GSK VEMGAL – User Requirement Specification

Document Title: Compressed Air System

Document
INS_00000371972 Version: 1.0
Number:

Function: Engineering Site or Site

Department:

Name Role

Content Owner: Steve Foster Capital Project Director

Author: T. Suresh Mechanical Lead

Steve Foster Capital Project Director

Sheril Christopher EHS Lead
Reviewed By:
Kaleemulla Koti Technical Lead
Andy Gibson Quality Lead
Steve Foster Capital Project Director

Approved for Sheril Christopher EHS Lead

Release by: Kaleemulla Koti Technical Lead
Andy Gibson Quality Lead

1 Revision History
Version Revision Reason / Change Request Number Revised by
1.0 Initial version
TABLE OF CONTENTS
1 REVISION HISTORY............................................................................................................... 1
2 INTRODUCTION ..................................................................................................................... 4
2.1 Purpose ............................................................................................................................ 4
2.2 Scope ............................................................................................................................... 4
2.2 Reference Documents ...................................................................................................... 4
3 OVERVIEW .............................................................................................................................. 5
3.1 Project Overview............................................................................................................... 5
3.2 Operational Overview ....................................................................................................... 7
4 SCOPE OF SUPPLY ............................................................................................................... 8
4.1 Main components/Description........................................................................................... 8
5 REQUIREMENTS.................................................................................................................... 9
5.1 Functionality Requirements .............................................................................................. 9
5.2 Operating Environment ................................................................................................... 13
5.3 Interfaces........................................................................................................................ 13
5.4 Computing Environment ................................................................................................. 13
5.5 System Security.............................................................................................................. 13
5.6 Data Recording and Storage .......................................................................................... 14
5.7 Environmental Health and Safety.................................................................................... 14
5.8 Supplier Support ............................................................................................................. 15
5.9 Documentation ............................................................................................................... 17
6 SYSTEM DESIGN INSTALLATION ...................................................................................... 18
6.1 Sequence of Events for Installation................................................................................. 18
6.2 Critical Pipe Work ........................................................................................................... 19
6.3 Utility Pipe Work ............................................................................................................. 20
7 COMMISSIONING................................................................................................................. 20
7.1 Factory Acceptance Test (FAT) ...................................................................................... 20
7.2 Site Acceptance Test (SAT)............................................................................................ 21
8 TRAINING ............................................................................................................................. 22
9 HEALTH AND SAFETY ........................................................................................................ 22
10 TIME SCHEDULE ................................................................................................................. 22
11 VALIDATION ACTIVITIES .................................................................................................... 22
12 VALIDATION......................................................................................................................... 23
13 FUNCTIONAL DESIGN SPECIFICATION............................................................................. 23
14 DOCUMENTATION ............................................................................................................... 24
 14.1 Before Installation Qualification....................................................................................... 24
14.2 After Installation Qualification.......................................................................................... 25
14.3 After Operation Qualification........................................................................................... 25
14.4 Before Delivery for Current Use ...................................................................................... 25
15 CHANGE CONTROL............................................................................................................. 25
16 ABBREVIATION ................................................................................................................... 25
17 APPENDIX SUMMARY ......................................................................................................... 27
APPENDIX 1: CONTROL/ALARM SIGNALS TO BE AVAILABLE ON THE SYSTEM ............. 27
APPENDIX 2: CONSUMERS POSITIONS................................................................................. 28
APPENDIX 3: LOAD PROFILE TABLE ..................................................................................... 31

1 REVISION HISTORY ................................................................................................................... 1

