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PRESENTeuGMP COMPLIANCE BY DESIGN FOR NHS

PHARMACEUTICAL CLEANROOMS

�The facility design must be driven by the Process Requirements.

�Determine the Process Steps from receipt of raw material to finished goods despatch and waste handling.

�Develop a Process Flow Chart mapping out how each Process Step is linked.

�Expand the Process Flow Chart to determine the environments, equipment and personnel required to support each Process Step.

�Design the facility to support the defined Process Requirements.

DESIGN FOR PROCESS REQUIREMENTS

�The facility design needs to satisfy the Process Requirements, however this needs to be sized to meet Production Demands in terms of Production Quantity.

�Define the Maximum Output for the facility.

�Determine the quantity of Raw Material and Finished Goods required together with Waste Material generated to support the Maximum Output Demand.

�Expand the Production Requirements to define support staff, utilities, production equipment and despatch logistics needed to support the Production Demands.

DESIGN FOR PRODUCTION REQUIREMENTS DESIGN FOR VALIDATION REQUIREMENTS

CLIENTPROCESS

VALIDATIOND.Q. COMMISSIONING

DESIGN IQ OQ

U.R.S. PQ

DESIGN FOR

GMP

REGULATORY

CHANGE

CONTROL

ENGINEERING

CHANGE CONTROL

USER REQUIREMENT SPECIFICATION

�The development of a User Requirement Specification by the agreed hierarchy is essential in understanding the client expectations for the facility and clearly defines the acceptance criteria limits to ensure the client expectations are met.

�The User Requirement Specification is required in order to ensure that all the manufacturing requirements and QA/QC regulatory compliance requirements are incorporated into the facility design and drive the details of construction.

�The User Requirement Specification is the starting point for the GMP compliance validation process.

�Excellent opportunity for Users to focus on what they actually want.

CONCEPT DESIGN CONSIDERATIONS

�Cleanroom environment must be designed for the process.

�GMP compliance must be the driving force for the design.

�Production capacity and production expansion limitations.

�Operational clean environment matched to operational production equipment.

�Process flow pattern – raw materials in – process manipulations –finished product out – waste product out – to be reflected in facility layout to avoid crossovers and mix-ups.

�Ease of personnel entry.

�Ease of production equipment entry, removal and maintenance.

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PRODUCTION FACILITY DESIGN CONCEPT PRODUCTION FACILITY LAYOUT

MODULAR PANEL CLEANROOM VINYL FINISHES CLEANROOM

PRODUCTION FACILITY HVAC HVAC INTEGRATION

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PROCESS EQUIPMENT INTEGRATION PROCESS EQUIPMENT INTEGRATION

�The Cleanroom, Process services and HVAC utilities integration is intensive with all process equipment located within the clean space and therefore heat load of the process equipment must be catered for in the HVAC design.

�Expansion of the facility requires major shut down time and re-engineering of services and structures.

� The use of centralised HVAC plant means the entire Cleanroom must remain in operation even if areas remain non-operational from a production point of view.

� The facility can be laid out to suit the process flow pattern but there is limited opportunity to change the facility layout after construction if a change is required to the process flow pattern.

DESIGN CONSIDERATIONS

�Personnel entry to the facility must be limited to a defined number of people but there is limited opportunity to increase the size of the change rooms if an increase in staff is required.

�The installation, removal or replacement of process equipment usually requires a breach of the Cleanroom and a shut down / re-certification of the facility.

�The materials of construction need to be selected to ensure compatibility with the client process and cleaning protocols and achieve GMP compliance.

DESIGN CONSIDERATIONS

WHO IS IN CHARGE

�The typical NHS project is a complicated puzzle of relationships with the top of that pyramid being the commercial management company followed by the many and varied members of a professional team with a number of specialist companies being contracted to deliver the project under the direction of the professional team within the stranglehold of constraints imposed by the commercial management company.

� This scenario assumes that the professional team understands the end user client requirements and can interpret those requirements correctly, only for the responsibility for the correct and compliant delivery of the project to rest with the various contractors and not with the members of the professional team who have developed the project details.

�This contract management process is designed to exclude the end user client from being intimately involved with all stages of the project development.

WHO SHOULD BE IN CHARGE

�The end user needs to be involved in the design and development of the project and in the generation of the various User Requirements Specifications for their facility.

�It is possible for the end user client to work in partnership with one of the few specialist cleanroom design and build contractors to ensure that the project is designed with compliance as the starting point so that at the end of the project, the end user moves into a facility that is exactly what they wanted and what they expected rather than to move into a facility that has been designed by a team who have no intimate knowledge of the process and constructed by contractors who havesimply managed to satisfy the commercial conditions imposed upon them rather that work to satisfy the end user requirements for the facility.

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DESIGN CONSIDERATIONS SUMMARY

�The typical cleanroom design and layout is rigidly fixed around a known process with little ability to expand and contract based upon production demand. Expansion beyond the preset maximum production limit is not easily achieved.

� The process operations to support the maximum production capacity must be clearly defined as the starting point for the detailed design of the cleanroom and the facility.

�The cleanroom design must be developed around the process and production operations.

�The facility building and infrastructure design must be developed around the cleanroom facility.

DESIGN CONSIDERATIONS SUMMARY

�The end user client takes full responsibility for the review and selection of all items of process equipment. The commercial management company and the professional team play no part in this critical part of the project because they have no knowledge or understanding of what items of process equipment would satisfy the end user client requirements.

�The cleanroom is the single biggest item of process equipment in the end user client inventory and the end user needs to be the single most important member of the professional team to ensure that this valuable item of process equipment is developed and delivered to meet the needs of the process.

�The facility must be compliant in the way it is constructed and in the way it integrates with the process operations carried out within it. The end user is the only person with the right knowledge and experience to interpret these individual requirements as a whole and working in partnership with a specialist contractor a compliant facility can be assured.

euGMP COMPLIANCE BY DESIGNFOR

NHS PHARMACEUTICAL CLEANROOMS

OPEN DISCUSSIONValidair Projects Limited

Unit 3 Invicta Business Park

London Road

Wrotham

KENT TN15 7RJ

Tel: +44 (0)1732 882 984

Fax: +44 (0)1732 882 644

Email: projects@validair.com

CONTACT INFORMATION