USER REQUIREMENT SPECIFICATION FOR WATER

TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

Name of The Water for Injection Storage and Distribution System

Equipment / System

Department / Area Production

Quantity Required 01 No.

Page 1 of 19
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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 WATER
TITLE :
FOR INJECTION STORAGE 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 5-8
3.0 OPERATIONAL / FUNCTIONAL REQUIREMENTS 8
3.1 Production Stage 8
3.2 Material inputs to the Equipment and Function 8
3.3 Desired outcome from the Equipment 8
3.4 Desirable material loading method into the equipment / System 8
3.5 Desirable material unloading method from the Equipment / System 8
3.6 Expected operational hours per day and output in lots per day 8
3.7 Preferable method of cleaning 8-9
3.8 Recommended cleaning and / or sanitization agent and its chemical
9
nature
3.9 Required Utilities 9
3.10 Process control requirements 9-10
3.11 Desired level of instrumentation and Accuracy levels 10 - 11
3.12 Language requirement 11
3.13 Data Acquisition 11 - 12
3.14 Attachment / connectivity with other equipments 12
3.15 Software details 12
3.16 Operational Range (Minimum & Maximum) 12
3.17 Tolerance Limits 12

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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

S.No. Name of the Content Page No.

3.18 Least Count (if applicable) 12
3.19 Any other specific requirements 12- 13
4.0 GMP REQUIREMENTS 13
4.1 Main component 13
4.2 Specification for Material of Construction 13
4.3 Working area Environmental requirement 13
4.4 Desired means for avoiding contamination & cross contamination of the
13 - 14
products
4.5 Power supply – Specify if uninterrupted power supply is required or not 14
4.6 Power failure and recovery – Specify the action taken in case of power
14
failure.
4.7 Any other specific GMP requirement 14 - 15
5.0 SAFETY REQUIREMENTS 15
5.1 Desired Product / Process safety systems 15
5.2 Desired personnel safety systems 15
6.0 DOCUMENTATION REQUIREMENT 15-16
7.0 AUTOMATION 16
8.0 SUPPORT REQUIRED FROM VENDOR 16
8.1 Pre- Installation support 16 - 17
8.2 Start-up support 17
8.3 Limitations and Requirement from vendor on post validation changes,
AMC / Service requirement on post installation vendor equipment and 17
training for Operation and Maintenance to staff concerned.
8.4 Any other specific requirements. 17
9.0 VALIDATION REQUIREMENT WITH SCOPE 17
10.0 ABBREVIATIONS 18
11.0 DISCUSSION REVIEW / COMMENTS 18
APPROVAL SIGNATORIES 19

REVISION HISTORY
Page 3 of 19
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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

Revision No. Date Revision Summary

00 –– First Issue

1.0 PROJECT DESCRIPTION

The AUROBINDO PHARMA LTD Unit-IV facility is located in Pashamylaram, Hyderabad,
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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

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 Water for Injection
Storage and Distribution System.
2.0 PROCESS DESCRIPTION
2.1 Name of the Equipment
Water for Injection Storage and Distribution System.
2.2 Purpose of the Equipment
The system should be suitable for the storage and distribution, considering that it should not
detoriate the WFI quality throughout the system
2.3 Number of Equipments Required
The system shall design for one storage tank with 20 KL capacity and Approx. 200 meters
distribution loop with all specified user and sampling points.
2.4 Process Description and Schematic Flow diagram
The flow diagram is as follows.
→ W FI Generation Plant → Collection of WFI in Storage → Tank Temperature Sensor →
Circulation Pump → Distribution to User Point → Return Loop → Temperature Sensor →
Conductivity Sensor → TOC Sensor → Flow Transmitter → Dumping Valve → BPRV →
Spray ball → Storage Tank.

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
Micro Organism : NMT 10 CFU /100 mL
Endotoxin : NMT 0.25 EU/mL
2.6 Suggested capacity
WFI storage tank shall be suitable for storage to meet requirement up to 20 KL.
2.7 Any other specific requirement
The in feed water shall be comply with pharmaceutical purified water specifications.
 Return loop velocity should be I to 3 meters per seconds
 Temperature of the water in storage and distribution system for WFI shall be maintained
all the times above 80 0 C.

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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

 All the use points shall be controlled by diaphragm sanitary design.

