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) and improve supply chain resiliency.
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 site additions for redundancy, moves to non-gamma radiation methods such as X-ray or electron beam sterilization, and reduced gamma radiation doses.
This master file applies to single-use, Class III devices that have already won FDA premarket approval (PMA). Instead of submitting a PMA supplement, device manufacturers working with Steris will be able to file a letter of intent to Steris for the change, and Steris will issue a letter of authorization to the manufacturer and copy the FDA.
In an FAQ on its website offering more details, Steris AST said the master file program allows its customers to reduce the volume of EtO needed for sterilization and to provide redundancy in processing locations and chambers.
“The FDA’s pilot programs align with the Steris mission to help our customers create a healthier and safer world,” Steris AST Americas GM and VP Ken Kohler said in a news release. “Following our prior acceptance into the EO Master File Pilot Program, we are excited to be the only contract sterilization provider accepted into both the EO and radiation programs. The pilot programs support our efforts to provide sterilization supply chain resiliency through a technology-neutral processing option that utilizes both radiation and gas technologies.”
The Radiation Sterilization Master File Program does not apply to devices with FDA 510(k) clearance. For those devices, the FDA awarded a master file to Andersen Sterilizers and sister company Andersen Scientific earlier this year.
The FDA has more information on the Radiation Sterilization Master File Program at its website.
