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December 2003

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Subject:
From:
"SHARON L. WOOD" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 16 Dec 2003 08:48:26 -0800
Content-Type:
Text/Plain
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Text/Plain (113 lines)
Scott,
The only time I had failures of growth promotion, it was due to metal
contamination of the medium. In one case it was an aluminum alloy, in
another it was oxidation from a mixing vessel. The runs were short, so I don
t know if the medium has the ability to recover.  

In both my cases, the ability of gram positive organisms to grow were
affected, other challenge organisms were OK.  

When the contaminating metal was replaced or removed, growth promotion
passed.  

 Sharon Wood
Pharmaceutical Microbiology Consulting
[log in to unmask]

-------Original Message-------
 
From: The Pharmaceutical Microbiology Forum Email List
Date: Tuesday, December 16, 2003 08:23:52
To: [log in to unmask]
Subject: [PMFLIST] Request for Help on Media Fill GPQ
 
Here is an interesting case study I have been asked to post anonymously:
 
Two aseptic filling lines:
   Line A - Product is filtered sterile immediately before aseptic filling
   Line B - Product is bulk sterilized (heat) and then aseptically filled
 
The problem:
    Filled bottles (Line B) from the beginning of the run fail GPQ for B
subtilis (and continue to fail on subsequent challenges of additional
units).
 
Background:
    Bulk media from both lines pass GPQ for all organisms
    Filled units from the end of the run (Line B) pass GPQ
    Filled units from Line A always pass GPQ, no matter from beginning or
end
of run
    Both media fills used same manufacturer's lot of TSB
    CIP is validated
    No evidence of sanitizers can be found in the media filled bottles.
 
================
 
When I first saw this question I thought that the CIP was suspect, but have
been assured that all is in place, and there is no evidence of residual
sanitizer being washed off the equipment into the filled units. Next
thought was that they had baked the TSB too much to support B subtilis (Line
B remember is sterilized in bulk by heat). If so, then why do samples from
the bulk and the end of the fill run support growth? Unfortunately, there
are no retains from the different sampling events to evaluate.
 
BTW - all other organisms used for GPQ (based on Sterility Test B/F plus
environmental) were fine.
 
Anyway, I held this post a couple of days to get the above clarification.
Does anyone have any ideas?
 
Scott Sutton
Moderator, PMFList
 
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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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