Guidelines that specify the frequency of ETO Sterilizer Re-Validation

I

ISO MAN

#1
Dear All,
Does any one has come across any guideline that specify the frequancy of the re-validation of the ETO sterilizer. Some of the notified auditor in my country is saying that you can extend the revalidation period up to three years.

Thanks
 
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J

Jimmy the Brit

#2
I have not come across any guidelines, however I insist on annual physical qualification using an appropriate PCD load (to demonstrate stability of the sterilization process), accompanied by a document equivalency review to demonstrate that the bioburden has no shifted significantly in terms of absolute numbers and the presence of spore forming contaminants; and then a bi-annual microbiological requalification, also using a PCD for each product family. I don't believe an annual micriobiological revalidation is a realistic tearget as it is so onerous and labour intenive.

I believe that the frequency you choose must be based on stability of the bioburden on your product - if you cannot demonstrate that, then you have no way of justifying a longer revalidation interval. However IMHO, three years does not sound unrealistic, as long as you can justify it this way.

Jimmy
 
M

MIREGMGR

#3
We use a base/maximum interval of three years in our EtO sterilization protocol, subject of course to FDA and ISO 11135 (12.3 Requalification) requirements upon any significant process or product changes.

That three year parameter has been accepted by past FDA inspectors, major OEM customers' auditors, our ISO 13485 registrar, and of course our sterilization contractor. However, I know of no specific regulatory foundation for that interval, therefore we are subject to a determination at any time by one of our regulatory-environment participants that a shorter interval is required.
 
B

Bug Killer

#4
See AAMI 11135-2 part 12.3.2 and 12.3.2

A review of the validation process must be done every year and a micro-requal must be done every two years.
 
P

phoexix

#5
you should review the sterilization process annual,

and every two years a reduced microbiological requalification is recommended.

see the interpretation in charpter 12 of ISO11135-2:2008
 
D

dejanew

#6
And, just as a watch out, if you have equivalent chambers, then each chamber has to be evaluated according to a documented planned schedule. We have chambers that are equivalent and each year we perform a review and a micro requalification in one chamber and a review on the other. This is, of course, if there are no changes in the product/packaging.
 
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