Polyzen Inc. has completed an expansion to its clean room, so now it can perform film extrusion in a Class 10,000 environment.
The Apex, N.C., firm said its additional capacity will support prototype development, scale-up and manufacturing of film for use in regulated medical devices, including wound care and implants.
Polyzen said its new extrusion line is capable of producing film up to 52 inches wide in thicknesses ranging from 0.0005 inches to 0.070 inches, with in-line X-ray gauge dimensional reporting. The line is able to process a range of materials, including urethanes, thermoplastic elastomers, polyolefins, polyamides, fluoropolymers, and bioresorbable polymers. A 450-square-foot clean room with high-efficiency particulate air filters encapsulates the entire extrusion line to allow for film processing of these materials in the Class 10,000 environment.
“Our customers are at the forefront of medical device innovation. While our extrusion capabilities have supported their needs for years, they are increasingly seeking film for use in devices that require greater regulatory controls, such as implants,” Polyzen managing director Rubin Shah said. “The new Class 10,000 extrusion line represents our ongoing commitment to innovative device development from the first prototype parts through full production.”
