POLYPLASTICS
New grade added to “Duracon” POM PM brand / High-flow material said to suit medical and healthcare industry
The company’s new POM materials are intended for healthcare and medical application (Photo: Polyplastics) |
Polyplastics (Tokyo / Japan; www.polyplastics.com) has announced the introduction of an additional “Duracon” polyoxymethylene (POM) PM series material, a high-flow grade for drug contact and delivery applications for the medical and healthcare market. The grade, “Duracon PM27S01N”, is said to provide for reduced wall thicknesses, miniaturisation, and lower weight for various medical devices.
According to Polyplastics, the material meets a range of 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. It adheres to strict quality management systems such as conformity to VDI 2017 guideline Medical-Grade Plastics (MPG), Polyplastics said, noting that it also provides full traceability of processes and products, and production management based on the GMP principle.
The company’s new PM series is said to complement its “Topas” cyclic olefin copolymer (COC) product, a high-purity material for a range of medical applications.
In other news, the company said that its trademark of PET products is being changed from “FR-PET” to “Renatus” as of 1 April 2021. Two years ago, Polyplastics merged the PET and PBT business from Wintech Polymer (Tokyo), which was taken over in 2016 (see Plasteurope.com of 01.09.2016), into its product portfolio.
Since 2020, Polyplastics is a wholly owned subsidiary of Daicel (Osaka / Japan; www.daicel.com); in Germany, the engineering plastics supplier is operating its subsidiary Topas Advanced Polymers (Raunheim; www.topas.com – see Plasteurope.com of 14.10.2020).
According to Polyplastics, the material meets a range of 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. It adheres to strict quality management systems such as conformity to VDI 2017 guideline Medical-Grade Plastics (MPG), Polyplastics said, noting that it also provides full traceability of processes and products, and production management based on the GMP principle.
The company’s new PM series is said to complement its “Topas” cyclic olefin copolymer (COC) product, a high-purity material for a range of medical applications.
In other news, the company said that its trademark of PET products is being changed from “FR-PET” to “Renatus” as of 1 April 2021. Two years ago, Polyplastics merged the PET and PBT business from Wintech Polymer (Tokyo), which was taken over in 2016 (see Plasteurope.com of 01.09.2016), into its product portfolio.
Since 2020, Polyplastics is a wholly owned subsidiary of Daicel (Osaka / Japan; www.daicel.com); in Germany, the engineering plastics supplier is operating its subsidiary Topas Advanced Polymers (Raunheim; www.topas.com – see Plasteurope.com of 14.10.2020).
05.03.2021 Plasteurope.com [247080-0]
Published on 05.03.2021