BaseLine Data Environmental Monitoring Program

Biodot ,
Plot No.57 ,
Door No.1404 ,
1 Floor ,
st
Thaila Nagar ,
Pudukkottai – 622 004.
Tamil Nadu , India
BaseLine Data
Environmental
Monitoring
Program
Prepared By Reviewed By Approved By
Department
Signature
Date
Name
Designation
Page 1 of 37
S.No Index Page No.
.
Non Viable
Laser Particle Counter 3
Viable
Air Sampler 4
Air Settle Plate 5
Compressed Air 6
Drainage Point
Swab , Settle Plate 6-9
Equipment
Contact Plate 10
Swab 11
Personal
Contact Plate Gown 12
Finger Dab 13
Swab Gown 14
Surface –Swab & Contact Plate 15-16

Air Velocity , Air Changes , Filter Integrity , 16-19
Temperature ,Humidity & Pressure
Water Chemical & Microbial Analysis 20-24
Baseline Data Report 25
Executive Summary 26-31
Baseline Data Result 31-34
Logo Biodot , Plot No.57 , Door No.1404 , 1st Floor , Thaila Nagar ,Pudukkottai –
622 004. Tamil Nadu , India
BaseLine Data Environmental Monitoring
Non Viable Laser Particle Counter Method Batch No.
Vitamins & Minerals Powder MNP (F2Mix ) Date
Page 2 of 37
Annexure - 1
A.R.No.
Date Of sampling
No.OF Sampling
Sampled By
Instrument Code
Area Location Code Grade Rest Operation Time R
>0.5 u >5u >0.5 u >5u
Conclusion
QC Asst
QC Microbiologist
QC Manager
Date
Page 3 of 37
Viable Air Sampler Method Batch No.
Monitoring Parameter Air

Monitoring Air sampler
Methodology
Monitoring Date XX-XX-XXXX
Monitoring Time XX:XX AM
Monitoring Materials
Monitoring Equipment
Equipment Calibration
Details
Frequency Daily
Duration
Base Line Data
Grade Area Location Result
Page 4 of 37
Conclusion
QC Asst
QC Microbiologist
QC Manager
Viable Air Settle Plate Method Batch No.
Monitoring Parameter Air
Monitoring 90 MM Diameter Settle Plate
Methodology
Details
Frequency Daily
Duration 4 Hours
Page 5 of 37
Compressed Air Batch No.
Annexure - 1
A.R.No.
Date Of Sampling
No.Of Sampling
Sampled By
Area Location Specification Compressed Oil Moisture Remarks
Code Air
Conclusion
QC Asst
QC Microbiologist
QC Manager
Date
Drainage Point –Swab , Settle Plate Batch No.
Method
Page 6 of 37
Page 7 of 37
Drainage Swab Sampling Method Annexure - 1
A.R.No
Date Of Sampling
No.Of Sampling
Swab Code
Sampled By
Area Location Drain CFU / Swab
Code ID Total Aerobic Bacterial Total fungal E.Coli Salmonella Pseudomonas Staphylococcus Remarks
Count Count Aeruginosa aureus
Conclusion
QC Asst
QC Microbiologist
QC Manager
Page 8 of 37
Drain Water Sampling Plate Method Annexure - 1
SOP No.
Medium : SCDA , Lot No. Diluents : Soya Lecithin Lot No.
SDA , Lot No.
Incubation Condition : SCDA : 30-35.C FOR 3 DAYS , SDA : 20-25.C FOR 5 Days
Report No.
Report Date :
Date Of Sampling
No.Of Sampling
Sanitization Method : Before / After
Sampled By
Area Location Drain Sample Dilution CFU / Plate ( P ) CFU / ML ( F X P ) Mean CFU / ML Remarks
Code ID Dilution Factor (F ) Bacterial fungal Bacterial fungal Bacterial fungal
Before / After Sanitization :

