Compliant masterbatch adds colour to medical devices

In today's competitive marketplace manufacturers must try to differentiate their product from others by improving functionality and design. Use of drug delivery devices increasingly occurs outside of a hospital setting and since it is the patient rather than a doctor who is the user, the device must be attractive as well as convenient and functional. They become more like any other consumer product. That is why colour and other visual elements are increasingly important in device design.

 At the same time, manufacturers must also take into account industry requirements for consistency, reliability and regulatory compliance, and the onus is on the manufacturer to monitor the raw materials used in its products. With so much invested in product development and approvals, it is critical to minimise risk at every stage of design and production.

 Designers and manufacturers looking to add a distinctive aesthetic touch to pharmaceutical packaging and medical devices can turn to new colour masterbatches such as the MEVOPUR?, a new breed of colour masterbatches and compounds from Clariant. MEVOPUR supports the use of colour to add differentiation and appeal to a device or packaging while helping to maintain regulatory requirements.

 "The same trend we have seen in the personal care market for achieving differentiation and shelf appeal through attractive colour choice is now influencing the medical device and pharmaceutical packaging sector," according to Mr. Steve Duckworth, Head of Global Market Segment Medical and Pharmaceutical at Clariant. "Pharmaceutical companies believe that a well designed and visually appealing package can extend the life - cycle of a pharmaceutical product beyond what would normally be expected, in particular after patent protection has expired."

 Meeting tight regulatory controls

 All MEVOPUR colour products are produced at Clariant's three ISO 13485:2003 accredited dedicated centres of competence for medical and pharmaceutical applications in the Asia, United States and Europe. The facilities offer segregated manufacturing lines to reduce the risk of cross contamination.

 Segregated storage and change-control processes reduce the potential for product alterations. In producing MEVOPUR, Clariant acknowledges the pharmaceutical and medical industry's need for material consistency, reliability and change - control. This is particularly relevant in light of tightening regulatory controls governing end product ingredients, and the increasing responsibility of pharmaceutical companies, packaging converters and device manufacturers to communicate their requirements regarding traceability, consistency and safety to suppliers.

 MEVOPUR offers vibrant colours and enhanced functionality for improved capability, innovative performance and design, convenience and reliability. Surface engineering provides advanced functions such as laser marking, friction-reducing solutions, and radiopacity used for the manufacture of components that can be visualised using X-ray or fluoroscopic evaluation.

 The MEVOPUR range includes masterbatches and compounds whose ingredients have been biologically evaluated against USP parts 87 and 88 (Class VI devices) and / or the international standard ISO10993. Clariant introduced evaluation against the ISO10993 standard in response to increasing requests from the sector for this compliance. Amongst the products complying with ISO10993 is a new range of globally harmonised standard colors for PP and PE as well as PEBA, where ingredients have been biologically evaluated according to ISO10993 and USP parts 87 and 88 (Class VI). The MEVOPUR product solutions cover a wide range of polymers and thermoplastic elastomers including PE, PP, ABS, SAN, PC / ABS ,Kobe XII 12 Shoes