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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:
Thu, 14 May 2020 13:18:55 +0000
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Hi Michael/Tim,

I haven't done any work yet with this product, I was just looking over documentation that bad been provided for previous suitability work. I do know that this is a suspension and the particle size is 1 - 3 microns, so that would rule out filtration. 

I have been wondering if since the antimicrobial activity is based on Bismuth, if any neutralization steps used for mercury would be a good candidate? I am guessing it's the Sodium Thiosulfate in the D/E broth that is likely providing the most "neutralization". 

Nick Sattelberg
Group Leader, Microbiology
   

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of [log in to unmask]
Sent: Thursday, May 14, 2020 7:32 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] USP <71> neutralizer validation vs alternate sterility method

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Can the product be filtered?

Michael



Sent from my iPhone
> On May 14, 2020, at 1:26 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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