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不干胶标签印刷中常用的粘胶剂不干胶标签印刷中使用到的胶水，以下壹鹰标签总结了不干胶标签中常用的12种永久性粘胶剂，仅供大家参考。
一、AF101 一种通用型永久性丙烯酸乳胶。
典型粘性值：(N/25mm)初始粘性(st,st)- FTM 9：11.020分钟90剥离粘性(st,st)- FTM 2：6.024小时90剥离粘性(st,st)- FTM 2：8.0最低贴标温度：7C使用温度范围：-50C ～90C这是一种适合各种温度的永久性强力粘胶剂。
在诸多包装材料上均有优异的表现性能。
具有很好的模切与排废性能。
此粘胶剂符合FDA第175.105项，可用于食品、药品及化妆品等产品的非直接接触贴标用途。
二、AP103 一种通用型永久性丙烯酸乳胶。
典型粘性值(N/25mm)：初始粘性(st,st)-FTM 9：14.0或撕裂20分钟90剥离粘性(st,st)-FTM 2：7.0或撕裂24小时90剥离粘性(st,st)-FTM 2：8.0或撕裂这是种适合各种温度的永久性强力粘胶剂。
在诸多包装材料上均有优异的表现性能。
有很好的模切与排废性能。
此粘胶剂符合FDA第175.105项，可用于食品、药品及化妆品等产品的非直接接触贴签用途。
三、AP104 一种通用型永久性丙烯酸乳胶。
典型粘性值：(N/25mm)初始粘性(st,st)- FTM 9：13.020分钟90剥离粘性(st,st)- FTM 2：7.024小时90剥离粘性(st,st)- FTM 2：9.0最低贴标温度：10C使用温度范围：-50C ~ +90C这种粘胶剂具有极高的初始粘性与最终粘性。
在诸多包装材料上均有优异的粘性。
具有很好的模切与排废性能。
尤其适用于有一定难度的贴标，如小口径瓶体标签及覆膜标签。
此粘胶剂符合FDA第175.105项，可用于食品、药品及化妆品等产品的非直接接触贴标用途。
四、AP104A 一种通用型永久性丙烯酸乳胶。
典型粘性值(N/25mm)：初始粘性(st,st)- FTM 9：16.0或撕裂20分钟90剥离粘性(st,st)- FTM 2：7.5或撕裂24小时90剥离粘性(st,st)- FTM 2：9.5或撕裂最低贴标温度：10C使用温度范围：-50C ~ +90C这是一种初始粘度与最终粘性都极高的粘胶剂。
芬欧蓝泰推出应用于医药行业的RP 31 Purus低迁移胶水佚名
【期刊名称】《标签技术》
【年(卷),期】2015(0)10
【摘要】根据美国食品和药物监督管理局(FDA)的规定,非固体药品包装不得渗出有害或超量物质,以免对正在服用该药物的患者造成不良影响。
例如,贴在药瓶上的标签,其所用胶水必须通过提取或迁移试验,以及毒理学试验。
芬欧蓝泰标签开发的全新RP31 Purus,最大程度降低了迁移风险,并严格遵照IPAC-RS制定的针对口服吸入和鼻用药物所用材料的指导原则,可满足医疗、制药和健康护理等应用领域的要求。
【总页数】1页(P12-12)
【关键词】RP;31;Purus;医药行业;健康护理;毒理学试验;应用领域;指导原则;药品包装;文件包;认证流
【正文语种】中文
【中图分类】F416.72
【相关文献】
1.芬欧蓝泰推出3种新型葡萄酒标签/美国施乐推出超高光彩色数码印刷纸/用于造纸废水深度处理的催化剂 [J],
2.芬欧蓝泰推出RP75新型胶黏剂 [J],
3.芬欧蓝泰推出不含APEO的胶水 [J],
4.芬欧蓝泰标签推出可耐75%酒精的新型湿巾封口标签胶粘剂 [J], 于娟
5.芬欧蓝泰推出Vanish PCR超薄透明薄膜标签 [J], 芬欧蓝泰
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目录金属制品用胶黏剂 (1)钢铁制品用胶黏剂 (1)铝及其合金制品用胶黏剂 (4)各种金属制品粘接用胶黏剂 (10)塑料制品用胶黏剂 (29)纤维素塑料制品用胶黍剂 (29)聚氯乙烯与其他材料粘接用胶黏剂 (30)聚苯乙烯制品用胶黏剂 (37)ABS塑料制品用胶黏剂 (38)有机玻璃用胶黏剂 (39)聚酯和聚碳酸酯制品用胶黏剂 (43)尼龙制品用胶黏剂 (45)玻璃钢制品用胶黏剂 (45)其他塑料制品用胶黏剂 (49)陶瓷及玻璃制品用胶黏剂 (55)陶瓷与其他材料粘接用胶黏剂 (55)玻璃与其他材料粘接用胶黏剂 (63)复合材料用胶黏剂 (64)金属与塑料制品粘接用胶黏剂 (64)金属与橡胶制品粘接用胶黏剂 (83)橡胶与塑料、织物粘接用黏剂 (91)织物用胶黏剂 (102)无纺织物用胶黏剂 (102)植绒、织物用胶黏剂 (104)服装用胶黏剂 (112)制鞋用胶黏剂 (113)皮鞋及皮革制品用胶黏剂 (113)胶鞋用胶黏剂 (119)塑料鞋用胶黏剂 (121)混合材料鞋用胶黏剂 (124)包装材料用胶黏剂 (126)纸制品用胶黏剂 (126)复合薄膜材料用胶黏剂 (137)封口、标签用胶黏剂 (141)木材加工用胶黏剂 (143)板材制造、粘接用胶黏剂 (143)木材及与其他材料粘接用胶黏剂 (153)建筑用胶黏剂 (164)建筑复合材料用胶黏剂 (164)建筑结构件用胶黏剂 (165)建筑内部装饰用胶黏剂 (170)机械设备用胶黏剂 (175)铸造用胶黏剂 (175)机床用胶黏剂 (176)农业机械用胶黏剂 (188)工具用胶黏剂 (192)特种用途胶黏剂 (193)阻燃胶197热熔胶202耐低温胶 (205)油面胶208点焊胶210应变胶和蠕变胶 (214)金属填补胶 (218)耐磨胶和制动胶 (219)导电胶和导磁胶 (220)光敏胶228多用途胶黏剂 (231)环氧树脂、改性环氧树脂胶黏剂 (231)聚氨酯胶黏 (245)不饱和聚酯胶黏剂 (248)聚乙烯醇缩醛胶黏剂 (249)酚醛树脂胶黏剂 (252)丙烯酸酯胶黏 (256)α-氰基丙烯酸酯胶黏剂 (259)丁腈、丁苯橡胶胶黏剂 (262)聚硫胶黏剂和硅橡胶胶黏剂 (263)天然橡胶胶黏剂 (264)金属制品用胶黏剂钢铁制品用胶黏剂用途本胶用于铁、钢等金属粘接。
3530型水基酪素胶是一种基于水基的胶粘剂，主要成分是酪素（一种牛奶中的蛋白质）。
这种胶粘剂主要用于纸张的涂布和标签的粘接。
3530型水基酪素胶的特点如下：
1. 环保友好：水基胶粘剂以水为分散介质，相对于传统的溶剂型胶粘剂，不会释放有害的挥发性有机化合物，对环境友好。
2. 粘性强：由于酪素具有较好的粘附性，因此3530型水基酪素胶具有较好的粘合力，能够满足纸张涂布和标签粘接的要求。
3. 稳定性好：水基胶粘剂在储存和使用过程中稳定性较好，不易发生沉淀和分层。
4. 易于使用：水基胶粘剂的稀释和水性涂料的涂布工艺相似，易于操作和掌握。
总的来说，3530型水基酪素胶是一种环保、粘性强、稳定性好、易于使用的胶粘剂，适用于纸张涂布和标签粘接等应用领域。
