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December 2009

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Subject:
From:
Himanshu Jain <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Tue, 8 Dec 2009 10:09:45 -0500
Content-Type:
text/plain
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text/plain (154 lines)
Hi there,

We have set the humidity limits as per ICH guidelines i.e. +/- 5% and have
more leeway by setting the calibration limits to +/- 2.5%.

Hope it will be of help to you.

Himanshu

On Mon, Dec 7, 2009 at 6:51 PM, Bob Kirsch <[log in to unmask]> wrote:

>        This is probably too tight since the ICH limits for humidity
> measurement is +/- 5%. I would give yourself as little more leeway by
> increasing the overall chamber calibration limits to +/- 3%. The limits, of
> course, should be based on the manufacturer specifications as well as your
> own observations derived from the chamber performance qualification
> studies.
> You would not want to set the limits so tight as to result in failure and
> frequent system alarms, but you do want to be significantly below the 5%
> limit so as not to result in deviations and the questioning of the accuracy
> and reliability of your stability results based on questionable humidity
> data.
>
>     Bob K.
>
> Robert Kirsch, Ph.D.
> Of: 847-818-8633, Cell: 847-909-1721
> Fax: 847-818-8714
> E-mail: [log in to unmask]
>
>
>
>
> -----Original Message-----
> From: Pharmaceutical Stability Discussion Group
> [mailto:[log in to unmask]] On Behalf Of
> [log in to unmask]
> Sent: Thursday, December 03, 2009 9:43 AM
> To: [log in to unmask]
> Subject: [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.
>
> ------------------
> 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
>



-- 
Himanshu Jain
Phone: 00-1-416-8459203
Fax: 00-1-832-3838124
Email: [log in to unmask] / [log in to unmask]

=================================
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

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