The formation of this sector-specific organization demonstrates Clariant's commitment to provide application knowledge and product expertise tailored to the specific requirements and challenges of the medical device and pharmaceutical packaging industries. In particular, it will support customers in meeting the increasingly strict controls governing end-product ingredients and manufacturers' need to minimize risk at every stage of design, production and product approval.
The new Medical and Pharmaceutical team includes:
•A dedicated commercial team with market segment heads in each global region to provide better customer support, and a good understanding of specific requirements. This team will be strengthened with local and regional appointments to the sales, market development, production site and technical functions as required.
•Dedicated medical and pharmaceutical technical managers at each of Clariant's three ISO-13485-certified sites. In conjunction with professionals from R&D, production, sales and marketing, and customer service, they 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.
•A dedicated global manager is being added, with responsibility for the ISO13485 quality system and the specific regulatory requirements across the three sites. This emphasizes Clariant's commitment to the unique needs of the segment. This person will be responsible for the ISO13485 quality system and the specific regulatory requirements across the three sites, also functioning as an expert resource for both the Clariant team and medical and pharmaceutical customers.
The MEVOPUR-branded color masterbatches, pre-colored compounds, standard color ranges and performance-enhancing solutions are produced under controlled, consistent and compliant conditions to help customers achieve appearance and performance enhancement for their medical device or packaging application while ensuring regulatory acceptability.
MEVOPUR uses raw materials that have been biologically evaluated against USP parts 87 and 88 (Class VI devices) and/or the international standard ISO10993. Segregated manufacturing lines help reduce the risk of cross contamination, and segregated storage and change-control processes ensure consistency.
Additional Clariant services to help customers more easily comply with local regulatory requirements include documentation support that is consistent with FDA guidelines. This includes 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.
George Pape, Medical Device and Healthcare Market Manager for North America, Clariant, comments: “Having a dedicated global medical device and pharmaceutical segment will enable us, in North America, to increase our support to our sales team, market development and technical specialists, and to the production and development facilities at Lewiston, Maine. This is our dedicated medical site certified with the same ISO 13485 quality management system, which is used by most US device manufacturers. For our North American customers, this will ensure we have the field and production capabilities to support customer development projects and meet the significant growth in demand we are experiencing for the color and functionality benefits of MEVOPUR.”
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.