Solvay introduces first medical-grade PESU with FDA Master Access File

Materials supplier Solvay Specialty Polymers (Alpharetta, GA) introduced its newest medical-grade material, Veradel HC A-301 polyethersulfone (PESU), at the MD&M West show in Anaheim, CA, this week. The polymer retains transparency and stiffness at high temperatures and offers processing advantages over other commercial high-heat, transparent polymers, says Solvay.

The material has been around in non-medical applications, notably foodservice and automotive, for some time, Jeff Hrivnak, Business Development Manager, Healthcare, told PlasticsToday from the company's booth. "But this is the first PESU polymer with an FDA Master Access File. FDA gets an open book," he adds, "but the information is secure. And most importantly, it makes life easier for medical device OEMs because it facilitates the application process and can accelerate time to market."

Veradel HC A-301 PESU has been tested under ISO 10993 biocompatibility standards for cytotoxicity, irritation and acute systemic toxicity, and it is expected to pass USP Class VI testing, according to Solvay.

solvay-veradel

The new medical-grade PESU offers heat resistance that is on par with Radel PPSU, says Solvay, and its high flow rate makes it particularly suited for injection molding thin-walled parts and components with complex geometries. It has the highest stiffness of all medical-grade sulfone polymers.

The material is being marketed as a viable alternative to polyetherimide (PEI,) as it reportedly exhibits properties similar to those of PEI for strength, transparency, dimensional stability, inherent flame resistance and compatibility with steam sterilization and chemical sterilants. Its lower inherent color and higher flow rate may prove advantageous in some applications, adds Solvay.

Target applications include housings and internal structural components for medical diagnostic equipment, monitoring and filtration devices, and biopharma processing applications such as sight windows and quick-connects.

The material is currently available worldwide for sampling in healthcare applications.

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