Clariant Masterbatches appoints regulatory and ISO 13485 expert to Medical and Pharmaceutical team

Muttenz, 22 March 2011 – Clariant Masterbatches reaffirms its commitment to the unique needs of its medical device and pharmaceutical packaging customers with the appointment of a dedicated global regulatory and ISO 13485 manager to its new Medical and Pharmaceutical segment.

Dr. Gunther Luebke will be responsible for the ISO 13485 quality system and overseeing the specific regulatory requirements across Clariant’s three sector-dedicated ISO 13485 certified global sites in Lewiston (ME) in the USA, in Malmö in Sweden and in Singapore.

He will provide an expert resource for both the Clariant team, and medical and pharmaceutical customers in meeting the increasingly strict controls governing end-product ingredients within this sector. The creation of this role underlies Clariant’s on-going efforts to support manufacturers in minimizing risk at every stage of design, production and product approval.

Gunther Luebke comes with extensive experience in polymers / additives as well as Product safety and general regulatory issues. He was previously part of Clariant's expert team within the Masterbatch Business Unit on REACH.

“We are delighted to welcome Gunther Luebke to our Medical and Pharmaceutical team,” comments Steve Duckworth, Head of Global Market Segment Medical and Pharmaceutical. “His appointment demonstrates how seriously we take our role in ensuring our production facilities and development processes meet the stringent controls required by the medical and pharmaceutical sector. It also reinforces our dedication to providing expert support and services to help our customers respond to the increasing regulations affecting their end products, and the need to minimize risk at every stage of their product development and process.”

Clariant’s Medical and Pharmaceutical segment manages the development, production, marketing and technical support for Clariant’s MEVOPUR® color masterbatches and custom performance compounds. These are manufactured exclusively for medical and pharmaceutical

applications.

The MEVOPUR branded color masterbatches, pre-colored compounds, standard color ranges and performance-enhancing solutions are produced under specially controlled, consistent and compliant conditions at Clariant’s three dedicated global ISO 13485 certified sites.

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.

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.