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/2022-03/MEVOPUR Chemical Foaming Agents Application Bulletin_JP.pdf
主な特徴 • • • • • • ISO 13485の管理基準化で製造。
規制対応 • • • 評価試験*: - ISO 10993-1 - USP および (Class VI) - 欧州薬局方 モノグラフ 3.1.3/ 3.1.5 (ポリオ レフィン系包装材料) - USP (ポリエチレン) - ICH Q3Dに準拠した元素不純物分析 DMF(Type III)および Device Master File 登 録済み 米国FDAおよびEUの食品接触規格 軽量化 ヘルスケア用途に制限ありー下記参照詳しくはAvientにお問い合わせください。
a) 米国食品医薬品局(FDA)または国際標準化機構(ISO)により「インプラント」機器として分類される医療機器、または米国薬局方(USP)または ISO 規格で定義される「パーマネント」 機器、または (b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または (c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives 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 • Non-phthalate and formulated without animal- derived substances • Available for use in a wide range of polymers including polyolefins, styrenics, polycarbonate and alloys, polyester, POM • Functionality can be combined with colorants into convenient combination concentrates and ready-to-use formulations 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 FUNCTIONALITY TARGET APPLICATIONS DRUG DELIVERY DEVICES SYRINGES & NEEDLES DIAGNOSTICS CATHETERS Clarifying PP Sorbitol-free for transparent applications with reduced migration and improved thermal stability Lubricant— permanent/ non-migrating Fast acting reduction in friction for wide variety of polymers such as PP, ABS, POM, PC Protection from UV in transparent applications for PP, PE, PETG, COP UV blocking in 290-450nm with no impact on clarity; can be combined with colors (e.g., amber) Antistatic ready-to- use solution for PP, ABS, PC/ABS Permanent/non-migrating; fast decay time independent of % relative humidity Gamma/e-beam sterilization protection of the polymer Preserving the properties of PP and COC/COP; reduction in yellowing using Color Compensation Technology (CCT) Reduced material consumption/cycle time—nucleation Fast acting new generation nucleant for PE and PP; improved thermal and mechanical properties allows wall thinning; reduction of tolerance/dimensional problems between different colors Laser marking replacing ink printing/labels Solvent-free, high-speed identification for Nd/YAG laser for PE,PP, ABS, PC, POM Antioxidants for PE, PP, TPE Thermal protection during converting/downstream sterilization Brand protection/ anticounterfeit Covert and non-covert systems Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2024-02/Gravi-Tech REC Recycled Formulations Product Bulletin.pdf
KEY CHARACTERISTICS • Customized density offering a wide range of specific gravities (1.2–11 gm/cm3) • Based on recycled resin from PIR and PCR sources • Broad modulus range, from very flexible to very rigid grades • Corrosion resistance that withstands oxidization for long-term use and benefit • Chemical resistance can be adapted depending on base resin as required • Provides visual surface effects, aesthetics, and cool touch • Design flexibility and processing ease MARKETS AND APPLICATIONS Applications in packaging and consumer goods in which a more sustainable solution is preferred: • Cosmetic caps and closures • Perfume caps • Spirit bottle caps • Luxury boxes • Handles and knobs SUSTAINABILITY BENEFITS • Formulated with recycled resin from post-industrial recycled (PIR) and/or post-consumer recycled (PCR) sources including ocean bound plastic waste • Reduces waste and supports the circular economy • Reduces carbon footprint compared to fossil feedstock alternatives • Simplifies manufacturing and lowers costs versus metal PRODUCT BULLETIN CHARACTERISTICS UNITS Gravi-Tech REC-CI GT5200-5089 PT Natural Gravi-Tech REC GT5200-5075 Black X2 Gravi-Tech REC GT5200-5078 Black Gravi-Tech REC GT5200-5079 Black Gravi-Tech REC GT5200-5060 Black Gravi-Tech REC GT5200-5057 Black Base Resin Ocean Bound rPP rPP rPP rPP rPP rPP Recycled Content/Filler g/cm >98% PIR+PCR 60% PIR/Mineral >95% PIR/Mineral >95% PIR+PCR/Mineral 30% PIR/Mineral 30% PIR/Mineral Density (ISO 1183) g/ccm 1.2 1.2 1.2 1.2 1.9 2.0 CHARACTERISTICS UNITS Gravi-Tech REC GT7300-5034 X2 FD Natural Gravi-Tech REC GT7300-5036 Black Gravi-Tech REC GT7300-5025 Black Gravi-Tech REC GT6000-5032 Black Gravi-Tech REC GT6000-5031 Black Base Resin ABS rABS/ABS rABS rPA6 rPA6 Recycled Content/Filler g/cm 50% PIR/Mineral 65% PIR/Mineral 10% PIR/Mineral 20% PIR/Mineral 20% PIR/Mineral Density (ISO 1183) g/ccm 1.5 1.5 2.2 2.7 2.8 AVAILABLE GRADES Copyright © 2024, Avient Corporation.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Colorants and Formulations Special Effects Application Bulletin_0.pdf
KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing 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 • Available as pre-colored formulation or concentrate and for use in 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 * Design note: Effect colors require careful consideration of part design and polymer flow paths to minimize visible flow lines.
