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Subject:
From:
Margo Hunt <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 11 Dec 2003 10:40:23 -0500
Content-Type:
text/plain
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text/plain (137 lines)
As to your question, if the positive control is not positive, this
indicates that the medium is not not satisfactory for growth.
Therefore, all negatives, including sterility checks, cannot be
validated.  Check NELAC standards, the EPA Office of Water's drinking
water laboratory certification manual (it has just been revised and may
not be out in print yet, therefore contact [log in to unmask]), and
Standard Methods.




                      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
                      Microbiology Forum
                      Email List
                      <[log in to unmask]
                      .LSOFT.COM>


                      12/10/03 10:32 PM
                      Please respond to
                      The Pharmaceutical
                      Microbiology Forum
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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/
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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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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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