After inoculating our samples we serial dilute and plate each dilution
out to 10^-5. For a category 3 product, that requires 1 log reduction
from initial for bacteria, do I need to show microbial recovery at the
first dilution for a "validation"? Or if I can just demonstrate
recovery at the 10^-3 dilution would that be acceptable, since that
would show if the 1 log reduction was met? Would that still meet the
second criteria of no increase from 14 to 28 days, assuming there isn't
any recovery at all in the actual testing? Thanks for your help.
Fleming & Company
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
American Type Culture Collection - http://www.atcc.org
ATS Laboratories - http://www.ats-labs.com
Biolog - http://www.biolog.com
Biomerieux - http://industry.biomerieux-usa.com
Dupont Qualicon - http://www.qualicon.com
EMD Chemicals - http://www.emdchemicals.com
EMSL Analytical, Inc. - http://www.emsl.com
Genomic Profiling Systems, Inc. - http://www.genprosys.com
MIDI, Inc. - http://www.midi-inc.com
Millipore - http://www.millipore.com
Pall - http://www.pall.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.