https://www.avient.com/sites/default/files/2025-02/31307-Certificate-17JUL2024.pdf
Certificate Avient Corporation A B S Q u al ity E va lu at io n s C er tif ic at io n E Certificate Of Conformance This is to certify that the Quality Management System of: Avient Corporation 33587 Walker Road, Building 428 Avon Lake OH 44012 United States has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: ISO 9001:2015 The Quality Management System is applicable to: Manufacture of plastic compounds, color and performance additives, engineered thermoplastics, vinyl resins, custom mixed plastic materials, custom and commodity colorants for plastics, polyurethane systems, and plasticizers with design and sampling support at Suwanee, GA, and purchasing, customer service, logistics, quality, design and sampling support at PolyOne Corporate Headquarters at Avon Lake, OH, and distribution of resins Certificate No: 31307 Certification Date: 12 OCT 1995 Effective Date: 11 JUL 2024 Expiration Date 07 OCT 2025 Revision Date: 17 JUL 2024 Dominic Townsend, President Copyright as of the Effective Date, ABS Quality Evaluations, Inc.
Page 1 of 4 https://abs.ez2xs.com https://abs.ez2xs.com A B S Q u al ity E va lu at io n s C er tif ic at io n E ISO 9001:2015 Certificate Of Conformance ANNEX Certificate No.: 31307 Avient Corporation At the below facilities FACILITY NAME FACILITY ACTIVITY ADDRESS Avient - Birmingham Manufacturing The Manufacture of Pultruded and Filament wound components Pultrusion and CRTM 3943, Valley East Industrial Drive, Buildings 1,2,3,4 Birmingham - AL 35217 United States Avient - Birmingham Manufacturing The Manufacture of Pultruded and Filament wound components Pultrusion and Filament Wound Tubing 3968, Valley East Industrial Drive, Building 5 Birmingham - AL 35217 United States Avient - Birmingham Manufacturing The Manufacture of Pultruded and Filament wound components Pultrusion 3950, Valley East Industrial Drive, Building 6 Birmingham - AL 3517 United States Avient Corporation Management of QMS.
https://www.avient.com/sites/default/files/2023-07/Versaflex HC _ Versaflex HC BIO - BT Series Product Overview.pdf
KEY CHARACTERISTICS • Meets critical need for thermal weldability and kink resistance • Minimizes extractables during processing • Provides excellent tensile strength • Complies with USP VI and ISO 10993-4, -5, -11 certifications • Suitable for gamma and autoclave sterilization methods • Bio-based grade option formulated with nearly 40% Gen 1 biomass content PRODUCT OVERVIEW 1.844.4AVIENT www.avient.com Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/resources/PDI_Healthcare_Brochure_2011_0.pdf
Polymer Diagnostics Inc. 33587 Walker Road Avon Lake, Ohio 44012 United States +1 800 438 2335 +1 440 930 1644 fax Polymer Diagnostics Inc. is a contract laboratory with accreditation to ISO/IEC 17025 by the American Association for Laboratory Accreditation (A2LA) for both chemical and mechanical capacities. 17.2 8 .25 in 8 .5 in 17 C M Y K HC_Industry bulletin_PDI_fi nal.indd REMAY 78810 TR: 16.5000" x 11.6875" and 17.000" x 11.000" Digital/IAM BL: 17.2500" x 11.9375" FINAL: 8.2500" x 11.6875" and 8.500" x 11.000" 11.6875 in 25 in 11.9375 in 8 .25 in 8 .5 in 11 in i n Asset No. 78810 Polymer Diagnostics Inc. is a wholly-owned subsidiary of PolyOne Corporation.
