As the world's leading manufacturer of masterbatches and modifiers, Clariant's Plastics & Coatings business recently announced that its plants in Louiston, Maine, Malmo, Sweden and Singapore have all approved plastic medical device manufacturers Strict new quality standard certification. These plants specialize in the production of medical polymer modifiers and masterbatches under the MEVOPUR® brand.
During the three-year transition period, manufacturers can continue to adopt the quality standards of the previous version. But at the beginning of this year, the new ISO 13485-2016 standard has come into full effect. Applications for equipment certification according to the old version will no longer be processed. In addition, existing products on the market will also be affected as the new European Medical Device Regulation (MDR) EU2017 / 745 and the In Vitro Diagnostic Regulation (IVDR) EU2017 / 746 come into effect in May 2020.
From a technical perspective, ISO 13485 is only applicable to medical device manufacturers, but for their suppliers, such as Clariant, this is still an important standard because it helps reduce risks, Includes the risk of material changes that affect equipment performance, reliability, or compliance. The increased use of Quality by Design (QbD) processes means that more consideration needs to be given to the materials used and their impact on patient safety. In addition, for the first time, these requirements have moved closer to the requirements of 21 CFR Part 820 of the US Food and Drug Administration (FDA).
Steve Duckworth, Clariant Plastics & Coatings Global Medical and Pharmaceuticals Business Chain Director, explains: "As new standards are introduced and risk assessments related to materials and change management are intensified, medical device and pharmaceutical companies may need to reassess their past dependencies Materials and methods. They increasingly rely on the expertise of material suppliers like Clariant to ensure that their product quality is trustworthy because they have a strong understanding of the healthcare market and have a range of products that meet that market. Products you want. "
More than a decade ago, Clariant launched the MEVOPUR® family of products and services designed to minimize the risk of medical devices at all stages of their life cycle. A global team of experts from R & D, production, sales and marketing and customer service work closely with individual customers to pre-test materials and conduct risk assessments to build compliant, targeted colors and features for each application.
These three global factories are almost exclusively dedicated to medical and pharmaceutical applications, ensuring consistency in the formulation and procedures of all MEVOPUR products and reliability in the supply chain. Factory raw materials are pre-tested in accordance with the standards commonly required for device and drug applications. These standards include: USP (USP Level 6) and ISO10993 standards, as well as USP <661.1>, elemental impurity guidelines ICHQ3D and related drug packaging and Section 3.1 of the European Pharmacopoeia (EP) of the transmission equipment. The risk of cross-contamination is reduced through the isolation of storage and production lines, and strict change control processes.
Despite the experience gained during the implementation and review of the original ISO13485 standard, the new ISO 13485-2016 standard also poses new challenges to the industry. For example, for the first time, a risk assessment of a computerized system has been proposed and appropriate validation or verification operations carried out. Even if software does not directly control the process flow, it often appears in test equipment used to control the quality of raw materials or end products. Clariant has launched plans to implement the new ISO13485-2016 standard worldwide, and asked Clariant's dedicated global quality and regulatory managers for healthcare operations to support the work of quality managers at each site.
Asia Pacific Capacity
In order to comply with the new ISO 13485-2016 medical standard and the ISO 22000 standard for food contact materials, the Clariant Regional Competence Center in Singapore pays high attention to product quality and risk reduction. The base is responsible for the development and supply of MEVOPUR products for the Asia-Pacific region, including China, covering color and modification compounds and masterbatch concentrates in resins including polypropylene (PP) and polyphenylene sulfide (PPS) and High temperature resins such as polyphenylsulfone (PPSU).
Given the success of the MEVOPUR product portfolio, the Clariant team is working to promote the ISO13485-2016 standard to other bases.