ETO Sterility Requirements for FIM Clinical Study in Europe

D

deviceguy

#1
All,

My client wants to release product for an FIM clinical study in Europe. Is there a way to release the product without a validated sterile cycle? Can I release on a lot basis? What are the requirements?

thanks.
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Another quick "Bump" in case anyone here can help with this one. My Thanks in advance!
 
M

MIREGMGR

#4
Various gamma sterilization providers offer pre-packaged validated sterilization, where anything that fits within a box they provide and that conforms to a weight limit and certain material-type and localized-density boundaries will be processed and can be released based on their prior studies. There's a considerable amount of overkill involved to permit this highly nonspecific validation, so there are limits on the materials that can be processed in this manner without being excessively radiation damaged.

Or, you could explore other sterilization techniques, without EtO's constraints...if your product design and materials would be suitable.

I don't know of anyone offering a pre-packaged EtO sterilization process. Because of molecular flow requirements, validation almost always must be device configuration-class specific.

You could talk to your sterilization contractor about how fast you and they could develop a cycle validation. Or, perhaps they have an existing validation for a nearly identical product, and a rigorous analysis would show that your product and the validated product are sufficiently identical that your product could be conservatively adopted into that cycle with only some quick adoption testing.
 
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