User Requirement Specification

Code:

System:
Project:

PW_URS_01

Version:

Purified Water Generation System

Date :

1.0

Page. 1 of 16

Fengxian Biopharmaceutical QC Building

Author
Name and Surname

Department

Date

Signature

Ricky Pomales,
P.E.

Document history
Version

Draft

Approval
Name and Surname

Department

Date

Signature

Modification

Initial Draft for comments/translation

/

Date

17Jun2011

User Requirement
Specification
Code:
PW_URS_01
System: Purified Water Generation System

Project:

Version:

1.0

Fengxian Biopharmaceutical QC Building

Page. 2 of 16

Date :

Index
1. Introduction .................................................................................................................................................................................................5
1.1.
1.2.
1.3.
1.4.

Project introduction ..................................................................................................................................................................................................................5

Scope and purpose of the document ...................................................................................................................................................................5
Reference & Related Documents ..............................................................................................................................................................................................5
Glossary .............................................................................................................................................................................................................................................5

2. General Description ....................................................................................................................................................................................6

2.1. Scope of supply overview ........................................................................................................................................................................................................6
2.2. Involved Processes ...........................................................................................................................................................................................................6
2.2.1. Feed water pre treatment unit ....................................................................................................................................................................................6
2.2.2. Softener .............................................................................................................................................................................................................................7
2.2.3. RO Unit ..............................................................................................................................................................................................................................7
2.2.4. EDI Unit ..........................................................................................................................................................................................................................7
2.3. Main Characteristics ..................................................................................................................................................................................................................7

3. Process related User Requirements ..................................................................................................................................7

3.1.
3.2.
3.3.
3.4.

Process description ..................................................................................................................................................................................................................7

Capacity .............................................................................................................................................................................................................................................7
Critical Process variables .................................................................................................................................................................................................8
Operative environment .............................................................................................................................................................................................................8

4. Mechanical User Requirements .........................................................................................................................................8

4.1. General Mechanical User Requirements ..................................................................................................................................................................8
4.1.1. Available Utilities .........................................................................................................................................................................................................8
4.1.2. Materials .......................................................................................................................................................................................................................................9
4.1.3. Finishing ........................................................................................................................................................................................................................................9
4.1.4. Electrical equipment ............................................................................................................................................................................................................10
121442488.doc

User Requirement
Specification
Code:
PW_URS_01
System: Purified Water Generation System

Project:

Version:

1.0

Fengxian Biopharmaceutical QC Building

Page. 3 of 16

Date :

4.1.5. Layout .....................................................................................................................................................................................................................................10

4.1.6. Delivery boundaries .............................................................................................................................................................................................................10

5. Automation User Requirements ...............................................................................................................................................10

5.1. Functions .........................................................................................................................................................................................................................................10
5.1.1. Process related functionality ................................................................................................................................................................................................11
5.1.2. System related functionality ................................................................................................................................................................................................11
5.1.2.1. General ................................................................................................................................................................................................................................11
5.1.2.2. Emergency situations ...................................................................................................................................................................................................11
5.1.2.3. Alarms and event handling ................................................................................................................................................................................11
5.2. Data ...........................................................................................................................................................................................................................................12
5.3. Technical System Requirements ....................................................................................................................................................................................12
5.3.1. Hardware ....................................................................................................................................................................................................................................12
5.3.1.1. PLC .............................................................................................................................................................................................................................................12
5.3.1.2. HMI..............................................................................................................................................................................................................................................12

6. User Requirements for the project execution ................................................................................................................13

6.1. Schedule ...................................................................................................................................................................................................................................13
6.2. Legal and regulatory requirements .......................................................................................................................................................................................13
6.3. Maintenance .....................................................................................................................................................................................................................................13

7. Life cycle ....................................................................................................................................................................................13

7.1. Development ....................................................................................................................................................................................................................................13
7.2. Testing ..............................................................................................................................................................................................................................................14
7.2.1. FAT ...............................................................................................................................................................................................................................14
7.2.2. IQ/OQ /..................................................................................................................................................................................................................14
7.3. Delivery .............................................................................................................................................................................................................................................14
7.3.1. Delivery of goods ........................................................................................................................................................................................................................14
7.3.2. Installation ...................................................................................................................................................................................................................................15
7.3.3. Documentation ..........................................................................................................................................................................................................15
7.3.4. Training .......................................................................................................................................................................................................................................15
7.3.5. Deliverables with the Quotation ............................................................................................................................................................................16
121442488.doc

User Requirement
Specification
Code:
PW_URS_01
System: Purified Water Generation System

Project:

Version:

1.0

Fengxian Biopharmaceutical QC Building

Page. 4 of 16

Date :

8. Attachments ...............................................................................................................................................................................................16

121442488.doc

User Requirement
Specification
Code:

Project:

Version:
PW_URS_01

1.0

Version: Purified Water Generation System

Rev.

