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December 2009

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Pharmaceutical Stability Discussion Group <[log in to unmask]>
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Mon, 7 Dec 2009 14:48:38 +0000
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Hi Roy,

We set the limits for humidity at +_ 5% as per ICH guidelines. If we set 
the spec controllers too tight or within the limits of ICH, then we would 
have the problem of the cabinet alarming and shutting down when the 
conditions are within spec.

Regards
Ann



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[PSDGLIST] Humidity chamber calibration limits






 

I was wondering what everyone used as 
Hi everyone,

 

I was wondering what everyone used as their calibration limits for 
humidity linked to their stability chambers?

 

I am using a  1.0%RH limit for the Relative Humidity Transmitter, the 
Relative Humidity Controller and the Chart Recorder Humidity, but am 
wondering whether this is too tight.

 

Thanks for your help!

 

Roy

 

 

Roy McIntyre

Senior Manager, Stability & Quality Control Systems

24 Ivey Lane, PO Box 2880

Windsor, Nova Scotia

B0N 2T0

 



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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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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.

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