2 INTRODUCTION .......................................................................................................................... 7
2.1 Purpose ............................................................................................................................................ 7
2.2 Scope................................................................................................................................................ 7
3 OVERVIEW .................................................................................................................................. 8
3.1 Project Overview............................................................................................................................. 8
3.2 Operational Overview................................................................................................................... 10
4 SCOPE OF SUPPLY.................................................................................................................. 11
4.1 Main Components/Description.................................................................................................... 11
5 REQUIREMENTS....................................................................................................................... 12
5.1 Functionality Requirements......................................................................................................... 12
This section defines detailed equipment user requirements. These requirements are provided
below with references as applicable...................................................................................................... 12
5.2 Operating Environment ................................................................................................................ 16
5.3 Interfaces ....................................................................................................................................... 16
5.4 Computing Environment .............................................................................................................. 16
5.5 System Security ............................................................................................................................ 17
5.6 Data Recording and Storage ...................................................................................................... 17
5.7 Environmental Health and Safety............................................................................................... 17
5.8 Environmental Health and Safety............................................................................................... 18
5.9 Supplier Support ........................................................................................................................... 18
5.10 Supplier Support ........................................................................................................................... 19
5.11 Documentation .............................................................................................................................. 20
6 SYSTEM DESIGN – INSTALLATION ....................................................................................... 21
6.1 Sequence of events for Installation............................................................................................ 21
6.2 Critical Pipe work .......................................................................................................................... 22
 6.3 Utility Pipe Work............................................................................................................................ 23
7 COMMISSIONING...................................................................................................................... 23
7.1 Factory Acceptance Test (Fat) ................................................................................................... 23
7.2 Site Acceptance Test (SAT)........................................................................................................ 24
8 TRAINING................................................................................................................................... 25
A minimum of 1 day training will be required for all GSK staff in the safe operation and
maintenance of the system as part of the handover. Procedures will be demonstrated in real
time and not by simulation....................................................................................................................... 25
9 HEALTH AND SAFETY ............................................................................................................. 25
 All containers with chemicals for disinfection or production process must be clearly marked
with warning signs and indications of measures to prevent accidents............................................. 25
 Equipment must be equipped with protective devices such LOTO. ......................................... 25
 All aspects of the design shall identify potential safety hazards and provide necessary
features to eliminate personal injury ...................................................................................................... 25
 Materials used for any hazardous process shall be contained with all relevant materials data
sheets. ........................................................................................................................................................ 25
10 TIME SCHEDULE ...................................................................................................................... 25
The Compressed Air Generation and Distribution Systems shall be installed commissioned and
validated in accordance with the approved project validation plan and agreed timetable. ........... 25
11 VALIDATION ACTIVITIES......................................................................................................... 25
11.1 Validation activities will be handled by the equipment supplier according to approved
documentation........................................................................................................................................... 25
11.2 Qualification includes the following: .............................................................................................. 25
 Design Qualification (DQ)................................................................................................................ 25
 Installation Qualification (IQ)........................................................................................................... 25
 Operation Qualification (OQ) .......................................................................................................... 25
 Performance Qualification (PQ) – this stage is exclusively the responsibility of GSK Vemgal
25
11.3 All qualification activities must be completed in the presence of an authorized person from
GSK ............................................................................................................................................................ 26
11.4 Finalising validation activities that involve supplier responsibilities ......................................... 26
11.5 Final report of every stage needs to be handed over to GSK for approval ............................ 26
11.6 Approval of qualification documentation is the responsibility of the Quality department at
GSK Vemgal.............................................................................................................................................. 26
11.7 Any deviation from approved specification need to be authorized by GSK Vemgal. This sort
of authorization may only be obtained in written paperwork and signed by both parties .............. 26
11.8 GSK Vemgal representatives will gain access to equipment installation during the
qualification process. They also are authorized to shut down any operation that is not meeting
the required specifications....................................................................................................................... 26
11.9 Payment according to signed contract. ........................................................................................ 26
12 VALIDATION.............................................................................................................................. 26
12.1 If the equipment has its own documentation for qualification, this documentation will be
forwarded in order to be approved by GSK Vemgal. In case GSK Vemgal does not consider the
forwarded documentation as valid, GSK Vemgal review documents to improve them.
Implementations will start only after approval of this documentation. .............................................. 26
12.2 Full validation (DQ, IQ, OQ and PQ) will be handled according to Vemgal requirements.
Extra details will be offered upon request............................................................................................. 26
12.3 Validation shall be documented according to Vemgal procedures. ......................................... 26
12.4 IQ/OQ/PQ shall be done by suppliers according to GSK Vemgal own protocols.................. 26
12.5 The validation plan will be completed by the validation team of GSK Vemgal and it shall be
based upon supplier documentation...................................................................................................... 26
13 FUNCTIONAL DESIGN SPECIFICATION ................................................................................ 26
13.1 The Supplier will provide a functional design specification (FDS) developed to meet the
requirements of this URS that will be consistent with the life cycle approach. The FDS should be
a detailed specification to define all of the functions of the system and be cross-referenced to
this URS. The FDS will contain typically, but not limited, to the following details:.......................... 26
13.2 Life cycle costs for the whole system for a minimum five-year period inclusive of utilities and
consumables. ............................................................................................................................................ 27
14 DOCUMENTATION.................................................................................................................... 27
14.1 Before Installation Qualification .................................................................................................. 27
 Any deviation from this document needs justifying and details shall be put down in hard
copy. ........................................................................................................................................................... 27
 Scheduling activities (with deadlines). Programme of Works.................................................... 27
 Standard procedures for equipment qualification: ....................................................................... 27
 Fabrication and installation Method Statement and Risk Assessment .................................... 27
 Pressure Test Pneumatic ................................................................................................................ 27
 Compliance Certificate..................................................................................................................... 27
 Qualification report completed before delivery to the Site (FAT). This report must contain
primary data, results, documentation, mechanical work documentation (welds, joints, quality
certificates for materials used for equipment assembly). ................................................................... 27
 Components and accessories list. ................................................................................................. 27
 Spare parts list estimated for a minimum of 2 years, list that will contain the recommended
spare parts and delivery deadline for each module. ........................................................................... 27
 Approved validation report for Design Qualification (DQ). ......................................................... 27
 Approved validation protocol for Installation Qualification (IQ).................................................. 27
14.2 After Installation Qualification ..................................................................................................... 28
14.3 After Operation Qualification....................................................................................................... 28
14.4 Before Delivery for Current Use ................................................................................................. 28
15 CHANGE CONTROL ................................................................................................................. 28
16 ABBREVIATION ........................................................................................................................ 28
17 APPENDIX SUMMARY.............................................................................................................. 30
2 INTRODUCTION

2.1 Purpose
The purpose of this User Requirements Specification is to define clearly and precisely, what
the user wants the system to do. It defines the functions to be carried out, the data on which
the system will operate, and the operating environment. It also defines any non-functional
requirements, constraints such as time and costs, and what deliverables are to be supplied.
This User Requirement Specification (URS) specifies the design parameters and lays down
the acceptance criteria, which the defined equipment is expected to meet. Any part of the
supply that does not conform to the requirements expressed in this document must be brought
to the attention of GlaxoSmithKline.

2.2 Scope
All compressed air system starting from Compressors & Dryers and Distribution Network.

2.2.1 REFERENCE DOCUMENTS

ISO 8573
Standard Tender Package for Compressed Air Systems
GSK Global Quality Policy No 4206 Compressed Gas Systems
GSK Facility and Process Guide
GES 301 – Management o Pressure Systems
GES 302 – Inspection of storage tanks, Pipe works and Flexible hoses
GES 303 – Pressure testing
GES 304 – Pressure relief and venting
GES 305 – Integrity of Bolted Joints
GES 110 – Machinery Safety
GES 106 – Hazard Area Classification
3 OVERVIEW

3.1 Project Overview

The purpose of this document is to define both functional and non-functional requirements to
be met by the Compressed Air system to ensure that it is fit for purpose and complies with the
requirements of cGMP.

This document describes user requirements for Compressed air generation and distribution to
users/consumers of the facility. The plant will serve outlets in the rooms within the Production
Plant and Lab areas in accordance with the consumer point of use table. The purpose of this
document is to provide a clear and complete statement of the user requirement for the
Compressed Air system covering the following:

Compressed Air Generation System including

The system shall be designed and constructed in accordance with both industry and GSK
cGMP guidelines, plus relevant engineering standards and regulations described by:

 The system shall be designed to generate compressed air complying to below quality-
Pressure dew point- -40deg C, Class 2 (in order to achieve -25 deg C PDP) Oil < 0.01
mg/m3, Class 1.
 Particles – Class 3
 GQP REQUIREMENTS FOR COMPRESSED GASES AND FORCED AIR SUPPLIES
 Products Particles Particles Viable Oil Moisture g/kg of
0.5 5.0 mg/m
m/m3 m/m3 Micro- 3
dry air at
organis atmospheric
ms pressure, (%RH
cfu/m3 at 15 C)
Large volume forced air nmt nmt
(LVFA) 350,000 nmt 2000 nmt 100 0.5*** Controlled as
or compressed gas
supplies
coming into direct appropriate at point
contact
of use
during processing with
secondary product or
final stage
of non-sterile API.
Examples
include fluid bed driers,
tablet
coating machines, filter
cake
driers etc.

