Stability and sterility testing and dating

Could recent guidance from FDA leave such testing in the past?Schneider wrote that “microbiological evaluation of medical device packages and packaging material will produce meaningful results only if relevant test methods are carefully selected and implemented.FDA officially accepts physical integrity testing in lieu of microbial-challenge testing for whole packages Testing the ability of a package to maintain product sterility has often been a dirty job. Engineers have stuck a whole package into a microbe-laden bath or overwrap and then tested either the product or a growth medium inside to see whether microbes had penetrated the package.These methods and others were described in Philip Schneider’s “Microbiological Evaluation of Package and Packaging-Material Integrity,” in the May 1980 issue MD&DI.

Results: No microbial growth was observed throughout the 14-day period.

Presence of endotoxins in a compound is evidence of a current or previous contamination.

Removal of endotoxins requires a specialized filtration system, and they are not removed by 0.2um filters used to sterilize compounded medications.

Using such methods has not been foolproof, however.

Some users have reported a high number of false positives.

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