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December 2015


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Sylvain Rousseau <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Tue, 1 Dec 2015 16:05:27 +0000
text/plain (70 lines)
Dear PMF members

With colleagues we are struggling how to interpret the Chapter <71< from USP

Let consider the following examples if a filled batch is made of 10 000 vials, each vials are filled at 0.7 mL.

How many vials are required to perform the sterility test according to USP <71> and do we need to pass half the content on each medium (TSB, FTM) ?

In order words do we need to use 40 vials;  The whole content of 20 of those vials will be used with TSB and another set of 20 vials and the whole content will be used with FTM


Can we used half of the content of 40 vials on TSB and the other half on FTM ?

Thank you for your help


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