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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:
Sat, 2 Nov 2019 20:28:29 +0530
Content-Type:
text/plain
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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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> > =================================
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> ------------------
> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
> The Microbiology Network (http://microbiologynetwork.com) and supported by
> our sponsors as a service to the scientific community.
>
> 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.
>

------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors as a service to the scientific community.

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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