New DURACON PM Series Polyoxymethylene Meets FDA Drug Master File and MAF Standards
Press Release Summary:
The DURACON® Polyoxymethylene PM Series is designed for use in medical applications. The PM09S01N is compliant to global medical and food regulations. The POM grade materials are manufactured to ISO10993 and USP Class VI biocompatibility/cytotoxicity, Device Master File and FDA food-contact 21 CFR 177.2470 standards.
Original Press Release:
Polyplastics Develops New DURACON® POM PM Series for Medical and Healthcare Industry
TOKYO, January 22, 2019 - The Polyplastics Group has announced the development of the DURACON® polyoxymethylene (POM) PM series for drug contact and delivery applications for the medical and healthcare market. The new PM series complements Polyplastics’ TOPAS® cyclic olefin copolymer(COC), a high-purity material for a range of medical applications.
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 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.
Polyplastics will highlight the PM Series and TOPAS COC at the Pharmapack exhibition in Paris, France (Booth #B92) February 6-7, 2019, and MD&M West in Anaheim, Calif., U.S. (Booth #666) February 5-7, 2019.
Please also visit: https://www.polyplastics.com/en/docs/lp/201901_01/index.vm
About Polyplastics
The Polyplastics Group is a global leader in the development and production of engineering thermoplastics. The Group’s product portfolio includes POM, COC, polybutylene terephthalate (PBT), polyphenylene sulfide (PPS), and liquid crystal polymer (LCP). With more than 50 years of experience, the company is backed by a strong global network of R&D, production, and sales resources.
Contact:
Miyuki Hedenstrom Hanaka
Polyplastics Co., Ltd.
Tel: +81-3-6711-8610
Email: ppc-info@polyplastics.com