Bacterial Count : CFU / ML
Fungal Count : CFU / ML
Conclusion
QC Asst
QC Microbiologist
QC Manager
Page 9 of 37
Drain Water Sampling Plate Method Annexure – 2 ( Pathogens )
SOP No.
Medium : SCDA , Lot No. Diluents : Soya Lecithin Lot No.
SDA , Lot No.
Incubation Condition : SCDA : 30-35.C FOR 3 DAYS , SDA : 20-25.C FOR 5 Days
Report No.
Report Date :
Date Of Sampling
No.Of Sampling
Sanitization Method : Before / After
Sampled By
Area Location Drain Sample Dilution EColi Salmonella ( Pseudomonas Staphylococcus Remarks
Code ID Dilution Factor (F ) ( Macconkey RVSE Broth Aeruginosa aureus
Broth , Agar ) , XLD Agar CFU / ML CFU / ML
CFU / ML ) CFU / 10
ML
Conclusion
QC Asst
QC Microbiologist
QC Manager
Page 10 of 37
Equipment –Contact Plate Method Batch No.
Monitoring Parameter Equipment

Monitoring Contact Plate Method
Methodology
Details
Frequency Daily
Duration
Base Line Data
Grade Location Equipment Result
Conclusion
QC Asst
QC Microbiologist
QC Manager
Page 11 of 37
Equipment –Swab Method Batch No.
Monitoring Parameter Equipment

Monitoring Swab Method
Methodology
Details
Frequency Daily
Duration
Base Line Data
Grade Location Equipment Result
Conclusion
QC Asst
QC Microbiologist
QC Manager
Page 12 of 37
Personal Contact Plate Method Gown Batch No.
Sampling
Monitoring Parameter Personal

Monitoring Methodology Contact Plate Method (Gown Sampling )
Details
Frequency Daily
Duration
Base Line Data
Grade Operato Head Middle R.F. L.F. R.Palm L.Palm Result
r Gear Chest Arm Arm
Code
Conclusion
QC Asst
QC Microbiologist
QC Manager
Page 13 of 37
Personal Finger Dab Method Batch No.

Monitoring Methodology Finger Dab Method
Details
Frequency Daily
Duration
Base Line Data
Grade Operator Code Right Left Finger Result
Finger
Conclusion
QC Asst
QC Microbiologist
QC Manager
Page 14 of 37
Personal Swab Method Gown sampling Batch No.

Monitoring Methodology Swab Method (Gown Sampling )
Details
Frequency Daily
Duration
Base Line Data
Grade Operato Head Middle R.F. L.F. R.Palm L.Palm Result
r Gear Chest Arm Arm
Code
Conclusion
QC Asst
QC Microbiologist
QC Manager
Page 15 of 37
Surface Swab & Contact Plate Method Batch No.
Monitoring Parameter Surface

Monitoring Swab Method
Methodology
Details
Frequency Daily
Duration
Base Line Data
Conclusion
QC Asst
QC Microbiologist
QC Manager
Page 16 of 37
Monitoring Parameter Surface
Monitoring Contact Plate Method
Methodology
Details
Frequency Daily
Duration
Base Line Data
Conclusion
QC Asst
QC Microbiologist
QC Manager
Page 17 of 37
Air Velocity , Air Changes , Filter Batch No.
Integrity ,Temperature , Humidity , & Pressure
Page 18 of 37
Annexure - 1
Air Velocity & Air Change Per Hour Test Report
AHU No. Location Filter ID Velocity in FPM No.of Location 5 Average Filter Filter Room Actual
ID V1 V2 V3 V4 V5 FPM Size CFM Volume ACPH
Ft 2/ Mt in Ft 2 /
2 Mt2
Checked By
Verified By
Reamrks
Date
Time
Page 19 of 37
Annexure – 1
Record the Temperature , Humidity Monitoring
Department Relative
Humidity
Temperature Frequency
Limit
Month SOP No.
Equipment ID
Date Time Observed Temperature Calculated RH % Checked By Verified By Remarks
Dry Bulb Wet Bulb
Note : If Shift Running More Than 12 Hours . Extra Reading to be Noted as per Frequency
Annexure – 2
Record the Temperature , Humidity Monitoring in QC
Department Relative
Humidity
Limit
Month SOP No.
Equipment ID
Date Time Observed Temperature Calculated RH % Checked By Verified By Remarks
Dry Bulb Wet Bulb
Annexure – 3
Record the Temperature , Humidity Monitoring in Digital Hygrometer
Department Relative
Humidity
Limit
Month SOP No.
Equipment ID
Page 20 of 37
Date Time Observed Temperature Observed RH Checked By Verified By Remarks
Annexure – 4
Record the Temperature , Minimum , Maximum Monitoring
Department Relative
Humidity
Limit
Month SOP No.
Date Time Observed Temperature Checked By Verified By Remarks
Min Max
Note . Minimum and Maximum Temperature to be recorded Every Day At 10 AM

