PolymaxTPE, a supplier of thermoplastic elastomers (TPEs) to a range of industries headquartered in Waukegan, IL, has announced USP Class VI approval for a new TPE material designed for use in medical and biopharmaceutical applications. MT-1205I was developed to address increasing demand for medical TPE tubing applications, said the company. The transparent elastomer is a high-purity compound with low leachables and extractables, as required by the USP Class VI standard for ensuring patient safety.
The flexibility, durability, neutrality and recyclability of the MT-1205I TPE make it a desirable alternative to PVC and thermoset rubber for medical tubing, according to Polymax TPE. It also has a lower rate of gas permeability and more design flexibility than silicone, at a lower cost.
PolymaxTPE's MT series of medical materials are already used in medical applications, where they are prized for their tactile feel, transparency, kink resistance and ability to withstand gamma, ethylene oxide and steam sterilization. The TPE compounds are available in hardnesses ranging from 70 to 92 Shore A and have passed cytotoxicity tests according to ISO 10993-5 and GB 14233 for medical use by the China Food and Drug Administration. (PolymaxTPE's sister company, Nantong Polymax, is one of the three leading TPE manufacturers in China, and is the company's global hub for TPE research and development.)
"The addition of USP Class VI approval to our material certifications allows us to offer alternative solutions to the U.S. medical market for a variety of tubing and non-tubing applications," said Tom Castile, Sales Vice President, in a prepared statement. "The unique properties of our newest material formulation provide a clear choice for medical device manufacturers who are looking for alternatives to PVC, natural rubber latex and silicone."
The company's product line includes materials appropriate for additional medical applications including tourniquets, medical films, syringe plunger seals, drip chambers, connectors and test tube plug caps. These materials range in Shore A hardness from 35 to 95 and cover a broad spectrum of physical properties.