23 Sep 2019
Clariant MEVOPUR® Medical Compounding Plants Certified Compliant with New ISO 13485 Standard
• ISO 13485-2016 becomes mandatory for device manufacturers requiring CE mark under European Medical Device Regulation
• Compliant suppliers reduce risk for users of plastic materials
• Global network with back-up supply from three sites in U.S.A., Europe and Asia
• Expansion to further sites planned
Shanghai, September 23, 2019 – Clariant Plastics & Coatings, a world leader in masterbatch and compounds, recently announced that its facilities in Lewiston Maine, Malmo Sweden, and Singapore, have been certified to the stringent new quality standard for makers of plastic medical devices. The plants produce specialized polymer compounds and masterbatches offered for medical applications under the MEVOPUR® brand.
After a 3-year transition period during which manufacturers could continue following an earlier version, ISO 13485-2016 went into full effect earlier this year. Device submissions under the old version will no longer be allowed, and will also impact existing products on the market as the new European Medical Device Regulation (MDR) EU2017/745 and In-Vitro Diagnostics Regulation (IVDR) EU2017/746 enters effect in May 2020.
Although ISO 13485 technically only applies to producers of medical devices, it is seen as an important standard for their suppliers, like Clariant, because it helps reduce risks such as risk of changes in raw materials impacting device performance, reliability, or regulatory compliance. Increased use of QbD (Quality by Design) processes means that more consideration needs to be given to materials used and impact on patient safety. Also, for the first time, the requirements are more closely aligned with the US FDA 21 CFR part 820.
“With the introduction of the new standard and increased assessment of risk related to materials and change management, medical device and pharmaceutical companies may need to re-evaluate their reliance on the materials and methods of the past,” explains Steve Duckworth, Head of the Global Medical and Pharmaceutical Segment for Clariant Plastics & Coatings. “Increasingly, they will need to ensure trust by using expertise coming from materials suppliers – like Clariant -- who have a good understanding of and products adapted to the needs of the healthcare market.
Clariant began introducing the MEVOPUR® family of products and services more than a decade ago, to help minimize risk at every stage of a medical device’s life cycle. A global team of specialists from R&D, production, sales and marketing, and customer service, works closely with individual customers to pre-test materials and assess risk in order to build compliant, targeted color and functionality into each application.
The three global facilities, almost entirely dedicated to medical and pharmaceutical applications, provide assurance of consistency in formulations and procedures, and supply-chain reliability for all MEVOPUR products. Raw materials are pre-tested to standards commonly required for device and drug filings, e.g.: USP <87><88> (‘USP Class VI’) and ISO10993, as well as the USP<661.1>, ICHQ3D and European Pharmacopeia monographs 3.1 covering drug packaging and delivery devices. Segregated storage and manufacturing lines, plus scrupulous change-control processes, reduce the risk of cross contamination.
Despite the knowledge gained during implementation and auditing of the original ISO13485 standard, the new ISO 13485-2016 standard presented additional challenges, however. For example, for the first time, computerized systems needed to be risk-assessed, and then the appropriate validation or verification activities carried out. Even if software is not directly controlling processes, it often presents in test equipment used to control raw materials or end-product quality. The project to implement the new version ISO13485-2016 was conducted on a global basis with local site quality managers supported by Clariant’s dedicated Global Quality & Regulatory manager for the healthcare sector.
ASIA PACIFIC REGION CAPABILITY
Compliance with the new ISO 13485-2016 standard for medical, along with ISO22000 for food contacting materials emphasizes the focus on quality and risk reduction at Clariant regional competence center in Singapore. The site develops and supplies MEVOPUR products across the Asia Pacific region including China covering color and modified compounds and masterbatch concentrates in resins from PP to high temperature resins such as PPS and PPSU.
Given the success of the MEVOPUR portfolio, Clariant’s team is committed to extending the ISO13485-2016 coverage to other sites.
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Clariant is a focused and innovative specialty chemical company, based in Muttenz near Basel/Switzerland. On 31 December 2018 the company employed a total workforce of 17 901. In the financial year 2018, Clariant recorded sales of CHF 4.404 billion for its continuing businesses. The company reports in three business areas: Care Chemicals, Catalysis and Natural Resources. Clariant’s corporate strategy is based on five pillars: focus on innovation and R&D, add value with sustainability, reposition portfolio, intensify growth, and increase profitability.
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