 Supplier should provide the confirmatory certificates for all the major components
 Online monitoring of TOC, conductivity and temperature permanent provision to be
made on near to the return of distribution loop to storage tank.
 System sampling points shall be providing for off line testing of other attributes shall be
located on the distribution loop at following points.
 Out flow from the storage tank.
 Immediately downstream of the pump on the distribution loop.
 Near to the return of the distribution loop to the storage tank.
 Each system sample point shall be given a unique identity number traceable to its
location on water system storage and distribution schematic diagram.
 It should be horizontal/vertical, 1/3 limped, jacketed and insulated storage tank with
proper support.
 All contact parts for tank shall be made up of SS 3 16 L, non-contact parts shall be SS
304.
 Tank is fabricated from SS 316 L Material, internally electro polished to a surface finish
of < 0.38 µ Ra, and externally matt finished.
 Jacket with provision for plant steam with safety valve shall be provided to WFI tank for
sanitization / Heating
 Electrics heater shall be provided on bottom of the tank for heating of WFI in absence of
plant steam for maintain of W FI temperature.
Vent Filter:
 Vent filter shall be installed on this tank for venting to avoid any vacuum hazards.
This vent filter should be supplied with electrical housing to maintain the element under
temperature during sanitization of the system to prevent condensation.
Vent filter shall be 0.2 micron hydrophobic to prevent any atmospheric contamination in the
tank and to prevent moisture entering the tank.
 Filter housing shall be 10 inch SS 316 L with Code7 and heating facility.

Spray Ball:
Spray ball shall be made up of SS316 L and should rotate in 360 0C

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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

Distribution skid:
 WFI distribution pump, one-flow diversion valves (return), and instruments (Pressure
Gauze, Conductivity and TOC Sensor, Temperature Sensor and Flow Transmitter) shall
be mounted on skid.
 One standby pump shall be provided in case of emergency.
 The skid frame shall be constructed with SS304. Interconnecting piping shall be 16
SWG thick, SS 316 L.
 All connections are sanitary tri-clove clamp fittings and gaskets for these fittings are of
PTFE / Silicon
Pump:
• Pump shall be designed and selected according to cGMP requirement for velocity, flow and
contact parts. Pressure gauge shall be provided at the discharge to monitor the pressure.

• One standby pump shall be provided in case of emergency.

• All contact parts of WFI should be SS 316 L.
• Supplier should provide the MOC certificate of impeller and mechanical seal of pump.

Back pressure release valve:

• Backpressure release valve shall be provided at return line to maintain positive pressure in
distribution system. MOC of backpressure release valve should be SS316 L.
Flow diversion valve:
• Flow diverter valve at the supply and discharge of pump shall be provided. It shall be
pneumatically operated.

• If any set parameter (Temperature, TOC and Conductivity) is beyond the set point, drain
port (dumping valve) should be open automatically and it shall not allow deteriorated water
to go to point of user, simultaneously VFD of the recirculation pump shall be slow down.
MOC of flow diverter valve should be SS316 L.
Distribution piping:
• Distribution system shall be fabricated out of SS 316 L and tube fittings (sanitary type). The
tubes shall have an inside surface finish of < 0.38 µ RA.

• The fabrication shall be done by using TIG / orbital welding machine with a closed head in
an inert atmosphere of argon gas to give crevice free welds with the concavity and convexity
of the weld well within permissible limits.

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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

• Care shall be taken for minimum amount of dead leg in the fabricated distribution system.
(Limit: NMT 1.5 D).

• The distribution loop consists of approx. 10 user points. At each user point orifice plate and
hose nipple with one end tri clover end connection shall be provided.

