Edited by Tim Sandle and Madhu Raju Saghee
ISBN 978-0-9573491-6-2 (Hb)
In nearly 600 pages this is a start-to-finish manual of cleanroom design, maintenance, operation and safety. This new edition addresses every hurdle and hoop you face, from agencies in the US, the EU, the ISO and beyond.
The book includes information on the following aspects:
- Technical issues including engineering, contamination risk and microbiology
- The ins and outs of air-handling systems and airflow studies
- Building and validating isolators
- Selecting the proper disinfectants for cleanrooms
- Using the right cleanroom clothing
- Conducting proper environmental monitoring
However, there is more to cleanroom GMP than technical issues:
- Discover how to conduct cleanroom audits
- Learn best practices and systems you can rely on
- Understand the science behind contamination control.
It’s all in this single practical volume.
A work of this scope and authority calls for a global team of experts. Editors Tim Sandle and Madhu Raju Saghee draw on the talents of 19 specialists from the U.S., Europe and Asia, and contribute chapters of their own.
In 26 chapters, the book covers every aspect of cleanrooms, from basic standards and GMP requirements to innovations in cleanroom technology.
With proper guidance, your cleanrooms will transform from Achilles heel to strongest link in your drug manufacturing chain. Cleanroom Management in Pharmaceuticals and Healthcare is the tool to help you accomplish this.
Since the first edition of this book in 2013, there have been many changes to the approach and methods for cleaning and certifying cleanrooms, most notably the revisions to Parts 1 and 2 of the ISO 14644 series of global cleanroom standards. In addition to setting out the principal changes in these revised standards, many of the other chapters in the book have been updated to reflect their requirements, 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 involved in the operation and management of cleanrooms.
"A new edition of the comprehensive textbook on cleanrooms, edited by Tim Sandle and Madhu Raju Saghee, has been issued. The book remains an indispensable text for those involved with cleanroom management, whether microbiologists, cleanroom operators, engineers or facilities managers. The book is particularly useful in balancing practical approaches with robust engineering practice and scientific theory.
What is good about the book for the microbiologist is that it interweaves engineering design with things that microbiologists need to know, such as environmental monitoring; airflow studies; and cleaning and disinfection practices.
The new edition highlights several changes to the approach and methods for certifying cleanrooms. Most importantly, there is a comprehensive update in relation to the revised ISO 14644 cleanroom standard, parts 1 and 2. With this, numerous chapters have been updated to reflect the requirements of the new global standard. Of particular importance is the risk-based approach required for particle counting as part of environmental monitoring.
Other chapters have been updated with U.S., FDA, EMA, and ISO expectations, which includes environmental monitoring and rapid methods. 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.
Across the book, many of the authors share best practice guidance. In summary, this updated edition will prove an essential resource to all practitioners of operation and management of cleanrooms."
Victor Grayson, Pharmig, May 2017.