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December 2003

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Subject:
From:
"Prinzi, Sam" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 15 Dec 2003 10:35:20 -0500
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Dawn
We got around this issue by adding the word "minimum" of 2,3...or 7 days to
our SOP's.
This way if you can't read them on that day you can read them the next day.
FDA has not had any issues with this.

Sam Prinzi
Genzyme Biosurgery
QC Unit Manager of Microbiology
Office (617) 761-8722
Fax (617) 252-9909


-----Original Message-----
From: McCabe Dawn D [mailto:[log in to unmask]]
Sent: Monday, December 15, 2003 10:08 AM
To: [log in to unmask]
Subject: [PMFLIST] incubation time question???


Hello,
I submitted water samples for bioburden analysis to a contract laboratory.
The plates were to be read at 3 and 5 days of incubation.  Day 5 fell on a
Sunday.  The technician removed the plates from the incubator on Saturday
(Day 4) and placed them in the refrigerator (2 to 8 deg C) until Monday
morning, and then returned them to the proper incubation temperature to
continue the final day of incubation.  The thinking was that no one would be
there to read the plates on Day 5, so it was better to place them under
refrigeration for 24 hrs and then reincubate and obtain "Day 5" results. I
have never heard of this practice.  I would like to know if anyone has heard
of doing this, is it acceptable?

Thank you in advance for your help.

Dawn M. McCabe, RM(NRM)

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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/
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Millipore - http://www.millipore.com/
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Raven Biological Labs - http://www.ravenlabs.com
Veltek Associates, Inc - http://www.sterile.com

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