https://www.avient.com/sites/default/files/resources/Polyone%2520Barbastro_ISO%252014001_2015_EXP%25202021_0.pdf
Industrial Valle del Cinca s/n Apartado 18 22300 Barbastro, Huesca Spain has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: ISO 14001:2015 The Environment Management System is applicable to: DEVELOPMENT, PRODUCTION & DISTRIBUTION OF TECHNICAL THERMOPLASTICS.
https://www.avient.com/sites/default/files/resources/Polyone%2520Barbastro_ISO%25209001_2015%2520EXP%25202021.pdf
Industrial Valle del Cinca s/n Apartado 18 22300 Barbastro, Huesca Spain 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: DEVELOPMENT, PRODUCTION & DISTRIBUTION OF TECHNICAL THERMOPLASTICS.
https://www.avient.com/sites/default/files/2024-05/Avient Zertifikat deutsch - 2024.pdf
Bergmann GmbH Adolf-Dambach-Str. 2-4 76571 Gaggenau die Einführung und Anwendung eines Managementsystems gemäß DIN EN ISO 50001:2018 für den Geltungsbereich: Entwicklung und Produktion von technischen Thermoplasten; an den Standorten gemäß Anlage.
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-bt218-biopharmaceutical-tubing-case-study.pdf
MEDICAL TUBING EXTRUDER B I O P H A R M A C E U T I C A L T U B I N G • Low leachables & extractables • Great tensile performance and kink resistance • Good thermal weldability • Excellent clarity and medical blue tint • ISO 10993-4 & 5, USP Class VI & Animal Derivative Free (ADF) • Supplied drop-in material replacement to overcome supply constraints of incumbent TPE • Offered a lower extractable profile than comparable materials in the market • Enabled easy material transition without changes in tooling or thermal welding machine settings • Formulated solution with proprietary additives to provide clarity and prevent yellowing after sterilization Versaflex™ HC BT218 Thermoplastic Elastomer KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-3810-covid-19-containment-tube-screw-caps-case-study.pdf
DIAGNOSTICS MANUFACTURER C O V I D - 1 9 C O N T A I N M E N T T U B E S C R E W C A P S • Wide range of durometers with consistent raw materials • Processing consistencies across the durometer ranges for an easy transition between materials • Materials formulated without animal derivatives at a competitive cost • Offered a comprehensive range of solutions to accommodate specific application demands such as barrier, flexibility, and sealing performance • Provided materials manufactured in an ISO 13485 certified facility • Delivered a series of medical-grade TPEs that could be extruded and injection molded Versaflex™ HC 3810 Thermoplastic Elastomers KEY REQUIREMENTS WHY AVIENT?
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/2022-12/15719637-22-AVIENT ESPAÑA SL-INGLES.pdf
Certificate Number: Certificate expiration date: Effective date: 31-10-2022 30-10-2025 Expiry date of previous cycle: 30-10-2022 31-10-2016 ES133794 Scope of certification: MANUFACTURING OF MASTERBATCHES, ADDITIVES AND COMPOUNDS FOR PIGMENTING THERMOPLASTIC MATERIALS USED IN FOOD INDUSTRY ISO 22000:2018 POLIGONO INDUSTRIAL EZCABARTE, C/H, Nº3 - 31194 - ORICAIN - NAVARRA - ESPAÑA AVIENT ESPAÑA, S.L.
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/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/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.