The first grade under the PM series, DURACON POM PM09S01N, delivers 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, which is a global manufacturer of POM materials for diverse end-use markets.

 

The new POM grade meets regulatory compliance requirements, including ISO10993 and USP Class VI iocompatibility/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 also 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 the GMP principle. Polyplastics also provides uniform quality and global supply.

 

Polyplastics 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 are also available. 

 

TOPAS COC is a glass-clear and highly pure plastic which offers stiffness and barrier resistance, biocompatibility, and drug compatibility for wearables, drug delivery, medical devices, pharmaceutical blisters and trays, and diagnostics and microfluidics.