DURACON® POM PM Series for Medical Applications
The Polyplastics Group has served the medical and healthcare market for many years with its high-purity material TOPAS® cyclic olefin copolymer (COC). Drug contact and delivery are among the highly technical applications for this medical plastic with global medical and food regulatory compliance.
In the growing and changing market, medical device manufacturers and end users demand for high quality materials by a reliable supplier.
As a leading manufacturer of polyoxymethylene (POM) material, Polyplastics now aims to add DURACON® POM “PM Series” to its medical portfolio.
The first to come out under the PM Series was the grade named “PM09S01N”. With a standard viscosity it holds very standard mechanical properties and moldability of POM. In addition, the high-flow type grade named “PM27S01N” will contribute to wall-thinning, miniaturization and lightening of various medical devices that are becoming more and more complicated and highly-functional. These grades will hold features that meet medical device manufacturers’ requirements as follows:
1. Agency Compliance
– ISO10993 and USP Class VI biocompatibility/cytotoxicity
– FDA Drug Master File (DMF) and Device Master File (MAF)
– EU 10/2011 and FDA food contact 21 CFR 177.2470
2. Quality Management System
– Conformity to VDI guideline “VDI 2017 Medical-grade Plastics”
– Full traceability of processes and products
– Follows change control and GMP Principles
3. Product Supply
– Global supply with uniform quality
Listed below are the physical properties and molding properties of the PM Series.
● Physical Properties
● Molding Properties
Polyplastics is an expert in innovation and technical solutions. We possess the largest amount of data on the long term reliability of materials. Furthermore, backed by our extensive knowledge and experience, we can provide various material data − i.e. extraction, moldability, durability, slip&wear, etc. − that are “customized” to your applications.
For inquiries, please contact us.
– The Materials are not designed, developed or manufactured for any use in transplantation or implant.
– There is no evidence that the Materials function well with sufficient quality and performance when it is used for any transplantation or implant.
– Polyplastics has never conducted appropriate studies or assessments as to the safety and suitability of the Materials for its use in any transplantation and implant.