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Japan’s Polyplastics Group (U.S. office in Farmington Hills, Mich.) is expanding its Duracon polyoxymethylene (POM) PM series portfolio with the development of a new high-flow grade for drug contact and delivery applications for the medical and healthcare market. New grade PM27S01N reportedly offers reduced wall thickness, miniaturization, and lower weight for various medical devices that are becoming increasingly complicated and highly functional.

PM27S01N is said to deliver global medical and food regulatory compliance. In a changing and growing marketplace, medical device manufacturers and end users demand high-quality materials and reliable suppliers, according to Polyplastics. The new grade meets regulatory compliance requirements including ISO10993 and USP Class VI biocompatibility/cytotoxicity, FDA Drug Master File (DMF) and Device Master File (MAF), and EU 10/2011 and FDA food-contact 21 CFR 177.2470.

The material adheres to strict quality management systems including conformity to VDI guideline, VDI 2017 medical-grade plastics. It also provides full traceability of processes and products, and production management based on GMP principle. Polyplastics has positioned itself to provide uniform quality and global supply.

Polyplastics’ Duracon PM series, which also includes Duracon PM09S01N, a standard viscosity workhorse grade, complements the company’s Topas cyclic olefin copolymer (COC) product, a high-purity material for a range of medical applications. The company offers medical device manufacturers extensive data on the long- term reliability of its materials. Customized data on extraction, moldability, durability, slip and wear, and other key attributes is also available.