TAGS: Medical
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.
Medical and Food Regulatory Compliant Grade
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, one of the global manufacturers 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
- Conformity to VDI guideline "VDI 2017 Medical-grade Plastics"
- Full traceability of processes and products
- 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.
Discover DURACON® POM PM series & TOPAS COC at Medical Events
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
Source: Polyplastics