Polyplastics begins global expansion of DURACON® POM medical products business

Polyplastics has now commercialized the “PM Series” of DURACON® POM medical grade. The healthcare market requires quality materials from trusted suppliers.

Our company has been providing high-purity TOPAS® COC materials to the healthcare market for many years. This time, we have added DURACON® to our product lineup for medical use.
“PM Series” aims to expand the market for medical use.

The company has launched two POM grade products for the medical market. The medium viscosity type PM09S01N will provide the highly anticipated, standard and highly reliable mechanical properties and formability of POM products. The high-flow PM27S01N will help achieve thinner wall, miniaturization and lightweight in more complex and functional medical devices.

These grades comply with the major regulations required by medical device manufacturers and are expected to be widely used in medical devices or drug delivery devices that come into direct contact with pharmaceuticals or liquids. In addition, sterilization can also be carried out under high-temperature steam and ethylene oxide gas (EtO) conditions.

Comply with various regulations and standards

● Biocompatibility/cytotoxicity testing in compliance with ISO 10993 and USP Class VI standards

● Registered in FDA Drug Master File (DMF) and Device Master File (MAF)

● European Commission Regulation (EU) No 10/2011 and FDA 21 CFR 177.2470 (US) Food Contact Plastic Regulations

Quality Management System

● Comply with the German Engineers Association (VDI) guideline “VDI 2017 Medical Grade Plastics”

● Traceability of manufacturing processes and products

● Production management based on GMP principles

Product Offering

● Globally unified quality

● Global supply

● For the first time, valve bags made of PE are used in DURACON® POM

Polyplastics is Japan’s first professional manufacturer of engineering plastics. As a pioneer in engineering plastics, our company has the largest amount of data in the industry. Based on this wealth of knowledge and experience, we can provide various data (dissolution, moldability, durability, sliding properties, etc.) in a form that meets customer needs.