Press Release Summary:
- 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
- Offers medical device manufacturers extensive data on the long- term reliability of its materials
- Provides traceability of processes and products, and production management based on GMP principle
Original Press Release:
Polyplastics to Showcase DURACON® POM PM Series at Upcoming Medical/Healthcare Trade Exhibitions
TOKYO, January 9, 2020 - The Polyplastics Group will showcase its latest material offering for the medical/healthcare market - DURACON®polyoxymethylene (POM) PM series for drug contact and delivery applications – at the Pharmapack exhibition in Paris, France (Stand #H72), February 5-6, and MD&M West in Anaheim, Calif., U.S. (Booth #440), February 11-13. The company will also feature the latest for its TOPAS® cyclic olefin copolymer (COC), a high-purity material for a range of medical applications which complements the PM series.
In a changing and growing marketplace, medical device manufacturers and end users demand high-quality materials and reliable suppliers, according to Polyplastics, a global manufacturer of POM materials for diverse end-use markets. The first grade under the PM Series, DURACON POM PM09S01N, is finding growing acceptance in the market by delivering global medical and food regulatory compliance.
The new POM 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 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 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.
For more information, visit https://www.polyplastics.com/en/docs/lp/201901_01/index.vm.
The Polyplastics Group is a global leader in the development and production of engineering thermoplastics. The Group’s product portfolio includes POM, PBT, PPS, LCP, GF-PET and COC. With more than 50 years of experience, the company is backed by a strong global network of R&D, production, and sales resources.
Polyplastics Co., Ltd.