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.
https://www.avient.com/company/sustainability/sustainability-report/metrics/planet-data-and-metrics
⁴Certificates can be found at https://www.avient.com/company/policies-and-governance/global-iso-certificate-library
https://www.avient.com/resource-center?document_type=221&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form&page=3
Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.
https://www.avient.com/resource-center?document_subtype=0&document_type=221&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=0&product_name=0&page=3
Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.
https://www.avient.com/industries/healthcare/catheter-materials-medical-tubing/medical-tubing
Medical-grade thermoplastic elastomers that meet various regulatory requirements, such as ISO 10993 and USP Class VI