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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
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Tue, 26 Nov 2013 08:37:21 -0500
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Is there a rationale in the USP for doing the 'worst case scenario'?  .. 
is there anything that forces you to incubate to the maximum of the time 
interval cited?  I know the argument but .........



Alfonso Albert <[log in to unmask]> 
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11/25/2013 04:48 PM
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Re: [PMFLIST] usp 62 suitability: working odd Night hours???






Candice, The worst case escenario is Test for Salmonella 18hrs, 18 hours 
and 18 hours again. We put the enrichment broth in at 10:00 pm first day, 
second day out at 4:00pm in 4:30pm,  3rd day out at 10:30am in at 11:00 am 
and read plate next day at 5:00am. Pain in the ...but found no other way 
to comply. 
 
hope this helps. 


________________________________
From: Candice Nurnberger <[log in to unmask]>
To: [log in to unmask] 
Sent: Thursday, November 7, 2013 9:58 AM
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 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

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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.


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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

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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.

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