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December 2002

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The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Wed, 11 Dec 2002 09:35:27 -0500
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Dear Amol;

180C for 3 hours is the minimum time and temperature requirement for
thermal destruction of lipopolysaccharide.  In order to meet the regulatory
requirements for validation of depyrogenation, you must demonstrate a three
log reduction of an endotoxin challenge.  Many people choose to validate
ovens at a higher temperature for a shorter time period.  Our company has
chosen to validate the "worst case" of 180 degrees for 180 minutes.  

Feel free to contact me if you have further questions or are looking for a
source of depyrogenation indicators or literature references.

Best regards,

Laurie Fife

Laurie Fife
Manager, Technical Services
Associates of Cape Cod and Seikagaku America
(800) 848-3248, ext. 2252
<http://www.acciusa.com>


-----Original Message-----
From: Amol Palaskar [mailto:[log in to unmask]]
Sent: Friday, December 06, 2002 6:26 AM
To: [log in to unmask]
Subject: [PMFLIST] Depyrogenation DHS


Dear Forum Members,

If the Depyrogenation cycle of 180C for 3 hours in a Laboratory Dry heat
steriliser is validated using the Endotoxin challenge,  will it comply the
regulatory requirement?

With thanks & regards,
-Amol Palaskar


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