Originally published in 2010, information in this yellow cover document remains useful

The chance or need to build or upgrade cleanrooms may come from a variety of
sources and at any time.

The reality is that standards change, as do demands for service. Services should be accommodated only by the use of facilities meeting current standards.

Designing and validating, or significantly upgrading, an aseptic suite is a task, which many pharmacy staff will be involved with only once in their careers. The majority find the task daunting and often find it difficult to obtain helpful and unbiased advice.

It was with the philosophy of “let’s learn from each other” that this guidance document was conceived. This second edition, now expanded and tailored to aseptic (including isolator) cleanrooms, continues this philosophy. Many excellent texts provide outline standards for pharmacy aseptic facilities. It is not the intention of this document to replace these standards in any way, but to supplement them with practical advice and indications of pitfalls to be avoided.

The topic of design, build and maintenance of cleanrooms can often be very dry, yet it is vitally important for the NHS. The style of this advisory document is deliberately informal so that it is easy to read to encourage staff to refer to it when required to design new cleanrooms.

The following information is meant to give the very broadest guidance on what designers, planners, builders and users may like to consider. It is hoped that it will, by drawing on the experiences of others, play a small part in conserving NHS resources and helping some of its staff.


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