MedTech and Ticona develop applications for a replacement substance of glass in medical and diagnostic devices
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South Plainfield and Summit, New Jersey; Kelsterbach, Germany - The MedTech Group, Inc., a leading contract medical device manufacturer, and Ticona, the technical polymers business of Celanese AG, have joined forces to develop and promote the use of Topas (R) cyclic olefin copolymer (COC) as a replacement for glass in medical and diagnostic devices, as well as in drug packaging and delivery products.
Topas COC combines optical transparency, high moisture barrier, and greater fracture resistance than glass. It prolongs the shelf life of moisture-sensitive drugs and prepared solutions in prefilled primary packaging, such as vials, ampoules, bottles and syringes, by keeping moisture out or by holding solution concentration steady. Other Topas COC healthcare applications include microtiter plates, needleless injectors, contrast media containers, and lenses and other optical components.
"Topas COC has great potential in healthcare, " says George Blank, President of The MedTech Group, Inc. "Our extensive knowledge of plastics technology and thorough understanding of the challenging requirements imposed on medical devices, enables us to compliment Ticona's materials expertise to create high-quality prefilled syringes and other injection-molded medical Topas(R) COC components. Our FDA-registered, ISO-certified facility provides the optimum setting to develop and expand Topas COC capabilities."
Topas COC also offers high stiffness and dimensional stability, low hydrolytic degradation and moisture absorption, and resistance to heat, acids, alkalis and polar solvents. It has excellent biocompatibility and is low in extractables. It meets U.S.P. Class VI requirements and has received U.S. FDA Drug and Device Master File numbers. An FDA Food Contact Substance Notification for COC allows its use in direct contact with all food types under all conditions of use.
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