FDA accepts Steris as first contract sterilizer in Radiation Sterilization Master File Pilot to reduce ethylene oxide use

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…

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Women in Medtech 2021: Kimberly Mollohan, STERIS Applied Sterilization Technologies EO Technology Center Manager

Kimberly Mollohan [Photo courtesy of STERIS Applied Sterilization Technologies ]

Kimberly Mollohan has 23 years of medical device industry experience, beginning her career in a laboratory that supported sterilization validation testing before moving to STERIS.

At STERIS, Mollohan worked her way from assisting with R&D programs to being the manager of a very talented and diverse team of validation specialists. They assist medical device manufacturers with their ethylene oxide sterilization needs, to ensure the products they supply to the public meet the stringent requirements of the medical device industry.

What first drew you to MedTech? When did you first know you wanted to be in the industry? Mollohan: I fell into medtech by accident as I wasn’t aware of it as a career path when I was in college. My original plan was to follow in the footsteps of my aunt and uncle who worked with the U.S. Fish and …

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Women in Medtech 2021: Betty Howard, STERIS Applied Sterilization Technologies Senior Radiation Sterilization Manager

Betty Howard [Photo courtesy of STERIS Applied Sterilization Technologies]

Betty Howard has more than 30 years in the medtech industry and disciplines.

She began her career with Public Health RD bench testing and virology, moving through Drug Discovery and new product assessment and applications development, and technical support and education across a variety of Biological Sciences and Chemistry areas. Betty currently supports irradiation sterilization technologies, validations and problem solving, a role she has held for nearly 20 years.

What first drew you to medtech? When did you first know you wanted to be in the industry? Howard: To me the definition of medtech wasn’t anything to considered or firmly defined. All my positions and focuses have been related to Biology, and support of safety and health care needs. With each position or each class taken you learn more skills, and the beauty of Medtech …

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