USER REQUIREMENT SPECIFICATION FOR PURE

TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

Name of The Pure Steam Generation and Distribution System

Equipment / System

Department / Area Production

Quantity Required 02 No’s.

Page 1 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR PURE
TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

S.No. Name of the Content Page No.

Cover Page 1
Table of Contents 2&3
Revision History 4
1.0 PROJECT DESCRIPTION 5
2.0 PROCESS DESCRIPTION 5
2.1 Name of the Equipment / System / Facility 5
2.2 Purpose of the Equipment / System / Facility 5
2.3 Number of Equipments Required 5
2.4 Process Description and Schematic Flow diagram 5
2.5 Chemical / Physical characteristics of the process material 5
2.6 Suggested capacity 5
2.7 Any other specific requirement 5-6
3.0 OPERATIONAL / FUNCTIONAL REQUIREMENTS 6
3.1 Production Stage 6
3.2 Material inputs to the Equipment and Function 6
3.3 Desired outcome from the Equipment 6
3.4 Desirable material loading method into the equipment / System 6
3.5 Desirable material unloading method from the Equipment / System 6
3.6 Expected operational hours per day and output in lots per day 6
3.7 Preferable method of cleaning 6
3.8 Recommended cleaning and / or sanitization agent and its chemical
6
nature
3.9 Required Utilities 6-7
3.10 Process control requirements 7-8
3.11 Desired level of instrumentation and Accuracy levels 8-9
3.12 Language requirement 9
3.13 Data Acquisition 9
3.14 Attachment / connectivity with other equipments 9
3.15 Software details 9
3.16 Operational Range (Minimum & Maximum) 9
3.17 Tolerance Limits 9
3.18 Least Count (if applicable) 9
3.19 Any other specific requirements 9 - 10
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR PURE
TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

S.No. Name of the Content Page No.

4.0 GMP REQUIREMENTS 10
4.1 Main component 10
4.2 Specification for Material of Construction 10
4.3 Working area Environmental requirement 10
4.4 Desired means for avoiding contamination & cross contamination of the
10
products
4.5 Power supply – Specify if uninterrupted power supply is required or not 10
4.6 Power failure and recovery – Specify the action taken in case of power
10
failure.
4.7 Any other specific GMP requirement 10 - 11
5.0 SAFETY REQUIREMENTS 11
5.1 Desired Product / Process safety systems 11
5.2 Desired personnel safety systems 11
6.0 DOCUMENTATION REQUIREMENT 11-12
7.0 AUTOMATION 12
8.0 SUPPORT REQUIRED FROM VENDOR 12
8.1 Pre- Installation support 12
8.2 Start-up support 12 - 13
8.3 Limitations and Requirement from vendor on post validation changes,
AMC / Service requirement on post installation vendor equipment and 13
training for Operation and Maintenance to staff concerned.
8.4 Any other specific requirements. 13
9.0 VALIDATION REQUIREMENT WITH SCOPE 13
10.0 ABBREVIATIONS 13
11.0 DISCUSSION REVIEW / COMMENTS 13
APPROVAL SIGNATORIES 14

REVISION HISTORY
Page 3 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR PURE
TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

Revision No. Date Revision Summary

00 –– First Issue

1.0 PROJECT DESCRIPTION

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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR PURE
TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

The AUROBINDO PHARMA LTD Unit-IV facility is located in Pashamylaram, Hyderabad,

India. The functional areas of the facility include GMP Production Areas, Packaging areas,
Warehousing and Storage areas, Analytical, Microbiological, Quality Control (QC), Quality
Assurance (QA) and offices.
The APL facility is used for injectable production, including supporting analytical and QC
activities for filing ANDA. The drug products produced are intended for medicines for human
use and as such are governed by current Good Manufacturing Practices (cGMP). This URS
describes the operational, environmental and cGMP requirements of the Pure Steam Generation
and Distribution System.
2.0 PROCESS DESCRIPTION
2.1 Name of the Equipment
Pure Steam Generation and Distribution System.
2.2 Purpose of the Equipment
To provide Pure Steam as per pharmacopeia’s specifications.
2.3 Number of Equipments Required
Two Equipment’s
2.4 Process Description and Schematic Flow diagram
The flow diagram is as follows.
→ Purified Water storage tank Input to Pure steam generation → Passing through columns
(shell tube heat exchangers) → Evaporation → Distribution to User.

