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Table of Contents
Doc. No.: <NDD15008-BD-PRO-URS-S2-001>
IPS-International
Page 1 of 25
Client Logo
User Requirement Specification
Client Name,
Location
Revision: <xx>
Introduction..........................................................................................................4
1.1
Responsibility..................................................................................................4
1.2
Statutory Regulation........................................................................................4
1.3
Process Description............................................................................................5
2.1
2.2
2.3
Productivity Requirement...................................................................................7
3.1
3.2
3.3
3.4
Cleaning..........................................................................................................7
3.5
Operational Requirements..................................................................................8
4.1
Process Control...............................................................................................8
4.2
4.3
InProcess control...........................................................................................8
4.4
Level of instrumentation..................................................................................9
4.5
Cleaning requirement......................................................................................9
4.6
Qualification Requirement.............................................................................10
4.7
Material of Construction................................................................................10
4.8
Use of lubricants............................................................................................10
4.9
4.10
Data integrity..............................................................................................11
4.11
4.12
Desired documents....................................................................................11
Page 2 of 25
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User Requirement Specification
Client Name,
Location
Revision: <xx>
4.13
Training......................................................................................................13
4.14
Safety Requirement...........................................................................................14
5.1
General..........................................................................................................14
5.2
5.3
Technical requirement.......................................................................................16
6.1
6.2
Level of automation.......................................................................................16
6.3
Specific requirements....................................................................................16
General..........................................................................................................17
7.2
7.3
Support..........................................................................................................18
Constraints.........................................................................................................18
8.1
8.2
Available utility...............................................................................................18
8.3
Timelines.......................................................................................................19
9
10
Change Log........................................................................................................19
Annexure.........................................................................................................19
Page 3 of 25
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User Requirement Specification
Client Name,
Location
Revision: <xx>
1Introduction
The objective of this document is to outline scope of supply, services and the minimum
requirements for a Supplier Standard system for Ampoule Washing Machine which shall be
operational within the <Project Description> of <Client Name>, <Location>, in terms of design basis
and function and operational requirements. It includes process and technical aspects only. The
following requirements listed in this URS are the minimum requirements which must be addressed
and are not an exhaustive list.
1.1
Responsibility
It is the responsibility of ___ to write this URS.
It is the responsibility of representatives of engineering, production / operation and QA of <Project
Name> to approve this URS.
1.2
Statutory Regulation
The equipment should comply with the following guidelines/ standard:
GMP Regulations
PIC/S guidelines
WHO Guidelines
21 CFR Part 211: Current Good Manufacturing Practice for finished Pharmaceuticals
GAMP
1.3
<The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated
Systems in Pharmaceutical Manufacture, Vol. 5>.
De-cartoned ampoules shall be physically inspected on de-cartoning table with inspection light
arrangement. Ampoules after inspection shall be fed to the washing machine either through
conveyor or shall be manually loaded on to the infeed table/ tray of washing machine.
Page 4 of 25
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User Requirement Specification
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Location
Revision: <xx>
In-feed conveyor: shall be responsible for feeding of the ampoules to the main washing
machine.
Infeed star wheel/ screw: Ampoules shall be separated & elevated out of the conveyor &
delivered to the revolving conveying system.
Cleaning station: Ampoules shall be passed through the cleaning station upside down & at the
individual station the spray tubes travel in synchronization. Internal and External washing of
ampoules is carried out with re-circulated water, Purified water & Fresh WFI. Atleast 6 washing
stations shall be provided in the washing machine. After each washing, drying shall be carried
out using filtered compressed air.
Outfeed star wheel/ worm: Ampoules shall be reversed by 180 & engaged in the slots of an out
feed star wheel & pushed back to the downstream tunnel in an upright position.
2Process Description
2.1
a) Unwashed ampoules: The ampoule washing machine requires an infeed station where
ampoules will be manually loaded from a tray or conveyed from de-cartoning room. In case of
manual loading, vendor shall design the required dimension of tray and infeed station, so that
tray could effectively fit to the loading station and optimum number of ampoules can be
charged at one time.