MATERIAL SAFETY DATA SHEETMay be used to comply with OSHA’s Hazard Communication Standard, 29 CFR 1910.1200. Standard must be consulted for specific requirements.IDENTITY: Ultrasound GelSection I – Manufacturer InformationManufacturer’s Name:Eco-Med Pharmaceuticals, Inc. Emergecny TelephoneNumber: (905) 405-1050Address (Number, Street, City, State, and ZIP Code): 7050-B Bramalea Rd., Unit 58Mississauga, OntarioCanada L5S 1S9 Telephone Number for Information: Date Prepared:February 3, 2003Section II – Hazardous Ingredients/Identity InformationHazardous Components (specific Chemical Identity; Common Name(s) OSHA PEL ACGIH TLV OtherLimits THIS IS A NON-HAZARDOUS PRODUCTSection III – Physical/Chemical CharacteristicsBoiling Point: Approx. 220°F Specific Gravity (H20 = 1): .97Vapor Pressure (mm Hg): N/A Melting Point: N/AVapor Density (Air = 1): N/A Evaporation Rate (Butyl Acetate = 1): N/A Solubility in Water: CompleteAppearance and Odor: Blue, odorless viscous gel.Section IV – Fire and Explosion Hazard DataFlash Point (Method Used): Non-flammable Flammable Limits:N/ALELN/AUELN/AExtinguishing Media:Use extinguishing media appropriate for the surrounding fire.Special Fire Fighting Procedures:NoneUnusual Fire and Explosion Hazards:NoneSection V – Health Hazard DataRoute(s) of Entry: Inhalation? Skin? Ingestion?N/A N/A N/A Health Hazards (Acute/Chronic) NONE.Carcinogenicity: NTP? IARC Monographs? OSHA Regulated? N/A N/A N/AMATERIAL SAFETY DATA SHEET Signs/Symptoms of ExposureN/AMedical Conditions N/AGenerally Aggravated by ExposureEmergency/First Aid Procedures:N/ASection VI – Reactivity DataStability Unstable Conditions to Avoid: NONEStable XIncompatibility (Materials to Avoid)N/AHazardous Decomposition/ByproductsN/AHazardous Polymerization May Occur Conditions to Avoid: NONE Will Not Occur XSection VII – Precautions for Safe Handling and UseSteps to be Taken in Case Material is Spilled or Released CAUTION SHOULD BE TAKEN, AS SPILL WILL BE VERY SLIPPERY. SWEEP WITH ABSORBENT MATERIAL.Waste Disposal Method FOLLOW ALL FEDERAL, STATE, AND LOCAL REGULATIONS FOR NON-HAZARDOUS WASTE DISPOSAL.Storage/Handling Precautions STANDARD STORAGE PROCEDURES FOR NON-HAZARDOUS MATERIALS.Other Precautions NONESection VIII – Control MeasuresRespiratory Protection (Specify Type) NOT REQUIREDVentilation Local Exhaust N/R Special N/RMechanical (General) N/R Other N/RHand ProtectionNOT REQUIRED Eye ProtectionNOT REQUIRED, AVOID EYE CONTACT.Other Protective Clothing/EquipmentNOT REQUIRED Work/Hygienic PracticesSTANDARDN/D – NOT DETERMINEDN/A – NOT APPLICABLE OR NOT AVAILABLEN/R – NOT REQUIRED。
时间：2021.02.06 创作：欧阳化乐泰瞬干胶乐泰瞬干胶在工业上得到了最广泛的应用。
乐泰瞬干胶涵盖了各种粘度，不同固化速度。
充分适应各种充间隙及与被粘接材料。
乐泰系列瞬干胶包括增强型、低气味、无白化，对表面不敏感耐热型的产品。
380增强型橡胶增强型，可粘接金属，橡胶及塑料，优良的抗剥离，冲击及剪切强度。
403低气味，低白化型耐湿性好，用于非精确配合的零件的粘接，低气味，低白化（不需要复杂通风系统）。
401表面不敏感型通用型，中粘度，用于惰性表面，粘接多孔、酸性及吸收性的材料。
408通用型是一种通用的，对表面不敏感的泰厌氧胶螺纹胶固持胶乐泰的预涂螺纹锁固胶是预成型螺纹胶。
适用于大批量生产需要。
可以提高了装配速度，并确保了质量。
乐泰管纹密封剂用于密封并固定金属管路及管件。
