Three medical-grade thermoplastic elastomers for biopharmaceutical tubing provide performance superior to the industry standard TPE in this application, making them effective alternatives to silicone. This was announced by Teknor Apex. The company will introduce the Medalist compounds at North America’s largest medtech event, MD&M West in February 2019 in Anaheim, CA, USA.
The three compounds are recommended for 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. The company said that 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.
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Translucent tubing made from Medalist TPE (Source: Teknor Apex) Medalist MD-12352 is a 52 Shore A translucent TPE designed for peristaltic pump tubing.
- Medalist MD-50357 is a 58 Shore A clear TPE for peristaltic pump tubing. It 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.
According to the company these compounds exhibit significantly lower permeability than silicones. They can be sterilised by means of e-beam, gamma irradiation, and ethylene oxide (EtO).
The 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.
| Teknor Apex at MD&M West, 5-7 February 2019 Anaheim Convention Center, Anaheim, CA, USA Stand 2015 Presentation at the “Tech Theater” at MD&M West, 1:30 pm, 6 February 2019 |