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/2023-07/TPEs for Healthcare Industry Bulletin.pdf
VERSAFLEX™ HC MEDICAL TUBING GRADES • Improve extrusion rates, achieve high service temperature performance or increase clarity in medical tubing • Traditional and bio- based formulations specifically for biopharmaceutical tubing to meet the needs for weldability and minimize extractables during processing VERSALLOY™ HC SERIES • Obtain better flow in long, thin paths and lower shrink rates versus typical TPVs with our alloys • Color easily and obtain a smooth tactile feel VERSAFLEX™ HC GASKETS & STOPPERS SERIES • Achieve no coring, good puncture and resealability in static stoppers • Meet low COF and low stiction requirements in dynamic seals VERSAFLEX™ CL E SERIES • Increase clarity and flexibility in bags, bottles and films • Mitigate risk with plasticizer-free formulations for film extrusion • Deliver excellent odor & O2 barrier performance for film extrusion INDUSTRY BULLETIN TPE HEALTHCARE PRODUCT SELECTOR GUIDE Versaflex™ HC Medical Tubing Grades Versaflex™ HC MT222 Clear 66A 0.88 14 - 334 2.30 629 4.34 898 6.19 430 220 36 ✔ ✔ High clarity, without plasticizersVersaflex™ HC MT224 Clear 75A 0.89 19 - 468 3.23 773 5.33 1360 9.40 530 321 56 ✔ ✔ Versaflex™ HC MT226 Clear 84A 0.88 20 - 606 4.17 885 6.10 1600 11.00 600 433 76 ✔ ✔ Versaflex™ HC MT317 Clear 68A 0.89 17 69 450 3.10 660 4.55 870 6.00 470 221 39 ✔ ✔ Very high service temperature Versaflex™ HC BT218 Natural 67A 0.89 19 69 381 2.60 683 4.70 1186 8.20 608 - - ✔ ✔ Weldable, kink resistant Versalfex™ HC BIO BT218 Natural 70A 0.88 18 58 416 2.87 668 4.60 1190 8.20 630 - - ✔ ✔ Weldable, kink resistant, contains 40% bio-derived content (Gen 1 biomass) Versaflex™ HC Gaskets & Stoppers Series Versaflex™ HC 2110-35N Natural 34A 0.90 19 47 145 1.00 261 1.80 400 2.76 620 97 17 ✔ ✔ Good resealing Versaflex™ HC 2110-43N Natural 43A 0.98 12 46 134 0.92 368 2.54 723 4.98 710 - - ✔ ✔ Good compression set Versaflex™ HC 2110-57B Black 59A 1.01 20 37 369 2.54 558 3.85 537 3.70 350 147 26 ✔ ✔ Low stiction Versaflex™ CL E Series Versaflex™ CL E85 Clear 84A 0.90 20 72 752 5.18 1160 8.00 1550 10.70 450 433 76 ✔ ✔ High clarity, without plasticizers; E95 also offers excellent odor & O2 barrier Versaflex™ CL E90 Clear 90A 0.90 27 73 1000 6.89 1230 8.50 1830 12.60 57 - - ✔ ✔ Versaflex™ CL E95 Clear 95A 0.90 38 71 1680 11.60 1730 11.90 2500 17.20 580 720 126 ✔ ✔ Versaflex™ HC 3810 Series Versaflex™ HC 3810-20N Natural 20A 0.88 16 54 123 0.80 185 