用于密封高，低压力。
耐各种介质。
度，触变性粘度表面，易拆卸。
用于M2～M12螺纹的锁固与密封。
应用于紧固件直径为1/4"(6mm)或更小比较理想，具有一定的润滑性以达到精确的夹持负荷。
242·通用型，中强度，触变性黏度。
·用于M6～M20螺纹的锁固与密封。
是一种可拆卸螺纹锁固剂。
具有一定的润滑性以达到精确的夹持负荷243耐机油/中强度·快速固化，可用于惰性表面，容油性好。
易拆卸，可在轻微油质的工作表面使用。
用于乐泰预涂剂Dir-Loc螺栓拆装后重装时锁的永久性锁固与密封。
可防止螺纹生锈及腐蚀，用加热及工具拆开。
290渗透级·中高强度，低黏度，快速固化。
用于已装配好的M2～M12螺纹的锁固与密封。
也可用于密封焊缝，铸件砂眼等（Ф0.10以下）微孔。
防止螺纹生锈及腐蚀，拆开时需局部加热及工具545液压/气动密封剂·不污染液压系统，在轻微油质表面上也可使用。
快速固化，低强度。
用于密封及锁固(带锥型螺纹)接头的高压液压统，M36以下锥螺纹（NPT ）。
它不含填料不会阻塞阀门或过滤系统。
3M ™Polisher STthat make up proteins. The large resonance structure of the guanidium functionality stabilizes the positive charge and is capable of multiple electrostatic-like interactions as well as providing the capability for hydrogen bonding and salt bridging, all of which help with increasing the ligand’s salt tolerance. Conventional Q-functional AEX resins and single-use media, which rely solely on electrostatic interactions, can be screened at elevated ionic strength.The use of functionalized membranes for highproductivity chromatographic purification processes that match upstream efficiency can eliminate the need for oversizing. 3M Polisher ST single usemembrane adsorber purification solution is designed for the downstream processing of monoclonalantibodies (mAbs) and other recombinant proteins in flow-through mode. 3M Polisher ST is designed to improve monoclonal antibody (mAb) development and manufacturing processes in traditional polishing process conditions.Data Sheet3M ™ Polisher ST is a fully encapsulated single-use anion exchange (AEX) product intended to reduce host cell protein (HCP) impurities, viruses, and other negatively charged contaminants in flow-through polishingchromatography of biopharmaceutical process streams. 3M Polisher ST is a synthetic, hybrid purifier containing two complementary AEX-functional media: a quaternary ammonium (“Q”) functional nonwoven and a guanidinium (Gu) functional membrane.The upstream Q-functional nonwoven provides reduction of turbidity (when present), DNA, and endotoxin, as well as a portion of the product’s AEX capacity for HCP and virusreduction. The downstream guanidinium functional membrane layers of 3M Polisher ST are salt tolerant and provide high HCP and virus reduction performance in a wider range of conditions compared to conventional Q-functional AEX resins.The novel guanidinium functionality of the downstream AEX polishing membrane mimics arginine, one of the three positively charged naturally occurring standard amino acids3M™ Polisher ST nonwoven and functionalized membraneThe guanidinium functional group ligand is grafted onto a polyamide membrane and follows the classical anion- exchange chromatography mechanism. The downstream polishing process is driven by mAb or therapeutic protein• 4 layers• Q FunctionalizedP olypropyleneNonwoven• 3 layers• G u FunctionalizedP olyamideMembrane• 1 layer• P olyamideS upportMembraneBenefits3M ™ Polisher ST can operate in most process