Clariant MEVOPUR medical compound factory passed the latest ISO13485 certification

◆According to the "European Medical Device Regulations", equipment manufacturers applying for the EU CE certification mark must comply with the ISO 13485-2016 standard

◆Compliant suppliers reduce risks for users of plastic materials

◆Supplies from three bases in the US, Europe and Asia will support the global business network

◆Plan to expand to other bases

Clariant's Plastics & Coatings business today announced that three of its factories in Lewiston, Maine, USA, Malmö, Sweden and Singapore have been certified to a stringent new quality standard for manufacturers of plastic medical devic.

New standards related to medical devices come into effect one after another

During the three-year transition period, manufacturers can continue to use the previous version of the quality standar.

In addition, the new European Medical Devices Regulation (MDR) EU2017/745 and In Vitro Diagnostics Regulation (IVDR) EU2017/746 will come into force in May 2020, and existing products on the market will also be affect.

From a technical point of view, ISO 13485 is only applicable to medical device manufacturers, but for their suppliers, such as Clariant, it is still an important standard because it helps reduce various risks, Includes the risk of changes in raw materials that affect equipment performance, reliability, or complian.

Greater use of Quality by Design (QbD) processes means more consideration of the materials used and their impact on patient safe.

Steve Duckworth, Director, Global Medical and Pharmaceutical Business Chain, Plastics & Coatings, Clariant explained: “With the introduction of new standards and the increased risk assessment associated with materials and change management, medical device and pharmaceutical companies may need to reassess their past reliance on materials and metho.

Clariant started more than a decade ago with the MEVOPUR® range of products and services designed to minimise the risks of medical devices at all stages of their life cyc.

The three global plants are almost entirely dedicated to medical and pharmaceutical applications, ensuring consistency of formulations and procedures for all MEVOPUR products and supply chain reliabili.

Factory raw materials are pre-tested to standards commonly required for device and drug applications, including: USP <87> <88> (USP Class 6) and ISO10993, and USP <661>, Guideline for Elemental Impurities ICHQ3D and Chapter 1 of the European Pharmacopoeia (EP) dealing with pharmaceutical packaging and delivery equipme.

Despite the experience gained during the implementation and review of the original ISO 13485 standard, the new ISO 13485-2016 standard also presents new challenges for the indust.

For example, for the first time, risk assessment of computerized systems and appropriate validation or verification operations are propos.

Clariant has initiated plans to implement the new ISO 13485-2016 standard globally, and has asked the dedicated global quality and regulatory managers of Clariant's healthcare business to support the work of the quality managers at each si.

Capacity in Asia Pacific

In order to comply with the new ISO 13485-2016 medical standard, as well as the ISO22000 standard for food contact materials, the Clariant Regional Competence Centre in Singapore has a high focus on product quality and risk reducti.

The site is responsible for the development and supply of MEVOPUR products for the Asia Pacific region, including China, covering color and modifying compounds and masterbatch concentrates in resins including polypropylene (PP) as well as polyphenylene sulfide (PPS) and High temperature resins such as polyphenylsulfone (PPS.

Given the success of the MEVOPUR product portfolio, the Clariant team is working on rolling out the ISO13485-2016 standard to other sit.