Tuesday, 30 August 2016

Contamination Control in Healthcare Product Manufacturing, Volume 4


A new edition of Contamination Control in Healthcare Product Manufacturing has been published. This is volume 4.

Contamination Control in Healthcare Product Manufacturing, Volume 4, edited by Russell E. Madsen and Jeanne Moldenhauer, is primarily focused on microbiological contamination and the methods used to monitor and control it, a secondary focus looks at chemical contamination that may result from the use of cleaning and disinfecting agents. There is something for almost everyone who has responsibility for developing or using microbiological contamination control programs and systems.


Edited by experts and written by global subject matter professionals, this vital addition to the Contamination Control series offers new chapters covering current, relevant information including:

Regulatory changes relative to ISO 14644, Parts 1 and 2
Updates to ISO 11737-1
Risks of spores including preventive measures and disinfection
Utilities, surfaces and practices that impact cleanrooms
Cleanroom gowning and behavior
Regulatory guidance and how-to relative to handwashing
Contamination in water systems
Contamination in gaskets, drains, cooling systems and many other problem areas
And more including chapters covering Monitoring relative to USP <1116>, control limits, excursions, risk-based big data in aseptic processing and methods for effective use of Maldi-Tof

Tim Sandle has contributed two chapter to volume 4:

Sandle, T. (2016) ISO 14644 Parts 1 and 2 - The revised cleanroom standard and contamination control. In Madsen, R. E. and Moldenhaurer, J. (Eds.) Contamination Control in Healthcare Product Manufacturing, Volume 4, DHI, River Grove, USA, pp3-32

Sandle, T. (2016) Risk of microbial spores, prevention measures and disinfection strategies. In Madsen, R. E. and Moldenhaurer, J. (Eds.) Contamination Control in Healthcare Product Manufacturing, Volume 4, DHI, River Grove, USA, pp59-95

For details see: PDA

Posted by Dr. Tim Sandle

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