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/2023-01/Mevopur Standard Colors Product Bulletin _ Color Card.pdf
Concentrates and pre-colored formulations are available for a wide range of polymers, including PE, PP, PEBA, PC, ABS, and others.
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/2023-01/Disinfectant Resistant Trilliant and Versaflex HC Materials Program Bulletin_0.pdf
Trilliant™ HC high performance formulations were developed for specific healthcare enclosure needs, including: • Chemical resistance to common disinfectants • UL 94 ratings of 5VA at 3.0, V-0 at 1.5 mm & V-1 at 0.75 mm • Retained color aesthetics after chemical exposure • Ability to utilize existing PC/PET & COPE tooling Tested using an adaptation from ASTM D543 for environmental stress cracking resistance (ESCR), 15 bars of each material were placed into jigs at 1% and 2% strain.
Virex® Tb Vesphene™ IIse CaviCide™ Trilliant™ HC 8910 +++ +++ +++ Trilliant™ HC 8920 (FR) – +++ +++ FR PC/PET – + ++ FR COPE (copolyester) + ++ +++ Tensile Strength Property Retention After 72-hour Continuous Exposure +++ Best (>90% retention), ++ Better (50-90% retention), + Good (
Designed for two- shot injection molding and formulated for the appropriate substrate, these medical-grade TPEs are compatible with rigid PVC, copolyesters, all PC alloys, ABS, TPUs and PEI substrates.
https://www.avient.com/sites/default/files/2020-10/auto-injector-application-study.pdf
Requirements: Excellent clarity, scratch resistance and exceptional toughness for visualization of medicant levels Solution: Avient Distribution HC Portfolio: Acrylic, copolyester, PC 2.
Requirements: Excellent clarity, scratch resistance and exceptional toughness Solution: Avient Distribution HC Portfolio: Acrylic, copolyester, PC, clarified PP Visual Identification Use colors and additives to differentiate and identify your brand, product or batch.
Requirements: Light diffusing optical properties Solution: Avient Distribution HC Portfolio: Light diffusing acrylics, PC 16.
https://www.avient.com/sites/default/files/2022-04/Asia SEM Healthcare Product Selection Guide_CN.pdf
Versaflex™ OM3060 PP包覆成型 硬度 法规 灭菌 特性 28A 环氧乙烷 柔软的半透明材料,粘性好 43A 环氧乙烷 高度可着色的解决方案, 粘性好,不易压缩变形 42A/ 50A 环氧乙烷 透明的耐高温级材料; ABS、PC可粘合 60A 环氧乙烷/蒸汽 弹性高,不易压缩变形 20A-90A 环氧乙烷 用途广泛,无填充 ABS,PC包覆成型 硬度 法规 灭菌 特性 40A USP VI级,ISO 10993 环氧乙烷 半透明 60A USP VI级,ISO 10993 环氧乙烷 透明 应用: VERSAFLEX™ CL与DYNAFLEX™ 热塑性弹性体 包覆成型,符合人体 工程学设计 • • • • • • 触感柔软,有利于形成良好的表面 有多种颜色效果和纹理可供选择 提高抓握力、缓冲力和舒适度 提高性能表现,如密封性能、减震、隔氧、 