- Class 10,000 environment for regulated medical devices
- Film made of TPU, TPE, fluoropolymers, and bioresorbable polymers
Polyzen Inc., a manufacturer of thin wall components for medical devices, has recently expanded its cleanroom 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 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 1,320 mm (52 inches) wide in thicknesses ranging from 0.0127 to 1.778 mm (0.0005 to 0.070 inches), 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. A 42 square meter (450 square foot) 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.