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PMFLIST  October 2005

PMFLIST October 2005

Subject:

Re: Sterility Test Isolator Requalification

From:

James Rickloff <[log in to unmask]>

Reply-To:

The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>

Date:

Wed, 12 Oct 2005 13:20:05 -0400

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (255 lines)

Hi Scott,

I don't see a need to heat shock unless you are verifying the vendor's
spore count. Isolator sterilants are not heat processes so there is no
need to remove spores that are weak in terms of being heated to a
certain temperature for a defined period of time. There should be a
minimal number of vegetative organisms on the stainless BI.

Regards,

Jim Rickloff
Partner / Principal Scientist
Advanced Barrier Concepts, Inc.

-----Original Message-----
From: Drummond, Scott [mailto:[log in to unmask]] 
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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International - http://www.ntint.com Raven Biological Labs -
http://www.ravenlabs.com Veltek Associates, Inc - http://www.sterile.com





-----------------------------------------
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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.

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

Accugenix - http://www.accugenix.com/
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

=================================
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.

------------------
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.

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

Accugenix - http://www.accugenix.com/
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

=================================
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.

------------------
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.

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

Accugenix - http://www.accugenix.com/
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

=================================
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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