Broad Range of High-Purity TPV Medical Elastomers Eliminate Pre-Drying, are Easily Colored, and Meet Stringent ISO and FDA Standards


Spanning 15 to 80 Shore A Hardness Range, Medalist® MD-200 Series from Teknor Apex Exhibits Low Compression Set in Rubber-Replacement Applications like Stoppers, Seals, and Gaskets

PHILADELPHIA: A series of thermoplastic vulcanizate (TPV) elastomers spanning a wide range of hardness levels exhibits high purity and resilience for replacing rubber in medical applications and provides performance and processing advantages over other thermoplastic elastomers (TPEs), it was announced today by Teknor Apex Company, which is highlighting the compounds at MD&M East (Booth 1123).

Medalist® MD-200 Series elastomers range from ultra-soft 15 Shore A compounds to 80 Shore A grades, avoid need for pre-drying because they are non-hygroscopic, and have a light natural color that permits efficient use of colorants. All grades have been certified to pass ISO 10993-5 and are Drug Master File listed with the U.S. Food and Drug Administration. The compounds contain none of the extractable heavy metals commonly used in the curing of thermoset rubber. Because they exhibit lower oxygen absorption than non-vulcanizate TPEs, they afford greater protection of pharmaceutical contents when used in seals or gaskets for vials.

"The TPV technology for the MD-200 series is one of multiple polymer chemistries employed by Teknor Apex in developing our Medalist family of medical elastomers," said Keith Saunders, senior market manager for the Thermoplastic Elastomer Division. "We uniquely manufacture our TPV compounds 'from scratch,' starting with polymers and all other basic ingredients, rather than using a masterbatch intermediary."

This focus on fundamentals enables Teknor Apex scientists to optimally formulate compounds to meet the most demanding requirements in the healthcare market, according to Saunders. "With the broadest technology portfolio of medical-grade TPE-O, TPE-S, TPE-V, TPE-U, and engineering alloys, we are best suited to provide practical alternatives to suppliers in the medical TPV field that have announced their withdrawal from the market."

As TPVs, Medalist MD-200 compounds exhibit greater resilience than other TPEs, perform well in high-temperature end uses, and are more chemical-resistant. They can be sterilized in steam, autoclave, or gamma irradiation processes. Like all thermoplastics, they process more easily and quickly than rubber, offer greater design freedom, and are recyclable. Most grades in the series adhere well to polypropylene in over-molding.

Used commercially as a replacement for thermoset rubber in syringe stoppers, Medalist MD-200 compounds have been shown to meet the requirements of ISO 7886 for single-use hypodermic syringes and exhibit a low coefficient of friction for consistent travel force in glass and polypropylene barrels.

MEDALIST® THERMOPLASTIC MEDICAL ELASTOMERS make up a broad array of high-purity styrenic, olefinic, vulcanizate, and alloy compounds. Hardness offerings range from ultra soft gels at 25 Shore OO to hard yet ductile compounds at 85 Shore D. Teknor Apex can further broaden customer options by customizing the surface aesthetics, haptics, clarity, and color. An expandable registered binder on Medalist products provides a comprehensive body of test data and resources for designers and processors and is available to qualified professionals in the medical device and healthcare product industries. It can be requested from the Medalist website at www.medalistmd.com or by emailing Teknor Apex at medalist@teknorapex.com.

The Thermoplastic Elastomer Division of TEKNOR APEX COMPANY is the most diversified manufacturer of TPEs, offering broad product families based on six generically distinct chemistries. Headquartered in Pawtucket, Rhode Island, U.S.A., the division compounds TPEs at eight locations in the U.S., Europe, and Asia and is an international supplier to the appliance, automotive, construction, medical-device, wire and cable, and other consumer and industrial product industries. Other plastics businesses of Teknor Apex include the Bioplastics, Nylon, Specialty Compounding, and Vinyl Divisions and Teknor Color Company. Visit www.teknorapex.com.

Robert J. Martino

Martino Communications Inc.

8 Main Street / P.O. Box 379

Hastings-on-Hudson, NY 10706 U.S.A.

Tel: 1-914-478-0754

Fax: 1-914-478-0959

Email: bob@martinocommunications.com

Visit www.martinocommunications.com

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