Typical value referred to in ISPE Good Practice Guide: Process Gases (2011)

The compressed dry air system shall be design to supply process & instrument air for following
equipment.

 Packaging lines
 Process equipment
 Service outlet plates
 Laboratories
 Instrument air for utilities
3.2 Operational Overview

Compressed Air System is to be purchased to serve the manufacturing building.

The system will be composed from one installation split in 2 units:-

Compressed Air Generation System including

The system shall comprise of oil-free (non-lubricated), Air cooled screw type compressors.

Oil free air cooled screw compressors, Non Lubricated Air/water cooled compressor (VFD
based) both working and stand by.

Heat of compression desiccant type drier equipped with pre-final filter, receivers, oil/water
removal sterile air filters on the distribution line. Necessary redundancy for
compressors/dryers/filters is considered in the design.

Suitable oil removal filter to maintain oil content < 0.01 mg/m3 shall be considered along the
main header.

Compressed Air Distribution System.

The distribution system shall consist of

 Pressure reducing valve on the header line shall be considered to achieve required
pressure of 7.0 – 8.0 bar g at POU.
 Receiver tank will be installed after drier to maintain the compressor header at
required pressures if any bulk usage at any point of production schedule.
 Receiver tank with Pressure safety valve, auto drain valve, Pressure gauge and
service door etc.
 Flow meter to measure the consumption
 The compressed air header shall be designed for 8 barg pressure in order to achieve
8-7barg at POU. Necessary pressure reducing valves near the process equipment
shall be considered.
 Interconnecting piping between compressor/dryer/receiver up to oil removal filter &
further up to Production building shall be of SS ASTM 269 dairy tube descaled and
degreased.
 Further distribution piping from inside production building shall be in SS304 up to
sterile filter (0.22 um size) at POU outlets.
  Post sterile filter till process equipment shall be in SS 316 L ASME BPE 2009 .

The compressed dry air system shall be located in second floor (+ 8.0 m lvl) of production
building which shall house compressors, dryers, filters & receiver.

4 SCOPE OF SUPPLY

This document defines the requirements for Compressed air system, storage and distribution
system for Production and lab areas at the GSK Vemgal site.

This document represents a first stage of validation activities, and is the starting point in
achieving the validation status of any equipment.

The document shows the end-user requirements in terms of equipment.

Based on this document, validation documents that support the activity will be developed by
the assessment of each specification requirements expressed in user requirements (protocols
for installation qualification, operational qualification and performance qualification).The scope
of the work to be provided by the installer shall include delivery and handover of a complete
system that has undergone client witnessed functional tests and is fully supported by
document dossiers. The installer will be responsible for preparation of an FDS, Equipment
schedules, IQ and OQ documentation to a format agreed by GSK, and execution thereof with
GSK or agent as a witness. GSK will prepare documentation and execute phases relating to
PQ. The installer shall demonstrate the performance of the system to the required quality
standards.

4.1 Main Components/Description

1- Three variable speed compressors provide at least 1322 m3/hr , oil free type
2- Two heated adsorption dryers , each of them with inlet flow not less than 2662 m3/hr,
with pressure dew point -40
3- Compressed air particle filters to remove particles down to 1 Micron and 0.01 Micron
at system flow remove particles down to at system flow
4- Compressed air filters to remove oil aerosol & liquid water down to 0.01 PPM at
system flow
5- Compressed air network pipes St.St 304 L orbital welding to guarantee pressure
looses at end point not more than 0.3 bar , or any other GSK approved pipe type
 6- Connecting the compressor and dryers to the nearest electric panel

5 Requirements
Compressed air system requirements are documented in the following tables. The
requirements are rated according to the following categories:

5.1 Functionality Requirements

This section defines detailed equipment user requirements. These requirements are provided
below with references as applicable.

Req. Requirement Essential (E) /

No. Desirable (D) /
GMP Critical
(GMP)
5.1.1 Three Variable speed compressors provide at least 1322 m3/hr E
m3/min , oil free type
5.1.2 Two heated adsorption dryers , each of them with inlet flow not E
less than 2662 m3/hr, with pressure dew point -40
5.1.3 Compressed air particle filters to remove particles down to 1 E
Micron at system flow
5.1.4 Compressed air particle filters to remove particles down to 0.01 GMP
Micron at system flow and to remove oil aerosol & liquid water
down to 0.01 PPM at system flow
5.1.5 Compressed air network pipes St.St 304 L orbital welding to E
guarantee pressure looses at end point not more than 0.3 bar or
any other GSK approved pipe type
5.1.6 Material selection for the system made by the Installer must GMP
ensure that the materials do not contribute any added substance
to the compressed air in normal operation.
5.1.7 Use cGMP hygienic design appropriate to the system GMP
 5.1 Functionality Requirements
This section defines detailed equipment user requirements. These requirements are provided
below with references as applicable.
5.1.8 Appropriate measures and controls shall be included to alert for E
filter failures, Low pressure, PDP and flow on out of the system if
such conditions occur and to allow ease of any corrective action
without serious disruption.

5.1.9 The Command and Control system shall be the central point for E
the starting and stopping of the systems. The design shall allow
the independent operation of the Air compressors and Driers. The
system will be designed such that an individual system can be
safely isolated and maintained without interruption to the other
system.
5.1.10 The whole system must be provided with a central control system E
for the supply and distribution of electrical power to items of
equipment and packaged systems within the plant room. The
system should be designed to control the equipment automatically
with the minimum of operator intervention. Table from Appendix A
outlines the minimum controls and alarms to be available on the
system
5.1.11 The control system construction should be based upon a multi- E
compartment control centre with a dedicated instrument section to
the fascia of which will be mounted operator switches, alarm
indication and monitoring instrumentation.
5.1.12 The control centre must be provided with a main isolator that will E
isolate the whole of the system from a single supply but also
provide separate isolation for the each compressor to allow the
loop distribution system to remain operational.
5.1.13 Visual indication must be provided of the operating status of the E
systems.
 5.1 Functionality Requirements
This section defines detailed equipment user requirements. These requirements are provided
below with references as applicable.

