Microbial challenge procedure

If parameters for the package design under consideration are established through PO, however, and adequate care is taken to ensure aseptic procedures for sterility testing, package microbial challenge testing can be effective. 

Sterilization validation procedures thus should rely primarily on the results of appropriately designed microbial challenge studies, with physical... 

With drug products containing preservatives, the stability protocol should include preservative efficacy testing. Microbial challenge testing should be conducted at appropriate intervals—at least once a year unless significant losses are observed earlier as a result of assay procedures. 

Aerosol Challenge. At the risk of oversimplifying the procedural demands of microbial testing, here is a summary of how a microbial challenge/product sterility test is performed. There are two types of whole-package microbial barrier tests currently in use. 

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