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Ampoule washing machine

User Requirement Specification


Client Name,
Location

Revision: <xx>

Project No. <Project No.>


Formulations Facility

Project: <Project description>

User Requirement Specification


For
Ampoule washing machine

Author
Name:

Initials:

Date:

Signature:

Initials:

Date:

Signature:

Initials:

Date:

Signature:

Initials:

Date:

Signature:

Reviewer
Name:
<Client> Reviewer
Name:
<Client> Approver
Name:

Table of Contents
Doc. No.: <NDD15008-BD-PRO-URS-S2-001>
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Page 1 of 25

Client Logo
User Requirement Specification
Client Name,
Location

Ampoule washing machine

Revision: <xx>

Introduction..........................................................................................................4
1.1

Responsibility..................................................................................................4

1.2

Statutory Regulation........................................................................................4

1.3

Equipment brief description.............................................................................5

Process Description............................................................................................5
2.1

Input & Charging.............................................................................................5

2.2

Brief Process Steps.........................................................................................6

2.3

Output & Discharging......................................................................................7

Productivity Requirement...................................................................................7
3.1

Desired/ suggested capacity...........................................................................7

3.2

Standard batch size.........................................................................................7

3.3

Change Over Time (if applicable)....................................................................7

3.4

Cleaning..........................................................................................................7

3.5

Other Productivity Requirement......................................................................7

Operational Requirements..................................................................................8
4.1

Process Control...............................................................................................8

4.2

Failure Mode Detection...................................................................................8

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

21 CFR Part 11 compliance..........................................................................10

4.10

Data integrity..............................................................................................11

4.11

Batch data display and record printing.......................................................11

4.12

Desired documents....................................................................................11

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User Requirement Specification
Client Name,
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Ampoule washing machine

Revision: <xx>

4.13

Training......................................................................................................13

4.14

GMP requirement (others).........................................................................13

Safety Requirement...........................................................................................14
5.1

General..........................................................................................................14

5.2

Power failure and recovery...............................................................................15

5.3

Containment <if applicable>.............................................................................15

Technical requirement.......................................................................................16
6.1

Basic technical requirement..........................................................................16

6.2

Level of automation.......................................................................................16

6.3

Specific requirements....................................................................................16

Good Engineering Practices.............................................................................17


7.1

General..........................................................................................................17

7.2

Inspection and testing...................................................................................17

7.3

Support..........................................................................................................18

Constraints.........................................................................................................18
8.1

Equipment location and available space.......................................................18

8.2

Available utility...............................................................................................18

8.3

Timelines.......................................................................................................19

9
10

Change Log........................................................................................................19
Annexure.........................................................................................................19

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User Requirement Specification

Ampoule washing machine

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

EU-GMP Guideline Part 1, Annex 1, 11 & 15

Code of Federal Regulations (CFR) 21, Part 210:


Packing and Holding of Drugs; General

21 CFR Part 211: Current Good Manufacturing Practice for finished Pharmaceuticals

<21 CFR Part 11: Electronic Records; Electronic Signatures>

cGMP in Manufacturing, Processing,

FDA Guidance for Industry

Sterile Drug Products Produced by Aseptic Processing

Documentation for Sterilization Process Validation

GAMP

1.3

<The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated
Systems in Pharmaceutical Manufacture, Vol. 5>.

Equipment brief description


The Ampoule washing machine shall consist of following parts in order to run operation smoothly.

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.

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User Requirement Specification
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Ampoule washing machine

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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

Input & Charging

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.

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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

Brief Process Steps

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 wash by fresh WFI for internal and external cleaning.

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.

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User Requirement Specification

Ampoule washing machine

Client Name,
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Revision: <xx>

c) <The final step of siliconization of ampoules is to be considered as a future option>.


d) <Vendor to also provide option for ultrasonic cleaning of ampoules.>

2.3

Output & Discharging

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.

3.2 Standard batch size


Approx. ______________ ampoules / batch of <ampoule size (in ml)>.

