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?
Lead Scientist, Microbiology
Catalent Pharma Solutions e-mail is for the designated recipient only and may contain privileged, proprietary, or otherwise private information. If you have received an e-mail in error, please notify the Catalent sender immediately and delete the original. Any other use of the e-mail by you is prohibited.
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors as a service to the scientific community.
Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]
Science Advisory Board https://www.scienceboard.net/
Steris - http://www.sterislifesciences.com/
Avista Pharma Solutions http://www.avistapharma.com
Charles River Laboratories - http://www.criver.com/
Veltek Associates, Inc - http://www.sterile.com
Microbiologics, Inc. - http://www.microbiologics.com
Nelson Labs - http://www.nelsonlabs.com
BD Diagnostic Systems - http://www.bd.com/ds/
Boston Analytical http://www.bostonanalytical.com/
Associates of Cape Cod, Inc. - http://www.acciusa.com/
The nature of this service is to provide a medium for communication. The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.