Annexure – 5
Record the Room Pressure Monitoring
Department
Room Pressure Limit Frequency
Month SOP No.
Equipment ID
Date Time Area Room ID Pressure Checked By Verified By Remarks
Page 21 of 37
Water Chemical & Microbial Analysis Batch No.
Annexure - 1
A.R.No.
Date Of Sampling
No.Of Sampling
Swab Code
Sampled By
Description Location ID Result Specification Remarks
Hardness
TSS
TDS
Acidity
Alkalinity
Ammonium
Calcium
Magnesium
Heavy Metals
Chloride
Nitrate
Sulphate
Oxidisable
substances
Residue on
evaporation
Total Organic
Carbon
Conductivity
PH
Conclusion
QC Asst
QC Microbiologist
QC Manager
Date
Page 22 of 37
Date of Sampling Date of Testing
Sampled By Analyzed By
Date of Completion
Method Used Membrane filtration Method/ Pour plate
Incubator ID:-
Sample Location
Sample Point ID No.
Test Media/Incubation Incubation Incubation count count count +ve ve
. lot NoCondition Started Completed Control Control
Date/sign Date/sign
Total aerobic R2A 30-35°c Plate Plate Plate Plate Plate Plate
microbial ……….. for I Il I Il I Il
count SCDA 5 days
Mean Mean Mean

= = =
Page 23 of 37
Test for specific Microorganism
Test Media Incubation Incubation Incubation Observation Observation Observation +ve -ve
Condition Started Completed Control Control
Date/sign Date/sign
Enrichment for SCDM 30-35°c Growth Growth Growth
Pathogen 18-24hrs Observed/ Observed/ Observed/
Not Not Not
observed observed observed
E.coli MCB 42-44°c Growth Growth Growth
24-48hrs Observed/ Observed/ Observed/
Not Not Not
MCA 30-35°c Growth Growth Growth
Not Not Not
Identification Test:Aseptically prepare culture suspension from the suspected colonies which are appears on MacConkeyagar in a sterilized
tube. Add 0.1 ml of the prepared suspension to the tubecontaining 10 ml of peptone water; incubate the tube at 30°C to 35°C for 18 - 24
hours. From incubated peptone water tube perform Indole test as follow:Add 0.5 ml of Kovac’s reagent to peptone water tube; allow to stand
for one minute. The presence of cherry red colour ring along the side of test tube indicates the positive test (the presence of Escherichia coli).
Presence of Escherichia coli shall be confirmed by Gram staining (Gram-ve rods).
Remarks:-
s. aureus MSA 30-35°c Growth Growth Growth

Observed/ Observed/ Observed/
18 - 72 Hrs Not Not Not
Identification Test:With the aid of an inoculating loop, individually transfer suspected colonies to separate tubes containing 0.5 ml of
Page 24 of 37
mammalian plasma (preferably rabbit or horse).Incubate in a water-bath at 37°C for 3 to 24 hours, in parallel with positive control using
known strain of Staphylococcus aureus and negative control using Plasma alone.Examine after 3 hours and at suitable intervals thereafter for
the presence of coagulation
If coagulation in any degree is observed, the presence of Staphylococcus aureus is indicated
Remarks:
p. aeruginosa CA 30-35°c Growth Growth Growth

