https://www.avient.com/sites/default/files/2023-09/65567-Certificate-08SEP2023.pdf
ISO 13485:2016 The Quality Management System is applicable to: Certificate No: 65567 Effective Date: 08 September 2023 Expiration Date: 07 September 2026 Revision Date: 08 September 2023 Dominic Townsend, President This certificate may be found on the ABS QE Website (www.abs-qe.com).
https://www.avient.com/sites/default/files/2022-09/54139-Certificate-29AUG2022%5B98%5D.pdf
ISO 13485:2016 The Quality Management System is applicable to: Certificate No: 54139 Certification Date: 04 September 2019 Effective Date: 29 August 2022 Expiration Date: 01 September 2025 Revision Date: 29 August 2022 Dominic Townsend, President This certificate may be found on the ABS QE Website (www.abs-qe.com).
https://www.avient.com/sites/default/files/resources/NEU%2520ISO%25209001-2015%2520Exp%25201-22%2520%25281%2529.pdf
ISO 9001:2015 The Quality Management System is applicable to: Certificate No: 47804 Certification Date: 07 January 2013 Effective Date: 17 December 2018 Expiration Date: 06 January 2022 Issue Date: 17 December 2018 Alex Weisselberg, President This certificate may be found on the ABS QE Website (www.abs-qe.com).
https://www.avient.com/sites/default/files/resources/ISO14001.2015PolyOneShanghai%25282018-2021%2529.pdf
Park, Pudong, Shanghai, China, 201203 has been found to conform to the Environmental Management System standard: ISO 14001:2015 This certificate is valid for the following scope: Design and Manufacture of Masterbatch
https://www.avient.com/sites/default/files/2021-08/versaflex-machine-cover-case-study-one-pager.pdf
RESPIRATORY DEVICE MANUFACTURER C P A P M A C H I N E C O V E R • Good aesthetics with high COF for grip functionality • Chemically bondable to FR PC/ABS down to 1mm • NCS S 9000-N color suitable for UV laser marking to white • Good scratch and mar resistance • Good chemical resistance to detergents, alcohols and bleach • Pass VOCs & out-gassing in accordance to ISO 18562-3/2:2017 • Customized formulation to balance mar resistance, flow, and laser marking whiteness and clarity • Collaborated on tooling improvements to widen processing window and increase yield rate • Provided application development and on- site technical support to manage short shot, sink marks, burn marks and air trap Customized VersaflexTM TPEs WHY AVIENT?
https://www.avient.com/sites/default/files/2022-12/reSound Ultra Low Carbon Footprint TPE Product Bulletin_0.pdf
Calculated using the ISO 14067:2018 standard, the greenhouse gas (GHG) emissions are lowered by carbon sequestration and Avient’s green manufacturing practices.
This literature shall NOT operate as permission, recommendation, or inducement to practice any patented invention without permission of the patent owner. * Calculated according to ISO 14067:2018
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Bio-based Polymer Solutions Application Bulletin.pdf
KEY CHARACTERISTICS • Available for polyethylene, polypropylene, ABS, polycarbonate and styrenics • Bio-content of resin carrier varies from 70% to 100% depending on polymer—calculated to ASTM D6866 standard • Manufactured at four ISO 13485 certified sites, providing global consistency and security of supply • Documented change control beyond CAS number, reducing risk of change • Drop-in solutions that can be processed like fossil-based grades on common injection molding and extrusion machines • Can be provided as ready-to-use pre-colored or additive formulation REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP and (incl. class VI) - European Pharmacopeia, monograph 3.1.3/ 3.1.5 (polyolefin packaging materials) - USP (polyethylene) - Elemental impurities as per ICH Q3D • Registered Drug Master File (Type III) and/or Device Master File • Food contact according to US FDA and APPLICATION BULLETIN Sustainability Spotlight Bio-polymers Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Nucleating Application Bulletin.pdf
REGULATORY SUPPORT • Drug delivery devices • Pharmaceutical packaging • Medical equipment KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number level, reducing the risk of change • Allows crystallization in semi-crystalline polymers to begin faster and complete earlier 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 Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-05/Mevopur Healthcare Colorants and Formulations Amber for Pharma Application Bulletin.pdf
KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number level, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Different tones of amber available on request —more or less red or yellow and/or lighter or darker • Also available in liquid form REGULATORY SUPPORT • Pre-tested raw materials: - ISO 10993-1 and USP parts (Class VI) - European Pharmacopeia, monograph 3.1.15, USP and elemental analysis as per ICH Q3D - USP criteria appearance of solution, color • Registered Drug Master File (Type III) by the FDA • Food contact compliance established with FDA/EU* • YBB00102002-2015 (oral liquid pharmaceutical PET bottles) compliance support APPLICATION BULLETIN * FDA/EU compliance information available upon request Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2020-09/oncolor-hc-product-bulletin-1.pdf
Also available are OnColor HC Plus Colorants, certified to meet or exceed USP Class VI and ISO 10993 bio-compatibility requirements.
KEY CHARACTERISTICS • Polymer colorants formulated specifically for healthcare product applications • Meets and exceeds various material performance requirements including FDA 21 CFR, ISO 10993 and USP Class VI • HC Plus colorants certified for bio-compatibility • Available as pre-color, concentrate, masterbatch or Smartbatch™ combined colorant/additive solution • Wide range of colors, striking special effects and custom color matching MARKETS AND APPLICATIONS OnColor™ HC and HC Plus Colorants are an excellent choice for medical devices and parts, pharmaceutical or cosmetic packaging, and many other healthcare related polymer applications.