1.30 342 2.40 650 - - ✔ - Formulated without animal derivatives, excellent colorability, translucent Versaflex™ HC 3810-30N Natural 30A 0.89 18 58 170 1.20 245 1.70 459 3.20 680 - - ✔ - Versaflex™ HC 3810-40N Natural 40A 0.88 19 59 191 1.30 275 1.90 506 3.50 670 - - ✔ - Versaflex™ HC 3810-50N Natural 50A 0.89 21 61 264 1.80 366 2.50 699 4.80 690 - - ✔ - Versaflex™ HC 3810-60N Natural 60A 0.88 24 65 459 3.20 594 4.10 790 5.40 510 - - ✔ - Versaflex™ HC 3810-70N Natural 70A 0.88 28 67 535 3.70 684 4.70 1000 6.90 570 - - ✔ - Versaflex™ HC 3810-80N Natural 80A 0.88 30 67 689 4.80 869 6.00 1390 9.60 620 - - ✔ - Versaflex™ HC 3810-90N Natural 90A 0.88 27 89 1087 7.50 1350 9.30 1890 13.00 570 - - ✔ - Versalloy™ HC 9210 Series Versalloy™ HC 9210-45N Natural 45A 0.89 19 39 160 1.10 320 2.20 484 3.33 480 100 18 - ✔ Smooth surface aestheticsVersalloy™ HC 9210-55N Natural 53A 0.89 20 44 208 1.44 335 2.31 580 4.00 610 120 21 - ✔ Versalloy™ HC 9210-70N Natural 70A 0.89 23 53 356 2.45 510 3.52 780 5.38 590 180 32 - ✔ Versalloy™ HC 9220 Series Versalloy™ HC 9220-70 Natural 70A 0.95 17 51 453 3.12 - - 643 4.43 265 208 36 ✔ ✔ ExtrudableVersalloy™ HC 9220-80 Natural 80A 0.94 18 59 553 3.67 777 5.36 945 6.52 415 208 36 ✔ ✔ Versalloy™ HC 9220-90 Natural 90A 0.94 25 55 1030 8.13 1350 9.33 1945 13.45 620 400 70 ✔ ✔ Standard Healthcare Grades Versaflex™ G2705N Natural 60A 0.88 - - - - 528 3.64 670 4.62 470 - - ✔ ✔ Natural, high strength Versaflex™ CL 2242 Clear 43A 0.89 23 - 152 1.05 294 2.02 731 5.00 780 124 22 ✔ ✔ High clarity, boilable Versaflex™ CL 2250 Clear 50A 0.89 20 - 220 1.52 337 2.32 827 5.70 770 140 25 ✔ ✔ Versaflex™ OM Series Versaflex™ OM 1040X Natural 42A 0.92 22 - 180 1.24 301 2.08 504 3.47 580 100 18 ✔ ✔ ABS/PC overmoldVersaflex™ OM 3060 Clear 59A 0.90 33 - 420 2.90 360 2.48 500 3.45 480 180 32 ✔ ✔ Versaflex™ OM 8940X-1 Clear 42A 0.91 - - 233 - 311 - 1573 - 1059 - - - - PK, COPE overmold Versaflex™ OM 4052 Natural 56A 1.01 27 - 271 - 557 - 1680 - 670 - - ✔ - Excellent chemical resistance; PK, PC, ABS, PC/ABS overmoldVersaflex™ OM 4063 Natural 54A 1.12 30 - 365 - 580 - 1640 - 670 - - ✔ - Color Hardness Specific Gravity Compression Set @ 23°C Compression Set @ 100°C 100% Modulus 300% Modulus Tensile Strength Elongation Tear Strength ISO 10993 USP VI Special Characteristics ASTM Shore A ASTM/ISO ASTM % ASTM % ASTM psi MPa ASTM psi MPa ASTM psi ISO MPa ASTM % ASTM pll ISO kN/m GENERAL PROPERTIES TENSILE PROPERTIES OTHER For further information on specific grades, review technical data sheets.
