Cleanroom Management in Pharmaceuticals and Healthcare Edited by Tim Sandle and Madhu Raju Saghee.

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Cleanroom Management in Pharmaceuticals and Healthcare

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Edited by Tim Sandle and Madhu Raju Saghee.


Everything you need to know about the operation and management of cleanrooms.

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.

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.

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


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Contents

1. Introduction
by Tim Sandle and Madhu Raju Saghee

2. History and development of cleanrooms
by Tim Sandle

3. Cleanroom standards and GMP requirements
by Mark Hallworth

4. Design and construction of pharmaceutical cleanrooms
by Alexander Fedotov

5. Air handling systems for the protection of pharmaceutical manufacturing processes
by Hans Schicht

6. Cleanrooms in hospitals
by Alexander Fedotov

7. Commissioning and qualification of cleanrooms
by Kevin Beauchamp and Miroslav Tonovski

8. Cleanroom certification and ongoing compliance
by Tim Sandle and Madhu Raju Saghee

9. Fundamentals of pharmaceutical isolators
by Brian Midcalf, John Neiger and Tim Sandle

10. The choice of isolators: A risk-based decision
by Didier Meyer

11. Validation concepts in pharmaceutical aseptic application isolators
by Rajesh Thempadiyil

12. Risk-based product and occupational exposure control in multi-product facilities
by Julian Wilkins

13. Future of aseptic processing
by James L Drinkwater

14. Aseptic process simulations/media fills
by Marco Budini

15. Microbial risk management during aseptic manufacture
by Tim Eaton

16. Airflow studies and airflow mapping
by Tim Sandle, Marco Budini and T Rajesh

17. Cleanroom contamination sources and control measures
by Eric Strauss

18. Particle counters and particle counting
by Tony Harrison

19. Environmental monitoring in cleanrooms
by Tim Sandle and Madhu Raju Saghee

20. Cleaning and disinfection practices
by Tim Sandle and Madhu Raju Saghee

21. Cleanroom clothing
by Matts Ramstorp

22. Quality assurance in hospital pharmacies
by Richard Bateman

23. Building Management Systems for cleanroom process parameters monitoring and control
by Sunil Chand Singhai and Rajesh Thempadiyil

24. Energy management and sustainable cleanrooms
by Nigel Lenegan and Ulla Thomsen

25. Auditing cleanroom operations
by Tim Sandle and Madhu Raju Saghee

26. Developments in cleanroom technology
by Tim Sandle and Madhu Raju Saghee

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