P
Philipp
Hello everyone,
I work in quality management for a medical device company and we produce class 3 implants. We have products which are gamma-sterilizied as well as products which are EO-sterilized.
My question is about the bioburden testing of the products.
- Do I have to do a bioburden testing for each batch?
- Or is there the possibilty to do some kind of process validation to reduce the frequency to 3 times a year for example?
- Is there a difference between gamma and eo sterilization?
- Does it makes a difference if the products are for the us or the european market?
At the moment we have some discussion with the production department about quality testing and costs, therefore it would be very helpful for me if you can also name the relevant regulations.
Thank you very much
Philipp
I work in quality management for a medical device company and we produce class 3 implants. We have products which are gamma-sterilizied as well as products which are EO-sterilized.
My question is about the bioburden testing of the products.
- Do I have to do a bioburden testing for each batch?
- Or is there the possibilty to do some kind of process validation to reduce the frequency to 3 times a year for example?
- Is there a difference between gamma and eo sterilization?
- Does it makes a difference if the products are for the us or the european market?
At the moment we have some discussion with the production department about quality testing and costs, therefore it would be very helpful for me if you can also name the relevant regulations.
Thank you very much
Philipp
Last edited by a moderator: