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December 2002

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Fri, 6 Dec 2002 08:48:24 -0500
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Amol,

If ,
this would meet the FDA requirement for a three log decrease in endotoxin
challenge, then it would meet the requirements of depyrogenation.  You must
have valididated the unit with three separate runs bracketing the minimim
and maximum load sizes.  You also must have thermocouple data indicating any
cold spots and calibrate all measuring equipment to a NIST standard.

The PDA has a  technical report that covers hot air depyrogenation issues.


Steven G Richter Ph.D.
President and Scientific Director
Microtest World Class Testing Services
www.microtestlabs.com
----- Original Message -----
From: "Amol Palaskar" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Friday, December 06, 2002 6:25 AM
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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