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/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/resources/Jurong_ISO22000.pdf
Avient Colorants Singapore Pte Ltd 8 Third Chin Bee Road Jurong Industrial Estate Singapore 618684 Singapore 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. 46390 Validity 25. 02. 2021 – 24. 02. 2024 Issue 30. 06. 2021 Swiss Madesqs.ch F.
https://www.avient.com/sites/default/files/2023-11/ISO14001.2015.pdf
Page 1 / 1 has been assessed and certified as meeting the requirements of ISO 14001:2015 For the following activities The Design and Manufacturing of Plastic Color Concentrated, Plastic Additive Concentrated and Pigment Powder for Thermoplastic & Rubber Industries.
https://www.avient.com/sites/default/files/2024-10/ISO9001证书 %28英文版%29 -2024.pdf
462307-2021-AQ-RGC-RvA Initial certification date: 23 June 2021 Valid: 24 June 2024 – 23 June 2027 This is to certify that the management system of Avient China Company Limited No. 188, Quanzhou Road, Zhongxin Suchu High-Tech Industrial Development Park, Chuzhou, Anhui, China 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 Color Concentrates, Filling Concentrates and Additive Concentrates http://www.dnv.com/assurance
https://www.avient.com/sites/default/files/2021-04/shanghai-14001.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/resources/Tangerang_ISO22000.pdf
Cibodas Kecamatan Cibodas, Tangerang 15138 Indonesia 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. 46391 Validity 25. 02. 2021 – 24. 02. 2024 Issue 30. 06. 2021 Swiss Madesqs.ch F.
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.