Req. Requirement Essential (E) /

No. Desirable (D) /
GMP Critical
(GMP)
5.1.14 The system shall be controlled by a PLC (Allen Bradley) based D
control system equipped with Allen Bradley
5.1.15 The operator Interface for the system shall be by a Menu Driven E
Graphics interface (HMI).

5.1.16 The control system must be capable of providing alarms on critical E

and non critical parameters.
5.1.17 The Air compressor shall be equipped with a pre-filter at the inlet E
of ambient air, after cooler to maintain the outlet temp. after
cooler and VSD with high efficiency motor IE3
5.1.18 The Treatment Unit shall be equipped with a DP measure unit E
filter module.
5.1.19 A Flow meter located at the outlet of the compressed air system E
will measure and monitor the quality of the Air produced.
5.1.20 The distribution unit must be equipped with a tank vessel not less D
than 3000 litres working volume.
5.1.21 The tank vessel shall be equipped with Hygienic overpressure E
safety valve, Auto drain, Manhole for cleaning of receiver,
Pressure gauge.
5.1.22 The tank vessel is to be fabricated of MOC: MS (IS:2062), Code E
of construction: 2825-1969 Class II, Operating pressure: 8.5 bar,
Design pressure: 14 bar.
5.1.23 The Air compressor will be fitted with a high efficiency motor IE3 E
with thermistors and variable speed drives.
 5.1 Functionality Requirements
This section defines detailed equipment user requirements. These requirements are provided
below with references as applicable.
5.1.24 Material selection for the system made by the Installer must E
ensure that the materials do not contribute any added substance
to the compressed air in normal operation.
5.1.25 Construction material for the distribution system is to be stainless E
steel. Point of use connections and isolation valves will be 0.22
micron GMP filters. The valves will be fabricated from 304
stainless steel with external surfaces polished to a 2B finish with
welds acid cleaned and left as laid. Internal finish of components.

5.1.26 The system will be fully welded with the exception of process E
connections which will be hygienic tri-clamp with PTFE faced
seals.
5.1.27 The system must be able to operate in the temperature below 40 E
°C
5.1.28 The HMI screens shall be in English together with parameter E
settings and menus.
5.1.29 All visual indication/labels with be in English. E
5.1.30 All main branded components will selected for quality and easy of E
maintenance serviceability locally where available, a proposed list
will be presented for GSK’s approval.
5.1.31 Electric cables to the nearest panel to connect dryers and E
compressor
5.2 Operating Environment
This section defines any special requirements for the physical environment related to
operation such as temperature, vibration, humidity, physical layout and required utilities such
as compressed air and power supply requirements.
Req. Requirement Essential (E) /
No. Desirable (D) /
GMP Critical
(GMP)
5.2.1 Electricity supply 400 V / 50 Hz for dryers and compressors E
5.2.2 Compressors room should be well ventilated E

5.3 Interfaces
This section defines any requirements for how the system components, e.g. machine, is to be
interfaced with Operator/other equipment.
Req. Requirement Essential (E) /
No. Desirable (D) /
GMP Critical
(GMP)
5.3.1 On line dew point detector should be installed after drying phase E
5.3.2 Pressure sensor on the o outlet of compressed air generation E
system

5.4 Computing Environment

This section defines any PC requirements to ensure appropriateness of operating system and
compatibility with company standard.
Req. Requirement Essential (E) /
No. Desirable (D) /
GMP Critical
(GMP)
NA
5.5 System Security
This section details the level of security required of the system, where applicable, e.g.
physical security, health and safety related physical security, instrument method security,
access control, access levels, user identification and authorisation processes, password
synchronisation, and logging access failures.
Req. Requirement Essential (E) /
No. Desirable (D) /
GMP Critical
(GMP)
NA

5.6 Data Recording and Storage

This section details any requirements for how electronic data are to be recorded and stored.
Req. Requirement Essential (E) /
No. Desirable (D) /
GMP Critical
(GMP)
NA

5.7 Environmental Health and Safety

This section defines any requirements that relate to operational safety and environmental
expectations.
Req. Requirement Essential (E) /
No. Desirable (D) /
GMP Critical
(GMP)
5.7.1 Required PPE's should be used E
5.7.2 Work order should be approved before job starting E
5.7.3 LOTO will be used if needed as per GSK requirements E
5.7.4 The System Should prevent access to the Moving parts or hot E
surface without guards
5.7.5 All E-stops should be located as close as possible to points of
E
access, clearly identified and labelled.
5.8 Environmental Health and Safety
This section defines any requirements that relate to operational safety and environmental
expectations.
Req. Requirement Essential (E) /
No. Desirable (D) /
GMP Critical
(GMP)
5.7.6 E
All safety systems and E-stop circuits must be hardwired
5.7.7 The E-stops on specific equipment must e-stop only that E
equipment.
5.7.8 Emergency stops must be on their own dedicated safety control E
circuit that requires a dedicated reset function to energise the
circuit.

