ISO 13485 certified manufacturing sites ISO 10993 and USP Class VI compliant solutions

Mevopur™ Healthcare Colorants, Functional Additives, and Bio-based Formulations: Manufactured across a global network of ISO 13485 facilities, this broad portfolio is pre-tested to United States Pharmacopeia (USP) Class VI, ISO 10993, USP 661, European Pharmacopeia 3.1, and International Conference on Harmonization (ICH) Q3D protocols.

For example, regulations in food-contact applications include EU 10/2011 (Plastics Implementation Measures, Europe), National Standards (GB, China), and regulations established by the Food and Drug Administration (FDA, USA).

DYNAFLEX(TM) G7940-9001-02 BLACK

XB424.3 PPO6730-9001 PPSU WHT HC

Certificate Number: 255 ISO2P Date First Registered: 03/04/2023 Issued on: 11/04/2023 Valid until: 10/04/2026 Awarded to AVIENT PAKISTAN (PVT) LTD 1A/1, Sector#20, Korangi Industrial Area, Sector 20 Karachi, Pakistan In recognition of the Organization´s Food Safety Management System which complies with : ISO 22000:2018 Food Category : I For the scope of activities described below: Manufacturing & Processing of Polymer Resins & Master batch F-3/22/ A 100 Issue date : 06/2022 Version:03 It is mandatory to carry out the surveillance audit on its time.

ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D and USP and evaluations reduce risk of non-compliance during regulatory submission​

Global ISO Certificate Library

Commercially available in the United States, it has been submitted for USP VI and ISO 10993-4,5 certifications.

OnColor™ HC Colorants for Healthcare: color concentrates developed to meet or exceed USP Class VI and ISO 10993 and formulated without heavy metals, phthalates and BPA or other requirements as specified