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Class 2 medical device - Process Validation - Test sterile or non-sterile units?

#1
For a process validation on a Class 2 medical device, should devices be tested sterile or non-sterile (Ethylene Oxide)?
(Product will be sterilized before going out to the end users. We have separate sterilization validation to prove that similar product is sterile.)

Before performing the PV tests, should the product be sterilized or not? In my experience at other companies, they generally did not sterilize PV units before testing since they made the argument that EO sterilization has minimal / no effect on most plastics & coatings OR they made the argument that "non-sterile" product was worst-case for the criteria they were testing for (low temp heating and wait time for EO sterilization further cross-links polymer chains in plastics / coatings / etc. ).

My current company has in the past done all their PV testing on sterilized product. I am trying to see if I can convince them to not require sterilization of PV units.
OR
Should I go along with my company's precedent of sterilizing PV units and then testing?
 
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yodon

Staff member
Super Moderator
#3
I got a little lost. Process validation is separate from device testing. If you're talking about process validation (some aspect of manufacturing whose outputs are not / cannot be 100% verified) then what is the normal 'input' to the process? Is it a sterilized device? Would seem unlikely but I can see where there could be cases. If so, as you note, sterilization CAN have an effect on materials which can then impact the process / validation. If the normal input is, indeed, sterilized product, then you would at least have to justify why non-sterile product is used / does not impact validation.
 
#4
PV - Process Validation
Test I'm referring to is friction testing of a hypdrophillic coating on a catheter. I'm trying to see if we should be doing the friction test on sterilized catheters or if we can do it on unsterilized catheters.

"Input" to the coating process is an uncoated unsterile catheter. Catheter gets coated. Catheter gets sterilized. Catheter gets shipped to customer.

I think if I can justify that the pre-sterile coating performance is "worst-case" before sterilization, then we can make the case we want to test on unsterile product. Since sterilization lowers / reduces the coating friction (assuming coating vendor has data that supports that).
 

yodon

Staff member
Super Moderator
#5
That makes sense if you can, indeed, get data to support that assertion. I would expect it would need to be pretty tight; i.e., same materials, same sterilization process (and parameters), etc.
 
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