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 Singapore Pte Ltd 8 Third Chin Bee Road Jurong Industrial Estate Singapore 618684 Singapore Scope Category I Production of customer specific Masterbatches for Food packaging materials on the dedicated extrusion lines Normative base ISO 22000:2018 Food Safety Management Systems Requirements for any organization in the food chain Reg. no. 46390 Validity 25. 02. 2021 – 24. 02. 2024 Issue 30. 06. 2021 Swiss Made sqs.ch F.

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.”

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 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.

This includes information when you sign up to learn more about becoming a supplier; or when you request documentation regarding SDS, ISO, REACH, ROHS, or UL documentation. Global ISO Certificate Library

Geon(TM) DB5323 Neutral TT Imp-Iso No-Stab Geon(TM) DB5324 Neutral TT Imp-Iso Stab Certificate of Analysis (COA) - labeled as "Material"

MAUVE DOOR, ISO FIX COVER HAZEL DOOR, ISO FIX COVER V2 Certificate of Analysis (COA) - labeled as "Material"

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

Biocompatibility: Our PEEK solutions have passed ISO 10993 biocompatibility testing, ensuring safety and reliability for medical applications. Passed ISO 10993 biocompatibility testing, suitable for medical use