In the healthcare sector color is widely used, both to help protect the patient by identifying the device type and increasingly as a design feature in branding. Attractive colors and design are also considered to help patient compliance with their daily dose regime. However, engineers have to consider an increasing list of new requirements to deal with the challenges of regulations, change management and international manufacture.
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 pre-testing of the ingredients used in the manufacture of MEVOPUR standard colorants helps to reduce customers' development times and costs, and minimizes risk of change during the product life-cycle. Masterbatches and compounds utilizing these colorants help to address the industry concern regarding extractables and leachables from the plastic components. By providing documentation on testing of ingredients according to USP parts 87, 88 Class VI and ISO10093 test protocols, Clariant supports converters and pharmaceutical companies in making a risk assessment at an early stage of the development process. This can not only save time and reduce potentially expensive delays during device approval, but helps reduce risk of potential changes during the life cycle.
"Within the healthcare sector there has been increased awareness of and much discussion of extractables and leachables from plastics and how changes in the materials may often result in unintended contamination of the drug or impact on biocompatibility of the device," comments Steve Duckworth, Clariant's Head of Global Segment Medical & Pharmaceutical. "In addition the regulators are aware of potential changes in the supply chain and therefore are demanding increased control. The complexity increases dramatically when it comes to international production and supply."
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.