.242 45.3
4.
C. Plantations 8.164 2.6
D. Crop land forest 0.628 0.2
WASTELANDS
A. Land with scrub 24.492 7.8
B. Land without scrub 8.164 2.6
5. C. Sheet rock area 6.908 2.2
D. Stony waste area 9.734 3.1
E. Mining area 10.676 3.4
TOTAL 314 100

FIGURE 3.7 PIE DIAGRAM SHOWING LAND USE THE IN STUDY AREA

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FIGURE 3.8: SATELLITE IMAGE OF THE STUDY AREA


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FIGURE 3.9: LAND USE / LAND COVER MAP OF THE STUDY AREA

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3.9 ECOLOGICAL ENVIRONMENT


Ecological studies are one of the important aspects of Environmental Impact
Assessment with a view to conserve environmental quality and biodiversity.
Ecological systems show complex inter-relationships between biotic and abiotic
components including dependence, competition and mutualism. Biotic components
comprise of both plant and animal communities, which interact not only within and
between themselves but also with the biotic components viz. physical and chemical
components of the environment.
Generally, biological communities are good indicators of climatic and edaphic
factors. Studies on biological aspects of ecosystems are important in Environmental
Impact Assessment for safety of natural flora and fauna. The biological environment
includes terrestrial and aquatic ecosystems.

Objectives of Ecological Studies


The present study was undertaken with the following objectives to assess both
terrestrial and aquatic habitats of the study area
To assess the nature and distribution of vegetation in and around the project site
 To assess the flora & fauna in the study area;
 To ascertain the migratory routes of fauna, presence of breeding grounds and
sensitive habitats in the study area, if any;
 To assess the presence of protected areas in the study area;
 To review the information from secondary sources and discuss the issues of
concern with the relevant authority and stakeholders;
 Impact prediction based on primary and secondary data sources to formulate
mitigation measures.

3.9.1 Detailed Description Of Flora And Fauna


Assessment of flora and fauna study location: Flora and Fauna studies were
carried out by using least count quadrate method at following six locations. Trees
were sampled by taking quadrates of 25 m 2 and shrubs 10 m2 and in case of
herbaceous vegetation of 1 m2 distributed randomly. Table 3.29 shows the flora and
fauna study locations of the study area.

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TABLE 3.29 - Sampling locations for flora and fauna study in study area
Distance from
Location Direction from
Sl.No. Name of the location Project Site
Code Project Site
(in km)
1 T-1 Project area -- --
2 T-2 Jaggayyapeta Extension R.F 0.39 N
3 T-3 Kuntimadi R.F 5.12 SSW
4 T-4 Ginjupalle R.F 5.60 SSW
5 T-5 Venkatayapalem R.F 7.80 SSW
6 T-6 Budavada R.F 4.68 W
Note: At each sampling location the protocol adopted to collect primary data were
trees - 10 quadrates of 25 m x 25 m, Shrubs – 10 Quadrates 10 m x 10 m and herbs -
10 quadrates of 1 m x 1 m.

The project site is located in Sy. No. 108 & 109, Jayanthipuram Village, Jaggayyapet
Mandal, Krishna District, Andhra Pradesh. The Primary surveys were conducted in
and around project area and 10 km radius study area, Reserve forests, open areas
near villages, waste lands and agricultural lands along the water bodies to identify
the floristic composition of the area and listed the plants species identified in the
Project area and 10 km radius study area is given in Table 3.30.

FLORA: Based on the physical setting and the kind of distribution of flora and fauna,
the study area can be classified into cropland, forest land, terrestrial vegetation
structure and aquatic ecosystems etc.

TABLE 3.30: List of plants found in the project area


Local name
S.No Botanical name English name Habitat
(Telugu )
1 Bidenspilosa Beggar tick Phutium Herb
Asian spider
2 Cleome viscose Kukka-vaminta Herb
flower
3 Partheniumhysterophorus Carrot Grass Chandani Herb
4 Abutilon indicum Indian Mallow Tuturabenda Shrub
5 Ageratum conyzoides Goat weed Pumpillu Shrub
6 Calotropis gigantean Crown Flower Jilledu Shrub
7 Cassia surattensis Scrambled Egg Mettatangedu Shrub
8 Cleistanthuscollinus Garari Kodisha Shrub
9 Drypetessepiaria Wild Caper Bush Bira Shrub
10 Acacia arabica Gum arabic tree Natutuma Tree
11 Acacia ferruginea Rusty Acacia Anisandra Tree
12 Acacia mearnsii black wattle Tumma Tree
13 Acacia melanoxylon Sally Wattle Kondakorinda Tree

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Local name
S.No Botanical name English name Habitat
(Telugu )
14 Acacia nilotica Babool Nallatumma Tree
15 Albizialebbeck Flea tree Dirisena Tree
16 Bambusa bamboo Bamboo Bonguveduru Tree
17 Barringtoniaacutangula Indian putat Kadimi Tree
Flame of the
18 Buteafrondosa Moduga Tree
forest
19 Eucalyptus globules Eucalyptus Jamayul Tree
20 Ficusbenghalensis Banyan Marri Tree
21 Ficusreligiosa Pee pal Raavi Tree
22 Magniferaindica Mango Mamidi Tree
23 Pongamiapinnata Indian beech Kanuga Tree
24 Techtonagrandis Teak Teku Tree

3.9.2 Vegetation and Flora of the study area:


Forest types found in the study area predominantly Reserve forest, open forest type,
scrub forest are distributed in the few patches surrounding project the site. Social
forestry development induced Eucalyptus Mango plantations can be seen in the
study area. The biodiversity study was conducted to provide information on flora
present in the study area. The study was conducted in radius of 10 km from the site.
The list of places covered in the floral biodiversity and faunal biodiversity survey are
Project area, Jaggayyapeta Extension R.F, Kuntimadi R.F, Ginjupalle R.F,
Venkatayapalem R.F, Budavada R.FNear Jaggayyapeta, Krishna River Near
Madipadu, Krishna River Near Ravirala etc. The various species of flora and fauna
recorded in the study are tabulated. Discussions were held with local people to
gather related information on the richness of plant and animal resources.
More than 83 plant species were recorded during floristic survey in the project and
study area. A list of plant species representing trees, shrubs and herbs list is given in
Table 3.31. A list of grasses, herbs, Climbers and herbaceous plants found in the
study area is given in Table 3.31.
There are no rare or endangered or threatened species all the species listed in Table
3.31 are widely distributed in most parts of Deccan region.

Cropland Ecosystem: The common crops land ecosystem in study area are Oryzha
sativa and Zea maze which are mainly dependent on rainwater during monsoon

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season, canal irrigation and also through ground water source, tube wells and open
wells during non-monsoon season.

TABLE 3.31., List of Trees, Shrubs, Grasses, Herbs, Climbers and Herbaceous
Species Found the Study Area
Sl. No Scientific Name Family Vernacular name
Staple crops and commercial crops
1 Abelmoschus esculentus Malvaceae Ladies Finger
2 Capsicum frutescens Solanaceae Chilli
3 Citrus limon Rutaceae Lemon
4 Coriandrum sativum Apiaceae Coriander
5 Oryza sativa Poaceae Paddy
6 Solanum melongena Solanaceae Brinjal
7 Zea mays Poaceae Maize
Trees
1 Mangifera indica Anacardiaceae Mamidi
2 Annona squamosa Annonaceae Custard apple
3 Polyalthia longifolia Annonaceae Ashoka
4 Polyalthia pendula Annonaceae Asoka
5 Borassus flabellifer Arecaceae Taati
6 Cocos nucifera Arecaceae Coconut
7 Phoenix sylvestris Arecaceae Eetha
8 Agave americana Asparagaceae Sentry plant
9 Spathodea companulata Bignoniaceae Flame of the forest
10 Bombax ceiba Bombacaceae Booruga
11 Bauhinia racemosa Caesalpiniaceae Ari
12 Bauhinia variagata Caesalpiniaceae Mandari
13 Cassia fistula Caesalpiniaceae Rela
14 Tamarindus indica Caesalpiniaceae Chinta
15 Terminalia arjuna Combretaceae Tella maddi
16 Diospyros melanoxylon Ebenaceae Tunki
17 Breynia vitis-ideae Euphorbiaceae Nalla purugudu
18 Euphorbia caducifolia Euphorbiaceae Brahma jemudu
19 Butea monosperma Fabaceae Modugu
20 Desmodium pulchellum Fabaceae Deyyapu mokka
21 Pongamia pinnata Fabaceae Ganuga
22 Prosopis juliflora Fabaceae English tumma
23 Lagerstroemia parviflora Lythraceae Chennangi
24 Azadirachta indica Meliaceae Vepa
25 Acacia arabica Mimosaceae Nalla tumma

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Sl. No Scientific Name Family Vernacular name


26 Acacia leucophloea Mimosaceae Tella tumma
27 Pithecellobium dulce Mimosaceae Seema chinta
28 Prosopis spicigera Mimosaceae Jammi chettu
29 Samanea saman Mimosaceae Nidrabhangi
30 Ficus benghalensis Moraceae Marri
31 Ficus religiosa Moraceae Raavi
32 Moringa oleifera Moringaceae Munaga
33 Muntingia calabura Muntingiaceae Wild cherry
34 Eucalyptus spp. Myrtaceae Jama oil
35 Syzygium cumini Myrtaceae Neradu
36 Breynia retusa Phyllanthaceae Chinna purugudu
37 Phyllanthus emblica Phyllanthaceae Usiri
38 Phyllanthus eticulates Phyllanthaceae Pulasari
39 Ziziphus nummularia Rhamnaceae Gotti
40 Ziziphus rugosa Rhamnaceae Regu
41 Aegle marmelos Rutaceae Maredu
42 Chloroxylon sweitenia Rutaceae Billudu
43 Feronia elephantum Rutaceae Velaga
44 Mimusops elengi Sapotaceae Pogada
45 Sterculia foetida Sterculiaceae Adavi badam
46 Tectona grandis Verbenaceae Teku
47 Vitex negundo Verbenaceae Vaavili
Shrubs
1 Hygrophila auriculata Acanthaceae Kokilakshi
2 Calotropis procera Asclepiadaceae Jilledu
3 Cassia auriculata Caesalpiniaceae Caesalpiniaceae
4 Sida acuta Malvaceae Nelabenda
5 Acacia caesia Mimosaceae Kirintha
6 Mimosa rubicaulis Mimosaceae Pariki kampa
7 Phyllanthus reticulatus Phyllanthaceae Pulasari / Puliseru
8 Triumfetta rhomboidea Tiliaceae Oekki. Chirusitrika
9 Lantana camara Verbenaceae Lantana
Climbers
1 Aristolochia bracteolata Aristolochiaceae Gadaparaku
Bedasatiga,
Ampelocissus latifolia Vitaceae
2 Bedalatiga
3 Argyreia nervosa Convolvulaceae Samudrapala
4 Ipomoea pes-carpae Convolvulaceae Chevulapilli theege
5 Merremia hederacea Convolvulaceae Kalasa
6 Rivea hypocrateriformis Convolvulaceae Nirubodi

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Sl. No Scientific Name Family Vernacular name


Herbs / Grasses
1 Allmania nodiflora Amaranthaceae Gurugu koora
2 Alternanthera pungens Amaranthaceae Mullu
3 Amaranthus spinosus Amaranthaceae Yerra Mullu-Gorinta
4 Digera muricata Amaranthaceae Chencheli-kura
5 Alternanthera sessilis Amranthaceae Ponna Ganti-Kura
6 Catharanthus pusillus Apocyanaceae Errimirapa, Guluvidi
7 Acanthospermum hispidum Asteraceae Palleru
8 Ageratum conyzoides Asteraceae Pumpullu
9 Eclipta alba Asteraceae Galagara
10 Sphaeranthus indicus Asteraceae Boddatarapu
11 Cassia absus Caesalpinaceae Chanupala-vittulu
12 Cassia occidentalis Caesalpinaceae Kasinta
13 Biophytum nervifolium Oxalidaceae Pulicenta
14 Chloris barbata Poaceae Uppu gaddi
 Endangered Plants: No endangered plant species observed during study period
and also from records of Botanical Survey of India (Red data of Books of Indian
Plants).
 Endemic Species: No endemic species recorded/reported as per BSI records.

3.9.3. Terrestrial fauna of the project area and the study area
As the animals, especially vertebrates and the winged invertebrates move from place
to place in search of food, shelter, mate or other biological needs, separate lists for
project area and study area are not feasible. As such there are no chances of
occurrence of any rare or endangered or endemic or threatened (REET) species
within the project area and study area. There are no wildlife sanctuaries, National
Parks, Tiger Reserve or Biosphere Reserve or Elephant Corridor or other protected
areas within 10 Km of radius from project area, It is evident from the available
records, reports and circumstantial evidence that the entire study area including the
project area and study area were free from any endangered animals. Among the
Mammals, only Squirrels, Mongoose, Rats, Bandicoots and Rabbits were seen
frequently during the survey. Among the reptiles, Lizards, Garden lizards were very
common. Rat snake and lizard were seen once during the survey. Other reptiles
were very rare. The amphibians were also rare. A list of Mammals, Reptiles and
Amphibians either found or reported from the area is given in Table 3.32. A list of
birds is given in Table 3.35. There were no resident birds other than Crows, Parrots,
Doves, and Weaver birds, Swifts and Mynas. It is apparent from the list that none of

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the species with the sole exception of Peacock either spotted or reported is included
in Schedule I of the Wildlife Protection Act. Peacocks are fairly common in these
areas. They do not come under the threatened category of the IUCN. Further it is
easy to multiply Peacocks and they can be easily domesticated if permitted.

3.9.3.1 Methodology for Mammals study: The mammal survey was carried out by
walking through different forest habitats, recording and collecting evidence of
mammals. Besides fixed transect survey as far as possible, random search was also
adopted to record the occurrence of mammalian species in the study area. Indirect
evidences such as scats, pug/foot marks, calls of different mammalian species and
discussion with the villagers in the surrounding villages were used for the identification
and documentation of the mammalian species there are several minor carnivorous and
herbivorous wild animals in the study area. The commonly observed or reported
mammals during study period are presented in below Table No. 3.32.

3.9.3.2 Methodology for Herpeto-fauna: Herpeto-fauna were noticed mainly in fresh


water and marshy places Different amphibians, Lizards and reptiles in the study area
Presented in below Table No. 3.33., Butterflies: Butterflies spotted in the study area
were identified as per Butterflies of India. List of butterflies in the study area are
presented in Table.3.34.

3.9.3.3 Methodology for Birds in Study Area: Survey for birds was done in
different areas like wetlands, forest types and cultivation lands. Birds were observed
mostly during most active period of the day around 5.30 hrs to 8.30 hrs and 15.30
hrs to 18.30 hrs. Birds were identified by direct observation, identifying the physical
features with the help of field guides (The book of Indian Birds by Salim Ali) and
reference books. In case of complications in identification, photographs were taken
for identification in later stages. Birds were observed in different types of habitats
and those areas where sighting chances are more. However, time schedule was
altered according to situation and availability of time. The list of avifauna observed
recorded or observed in study area is presented in below Table No. 3.35.

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TABLE 3.32 List of mammals observed in study area


S. IUCN
Scientific Name Local name Schedule
No Status
1 Canisaurius Jackal* II LC
2 Cynopterus sphinx Short-nosed fruit bat IV LC
3 Funumbulspalmarum Three striped squirrel IV LC
4 Herpestesedwardsii Common Mongoose II LC
5 Hystrixindica Indian porcupine* IV LC
6 Lepusnigricollis Indian hare IV LC
7 Macacamulata Rhesus macaque II LC
8 Musrattus Indian rat V LC
9 Rousettus leschenaultia Fruit Bat V LC
10 Susscrofa Wild Pig* III LC
* Ecological data collection - interactions with local personnel, forest officials of respective forest
ranges and direct indirect observation in the project area and project study area

TABLE 3.33: List of reptiles and amphibians observed in study area


IW (P) A,
Sl.
Scientific Name Common Name IUCN 1972,
No.
Schedule
Common Indian
1 Bungaruscaeruleus LC IV
Krait
2 Calotesversicolor Garden Lizard LC IV
Common Indian
3 Duttaphrynusmelanostictus LC IV
Toad
4 Duttaphrynusscaber Ferguson's Toad LC IV
5 Euphlyctiscyanophlyctis Skittering Frog LC IV
6 Euphlyctishexadactylus Indian Pond Frog LC IV
7 Hemidactylusbrookii House Lizard LC IV
8 Hemidactylusmacolatus Reticulated gecko LC IV
9 Hoplobatrachustigerinus Tiger Frog LC IV
10 Mabuyacarinata Common Skink LC IV
11 Najanaja Common Cobra LC II
12 Ptyasmucosus Rat Snake LC II
13 Sitanaponticeriana Fan-throatedlizard LC IV
* Ecological data collection - interactions with local personnel, forest officials of respective forest
ranges and direct indirect observation in the project area and project study area

TABLE 3.34: List of butterflies observed in study area


W(P)A,
S. No. Scientific name Common name IUCN Status
1972
1 Castalius rosimon Common Pierrot LC Sch-IV
2 Danaus chrysippus Plain Tiger LC Sch-IV
3 Danaus genutia Striped Tiger LC Sch-IV

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W(P)A,
S. No. Scientific name Common name IUCN Status
1972
4 Euploea core Common Crow LC Sch-IV
5 Junonia lemonias Lemon Pansy LC Sch-IV
6 Papilo polymnstor Blue Mormon LC Sch-IV
7 Juninia almanac Peacock Pansey LC Sch-IV
* Ecological data collection - interactions with local personnel, forest officials of respective forest
ranges and direct indirect observation in the project area and project study area

TABLE 3.35: List of birds either spotted or reported from the areas in and
around the project site
S. IUCN
Local name Scientific Name Schedule
No Status
1 Ashy Prinia Priniasocialis IV LC
Ashy-crowned Sparrow-
2 Eremopterixgrisea IV LC
Lark
3 Asian Koel Eudynamysscolopacea IV LC
4 Asian Open bill- Stork Anastomusoscitans IV LC
5 Asian Palm-Swift Cypsiurusbalasiensis IV LC
6 Baya Weaver Ploceusphilippnius IV LC
7 Black Drongo Dicrurusmacrocercus IV LC
8 Black Ibis Pseudibispapillosa IV LC
9 Black Kite Milvusmigrans IV LC
10 Black-Shouldered Kite Elanuscaeruleus IV LC
11 Blue Rock Pigeon Columba livia IV LC
12 Blue-tailed Bee-eater Meropsphillippinus IV LC
13 Brahminy Kite Haliasturindus IV LC
14 Cattle Egret Bubulcus ibis IV LC
15 Common Babbler Turdoidescaudatus IV LC
16 Common Myna Acridotherestristis IV LC
17 Common Swallow Hirundorustica IV LC
18 Common Tailor Bird Orthotomussutorius IV LC
19 Common Teal Anascrecca IV LC
20 Eurasian Golden Oriole Oriolusoriolus IV LC
21 Greater Coucal Centropussinensis IV LC
22 Grey Wagtail Motacillacinerea IV LC
23 House Crow Corvussplendens V LC
24 House Sparrow Passer domesticus IV LC
25 House Swift Apusaffinis IV LC
26 Indian Peafowl Pavocristatus I LC
27 Indian Pond Heron Ardeolagrayii IV LC
28 Indian Robin Saxicoloidesfulicata IV LC
29 Indian Roller Coraciasbenghalensis IV LC
30 Indian Treepie Dendrocittavagabunda IV LC

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31 Jungle Babbler Turdoidesstriatus IV LC


32 Large Cuckoo Shrike Coracinamacei IV LC
33 Large Grey Babbler Turdoidesmalcolmi IV LC
34 Large Pied Wagtail Motacillamaderaspatensis IV LC

Lesser Golden-backed
35 Dinopiumbenghalense IV LC
Woodpecker
36 Little Cormorant Phalacrocoraxniger IV LC
37 Little Egret Egrettagarzetta IV LC
38 Oriental Magpie- Robin Copsychussaularis IV LC
39 Paddy field Pipit Anthusrufulus IV LC
40 Painted Stork Mycterialeucocephala IV LC
41 Pied Bushchat Saxicolacaprata IV LC
42 Purple Sunbird Nectarineaasiatica IV LC
43 Red-rumped Swallow Hirundodaurica IV LC
44 Red-vented Bulbul Pycnonotuscafer IV LC
45 Red-wattled Lapwing Vanellesindicus IV LC
46 Rose-ringed Parakeet Psittaculakrameri IV LC
47 Shikra Accipiter badius IV LC
48 Small Blue Kingfisher Alcedoatthis IV LC
49 Spot-billed Duck Anaspoecilorhyncha IV LC
50 Spotted Dove Streptopeliachinensis IV LC
51 Spotted Munia Lonchurapunctulata IV LC
52 White Wagtail Motacilla alba IV LC
White-breasted
53 Halcyon smyrnensis IV LC
Kingfisher
White-breasted Water
54 Amauronisphoenicurus IV LC
hen
55 Wire-tailed Swallow Hirundosmithii IV LC
56 Yellow-wattled Lapwing Vanellesmalabaricus IV LC
* Ecological data collection - interactions with local personnel, forest officials of respective forest
ranges and direct indirect observation in the project area and project study area

3.9.4 AQUATIC FLORA AND FAUNA:


The conditions of the aquatic ecology of the water bodies were also studied. Major
components of aquatic life that have been studied are as aquatic plant and aquatic
animals.

Plankton studies - primary survey


Biological assessment studies were conducted by collecting plankton samples from
the surface waters to assess the primary productivity of the water ecosystem. The
details of Planktonic sampling locations are presented in Table no. 3.36 given below.

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TABLE – 3.36, Aquatic ecological locations in study area


Distance from Direction from
Sl. No Name of the water body
Project Site Project Site
AS-1 Waterbody Near Jaggayyapeta 5.54 NW
AS-2 Krishna River 3.30 SSW
AS-3 Gauravaram Cheruvu 5.40 E

Results and discussions


About 14 aquatic plant species and 17 Aquatic Fauna species are recorded from all the
sampling locations. The list of recorded aquatic fauna from study area and aquatic flora
species is presented in the Table No 3.37 & 3.38.

TABLE – 3.37 Check list of fishes found in Krishna River


IW (P)A, 1972,
S. No. Scientific Name Common Name IUCN Status
Schedule
FISHES
1 Catla catla Catla LC IV
2 Channa punctatus Spotted snakehead LC IV
3 Channa striatus Striped snakehead LC IV
4 Clarias batrachus Magur LC IV
5 Cyprinus carpio Common carp LC IV
6 Etroplus maculatus Orange chromide LC IV
7 Etroplus suratensis Banded pearlspot LC IV
8 Eutropiichthys vacha Batchwa vacha LC IV
9 Heteropneustes fossilis Stinging catfish LC IV
10 Labeo rohita Rohu LC IV
11 Mastacembelus armatus Tire- track spiny eel LC IV
12 Puntius dorsalis Long – snouted barb LC IV
13 Puntius fasciatus Ember barb LC IV
14 Puntius ticto Ticto barb LC IV
15 Sperata seenghala Giant river catfish LC IV
16 Striped panchax Tiger panchax LC IV
17 Tenualosa ilisha Hilsa LC IV
* Ecological data collection - interactions with local personnel, forest officials of respective forest
ranges and direct indirect observation in the project area and project study area

TABLE – 3.38, List of aquatic flora species recorded in study area


Sl. No. Scientific Name Family Distribution Status
1 Aponogeton natans Aponogetonaceae Common
2 Pistia stratoides Araceae Widespread
3 Azolla pinnata Azollaceae Scattered and common
4 Cyperus arenarius Cyperaceae Locally abundant

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Sl. No. Scientific Name Family Distribution Status


5 Phragmites karka Cyperaceae Dominant along boundaries
6 Vallisneria spiralis Hydrocharitaceae Widespread
7 Marsilia quadrifoliata Marsiliaceae Very common Pteridophyte
8 Nelumbo nucifera Nelumbiaceae Very common
9 Nymphoides hydrophylla Nympheaceae Scattered
10 Nymphoides indica Nympheaceae Scattered
11 Brachiaria mutica Poaceae Sporadic
12 Chrysopogon aciculatus Poaceae Occasional
13 Cynodon dactylon Poaceae Extensive and widespread
14 Paspalidium geminatum Poaceae Common
* Ecological data collection - interactions with local personnel, forest officials of respective forest
ranges and direct indirect observation in the project area and project study area

3.9.5 RET and Schedule I Fauna


On the basis of literature survey, from Red data books of Indian plants, detailed list
Rare and Endangered flora reveals that there are no Endangered, Threatened, Rare
plant species observed or recorded during study period.
There are no endangered animals, however recorded or observed list of wild animals
and their conservation status as per Wildlife (Protection) Act, 1972 are presented
above tables. As per Ministry of Environment, forests and climate change, Forest
department of Government of Andhra Pradesh state notifications reveals that there are
no Biospheres, Tiger Reserves, Elephant Reserves, National Parks, Wildlife
Sanctuaries, Conservation Reserves and Community Reserves in 10 - km radius from
plant boundary.

3.10. Socio Economic Study


The socio- economic aspects of people in the 10 km radius of the Project site at
Jayanthipuram (V), Jaggayyapet (M), Krishna District, Andhra Pradesh was
analyzed. The socio-economic data forms the basis for developing a suitable
enterprise social responsibility plan to address the needs of the population.

3.10.1. Methodology Adopted for the Study


The methodology adopted for the study mainly includes review of published
secondary data and primary data collection through sample survey conducted
project study area. Census of India - 2011 for respect to population, density,

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household size, sex ratio, literacy rate and occupational structure for 10 km radius
study area.

3.10.2. Distribution of Population in the study area


As per 2011 census the study area consists of 2,04,510 persons inhabited in the
study area of 10km radial distance from the periphery of the project. The distribution
of population in the study area is given in Table 3.39.

Table 3.39: Population Distribution


Number of Total population 0-6 years aged population
S. No Name of Village
households Total Male Female Total Male Female
0 - 3 Km
1 Jayanthipuram 619 2348 1191 1157 361 198 163
Sub Total 619 2348 1191 1157 361 198 163
3 - 5 Km
2 Ravirala 316 1275 626 649 173 89 84
3 Kowthavari Agraharam 698 2759 1392 1367 329 153 176
4 Vedadri 590 2155 1099 1056 231 105 126
Sub Total 1604 6189 3117 3072 733 347 386
5-7 Km
5 Bandipalem 1163 4568 2297 2271 425 224 201
6 Konakanchi 955 3372 1690 1682 341 183 158
7 Pochampalle 978 3798 1928 1870 430 243 187
8 Gowravaram 1293 4781 2355 2426 494 243 251
9 Torraguntapalem 873 3295 1661 1634 366 179 187
10 Chillakallu 2983 11734 5779 5955 1386 686 700
11 Jaggayyapeta 32711 126275 62713 63562 13801 7061 6740
12 Mukteswarapuram 713 2742 1385 1357 253 134 119
Sub Total 41669 160565 79808 80757 17496 8953 8543
7 - 10 Km
13 Katrenipadu 1503 5673 2847 2826 608 289 319
14 Peddavaram 321 1231 645 586 96 48 48
15 Konakanchi 955 3372 1690 1682 341 183 158
16 Bhimavaram 1474 5543 2783 2760 614 333 281
17 Makkapeta 1186 4306 2106 2200 459 243 216
18 Gopinenipalem 747 2752 1368 1384 275 145 130
19 Tirumalagiri 372 1478 730 748 205 103 102
20 Veerareddi Palle 435 1835 899 936 174 97 77
21 Shermohammedpet 1822 7002 3471 3531 804 412 392
22 Tripuravaram 32 128 73 55 8 7 1
23 Srinivasapur 50 273 135 138 31 20 11
24 Kothagudem 475 1815 945 870 151 70 81
Sub Total 9372 35408 17692 17716 3766 1950 1816
Grand Total 53264 204510 101808 102702 22356 11448 10908
(Source: Hand Book of Statistics, Krishna District, 2011 and Census data 2011)

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The male and female population constitutes about 49.75 % and 50.25 % in the study
area respectively.

Figure 3.10: Diagram Showing Total Population Distribution in the Study Area

3.10.3. Literacy & Illiteracy Rate:


Literacy level is quantifiable indicator to assess the development status of any area.
The literate male and female in the study area are 68273 and 55524 which implies
that the percentage of literacy rate is 67.06 % with male and 54.06 % with female
respectively.
The male and female illiterates population in the study area are 33535 and 47178
respectively which implies that the percentage of illiteracy rate is 32.93 % with male
and 45.93 % with female respectively. The distribution of literate and literacy rate in
the study area is given in Table 3.40. The graphical presentation of literates and
illiterates in study area is given in figure 3.12.

Table 3.40: Distribution of Literacy Rate and Illiteracy Rate in the Study Area
S. No Particulars Population
1. Male Population 101808
2. Female Population 102702
3. Total Population 204510

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4. Male population Literates 68273


5. Male population Literates % 67.06 %
6. Male population illiterates 33535
7. Male population Illiterates % 32.93 %
8. Female population Literates 55524
9. Female population Literates % 54.06 %
10. Female population Illiterates 47178
11. Female population Illiterates % 45.93 %
(Source: Hand Book of Statistics, Krishna District, 2011 and Census data 2011)

Figure 3.11: The Diagram Showing Literates and Illiterates in Study Area

3.10.4. Occupational Structure


The occupational structure of residents of work participation rate in the study area is
studied with reference to main workers, marginal workers and non workers. The
main workers include 10 categories of workers defined by the Census Department
consisting of cultivators, agricultural laborers, those engaged in live-stock, forestry,
fishing, mining and quarrying; manufacturing, processing and repairs in household
industry; and other than household industry, construction, trade and commerce,
transport and communication and other services.
The marginal workers are those workers engaged in some work for a period of less
than six months during the reference year prior to the census survey. The non-
workers include those engaged in unpaid household duties, students, retired
persons, dependents, beggars, vagrants etc.; institutional inmates or all other non-
workers who do not fall under the above categories.
Occupational pattern of the concerned study area is recorded to assess skills of
people.

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Occupational pattern also helps in identifying dominating economic activity in the


area. In the study area the main and marginal workers are 86663 and 13633
respectively of the total population while the remaining 104214 constitutes non-
workers.
Table 3.41: Occupational Structure in Study Area
S. No Parameter Total Male Female
1 Main Workers 86663 54319 32344
2 Marginal Workers 13633 5582 8051
3 Non-Workers 104214 41907 62307
Total Population 204510 101808 102702
(Source: Hand Book of Statistics, Krishna District, 2011 and Census data 2011)

Figure 3.12: The Diagram Showing Occupational Structure in Study Area

3.10.5 Civic Amenities Available In The Study Area


The project site is located near Jaggayyapet – where all the basic social
amenities like, Emergency Medicare, Drinking-Water, Communications,
Educational facilities , Roads and Power supply are readily available.

