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November 2019

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Subject:
From:
Robert Guardino <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 6 Nov 2019 16:52:55 -0500
Content-Type:
text/plain
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I do not believe that there is regulatory guidance regarding the use of
compressed air in place of nitrogen during media fills. PDA TR22 Process
Simulation  for Aseptically Filled Products makes the statement that you
are looking for, "*Nitrogen or other inert gases are used to provide a low
oxygen environment for oxygen-sensitive products. They are also used to
provide positive pressure for solution transfer. Nitrogen (or other gases)
for these uses does not provide a true anaerobic environment (less than
0.1% residual oxygen is needed for anaerobic conditions). In these
instances, filter sterilized air should be utilized in lieu of an inert gas
for process simulation studies. Air should replace the inert gas and be
delivered by the same delivery system thus assuring the purge/transfer
set-up and delivery considerations are fully considered in the simulation*
."

Robert F Guardino
MicroGuard Consulting
910-616-0066
[log in to unmask]
www.microguardconsulting.com




On Mon, Nov 4, 2019 at 9:32 AM Nilay Joshi <[log in to unmask]> wrote:

> 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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> >
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> >
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> >
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> >
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> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
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> 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
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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.
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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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