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December 2003

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Subject:
From:
William Miele <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 11 Dec 2003 10:18:41 -0500
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To All

Comments on the two points below;

1)  There is no requirement to do media fills using thioglycollate media.
Soybean casein medium is typically used since it is regarded as a general
purpose media and has the capability of recovery of most microorganisms
potentially found in a controlled filling environment.  There is mention in the
Aseptic Guideline and in USP <1116>of the potential  need to utilize an
anaerobic medium should there be reasonable cause, i.e, recovery of organisms in
the thioglycollate medium of sterility tests.  If there is no history then there
is no cause.  A sound approach to microbiological control of manufacturing /
filling environments showing good control will also be evidence to support not
using and anaerobic medium.  The rationale being, aerobic organisms predominate
in a "clean" aerobic environment.  Control aerobic microbes and anaerobic should
not be a problem

2) The use of a perpetual positive control is not necessary and may actually
have some risk associated with it. If you growth promote your media and have a
solid sterility test validation program (BSFS) there is no need to run
continuous positive controls.

Bill
~~~~~~~~~~~~~~~~~~~~~~




                      JAMES DONNELL
                      <james.donnell2@VER        To:       [log in to unmask]
                      IZON.NET>                  cc:
                      Sent by: The               Subject:  Re: [PMFLIST] media fill using thioglycollate medium
                      Pharmaceutical
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                      12/10/2003 10:32 PM
                      Please respond to
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Kuel and forum,

I have seen this issue arise in the past.  USP says something like "...a
general growth medium such as soybean casien digest medium..." (TSB) "... is
sufficient...".  I guess it would also depend on your resident microflora
from your EM program.  I can't imagine getting a 483 for not doing a media
fill with FTM.

I have a question too:  Has anyone ever read a sterility test procedure
which directs a perpetual positive control (ala growth promotion w/ <100cfu)
which is incubated along with the article under test AND if the positive
controls don't indicate positive, the sterility test is invalid?

Please reply,


JD


----- Original Message -----
From: "Kuehl" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Wednesday, December 10, 2003 7:46 AM
Subject: [PMFLIST] media fill using thioglycollate medium


> Dear list,
>
> did someone of you perform media fills using thioglycollate medium or
> was soybean-casein-medium mostly sufficient?
>
> Any comments on it ?
>
> Thanks in advance,
>
> Henning
>
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Please take a second to visit our sponsors' web sites and say thank you for
their support of this service.
AAI - http://www.aaiintl.com/Micro.htm
Accugenix - http://www.accugenix.com/
Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
Microcheck - http://www.microcheck.com/
MIDI, Inc. - http://www.midi-inc.com/
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MicroTest World Class Services - http://www.microtestlabs.com/
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Millipore - http://www.millipore.com/
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Raven Biological Labs - http://www.ravenlabs.com
 Veltek Associates, Inc - http://www.sterile.com

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The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.
AAI - http://www.aaiintl.com/Micro.htm
Accugenix - http://www.accugenix.com/
Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
Microcheck - http://www.microcheck.com/
MIDI, Inc. - http://www.midi-inc.com/
Microbial ID, Inc. - http://www.microbialid.com/
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI Labs, Inc. - http://www.midilabs.com/
Millipore - http://www.millipore.com/
NovaTek International - http://www.ntint.com
Raven Biological Labs - http://www.ravenlabs.com
Veltek Associates, Inc - http://www.sterile.com

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