Solvay and TSO3 Inc., jointly announced that, as part of the U.S. FDA’s 510(k) premarket clearance for TSO3’s new STERIZONE VP4 Sterilization System received in December 2014, light weight 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 TSO3is a low-temperature sterilization system that utilizes vaporized hydrogen peroxide and ozone. It is the only system to have received FDA’s premarket clearance for dual sterilant processes. It can sterilize a large number and wide range of compatible devices in a cost-effective, error-free single cycle. TSO3’s unique Dynamic Sterilant Delivery System automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. With its large, 75-lb (34-kg) capacity and short cycle time, the STERIZONE VP4 Sterilizer can enhance throughput and lower sterilization costs.
“TSO3’s sterilant delivery technology represents significant value to our customers by offering them the option to select standard, highly durable, light weight instrument trays made from Solvay’s high-performance Radel material and, as a result, lower their inventories and costs,” said R.M. (Ric) Rumble, president and CEO of TSO3.
“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 gas,” said Dane Waund, global healthcare market manager for Solvay Specialty Polymers. “To support this growing demand, Solvay conducted extensive studies to confirm Radel PPSU’s strong compatibility with TSO3’s unique sterilization technology.”