Polymer Diagnostics Inc. 33587 Walker Road Avon Lake, Ohio 44012 United States +1 800 438 2335 +1 440 930 1644 fax Polymer Diagnostics Inc. is a contract laboratory with accreditation to ISO/IEC 17025 by the American Association for Laboratory Accreditation (A2LA) for both chemical and mechanical capacities. 17.2 8 .25 in 8 .5 in 17 C M Y K HC_Industry bulletin_PDI_fi nal.indd REMAY 78810 TR: 16.5000" x 11.6875" and 17.000" x 11.000" Digital/IAM BL: 17.2500" x 11.9375" FINAL: 8.2500" x 11.6875" and 8.500" x 11.000" 11.6875 in 25 in 11.9375 in 8 .25 in 8 .5 in 11 in i n Asset No. 78810
https://www.avient.com/sites/default/files/2024-12/67599-Certificate-06DEC2024.pdf
Certificate Avient Corporation Certificate Of Conformance This is to certify that the Quality Management System of: Avient Corporation 33587 Walker Road Avon Lake OH 44012 United States has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: ISO 9001:2015 The Quality Management System is applicable to: Design and manufacture of colour and additive concentrates, thermoplastic resins and specialty compounds Certificate No: 65799 Certification Date: 01 OCT 2020 Effective Date: 25 SEP 2023 Expiration Date 30 SEP 2026 Revision Date: 06 DEC 2024 Dominic Townsend, President Copyright as of the Effective Date, ABS Quality Evaluations, Inc.
Page 1 of 4 https://abs.ez2xs.com https://abs.ez2xs.com ISO 9001:2015 Certificate Of Conformance ANNEX Certificate No.: 65799 Avient Corporation At the below facilities FACILITY NAME FACILITY ACTIVITY ADDRESS Avient Corporation - Avon Lake, OH Management of QMS, Design and manufacture of colour and additive concentrates, thermoplastic resins and specialty compounds 33587 Walker Road Avon Lake OH 44012 United States Avient (Argentina) SA Administration, Site management, Manufacture, Laboratory (QC and Colormatching), Procurement, Maintenance, Infrastructure, Warehouse and Transport, Sales Av.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives for Bormed Resins Application Bulletin.pdf
MEVOPUR COLORANTS • Standard colors in PP and PE to shorten time-to-market • Custom colors matched to Pantone, RAL or other color reference • White colorants for pharmaceutical packaging for LDPE, HDPE and PP with opacity to reach USP chapter MEVOPUR FUNCTIONAL ADDITIVES • Antistatic formulation with good flow/impact for injection molding • Amide- and amine-free antistatic for film in contact with API (Active Pharmaceutical Ingredients) • UV blocking for transparent PP and PE packaging to meet USP chapter • Non-migrating friction reduction/processing aid for PE and PP • Laser marking/welding additive for fast, reliable marking/assembly • MVTR (Moisture Vapor Transmission Rate) reduction for HDPE to improve shelf-life • Thermal protection of the polymer during processing • Gamma/e-beam sterilization protection for PP (up to 50kGy) with color compensation for reduced yellowing REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request Bormed™ is a registered trademark of Borealis Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2021-03/colorant-chromatics-high-temp-compounds-selection-guide.pdf
COLORANT CHROMATICS HIGH-TEMPERATURE POLYMER FORMULATIONS PRODUCT SELECTION GUIDE COLORANT CHROMATICS HIGH TEMPERATURE COMPOUNDS PROPERTY ISO Test Method Units PES PPSU PEI LCP PEEK PSU PHYSICAL Density 1183 — 1.37 1.29 1.27 1.40 1.30 1.24 Mold Shrinkage Flow/X-flow 294–4 % 0.8/0.85 0.7/XX 0.6/0.7 0/0.7 1.0/1.3 0.7 MECHANICAL Tensile Strength 527 Mpa 85 70 85 200 100 70 Tensile Elongation Yield 527 % 7 7.5 6 — — 6 Tensile Elongation Break 527 % >25 >60 60 3 30 >50 Izod Notched 180 kJ/m2 7 55 5 95 7 5.5 THERMAL HDT 1.8 MPa 75 °C 205 200 190 190 150 175 FLAMMABILITY Flame Rating UL-94 — V-0 V-0 V-0 V-0 V-0 HB ADDITIONAL Steam Sterilizable — Cycles 100 2000 2000 1500 1000 100 CUSTOM OPTIONS Color — — Yes Yes Yes Yes Yes Yes Reinforced — — Yes Yes Yes Yes Yes Yes Conductive — — Yes Yes Yes Yes Yes Yes Lubricated — — Yes Yes Yes No Yes Yes Radiopaque — — Yes Yes Yes No Yes Yes Trade Names — — Veradel Ultrason E Radel Ultrason P Ultem Vectra Zenite Xydar KetaSpire Victrex Vestakeep Udel Ultrason S Avient high temperature precolored and specialty compounds are your solutions for high performance products.
