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Designing Biopharma and Pharmaceutical Cleanrooms

The design, specification and selection of cleanrooms is a complicated process which requires due consideration involving the impact on the final build solution and comparing different classes and finishes to show the advantages or disadvantages of each. With an overview to the key issues that need to be reviewed by a project team when developing a cleanroom for an existing or new pharmaceutical process, operation or product, this article gives an insight into the complex process of cleanroom design.

The 'cleanroom' has been defined by the International Organisation for Standardisation (ISO) new standard 14644-1 as:

"A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimise the introduction, generation, and retention of particles inside the room and in which other relevant parameters, for example, temperature, humidity, and pressure, are controlled as necessary". (William Whyte, Cleanroom Technology, p1, 2001)

This definition may sound simple but when people, products, regulatory and pharmaceutical equipment, and operational/budget requirements are introduced into the equation, it becomes a complex problem to which there are many contributing factors. In addition, the production throughputs and flexibility required by the cleanroom suite will have an effect on a cleanroom's size and layout.


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By Richard Paley, Principal Architect and Pharmaceutical Consultant at Bovis Lend Lease

Richard Paley has been Principal Architect and Pharmaceutical Consultant for Bovis Lend Lease for 15 years and is experienced in the design of pharmaceutical, biopharma cleanrooms and R&D, QA/QC laboratory and process facilities. His previous experience includes working with international design and build contractors, architectural practices specialising in pharmaceutical manufacturing facilities and laboratories, as a lecturer for the PEAT course Facility Design Module at UMIST, Manchester, UK. Richard has designed projects across EMEA and Asia, and is a member of the ISPE, and the Irish Cleanroom Society.

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