What is your experience with FDA using "mixed load" i EO sterilization




We have a sterilization vendor that runs a mixed load program in a dedicated chamber at a contract sterilizer. Now we are thinking about cutting out the sterilization vendor and joining the mixed load program at the contract sterilizer. Essentially it is the same concept - our products will run through the process with other products that we do not know anything about.

Does anyone have any first hand information about the FDA's position on using mixed load in EO?

Top Bottom