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May 2020


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"Sattelberg, Nicholas" <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Tue, 12 May 2020 22:48:40 +0000
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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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