Risk control tops agenda for medical devices

That's the view of Clariant Masterbatches (Muttenz, Switzerland), which was presenting its package of dedicated products and support designed to help customers' control risk in medical device manufacture and pharmaceutical packaging at the recent Medtec China show in Shanghai. (The Medtec show is organized by PlasticsToday owner Canon Communications.)

Clariant's Duckworth: "You need to ensure that you have a committed and educated supply chain in order to serve the medical device sector."

Clariant's specific range of medical color and performance masterbatches and compounds add cutting-edge functionality and brand appeal to customers' applications while taking into account industry requirements for consistency, reliability and regulatory compliance.

Steve Duckworth, Head of Global Market Segment Consumer Goods & Medical, and project leader at Clariant, comments: "Minimizing risk at every stage of design and production is critical for the medical sector, and the onus is on manufacturers to monitor the raw materials used in a device's components has never been greater."

"Clariant's long involvement in this sector put us in a good position to discuss the changing requirements and critical issues regarding plastics use with small and large device producers. Their need for a higher level of support than traditionally provided by compound and masterbatch producers led us to rethink our approach," adds Duckworth. "We have pooled our expertise with dedicated facilities that allow us to develop innovative color and performance masterbatches and compounds that can help customers more easily comply with regulatory requirements."

Clariant operates three specialist centers of competence, one in Lewiston MA,, one in Malmö, Sweden, and one in Singapore, focused on developing and manufacturing masterbatches and compounds for the medical and pharmaceutical sectors. These sites offer full manufacturing line segregation to reduce risk of cross contamination between products. In addition a globally harmonized quality management system in line with ISO13485 supporting the sector's need for consistency and reliability of formulations and procedures is being introduced.

Clariant's capability is further underlined by its extensive expertise in developing coloration and functional formulations that help to control the risks in a product's development and lifecycle. For example, a range of standard colors are available where ingredients have been biologically evaluated according to USP parts 87 and 88 (Class VI devices). In addition similar and globally harmonized products are being introduced where the evaluation and characterization is according to the ISO 10993 standard.

Clariant's product solutions cover a wide range of polymers and thermoplastic elastomers including PE, PP, ABS, SAN, PC/ABS, PC, PA6, 66 and 12, high performance polymers, and elastomers such as EVA. SEBS, TPU, COPE and COPA. —immeditorial@cancom.com