Polyzen has expanded cleanroom manufacturing operations to include 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 cleanroom, 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 range of materials that includes thermoplastic urethanes (TPU), thermoplastic elastomers (TPE), polyolefins, polyamides, fluoropolymers, and bioresorbable polymers. A 450 square foot (42 square meter) cleanroom with high-efficiency particulate air (HEPA) 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.”