Not Not Not
Identification Test: If growth of suspected colonies occurs carry outOxidase test.
Transfer suspected colonies using inoculating loop on to Oxidase disc; Standard result: Development of purple colour in 5 to 10 seconds
Remarks
Salmonella RVS 30-35°c

species 18-24hrs
………
XLDA 30-35°c Growth Growth Growth
……... Not Not Not
Identification: If colonies found transfer a few of suspect colonies by first Sub culturing the slope of slant of TSI agar and then stabbing with
inoculating straight wire well in the butt; Media lot No. ____________ , Incubate at 300C to 350C for 24 to 48 hrs; Incubator ID
No._______________.
Page 25 of 37
Remarks:
Shigella GN Broth 30-35°c Growth Growth Growth

Not Not Not
XLDA 30-35°c Growth Growth Growth
Not Not Not
Identification Test: If growth of suspected colonies occurs Subculture the growth on Modified SS agar Media lot No. ____________. If
the characteristic growth than confirms the presence of Shigella in the sample, sample fails the test for absence of Shigella.
Remarks:-
Conclusion of analysis Complies/ Complies/ Complies/

does not does not does not
complies complies complies
Page 26 of 37
Page 27 of 37
Biodot ,
Plot No.57 ,
Door No.1404 ,
1 Floor ,
st
Thaila Nagar ,
Pudukkottai – 622 004.
Tamil Nadu , India
BaseLine Data Report
Environmental
Monitoring
Program
Page 28 of 37
1.Executive Summary .
1.0 Introduction
M/s Biodot , Proposed Small Scale Manufacturing Unit Located At Plot

No. 57 , Door No. 1404 , 1 st Floor , Thaila Nagar , Pudukkottai -622 004 . Tamil Nadu ,
India. At Present the Unit Manufacturing Dedicated Nutraceuticals Multiple Micro Nutrients
Powders ( MNP ) Various Category. The Total Proposed Production Capacity
XXXXXXXXXX Per Annum .The Proposed Project Covered Under XXXXXXXXXX. The
Biodot Require to Submit the Base Line Data Study Report to UNICEF , DENMARK for
Quality & Efficacy of the Products .The Base Line Data Study Report Prepared & Carried
Out By S.Naveen Babu Proprietor & Team of M/s.Biodot .The Study based on one season
field data collected from the area during
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX (XXXXXXXXXXX) and the
same data has been used in assessment of impacts due to the proposed project
S.No Project Location Environmental Setting
.
1 Proponent M/s.Biodot
2 Location Plot No.57 , Door No.1404 ,1st Floor , Thaila Nagar ,Pudukkottai – 622
004 .Tamil Nadu ,India
3 Geographical Altitude : XXXXXXX
Details Latitude : XXXXXXX
Longitude :XXXXXX
4 Land Use of City Outer Area , 25 % Residential Area 75% Vacant Land Area
Plant Site
5 Distance From Plant Site
6 Sea Port
7 Air Port
8 Railway Station
9 High Way
10 City
11 Distance from
Severely
Polluted Area
12 Displacement of
Population
13 Seismic Zone
2.0.Google Map of Proposed Plant Site & Topography
Annexure – 1
3.0.Project Description
Product Capacity
XXXXXX XXX TPA
XXXXXX XXXTPA
XXXXXX XXXTPA
XXXXXX XXXTPA
Page 29 of 37
4.0. Noise Pollution .
There will be no other source of noise and vibration from the proposed manufacturing
activity except Plant machineries. The adequate precautions are being taken for abatement of
noise pollutions
5.0.Pollution Potential & Control Measures
Contraction Phase
Activity Potential Control Measures Remarks
Pollution
Installation of Air , Water , 1. Well maintained vehicles will be used. Implementing
Plant Soil , Noise 2. Metalled Road for Vehicle Movement Responsibility
Machineries & 3. Well maintained equipment will be utilized to
Equipments prevent noise generation M/s Biodot
4. Local labour will be hired for the work so that
housing arrangement will be avoided.
Operational Phase
M/s .Biodot has planned all the necessary steps to control Water Pollution, Air Pollution, noise pollution as well
as Hazardous Waste Pollution. The detailed Control Measures planned during operation phase of the project are
as follows:
Mfg. Air , Water , 1. Ensure proper handling of all Active & In Active Implementing
Activities Soil , Noise Ingredients by Using Standard Operating & Responsibility
Control Procedure
2. Ensure usages of PPE’s by workers M/s Biodot
3. Strictly following the appropriate SOP & SCP

