Polyzen, Leading Disposable Medical Device Contractor, Expands Polyurethane & Silicone Dip Molding Operations
Adds People, Equipment, and Full-Size in-House Machine Shop to Expedite Design and Development and Rapid Turnaround
Polyzen, Inc., one of the medical industry’s leading developers and manufacturers of specialty disposable components and devices and only one of a handful of industry firms that does large-volume dip molding, announces a major expansion in their dip molding capabilities for polyurethane and silicone products.
According to Polyzen president Tilak M. Shah, a renowned polyurethane and medical polymer industry scientist, “increasing demands for specialized dip molding services has seen Polyzen respond by adding new equipment, increasing space, and completing a full-size, in-house machine shop for the design and manufacture mandrels and hiring new personnel to work in this area. Our proprietary new systems for dip molding products made out of polyurethane and silicone now give us one of the most versatile operations in the business, with all products manufactured in class-10,000 (BSI Class K) clean room conditions.” As this news was being released, the company is in the final throes of achieving ISO 9002 certification. Further, Polyzen is FDA registered and Good-Manufacturing compliant, in addition to being one of very few contract manufacturers to offer molding, welding, and assembly in clean room conditions.
Products ideally suited for dip molding include low-pressure balloons for cardiovascular, oncology, and urology products, among others, coatings for stents, scope tubing and multi-functional sleeves for endoscopes, as well as caps, tips, plugs, grips, or other custom-molded items. The Polyzen process is capable of producing dip-molded products ranging in size from interior diameters of 0.10″ to 6″ and in film thicknesses ranging from 0.1 mm (4 mil) to 1 mm (40 mils), in various colors and varying hardness and wall thickness.
The medical and polymer divisions of Polyzen, Inc. offer a one-stop source for the production of quality products and materials for medical device OEMs. Products and services of Polyzen include thin-film welding, dip molding of both polyurethane and silicone materials, LIM molding, thermo/vacuum forming, thin-wall film (1-10 mils), lay-flat tubing (1-5 mils), blow molding of balloons, bellows, and containers, insert molding, catheter and device assembly, and kit packing. Specialties of Polyzen include contract research and development, specialty polymer formulations, and development and radiopaque compounding. The firm is FDA registered, GMP compliant, and has class-10,000 clean room facilities. Polyzen is also ISO 9002 certified.