USP Microbial Limits Prep Test

ATG 76235.2473 at CompuServe.COM
Sun Nov 19 12:01:32 EST 1995


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)?



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