Clariant announces the global availability of an expanded range of Mevopur® standard master batches and compounds in polycarbonate (PC) resin. According to the vendor, the move offers medical device manufacturers a consistent and traceable supply of products that support the acceleration of medical device regulatory approval processes.
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.
Clariant offers standard color ranges in multiple polymer carriers, where the ingredients of the master batch have been pre-tested according to ISO10933-1 and U.S. 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.
PC resins are often chosen for medical device applications because they offer a combination of properties such as clarity, toughness, and heat resistance; for example, 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 master batch 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 lifecycle. Master batches and compounds using 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 not only saves time and reduces potentially expensive delays during device approval, but helps reduce risk of potential changes during the lifecycle.
