Monday, 15 May 2017

Cleanroom Management in Pharmaceuticals and Healthcare (new edition)


Everything you need to know about the operation and management of cleanrooms – a new edition of the book edited by Tim Sandle and Madhu Raju Saghee is now available from Euromed Communications.

In 26 Chapters and over 600 pages this book provides a unique tool to help you achieve regulatory compliance. It first creates a foundation in history and established practice and then helps you understand how state of the art technology and engineering solutions can deliver the best practice and so provide reliable systems performance.

An essential read for practitioners in cleanroom technology.

Since the first edition of this book in 2013 there have been many changes to the approach and methods for cleaning and certifying cleanrooms. This was most notable in the revised ISO 14644 cleanroom standard, parts 1 and 2. Numerous chapters have been updated to reflect the requirements of the new global standard.

In addition to incorporating the new standard, many of the other chapters in the book have been updated. For example, in bringing current practices and Good Manufacturing Practice regulations up-to-date. The book also details the leading international cleanroom requirements and regulations: U.S., FDA, EMA, and ISO. Many of the authors share best practice guidance.

The chapters on isolators and other barrier devices, contain added information about vapour phase bio-decontamination using hydrogen peroxide. There are also updates to those chapters surveying the future of aseptic processing and cleanroom technology, with a special focus on areas like automation.

This updated edition will prove an essential resource to all practitioners of operation and management of cleanrooms.

For further details see Euromed Communications

Sandle, T. and Saghee, M. R. (Eds) Cleanroom Management in Pharmaceuticals and Healthcare, 2nd Edition, Euromed Communications, Passfield, U.K.

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Posted by Dr. Tim Sandle