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May 2006

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Subject:
From:
Neil LORIMER <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 1 May 2006 10:05:17 -0500
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I have seen that some suggest that the probe should be placed in Glycerol
to damp out the fluctuations and better simulate what the stored materials
temperature is.  Certainly this is a validid approach that many use.
However I would say it depends on what you are trying to monitor, the
temperature of materials or the temperature of the refrigerated
environment.  The problem with placing the probe in Glycerol or other
liquid is that you have a delay in detecting changes in the enviromental
temperature that in some cases may make it difficult to troubleshoot any
problems that may be occuring.  Normally this is not of serious concern but
on occassion it does cause problems.

If you are using chart recorders to monitor the process I would say that
placing the probe in a tube filled with Glycerol or other liquid is the
best approach since you have limited ability to detect changes in the
process in real time (since you can't have someone watching the charts all
of the time).  In such cases someone normally checks the chart for
deviations on a periodic basis.

However if you are using some type of continuous monitoring system it may
be better to monitor the temperature of the environment to more quickly
detect when problems may occur in real time.  Such systems usually have
multiple levels of alarms that allow you to handle temperature fluctuations
in other ways.  For example we have a system that signals that the system
is deviating from the desired range in real time, but it does not log it as
a deviation unless the deviation occurs for X time or outside of limits
that are set to detect either rapid changes in conditions or outside of
ranges that would indicate a severe failure.  This allows us to more
rapidly respond to any potential problems, gives us information about what
the systems are doing in real time, yet does not require us to respond to
fluctuations that are normal to the process.



Neil Lorimer
Senior Validation Engineer
bioMérieux, Inc. - INDUSTRY
Tel: 630.628.6055 Ext. 529
Fax:630.628.9893
[log in to unmask]


                                                                                                                                  
                      Melanie Strong                                                                                              
                      <mstrong@COOKPHARM        To:       [log in to unmask]                                             
                      ICA.COM>                  cc:                                                                               
                      Sent by: The              bcc:                                                                              
                      Pharmaceutical            Subject:  [PMFLIST] Refrigerator/Cold Room Temperature Monitoring                 
                      Microbiology Forum                                                                                          
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                      <[log in to unmask]                                                                                          
                      ROBIOL.ORG>                                                                                                 
                                                                                                                                  
                                                                                                                                  
                      04/28/2006 03:39                                                                                            
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                      The Pharmaceutical                                                                                          
                      Microbiology Forum                                                                                          
                      Email List                                                                                                  
                                                                                                                                  
                                                                                                                                  




We are a new contract pharmaceutical manufacturer and are in the process of
qualifying our lab equipment, including laboratory refrigerators (2-8°C).
When mapping the temperature distribution of the units (using remote data
loggers) both empty and full, we are experiencing temperature fluctuations
beyond our acceptable range (barley below 2°C in certain locations).  It
was suggested that the temperature of the media and not the air itself was
the critical factor that must remain in the temperature range, and the data
loggers should be placed in the outermost layer of double bagged stacks of
media in order to better simulate the temperature exposure of the media
itself.  When the unit was mapped again under these conditions, the
temperature fluctuations were minimized and all the data fell within the
acceptance criteria.  My concern is once we install our temperature
monitoring probe from the chart recorder in the "worst case location," we
will constantly fluctuate out of range since this probe will be exposed to
the air flow and not covered.



I am curious how others in the pharmaceutical industry are monitoring their
cold spaces (fridges, cold rooms, etc...).  Are temperature monitoring
probes routinely placed in some sort of substance (mannitol, WFI, or
other), or are they left exposed to direct air currents?



Any insight would be greatly appreciated.



Thanks!

Melanie







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

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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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