Sunday, 7 September 2014

Cleanroom Management in Pharmaceuticals and Healthcare



Cleanroom Management in Pharmaceuticals and Healthcare

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.

An essential read for practitioners in cleanroom technology: engineers, microbiologists, quality assurance, healthcare practitioners and pharmaceutical professionals.

For further details see: cleanrooms

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

Published by Euromed

Posted by Tim Sandle