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?
(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?