4. The charging of the hazardous Ingredients will be
done through very carefully
5. MSDS of Raw material & products will be
displayed at
storage & handling area
6. Water usage will be strictly by putting water meter
plant wise.
7. Monitored data will be analyzed and reviewed time

to time
8. Contaminated solid waste will be sent to approved
Local Municipality Waste Facilities
9. Storage area will be designed in line with the
factory
Act requirement
Storage, Air , Water , 1. All Ingredients to be stored in accordance with the rules Implementing
Handling & Soil , Noise and regulations of the Safety Department Responsibility
Transportation 2. Separate storage area for solid/liquid raw materials
of Raw 3. Install proper facilities to prevent rain/storm water M/s Biodot
Page 30 of 37
materials contamination during the storage of solid raw
and Products materials.
4. Ensure disposal of used drums, bags as per the
rules/regulations
Transportation Air , Water , 1.Work will be given to Trained / Approved Transports for Implementing
of all the raw Soil , Noise the transportation of the raw Materials/products Responsibility
materials, 2. Ensure availability of MSDS of all the raw materials and
finished finished products to the Off-site Emergency team M/s Biodot
products &
hazardous
wastes.
Development Air , Water , 1.Ensure development and maintenance of proper green Implementing
and Soil , Noise belt as proposed Responsibility
maintenance
of green belt M/s Biodot
Direct / Socioeconomic 1. Continue policy of local employment according to the Implementing

Indirect issue skill and availability of the manpower Responsibility
Employment
M/s Biodot
6.0 Waste Management
Solid Construction Phase

Type Qty Disposal Method
Organic Local municipal bin
including food waste
In Organic Authorized Recycler
Solid Operational Phase
Organic Local municipal bin
including food waste
In Organic Authorized Recycler
Paper / Card Local municipal bin
Board
Dust Bin Local municipal bin
Collections
Metal Chip Sold as scrp to vendors
under agreement
Wood Chip Burnt in Boiler
Glass Chip Sold as scrp to vendors
under agreement
Hazardous Waste Operational Phase
Oil & Lubricants Collected in leak proof
containers and disposed
only to registered
authorized re-processor
Contaminated Waste Collected in leak proof
only to registered
Page 31 of 37
Ingredients Spoilages Collected in leak proof
only to registered
Reagents & Solvents Collected in leak proof
only to registered
Process Residues & Waste Will be collected in
carboys
and stored in Hazardous
waste storage area handed
over to Authorized
incinerator
HDPE Bag & Drums Stored in secure manner
and handed over to
authorized recycler
7.0.Risk & Safety Management
The unit is very much aware of their obligation to protect all persons at work and others
in the neighborhood that may be affected by an unfortunate and unforeseen incidence
occurring at the works. Unit has provided all the adequate safety measures in the
plant. any hazard either to employees or others arising from activities at the plant site shall
as far as possible, be handled by the personnel of the company and prevented from spreading
any further. In the case of eventuality the on-site and off-site emergency plan proposed by the
unit will be adequate and may be able to control the situation. After the proposed project all
the
required safety measures will be taken and unit will also carry out safety audit through
authorized agency/organization
8.0.Environmental Management Plan
Activity Management Plan