https://www.avient.com/sites/default/files/2022-12/Mevopur Colors for Ophthalmic Closures Application Bulletin_A4.pdf
KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing 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 • Standard concentrates in a PE carrier and on request in PP • Pre-colored formulations can be supplied in specific resins selected for the application 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) • Food contact established with FDA/EU* APPLICATION BULLETIN DRUG TYPE COLOR DESCRIPTION PANTONE REFERENCE AVIENT PRODUCT CODE PE BASED Adrenergic agonist combinations Light Green 373 C PE6M176349 Adrenergic agonists Purple 2583 C PE4M176057 Anti-infectives Tan 467 C PE8M176130 Anti-inflammatory, nonsteroidal Grey Cool Grey 4 C PE7M176184 Anti-inflammatory, steroids Pink 197 C PE3M176237 Anti-inflammatory, immunomodulators Olive Green 5763 C On request Beta-blockers Yellow Yellow C PE1M176160 Beta-blocker combinations Dark Blue 281 C PE5M176272 Carbonic anhydrase inhibitors Orange 1585 C PE2M176089 Cytotoxic Black 6 C PL9M176008 Miotics Dark Green 348 C PE6M176267 Mydriatics and cycloplegics Red 1797 C PE3M176236 Prostaglandin analogues Turquoise 326 C PE5M176273 Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2022-12/Mevopur Laser Marking Additives Application Bulletin.pdf
KEY CHARACTERISTICS • Designed for Nd:YAG lasers operating between 1060-1070 nm • Available for different polymers including PP, PE, PC, PBT, POM, ABS, MABS • 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 • Can be designed for dark marking on natural or white/light colored background or light marking on black/dark background 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.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Functional Additives Pharma Pkg 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 • Non-phthalate and formulated without animal- derived substances • Available for use in a wide range of polymers including polyolefins, styrenics, polycarbonate and alloys, polyester, POM • Functionality can be combined with colorants into convenient combination concentrates or formulations REGULATORY SUPPORT • Pre-tested raw materials: - 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) • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request FUNCTIONALITY TARGET APPLICATIONS EBM/IBM CONTAINERS CLOSURES FILM COMBINATION DEVICES Clarifying PP Sorbitol-free—possibilities in packaging ocular solutions Slip/torque reduction Slip for PE, PP films, processing aid, torque reduction for closures Protection from UV in transparent packaging for PP, PE, PETG, COP UV blocking in 290–450nm with no impact on clarity Antistatic ready-to-use solution for PE films e.g. for API handling Permanent/non-migrating; fast decay time independent of % relative humidity Antistatic masterbatch for PE films Cost effective, long-lasting, migrating type but with biological evaluation Gamma/e-beam sterilization protection of the polymer Preserving the properties of PP and COC/COP.
https://www.avient.com/sites/default/files/2021-12/Chemically Resistant Materials Whitepaper.pdf
MATERIAL BRIEF DESCRIPTION FR PC/ABS Flame retardant, chemical resistance, high ESCR FR PC/PET Flame retardant, impact modified, chemical resistant FR PC/PBT Skin-contact biocompatible, flame retardant, high chemical resistance FR Copolyester Flame retardant, chemical resistant, may incorporate agency-rated materials to meet USP Class VI or ISO 10993 requirements Trilliant™ HC8910 Unfilled PK blend, BPA-free, high chemical resistance, may incorporate agency-rated materials to meet USP Class VI or ISO 10993 requirements Trilliant™ HC8920 FR Non-halogenated flame retardant PK blend, BPA-free, high chemical resistance, may incorporate agency rated materials to meet USP Class VI or ISO 10993 requirements Edgetek™ ET8900 CR Unfilled PK blend, high chemical resistance Edgetek™ ET8900 HI CR High impact PK blend, high chemical resistance Edgetek™ ET8920 FR CR Non-halogenated flame retardant PK blend, high chemical resistance Table 2.
https://www.avient.com/sites/default/files/2022-02/MEVOPUR Bio-based Solutions Application Bulletin_JP.pdf
規制対応 • • • 評価試験: - ISO 10993-1 - USP および (Class VI) - 欧州薬局方 モノグラフ 3.1.3/ 3.1.5 (ポリオ レフィン系包装材) - USP (ポリエチレン) - ICH Q3Dに準拠した元素不純物分析 DMF(Type III)および Device Master File 登 録済み 米国FDAおよびEUの食品接触規格 ヘルスケア用途に制限ありー下記参照詳しくはAvientにお問い合わせください。
a) 米国食品医薬品局(FDA)または国際標準化機構(ISO)により「インプラント」機器として分類される医療機器、または米国薬局方(USP)または ISO 規格で定義される「パーマネント」 機器、または (b)EU指令90/385/EECの改正で定義された能動埋込型医療機器、または (c)EU指令93/42/EECの改正で定義された「長期」使用のための医療機器。