Hi Folks…proposal here to allow parametric release of devices post completion of sterilisation cycle. In the event of issues with the sterilisation cycle a proposal by team is to qualify the option of a second sterilisation cycle. Current process runs on ETO x 1 cycle. In the event of issues the products will be processed to a 2 x ETO.
Orignal process validations were completed post 1 x ETO…what is standard practice out there if a second cycle is made available (this is a non-API device)? Is process validation reexecuted? Bear in mind that a repeat of design testing will be completed…
Would appreciated your thoughts!