5.9 Supplier Support

This section defines the level of support required from the supplier and the service provided.
Req. Requirement Essential (E) /
No. Desirable (D) /
GMP Critical
(GMP)
5.8.1 Compressor & dryers supplier should guarantee the equipments E
for 1 year
5.8.2 Commissioning report for all equipments should be done & E
approved by supplier
5.8.3 Supplier will provide a single line diagram for the new equipment E
installation
5.8.4 Minimum critical spares list for 2nd and 3rd year maintenance E
5.8.5 The scope of the work to be provided by the installer shall include E
delivery and handover of a complete system that has undergone
client witnessed functional tests and is fully supported by
document dossiers. The installer will be responsible for
preparation of an FDS, Equipment schedules, IQ and OQ
documentation to a format agreed by GSK, and execution thereof
with GSK or agent as a witness.
5.10 Supplier Support
This section defines the level of support required from the supplier and the service provided.
Req. Requirement Essential (E) /
No. Desirable (D) /
GMP Critical
(GMP)
5.8.6 Documentary proof of all contact materials is required through E
certificates of conformity and identification of each component
with the mill heat number or batch.
5.8.7 The installer shall demonstrate the performance of the system as E
required for the PQ execution and system acceptance by GSK.
5.8.8 Supplier should have an agent for services and maintenance with E
agreed response time.
5.8.9 Supplier should add periodic maintenance plan procedures in E
user manual
5.8.10 FAT of the generation equipment, Inspection of the Storage E
Vessel, FAT of the Control system, at the manufacture premises,
FAT witness by integrator, GSK persons may be present if
desired at GSK expense.
5.8.11 Avail backup copy of all installed application software on E
applicable media
5.8.12 Supplier must provide suitable training (practical, theoretical and E
materials)
5.8.13 calibration certificates must be supplied prior to OQ testing, E
calibration certificates for reference equipments must to be
provided
5.11 Documentation
URS Requirement Limits Essential (E) /
Ref. No. Desirable (D) /
GMP Critical
(GMP)
5.9.1 Documentation must be provided to meet E
GlaxoSmithKline Standards
5.9.2 Supplier to provide 2 hard copies and 1 E
electronic copy of all documentation excluding
quality dossier.
5.9.3 The supplier documents should include, but not
be limited to:
Critical Device List
Instrument list, with details of sensor
manufacturer, serial number, operating range
and calibrated range with tractability meeting
NIST standards
Product contact parts list, with certificates of
conformance for filters.
Full parts list with – Change Parts and Spare
Parts
System GA/Schematic
P&ID (as built) E
Piping documentation including (if applicable):
Construction data for other lines with materials
certification (3.1b) and weld inspection data.
Component (detailed) electrical schematics
Panel layouts and GA
Field wiring diagrams
System Operation and Maintenance Manuals in
English language
5.11 Documentation
URS Requirement Limits Essential (E) /
Ref. No. Desirable (D) /
GMP Critical
(GMP)
Validation documentation shall be in English
language
Component Maintenance Instructions and
system maintenance instructions
Recommended ‘Planned Preventative
Maintenance’ activities and frequency
Maintenance and calibration procedures and
instructions for system and all components
Electrical safety certificate
Installation verification documentation
Software Installation and back-up Copy Storage
Applications software (firmware) with back-up
Copy Storage
Input/output Verification test results
Equipment Settings and Configuration Records.
Software development and validation certification
Job plan procedures in accordance.
Calibration master list in accordance

6 SYSTEM DESIGN – INSTALLATION

6.1 Sequence of events for Installation

6.1.1 The detailed design project will be delivered to GSK for acceptance prior to start the
work.

6.1.2 The provider will describe the functions for the project based on the tender package.

6.1.3 The Compressed Air vessel complete with all equipment required for the distribution
loop will be purchased at the same stage. It is expected that the complete loop will be installed
before the water treatment equipment is installed. The Distribution system will be pressure
tested, then connected to the vessel,

6.1.4 The entire installed Generation and Distribution system will undergo IQ/OQ, fully
documented and handed over for PQ

Note: The sequence of installation will be subject to change due to the site execution
schedule. A site programme to be issued.

6.2 Critical Pipe work

6.2.1 Pipe work will be supplied to GSK Global Technical Specification

6.2.2 Pipe work will be installed to ensure adequate support throughout to prevent undue
stress or forces on the pipe work installation. Consideration will by made for thermal
expansion. Ref: ANSI B31.3

6.2.3 The pipe work routing will be agreed with GSK.

6.2.4 Calculation will be made for stresses due to pipe work expansion. Where necessary the
stresses will be relieved by changes in direction.

6.2.5 Particular attention should be made to any external piping that will be subjected to the
local environmental conditions.

6.2.6 The system will be fully welded with the exception of process connections which will be
hygienic tri-clamp with PTFE faced seals.

6.2.7 All hygienic pipe work used in fabrication of the distribution will be Orbital Tig welded.
Where this is impractical, manual welds utilising a pulse welder may be used in consultation
with the GSK.

6.2.8 The distribution system must be pressure tested to 1.5 times working pressure after
completion.

6.2.9 All welded stainless steel pipe work must be cleaned and passivated.

6.2.10 All equipment and pipeline components must be identified with a pre-approved tagging
system.
6.3 Utility Pipe Work

6.3.1 Utility pipe work must be installed to the local site standard

6.3.2 The utility requirement must be sized by the supplier with due consideration to the utility
available at the plant room.

6.3.3 All pipe work must be identified with a pre-approved pipe line marker system

6.3.4 All equipment and pipeline components must be identified with a pre-approved tagging
system.

7 COMMISSIONING
7.1 Factory Acceptance Test (Fat)

7.1.1 The Generation system will be tested at the supplier’s factory for acceptance before it is
released for shipment. This acceptance testing ensures that the equipment is constructed
and finished and works correctly before shipment to site. This is done to minimise any
problems that can occur when the equipment is installed on site and is in both the Supplier
and GSKs’ interest.

7.1.2 The Factory Acceptance Test (FAT) should be carried out to the supplier’s standard and
documentation. This is subject to the approval by GSK, and may be modified to include
supplementary testing that is considered necessary to demonstrate the equipment functions
as specified. The test plan should be similar to the IQ and OQ test plans that the Supplier will
produce for execution.

7.1.3 Typical test and inspection that will be included but will not be limited to: -

 Documentation
 Mechanical inspection
 FAD and Efficiency of Air Compressor
 Pressure and Temperature of Air at discharge of compressor
 Calibration status of instruments and their control loops
 Checking of control panel and external finishes & internal standards
 Checks on accessibility operability
 Functional tests against simulated probe signals with alert and alarm conditions. The
test protocol will be required as part of the FAT protocol, and must be based upon the
system functional design specification.
 Wet run tests to check all aspects of system function where possible.
 Pressure hold test to demonstrate system integrity.

