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.
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.