conditions, eliminating the need for depth and membrane filtration post-viral inactivation (VI), allowing process compression. With its combination of high dynamic antibody-loading (10 kg/m²) capacities with low residence time (about 0.2 min compared to 1 minute for chromatography resins), 3M Polisher ST opens the way to an intensified high-productivity, truly single-use purification platform.3M Polisher ST is a compact, small footprint solution with greater capacity for delivering higher purity and yield in thedownstream polishing unit operation, when compared with a traditional chromatographic column, in a connected continuous downstream operation for the flexible facility of the future.3M Polisher ST allows for a facility strategy that can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for biologics.Depth filter + membrane + AEX column → 3M ™ Polisher SThe smaller footprint of the 3M ™ Polisher ST (right) allows for a more streamlined process and efficient use of space.ApplicationsIon exchange chromatography is a commonly used downstream polishing purification technique in the production of mAbs and many other therapeutic proteins. The limitation with traditional anion exchange chromatography is that the binding capacity is diffusion-limited and the interaction strength of the ligand depends on operating conditions like pHand conductivity. 3M ™ Polisher ST, with its nonwoven and membrane skeletons, provides mechanical strength and durability, while the grafted hydrogel functionality creates a large three-dimensional surface area that contains a high density offunctional groups with interconnected pores allowing for convective flow channels which are able to achieve high flow rates.The high density of binding sites, together with a macroporous structure, enables high binding capacity for not only HCP , but also large molecules, such as viruses and DNA. The high density of binding sites and low residence time results in high mAb recovery (>95%).The high ligand density on our advanced anion exchange membrane provides robust impurity removal and viral clearance. It also provides a 50 to 100✕ higher mAb load capacity than chromatography resin beads, which allows further reduction of the media volume requirement. The impurity clearance performance (HCP ≤1000 ppm, ≤100 ppb DNA, and viral clearance) is independent of the load up to 10 kg/m², enabling downsizing of the unit operation.BSA Dynamic Binding Capacity – Effects of pH and Conductivity3M ™ Polisher ST BSA DBC3M ™ Polisher ST △P @ 1 mL/min/cm 2The BSA Dynamic Binding Capacity (DBC) specification for the functional membrane only is 7.8-12 mg BSA/cm 2 in 25 mM Tris, pH 8, 50 mM NaCl. High salt (20 mS/cm) reduces the capacity of the membrane by ~ 2-3 mg/cm 2. Additional capacity provided by the FNW at conductivities < ~10 mS/cm.