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.
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/sites/default/files/2021-08/avient-cdp-climate-change-questionnaire-2021.pdf
In addition, Avient has externally certified EHS&S management systems, including ISO 9001 worldwide.
ISO 14001, Responsible Care 14001, ISO 45001, ISO 50001, and OHSAS 18001, certification at 74% of facilities.
In addition, Avient has ISO 9001 worldwide and ISO 14001 and ISO 50001 certification at many facilities.