Changes in regulations and market conditions are prompting medical device manufacturers to look for solutions via other materials. With that in mind, Colorite, a Tekni-Plex business, is expanding its CelleneĀ® TPE compound line to help medical device manufacturers and others looking for alternatives to PVC, phthalate-plasticized compounds and various rubber materials.
The line expansion is designed to assist in reducing the development cycle and provide manufacturers with greater options to obtain the durometer rating required for their applications.
CelleneĀ® TPE compounds are available in four series: 1,000 (extrusion grades for IV therapy with high clarity, improved bonding and kink resistance); 2,000 (injection molding and extrusion grades targeting cost-driven IV therapy solutions); 3,000 (injection molding and extrusion grades for general purpose healthcare, foodservice, caps, liners, gaskets/seals, syringe stoppers, profiles); and 4,000 (injection-molded grades for high-clarity applications such as drip chambers.)
The compounds are formulated to be silicone, latex, phthalate, halogen and PVC-free using FDA-compliant raw materials to meet USP Class VI and ISO 10993 standards.