2.5 Chemical / Physical characteristics of the process material

The system shall design by considering the quality parameters as introduced by USP-34 as
maximum allowable parameters at user point.
 pH: 5.0 - 7.0
 Conductivity: < 1.3 µS/cm @ 25 oC
 TOC: < 500 ppb
 Endotoxin : NMT 0.25 EU/mL
As per EN285/ISPE Guidelines 'condensate analysis:
 Non condensable gas: Less than 3.5%
 Dryness factor: The dryness value should be in the range of 0.9 to 1.0
 Dcgrce of super heat: At atmospheric pressure should not exceed 25 0 c

2.6 Suggested capacity

1000 kg / hr and approximate 07 user and sampling points in production area
2.7 Any other specific requirement
• Require sanitary construction features such as double tube sheets, sloped piping and low
point drains, minimum dead legs and sanitary connections.
• Required uniform wetting and heat transfer. Elimination of bio growth Feed water level
control: Need PID control loop senses the actual level and adjusts the flow rate of feed

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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR PURE
TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

water up or down to maintain the level at the desired point.

• Feed water pump should stop when; feed water conductivity is high, Boiler steam
temperature is low, in case of insufficient evaporation, feed water pressure low.
• Inner and Outer column shell should be < 0.6 Ra, electro polished. Pipeline should be
orbital welded wherever technically possible.
• Required to control the water droplets, particulate matter and Endotoxin from the
evaporation at desired level.
• Required a provision for non-condensable gas removal arrangement.
3.0 OPERATIONAL / FUNCTIONAL REQUIREMENTS
3.1 Production Stage
Generation of pure steam.
3.2 Material inputs to the equipment and function
Purified water and plant steam.
3.3 Desired outcome from the equipment
Pure steam as per above specification mentioned under point 2.5.
3.4 Desirable material loading method into the equipment / System
In feed through SS 316, < 0.8 Ra electro polished pipeline from Purified Water storage tank to
Pure steam generation unit.
3.5 Desirable material unloading method from the equipment / System
The feed water is sequentially evaporated from the column or effect. The delivered pure steam
is maintained in continuous loop at NLT 121 0 C with all user points.
3.6 Expected operational hours per day and output in lots per day
24 x 7 x 365 Day (continuous or uninterrupted).
3.7 Preferable method of cleaning
Manual cleaning.
3.8 Recommended cleaning and / or sanitization agent and its chemical nature
Supplier should provide information for cleaning procedure.
3.9 Required Utilities:
Utility Name Specification Purpose
Pharma grade, oil free.
Compressed Air For pneumatic operations
Pressure: NLT 6.0 kg / cm2
Electric supply 400-440 V, 50 Hz, 3 phase Power supply
Purified water 2 Kg/Cm2 For product input
Plant steam supply 6.0 kg / cm2 For Column Heating
Vendor should specify the utility requirements
3.10 Process control requirements
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR PURE
TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

PLC based control panel:

 PLC based control panel is with two line Display 7.0" Colour HMI which will be
communicating through the Supervisory Control and Data Acquisition System
(SCADA). Operation of system is through PLC, which is programmed and stored in
CPU of the PLC set.
 The equipment should have control system to stop the feed pump in case of low plant
steam temperature and low feed water level in column.
 The equipment should have pressure control system to regulate the cooling water
 The equipment should have Flow control flow meter for controlling the flow rate of feed
water.
Required online:
 Conductivity meter: To monitor conductivity of PW and Pure steam condensate. Range
should be 0-100 micro Siemens /centimetre or better. Make: Rosemount.
 Flow meter: To indicate feed water flow. Range should be 0 to 5000 Litre/Hour or
better.
 Pressure gauge: To indicate plant steam pressure and air pressure. Range should be 0-14
Kg/cm2 (2 No's) and 0-7 Kg/cm2 (l No's) respectively. Placement is one at plant steam,
one at feed water line and one at cooling water line.
 Temperature control: To monitor and control the temperature of Boiler and Pure steam.
Range should be 0 to 200 0 C. The placement should be; One RTD in Plant steam line,
one RTD in WFI Line, four in each columns.
Required the following indication on control panel:
 MMI
 Emergency push button
 Conductivity analyzer
 DTIC for boiler steam and pure steam output temperature.
 Switches for manual operation- feed pump, purging valve, venting valve and dumping
valve.
 Indication Lamp for - feed pump on.
 Auto/Manual mode switch.
 Main supply switch
Feed pump and sampling valve should stop automatically with respect to following
controls:

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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR PURE
TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

