Monday, 16 February 2015

Understanding and Monitoring the Personnel Factor

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 behaviour in pharmaceutical cleanrooms, and how cleanroom risk can be minimized. The human skin ecosystem is discussed.

This important subject is the basis of a new paper by Tim Sandle for the Journal of GXP Compliance.

The abstract runs:

“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. 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. (2014) People in Cleanrooms: Understanding and Monitoring the Personnel Factor, Journal of GXP Compliance, 18 (4): 1-5

For further details, see: IVT

Posted by Tim Sandle