Global network of ISO 13485 certified manufacturing sites ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D evaluations reduce risk of non-compliance during regulatory submission MEVOPUR™ ISO 6009 Standard/Customized Solutions met compliance requirements and improved quality for needle hub, cover and shield

In addition, Avient has externally certified EHS&S management systems, including ISO 9001 worldwide. ISO 14001, Responsible Care 14001, ISO 45001, ISO 50001, and OHSAS 18001, certification at 74% of facilities. In addition, Avient has ISO 9001 worldwide and ISO 14001 and ISO 50001 certification at many facilities.

In addition, Avient has externally certified EHS&S management systems, including ISO 9001 worldwide. Additionally, 52% of our facilities are certified to ISO 14001, 56% to Responsible Care 14001 and ISO 45001, and 10% of our high energy sites are certified to ISO 50001. In addition, Avient has externally certified EHS&S management systems, including ISO 9001 worldwide.

Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for identification and differentiation Color and additive solutions based on biopolymers pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICHQ3D protocols to reduce product carbon footprint Flexible, durable, and colorable TPEs for improved grips and gaskets that comply with USP Class VI and ISO 10993

Mevopur™ Healthcare Colorants and Formulations: a range of medical grade concentrates and pre-colored formulations for a wide range of polymers used in applications such as remote patient monitoring, circulating blood contact, and invasive devices, with pre-tested biocompatibility according to ISO 10993, change control in place, production certified to ISO 13485-2016 and DMF/MAF files available Colorant Chromatics™ Transcend™ Premier Healthcare Colorants: high-temperature solutions offered in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety

All Mevopur formulations are manufactured across a global network of ISO 13485 facilities, and they meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661, European Pharmacopeia, and ICH Q3D. They are available in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards.

To find more details about our certifications, visit our ISO Certifications Library. Avient has 104 global manufacturing facilities. 96% of these sites are certified through independent third parties to management system standards including ISO 14001, ISO 9001, RCMS and RC 14001. ZERO Major Non-Conformances at ISO Sites 96% Manufacturing Sites Certified to an International Standard 1,000+ Product Carbon Footprint Calculations Completed HOME | Contents | Message from the CEO | About Us | People | Products | Planet | Performance | Metrics | Index Sustainability Report | 2022 52Sustainability Report | 2022 52 https://www.avient.com/company/policies-and-governance-0/global-iso-certificate-library https://www.avient.com/company/policies-and-governance-0/global-iso-certificate-library https://www.certipedia.com/certificates/C01-2023-03-21257059?

Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards. Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards.

Because Transcend is fully bio-compatible per ISO 10993 standards, we’re helping customers speed up development and market introduction. They are tested to ISO 10993 standards and can be customized with the addition of functional additives to enhance product performance.

XB424.3 PPO6730-9001 PPSU WHT HC Certificate of Analysis (COA) - labeled as "Material"