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ETO Product Sterilisation Testing Standard Requirements

T

Tiffany

#1
hi folks,

My company products will send out for ETO sterilisation, and this sterlisation will be subcontractor. Now we are in the stage to look for a competence and qualified ETO sterilisation sub-con.

What is the product testing i need to carried out during and after the sterlisation?

What is the standard that should be comply to instead of EN ISO 10993-10 and EN ISO 10993-5 & EN ISO 11135?

Tiff
 
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G

Gert Sorensen

#2
Re: ETO Sterilisation

hi folks,

My company products will send out for ETO sterilisation, and this sterlisation will be subcontractor. Now we are in the stage to look for a competence and qualified ETO sterilisation sub-con.

What is the product testing i need to carried out during and after the sterlisation?

What is the standard that should be comply to instead of EN ISO 10993-10 and EN ISO 10993-5 & EN ISO 11135?

Tiff
You will need to have the process validated with you products according to EN550. The validation is normally the responsibility of the subcontractor, but you shall provide them with items for the validation and approve protocols before and after validation. Take notice, the responsibility for the sterilization of the products is yours, so you need to be absolutely sure that they will be sterile after the process.
 
R

Roland Cooke

#3
Re: ETO Product Sterilisation Testing Standard

You need to validate that the product will continue to work as intended after being exposed to the sterilisation, and that no new hazards or risks have been introduced as a result of the sterilisation process.

You need to justify the shelf-life of the device, which is presumably based on the packaging sealing validation. This tends to be done by a combination of reliance on the packaging supplier's performance evidence, together with accelerated aging studies (supported by real-time studies in the background).

Additionally you will probably want to perform a risk management exercise to determine the follow-up to a failed/interrupted sterilisation cycle. Can the product tolerate re-sterilisation, or will you destroy all product?

If the former, your validations need to be done on repeat-sterilised product of course.
 
R

Roland Cooke

#4
Re: ETO Product Sterilisation Testing Standard

Additionally there is a need to perform testing to confirm the levels of ETO residuals are below the specified limits.
 
X

X.Liu

#5
Re: ETO Product Sterilisation Testing Standard

You need ISO 11135-1: 2007 and ISO 10993-7:2008. I am not sure how long EN 550 will stand. I think EN 550 is or will soon be reissued as EN ISO 11135.
 
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