Teknor Apex’s facility for manufacturing its ‘Medalist’ medical thermoplastic elastomers (TPEs) in Oldbury, West Midlands, has achieved ISO-13485 certification, meaning a huge boost in supplying the European market.
The company states its UK plant can now produce TPEs with the same properties as those from the USA, making it a single source for multinational customers and extending its international supply capabilities.
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 USA 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 programme required for ISO-13485 certification requires focusing of the entire compounding operation on processes and procedures that maximise 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.