• The user point valves shall be manual zero dead leg diaphragm type. Internal Finish: < 0.38
µ Ra, Internal electro polish.
 Tubes for Distribution: SS 316 L.
 Internal Finish (Electro polish) < 0.38 µ Ra.
 Welding TIG / Orbital Welding.
 Tri clover Clamps with PTFE / Silicon Gaskets: As per Requirements.
 Valve in process piping: Contact Parts SS 316 L.
 Diaphragm in Valves: PTFE backed by EPDM.
 Slope: Min of I: 100.
 Dead league : Normal dead league NMT 1.5 D (D = diameter of branch)
 100% Drain ability for shell, jacket components and distribution loop.
3.0 OPERATIONAL / FUNCTIONAL REQUIREMENTS
3.1 Production Stage
Storage and distribution of WFI.
3.2 Material inputs to the equipment and function
WFI and Pure steam / Plant steam for sterilization.
3.3 Desired outcome from the equipment
Storage and distribution of WFI to distribution loop
3.4 Desirable material loading method into the equipment / System
Outlet of WFI Generation plant connected to inlet of storage tank
3.5 Desirable material unloading method from the equipment / System
Diaphragm valve shall be provided for collection of WFI in user and sampling points.
3.6 Expected operational hours per day and output in lots per day
24 x 7 x 365 Day (contentious or uninterrupted).
3.7 Preferable method of cleaning
 Passivation.
 Sanitization with WFI.
3.8 Recommended cleaning and / or sanitization agent and its chemical nature
Supplier should provide information for any specific cleaning procedure /effective cleaning
method / agents.
Page 8 of 19
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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

3.9 Required Utilities:

Utility Name Specification Purpose
Pharma grade, oil
Compressed Air free. Pressure: For pneumatic operations
NLT 6.0 kg / cm2
400-440 V, 50 Hz,
Electric supply Power supply
3 phase
Plant steam supply for jacketed Maintaining temperature during
3 kg/cm2
storage tank sanitization
3.10 Process control requirements
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.
 PLC based control panel is equipped with the following accessories, PLC (Siemens) 57-
400 or Allen Bradley micrologix-1400 with 15% extra I/O.
Programmable logic controller (plc):
• Versatile modular processor with power supply and memory back-up.
• Digital input and digital relay output module.
• Analog Input and Output module with 15 % Extra I/O module to future expansion.
The control philosophy stands to automatic control systems with sanitization for the
purpose of:
 Electrical safety / protection as per IEC 17000 Standard.
 Equipment / interlocking for fail-safe operations via field devices water
parameters monitoring and controls in normal mode of operation viz.
storage tank level, tank temperature, loop temperature etc.
 Calibration- As per ISO-17025-2005 Standard or As per GAMPS Practices.
Human machine interface (HMI):
• Line display HMI shall be mounted on the control panel. HMI is for on-line monitoring
and control of the process with direct access via predefined function keys on the operator
console.

Pneumatic controls:
• Shall Consists of AFRL units mounted separately on the side of the panel connected to

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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

many fold units to which 3/2 way pilot solenoid valves and coils. The PLC outputs are
connected to the coils and the pneumatic output will be field terminated.

Data logging:
• PLC based control panel is communicating through HMI. Access to all Input / Output
values and system status bit is provided through a communication link, data is recorded
internally, and the user is able to take the online printout through external printer. Data
can be stored in computer and can be accessed offline, SCADA Based for monitor and
controlling through SCADA with 3rd Party reports.

Interlock and alarm:

Following Interlock and Alarm shall be provided to system.

• If low pressure in the air inlet line will initiate an alarm and trip the whole system
immediately.
• Very High level of WFI in tank will close WFI tank inlet valve.
• Low level of tank will trip the pump.
• High conductivity in the supply line shall initiate an alarm with hooter. Very High
conductivity in supply line of the loop will open port to drain and pump RPM will close
its inline port. After presentable time will trip pump, if conductivity comes down below
set point.
• Low flow in the Return line of the loop will initiate an alarm.
•When the system in normal mode is in progress a power failure, after availability of
power again it should restart automatically with VFD control accretion time to avoid
spikes on pressure fluctuation
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
% FS
Conductivity transmitter:
• A conductivity transmitter in the supply line shall monitor the quality of PW.
• Accuracy: +/- 0.2 to 0.5 % in full scale
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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

• Range 0 to 20 µs/cm
Temperature transmitter:
• RTD 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% in full scale, Duplex type.
• During sanitization, these temperature transmitters shall give the necessary signal to
PLC as per interlock write up to control temperature of WFI during sanitization by
controlling steam ON/OFF valve.
Flow transmitter:
•A flow transmitter shall be installed in return line of distribution system is being
continuously sensing the flow of water and maintains the necessary velocity required
in the return line by controlling speed of distribution pump with the help of variable
frequency drive.
• Accuracy: +/- 0.5% in full scale with totalized, audio visual alarm indication locally.
Pressure gauge:

• Pressure gauge shall be bourdon type with a diaphragm isolator and shall be required
for monitoring of pressure at pump discharge.
• Accuracy: +/- 0.5% in full scale.
Online TOC:

