Hi there,
Can someone help to advise me for below:
1. As according to ISO11135, how many EO certificate of sterilization is allowed per manufacturing lot?
The reason I am asking is because one sterilization cycle might not be able to complete one manufacturing lot.
2. In this situation, can the lot be partial released by cycle if result passed. Or the product lot can only be released after the completion of the whole sterilization process.
3. Another question is, can one cos contents few lots which sterilized in the same cycle.
Waiting for your advise. Appreciated.
Thanks!
Regards,
Lisa
Can someone help to advise me for below:
1. As according to ISO11135, how many EO certificate of sterilization is allowed per manufacturing lot?
The reason I am asking is because one sterilization cycle might not be able to complete one manufacturing lot.
2. In this situation, can the lot be partial released by cycle if result passed. Or the product lot can only be released after the completion of the whole sterilization process.
3. Another question is, can one cos contents few lots which sterilized in the same cycle.
Waiting for your advise. Appreciated.
Thanks!
Regards,
Lisa