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December 2003

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Subject:
From:
Russ Nyberg <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 18 Dec 2003 09:22:58 -0600
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Chad,  Your manufacturing process has demonstrated a 5 Log reduction.
Russ

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Chad Ronholdt
Sent: Tuesday, December 16, 2003 3:36 PM
To: [log in to unmask]
Subject: [PMFLIST] Addition of Log Reduction Values


Greetings forum members,

My question relates to whether or not it is acceptable to add individual
microbial log reduction steps from a multiple step process into a
cumulative log reduction for your entire process. For example, I have a
manufacturing process that has 5 steps with worse case microbial log
reductions of 5, 4, 3, 2, 1, respectively. Therefore, is my overall log
reduction for the entire process 15 logs or is it simply the greatest
log reduction demonstrated by the first step--5 logs?

I have an issue with reporting the 15 log value since that would
indicate my manufacturing process would produce a "sterile" product with
some level of assurance. Clearly, this isn't the case since I use a
terminal sterilization step to obtain the sterile label claim and I have
positive sterility cultures from time to time prior to sterilization.

Any comments or suggestions on how to report the efficacy of my
manufacturing process would be helpful. Thanks.

Regards,
Chad

Chad J. Ronholdt, MBA
Scientific Affairs Manager
AlloSource
6278 S. Troy Circle
Centennial, CO 80111
Ph: 720.873.4782
Fax: 720.873.0212
[log in to unmask]






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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.
AAI - http://www.aaiintl.com/Micro.htm
Accugenix - http://www.accugenix.com/
Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
Microcheck - http://www.microcheck.com/
MIDI, Inc. - http://www.midi-inc.com/
Microbial ID, Inc. - http://www.microbialid.com/
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI Labs, Inc. - http://www.midilabs.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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