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.

Attachments

All our resources on Patient Group Directions (PGDs) and other legal mechanisms for the supply or administration of medicines.
Strategies, signposting and initiatives to support safer use of insulin.
Associate Regional Pharmacy Procurement Specialist - East of England, Procurement
Discussion about implementing biosimilar insulin in primary care: key considerations, hints, and tips for systems planning the transition. 10 June 2025.
There are many artificial saliva products for dry mouth (xerostomia). We summarise eligibility for dental prescribing and key pharmaceutical considerations.
Artificial saliva products for dry mouth (xerostomia) vary in formulation. We advise on pharmaceutical considerations and prescribing or supplying in dentistry.
Advice on the management of PGDs when organisations merge, cease to exist or services are transferred to a new provider to ensure safe care and good governance

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