Dear All,
I would like to validate effectiveness of a sterilization of a powder using radiation. The related standard (as this is a medical device part) is ISO 11137-1/-2. This standard is more for items than powders. I`m not sure how to calculate dose setting, dose mapping etc. At the end I`m looking for a best practice approach for process validation or a standard that better fits the scenario.
Any ideas?
Thanks
Carsten