△P specification for the functional membrane only is <10 psid in 25 mM Tris, pH 8, 50 mM NaCl at 1 mL/min/cm 2. Lower salt (<6 mS/cm) slightly increases pressure due to contribution from functional non-woven. Maximum differential pressure (all capsule sizes) is 35 psid.B S A D BC (m g B S A /c m 2)302520151050• FM Only (6 mS/cm) 6 mS/cm20 mS/cmpH456789△P (p s i d )6 mS/cm20 mS/cmGraph 1: BSA dynamic binding capacity of functional membrane and full construction as a function of pH.Graph 2: Differential pressure across capsule at 1 mL/min/cm² as a function of pH.3M Polisher ST (10 kg/m )H C P R e d u c t i o n (%)■ Acetate ■ Citrate ■ Tris ■ Phosphate0.00.20.40.60.81.0■ Low Conductivity (<7 mS/cm) ■ High Conductivity (20 mS/cm) − − − − Detection LimitD N A C o n c e n t r a t i o n (p p b )pHHCP Reduction in Monovalent and Polyvalent mAb SolutionsDNA Reductionin mAb SolutionsmAb Recovery in Monovalent and Polyvalent Buffers% mAb Recovery in Monovalent and Polyvalent Buffers■ Acetate ■ Citrate ■ Tris ■ Phosphatem A b r e c o v e ry (%)% mAb Recovery in Monovalent and Polyvalent Buffers % mAb Recovery vs. pH and Conductivity (mS/cm)3M ™ Polisher ST (10 kg/m 2)3M ™ Polisher ST (5-10 kg/m² loading fraction)% mAb RecoveryConductivity (mS/cm)p H■ <95% ■ 95 - 96% ■ 96 - 97% ■ 97 - 98% ■ 98 - 99% ■ 99 - 100% ■ >100%Graph 3: HCP reduction in mAb solution by 3M ™ Polisher ST as a function of conductivity, pH and buffer.Graph 5: mAb recovery as a function of pH and conductivity, Acetate/Tris buffer.Graph 4: Residual DNA concentrations post 3M ™ Polisher ST for different test conditions.Graph 6: mAb recovery as a function of pH and conductivity, Acetate/Tris buffer.Viral Clearance in 6 Model mAb Feed StreamsViral Clearance studies were performed with MVM and XMuLV using mAb solutions representing model feed streams. The Tris pH 7.5, 5 mS/cm MVM study was performed at Charles River. All other studies were performed at Texcell.Table 1: Viral clearance of MVM and XMuLV by 3M™ Polisher ST in different model mAb solutions.Benefits:• Operates in robust process conditions (pH 5.0 to 9.0 and conductivity 3 to 20 mS/cm)• HCP reduction >60% reduction in Phosphate buffer, >22% reduction in Citrate buffer• Viruses reduction >4 log• DNA clearance down to LOD levels (~0.05ppb DNA)• Easy to use: elimination of column packing, unpacking, cleaning and storage• Enables downstream process intensification through combination of high flow rates with high bindingFor more information about the 3M ™ Polisher ST, contact your local sales representative by calling 1-800-243-6894, option 4, or visiting us at /polisher.Product Specifications1. F ill Volume is defined as the volume of liquid that is required to fill the capsule.2. P ost Blow-Down Hold-Up Volume is defined as the volume of the residual liquid after air/gas blow down.3. D o not use this product for continuous service with compressed gasses. The use of compressed gas is permissible for post-use integrity testing and blow down purposes.4. A Preconditioning Flush is required for the product