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November 2018

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Subject:
From:
"Sattelberg, Nicholas" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 30 Nov 2018 15:15:04 +0000
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Hello,

In the past we have always followed the guidance in USP <71> tables 2 and 3 for number of samples to test per batch and volume from each sample to be tested. These requirements seem to be pretty black and white.

I have come across a couple instances where clients already have methods in place that do not adhere to these requirements. One example: 10 mL vials, 1 mL from each of 20 vials pooled and filtered through a Steritest canister set. In this instance not even close to half the contents of each vial are being tested per media.

I understand antibiotic products have a 1 mL minimum test volume, but this does not apply in the situations I've encountered. I've worked with difficult products in the past where a limited amount could be filtered, in those instances we had to increase the total number of filters used (multiple TSB or FTM containers per sample) to still meet USP requirements.

Besides antibiotics, are there any other instances where it could be justified to not use the minimum volumes listed in USP? Am I missing something?

Nick Sattelberg
Lead Scientist, Microbiology



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