Global ISO Certificate Library

Global ISO Certificate Library

Global ISO Certificate Library

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.

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.

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

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.

C e rt if ie d M an ag ement System s by Sw itze rla nd Certificate The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. Avient Colorants Germany GmbH Hohenrhein 1 56112 Lahnstein Germany Scope Production of Color Concentrates and Compounds Normative base ISO 50001:2018 Energy Management System Reg. no. 46089 Validity 17. 12. 2020 – 16. 12. 2023 Issue 12. 04. 2021 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.

View PDF The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. 7 0 0 1 _1 /A p ri l 2 0 2 2 /V er si o n 2 .0 Certificate Avient Colorants Germany GmbH Kornkamp 50 22926 Ahrensburg Germany Scope Production of Color- and Additives Concentrates, Compounds and Foaming Agents Normative base ISO 50001:2018 Energy Management System Reg. no. 46090 Page 1 of 1 Validity 20. 01. 2024  – 19. 01. 2027 Issue 20. 01. 2024  A.Grisard, President SQS F.

C e rt if ie d M an ag ement System s by Sw itze rla nd Certificate The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative basis mentioned. Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 46154 Validity 12.01.2022 – 11.01.2025 Issue 12.01.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland F.