A) Power and Energy:


All Villages, in the Project Study Area, are electrified – both for common facilities
like, Street Lights, Public Water Pumping, etc. and also almost all houses are
electrified for home lighting, while LPG, Kerosene Oil and in some cases Waste

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Agri-Waste, Fallen Firewood, Cow Dung Cakes, etc. are used for cooking
purpose.

B) Health and Medical Facilities:


Most Villages have PHCs or Visiting ANMs / Health Counseling-cum-Primary
Health Care Mobile Units. For Maternity and Specialist Care & basic Diagnostics,
adequate facilities are available near to project site, which is 10 km from the
proposed project site. And for Critical and Advanced Medicare & Diagnostics,
local communities visit Vijayawada City, which is about 57 km from the project
site.
Ambulance is available for emergencies to evacuate patients of serious health
condition/s to the Multi-Specialty.

C) Tele-Communications:
Telecommunication facility in the Project Study Area is adequate; BSNL
Electronic Telephone Exchange is available and BSNL / Airtel / Vodafone, Idea
Cellular & Reliance Telecom Services available everywhere.

D) Local Administration & Law:


While all the Villages and Towns do have ‘Village Panchayat’, duly elected by the
local electorates to assure Sanitation, Local Law & Order and to coordinate with
various Government Departments & Other Agencies, concerned for local
Sanitation, General Hygiene, Immunisation, Nutrition Programmes, Enhancement
of Literacy Levels and Crime / Law & Order as well as all Central and State
Governmental Developmental Projects.

E) Other Administrative Issues:


They are further supported by the Mandal Revenue Office (M.R.O.) stationed at
Jaggayyapet (6.0 km).

F) Transportation & Other Important Facilities:


The nearest Police Station, the Fire Station and Bus Station are located at
Jaggayyapet which is near to the project site and there are also Bus-Station, Bus-
Stops at Jaggayyapet to all major Towns & Cities.

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3.10.6 Corporate Social Responsibility of the Project Proponent


 Due to proposed project there is no major negative impact on socio
economic environment.
 The proposed project requires a workforce of 100 persons. Thus industrial
activity will boost up the commercial and economical status of the locality
to some extent. And, the overall impacts on socio-economic environment
due to the proposed project are positive in nature and accrue to the
community on the long-terms basis.

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CHAPTER -IV

ANTICIPATED
ENVIRONMENTAL IMPACTS
&
MITIGATION MEASURES
EIA Report Archimedis Laboratories Pvt. Ltd.

CHAPTER - IV
ANTICIPATED ENIVORNMENTAL IMPACTS
& MITIGATION MEASURES

4.1 INTRODUCTION
Environment and development should be considered as mutually Complementary,
interdependent and an instrument of reinforcing the quality of life. Environmental
Impact Assessment (EIA) is the important aspect of overall environmental
management strategy and an important tool for sustainable development. It identifies
major impacts of Industrial and associated activities on environment and provides
guideline to prepare the necessary control measure termed as Environmental
Management Plan (EMP).
The identified impacts for various components of environment viz., Air, Noise, Water,
Land, Socio-Economy, etc. are presented herewith. EIA is an activity or an attempt
to identify, predict, evaluate and communicate the likely environmental impacts of the
activity/project on the environment.
Based on results [Baseline Data] of prediction and evaluation, pollution abatement
and control measures in order to mitigate the adverse impacts on the environment
are delineated in an Environmental Management Plan
The proposed project is likely to create impact on the environment in two distinct
phases:
 During the construction phase, which may be temporary and short term; and
 During the operation phase that would have long-term effects.

4.2. INVESTIGATED ENVIRONMENTAL IMPACTS DUE TO PROPSED PROJECT


The environmental impact assessment is accomplished by identification and
prediction of impacts and their assessment. Potential impacts of proposed project on
various environmental attributes given below are predicted;
 Air environment
 Water resources and quality
 Noise levels
 Land use
 Soil quality
 Solid waste

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 Terrestrial and aquatic ecology


 Demography and socio-economics.
 Hydrology & Geology

4.3. CONSTRUCTION PHASE


During the construction phase, the activities which are likely to contribute to impact
on various environmental components which are temporary in nature are site
clearing, leveling, construction of various structures of Drug manufacturing activities,
lying of internal roads, erection of equipment etc.
The construction activities will be confined within the project area of 11.62 acres.
The environmental impacts and management plan during construction phase are
detailed below.

4.3.1 IMPACT ON LAND USE


Present land is Barren. Now the site is converting in to industrial use and the
proposed project will be in an area of 11.62 Acres (47024.47 SQM) Change will
occur on the land use pattern of the surrounding villages
Any construction of infrastructure will lead to permanent change in land use pattern
at the site as a direct impact. No major changes in land use pattern will occur due to
the project activities.

4.3.2 IMPACT ON SOIL ENVIRONMENT


The activities of proposed project will be confined within the site premises. During
construction works, top soil generated from various activities like excavation etc. will
be stored and preserved to use it during restoration period as far as possible.
The construction activities will result in loss of topsoil and earthen material to some
extent in the plant premises. However, it is proposed to use the soil and earthen
material in greenbelt development.
No solid or hazardous waste will be generated during construction thus no impact on
soil environment is likely.

4.3.3 IMPACT ON TOPOGRAPHY


The proposed site is plain terrain and during the construction phase there would be
proper leveling of the proposed site. There is no additional stress expected due to

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this project activity on topography and soil strategy of the project site and its
surroundings
Since it is a new project, changes occur in topography due to excavation of soil in
the proposed project area and construction of buildings and facilities. During
construction, excavated soil will be restored to its original shape. Thus the impact
during the construction is reversible, for short term and insignificant.

4.3.4 IMPACT ON AIR ENVIRONMENT


The sources of air emissions during construction phase will be due to development
of site, emissions from vehicles used for transportation of men and materials and
emission from construction equipment’s. These activities are likely to result in
emission of SO2, NO2, CO2 and Particulate matter. However, the quantity of these
will be very negligible and that too only for a very short period. Hence no adverse
impact on air quality is likely to occur.

4.3.5 IMPACT ON WATER ENVIRONMENT


No surface water body is located in the vicinity of the project site; hence project
related impact on water environment would mainly be limited to the groundwater
resources. The potential impacts during construction phases are assessed based on
the various activities.
● Improper disposal of construction debris may lead to off-site contamination of
water resources.
● Unaccounted disposal of domestic wastewater from temporary labour camps.
● Spillage of oil and grease from the vehicle maintenance activity and wastewater
stream generated from activities, such as vehicles washing and maintenance.

Site Workshop:
The repair and maintenance of equipments/ vehicles at site would generate waste
containing oil and grease. The wastewater stream would also be generated from
vehicle washing. The impact can be mitigated to a great extent by installing oil and
grease traps during construction phase.

Construction of Roads and Parking Areas:


The impact from the road construction depends on both the construction practices
and the type of material used. Construction waste of electrical installation, painting

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and flooring may create significant impact. This type of waste would be stock piled
and disposed off to authorized vendor.
Development of the proposed site could lead to stockpiling and excavation activity on
site, thereby causing erosion of base soil. The run-off from the site may contain high
quantity of suspended solids (SS). The impact of runoff may not be very significant
except during rainy season. Further, construction of garland drains will reduce the
runoff from the stockpiles
Domestic Wastewater generated during construction, which will be collected in
sewage collection tank [septic tank]
The contamination of groundwater might occur due to the irrational disposal of liquid
wastes. The overall impact on water environment during construction phase due to
proposed project is likely to be short term and insignificant. There seems no impact
on the water environment of the study area.

4.3.6 IMPACT ON NOISE LEVELS


Noise will be generated due to construction traffic for loading and unloading,
fabrication and handling of equipment and materials are likely to cause an increase
in the ambient noise levels. The areas affected are those close to the site. However,
the noise will be temporary and will be restricted mostly to daytime.

4.3.7 IMPACT ON ECOLOGY


The proposed project will not involve removal of any vegetation from the soil and
loosening of the topsoil generally causes soil erosion as it is. However, such impacts
will be confined to the project site and will be minimized through paving and water
sprinkling. However, 36.8% of greenbelt will be developed in the proposed project
site. The existing trees will be preserved to the extent possible. Thus, there will no
major adverse impacts are envisaged on ecological environment due to project
activities.

4.3.8 IMPACT ON SOCIO-ECONOMIC ENVIRONMENT


Due to proposed project there is no major negative impact on socio economic
environment. The proposed project will requires a workforce of 100 persons during
plant operations. Thus industrial activity will boost up the commercial and
economical status of the locality to some extent. And, the overall impacts on socio-

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economic environment due to the proposed project are positive in nature and accrue
to the community on the long-terms basis.
TABLE – 4.1: Summary – Identification Of Impacts During Construction Phase
S.No Components Aspect Potential Impacts

1 Topography & Site development No significant adverse


Geology Impacts
Construction activity
Soil leading to topsoil removal Minor negative impact
2
and erosion.
3 Landuse & Land development Positive impact
Aesthetics
 Surface runoff from
project site

 Oil/ fuel and waste spills


4 Water Quality Short term, but no
 Improper debris disposal significant negative
impact
 Discharge of sewage
from labour camp.
Dust emissions from site Short term minor
preparation, excavation, negative impact inside
5 Ambient Air Quality material handling and the site premises.
other construction No negative impact
activities at site. outside the site.
Short term minor
negative impact near
Noise generated from
noise generation sources
6 Noise construction activities,
inside premises.
operation of construction
No significant impact on
equipment and traffic.
ambient noise levels at
sensitive receptors.
Ecology Flora and Habitat disturbance during Short term minor
7
Fauna construction activity. negative impact
Increased job opportunity.
Short term positive
8 Economy related to
Socio - economy impact by employment
semiskilled expected to
generation
boom.
Haul Truck movement and
9 Traffic possibility of traffic
Minor negative impact
Pattern congestion outside site on
Sector Road
Proper disposal plan will
10 Waste will be generated
Solid Waste be implemented.
from construction activities
No adverse impact

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4.4. MITIGATIVE MEASURES OF IMPACTS DURING CONSTRUCTION PHASE


Mitigative measures of identified impacts during construction phase are listed in
tabular form.

TABLE – 4.2: Mitigation Measures During Construction Phase


S.No Components Impacts Mitigative Measures
Construction will be carried out within
the site premises; therefore no change
will occur in land use pattern as well
as there will not be any significant
Topography & No significant
Topographical change. However,
1 Geology adverse Impacts
temporary change in top layer of soil
will be occurred but the construction
activity will help in fixation of soil
thereby reducing the soil erosion

The earthen material generated during


excavations and site grading periods,
will be properly dumped and slope
stabilization shall be taken. The
Short term minor topsoil generated during construction
Land/Soil negative impact shall be preserved and reused for
2 due to change in plantations
top layer of soil
Greenbelt development will have
significant impact in reduction of the
soil erosion
The emissions will be temporary and
confined within proposed project site
boundary. It is not expected to
contribute significantly to the ambient
air quality

However, the unit will take following


Sort term negative measures for control of dust
impacts because emissions:
of dust emission
 Use of plastic cover sheet while
3 due to site
Ambient Air transporting construction material at
cleaning, road
Quality site
laying, earthwork,
 Storage of sand and other such
transportation &
dispersible material by covering with
construction
tarpaulin sheet
 Storage of sand and other such
dispersible material by covering with
tarpaulin sheet
 Keeping minimum inventory/stock of
sand and other such dispersible
material at site

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S.No Components Impacts Mitigative Measures


 The heights, from which materials
will be dropped, will be the minimum
practical height to limit fugitive dust
generation.
 Use of water sprinkling system at
site for dust suppression
 During high wind condition,
construction activities will be
restricted, so that minimum flow of
dust particle takes place.

Proposed Greenbelt development will


be started from the construction phase
 Water requirement for construction
phase will be very minor and for
short period and that will be fulfilled
by ground water source Thus, there
will not be any significant impact on
water environment
 The wastewater generation will be
from the domestic activities.
Domestic effluent will be disposed of
Short term, but no
4 through septic tank into soak pit.
significant
Water Quality  Measures will be implemented to
negative impact
prevent seepage of liquid materials
into ground where it could
contaminate groundwater and soil.
 Fence will be constructed around the
site to trap sediments whilst allowing
the water to flow through.
 All mud & dirt deposited on the roads
from the construction activities will
be cleaned.
 The noise generated from
construction machinery will be kept
low by keeping the moving parts
Short term serviced and properly lubricated.
negative impact
 The construction activity will be
due to increase
carried out during day time only.
in noise level by
 Vehicular movement carrying
5 site cleaning,
Noise materials will be avoided during night
road laying,
time.
earthwork,
transportation &  The vehicles will be regularly
construction maintained and optimum use of the
activities same will be made.
 Adequate PPE’s (ear plugs, ear
muffs helmet, mask etc) will be
provided to the workers

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S.No Components Impacts Mitigative Measures


 Greenbelt development will have
significant impact in reduction of the
noise
Short term minor
 The felling of trees will be kept at
negative impact
minimum.
6 Ecology Flora and but, long term
 Adequate Greenbelt will be
Fauna positive impact
developed.
due to green belt
development
 Temporary employment will be
Short term generated due to construction
7 positive impact activities and related services like
Socio - economy
by employment transportation of construction
generation materials, mechanical erections etc.
[25 Workers]
8 Minor negative
Traffic Pattern 
impact
Waste will be generated from
9 construction activities
Solid Waste No adverse impact
Proper disposal plan will be
implemented.

4.5. PREDICTION OF IMPACTS DURING OPERATIONAL PHASE


This phase of the project is important because it generates long-term impacts as the
production starts.
The following activities related to the operational phase will have varying impacts on
the environment and are considered for impact assessment:
 Air environment
 Water resources and quality
 Noise levels
 Land use
 Soil quality
 Solid waste
 Terrestrial and aquatic ecology
 Demography and socio-economics.
 Hydrology & Geology

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4.6 AIR ENVIRONMENT


The impacts on air quality from project depend on various factors like design
capacity, configuration, process technology, raw material, fuel to be used, air
pollution control measures, operation and maintenance. Apart from the above, other
activities associated with transportation of fuel, raw materials and finished products,
storage facilities and material handling within the plant premises may also contribute
to air pollution.

4.6.1 Source of Air Pollution


The operational phase activities are expected to have long - term impacts on the air
quality. The main sources from project are detailed below.

A. Flue gas Emissions


Boilers and DG set are the two main sources of emissions from the plant. Industry
proposes to install 8 TPH & 4 TPH coal fired boilers. A 500 KVA & 1000 KVA DG
Sets are kept as standby power during power failures.
PM, SO2 and NOx are the main air pollutants generated from the boilers and DG
sets.
The emissions from the boiler stacks and DG Set Stack are given in Table 4.3 & 4.4.

TABLE 4.3: Emission Details from Proposed Boiler Stack


8.0 TPH Coal fired 4.0 TPH Coal fired
Particulars Units
Boiler Boiler
Indian Coal with CV Indian Coal with CV
Type of Fuel -- of 4000 kcal/kg to of 4000 kcal/kg to
5000 kcal/kg 5000 kcal/kg
Coal Consumption TPD 32 16
Ash Content % 35 35
Sulphur Content % 0.4 0.4
No. of Stacks No 1 1
Height of stack M 34 30
Diameter of Stack M 0.50 0.40
o
Temperature of Flue Gas C 200 180
Velocity of Flue Gas m/s 16 14
Particulate Matter gm/sec 0.26 0.13
Sulphur dioxide emission gm/sec 2.95 1.48
Oxides of Nitrogen emission gm/sec 9.70 4.86

Note: 5 TPH Coal fired Boiler is kept as standby.

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TABLE 4.4: Emission Details from DG Set Stack


Emission Emission Emission Stack Flue Gas Stack Flue gas
Capacity
of SPM in Of SO2 in of NOx dia. Temp. in Height Velocity
In KVA
mg/Nm3 mg/Nm3 in mg/Nm3 in m O
C in m in m/sec.
500 KVA
80 150 180 0.30 220 10 16
(Proposed)
1000 KVA
120 170 200 0.35 280 10 18
(Proposed)

B. Process Emissions
The Predicted Process emissions are
 CO2, [Carbon dioxide] – Pollutant
 SO2, [Sulphur dioxide] - Pollutant
 O2, [Oxygen] – Non Pollutant
 HCl [Hydrochloric acid] - Pollutant
 NH3 [Ammonia] – Pollutant
 (CH3)2NH [Dimethylamine] – Pollutant
 HF [Hydrogen fluoride] – Pollutant
 H2 [Hydrogen] - Non Pollutant
 CH4 [Methane] - Pollutant
Which will liberate from manufacturing process of proposed products. The process
emissions are based on reactants quantity and chemical reactions between them in
relation with desired product output.

C. Fugitive emission
The main sources of fugitive emissions from project are
 Storage & Handling of raw materials
 Storage & Handling of Solvents.
 During reaction period
 During Product filtrations & Finished operations
The raw materials will be stored in PP bags, Fibre drums and HDPE drums in
elevated flat from under the roof. Bulk quantities will be stored in storage tanks with
vent condensers to avoid the fugitive emissions. Solvents are handled in closed
conditions thereby reducing the losses in the form of evaporation.

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4.6.2 Prediction of Impacts on Air Environment


The objective of dispersion modeling is to predict the ground level concentration
during the operation of plant and its impact on ambient air quality of the area.
Air quality assessment is done by integrating the measurement techniques and
modeling tools. The air modeling tools are routinely used in the environmental impact
assessments, risk analysis, emergency planning, and source apportionment studies.
Recent strategies for air pollution control in industries have largely neglected the
emission reduction measures which are the prime polluting sources. To accomplish
this, various air dispersion models have been developed and used worldwide so far
for different applications under different scenarios. The Gaussian plume model is a
standard approach for studying the transport of pollutants due to turbulent diffusion
and advection by the wind. Applications of such models have been made mandatory.
In this study, the AERMOD (the American Meteorological Society/Environmental
Protection Agency Regulatory Model Improvement Committee’s Dispersion Model,
Gaussian dispersion model is selected to predict the ground level concentrations
(GLC’s) of Particulate Matter (PM) µg/m3, sulphur dioxide (SO2) µg/m3 , and oxides
of nitrogen (NOx)- µg/m3 from point source emissions will be investigated in the
study area.

Methodology
Prediction of GLC values are made by using AERMOD software approved by U.S.
Environmental Protection Agency (USEPA) and has adopted it as its regulatory
model since 2005. In point source emissions, the stacks are subjected to plume rise
which again is dependent on force of buoyancy and momentum. The higher is the
plume rise or stack, the lesser will be ground level concentrations (GLC’s).The
emissions when released into the atmosphere are subjected to transportation,
dispersion, transformation, and fall out and wash out and finally reach the ground
level at a particular distance and concentrations. The relationship between the
source of emissions and its magnitude with the ground level concentrations (GLC’s)
at receptor points is governed by air dispersion models which take into the account
by the source strength, plume rise, atmospheric stability, mixing height, wind
velocity, terrain and other meteorological conditions. The comparison between the
predicted and field sampled downwind concentrations for PM, SO2 & NOX (µg/m3)

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will be carried out in this study to predict the average downwind ground level
concentrations (GLC’s)

Data Used for Computation


Stack emissions data have been used for prediction of short-term incremental GLC
values of PM, SO2 & NOx using the meteorological data collected at site during the
March – 2018 to May – 2018. Details of the data used for computations are given
below:

Source Characteristics/Release Characteristics


The details of estimated stack emissions load are given in Table 4.2.
Meteorological Data
The meteorological data recorded continuously during the month of March – 2018 to
May - 2018, on hourly basis. AERMOD model requires hourly surface data values for
wind speed, wind direction, temperature, relative humidity and cloud cover. Both
data files for the surface and profile files were then used to generate the
meteorological file required by the AERMOD dispersion model using the AERMET
meteorological pre-processor. This AERMET has three stages to process the data.
The first stage extracts meteorological data and assesses data quality through a
series of quality assessment checks. The second stage merges all data available for
24-hour periods and writes these data together in a single intermediate file. The third
and final stage reads the merged meteorological data and estimates the necessary
boundary layer parameters for dispersion calculations by AERMOD.

Dispersion Modeling Results


The 24 hourly average ground level concentration (GLC) values from plant have
been computed for PM, SO2 & NOx considering topographical features around the
plant and applicable stability classes. The maximum 24 hourly average GLC values
for PM, SO2 & NOx from plant are given in Table 4.5 to Table 4.6. Corresponding
isopleths plotted are shown in Figure 4.1 to Figure 4.3 for SPM, SO 2 & NOx.

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TABLE 4.5: Predicted 24-Hourly Short Term Incremental Concentrations


Maximum Incremental GLCs
Distance
Season (μg/m3) Direction
(km)
SPM SO2 NOx
Mar – 2018 to
0.759 4.694 9.47 0.5 NW
May – 2018

TABLE 4.6: Resultant Concentrations Due to Incremental GLC's


Maximum Incremental NAAQ
Resultant
Baseline Concentrations due Standards
Pollutant Concentration
Concentration to Proposed Project (μg/m3)
(μg/m3)
(μg/m3) (μg/m3)
SPM 68.88 0.759 69.639 100
SO2 15.15 4.694 19.844 80
NOx 22.33 9.47 31.80 80

With this marginal contribution due to the proposal of the project, the levels of SPM,
SO2 &NOx, will remain below the 24 –hourly ambient air quality standards for SO2 &
NOx (80 μg/m3) and PM10 (100μg/m3) prescribed by CPCB. The operation of plant is
not likely to cause any significant impact on the ambient air quality of the study area.

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FIGURE - 4.1: SHORT TERM 24 HOURLY INCREMENTAL GLCs OF SPM

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FIGURE - 4.2: SHORT TERM 24 HOURLY INCREMENTAL GLCs OF SO2

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FIGURE - 4.3: SHORT TERM 24 HOURLY INCREMENTAL GLCs OF NOX


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MITIGATION MEASURES
The industry will take measures for reduction of fugitive emissions emanating out of
process reactions by adopting the following;
 Good ventilation will be provided to reduce the workroom concentrations.
 Fugitive emissions will be reduced by providing vent condensers to the all the
reactors and Storage tanks
 Adequate stack height of 34 Mtrs & 30 mts will be provided to the 8 TPH & 4
TPH boilers respectively.
 Stack monitoring facilities for the periodic monitoring of the stack to verify the
compliance of the stipulated norms. Apart from this Cyclone Separator, Bag
filters will be provided to the boiler.

Table No.4.7 Process Emission details and mitigation measures


Quantity
S. No Name of the Gas Treatment Method
in Kg/Day
1 Carbon dioxide 270 Dispersed into the atmosphere
2 Oxygen 224 Dispersed into the atmosphere
3 Ammonia 9 Scrubbed by using Chilled water media
4 Hydrogen chloride 426 Scrubbed by using Chilled water media
5 Sulfur dioxide 312 Scrubbed by using C.S.Lye Solution
6 Dimethylamine 8 Scrubbed by using chilled water media
7 Hydrogen fluoride 5 Scrubbed by using C.S.Lye Solution
Diffused by using Nitrogen through
8 Hydrogen 35
Flame arrestor
9 Methane 15 Dispersed into the atmosphere

 In order to minimize the air pollution, unit will develop greenbelt in and around
its premises.

ODOR CONTROL
The chance of odours within premises is mainly due to
Raw materials
 Storage / Handling
 Transportation of raw materials
Process
 Raw materials transportation
 During reaction
 Drying

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ETP Operations
Storage / Handling
Storage
 Industry will provide adequate and proper storage facilities for all the raw
materials and finished products.
 Corrosive substances will be stored away from the moisture.
 Solid raw material will be stored in covered area and Liquid raw material will
be stored in closed Horizontal / Vertical tanks.
 Hazardous chemicals and solid wastes will be stored away from other plant
activities.
 The storage yard of chemicals will be isolated and it will be equipped with all
necessary measures to control odours.

Handling
 All the raw materials and finished products will be handled as per the standard
practice.
 For proper handling, company will adapt good housekeeping technology to
entire shed.
 To avoid any leakage or spillage of chemicals from all storage tanks, third
party will inspects transfer lines, valves, fittings and every joint periodically.

Transportation of Raw materials


 All the necessary precautions will be taken while carrying out transport of the
above materials as per the Hazardous Rules of transportation.
 The vehicles for transportation of raw materials and products will be parked at
specified loading facilities where there will be a provision of fire extinguishers.
 The finished product will be transported by road, rail and ship route in closed
containers.

Other sources of odour nuisance are as follows


Leaks from pressurized process equipment generally occur through valves, pipe
connection, mechanical seals or related equipment.

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Control measures
 To minimize & control leaks at process facilities operators carry out regular
leak detection test and repair activities.
 Routine inspections of process equipment with gas detectors can be used to
identify leaks & estimate the leak rate in order to decide an appropriate
corrective action.
 Proper routine maintenance of equipment reduces the likelihood of leaks.
 Solvents will be transferred through the closed pipe line system.

Cleaner production practices


Process vessels:
 Liquid raw material will be charged by pumping and closed loops and dosing
will be done by metering system to avoid odour.
 Double mechanical seals will be provided to the process vessels having
agitator for reduction of odour and leakages.

Storage tanks
 Storage tanks for products as well as raw materials will be fitted with
appropriate control devices [Condensers with chilled water circulation
systems] to avoid possible odours / leakages.

House keeping
 Keep work areas clean.
 Keep aisles clear.
 Keep exits and entrances clear.
 Use proper waste collection containers.
 Cleanup spills and leaks off’s any type quickly and properly.
 Follow up preventive predictive maintenance.

4.7 WATER ENVIRONMENT


With respect to water environment; three aspects are considered in EIA, availability
& Requirement of fresh water, Wastewater generation and its disposal.

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Fresh Water Requirement


The total water requirement for the proposed project is 259 KLD. Water requirement
of unit is met through Ground water. Unit will be bought water from private water
supplier through tankers in case of non-availability of main source [Ground water]
this will be kept as stand by source.

Waste water generation


Total effluent generation is 105.8 KLD, which is from process, scrubbers, boiler,
cooling towers and washing activities. The HTDS waste water of 52 KLD from
Process after neutralization taken for treatment in stripper followed by MEE and
ATFD. LTDS waste water of 53.8 KLD including domestic sewage, floor Washes.

Disposal of Effluent – ZLD System


Utilities waste water taken along with Vapour Condensate from MEE & ATFD for
Biological Effluent Treatment plant. Treated effluent from ETP sent to RO and RO
permeate water is recycled and RO rejects are sent to MEE followed by ATFD for
evaporation. Evaporation salts collected and sent to TSDF. MEE & ATFD vapour
condensate reused along with RO permeate.

MITIGATION MEASURES
 Effluent generated in the plant will be treated in Proposed ZLD system.
 The industry is proposing to install a MEE System with 85 KLD capacity,
Biological Treatment system of 110 KLD and RO system with 100 KLD
capacities for treatment of 105.8 KLD effluents generated from plant
operations.
 Total Water requirement is 259 KLD out of which 84 KLD recycled water
recovered from ZLD system. The fresh water of 175 KLD will be met from
Ground Water source.
 The leakages of oil spills from machinery shall be collected in leak proof
barrels and then disposed off to SPCB authorized dealers.
 The groundwater levels need to be monitored with setting up of piezometers
in the core and buffer zone.

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 Unit is proposed to recharge ground water through roof water harvesting pits
in the project area and rain water harvesting pits outside plant area wherever
possible to balance the water table.
 Minimization of water use providing drip system for gardening.
 Use of high-pressure hoses for cleaning the floor and process equipment to
reduce the amount of wastewater generated during washings.
 Conjunctive use of groundwater.

4.8 NOISE ENVIRONMENT


PREDICTION OF IMPACT
Identification of potential impacts on noise environment from the proposed project is
as important as other components of the environment. The main sources of noise
pollution are Boiler, Reactors, DG Set, Air compressors, and other Noise generating
units. Vehicular movements during operation phase for loading / unloading of raw
materials and finished products and transporting activity may also increase noise
level. Noise levels in the ambient air are well within the permissible limits given by
the National Ambient Noise level standards as confirmed during baseline study. Leq
values of the noise levels within the plant premises will be kept less than 75 – 70 db
[A] [during day time and night time] which will be within the permissible limit.

MITIGATION MEASURES
To minimize the noise pollution the unit proposes the following noise control
measures,
 Noise suppression measures such as enclosures, exhaust mufflers, buffers
and / or abatement measures that will be implemented.
 Employees will be provided with earplugs or earmuffs.
 Extensive oiling, lubrication and preventive maintenance will be carried out for
the machineries and equipments to reduce noise generation.
 Green Belt Development.

4.9. LAND/ SOIL ENVIRONMENT


IDENTIFICATION OF IMPACTS
Infrastructural development for the proposed project as well as subsequent
developments in the nearby area may change the land use pattern of area.

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The impact on land and soil environment may be due to effluent disposal, chemical
and hazardous waste storage & handling. Spillage of chemicals during loading,
unloading and transfer, leakage of pumps, flange leakage in pipelines may create
soil/land contamination.

PREDICTION OF IMPACTS
 The Proposed project will be carried out within the acquired land premises; there
will not be any change in land use pattern, forest cover or vegetation in
surrounding area. Moreover, electricity, water, roads, all basic amenities and
infrastructure are already available in the area.
 There will not be any disposal of untreated effluent on land. Industrial wastewater
will be properly treated and reuse in various activities within the premises.
 Spillage of chemicals during loading, unloading and transfer, leakage of pumps,
flange leakage in pipelines may create soil/land contamination. However, the
regular maintenance of pumps and flange connections in the pipelines will be
carried out and proper care will be taken while loading, unloading and transfer of
materials to avoid any soil/land contamination.

MITIGATION MEASURES
 During operational phase, the chances of any enhanced soil erosion are not
anticipated. But improper disposal of toxic wastes and accidental spillages of
toxic chemicals can pose a serious threat to the soil, ground and surface waters.
But the chances of such events cannot be quantified and predicted. Since the
industry is expected all rules and regulations relating to the use, handling and
disposal of all toxic and hazardous chemicals, no additional safety methods are
required especially to prevent contamination of soil.
 Liberal use of locally available farmyard manure will be used for the plants in the
greenbelt and block plantations for improving the productivity, fertility and health
of soils.
 In case of any spillage, the same will be collected and treated in ETP. The unit
will provide an adequate designated storage area with impervious flooring system
and roof cover with leachate collection system for the storage of hazardous
wastes.