Trays shall be provided by the user.
b) Re-circulated water: WFI used in the final rinsing of ampoules shall be stored and
recirculated for initial washing of ampoules. The ampoule washing machine should have all
arrangement for recirculation of water. The recirculated water should pass through a <10
micron (vendor to specify)> cartridge filter. The vendor shall inform the exact arrangement of
recirculation system in its technical offer. Fresh WFI to be considered for volume makeup of
the tank.
Vendor shall quote for filter cartridge and SS housing, on recirculated water line, as optional.
c) Fresh Purified water (PW): PW shall be used as intermediate washing step. The ampoule
washing machine shall be suitable to collect PW directly from the room supply valve of PW
distribution loop. The interface location of connecting PW collection pipe to the room supply
valve is to be decided during detail engineering stage.
Vendor shall quote for <5 micron (vendor to specify)> filter cartridge and SS housing on PW
line, as optional.
Page 5 of 25
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User Requirement Specification
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Location
Revision: <xx>
d) Fresh Water for injection (WFI): WFI shall be used as final washing media in the ampoule
washing machine. The ampoule washing machine should be suitable to collect WFI directly
from the room supply valve of WFI distribution loop. The interface location of connecting WFI
collection pipe to the room supply valve is to be decided during detail engineering stage.
Vendor shall quote for <5 micron (vendor to specify)> filter cartridge and SS housing on PW
line, as optional.
e) Filtered compressed air: Filtered (0.22 micron) compressed air shall be used for flushing of
internal & external surface of ampoules to remove larger particulate and in final blowing step
to remove water from the washed ampoules to make it visually dry.
Vendor shall quote for filter cartridge long with SS housing (suitable for connection with
integrity test apparatus) as optional.
f)
Transport System: Pincers/ grippers shall be used for holding the ampoules at the neck and
transport it to the washing station in the upside down position for easy cleaning, and after
washing the ampoules will be re-inverted to their original position an transferred to the
depyrogenation tunnel.
2.2
a) Washing of glass ampoules is to be completed using four selectable washing media i.e.
recirculated water (>50C), Purified water (Ambient temperature), WFI (>70C) and filtered
(0.2 micron) compressed air.
b) Exact cleaning sequence is to be proposed by the vendor. However following rules are to be
complied:
Initial washing by recirculated water for internal and external surface cleaning.
Drying of washed ampoules with filtered (0.2 micron) compressed air for internal and
external surfaces.
Further washing of the ampoules with purified water for internal and external surfaces.
Drying of washed ampoules with filtered (0.2 micron) compressed air for internal and
external surfaces
Final drying of the ampoules (no visual droplets or wetting) by filtered (0.2 micron)
compressed air blowing.
Transportation of the washed ampoules from the washing outfeed to the drying zone of the
tunnel under protected acrylic cover (if distance is 200 mm, else LAF has to be provided).
Note: All washing stations shall have internal and external washing provisions.
Page 6 of 25
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User Requirement Specification
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Location
Revision: <xx>
2.3
The washed and dried ampoules shall be rotated 180 after the final drying by the individual grippers
and placed on the outfeed discharge system. The washed ampoules shall then be transfered from
the washing machine outfeed conveyor to the drying zone of tunnel.
3Productivity Requirement
3.1 Desired/ suggested capacity
The washing machine shall be suitable to produce washed ampoules at below mentioned capacity:
<No. of ampoules> per minute of <ampoule size (in ml)>.
Vendor to quote capacity of other ampoule sizes also.
3.4
Cleaning
The design ensures easy clean-ability and non-dust accumulation by providing smooth surface
finishes and rounded edges.
Equipment contact parts shall be easily dismantle-able and cleanable.
