Cleanroom Management inPharmaceuticals and Healthcare ISBN 978-1-899015-83-2

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INPHARMACE

UTICALS

ANDHEALTHCAR

E

Edited by Tim Sandle and Madhu Raju Saghee

Everything you need to know about the operationand management of cleanrooms

PRE-PUBLICATIONOFFER

Cleanroom 4pp leaflet 2012_Layout 1 20/11/2012 14:59 Page 1

www.euromedcommunications.com

Contents1. Introductionby Tim Sandle and Madhu Raju Saghee

2. History anddevelopment of cleanrooms by Tim Sandle

3. Cleanroom standardsand GMP requirementsby Mark Hallworth

4. Design and constructionof pharmaceuticalcleanroomsby Alexander Fedotov

5. Air handling systems forthe protection ofpharmaceuticalmanufacturing processesby Hans Schicht

6. Cleanrooms in hospitalsby Alexander Fedotov

7. Commissioning andqualification of cleanroomsby Kevin Beauchamp and Miroslav Tonovski

8. Cleanroom certificationand ongoing complianceby Tim Sandle andMadhu Raju Saghee

9. Fundamentals ofpharmaceutical isolators by Brian Midcalf, John Neiger andTim Sandle

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

11. Validation concepts inpharmaceutical asepticapplication isolators by Rajesh Thempadiyil

12. Risk-based product andoccupational exposurecontrol in multi-productfacilities by Julian Wilkins

13. Future of asepticprocessing by James L Drinkwater

14. Aseptic processsimulations/media fills by Marco Budini

15. Microbial riskmanagement during asepticmanufacture by Tim Eaton

16. Airflow studies andairflow mapping by Tim Sandle, Marco Budini andT Rajesh

17. Cleanroomcontamination sources andcontrol measures by Eric Strauss

18. Particle counters andparticle counting by Tony Harrison

19. Environmentalmonitoring in cleanroomsby Tim Sandle andMadhu Raju Saghee

20. Cleaning anddisinfection practicesby Tim Sandle andMadhu Raju Saghee

21. Cleanroom clothingby Matts Ramstorp

22. Quality assurance inhospital pharmacies by Richard Bateman

23. Building ManagementSystems for cleanroomprocess parametersmonitoring and controlby Sunil Chand Singhai andRajesh Thempadiyil

24. Energy management andsustainable cleanrooms by Nigel Lenegan andUlla Thomsen

25. Auditing cleanroomoperations by Tim Sandle andMadhu Raju Saghee

26. Developments incleanroom technology by Tim Sandle andMadhu Raju Saghee

Editors:Tim Sandle, Madhu Raju Saghee

Published by:

Passfield Business Centre, Lynchborough Road, Passfield,Hampshire GU30 7SBTel: 44 (0) 1428 752222 Fax: +44 (0) 1428 752223

In 26 chapters and over 600pages this book provides aunique tool to help youachieve regulatorycompliance. It first creates afoundation in history andestablished practice and thenhelps you understand howstate of the art technologyand engineering solutions candeliver the best practice andso provide reliable systemsperformance.

Wide application

Covers all aspects ofcleanroom operations forpharmaceutical cleanrooms,hospital pharmacies andresearch laboratories.

Expert advice

The chapters are written byacknowledged internationalexperts from companiesinvolved in every aspect ofcleanroom management,each providing practicaladvice and information.

International

The book includes guidanceto regulatory approaches andlegislation in Europe, Asia andthe USA

Cleanroom Management inPharmaceuticals and

HealthcareEditors: Tim Sandle and Madhu Raju Saghee

Foreword by Gordon J Farquharson

order online at www.euromedcommunications.com

“An essential read forpractitioners in

cleanroom technology”

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