PSDGLIST Archives

December 2009

PSDGLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Doug Gackstetter <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Tue, 8 Dec 2009 17:02:06 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (22 lines)
I think we are confusing range with accuracy.  The ICH humidity requirements 
of +/- 5% are for an acceptable range (35 - 45 %RH and 55 - 65 %RH) for 
stability testing of materials.  

When we are looking at the instrumentation we should be as tight as is 
reasonable.  Since the requirement is in whole numbers, an accuracy of +/- 
1% for the Transmitter, Controller and Chart Recorder Humidity is the right 
answer.

=================================
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.

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

ATOM RSS1 RSS2