Fengxian Biopharmaceutical QC Building

Page. 5 of 16

Date :

UR#

Text

1. Introduction
1.1.

Project introduction
The project comprises a new QC Building of Labs and Offices to support a new biopharmaceutical
manufacturing facility. QC
The project will install a dedicated purified water generation system.

The system will be installed in SIBP Fengxian

The Tag number assigned to this equipment will be XXXXXX XXXXXX

1.2.

Scope and purpose of the document

This document is used as a specification to obtain competitive tenders.
The supplier shall use proven standard technology preferably standard equipment and control as far
as practical. The supplier must advise where his standards do not comply with the specification.

1.3.

Reference & Related Documents

CFR 21 part 11 is required for applicable levels of control functionality CFR 21
part 11( 21 11 )

1.4.

Glossary
SIBP
FAT
FDA
HMI
I/O
IQ

121442488.doc

Abbreviation for the project: Shanghai Institute of Biological Products

Factory Acceptance Test
Food and Drug Administration (US regulation body for pharmaceutical market)
Human Machine Interface (Operational Panel).
Input/Output /
Installation Qualification

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User Requirement
Specification
Code:

Project:

Version:
PW_URS_01

1.0

Version: Purified Water Generation System

Rev.

Fengxian Biopharmaceutical QC Building

Page. 6 of 16

Date :

UR#

Text

OQ
WHO
EU
SIP

Operational Qualification
World Health Organisation
European Union
Sterilization In Place

2. General Description
2.1.

Scope of supply overview

The scope of supply includes:
Feed water pump
Water pre-treatment unit
Softener , RO unit and EDI unit
Temperature probes, safety valves, filter ,vacuum breaker, valves and the other
instruments to be installed on the purified water storage tank

control valves for each use points

PLC based control system PLC

Qualification & documentation required by the specification.

The supplier of purified water generation system shall provide a nozzle orientation for the storage
tank. The storage tank for purified water will be supplied by other

2.2.

Involved Processes
2.2.1. Feed water pre treatment unit
The Feed water will be pumped to the pre-treatment unit and pass through an automatic backflush
filter.

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User Requirement
Specification
Code:

Project:

Version:
PW_URS_01

Version: Purified Water Generation System

Rev.

Fengxian Biopharmaceutical QC Building

1.0

Page. 7 of 16

Date :

UR#

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2.2.2. Softener
A two stage ion-exchanger will soften the filtered water

2.2.3. RO Unit
The water after softener will pass to the RO unit. The ionic and bacterial contaminant s in the water
will be removed in the RO unit.

2.2.4. EDI Unit

EDI unit remove most of the rest contamination left after

2.3.

Main Characteristics
The equipment must fulfil cGMP requirements. cGMP
The equipment shall have automatic disinfection capabilities.

3. Process related User Requirements

3.1.

Process description
The system will be used to produce and distribute purified water to a building circulation loop
serving all use points. The package will interface with a distribution loop installed by other.

The purified water will be used in:

- solution preparation
- process equipment cleaning
- As feed water for clean steam generation.
The water quality shall fulfil the requirement on USP , E.U. P.h and CHP.

3.2.
121442488.doc

Capacity

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User Requirement
Specification
Code:

Project:

Version:
PW_URS_01

1.0

Version: Purified Water Generation System

Rev.

Fengxian Biopharmaceutical QC Building

Page. 8 of 16

Date :

UR#

Text

Output of this purified water generation system is XXXlitres /hr. XXX /

3.3.

Critical Process variables

3.4.

Feed water conductivity

Outlet water conductivity
Outlet water pH pH
Water level in the storage tank

Operative environment
All elements, which are required for operational reasons, must be easily accessible from the
operation side.
The machine technical area shall have enough space for maintenance purpose..

The room is not classified, which is general utility equipment and services distribution.

4. Mechanical User Requirements

4.1.

General Mechanical User Requirements

4.1.1. Available Utilities

SIBP will provide all utilities as recommended by the Supplier. The Supplier will provide the
minimum and maximum values of temperature and pressure for each utility required to safely
operate the equipment. Utilities as recommended by the supplier:

All equipment to change the characteristics of the utilities (e.g. pressure reduction for compressed
air, absolute filters, etc.) forms part of the Suppliers scope of work and delivery.

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User Requirement
Specification
Code:

Project:

Version:
PW_URS_01

Version: Purified Water Generation System

Rev.

Fengxian Biopharmaceutical QC Building

1.0

Page. 9 of 16

Date :

UR#

Text

Generally, the following utilities are available:

Electric Power
3 x 380 V (3 Ph, N, E)
Potable Water
3 5 bar
Purified Water
To be advised
Industrial Steam
5 6 bar
Condensate return
To be advised
Compressed Air
6 bar
Wastewater drain
100 mm PVC
The supplier shall provide the consumption details of each utility including minimum, average and
peak flows. Contemporary factor shall be considered and identified where necessary.

