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November 2013

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Subject:
From:
Daniel Guntle <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 13 Nov 2013 12:29:11 -0800
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Hi Candice,

The minimum incubation time is most critical for when you are validating the method. Once you validate recovery at the minimum time, for the routine testing of the same material you can utilize the full period of incubation specified in the USP (18-24 hours in most cases). Yes the 18 hour minimum incubation time does force the microbiology lab to perform some extra planning but it can be done within the normal 8-5 work day. 

Thank You,

Daniel GuntleĀ 
Sr. Microbiology Manager
T: 949.951.4425 x 257 | F: 949.587.8435 
E: [log in to unmask] 

Irvine Pharmaceutical Services, Inc. 
www.irvinepharma.com|www.avriobiopharma.com 


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Candice Nurnberger
Sent: Thursday, November 07, 2013 6:58 AM
To: [log in to unmask]
Subject: [PMFLIST] usp 62 suitability: working odd Night hours???

Hi All-

I'm curious what others are doing to meet the requirement in USP 62 suitability testing of "minimum incubation time" being 18 hours after a 24 hour pre-incubation time.  
If your laboratory is not working around the clock hours, how are you meeting this (or are you NOT meeting this and finding it ok/reasonable?)  

Our laboratory is analyzing personal care/cosmetics for TAMC/TYMC and USP 62 organisms- we have a few OTC products (creams).  Guidance as it relates to an FDA GMP/GLP stance is much appreciated.

Happy to have this forum! Thanks a lot!

Candice Nurnberger
QC Microbiologist
Process Technologies & Packaging

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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.

------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors 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.


Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

ATS Labs - http://www.ats-labs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

MicroBioLogics, Inc. - http://www.microbiologics.com

Microtest Laboratories, Inc. - http://www.microtestlabs.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

Steris - http://www.sterislifesciences.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.

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