https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives_Laser Welding Additives for 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 • Available as additive concentrates, ready-to-use additive formulations or ready-to-use additive/ colorant formulations for 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 * FDA/EU compliance information available upon request; exceptions may occur Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-10/Value Added Services Brochure.pdf
A RANGE OF WORLD-CLASS SERVICES COLOR TECHNOLOGY Custom matching, saturated colors, and special effects to fill market niches, eliminate secondary operations, and strengthen your brand PCR COLOR PREDICTION SERVICE Digital prediction tool illustrating color possibilities and limitations of post-consumer recycled (PCR) content to simplify decision making and shorten time to launch PRODUCT CARBON FOOTPRINT (PCF) CALCULATOR Methodology that evaluates the carbon footprint of Avient solutions, contributing a data point to your overall carbon footprint and supporting credible reporting AVIENT DESIGN A highly specialized group of industrial designers and project engineers that provides advanced design and detailed analysis to foster higher levels of innovation TESTING AND VALIDATION Fully accredited and in-house testing capabilities to generate data for insight into material behavior, environmental effects, and more REGULATORY SUPPORT Dedicated product stewardship team assisting with new product approvals to reduce regulatory overhead and minimize risk COLOR AND ADDITIVE DESIGN SERVICES Trend and color insights along with product development assistance from concept through commercialization to optimize design and gain speed to market RESEARCH AND DEVELOPMENT Long-term strategic solution development that addresses complex and unmet product innovation needs APPLICATION DEVELOPMENT TECHNICAL SUPPORT Technical experts specifically trained to work directly with your team to solve definitive application challenges with new or existing approaches FIELD TECHNICAL SERVICE Onsite support for tool design, startup, and production optimization to gain manufacturing efficiencies and help resolve technical issues Common compliance categories where we can assist: • UL • USP Class VI • ISO 10993 • ISO 1345 • REACH • RoHS • FDA • EU 10/2011 • China GB • MERCOSUR • USP • ISP • CPSIA • Prop 65 ColorWorks™ Design & Technology Centers Our global ColorWorks centers are focused on design, technology, and innovation for plastics.
https://www.avient.com/sites/default/files/2023-10/Stat-Tech TPE Static Dissipative _ Electrically Conductive Thermoplastic Elastomers Product Overview_A4.pdf
这些包括:• Industrial – Conveyor belts (food production and pharmaceutical industries) and controls ( joy sticks, machinery handles and knobs, corrugated bellows, tool grips) • Electrical and electronic devices – Seals and gaskets, radars and sensors • ADAS components – Camera systems, navigation systems, vehicle control systems, infotainment systems PRODUCT OVERVIEW STAT-TECH SOLUTIONS KEY TECHNICAL PROPERTIES Material Description Base Resin Color Hardness Range Surface Resistivity (Ω) Key Characteristics ST0100-5003 ESD FD White VN8904 GP0F025721 TPU White 85 ShA 108 to 109 High elongation, static conductive, FDA compliance ST0100-5006 ESD X2 Natural TPU Natural 85 ShA 107 to 109 High elongation, static conductive ST0200-5001 ESD Natural X1 TPE Natural 40 ShD 107 to 109 High elongation, permanent anti-static, static conductive SST0200-5004 ESD Black TPE Black 40 ShA 103 to 105 Electrically conductive, static dissipative, lower hardness ST0200-5002 EC ES Black TPE Black 60 ShA 100 to 102 Electrically conductive, high elongation ST0200-5009 EC Black TPE Black 60 ShA 100 to 102 Electrically conductive, high elongation Property Unit Standard Test Methods ST0100-5003 ESD FD White VN8904 GP0F02571 ST0100- 5006 ESD X2 Natural ST0200- 5001 ESD Natural X1 ST0200- 5004 ESD Black ST0200- 5002 EC ES Black ST0200- 5009 EC Black Base Resin TPU TPU TPE TPE TPE TPE Physical Properties Hardness Shore ISO 48-4 85A 85A 50D 40A 60 A 60A Density ISO 1183 1.19 1.15 1 1.01 0.965 1.21 Mechanical Properties Tensile Strength (Break) Mpa DIN 53404 10 15 15 4 5.7 2.5 Elongation, Break % DIN 53504 600 650 500 300 400 250 Electrical Properties Surface Resistivity Ω IEC 60093 108 to 109 107 to 109 107 to 109 103 to 105 100 to 102 100 to 102 Volume Resistivity Ω.cm IEC 60093 108 to 109 107 to 109 107 to 109 103 to 105 100 to 102 100 to 102 Color White Natural Natural Black Black Black Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2024-08/OnColor REC Door Panel Case Study Snapshot.pdf
AUTOMOTIVE OEM I N T E R I O R D O O R P A N E L • Available for multiple resins and approved OEM colors • Maintain performance characteristics of traditional raw materials that use conventional carbon black • Pass REACH and RoHS requirements • Retain color consistency and stability • Provide a Product Carbon Footprint (PCF) calculation that aligns with ISO 14067:2018 • Provided recycled content formulations that met all design and engineering goals while achieving sustainability targets • Provided effective alternative to materials using virgin carbon black • Achieved color stability under xenon arc and TUV methodology • Supplied necessary PCF calculation certified by TÜV Rheinland and aligning with ISO 14067 requirements OnColor™ REC Polymer Colorants KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2024-08/Textile _ Fabric OnColor REC Snapshot.pdf
FIBER MANUFACTURER T E X T I L E S & F A B R I C S • Provide a Product Carbon Footprint (PCF) calculation to align with ISO 14067:2018 and to help in meeting sustainability goals • Procure feedstock from renewable resources • Maintain comparative performance to conventional carbon black • Achieve color stability under xenon arc and TUV testing • Offer solutions for rPET, PP, PE, PBT, and PA6 where a desire for environmentally responsible products exists • Offered sustainable platform approach supported by extensive fiber expertise • Helped meet sustainability targets while attaining all design and engineering goals • Supplied necessary PCF calculation certified by TÜV Rheinland and aligning with ISO 14067 requirements • Provided effective alternative to virgin carbon black • Achieved reductions in CO2e emissions vs.
https://www.avient.com/sites/default/files/2021-05/unterzertifikat-th.-bergmann.engl-.pdf
Bergmann GmbH Adolf-Dambach-Str. 2-4 76571 Gaggenau the introduction and application of a management system according to ISO 50001:2018 Scope: DEVELOPMENT AND PRODUCTION OF TECHNICAL POLYMERS The proof has been furnished by an audit.
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/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/2021-10/remafin-ep-white-masterbatches-for-pharma-application-bulletin_0.pdf
KEY CHARACTERISTICS • Manufactured under change control principles beyond CAS number (similar level as MEVOPUR concentrates), reducing risk of change • Free from animal-derived substances and phthalates • Suitable for blown film, injection molding, blow molding and extrusion REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP chapters , including Class VI, a requirement for ophthalmic and nasal drugs - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities - USP and USP light transmission • Registered Drug Master File (Type III) • Food contact compliance established with FDA/EU* APPLICATION BULLETIN CARRIER MATERIAL PIGMENT CONTENT/TYPE LIGHT FASTNESS THERMAL STABILITY PRODUCT CODE 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 Healthcare use limitations apply—see below. Avient products have not been designed for nor are they promoted or intended for use in: (a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under US Pharmacopoeia (USP) or ISO standards; or (b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or (c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended.
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.