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 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.
