These include ISO pre-certified colorants; FDA-compliant materials from engineering thermoplastics and elastomers to vinyl, styrenics and olefins; RoHS and REACH compliant materials; and much more.

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"

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

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

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 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.

C er ti fi ed M anagement System s by Switzerland 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 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 Validity 20. 01. 2021 – 19. 01. 2024 Issue 12. 04. 2021 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.

C er ti fi ed M anagement System s by Switzerland Certificate The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. Martorell no.124 08740 Sant Andreu de la Barca Spain 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. 46388 Validity 25. 02. 2021 – 24. 02. 2024 Issue 25. 02. 2021 Swiss Madesqs.ch F.

MEDICAL DEVICE MANUFACTURER G U I D I N G C A T H E T E R • Ultra-soft hardness of about Shore 50A • Excellent extrusion performance, achieving a thickness of about 0.1 mm • Smooth surface • Certification for biocompatibility • Delivered an ultra-soft TPU that has good elasticity, abrasion, and tear resistance • Complied with ISO 10993 biocompatible properties • Offered onsite service to support rapid extrusion performance for the customer NEUSoft Thermoplastic Polyurethanes KEY REQUIREMENTS WHY AVIENT?