PHARMACEUTICAL PACKAGING OEM V I A L S , B O T T L E S & C O N T A I N E R S • Raw materials pre-tested to USP 661.1 and ICHQ3D guidelines • Stabilization during molding and sterilization processes for both opaque and transparent polymer materials • Certified formulations available globally • Offered pre-tested raw materials and produced in an ISO 13485 certified site, minimizing risk across the pharmaceutical value chain • Delivered specialized formulated solutions to meet stringent pharmaceutical packaging requirements • Provided global formulations transferrable from our three ISO 13485 certified facilities Mevopur™ Healthcare Concentrates KEY REQUIREMENTS WHY AVIENT? AVIENT SOLUTION CERTIFICATION + AVAILABILITY LEARN MORE © 2021, Avient Corporation, All Rights Reserved https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/mevopur-custom-colors-and-formulations

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.”

Global ISO Certificate Library

View PDF The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. 70 01 _1 /A pr il 20 22 /V er si on 2 .0 Certificate Avient Colorants MX S.A. de C.V. Normative base ISO 22000:2018 Food Safety Management Systems - Requirements for any organization in the food chain Reg. no. 46389 Page 1 of 1 Validity 25. 02. 2024  – 24. 02. 2027 Issue 20. 12. 2023  A.Grisard, President SQS F.

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.

Produced under rigorous cGMP and medical manufacturing protocols, the new amber color concentrates are made in three dedicated EN ISO 13485-2016 registered facilities using only medical-grade ingredients. They are formulated without animal-derived substances and phthalates, and have been pre-tested for compliance with: •    ISO 10993-1 and USP parts , (including class VI) •    European Pharmacopoeia, monograph 3.1.15 •    USP and •    elemental analysis, as per ICH Q3D

CSA International is an independent product safety certification organization that helps achieve compliance with US and Canadian standards.  Avient currently has twenty-three facilities globally certified to the Corporation’s GMP program and two facilities certified to "ISO 13485, Medical Device - Quality Management Systems - Requirements for Regulatory Purposes." Global ISO Certificate Library

2023 CDP Certification Global ISO Certificate Library

In order to receive certification, an ACC member or Partner company must demonstrate conformance to the Responsible Care Management System’s comprehensive set of EHS&S requirements, which are validated through an independent, third-party audit process. Global ISO Certificate Library

CERTIFIED FOR ACCURACY AND RELIABILITY Our PCF Calculator is third-party certified by TÜV Rheinland and aligns with the ISO 14067:2018 standard for quantifying and reporting the carbon footprint of a product. This certification ensures that our tool meets rigorous criteria and addresses relevant safety aspects, providing you with reliable and accurate data.