PolymaxTPE, a manufacturer of premier quality thermoplastic elastomers, announced 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. This 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.
PolymaxTPE MT medical materials have already 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 like gamma, ethylene oxide (EtO) and steam. The medical grade materials from PolymaxTPE are elastic, flexible TPE compounds with a unique tactile feel available in a hardness range from 70 to 92 Shore A. They passed cytotoxicity tests according to ISO 10993-5 and GB 14233 for medical use by China Food and Drug Administration.
“The addition of USP Class VI approval to our material certifications allows us to offer alternative solutions to the US medical market for a variety of tubing and non-tubing applications,” states Tom Castile, Sales Vice President for PolymaxTPE. “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.” he continued.
The PolymaxTPE 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.
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