Hi Nick.  I don't know of any customers using D/E Broth in a classical USP 71 method.  That chapter specifically designates TSB and FTM as the media with the possibility of adding neutralizers for penicillin or cephalosporin.

Can you dilute or neutralize the product prior to adding the media?

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Sattelberg, Nicholas
Sent: Tuesday, May 12, 2020 3:49 PM
To: [log in to unmask]
Subject: [PMFLIST] USP <71> neutralizer validation vs alternate sterility method

Hello All,

I am curious how far removed from the validated method in a USP General micro chapter you need to before you can really no longer reference the chapter, and instead would call it an "alternate method".

I have a product that needs a sterility method suitability performed. It is an antimicrobial suspension (not a true antibiotic, it's based on Bismuth), and I was sent some sterility suitability work that had been done by a different lab previously. They ended up using a modified D/E broth as the final growth medium (direct inoculation), instead of FTM and TSB. At that point, is it still even appropriate to reference USP <71>?

I haven't done any work with this yet so I'm hoping we can get something else to work, but I am wondering if we go down the same path, would this have to be fully "validated" as an alternate sterility method?

Nick Sattelberg
Group Leader, Microbiology



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