Building on the international success of Medalist medical thermoplastic elastomers (TPEs) produced in the U.S., Teknor Apex Company has expanded its supply capabilities for these compounds in Asia by achieving ISO-13485 certification for its TPE production facility in Singapore.
ISO-13485 is an international standard for quality management in medical manufacturing. Teknor Apex previously achieved ISO-13485 certification for Medalist facilities in the USA and will now produce Medalist compounds in Singapore as well. The certification is accredited by Det Norske Veritas Certification, Inc. (DNV) and must be audited annually by the DNV to assess continuous improvement.
“Certified production of Medalist TPEs in Singapore helps Teknor Apex to save transit time and shipping costs in supplying the Asian market, and it enables us to offer compounds that provide the same properties as those from the USA and meet the same exacting standards,” said Stanly Tan, managing director of Teknor Apex Asia Pacific. “We are prepared to supply precisely the same Medalist compounds to companies that produce medical devices at multiple locations around the world.”
ISO-13485 certification in Singapore comes at a time of rapid innovation for the Medalist product range, noted Serene Cheng, TPE business director.
“Working with partners in the processing equipment and medical manufacturing sectors, Teknor Apex has developed new Medalist technologies for replacement of latex in films, extrusion blow molding of bags and bottles, coating of wire and cable, calendering, and welding of bags and pouches,” said Ms. Cheng.
“For medical tubing, we have created an extensive portfolio of compounds that provide the first practical alternative to PVC, not only exhibiting the same flexibility and clarity but also duplicating critical clinical properties like resistance to kinking and necking, clamp resilience, and haptics.”
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.
In addition to being produced in ISO-13485-certified facilities, Medalist medical elastomers are fully compliant with regulations for medical uses and meet stringent standards for biocompatibility and purity. All Medalist elastomers are made with FDA-compliant ingredients, are compliant with ISO 10993-5 and REACH SVHC, and are free of phthalates.