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MICROBIAL CONTROL STANDARDS FOR ASEPTIC PROCESSING

This article was originally published in The Gold Sheet

Executive Summary

...are being reviewed by the pharmaceutical industry to make sure they reflect the risk of product contamination. At recent public meetings, concern has been expressed about current expectations for environmental monitoring and isolator control, in particular. Industry experts are questioning the tendency to treat environmental data as a product release criterion and the application to the data of chemistry-type out-of-spec investigation procedures. Regarding filling-line isolators, the view is that there is room to loosen certain aseptic processing standards in view of the better sterility assurance achieved. Industry surveys show that isolator usage continues to grow and that campaign run times are expanding to maximize efficiencies. [A response by FDA compliance officials to common industry questions on isolator usage is included.]
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