Calling the material the industry's first cyclic olefin copolymer (COC) elastomer, TOPAS Advanced Polymers has received Food Contact Notification (FCN) #1104 from the U.S. Food and Drug Administration (FDA) for its TOPAS Elastomer E-140. TOPAS is positioning the material as a high-performance alternative to traditional flexible materials for a range of applications in food packaging, medical devices, and specialty pharmaceutical packaging, noting that it has already passed USP Class VI and ISO 10993 protocols for medical uses and is listed in TOPAS' drug and device master files at the FDA.
This latest certification allows the material be used in aqueous, acidic, dry (with no free surface fat or oil), and low-alcohol (up to 15% alcohol) food-contact applications under FDA's Conditions of Use C through G.
The material has seen use in a film application, as a component of a barrier layer for enhanced flexibility and abuse resistance. In nylon replacement, TOPAS Elastomer E-140 provides flexibility, toughness, cost reduction, improved thermoforming, and enhanced sustainability in multilayer film structures. TOPAS also points out that the material offers strong physical properties with more disposal options than polyvinyl chloride (PVC) for healthcare uses such as blood bags and tubing. On that front, the company completed a medical-tubing trial to demonstrate its kink-resistant qualities.
In terms of strength and stiffness, tensile modulus is reported at 6400 psi while elongation at break is greater than 450%. Its low dielectric properties are comparable to fluoroelastomers, providing strong electrical insulation performance, and the COC can maintain ductility at temperatures below -80°C. It is highly flexible and has an 89 Shore A hardness.
Early testing shows that it withstands gamma and e-beam sterilization. It can be injection molded or extruded into film, sheet, tubing, or other components on conventional processing equipment. Unlike some thermoplastic polyurethanes (TPU), the material requires no pre-drying. It can be overmolded on standard TOPAS COC grades as well as other olefins.