Industrial microbiologists: what do you do when Prep Testing for
a pharmaceutical product does not validate your ability to
recover the test species, despite addition of sorbate, lecithin,
attempts at membrane filtration, etc.? If the product is so
inhibitory, does it make sense to run microbial analysis on it in
the first place. Or more importantly, can any one predict the
Agency's interpretation of this oxymoron (microbial limits on an
antimicrobial product/ingredient)?
