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December 2009

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Pharmaceutical Stability Discussion Group <[log in to unmask]>
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Mon, 30 Nov 2009 12:23:54 +0000
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Dear Terry,

In the past, if a major componment such as a refrigeraton unit was 
replaced, we would have carried out  a mini re-qualification on the unit. 
such as a 24hour of temperature and RH mapping using nine calibrated 
probes situated at various points within the cabinet.

Kind regards
Ann




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[PSDGLIST] Betr.: [PSDGLIST] Requalification of chambers after repairs






Dear Terry,

Since the shape of the stability chamber did not change I would suggest 
that you donīt need to perform a total requalification.
Calibration of controllers and a check if the settings are still the same 
as before should be sufficient.

Fred Molenaar
Supervisor Quality Control
Teva Pharmachemie
Phone +31 (0)23 5147837
Fax      +31 (0)23 5147314
E-mail:  [log in to unmask]
www.tevapharmachemie.com




"Geiger, Terry" <[log in to unmask]> 
Verzonden door: Pharmaceutical Stability Discussion Group 
<[log in to unmask]>
18-11-2009 23:29
Antwoord a.u.b. aan
Pharmaceutical Stability Discussion Group <[log in to unmask]>


Aan
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Cc

Onderwerp
[PSDGLIST] Requalification of chambers after repairs






Dear All,

I looked in the archives for this subject but wasn't able to find what I 
was looking for.  I was wondering how other companies approach this. 

When major repairs are conducted on a chamber does this require a 
re-qualification or limited re-qualification?  These major repairs would 
be replacing controllers, replacing refrigeration components and 
refrigeration gases.

Thanks for your time


Terry Geiger M.S.
Senior Research Associate 
 Formulation Development
(970) 212-4804 x4831 
(970) 482-9735 (fax) 
 
Reckitt Benckiser Pharmaceuticals, Inc. 
2579 Midpoint Dr. 
Fort Collins, CO  80525 
www.reckittbenckiser.com 



 
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The PSDGList (http://microbiol.org/psdglist.htm) is operated from The 
Microbiology Network (http://www.microbiol.org) 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.

Bahnson Environmental Specialties - http://www.eschambers.com/

Veriteq Instruments - http://www.veriteq.com/

Vectech Pharmaceutical Consultants, Inc - http://www.vectech.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 PSDG, or the sponsors of the list.

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The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) 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.

Bahnson Environmental Specialties - http://www.eschambers.com/

Veriteq Instruments - http://www.veriteq.com/

Vectech Pharmaceutical Consultants, Inc - http://www.vectech.com

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