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 Leachate, if any will be collected and treated in ETP. Thus, there will not be any
chances of contamination of soil due to the storage of chemicals and hazardous
waste.
 The hazardous waste generated will be stored and handle as per the Hazardous
Wastes (Management, Handling and Transboundary Movement) Rules, 2016
 The project does not have any impact on the soils beyond the boundaries of the
project site since it is a zero liquid discharge unit. Physicochemical characteristics
of the soil samples obtained from 7 areas in the buffer zone and one from the
project site reveals that all basically sandy loams.

4.10. IMPACT OF SOLID WASTE


The details of hazardous waste to be generated from the proposed project, is
mentioned at Chapter -2. The current practice of storage of generated hazardous
waste, in a closed room having an impervious bottom, and disposed of as per the
prescribed guidelines will be continued for the generation of hazardous waste.
Hence, the impact due to the same will be negligible as the handling of hazardous
waste to be generated will be disposed as per guidelines. The details of
solid/Hazardous waste details are shown in below Table. The ash from boilers will be
used in the brick manufacturing. The ash of 0.5 µm to 45 µm will be used in the
cement manufacturing as a filler material, stabilization of soft soils, mineral filler in
asphaltic concrete, floor and metal castings etc.

MITIGATION MEASURES
To reduce the quantity of solid / hazardous waste generation as well as possible
contamination of land (soil) due to spillages / leaks from the plant operations,
following

Mitigation measures can be implemented:


 There will not be any leakages / spillage from the raw-materials storage and
from the storage of generated effluent from the project.
 The generated Hazardous waste will be stored on floor with suitable packing
and this dedicated area will be covered with the roof.

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 The records on quantity of hazardous waste generation and disposal will be


maintained for each category and possibilities will be explored for
minimization and reuse.
 Classification of waste, Collection, Storage, Transportation, & disposed/sale
to authorized recycler or re-user.
 Data Management and Reporting
 Personnel Training
 Solid/Hazardous Waste Generation and Disposal mode

Table No.4.8 Hazardous & Solid Waste Disposal Details


Name of the
S. No Quantity Disposal Method
Hazardous Waste
1 Organic Solid Waste 3757 Kg/Day
2 Spent Carbon 108 Kg/Day
3 Solvent distillation residue 1174 Kg/Day
Sent to Cement Industries
Organic Evaporate liquid from
4 1040 Kg/Day
MEE stripper
5 Mixed Solvents 3933 Kg/Day
6 ETP Sludge 1000 Kg/Day
7 Inorganic solid waste 366 Kg/Day Sent to TSDF
8 MEE Salts 4954 Kg/Day
1000 SPCB Authorized Agencies
9 Used Oils
Ltrs/Annum for Reprocessing/Recycling
After Detoxification sent back
1000
10 Detoxified Containers to suppliers/sent to outside
No’s/Month
Parties
Send back to suppliers for
11 Used Lead Acid Batteries 9 No’s/Year
buyback of New Batteries
Solid Waste Details
16800
12 Ash from boiler Sent to Brick Manufacturers
Kg/Day

4.11. IMPACTS ON ECOLOGY


Prediction of impacts is based both on the direct and indirect; short-term as well as
long-term; irreversible and irreversible impacts that are most likely to occur owing to
the industrial activity during establishment and operation. The ecological factors that
are considered most significant as far as the impact on flora and fauna are
concerned:
1. Whether there shall be any reduction in species diversity.
2. Whether there shall be any habitat loss or fragmentation.

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3. Whether there shall be any risk or threat to the rare or endangered or


endemic or threatened (REET) species.
4. Whether there shall be any impairment of ecological functions such as (i)
disruption of food chains, (ii) decline in species population and or (iii)
alterations in predator-prey relationships.

NEGATIVE IMPACTS
As there is change in the land use and land cover on account of the proposed
project, the proposed action is not going to have any direct and significant negative
impacts of flora and fauna or biodiversity.

MOST PROBABLE SCENARIO


As stated earlier, it is a new project there will be change in the land use and land
cover within the project site. No damage is going to be done to the existing green
cover within the project site. Except for a few weeds, there are only cultivated plants
and no RET species in the core area. No species is going to be lost on account of
the proposed project. No direct or indirect damage is expected to the flora and fauna
of the buffer zone. Further, as there are no rare or endangered or endemic or
threatened (REET) species, the project does not pose any threat to the flora and
fauna of the study area. As the industry is required to operate and maintain the
emissions and effluents within the limits specified by the CPCB / SPCB, the effects
of the industry on the flora and fauna of the buffer zone may be negligible. Neither
the storm water nor the effluent water nor any other kind of rain or waste water from
the industry shall get in to the drinking water resources.

MITIGATION MEASURES
Extensive plantation and green area development of 4.27 Acres is planned in the
proposed project along with landscaping. This is hereby ensured that the mostly
indigenous/local plants will be planted all around the periphery of the project area
and along the compound wall sides. Plantations would be of large leaf trees that
provide adequate shade and are semi evergreen to evergreen. Various native and
indigenous trees would be planted for mitigation purpose

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4.12. IMPACTS ON SOCIO- ECONOMY


During the erection phase short term direct or indirect employment will be
generated. Project Proponent shall give first preference to the Local people wherever
found suitable for all the jobs in the plant operations. Economic status of the local
people will improve due to the increased employment & business opportunities,
thereby, making a positive impact to the Local Economy. Educational, medical and
housing facilities in the study area will considerably improve. Thus, the proposed
project will have significant positive impact on the socio-economic environment.

MITIGATION MEASURES
 Due to proposed activity the employment generation will be around 100
persons including, skilled, semi-skilled & unskilled labour and office staff.
Local qualified personnel can be employed.
 Under CSR & CER Budget, the proponent has allotted 135 lakhs to take up
Environment & welfare activities.

4.13. IMPACTS ON HYROLOGY & GEOLOGY


 The generation of ash from the industry will have sedimentation affect over
the wind ward side on the soil regime as well as the buffer zone over a period
of time affecting the Green cover/ plantation thereby affecting the growth of
plants / crops.
 The chemically loaded waste water leakage from the industry will adversely
affect the soil, surface and groundwater.

MITIGATION MEASURES
 Ash generation and storage will be monitored closely to avoid leakages and
will be disposed safely to the brick manufacturing industries and infrastructure
projects.
 The ash spreading in and around the plant will be avoided by storing under
closed conditions at dedicated place till it is disposed to users. The prevention
suggested is not to allow the waste water leakage from the industry by
implementing proper storage tanks for wastewater collection and ZLD system.

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CHAPTER -V

ANALYSIS OF
ALTERNATIVES
(TECHNOLOGY & SITE)
EIA Report Archimedis Laboratories Pvt. Ltd.

CHAPTER – V
ANALYSIS OF ALTERNATIVES
(TECHNOLOGY & SITE)

5. ANALYSIS OF ALTERNATIVES
This chapter deals with the criteria for site selection and process technology in the
proposed project by assessment of alternatives and comprehensive comparison of all
potential impacts, both direct and indirect and cumulative, on the environment. The goal
of evaluating alternatives is to find the most effective way of meeting the need and
purpose of the proposal.

5.1. SITE SELECTION CRITERIA


SITE LOCATION: To establish a Bulk drug Intermediates manufacturing, the site is
selected at Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet (M), Krishna District,
Andhra Pradesh based on these factors Practicability, Feasibility, Relevance,
Reasonable & Viability.
TABLE – 5.1 SITE DESCRIPTION
Project location Details
Latitude: 16°50'51.19"N
Latitude & Longitude
Longitude: 80°08'11.93"E
Annual Max Temp is 47.1 0C
Climatic Conditions Annual Min Temp is 9.3 0C
Normal Annual Rainfall is 982 mm
(Source: IMD Climatatological Normals, 1981 - 2010)
Land acquired for the plant 11.62 Acres (47024.47 Sq.m)
Land use Industrial use
Nearest Habitation Jayanthipuram Village 1.80 km (WNW)
Major urban Settlements Vijayawada - 58 km (SE)
Nearest Highway National Highway No.65 – 4.45 km (N)
Nearest Railway station Motumuri Railway Station – 22.6 km (NE)
Nearest Airport Vijayawada Airport - 77 km (SE)
National Parks None within 10 km radius
Wild life sanctuary None
Palleru River – 3.30 kms (W)
Krishna River – 3.30 kms (SSW)
Nagarjuna Sagar Left bank Canal- 2.50 kms (E)
Water Bodies within 10 km radius
Chillakallu Major canal - 2.10 km (WNW)
Gauravaram Cheruvu – 5.40 kms (E)
Pochampalli Cheruvu – 3.38 kms (ESE)

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Konakachi Cheruvu – 5.51 kms (ESE)


Nawabpeta Cheruvu – 9.53 kms (ESE)
Water body near Jaggayyapet – 5.54 kms (NW)
Tank Near Chillakallu – 4.57 kms (N)
Tank near Shermohammedpet – 8.55 kms (NNW)
Jaggayyapeta Extension R.F – 0.52 KM (S),
0.39 KM (N) of Project Site
Kuntimadi R.F- 5.12 km (SSW)
Reserve Forest within 10 km radius
Ginjupalle R.F- 5.60 km (SSW)
Venkatayapalem R.F- 7.80 km (SSW)
Budavada R.F- 4.68 km (W)

The proposed project site is identified based on the following considerations:


 Land acquired for proposed Project is 11.62 Acres (47024.47 Sq.m),
topographically the area is generally plain, with gentle slope.
 The area is not covered by any notified forests.
 Proximity of National Highways and railways stations, for transport of raw
materials and manufactured products.
 Availability of infrastructure facilities.
 Well connected road networks.

The location of the site have distinct advantages such as accessibility to Road, Rail,
Electricity, Ground water and other facilities which are adequate for the proposed
project and hence, no alternate sites were considered.

5.2. SELECTION OF PROCESS TECHNOLOGY


 Proposed to manufacture different types of bulk drugs & intermediates.
 All the products will be manufactured on a batch basis.
 The products are categorized on similarity in process or therapeutic usage.
 Bulk Drugs substances typically consist of structurally complex organic chemical
compounds which are manufactured via a series of intermediate steps and
reactions under precise process conditions.

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The drug intermediates are manufactured by:


 Chemical synthesis;
 Isolation / recovery from natural sources; and /or
 Combination of above.
In the proposed project, resource availability may limit the range of alternatives in a
particular context. Bulk drug Intermediates will be manufactured using proven Chemical
synthesis technology; hence no alternative technology has been analyzed thus, no new
or untested technology will be used.

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CHAPTER -VI

ENVIRONMENTAL
MONITORING PROGRAM
EIA Report Archimedis Laboratories Pvt. Ltd.

CHAPTER – VI
ENVIRONMENTAL MONITORING PROGRAM

6.1. INTRODUCTION
Regular monitoring of environmental parameters is of immense importance to assess
the status of environment during plant in operation. With the knowledge of baseline
conditions, the monitoring programme will serve as an indicator for any deterioration in
environmental quality due to operation of the expansion project, to enable taking up
suitable mitigatory steps in time to safeguard the environment. Monitoring is as
important as that of control of pollution since efficiency of control measures can only be
determined by monitoring.

The baseline study is carried out for post monsoon season. Hence, post project
monitoring programme of the environmental parameters is essential to take into account
the changes in the environmental quality to ascertain the following:
 State of Pollution within the plant site and in its vicinity.
 Generate data for predictive or corrective purpose in respect of pollution.
 Examine the efficiency of air pollution control system adopted at the site.
 To assess environmental impacts.
Monitoring will be carried out at the site as per the norms of CPCB.
Environmental Monitoring Programme will be conducted for various environmental
components as per conditions stipulated in Environmental Clearance Letter issued by
MoEF&CC & Consent to Operate issued by SPCB. Six monthly compliance reports will
be submitted on regular basis, to MoEF&CC, Regional Office, Chennai on 1st of June &
1st of December. Quarterly compliance Report for conditions stipulated in Consent to
Operate will be submitted to SPCB on regular basis.

6.2. ENVIRONMENTAL MANAGEMENT SYSTEM


In order to maintain the environmental quality within the standards, regular monitoring of
various environmental components is necessary. The company will establish full-
fledged environmental management cell (EMC) reporting directly to Plant Manager for

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environmental monitoring and control. The EMC team will takes care of pollution
monitoring aspects and implementation of control measures.
A group of qualified and efficient engineers with technicians is deputed for maintenance,
up keeping and monitoring the pollution control equipment, to keep them in working at
the best of their efficiencies. For effective and consistent functioning of the plant, the
EMS at the site will be strengthened further with the following:

• Environmental management cell covering EHS (Environment, Health & Safety) team
• Environmental Monitoring
• Personnel Training
• Regular Environmental Audits and Corrective Action Plan
• Documentation – Standard operating procedures, Environmental Management plans
and other records

6.3. ENVIRONMENTAL MANAGEMENT CELL RESPONSIBILITIES


It is necessary to have a permanent organizational set up charged with the task of
ensuring its effective implementation of mitigation measures and to conduct
environmental monitoring. The major duties and responsibilities of Environmental
Management Cell will be as under:
 To implement the environmental management plan (EMP)
 To ensure regulatory compliance with all relevant rules and regulations
 To ensure regular operation and maintenance of pollution control devices
 To minimize environmental impacts of operations by strict adherence to the EMP
 To initiate environmental monitoring as per approved schedule
 Review and interpretation of monitored results and corrective measures with
reference to prescribed standards
 Maintain documentation of good environmental practices and applicable
environmental laws for ready reference.
 Maintain environment related records.
 Coordination with regulatory agencies, external consultants, monitoring
laboratories.

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 Organising meetings of the Environmental Management Committee and


reporting to the committee.
To improve the capacity building of the Environment Department, as a part of the
management, a separate division will be created under the leadership of Plant Manager,
who is assisted by EHS - Manager will be working for day to day operation of
environmental management systems with documentation, procedures & Compliances.
All executives/Supervisors and workmen/Helpers will be responsible for the operations.
The Organizational Structure of Environmental Health and Safety is presented in Fig.
6.1.
Any non-compliances/violations of serious nature will be addressed by the Plant general
manager in consultation with the directly involved officials and will report to the Board of
Directors of the company. The primary focus is to comply with the regulations and work
out on action taken report to be placed before the Board of Directors. Similarly a
preventive action for non-recurrence of such violations/non-compliances will also be
worked out and strict monitoring will be done by the Management for implementation of
the same

Fig - 6.1. Organisational Structure of Environment Health & Safety

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6.4. ENVIRONMENTAL MONITORING AND REPORTING PROCEDURE


Monitoring may take the form of direct measurement and recording of quantitative
information, such as concentrations of discharges, emissions and wastes, for
measurement against corporate or statutory standards, consent limits or targets. It may
also require measurement of ambient environmental quality in the vicinity of a site using
ecological/biological, physical and chemical indicators. Monitoring may include
socioeconomic interaction, through local liaison activities or even assessment of
complaints. Monitoring will also be required to meet compliance with statutory and
corporate requirements. Finally, monitoring results will provide the basis for auditing.

6.4.1. OBJECTIVES OF MONITORING


The objectives of environmental post-project monitoring are to
 Verify effectiveness of planning decisions
 Measure effectiveness of operational procedures
 Confirm statutory and corporate compliance and
 Identify unexpected changes.

6.4.2. MONITORING SCHEDULE FOR CONSTRUCTION AND OPERATION PHASES


Environmental monitoring schedules of Archimedis Laboratories Pvt. Ltd are prepared
covering various phases of project advancement, such as construction and operation
phases.

Construction Phase
The proposed project envisages setting up of buildings and machinery, establishment of
production and storage facilities. The construction activities are expected to last for
about one year. As there are no major construction activities for the plant, simple and
generic environmental monitoring measures that need to be undertaken during project
construction stage.

Operation Phase
During operation stage of the project, air emissions from process areas, Boilers,

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DG sets. Full-fledged Effluent treatment plant with ZLD Scheme operates for water
recovery and reuse, hazardous and nonhazardous waste generation is envisaged. The
following attributes which meet regular monitoring based on the environmental setting
and nature of project activities are listed below:
 Source emissions and ambient air quality.
 Work zone monitoring for VOCs/solvents in air.
 Groundwater levels and ground water quality in bore wells.
 Raw and ETP effluent quality.
 Hazardous and solid waste characterization (process hazardous waste, ash,
ETP sludge, used and waste oils).
 Soil quality.
 Noise levels (equipment and machinery noise levels, occupational exposures
and ambient noise levels) and
 Ecological preservation and afforestation.

Monitoring Schedule: Details of the Post Project Environmental Monitoring schedule,


which will be undertaken for various environmental components, are detailed below:

Table No.6.1 Post Project Environmental Monitoring schedule details


Sl. No. Description Frequency of Monitoring
1 Ambient Air Quality at Plant site Once in a month
2 Water Quality Monthly Basis
3 Noise Level Monitoring Monthly Basis
4 Soil Quality Once in six months

Methodology Adopted: Post project monitoring will be carried out as per conditions
stipulated in Environmental Clearance Letter issued by MoEF&CC, Consent issued by
concerned State PCB as well as according to CPCB guidelines. The plant site is
considered as core zone and the area lying within 10 km radius from the plant site is
considered to be the buffer zone. In the Buffer zone slight impact may be observed and
that too is occasional.

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Table No. 6.2 Environmental Monitoring Plan during Operation Phase


Action to be Parameters for Frequency of
Sl. No Potential Impact
Followed Monitoring Monitoring
Stack emissions
Gaseous
from Monthly with
emissions
process stacks to recommended
(HCl, SO2, NH3,
be optimized and methods of CPCB
as applicable)
monitored
Stack emissions Gaseous
Monthly with
from Boilers, DG emissions
recommended
sets to be (PM, SO2, HC,
methods of CPCB
monitored NOx)
Ambient air quality
within the plant
premises of the
Ambient air quality
proposed
will conform to the
1 Air Emissions expansion unit and Online continuous
standards for
nearby habitations AAQ one station
NAAQ parameters
to be monitored. and Monthly in
(MoEF circular
Exhaust from Industry and
dated 16-11-
vehicles to be nearby habitants
2009) and HCl, Cl2
minimized by use with recommended
and HC Vehicle
of fuel efficient methods of CPCB.
logs to be
vehicles and well
maintained
maintained
vehicles having
PUC certificate.
Vehicle trips to be
minimized to the Vehicle logs Daily records
extent possible
Noise generated
from operation of
boiler/cooling
towers to be
optimized and
monitored (3
Spot Noise Level
locations within
recording; Regular and
plant and 2
Leq(night), Monthly
2 Noise Levels locations outside
Leq(day), Leq(dn)
plant) Noise
generated from
operation of DG
sets to be
optimized and
monitored
Generation of Maintain records of
Monthly
vehicular noise vehicles
Segregated ETP performance Daily with internal
Waste water
3 effluent Stream will be monitored lab and monthly
Discharge
wise (3 streams) for raw and treated from authorized lab

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Action to be Parameters for Frequency of


Sl. No Potential Impact
Followed Monitoring Monitoring
effluent
characteristics for
reuse of treated
effluent.
Basic parameters
like pH, TSS, TDS,
COD, Oil & grease
In-house ETP Daily monitoring at
treated Effluents pH, TDS, COD and In house
reuse in Cooling Temperature etc. Laboratory for
Towers treated effluent
Ensure drainage
Drainage and system and Visual inspection
4 effluent specific design of drainage and Daily
Management measures are records thereof
working effectively.
Surface and
Comprehensive
Groundwater
5 Water Quality monitoring as per Quarterly
quality surrounding
BIS 10500-2012.
plant site
Contaminants such
as VOCs to be Indoor monitoring
Work zone
6 reduced by of On Daily Basis
air quality
providing adequate VOCs.
ventilation
Implement waste
management plan
that identifies and
characterizes
every waste arising
Records of solid
Hazardous / associated with Regular Basis
waste generation,
7 Solid Waste proposed activities during operation
storage and
Management and which phase
disposal
identifies the
procedures for
collection, handling
& disposal of each
waste arising.
3 locations within
plant site, solid
Physico-chemical On regular basis
waste storage
8 Soil quality parameters and (Once in six
area, near
Heavy metals. Months)
production block
and ETP area
Employees and All relevant
Occupational migrant labour parameters Once in a Year
9
Health health check -up including HIV
 Comprehensive Pre-employment medical checkup for all

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Action to be Parameters for Frequency of


Sl. No Potential Impact
Followed Monitoring Monitoring
employees.
 Medical examination will be done for all the employees
once in a year.
 Tie up with local hospitals and Govt. health monitoring
system will be engaged during emergency.
 Dispensary and ESI facility will be provided to all workers
as applicable.
 All safety gears will be provided to workers and care will
be taken by Environmental Management Cell (EMC) that
these are used properly by them. All safety norms will be
followed.

6.5. LOCATION OF MONITORING STATIONS


Location of the monitoring stations will be selected on the basis of prevailing micro –
meteorological conditions of the area like; Wind direction & wind speed, Relative
Humidity, Temperature. Post project air quality monitoring will be carried out at plant site
and 2 locations (one each in upwind and downwind direction) to asses’ ambient air
quality of the area. Major surface water body lies within 10 km area of plant site and
ground water quality monitoring will be carried out. Regular monitoring of noise will be
done to control noise levels at plant site. Soil quality will be tested of the plant site area
regularly to keep check on any leakage in storing hazardous waste. Locations for the
post project monitoring will be as under:

Table No.6.3 Details of Post Project Monitoring Locations


Sl. No. Description Location of Monitoring
Plant site, Villages in upwind & downwind direction
Ambient Air
1 (with Max. Ground level concentration) from the plant
Quality
site
Noise Level Plant Boundary, High Noise generating areas within the
2
Monitoring plant boundary
From Nearby Surface water Source and Ground Water
3 Water Quality
Source
4 Soil Quality At plant Site and Nearby area

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6.6. MONITORING AND DATA ANALYSIS


6.6.1. AIR QUALITY MONITORING AND DATA ANALYSIS
Stack Monitoring: The emissions from all the stacks will be monitored for exit gas
temperature, velocity and pollutant concentrations. Any deviation from the design
criteria will be thoroughly examined and appropriate correction will be initiated. Air
blowers will be checked for any drop in exit gas velocity. The monitoring will be done by
authorised laboratory and test result will be submitted to the SPCB.

Work Zone Monitoring: The concentration of air borne pollutants in the


workspace/work zone environment will be monitored periodically. If concentrations
higher than threshold limits are observed, the source of fugitive emissions will be
identified and necessary measures taken. In addition, industry will continue to monitor
the VOC in all process & storage areas on regular basis. In case, the levels are high,
suitable measures as detailed in EMP will be implemented.

Ambient Air Quality Monitoring: The concentrations of PM, SO2, NOX, VOC, CO and
HC in the ambient air will be monitored at regular intervals. In case of any excess
concentration in the ambient air quality due to the proposed production enhancement,
proponent will take necessary action and follow the air pollution control measures.
Greenbelt will further be developed for minimising dust propagation. The ambient air
quality data will be transferred and processed in a centralised computer facility
equipped with required software. Trend and statistical analysis will be carried out as per
the CPCB guidelines.

6.6.2. WATER AND WASTEWATER QUALITY MONITORING AND DATA ANALYSIS


To ensure a strict control over the water consumption, flow meters will be installed for
existing and proposed facilities for all major inlets in expansion. All leakages will be
identified and rectified. In addition, periodic water audits will be conducted to explore
possibility of water conservation.
Industry will analyse the basic parameters and the procedures prescribed in "Standard
Methods for Examination of Water and Wastewater" prepared and published jointly by
American Public Health Association (APHA), American Water Works Association

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(AWWA) will be followed for all the parameters of monitoring. As per the CPCB
guidelines, industry will be installed the online sensors in the treated effluent for pH,
Conductivity, DO with night vision cameras.

Surface and Groundwater Monitoring: The monitoring of Surface and groundwater is


the most important tool to know the variations from the baseline study. This is
indispensable as it provides detection of the presence of waste constituents in ground
water in case of leachate migration. In this project, chances are very less for leachate
as the total effluent is segregated and is sent to ETP – ZLD and the treated effluent will
be reused in cooling tower. The water samples from the nearby surface water bodies
and bore wells will be analysed for relevant parameters as per monitoring program.
Records of analysis will be documented.

Monitoring of Wastewater Streams: All the segregated wastewater streams will be


regularly measured for flow rate, physico-chemical, nutrient & demand parameters. The
monitoring will be carried out from stream wise raw wastewater, raw and treated effluent
characteristics of ETPs before recycling to utilities. These data will be documented and
compared against the design performance values of ETPs for necessary corrective
action.
The ETP will be operated and maintained by existing & additional skilled and dedicated
personnel. Daily log sheets for no. of hours of the ETP operation, chemicals, electrical
and steam consumption; effluent monitored parameters with their results, etc. will
continue to be maintained.

6.6.3. NOISE LEVELS


Noise levels in the work zone environment such as boiler house, cooling tower area,
and DG house will be monitored. The frequency will be once in a month in the work
zone. Audiometric tests will be conducted periodically for the employees working close
to the high noise sources.

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6.6.4. SOIL QUALITY


Soil quality will be tested for the parameters given in schedule for every six months.

6.7. REPORTING SCHEDULES OF THE MONITORING DATA


It is proposed that voluntary reporting of environmental performance with reference to
the EMP will be undertaken. The environmental monitoring department will co-ordinate
all monitoring programmes at site and data thus generated will be regularly furnished to
the State regulatory agency. The frequency of reporting will be on monthly basis to the
local state PCB officials and six monthly reports to Regional Office of MoEF&CC. The
Environmental Audit reports will be prepared for the entire year of operations and will be
regularly submitted to regulatory authorities in Form V Environmental Statement.

6.8. ENVIRONMENTAL LABORATORY


Environmental laboratory will be well-equipped analytical instruments and consumable
items for monitoring of environmental parameters at the site. Alternatively, monitoring
will be continued to be outsourced to a recognized/approved laboratory. The equipment
and consumable items will be made available at the site for environmental monitoring.
The sampling is done as per the standard procedures laid down by IS: 2488. The
equipment’s will be in the Environmental Laboratory are Heating Mantle, Digital
conductivity meter, Digital pH Meter, COD Digestion Apparatus, BOD Incubator, Hot air
oven, Muffle Furnace, Thermometer, Microprocessor based conductivity meter,
Microprocessor based pH Stat Analyzer, Electronic Balance, HOT Plate, Mechanical
Balance, Hand Held DO meter, Hand Held Turbidity meter, Magnetic Stirrer and
consumables, chemicals and Glassware.

6.8.1. AIR QUALITY AND METEOROLOGY


Proposed: Manual AAQ monitoring stations – 3 Nos., on monthly basis third party
monitoring will be done by NABL / MoEF&CC authorised laboratory and the test report
will be verified for any deviation in air quality standards for corrective action and the test
reports will be submitted to the respective SPCB.

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6.9. OCCUPATIONAL SAFETY AND HEALTH ASPECTS


All the preventive and corrective actions of environmental impacts to protect the health
of all the employees from any possible occupational health problems, the periodical
medical and health checkups of all the employees will be done to assess the any
occupational health problems.

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CHAPTER -VII

ADDITIONAL STUDIES
EIA Report Archimedis Laboratories Pvt. Ltd.

CHAPTER – VII
ADDITIONAL STUDIES

[Risk Assessment, & Disaster Management]

Archimedis Laboratories Pvt Ltd is proposed to manufacture Bulk Drugs &


Intermediates at survey no‘s. 108 &109, Jayanthipuram (v), Jaggaiahpet, Krishna
District, Andhra Pradesh and is covered under Category- A of the EIA Notification –
2006. The Environmental Public Hearing was conducted on 27/10/2018 in
Jayanthipuram village, Jaggayyapet Mandal, Krishna District, Andhra Pradesh. The
Public Hearing paper ads, PH Minutes and its compliance Report are enclosed as
enclosures.

7.1 ADDITIONAL STUDIES


In order to support the environment impact assessment and environment
management plan, following additional studies have been included in this report.
 Risk Assessment
 Disaster management plan
 Occupational Health

7.1.1 Scope Of This Study


The QRA (Quantitative Risk Assessment) study in this report has been conducted
considering the Terms of References (TORs) given for Environment Clearance (EC).
The study has been carried out with a view to comply TOR points with respect to
Risk assessment.

7.1.2 Methodology:
 The following parameters are considered to prepare Quantitative Risk
Assessment.
1. Discussions were held with Plant officials on proposed individual safety
systems of plant operations.
2. Hazard Identification exercise in coordination with plant officials was
conducted taking into consideration the proposed storage of Hazardous
Chemicals/Solvents, operating parameters and proposed safety systems.

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3. Containment failure scenarios related to flammable chemicals & hazardous


chemicals have been considered for Risk Assessment and consequences in
detail. Thus, this study is mainly oriented towards acute risks rather than
chronic risks.
4. Discussed on proposed Raw materials Hazards and their Risks in handling.

7.2 Risk Assessment


Archimedes laboratories Private Limited will handle various chemicals, some of
which are hazardous in nature by virtue of their intrinsic chemical properties or their
operating temperatures or pressures or a combination of them. Fire, explosion, toxic
release or combinations of them are the hazards associated with industrial plants
using hazardous chemicals. More comprehensive and systematic methods have
been adopted in Hazard Identification and Quantitative Risk Assessment to improve
upon the integrity, reliability and safety of the plants. The same has been discussed
in detail under their respective headings.

7.2.1 Objectives of Risk Assessment


Risk analysis follows an extensive hazard analysis. It involves the identification and
assessment of risks the neighboring populations are exposed to as a result of
hazards present. This requires a thorough knowledge of failure probability, credible
accident scenario, vulnerability of population etc., much of this information is difficult
to get or generate. Consequently, the risk analysis is often confined to maximum
credible accident studies.
The risk assessment process is primarily based on likelihood of occurrence of the
risks identified and their possible hazard consequences particularly being evaluated
through hypothetical accident scenarios. With respect to the Proposed project, major
risks are leaks from storage tanks, rupture of Pipelines, Spillages from containers
during transfer operations and Storage in the Ware house have been assessed. Risk
associated with the flammable chemicals storages have been determined semi-
quantitatively as the product of likelihood/probability and severity/consequence by
using order of magnitude data (risk ranking = severity/consequence factor X
likelihood/probability factor). Significance of such project related risks have been
established through their classification as high, medium, low, very low depending
upon risk ranking.

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It provides basis for:


 The type and nature of its on-site and off-site emergency plan
 The types of safety measures required

7.2.2 Identification Of Hazards


 Hazard identification is carried out to ascertain the controls required and
available in order to mitigate the risk of exposure to the hazards. This would
substantially help in overcoming costly errors and prolonged delays that may
be caused due to the design changes that may be required on a later date.
 Hazard assessment in the proposed plant is carried out examining the Liquid
and solid chemicals storage in the ware house such as Hydrobromic acid,
Sulfuric acid and toxic chemicals such as Thionyl chloride, Ammonia and solid
chemicals such as sodium boro hydride, potassium hydroxide and Storage of
Flammable liquid chemicals such as Methanol, Toluene, Acetone, THF, Ethyl
Acetate, n-hexane in bulk quantities in plant premises, locations to find out the
adequate facilities in place to overcome the Risks of exposure to the Hazards.

