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/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/2024-02/Santa Clara_ISO22000.pdf
Plasticos 28 Santa Clara Coatitla 55540 Ecatepec de Morelos, Estado de México Mexico 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. 46389 Validity 25. 02. 2021 – 24. 02. 2024 Issue 30. 06. 2021 Swiss Made sqs.ch F.
https://www.avient.com/sites/default/files/2024-07/Versaflex TPE for Orthopedic Sole Insert - Application Snapshot.pdf
O RT H O P E D I C PA RT S M A N U FAC T U R E R O R T H O P E D I C S O L E I N S E R T • A super soft TPE (
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/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/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.