USP Guidances on Environmental Control including related USP, FDA, EMEA & PDA Activities – Free PDF download




A New Reality?

“It is not possible to maintain a manufacturing environment that is sterile.
In any environment where human operators are present microbial contamination is inevitable.
Best clean room environment design and operating practices cannot prevent the shedding
of microorganisms into the environment by human operators.
Thus, an expectation of zero contamination at all locations during every aseptic processing
operation is technically wrong and unrealistic.”

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Manostaxx – Industrial Management Consulting

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