PMFLIST Archives

December 2003

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
"Daniel L. Prince" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 17 Dec 2003 19:04:48 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (104 lines)
HI Chad,
Your overall reduction will be less than or equal to the number of organisms
inoculated. To calculate log reduction at a given interval do log n(0)-log
n(i), where n(0) is the initial bioburden and n(i) is the number  of
organsims recovered after the process interval. It is not possible that you
can demonstrate a log redcuton  greater than the  initial amount of
organsims present.
Sincerely,

Daniel Prince, Ph.D.
Gibraltar Laboratories, Inc.
122 Fairfield Road
Fairfield NJ 07004-2401
973-227-6882 x519
www.gibraltarlabsinc.com
----- Original Message -----
From: "Chad Ronholdt" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Tuesday, December 16, 2003 4:35 PM
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]
>
>
>
>
>
>
> ------------------
> 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
>

------------------
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

ATOM RSS1 RSS2