Page 7 of 25
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User Requirement Specification
Client Name,
Location
Revision: <xx>
4Operational Requirements
4.1 Process Control
a) The equipment should have facility for monitoring of pressure and temperature of WFI with
alarm in case of low or very high temperature or pressure.
b) The equipment should have facility for monitoring of pressure of PW with alarm in case of low
or very high pressure.
c) The water recirculation system and water bath shall have all arrangement to maintain the
water temperature more than 50C and shall have the facility for controlling and monitoring the
pressure and temperature of delivery with alarms in case low or very high values.
d) The compressed air supply pipeline should be provided with the facility to monitor the pressure
of delivery with alarm in case of low or very high values of pressure.
e) The equipment control system should be suitable to adjust the equipment speed.
f)
Page 8 of 25
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Ampoule washing machine
Revision: <xx>
g) Motor overload
h) Infeed empty
i)
j)
4.3
InProcess control
Sampling valves should be present on the PW, WFI, Compressed air and recirculation water
line before and after filters for in-process sampling.
4.4
Level of instrumentation
Sufficient and suitable instrumentation for the process, safety and productivity control as
indicated in the following table:
Type of
control
Purpose
Range of
measurement
Desired
Least
Count
Extent of Instrumentation
Indication Alarm Control Recording
Temperature
To monitor the
temperature of
recirculated water.
0 - 150C
1C
Temperature
To monitor the
temperature of
WFI.
0 - 150C
1C
1 6 Kg/cm2
0.1 Kg/cm2
1 6 Kg/cm2
0.1 Kg/cm2
Pressure
Pressure
Pressure of WFI
supply
Pressure of recirculated water
Page 9 of 25
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Ampoule washing machine
Revision: <xx>
supply
Pressure
Pressure of
compressed air
supply
Pressure
Pressure of PW
supply
1 6 Kg/cm2
0.1 Kg/cm2
VTS
VTS
Level of water in
recirculated water
tank.
Level
For counting
number of /
ampoules
Counter
2.
Password Policy
Yes ()/
No (X)
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User Requirement Specification
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Location
Revision: <xx>
3.
4.
5.
6.
6.
1
Page 11 of 25
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Revision: <xx>
display or printout)."
6.
2
7.
8.
Page 12 of 25
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Revision: <xx>
Page 13 of 25
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b) Design of equipment should enhance cleaning feasibility by providing minimum sharp corners,
minimum crevices & smooth finished welds joints.
c) Parts, which are required for cleaning, should be provided with quick fixing arrangement.
d) All gaskets provided to avoid leakage should be amenable for easy removal & re- fixing.
e) All bolts, nuts on the exterior part of equipment will be with dome nut.
f)
Vendor to provide suitable arrangement for draining of water from the conveyor belt.
Internal welds and welds likely to be in contact with the cleaning media shall be ground
smooth and flush. All other welds shall be ground smooth.
g) All the valves & fittings (if applicable) installed on the clean media pipings should be of
hygienic design. MOC should be SS 316 or better.
h) Clean media pipes should be orbital welded.
i)
The MOC of safety cabinet shall be compatible with the different disinfectants used. The most
preferred one is Polycarbonate.
Page 14 of 25
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User Requirement Specification
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4.10
Revision: <xx>
The control system should have a provision to connect to a 21 CFR part 11 compliant SCADA
software in the future.
4.11
Data integrity
System security shall be provided to access the operation system and to alter configurable
parameter values through access password. System security access shall consist of the following 3
level password protection with unique passwords:
a) Operator minimum 10 nos.
b) Supervisor minimum 03 nos.
c) Administrator 01 no.
4.12
The HMI should be able to display independent batch record, which should contain the following:
Page 15 of 25
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Client Name,
Location
Revision: <xx>
a) Name of Company
b) Equipment identification number
c) Product Details
d) Ampoule size
e) Batch No
f)
g) Alarm Messages
Each process step of the equipment shall generate online printing of the independent batch record,
which shall contain the following
h) Name of Company
i)
j)
Process parameters and operation time as start date with start time, end date with end time
and total cycle time
k) Alarms
l)
4.13
Desired documents
Following documents, but not limited to these, are expected from the vendor as part of the supply
package as hard copy and electronic editable version in English language
a) The electronic documents shall be in the following formats:
Equipment descriptions
List of interlocks and block diagram with their functions and Alarms
Critical list of major component, devices and instruments with their specific
functions, specification data sheet.