4.1.2. Materials
Metal surfaces in contact with purified water shall be AISI 316L with material certificates
AISI 316L

Metal surfaces with no purified water contact surfaces shall be: AISI 304 or better
AISI 304

Non-metal surfaces in contact with product have to be China SFDA compliant or to be food grade
quality with material certificates (e.g. hoses, bellows, and gaskets).
SFDA

All filters of process and utilities are to be supplied with filter certificates.

4.1.3. Finishing
All surfaces in purified water contact shall be free from cracks & crevices with no sharp edges or
crevices which may impede proper cleaning.

Internal surface finishes must be at least ra 0.8m. ra 0.8m

External finishes to suppliers standard for pharmaceutical facilities.
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User Requirement
Specification
Code:

Project:

Version:
PW_URS_01

Version: Purified Water Generation System

Rev.

Fengxian Biopharmaceutical QC Building

1.0

Page. 10 of 16

Date :

UR#

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All welds within the washer must be flush ground. All other welding shall be brushed and fully
cleaned. Pickling and Passivation as required

4.1.4. Electrical equipment

Minimal IP protection level classification is IP55. IP()
IP55()

4.1.5. Layout
The provisional layout is attached for reference but may be revised according to the Suppliers and
equipment requirements.
The system shall fit within the maximum 7.00 metre clear ceiling height in the production zone. Any
additional height requirements for the equipment must be discussed and agreed with SIBP.
7

The supplier shall provide a layout of his equipment within the allocated space and details of his
connection points.

4.1.6. Delivery boundaries

The Supplier shall furnish all material, within the specified battery limits, required for all equipment
in the specified scope. Generally the battery limits excludes all interconnecting piping/ducts and
wiring. For example SIBP will supply electrical power to the main electrical panel and utility
connections only

5. Automation User Requirements

5.1.
121442488.doc

Functions

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User Requirement
Specification
Code:

Project:

Version:
PW_URS_01

1.0

Version: Purified Water Generation System

Rev.

Fengxian Biopharmaceutical QC Building

Page. 11 of 16

Date :

UR#

Text

5.1.1. Process related functionality

Shall be described by the supplier (FDS)

5.1.2. System related functionality

5.1.2.1. General
The automation system shall be compliant with China SFDA regulation appertaining to electronic
record handling. The 21 CFR Part 11 specified requirements are a condition for this project which
foresees supply to the International market. GAMP 5 is applicable. SFDA
The 21 CFR Part 11( 21 11
)GAMP 5

5.1.2.2. Emergency situations

The automation system (HMI and PLC) shall provide a connection for the SIBP UPS / emergency
generator. The voltage and consumption to be given by the Supplier.(HMI PLC)
/

According the developed layout at least one emergency shut down button shall be installed to shut
down the complete system (including all pumps). The Data logging function shall be maintained in
that status.()

5.1.2.3. Alarms and event handling

During the project an alarm concept shall be developed which classifies the alarms according to
their impact and the needed action for resetting.

Alarms and events display and log must be date and time stamped.

A log file shall keep track of all alarms in order to do an analysis in case of interventions
(maintenance, etc). The log shall contain at least the latest 60 days from where they can be
exported or copied for off-line analysis.()
60
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User Requirement
Specification
Code:

Project:

Version:
PW_URS_01

Version: Purified Water Generation System

Rev.

Fengxian Biopharmaceutical QC Building

1.0
Date :

UR#

5.2.

Page. 12 of 16

Text

Data
All handling of process critical data has to be compliant to a standard to be agreed between SIBP
and the Supplier. GAMP 5 shall be followed.
GAMP5

A clear concept has to be agreed, during project development, which data is defined as critical.

5.3.

Technical System Requirements

5.3.1. Hardware
5.3.1.1. PLC
The PLC software must be backed up non-volatile data carrier, e.g. EEPROM. PLC
EEPROM()

All inputs and outputs; both digital and analogue must be galvanically isolated.

The voltage supply for the inputs and outputs must be 24 V DC. 24VDC
Preferably, the I/O supply voltage shall be an independent supply, i.e. separated from the panel
internal 24 V DC supply. 24VDC
All inputs and outputs, both digital and analogue, must be protected against short circuit. This
means for example, that a short circuit of the I/O supply voltage to ground, may neither destroy the
I/O, nor trip the power supply.

5.3.1.2. HMI
The HMI must be from plane surfaces that can easily be cleaned, e.g. using a humid cloth. HMI

For the local output of the batch report, the recipes, etc. a printer shall be provided

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User Requirement
Specification
Code:

Project:

Version:
PW_URS_01

Version: Purified Water Generation System

Rev.

