https://www.avient.com/news/avient-feature-specialty-technologies-and-services-healthcare-mdm-west-2023
Manufactured across a global network of ISO 13485 facilities, they meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661, and ICH Q3D.
Like other Mevopur formulations, they are manufactured in dedicated ISO 13485 facilities and supported by testing to ISO 10993-1, USP, European Pharmacopeia, and ICH Q3D guidelines.
They are 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.
https://www.avient.com/news/avient-develops-new-dairy-packaging-additive-technology-meet-tio2-restrictions
POMMERLOCH, Luxembourg – August 25, 2020 – Avient Corporation, a premier provider of specialized and sustainable material solutions and services, today announced availability of a new light blocking additive technology for PET dairy packaging as an addition to its existing portfolio of ColorMatrix™ Lactra™ light blocking additive concentrates.
https://www.avient.com/news/oncap-aversive-masterbatch-additives-polyone-receive-biocidal-product-regulation-authorization-europe
POMMERLOCH, Luxembourg – October 1, 2018 – Wire and cable OEMs rely on PolyOne’s industry-leading OnCap™ Aversive masterbatch additives to produce jacketing that resists insect and animal attacks.
https://www.avient.com/news/polyone-sustainability-portfolio-europe-expanded-support-circular-economy
POMMERLOCH, Luxembourg – June 17, 2020 – Today, PolyOne announced it is adding production of both post-industrial recycled nylon grades (Nymax™ PIR) and bio-based thermoplastic elastomers (reSound™ OM) in Europe.
https://www.avient.com/news/polyone-launches-new-eccoh-lsfoh-grades-optical-fiber-cables
POMMERLOCH, Luxembourg – June 18, 2020 – PolyOne today launched new specialized polymer grades with enhanced chemical resistance and improved productivity for optical fiber cables (OFC).
https://www.avient.com/news/molded-color-parts-replace-metallic-paint-suv-center-console-housing
POMMERLOCH, Luxembourg – May 25, 2020 – PolyOne recently collaborated with a leading global automotive OEM and its injection molder to eliminate paint from a new vehicle’s interior.
https://www.avient.com/news/polyone-expands-lineup-pre-certified-biocompatible-healthcare-colorants-and-additives
These colorants and additives are pre-certified to meet USP Class VI or ISO 10993 biocompatibility testing for global healthcare applications, such as medical devices, pharmaceutical, and health & wellness products.
We can now offer expanded resin families that incorporate biocompatible functional additives, in both masterbatch and compounded forms, that meet or exceed industry standards for USP Class VI or ISO 10993 biocompatibility testing.”
https://www.avient.com/news/specialty-polymer-solutions-avient-improved-durability-and-sustainability-healthcare-products-pharmapack-2023
All materials in this range are formulated to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS.
All the materials are manufactured in ISO 13485-2016 certified sites and supported by testing to ISO 10993-1, USP, EP, and ICH Q3D protocols.
https://www.avient.com/products/polymer-additives/healthcare-additives/mevopur-healthcare-functional-additives
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
https://www.avient.com/company/policies-and-governance-0/avients-human-rights-policy
Global ISO Certificate Library