3.3 Change Over Time (if applicable)


Vendor shall ensure minimum time for change over of format parts for assembling and
disassembling (i.e. within 60 minutes) with minimum usage of tools and also inform the exact time
for change over
To fix the right position of the change parts, they should be marked in a way that is not erasable
and each change part size shall be engraved on the change part.

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.

3.5 Other Productivity Requirement


The washing machine shall have one working hours counter and object counter at the outlet of
washing machine.
Vendor shall inform the water requirement (Litres per hour) for washing of ampoules at said
capacity for each size of ampoule in their technical offer.

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User Requirement Specification

Ampoule washing machine

Client Name,
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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)

The equipment should stop in case of infeed conveyor is empty.

4.2 Failure Mode Detection


Equipment shall be capable to detect the following failure, notify the operator with alarm and
shutdown the process.

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Ampoule washing machine

User Requirement Specification


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a) Pressure of WFI/ PW beyond low/high limit


b) Pressure of recirculated water beyond low/ high limit.
c) Temperature of recirculated water beyond low/high limit
d) Pressure of compressed air beyond low/high limit
e) Level of recirculation water tank is very low
f)

Continuous malfunction of washing process e.g. malfunction of ampoule clamps

g) Motor overload
h) Infeed empty
i)

Maximum outfeed condition reached at the inlet of tunnel

j)

Sterilizing tunnel belt stops

k) Emergency stop activated


l)

Safety Guard opens

m) Following condition need only notification to operator for procedural control


n) Malfunctioning of vapour exhaust system

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

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Ampoule washing machine

User Requirement Specification


Client Name,
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Revision: <xx>

supply

Pressure

Pressure of
compressed air
supply

1 10 Kg/cm2 0.2 Kg/cm2

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

Y Required; N Not required; VTS Vendor to specify

4.5 Control System


a) The Ampoule washing machine should be fully automatic and PLC based with HMI for local
operation.
b) PLC should be connected to SCADA software for printing and to check and control the real
time status of the equipment.
c) Equipment and software shall have following facility:
1.

2.

Password Policy

Yes ()/
No (X)

Password-protected individual user accounts


Password and User ID policy (Individual unique ID and Password, minimum
length and strength of ID and Password)
After generation of user ID (user creation) system shall ask for password change
on first login.
Automatically limit number of failed login attempts
Automatically record unauthorized login attempts
Electronically require users to change their passwords at regular intervals.
System shall ask to change the password to user periodically (at settable interval
of time) by giving prior notification on each logging. Time for prior notification
shall be settable at user end
Automatically password protects computer/SCADA systems when idle for short
periods.
User management system & Privileges
Ensure that the user level based on functionality and authority is defined.

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Ampoule washing machine

Revision: <xx>

3.

4.

5.

6.

6.
1

Facility to create the groups such as operator, supervisor, manager,


administrator, maintenance, calibration etc and allocation of their user privileges
can be defined and can be changed as per requirement at site.
Ensure that the privileges like delete, copy, cut, paste, rename, etc. shall not be
allowed to un-authorized user.
Electronic Data
Electronic data and report should be human readable and suitable for inspection
and review.
Ensure the content: Performed by with date and time stamp, Print by with date
and time, Reviewed by with date and time stamp, system and analysis
parameter related information, etc.
Electronic data storage
Only authorized users can access configuration screen and partitions of hard
disk
Generated data shall not be edited or altered.
Data should be saved automatically to pre define location
Progressive number of cycle or batch should reflect in batch or cycle report.
Audit Trail
System should track for all creations, modifications, and deletions performed in
the system (All activity should be logged between login and log out) with time
and date stamp along with user details.
All critical hardware related errors and warning should be logged in audit trail
(System audit trail).
Maintain all entered data: Don't obscure original data when changes are made
(shall maintain revision history for the changes made).
Time and date stamp change automatically, it shall be locked and not editable
unless performed by authorized user (shall be defined through user rights
distribution)
Computer/SCADA system shall be designed in a way that user to record reason
for change through use of authorized login I password to go ahead with
changes.
Automatically record identity of individual who made change.
System shall prevent to modify or delete audit trail.
Audit trail documentation shall be retained for a period at least as long as that
required for the subject electronic records and shall be available for agency
review if required. Atleast for 5 years.
Electronic Signature
Electronically signature documents have following content (Automatically
generate)
The printed name of the signer.
The date and time when the signature was executed.
The meaning (such as review, approval, responsibility, or authorship) associated
with the signature.
The items identified in paragraphs 6.1.1, 6.1.2, and 6.1.3 of this section shall be
subject to the same controls as for electronic records and shall be included as
part of any human readable form of the electronic record (such as electronic

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Ampoule washing machine

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display or printout)."

