Scope

This chapter addresses the importance of an integrated design approach to microbiological contamination control in pharmaceutical manufacturing areas and clean-room construction. Other industries where clean-room manufacturing is highly regulated (food, beverage, electronics, banking, nuclear etc.) will all benefit from the information collated here.

We deal with the fit-out of the manufacturing enclosure and review the requirements for good architectural detailing and selection of appropriate construction materials and finishes.

The design of the layout for the clean room is briefly reviewed in terms of configuration, equipment layout, general operability and good manufacturing practice (GMP). Some typical examples are used to illustrate some of the key layout issues affecting clean-room design.

Detailed guidance is also given on the architectural design issues relative to the selection, performance and architectural detailing of construction materials and room finishes. In addition we look at the requirements for fixtures and fittings. Summary tables provide guidance on the standard of architectural detailing and surface finishes required to meet the appropriate clean room classifications.

The chapter deals with the interaction of cleaning and disinfection methods and materials on the fabric and finishes of the clean room. It also addresses the methods used for supplying the correct air quality and physical integration of this requirement with the clean room.

In architectural terms, the definition of a clean room is taken as the room enclosure, including any openings, penetrations, etc., to be constructed with sufficient integrity and detail so as to provide a microbiologically contained environment, which can be maintained within particulate and microbiological limits, in order to give the product, and sometimes the operator, protection from contamination.

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