https://www.avient.com/sites/default/files/2023-01/Mevopur Standard Colors Product Bulletin _ Color Card.pdf
KEY CHARACTERISTICS • Globally harmonized formulations are manufactured at four ISO 13485 certified medical sites, providing global consistency and increased security of supply • Documented change control available • A range of standard colors eliminates color matching to expedite development time • The portfolio includes compliant colors for use in: - Needle hub applications: ISO 6009 - Ophthalmic container closures (American Academy of Ophthalmology) REGULATORY SUPPORT • A library of pre-tested raw materials including: - 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* HEALTHCARE APPLICATIONS • Medical devices such as catheters, surgical and dental instruments, and drug delivery devices • Pharmaceutical packaging including vials and bottles • Diagnostics for blood analysis or In Vitro Diagnostics (IVD) PRODUCT BULLETIN & COLOR CARD * FDA/EU compliance information available upon request; exceptions may occur Color Pantone Reference PE Base PP Base Transparent PP Base PEBA Base PC Base Transparent PC Base* ABS Base* White — PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206 Yellow 102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958 Orange 158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939 Red 199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037 Pink 196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039 Violet 2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978 Light Blue 292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402 Mid Blue 285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404 Dark Blue 288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406 Light Green 346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070 Bluish Green 3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068 Medium Green 348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072 Dark Gray 425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297 Mid Gray Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295 Beige 7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871 Brown 463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869 Black Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896 Colors may vary from actual color shown.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations for Needle Hubs Application Bulletin.pdf
Mevopur™ Healthcare Colorants and Formulations for Needle and Catheter Hubs APPLICATION BULLETIN * FDA/EU compliance information available upon request To help our customers meet healthcare industry standards, Avient offers a range of standard colors for needle hubs, canula hubs and wings matching the color coding of the ISO 6009 standard.
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 • Color can be combined with additives to enhance performance and protection 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 Device Master File • Food contact established with FDA/EU* NOMINAL OUTSIDE DIAMETER OF NEEDLE (MM) COLOR DESCRIPTION RAL PANTONE TRANSPARENT PRODUCT CODE OPAQUE PRODUCT CODE 0.4 Medium Grey 7035 423 C PP7M665125 PP7M665127 0.45 Brown 8017 7588 C PP8M665294 PP8M665296 0.5 Orange 2003 173 C PP2M665298 PP2M665300 0.55 Medium Purple 4005 7676 C PP4M665290 PP4M665292 0.6 Deep Blue 5010 288 C PP5M665894 PP5M665896 0.7 Black 9005 Black C PP9M664950 PP9M664952 0.8 Deep Green 6001 7483 C PP6M665687 PP6M665689 0.9 Yellow 1021 115 C PP1M665211 PP1M665213 1.1 Cream 1015 7401 C PP0M665290 PP0M665292 1.2 Pink 3015 502 C PE3M665725 PP3M665727 Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2024-12/ISO 22000-2024. Avient Sta. Clara 308865_en_46389 %2811%29.pdf
Normative base ISO 22000:2018 Food Safety Management Systems - Requirements for any organization in the food chain Reg. no. 46389 Page 1 of 1 Validity 25. 02. 2024 – 24. 02. 2027 Issue 20. 12. 2023 A.Grisard, President SQS F.
https://www.avient.com/sites/default/files/2022-07/REMAFIN EP White Masterbatches for Pharma Application Bulletin_CN.pdf
主要特性 生产符合高于CAS编号级别的变更控制原则 (与MEVOPUR母粒类似),降低变更风险 不含动物源性物质和邻苯二甲酸盐 适用于吹膜、注塑、吹塑和挤出 • • • 注册药品主文件(III型) 食品接触符合FDA/EU*要求 法规支持 原材料根据以下法规测试: - ISO 10993-1 - USP第、章,包括VI级别,符合眼 科和鼻腔用药物要求 - 欧洲药典3.1.3/3.1.5(聚烯烃) - 美国药典(聚乙烯) - ICH Q3D 杂质元素 - USP和USP,透光率 • • • 载体材料 耐光性 热稳定性 产品代码颜料含量/类型 HDPE 50% TiO2 8 300°C PH00075525 LLDPE 60% TiO2 8 300°C PL00075542 LLDPE 70% TiO2 8 300°C PL00075545 PP 50% TiO2 8 300°C PP00075717 适用医疗保健使用限制—见下文。
埃万特的产品不为以下目的或用途而设计,也不会宣传或预期用于以下目的或用途: (a) 被美国食品药品监督管理局(FDA)或国际标准化组织(ISO)归类为“植入”类器械的医疗器械;或美国药典(USP)或ISO标准定义的“永久”使用器械;或 (b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械;或者 (c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。
https://www.avient.com/sites/default/files/resources/GHS%2520MSDS%2520Updates%2520Letter.pdf
Zoretich Senior Manager, Product Stewardship Phone: 440.930.1291 Fax: 440.930.3034 www.polyone.com brian.zoretich@polyone.com PolyOne Corporation is a global leader in innovative polymer materials, services and solutions. 33587 Walker Road, Avon Lake, Ohio USA 44012 April 2014 Dear Valued Customer, As part of PolyOne’s commitment to offer our customers the most value in a competitive global marketplace, we are making changes to our Material Safety Data Sheets (MSDSs) in order to meet the coming requirements of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).
https://www.avient.com/sites/default/files/2020-12/maxxam-fr-case-study.pdf
© 2020, All Rights Reserved Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012 THE CHALLENGE Category cables serve a critical role in our increasingly connected world.
https://www.avient.com/sites/default/files/2020-10/antimicrobial-dental-case-study.pdf
SOLVING PRODUCTION BOTTLENECKS WITH A CUSTOMIZED ADDITIVE FORMULATION © 2020, All Rights Reserved Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012 To learn more about WithStand Antimicrobials, contact Avient at +1.844.4AVIENT (1.844.428.4368) THE CHALLENGE A well-known manufacturer of private label toothbrushes and dental care products for national drug store chains was experiencing several production problems in its molding operations.
https://www.avient.com/sites/default/files/2020-11/excelite-im-auto-case-study.pdf
Excelite IM Chemical Foaming Additives: • The only patented liquid CFA in North America and Europe • Supported with customized dosing equipment and technical assistance • Typically contains 70% active CFA content, dispersed in proprietary liquid vehicles LIQUID CFAs PROVIDE A TOP TIER-1 MOLDER WITH A CONSISTENT SOLUTION © 2020, All Rights Reserved Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012 Interested in learning about how Avient can help your business?
https://www.avient.com/sites/default/files/2020-10/light-diffusion-case-study.pdf
Applications include: • Lighting • Appliances • Consumer Electronics • Transportation © 2020, All Rights Reserved Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012 AESTHETIC DESIGN AND MANUFACTURING EFFICIENCIES ACHIEVED WITH A SINGLE SOLUTION
https://www.avient.com/sites/default/files/2023-05/SG Liner for Pipe Replacement - Case Study.pdf
SOURCE: Repurposing gas infrastructure for hydrogen | 2020 Siemens Energy Global (siemens-energy.com) © 2023, All Rights Reserved Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012 https://www.fiber-line.com/en/ https://www.siemens-energy.com/global/en/news/magazine/2020/repurposing-natural-gas-infrastructure-for-hydrogen.html https://www.siemens-energy.com/global/en/news/magazine/2020/repurposing-natural-gas-infrastructure-for-hydrogen.html