Following are the Hazards identified in proposed plant activities:


 Fire Hazards due to Flammable chemicals leakage from storage tanks, pipe
line ruptures during transfer of material which may get ignited due to any
spark.
 Fire Hazard due to improper earthing of storage tanks and material transfer
lines
 Fire hazard due to leakage of flammable chemicals from transfer pumps gland
leaks.
 Spillage/Leakage of Hazardous chemicals - Solvents, Acetic acid, Hcl,
Formaldehyde, Hcl, Thionyl chloride which leads to Air pollution, Water
pollution and Ground pollution
 Explosion Hazard during hydrogenation to manufacture 2, 4- DIHYDRO-4-(4-
4 HYDROXY PHENYL) -1-PIPERAZINYL) – 2-(1-METHYL PROPYL)-3H-1, 2,
4-TRIAZOLE-3-ONE.
 Ammonia leakage during transfer to reactors or container leakage.

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The exposure to hazards depends upon the concentration of hazard, Frequency and
duration. The exposure to hazard could be controlled by reducing either the
concentration of hazard, frequency or duration.
After a critical analysis of the chemicals propose to use, stored and for products to
manufacture a defined safe operating procedures will be in place with safety and
mitigation measures to overcome the hazards.
The exposure to the hazard could be controlled by implementing the following:
Engineering controls at the source
Environmental controls that remove the hazard from the environment
Inspection of solvents transfers pipelines & Hydrogen gas conveying lines once in a
month.
Earthing to all storage tanks and providing jumpers to transfer pipe lines to have
continuity of earthing
Process reactor which is proposing to use for hydrogenation should be kept away
from production block to minimize the effect in case of explosion.
Providing suitable personal protective equipment
Employing experienced trained personnel
All the proposed process reactors will have temperature control and pressure control
system for process as well as suitable Rupture disc followed by a safety valve to
avoid explosion due to excess pressure.

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TABLE: 7.1.AREA WISE IDENTIFIED HAZARDS, PRECAUTIONS PROPOSED WITH MITIGATION MEASURES.

SEVERITY &
S.NO AREA IDENTIFIED NO. OF PRECAUTIONS PROPOSED MITIGATION MEASURES
HAZARD PERSONS
EXPOSED
1. Approved layout as per legal requirements.
1. Area will be cordoned off.
2. Flame proof electrical fittings will be
2. Information will be passed to
installed
Emergency control center is informed.
3. Chemicals will be stored in safe Containers
3. Information will be given to the
with secondary containment to prevent
declarer of emergency on the scale of
spillages.
Leakage.
4. Storage quantity is limited
1] RM 4. Emergency Response teams will be
Spillage of Low to
kept on alert for swift response.
Storage chemicals medium 5. Storage area will be well ventilated by a
area 4 persons forced air ventilation system.
5. All hot works being carried out in
the surrounding areas will be stopped
6. Material will be accessed only by
authorized personnel using mechanized
6. Personnel working in the area will be
systems
evacuated.
7. Double door entry to ensure a clean
atmosphere.

8. Showers will be provided for


decontamination.

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SEVERITY &
S.NO AREA IDENTIFIED NO. OF PRECAUTIONS PROPOSED MITIGATION MEASURES
HAZARD PERSONS
EXPOSED

9. Personnel will be provided with full body 7. Spilled powders will be collected using
protection suits and nose masks to vacuum cleaners.
Prevent exposure to chemicals.
8. The spillage will be cleared and the
10.Fire hydrant system with hydrant points area is made fit work
with hose reels and nozzles will be installed
to mitigate fire hazards .

11.Fire extinguishers will be deployed


adequately

12. Fully fledged medical center will be


arranged.

13. Periodical occupational health checks will


be done to personnel working in the area to
Access health effects, if any. 9. In case of liquid chemical spillage, the
container will be shifted from ware house
14. Liquid chemicals such as Hcl, Ethyl to the outside for arresting the leakage
acetate, THF, Acetic acid, formaldehyde, and and transferring the contents to another
Thionyl chloride will be stored in dedicated vessel depends on situation.
area. The area where leakage is occurred will
Solid chemicals such as Sodium boro hydride, be neutralized if necessary and cleaned
sodium hydroxide, potassium hydroxide, The warehouse will have good
sodium methoxide will be stored in dedicated ventilation so as to minimize the
area. concentration of respective chemical in
Solid and liquid chemicals will not be stored in the working area.
the same area.

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SEVERITY &
S.NO AREA IDENTIFIED NO. OF PRECAUTIONS PROPOSED MITIGATION MEASURES
HAZARD PERSONS
EXPOSED
1. Storage facility will be provided in isolated 1. Area will be cordoned off.
area to have natural ventilation
2. No Hot work will be carried out in the
vicinity to prevent accidental spread of
2. Flameproof electrical fittings to be allowed in
fire.
storage area to prevent any fire hazard.
3. Personnel working in the area will be
3. No electrical gadgets or items capable of
evacuated
generating static electric charges will be
permitted in the area.
4. Emergency control center will be
Solvents
informed
2] Storage Fire, Medium to 4. Personnel will be trained about Do‘s &
area Flammable High Don‘ts during emergency. 5. Information will be given to the
area of vapor two declarer of emergency on the scale of
cloud 5. No heat sources will be permitted near the
Leakage of solvent, Fire.
Facility.
6. Emergency Response teams will be
6. Hot work will be controlled through a work
kept on alert for swift response.
permit system
7. The leakage will be cleared and the
7.For all storage tanks double earthing will be
area is made fit work
arranged

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SEVERITY &
AREA IDENTIFIED NO. OF PRECAUTIONS PROPOSED MITIGATION MEASURES
S.NO HAZARD PERSONS
EXPOSED
8. Adequate size Dyke wall will be provided to 8. In case leakage is found, the contents
for containment in case of leakage of chemical will be transferred to a spare tank or in to
/solvent. HDPE drums.

9. Storage quantity and material will be handled


by trained and authorized personnel.

10. Mechanical foam type fire & DCP fire


extinguishers will be provided at all solvent
storage tanks

11. Fire hydrant system with hose reels will be


Provided in the solvents storage area.
12. Hydrocarbon detectors will be provided in
the storage tanks area.
13. Flame arrestor will be provided for each
storage tank.

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SEVERITY &
S.NO AREA IDENTIFIED NO. OF PRECAUTIONS PROPOSED MITIGATION MEASURES
HAZARD PERSONS
EXPOSED

1. Area will be cordoned off.


1.Flame proof electrical fittings will be installed
2. Power supply will be cut off to the area
2. Freight lift will be installed for movement of to prevent accidental fire.
material
3. All hot work carried out in the vicinity
3. Material will be stored at production blocks in will be stopped.
safe containers for batch charging with
secondary containment to prevent 4. Emergency control center will be
Spillages. informed.
3] Production Spillages / Low to
Block Fire medium 4. Earthing and bonding will be carried out for 5. Information will be given to the
Toxic gas 5 persons all reactor vessels and pipelines declarer of emergency on the scale of
release spillage / fire/Toxic gas release
5.Nitrogen lines will be provided to reaction
vessel to create inert atmosphere inside 6. Emergency Response teams will be
the reactor to avoid fire and explosion Kept on alert for swift response.

6. Work permit system will be implemented for 7. Personnel working in the area will be
hazard assessment in case of any hot Evacuated.
work / work at elevated places.
8. Manufacturing area will be ventilated by a 8.Scrubber will be kept in operating
Forced air ventilation system to prevent condition with caustic scrubbing solution
formation of flammable mixture.
9. Fire hydrant system will be put in use.
9. Fire hydrant system with hydrant points 10. If situation beyond control
with hose reels and nozzles will be installed information will be given to Inspector of
to mitigate fire hazards factories. police, fire department for their
assistance.
10. Fire extinguishers will be deployed

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adequately

11. Emergency exit door will be provided to


each floor for safe escape in case of
emergency

12. Eye wash fountain / Body shower Will


be provided for decontamination at each floor.

13. Limit switches will be provided for


centrifuges for safe operation.
14. Nitrogen purging will be arranged for each
Centrifuge to prevent formation of explosive
flammable mixture.
15. Each reactor will be connected to a
scrubber to neutralize or decrease the pressure
in case sudden rise in pressure.

Production Ammonia 25 persons Material will be transferred to reactor by .1. Scrubber will be kept in operating
block Toxic gas experienced operating personnel under mild condition with cooled water circulation
release negative pressure to avoid release of fumes to During transfer of the material.
atmosphere 2. Emergency Response teams will be
Kept on alert for swift response
3. Area will be cordoned off.
4. Emergency control center will be
informed
5. Information will be given to the
declarer of emergency on the scale of
Leakage.
6. Neighboring industries and statutory
authorities will be informed in case
situation is severe.

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SEVERITY &
IDENTIFIED NO. OF
AREA PRECAUTIONS PROPOSED MITIGATION MEASURES
HAZARD PERSONS
EXPOSED

1. All requirements specified under Boiler


Act will be followed 1. Shutting down the plant, declaring the
emergency.
2. All electrical fittings will be of flame proof
Type. 2. Electrical supply will be isolated.

3. Entry will be restricted only to trained and 3. Type of emergency will be informed to
4] Boiler Fire/ Low to Authorized personnel to work in the area. the emergency declarer/ central
House Explosion medium authority.
2-persons 4. Fire extinguishers will be positioned at
different locations in case of any 4. Emergency response teams will be
Emergencies. kept on alert for swift action.

5. No material storage will be permitted in the 5 Movement of personnel and vehicles


Area. will be prohibited.
6. Auto level controller for Water and high 5 Fire hydrant system will be put in
temperature alarms will be provided. use
7. Water hardness will be checked on shift
wise.

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SEVERITY &
IDENTIFIED NO. OF
S.NO AREA PRECAUTIONS PROPOSED MITIGATION MEASURES
HAZARD PERSONS
EXPOSED
8. Area will be well ventilated and illuminated
for safe working.

9. 24 x 7 manning of the area is done for


monitoring of operation.

10. All maintenance /repair works will be


carried out after issuing work permits and
under constant supervision of experts.

11. Periodical cleaning of soot in furnace to


Prevent formation of explosive mixtures.

12. Checking of boiler internals as per given


schedule to prevent Accidents.

13. Signage‘s will be displayed to inform


personnel about the hazards present in the
area

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SEVERITY &
IDENTIFIED NO. OF
S.NO AREA PRECAUTIONS PROPOSED MITIGATION MEASURES
HAZARD PERSONS
EXPOSED

5] Diesel Noise & Fire Low 1. Noise abatement thru‘ modular acoustic 1. Information will be given to
Generator One person paneling of D.G set Emergency control center.

2. Secondary containment is done to prevent 2. Power supply will be cut off to the
Diesel leakage from day tanks. storage area to prevent accidental fire.

3. Two nos. of Co2 fire extinguishers will be 3. All hot work around the area will be
kept to handle emergency. stopped and the area will be cordoned
. off
4. Entry access to the area will be only for
Authorized personnel. 4. The concerned maintenance
personnel will be carried repairs to
mitigate the leakages.

5. Emergency Response Team will be


kept on alert for swift response.

6. Periodical occupational health checks


will be done to personnel working in the
area to assess exposure to noise.

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SEVERITY &
IDENTIFIED NO. OF
S.NO AREA PRECAUTIONS PROPOSED MITIGATION MEASURES
HAZARD PERSONS
EXPOSED

1. Layout confirm to legal requirements as per 1. Information will be given to


Indian Electrical Rules. Emergency control center.

2. Entry will be restricted to licensed and 2. Power supply will be cut off from
authorized personnel only. incoming source.

3. Earthing will be provided for leakage of stray 3. Electricity supply company will be
Currents. alerted for cut off power supply in case of
major risks
6] Electrical Electric High 4. Electronic mimic panels will be installed for
sub -station shock / fire One person fault indication at the entry of the sub-station. 4. All hot work around the area will be
Stopped and the area is cordoned off.
5. Insulating rubber mats confirming to
IS 15652:2006 will be provided in front of all 5. The concerned maintenance
electrical panel boards. personnel will be carried repairs to
restore normalcy.
6. Periodical inspection and maintenance
Will be carried out to ensure good health of 6.Emergency Response Team will be
the equipment. kept on alert for swift response

7. CO2 / DCP fire extinguishers will be


deployed to handle emergency fires

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SEVERITY &
S.NO AREA IDENTIFIED NO. OF PRECAUTIONS PROPOSED MITIGATION MEASURES
HAZARD PERSONS
EXPOSED

1. Storage shed will be at an isolated location. 1. Information will be given to


Emergency control center.
2. Conditions specified in hazardous waste
Authorization issued by SPCB will be 2. Power supply will be cut off from
implemented. incoming source.

3. Compatible wastes will be stored in separate 3. All hot work around the area will be
enclosures stopped and the area is cordoned off.

Hazardous Low to 4. Layout provides adequate ventilation 4. The concerned maintenance


waste medium and illumination personnel will be carried repairs to
7] storage Fire/Leakage 2- Persons restore normalcy
shed 5. Secondary containment provided to prevent
leakages / spillages 5. Fire hydrant system will be put in use

6. Storage quantity will be limited.

7. Periodical disposal of accumulated waste will


be sent to authorized landfills.

8. Flame proof electrical fittings will be installed


to prevent fire / explosion hazards

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SEVERITY &
S.NO AREA IDENTIFIED NO. OF PRECAUTIONS PROPOSED MITIGATION MEASURES
HAZARD PERSONS
EXPOSED

9. Eye wash / body shower will be provided for


decontamination in case of spillage on body 6. Emergency Response Team will be
parts. kept on alert for swift response.

10. PPE box will be equipped with gum boots, 7. Support of external agencies will be
splash proof safety goggles, aprons for use sought in case situation poses major
during handling of chemicals. risks and is not controllable by in-house
infrastructure
11. Access to the area will be restricted to
authorize personnel only.

12. Fire hydrant point with hose reels will be


provided for fire mitigation

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7.3 SOLVENTS/CHEMICALS
NAME OF MAX. NATURE OF NFPA
S.No MODE OF STORAGE
SOLVENT/CHEMICAL INVENTORY IN TONS HAZARD RATING
1 Methanol MS Tank 20 Flammable H : 1 F: 3 R : 0
2 Toluene MS Tank 20 Flammable H : 2 F: 3 R : 0
3 MDC MS Tank 20 Harmful H : 2 F: 1 R : 0
4 Acetic anhydride MS tank 10 Corrosive H : 3 F: 2 R : 1
5 Acetone MS Tank 20 Flammable H : 1 F: 3 R : 0
6 Ethyl acetate MS Tank 20 Flammable H : 1 F: 3 R : 0
7 Hcl PP+FRP Tank 10 Corrosive H:3 F:0 R:1
30 no.s
11 Ammonia Cylinders Toxic H : 3 F: 1 R : 0
(Each of 50 kgs)
12 Formaldehyde HDPE Carboys 1.5 Toxic H:3 F: 2 R : 0
13 Sulfuric acid HDPE Carboys 6.0 Corrosive H:3 F:0 R:2
14 Hydrogen peroxide (50%) HDPE Carboys 2.5 Corrosive H:2 F: 0 R : 1
15 Palladium on carbon (5%) HDPE Drums 0.05 Flammable H:1 F: 3 R : 0
16 Hydrogen Cylinders 60 nos Explosive H:0 F:4 R:0
17 Cyclohexane HDPE Drums 10 Flammable H:1 F: 3 R : 0
18 THF HDPE Drums 5 Flammable H:2 F: 3 R : 1
19 Thionyl chloride HDPE Carboys 2 Toxic H:4 F:0 R:2
20 Hydrobromic acid HDPE Carboys 5 Corrosive H:3 F:0 R:1
21 Raney nickel HDPE Carboys 0.4 Flammable H:2 F:4 R:1
22 Sodium boro hydride HDPE Carboys 2.0 Flammable H:3 F:4 R:2
23 Sodium cyanide HDPE Carboys 1.5 Toxic H:3 F:0 R:0
24 n-Hexane MS Tank 20 Flammable H:1 F:3 R:0
25 Chloroform MS Tank 20 Irritant/Anesthetic H:2 F:0 R:0
26 DMF HDPE Drums 6 Flammable H:1 F:2 R:0

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7.4 Potential Hazards of solvents and chemicals


Acetone: It is a clear, volatile, flammable liquid. Vapors may form explosive
mixtures with air. Vapors are heavier than air and may travel along the ground to
some distance source of ignition and flash back.

On combustion may emit toxic fumes of carbon monoxide and CO2.


This product causes irritation of eyes, skin, and mucous membranes in case of
contact. It will cause lung damage if swallowed. Do not breathe vapors.

N-Hexane: It is a clear, volatile, highly flammable liquid. Vapors may form explosive
mixture with air. Vapors are heavier than air and may travel along the ground to
some distance source of ignition and flash back. Fire or intense heat may cause
violent rupture of packages. Hazardous combustion products may include carbon
monoxide, carbon dioxide.

Use foam, carbon dioxide or dry chemical. Suppress vapors/mists with a water spray
jet.

In case of spillage soak up with inert absorbent material such as sand, silica gel, saw
dust. Do not use sparking tools. Do not allow product to enter sewer or waterways.

Store in a well-ventilated place to effectively remove and prevent buildup of any


vapors or mists generated from handling of this product.

While handling wear impervious gloves and anti-static protective clothing. For leak,
spills, or other emergency, use full protective equipment.
It is incompatible with oxidizers, halogens, chromates, perchlorates, peroxides.
Methanol: Extremely flammable and vapour may form ignitable vapour air mixtures
in storage tanks or other containers. Ignition and busing can release carbon
monoxide, carbon dioxide and non combustible hydrocarbons (Smoke)
Inhalation can Cause dizziness, head ache and nausea, kidney and liver disorder

Sodium cyanide: All containers of sodium cyanide are to be stored in locked room.
Keys of this room should be accessible to only those persons familiar with handling
requirements. This material to be stored in area protected from possible contact with
water, acid metals such as copper, magnesium, and zinc.

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Sodium cyanide shall be dispensed and handled only in an operational fume hood.
No containers of acid should be in the hood or work area.
A pH 10 buffer solution and dilute bleach solution should be available to clean up the
surfaces after handling.
Sodium cyanide is a highly toxic compound that may be injected or absorbed
through the skin.
Sodium cyanide reacts with strong acids (Hcl, H2So4, and HNo3). With Water,
Damp air will form highly flammable Hydrogen cyanide gas.
A deadly compound when inhaled.
In the event of a dermal exposure get the person to the nearest shower and
thoroughly flush with water for at least 15 minutes while removing contaminated
clothing and shoes.
Wherever possible automatically transfer Sodium cyanide from drums or other
storage containers to process use.
Use vacuum to reduce dust during cleaning. Do not dry Sweep.
Clothing: Avoid skin contact with sodium cyanide. Wear protective gloves and
clothing. Wear impact resistant eye protection with side shields .As and when
sodium cyanide handled use air respirator with a full face piece operated in positive
pressure mode.

Raney nickel catalyst: Keep container tightly closed and to be stored in a cool, well-
ventilated area. Do not allow material to dry. If allowed to dry in air, it turns to red hot
and provides a combustion source for exposed combustible materials.
It should be kept away from incompatibles such as oxidizing agents, combustible
materials, organic materials, metals, acids, flammable solvents and source of
ignition.
In case of spill, do not touch the spilled material. Cover with wet earth and sand.
Eliminate all ignition sources.
Always use protective clothing with dust respirator and goggles while handling.

Hydrogen: It is a flammable, colorless, compressed gas packaged in cylinders at


high pressure. It poses an immediate fire and explosive hazard when concentrations
exceed 4%.It much lighter than air and burns with an invisible flame.

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It should be noted that, before suffocation could occur, the lower flammability of
hydrogen in air would exceed possibly causing both an oxygen-deficient and
explosive atmosphere. Exposure to moderate concentrations may cause dizziness,
headache, nausea and unconsciousness.
Cylinder storage locations should be well protected, well ventilated, dry, and
separated from combustible materials. Cylinders should never knowingly be allowed
to reach a temperature exceeding 520c. Cylinders of hydrogen should be separated
from oxygen cylinders or other oxidizers by minimum distance of 20 ft. Do not keep
any other cylinders in Hydrogen storage area.
Cylinders should be stored upright with valve protection cap in place and firmly
secured to prevent falling or being knocked over. Protect cylinders from physical
damage, do not drag, roll, slide or drop. Post ―No Smoking or Open flames‖ signs in
the storage areas. There should not be any sources of ignition.
All electrical equipment should be explosion proof in the storage and use areas.
Provide natural or explosion-proof ventilation adequate to ensure hydrogen does not
reach its lower explosive limit of 4% .Hydrogen is incompatible with oxidizing agents.

Sodium meth oxide: It is highly flammable and toxic. Reacts violently with water.
Keep away from sources of ignition.
In case of skin contact, flush with copious amounts of water for at least 15 minutes.
Remove contaminated clothing and shoes.
If inhaled, remove to fresh air and if necessary give artificial respiration. Material is
extremely destructive to the tissue of the mucous membranes and upper respiratory
tract.
Wear self-contained breathing apparatus and protective clothing to prevent contact
with skin and eyes.
In case of spillage cover with dry-lime, sand or soda ash. Avoid contaminating
sewers and water ways with this material.
Incompatible with water, acids, chlorides, alkali metals, oxidizing agents, chlorinated
solvents

Sulfuric acid: Water Reaction


Reaction with water is negligible unless acid strength is above 70% then heat from
hydrolysis is extreme, may cause severe burns

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Fire Hazard
It is highly reactive and capable of igniting finely-divided combustible materials on
contact. When heated, it emits highly toxic fumes. Avoid heat; water and organic
materials. Sulfuric acid is explosive or incompatible with an enormous array of
substances. Can undergo violent chemical change at elevated temperatures and
pressure. May react violently with water.

Health Hazard:
Corrosive to all body tissues. Inhalation of vapor may cause serious lung damage.
Contact with eyes may result in total loss of vision. Skin contact may produce severe
necrosis.

Fatal amount for adult: between 1 teaspoonful and one-half ounce of the
concentrated chemical. Chronic exposure may cause tracheobronchitis, stomatitis,
conjunctivitis, and gastritis. Those with chronic respiratory, gastrointestinal, or
nervous diseases and any eye and skin diseases are at greater risk.

Protective Clothing:
Skin: Wear appropriate personal protective clothing to prevent skin contact.
Eyes: Wear appropriate eye protection to prevent eye contact.
Wash skin: The worker should immediately wash the skin when it becomes
contaminated.
Remove: Work clothing that becomes wet or significantly contaminated should be
removed and replaced. Provide: Eyewash fountains should be provided in areas
where there is any possibility that workers could be exposed to the substance; this is
irrespective of the recommendation involving the wearing of eye protection.
Facilities for quickly drenching the body should be provided within the immediate
work area for emergency use where there is a possibility of exposure.
It is intended that these facilities provide a sufficient quantity or flow of water to
quickly remove the substance from anybody areas likely to be exposed.

Hydrochloric acid:
Water Reaction
An aqueous solution. Dilution may generate heat. Fumes in air.

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Fire Hazard
Special Hazards of Combustion Products: Toxic and irritating vapors are generated
when heated.

Health Hazard
Inhalation of fumes results in coughing and choking sensation, and irritation of nose
and lungs. Liquid causes burns.

Reactivity Profile
Hydrochloric Acid is an aqueous solution of hydrogen chloride, an acidic gas. Reacts
exothermically with organic bases (amines, amides) and inorganic bases (oxides and
hydroxides of metals).
Reacts exothermically with carbonates (including limestone and building materials
containing limestone) and hydrogen carbonates to generate carbon dioxide.
Reacts with sulfides, carbides, borides, and phosphates to generate toxic or
flammable gases.
Reacts with many metals (including aluminum, zinc, calcium, magnesium, iron, tin
and all of the alkali metals) to generate flammable hydrogen gas.

Protective Clothing:
Skin: If chemical is in solution, wear appropriate personal protective clothing to
prevent skin contact and to prevent skin from becoming frozen from contact with the
liquid or from contact with vessels containing the liquid.
Eyes: Wear appropriate eye protection to prevent eye contact with the liquid that
could result in burns or tissue damage from frostbite.
Wash skin: If the chemical is in solution, the worker should immediately wash the
skin when it becomes contaminated.
Remove: If chemical is in solution, work clothing that becomes wet or significantly
contaminated should be removed and replaced.
Provide: Eyewash fountains should be provided (when chemical is in solution) in
areas where there is any possibility that workers could be exposed to the substance;
this is irrespective of the recommendation involving the wearing of eye protection.
Facilities for quickly drenching the body should be provided (when chemical is in
solution) within the immediate work area for emergency use where there is a
possibility of exposure. It is intended that these facilities provide a sufficient quantity

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or flow of water to quickly remove the substance from anybody areas likely to be
exposed.
Quick drench facilities and/or eyewash fountains should be provided within the
immediate work area for emergency use where there is any possibility of exposure to
liquids that are extremely cold or rapidly evaporating.

Acetic acid:
Above 39°C explosive vapour/air mixtures may be formed. Risk of fire and explosion
on contact with strong oxidants. It is flammable.
Above 39°C use a closed system, ventilation and explosion-proof electrical
equipment. Remove all ignition sources.
Personal protection: chemical protection suit including self-contained breathing
apparatus. Do NOT let this chemical enter the environment. Collect leaking liquid in
sealable containers.
Cautiously neutralize spilled liquid with sodium carbonate only under the
responsibility of an expert.
Effects of short-term exposure: The substance is corrosive to the eyes, skin and
respiratory tract. Corrosive on ingestion. Inhalation may cause lung edema,

Protective Clothing:
Skin: Wear appropriate personal protective clothing to prevent skin contact.
Eyes: Wear appropriate eye protection to prevent eye contact.
Wash skin: The worker should immediately wash the skin when it becomes
contaminated.
Remove: Work clothing that becomes wet or significantly contaminated should be
removed and replaced.
Provide: Eyewash fountains should be provided in areas where there is any
possibility that workers could be exposed to the substance; this is irrespective of the
recommendation involving the wearing of eye protection.

Formaldehyde 37% (FORMALIN)


Formalin, when exposed to air, will emit formaldehyde gas.
Formaldehyde is a highly flammable liquid/gas and should be considered a fire
hazard. It strongly oxidizes in the presence of alkalis, acids and phenols. Store in

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well ventilated place, away from sources of ignition and direct sunlight. Avoid
contact with heat, sparks, flames, or other sources of ignition.
General Handling:
At all times, disposable gloves must be worn to prevent dermal exposure when
handling and/or mixing this product. Do not get in eyes. Avoid contact with skin and
clothing. Avoid breathing mist or vapor. Use only with adequate ventilation. Wash
thoroughly after handling.

Sodium boro hydride:


Sodium borohydride is a white to grayish crystalline powder. It is decomposed by
water to form sodium hydroxide, a corrosive material, and hydrogen, a flammable
gas. The heat of this reaction may be sufficient to ignite the hydrogen. The material
itself is easily ignited and burns vigorously once ignited. It is used to make other
chemicals, treat waste water, and for many other uses. Reaction of water with the
borohydride liberates flammable hydrogen gas. Sodium borohydride burns in air.
Fire Hazard
Behavior in Fire: Decomposes and produces highly flammable hydrogen gas.
Health Hazard
Solid irritates skin. If ingested can form large volume of gas and lead to a gas
embolism
Protective Clothing
Goggles, rubber gloves, and protective clothing

Thionyl chloride:
A colorless to yellow fuming liquid with a suffocating pungent odor. A lachrymator.
Highly corrosive and toxic.
Long-term inhalation of low concentrations or short-term inhalation of high
concentrations has adverse health effects.
Emits dense corrosive fumes in moist air. Violently reacts with water to liberate
hydrochloric acid and sulfur dioxide. Based on a scenario where the chemical is
spilled into an excess of water (at least 5 fold excess of water), half of the maximum
theoretical yield of Sulfur Dioxide gas will be created in 0.25 minutes.

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Protective Clothing
Skin: Wear appropriate personal protective clothing to prevent skin contact.
Eyes: Wear appropriate eye protection to prevent eye contact.
Wash skin: The worker should immediately wash the skin when it becomes
contaminated.
Provide eyewash fountains in areas where there is any possibility that workers
could be exposed to the substance; this is irrespective of the recommendation
involving the wearing of eye protection

Ammonia:
Appearance: Colorless gas
Main Routes of Exposure: Inhalation, Skin contact, Eye contact.
Inhalation: VERY TOXIC. Can cause severe irritation of the nose and throat. Can
cause life-threatening accumulation of fluid in the lungs (pulmonary edema).
Symptoms may include coughing, shortness of breath, difficult breathing and
tightness in the chest. Symptoms may develop hours after exposure and are made
worse by physical effort. Long-term damage may result from a severe short-term
exposure.
Skin Contact: CORROSIVE. The gas irritates or burns the skin. Permanent scarring
can result. Direct contact with the liquefied gas can chill or freeze the skin
(frostbite). Symptoms of more severe frostbite include a burning sensation and
stiffness. The skin may become waxy white or yellow. Blistering, tissue death and
infection may develop in severe cases.
Eye Contact: CORROSIVE. The gas irritates or burns the eyes. Permanent damage
including blindness can result. Direct contact with the liquefied gas can freeze the
eye. Permanent eye damage or blindness can result.
Flammable Properties: FLAMMABLE GAS. High airborne concentrations can be
ignited and pose a significant fire and explosion hazard, especially in a confined
space. A large and intense energy source is necessary to ignite ammonia gas.
Suitable Extinguishing Media: Carbon dioxide, dry chemical powder, appropriate
foam, water spray or fog.
Hazards: Heat from fire can cause a rapid build-up of pressure inside cylinders.
Explosive rupture and a sudden release of large amounts of gas may result.

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Cylinder may rocket. In a fire, the following hazardous materials may be generated:
flammable hydrogen.
Eye/Face Protection: Wear chemical safety goggles. A face shield (with safety
goggles) is necessary.
Skin Protection: Wear chemical protective clothing e.g. gloves, aprons, boots.

