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ISO-13485 CERTIFICATION IN THE UK STRENGTHENS TEKNOR APEX’S EUROPEAN SUPPLY CAPABILITIES FOR MEDALIST® MEDICAL ELASTOMERS

UK Plant Can Produce TPEs with the Same Properties as Those from the U.S.A., Making Teknor Apex a Single Source for Multinational Customers and Saving Time and Costs for Users in EU

STUTTGART, February 26, 2013: Following the commercial success of Medalist® medical thermoplastic elastomers (TPEs) in the U.S.A., Teknor Apex Company has extended its international supply capabilities for these compounds by achieving ISO-13485 certification for its manufacturing facility in Oldbury, West Midlands, UK, the company announced today at MedTech 2013 (Stand 1L4).

ISO-13485 is an international standard for quality management in medical manufacturing. The facility in the UK has passed the final audit and is expected to achieve full certification by the end of the current calendar quarter, according to Stef Hordijk, strategic market manager for the Thermoplastic Elastomer Division of Teknor Apex. A Medalist production facility in St. Albans, VT, U.S.A. obtained ISO-13485 certification in 2010.

“Certified production of Medalist TPEs in the UK helps Teknor Apex to save transit time and shipping costs in supplying the EU market, and it enables us to offer European customers compounds that provide the same properties as those from the U.S.A. and meet the same exacting standards,” said Mr. Hordijk. “The startup of a second production facility for Medalist compounds increases our capability to serve as a single source of material for companies that manufacture internationally at multiple locations.”

ISO-13485 specifies systems for consistent compliance with regulatory and customer requirements and includes provisions for risk management, sterile manufacturing, and traceability. The comprehensive implementation program required for ISO-13485 certification requires focusing of the entire compounding operation on processes and procedures that maximize the safety and reliability of the compounds supplied to medical device manufacturers.

Developed for device manufacturers, ISO-13485 is not an essential standard for a compounder. Medalist elastomers are already fully compliant with regulations for medical uses and meet stringent standards for biocompatibility and purity. “Teknor Apex undertook procedures for achieving ISO-13485 certification in order to provide our customers with an extra dimension of quality assurance and to demonstrate our commitment to the Medalist brand,” said Mr. Hordijk.

From the point of view of the medical device manufacturer, one of the most important aspects of ISO-13485 is the increased management of change by the compounder. Testing of incoming compound ingredients, as well of the finished compound, is key to maintaining tight process control. In turn, this ensures the consistency of the material received by the customer.

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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.

TEKNOR APEX EUROPE, Mijnweg 1, 6167 AC Geleen, The Netherlands. Tel: +31 (0) 46-70-20-970. Fax: +31 (0) 46-70-20-990. E-mail: eutpe@teknorapex.com. www.teknorapex.com