6.
2

7.

8.

The unique ID and Password for electronic signature


Electronic signatures and handwritten signatures executed to electronic records
shall be linked to their respective electronic records to ensure that the
signatures cannot be excised, copied, or otherwise transferred to falsify an
electronic record by ordinary means
The each process of electronic signature should be electronically logged in audit
trail with time and date stamp and user ID.
Uniqueness to be maintained between password and ID, Both are same is not
acceptable by system.
Data Backup.
Software shall have facility for auto data back-up to any client or connected
central server
Other
User shall not be able to save or relocate the result files, it should be controlled
through software only
User shall not have rights to create folders or project in software these rights
shall be with administrator

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Ampoule washing machine

Client Name,
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4.6 Cleaning requirement


a) Cleaning shall be done manually. Recommended cleaning agents are mild alkaline solution of
sodium hydroxide or ammonium hydroxide, 70% IPA and WFI.
Vendor to suggest and quote for different possible options of the same.

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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.

4.7 Qualification Requirement


a) All equipments shall be qualified with life cycle approach, i.e. DQ, IQ & OQ. Vendor shall
provide all documentation support including protocol subject to approval by the user.
b) Vendor shall provide execution support to the user to complete all stages of the qualification
report

4.8 Material of Construction


a) All metallic critical contact surfaces & critical utility pipelines should be constructed of 316
grade stainless steel or better with internal mirror surface finish 0.8 m Ra and external
surface matt finish.
b) All non product contact metallic surfaces should be constructed of 304 grade stainless steel or
better, external surface finish 1.2 m Ra, matte finish.
c) Gaskets, seals and O-rings coming in direct / indirect contact surfaces should be constructed
of food grade polymeric materials only. It should be temperature resistant i.e. >70C in case of
recirculated water and WFI.
d) Stainless steel fabrications must be welded under inert gas, and treated by pickling and
passivation to pharmaceutically accepted standards, to prevent corrosion.
e) All welds shall be crack and crevice free and should be ground finished to 1.2m Ra.
f)

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.

4.9 Use of lubricants


Any lubricant, if used in the equipment must be food grade and non-toxic. Used lubricants must not
come in contact of the potential product contact surfaces. Lubrication system shall be leak proof

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4.10

Ampoule washing machine

Revision: <xx>

21 CFR Part 11 compliance

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

Batch data display and record printing

The HMI should be able to display independent batch record, which should contain the following:

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a) Name of Company
b) Equipment identification number
c) Product Details
d) Ampoule size
e) Batch No
f)

Machine parameters with set values and process values

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)

Equipment identification number

j)

Process parameters and operation time as start date with start time, end date with end time
and total cycle time

k) Alarms
l)

Number of units washed

m) Operator Name and Code


n) Identified space to sign for operator & supervisor
o) There should be a possibility to store and archive the data for future retrieval and analysis. (To
be quoted as optional)

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:

Textual documents Word (.doc)

Drawings AutoCAD (.dwg or .dxf)

b) Functional design specification/ Design Qualification containing:

Equipment descriptions

Equipment operation steps

HMI functions with screen shot

List of failure indications

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.

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Schematic diagram of the equipment

List of Input and Output signals

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)

Final As-built drawing for equipment

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)

Spare and/ or change parts list with ordering information

j)

MOC certificates for all direct/ indirect product contact surfaces

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

m) Recommended SOPs for operation, cleaning and maintenance of each equipment


n) Guaranty/ warranty certificates for each equipment and major bought-out items, such as PLC,
printer, recorders, instrumentation etc.
o) Software installation CD/ floppy with back-up, wherever applicable.
p) Software recovery procedures in case of control system breakdown, for equipment control
system.
q) Shipping checklist
r)

DQ, IQ and OQ protocols

s) Types of Lubricant and Lubrication instructions. Food grade certificate (if applicable).

