Each test battery performs a separate function,
i.e., the Microbial Limit Tests (MLT) define the amount and type(s) of
microorganisms intrinsic to both the equipment, materials of manufacture,
and any potential human contamination. It should be part included
as part of the finished product, batch-approval process.
The AET/PET on the other hand defines how
effective your preservative system works (i.e., during multiple-use
insults) and its stability (i.e., over the life of the product) in the
particular formula. It should be performed initially and at
specific timepoints during the product's shelf-life.
Bob Friedel
drugmicrobiology@comcast.net
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