http://www.nwda.co.uk/docs/00214_URSLot9

User Requirement Specification (URS) Area:

Process Development

URS Reference No:

URS009_07

Version No:

1 draft 1

Supersedes:

Not applicable

Change Control No:

Not applicable

USER REQUIREMENTS SPECIFICATION (URS) FOR A MICROBIOLOGICAL SHAKER INCUBATOR

Author:

NAME

TITLE

Simon Routledge

Production Manager

SIGNATURE

DATE

Reviewer:

Approved by: Authorised by (QA):

EDEN BIODESIGN CONFIDENTIAL – FORM.QA.026.03

Page 1 of 8

User Requirement Specification (URS) Area: Process Development URS Reference No: Effective Date:

URS009_07

Version No.:

1 draft 3

Periodic Review Date:

CONTENTS 1. INTRODUCTION....................................................................................................3 2. OVERVIEW............................................................................................................ 3 3. OPERATIONAL REQUIREMENTS .......................................................................3 3.1 Scope ............................................................................................................... 3 3.2 Operation ......................................................................................................... 3 3.3 Options and Ancillaries ....................................................................................4 3.4 Data and Security .............................................................................................4 3.5 Interfaces ......................................................................................................... 4 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 .....................................................................................5 5. LIFE CYCLE........................................................................................................... 5 5.1 Development Procedures .................................................................................5 5.2 Testing Requirements ......................................................................................5 5.3 Delivery Requirements......................................................................................6 5.4 Support ............................................................................................................6 6. GLOSSARY...........................................................................................................6 7. REFERENCES AND ASSOCIATED DOCUMENTS..............................................6 8. VALIDATION REQUIREMENTS............................................................................8

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User Requirement Specification (URS) Area: Process Development URS Reference No:

URS009_07

Effective Date:

1.

Version No.:

1 draft 3

Periodic Review Date:

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 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 User Requirement Specification (URS) describes the operational, environmental and cGMP requirements for a shaker incubator which will be used in one of the Process Development pilot suites.

2.

OVERVIEW The shaker incubator will be used by Process Development.

3.

OPERATIONAL REQUIREMENTS

3.1

Scope

The vendors scope shall include the following: A. Supply B. Installation C. Documentation including calibration certificates D. User Training E. Details of Service/Maintenance Contracts available.

3.2

Operation

The incubator will be required to operate over the following ranges: •

Agitation 25 to 400 rpm. Accurate to within Âą 4rpm

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User Requirement Specification (URS) Area: Process Development URS Reference No:

URS009_07

Effective Date:

3.3

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•

Operating temperature 5˚C to 75˚C. Accurate to within ± 0.1˚C.

•

Orbit 1 inch & or 2 inch

•

Intuitive programming allowing multiple changes in temperature and speed on a timed basis.

•

Ability to stack systems for future expansion whilst limiting increase in required footprint. Must be front loading.

•

Audible and visual alarms for temperature and shaker speed.

•

Humidified chamber (up to 80% RH non-condensable).

•

Maximum capacity 6 x 5L erlenmeyer flasks

•

Interior lighting.

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:

3.4

•

A range of additional validation support and services up to IQ/OQ

•

Range of options for test tube holders and flask clamps and platforms for sizes between 50ml and 5L

•

Ability to directly gas ≥6 flasks.

•

Humidity monitor

•

Robust design that is easily cleanable and easy to service.

•

Computer RS-232 interface for data logging

•

Ultraviolet light to reduce bio-burden of circulated air

Data and Security

Visual display for temperature and shaker speed.

3.5

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: Process Development URS Reference No:

URS009_07

Effective Date:

3.6

Version No.:

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Periodic Review Date:

Environment

The equipment will be used within Process Development Laboratories (ambient temperature 15-25ËšC RH 10-70%). The outer casing of the incubator will be constructed of non-shedding, non-static producing, cleanable material.

The available footprint is 150cm x 100cm (width x depth) in size with no restriction on height.

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, surface disinfectant chemicals used in Biomanufacturing.

230V 50Hz power supply is available.

4.3

Maintenance Requirements

The supplier should provide details of any maintenance/breakdown packages and support available.

The supplier must be able to provide routine maintenance, calibration, testing 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 testing requirements

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User Requirement Specification (URS) Area: Process Development URS Reference No:

URS009_07

Effective Date:

5.3

Version No.:

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Periodic Review Date:

Delivery Requirements

On supply the following documentation should be supplied: •

5.4

Operation and maintenance manual (including manufacture’s recommendations for maintenance schedules).

•

Calibration certificates.

•

Parts list and spares requirements.

•

System specifications.

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.

6.

7.

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

REFERENCES AND ASSOCIATED DOCUMENTS

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User Requirement Specification (URS) Area: Process Development URS Reference No: Effective Date:

URS009_07

Version No.:

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The homogeniser 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: Process Development URS Reference No:

URS009_07

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8.

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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

Documentation and drawings

Example Calibration Certificates

Y

Vendor to supply the specified documentation as a minimum

System Technical Specification

Y

Impact assessment/ Installation

Operation and Maintenance Manual

Y

Calibration Certificates

Y

Parts List and Spares requirements

Y

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IOQ