The FDA has accepted Steris as the first contract sterilizer for its Radiation Sterilization Master File Pilot Program.
That program is part of the agency’s initiative to promote new and existing alternatives to ethylene oxide (EtO). EtO is the most commonly used sterilization method for medical devices due to its ability to permeate packaging in bulk quantities. But the medtech industry faces EtO sterilization capacity limits and new regulations that could increase sterilization costs or wait times.
Steris Applied Sterilization Technologies (AST) customers can now use the contract sterilizer’s master file with the FDA to change the way their devices are sterilized, making it easier for them to move from EtO sterilization to gamma radiation.
The master file would also simplify sterilization site changes or processing redudancy additions, moves to non-gamma radiation medthods such as X-ray or electron beam sterilization, and reduced ga…