 Boiler steam temperature low

 Feed pump over load relay
 Insufficient feed water
 Pure steam pressure high
 Feed water conductivity high
 Emergency stop
Purging valve should start automatically with respect to following control:
 Boiler steam temperature low
 Column water level high
 Required safety interlocking between steam control valve to non-condensable gases
regulator
 Required indication of any respective fault at the P & I diagram with LED indication
3.11 Desired level of instrumentation and Accuracy levels
Level transmitter:
• Level transmitter for opening and closing of inlet valves for storage tank to avoid dry
running of distribution pump.
• Accuracy: +/- 0.5% in full scale, capacitance type.
Compound pressure gauge diaphragm type:
• Compound pressure gauge shall be provided to monitor positive and negative pressure
in the tank. This shall be chemical sealed sanitary diaphragm type.
• Accuracy: +/- 0.5% in full scale
Conductivity transmitter:
• The quality of PW shall be monitored by a conductivity transmitter in the supply.
• Accuracy: +/- 0.2 to 0.5 % FS
• Range 0 to 20 µs/cm.
Temperature transmitter:
• RID type temperature transmitters shall be installed in the tank and in the return line of
distribution loop for monitoring the temperature continuously while the system is in
normal mode.
• Accuracy: +/- 0.5% FS, Duplex type.
Pressure Gauge:
• Pressure gauge shall be bourdon type with a diaphragm isolator and shall be required for
Page 8 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR PURE
TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

monitoring of pressure at pump discharge.

• Accuracy: +/- 0.5% FS

Slope: Min of 1:120
Language requirement (Specify such as English/others).
3.12
English
Data Acquisition
3.13 The vendor should provide the print out facility with memory and with 3 level password
protection.
Attachment / connectivity with other equipments
• Required attachment to Purified water storage tank for input of feed water
3.14
• Required attachment to pure steam distribution loop.
•
Required attachment to Plant steam generator and Compressed air generator
Software details
 HMI: Siemens colour touch screen with a suitable size for easy operation
 PLC：Siemens
 Siemens with 21 CFR part11 compliance GAMP-5. Software backup, auto password
3.15 expiry and password change option, printer required and online web support through
modem for emergency trouble shooting.
 3 to 4 unique levels should be available for the system to perform various operations
such as operator/ supervisor/ manager etc. Each level should have a unique password.
 Required PLC and Software backup
Operational Range
3.16 Minimum Maximum
Supplier should provide operating ranges.
Tolerance Limits
3.17
0.2 to 0.3 of any instrument
Least Count (if applicable)
3.18
Minimum legibility.
3.19 Any other specific requirements (e.g. Maintenance requirement)

 All product contact pipeline should be orbital welded.

 The vendor must be able to provide routine repairs when needed beyond the warranty
period at cost to the customer.
 Required audio / visual alarms for all critical insufficiency.

Page 9 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR PURE
TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

Bought out components make:

S. No COMPONENT DESCRIPTION MAKE

Diaphragm valves with SS handle with PTFE
I Gemu
diaphragm
2 Conductivity sensor Rose mount
3 Flow meter E+H
4 Pressure gauge Warre / Baumer
5 Compound gauge Warre / Baumer
6 ORP Sensor Georg fischer
7 Manual ball valve for jacket condensate Shaktti /approved vendor
8 PLC Allen bradlly / Siemens
9 Temperature sensor Radix
10 Level transmitter Endress + Hauses
11 Pump Ground foss
12 Safety valve Approved vendor

4.0 GMP REQUIREMENTS

Main component
4.1
Main component should comply with valid regulated guidelines for cGMP practice.
Specification for material of construction

4.2 Product contact parts SS 316L, <0.38 µ Ra electro polished.

Non contact parts SS 304

Working area environmental requirement
4.3
Machine should operate under clean environment / unclassified area.
Desired means for avoiding contamination and cross contamination of the products
4.4
NA.
Power supply – Specify if uninterrupted power supply is required or not
4.5
 Required uninterrupted power supply for PLC. UPS port is reserved for PLC.
Power Failure and recovery– Specify the requirements in case of power failure.
4.6
Redundancy power sup Vendor should assist power failure study during qualification.
4.7 Any other specific GMP requirement
 Require a design to prevent mixing of plant steam and pure steam
 All parts coming to contact with pure steam are electro polished, pipe joints are orbital
welded and gaskets are made from pure Teflon or pharmaceutical grade silicon

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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR PURE
TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

 Steam safety valve shall (Non-sanitary) spring loaded, MOC CS maximum.

