Clariant achieves ISO 13485 milestone for medical, pharma sector

10 Jun '10

3 min read

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.

Clariant's approach is particularly significant in light of the ever-tightening performance and regulatory standards affecting manufacturers' responsibilities towards the materials used in the production of medical devices and pharmaceutical packaging.

The competence centers offer full manufacturing line dedication and segregation to minimize risk of cross contamination between products and strive to deliver the purity 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 Class VI, Part 87 and 88, and ISO 10993, and specific training procedures for equipment, laboratory, and quality control operators.

“Clariant's goal is to help customers more easily comply with regulatory requirements while meeting the latest industry trends for surface functionality and aesthetics,” comments Steve Duckworth, Head of Global Marketing Segment Consumer Goods and Medical at Clariant Masterbatches. “While it is by no means a must-have for a raw material supplier to demonstrate ISO 13485 accreditation, it however reinforces the focus of our facilities and systems that already govern the production ofour medical color and performance masterbatches and compounds. It provides further proof and reassurance of Clariant's commitment to this industry and our goal to ensure that our materials are manufactured to the high standards customers will require in this environment of ever-tightening regulations within their industry.”

Clariant is a global leader in the field of specialty chemicals. Strong business relationships, commitment to outstanding service and wide-ranging application know-how make Clariant a preferred partner for its customers.

Clariant International Ltd

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