耐刮擦和耐磨性能 降低装配成本,加工性能良好 可牢固包覆于各种基材上 • • • • 血糖仪 医用工具包覆成型 注射笔 分析仪器 Dynaflex™ G2706 Dynaflex™ G2711 Versaflex™ CL2242 & CL2250 Versaflex™ G2705 N Versaflex™ HC3810 Versaflex™ OM1040 USP VI级,ISO 10993, 食品接触 USP VI级,ISO 10993, US食品接触 USP VI级,ISO 10993, 食品接触 USP VI级,ISO 10993 USP VI级,ISO 10993, 食品接触 材料描述 硬度 法规 灭菌 特性 45A USP VI级 55A USP VI级 70A USP VI级 43A 环氧乙烷 34A USP VI级, ISO 10993-4/5 FDA,USP VI级, ISO 10993 57A 挤出级,耐高温 再密封,压缩变形性能提高 摩擦低 Versalloy™ HC 9210-55N Versalloy™ HC 9210-70N Versalloy™ HC 9220-43N Versaflex™ HC 2110-35N Versaflex™ HC 2110-57B FDA,USP VI级, ISO 10993 环氧乙烷 加工性能良好,表面光洁、美观 环氧乙烷 环氧乙烷 加工性能良好,表面光洁、美观 加工性能良好,表面光洁、美观 高压灭菌、环氧乙烷、 辐射灭菌 高压灭菌、环氧乙烷、 辐射灭菌 应用: VERSALLOY™ HC与VERSAFLEX™ HC 热塑性弹性体 密封和再密封 • • • • • 柔软的橡胶质感 无抽芯,静态推塞被刺穿后再密封性良好 满足动态密封的低摩擦系数要求 可萃取物含量低 适合在聚烯烃上包覆成型 • • • 密封和密封隔膜 密封件和卫生垫圈 注射器推塞和塞头 Versalloy™ HC 9210-45N 材料描述 硬度 法规 灭菌 特性 65A/ 75A/ 84A 54A 67A 辐射灭菌 高压灭菌器 透明度高,不含增塑剂,无油 工作温度高,可高温灭菌 环氧乙烷、辐射灭菌 Versaflex™ HC MT555 Versaflex™ HC BT218 应用: VERSAFLEX™ CL与DYNAFLEX™ 热塑性弹性体 高透明度级,不含增塑剂 • • • • • • • 无色透明级,配方不含邻苯二甲酸酯增塑剂 符合医疗法规USP VI级和ISO 10993-4、5的 要求 食品接触用并符合FDA标准 可高压灭菌和辐射灭菌 可萃取物含量低 透明度高(雾度50 4.1, 100 4.5, 100 4, 70 6, 70 拉伸模量(MPa) 2200 2700 2600 2350 1820 1820 挠曲强度(MPa) 80 90 104 86 68 68 挠曲模量(MPa) 2500 2700 2500 2300 1980 1590 HDT:0.45、1.8(MPa) 110, 80 90, 80 100, 89 123, 100 123, 64 100, 70 UL-94等级,3.0mm 5VA V-0 5VA V-0 HB V-0 UL-94等级,1.5mm V-0 V-0 5VB V-0 HB V-0 UL-94等级,0.75mm V-1 V-2 V-0 无 无 V-2 竞争材料对比 医疗保健特种工程聚合物配方 TRILLIANT™ HC热塑性塑料 Trilliant™ HC高性能热塑性弹性体系列配方是专为应对日趋严苛的医疗器械和设备而开发的。
TRILLIANT™ HC8920 TRILLIANT™ HC2020 Trilliant™ HC2020 材料描述 基料 共聚酯 Trilliant™ HC8910/8920 聚酮/ABS共混物 Trilliant™ HC2120 Tritan Trilliant™ HC3120 PC Trilliant™ HC5210 PP Trilliant™ HC6010 PA6 Trilliant™ HC6610 PA66 Trilliant™ GRV-NP-110-W PA12 应用: TRILLIANT™ HC热塑性塑料 • • • • • 作为FR PC/ABS、FR PC/PET和FR COPE的 耐化学性替代品,在各种颜色的应用中,其 阻燃等级在1.5mm和0.75mm厚度下分别可 达到UL 94黄卡V-0级和V-1级。
在对普通消毒剂的耐受性方面优于PC/ABS、 PC/PET和COPE 暴露在普通医院消毒剂下72小时后仍能保持 抗拉强度,相较于PC混合物和COPE,具有 更出色的长期耐化学性 具有良好的抗冲击性和耐热性 有自然色等级、标准医用颜色或定制预着色 产品可供选择 • • • • 医疗设备外壳 核磁共振成像、X射线、CT扫描仪部件 手术器械,如吻合器、解剖器、剪刀等 自动注射笔 测试项 比重 熔体流动指数 (230OC, 2.16KG) 抗拉强度 挠曲强度 挠曲模量 冲击强度 缺口,IZOD 测试项 方法 ASTM D-792 ASTM D-1238 ASTM D-638 ASTM D-790 ASTM D-790 ASTM D-256 ASTM D-257 单位 -- g/10min MPa MPa MPa J/m Ohms/sq.
https://www.avient.com/sites/default/files/2023-01/Mevopur Colorants _ Additives Brochure.pdf
These include PE, PP, ABS, SAN, PC/ABS, PC, PA6, 66 and 12, cyclic olefins (COP), high performance polymers, and elastomers such as EVA, SEBS, TPU and PEBA.
