https://www.avient.com/sites/default/files/2025-02/Mevopur White Formulation for PCR Well Plates - Case Study_0.pdf
LABORATORY EQUIPMENT MANUFACTURER P C R W E L L P L A T E S • Very high level of TiO2 to prevent “cross-talk” between the wells during the qPCR fluorescence testing procedure • Minimized background phosphorescence caused by agglomeration of TiO2 and/or oxidized (stressed) polystyrene • Preservation of polystyrene grade properties • Change control of formulation and manufacturing process • Robust product quality from batch to batch • Developed optimally dispersed, ready-to-use white formulation that maintains adequate signal transmission, as well as minimizing “cross-talk” and background phosphorescence • Optimized the use of general purpose polystyrene (GPPS) for a good balance between melt flow and other physical properties, such as stiffness • Provided comprehensive change control of raw materials and formulation, with a robust manufacturing process and quality control under a third party ISO 13485:2016 certified QMS Mevopur Healthcare Colorants and Formulations – pre-colored solution WHY AVIENT?
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.pdf
KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Available as concentrates or ready-to-use formulations in a wide range of polymers • Functionality and color can be combined in one product for convenience 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 • Documentation support for approval or transition to comply with (new) regulations such as IVDR APPLICATION BULLETIN Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2025-02/31307-Certificate-17JUL2024.pdf
Certificate Avient Corporation S E s 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 Page 1 of 4 S E s ISO 9001:2015 Certificate Of Conformance ANNEX Certificate No.: 31307 Avient Corporation At the below facilities 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 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 The Manufacture of Pultruded and Filament wound components Pultrusion 3950, Valley East Industrial Drive, Building 6 Birmingham - AL 3517 United States Corporation Management of QMS.
https://www.avient.com/sites/default/files/2020-08/willowwood-prosthetics-case-study.pdf
After extensive testing, including mechanical testing to ISO 10328 standards and a six-month participant clinical trial, WillowWood introduced DuraWalk™, their most advanced low-activity foot.
https://www.avient.com/sites/default/files/2022-12/Cesa Fiber Additives Antimicrobials Product Bulletin.pdf
PRODUCT BULLETIN KEY BENEFITS Avient’s antimicrobial concentrates for fiber applications provide the following benefits: • High active-ingredient loading which translates to excellent efficacy at low let-down ratios • Easily withstand 50 washings in ISO 20743 standard tests • Also applicable for bi-component technology • Low levels of abrasiveness means higher process performance—reducing cost in the spinning phase • Can be combined with colors and with other additives (e.g., flame retardants) into a single combination concentrate for convenience • Product guidance and technical assistance from our experts Copyright © 2022, Avient Corporation.
https://www.avient.com/sites/default/files/2023-12/Cesa Light Additives for Injection Molding Product Bulletin.pdf
The white ABS plastic samples, produced with and without Cesa Light Additives, were exposed to simulated sunlight conditions using the weathering test ISO 4892- 2:2013.
https://www.avient.com/sites/default/files/2025-01/NEUSoft Product Selection Guide.pdf
Whether your application demands can be supported by the NEUSoft Express color palette or require customization, all our NEUSoft TPUs are designed with patient safety and regulatory specifications in mind, complying with ISO 10993 and USP Class VI standards.
https://www.avient.com/products/thermoplastic-elastomers/versaflex-hc-thermoplastic-elastomers
ISO 10993 & USP Class VI compliant solutions
https://www.avient.com/sites/default/files/2022-08/ISO9001-2015 EN -EM.pdf
Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance Certificate No: 2997-2006-AQ-RGC-RvA Initial certification date: 08 June, 2006 Valid: 11 April, 2022 – 11 April, 2025 This is to certify that the management system of Polyone - Suzhou, China EM Sector, 77 Shenggang Street, Suzhou Industrial Park, Suzhou, Jiangsu, China, 215024 and the sites as mentioned in the appendix accompanying this certificate has been found to conform to the Quality Management System standard: GB/T 19001-2016/ISO 9001:2015 This certificate is valid for the following scope: Design and Manufacture of Plastic Compounding Material Certificate No: 2997-2006-AQ-RGC-RvA Place and date: Shanghai, 27 April, 2022 Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
https://www.avient.com/sites/default/files/2021-04/shanghai-9001.pdf
Park, Pudong, Shanghai China, 201203 and the sites as mentioned in the appendix accompanying this certificate has been found to conform to the Quality Management System standard: GB/T 19001-2016/ISO 9001:2015 This certificate is valid for the following scope: Design and Manufacture of Masterbatch Certificate No: 7071-1998-AQ-RGC-RvA Place and date: Shanghai, 19 March, 2021 Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.