Manufacturing Ensure provision of Environmental Management system (EMS)
activities and as proposed / committed for environmental pollution control
operations of Ensure the efficient operations of provided EMS
utilities Ensure proper treatment and reuse of treated effluent for greenbelt development
Regular monitoring w.r.t EMS, ambient air quality, work area, noise, water quality as per the
monitoring program
Review the monitoring reports and take corrective measures as required
Ensure the submission of monitoring reports to the concerned authority as per the norms.
Ensure compliance of stipulated conditions by concerned authorities
Page 32 of 37
Ensure optimum use of resources
Regular monitoring of water consumption
Maintain proper record of resources utilization
Ensure the close manufacturing systems in order to minimize fugitive emissions
Ensure the regular maintenance of reactors and other process equipments
Ensure regular usage of proper PPE's by workers in the plant
Ensure the collection, storage, handling, transportation & disposal of all the hazardous wastes
as per the Hazardous Waste (Management, Handling & Transboundary Movement)
Rules, 1989
Proper and timely oiling, lubrication, preventive maintenance of all plant machinery &
equipments.
Explore the technology for cleaner production, waste minimization, treatment/ reuse / recycle /
co-incineration of wastes
Storage & Ensure the storage and handling of all the chemicals in a proper manner to avoid any spillages
handling of and also to prevent runoff contamination in monsoon Ensure collection & treatment of
hazardous spillages, if any ensure good housekeeping to maintain clean and orderly working
chemicals and environment.
hazardous Provide training to the persons handling chemicals & hazardous wastes
waste Ensure the provision of designated hazardous waste storage area with proper roofing and
leachate collection
Ensure the disposal of hazardous wastes at approved TSDF with manifest only.
Ensure availability of MSDS of all the Hazardous materials to the on-site emergency team.
Transportation Vehicles must be PUC certified
of hazardous Ensure vehicular movement only during day time
chemicals and Ensure the transportation only by covered vehicles
hazardous Ensure availability of manifest/TREM card with driver during the transportation of Hazardous
waste Waste / hazardous chemicals
Ensure regular maintenance and optimum use of the vehicles
Educate driver about the characteristics of wastes/ chemicals and immediate actions in case of
any spillage or accident
Ensure availability of MSDS of all the Hazardous materials to the Off-site Emergency team.
Domestic Regular monitoring of water consumption and ensure optimum use of water
activities Ensure proper discharge of sewage to soak pit through septic tank.
Green belt Maintain existing green belt by regular watering, soil enrichment work (applying manure)
development weeding and provide proper protection
Ensure the further development of greenbelt as proposed
Citizenship Give preference to local people for the recruitment
Activities Ensure to carry out Citizenship activities as proposed
9.0.Water Management Plan
Waste Water Management

Domestic The sewage generated from domestic will be disposed through by soak pit
Proposed The sewage will be sent to Packaged sewage treatment plant of XXXXXX
process ( 3 KLD )Capacity and the treated sewage will be used for Greenbelt
9.1. Rain Water Harvesting
Page 33 of 37
The surface water and groundwater are the life line of the villages. All the ponds in the area
are working as recharge sites for the under lying groundwater and hence the surface water
and ground water systems are acting like a single unit and therefore cannot be seen in
Isolation.
Any contamination in surface drainage due to operation of project could collapse the system
and will have serious impacts to the water resources especially the availability of potable
water in the PIA area. The impacts will be high in the core area especially the 5.0 km radius
area. Therefore the efficiency of Zero Liquid Discharge will be ensured with proper
regulatory and institutional arrangements
Though the proposed development will not draw Groundwater, the following measures are
proposed as a part of development to improve the ground water scenario and also to ensure
that ground water is not contaminated.
Strategic plans such as implementing the following structures for rainfall harvesting and
groundwater recharging purposes in project site will be adhered.
1. Recharge pits
2. Only roof-top rain water harvesting
3. Rainwater storage ponds/tanks
4.Storage cum recharge ponds
5.Monitoring of water quality and groundwater level variations in the project site
.10.0. Biological Management Plan
There are no identified migratory paths for major and minor wildlife in the project site and
the
study area. The identified fauna which are observed at the project site and in the study area
are local species only. Therefore the proposed project operations are not likely to have any
adverse impact on the paths for avid-fauna.
2. Baseline Data Result

