- Language: English
- Published: January 2013
- Region: United States
Cleanroom Management in Pharmaceuticals and Healthcare
- Published: February 2013
- Region: Global
- 598 Pages
- Euromed Communications
This book is essential for anyone associated with the cleanroom industry.
In 26 Chapters and approx 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.
Captures in a single volume all aspects of cleanroom operations – from how to select disinfectants to conducting airflow studies, and from commissioning cleanrooms to building isolators. The book also embraces pharmaceutical cleanrooms, hospital pharmacies and laboratory clean air devices.
Editors: Tim Sandle and Madhu Raju Saghee
Chapter 1: Introduction by Tim Sandle and Madhu Raju Saghee
Chapter 2: History and Development of Cleanrooms by Tim Sandle
Chapter 3: Cleanroom Standards and GMP Requirements by Mark Hallworth and Madhu Raju Saghee
Chapter 4: Design and Construction of Pharmaceutical Cleanrooms by Alexander E Fedotov
Chapter 5: Air Handling Systems for the Protection of Pharmaceutical manufacturing Processes by Hans H Schicht
Chapter 6: Cleanrooms in Hospitals by Alexander E Fedotov
Chapter 7: Commissioning and Qualification of Cleanrooms by Kevin Beauchamp and Miroslav Tonovski
Chapter 8: Cleanroom Certification and Ongoing Compliance by Tim Sandle and Madhu Raju Saghee
Chapter 9: Fundamental of Pharmaceutical Isolators by Brian Midcalf, John Neiger and Tim Sandle
Chapter 10: The Choice of Isolator: A Risk-Based Decision by Didier Meyer
Chapter 11: Validation Concepts in Pharmaceutical Aseptic Application Isolators by Rajesh Thempadiyil
Chapter 12: Risk-based product and Occupational Exposure Control in Built-Product facilities by Julian Wilkins
Chapter 13: Future of Aseptic Processing by James L Drinkwater
Chapter 14: Aseptic process Simulations/Media Fills by Marco Budini
Chapter 15: Microbial Risk Management During Aseptic Manufacture by Tim Eaton
Chapter 16: Airflow Studies and Airflow Mapping by Tim Sandle, Marco Budini and Rajesh Thempadiyil
Chapter 17: Cleanroom Containment Sources and Control Measures by Eric Strauss
Chapter 18: Particle Counters and Particle Counting by Tony Harrison
Chapter 19: Environmental Monitoring in Cleanrooms by Tim Sandle and Madhu Raju Saghee
Chapter 20: Cleaning and Disinfection practices by Tim Sandle and Madhu Raju Saghee
Chapter 21: Cleanroom Clothing by Matts Ramstorp
Chapter 22: Quality Assurance in Hospital Pharmacies
Chapter 23: Building management Systems for Cleanroom process Parameters Monitoring and Control by Sunil Chand Singhai and Rajesh Thempadiyil
Chapter 24: Energy management and Sustainable Cleanrooms by Nigel Lenegan and Ulla Thomsen
Chapter 25: Auditing Cleanroom Operations by Tim Sandle and Madhu Raju Saghee
Chapter 26: Developments in Cleanroom Technology by Tim Sandle and Maju Raju Saghee
"The most up-to-date and all-embracing publication covering the complete aspects of cleanroom management within the pharmaceutical and healthcare industries"
"Contains all the necessary information in the one publication".
- Enda McKeon, Elanco, Ireland
"Highly recommended for the shelf of any cleanroom manager, engineer, microbiologist or quality assurance manager. It is indeed the indispensable guide to cleanrooms and cleanroom management"
- Victor Grayson, Sterility Assurance Office, Bio Products
*NOTE: Please see 'Download Free Sample' section for full reviews