https://www.avient.com/sites/default/files/2020-09/versaflex-pf-technical-bulletin-sept-2020-pt-br.pdf
VERSAFLEX™ PF Camada de aderência para para películas protetoras de superfície BOLETIM TÉCNICO Propriedades Versaflex PF MD6727 Versaflex PF DM6741 Versaflex PF DM6649 Versaflex PF 9512 Versaflex PF MD6666 Versaflex PF DM6748 Versaflex PF DM6700 Características Baixa aderência Baixa aderência; usado para personalizar aderência com MD6700 Aderência de baixa a média Oferta de valor Aderência média Gel/resíduos baixos Estrutura de baixa aderência Alta aderência Resistência a descolamento Baixa Baixa a média Média Média a alta Média a alta Alta Alta Aplicações Películas ópticas Eletrodomésticos Plásticos Construção/metais expostos Metais acabados Aço/metais pintados Metais expostos MFR a 190 °C/2,16 kg -- 4,5 17 5,4 21 4,8 6,5 MFR a 230 °C/2,16 kg 10 20 -- -- -- -- -- Gravidade específica, g/cc 0,92 0,91 0,92 0,92 0,94 0,94 0,94 Dureza, Shore A 50 49 37 38 37 31 30 G' a 23°C, Pa 28,0 x 105 10,4 x 106 8,3 x 105 -- 9,9 x 105 11,8 x 105 10,0 x 105 DMA Tg, °C -29 -30 -9 10 11 15 21 Película LDPE/Versaflex PF1 Descolamento de 180°, N/25 mm Aço inoxidável após 20 min a 25 °C 0,5 2,2 3,2 6,1 6,7 8,5 8,6 após 7 dias a 25°C 0,6 2,7 4,3 5,5 8,2 8,3 10,3 PMMA2 após 20 min a 25 °C 1,1 1,7 3,8 4,9 6,9 8,3 8,8 após 20 min a 75 °C 2,8 4,1 5,1 6,9 9,0 10,7 11,8 após 7 dias a 75°C 4,0 4,4 5,9 9,8 8,4 9,8 10,3 Policarbonato3 após 20 min a 25 °C 1,4 2,2 3,8 6,8 6,3 8,4 7,0 após 20 min a 75 °C 3,4 4,8 6,7 8,8 8,8 10,0 11,8 após 7 dias a 75°C 4,6 6,5 7,5 10,6 11,6 10,6 13,8 1 Espessura da película: LDPE 51 mícrons/Versaflex PF 25 mícrons 2 Arkema Plexiglas™ V052-100 (Plexiglas é uma marca comercial da Arkema France Corp). 3 Sabic Lexan™ L52-111 (Lexan é uma marca comercial da Sabic Innovative Plastics) PROPRIEDADES FÍSICAS DE FORMULAÇÕES DE CAMADA DE ADERÊNCIA VERSAFLEX PF SELECIONADAS DESCRIÇÃO DO PRODUTO As formulações Versaflex™ PF são especialmente desenvolvidas para a fabricação de películas protetoras de superfície coextrudadas de fácil aplicação, mantêm a aderência com espessura mínima, descolam suavemente e são removidas completamente, sem nenhum ou com pouco resíduo.
OS BENEFÍCIOS DO VERSAFLEXTM PF PARA PELÍCULAS PROTETORAS DE SUPERFÍCIE: • Aderência personalizável • Processo de fabricação de etapa única (coextrusão) • Baixas emissões de compostos orgânicos voláteis (COV) durante a fabricação • Elimina operações secundárias de revestimento e secagem • Elimina produtos químicos líquidos perigosos em comparação com os sistemas de solventes • Reduz custos de conversão em comparação com revestimento • Reduz o consumo de energia MERCADOS E APLICAÇÕES As formulações Versaflex PF, personalizáveis com base no nível desejado de aderência, são coextrudadas com películas protetoras para fornecer apenas a quantidade certa de proteção durante a fabricação, montagem, envio, armazenamento e instalação de produtos acabados em muitas indústrias e aplicações de uso final, incluindo: • Películas ópticas e painéis de exibição de eletrônicos para o consumo • Eletrodomésticos • Construção e materiais de construção • Móveis e armários • Automotivo e outros transportes 100/0 90/10 80/20 70/30 60/40 40/60 30/70 20/80 10/90 0/100 0,9 1,1 2,0 2,4 2,8 3,7 3,8 4,9 0 1 2 3 4 5 6 7 8 6,5 1,6 Versaflex PF MD6727 Versaflex PF MD6748 Versaflex PF MD6700 Versaflex PF MD6666 Versaflex PF 9512 Versaflex PF MD6649 Versaflex PF MD6741 0 2 4 6 8 10 12 % de MD6741/MD6700 O grau de aderência pode ser personalizado para superfícies de substrato.
https://www.avient.com/sites/default/files/2021-06/fl.datasheet-extrusion.pdf
PVC PVC BARE PERFORMANCE Operating Temperature Range -55°C - 105°C Chemical Resistance P Flame Resistance P UV Resistance P Flex Properties P EXTRUSION FIBERS PROCESSES PRODUCTS PVDF BARE PERFORMANCE Operating Temperature Range -40°C - 140°C Chemical Resistance P Flame Resistance P UV Resistance P Flex Properties P PVDF MOVING HIGH PERFORMANCE FIBERS FORWARD LOCATIONS Headquarters, R&D, Manufacturing FIBER-LINE® LLC 3050 Campus Drive Hatfield, PA 19440 +1 215.997.9181 fiber@fiber-line.com Manufacturing Operations FIBER-LINE® LLC 280 Performance Drive SE Hickory, NC 28602 +1 828.326.8700 fiber@fiber-line.com EMEA & Asia Pacific Operations FIBER-LINE® INTERNATIONAL B.V.
