Hello Min,
What specifically are you calibrating?
We utilize type T premium thermocouples as single point monitoring for
internal chamber conditions. The t/c's are calibrated annually at points
20C apart including an ice point at 0C and report values into an
electronic monitoring system. The t/c's are removed from the chamber
interior during recalibration and product remains within the chamber
during activity. The calibration generally takes less than two hours to
complete.
A chamber operating at 5C would require the monitoring t/c to be
calibrated at -20C, 0C and 20C for instance. A stability chamber
operating at 40C would have its monitoring t/c calibrated at 0C, 20C,
40C and 60C to encompass possible excursion events to ensure reliable
data.
The chamber itself is re-qualified with contents remaining in an "as
found" condition through provision of thermal mapping techniques to
ensure internal temperature uniformity. GE Sensing, Inc offers equipment
for thermal mapping or you can develop a program using electronic data
loggers. Empty and simulated full qualifications are performed as part
of the initial operational qualification effort before product is stored
within. It is theoretically possible to qualify a chamber at a multitude
of temperature ranges but of course the validation effort would need to
be more robust to be defendable.
Recommended reading: Handbook of Stability Testing in Pharmaceutical
Development: Kim Huynh-Ba, Editor. It contains a section on chamber
validations that will answer most questions.
I hope this helps a little.
Sincerely,
David
-----Original Message-----
From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Min He
Sent: Tuesday, November 08, 2011 2:16 PM
To: [log in to unmask]
Subject: [PSDGLIST] Question regarding stability chamber calibration
Hi there,
I would like get your input regarding stability chamber calibration.
Usually, how many calibration setpoints would you calibrate against
to? Does your SOP allow single point calibration (verification) so
that you do not need empty the chambers each time?
Thanks,
Min
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Stability Environments, Inc., an affiliate of Solar Light Company, Inc.
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High quality controlled environmental walk-in rooms and reach-in
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Full installation, validation and spare parts also available
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
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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.
Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
High quality controlled environmental walk-in rooms and reach-in chambers
Full installation, validation and spare parts also available
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
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