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4.14

Revision: <xx>

Training

a) A special training for operators has to be included in the offer.


b) A special training for technical staff has to be included in the offer

4.15

GMP requirement (others)

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
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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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Ampoule washing machine

Client Name,
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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.

5.2 Power failure and recovery


a) On power failure equipment shall come to rest, to protect operator, equipment itself and the
product (vials).
b) Power restart must not be automatic and human intervention must be required.
c) On power recovery, the operational parameters have to be retrieved by memory backup
mechanism.

5.3 Containment <if applicable>

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Ampoule washing machine

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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.

6.2 Level of automation


a) The equipment should operate with minimum operator involvement. The equipment control
panel must be provided with a Human machine interface based on English language with
appropriate number (a minimum of 10 programs) of recipe of all process parameters.
b) The equipment should control automatically all critical parameter and detect failure mode
automatically. Critical process parameters and failure modes are listed in the preceding
sections
c) Human machine interface must be used to enter the process details, which should appear in
the print out. Print out must provide results of all critical process parameter and failure alarms
d) The PLC real time clock should be synchronized.
e) GMP relevant parameters limits should be defined and alarmed
f)

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

g) The parameter setting in the HMI should be in numeric only.

6.3 Specific requirements


a) In general the equipment has to be designed in a way to get easy and quick access to all
necessary maintenance points e. g. pumps, motors, filters, etc.
b) As a special requirement the machine must allow set up by tip switches with cable
c) HMI shall be touch screen type.
d) The machine operating height shall be 925 25 mm and the clearance from the bottom shall
be 100-150 mm
e) The make of the PLC shall preferably be Siemens / Allen Bradley/ Mitsubishi/ Beijer
f)

All setting shall be user adjustable and through the control panel whichever is possible.

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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)

Supply voltage to the ampoule washing machine should be 415V, 50 Hz.

j)

The Vendor shall ensure maintenance parts availability for a minimum of 15 months from
delivery.

k) Recirculation pump of AISI SS 316L required for recirculation of WFI tank.

7Good Engineering Practices


7.1 General
a) Equipment must be fabricated following all Good Engineering Practices. The vendors Quality
System must follow applicable national or international standards.
b) Vendor must generate all applicable documents during all phases of equipment fabrication i.e.
design, fabrication, testing and shipment as per applicable standards e.g. GAMP
c) All sensors, controllers, PLC, transmitters, indicators and any other controller or indicators to
read, print or control any of the parameter, will have to be calibrated, traceable to National or
international standards. Original calibration certificate along with traceability to be submitted by
vendor in their IQ file.
d) All material of construction should have test certificate.
e) Vendor must generate and provide all specifications and test certificates of software used in
the equipment control and/or monitoring system.
f)

All measuring instruments should have suitable measuring range and appropriate accuracy.
The material of sensor should also resist thermal load.

g) Sensors should be provided with mechanical protection and positioned properly so as to


prevent damage. It should be feasible to dismount, replace or calibrate sensors.
h) Re-calibration of sensors should be possible.
i)

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)

All joints should be orbitally welded.

k) Strainer should be provided on the drain line to prevent choking.


l)

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.

7.2 Inspection and testing


a) System shall be inspected and tested (FAT) at the suppliers site in the presence of users
representative before delivery.

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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)

8.2 Available utility


a) Electricity: ______________(Report Requirement)
b) Water for injection:______________(Report Requirement)
c) Purified Water:______________(Report Requirement)
d) Compressed air: ______________(Report Requirement)

Note: Vacuum system to be supplied by the Vendor

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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)

Mechanical and electrical drawings-: Two weeks before FAT.

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

Ref. Document/ Drawing No.

Layout showing positioning of Ampoule


Washing machine.

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Ampoule washing machine

Revision: <xx>

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