Environmental Monitoring Handbook for Pharmaceutical Manufacturers: Volume 1

[Article Title]

Set appropriate alert and action limits. That is what the regulation says, and that is as specific as it gets. The number is yours to choose and yours to defend in front of an inspector. Getting there means separating classification from monitoring, two exercises many programs still blur, and knowing what your instruments are actually measuring. This handbook starts at the ground floor, from how a particle counter sees a particle to why the common assumption that decompression sterilizes your process gas has been tested and does not hold.

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