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December 2003

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From:
Paula Cannella <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 17 Dec 2003 10:17:52 -0500
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To answer I need you to clarify. Step 1 reduces the Bioburden. 5 log
independent of other steps, Steps 2 reduces the Bioburden 4 log
independent of other steps and so forth? How did you determine the
individual steps log reduction values? If you saw a 1 log reduction
within each step then you would report 5 log for the overall process.
This would be assuming that you started with one sample with a given
Bioburden of X and the drop (log reduction observed) continue 1 log from
samples pulled prior to each continuing step. If the log reduction
evaluations were done independently for each of the steps you might have
to state something differently such as a combined Log Reduction of 15.
This does not represent the start to finish affect of your process
however.

If the 5,4,3,2,1 numbers represent the log value observed at the
completion of each step, then again it would be a 5 log reduction for
the process since 5 log recovery was observed after step 1, 4 log after
2, and so forth.

I am not sure if this helps! My 2-cents worth.

Paula
-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Chad Ronholdt
Sent: Tuesday, December 16, 2003 4:36 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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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/
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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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