 Orbital welding shall be done using 99.993 % pure argon gas.
 Provide to provide condensable free pure steam to all user point.
5.0 SAFETY REQUIREMENTS
Desired Product / Process Safety Systems
• Safety valve provided on the boiler stream inlet at column and pure steam line.
• Feed Pump: Regarding feed pump thermal over loaded relay, feed water pressure sensor
at the inlet of the feed pump and NRV
• Required float type level controller for last column wastewater Emergency off.
• Level sensor: Level sensor in column should control the level of water to prevent the
5.1 plant steam from contamination with the feed water
• Pressure control: At high pressure of pure steam, feed pump should stop
• Out of Specification and system failure audio and visual alarm system
•
Feed water pump should start after and if plant steam temperature meets the process set
point. Feed water pump should stopped when air pressure is below the set point, feed
water conductivity is high, Boiler steam temperature is low, in case of in sufficient
evaporation, feed water pressure low.
Desired personnel safety systems
5.2  Emergency stop provision.
 All Electrical Wiring should be concealed
6.0 DOCUMENTATION REQUIREMENT
Desired Document
1. User manuals:
Operation and Maintenance manuals
 Specialized procedures, if applicable (such as Calibration, Cleaning, etc.)
 Specifications and sources of some important materials, if applicable (such as
lubricants, cleaning agents, etc.)
2. Preventive maintenance manual including:
Equipment and Instrument list with component descriptions
Electrical component parts list with descriptions
Spare parts list with appropriate identification nos., if any
Change parts list with appropriate identification nos., if any
The equipment shall be designed to use standard tools for maintenance and repairing.
Any special tools required for maintenance should be provided along with the
equipment.

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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR PURE
TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

3. Drawings:
Engineering drawings (For approval, Approved, As built, As installed)
Electrical circuit diagrams
Piping and Instrument drawings for the product path shall meet the ASME and 3A
specifications requirements as applicable.
System schematics.

4. Factory Acceptance test:

Detailed list of modifications after contract and / or in final approved design, Material
specifications and test certificates, Instrument Calibration certificates, Functional /
Factory acceptance certificates (such as weld inspection, Passivation, pressure /
vacuum holds, etc.)
5. Validation documents:
Detailed list of modifications after contract &/or in final approved design
Material specifications and test certificates
Instrument Calibration certificates
Design Qualification Protocol.
Installation Qualification Protocol
Operational Qualification Protocol
Required PLC validation
Certificates of Materials and gauges with respect to NIST/NPL.
Certificates of All welding joints.
Required PLC and Software backup

AUTOMATION
7.0 Minimum requirements in critical process area to be subjected to automation.
8.0 SUPPORT REQUIRED FROM VENDOR
Pre- Installation support
8.1
Foot prints of Machine, Utilities and Piping requirements.
Start up support
FAT required before delivery. Supplier should provide a checklist and is responsible for total
completion up to performance qualification including training.
i. Technical staff of supplier shall come to install the equipment and shall be present up to
8.2 first three successful performance qualifications run.
ii. Technical staff of supplier shall train the applicable equipment operator of Aurobindo
Pharma Ltd before operation qualification testing.
iii. Technical staff shall help Aurobindo Pharma Ltd to prepare the SOP of Operation,
Cleaning and Preventive maintenance of the equipment.

Page 12 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR PURE
TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

Limitations and Requirement from vendor on post validation changes, AMC / Service
Requirement on post installation vendor equipment and training for Operation and
Maintenance to staff concerned.
8.3

Vendor is responsible for performance of the equipment even in post validation
discrepancy.
 Required training on Operation and Maintenance.
Any other specific requirement

8.4
• Required failure modes and effective analysis document.
• Operation and maintenance manuals.
•Calibration certificates with traceability
VALIDATION REQUIREMENT WITH SCOPE
Validation topic Yes/ No Scope
Design Qualification YES Supplier
9.0 FAT & SAT YES Supplier / user
Installation Qualification YES Supplier / user
Operational Qualification YES Supplier / user
Performance Qualification YES Supplier / user
ABBREVIATIONS
AMC : Annual Maintenance Contract
ANDA : Abbreviated New Drug Application
ASME : American Society for mechanical engineering
FAT : Factory Acceptance Test.
GMP : Good Manufacturing Practices
ISO : International Organization for standards
10.0 PLC : Programmable Logic Control
MOC : Material of Construction.
NIST : National Institute of Standards and Technology
NPL : National Physical Laboratory
NEC : National Electrical Code
WFI : Water for injection
PW : Purified water
HMI : Human machine interface
DISCUSSION / REVIEW / COMMENTS
11.0 The user requirement specification of Pure Steam Generation and Distribution System reviewed
for releasing the purchase order.

Page 13 of 14
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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307
 USER REQUIREMENT SPECIFICATION FOR PURE
TITLE :
STEAM GENERATION AND DISTRIBUTION SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

APPROVAL SIGNATORIES

Name / Designation Signature Date

Prepared By

Reviewed By

Approved By

END OF DOCUMNET

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Formulations Unit-IV, AUROBINDO PHARMA LIMITED, Plot No’s - 4, 34 to 48, EPIP, IP-Pashamylaram, Sanga Reddy (Dist.), Hyderabad – 502307