Clariant achieves industry leading ISO 13485 milestone for medical and pharma masterbatches and compounds

09-Jun-2010 - Switzerland

Clariant Masterbatches celebrates an industry milestone with the achievement of ISO 13485 accreditation for its global production plants for masterbatches for the medical and pharma sector. Clariant is pioneering the global implementation of ISO 13485 by masterbatch and compound suppliers with now two of its three specialist regional competence centers attaining external accreditation of the quality management standard for the medical and pharmaceutical industry.

Clariant’s centers of competence are focused on developing and manufacturing color and performance masterbatches and compounds for medical and pharmaceutical applications. Its facilities at Malmö (Europe) and Singapore (Asia) achieved full ISO 13485: 2003 accreditation in April, with project teams working on local and global basis, directed by the corporate functions. The company is on target to complete ISO 13485 at its North America site by the end of Q3 2010, thereby giving Clariant a leading position in being able to support customers from three locations operating the same processes and procedures.

ISO 13485 certification is the latest step in Clariant’s active commitment to helping medical and pharma customers minimize the risks and costs of non-compliance in a product’s development and lifecycle, by demonstrating high standards of product control, consistency and compliance within its own operations. The ISO 13485 standard includes evaluation of risk potential within the processes from formulation of a masterbatch or compound, incoming raw materials, production and finished masterbatch or compound, and establishes controls to address this.

https://www.bionity.com/en/news/118724/clariant-achieves-industry-leading-iso-13485-milestone-for-medical-and-pharma-masterbatches-and-compounds.html