November 2020 – STERIS Applied Sterilization Technologies (AST) continues to expand its capacity for routine sterilization of medical devices, including new X-ray facilities in a number of locations worldwide.
In addition, STERIS is adding new specialized Radiation Technology Centers in the UK and North America.
Our STERIS laboratory testing services are integral in supporting these new facilities by providing medical device manufacturers with a comprehensive suite of microbiological and analytical testing and validation services to support registration of medical devices.
These tests include:
- Full-service testing to support ISO 11137 – Dose Setting and Audits (VDmax and Method 1)
- Full-service testing to support ISO 11135 (EO residual, Biological Indicator, Bioburden and Sterility Testing)
- LAL testing for product release
- Bioburden and environmental monitoring of routine production
- Packaging testing validation support (ISO 11607)
- Product testing including LUER Testing (ISO 80369-7)
- Design verification and technical services for products
The increased complexity of medical devices is supported by an evolving sterilization services offering, including technologies such as X-ray and vaporized hydrogen peroxide (VHP).
By combining our global network of technology-neutral sterilization facilities, laboratory testing capabilities, and the technical knowledge of our TechTeam® professionals, STERIS AST supports Customers through new product registrations and technology transfers.