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March 2016

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Subject:
From:
Uday Bhatambarekar <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 25 Feb 2016 07:52:41 +0530
Content-Type:
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Would you please share your company's practice regarding 'humidity' mapping
during the OQ/PQ of new or existing chambers. Does your company map
humidity or just temperature?
I would also like to know what the industry standard is regarding:
Type of equipment, probes uses
Number of probes per cubic foot
Placement of probes
Pass/fail criteria?  How much tighter than ICH +/- 5% does the test method
require?

Uday Bhatambarekar

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BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Cincinnati Sub-Zero - http://www.cszindustrial.com/
   Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.

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