Page 16 of 25
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User Requirement Specification
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Location
Revision: <xx>
c) Operation and maintenance manuals, preventive maintenance schedule for equipment major
component as well as the operating system
d) Operation and maintenance manuals for the bought out items
e) Installation instructions/ guideline for equipment
f)
g) Detailed drawing (Plan and minimum one elevation) marking clearly all the necessary
dimensions and locations of utilities along with requirement of utilities on the drawing along
with the offer
h) Other drawings (such as P&ID, electrical, instrumentation etc.)
i)
j)
k) Instrument calibration certificates with respect to the traceable national reference standard
instrument and their calibration procedure
l)
Factory acceptance test specifications and reports with actual test results/ data for equipment
s) Types of Lubricant and Lubrication instructions. Food grade certificate (if applicable).
Page 17 of 25
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4.14
Revision: <xx>
Training
4.15
a) The infeed conveyor should have slot for collection of fallen ampoules on the conveyor.
b) Speed of the machine should be settable through the HMI.
c) The connection of WFI/ PW collection pipe of ampoule washing machine with WFI/ PQ supply
valve in the room shall be detachable and sanitary.
d) The collection pipe should be provided with a sampling point before the point of delivery at
washing machine.
e) The recirculation water tank shall be completely drainable with drain valve for draining the
water. The sloping inside the tank shall be towards the drain point.
f)
The supply line should be compatible with hot WFI (> 70C).
g) The WFI/ PW collection pipe should have sufficient slope (minimum 1%) for complete
drainage of the pipeline.
h) The WFI/ PW collection line should not have any dead leg more than 2 times the pipe
diameter.
i)
When washing machine stops, the machine should have suitable arrangement to prevent
stagnancy of water in the collection pipeline, e.g. automatically close the room supply valve of
the distribution pipeline or give alarm for operator intervention.
j)
Vendor to provide 0.45 micron filter on the recirculated water line to reduce contamination and
bioburden.
k) Filters on utility lines should be equipped with ports for integrity testing.
l)
Heating arrangement shall be provided for heating and maintaining the temperature of
recirculating water above 50C. Temperature sensor should be provided for monitoring of the
same along with alarm provision.
m) Level sensor should be provided to control the level of water inside the recirculating water
storage tank.
n) The complete transport of the Ampoules from the last rinsing station of the washing machine
up to the infeed part of the tunnel should be either covered (if distance is <200 mm) or
supplied by unidirectional air flow from a laminar air flow unit.
o) The ampoule washing machine shall have the arrangement to remove the vapour from the
washing machine / room. A vapour exhaust system should be considered with backflow
arrester.
p) Vendor shall inform the detail arrangement of the vapour exhaust system in their technical
offer
Doc. No.: <NDD15008-BD-PRO-URS-S2-001>
IPS-International
Page 18 of 25
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User Requirement Specification
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Location
Revision: <xx>
q) The washing machine should be designed to prevent the risk of contamination from
condensate.
r)
Ampoule washing machine should consistently remove the soluble and in-soluble contaminant
from the glass ampoules when the washing process is conducted within operating ranges of
the process parameter. Washed Ampoules should be essentially free from the visual
particulate.
s) At the end of washing cycle, Ampoules should be free from any water droplet or wetting when
checked visually.
t)
Vendor to provide the acceptance criteria for residual moisture content on ampoules after
washing.
u) All the components should be labeled properly along with proper flow direction. The labelling
must be in English language.
5Safety Requirement
5.1 General
Following features shall be considered to ensure the safety of personnel, process and product.
Design shall also ensure no contamination of working area.
