FLORENCE, Ky., September 26, 2011 – TOPAS Advanced Polymers has received Food Contact Notification (FCN) #1104 from the U.S. Food and Drug Administration (FDA) for its TOPAS® E-140 cyclic olefin copolymer (COC) elastomer for use in aqueous, acidic, dry, and low-alcohol food-contact applications under conditions of use B thru G. This developmental resin 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 US FDA.
TOPAS E-140 - the industry’s first COC elastomer – is targeted as a high-performance alternative to traditional flexible materials for a broad range of applications in food packaging, medical devices, and specialty pharmaceutical packaging. In one application, the COC is used as a component of a barrier layer for enhanced flexibility and abuse resistance. In nylon replacement applications, TOPAS E-140 delivers flexibility, toughness, cost reduction, improved thermoformability, and enhanced sustainability in multilayer film structures. Meanwhile, the material offers strong physical properties with more disposal options than polyvinyl chloride (PVC) for healthcare uses such as blood bags and tubing. A recent trial in medical tubing has demonstrated the material’s excellent kink-resistant qualities.
TOPAS E-140 elastomer expands the company’s product offering and opens up multiple new market opportunities. It extends TOPAS’ technology platform beyond the current line of amorphous transparent grades which have been successful in medical devices and drug delivery, food and pharmaceutical packaging, optics, and electronics.
“This transparent polymer now delivers toughness and flexibility that go well beyond typical cyclic olefin resins,” said Timothy Kneale, president of TOPAS Advanced Polymers Inc.
TOPAS E-140 COC elastomer possesses strength and stiffness suitable for numerous flexible applications. Tensile modulus is reported at 6400 psi while elongation at break is greater than 450%. In addition, the material’s low dielectric properties are comparable to fluoroelastomers, providing strong electrical insulation performance. Another key feature is the material’s ability to maintain ductility at temperatures below -80°C. It is highly flexible and has an 89 Shore A hardness.
Early testing shows that TOPAS E-140 COC elastomer withstands both gamma and e-beam sterilization. It can be injection molded and extruded into film, sheet, tubing, or other components on conventional processing equipment. Unlike some thermoplastic polyurethanes (TPU), the material requires no pre-drying.
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