Cleanroom contamination can arise from a number of sources. Most contamination within the pharmaceutical facility can be traced to humans working in cleanrooms. The paper discusses staff gowning and personnel behavior in pharmaceutical cleanrooms, and how cleanroom risk can be minimized. The human skin ecosystem is discussed. Tim Sandle has written a new book chapter:
The Human Microbiome Project (HMP) from the US NIH characterized microorganisms found in association with both healthy and diseased humans. Information from this project has great impact on cleanroom activities including gowning practices. Topics associated with cleanroom garments are discussed including fabric types, garment lifespan, recycling, laundering, human changing procedures, training, behavior, hand sanitization, ongoing assessments, and associated topics.
The reference is:
Sandle, T. (2018) Personnel Monitoring for Controlled Environments. In Masden R. E. and Moldenhauer, J. M. (Eds.) Contamination Control in Healthcare Product Manufacturing, Vol.5, pp357-400
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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