•
Range: 0 to 1000 ppb Accuracy: +/- 0.5% FZS, connected to PLC, with online printer,
signed to be connected to dump valve operation and allow throw SCADA
connectivity.
Variable frequency drive:

• VFD shall provide a reliable mean of adjusting or changing the frequency of alternating
current applied to the motor and thereby changing the motor speed with online
monitoring screen.
Language requirement (Specify such as English/others).
3.12
English
3.13 Data Acquisition
 The vendor should provide the print out facility with memory and with 3 level password
protection.
 PLC based control panel shall communicating through HMI. Access to all Input / Output
values and system status bit through a communication link and data shall be recorded
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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

internally and the user is able to take the online printout through external printer.
 Data can be stored in computer and can be accessed offline /online with cold prints,
software should compile as per 21 CFR Part 11 compliance, 5000 tags capacity SCDA,
3rd party reports.

Attachment / connectivity with other equipments

 PLC: Allan Bradley, HMI: PVP 600 plus colour HMI.
 Higher end and Current versions with minimum 2500 Tags Capacity.
3.14  Original Software with Editable License Key of Advanced work version and minimum
Client 2-user software.
 During Sterilization / Sanitization time, isolation valve shall be closed and system shall
be done through SCADA system

Software details
 HMI: Siemens colour touch screen with a suitable size for easy operation
 21 CFR part11 compliance GAMP-5. Software backup, auto password expiry and
password change option, printer required and online web support through modem for
3.15
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)

 If any add on module of the PLC has been damaged for any reason, it can be replaced
immediately with a new one without changing the configuration of the system.
 The vendor must be able to provide routine repairs when needed beyond the warranty
period at cost to the customer.

Bought out components make:

S. No COMPONENT DESCRIPTION MAKE

Diaphragm valves with SS handle with PTFE
I Gemu
diaphragm
2 Conductivity sensor Rose mount/ Emerson
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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

3 Flow meter E+H

4 Pressure gauge Warre / Baumer
5 Compound gauge Warre / Baumer
6 Steam trap Forbs Marshall / Spirax
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 Distribution Pump Alfa level
12 Safety valve Approved vendor
13 SS 316 L Storage Tank Capacity 20 KL Approved vendor
14 Vent filter housing / cartridge Pall
15 Back pressure valve Neela / approved vendor
16 Dumping valve Alfa / Neela
17 VFD Donfoss / Schneider
18 Spray ball Lechler
Hatch / Equivalent
19 TOC Meter
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, <0.38µ Ra electro polished.

Non contact parts SS 304

Working area environmental requirement
4.3
Machine should operate under clean environment / unclassified area.
4.4 Desired means for avoiding contamination and cross contamination of the products
• Flow diverter valve at the discharge of pump shall provide and if conductivity of WFI
is greater than the set point of conductivity transmitter provided at the suction of
distribution pump, drain port of this valve shall open and in turn shall not allow quality
deteriorated water to go to point of use.
• Backpressure valve shall be provided at return line to maintain positive pressure in
distribution system.
• Vent filter shall be 0.2µ hydrophobic to prevent any atmospheric contamination in the
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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

tank and to prevent moisture entering the tank. Filter housing is of SS 316 L.
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.

Upon loss of electrical power, all components shall fall into "safe" positions. Upon restoration
4.6 of electrical power, WFI Storage and Distribution System shall restart automatically. An input
from the operator or the communication link shall not be required to restart the system. No
additional action shall be required for full recovery after an electrical power failure.

