By Bruce Geiselman
The Polyplastics Group highlighted its high-flow Duracon PM27S01N grade of polyoxymethylene (POM) resin in February during the Medical Design and Manufacturing (MD&M) West show in Anaheim, Calif.
The Duracon PM series of resins is designed for drug-contact and -delivery applications.
“It is an extremely wear-resistant, low-friction material that’s excellent for moving parts and parts requiring high strength in medical devices,” said Timothy Kneale, executive director for the TOPAS COC segment at Polyplastics USA Inc. “Examples would be injectors or inhalers. A lot of inhalers have rotating parts for instance for multidoses. It’s the same with pen injectors that are multidose. You want the moving parts to withstand multiple cycles, and POM’s custom-made for them.”
Another application for POM resins might be the manufacture of patch pumps, such as those designed for delivering insulin.
POM plastics have been available for decades, but, about two to three years ago, Polyplastics decided to enter the medical market, Kneale said.
“There are a whole set of regulatory guidelines that need to be complied with,” Kneale said. “We’ve done all the right things internally and with the FDA and other regulatory agencies around the world to ensure that this meets medical guidelines.”
The Duracon POM PM series meets medical regulatory compliance requirements including ISO 10993 and USP Class VI biocompatibility/cytotoxicity, Food and Drug Administration (FDA) Drug Master File (DMF) and Device Master File (MAF), and EU 10/2011 and FDA food contact 21 CFR 177.2470, according to the company.
Duracon POMs offer excellent slip and wear properties that permit lower friction and thus greater design freedom, according to the company. The materials also offer better heat and moisture durability compared with competitive medical grades.
Polyplastics rolled out its first grade of the Duracon PM series for medical applications about three years ago. Duracon PM09S01N with standard viscosity is suitable for medical equipment and components made by injection molding. The high-flow Duracon PM27S01N grade is suitable for thin-wall molding, enabling miniaturization and lightweighting for various medical devices that are becoming increasingly complicated, according to the company.
“It turns out a lot of medical requires high flow because, compared to industrial apps, there are relatively smaller, more detailed parts,” Kneale said.
Bruce Geiselman, senior staff reporter
Contact:
Polyplastics USA Inc., Farmington Hills, Mich., 248-479-8928, www.polyplastics.com
