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Sterilisation ISO 11135 EtO-in-a-Bag (Novel Non-Traditional EtO Sterilization)

A

amooney

#11
As I say - best to look at the hospital paper as a starting point for those not familiar with flexible chamber technology.

The Andersen flexible chamber systems (Anprolene, Series 3 and Series 4) do NOT inject EtO into product packages. The flexible chamber is NOT part of the product packaging.

Andersen, and others, DO make EtO sterilization systems that inject EtO into product packages. The Andersen system is called Sterijet. Even for Sterijet, validations would stil lbe done in accordance with ISO11135 as applicable, as it is the nearest applicable standard available. There is an NWIP out with ISO TC 198 which is specifically applicable to flexible chanber systems and this may well include Sterijet in due course.
 
Elsmar Forum Sponsor
#12
Any update on this topic? Have any of you ( device manufacturer) got this process accepted with FDA or Notified Bodies or other authorities? If yes, which ISO standard did you use to validate the process?
 

planB

Super Moderator
#13
FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" from 2016 classifies flexible bag sterilization as "Established Category B" according to section IV.A.2

There is also AAMI TIR56:2013, "Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices".

Hope this helps,
 
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