4.7 Any other specific GMP requirement

 The storage vessel shall be constructed SS 316L, Non-Contact Parts SS 304, Internal
Electro Polished < 0.38 µ Ra, Externally Matt Finished.
 Steam Trap shall Inverted Bucket Type and Contact parts - SS 304, Body - CI, Operating
Pressure - 10.5 Kg / cm2 And Operating Temperature - 180 oC.
 Temperature transmitter shall PT 100 type, top mounted, 4 — 20 mA output, Probe
MOC — SS 3 16, TC end connection.
 Conductivity sensor to Outlet of Tank, 0-10 µS/cm 0.01 cell constant, Sensor MOC- SS
316, TC End.
 Distribution pumps Suction Valve Manual diaphragm type, SS 316L Body, SS bonnet,
Wheel, PTFE backed by EPDM Diaphragm, TC End Connection.
 Steam safety valve shall (Non-sanitary) spring loaded, MOC CS maximum.
 Sampling Valve of distribution system shall 8 mm Contact MOC - SS 316, Silicon
Gasket, TC end. Standard - ASTM A 270 TP SS 3 16 L, ERW, 16 SWG, Internally
electro polished to < 0.38µ Ra and externally sanitary finish
 All Bend and Tees MOC SS 316L, Internally electro polished to < 0.38µ Ra and
externally sanitary finish, variable piping - made from parent tube.
 Tri-clove clamps- SS 304 Tri clamps (Casting), two segments heavy duty with metal
wing nut and 'O t rings.
Following basic features should be incorporated in the system design to make it cGMP
compliant
 Material in contact with WFI shall be SS 3161.
 Distribution piping shall be SS 316L grade and electro polished to < 0.38 µ Ra.
 Gradient shall be l: 100 to ensure complete drain ability.
 Only sanitary design pump with mechanical seal shall be used.
 Liquid velocity shall be 5 ft. /sec (1.5 meter/second) or higher in the circulation loop and
3 ft. /sec (0.9 meter/second) or higher in the return section of circulation loop during
peak usage.
 All Point of Uses (POU) shall be zero dead Leg design.
 Dead leg in piping shall be < 1.5 D (D = diameter of tube)
Page 14 of 19
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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

 Only orbitally welded joints shall be used, other than these specially mentioned like zero
dead leg valves shall be used for critical areas where orbital weld is not possible, etc.
 Orbital welding shall be done using 99.993 % pure argon gas.

5.0 SAFETY REQUIREMENTS

Desired Product / Process Safety Systems
Upon loss of electrical power, all components shall fall into "safe" positions. Upon
restoration of electrical power, WFI Storage and Distribution System shall restart
automatically. An input from the operator or the communication link shall not be
5.1 required to restart the system. No additional action shall be required for full recovery
after an electrical power failure.
 WFI Storage and Distribution System are equipped with several alarms that will alert the
operator (or the User's main control system through the data communication link) that
system operation is outside of established parameters.
Desired personnel safety systems
5.2
 Emergency stop provision.
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.
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.

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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

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
Minimum requirements in critical process area to be subjected to automation.
• Graphical representation of P & ID and Trends, Events and Numerical Report.
20% Extra I/O points required for both hard ware & Software Tags.
• Software should be compatible to 21 CFR Part 11 compliance, 5000 tags I/O.
7.0
• Logic shall be as per existing vendor supplied shall be hook-up for both WFI, and WFI
distribution system.
• PLC Eeprom and Flash memory card required
• Critical alarms, Common alarms shall be configured.
• Audible alarm required for control panel area
8.0 SUPPORT REQUIRED FROM VENDOR
Pre- Installation support
8.1
Foot prints of Machine, Utilities and Piping requirements.
8.2 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

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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

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.

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 The machine should be such a way that to fit with tunnel sterilizer.
Control cabinet with integrated temperature monitoring to protect the installed components

VALIDATION REQUIREMENT WITH SCOPE

Validation topic Yes/ No Scope

Design Qualification YES Supplier

FAT & SAT YES Supplier / user

9.0
Installation Qualification YES Supplier / user
Operational Qualification YES Supplier / user

Performance Qualification Supplier / user

YES

ABBREVIATIONS
AMC : Annual Maintenance Contract
ANDA : Abbreviated New Drug Application
ASME : American Society for mechanical engineering
10.0 DQ : Design Qualification
EU : European Union,
FAT : Factory Acceptance Test.
GMP : Good Manufacturing Practices
ISO : International Organization for standards
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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

IQ : Installation Qualification
LAF : Laminar Air Flow
OQ : Operational Qualification
PQ : Performance Qualification
PLC : Programmable Logic Control
MOC : Material of Construction.
NIST : National Institute of Standards and Technology
NPL : National Physical Laboratory
NEC : National Electrical Code

DISCUSSION / REVIEW / COMMENTS

11.0 The user requirement specification of Water for Injection Storage and Distribution System
reviewed for releasing the purchase order.

APPROVAL SIGNATORIES

Name / Designation Signature Date

Prepared By

Page 18 of 19
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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 WATER
TITLE :
FOR INJECTION STORAGE AND DISTRIBUTION
SYSTEM

REFERENCE SOP : FU4-QA-GEN-001

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