Hydrobromic Acid, 33% Solution in Acetic Acid:


Hazards: Very hazardous in case of skin contact (irritant) or eye contact (irritant), or
ingestion, Inhalation of the spray mist may produce severe irritation of respiratory
tract, characterized by coughing, choking, or shortness of breath.
Inflammation of the eye is characterized by redness, watering, and itching. Skin
inflammation is characterized by itching, scaling, reddening, or occasionally
blistering.
Storage: Store in a segregated and approved area. Keep container in a cool, well-
ventilated area. Keep container tightly closed and sealed until ready for use. Avoid
all possible sources of ignition (spark or flame).
Engineering Controls: Provide exhaust ventilation to keep the airborne
concentrations of vapors below their respective threshold limit value.
Ensure that eyewash stations and safety showers are proximal to the work-station
location.
Personal Protection: Face shield. Full suit.
Vapor respirator. Be sure to use an approved respirator.
Use Gloves, Boots, and personal protection in case of a Large Spill.
A self contained breathing apparatus should be used to avoid inhalation of the
product.

7.5. SAFE PRACTICES [HANDLING, STORAGE, TRANSPORTATION AND


UNLOADING OF CHEMICALS]

Liquid Raw materials will be transferred from the drums to the day tank situated at
the production block with the help of leak proof drum pumps / AODD pumps
/Vacuum .From day tank to process reactor unloading is by gravity.

7.5.1 Measures to Avoid Evaporation


All liquid chemicals/solvents stored in containers will be tightly closed.

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Will Keep away from heat, sparks, and flame


Will Keep away from sources of ignition
Ammonia will be stored in well ventilated area away from combustibles, oxidizable
materials etc.

7.5.2 Safety Systems


 Designated areas with proper indication & safety signs
 Double earthling systems for all solvent storage tanks & process reactors
 Flame arrestor to the vent of Solvent storage tanks
 Flame proof transferring pumps for all flammable chemicals
 Handling precautions/sop protocol
 Pressure Gauges and temperature gauges on each reactor
 Level indicators, Vent lines, earthing system on all solvent storage
tanks(Methanol, Toluene, MDC, Ethyl acetate, ,Acetone, n-hexane)
 Each solvent storage tank will be placed in dyke wall with Fire hydrant system
 Flame proof lighting to solvent storage yard
 Safety valve & Rupture disc on each process reactor.
 Well ventilated warehouse with suitable fire extinguishers will be used for
storage of liquid chemicals/Ammonia/Hcl /HBr/Solid Chemicals.

7.5.3 TRANSPORTATION / UNLOADING


Highly inflammable chemicals will be transported by road. Therefore, adequate
safety precautions for transportation will be followed. During transportation of
hazardous chemicals, MSDS & TREM card will be provided to driver. As per Motor
Vehicle Rules, PESO rules and Factory Rules all safety precautions will be followed
during transportation of hazardous chemicals.
The following safety precautions are suggested during transportation of toxic,
inflammable and corrosive chemicals in tankers, while loading and unloading,
transportation and meeting the emergencies arising out of leakages and spillages of
hazardous materials:
The name of the chemical along with pictorial sign denoting the dangerous
goods should be marked on the vehicle and the packing material.
 The name of the transporter, his address and telephone number should be
clearly written on the road tanker and on the vehicle.

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 Only trained drivers and cleaners should transport hazardous chemicals.


 The Tanker / Vehicle should be checked for its fitness and safe condition
before loading.
 During loading and unloading, the tanker/vehicle should be braked and
isolated against any movement, while loading/unloading, use safety
appliances.
 Park the vehicle at designated place.
 Stop the engine.
 Check-up spark arrester.
 Provide earthing to tanker securely.
 Ensure that fireman is available near the place with proper equipment‗s.
 Connect the piping properly
 Before start unloading, check that, there should not be any leakage.
 In case of leakage, immediately attend the leakages & rectify it.
 After unloading is over, close the lid properly.
 Vehicle to be started only after removal of all pipelines connected with
tanker.

7.5.4 SPILL CONTROL


 For all chemicals spill control procedures will be displayed. Spillage shall be
controlled as per concerned spill control procedure.
 Like any spilled materials to contain, absorb spilled liquid by dry absorbent
clay or vermiculite.
 Collect most of the contaminated absorbent with shovel for further
disposal/incineration.
 If material spills directly on the ground, dig up and remove saturated soil for
disposal/incineration.
 In case HBr /Hcl /H2So4 spills on to the ground use dry absorbent
clay/vermiculate and neutralize with sodium carbonate
 The plant is more vulnerable for solvent leakages, fire due to Raney nickel
exposure to dry condition.

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7.5.5 EFFECT AND CONSEQUENCE ANALYSIS


 In a plant handling hazardous chemicals, the main hazard due to storage &
handling of solvents, Ammonia, Thionylchloride, Hydrogen, HBr/Hcl/H2So4,
Sodium boro hydride ,.
 If Flammable chemicals are released into the atmosphere, they may cause
damage due to resulting fires or vapor clouds.
 Toxic gas dispersion due to leakage of thionyl chloride, Ammonia into
atmosphere may cause health problems to plant personnel and surrounding
areas of the plant.

7.6 INVENTORY
 Inventory analysis is commonly used in understanding the relative hazards
and short listing of release scenarios.
 Inventory plays an important role in regard to the potential hazard.
 Larger the inventory of a vessel or a system, larger the quantity of potential
release.
 The potential vapor release [source strength] depends upon the quantity of
liquid release, the properties of the materials and the operating conditions
[pressure, temperature].
 If all these influencing parameters are combined into a matrix and vapor
source strength estimated for each release case, a ranking should become a
credible exercise.

7.7 LOSS OF CONTAINMENT


 Plant inventory can get discharged to environment due to Loss of
Containment.
 Certain features of materials to be handled at the plant need to the clearly
understood to firstly list out all significant release cases and then to short list
release scenarios for a detailed examination.
 Liquid release can be either instantaneous or continuous.
 Failure of a vessel leading to an instantaneous outflow assumes the sudden
appearance of such a major crack that practically all of the contents above the
crack shall be released in a very short time.

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 The more likely event is the case of liquid release from a hole in a pipe
connected the vessel. The flow rate will depend on the size of the hole as well
as on the pressure, which was present, in front of the hole, prior to the
accident. Such pressure is basically dependent on the pressure in the vessel.
 The vaporization of released liquid depends on the vapor pressure and
weather conditions.
In the study the largest potential hazard inventories have been considered for its
consequence Risk estimation how vulnerable the organization is to a specific
incident consequence.
Hazards from Flammable chemicals (solvents) Storages, Ammonia & Thionyl
chloride
There are a number of hazards that are present at the proposed project site
that may result in injury to people or a fatality in more serious cases. This
study is only concerned with ‗major hazards‘, which are as follows:
Jet fires;
Hydrocarbon fires associated with tank failures;
Pool fires, Vapor cloud explosion;
Each of these hazards has been described below.

Jet Fire
Jet fires result from ignited releases of pressurized flammable gas or
Superheated/pressurized liquid. The momentum of the release carries the
material forward in a long plume entraining air to give a flammable mixture.
Jet fires only occur where any other flammable gas is being handled under
pressure or when handled in gas phase and the release are unobstructed

Pool Fires
If a liquid release has time to form a pool and is then ignited before the pool
Evaporates or drains away, then a pool fire results.
Because they are less well aerated, pool fires tend to have lower flame
temperatures and produce lower levels of thermal radiation than some other
types of fire (such as jet fires); however, this means that they will produce
more smoke. Although a pool fire can still lead to structural failure of items
within the flame, this will take several times longer than in a jet fire.

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A burning liquid pool can spread along a horizontal surface or run down a
vertical surface to give a running fire. Due to the presence of kerbs, slopes,
drains and other obstacles; pool fire areas and directions can be
unpredictable.

Vapour Cloud Explosion


The facility presently stores and also plans to store highly flammable
Chemicals Methanol, Acetone, Toluene, MDC, Ethylacetate, THF,
Cyclohexane, DMSO etc. for a maximum credible loss scenario the release of
such chemicals is likely to form a vapor cloud. If the cloud encounters an
ignition source, the parts of the cloud where the concentration is within the
flammable range will burn and may in some situations, also create an
explosive force (blast wave). The effects of an explosion, defined by blast
overpressure, can be significant.
In most VCEs the expanding flame front travels more slowly than the pressure
Wave; this type of explosion is called a deflagration and the maximum
Overpressure is determined by the expansion ratio of the burning gases. If the
flame front travels fast enough to coincide with the pressure wave then the
explosion is called a detonation and very severe overpressures can be
produced. Detonation is most likely to occur with more reactive gases such as
hydrogen.

Toxic vapor release:


Toxic vapor release due to Ammonia, Thionyl chloride leakage and effected
area with airborne concentration

7.8 Damage Criteria


In consequence analysis, use is made of a number of calculation models to estimate
the physical effects of an accident [spill of hazardous material] and to predict the
damage [lethality, injury, material destruction] of the effects. The calculations can
roughly be divided in three major groups.
 Determination of the source strength parameters;
 Determination of the consequential effects;
 Determination of the damage or damage distances.

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Table 7.3 Severity Categories and Criteria

Consequence Ranking Criteria Definition


Catastrophic 5 Multiple fatalities/permanent total disability
Major 4 Single fatality/permanent total disability
Short term hospitalization & rehabilitation leading
Moderate 3
to recovery
Minor 2 Medical treatment injuries
Insignificant 1 First Aid treatment

Risk Evaluation
Based on ranking of likelihood and frequencies, each identified hazard has been
evaluated based on the likelihood of occurrence and the magnitude of
consequences. The significance of the risk is expressed as the product of likelihood
and the consequence of the risk event, expressed as follows:

Significance = Likelihood X Consequence


The below table illustrates all possible product results for the five likelihood and
consequence categories while the next table assigns risk significance criteria in three
regions that identify the limit of risk acceptability.
Depending on the position of the intersection of a column with a row in the risk
matrix, hazard prone activities have been classified as low, medium and high thereby
qualifying for a set of risk reduction / mitigation strategies.

Risk Matrix
Likelihood
Consequence Frequent Probable Unlikely Remote Improbable
5 4 3 2 1
Catastrophic 5 25 20 15 10 5
Major 4 20 16 12 8 4
Moderate 3 15 12 9 6 3
Minor 2 10 8 6 4 2
Insignificant 1 5 4 3 2 1

Risk Criteria and action Requirements


S.No. Risk Significance Criteria Definition & Action Requirements
―Risk requires attention‖ – Project Management
need to ensure that necessary mitigation are
1 High (16-25)
adopted to ensure that possible risk remains within
acceptable limits.
2 Medium (10-15) ―Risk is tolerable‖ – Project Management to adopt

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necessary measures to prevent any


change/modification of existing risk controls and
ensure implementation of all practicable controls.
―Risk is acceptable‖ – Project related risks are
managed by well established controls and routine
3 Low (5-9) processes/procedures.
Implementation of additional controls can be
considered.
―Risk is acceptable‖- All risks are managed by well
established controls and routine
4 Very Low (1-4)
processes/procedures. Additional risk controls need
not to be considered.

The basic physical effect models consist of the following.

Source strength parameters


 Calculation of the outflow of liquid, vapor or gas out of a vessel or a pipe, in
case of rupture. Also two-phase outflow can be calculated.
 Calculation, in case of liquid outflow, of the instantaneous flash evaporation
and of the dimensions of the remaining liquid pool.
 Calculation of the evaporation rate, as a function of volatility of the material,
pool dimensions and wind velocity.
 Source strength equals pump capacities, etc. is some cases.

Consequential effects
 Dispersion of gaseous material in the atmosphere as a function of source
strength, relative density of the gas, weather conditions and topographical
situation of the surrounding area.
 Intensity of heat radiation [in KW / m2] due to a pool fire or a BLEVE, as a
function of the distance to the source.
 Energy of vapor cloud explosions [in KW / m2], as a function of the distance to
the distance of the exploding cloud.
 Concentration of gaseous material in the atmosphere, due to the dispersion of
evaporated chemical. The latter can be either explosive or toxic.

It may be obvious, that the types of models that must be used in a specific risk study
strongly depend upon the type of material involved:
 Gas, vapor, liquid, solid

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 Inflammable, explosive, toxic products


 Stored at high/low temperatures or pressure.

Selection of Damage Criteria


 The damage criteria give the relation between extent of the physical effects
(exposure) and the percentage of the people that will be killed or injured due
to those effects
 The knowledge about these relations depends strongly on the exposure. For
instance, much more is known about the damage caused by heat radiation,
than about the damage due to toxic exposure, and for these toxic effects, the
knowledge differs strongly between different materials.
In consequence analysis studies, in principle three types of exposure to hazardous
effects are distinguished:
 Heat radiation from a jet, pool fire or a BLEVE.
 Explosion
 Toxic effect from toxic materials or toxic combustion products.

Heat Radiation
The consequence caused by exposure to heat radiation is a function of:

 The radiation energy onto the human body [KW / M2]


 The exposure duration [sec]
 The protection of the skin tissue [clothed or naked body]
The limits for 1% of the exposed people to be killed due to heat radiation, and for
second-degree burns are given in below:

7.9 DAMAGES TO HUMAN LIFE DUE TO HEAT RADIATION


Injuries to People —Definition of Burn Degrees
First Degree: A mild level of skin burn affecting the epidermis, with persistent
redness but no formation of blisters. More severe first - degree burns will produce
some pain, but no permanent damage. Flaking or scaling of the outer skin layer will
occur several days after exposure.
Second Degree: An intermediate level of skin burn characterized by the formation of
blisters. The blister depth may be shallow (epidermis), with only the surface layers of

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the skin damaged, or more severe with nearly the full depth of the skin destroyed
(epidermis and dermis).
Third Degree: Deep burns characterized by the destruction of all skin layers and by
charring. The underlying tissue may also be damaged.

Table 7.4 Heat flux Intensity and exposure time-Damage criteria for people
Thermal Radiation
Intensity Type of Damage
(kW/m2)
1.6 No harm for long exposures.
4 to 5 Pain for 20 seconds exposure; first degree burn
9.5 Second degree burn after 20 Seconds
10 to 15 Potentially lethal with in 1 minute.
Significant injury in 10 seconds; 100 % lethality in 1
25
minute.
35 to 37.5 1 % lethality in 10 seconds.

Since in practical situations, only the own employees will be exposed to heat
radiation in case of a fire, it is reasonable to assume the protection by clothing. It can
be assumed that people would be able to find a cover or a shield against thermal
radiation in 10 sec. time. Furthermore, 100% lethality may be assumed for all people
suffering from direct contact with flames, such as the pool fire, a flash fire or a jet
flame.

Explosion
In case of vapor cloud explosion, two physical effects may occur:
 A flash fire over the whole length of the explosive gas cloud;
 A blast wave, with typical peak overpressures circular around ignition source.
As explained above, 100% lethality is assumed for all people who are present within
the cloud proper.
For the blast wave, the lethality criterion is based on:

 A peak over pressure of 0.1 bars will cause serious damage to 10% of the
housing/structures.
The following damage criteria may be distinguished with respect to the peak
overpressures resulting from a blast wave:

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Table 7.5 DAMAGE DUE TO OVERPRESSURES


PEAK DAMAGE
OVERPRESSURE TYPE
0.83 bar Total destruction
0.30 bar Heavy damage
0.10 bar Moderate damage
0.03 bar Significant damage
0.01 bar Minor damage

7.10 INCIDENTS IMPACT


The identified failure scenarios in plant have been analyzed for the impact zones
considering damage due to thermal, explosive and toxic impacts. Each incident will
have Impact on the surrounding environment which in extreme case may cross plant
boundary.

7.11 MAXIMUM CREDIBLE LOSS ACCIDENT SCENARIOS


A Maximum Credible Accident (MCA) can be characterized as the worst credible
accident. In other words: an accident in an activity, resulting in the maximum
consequence distance that is still believed to be possible. A MCA-analysis does not
include a quantification of the probability of occurrence of the accident. Another
aspect, in which the pessimistic approach of MCA studies appears, is the
atmospheric condition that is used for dispersion calculations. The Maximum
Credible Loss (MCL) scenarios have been developed for the Facility. The MCL
cases considered, attempt to include the worst ―Credible‖ incidents-what constitutes
a credible incident is always subjective. Nevertheless, guidelines have evolved over
the years and based on basic engineering judgment, the cases have been found to
be credible and modeling for assessing vulnerability zones is prepared accordingly.
The objective of the study is Emergency planning, hence only holistic & conservative
assumptions are used for obvious reasons. Hence, though the outcomes may look
pessimistic, the planning for emergency concept should be borne in mind whilst
interpreting the results.
In Consequence analysis, geographical location of the source of potential release
plays an important role. Consideration of a large number of scenarios in the same

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geographical location serves little purpose if the dominant scenario has been
identified and duly considered.
The Consequence Analysis has been done for selected scenarios. The details of
software used for MCA analysis are described below.
 A computer based version ALOHA is used to calculate toxic and explosive
effect of the accidental release of liquid chemicals within the plant area.
 ALOHA models key hazards-toxicity, flammability, thermal radiation (Heat),
and over pressure (expansion blast force)-related to chemical releases that
result in toxic gas dispersion, fire and/or explosion

7.12. Risk analysis


Risk Analysis – Ammonia/Thionyl chloride/Solvents (Methanol, Toluene,
Acetone -Hexane)
The main hazard Toxic gas release associated with the storage and handling of
Thionyl chloride and Ammonia gas with respect to the proposed Unit.
Hazards associated with the storage and handlings of Flammable chemicals
(Solvents) are pool fire, jet fires and VCE‘s resulting from the ignition of released
material. The hazards may be realized during tank overfilling and leaks/failures
in the storage tank and ancillary equipment such as transfer pumps, metering
equipment, etc. all of which can release significant quantities of flammable
material or toxic material on failure.

7.13 Risk Modeling Scenarios


In addition to overfill, the scenarios considered for liquid and gaseous
Chemical leaks and catastrophic failures. Factors that have been identified as
having an effect on the integrity of tanks are related to design, inspection,
maintenance, and corrosion.
From the liquid chemicals Thionyl chloride has been considered for the
consequences analysis considering its hazardous nature, Storage conditions and
threshold values.
From the Solvents – Methanol, Toluene, Acetone, n-Hexane have been
considered for the consequences analysis considering their hazardous nature,
Storage conditions and threshold values.

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RISK & VULNERABLE AREAS

SITE DATA:
Location: ARCHIMEDIS LABS PVT LTD, A.P. INDIA
CHEMICAL DATA:
Chemical Name: ACETONE
CAS Number: 67-64-1
Molecular Weight: 58.08 g/mol
LEL: 26000 ppm UEL: 130000 ppm
Ambient Boiling Point: 56.20 c
ATMOSPHERIC DATA:
Wind: 2.8 meters/second from S at 3 meters
Air Temperature: 38° C
Relative Humidity: 75%
SOURCE STRENGTH:
Leak from hole in vertical cylindrical tank
Flammable chemical is burning as it escapes from tank
Tank Diameter: 2 meters
Tank Length: 6.5 meters
Tank Volume: 20.4 cubic meters
Tank contains liquid
Chemical Mass in Tank: 15.5 tons
Tank is 88% full
Total Amount Burned: 5486 kgs
Note: The chemical escaped as a liquid and formed a burning puddle.
The puddle spread to a diameter of 6.9 yards.
THREAT ZONE:
Threat Modeled: Thermal radiation from pool fire
Red : 14 yards --- (10.0 kW/(sq m) = potentially lethal within 60 sec)
Orange: 18 yards --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec)
Yellow: 26 yards --- (2.0 kW/(sq m) = pain within 60 sec)

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In case the Leakage of Acetone from storage tank got ignited, the vulnerable
areas, which are in radius of 12.8 meters within a minute, will get affected.
The Thermal radiation from pool fire of Acetone having value of 10 kw/sqm is
potentially lethal to the plant personnel from south of the plant with in the radius
of 12.8 meters .The plant personnel with in radius of 16.5 meters are vulnerable
for second degree burns within a minute.
The leakage of Acetone in the plant and its consequence considered as Major
and its likelihood is unlikely
Significance = Likelihood X Consequence
=3*4
=12
As defined in Risk Criteria and action requirements
The risk significance is Medium.
―Risk is tolerable‖ –
Mitigation measure: It is Flammable liquid. Storage tank should be checked at
regular intervals for any corrosion, weak joints and tank bottom isolation valve for
its operating condition and earthing of the tank. Check regularly earth pit
resistance. At any point of time do not place any ignition source near by the tank.
In case of fire use fire hydrant system to extinguish the fire in order to minimize
the risk level and avoid fire spread to other areas of the plant. Inform plant head

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for emergency preparedness. Put water curtain on adjacent tanks to avoid heat
radiation to contents of the tank.

Acetone
SOURCE STRENGTH:
Leak from hole in vertical cylindrical tank
Flammable chemical escaping from tank (not burning)
Tank Diameter: 2 meters
Tank Length: 6.5 meters
Tank Volume: 20.4 cubic meters
Tank contains liquid
Chemical Mass in Tank: 15.5 tons
Tank is 88% full
Circular Opening Diameter: 2 inches
Total Amount Released: 4200 kgs
Note: The chemical escaped as a liquid and formed an evaporating puddle.
The puddle spread to a diameter of 23 yards.
THREAT ZONE:
Model Run: Heavy Gas make dispersion predictions less reliable for short
distances.
Orange: 66 yards --- (3200 ppm = AEGL-2 [60 min])
Yellow: 327 yards --- (200 ppm = AEGL-1 [60 min])

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In case the Leakage of Acetone from storage tank the vulnerable areas, which
are in radius of 60 meters will get affected.
The airborne concentration of Acetone will affect seriously the plant personnel &
general population towards north side of the plant with in the radius of 60 meters
They may experience eye exposure & inhalation exposure.
The leakage of Acetone in the plant and its consequence considered as
moderate and its likelihood is unlikely
Significance = Likelihood X Consequence
=3*3 =9
As defined in Risk Criteria and action requirements
The risk significance is low.
―Risk is acceptable‖ –
Mitigation measure: It is Flammable liquid. Storage tank should be checked at
regular intervals for any corrosion, weak joints and tank bottom isolation valve for
its operating condition. The tank should have dyke wall equal to 110% of the tank
volume. This is to contain the leaked Acetone in the dyke only.
In case of leakage the contents should be transferred to another spare tank to
minimize the Risk level. Prevent entry into sewers, basements or confined areas.
Keep away from heat. Keep away from sources of ignition. Meanwhile the leaked
material should be contained. Absorb with dry earth, sand or other non-
combustible material.

CHEMICAL DATA:
Chemical Name: METHANOL
Molecular Weight: 32.04 g/mol
LEL: 71800 ppm UEL: 365000 ppm
Ambient Boiling Point: 64.70 c
ATMOSPHERIC DATA:
Wind: 2.8 meters/second from S at 3 meters
Air Temperature: 38° C
Relative Humidity: 75%
SOURCE STRENGTH:
Leak from hole in vertical cylindrical tank
Flammable chemical is burning as it escapes from tank

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Tank Diameter: 2 meters Tank Length: 6.5 meters


Tank Volume: 20.4 cubic meters
Tank contains liquid
Chemical Mass in Tank: 15.4 tons
Tank is 88% full
Circular Opening Diameter: 2.5 inches
Total Amount Burned: 8187 kgs
Note: The chemical escaped as a liquid and formed a burning puddle.
The puddle spread to a diameter of 14.7 yards.
THREAT ZONE:
Threat Modeled: Thermal radiation from pool fire
Red : 15 yards --- (10.0 kW/(sq m) = potentially lethal within 60 sec)
Orange: 19 yards --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec)
Yellow: 26 yards --- (2.0 kW/(sq m) = pain within 60 sec)

In case the Leakage of Methanol from storage tank got ignited, the vulnerable
areas, which are in radius of 13.7 meters within a minute, will get affected.
The Thermal radiation from pool fire of Methanol having value of 10 kw/sqm is
potentially lethal to the plant personnel towards south side of the plant with in the
radius of 13.7 meters.
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The plant personnel will be vulnerable for second degree burns within the radius
of 17.3 meters in a minute.
The fire due to leakage of Methanol in the plant and its consequence considered
as Major and its likelihood is unlikely
Significance = Likelihood X Consequence
=3*4 =12
As defined in Risk Criteria and action requirements
The risk significance is Medium.
―Risk is tolerable‖ –
Mitigation measure: It is highly flammable liquid in presence of open flames and
spark. Storage tank should be checked at regular intervals for any corrosion,
weak joints and tank bottom isolation valve for its operating condition and
earthing of the tank. Check regularly earth pit resistance. At any point of time do
not place any ignition source near by the tank.
In case of fire use fire hydrant system and fire extinguisher -alcohol foam to
extinguish the fire in order to minimize the risk level and avoid fire spread to other
areas of the plant.
Inform plant head for emergency preparedness. Put water curtain on adjacent
tanks to avoid heat radiation to contents of the tank.

CHEMICAL DATA:
Chemical Name: TOLUENE
Molecular Weight: 92.14 g/mol
LEL: 11000 ppm UEL: 71000 ppm
Ambient Boiling Point: 1100 c
ATMOSPHERIC DATA:
Wind: 2.8 meters/second from S at 3 meters
Air Temperature: 38° C
Relative Humidity: 75%
SOURCE STRENGTH:
Leak from hole in vertical cylindrical tank
Flammable chemical is burning as it escapes from tank
Tank Diameter: 2 meters
Tank Length: 6.5 meters

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Tank Volume: 20.4 cubic meters


Tank contains liquid
Chemical Mass in Tank: 16.9 tons
Tank is 88% full
Circular Opening Diameter: 2.5 inches
Opening is 6 inches from tank bottom
Total Amount Burned: 9020 kgs
Note: The chemical escaped as a liquid and formed a burning puddle.
The puddle spread to a diameter of 6.8 yards.

THREAT ZONE:
Threat Modeled: Thermal radiation from pool fire
Red : 19 yards --- (10.0 kW/(sq m) = potentially lethal within 60 sec)
Orange: 26 yards --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec)
Yellow: 38 yards --- (2.0 kW/(sq m) = pain within 60 sec)

In case the Leakage of Toluene from storage tank got ignited, the vulnerable
areas, which are in radius of 17.4 meters within a minute, will get affected.
The Thermal radiation from pool fire of Toluene having value of 10 kw/sqm is
potentially lethal to the plant personnel towards south side of the plant with in
the radius of 17.4 meters .The plant personnel with in radius of 23.7 meters are
vulnerable for second degree burns within a minute.

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The leakage & fire of Toluene in the plant and its consequence considered as
Major and its likelihood is unlikely
Significance = Likelihood X Consequence
=3*4 =12
As defined in Risk Criteria and action requirements
The risk significance is Medium.
―Risk is tolerable‖ –
Mitigation measure: It is flammable liquid in presence of open flames and spark.
Storage tank should be checked at regular intervals for any corrosion, weak joints
and tank bottom isolation valve for its operating condition and earthing of the
tank. Check regularly earth pit resistance. At any point of time do not place any
ignition source near by the tank.
In case of fire use fire hydrant system and fire extinguisher -alcohol foam to
extinguish the fire in order to minimize the risk level and avoid fire spread to other
areas of the plant. Inform plant head for emergency preparedness. Put water
curtain on adjacent tanks to avoid heat radiation to contents of the tank.

CHEMICAL DATA:
Chemical Name: N-HEXANE
Molecular Weight: 86.18 g/mol
LEL: 12000 ppm UEL: 72000 ppm
Ambient Boiling Point: 68.5° c
ATMOSPHERIC DATA:
Wind: 2.8 meters/second from S at 3 meters
Air Temperature: 38° C
Relative Humidity: 75%

SOURCE STRENGTH:
Leak from hole in vertical cylindrical tank
Flammable chemical is burning as it escapes from tank
Tank Diameter: 2 meters
Tank Length: 6.5 meters
Tank Volume: 20.4 cubic meters
Tank contains liquid

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Chemical Mass in Tank: 12.9 tons


Tank is 88% full
Circular Opening Diameter: 3 inches
Opening is 6 inches from tank bottom
Total Amount burned: 11375 kgs
THREAT ZONE:
Threat Modeled: Thermal radiation from pool fire
Red : 22 yards --- (10.0 kW/(sq m) = potentially lethal within 60 sec)
Orange: 30 yards --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec)
Yellow: 44 yards --- (2.0 kW/(sq m) = pain within 60 sec)

In case the Leakage of n-Hexane from storage tank got ignited, the vulnerable
areas, which are in radius of 20 meters within a minute, will get affected.
The Thermal radiation from pool fire of n-Hexane having value of 10 kw/sqm is
potentially lethal to the plant personnel towards south side of the plant with in
the radius of 20 meters .The plant personnel with in radius of 27.4 meters are
vulnerable for second degree burns within a minute.

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The leakage & fire of n-Hexane in the plant and its consequence considered as
Major and its likelihood is unlikely
Significance = Likelihood X Consequence
=3*4 =12
As defined in Risk Criteria and action requirements
The risk significance is Medium.
―Risk is tolerable‖ –
Mitigation measure: It is flammable liquid in presence of open flames and spark.
Storage tank should be checked at regular intervals for any corrosion, weak joints
and tank bottom isolation valve for its operating condition and earthing of the
tank. Check regularly earth pit resistance. At any point of time do not place any
ignition source near by the tank.
In case of fire use fire hydrant system and fire extinguisher -alcohol foam to
extinguish the fire in order to minimize the risk level and avoid fire spread to other
areas of the plant. Inform plant head for emergency preparedness. Put water
curtain on adjacent tanks to avoid heat radiation to contents of the tank.

CHEMICAL DATA:
Chemical Name: THIONYL CHLORIDE
Molecular Weight: 118.97 g/mol
ATMOSPHERIC DATA:
Wind: 2.8 meters/second from S at 3 meters
Air Temperature: 38° C
Relative Humidity: 75%
SOURCE STRENGTH:
Direct Source: 100 kilograms
Total Amount Released: 100 kgs
THREAT ZONE:
Model Run: Heavy Gas
Red : 886 yards --- (14 ppm = AEGL-3 [60 min])
Orange: 1749 yards --- (2.4 ppm = AEGL-2 [60 min])

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The leakage of Thionyl chloride liquid and its consequences are considered
as Minor and its likelihood is probable
Significance = Likelihood X Consequence
=2*4 =8
As defined in Risk Criteria and action requirements
The risk significance is low.
―Risk is Acceptable.‖ –
Mitigation measure: During unloading from Drum if unloading transfer pipe is
not fixed properly there may be sudden leakage of contents on to the
ground. This results in formation toxic area of vapor cloud of 14 ppm up to a
distance of 810 mts in which people may experience life threatening health
effects within one hour.
During transfer of material it is advisable to use diaphragm pumps where
spillages can be eliminated. While transferring the material the responsible
officer should be present.

