The new closure is available in United States, it has been submitted for USP VI and ISO 10993-4,5 certifications
Polyone develops new silicone-alternative TPE for medical tubing. (Credit: Polyone)
At Medical Design and Manufacturing (MD&M) West next week, PolyOne will launch its newest medical grade, Versaflex HC BT218, formulated in response to supply challenges stemming from silicone shortages and sterilization facility closures.
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.
In response, PolyOne formulated Versaflex HC BT218 TPE for biopharmaceutical tubing applications. Delivering on critical application demands, the new grade offers weldability, kink resistance, and tensile strength performance comparable to leading medical tubing materials, including silicone and TPEs. Commercially available in the United States, it has been submitted for USP VI and ISO 10993-4,5 certifications.
“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,” said Jim Mattey, global marketing director, Specialty Engineered Materials at PolyOne. “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 uncertainties.”
Versaflex HC BT218 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.
Source: Company Press Release