The baseline Data environmental quality of air, water, Equipment , Personal Surface , noise,
Drainage Point , Temperature , Pressure , Humidity Etc …….socioeconomic status has been
assessed in the XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
winter season (December 2013 to February 2014).
Baseline study was conducted as per the approved WHO Norms
10 KM Radius Outside the Manufacturing Unit ( Base Line Data )
2.1. Micro-Meteorology
The site-specific micrometeorological data was collected continuously during the study
period by Weather Monitoring Equipments at project site. During the study
period wind was blowing mostly from XXX NNW with average speed of XXXXX 0.85 m/s
and
maximum speed of XXXXXX 7.1 m/s. Average temperature recorded was XXXXXX
20.1°C with maximum temperature of XXXXXXXXXXXX 34.3°C and minimum of
Page 34 of 37
XXXXXXXXXX 12.1°C. The average relative humidity was recorded as XX 46% and
maximum as XX 83%.
2.1. Ambient Air Quality

The ambient air samples were collected from six locations and analyzed for PM10,
PM2.5, SO2, NOx, HCl, NH3, CO & VOC. All the parameters are well within the NAAQS
except PM10 at three locations including project site. HCl concentration at project site
was also well within the GPCB norms prescribed for industrial area. It was below
detectable limit at other locations. VOC and NH3 concentration (as isobutylene) was
below detectable limit (BDL) at all locations.
2.2. Water Quality

Ground water samples were collected from the five locations and pipe water was
collected from project site once during the study period. TDS was permissible limit at Pardi
Village. Total Hardness was found the permissible limit at Pardi, Veraval (Shapar) and
Ribda Village. Heavy metals and other parameters except specified above were well within
the permissible limit at all locations and water collected from all the location is fit for the
drinking purposes except the ground water of Pardi Village.
2.3. Background Noise Level

The monitored noise levels have been compared with the standards prescribed by
MoEF which indicates that Noise levels at project site were found well within the limit for
day & night time. Noise levels at all the residential locations were found higher than the
limit for day time and for night time noise levels were well within the limit. Due to
vehicular movement during day as well as night time, noise levels on Shapar-Veraval
Junction at NH-8A were observed higher than the limit.
2.4. Soil Quality
Water Holding Capacity of soil samples were in range of 32% (Veraval (Shapar)
Village) to 40% (Gundasara Village). The texture of soil is observed mainly Sandy Clay
Loam in the study area. The concentration of available Nitrogen, Phosphorous and
Potassium were in the range of 0.3 to 1.2 gm/Kg, 0.04 to 0.1 gm/Kg and 0.5 to 1.0
gm/Kg respectively, which signifies that the soil of the area is fertile. The organic matter
in the soil ranged from 1.2 to 3.9 mg/Kg
In Side the Manufacturing Unit Base Line Data
Viable Monitoring
Air Settle Plate Annexure
Air Sampler Annexure
Compressed Air Air Annexure
Oil Annexure
Moisture Annexure
Equipment Contact Plate Annexure
Swab Annexure
Surface Contact Plate Annexure
Swab Annexure
Personal Finger Dab Annexure
Swab Gown Annexure
Contact Plate Annexure
Drainage Point Swab Annexure
Contact Plate Annexure
Page 35 of 37
Temperature Annexure
Humidity Annexure
Air Velocity Annexure
Air Change Annexure
Water Annexure
.Environmental Monitoring Equipments Details

Equipments Cleaning Date / Calibration Date /
ID / SOP No. ID / SOP No.
3.0 Action Plan for Count Exceeding Alert Level

