Solvay and TSO3Inc. jointly announced that, as part of the FDA’s 510(k) premarket clearance for TSO3’s new Sterizone® VP4 Sterilization System received in December 2014, lightweight instrument trays made of Solvay Specialty Polymer’s Radel® polyphenylsulfone (PPSU) resin demonstrate strong compatibility for sterilizing a wide range of medical devices.
The Sterizone VP4 Sterilizer developed by TSO3 is a low-temperature sterilization system that uses vaporized hydrogen peroxide and ozone. It is the only system to have received FDA’s premarket clearance for dual sterilant processes. According to the vendor, it can sterilize a large number and wide range of compatible devices in a cost-effective, error-free single cycle. TSO3’s Dynamic Sterilant Delivery System™ automatically adjusts the quantity of injected sterilant based on the load composition, weight, and temperature. With its large, 75-lb capacity and short cycle time, the Sterizone VP4 Sterilizer can enhance throughput and lower sterilization costs.
The growing use of electronics, flexible endoscopes, and other delicate medical devices that are incompatible with high-temperature steam sterilization has increased the need for low-temperature sterilization techniques, such as hydrogen peroxide. To support this growing demand, Solvay conducted extensive studies to confirm Radel PPSU’s strong compatibility with TSO3’s sterilization technology.
