Lewiston joins Clariant’s facilities at Malmo, Sweden and in Singapore that achieved ISO 13485 earlier this year to complete its pioneering global network of ISO13485 accredited specialist facilities dedicated to the development and production of masterbatches, precolor compounds and radiopaque materials for medical devices and pharmaceutical packaging.
Clariant is one of few suppliers of masterbatches and compounds to achieve this external accreditation of the audited quality management standard widely recognized by the medical and pharmaceutical industry. It is unique in implementing it simultaneously across sites in 3 continents. The network gives Clariant an advantageous position in being able to support customers who implement production across regions from locations operating the same processes and procedures.
Full ISO13485 accreditation was made possible by project teams working over the last 18 months on a local and global basis, directed by the corporate functions. It is the latest step in Clariant’s unique support package for the medical and pharmaceutical industry developed over the last 2 years.
Clariant’s dedicated brand of MEVOPUR® color and performance masterbatches and compounds for medical and pharmaceutical applications was launched to visitors at K 2010.
MEVOPUR is produced at the above ISO13485 certified competence centers, with the possibility of manufacturing line dedication and segregation to minimize the risk of cross contamination between products. Through this, Clarian strives to deliver controlled
consistent and compliant materials required for today’s final applications. Strict controls help to ensure the consistency and reliability of formulations and procedures across the three sites, including change control agreements, standardization of selected raw materials that are pre-tested according to USP Parts 87 and 88 (Class VI), and ISO 10993, and specific training procedures for equipment, laboratory, and quality control operators.
A dedicated organization with a team of specialists further reinforces Clariant’s active commitment to help medical and pharma customers in ensuring compliance in a products development or lifecycle. "The medical and pharmaceutical sectors are operating under an environment of tightening performance and regulatory standards affecting manufacturers’ responsibilities towards the materials used in the design production of medical devices and pharmaceutical packaging, and in particular to control and minimize the risk of changes that can occur in these materials," comments Steve Duckworth, who became Head of the newly formed Global
Segment Medical and Pharmaceutical.
"We firmly believe that our dedicated medical organization, the launch of MEVOPUR and the ISO 13485 project together deliver a giant step forward in giving the industry the confidence it needs to address risk potential and in supporting the future development of
advanced and creative medical devices and pharma packaging. This significant investment will reinforce our position as a trusted supplier of controlled, consistent and compliant materials and support for these highly-demanding segments across the globe, and we are committed to further improvements in this approach."