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November 2019

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Subject:
From:
Timothy Cser <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 4 Nov 2019 17:07:49 +0000
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Hi Nilay.  Does your product support anaerobic growth?   Annex 1 talks about performing an anaerobic media fill if your aseptic process is anaerobic but I'm not sure if they mean the entire process is anaerobic, or just the final product.  Either way, if the product supports anaerobic growth, you may want to consider a yearly media fill study.  The common sense scientific argument is that if the production is performed in an aerobic environment, a strict anaerobe couldn't survive.  Organisms like Cutibaceterium acnes (formerly Propionibacterium) are aerotolerant and do exist on humans so perhaps giving it an anaerobic environment will allow it to thrive even if the aseptic process is aerobic.  A study may be in order.....

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Nilay Joshi
Sent: Saturday, November 2, 2019 7:58 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Media Fill

I do have one question regarding media fills,

During routine filling operations we are using nitrogen gas for purging but during we are substituting it with compressed air.

Many times auditor ask and we explain that media fill being a microbial growth detection study we are using compressed air to create a aerobic environment to facilitate growth of microorganisms if any.

Can anyone point out any regulatory guidence documents regarding this.


Thanking you,
Nilay Joshi

On Sat 2 Nov, 2019, 20:23 Joel Russo, <[log in to unmask]> wrote:

> I’ve personally seen more than one scheme that was adequate for the
> FDA and international agencies.  It needs to be qualified / validated however.
> Generally 7d at 20-25, followed by an additional 7d at 30-35 is a safe bet.
>
> Generally speaking, incubating nonselective media at a lower
> temperature first allows for stressed molds that would commonly be
> found in cleanroom environments to begin growing, while keeping human
> bourne flora surviving during that initial time period.  The higher
> temp then allows for sufficient proliferation of human borne flora to
> best assure that it could be detected adequately by the end of total incubation.
>
> Kind Regards,
> Joel Russo
>
>
> > On Nov 1, 2019, at 8:30 AM, Reuven Baum <[log in to unmask]> wrote:
> >
> > What  temperature do people use first in a media fill incubation
> > 20-25C
> or
> > 30-35C?
> > Is it important? Is there any rational for the choice?
> > I have seen conflicting statements in the literature.
> >
> > Reuven
> > QC Microbiology
> > Yavneh
> >
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