ETO Annual review

#1
Hi,

we need to do our annual review for ETO in 2021. We havent requalified in 2019 and 2020 as there were no changes. As per requalification decision tree, do we have to perform reduce qualification in 2021 as we havent re-qualifed in the last couple of years? We performed a review and this year too, there are no changes.

Please advise if we have to perform reduced Qualification ? and what cycles are required for reduced qualification.

Thanks,
Bala
 
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planB

Super Moderator
#2
Bala,

have a look into ISO11135:2014, section 12.3.2 - quote:
Requalification of a sterilization process carried out with specified equipment shall be performed at defined intervals against specified acceptance criteria and in accordance with documented procedures. These intervals shall be justified.
and associated informative guidance in section D.12.3.3 - quote:
[...] This would typically include, minimally, one fractional or half cycle exposure including load temperature and humidity measurements [...] at least every two years [...]. Requalification can also include [...] that product meets allowable limits for EO residuals as specified in ISO 10993-7.
HTH,
 
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