https://www.avient.com/sites/default/files/2020-09/versaflex-pf-technical-bulletin-sept-2020.pdf
TECHNICAL BULLETIN VERSAFLEX™ PF Tack Layer for Surface Protective Films Properties Versaflex PF MD6727 Versaflex PF MD6741 Versaflex PF MD6649 Versaflex PF 9512 Versaflex PF MD6666 Versaflex PF MD6748 Versaflex PF MD6700 Features Low Tack Low Tack; Used for tailoring tack with MD6700 Low-Medium Tack Value Offering Medium Tack Low Gel/Residuals Low Tack Build High Tack Peel Strength Low Low-Medium Medium Medium-High Medium-High High High Applications Optical Films Home Appliances Plastics Construction/Bare Metals Finished Metals Steel/Painted Metals Bare Metals MFR @ 190°C/2.16 kg -- 4.5 17 5.4 21 4.8 6.5 MFR @ 230°C/2.16 kg 10 20 -- -- -- -- -- Specific Gravity, g/cc 0.92 0.91 0.92 0.92 0.94 0.94 0.94 Hardness, Shore A 50 49 37 38 37 31 30 G' @ 23°C, Pa 28.0 x 105 10.4 x 106 8.3 x 105 -- 9.9 x 105 11.8 x 105 10.0 x 105 DMA Tg, °C -29 -30 -9 10 11 15 21 LDPE/Versaflex PF Film1 180° Peel, N/25mm Stainless Steel after 20 min @ 25°C 0.5 2.2 3.2 6.1 6.7 8.5 8.6 after 7 days @ 25°C 0.6 2.7 4.3 5.5 8.2 8.3 10.3 PMMA2 after 20 min @ 25°C 1.1 1.7 3.8 4.9 6.9 8.3 8.8 after 20 min @ 75°C 2.8 4.1 5.1 6.9 9.0 10.7 11.8 after 7 days @ 75°C 4.0 4.4 5.9 9.8 8.4 9.8 10.3 Polycarbonate3 after 20 min @ 25°C 1.4 2.2 3.8 6.8 6.3 8.4 7.0 after 20 min @ 75°C 3.4 4.8 6.7 8.8 8.8 10.0 11.8 after 7 days @ 75°C 4.6 6.5 7.5 10.6 11.6 10.6 13.8 1 Film thickness: 51 micron LDPE/25 micron Versaflex PF 2 Arkema Plexiglas™ V052-100 (Plexiglas is a trademark of Arkema France Corp.) 3 Sabic Lexan™ L52-111 (Lexan is a trademark of Sabic Innovative Plastics) PHYSICAL PROPERTIES OF SELECTED VERSAFLEX PF TACK LAYER FORMULATIONS PRODUCT DESCRIPTION Versaflex™ PF formulations are specially developed for the manufacture of co-extruded surface protective films that apply easily, maintain tack with minimal build, peel smoothly and remove completely with little-to-no residue or ghosting.
BENEFITS OF VERSAFLEX PF FOR SURFACE PROTECTIVE FILMS: • Customizable tack • Single-step manufacturing process (co- extrusion) • Low volatile organic compound (VOC) emissions during manufacturing • Eliminates secondary coating and drying operations • Eliminates hazardous liquid chemicals compared to solvent systems • Reduces converting costs versus coating • Reduces energy consumption MARKETS AND APPLICATIONS Versaflex PF formulations, customizable based on desired level of tack, are co-extruded with protective films to provide just the right amount of protection during the fabrication, assembly, shipment, storage and installation of finished goods in many industries and end-use applications including: • Optical films and display panels for consumer electronics • Home appliances • Construction and building materials • Furniture and cabinetry • Automotive and other transportation 100/0 90/10 80/20 70/30 60/40 40/60 30/70 20/80 10/90 0/100 0.9 1.1 2.0 2.4 2.8 3.7 3.8 4.9 0 1 2 3 4 5 6 7 8 6.5 1.6 Versaflex PF MD6727 Versaflex PF MD6748 Versaflex PF MD6700 Versaflex PF MD6666 Versaflex PF 9512 Versaflex PF MD6649 Versaflex PF MD6741 0 2 4 6 8 10 12 % of MD6741/MD6700 Degree of tack can be customized for substrate surfaces.
