Materials: TPE for Biopharmaceutical Tubing

The latest addition to the Versaflex line of proprietary TPE alloys from PolyOne Corp., Avon Lake, Ohio, has been formulated to address supply challenges stemming from silicone shortages and sterilization facility closures. It makes it debut at MD&M West 2020.

Versaflex HC BT218  BT218 TPE for biopharmaceutical tubing applications, is said to offer weldability, kink resistance, and tensile strength performance comparable to leading medical tubing materials, including silicone and TPEs.  The new TPE adds to PolyOne’s broader portfolio of specialty engineered polymers for healthcare that meet stringent regulatory demands and are suitable for alternative sterilization methods, including gamma and autoclave. Now commercially available in the U.S., it has been submitted for USP VI and ISO 10993-4,5 certifications.

Throughout 2019, the FDA issued multiple alerts regarding medical tubing and potential medical device shortages due to reduced supplies of siloxane, a key ingredient in silicone, and the closure of multiple ethylene oxide (EtO) sterilization facilities. These constraints are fostering higher prices, longer lead times, and increased interest in silicone alternatives such as thermoplastic elastomer (TPE) tubing solutions.

Said Jim Mattey, global marketing director for specialty engineered materials, “We’re excited to add the new Versaflex grade to our expanding set of solutions that enable customers to continue pursuing product innovation and meet market demands. We are committed to leveraging our material science expertise to formulate alternative and customized solutions that meet regulatory demands and functional necessity for life-saving medical devices, especially in the face of market