E
engineer0129
Hi everyone-
What is the typical lead time for a quarterly dose audit of a gamma sterilized device?
My packaging/sterilization vendor is claiming that it takes 8 weeks, and they need to hold the entire lot of product for those 8 weeks post sterilization. There has been no significant change in product or manufacturing since the last dose audit.
However, our in-house sterilization "expert" says the test only takes 2 days.
This doesn't make sense to me - why would anyone use gamma if 4 times a year their shipments are delayed by 8 weeks?
Thanks very much for any input!
What is the typical lead time for a quarterly dose audit of a gamma sterilized device?
My packaging/sterilization vendor is claiming that it takes 8 weeks, and they need to hold the entire lot of product for those 8 weeks post sterilization. There has been no significant change in product or manufacturing since the last dose audit.
However, our in-house sterilization "expert" says the test only takes 2 days.
This doesn't make sense to me - why would anyone use gamma if 4 times a year their shipments are delayed by 8 weeks?
Thanks very much for any input!