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April 2000

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Subject:
From:
"Balkovic, Ed" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 27 Apr 2000 14:49:39 -0400
Content-Type:
text/plain
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You are not alone, we have also run into thermophilic Actinomyces in
sterilization failures.
Our IDs have been based on morphology and growth characteristics.

Ed Balkovic, PhD
QC Micro Tech Support
Genzyme Corporation
(T)  508-271-3660
[log in to unmask]





-----Original Message-----
From: mcc [mailto:[log in to unmask]]
Sent: Thursday, April 27, 2000 10:00 AM
To: [log in to unmask]
Subject: [PMFLIST] Thermophilic Mold


THIS is a real, genuine cry for help.
During revalidation studies of sterilization processes, we have begun
encountering positives, which are NOT B. stearothermophilus or any other
bacteria-- they are a MOLD, source and type unknown. This thing grows ONLY
at elevated temperatures (55 C), and best on TSA (much more slowly and
poorly on SAB). Visually, it appears whitish and without aerial mycelia;
microscopically, it is small, and resembles either Rhizomucor or Actinomyces
(colonies look more like Actinomyces).
SEVERAL QUESTIONS:
1) Who, in reference labs, academia, or industry, is equipped to do work on
such organisms, such as identification and/or "D-value" studies?
2) Is there any body of literature and/or scientific forum out there, which
would support any claim that a sterilization process, aimed at generating
Fo's of 24 and above, would be adequate to obliterate such an organism and
its spores?
   TIME is of the essence-- all replies and assistance gratefully
appreciated. THANKS in advance--
  M.Carroll ([log in to unmask])


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