7.1.4 Satisfactory performance at the FAT and complete documented resolution of all
action items is a pre-requisite for FAT acceptance and acceptance for packaging and
delivery.

7.2Site Acceptance Test (SAT)

7.2.1 The equipment will be installed and commissioned, inclusive of Site Acceptance test
in the plant room of the production building at GSK

7.2.2 The Site Acceptance Test (SAT) should be carried out to the supplier’s standard and
documentation. This is subject to the approval by GSK, and may be modified to include
supplementary testing that is considered necessary to demonstrate the equipment
functions as specified. The test plan should be similar to the IQ and OQ test plans that the
Supplier will produce for execution.

7.2.3 The site acceptance test will only be considered as complete when the total
functionality of the system has been proved. The system must be seen to operate without
intervention for a GSK approved time interval.

7.2.4 Typical test and inspection that will be included but will not be limited to: -
 Documentation and certification.
 Mechanical inspection
 Materials and Finish Inspection.
 Check list on accessibility operability
 FAD and Efficiency of Air Compressor
 Quality test of air at each POU, which shall include Particle count, Moisture content,
Oil content, Pressure, PDP, Temperature and Air Quantity.
8 TRAINING
A minimum of 1 day training will be required for all GSK staff in the safe operation and
maintenance of the system as part of the handover. Procedures will be demonstrated in real
time and not by simulation.
The training will include but not be limited to Log book and maintenance procedures.

9 HEALTH AND SAFETY

 All containers with chemicals for disinfection or production process must be clearly
marked with warning signs and indications of measures to prevent accidents.
 Equipment must be equipped with protective devices such LOTO.
 All aspects of the design shall identify potential safety hazards and provide
necessary features to eliminate personal injury
 Materials used for any hazardous process shall be contained with all relevant
materials data sheets.

10 TIME SCHEDULE
The Compressed Air Generation and Distribution Systems shall be installed commissioned
and validated in accordance with the approved project validation plan and agreed timetable.

11 VALIDATION ACTIVITIES

11.1 Validation activities will be handled by the equipment supplier according to approved
documentation.
11.2 Qualification includes the following:
 Design Qualification (DQ)
 Installation Qualification (IQ)
 Operation Qualification (OQ)
 Performance Qualification (PQ) – this stage is exclusively the responsibility of GSK
Vemgal
 11.3 All qualification activities must be completed in the presence of an authorized person
from GSK
11.4 Finalising validation activities that involve supplier responsibilities
11.5 Final report of every stage needs to be handed over to GSK for approval
11.6 Approval of qualification documentation is the responsibility of the Quality department at
GSK Vemgal
11.7 Any deviation from approved specification need to be authorized by GSK Vemgal. This
sort of authorization may only be obtained in written paperwork and signed by both parties
11.8 GSK Vemgal representatives will gain access to equipment installation during the
qualification process. They also are authorized to shut down any operation that is not meeting
the required specifications.
11.9 Payment according to signed contract.

12 VALIDATION

12.1 If the equipment has its own documentation for qualification, this documentation will be
forwarded in order to be approved by GSK Vemgal. In case GSK Vemgal does not consider
the forwarded documentation as valid, GSK Vemgal review documents to improve them.
Implementations will start only after approval of this documentation.

12.2 Full validation (DQ, IQ, OQ and PQ) will be handled according to Vemgal requirements.
Extra details will be offered upon request.

12.3 Validation shall be documented according to Vemgal procedures.

12.4 IQ/OQ/PQ shall be done by suppliers according to GSK Vemgal own protocols.

12.5 The validation plan will be completed by the validation team of GSK Vemgal and it shall
be based upon supplier documentation.

13 FUNCTIONAL DESIGN SPECIFICATION

13.1 The Supplier will provide a functional design specification (FDS) developed to meet the
requirements of this URS that will be consistent with the life cycle approach. The FDS should
be a detailed specification to define all of the functions of the system and be cross-referenced
to this URS. The FDS will contain typically, but not limited, to the following details:
  System Schematic

 Control System Architecture

 Installation Details

 Equipment and Instrument details

 Installation Pressure Testing

13.2 Life cycle costs for the whole system for a minimum five-year period inclusive of utilities
and consumables.

14 DOCUMENTATION
14.1 Before Installation Qualification

 Any deviation from this document needs justifying and details shall be put down in
hard copy.
 Scheduling activities (with deadlines). Programme of Works.
 Standard procedures for equipment qualification:
 Fabrication and installation Method Statement and Risk Assessment
 Pressure Test Pneumatic
 Compliance Certificate.

 Qualification report completed before delivery to the Site (FAT). This report must
contain primary data, results, documentation, mechanical work documentation
(welds, joints, quality certificates for materials used for equipment assembly).
 Components and accessories list.
 Spare parts list estimated for a minimum of 2 years, list that will contain the
recommended spare parts and delivery deadline for each module.
 Approved validation report for Design Qualification (DQ).
 Approved validation protocol for Installation Qualification (IQ).
14.2 After Installation Qualification
 Approved validation report for Installation Qualification phase (IQ).

 Operational and checking procedure for the equipment (at least a draft form).

 Approved validation prortocol for Operation Qualification phase (OQ).

14.3 After Operation Qualification

 Approved validation report for Operation Qualification phase (OQ).

 Approved validation protocol for Performance Qualification phase (PQ).

14.4 Before Delivery for Current Use

 Interim Validation report.

 Training report.

 Operational procedure for equipment handling.

 Operational procedure for calibration and equipment checking.

15 CHANGE CONTROL
Any change occurred during commissioning must be approved by GSK personnel. Any
deviation from approved specifications must be authorized in hard copy by management
with the approval of the Quality Department, before implementation.