Fengxian Biopharmaceutical QC Building

1.0

Page. 13 of 16

Date :

UR#

Text

6. User Requirements for the project execution

6.1.

Schedule
The supplier will give his best delivery schedule.

6.2.

Legal and regulatory requirements

Delivery must be compliant with all EU/WHO andSFDA/China laws. This includes, but is not limited
to, CE certification rules.\/ CE
The equipment and the software shall be compliant to cGMP rules applied by the WHO/European
authorities and the China SFDA. WHO// cGMP

6.3.

Maintenance
The equipment shall be designed for continuous (24h/day, 7 days/week) operations. In this context
operation means production and cleaning. Any planned inspections and or maintenance in addition
to the yearly inspection shall be kept to a minimum. (24h/,7 /)

7. Life cycle
7.1.

Development
The system will be used for providing purified water for the production of pharmaceutical
products/media/reagents and has to fulfil cGMP requirements as set by the authorities (China
SFDA, EMA, WHO etc.), and will be subject of qualification / validation activities. Therefore
adequate project documentation has to be prepared from the initial time of working on the project
(e.g. material certificates, etc.).,//,(,EMA
WHO ) cGMP ,/.()

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User Requirement
Specification
Code:

Project:

Version:
PW_URS_01

Version: Purified Water Generation System

Rev.

Fengxian Biopharmaceutical QC Building

1.0

Page. 14 of 16

Date :

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The Supplier shall develop a Quality Plan for the project.

7.2.

Testing

7.2.1. FAT
Before delivery, equipment and software have to be accepted by a Factory Acceptance Test (FAT)
executed in the suppliers (or sub suppliers) workshop or factory. (
) FAT

Test protocols are to be prepared by the Supplier and approved by SIBP prior to the FAT. The
Supplier shall execute tests at their premises and SIBP will indicate which tests will be witnessed by
them.FAT

7.2.2. IQ/OQ /
Test protocols have to be prepared by the Supplier and approved by SIBP. SIBP will integrate the
Suppliers Protocols in its templates as one test point. The Supplier shall execute tests with
personnel and material supplied by SIBP and will witness all IQ/OQ tests. The preparation of
qualification documentation and the execution of tests, etc., shall be priced separately.

IQ/OQ

In OQ the critical functions defined must be tested including conditions or set of conditions
encompassing upper and lower operating limits covering the defined range of tolerances.

Furthermore alarms, interlocks, timers, displays and registration must be checked.

7.3.

Delivery

7.3.1. Delivery of goods

The goods shall be delivered to: SIBP Fengxian Site , Shanghai, Peoples Republic of China.

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User Requirement
Specification
Code:

Project:

Version:
PW_URS_01

Version: Purified Water Generation System

Rev.

Fengxian Biopharmaceutical QC Building

1.0

Page. 15 of 16

Date :

UR#

Text

7.3.2. Installation
Supplier shall be responsible for the installation of all equipment and materials within the specified
scope. Supplier will provide all required supervision for mechanical, electrical and pneumatic
assembly and installation. Local mechanical and electrical subcontractors will execute the
installation work including erection of equipment, piping, ductwork, instrumentation, cabling, etc.

All required labour from the mechanical and electrical subcontractor shall be available and is the
responsibility of SIBP and/or its representative CM contractor./

Supplier shall provide detailed engineering (drawings and isometrics) for ductwork and utility piping
distribution, venting and drainage system, electrical and pneumatic cable tray routing.
()

7.3.3. Documentation
The Supplier shall provide all documents that allow the plant to operate efficiently, safely and under
GMP conditions over the whole plant life cycle. In addition the documentation shall allow SIBP to
qualify and validate the scope of supply to the complete satisfaction of the Authorities. See
attachment 1. If the vendor cannot supply any of this documentation it MUST be stated in the tender
GMP

The documents will be requested from the supplier according to the overall project schedule.

7.3.4. Training
The Supplier shall include in its proposal the cost of adequate training of operators, supervisors and
maintenance staff. This may be set out it n the form of an optional price.

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User Requirement
Specification
Code:

Project:

Version:
PW_URS_01

1.0

Version: Purified Water Generation System

Rev.

Fengxian Biopharmaceutical QC Building

UR#

Page. 16 of 16

Date :
Text

7.3.5. Deliverables with the Quotation

The quotation shall include at least the following data and information:

P&I Diagrams ( for Basic Design)()

Specification of equipment components ( Datasheets)()
Layout drawing (for Basic Design) with location of system components and indication of main
dimensions ()
Specification of material and finish (standard of manufacturer)()
Dimension and weights of main components
Delivery time
Time for installation supervision at SIBP site
Time for Qualification (IQ, OQ)
Time for SIBP operator training
Electrical power and utility consumption

8. Attachments
1

121442488.doc

Final Package Documentation Requirements

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