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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 14 May 2020 18:31:11 -0400
Content-Type:
text/plain
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Tim is quite right. In terms of recovery and equivalency to (71) D/R broth
would be a poor choice.

On Thu, May 14, 2020, 1:28 AM Timothy Cser <[log in to unmask]>
wrote:

> 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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Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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