16 ABBREVIATION

The following definitions apply to the corresponding terms within this user requirement
specification:
Abbreviation Term

PDP Pressure Dew point

Abbreviation Term

ASME-BPE American Society Mechanical Engineers-Bioprocessing Equipment

International Standard

BMS Building Management System

DQ Design Qualification

FAT Factory Acceptance Test

FDS Functional Design Specification

GA General Arrangement Drawing

cGMP Current Good Manufacturing Practice

GSK GlaxoSmithKline

HMI Human Machine Interface

IQ Installation Qualification

ISPE International Society of Pharmacuetical Engineers

LOTO Log Out Tag Out (Debransat, Blocat deschis, Marcat)

NDT Non Destructive Testing

OQ Operational Qualification

POU Point of use

PQ Performance Qualification

SAT Site Acceptance Test

SVP System Validation Plan

URS User Requirement Specification

17 APPENDIX SUMMARY

APPENDIX 1 – CONTROL/ALARM SIGNALS TO BE

AVAILABLE ON THE SYSTEM
Analog
Local No-volt
Central Central Retransmissi
Indication digital
Function Location Panel Panel on
Field or output
Display Alarm To remote
package
system
Outlet
Gen System Yes Yes H+ Fault Yes No
Pressure
PDP Gen System Yes Yes H+ Fault Yes No
General
Gen System No Yes H Yes Yes
Fault
Outlet
Gen System Yes Yes H+ Fault Yes No
Temperature
System
Gen System No Running H Yes Yes
Stop/Start
Conductivity Dist.
No Yes H+ Fault Yes No
(return) Package
Air Flow rate Dist.
Yes Yes L Yes No
Package
APPENDIX 2– CONSUMERS POSITIONS
APPENDIX 3 – LOAD PROFILE TABLE
Project Name: GSK OSD Project
Project Number: IN501004910
DESIGN MATRIX FOR COMPRESSED DRY AIR
3 U. Factor Pressure (barg)
Flow (Nm /hr) 3
Design Flow (Nm /hr)
P.O.U total (u.f.)
System ID System Description Room ID Tool ID Process Equipment Qty
at POU
V avg V max V avg V max V avg V max

PROCESS AIR
A Loedige Blender Loedige-Loss-in-Weight-Feeder 0 0.5 0.5 0.00 0.00 1.00 0.0 0.0 -
3 Fette Tableting, Zinetac suite Tablet Press 1 1 18 18 18.00 18.00 1.00 18.0 18.0 6
4 Fette Tableting, Zinetac suite Tablet Press 2 1 18 18 18.00 18.00 1.00 18.0 18.0 6

5 Fette Tableting, Zinetac suite Tablet Press 3 1 18 18 18.00 18.00 1.00 18.0 18.0 6

6 Thomos Flex coating,Zinetac suite Tablet Coater 1 306 306 306.00 306.00 1.00 306.0 306.0 7

8 Thomos Flex coating, Zinetac suite Tablet Coater 1 306 306 306.00 306.00 1.00 306.0 306.0 7

3 Fette dust discharge Deduster 2 6 6 12.00 12.00 1.00 12.00 12.00 7

4 Fette dust discharge Deduster 2 6 6 12.00 12.00 1.00 12.00 12.00 7
5 Fette dust discharge Deduster 2 6 6 12.00 12.00 1.00 12.00 12.00 7
1 Hecht Big Bag Unloading Station Lifting devices-Big bag Elec panels 1 10 48 10.00 48.00 1.00 10.00 48.00 6
M Mill Mill Room 1 60 60 60.00 60.00 0.30 18.0 18.0 -
CDA COMPRESSED DRY AIR 26 GEA Granulation Suite Granulator - PMA1200 1 90 90 90.00 90.00 0.00 0.0 0.0 6
26 GEA Granulation Suite Vacuum transfer 0 72 72 0.00 0.00 0.30 0.0 0.0 6
26 GEA Granulation Suite Granulator/FBP - CIP 2 1 120 120 120.00 120.00 0.50 60.0 60.0 6
27 Fette Granulation Suite Tablet Press 1 1 18 18 18.00 18.00 1.00 18.0 18.0 6
28 Fette Granulation Suite Tablet Press 2 1 18 18 18.00 18.00 1.00 18.0 18.0 6
27 Fette dust discharge Deduster 2 6 6 12.00 12.00 1.00 12.00 12.00 7
28 Fette dust discharge Deduster 2 6 6 12.00 12.00 1.00 12.00 12.00 7
20 Bosch Capsule filler 1 Capsule mc 1 1 50 50 50.00 50.00 1.00 50.0 50.0 7
21 Bosch Capsule filler 2 Capsule mc 1 1 50 50 50.00 50.00 1.00 50.0 50.0 7
25 Hechte IBC charging Room Betnosol-Unloading of Raw materials 1 10 48 10.00 48.00 1.00 10.0 48.0 6
10 IBCWash Room CIP 2 120 120 240.00 240.00 0.80 192.0 192.0 6
GEA
7 Hecht Opadry Big Bag unloading Big bag -Lifting Devices 1 10 48 10 48 1.00 10.00 48.00 6
Bulk automated dispensary Vitamin Capsules:Unloading of raw
15 Betnesol 1 10 48 10.00 48.00 0.30 3.00 14.40 6
for capsules materials
TOTAL 1334.5 1486.5 1412.00 1564.00 1165 1290
INSTRUMENT AIR
Vacuum conveyor to tablet press -
For vacuum conveyor lift up -
A Hecht Vacuum Transfer 0 114 114 0 0 1.00 0 0
Synchronic tension (driving) -
Container station -
3 Fette Tableting, Zinetac suite Tablet Press 1 1 0.00 0.00 1.00 0.00 0.00 6

4 Fette Tableting, Zinetac suite Tablet Press 2 1 0.00 0.00 1.00 0.00 0.00 6

5 Fette Tableting, Zinetac suite Tablet Press 3 1 0.00 0.00 1.00 0.00 0.00 6

Dust discharge, Tablet press

3 HET ANKE Dust collector included in Tablet press 1 108 108 108.00 108.00 1.00 108.00 108.00 6
1 zinetac suite

Dust discharge,Tablet Press

4 HET ANKE Dust collector included in Tablet press 1 108 108 108.00 108.00 1.00 108.00 108.00 6
2 zinetac suite

Dust discharge,Tablet Press

5 HET ANKE Dust collector included in Tablet press 1 108 108 108.00 108.00 1.00 108.00 108.00 6
3 zinetac suite
Bin lifting and positioning,
3 GEA Hoist 1 10.8 10.8 10.80 10.80 1.00 10.80 10.80 6
Tablet press 1 zinetac suite
Bin lifting and
4 GEA positioning,Tablet Press 2 Hoist 1 10.8 10.8 10.80 10.80 1.00 10.80 10.80 6
zinetac suite
Bin lifting and
5 GEA positioning,Tablet Press 3 Hoist 1 10.8 10.8 10.80 10.80 1.00 10.80 10.80 6
zinetac suite
A Thomos Conditioning unit Feeding of coater 0 11 11 0.00 0.00 1.00 0.00 0.00 -
6 Thomos Flex coating, Batch Coater 1 Tablet Coater 1 1 1 1.00 1.00 1.00 1.00 1.00 7
8 Thomos Flex coating, Batch Coater 2 Tablet Coater 1 1 1 1.00 1.00 1.00 1.00 1.00 7