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CHEMICAL DATA:
Chemical Name: AMMONIA
Molecular Weight: 17.03 g/mol
Ambient Boiling Point: -33°c
ATMOSPHERIC DATA:
Wind: 2.8 meters/second from S at 3 meters
Air Temperature: 38° C
Relative Humidity: 75%
SOURCE STRENGTH:
Direct Source: 50 kilograms
Total Amount Released: 50 kgs
THREAT ZONE:
Model Run: Gaussian
Red : 90 yards --- (1100 ppm = AEGL-3 [60 min])
Orange: 237 yards --- (160 ppm = AEGL-2 [60 min])
Yellow: 541 yards --- (30 ppm = AEGL-1 [60 min])

The Leakage of Ammonia gas and its consequences are considered as Minor
and its likelihood is probable
Significance = Likelihood X Consequence
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=2*4 =8
As defined in Risk Criteria and action requirements
The risk significance is low.
―Risk is Acceptable.‖ –
Mitigation measure: During charging ammonia from cylinder to reactor if
transfer pipe is not fixed properly there may be sudden leakage of gas in to
atmosphere. This results in formation toxic area of vapor cloud of 1100ppm up
to a distance of 82 mts in which people my experience life threatening health
effects within a hour.
During transfer of material it is advisable to use tested transfer pipe and its end
connections should be ensured for leak proof. While charging the material the
responsible officer should be present.

7.14. OCCUPATIONAL HEALTH


Hazardous and toxic substances will be defined as those chemicals present in the
work place which are capable of causing harm.
 For handling hazardous chemicals and to take care of employee‘s health,
and predictive maintenance looking to the nature of hazardous chemicals
being handled/processed. All the equipments in the plant areas shall be
inspected / tested by an outside agency.
 The various safety equipments like breathing apparatus and critical
instrumentation will be provided on various equipments are inspected and
tested frequently to ensure their operability all the time. Besides, all the first
aid, fire fighting devices will be inspected, tested and maintained by a
competent third party and kept all the time in ready to use condition.
 Health of all the employees in plant area will be monitored by outside
physician. If any abnormality is found necessary treatment is also being
given time to time. Necessary history cards, records will be maintained which
is up-dated time to time.

Common Hazards
 Physical such as ventilation, poor illumination, noise, extreme temperature,
humidity and radiation.
 Biological such as variety of pathogenic bacteria and parasites.

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 Chemical due to hazardous gases and dusts.


 Ergonomic.

Industrial Hygiene Monitoring


 Industrial hygiene monitoring is to be located and identify source of exposure
in the workplace so that they can be corrected and to quantify the exposure of
employees to chemicals in the air.

Occupational Health Monitoring System


A. Air samples
Locations of samples – air samples are generally collected in one or three
locations:
 At the breathing zone of the worker [Personal sample]
 At the operation which is generating the hazardous substance [Area
sample]
Lengths of samples – Air samples are generally collected for two lengths of time.
 Grab samples [instantaneous] measure conditions at one moment in time
and can be likened to a still photograph. They give only a picture of
conditions at one place at one instant in time.
 Continuous Samples [range from twenty minutes to 8 – 10 Hours].These
is used to evaluate all day exposure by a series of continuous samples.

B. Other sampling methods


Bulk samples
Bulk samples will be collected from settled dust in the work place or from drums
or bags of chemicals in the Warehouse. Their purpose is to analyze and identify
the substances present. For example, bulk samples are used to analyze the
percent of asbestos in insulation, dust & Chemical Powder. Usually, a substance
which is greater than one percent of bulk sample is considered a concern.

Wipe Samples
Wipe samples will be used when skin absorption or ingestion is a suspected
route of exposure. The purpose is to show whether skin, respirators, clothing,
lunch rooms, lockers, etc. are contaminated.

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It can show which surfaces are clean and which are contaminated. It can also
show if some surfaces are more contaminated than others.

7.14.1 Sampling Devices


The general principle of sampling is to collect an amount of a contaminant onto a
medium from a known quantity of air.
Air samples will be collected using small pumps to suck air from the workroom. The
pump is attached by tubing to a sampling device which contains the sampling
medium; for example a glass tube containing charcoal.
The sampling method will be used depends on the physical form of the substance:
 DUSTS –The sampling device is a filter of plastic or paper in s holder:
 VAPORS –The sampling device is a glass tube containing activated charcoal
as a medium.
 GASES –The sampling device is a bubbler containing a fluid medium to
dissolved or react with the gas
The collected samples will be sent to a laboratory where the amount of the
substance on the sampling medium [filter, tube, etc.] is measured.
In some cases air monitoring will be conducted by using direct reading instrument
such as a monitoring for carbon monoxide these instruments can measure the
amount of a contaminant in the air immediately without being sent to a laboratory.
 PELs [Permissible Exposure Limits] – these are legal‘s limits which have been
established by OSHA.
 Recommended PELs – also reference to as RELs [Recommended Exposure
Limits] often these values are based on more recent scientific information than
the legal PELs enforced by OSHA.
 TLVs [Threshold Limit Values] – These are exposure limits put out by a
nongovernmental group, the ACGIH [American Conference of Governmental
Industrial Hygienists]. Many of these were adopted as legal requirements.
Revised TLVs are often based on the most recent and accurate scientific
information.
 Permissible Exposure Limits by OSHA [Occupational Safety and Health
Administration] when it started back in 1970.
 IDLH [Immediate Dangerous to Life or Health] limits are prescribed by NIOSH
[National Institute of Occupational Safety and Health]

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 PAC [Protective action criteria] for Hazardous chemicals prescribed by


Emergency management issues special interest group, UNITED STATES.
 AEGL [Acute exposure guideline levels] values given by U.S Environmental
protection agency.

7.15 CHEMICAL EXPOSURE LIMITS & EMP FOR THE OCCUPATIONAL SAFETY
& HEALTH HAZARDS

TABLE: 7 .6 CHEMICAL EXPOSURE LIMITS


ACGIH OSHA
S. No SOLVENT NAME
[TLV ] [ PEL ]
1 Methanol 200 200
2 Toluene 50 200
3 Acetone 500 1000
4 Ethyl acetate 400 400
5 MDC 50 500
6 Cyclohexane 300 300
7 Thionyl chloride 1 1
8 Ammonia 25 50
9 n-Hexane 50 50

Notes:
 All the above Values are in ppm
 PPE Means Personal Protective Equipment like Helmets, Safety Google,
Breathing apparatus, Nose Masks, Gloves, Gum Shoes etc.,

NOTE: Medical testing reports of the Employees will be available at the time of
industry in operation

EMP for the Occupational Safety & Health Hazards so that such exposure can be
kept within permissible exposure level (PEL) / Threshold Limit value (TLV) so as to
protect health of workers.
1. It is proposed to formulate and implement an EMP for Occupational Safety and
Health with following aim

 To keep air-borne concentration of toxic (if available) and hazardous


chemicals below PEL and TLV.
 Protect general health of workers likely to be exposed to such chemicals

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 Providing training, guidelines, resources and facilities to concerned


department for occupational health hazards
 Permanent changes to workplace procedures or work location to be done if it
is found necessary on the basis of findings from workplace Monitoring Plan.

2. Proposed EMP will be incorporated in Standard Operating Procedure also


3. The proposed EMP will also include measure to keep air-borne concentration of
toxic and hazardous chemicals below its PEL and TLV, like…
 Leak Surveys
 Separate storage for toxic chemicals
 Exhaust Ventilation
 Proper illumination
 Close processes to avoid spills and exposures
 Atomization of process operations to hazards of manual handling of chemicals
 Supply of proper PPEs like Air mask, Breathing canisters, SCBA sets.
Decontamination procedure for empty drums and carboys.
 Regular maintenance program for pumps, equipment, instruments handling
toxic and corrosive chemicals
 Display of warning boards
 Training to persons handling toxic and corrosive chemicals.

4. Workplace Monitoring Plan


 It is proposed that a Workplace Monitoring Plan to be prepared &
implemented accordingly.
 Each workplace must be evaluated to identify potential hazards from toxic
substances or harmful physical agents. Air-borne concentration of toxic
chemicals will be measured and record will be kept.
 The current state-of-the-art exposure measurement model is as follows: For
purposes of measuring worker exposure across a single shift it is sufficient to
place a reasonably accurate exposure measuring device near the worker‘s
area, within the worker‘s breathing zone, and have it operate for nearly the full
shift. Client has been proposed to study the exposure data when the plant is
operative.

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5. Health Evaluation of Workers


 It is proposed that management will devise a plan to check and evaluate the
exposure specific health status evaluation of workers.
 Workers will be checked for physical fitness with special reference to the
possible health hazards likely to be present, where he/she is being expected
to work before being employed for that purpose. Basic examinations like
1. Liver Function tests,
2. Chest X-ray,
3. Audiometry,
4. Spirometry Vision testing (Far & Near vision, color vision and
Any other ocular defect)
5. ECG, etc. will be carried out.

However, the parameters and frequency of such examination will be decided in


consultation with Factory Medical Officer.
 While in work, all the workers will be periodically examined for the health with
specific reference to the hazards which they are likely to be exposed to during
work. Health evaluation will be carried out considering the bodily functions
likely to be affected during work. The parameters and frequency of such
examination will be decided in consultation with Factory Medical Officer. Plan
of monthly and yearly report of the health status of workers with special
reference to Occupational Health and Safety, will be maintained.

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7.16. TREATMENT OF WORKERS AFFECTED BY ACCIDENTAL SPILLAGE OF


CHEMICALS
[Interim First Aid for General Injuries & Wounds]
Interim First Aid is essential in many injuries while injured waits for trained personnel
to arrive.

BLEEDING
 Apply direct pressure on the wound with a clean dressing.
 If bleeding continues and you do not suspect a fracture, elevate the wound
above the victim‘s heart and continue to apply direct pressure.
 If bleeding continues, apply pressure at a pressure point.
 Maintain body temperature.
 Do not use a tourniquet unless this is a serious amputation.

BREATHING PROBLEMS
 Move victim to fresh air if smoke or dangerous gases are present.
 Otherwise, do not move victim.
 If victim loses consciousness, call doctor
 Never enter into a room with toxic gases released -call without protection

UNCONSCIOUS VICTIM
 Move victim to fresh air if smoke or dangerous gases exist.
 Begin rescue breathing- is First Aid trained ahead of time
 Never enter into a room where toxic gases released

CHEMICAL BURNS
 Have victim remain under a safety shower or flush skin with an available
water source for 15-30 minutes.
 Remove all contaminated clothing and jewellery.
 Cover burns with dry, loose dressings.
 Wash all clothing thoroughly before wearing it again.

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ACID BURNS
 In case of acid burn, the operator should with all possible speed get under a
safety shower and use the full flow of water - the more water the better. A
small amount of water will incase severity o f the burn Water should be used
until all traces of acid have been washed from the burn. Alkaline solutions are
not needed; if used at all they should be used only after all acid has been
washed from the burn, it may to treat in the same manner as a heat burn.

CHEMICAL INGESTIONS
 Never enter into a room where toxic gases released, without protection
 Do not give victim any food or liquids without specific advice from physician.

EYE INJURIES FROM CHEMICALS


 Get victim to a safety shower or eye wash immediately.
 Never enter into a room where toxic gases released
 Flush eye for 15-30 minutes with both lids held open. Keep the injured eye
lower than the uninjured eye.
 Keep the eyelids open hold fingers at top and bottom of the eyeball. Wrap a
bandage loosely around both eyes.

SAFE OPERATING PROCEDURES


 Safe operating procedures will be available for all materials, operations and
equipment.
 The workers will be informed of consequences of failure to observe the safe
operating procedures.
 Safe operating procedures will be formulated and updated, specific to process
& equipment and distributed to concerned plant personnel.
 Safety procedures will be prepared and displayed meticulously in Telugu and
English languages.

FIRE PROTECTION
 Well-designed pressured hydrant system comprising with jockey pump,
electrical & diesel pumps, hydrant, monitor etc. Will be installed at the plant.

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 The fire fighting system and equipment will be tested and maintained as per
relevant standards.
 Heat and smoke detectors will be provided at the plant and warehouse(
solvent storage in drums) and calibrated and maintained properly.

STATIC ELECTRICITY
 All equipment and Storage tanks / Containers of flammable chemicals are will
be bounded and earthed properly.
 Electrical pits will be maintained clean and covered.
 Electrical continuity for earthing circuits shall be maintained.
 Periodic inspections shall be done for earth pits and record will be maintained.

7.18 COMMUNICATION SYSTEM


Communication facilities will be checked periodically for its proper functioning.

7.19 SAFETY INSPECTIONS


The system will be initiated for checklist based routine safety inspection and internal
audit of the plant. Safety inspection team will be formed from various disciplines and
departments.

7.17 PREDICTIVE AND PREVENTIVE MAINTENANCE


Predictive and preventive maintenance schedule will be followed in religious manner.

ELECTRICAL SAFETY
 Insulation pad at HT panels will be replaced at regular interval.
 Housekeeping in MCC room will be kept proper for safe working conditions.

COLOUR CODING SYSTEM


Colour coding for piping and utility lines are will be followed in accordance with IS:
2379:1990.

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DISASTER MANAGEMENT PLAN


 ONSITE EMERGENCY PLAN
 OFFSITE EMERGENCY PLAN

7.18. ONSITE EMERGENCY PLAN


The details of Onsite emergency plan system are discussed in the following sections

DEFINING THE NATURE / LEVEL OF EMERGENCY


The levels of emergency can be classified in three categories

LEVEL-1
The leakage or emergency which is confinable the plant, premises. It may be due to-
 Small fire in the plant
 Low toxic gas release for short duration.
 Collapsing of equipment that do not affect outside premises.

LEVEL-2
The emergency which is confinable within the factory premises. It may arise due to-
 Major fire inside the factory premises.
 Medium scale explosion confined to the factory premises.
 Heavy toxic/flammable gas leakage for short duration.

LEVEL-3
The emergency, which is not confinable within the factory premises and general
public in the vicinity likely to be affected. It may arise due to-
 Explosion of high magnitude affecting the adjacent area
 Heavy/profuse leakage of toxic/flammable gases for a long duration.

7.19 STRUCTURE OF EMERGENCY MANAGEMENT SYSTEM


The company will develop an emergency management team. The management
structure includes the following personnel
 Site main Controllers
 Incident Controllers and Deputy Incident Controllers
 Key Personnel‘s
 Essential Workers

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The other elements of Disaster management plan are


 Assembly points
 Emergency control center
 Fire control center
 Medical arrangements
 Other arrangements

7.20 EMERGENCY MANAGEMENT SYSTEM – ROLES & RESPONSIBILITIES


Roles and responsibilities of the responsible persons are described.

7.20.1 SITE MAIN CONTROLLER [SMC]


PLANT HEAD will be the site main controller. In absence of PLANT HEAD, EHS
HEAD will act as a SMC
His task will be to co-ordinate all internal and external activities from the emergency
control centre at main security gate from where all operations will be directed. He
shall:
 Immediately on being informed of the emergency and its location, will arrive
at the scene and handle the situation.
 Relieve the incident controller from responsible of the main controller
 Co-ordinate to avail services from external agencies like fire brigade,
hospitals etc. is called for, following the declaration of major emergency. If
necessary, major installations in the vicinity may also be informed of the
situation.
 Exercise direct operational control of the unaffected section of the plant.
 In consultation with the advisory team, expedite the shutting down of
loading/unloading operations of tankers and if necessary, instruct the
supervisor/security/personnel to evacuate tankers.
 Ensure that all employees are evacuated from the affected area and the
casualties, if any, are given necessary medical attention. Instruct P&A
Assistant/security for rushing casualties to hospitals if required.
 Liaise with fire and police officials, pollution control board officials and other
statutory bodies and advise them of all possible consequence effects
outside the premises.
 Arrange for relief of personnel when emergency is prolonged

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 Issue authorized statement or press release to the news –media


 Ensure preservation of evidence for enquiries to be conducted by statutory
authorities.
 Authorize the sounding of “All Clear” and “Evacuation Siren”
 Arrange for obtaining the head-count of all personnel within the premises
and cross-checking with the data from records available for no. of persons
within the premise.

7.21 INCIDENT CONTROLLER/ DEPUTY INCIDENT CONTROLLER


Role of Incident Controller [Plant Manager/Shift in Charge].He is the shift supervisor
of the plant. Assume the role of the incident controller and take charge of the
situation. Keep the SMC informed of the situation from time to time.
1. Proceed to the scene of emergency and assess the situation
2. Direct all operation within the affected area with the following priorities
 Safety of personnel
 Minimize damage to property and loss of material
 Arrange for rescue of trapped workers and those in a state of shock
 Get all non-essential persons safely evacuated after stopping all the
engineering/hot jobs.
 Set up a communication system with the main control center at the main
security gate through telephone or messenger system.
 Pending arrival of the main controller, direct the shutting down and
evacuation of the site
 Report all developments to the main controller
 Preserve all evidence for use in the subsequent enquiry.
 Intimate to the Emergency Control Center (Main Security Gate) the head
count of plant.

7.22 KEY PERSONNELS


 Key Personnel are required to provide and to implement the decisions made
by the SMC in the light of information received on the developing situation at
the time of emergency.
 As necessary, they will decide the actions needed to shut down plants,
evacuate personnel, carryout emergency engineering work, arrange for

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supplies of equipment, utilities, carryout environment monitoring, provide


catering facilities, liaise with police, fire brigade and other local authorities,
relative of casualties, hospital, press & neighboring industries
 Action at assembly points, outside shelters and mutual aid center under the
direction of the SMC.
 All the key personnel and other called in so to assist shall report to the ECC.
 They shall be available at any time on duty or on call or on holiday.

7.23 ESSENTIAL WORKERS


A task force of essential trained workers [Expert‘s team] is available to get the work
done by the Incident controller and the SMC. Such work will include:
 Fire fighting and spill control till a FIRE BRIGADE takes the charge
 To help FIRE BRIGADE and MUTUAL AID teams, if it is so required
 Shutting down plant and making it safe
 Emergency engineering work e.g. isolating equipments, material process,
providing temporary by pass lines, safe transfer of materials, urgent repairing
or replacement, electrical work, etc
 Provision of emergency power, water, lighting, instruments, equipments,
materials, etc
 Movement of equipment, special vehicle and transport to or from the scene of
the accident.
 Search, evacuation, rescue and welfare.
 The injured is given First Aid.
 Moving tankers or other vehicles from area of risk.
 Carrying out atmospheric test and pollution control.
 Manning of assembly points to record the arrival of evacuated personnel.
Manning for outside shelters and welfare of evacuated persons there.
 Assistance at causalities reception areas to record details of causalities.
 Assistance at communication centers to handle outgoing and incoming calls
and to act as messengers if necessary.
 Manning of works entrances in liaison with the police to direct emergency
vehicles entering the work. To control traffic leaving the works and to turn

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away or make alternative safe arrangements for visitors for visitors,


contractors and other traffic arriving at the works.
 Inform neighbouring factories and the public as directed by the Site Main
Controller.
 Any special help required.

7.24 OTHER ELEMENTS OF DMP


There are some other elements of DMP which are described as follows:

7.24.1 ASSEMBLY POINT


Assembly points are those locations where the persons who are not connected with
emergency operations can await either for further instructions or for rescue transport
and rehabilitation. Security office will be considered assembly point, taking into
consideration of the size of the plant facilities.

The affected & vulnerable plants, all non-essential workers [who are not
assigned any emergency duty] will be evacuated from the area & they shall
report to specified Assembly point.
 Assembly Point shall be located at a safe place, well away from area of risk
and least affected by the down wind direction.
 To ensure that workers do not have to approach the affected area to reach
the Assembly point proper location and numbers have been marked at
Assembly point.
 Each Assembly Point is manned by a nominated person to record the names
and dept.
 At each Assembly point duties of In - charge shall be displayed in brief.
 Before reaching an Assembly point or subsequently, if it is required to pass
through an affected area or due to presence of toxic substances, suitable
PPE‘s including respirators, helmet etc., are issued & made available with
workers.

7.24.2 EMERGENCY CONTROL CENTER


The emergency Control Center is the place or room from where the operations to
handle the emergency are directed and coordinated. Main Control Room has been
earmarked / identified as the Emergency Control Room. Fire Control Room shall be

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earmarked / identified as the alternative Emergency Control Room to be operated in


case of unfavorable wind direction. Adequate Telecommunication System is
available in the Emergency Control Room.
The ECC center has been equipped with the following facilities.
1. Internal and external telephone including STD facility
2. Telephone directory
3. Factory layout plan
4. Map of the area
5. Employee blood group and their address
6. Messengers / Runners for sending messages
7. Adequate numbers of PPE‘S
8. Telephone nos. of mutual aid centers, Statutory authorities & Hospitals

7.24.3 FIRE SERVICES


Fire Fighting, Gas leak Control and Rescue operation

A] Role of Manager -Fire and Safety/shift in-charge

 Manager [EHS] shift in-charge [EHS] will be the only person to direct the
fire fighting and emergency operation.
 Keep the constant touch with the chief emergency controller.
 Direct the crew members to the scene of emergency and arrange
replenishment of man power/equipment/extinguishing media etc.

B] Fire and Safety officer


 On being notified about the location of fire/gas leakage immediately
proceed to the scene of incident with fire tender and crew.
 Position the fire tender in upwind direction.
 Decide his line of action in consultation with incident controller and take
appropriate measures to handle the emergency.
 Assessing the severity of the incident immediately report to emergency
controller about the gravity of the situation.
 He will assess the extra requirement required if any from the neighboring
industry.

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C] Fire Crew Members


 On hearing fire alarm, emergency siren they shall immediately report to
control room and proceed to the scene of emergency and work under the
direction of shift fire & safety officer.
 The personal availability at the scene of incident to be made optimize.

D] Emergency Squad Members


 On hearing Emergency Siren ,they shall immediately report to site main
controller, safety in charge or incident controller
 They shall combat the emergency situation as per the direction of site main
controller, Safety In- charge or Incident controller
 They shall help for safe evacuation

7.24.4 MEDICAL SERVICES

A] Role of Chief Medical Officer/Medical Officer [Medical Assistance]


 He will contact immediately to chief emergency controller
 He will render necessary treatment as first aid center and hospital.
 He will arrange for hospitalization and treatment at outside hospitals if
required.
 He will mobilize extra medical assistance from outside if necessary.
 He will make arrangement for treating public if necessary.

B] Role of other Medical staff


 As directed by medical officers.

7.24.5 SECURITY SERVICES


Role of H.O.D. (Security) / Security Officers.
 Receive message from the observer
 Initiate the emergency siren to declare the emergency
 Announce on the public address system
 Arrange to close all the gates and stop traffic
 Keep vehicle/ambulance ready and keep track of casualty sent to hospital
during off hours

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 Ensure that unauthorized persons/vehicles do not enter the premises


 Organize the positioning and transport of vehicles near the main gate
 Depute security guard for controlling traffic at the scene of emergency
 Call up for additional help from the outside agency like fire brigade,
hospitals during off hours.

Role of Security Guard


 On hearing emergency siren contact security officer and work under his
directions

7.24.6 MUTUAL AID


In emergency situations, resources over and above those available at the works may
be needed. Emergency Coordinator would be contacting neighboring factories for
help. A survey of industries who can come to help and also the help, they can extend
is done as mentioned below.
 The help would be in the form of technical manpower, medical aid,
transport for rescue and Rehabilitation, fire fighting, additional special
protective wear or any other help as the case may be.
 Manager – Safety who is Emergency Coordinator is assigned with this
responsibility and he would maintain liaison during non-emergency period
and ensure co-operation
 Similarly, the help required from civil administration, in respect of medical
aid, transport, law and order, rehabilitation etc. are identified and liaison is
established with Mandal Revenue Officer and Police Officials.

7.25 EMERGENCY RESPONSE


Concept of operations deals with the possible steps associated with an
emergency response assuming the most severe emergency scenario. This
includes:
 Accident initiation and rising of alarm
 Accident evaluation and emergency declaration
 Off site and external agency notification
 Implementation of onsite response actions
 Implementation of protective actions and evacuations

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 Co-ordination of response action with external agencies


 Management of emergency resources
 Recovery and facilitate re-entry procedures

7.26 EMERGENCY CAPABILITIES


The primary emergency response facilities comprise with emergency control
center upon declaration of emergency, the main security gate office will become
the emergency control center [ECC].The ECC is located in a low /minimal risk
zone of the plant. It is manned round.

7.27 EMERGENCY HANDLING PROCEDURES


Action plan
 On hearing emergency declaration siren and announcement on public
address system, all key persons will rush to their nominated location and
start actions.
 The main controller will continuously assess the situation by taking
feedback from the incident controller. He will consult the advisory team
members to get essential information if required but if does not required to
take help from advisory team; he can assign other jobs to advisory team.
 Once the emergency is brought under control, Main Controller will inform to
security to give “ALL CLEAR” siren and announce on Public Address
System about termination of emergency.
In the case the emergency assumes off site dimensions and cannot be controlled,
then if the chief controller with his advisory team decides to evacuate the plant, he
will instruct the security to sound ―EVACUATION SIREN”

Procedure in case emergency tends to have off site implications


 As per the sire plan and wind direction at the time of emergency, the likely
affected area will be identified and population within will estimated.
 The police will be informed so that in-coming traffic on highway can be
controlled from both the ends. The police force will be helpful in
evacuation of villages, factories or other public places in the vicinity
 The fire brigade will be informed and ambulance will be called and kept
ready to meet any eventuality.

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 Neighboring factories will be communicated for sending help.


 Statutory authorities such as factory inspector, district collector and others
concerned to be intimated.
Procedure for salvage operations
 The salvage operation will be carried out under the guidance of the main
controller, his advisory team and incident controller.
They will conduct accident investigation; assess the damages-the clock by
security supervisors.
During emergency, the main controller and his advisory-team will confirm:
 Layout of facility, equipment and storages, displayed on table and wall
 Availability and location of personal protective equipment
 Self-contained breathing apparatus sets and the spare cylinders
 External telephone with direct dialing and STD facilities/Mobile phone
 Internal telephone
 List of important internal and external telephone numbers displayed on
table and wall.
 Transport facility
 Extra copies of plant layout for marking during emergency
 General stationary like paper, pencil etc.
 Nominal roll and address of all employees with contract telephone no‘s
and blood group
 List of first aiders and emergency squad members
 Details of all contractors and their employees.
 Details of meteorological information during different seasons such as
wind speed, direction, temperature, humidity etc.
The location of ECC, Assembly point, availability of first aid boxes, fire
extinguishers, PPE should be marked onsite.

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7.28 MITIGATION OF ENVIRONMENTAL IMPACT DURING FIRE EMERGENCY


 In case of fire, cut of contact of fire with flammable material or prevent of
fire by other means
 Use water or suitable fire extinguisher to extinguish fire
 Contain the contaminated water or any other liquid to prevent it going to
soil or drain and divert it to ETP storage tank. If required treat it before
sending to ETP tank.
 Any solid waste generated should be collected, stored and send to TSDF
site.
 During fire emergency use necessary PPE.
 Bottom valve failure: mitigation of environment impact during failure of
between valves or tank failure.
 In case of material coming out of the bottom valve shall be contained
inside the dyke wall and will be transferred to HDPE plastic drum by help
of pump/piping.
 In case of acid spillage after pumping shall be neutralized and waste shall
be cleaned with help of water and send the water to ETP.
 The failed bottom valve shall be replaced or repaired and restart. After
tank is empty valve will be repaired, or replaced. In case of leakage form
tank body tank will be repaired.
 Preventions of failure: preventive maintenance of bottom value shall be
carried out as per schedule. To prevent any leakage from tank body,
thickness checking shall be same as per schedule.
 In case of bottom value failure or heavy leakages from tank body material
in the tank shall be transferred to the HDPE drums, by running the pump.
 Preventions of failure: preventive maintenance of bottom valve shall be
carried out as per schedule. To prevent any leakage from tank body,
thickness checking shall be same as per schedule.
 In case of any material leaching the soil it shall be neutralized and
washed with water.

7.28.1 RAISING THE ALARM


 Emergency alarm shall be raised in the event of an emergency.

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 Any person noticing an unusual occurrence, fire,toxic or corrosive


substance leakage etc. shall inform the concerned department/section
head/shift in charge immediately and try to control/contain the incident.
 Departmental head/shift in charge will immediately go to the site of
incident, assess the situation and initiate the action to ―blow the
emergency Alarm‖ by telephoning the main gate to security officer/Asst,
security officer/Security supervisor.
 In case of telephone failure a messenger will be sent running to main gate
to inform.
Details of siren are given below

Siren codes
 Declaration of emergency:-A long short wailing siren for one minute will
mean that there is an emergency within the premises.
 All clear siren: - A long siren for one minute will mean that the emergency
declared is under control, i.e. all clear. This siren code will mean All clear,
normal condition.
 Evacuation siren: - A long short wailing siren for 3 [three] minutes, will
mean that emergency declared cannot be controlled. Hence all persons in
the premises will evacuate as per the plan.

7.29 DECLARING MAJOR EMERGENCY


Major emergency may be declared after sufficient thought because it activates many
agencies and the nominated persons to declare major emergencies.

7.30 TRANSPORT AND EVACUATION ARRANGEMENTS


 Arrangements shall be made for the transport and evacuation of persons in
case of any emergency situation arises in the factory.
 Those employees who have own vehicles will make arrangements to shift the
injured.

7.31 PLANT OPERATIONS


1. Role of HOD
 He will take plant related decisions, which will facilitate the fire fighting
operation.
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2. Plant Employees
They shall:
 On heaving the siren, report to plant supervisor
 Do as directed by plant supervisor
 Stop all hot works
 Remove unwanted persons from the affected area to the ―Assembly Point
―near main security gate viz visitors, guests
 Stop all non-essential operations

3. Non-plant Employees
On hearing the siren, shall stop their work assemble at ―Assembly Point‖ near main
security gate along with guests and visitors.

7.32 TELEPHONE MESSAGES


Telephone operator has to pay vital role in case of emergency. After hearing the
siren/hooter, he/she should inform to all key personnel immediately on phone.
He/she should receiving be very sharp, precise, attentive and quick in & noticing the
message.

7.33 MOCK DRILL


In spite of detailed training, it may be necessary to try out whether, the OSEP works
out and will there be any difficulties in execution of such plan. In order to evaluate
the plan and its effectives of meeting the objective of the OSEP, occasional mock
drills are contemplated. After a few pre- informed mock drills, few un-informed mock
drills would be taken. All this is to familiarize the employees with the concept and
procedures and to see their response. These scheduled and unscheduled mock
drills would be conducted during shift change, public holidays, in night shifts etc, to
improve preparedness. Emergency Coordinator [EHS] is responsible for organizing
planned and unplanned mock drills.
Two types of Mock drills are in practice. They are
1. Announced-Once in 3 months
2. Unannounced –Once in 6 months.

