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December 2003

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Subject:
From:
M Carroll <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 11 Dec 2003 09:25:59 EST
Content-Type:
text/plain
Parts/Attachments:
text/plain (133 lines)
I believe the Australian sterility test procedure requires inoculation of
the actual test canisters AFTER their full incubation is completed, and
if they fail to grow, the test is invalid. This isn't the concurrent
positive you're describing, but it's close.

M. Carroll
[log in to unmask]

On Wed, 10 Dec 2003 21:32:29 -0600 JAMES DONNELL
<[log in to unmask]> writes:
> 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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>


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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/
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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