6 Thomos Cleaning Tablet Coater:WIP 1 1 1 1 1.00 1.00 0.00 0.0 0.0 7

6 Thomos dust discharge Tablet coater - Dust collector 1 17 17 17 17 1.00 17.00 17.00 7
8 Thomos dust discharge Tablet coater - Dust collector 1 17 17 17 17 1.00 17.00 17.00 7

6 Thomos inlet air Tablet Coater-AHU 1 2 2 2 2 1.00 2.00 2.00 7

8 Thomos inlet air Tablet Coater-AHU 1 2 2 2 2 1.00 2.00 2.00 7

Tablet feeding to coater,

GEA Hoist 1 10.8 10.8 10.80 10.80 0.00 0.00 0.00 6
batch coater 1
Tablet feeding to coater,
GEA Hoist 1 10.8 10.8 10.80 10.80 0.00 0.00 0.00 6
batch coater 1
7 Thomos Coating solution Tablet Coater-Solution Prep 1 4 4 4.00 4.00 0.00 0.00 0.00 7
23 Betnesol extract Isolator, Betamethasone 1 3 6 3.00 6.00 0.10 0.30 0.60 7-8
26 GEA Granulation Suite FBD 1 90 90 90.00 90.00 0.30 27.0 27.0 6
Vitamin Capsules: Automated weighing
D Capsules 0 0 0 0 0 0.30 0.00 0.00 -
system
D Capsules Vitamin Capsules:Extract system 0 0 0 0.00 0.00 0.30 0.00 0.00 -
M Mill Room Mill Room 0 10 10 0.00 0.00 0.30 0.00 0.00 -
26 GEA Granulation suite Hoist 2 10.8 10.8 21.6 21.6 0.30 6.48 6.48 -
26 GEA Granulation suite IBC Blender 1 10 10 10.00 10.00 0.30 3.00 3.00 6
27 Fette Granulation suite Tablet Press 1 1 0.00 0.00 0.10 0.0 0.0 6

28 Fette Granulation suite Tablet Press 2 1 0.00 0.00 0.10 0.0 0.0 6

Dust discharge,Tablet Press

27 HET ANKE Dust collector included in Tablet press 1 108 108 108.00 108.00 1.00 108.00 108.00 6
1 granulation suite

Dust discharge,Tablet Press

28 HET ANKE Dust collector included in Tablet press 1 108 108 108.00 108.00 1.00 108.00 108.00 6
2Granulation suite
27 GEA Tablet Press 1 granulation Hoist 1 10.8 10.8 10.80 10.80 1.00 10.80 10.80 6
28 GEA Tablet Press 2Granulation Hoist 1 10.8 10.8 10.80 10.80 1.00 10.80 10.80 6
20 Bosch Capsule Filler 1 Capsule Mc 1 1 50 50 50.00 50.00 1.00 50.00 50.00 7
20 GEA Capsule Filler 1 Hoist 4 1 10.8 10.8 10.8 10.8 0.10 1.08 1.08 6
21 Bosch Capsule Filler 2 Capsule Mc 1 1 50 50 50.00 50.00 1.00 50.00 50.00 7
21 GEA Capsule Filler 2 Hoist 4 1 10.8 10.8 10.8 10.8 0.10 1.08 1.08 6
P Hechte IBC charging Room Betnosol-Unloading of Raw materials 0 50 50 0.00 0.00 1.00 0.0 0.0 -
17 GEA Capsule blending Area IBC Blender 1 25 25 25 25 0.60 15.00 15.00 6

17 GEA Capsule blending Area Hoist 1 10.8 10.8 10.8 10.8 0.10 1.08 1.08 6
10 GEA IBC Wash Room IBC Washer 1 2 20 20 40 40 0.80 32.00 32.00 6
19 GEA blender room IBC Blender 1 25 25 25 25 0.60 15.00 15.00 6
10 GEA IBC washer CIP 2 20 20 40 40 0.00 0.00 0.00 6
11 Alpha Phonix WASH BAY 2 Parts Washer 2 72.4 72.4 144.8 144.8 0.50 72.40 72.40 5-10
IMA Primary packing Blister Machine-Thermo/Cold Former 7 20 39 140.00 273.00 1.00 140.00 273.00 7

IMA Secondary packing Packaging (50 cartons/mc)-Cartoner 7 3 3 21.00 21.00 1.00 21.00 21.00 7

IMA Secondary packing Checkwiegher 7 1 1 7.00 7.00 1.00 7.00 7.00 7

IMA Secondary packing Casepacker (2 outers/min) 7 3 20 21.00 140.00 1.00 21.00 140.00 7

GEA Hoist 7 10.8 10.8 75.60 75.60 0.10 7.56 7.56 6

05-GRN-023 Sample room 1 Isolator 1 6 10.8 6 10.8 1.00 6.00 10.80 6

Lab Laboratory 0 5 5 0 0 1.00 0.00 0.00 -
8.0LVL Dust Extraction System 0 20 20 0 0 1.00 0.00 0.00 -
BOILER & HOT WATER SYSTEMS
Energy center
CONTROL/ACTUATED VALVES 15 5.00 5.00 84.00 84.00 0.50 42.00 42.00 6-7

WTP, PW ACTUATED VALVES 40 5.00 5.00 185.00 185.00 0.50 92.50 92.50 6
TOTAL 1333.00 1376.80 1732.00 1991.80 1245.48 1502.58
GRAND TOTAL 2668 2863 3144 3556 2410 2793