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:
For further details, see: IVT
Posted by Tim Sandle
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