https://www.avient.com/sites/default/files/2022-07/MEVOPUR Chemical Foaming Agents Application Bulletin_CN.pdf
主要特性 根据ISO 13485规定的程序生产 变更控制记录的级别高于CAS编号级别,降低 变更风险 可用于常规注塑机和挤出设备—由技术支持团 队提供设置支持 可用于聚烯烃、苯乙烯和共聚物 可与着色剂联用 • • • • • 注册药品管理档案(III类)和/或医疗器械主 文件 食品接触声明符合美国FDA和EU规范 法规支持 原材料根据以下法规测试: - ISO 10993-1 - USP第、章(包含VI级) - 欧洲药典,各论3.1.3/3.1.5章节(聚烯烃包 装材料) - 美国药典(聚乙烯) - 杂质元素符合ICH Q3D要求 • • • 轻量化 1.844.4AVIENT www.avient.com 版权所有© 2022埃万特公司。
在不限制本声明的一般性的情况下,不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用: (1) 接触人体组织或体液长达30天或更长时间; (2)“整形”(整容或重建)手术; (3) 生殖植入物或任何节育器械;或者 (4) 用于支持或维持人类生命的永久性(超过30天)植入式医疗器械中的任何关键组件。
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。
在不限制本声明的一般性的情况下,不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用: (1) 接触人体组织或体液长达30天或更长时间; (2)“整形”(整容或重建)手术; (3) 生殖植入物或任何节育器械;或者 (4) 用于支持或维持人类生命的永久性(超过30天)植入式医疗器械中的任何关键组件。
https://www.avient.com/sites/default/files/2024-09/Terms and Conditions of Sale for Germany.pdf
ACCEPTANCE 1.
Terms and Conditions (October 1, 2024) Allgemeine Geschäftsbedingungen (1.
Oktober 2024) 1.
https://www.avient.com/sites/default/files/2022-09/Omnicolor Product Bulletin.pdf
KEY CHARACTERISTICS • Multipurpose, multi-resin colorant concentrates • Formulated with high quality, heavy metal-free pigments • Carrier system designed for compatibility across different resin systems • Samples available with quick turnaround in small lots for customer evaluation • Available in a wide range of stock and standard colors* • Low LDRs—typically 1–3% • Low minimum order quantities for both stock and non-stock colors * Color availability dependent on region or country PRODUCT BULLETIN MARKETS AND APPLICATIONS Omnicolor Multipurpose Colorants can be used for injection molding, blow molding, or profile and sheet extrusion processes.
https://www.avient.com/sites/default/files/2021-06/inscripcion-registro-santiago-cambio-razon-social-performance-masterbatches618874v1.pdf
Santiago, 3 Junio 2021 C ód ig o de V er ifi ca ci ón : 0 12 -2 10 6- 03 09 -1 14 2 012-2106-0309-1142 Documento incorpora Firma Electronica Avanzada Código de Verificación: cec_1c0abd-0 pagina 2 de 2 EDUARDO JAVIER DIEZ MORELLO 2021-06-03T10:28:54-0600 Santiago Firma Electrónica Notario 2021-06-04T10:37:47-0400
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives Chemical Foaming Agents Application Bulletin.pdf
KEY CHARACTERISTICS • Manufactured under ISO 13485 procedures • Documented change control beyond CAS number, reducing risk of change • Can be used on common injection molding and extrusion machines—set-up support by a technical assistance team • Available for use in polyolefins, styrenics and copolymers • Can be combined with colorants 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 USA FDA and EU norms APPLICATION BULLETIN Sustainability Spotlight Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Antistatic Application Bulletin_0.pdf
APPLICATIONS • Medical devices • Drug delivery devices • Labware 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 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* * FDA/EU compliance information available upon request Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2020-11/2020-trilliant-hc8910-hc8920-processing-guide.pdf
Barrel Temperatures English (°F) Metric (°C) Comments Zone 1 - Rear 410°F 450°F 210°C 230°C If smoking starts to occur, purge machine immediately and reduce mold and barrel temperatures.
https://www.avient.com/sites/default/files/2023-11/Capture Oxygen Scavenger Product Bulletin.pdf
KEY CHARACTERISTICS • Extends product shelf life and reduces waste • Maintains clarity and aesthetics of the bottle while keeping contents fresh • Located in the closure, eliminating the need to add a scavenger to the container wall • Allows unlimited design freedom, including lightweighting • Has achieved APR Critical Guidance Recognition • Allows up to 100% rPET usage • Does not negatively impact the PET or polyolefin recycle streams PRODUCT BULLETIN PROCESSING PARTICULARS Capture is designed to work with 1-piece HDPE and PP plug seal closures.
https://www.avient.com/sites/default/files/2022-10/PREPERM SatCom Application Bulletin.pdf
Feasible form factors can be obtained even below 1 GHz with high permittivity materials.