Polyzen Expands Clean-Room Film Operations for Regulated Medical Devices

Polyzen Inc. recently has expanded clean-room manufacturing operations to include state-of-the-art film extrusion in a Class 10,000 environment. This new capacity will support prototype development, scale-up and manufacturing of film for use in regulated medical devices, including wound care and implants.

Medical devices that present increased risk to patients or clinicians often require greater regulatory controls, including clean-room manufacturing. At the same time, these applications are increasingly relying on specialty polymers, including bioresorbable polymers and fluoropolymers, for specific performance requirements. Few film manufactures have capabilities to process these specialized polymers in a clean room, and fewer are committed to supporting small volume film extrusions for product development and manufacturing of niche devices.

Polyzen’s new extrusion line is capable of producing film up to 52 inches (132 cm) wide in thicknesses ranging from 0.0005 to 0.070 inches (0.0127 to 1.778 mm), with in-line X-ray gauge dimensional reporting. The new line is able to process a wide range of materials that include thermoplastic urethanes (TPU), thermoplastic elastomers (TPE), polyolefins, polyamides, fluoropolymers, and bioresorbable polymers, according to the company. 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,” said Rubin Shah, managing director of Polyzen. “The new Class 10,000 extrusion line represents our ongoing commitment to innovative device development from the first prototype parts through full production.”

Based in Raleigh, N.C., Polyzen provides services for device manufacturers including dip and blow molding, thin film RF welding, extrusion, thermo/vacuum forming, and catheter and device assembly.