https://www.avient.com/sites/default/files/2022-08/ISO9001-2015 EN -EM.pdf
China TEL: +86 21 32799000 Zhu Hai Ming Management Representative Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid. ACCREDITED UNIT: DNV Business Assurance B.V., Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance Certificate No: 2997-2006-AQ-RGC-RvA Initial certification date: 08 June, 2006 Valid: 11 April, 2022 – 11 April, 2025 This is to certify that the management system of Polyone - Suzhou, China EM Sector, 77 Shenggang Street, Suzhou Industrial Park, Suzhou, Jiangsu, China, 215024 and the sites as mentioned in the appendix accompanying this certificate 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 Plastic Compounding Material Certificate No: 2997-2006-AQ-RGC-RvA Place and date: Shanghai, 27 April, 2022 Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid. ACCREDITED UNIT: DNV Business Assurance B.V., Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance Page 2 of 2 Appendix to Certificate Polyone - Suzhou, China Locations included in the certification are as follows: Site Name Site Address Site Scope PolyOne Management (Shanghai) Co., Ltd.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Colorants and Formulations Special Effects Application Bulletin_0.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 pre-colored formulation or concentrate and for use in different polymers 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 * Design note: Effect colors require careful consideration of part design and polymer flow paths to minimize visible flow lines.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives Medical Devices 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 reducing risk of change • Non-phthalate and formulated without animal- derived substances • Available for use in a wide range of polymers including polyolefins, styrenics, polycarbonate and alloys, polyester, POM • Functionality can be combined with colorants into convenient combination concentrates and ready-to-use formulations 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 FUNCTIONALITY TARGET APPLICATIONS DRUG DELIVERY DEVICES SYRINGES & NEEDLES DIAGNOSTICS CATHETERS Clarifying PP Sorbitol-free for transparent applications with reduced migration and improved thermal stability Lubricant— permanent/ non-migrating Fast acting reduction in friction for wide variety of polymers such as PP, ABS, POM, PC Protection from UV in transparent applications for PP, PE, PETG, COP UV blocking in 290-450nm with no impact on clarity; can be combined with colors (e.g., amber) Antistatic ready-to- use solution for PP, ABS, PC/ABS Permanent/non-migrating; fast decay time independent of % relative humidity Gamma/e-beam sterilization protection of the polymer Preserving the properties of PP and COC/COP; reduction in yellowing using Color Compensation Technology (CCT) Reduced material consumption/cycle time—nucleation Fast acting new generation nucleant for PE and PP; improved thermal and mechanical properties allows wall thinning; reduction of tolerance/dimensional problems between different colors Laser marking replacing ink printing/labels Solvent-free, high-speed identification for Nd/YAG laser for PE,PP, ABS, PC, POM Antioxidants for PE, PP, TPE Thermal protection during converting/downstream sterilization Brand protection/ anticounterfeit Covert and non-covert systems Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives Pharma Pkg 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, reducing risk of change • Non-phthalate and formulated without animal- derived substances • Available for use in a wide range of polymers including polyolefins, styrenics, polycarbonate and alloys, polyester, POM • Functionality can be combined with colorants into convenient combination concentrates or formulations REGULATORY SUPPORT • Pre-tested raw materials: - 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) • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request FUNCTIONALITY TARGET APPLICATIONS EBM/IBM CONTAINERS CLOSURES FILM COMBINATION DEVICES Clarifying PP Sorbitol-free—possibilities in packaging ocular solutions Slip/torque reduction Slip for PE, PP films, processing aid, torque reduction for closures Protection from UV in transparent packaging for PP, PE, PETG, COP UV blocking in 290–450nm with no impact on clarity Antistatic ready-to-use solution for PE films e.g.
https://www.avient.com/sites/default/files/2022-12/Mevopur Laser Marking Additives Application Bulletin.pdf
KEY CHARACTERISTICS • Designed for Nd:YAG lasers operating between 1060-1070 nm • Available for different polymers including PP, PE, PC, PBT, POM, ABS, MABS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Can be designed for dark marking on natural or white/light colored background or light marking on black/dark background 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.
https://www.avient.com/sites/default/files/2022-12/Mevopur Colors for Ophthalmic Closures Application Bulletin_A4.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 • Standard concentrates in a PE carrier and on request in PP • Pre-colored formulations can be supplied in specific resins selected for the application 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) • Food contact established with FDA/EU* APPLICATION BULLETIN DRUG TYPE COLOR DESCRIPTION PANTONE REFERENCE AVIENT PRODUCT CODE PE BASED Adrenergic agonist combinations Light Green 373 C PE6M176349 Adrenergic agonists Purple 2583 C PE4M176057 Anti-infectives Tan 467 C PE8M176130 Anti-inflammatory, nonsteroidal Grey Cool Grey 4 C PE7M176184 Anti-inflammatory, steroids Pink 197 C PE3M176237 Anti-inflammatory, immunomodulators Olive Green 5763 C On request Beta-blockers Yellow Yellow C PE1M176160 Beta-blocker combinations Dark Blue 281 C PE5M176272 Carbonic anhydrase inhibitors Orange 1585 C PE2M176089 Cytotoxic Black 6 C PL9M176008 Miotics Dark Green 348 C PE6M176267 Mydriatics and cycloplegics Red 1797 C PE3M176236 Prostaglandin analogues Turquoise 326 C PE5M176273 Healthcare use limitations apply—see below.
https://www.avient.com/news/enabling-manufacturers-expand-global-reach-new-ul-certification
Homepage // News Center // Enabling Manufacturers to Expand Global Reach with New UL Certification With this new certification, customers can confidently select Bergamid solutions for their electrical and electronics products around the globe.”标题:New UL certification for Bergamid™ high-performance solutions helps manufacturers meet global standards for outdoor electrical devices.
https://www.avient.com/news/halal-certification-expands-avient-s-colorants-and-additives-produced-indonesia-site
Homepage // News Center // Halal Certification Expands for Avient’s Colorants and Additives Produced at Indonesia Site Avient Obtains Halal Certification Expansion to Include its Colorants and Additives Produced at the Tangerang, Indonesia Facility. This expands the Halal certification already obtained for Remafin™, Renol™, Cesa™, Hiformer™, and Omnicolor™ brands since 2019.
https://www.avient.com/investor-center/news/polyone-achieves-responsible-care-certification-american-chemistry-council
Certification was granted by an independent, third-party auditor, based on In order to receive certification, an ACC member or Partner company must demonstrate conformance to the Responsible Care Management System's comprehensive set of EHS&S requirements, which are validated through an independent, third-party audit process. View original content:http://www.prnewswire.com/news-releases/polyone-achieves-responsible-care-certification-by-american-chemistry-council-300577923.html
https://www.avient.com/sites/default/files/resources/NEU%2520ISO%25209001-2015%2520Exp%25201-22%2520%25281%2529.pdf
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. 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). For certificates issued in the People's Republic of China information may also be verified on the CNCA website (www.cnca.gov.cn).