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October 2005

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Subject:
From:
Ravi Talluri <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 12 Oct 2005 10:06:49 -0600
Content-Type:
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We verify our BI's with population verification and compare to manufacturer's population. We had issue's meeting manufacturer's population because their procedure include longer sonication, even then we are not that close. It is always a good idea to verify the population before using the BI's.

Ravi Talluri


Isolator Product Sterility Study Director,
Nelson Laboratories, Inc.
6280 South Redwood Road
Salt Lake City, UT  84123
Phone: 801-963-2600 X9175
Fax:      801-963-2630
www.nelsonlabs.com

>>> [log in to unmask] 10/12/2005 6:40:32 AM >>>
Scott:
Knowing the high variability in the population quantification of BIs based on test method, I asked the BI vendor for their population verification test method, which they provided.

The test method included sonication and heat shock.

Garry Schmitt
Cardinal Health
[log in to unmask] 

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]]On Behalf Of Drummond, Scott
Sent: Tuesday, October 11, 2005 5:53 PM
To: [log in to unmask] 
Subject: Re: [PMFLIST] Sterility Test Isolator Requalification


A question to the group

As an in house check for BIs that are being used for Isolator Qualification
are you...

Performing a heat shocked count on spores 
or
Counting total viable organisms?

Thanks 
Scott 

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]]On Behalf Of Ravi Talluri
Sent: Monday, October 10, 2005 2:23 PM
To: [log in to unmask] 
Subject: Re: [PMFLIST] Sterility Test Isolator Requalification


I agree that the initial validation is extensive. We pe
Garry,

I agree that the initial validation is extensive. We perform 6months
maintenance/calibration and annual re-validation. For re-validation you do
not need to include everything from the initial qualification, if you show
that the isolator is still performing the way it was performing when the
initial qualification was performed then I think that's sufficient. May be
include some BI's and CI's and show you are getting the same results as your
initially validated cycle.

Ravi Talluri


Isolator Product Sterility Study Director,
Nelson Laboratories, Inc.
6280 South Redwood Road
Salt Lake City, UT  84123
Phone: 801-963-2600 X9175
Fax:      801-963-2630
www.nelsonlabs.com 

>>> [log in to unmask] 10/10/2005 11:55:21 AM >>>
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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Dupont Qualicon - http://www.qualicon.com 
EMSL Analytical, Inc. - http://www.emsl.com 
Genomic Profiling Systems, Inc. - http://www.genprosys.com 
Microcheck Inc,  Microbial Analysis Laboratory - http://www.microcheck.com 
MicroTest World Class Services - http://www.microtestlabs.com/ 
MIDI, Inc. - http://www.midi-inc.com/ 
Millipore - http://www.millipore.com/ 
NovaTek International - http://www.ntint.com 
Raven Biological Labs - http://www.ravenlabs.com 
Veltek Associates, Inc - http://www.sterile.com 

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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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ATS Laboratories - http://www.ats-labs.com 
Biolog - http://www.biolog.com 
Biomerieux - http://industry.biomerieux-usa.com/ 
Dupont Qualicon - http://www.qualicon.com 
EMSL Analytical, Inc. - http://www.emsl.com 
Genomic Profiling Systems, Inc. - http://www.genprosys.com 
Microcheck Inc,  Microbial Analysis Laboratory - http://www.microcheck.com 
MicroTest World Class Services - http://www.microtestlabs.com/ 
MIDI, Inc. - http://www.midi-inc.com/ 
Millipore - http://www.millipore.com/ 
NovaTek International - http://www.ntint.com 
Raven Biological Labs - http://www.ravenlabs.com 
Veltek Associates, Inc - http://www.sterile.com 

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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

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Biolog - http://www.biolog.com
Biomerieux - http://industry.biomerieux-usa.com/
Dupont Qualicon - http://www.qualicon.com
EMSL Analytical, Inc. - http://www.emsl.com
Genomic Profiling Systems, Inc. - http://www.genprosys.com
Microcheck Inc,  Microbial Analysis Laboratory - http://www.microcheck.com
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI, Inc. - http://www.midi-inc.com/
Millipore - http://www.millipore.com/
NovaTek International - http://www.ntint.com
Raven Biological Labs - http://www.ravenlabs.com
Veltek Associates, Inc - http://www.sterile.com

=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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