User Requirement Specification (URS)

Area: Development, Production & Quality Control

URS Reference No: URS008/07 Version No: 1 draft 1
Effective Date: Periodic Review
Date:

USER REQUIREMENTS SPECIFICATION (URS)

FOR A SINGLE USE DISPOSABLE BIOREACTOR
SYSTEM

NAME TITLE SIGNATURE DATE

Author: Mark Process

Rayner Dev
Manager
Reviewer: Validation
Consultant

Approved by: Anita Bate Science

Director

Authorised by (QA): Qualified

Ken Hart
Person

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 User Requirement Specification (URS)

Area: Development, Production & Quality Control

URS Reference No: URS008/07 Version No: 1 draft 1
Effective Date: Periodic Review
Date:

CONTENTS

1. INTRODUCTION................................................................................................3
2. OVERVIEW........................................................................................................ 3
3. OPERATIONAL REQUIREMENTS....................................................................3
3.1 Scope.......................................................................................................... 3

3.2 Operation....................................................................................................4

3.3 Options and Ancillaries................................................................................4

3.4 Interfaces....................................................................................................4

3.5 Data and Security........................................................................................5

3.6 Environment................................................................................................5

4. CONSTRAINTS..................................................................................................5
4.1 Milestones and Timelines............................................................................5

4.2 Compatibility and Support...........................................................................5

4.3 Maintenance Requirements........................................................................5

4.4 Procedural Constraints................................................................................6

5. LIFE CYCLE.......................................................................................................6
5.1 Development Procedures............................................................................6

5.2 Testing Requirements.................................................................................6

5.3 Delivery Requirements................................................................................6

5.4 Support.......................................................................................................6

6. GLOSSARY........................................................................................................7
7. REFERENCES AND ASSOCIATED DOCUMENTS...........................................8
8. Validation requirements......................................................................................9

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 User Requirement Specification (URS)

Area: Development, Production & Quality Control

URS Reference No: URS008/07 Version No: 1 draft 1
Effective Date: Periodic Review
Date:

1. INTRODUCTION

The National Biomanufacturing Centre (NBC) is located on the Estuary

Development site in Speke, Liverpool, UK. The functional areas of the
facility include a current Good Manufacturing Practice (GMP) Production
Area (comprising 3 production suites and a support area), Warehousing
and Storage areas, Analytical, Quality Control (QC) and Process
Development labs and offices.

The NBC facility is used for biopharmaceutical process development and

clinical trial phase I and II production, including supporting analytical and
QC activities. The drug substances produced are intended for medicines
for human use and as such are governed by current Good Manufacturing
Practice (cGMP).

This URS describes the operational, environmental and cGMP

requirements of the Single use/disposable bioreactor that will be used in
the Process Development laboratories.

2. OVERVIEW

The single use/disposable bioreactor will be used during development,

optimisation and growth of cell culture (e.g. mammalian, insect
cell/baculovirus, viral production) during biopharmaceutical process
development.

It will be constructed of robust, easy cleanable materials.

3. OPERATIONAL REQUIREMENTS

3.1 Scope

The disposable bioreactor will require low maintenance, and be designed

for ease of use.

The Vendors scope shall include the following:

a) Supply.

b) Installation.

c) Documentation including calibration certificates.

d) User training.

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 User Requirement Specification (URS)

Area: Development, Production & Quality Control

URS Reference No: URS008/07 Version No: 1 draft 1
Effective Date: Periodic Review
Date:

e) Details of service / maintenance contracts available.

3.2 Operation

The disposable bioreactor should have/be:

 Control and real time measurement of pH, DO, temperature,

agitation.

 Data logging (21 CFR part 11)

 The capability of retrofit to existing/3rd party control units.

 Ability to use disposable or re-usable probes.

 The capability of operating with different working volumes up to

20L

 Be validatable

 Have the required safety cut outs and over load protection.

3.3 Options and Ancillaries

The vendor should identify, where applicable, their standard equipment

that fits this specification. The vendor shall (where possible) also provide
costs for the following additional items:

 A range of additional maintenance support and services.

 Any additional accessories to fulfil the requirements indicated in

section 3.2.

3.4 Interfaces

A user-friendly control system is required, that can allow system

operation with a minimal amount of training.

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 User Requirement Specification (URS)

Area: Development, Production & Quality Control

URS Reference No: URS008/07 Version No: 1 draft 1
Effective Date: Periodic Review
Date:

3.5 Data and Security

Not applicable.

