Microbial Limits Prep Test

Eric Strauss microbes at dialup.netvision.net.il
Sat Jan 13 22:03:50 EST 1996

ATG <76235.2473 at CompuServe.COM> wrote:

>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)?

If you have tried all the tricks up your sleeve, including all those mentioned 
in sec.<61> itself, and any "inventive" ones you can think of, you could have 
a pretty good case for relying on the end part of that section (..the product 
is likely not to be contaminated we the organism..). You don't get a complete 
out, for you are still required to investigate other organism to build a 
spectrum of inhibition. Since we all know that the FDA does not hold the USP 
to be holy writ,to be on the safe side you may want to repeat some off your 
validation work using methods described in the FDA's BAM. I don't think it 
will make any diff, but they may be happier. 
One final note, you should try asking the FDA themselves what they think, they 
have been trying to put themselves at our dissposal of late (hard to believe 

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