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/2022-05/MEVOPUR LQ for Silicone Elastomers_CN.pdf
可根据要求提供多种定制化 颜色解决方案 根据ISO 13485/GMP质量体系生产,并拥有变 更控制管理 原材料红外光谱分析和常规批次检测 根据ISO 10993第18部分对正己烷、异丙醇及 水中的可萃取性进行评估 • • • • 法规支持 原材料根据ISO 10993-1和USP第、 章(VI类)对原材料进行生物评估的预测试 向FDA提交所有标准颜色的DMF/MAF文件 • • 应用 医疗器械,如导管和连接器、注射器针头及无 针连接器 与皮肤接触设备,如可穿戴设备或医疗器械的 柔软触感表面 • • MEVOPUR LQ 配方可用于要求严苛的应用,包 括:MEVOPUR™-LQ 不透明红(PMS198C) 产品编号:FZ3M415008 MEVOPUR™-LQ 透明红 产品编号:FZ3M415009 MEVOPUR™-LQ 不透明蓝(PMS292C) 产品编号:FZ5M415008 MEVOPUR™-LQ 透明蓝 产品编号:FZ5M415009 MEVOPUR™-LQ 不透明黄(PMS1205C) 产品编号:FZ1M415005 MEVOPUR™-LQ 透明黄 产品编号:FZ1M415006 MEVOPUR™-LQ 不透明绿(PMS346C) 产品编号:FZ6M415008 MEVOPUR™-LQ 透明绿 产品编号:FZ6M415009 MEVOPUR™-LQ 不透明紫(PMS2655C) 产品编号:FZ4M415003 MEVOPUR™-LQ 透明紫 产品编号:FZ4M415004 定制化选择 也可以根据您的需求 定制颜色, 请联系我们。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/2021-09/mevopur-colors-for-needle-hubs-bulletin-cn.pdf
MEVOPUR Colors for Needle Hubs Bulletin_CN * 可根据要求提供FDA/EU合规信息 应用公告 MEVOPUR™用于针头和导管座的 标准颜色 为了帮助我们的客户满足医疗行业标准要求,埃 万特开发了一系列符合ISO 6009标准颜色编码的 针座、导管座和翼梁的标准颜色。主要特性 在三个通过ISO 13485认证的医疗生产线生 产全球统一的配方,提供全球一致性和供应 链保障 变更控制记录不限于CAS编号级别,降低变 更风险 不含动物源性物质和邻苯二甲酸盐 可将颜色与添加剂相结合,以增强产品性能 和防护性能 • • • • 法规支持 经过预测试的原材料:- 美国药典(USP)23,第87和88章(VI类) 萃取和生物学评价 - ISO 10993,第4、5、10、11和18部分, 萃取和生物学评价 - 美国药典和欧洲药典中针对USP 、 ICH Q3D可萃取金属和EP3.1聚烯烃的测试的 其他监管支持信息 FDA器械主文件 食品接触符合FDA/EU*要求 • • • 针头的标称外径 (mm) 颜色说明 RAL 潘通色号 透明产品代码 不透明产品代码 0.4 中灰色 7035 423 C PP7M665125 PP7M665127 0.45 褐色 8017 7588 C PP8M665294 PP8M665296 0.5 橘黄色 2003 173 C PP2M665298 PP2M665300 0.55 中紫色 4005 7676 C PP4M665290 PP4M665292 0.6 深蓝色 5010 288 C PP5M665894 PP5M665896 0.7 黑色 9005 黑色 C PP9M664950 PP9M664952 0.8 深绿色 6001 7483 C PP6M665687 PP6M665689 0.9 黄色 1021 115 C PP1M665211 PP1M665213 1.1 乳白色 1015 7401 C PP0M665290 PP0M665292 1.2 粉色 3015 502 C PE3M665725 PP3M665727 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/2025-02/Mevopur White Formulation for PCR Well Plates - Case Study_0.pdf
L A B O R ATO RY E Q U I P M E N T M A N U FA C T U R E R P C R W E L L P L A T E S • Very high level of TiO2 to prevent “cross-talk” between the wells during the qPCR fluorescence testing procedure • Minimized background phosphorescence caused by agglomeration of TiO2 and/or oxidized (stressed) polystyrene • Preservation of polystyrene grade properties • Change control of formulation and manufacturing process • Robust product quality from batch to batch • Developed optimally dispersed, ready-to-use white formulation that maintains adequate signal transmission, as well as minimizing “cross-talk” and background phosphorescence • Optimized the use of general purpose polystyrene (GPPS) for a good balance between melt flow and other physical properties, such as stiffness • Provided comprehensive change control of raw materials and formulation, with a robust manufacturing process and quality control under a third party ISO 13485:2016 certified QMS Mevopur Healthcare Colorants and Formulations – pre-colored solution WHY AVIENT?
