Users of Advanced Medical Polymers Gain Controlled, Consistent, Compliant Color With New Clariant MEVOPUR® Masterbatches

Muttenz, 9 March 2011 – Manufacturers of medical devices and packaging who choose newer plastic materials like Eastman Tritan™ co-polyester and TOPAS® cyclic olefin copolymer (COC) now have readily available color options that are pretested and compliant with key standards governing materials used in medical and pharmaceutical applications. Available under the new Clariant Masterbatches brand name MEVOPUR®, these color concentrates and pre-color compounds are produced under specially controlled conditions in ISO13485 certified plants, using raw materials that have been biologically evaluated against USP parts 87 and 88 (Class VI devices) and/or the international standard ISO10993, and spectroscopically analyzed on delivery.

New MEVOPUR masterbatches and pre-color compounds are an addition to Clariant’s globally available ‘ISO10993/ USPVI standard color’ range for such polymers as specialty polyether block amide (PEBA) and more widely used polyethylene and polypropylene materials.

“Designers, manufacturers and marketers of medical and pharmaceutical devices and packaging have to contend with strict regulatory controls governing end-product ingredients, traceability, consistency and safety,” explains George Pape, Medical Device and Healthcare Market Manager. “At the same time, they want to take advantage of the performance benefits of these advanced polymers. Our newest MEVOPUR masterbatches give them bright, vibrant colors and advanced performance properties while helping to minimize risk at every stage of the development process.”

The new colors for TOPAS COC polymers were developed to work with the inherent transparency of the material. No dyes are used, eliminating the risk of color migrating to the surface of molded products. Masterbatches and precolored compounds for Tritan co-polyester are available in both translucent and opaque formulations. The medical-grade pigments allow Clariant to produce a wide range of standard and custom colors to meet specific customer requirements. Clariant recently launched a range of globally harmonized standard colors for polypropylene and polyethylene as well as other materials such as PEBA. This range of up to 17 standard colors can be especially beneficial in small-volume applications, where a custom formulation is not justified.

Both TOPAS COC and new grades of Tritan resins are being widely considered as substitutes for glass and polycarbonate in medical device and pharmaceutical packaging applications. Both of these new materials offer good resistance to hydrocarbon-induced stress cracking, and are free of bisphenol-A, a minor ingredient in polycarbonate and some other resins that has recently come under scrutiny by regulatory authorities.

The colors on display at MD&M – West 2011 were manufactured under carefully controlled conditions in Lewiston, Maine, at one of three global sites dedicated for medical and pharmaceutical applications. The Lewiston plant, along with the other two centers of competence in Singapore and Malmö, Sweden, has been accredited to ISO 13485:2003. Segregated manufacturing lines to reduce the risk of cross contamination, and segregated storage and change-control processes ensure consistency. Every lot of raw materials, including pigments, additives and polymers, are spectroscopically analyzed to confirm chemical composition and the absence of contamination against the documented standard for that material.

Additional Clariant services to help customers more easily comply with local regulatory requirements include documentation support in line with FDA guidelines, covering relevant product safety and compliance documentation and information on potential leachables and extractables. The company operates an open-to-audit policy and fully traceable production.

COLOR CRITICAL

Color is becoming an increasingly important differentiator in making off-the-shelf applications stand out or aiding identification for safety purposes. 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. Medical products, therefore, become much like any other consumer product, with color and other visual elements becoming increasingly important in the design of both devices and packaging.

MEVOPUR-brand products and Clariant’s global team of medical application specialists help to minimize risk at every stage of design, production and approval. Professionals from R&D, production, sales and marketing, and customer service, work closely with individual customers from the concept stage through to production to pre-test materials and assess risk in order to develop compliant, targeted color and functionality for each application.

Besides color masterbatches, the MEVOPUR product family includes pre-colored compounds ready for processing, and performance-enhancing solutions. These include the latest surface engineering developments, providing functions such as laser marking, friction-reducing solutions, and radiopacity used for the manufacture of components that can be visualized when using X-ray fluoroscopic procedures.

Clariant Masterbatches products are marketed under the following global brand names: REMAFIN® olefinic masterbatches and compounds; RENOL® masterbatches and compounds based on engineering resins, styrenics and PVC; CESA® additive masterbatches; HYDROCEROL® chemical foaming and nucleating agents; OMNICOLOR® universal color masterbatches; MEVOPUR® color and performance masterbatches and compounds for medical and pharmaceutical applications. These brand names are registered trademarks of Clariant.

Tritan™ is a trademark of Eastman Chemical Company and TOPAS® is a registered trademark of TOPAS Advanced Polymers GmbH.