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Cleanroom Management in Pharmaceuticals and Healthcare Product Image

Cleanroom Management in Pharmaceuticals and Healthcare

  • Published: February 2013
  • Region: World
  • Euromed Communications Ltd

"An essential read for practitioners in cleanroom technology”

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.

Wide application

Covers all aspects of cleanroom operations for pharmaceutical cleanrooms, hospital pharmacies and research laboratories.

Expert advice

The chapters are written by acknowledged international experts from companies involved in every aspect of cleanroom management, each providing practical advice and information.

International

The book includes guidance to regulatory approaches and legislation in Europe, Asia and the USA

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 (authors to be confirmed)

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

10. The choice for 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 Thompson

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

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

Editors: Tim Sandle and Madhu Raju Saghee
Foreword by Gordon J Farquharson

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