https://www.avient.com/sites/default/files/2020-07/PH -AVIENT LUXEMBOURG - 15608678 - ISO 14001.pdf
POLYONE FRANCE TOSSIAT 43, PLACE DE LA GARE 01250 TOSSIAT FRANCE Bureau Veritas Certification France certify that the Management System of the above organization has been audited and found to be in accordance with the requirements of the management system standard detailed below: Standard ISO 14001:2015 Scope of certification THE DESIGN AND MANUFACTURE OF COLOUR AND ADDITIVE CONCENTRATES FOR THERMOPLASTICS Certification/Recertification Cycle Start Date: 03 May 2023 Subject to the continued satisfactory operation of the organization’s Management System, this certificate expires on: 02 May 2026 Expiry date of previous cycle: NA Certification/Recertification Audit date: 08 March 2023 Original Cycle Start Date: 15 July 2011 Certificate n°: FR081968-1 File n°:15608678 Revision date:24 April 2023 Laurent CROGUENNEC - President Local Office: Bureau Veritas Certification France Le Triangle de l'Arche - 9 Cours du Triangle - 92937 Paris La Défense Further clarifications regarding the scope of this certificate the applicability of the management system requirements may be obtained by consulting the organization. To check this certificate validity, please use the QR Code. 1/1
https://www.avient.com/sites/default/files/2022-06/ISO_9001_2015_Cert_PolyOne.pdf
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. F-27, MIDC, Ranjangaon, Shirur Pune, Maharashtra 412 220 India ISO 9001:2015 The Quality Management System is applicable to: Certificate No: 51482 Certification Date: 08 April 2015 Effective Date: 03 March 2021 Expiration Date: 07 April 2024 Revision Date: 08 March 2021 Dominic Townsend, President THE DESIGN AND MANUFACTURE OF COLOR, ADDITIVE CONCERTRATES AND SPECIALITY COMPOUNDS This certificate may be found on the ABS QE Website (www.abs-qe.com). For certificates issued in the People's Republic of China information may also be verified on the CNCA website (www.cnca.gov.cn).
https://www.avient.com/sites/default/files/2020-07/ISO 45001 14 March 2026.pdf
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. F-27, MIDC, Ranjangaon, Shirur, Pune, Maharashtra 412 220 India ISO 45001:2018 The Occupational Health and Safety Management is applicable to: Certificate No: 55689 Certification Date: 15 March 2017 Effective Date: 09 March 2023 Expiration Date: 14 March 2026 Revision Date: 15 March 2023 Dominic Townsend, President DESIGN MANUFACTURE OF COLOR MASTER BATCHES, ADDITIVES CONCENTRATES AND SPECIALTY COMPOUNDS. This certificate may be found on the ABS QE Website (www.abs-qe.com).
https://www.avient.com/sites/default/files/2020-07/ISO 14001 - 14 March 2026.pdf
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. F-27, MIDC, Ranjangaon, Shirur, Pune, Maharashtra 412 220 India ISO 14001:2015 The Environmental Management System is applicable to: Certificate No: 55688 Certification Date: 15 March 2017 Effective Date: 09 March 2023 Expiration Date: 14 March 2026 Revision Date: 21 March 2023 Dominic Townsend, President DESIGN MANUFACTURE OF COLOR MASTER BATCHES, ADDITIVES CONCENTRATES AND SPECIALTY COMPOUNDS This certificate may be found on the ABS QE Website (www.abs-qe.com). For certificates issued in the People's Republic of China information may also be verified on the CNCA website (www.cnca.gov.cn).
https://www.avient.com/sites/default/files/2023-12/Jeddah%2C Saudi Arabia ISO 9001.pdf
Quality Management System Certificate of Approval This is to certify that the QMS of Avient Saudi Industries Co. Limited PO Box 2137, Jeddah 22758 Saudi Arabia Has been assessed and found to meet the requirements of ISO 9001:2015 This certificate is valid for the following scope of operations: Production and Supply of Color and Additive Master Batches Authorised by: Stan Wright Director Date of Certificate Issue: 17 October 2022 Certificate Valid Until: 29 September 2025 Recertification audit before 30 August 2025. This certificate is the property of SN Registrars (Holdings) Limited and remains valid subject to satisfactory annual Surveillance audits.