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December 2003

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Subject:
From:
Anthony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 16 Dec 2003 12:08:59 -0500
Content-Type:
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Scott,
I am not a supporter of bulk sterilization of media fill material.
There a serious heat transfer and mixing issues with this procedure
unless you have specialized equipment.

Was there differences in color or pH in the media fill containers from
the beginning of the fill? If it was sanitizer contamination I would add
sterile pads soaked with the medium to a plate inoculated to grow a lawn
of the Bacillus subtilis to demonstrate a zone of inhibition.
Alternately you can autoclave tubes of the media for increasing lengths
of time to determine if heat damage is the cause.

Tony

>>> [log in to unmask] 12/16/03 11:20AM >>>
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 scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
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Accugenix - http://www.accugenix.com/
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Veltek Associates, Inc - http://www.sterile.com

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