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Mock drill observation


Mock drill observation team is constituted and they note down the action of various
coordinators in chronological order. The time of arrival of each coordinator and their
duties are detailed in a note. Immediately after mock drill, the advisory team and
emergency coordinators meet and review the mock drill records in chronological
order and take note of corrective action. The record of this meeting note is circulated
for compliance of concerned.

Role of Mock drill observers


 Note readings of plant instruments
 Meteorological conditions
 Time of emergency declaration and time when the personnel responded /
reported
 Ambulance reported and time when additional vehicles reported
 Collect information description of the event, estimated quantity of the gas
release, fire, contamination and effected levels at various locations, injuries
and equipment damage.

7.34 OFFSITE EMERGENCY PLAN
―If the accident is such that its affects inside the factory are uncontrollable and it
may spread outside the factory premise, it is called as “OFFSITE EMERGENCY”

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FLOWCHART FOR OFFSITE EMERGENCYPLAN

The Offsite emergency plan is made based on events, which could affect people and
Environment outside the premises. The off site plan is largely a matter of ensuring
the co-ordination of proposed services and their readiness as far as possible, for the
specific hazards and problems, which may arise in as incident. Briefly two main
purposes of the plan are as under:
To provide the local district authorities, police, fire brigade, doctors etc. the basic
Information of risk and environmental impact assessment and to appraise them of
the consequences and the protection / prevention measures and control plans and to
seek their help to communicate with the public in case of major emergency.
To assist the district authorities in preparing the Offsite emergency plan of the
district or particular area. We will make our key personnel and others fully aware
about this off-site emergency plan. The function of the offsite plans are as under:
Structure of the offsite emergency plan includes the following:-
 Organizational set up-Incident controller /Site main controller, Key personnel,
etc
 Communication facilities - List of important telephones
 Specialized emergency equipment - Firefighting equipment

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 Specialized Knowledge - Trained people


 Voluntary Organization - Details of organization
 Chemical information - MSDS of hazardous substances
 Meteorological information - Weather condition, Wind velocity etc
 Humanitarian arrangement - Transport, First aid, Ambulance

7.35 ROLE OF THE FACTORY MANAGEMENT


The Onsite and Offsite plans are come together so that the emergency services are
call upon at the appropriate time and are provided with accurate information and a
correct assessment of situation.
7.35.1 ROLE OF LOCAL AUTHORITY
Generally the duty to prepare the off-site plan lies with the local authority. They may
have appointed an Emergency planning officer (EPO) to prepare whole range of
different emergency within the local authority area.

7.35.2 ROLE OF FIRE AUTHORITY


The control of a fire is normally the responsibility of the senior fire brigade officer who
would take over the handling of fire from the Incident Controller on arrival at the site.

7.35.3 ROLE OF POLICE


The overall control of an emergency is normally assumed by the police with a senior
officer designated as emergency coordinating officer. Formal duties of the police
during emergency include protection of life and property and controlling traffic
movements.

7.35.4 ROLE OF HEALTH AUTHORITIES


Health authorities, including doctors, surgeons, hospitals, ambulances etc. have a
vital role to play following a major accident and they should form an integral part of
the emergency plan. Major off site incidents are likely to require medical equipments
and facilities in addition to those available locally.

7.35.5 ROLE OF THE “MUTUAL AID” AGENCIES


Some types of mutual aids are available from the neighboring factories, as per need,
as a part of the onsite and Offsite emergency plan.

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7.25.6THE ROLE OF THE FACTORY INSPECTORATE


In the event of an accident, the factory inspector will assist the District Emergency
Authority for information and help in getting mutual aid from neighboring factories.
Unit maintains the records of details of emergency occur, corrective preventive
measures taken and in future the same practice will be continued. Unit will be
displayed the details like list of assembly points, name of the persons involve in the
safety team like Site Controller, Incident controller etc.

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CHAPTER -VIII

PROJECT BENEFITS
EIA Report Archimedis Laboratories Pvt. Ltd.

CHAPTER – VIII
PROJECT BENEFITS

The proposed project will become beneficial to the surrounding area or community in
terms of employment, social development and other benefits as described hereunder;

8.1 EMPLOYMENT POTENTIAL


The proposed project has employment potential for skilled (50 persons), semi-skilled
(30 persons) and unskilled (20 persons). The preference will be given to local
population for employment; this will increase the employment opportunity in the
surrounding area. Indirect employment is also bound to be generated to provide day-to-
day needs and services to the work force and industrial activity. This will also increase
the demand for essential daily utilities in the local market. The employed people will be
benefited financially.

8.2 CORPORATE SOCIAL RESPONSIBILITY (CSR) & CORPORATE


ENVIRONMENT RESPONSIBILITY (CER)
Archimedis Laboratories Pvt. Ltd not only carries out business but also understands
obligations towards the society. Unit will employ people from the nearby villages for the
proposed project. The wages paid to direct and indirect workforce in the proposed
project will fulfill their monetary requirements, which in turn leads to socio economic
development in the surrounding villages. The Project proponent is well aware of the
obligations towards the society and to fulfill the social obligations Unit will also try to
generate maximum indirect employment in the nearby villages by appointing local
contractors during construction phase as well as during operation phase. Unit will be
contributing reasonably as part of their CSR & CER activities. Unit will spend about
2.5% for CSR & 2% for CER activities like potable water supply & educational aid and
conduct medical camps & Self Help Skill Training to the nearby villages. CSR activities
identified and planned at present are described below Table.

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CSR & CER BUDGET FROM ARCHIMEDIS LABORATORIES PVT. LTD.

Project Location : Archimedes Laboratories Pvt. Ltd.


CSR Plan Period : Five Years from the date of commercial production.
Project cost : Rs. 30 Crores
Corporate Social Responsibility Budget : Rs. 75 Lakhs [2.5% of the Project cost] for 5 Years
Corporate Environment Responsibility Budget : Rs. 60.0 Lakhs [2% of the Project cost]

Total
CSR & CER 1st 2nd 3rd 4th 5th
S.No (Rs. In Proposed Action Plan
Activity Year Year Year Year Year
Lakhs)
 Proposed to establish RO plant for
Drinking water drinking water supply to Jayanthipuram
1 supply to 9.0 9.0 9.0 9.0 9.0 45.0
Pochampalli, Ravirala & Bandipalem,
nearby villages.
villages.
Educational Aid  Supply of books, uniforms and other
2 to the school 5.0 5.0 5.0 5.0 5.0 25.0 educational aides like computers with
students internet facilities to nearby village schools.
 Free Health checkup and supply of
3 Medical Camps 5.0 5.0 5.0 5.0 5.0 25.0 medicines to the sick people in the nearby
villages.
 Based on local identified needs, we will
set up training centre to impart skills such
as tailoring, toys making, book binding and
Self Help Skill
4 8.0 8.0 8.0 8.0 8.0 40.0 basic computer skills to local women and
Training
men
 Self help skill Training : Unskilled
/Semiskilled persons will be identified in

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Total
CSR & CER 1st 2nd 3rd 4th 5th
S.No (Rs. In Proposed Action Plan
Activity Year Year Year Year Year
Lakhs)
villages and given necessary training as
per industry requirement and we will
absorb the personnel in industry as and
when need arises
Total CSR & CER
27.0 27.0 27.0 27.0 27.0 135.0
Budget

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8.3 DIRECT REVENUE EARNING TO THE NATIONAL AND STATE EXCHEQUER


This project will contribute additional revenue to the Central & State exchequer in the
form of Central GST & State GST. Thus, the proposed project will help the Government
by paying taxes from time to time, which is a part of revenue and thus, will help in
developing the area. Demand of the proposed products in foreign market is also
significant, which will boost the export potential of the company as well as country.
Export oriented units plays vital role in development of economy as well as local
physical infrastructure for further boosting of industrial development with sustainable
approach as the industries need to maintain good environment & safety environment to
get better foreign market.

8.4 IMPROVEMENTS IN THE PHYSICAL INFRASTRUCTURE


The project proponent has proposed to develop infrastructural facilities like roads,
drinking water and power to the proposed site, easily accessible approach roads
required for public transport and material transport to the project site. Hence major
benefit to the public infrastructure is anticipated due to the proposed project.

8.5 IMPROVEMENTS IN THE SOCIAL INFRASTRUCTURE


The proposed project will have many employment & trade opportunities from the
inception of the construction activities. Thus, these considerable employment & trade
opportunities will eventually result in appreciable economic benefits to the local people
& businesses/contractors and helps to improve in the social infrastructure.

8.6 OTHER TANGIBLE BENEFITS


With this new unit, Archimedis Laboratories Pvt. Ltd. contributes to growth in
manufacturing sector and the country will also benefit from GST revenues, Foreign
exchange earnings from exports are envisaged. Beside economic benefits, the general
social & cultural development of the area is anticipated due to the CSR & CER activities
planned by the company. The long-term implications of this change can be definitely
considered as progressive development of surrounding area.

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CHAPTER -IX

ENVIRONMENT COST
BENEFIT ANALYSIS
EIA Report Archimedis Laboratories Pvt. Ltd.

CHAPTER - IX
ENVIRONMENT COST BENEFIT ANALYSIS

9.0 COST BENEFIT ANALYSIS


During the scoping stage; no recommendation of environmental cost benefit analysis is
suggested by the appraisal committee.

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CHAPTER -X

ENVIRONMENTAL
MANAGEMENT PLAN
EIA Report Archimedis Laboratories Pvt. Ltd.

CHAPTER – X
ENVIRONMENT MANAGEMENT PLAN

10.1 INTRODUCTION
Environmental Management Plan reflects the commitment of the management to
protect the environment within and outside the industrial premises. An environmental
management plan is required for formulation and monitoring of environmental
protection measures during and after construction / Modification and commissioning
of the projects. Hence, the construction and operational phase is considered for
outlining the Environmental Management Plan for the said industry. The plan
indicates the details as to how various measures have been taken by the industry to
mitigate the pollutants generated due to its operations.
The Potential Environmental Impacts from the construction and operational activities
of the industry are summarized below.

A. Construction / Modification Phase:

 Site preparation, sanitation, noise, construction equipment & waste and site
security.

B. Operation Phase:
 Air pollution due to emission of Particulate Matter, Sulphur dioxide, Nitrogen
oxide from the boiler stack and D.G. Set.
 Gaseous emissions from process leading to workroom air pollution.
 Noise pollution due to noise generating equipment operation.
 Disposal of effluent generated due to plant operations.
 Disposal of Solid Wastes generated due to the plant operation.

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FIGURE -10.1: FLOW CHART OF EMP

IDENTIFICATION OF THE
POTENTIAL IMPACTS

RECOMMENDED MITIGATION
MEASURES

DESCRIPTION OF MONITORING
PROGRAM
 ENSURE COMPLIANCE
WITH RELEVANT
STANDARDS AND
RESIDUAL IMPACTS

ALLOCATION OF RESOURCES
AND RESPONSIBLITIES FOR
PLAN IMPLEMENTATION

IMPLEMENTATION SCHEDULE
AND REPORTING
PROCEDURES

CONTIGENCY PLAN WHEN


IMPACTS ARE GREATER THAN
EXPECTED

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10.2 PRE- PROJECT ENVIRONMENTAL MANAGEMENT PLAN


Construction related impacts:
The industry is proposed to establish Bulk Drug Intermediates manufacturing unit.
The potential for environment pollution during the construction is obviously
considerably less than when the plant is in operation. The following factors require
control during the construction phase.

10.2.1 Site Preparation


The leveling operation will involve stockpiling of backfill materials. All the disturbed
slopes shall be stabilized with grass cover and dust nuisance controlled.

10.2.2 Sanitation
The site will be provided with sufficient and suitable toilet facilities with proper
hygiene for construction workers. Adequate potable water supply will be provided for
onsite workers.

10.2.3 Noise
The total noise effect in the vicinity during construction stage will be negligible in the
site and the site is far away from the nearest human habitation.

10.2.4 Construction Equipment and Waste


It will be ensured that construction related vehicles are properly maintained to
minimize exhaust emissions. Combustible waste will be burnt in a controlled manner.
Other wastes will be disposed off in to a dedicated dump. Spent liquid waste if any,
arising from chemical treatment of built-up portions for termites etc, will be correctly
neutralized and disposed off.

10.2.5 Site Security


The site will be secured by fencing and manned at entry points.

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10.3. ENVIRONMENTAL MANAGEMENT DURING OPERATION


10.3.1 AIR QUALITY
The emissions from boilers & D.G. Set are the sources likely to contribute to air
pollution. Adequate measures are being taken to minimize the impacts of these
emissions on the environment.
The baseline data collected during the study period indicate that all five pollutants
namely PM2.5, PM10, SO2, NOX, CO, NH3 and VOCs.
For generation of Steam, the industry proposed to install 4 TPH & 8 TPH coal fired
boilers & 5 TPH coal fired boiler is kept as stand by.
The coal requirement of 48 TPD will be met from government allocation or from local
authorized sources.
A 500 KVA & 1000 KVADG set is proposed for this project for usage during the
power failures. The industry proposed to install 6x200 TR, 1x250 TR & 1x300TR
cooling towers.

10.3.1.1 AIR POLLUTION CONTROL / MANAGEMENT


Following are the proposed pollution control schemes and which will be used to
minimize and control the emission of air pollutants as well as their effective
dispersion into the atmosphere.

A. Stack Design
The stacks of height 34 mtrs & 30 mtrs with controlling equipment (cyclone separator
followed by Bag Filters) will be provided for the coal fired boilers with the
approximate flue gas exit velocity of 16 m/s & 14 m/s ensures proper dispersion of
the flue gas into atmosphere. This design will ensure the ground level concentration
of the pollutants to comply with the ambient air quality standards.
DG Set Stack emission Controlled by providing adequate stacks height to disperse
into atmosphere and maintain the air pollutants within the limits prescribed by CPCB.

B. Fugitive Emissions from Solvents


Various types of solvents will be used in the proposed Bulk Drugs manufacturing
process. The solvents will be stored in drums and Bulk quantities will be stored in
storage tanks with vent condensers. These are handled in closed conditions thereby
reducing the losses in the form of evaporation. The industry will take measures for
reduction of fugitive emissions by providing Chilled brine circulation to the
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condensers, which ensures the recovery of 95% and also controlled by closed
operations and handling methods. Good ventilation will be provided to reduce the
workroom concentrations. The reactor generating solvent vapors will be connected
to condensers with receivers.

C. Storage and Transportation of Raw Materials


The Raw materials / chemicals will be received in Fiber drums, HDPE drums, PP
bags by trucks. The same will be stored in ware house under lock & key
arrangement. Slight increase of Ground level Dust and VOC in air and it can be
minimized by developing Greenbelt in and around the plant premises and providing
proper roads for transportation.

10.3.2 NOISE POLLUTION


All the equipment in the plant would be designed as per the requirement of CPCB
standards.

NOISE ENVIRONMENT
Compressors, Boiler and DG set will be the major noise generating units in the plant,
of which generator will be functioning only at the time of power failure. There is no
need for the workers to be near the DG set & compressor units continuously. The
Generator sets will be placed in acoustic enclosures to maintain the noise levels as
permitted by CPCB.

NOISE POLLUTION CONTROL / MANAGEMENT


 The noise levels in the work place environment will be monitored periodically
and if necessary action will be taken in the form of regular maintenance
schedule to reduce noise and vibration in generating sources.
 The effects of the vibrations coming out of the base of the body over the
surrounding civil structures are minimized by providing Damping pads/Resilient
mounting at the time of installation.
 Under the general health check up scheme as per factory act, the workers will
however be checked up for any Noise induced Hearing Loss (NIHL) by a trained
ENT Doctor.

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10.3.3 WATER QUALITY


Water is essentially used in process, Boiler and for cooling tower along with
domestic purpose. The total water required for the plant operations will be met from
Ground Water source.

WATER POLLUTION CONTROL / MANAGEMENT


The effluent generation is from process, boiler blow down, DM Plant Regeneration,
Scrubbing System, Floor & Reactor washings and Domestic sections.
 The unit will provide proper wastewater collection and Treatment methods to
treat the trade effluent in the plant premises.
 Process effluent will be segregated based on COD & TDS concentration and
collected separately by gravity from all sources into a collection Pit.
 Collected waste water will be pumped in to the above ground level tanks
separately.
 The industry by opting ZLD treatment system to recover water for recycle and
reuse for plant operations and to conserve the scarce resource of water.

Treatment system
 The effluent will be neutralized, the HTDS/HCOD effluent will be sent to steam
stripping Column for collection of Organic distillate which is mixed in the waste
water stream. After stripping, effluent will be sent to Multi Effect Evaporation
System, Stripped Organics collected and sent to cement industry/TSDF
incinerator.
 The concentrate from the MEE System will be sent to ATFD and salts from
the ATFD will be collected and sent to TSDF for safe disposal.
 The condensate from MEE followed by ATFD sent to biological system for
Treatment.
 The LTDS effluent along with MEE / ATFD condensate will be sent to
Biological treatment, treated effluent sent to RO for water recovery.
 The RO permeate will be reused and RO reject will be sent to MEE followed
by ATFD for further evaporation. MEE condensate collected along with RO
permeates for reuse. Salts from ATFD collected and sent to TSDF.
 All the treatment tanks etc. is constructed only with acid proof tiles and 1.5 to
2.5 meters above the ground Level.

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 Roof Water Harvesting System will be put in practice to recharge the ground
water.

Strategic Control / Management


 Minimizing water usage.
 Segregation and collection of effluent for proper treatment and to minimize
waste generation at treatment facility and to recover water for recycle and
reuse.
 Reducing the water consumption for the process by way of developing the
process and operation methods.
 Prepare SOPs for handling and treatment of effluent water.

 Minimize spillage and leakage of effluent to avoid Land pollution.

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FIGURE -10.2: SCHEMATIC DIAGRAM OF PROPOSED WASTE WATER TREATMENT- ZLD SYSTEM

HTDS Effluent
52 KLD

Organic Distillate to
Stripper Cement Industry @
2% 1.0 KLD

MEE
51 KLD
Vapor LTDS Effluent
Condensate@80% 53.8 KLD
40.7 KLD
ATFD

Salts to TSDF BTP Losses @5%


94.5 KLD 4.7 KLD

RO Reject to RO System RO permeate for Reuse


MEE
MEE 27 KLD 89.8 KLD @70% 62.8 KLD

Condensate Water for Reuse


ATFD @80% 21.6 KLD 84.4 KLD

Salts to TSDF *Water recovery from ZLD system is 84 KLD

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FIGURE-10.3: FLOW CHART FOR EFFLUENT TREATMENT HTDS

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FIGURE-10.4: FLOW CHART FOR LTDS EFFLUENT TREATMENT LTDS

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10.3.3.1 DETAILS OF ZLD SYSTEM


All the effluent generated from the plant are collected in the Effluent collection pits
and from those pits effluent will be pumped to the above ground storage tanks
through the closed HDPE pipe lines. All these effluent collection pits are lined with
acid proof tiling or HDPE lining.
The Industry will construct the above ground storage tanks to store the collected
effluent from various streams. The tanks consist of 6 Compartments and are used to
store the HTDS in two compartments and LTDS in four compartments effluents
separately. These tanks can accumulate more than 4 days generation of effluent.
The HTDS effluent consists of COD will be sent to the Stripping Column for the
removal of same and thereafter the effluent will be sent to the MEE system which
consists of 3 Calendrias and the condensate will be collected. The concentrate will
be sent to ATFD for separation of salts. The condensate collected from MEE &
ATFD sent to ETP for treatment. The salts generated from the ATFD will be stored &
disposed to TSDF for secure Land Fill.
Now, the Condensate water from the MEE system along with the LTDS effluent will
be sent to the ETP system for the removal of BOD etc., The ETP system consists of
Aeration and Clarification. After this the treated effluent from biological system is
passed through the Sand Filter, Carbon Filter and Micron Filters and finally sent to
RO System.
70% water recovered as RO permeates. Remaining 30% reject water will be sent to
MEE followed by ATFD system for Evaporation. In this ZLD treatment we can
recover 70% of the water for recycle and reuse in the plant Utilities.

Figure-10.5: FLOW CHART FOR EFFLUENT TREATMENT


Effluent Type Treatment Flow
Collection  Equalization & neutralization  Stripper  MEE
 ATFD  TSDF
HTDS MEE/ATFD Condensate sent to Biological Treatment followed
by RO.
Collection ETP (Biological Treatment)  Sand Filter 
Carbon Filter  Cartridge Filter  RO Plant  RO Reject to
LTDS
MEE. RO Permeate for Re-usage.

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10.3.3.2 THE TECHNICAL DETAILS OF THE SYSTEMS ARE AS FOLLOWS:


MEE System Capacity: 85 KLD
RO System Capacity: 100 KLD

10.3.3.3 MEE PLANT CONFIGURATION


Part – A: Stripper Unit with Flash Condenser, Re boiler and Recirculation Pump
Part – B: Triple Effect Forced Circulation Evaporation Plant with Thermo
Compressor, Required Equipment & Components.
Part – C: Agitated Thin Film Dryer

10.3.3.4 PROCESS DESCRIPTION (Part – A)


1. Feed will enter to the series of Pre heaters of Evaporator P4, P3, P2 and then
P1 using Feed Pump. From Discharge of Feed Pump Feed will be heated
through Series of Pre heater using Vapour from Jacket of respective
Calandria. Feed will be heated to the boiling point and will enter to the
recirculation loop of Stripper.
2. Recirculation Loop of Stripper will comprise of Flash Vessel, Recirculation
Pump and Re boiler.
3. Feed coming out from Pre heater of Evaporation Plant will re-circulated
through boiler and heated up using Steam.
4. Heated Feed will allow flashing in Flash Vessel and by flashing high volatiles
and Water will convert to vapour. Vapour will travel from bottom to top of
Stripping column where feed liquid will flow from top to bottom. Random
packing inside the stripping column provide mass transfer surface to vapor
liquid interface.
5. Rich organic vapour with some water vapour will come out from the top of
Stripper column. This vapour will be condensed in Flash Condenser at the top
of Stripper column.
6. Condensed organic rich liquid will be collected in Reflux pot from condenser.
From Reflux pot partly it will be withdraw according to the desired Water
Vapour/ Organic ratio and remaining will enter to the column as reflux.

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10.3.3.5 PROCESS DESCRIPTION (Part - B)


1. From Discharge of Stripper recirculation Pump feed will enter to the
Evaporation Plant. Feed will enter to the Evaporation Plant from Discharge of
recirculation pump of Stripper.
2. First Effect is a Forced Circulation Type comprising of Calandria-1, Vapour
Separator-1 and Recirculation Pump– 1. Liquid will recirculate continuously a
through Calandria Tubes at high velocity and will get heated using Heat of
Condensation of First Effect Jacket. This Heated Mass will allow flashing in
Vapour Separator and Water Vapour being generated.
3. This Flash Vapour will partly recompressed to the Jacket of First Effect using
Thermo compressor which will convert high pressure motive steam to low
pressure and will create suction and take part of the water vapour from
Vapour Separator -1.
4. Condensate from Jacket of First Effect will travel to 2 nd Effect using pressure
difference available between these two Jackets.
5. Concentrate will be coming out from 1stEffect will be sent to Balance Tank -1
which will be placed between 1stand 2ndEffect.
6. Second Effect also is a Forced Circulation Type comprising of Calandria-2,
Vapour Separator-2 and Recirculation Pump– 2. Liquid will recirculate
continuously a through Calandria Tubes at high velocity and will get heated
using Heat of Condensation of Second Effect Jacket. This Heated Mass will
allow flashing in Vapour Separator and Water Vapour being generated.
7. Concentrate coming out from 2nd Effect will be below saturation level and
there will not be any crystallization takes place in 2 nd effect.
8. This Heated Mass will allow flashing in Vapour Separator and Water Vapour
being generated.
9. Concentrate will be coming out from 2nd Effect will be sent to Balance Tank -2
which will be placed between 2nd and 3rd Effect
10. Condensate coming out from 3rd Effect Jacket is a mixture of Steam utilized in
Thermo compressor and Evaporated Water Vapour from 2 nd and 3rd effect.
Condensate will be taken out from plant using Condensate Outlet Pump and
send for Storage.
11. Concentrate from Evaporation will be taken out from the Plant using
Concentrate Outlet Pump and send to ATFD.
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12. Water Vapour from Last Effect will be condensed in surface type condenser
using Cooling Water as condensing media. Steam Jet Ejectors/ Water ring
Vacuum Pump will maintain vacuum in the plant back to the condenser.

10.3.3.6 PROCESS DESCRIPTION (Part - C)


1. Feed Pump will be gear/ roto type pump to handle viscous Feed. Feed will not
required to preheat as it will come at 85-90 Deg C from the tank. Feed will
enter to the Vertical ATFD first for initial evaporation. Feed will splash to the
Heat Transfer Surface of ATFD using liquid distributor.
2. V-ATFD will be a hollow cylindrical Jacketed Vessel having Agitator and
specially designed Scrapper blades to wipe out the Surface of ATFD all the
time to keep it clean. This will maintain consistent performance of ATFD for a
long time.
3. ATFD Scrapper will rotate at medium RPM using Gear Box for reduction of
RPM which will be govern by Variable Frequency Drive.
4. ATFD Heat Transfer Surface will be heated through Steam in Jacket. Vapour
outlet will be connected with Entrainment Separator to avoid product
contamination in Condensate. Vapor will be condensed in Condenser and
Negative draft will be maintained by Water Ring Vacuum Pump.
5. Product coming out from bottom of Vertical ATFD. Steam will be applied in
Jacket of same to allow the product dry.

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FIGURE-10.6: SCHEMATIC DIAGRAM OF MEE SYSTEM

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10.4 HAZARDOUS / SOLID WASTE MANAGEMENT


Generation of hazardous / Solid Wastes
The hazardous / solid waste generation from process, spent carbon, used oils, ETP
sludge, Evaporation Salts, ash from boiler; will be sent to TSDF/Cement plants/Brick
manufacturers as per respective waste category.

Resource Conservation / Waste Minimization


The unit will also implement the concept of waste minimization circle including:

 Volatiles in the by-products will be condensed and reused.


 Volatile raw materials will be separated by rectification and these can be
recycled into process.
 Good House Keeping practices make the system easier and less costly.
Some of these are as follows:
Solid wastes e.g. powders, spills, etc. in process, and packaging will be
separately collected and disposed off instead of allowing these to join
effluent streams. This will reduce load and increase the efficiency of
treatment system.
 Search for future recycling schemes and evaluate their worth and
implement such schemes wherever a promise of economic feasibility
exists.

Discarded Container / Barrels/ Liners Management


 Discarded containers/ barrels/ liners will be kept at a designated place
with paved surface.
 These will be decontaminated (washed/ cleaned) and stored in the
designated area in scrap yard. Washed water sent to ETP.
 These will be sold to the actual users/ recyclers as per the Hazardous
Waste (Management, Handling and Transboundary Movement) Rules,
2016.
 The record of discarded containers/ barrels/ liners stored in scrap yard
shall be maintained and also, inventory of their selling to the registered
recyclers shall be maintained. The same shall be reviewed by the HSE
Department of the project.

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Handling of Solid Waste and Hazardous Waste


 The solid wastes and hazardous wastes will be packed in double lined
PP bags and stored in dedicated area. As and when sufficient stock is
accumulated, Organic Waste will be sent to Cement Industry for
incineration and Inorganic waste will be sent to TSDF for further
treatment and safe land fill.
 Industry will enter into an agreement with concerned Hazardous Waste
Management unit.

10.5 EB [ECOLOGY & BIODIVERSITY]:


The project activity does not require tree cutting. Also, the study zone does not have
any ecologically sensitive location and hence, the plant activities are not expected to
have any impact on ecology and biodiversity.
Air emissions, liquid effluent disposal and solid waste generation are likely to have
some impact on terrestrial ecosystems. However there will be no net increase in air
pollution.
Proponent will develop greenbelt around 36.8% of its total area.

Management
 Raw material dispensing stations will be equipped with vacuum duct
hoods with top cover.
 All tanks vents being used for storage flammable chemicals will be
connected to respective condensers to avoid VOCs in the plant area.

10.6 SE [SOCIO-ECONOMIC ASPECTS]:


This project will have positive impacts on Socio-Economic Environment.

Positive impacts
 Direct employment generation potential of the project will be for about 40
persons, wherein the first preference will be given to the Qualified People
from within the Study Area.

 Various modes of indirect employment i.e. providing Conveyance,


Transportation, Goods and Services will also increase.

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 Overall improvement in quality of life of people of the study area will


increase.

10.7 HG [HYDROGEOLOGY, GROUND WATER & WATER CONSERVATION]:


The proposed project is located on the divide portion of the catchment and is over
the run off zone. No major streams are passing through the site. The catchment area
of the plant site is small and recharge conditions are moderate. However, the buffer
zone of 10km radius has good catchment and recharge potential with streams and
tanks of considerable storage potential.
All the stream courses are ephemeral in character and carry large volumes of storm
flows during rainy season and remain dry during non - monsoon season. The width
of the streams is narrow and follows the weak planes within the hard rock
formations.

Ground Water Conditions


Groundwater occurs under semi-confined conditions in the fissured zone of the
banded biotitic hornblende gneisses. Ten bore wells were inventoried to assess the
groundwater conditions. The depth to water levels was found to be 8 -132m bgl. The
yield ranges of bore wells were found to be 1-3 lps. The quality of water is found to
be potable.
As the extent of the proposed site is very small only roof top rainwater harvesting is
suggested for improving the recharge to the groundwater.
The proposed area is categorized as safe by the Groundwater department and
scope for development & stage of groundwater is good. The site is feasible for
groundwater extraction for the proposed Bulk drug intermediates manufacturing unit.

Possible Impacts on Groundwater & Mitigation


 The generation of ash from the industry will have sedimentation affect over
the wind ward side on the soil regime as well as the buffer zone over a period
of time affecting the flow rates of water.
 The chemically loaded waste water leakage from the industry may affect the
soil, surface and groundwater sources, so we will closely monitor to avoid any
spillage or leakages.

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 The ash spreading in and around the plant will be avoided by storing under
closed conditions at dedicated place till it is disposed to users. The prevention
suggested is not to allow the waste water leakage from the industry by
implementing proper storage tanks for wastewater collection and ZLD system.
 Ash generation and storage will be monitored closely to avoid leakages and
will be disposed safely to the brick manufacturing industries and infrastructure
projects.
 All the chemically charged liquid discharges will not be allowed to be in
contact with surface/ groundwater.

10.8 GEO [GEOLOGY]:


The district is underlain by variety of geological formations comprising from the
oldest Archaeans to Recent Alluvium.

