Bringing distinctive style to medical devices while ensuring safety and regulatory compliance

Muttenz, November 4, 2010 - 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 color 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 minimize risk at every stage of design and production.

Recognizing these evolving requirements, Clariant Masterbatches is now perfectly positioned to help brand owners and designers navigate the tricky waters of a product development in the pharmaceutical and medical industry. Under the motto “Controlled, Consistent, Compliant,” its new MEVOPUR® brand of medical masterbatches and compounds are produced in three global centers of competence accredited with ISO 13485. At the same time, ColorWorks™ design and technology centers have a history of helping designers transform their creative ideas into successful products. Together with Clariant’s unparalleled knowledge of color, special effects, polymers and processing, these resources can be invaluable to customers in the medical and pharmaceutical market.

For example, consider the pharmaceutical company who came to Clariant for assistance with a device that delivers a drug via transdermal spray. The device delivers a controlled-dose spray through a cone that confines the spray to a small area of skin. Because the pharmaceutical comes into contact with the device during use, the plastic materials would need to meet strict regulatory standards. This needed to be balanced with designing a device that is attractive to the women in the target market. In developing a product with this balance, manufacturers today are taking a lesson from the personal care industry and creating devices that look more like a cosmetics package than a medical device. By making the shape and color of devices more feminine a user would be comfortable keeping the device in a shoulder bag or purse. As these devices are generally mass-produced by injection molding, it is important also to ensure that all the components – like the snap-on dust cover for the transdermal-spray cone – fit together consistently.

When so many challenging criteria need to be met, it is very important to make decisions about color early in the design process. Fortunately, in this instance the pharmaceutical company understood this and arranged for a team – drawn from its own staff and the firm that would develop the tooling and mold the parts – to visit Clariant ColorWorks in Holden, Massachusetts, USA. This facility is one of Clariant’s seven design and technology centers located strategically around the world where designers and project managers can realize their creative ideas in plastics, while shortening time to market and reducing costs. At ColorWorks, the team tapped into Clariant’s deep knowledge of pigments and medical regulations and, very quickly arrived at an effective solution.

From the wide array of colors and effects for plastics displayed at the facility, the professional team was able to identify several characteristics that would be both practical and appealing. To maximize appeal to women, the team initially considered including a pearlescent special effect along with a soft, pastel color. However, if the plastic resin and the color and effects components are not correctly matched, the result might be less than ideal. Not only do the plastics resin, the color and the effects components need to be totally compatible, the injection mold must be optimized to achieve proper flow and minimize potential for cosmetic flaws, which will be accentuated by the pearlescent effect.

Fortunately, this is exactly the kind of challenge that ColorWorks was created to address. First, the designers assess various color and effects options by browsing through Clariant’s Wall of Color, the ENIGMA® special effects presentation, the latest ColorForward™ analysis of consumer trends and preferences, and other materials assembled to inspire creative thinking and problem solving. Once some basic choices are made, the ColorWorks technicians can develop three-dimensional computer renderings of what a device might look like using different color/effect combinations. Color chips and sample moldings are produced to present the selected colors in injection-molded parts, and flow-simulation software can be used to help predict where weld lines might occur so that the tooling design could be adjusted make them less noticeable.

In just two days, the team arrived at a color and a design that would not only be attractive, but could meet regulatory requirements and help facilitate production. The masterbatch was produced in Lewiston, Maine, in one of three global Clariant competence centers specially created and accredited to produce plastic materials for the medical and pharmaceutical industry. Here, Clariant is able to deliver its “Trusted Color and Performance” package of dedicated products and support designed to help customers’ control risk in medical device manufacture and pharmaceutical packaging.

The medical manufacturing centers are a new innovation for the market aimed at device manufacturers that have made it clear they could benefit from a higher level of service. Since 2008, Clariant has invested in three sites: the one in Lewiston, USA, another in Malmö, Sweden, and one in Singapore. All three sites have completed ISO13485 certification, recognizing a globally harmonized quality management system that supports sector’s need for consistency and reliability of formulation and manufacturing practices.

These three production sites are being linked to the ColorWorks centers so that companies – like the manufacturer of the transdermal spray device mentioned above –are helped 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), and the ISO10993 standards.

Clariant’s product solutions cover a wide range of polymers including PE, PP, ABS, SAN, PC/ABS, PC, polyester co-polymers (e.g., Eastman’s Tritan™) PA 6, 66 and 12, as well as high-performance polymers and thermoplastic elastomers including EVA, SEBS, TPU, polyester-based elastomers (e.g., Du Pont’s Hytrel®) and PEBA.

As Steve Duckworth, Global Head of Consumer Medical and Pharmaceutical, and project leader at Clariant, explains, “Clariant’s package of dedicated service and expertise, product reliability and innovative material performance is focused on giving the medical industry the confidence it needs to address risk potential. As a result, medical device manufacturers can trust Clariant to meet all of their color and performance needs.”

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 and ENIGMA® are all registered trademarks and ColorForward™ and ColorWorks™ are trademarks of Clariant. Tritan™ is a trademark of Eastman Chemical Company and Hytrel® is a registered trademark of E. I. du Pont de Nemours and Company.

Please visit www.medical.clariant.com.

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