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November 2019

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Subject:
From:
Nilay Joshi <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 5 Nov 2019 21:56:03 +0530
Content-Type:
text/plain
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text/plain (293 lines)
Dear jovan,

Thank you for clarifying, i did refer TR 22 they have clearly mentioned it.
For strictly anaerobic environment residual oxygen concentration should be
less than 0.1%


Regards,
Nilay Joshi


On Tue 5 Nov, 2019, 21:31 Jovan Rankov, <[log in to unmask]> wrote:

> Dear Nilay,
>
> You should check the oxygen concentration in your final product. Ig it is
> less than 0,1 (I think) you should do a thio broth media fill once per
> year. And if you are gassing with nitrogen in routine production, you
> should do it in the media fillm too. That’s the whole point, simulating
> exact conditions occurring in routine monitoring. Check out the PDA TR 22.
>
> Kind regards,
>
> Jovan
> Microbiologist
>
>
>
>
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Forum Email List <
> [log in to unmask]> On Behalf Of Nilay Joshi
> Sent: Saturday, November 2, 2019 3:58 PM
> 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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> BD Industrial Media - http://www.bd.com/ds/
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> Boston Analytical http://www.bostonanalytical.com/
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> Associates of Cape Cod, Inc. - http://www.acciusa.com/
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> Steris - http://www.sterislifesciences.com/
>
> Charles River Laboratories - http://www.criver.com/
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> BD Industrial Media - http://www.bd.com/ds/
>
> Boston Analytical http://www.bostonanalytical.com/
>
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>
>
> =================================
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> the PMF, or the sponsors of the list.
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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Science Advisory Board https://www.scienceboard.net/

Steris - http://www.sterislifesciences.com/

Charles River Laboratories - http://www.criver.com/

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

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

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

Boston Analytical http://www.bostonanalytical.com/

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


=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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