PAWTUCKET, R.I.—Teknor Apex Co. has unveiled three new medical-grade thermoplastic elastomers for biopharmaceutical tubing that the firm said provide performance superior to the industry standard TPE, making them effective alternatives to widely used silicone.
Teknor said it recommends its new Medalist-brand 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, Teknor said its 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.
The grades include: Medalist MD-12352, a 52 Shore A translucent TPE designed for peristaltic pump tubing; Medalist MD-50357, a clear, slightly harder TPE (58 Shore A) for peristaltic pump tubing, which can be sterile welded and heat sealed; and Medalist MD-10353, a clear compound used in biopharma tubing in extreme low temperature applications. With a brittleness temperature below -60° C, Teknor said 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. Teknor said they can be sterilized by means of e-beam, gamma irradiation, and ethylene oxide. The compounds are made with FDA-listed ingredients, certified at a minimum to the ISO 10993-5 standard for biocompatibility and are REACH SVHC compliant. They also are free of DEHP and other phthalates, BPA and latex. Standard grades are ADM-free.
For more information, visit www.teknorapex.com.
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