Hello Patrick:
I am not aware of any official guidelines or technical reference with regard
to industry standards. However, there may be validation packages from
chamber manufacturers.
I faced the same issue of lack of references in this area before, thus I had
asked Mr. Jack B. Davis to write a book chapter on this topic for the
Stability Handbook. (You might have known Jack as a Stability long-timer.)
Chapter 14 was written specifically for stability chambers, and here, he did
provide some recommendations of placements of the temperature as well as
humidity probes for different qualification phases. The last section also
discussed monitoring, alarms and how to handle excursions. This chapter is
not lengthy, but quite concise. I just thought you might be interested.
Here is the reference again: "Handbook of Stability Testing in
Pharmaceutical Development: Regulations, Methodologies and Best Practices",
(ISBN 978-1441927569).
Hope this helps!
Warm regards,
Kim.
__________________________
Kim Huynh-Ba
[log in to unmask]
-----Original Message-----
From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Patrick Forenzo
Sent: Tuesday, May 17, 2011 3:10 PM
To: [log in to unmask]
Subject: [PSDGLIST] Humidity Mapping
Can someone point me to a guideline or technical reference as to number and
placement of humidity measurement devices to be used for mapping of a reach
in chamber- I have seen where companies have placed devices in all 4 corners
+ the center of each shelf and other companies just place devices in the
center of each shelf and still other companies map just 2 locations
- is there an industry standard that can be referenced for placement, time
interval of data points and length of collection time ?
Best regards, Mit freundlichen Grüssen, Meilleures salutations, Patrick
Forenzo Novartis Pharmaceuticals Corporation
PDU4 Team 2
Fellow / Stability Expert
USEH, 401-128B
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
USA
Phone: +1 862 7786690
Email : [log in to unmask]
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High quality controlled environmental walk-in rooms and reach-in chambers
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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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