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EFHSS Questions and Answers - Answer to Question Q00713

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EFHSS - Questions & Answers - Quality Assurance - Q00713
Revalidation 		Follow Up
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From: (Singapore)   Date: 7 January 2005, 06:16 [GMT]
Subject: Revalidation

Hi,

we are a manufacturer of sterile medical device and we have validated our steriliser with ref. to en 550. we need to revalidate the sterilization process this yr, can u highlight the min. requirements in revalidating the cycle. we use a "curve construction method" in the original validation, do I need to run the empty and humility(conditioning) cycle again in this validation.

In the original cycle we run at 0, 5, 10, 20 7 40 min for the microbial performance vali. can we jus run the 40min(kill time) for this revalidation.

appreciate yr comments. thanks

Jason
From: Miki   Date: 8 January 2005, 20:16 [GMT]
Subject: Re: Revalidation

Jason.
It is difficult to answer you a "2005 answer" if your approach is based on a "1994 approach" (EN 550 issue date)
Are you aware that EN 1422, concerning ETO Sterilizers was published in 1997? EN 556-1 was issued in 2002, and ISO/EN 17665 (is intended to replace EN 550) reflect the appropriate approch. The last one is an excellent guidance.
miki
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