Suzanne ,
In your case there should be no requirement for clean steam; if there is a
requirement documented anywhere it is completely an illogical , unscientific
and downright stupid regulation/requirement. Your process is based upon
straight heat transfer through the glass to the fluid within your "sealed"
container which will immediately be handled with non-sterile hands upon exit
from the autoclave.
Claude Anger
Director
Pharmaceutical Microbiology
(714) 246-4533
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 -----Original Message-----
From:   Randall, Suzanne [mailto:[log in to unmask]]
Sent:   Monday, May 14, 2001 11:44 AM
To:     [log in to unmask]
Subject:        [PMFLIST] clean steam/terminal sterilization

I am looking for some help on an internal debate we are currently having.
Is clean steam required for moist heat terminal sterilization of a closed
vial?  There is no product contact since it is a crimped vial.

Thank you in advance for your answers.

Suzanne Randall
Sr. Scientist
PerkinElmer Life Sciences
331 Treble Cove Road
Billerica, MA 01862
(978) 671-8137
[log in to unmask]


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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.