ADDING VALUE TO A WIDE RANGE OF HEALTHCARE APPLICATIONS PROVIDING STANDARD AND CUSTOM COLORANTS & ADDITIVES STANDARD COLOR RANGES To speed up time to market, Avient offers a standard range of colorants using pre-tested raw materials suitable for a wide range of polymers including PE, PP, PEBA, PC, and others.
APPLICATION PORTFOLIO DESCRIPTION General use Opaque and transparent colors in PP, PE, COC, ABS, POM, PC, TPU, PEEK, and more Needle hubs and cannulae Opaque and translucent colors evaluated to ISO 6009 Ophthalmic caps and closures 13 standard colors in PE matched to American Academy of Ophthalmology; biologically evaluated to USP standard White pharmaceutical packaging White colorants for PE, HDPE, PP covering solid dose to nasal packaging needs Amber pharmaceutical packaging Pre-tested amber colorants LSR silicones For LSR silicones and transparent color PET/PP (e.g. amber) FUNCTIONALITY ADDITIVE PERFORMANCE UV protection in transparent packaging Blocks UV in 290–450nm for PP, PE, PETG, COP Processing aid/friction reduction Optimizes processing for PE, PP, ABS, POM—non-migrating Nucleation for reduced material consumption/cycle time Improves thermal and mechanical properties of PE and PP and allows wall thinning to support sustainability Clarifying Improves clarity of transparent PP applications with reduced migration and improved thermal stability—sorbitol-free Laser marking/welding Activates the polymer to absorb Nd-YAG laser for fast reliable marking/assembly Gamma/e-beam sterilization Preserves the properties of PP and COP, reduces yellowing and compensates for discoloration Anti-static Reduces static buildup in applications such as films in API handling and inhaler spacers/nebulizers Antioxidant Provides thermal protection during converting/ downstream sterilization Anti-counterfeit/brand protection Covert and non-covert systems SUPPORTING SUSTAINABILITY TARGETS As the need to integrate sustainability in the design of healthcare products is growing, manufacturers of medical devices, diagnostic products and pharmaceutical packaging are looking for materials with a more environmentally friendly profile.
https://www.avient.com/sites/default/files/2020-09/stat-tech-tri-fold-processing-guide.pdf
Base Resin PC PC/PSU PES PEI PP ABS PEEK PA Barrel Temperatures* °F (°C) Rear Zone 530–560 (277–293) 550–575 (288–302) 660–700 (349–371) 675–725 (357–385) 390–420 (199–216) 425–460 (219–238) 680–730 (360–388) 430–500 (221–260) Center Zone 515–560 (269–288) 540–565 (282–296) 650–690 (343–366) 655–710 (352–377) 380–405 (193–207) 415–450 (213–232) 670–710 (354–377) 420–490 (216–254) Front Zone 510–525 (266–274) 530–555 (277–291) 640–680 (338–360) 655–700 (346–371) 370–395 (188–202) 405–440 (207–227) 650–690 (343–366) 410–480 (210–249) Nozzle 520–535 (271–280) 540–565 (282–296) 650–690 (343–366) 665–710 (352–377) 380–400 (193–204) 415–450 (213–232) 660–700 (349–371) 420–490 (216–254) Melt Temperature 525–560 (274–293) 530–580 (277–304) 650–700 (343–371) 660–730 (349–388) 375–395 (191–202) 410–460 (210–238) 650–730 (343–388) 420–500 (216–260) Mold Temperature 175–250 (80–121) 160–220 (71–104) 280–350 (138–177) 275–350 (135–177) 100–135 (38–57) 150–180 (66–82) 300–425 (149–219) 160–230 (71–110) Pack & Hold Pressure 50%–75% of Injection Pressure Injection Velocity in/s 0.5–2.0 Back Pressure psi 50 Screw Speed rpm 40–70 40–70 40–70 40–70 40–70 40–70 40–70 40–70** Drying Parameters °F (°C) 6 hrs @ 250 (121) 4 hrs @ 250 (121) 4 hrs @ 275 (135) 4 hrs @ 250 (121) 3 hrs @ 300 (150) 2 hrs @ 200 (93) 3 hrs @ 275 (135) 4 hrs @ 180 (82) Cushion in 0.125–0.250 Screw Compression Ratio 2.0:1–2.5:1 2.0:1–2.5:1 2.5:1–3.5:1 2.5:1–3.5:1 2.5:1–3.5:1 2.5:1–3.5:1 2.5:1–3.5:1 2.5:1–3.5:1 Nozzle Type General Purpose General Purpose General Purpose General Purpose General Purpose General Purpose General Purpose Reverse Taper Clamp Pressure 5–6 Tons/in2 * A reverse temperature profile is important to obtain optimum conductive properties.