10.9 SC [SOIL CONSERVATION]:


The proposed project does not have any impact on the soils beyond the boundaries
of the project site and it is a Zero Liquid Discharge Unit; the chances of any
enhanced soil erosion are not anticipated. But improper disposal of toxic wastes and
accidental spillages of toxic chemicals can pose a serious threat to the soil, ground
and surface waters. But the chances of such events cannot be quantified and
predicted. Since the industry is expected all rules and regulations relating to the use,
handling and disposal of all toxic and hazardous chemicals, no additional safety
methods are required especially to prevent contamination of soil. Liberal use of
locally available farmyard manure will be used for the plants in the greenbelt and
block plantations for improving the productivity, fertility and health of soils.
The project does not have any impact on the soils beyond the boundaries of the
project site since it is a zero liquid discharge unit.
Physicochemical characteristics of the soil samples obtained from 7 areas in the
buffer zone and one from the project site reveals that all basically sandy loams.

10.10 RH [RISK & HAZARDS MANAGEMENT]:


All the provisions as per the Factories act, 1948 manufacture, storage and import
of hazardous chemicals [MSIHC] Rules, 1989 and amendments thereafter and

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also, the Hazardous Waste (Management, Handling and Transboundary


Movement) Rules, 2016 will be followed.
Work environment monitoring as well as noise monitoring will be carried out on
regular interval through third party.
Following hazards may occur during the operation.
 Fire Hazards
 Chemicals handling and Storage
 Road accidents
 Process hazards
 Health hazards
Following procedures will be followed for effective management of any disaster in
the plant.
 Identification of Hazards and Risk assessment
 Identification of persons at risk
 Mitigation measures to minimize or elimination of Risk
 Disaster management plan

10.11 GREENBELT DEVELOPMENT


10.11.1 OBJECTIVE
The purpose of a green belt around the plant site is to capture the fugitive emissions
emanating from Plant operations, attenuate the noise generated and improve the
aesthetics.
Environmental protection has been considered as an important domain for industrial
and other developmental activities in India. Ministry of Environment, Forest and
Climate Change (MoEF&CC) has taken several policy initiatives and promoted
integration of environmental concerns in developmental projects. One such initiative
is the notification on Environmental Impact Assessment (EIA) of developmental
projects issued in 1994 and further revised notification in year 2006 under the
provisions of Environment (Protection) Act, 1986 EIA Guidance Manual for building,
construction, townships and area development projects proactively talks about the
importance of greenbelts in such projects.
Greenbelt in India refers to a buffer zone created beyond which industrial activity
may not be carried on. This concept has developed through a long line of cases and

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today, greenbelts are present not only for the purpose of protecting sensitive areas
to maintain ecological balance, but are also be found in urban areas so as to act as a
sink for the harmful gases released by vehicles and industries operating in the city
area. In this regard, comprehensive Guidelines for Developing Greenbelts have been
compiled by the Central Pollution Control Board.

10.11.2 ACTION PLAN


As per the stipulations of MoEF&CC, greenbelt is to be provided all along the
boundary by planting tall, evergreen trees and the total green area including
landscaping area will be about 36.8% of the project area. There are block plantations
within the project site. Typical industrial greenbelt on all sides of the plant site with 5
to 10 m width patches and strips of greenbelt with a spacing of 2m x 3 m (1500 trees
per Ha). About 2592 trees will be grown in the space available in the project area.
Since there will be two rows of trees, they get direct light at least from one side and
the branches can expand. Hence, potentially large trees with wide canopy are
chosen instead of the less branched and straight growing trees. In addition to
greenbelt development in the plant site, proponent proposed to develop green area
with trees such as fruit bearing, Neem, Kadamba plantations of 1000 trees/year for
five years in the nearby three identified villages (Jayanthipuram, Dhramavarappadu
Tanda and Vedadri Tanda). Soil is good and suitable for plant growth but water
supply is critical during the dry season. Special care shall be taken to water them at
least once in 3 days during the dry period. A list of plants suitable for greenbelt and
to the local agro climatic conditions.
A list of multipurpose trees proposed to be planted in the greenbelt is given in Table
10.1.

TABLE -10.1: List Of Plants Identified For Greenbelt And Avenue Plantations.
Local name
S.No Botanical name English name Habitat
(Telugu )
1 Bidenspilosa Beggar tick Phutium Herb
Asian spider
2 Cleome viscose Kukka-vaminta Herb
flower
3 Partheniumhysterophorus Carrot Grass Chandani Herb
4 Abutilon indicum Indian Mallow Tuturabenda Shrub
5 Ageratum conyzoides Goat weed Pumpillu Shrub
6 Calotropis gigantean Crown Flower Jilledu Shrub
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Local name
S.No Botanical name English name Habitat
(Telugu )
7 Cassia surattensis Scrambled Egg Mettatangedu Shrub
8 Cleistanthuscollinus Garari Kodisha Shrub
9 Drypetessepiaria Wild Caper Bush Bira Shrub
10 Acacia arabica Gum arabic tree Natutuma Tree
11 Acacia ferruginea Rusty Acacia Anisandra Tree
12 Acacia mearnsii black wattle Tumma Tree
13 Acacia melanoxylon Sally Wattle Kondakorinda Tree
14 Acacia nilotica Babool Nallatumma Tree
15 Albizialebbeck Flea tree Dirisena Tree
16 Bambusa bamboo Bamboo Bonguveduru Tree
17 Barringtoniaacutangula Indian putat Kadimi Tree
Flame of the
18 Buteafrondosa Moduga Tree
forest
19 Eucalyptus globules Eucalyptus Jamayul Tree
20 Ficusbenghalensis Banyan Marri Tree
21 Ficusreligiosa Pee pal Raavi Tree
22 Magniferaindica Mango Mamidi Tree
23 Pongamiapinnata Indian beech Kanuga Tree
24 Techtonagrandis Teak Teku Tree

10.12 POST PROJECT MONITORING


Regular monitoring of all significant environmental parameters is essential to check
the compliance status vis-à-vis the environmental laws and regulation. The objective
of the monitoring will be as follows.
 To verify the results of the impact assessment study with respect to the
proposed project.
 To study the trend of concentration values of the parameters, which have
been, identified as critical and planning the mitigate measures.
 To check and assess the efficacy of pollution control equipment.
 To implement the EMP, a structured Environment Management Cell (EMC)
interwoven with the management system will be created.
 EMC will undertake regular monitoring of the proposed pollution control
system and conduct yearly audit of the environmental performance of the
system. It will also check that the stipulated measures are being satisfactory
implemented and operated.

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A comprehensive environmental monitoring program that will be prepared for the


purpose of implementation in the proposed manufacturing unit by the EMC is
described below.

10.12.1 AIR POLLUTION MONITORING


The Stack emissions from boilers & DG Set will be monitored once in a month for
PM10, NOX & SO2. The ambient air at the plant site will be monitored once in a month
for PM10, NOX & SO2. The Fugitive Emissions like VOC’s will be monitored in
Production block, Raw Material and Finished goods section.

10.12.2 WASTE WATER MONITORING


The quantity of waste generated from ETP unit will be regularly measured using flow
meters. Wastewater samples will be collected and analyzed for critical parameters
like pH, TDS, BOD, COD, Oil and Grease, Chlorides, Sulphates etc.,

10.12.3 GROUND WATER MONITORING


Ground water quality of bore well will be regularly monitored preferably once in a 6 /
12 months.

10.12.4 HAZARDOUS / SOLID WASTE MONITORING


Hazardous / Solid waste generated from the plant will be monitored once in a
month/change of the product.

Table- 10.2: The Details of the Monitoring Program


Location of Frequency Duration
Type of Parameters
S. No Monitoring of of Instrument
Monitoring to be tested
station Sampling Sampling
3 Places at 120o Once in a 8 hrs/24 PM10, SO2,
1 Ambient Air RDS
angle month hrs NOX
Production
Work room Once in 3 Personal
2 Block, Store --- VOC’S
concentration Months Sampler
rooms
PM10, SO2,
Boilers, D.G. Stack
Stack Once in a NOX and
3 Sets, Scrubber --- Monitoring
Monitoring month Scrubbing
vents Instrument
gases.
D.G. Set,
Day – Night
Compressors, Once in a
4 Noise Levels --- Noise meter Noise levels
Chillers, Boilers month
in Leq
section,
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Production
block, Admin.
block, ETP area,
Open area etc.
Raw HTDS &
LTDS effluent,
5 Effluent Condensate, Daily ---
Treated
wastewater Physical and
Internal &
Ground Nearest Bore Once in six Chemical
6 --- External
water well months Parameters
Lab
Sludge from Once in six
7 Solid Waste ---
Process, ETP months

All the above observations will be complied and documented by the EMC to serve
the following purposes.
 Identification of any environmental problems that are occurring in the area.
 Initiating or providing solution to those problems through designed channels
and verification of the implementation status.
 Controlling activities inside the plant, until the environmental problem is
corrected.
 Suitably responds to emergency situations.
The industry will engage recognized laboratories to carry out all necessary
monitoring parameters. Qualified staff will be appointed for the purpose of Operation
and maintenance of the pollution control facilities. Stand-by facilities are provided to
all the facilities so as to ensure fail proof treatment.

10.13 MANAGEMENT OF PUBLIC INTERESTS


10.13.1 OBJECTIVE
To assure the neighboring communities that the promoters and management have
high consideration for the welfare of this region, the following commitments are made
by the project promoters.

10.13.2 PREFERENCE TO LOCAL POPULATION


For the recruitment of semi-skilled and unskilled workers preference will be given for
the local people.

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10.13.3 HEALTH CAMPS


Health camps will be organized along with the local administration and voluntary
organizations like Red Cross, Rotary Club etc., in the surrounding villages.

10.13.4 PUBLIC AMENITIES


The management will support the local administration with funds and other forms of
assistance for the development of public amenities in this region.

10.13.5 PUBLIC RELATIONS


The management will set up a public relations office to maintain to good line of
communication between the management and the public on matters of
environmental concern.

10.14 WATER REQUIREMENT


Proposed Water Consumption Details
Table- 10.3: Proposed Water Consumption Details
Water input
S.No Purpose
KLD
1 Process 59
2 Washings 10
3 Boiler make up 71
4 Cooling towers make up 104
5 Scrubbing system 5
6 Domestic 4
7 Gardening 6
Total 259

The fresh water of 175 KLD will be met from Ground Water source.
Recovered water 84 KLD from ZLD system is reused.

10.15 PROCESS EMISSION CONTROL SYSTEM


a) No. of scrubbers and capacity : 2 No. scrubbers installed.
1 No: 300 mm (Diameter) X 3 meters (Height)

b) Type of scrubber : Scrubber material of construction is PP+FRP with


one inch poly propylene rings as packing material with a circulation pump.
C). Chemical used in scrubber : Alkali solution

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FIGURE- 10.7: SCHEMATIC DIAGRAM OF EMISSION CONTROL SCRUBBING


SYSTEM

10.16 FUGITIVE EMISSIONS


Various types of solvents will be used in the manufacturing process. The solvents
will be stored in storage tanks with vent condensers. These are handled in closed
conditions. The industry will take measures for reduction of fugitive emissions by
providing chilled brine circulation to the condensers which, ensures the recovery of
95%. Good ventilation will be provided to reduce the workroom concentrations. The
reactor generating solvent vapors will be connected to condensers with reflux
system. Dyke walls will be provided to the solvent storage tanks. The solvents like
Ethyl acetate, Methanol and Toluene will be recovered up to 95 % by using
distillation and the remaining 5% will be the loss.

10.17 SOLVENT MANAGEMENT PLAN


Solvent management consists of the following:
 Unloading
 Storage
 Handling / transferring
 Process / Reaction
 Recovery
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i) Unloading
Solvents are received in drums / tankers
Drums
 Before unloading the drums from the truck, check the drums condition.
 Drums may be MS or HDPE Carboys
 Drums / barrels will be unloaded from the vehicles onto the unloading platform
by using the drum lifter provided for the purpose. Under no circumstances
drums shall be dropped or rolled on the ground or on any other material
 Carboys will not be dropped or allowed to strike against each other and shall
be unloaded on the pallets
 Personal protective equipments like safety goggles, hand gloves, PVC aprons
and safety shoes will be used while handling chemicals.

Road tankers
 Security will ensure that vehicle personnel shall not carry any match box /
lighters
 The store personnel, has to check the paper work before unloading to confirm
that the correct chemical received as well as discharged into the dedicated
tank.
 Barriers and flags should be positioned to warn personnel at the unloading.
 Brakes should be set and the wheels chocked.
 The truck should be earthed.
 Tanker should be kept under inert gas flushing through vent while unloading
 Make sure that the inert gas valve remains open during the entire unloading
period of delivery is by gravity or by pumping.
 Connect the flexible hose to the tanker and to the transfer pump
 Check liquid level guage on storage tank to ensure liquid is being transferred
 When tanker is empty, stop pump and close valves on tanker, close valves in
transfer line.
[For flammable material, stop inert gas purge]
 Disconnect flexible hose and put into proper catch container to ensure no
product is lost on to the ground.
 Remove choked warning signs, earthing and switch locks

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 Read storage tank liquid level gauge and record reading

ii) Storage/ handling/ transferring


Storage Tanks
 2 or 3 Square meter condenser [depends on solvent volatility] with cooling
water circulation is connected to each solvent storage tank to prevent solvent
vapors escaping from tank surface in to atmosphere. The condensed solvent
will go to respective tank. This results in recovery of solvent and prevention of
VOCs into the atmosphere.
 The solvent pump which is having mechanical seal will be used for
transferring the solvent to the Day Tank of the respective reactor as and when
required. The entire solvent transfer takes place in a closed system. There is
no manual handling.
The above management will results in recovery of solvent more than or equal to
95%.

Drums
 As and when required the solvent drums in closed condition will be transferred
to the respective reactor.
 By using AODD pump the solvent will be transferred in to the reactor. Hence,
there is no loss of solvent during transfer.

iii) Reaction /Recovery


 During reaction stage the solvent vapors will be sent to a primary condenser
having cooling water circulation and later to secondary condenser having
temperature < 50 C chilled brine circulation.
 Above system will eliminate solvent losses during reaction stage and
recovery will be the maximum extent possible.
The above management will results in recovery of solvent more than or equal to 95 %.

Chlorinated solvents
 Solvent drums will be stored in ware house below 250C
 As and when required the solvent drums in closed condition will be transferred
to the respective reactor. By using AODD pump the solvent will be transferred
in to the reactor. Hence, there is no loss of solvent during transfer.
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 During reaction stage the solvent vapors will be sent to two primary
condensers which are arranged in parallel having cooling water circulation
followed by a secondary condenser having brine circulation at temperature of
50C.
System will eliminate solvent losses during reaction and recovery will be the
maximum extent possible.
The above management will results in recovery of solvent more than or equal to
95%.

10.18 EMISSIONS – UTILITIES


For generation of Steam, the industry proposed to install 4 TPH & 8 TPH coal fired
boilers. The coal requirement will be met from government allocation or from local
authorized sources.
The unit is proposing 500 KVA & 1000 KVA DG set, for usage during the power
failures.
The emission details are presented in bellow Table No.10.4, Table No.10.5 & Table
No. 10.6

Table- 10.4: Characteristic Details of Proposed Boiler


8.0 TPH Coal fired 4.0 TPH Coal fired
Particulars Units
Boiler Boiler
Indian Coal with CV Indian Coal with CV
Type of Fuel -- of 4000 kcal/kg to of 4000 kcal/kg to
5000 kcal/kg 5000 kcal/kg
Coal Consumption TPD 32 16
Ash Content % 35 35
Sulphur Content % 0.4 0.4
No. of Stacks No 1 1
Height of stack M 34 30
Diameter of Stack M 0.50 0.40
o
Temperature of Flue Gas C 200 180
Velocity of Flue Gas m/s 16 14
Particulate Matter gm/sec 0.26 0.13
Sulphur dioxide emission gm/sec 2.95 1.48
Oxides of Nitrogen emission gm/sec 9.70 4.86
Note: 5 TPH Coal fired Boiler is kept as standby.

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TABLE- 10.5: Stack Emission Details for Thermic Fluid Heater


2,00,000 kcal/hr.
Particulars Units
Thermic fluid heater
Thermo pack Boiler Capacity Kcal/hr. 2,00,000
Type of Fuel -- Diesel
Stack Temperature Before o
C 200
Air preheater
Stack Temperature After Air o
C 130
preheater
Stack Height m 15
Fuel Consumption per Day TPD 0.57
Diameter m 0.3

Table- 10.6: Stack Emission Details of Proposed DG Set


Emission Emission Emission Stack Flue Gas Stack Flue gas
Capacity
of SPM in Of SO2 in of NOx dia. Temp. in Height Velocity
In KVA
mg/Nm3 mg/Nm3 in mg/Nm3 in m O
C in m in m/sec.
500 KVA
80 150 180 0.30 220 10 16
(Proposed)
1000KVA
120 170 200 0.35 280 10 18
(Proposed)

10.19 WASTEWATER LOADS


The waste water generation will be 105.8 KLD which is from process, floor & reactor
washes, cooling tower blow down, boiler blow down, scrubber, DM plant and
domestic usage. The effluent generation and its HTDS & LTDS effluent details are
given below.

Table-10.7: Effluent Generation Details


Effluent
S.No Purpose
Details KLD
1 Process 66
2 Washings 10
3 Boiler Blow down 10
4 Cooling towers Blow down 12
5 Scrubbing system 5.00
6 Domestic 2.80
Total 105.8

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Table-10.8: HTDS & LTDS Effluent Details


HTDS LTDS Effluent
S. No Purpose Disposal Method
In KLD In KLD In KLD
1 Process 47.0 19.0 66.0 HTDS Effluent sent to MEE
System. MEE Condensate sent to
Biological treatment.
2 Washings 0.0 10.0 10.0
LTDS Effluents along with
3 Boiler Blow down 0.0 10.0 10.0 Domestic sewage sent to ETP,
treated effluent sent to RO
followed by MEE & ATFD.
Cooling towers bleed
4 0.0 12.0 12.0
off RO Permeate and MEE
Condensate water recovered for
5 Scrubbing system 5.0 0.0 5.0 reuse
MEE Salts collected and disposed
6 Domestic 0.0 2.8 2.8 to TSDF.
Total 52.0 53.8 105.8

The pollution loads for various pollutants viz., TDS, Inorganics, Organics; COD for
proposed products has worked out based on the material balance.

10.20 STAGEWISE EFFLUENT CHARACTERSTICS


The stage wise effluent characteristics have been arrived for the proposed products
based on the material balance, which is given in Chapter-II

10.21 HAZARDOUS / SOLID WASTE DETAILS


Solid Waste Generation Details
The Hazardous/Solid waste generated and disposal methods from proposed project
are given below.

Table- 10.9: Hazardous/Solid Waste Generation, Disposal Details


Name of the
S. No Quantity Disposal Method
Hazardous Waste
1 Organic Solid Waste 3757 Kg/Day
2 Spent Carbon 108 Kg/Day
3 Solvent distillation residue 1174 Kg/Day
Sent to Cement Industries
Organic Evaporate liquid from
4 1040 Kg/Day
MEE stripper
5 Mixed Solvents 3933 Kg/Day
6 ETP Sludge 1000 Kg/Day Sent to TSDF

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7 Inorganic solid waste 366 Kg/Day


8 MEE Salts 4954 Kg/Day
1000 SPCB Authorized Agencies
9 Used Oils
Ltrs/Annum for Reprocessing/Recycling
After Detoxification sent back
1000
10 Detoxified Containers to suppliers/sent to outside
No’s/Month
Parties
Send back to suppliers for
11 Used Lead Acid Batteries 9 No’s/Year
buyback of New Batteries
Solid Waste Details
16800
12 Ash from boiler Sent to Brick Manufacturers
Kg/Day

Hazardous / Solid waste will be segregated. Detoxified containers, HDPE


Drums/Bags will be stored in the covered and raised platform with Leachate
collection system and disposed to authorized parties. Non- incinerabale solid waste
will be disposed to TSDF for secured landfill.
The Hazardous / solid waste will be disposed off through 7-copy manifest system
within 90 days from the generation. All records will be maintained properly.

10.22 PROPOSED ROOF WATER HARVESTING


To augment the declining ground water levels and water harvesting is the need of
the hour.
Rainwater harvesting is a mechanism involved in collecting, storing and using. A
rainwater harvesting system comprises various stages – flow of rainwater through
pipes or drains, filtration and storage in tanks for reuse or recharge. There are five
components in rainwater harvesting namely catchment, conveyance, filtration,
storage and recharge.
Roof top area is considered for harvesting rainwater for this project and other areas
are excluded due to possibility of chemical contamination. Roof top rainwater
harvesting is one of the appropriate options for augmenting ground water recharge/
storage in urban areas where natural recharge is considerably reduced due to
increased urban activities and not much land is available for implementing any other
artificial recharge measure. Roof top rainwater harvesting can supplement domestic
requirements in rural areas as well.

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Design of Roof Water Harvesting Structure


Quantity of Rain water collection and recharging depends upon
 Average rainfall
 Catchment area
 Run-off coefficient
 Infiltration rate
 Evapo Transpiration
 Porosity
 Permeability
Generally used Rain water harvesting structures are like Recharge Pits, Invert Well,
Surface storage pond (where areas are large and Optimum rainfall), Check Dams,
Nalla Bunds.
The rain water from the Roof top will be collected through PVC pipes and transferred
to the proposed roof water harvesting pits through steps of eliminating suspended
particles, oil & grease through finally to the ground.
Since the area of harvesting is small the above parameters are not studied in detail
and only applicability as to conserve and harvest the available quantum is
considered and suitable structure suggested Based on IMD Climatological Normal,
1981-2010.

Normal Annual Rainfall =981 mm (0.98 m)

Table- 10.10: Available Rainwater (Annual) for Harvesting


Rainfall Runoff Total Rainwater
Description Area (m2)
(m/Annum) coefficient (m3/Annum)
Roof Area 11536 0.98 0.8 9044.224
3
Total available rainwater (in m /annum) 9044

Details of Roof water harvesting pits:


Size of pits 8m x 4m x 3m
Size of Bore 350 mm dia.
Size of pipe 150 mm dia.

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FIGURE-10.8: ROOF WATER HARVESTING STRUCTURE

10.23 INVESTMENT
The proposed total gross investment in Buildings and Plant & Machinery will be
approximately Rs. 30 Crores. Industry will allocate an amount of about Rs.110
Lakhs for Environmental Protection measures. Recurring cost will be about Rs. 20
Lakhs per annum.

10.23.1 BUDGETARY ALLOCATION


The management will be set aside adequate funds in its annual budget to fully meet
the stated objectives of the environmental policy. The capital equipment for
environmental management include effluent treatment plants, pipelines and channels
for waste water discharge, green belt development and the environment laboratory.

Table- 10.11: Proposed Budget for Environmental Management Plan [EMP]


Proposed Recurring
S. No Particulars Capital Cost Cost
(Rs. Lakhs) (Rs. Lakhs)
Pollution Control Equipment
1 (Scrubbers, Cyclone separator, Bag filter, 30.0 2.0
Sampling port arrangements etc.,)
2 ZLD System 70.0 12.0

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(MEE, RO, ETP system)


Rain Water Harvesting
3 (Roof top water collection pit and Roof top water 3.0 0.5
towards the rain water harvesting pit)
Green Belt Development
4 5.0 2.0
(Plantation and Maintenance)
Health & Safety
5 2.0 1.0
(PPEs, Medical Surveillances Expenses etc.,)
Environmental Monitoring
6 (Air, Water, Noise, VOCs, Boiler Stack flue 0.0 2.5
gases, DG sets stack monitoring expenses etc.,)
Total 110.0 20.0

10.24 MITIGATION PLAN


There will be few gaseous emissions generated or released from the manufacturing
process. The industry will provide the efficient scrubbers for controlling the gaseous
emissions and plant will be well ventilated to improve the work zone environment
and layout is worked out in such a way that the workman works in a comfortable
atmosphere by using adequate personal protective equipment. Industry will be taking
all precautions to minimize the emissions on handling of various chemicals etc.
Sufficient fire extinguishers and fire hydrants will be provided in the plant to handle
any emergency.
Full-Fledge ZLD Treatment system will be provided for treating the effluents
generated from the industrial activity. Full-Fledge Treatment facility will be
constructed above ground level to prevent seepage.
First aid kits will be provided in all the departments and training on First aid will also
provide to all the employees for early treatment.
Candidates to be recruited to work in the factory will be subjected to pre employment
medical checkup. Only those certified to be medically fit will be recruited. Candidates
on recruitment safety training will be given for one week on handling of chemicals.
Archimedis Laboratories Pvt. Ltd will strictly follow the safety norms as per the
guidelines of the Director of Factories for a process industry and will provide all the
necessary safety equipment for the protection of the Industrial establishment as well
as the personnel working in the plant premises. Personnel Protective Equipment will
be provided to all its employees who are involved in the handling of hazardous
activities. The storage and handling of various chemicals will be according to the

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norms of MSDS and the Inspector of Factories. Personnel involved in the production
will be provided with protective clothing, helmets, goggles, masks, gloves, etc.
These handling operations will be carried out under the strict supervision of the
trained and highly skilled personnel. Supervision will be provided to ensure the
usage of these PPE’s. Necessary fire fighting facilities like extinguishers, sand
buckets, etc. will be provided to meet the on-site emergencies. A detailed On-site
Emergency plan will be prepared and implemented comply the provisions of
Factories Act. An agreement with a nearest hospital for treating the employees due
to unforeseen emergencies will be entered into.

10.25 SOCIO-ECONOMIC DEVELOPMENT ACTIVITIES


Socio-Economic Development activities will be implementing in coordination with the
NGOs, Village Panchayats and other Governmental Entities.

A. Social Activities:
 Health check up camps and Medical facilities to Infants and senior citizens,
free medicine supply etc., will be provide on regular basis.
 Help Implement and Run a Safe Drinking Water in Vedadri Tanda village
where the project site is located to facilitate Healthy Water for both Drinking &
Cooking Purposes.
 Contribution towards any development activity useful for village development.

B. Economic Activities:
 The company will give preference to the local people for employment.
 The company will be giving contract works like civil, machine repair,
transportation, canteen, etc. to the local people / parties.
 The proposed project will create jobs for at least 100 persons.

10.26 WASTE MINIMIZATION / RESOURCE CONSERVATION 5 R Concept


(Recycle / Refuse / Reduce / Reuse / Reform)
In our company, the 5R, representing five environment-conscious words starting with
the letter R, has been adopted as a keyword for environmental activities. The five
environment-conscious words include the three R words of the 3R, the keyword for

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establishing a recycling-oriented society, and two additional words that are "Refuse"
and "Reform".
Refuse: Avoid purchase of environmentally burdensome materials
whenever possible
Reduce: Reduce waste material
Reuse: Reuse waste material without processing
Reform: Reuse materials in a different form
Recycle: Reuse materials as resources

We will achieve the above concept; all efforts will be made by the industry to carryout
R&D on the isolated by-products / wastes

FIGURE- 10.9: 5 R CONCEPT

The units shall also implement the waste minimization circle including:
 Good House Keeping: Proper housekeeping practices make the system
easier and less costly.
 Roof water harvesting system shall be adopted to reduce the fresh water
requirement.
 Cleaner production technology may be adopted for the resource conservation
and pollution control.

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10.27 CONCLUSION
The industrialization plays an important role in their development process. The
countries with rapidly growing industrial sector were able to manage the
development problems particularly employment, poverty and inequality. The
Industrial development as legitimate objective to solve economic and social
problems, therefore project Management have appropriately decided to setup a
manufacturing unit. The infrastructure like roads, water and regular supply of power
are available at the project site. Availability of adequate skilled, semi-skilled man
power at reasonable salaries and wages, local amenities at reasonable cost, has
encouraged the technocrat. Importantly, the helping hand extended to the most
experienced and reputed person in the bulk drugs manufacturing industrial belt, by
the state Government in meeting the needs of the aspirant.
The likely adverse effects due to the operations of the unit are marginal. More over
the residential area is far away. However, the effective implementation of the
recommended Environment Management Plan and Monitoring Program, by which all
the negative effects on the environment, will be minimized.

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CHAPTER -XI

SUMMARY & CONCLUSION


[SUMMARY OF EIA REPORT]
EIA Report Archimedis Laboratories Pvt. Ltd.

CHAPTER – XI
PROJECT SUMMARY & CONCLUSIONS

Archimedis Laboratories Pvt. Ltd. Proposed to establish a Bulk Drug & Intermediates
manufacturing unit with the production capacity of 115.00 TPM respectively.

11.1 SALIENT FEATURES OF THE PROJECT

S. No Contents Details
Archimedis Laboratories Pvt. Ltd.
1 Name of the Project: Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet
(M), Krishna District, Andhra Pradesh.
Mr. Y Maddireddy Venkateswara Reddy
(Managing Director)
5-163/1, 2nd floor, Malleswari Nilayam, Chintalkunta,
2 Details of Applicant
LB Nagar Post, Hyderabad – 500074.
E-mail: 111mvreddy@gmail.com,
archimedislabs@gmail.com
Archimedis Laboratories Pvt. Ltd. Proposed to
establish a Bulk Drugs & Intermediates
3 Status manufacturing unit at Sy No: 108 & 109,
Jayanthipuram (V) Jaggayyapet (M), Krishna
District, Andhra Pradesh.
Industrial land.
4 Type of Land & Status
Proposed Land: 11.62 Acres (47024.47 Sq.m)
Capital Investment of the
5 30.0 Crores
Project, Rs. in Crores
Capital cost for EMP, Rs. in
6 110 Lakhs
Lakhs
Recurring cost for EMP, Rs.
7 20 Lakhs
in Lakhs
8 Employment opportunity 100 persons
It is envisaged to develop greenbelt on all sides of
9 Green belt Development the industry in an area of about 4.27 Acres
(17287.11 SQM).
Pollution control measures adopted
Effluent water disposal ZLD System
Adequate stacks of height of 34 mts & 30 mts are
10
provided for wider dispersion of pollutants.
Flue gas emission control
For SPM control, provided cyclone separator
followed by bag filter

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Two stage scrubbers installed for process gas


Process gas emission control
emissions
Vent condensers to the storage tanks and reactors
Fugitive emission control
Solvents and chemicals are handling in closed
system
All the hazardous waste will be collected, stored,
handled, transported and disposed to TSDF as per
Hazardous waste the Hazardous Waste (Management, Handling and
management Transboundary Movement) Rules, 2016, amended
time to time etc are major Act/rules/notification
applicable to industry.
11 Expenditure for CSR activities Rs. 135 Lakhs for five years.

11.2 CONCLUSIONS
It can be concluded on a positive note that due to the adequate provision and efficient
operation of Environmental Management Systems and after the implementation of the
proposed mitigation measures and environmental management plans, the project
activities during the construction and operation phase would have manageable & largely
have reversible impacts on the environment, and on balance the project would be
beneficial to surrounding communities and the region.

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