https://www.avient.com/sites/default/files/2022-02/Notificación de Presentación 120222330 Huesca.pdf
Notificación desde Registro HUESCA 2 MERC PLAZA CONCEPCION ARENAL,3 2º A 22002 - HUESCA NOTIFICACIÓN DE INSCRIPCIÓN TOTAL Se pone en su conocimiento que el documento del día veinticinco de enero de dos mil veintidós, que fue presentado el día veintisiete de enero de dos mil veintidós, con el número de entrada 1/2022/233,0, diario 46, asiento 131, ha sido inscrito con fecha diecisiete de febrero de dos mil veintidós, en el tomo 661, folio 67, inscripción 5 con hoja HU-13568, de la entidad AVIENT SÀ RL SUCURSAL EN ESPAÑA.
Art. 27.3 de la Ley 39/2015, de 1 de octubre, del Procedimiento Administrativo Común de las Administraciones Públicas.).
https://www.avient.com/sites/default/files/2024-09/Maxxam FR Polyolefin Formulations - Product Overview.pdf
Temp (HDT 0,45 MPa) °C 60–100 80–145 80–160 40–80 60–120 60–110 60–100 80–145 80–145 40–80 60–120 60–110 Flammability, UL94 Step V2-V0/5VA V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 V2-V0 Glow Wire Flammability Index °C 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960 750–960 CTI V 450–00 450–600 450–600 450–600 450–600 450–600 350–600 350–600 350–600 350–600 350–600 350–600 Oil Resistance – + + + + + + + + + + + + Drying Required – Y Y Y Y Y Y Y Y Y Y Y Y Process (IM, EX, BM)1 – (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) (IM, EX) Other Modifications2 – Impact, HS, UV, LM GB, T, HS, UV, LM GF, HS, UV, LM Impact, HS, UV, LM GB, T, HS, UV, LM GF, HS, UV, LM Impact, HS, UV, LM GB, T, HS, UV, LM GF, HS, UV, LM Impact, HS, UV, LM GB, T, HS, UV, LM GF, HS, UV, LM Descriptions Lower density with moderate strength.
Good chemical resistance. 1 IM: Injection Molding, EX: Extrusion, BM: Blow Molding 2 HS: Heat Stabilized, UV: UV Stablized, LM: Lasermarking.
https://www.avient.com/sites/default/files/2021-07/neu-quality-commitment-2021.pdf
Approved Plant/Local : Reference Document Document #: DOC-10815 Revision: 4 Document Owners: Dean Clark Effective Date: Jul 15, 2021 Title: NEU Quality Commitment Page 1 of 4 Only the electronic version of this document in ETQ is the controlled version of the document.
In the event that the NEU determines that it is the root cause of the Customer complaint, a corrective action will be issued, and preventive actions will be developed to address the root cause. 10.0 MANAGEMENT OF SUPPLIERS 10.1 NEU will maintain and ensure oversight and monitoring of applicable suppliers in accordance with the requirements of ISO 13485 Quality Management System. 11.0 TRACABILITY, RECORDS & RETENTION 11.1 NEU is responsible for establishing and maintaining controlled documentation of product and raw material component traceability during all stages of production and shipment. 11.2 An electronic record of the manufacturing conditions and raw materials (vendor ID and lot number) used to manufacture each batch is retained and preserved for a period of at least 7 years from the manufacture date or as specified by applicable Regulatory Requirements. 11.3 An electronic record of the Customer purchase order and NEU sales order confirmation will be retained and for a period of at least 7 years from order acceptance date. 11.4 A representative sample of the product manufactured will be retained for a period of at least 1 year from manufacture date. 12.0 EXPIRATION 12.1 NEU’s obligations contained in this Quality Commitment will automatically expire if the Customer does not purchase product from NEU for a period of one year.
https://www.avient.com/sites/default/files/2024-10/Replacing Aluminum with Long Fiber Thermoplastics _LFT_ Application Bulletin.pdf
Evaluating a metal substitution involves two primary factors: 1) the difference in processing methodologies, and 2) the material capabilities.
Though the upfront tooling costs can be high, the investment can yield a life expectancy of 100,000 to over 1 million cycles.
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.