3.6 Environment

The equipment will be located in the Process Development Laboratories

(ambient temperature 15-25ºC RH 10-70%).

The outer casing of equipment will be constructed of non-shedding, non-

static producing, cleanable material. The surface will be resistant to mild
acid / alkali solutions and organic solvents, and the materials of
construction must be non-corrosive.

The Single use/disposable bioreactor must operate accurately at ambient

temperature away from direct sunlight and draughts, at < 90% humidity.

The Single use/disposable bioreactor is required to fit on bench space 90

cm deep and 120 cm wide with no height restriction.

4. CONSTRAINTS

4.1 Milestones and Timelines

Not applicable.

4.2 Compatibility and Support

The internal components of the system must be compatible with, and

resistant to, the materials used during operation.

The single use/disposable bioreactor must be capable of being powered

by single-phase 240V (50 Hz) electricity.

4.3 Maintenance Requirements

The manufacturer should supply details of any maintenance / breakdown

packages available.

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 User Requirement Specification (URS)

Area: Development, Production & Quality Control

URS Reference No: URS008/07 Version No: 1 draft 1
Effective Date: Periodic Review
Date:

Supplier must be able to provide routine maintenance and repair when

needed beyond the warranty period at cost to the customer.

4.4 Procedural Constraints

Not applicable.

5. LIFE CYCLE

5.1 Development Procedures

Not applicable.

5.2 Testing Requirements

See Section 8 for a detailed matrix of the validation testing requirements.

5.3 Delivery Requirements

On supply the following documentation should be supplied:

 Operation and maintenance manual (including manufacturer’s

recommendations for maintenance schedules).

 Calibration certificates.

 Parts list and spares requirements.

 System specifications.

5.4 Support

The vendor must supply details of all service and maintenance

requirements of the equipment. The vendor must also supply details of
any service and maintenance support that they can supply.

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 User Requirement Specification (URS)

Area: Development, Production & Quality Control

URS Reference No: URS008/07 Version No: 1 draft 1
Effective Date: Periodic Review
Date:

6. GLOSSARY

cGLP Current Good Laboratory Practice

CFR Code of Federal Regulations
cGMP current Good Manufacturing Practice
EC European Community
EEC European Economic Community
GAMP Good Automated Manufacturing Practice
GMP Good Manufacturing Practice
IOQ Installation / Operational Qualification
ISPE International Society of Pharmaceutical Engineers
NBC National Biomanufacturing Centre
Ph Eur European Pharmacopoeia
QC Quality Control
RH Relative Humidity
URS User Requirement Specification
USP United States Pharmacopoeia

7. REFERENCES AND ASSOCIATED DOCUMENTS

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 User Requirement Specification (URS)

Area: Development, Production & Quality Control

URS Reference No: URS008/07 Version No: 1 draft 1
Effective Date: Periodic Review
Date:

The Single use/disposable bioreactor should be fully compliant with the

following documents/regulations:

a) GMP-EC directive 91/356/EEC - Principles and Guidelines of

Good Manufacturing Practice for Medicinal Products for Human Use.

b) cGMP - United States Code of Federal Regulation (CFR) Title 21,

Parts 210 and 211 - Current Good Manufacturing Practice.

c) cGMP - United States Code of Federal Regulation (CFR) Title 21,

Part 11 - Current Good Manufacturing Practice.

d) GAMP - International Society of Pharmaceutical Engineers (ISPE)

Guide to Good Automated Manufacturing Practice.

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 User Requirement Specification (URS)

Area: Development, Production & Quality Control

URS Reference No: URS020/05 Version No: 1 draft 1
Effective Date: Periodic Review Date:

8. VALIDATION REQUIREMENTS

The following details the test requirements for documentation, testing and the stage of the project at which they must be provided/performed.
These requirements are a minimum tariff and the vendor is required to include any documentation, not all ready requested here, which are considered
necessary to support successful validation of the system.
Test Requirements Test Stage
Tender Impact assessment/ IOQ
Installation
Documentation and drawings Example Calibration Certificates Y
Vendor to supply the specified System Technical Specification Y
documentation as a minimum
Operation and Maintenance Manual Y
Calibration Certificates Y
Operational Testing Testing which demonstrates that the equipment Y
operates a Precise, Accurate and reproducible
manner
Parts List and Spares requirements Y

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