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December 2003

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Subject:
From:
De Matteo Walter <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 16 Dec 2003 18:36:02 +0100
Content-Type:
text/plain
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text/plain (111 lines)
Scott,
1) What temperature is for GP for B. subtilis? Did they follow EP (30-35
░C), or USP (20-25 ░C). In case, have they tried the other one?
2) Where did they sample the bulk? Directly from the tank, or close to the
filling? 
3) Have they tried to perform a GP on other units, let's say, after 200-300
units from the beginning (it depends on the volume of the transfer line)? 
If they have sampled from the tank and just after the beginning everything
is OK, I would say that you are right when you suppose that there is
something wrong with the CIP.

Hope this helps,

Walter 


-----Messaggio originale-----
Da: Scott Sutton [mailto:[log in to unmask]]
Inviato: martedý, 16. dicembre 2003 17:21
A: [log in to unmask]
Oggetto: [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 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/
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Microcheck - http://www.microcheck.com/
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MicroTest World Class Services - http://www.microtestlabs.com/
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NovaTek International - http://www.ntint.com
Raven Biological Labs - http://www.ravenlabs.com
Veltek Associates, Inc - http://www.sterile.com

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