MOSCOW (MRC) -- Clariant, a world leader in specialty chemicals, has announced the global availability of an expanded range of MEVOPUR standard masterbatches and compounds in the popular polycarbonate (PC) resin, reported the company on its site.
The move offers medical devices manufacturers a consistent and traceable supply of products that support the acceleration of medical device regulatory approval processes.
For five years Clariant has been a pioneer in offering a globally available standard color ranges, in multiple polymer carriers, where the ingredients of the masterbatch have been pre-tested according to ISO10933-1 and US Pharmacopoeia 87 and 88 (USP Class VI). In 2010 Clariant introduced the brand MEVOPUR for products specifically developed for the medical device and pharmaceutical packaging markets. These products are produced under controlled manufacturing process in EN-ISO13485 certified plants on three continents. In the same year the first 'ISO/USP standard colors' in polyolefins and PEBA elastomers were launched.
Polycarbonate (PC) resins are often chosen for medical device applications because they offer a combination of properties such as clarity, toughness and heat resistance e.g. for steam sterilization. In addition, PC is used as one component in 'alloys' such as PC/ABS resins; often selected for use in the outer casing of drug-delivery pen devices. To maximize the properties it is important that the carrier for the masterbatch is compatible with the PC or PC/ABS resin. Clariant has addressed this issue by using a medical grade PC resin in the new products added to the MEVOPUR range.
Clariant’s MEVOPUR standard colorants are based on biologically-evaluated ingredients using the test protocols of USP monographs 87, 88 for Class VI devices or ISO10993 parts 4, 5, 10, 11 and 18. "The continuous expansion of the standard portfolio plus Clariant’s expertise in color design shows we are committed to trying to simplify the life of a project engineer or regulatory manager by reacting to the requirements of the healthcare industry," explains Duckworth.
As MRC reported before, Clariant's Masterbatches, a devision of the world leader in specialty chemicals Clariant, has recently presented two innovative products - REMAFIN-EP white masterbatches and Hydrocerol nucleating agents, which cater to the needs of India’s pharmaceutical and infrastructure industries, respectively.
Clariant AG is a Swiss chemical company and a world leader in the production of specialty chemicals for the textile, printing, mining and metallurgical industries. It is engaged in processing crude oil products in pigments, plastics and paints. Clariant India has local masterbatch production activities at Rania, Kalol and Nandesari (Gujarat) and Vashere (Maharashtra) sites in India.
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