https://www.avient.com/sites/default/files/2020-07/versaflex-hc-syringe-plunger-spanish.pdf
Versaflex HC - Syringe Plunger - Spanish FABRICANTE DE JERINGAS É M B O L O D E J E R I N G A D E S E C H A B L E • Cumplir con las normas USP VI e ISO 10993-4,5 • Esterilización con gamma y EtO • Rendimiento de sellado a largo plazo • Bajo coeficiente de fricción (COF) • Rendimiento uniforme en jeringas de diferentes diámetros • Ofreció una solución formulada que cumple con los requerimientos rigurosos de una aplicación médica • Mejoró la continuidad del suministro global • Aumentó la eficiencia del proceso al sustituir el material termoestable anterior con un TPE Versaflex™ HC 2110-57B REQUERIMIENTOS CLAVE ¿POR QUÉ AVIENT?
https://www.avient.com/sites/default/files/2024-06/Avient Melle - 2024.pdf
Bergmann GmbH Adolf-Dambach-Str. 2-4 76571 Gaggenau die Einführung und Anwendung eines Managementsystems gemäß DIN EN ISO 50001:2018 für den Geltungsbereich: Entwicklung und Produktion von technischen Thermoplasten; an den Standorten gemäß Anlage.
https://www.avient.com/sites/default/files/2021-08/versaflex-machine-cover-case-study-one-pager.pdf
RESPIRATORY DEVICE MANUFACTURER C P A P M A C H I N E C O V E R • Good aesthetics with high COF for grip functionality • Chemically bondable to FR PC/ABS down to 1mm • NCS S 9000-N color suitable for UV laser marking to white • Good scratch and mar resistance • Good chemical resistance to detergents, alcohols and bleach • Pass VOCs & out-gassing in accordance to ISO 18562-3/2:2017 • Customized formulation to balance mar resistance, flow, and laser marking whiteness and clarity • Collaborated on tooling improvements to widen processing window and increase yield rate • Provided application development and on- site technical support to manage short shot, sink marks, burn marks and air trap Customized VersaflexTM TPEs WHY AVIENT?
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Bio-based Polymer Solutions Application Bulletin.pdf
KEY CHARACTERISTICS • Available for polyethylene, polypropylene, ABS, polycarbonate and styrenics • Bio-content of resin carrier varies from 70% to 100% depending on polymer—calculated to ASTM D6866 standard • Manufactured at four ISO 13485 certified sites, providing global consistency and security of supply • Documented change control beyond CAS number, reducing risk of change • Drop-in solutions that can be processed like fossil-based grades on common injection molding and extrusion machines • Can be provided as ready-to-use pre-colored or additive formulation 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 US FDA and APPLICATION BULLETIN Sustainability Spotlight Bio-polymers Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Nucleating Application Bulletin.pdf
REGULATORY SUPPORT • Drug delivery devices • Pharmaceutical packaging • Medical equipment 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 the risk of change • Allows crystallization in semi-crystalline polymers to begin faster and complete earlier 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 Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2023-05/Mevopur Healthcare Colorants and Formulations Amber for Pharma 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 level, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Different tones of amber available on request —more or less red or yellow and/or lighter or darker • Also available in liquid form REGULATORY SUPPORT • Pre-tested raw materials: - ISO 10993-1 and USP parts (Class VI) - European Pharmacopeia, monograph 3.1.15, USP and elemental analysis as per ICH Q3D - USP criteria appearance of solution, color • Registered Drug Master File (Type III) by the FDA • Food contact compliance established with FDA/EU* • YBB00102002-2015 (oral liquid pharmaceutical PET bottles) compliance support APPLICATION BULLETIN * FDA/EU compliance information available upon request Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2020-09/oncolor-hc-product-bulletin-1.pdf
Also available are OnColor HC Plus Colorants, certified to meet or exceed USP Class VI and ISO 10993 bio-compatibility requirements.
KEY CHARACTERISTICS • Polymer colorants formulated specifically for healthcare product applications • Meets and exceeds various material performance requirements including FDA 21 CFR, ISO 10993 and USP Class VI • HC Plus colorants certified for bio-compatibility • Available as pre-color, concentrate, masterbatch or Smartbatch™ combined colorant/additive solution • Wide range of colors, striking special effects and custom color matching MARKETS AND APPLICATIONS OnColor™ HC and HC Plus Colorants are an excellent choice for medical devices and parts, pharmaceutical or cosmetic packaging, and many other healthcare related polymer applications.
https://www.avient.com/sites/default/files/2022-07/Mevopur Standard Colors Product Bulletin-CN.pdf
Mevopur Standard Colors Product Bulletin-CN3.26-1 MEVOPUR™ 着色剂 医疗应用的标准颜色 关键特性 • • • • • 监管支持 • • 预先测试的原材料库,包括: - ISO 10993 - USP , (class VI) - USP - ICHQ3D 可提取金属 - EuPh 向FDA提交的DMF / MAF文档适用于所有标 准颜色 医疗应用 • • • 医疗设备,例如导管,手术和牙科器械或药 物输送设备 药物包装,包括药瓶或瓶子 血液分析诊断或体外诊断(IVD) 产品公告 & 色卡 MEVOPUR 着色剂解决方案组合专为当今日益复 杂的医疗保健应用而设计。
™ 在三个通过ISO 13485认证的医疗产线生产 全球统一的配方,提供全球一致性和供应链 保障 提供文件化的变更控制 原料指纹图谱和常规批次测试 多种标准颜色缩短产品开发时间 产品组合里符合标准的颜色用于: - 注射针头ISO 6009 - 眼科容器盖(美国眼科学院 / AAO - American Academy of Ophthalmology) 颜色 潘通色 参照 PE 基料 PP 基料 透明PP 基料 PEBA 基料 PC 基料 ABS 基料* — PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206 102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958 158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939 199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037 196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039 2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978 292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402 285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404 288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406 346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070 3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068 348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072 425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297 Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295 7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871 463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869 Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896 颜色可能与显示的实际颜色有所不同。
https://www.avient.com/sites/default/files/2021-09/avient-hong-kong-holding-certificate-of-change-of-name-aug-2-2021.pdf
公公公公 司司司司 更更更更 改改改改 名名名名 稱稱稱稱 證證證證 明明明明 書書書書 CERTIFICATE OF CHANGE OF NAME 本 人 謹 此 證 明 I hereby certify that POLYONE HONG KONG HOLDING LIMITED 已 藉 特 別 決 議 更 改 其 名 稱 , 該 公 司 根 據 having by special resolution changed its name, is n ow incorporated under the 香 港 法 例 第 622 章《 公 司 條 例 》註 冊 的 名 稱 現 為 Companies Ordinance (Chapter 622 of the Laws of Hon g Kong) in the name of Avient Hong Kong Holding Limited 本 證 明 書 於 二二二二 OOOO 二二二二 一一一一 年 八八八八 月 二二二二 日 發 出 。
https://www.avient.com/resources/safety-data-sheets?page=4561
Geon(TM) DB5261 Neutral TT Iso Stable
Certificate of Analysis (COA) - labeled as "Material"