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October 2005

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Subject:
From:
"Hewitt, Jackie" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 10 Oct 2005 13:55:21 -0400
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text/plain
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Garry,

We quandered the same question, but decided that, as you say, as everything
was extensively validated initially, the isolators and VHP generator are
under 6 month preventative maintenance/calibration protocols, there should
be no need to perform regular re-validation, except if something changes in
our usage or there were significant repairs or alterations to the system.

Jackie Hewitt
Microbiology Manager
Luitpold Pharmaceuticals
PO Box 9001, Shirley, NY 11967-9001
Tel. (631) 205-2321
Fax. (631) 205-2375
e-mail: [log in to unmask]
 


-----Original Message-----
From: Schmitt, Garry [mailto:[log in to unmask]] 
Sent: Monday, October 10, 2005 12:41 PM
To: [log in to unmask]
Subject: [PMFLIST] Sterility Test Isolator Requalification


To those who are using isolators for sterility testing:

I'm interested in learning if those who use isolators for sterility testing,
if after full validation, the isolators are requalified on a regular basis.
Assuming the isolator is on a PM program and calibrated on a routine basis,
is requalification conducted?  If so, what frequency is used and what
parameters are requalified?

Regards,

Garry Schmitt
Cardinal Health
[log in to unmask] 

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