Home / Knowledge / News / Clariant achieves ISO 13485 milestone for medical, pharma sector
Clariant achieves ISO 13485 milestone for medical, pharma sector
10
Jun '10
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


Must ReadView All

Courtesy: Raymond

Apparel/Garments | On 28th Jun 2017

Raymond plans to invest Rs 1,400 crore in Amravati plant

Raymond, Indian textiles and apparel major, has decided to invest Rs...

Textiles | On 28th Jun 2017

GST and textiles industry: Analysis and opinion

The Goods and Services Tax (GST) is at long last all set to be rolled ...

Textiles | On 28th Jun 2017

India probing dumping of polyester yarn by China

Indian government is probing anti-dumping allegations against a...

Interviews View All

Smith Vaghasia
Sanado India

Online remains the best destination for shopping

Abhimanyu Singh Rathore & Barbara Anna Kosiorek
Kannbar

‘Blending cultures is the true beauty of fashion, where one’s imagination...

Shiladitya K Joshi
Truetzschler India Private Limited

India ITME provides a platform to interact with our stakeholders

Larry L Kinn
Suominen Corporation

Larry L Kinn, Senior Vice President - Operations Americas of Suominen...

Kai Poehler
Voith Paper GmbH & Co. KG

The glass mat industry is growing by five to eight per cent annually. Kai...

Silke Brand-Kirsch
Schlegel und Partner

Silke Brand-Kirsch, executive partner of Schlegel und Partner, a leading...

Bani Batra

Bani Batra’s couture wedding collection is inspired by traditional Indian...

Judy Frater
Somaiya Kala Vidya

Among the many honours showered on Frater, including Fulbright and Ford...

Sonam & Paras Modi
SVA

Sonam and Paras Modi's Sva Couture is synonymous with head-turning...

Press Release

Press Release

Letter to Editor

Letter to Editor

RSS Feed

RSS Feed

Submit your press release on


editorial@fibre2fashion.com

Letter To Editor






(Max. 8000 char.)

Search Companies





SEARCH

news category


Related Categories:
July 2017

July 2017

Subscribe today and get the latest update on Textiles, Fashion, Apparel and so on.

SUBSCRIBE


Browse Our Archives

GO


E-News Insight
Subscribe Today and Get the
Latest News Update in Your Mail Box.
Advanced Search