https://www.avient.com/sites/default/files/2023-10/Cesa Laser Additives Laser Welding Product Bulletin.pdf
waterproof watches, and eyewear frames • Healthcare products – ISO and USP pre-tested solutions are sold as Mevopur™ Healthcare Functional Additives BENEFITS • Produces strong, durable, and consistent seams • Available for polyolefins, TPE, ABS, SAN, PA, PC, PMMA, and others on request • Delivered as concentrates or ready-to-use formulations • Can be combined with color into a single product • Specific regulatory compliance available on request, e.g., UL 94 recognition, EU and US food contact • Product guidance from our experts PRODUCT BULLETIN Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2020-09/oncap-hc-product-bulletin.pdf
KEY CHARACTERISTICS • Formulated specifically for healthcare product applications • Wide portfolio of polymer additive solutions, including: - Antimicrobial technology - Surface energy modification, including low retention - Authentication technology - Lasermarking - Sterilization and content protection - Processing optimization - FDA compliant resin and color changeover solutions • OnCap HC Plus certified for USP Class VI and ISO 10993 bio-compatibility requirements; includes anti-oxidant, lasermarking, antimicrobial, radiopacifier, anti-stat, and polymer and gamma stabilization performance additives OnCap™ HC & OnCap™ HC Plus Additives for Healthcare PRODUCT BULLETIN INDUSTRY SUPPORT • Supported with a broad range of technical support and services: - Restricted medical-grade raw material selection process - Sampling program - World-class FDA cGMP manufacturing facilities - Batch traceability and formulation lockdown systems - FDA Drug Master Files or Medical Device Files maintenance MARKETS AND APPLICATIONS OnCap HC and OnCap HC Plus Additives are an excellent choice for medical devices and parts, pharmaceutical or cosmetic packaging, and many other healthcare related polymer applications.
https://www.avient.com/sites/default/files/2020-09/crtm-panel-product-bulletin-2020.pdf
Composite panels for modular ISO shelters, transport containers and pallets TRANSPORTATION Rail car doors, floors and body panels, shipping containers, tractor trailer panels, large trucks, trailers, RVs, and mass transit vehicles MARINE Structural bulkheads, transoms, decks/soles, subflooring, and interior walls www.avient.com Copyright © 2020, Avient Corporation.
https://www.avient.com/sites/default/files/2020-09/cai-healthcare-application-bulletin.pdf
GLOBAL REGULATORY COMPLIANCE Our regional tech centers around the world offer regulatory support and product stewardship expertise to help you qualify your products BIO-COMPATIBILITY APPLICATIONS Bio-compatible additives and colorants, tested under USP Class VI and ISO 10993, allow your materials to achieve required functional performance while meeting brand and color standards STERILIZATION REQUIREMENTS A standard color range and deliberate formulations provide stability under harsh sterilization methods AUTHENTICATION TECHNOLOGY Protect your brands with our Percept™ anti-counterfeit, security and tracking taggant technologies, or utilize radiopacifiers for placement protection LASER MARKING SOLUTIONS Optimized for color and contrast without diminishing physical property characteristics for branding, inventory management, data coding, or universal device identification PRODUCT & PROCESS OPTIMIZATION Maximize production throughput or eliminate waste with solutions including dimensional stabilization, cycle time reducers, chemical foaming agents, nucleation or hybrid technology ONCOLOR™ HC Colorants designed to be healthcare-friendly.