WAUKEGAN, Ill.—Polymax Thermoplastic Elastomers Inc. said it has received USP Class VI approval for a new TPE material designed for use in medical and biopharmaceutical applications.
MT-1205I was developed to address the increasing demand for medical TPE tubing applications, the company said.
The transparent elastomer is a high-purity compound with low leachables and extractables required for ensuring patient safety. Due to the material's flexibility, durability, neutrality and recyclability, it is a desirable alternative to PVC and thermoset rubber for medical tubing. It also provides less gas permeability and more design flexibility than silicone, at a lower cost.
The company said its MT medical materials have gained acceptance in medical applications. They have been approved for medical use due to their tactile feel, high level of transparency, kink resistance and ability to withstand various sterilization methods such as gamma, ethylene oxide (EtO) and steam.
These elastic, flexible TPE compounds feature a unique tactile feel available in a hardness range from 70 to 92 Shore A. They have passed cytotoxicity tests according to ISO 10993-5 and GB 14233 for medical use by the China Food and Drug Administration.
“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. “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 materials can also be used for medical applications including tourniquets, medical films, syringe plunger seals, drip chambers, connectors and test tube plug caps.
Polymax is based in Waukegan with compounding production there and in Nantong, China.