TAGS: Medical
The Polyplastics Group 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. The new grade, DURACON PM27S01N, offers reduced wall thickness, miniaturization, and lower weight for various medical devices that are becoming increasingly complicated and highly functional.
Regulatory Compliant Grades for Medical Applications
Polyplastics’ PM series, which also includes
DURACON PM09S01N, a standard viscosity grade, complements the company’s TOPAS® cyclic olefin copolymer (COC) product, a high-purity material for a range of medical applications.
DURACON PM27S01N 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 markets.
DURACON PM27S01N 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.
University Quality and Global Supply
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 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 is 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.
Source: Polyplastics Group