Teknor Apex’s New Medical-grade TPEs Replace Silicone in Biopharmaceutical Tubing

Three new medical-grade thermoplastic elastomers (TPEs) for biopharmaceutical tubing provide performance superior to the industry standard TPE in this application, making them effective alternatives to widely used silicone.
Teknor Apex Company will introduce the new Medalist® compounds at MD&M West (Booth 2015) and will make a presentation on grades for peristaltic pump applications at the “Tech Theater” during the show. The presentation is scheduled for 1:30 pm on Wednesday, February 6.

Clear & Translucent Medalist® Medical TPEs

Teknor Apex recommends three compounds for challenging tubing applications in the biopharma industry for peristaltic pumps and extreme low temperature applications. The materials designed for peristaltic pump tubing provide the elasticity required to keep pace with rapid pump action and the durability needed for the tubing to retain its shape and remain intact over time. In comparison with the industry-standard TPE alternative to silicone, the Medalist TPEs exhibit lower levels of spallation—the shedding of particles from the inner and outer surfaces of the tubing caused by repeated compression and release during pump operation.

Three New Medalist® Compounds

 • Medalist MD-12352 is a 52 Shore A translucent TPE designed for peristaltic pump tubing.
• Medalist MD-50357 is a clear, slightly harder TPE (58 Shore A) for peristaltic pump tubing, which can be sterile welded and heat sealed.
• Medalist MD-10353 is a clear compound used in biopharma tubing in extreme low temperature applications. With a brittleness temperature below -60° C, this TPE can be used for tubing that remains flexible and elastic, facilitating fluid transfer in the manufacturing process of heat-sensitive biopharmaceuticals.
These three Medalist compounds exhibit significantly lower permeability than silicones. They can be sterilized by means of e-beam, gamma irradiation, and ethylene oxide (EtO).
Ross van Royen, senior market manager of regulated products, said: “At a time when silicones are in short supply, Teknor Apex can provide an assured global supply chain for all Medalist TPEs, producing them at ISO-13485-certified facilities in the U.S, and Singapore. As alternatives to silicone, our three new Medalist compounds provide better performance than the industry-standard TPE used thus far.”

Certifications & Compliance

The new Medalist compounds are made with FDA-listed ingredients, are certified at a minimum to the ISO 10993-5 standard for biocompatibility, and are REACH SVHC compliant. They are free of DEHP and other phthalates, BPA, and latex. Standard grades are ADM-free.
 
Source: Teknor Apex Company