1. During Routine Monitoring if the Environmental Monitoring Count Exceed Alert Level , It
has to be Brought to the Notice of Section In Charge QA Dept. ,Production Dept., And
Maintenance Dept. , and Necessary Action has to taken to Reduce the Microbial Load .
2. Cleaning Frequency Interval Shall be Decreased and After Every Cleaning Activity
perform Environmental Monitoring to Check Bio Load
3.Continue the Above Procedure till the Bio Load Level Comes Below Alert Level
4.During this period Production Activity will be Continued
Page 36 of 37
4.0 Action Plan for Count Exceeding Action Level
Maintenance Dept. , and Necessary Action has to taken to Reduce the Microbial Load
2. The Source of Contamination Shall be Investigated Through Deviation Control .Sources
could Include AHU System Damaged HEPA Filters and Changes in Personal Garbing habits
or Working Practices
3. During this period Production Activity will be Stopped
4.Thoroughly Sanitize the Areas by means of Fumigation
5.Keep the Areas Clean & Dry Sanitize the Equipments with 70 % IPA Solution
6.Minimize the Movements in the Production Areas
7.After Above Necessary Action Perform Environmental Monitoring to Check Bio Load
8.Repeat the All Above Procedure till the Bio Load Level comes Below Alert Level
5.0. Action Plan for Count Exceeding Standard Level

Maintenance Dept. , and Necessary Action has to taken to Reduce the Microbial Load
2.Inform the Mfg.Dept . to Stop the Activity in that particular Area
3.Carry Out the Fumigation Activity and Proper Cleaning Procedure
4.Clean the Area Walls ,with Floor Disinfectants and Frequently change the Disinfectants
Solution
5. After Above Necessary Action Perform Environmental Monitoring to Check Bio Load
6.Continue the Procedure Till the Bio Load Level Comes the Below Standard Level
6.0.Conclusion
It is concluded that all sections of Solid Dosage manufacturing unit are comply with WHO
clean room standards. In each sampling site of all clean zones shows viable and non-viable
counts within the limits set by local and international clean room standards. It is Beneficial
to Product Quality & Safety .
It can be concluded on a positive note that after the implementation of the mitigation
measures and environmental management plans, the proposed 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.
Prepared By Reviewed By Approved By

Department
Signature
Date
Name
Designation
Page 37 of 37

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BaseLine Data Environmental Monitoring Program

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Biodot ,

Surface –Swab & Contact Plate 15-16

Water Chemical & Microbial Analysis 20-24

Baseline Data Report 25

Executive Summary 26-31

Baseline Data Result 31-34

Monitoring Parameter Air

Grade Area Location Result

Before / After Sanitization :

Monitoring Parameter Equipment

Monitoring Parameter Equipment

Monitoring Parameter Personal

Monitoring Parameter Personal

Monitoring Parameter Personal

Monitoring Parameter Surface

Note . Minimum and Maximum Temperature to be recorded Every Day At 10 AM

Mean Mean Mean

s. aureus MSA 30-35°c Growth Growth Growth

p. aeruginosa CA 30-35°c Growth Growth Growth

Salmonella RVS 30-35°c

Shigella GN Broth 30-35°c Growth Growth Growth

Conclusion of analysis Complies/ Complies/ Complies/

M/s Biodot , Proposed Small Scale Manufacturing Unit Located At Plot

2.0.Google Map of Proposed Plant Site & Topography

5.0.Pollution Potential & Control Measures

3. Strictly following the appropriate SOP & SCP

7. Monitored data will be analyzed and reviewed time

Direct / Socioeconomic 1. Continue policy of local employment according to the Implementing

6.0 Waste Management

Solid Construction Phase

7.0.Risk & Safety Management

8.0.Environmental Management Plan

Activity Management Plan

9.0.Water Management Plan

Waste Water Management

9.1. Rain Water Harvesting

2. Baseline Data Result

10 KM Radius Outside the Manufacturing Unit ( Base Line Data )

2.1. Ambient Air Quality

2.2. Water Quality

2.3. Background Noise Level

.Environmental Monitoring Equipments Details

3.0 Action Plan for Count Exceeding Alert Level

5.0. Action Plan for Count Exceeding Standard Level

Prepared By Reviewed By Approved By

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