Teknor Apex Presents New Thermoplastic Elastomers for Medical-Grade Applications
Press Release Summary:
The Thermoplastic Elastomers include Medalist MD-12352 (52 Shore A), MD-50357 (58 Shore A) and MD-10353 compounds. The three compounds are used in biopharma industry for peristaltic pumps and extreme low temperature applications. The MD-10353 TPE exhibits a brittleness temperature below -60°C. The compounds feature low permeability than silicones and are compliant FDA and REACH SVHC standards.
Original Press Release:
New TPE Alternatives to Silicone Outperform Standard TPEs for Peristaltic Pump and Low-Temperature Biopharmaceutical Tubing
Clear and Translucent Medalist® Medical TPEs from Teknor Apex Provide Effective Alternatives to Silicone, Which Is in Short Supply
PAWTUCKET, RI, U.S.A., December 3, 2018: 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.
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.
- 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 peristlatic 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).
“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,” said Ross van Royen, senior market manager of regulated products. “As alternatives to silicone, our three new Medalist compounds provide better performance than the industry-standard TPE used thus far.”
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.
About Teknor Apex. Teknor Apex Company, a privately held firm founded in 1924, is one of the world’s leading custom compounders of plastics. Teknor Apex produces flexible and rigid vinyl, thermoplastic elastomers, nylons, color masterbatches, specialty chemicals, and hoses. The company is headquartered in Pawtucket, RI, U.S.A. and operates thirteen manufacturing facilities worldwide in the United States, Belgium, Germany, China, and Singapore. To learn more visit: www.teknorapex.com.
The Thermoplastic Elastomer Division of Teknor Apex Company offers the broadest portfolio of TPE compounds available from a single source. The division compounds TPEs at eight locations in the U.S., Europe, and Asia under the brands: Elexar® (electrical and electronics applications), Medalist® (medical devices), Monprene® (consumer and industrial products), and Sarlink® (transportation).
READER INQUIRY INFORMATION: Americas: Teknor Apex, 505 Central Avenue, Pawtucket, RI 02861 U.S.A. Tel: 1-401-725-8000. Tel. from U.S. only: 1-866-GET-TPEs (1-866-438-8737). Fax: 1-401-728-5680. E-mail: tpe@teknorapex.com. Europe: Teknor Apex, Mijnweg 1, 6167AC, Geleen, Netherlands. Tel: 31 (0) 46-7020950. Email: eutpe@teknorapex.com. Asia: Teknor Apex Asia Pacific, 41 Shipyard Road, Singapore 628134. Tel: 65-6265-2544. Fax: 65-6265-1821. Email: apactpe@teknorapex.com.
