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May 2006


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"merideth, curtis" <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Tue, 16 May 2006 12:02:55 -0500
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After inoculating our samples we serial dilute and plate each dilution
out to 10^-5.  For a category 3 product, that requires 1 log reduction
from initial for bacteria, do I need to show microbial recovery at the
first dilution for a "validation"?  Or if I can just demonstrate
recovery at the 10^-3 dilution would that be acceptable, since that
would show if the 1 log reduction was met?  Would that still meet the
second criteria of no increase from 14 to 28 days, assuming there isn't
any recovery at all in the actual testing?  Thanks for your help.
Curt Merideth
Fleming & Company

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