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.
Chad J. Ronholdt, MBA
Scientific Affairs Manager
6278 S. Troy Circle
Centennial, CO 80111
[log in to unmask]
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.
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