Venting • Place vents at the end of fill and anywhere potential knit/weld lines will occur. • All vents need to be vented to atmosphere. • For circular parts, full perimeter venting is recommended. • Cut vent depths to: - PC Compounds: 0.001"–0.002" depth and 0.250" width - PC/PSU Compounds: 0.002"–0.003" depth and 0.250" width - PES Compounds: 0.003"–0.004" depth and 0.250" width - PEI Compounds: 0.001"–0.003" depth and 0.250" width - PP Compounds: 0.001"–0.002" depth and 0.250" width - ABS Compounds: 0.0015"–0.0025" depth and 0.250" width - PEEK Compounds: 0.002"–0.004" depth and 0.250" width - Nylon Compounds: 0.002" min. depth and 0.250" width • Increase vent depth to 0.040" (1.0mm) at 0.250" (4.0mm) away from the cavity and vent to atmosphere.
https://www.avient.com/sites/default/files/2022-05/ColorMatrix Amosorb Solo Technical Bulletin.pdf
Picture of plaques originally made from preforms containing Fortis Amber-1 and Amosorb Solo2-2.
After having the flakes coming from the original bottles go through up to 5 melt histories, it was shown that the L*, a* and b* values underwent minimal changes, thus allowing for retention of the original desired tone of the bottles.
This could represent an opportunity for the value chain looking into introducing bottles-to-bottles back to their original standard.
https://www.avient.com/sites/default/files/2020-09/chemically-compatible-tpes-for-cosmetic-pkg-application-bulletin.pdf
VERSAFLEX PKG 4345, 4355, 4365 VERSAFLEX PKG 4465 VERSAFLEX PKG 4570 VERSAFLEX PKG 4665 Chemical Compatibility Soaps, low-cost solution for non-polar oils Soaps, some oils Polar & non-polar oils, non-polar solvents Non-polar oils (abrasion resistant) Regulatory Compliance* REACH SVHC, FDA 21 CFR EU 10/2011 REACH SVHC & FDA 21 CFR REACH SVHC & FDA CFR REACH SVHC & FDA CFR Hardness 45A, 55A, 65A 65A 70A 65A Overmolded Substrate Polypropylene Polypropylene Polycarbonate ABS PC/ABS Polycarbonate ABS PC/ABS Color Translucent Translucent Natural Natural * Please contact Avient for additional information HOW CHEMICALLY COMPATIBLE VERSAFLEX PKG TPEs MAKE THE DIFFERENCE IN COSMETIC PACKAGING Chemical compatibility – Versaflex PKG TPEs do not discolor, etch, crack or delaminate when in contact with most soaps, lotions, oils, surfactants and solvents found in cosmetics.
https://www.avient.com/sites/default/files/2021-02/versaflex-non-blooming-solution-technical-bulletin.pdf
TECHNICAL BULLETIN 1.844.4AVIENT www.avient.com PROPERTY TEST METHOD UNITS VERSAFLEX™ CE 3130-80N VERSAFLEX™ CE 3130-70N Shore Hardness ASTM D2240 Shore A 79 69 Specific Gravity ASTM D792 g/cm3 1.08 1.04 Tensile Strength ASTM D412 psi 2,484 2,222 Melting Flow Index (190°C, 21.6kg) ASTM D1238 g/10min 5.2 4.4 Elongation ASTM D412 % 864 667 Flexural Modulus @ 300% ASTM D790 psi 975 855 Viscosity @ 11,170 sec, 200°C ASTM D3835 Pa.s 30.6 22.2 Abrasion (Mass Lost) ASTM D3389 mg 1.1 2.6 UV Resistance 0.68W/m2 45°C 168hours — Good Good Stain Resistance *Condition 1 *Condition 2 — Excellent Excellent Blooming 85% RH 30°C,168 hours — Non Non Processing (Demold) — — Excellent Good Cycle Time — — Short Middle Overmold Substrate — — PC/ABS PC/ABS KEY PROPERTIES AND OVERMOLD PERFORMANCE Copyright © 2021, Avient Corporation.