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User Requirement Specification
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Location
Revision: <xx>
a) Equipment location shall be appropriate to minimize the risk of accident (e.g. material flow,
process flow, personnel flow, etc...).
b) Noise level below 80 db at a distance of 1 m from the equipment.
c) Emergency stop function on accessible areas.
d) The outside surface temperature of the equipment at places where the operator may touch,
shall not exceed a temperature of 45C; else it shall be clearly marked with safety signs.
e) Warning stickers on all hot surfaces and moving parts.
f)
All electrical wiring shall be concealed and proper earthing shall be provided.
g) The operator shall not be exposed to any moving parts or hot surfaces during normal
operation.
h) All machine doors, which are closed during production for operator safety, have to be
supervised by security switches. In case of opening the machine must stop immediately.
Page 20 of 25
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User Requirement Specification
Client Name,
Location
Revision: <xx>
6Technical requirement
6.1 Basic technical requirement
a) The layout must be taken into account when determining the layouts of the units.
b) A proposal of a possible installation layout should be added to the documentation
c) The manufacturer has to give the clear details on the dimension, total weight and the capacity
of all equipments of the filling line
d) The heat given off by the unit must be stated
e) The construction of the complete system should be described in the documentation in detail
f)
Vendor shall provide special tools for assembling, disassembling and maintenance.
The HMI should display all the status parameters during each process stage. The flow of
process shall be provided with the help of arrows. Audio/ visual alarms should also be
visualized along with fault displayed
All setting shall be user adjustable and through the control panel whichever is possible.
Page 21 of 25
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User Requirement Specification
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Location
Revision: <xx>
g) Arrangement of alternative power supply (UPS) to control and monitoring system. (Optional)
h) Vendor shall provide special tools for maintenance of the equipment.
i)
j)
The Vendor shall ensure maintenance parts availability for a minimum of 15 months from
delivery.
All measuring instruments should have suitable measuring range and appropriate accuracy.
The material of sensor should also resist thermal load.
The dead legs in the pipelines should be minimized (preferred 1.5d) and all the utility pipelines
should be inclined towards the washing machine
j)
Machine should be easy to maintain. The unit must contain necessary protection devices to
ensure that the equipment & the article remain in a safe condition.
Page 22 of 25
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Revision: <xx>
b) Performance test during FAT: Checking of the 100% reliability of the machine by performing 3
successful running trials for any one ampoule size.
c) Performance test during SAT: Checking of the 100% reliability of the machine by performing
three successful running trials for all the available ampoule sizes.
7.3 Support
a) The Vendor shall provide start-up services through successful completion of the site
acceptance test. The site acceptance test will be a repeat of the factory integration test
performed at the Vendors facility.
b) The Vendor shall provide a four (4) hour training course to twelve (12) maintenance people on
troubleshooting and repair of the system.
c) The Vendor shall provide a twenty-four (24) hour technical support phone number with a
maximum of thirty (30) minute response time to calls requesting assistance. Support
personnel for this hotline must be knowledgeable and professional .
8Constraints
8.1 Equipment location and available space
This equipment will be installed in the Sterile formulations facility.
Floor: Ground Floor; Room Name & No.: Ampoule Washing & Depyrogenation (GF045)
Room size: 4650 mm x 5850 mm (Room layout attached as Annex 01)
Page 23 of 25
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Ampoule washing machine
Revision: <xx>
8.3 Timelines
a) Response to URS: Within 2 weeks of receipt of URS
b) Quotation Submission: Within three weeks of receipt of URS
c) Submission of detail functional design specification, Design Qualification (DQ) and schematic
drawings: Four weeks after order finalization
d) Submission of FAT/SAT Specification-: Four weeks before FAT
e) Submission of Installation Qualification (IQ) and Operational Qualification (OQ) protocols -:
Two months after order finalization
f)
g) Submission of control system details and control system verification protocol: 2 weeks before
FAT
h) The Supplier shall notify customer two weeks in advance of the start of the FAT
9Change Log
Date
10
Initial
Revision
Change/Comments
Annexure
Annexure
No.
01
Description
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Revision: <xx>
Page 25 of 25