Clariant will present an integrated design concept from the MEVOPUR® family of consistent and compliant masterbatches and compounds at CPhI/InnoPack Europe 2016. A medical device on display combines the aspects of color design, unique device identifiers (UDI) and brand protection.
Several factors combine to increase the importance of using color creatively in the healthcare market, explains Steve Duckworth, Clariant’s Global Head, Healthcare Polymer Solutions. “U.S. studies indicate only 28% patient-adherence to treatment programs and companies are looking for ways to make their devices more attractive and easier to use,” he says. “If special effects, such as pearlescents or metallics have successfully improved consumer appeal in consumer goods, why not in medical devices?”
Until recently, however, use of these effects in healthcare applications has been limited because they lacked regulatory documentation. Clariant has addressed this problem with new products being released as part of the MEVOPUR family. All raw-material ingredients used in the masterbatches or compounded materials have been pre-tested to USP parts 87 and 88 (Class VI devices) and ISO10993 and offer declarations that support regulatory compliance. Another feature of the part will be inclusion of functionality combined with color to address two problems the medical and pharmaceutical sectors face: traceability and protection against counterfeiting. “Although colors are a very visual part of Clariant’s business,” Duckworth states, “sometimes, what you can’t see provides even more important enhancements to the performance of the polymer.”
During next few years, regulations in USA and Europe will force medical device companies to implement Unique Device Identifiers (UDI), which requires a unique serial number or code marked directly on medical devices. The device Clariant is displaying at CPhI Barcelona demonstrates how fast, reliable and permanent marking can be achieved by activation of the polymer to Nd-YAG laser. The MEVOPUR additive is available in concentrated masterbatch form or in finished compound. The activation additive can be supplied alone, or in combination with the colors, and has the additional benefits of Clariant’s pre-testing protocol and declarations supporting regulatory compliance.
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