to be compliant with USP Biological Reactivity Tests, including USP <87> and <88> Class VI. The RequiredPreconditioning Flush is an aqueous solution, having a minimum conductivity of 3 mS/cm. DO NOT use water to flush the capsule. Refer to Installation and Operation Instructions for complete instructions on how to perform the preconditioning flush.3M and Emphaze are trademarks of 3M Company.All other trademarks are property of their respective owners. © 2021 3M Company. All rights reserved. Please recycle. Printed in U.S.A. 70-2016-0020-53M Purification Inc.3M Separation and Purification Sciences Division 400 Research Parkway, Meriden, CT 06450 USA Phone 1-800-243-6894 1-203-237-5541Web /polisherIntended Use: 3M ™ Polisher ST single-use filter products are intended for use in biopharmaceutical processing applications of aqueous based pharmaceuticals (drugs) and vaccines in accordance with the product instructions and specifications, and cGMP requirements, where applicable. Since there are many factors that can affect a product’s use, the customer and user remain responsible for determining whether the 3M product is suitable and appropriate for the user’s specific application, including user conducting an appropriate risk assessment and evaluating the 3M product in user’s application.Prohibited Use: 3M advises against the use of these 3M products in any application other than the stated intended use(s), since other applications have not been evaluated by 3M and may result in an unsafe or unintended condition. Do not use in any manner whereby the 3M product, or any leachable from the 3M product, may become part of or remains in a medical device that is regulated by any agency, and/or globally exemplary agencies, including but not limited to: a) FDA, b) European Medical Device Directive (MDD), c) Japan Pharmaceuticals and Medical Devices Agency (PMDA) or in applications involving permanent implantation into the body; Life-sustaining medical applications; Applications requiring food contact compliance.Product Selection and Use: Many factors beyond 3M’s control and uniquely within user’s knowledge and control can affect the use and performance of a 3M product in a particular application. 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RP 31 PURUS 低渗透性胶粘剂助力顶尖制药企业芬欧蓝泰标签-引领制药行业应用的革新趋势芬欧蓝泰标签密切关注制药行业的发展趋势和市场需求，并紧随监管要求的发展变化而不断进行自身完善。
我们致力于开发出可满足行业需求的创新型解决方案。
应用于制药行业的每一个包装和标签解决方案均须恪守严格的监管和安全要求。
药物包装需要保护药物免受一切物理、环境和生物方面的外部不良影响，因为这些影响可能会导致药品的性状和功效发生变化。
此外，药物成分不应改变包装的特性或保护功能，以免造成不良影响。
相应地，无论是由于化学反应、吸附还是渗透，包装本身均不应对药品产生不良影响。
芬欧蓝泰标签即是提供该类解决方案的中坚力量。
通常，药物成分会长时间接触一级包装和给药系统，例如预填式注射器、吸入器和点滴器。
此外，在玻璃容器与LDPE等易吸附塑料容器间容易产生物质的渗移，因此选择标签材料时须格外小心。
对此，我们专门研发出医药用胶粘剂RP 31 Purus，作为上述问题的解决方案。
该产品具有低渗透特性，可满足当今法规和市场的需求。
2按照药品和给药途径之间的利害关系程度而进行的 RP 31 Purus 适用性排序常见药品的包装利害关系示例FDA 对包装材料低渗透性要求较高的药品分为以下几类：（来源：FDA ）3RP 31 Purus –胶粘剂安全新标我们的首要任务是从标签方面确保药品的安全使用，从而为用户和患者的安全保驾护航。
选择材料时需要兼顾功能性和化学安全性需求，并查证生产商所采取的制造方式是否得当。
对于所有医药用不干胶标签，芬欧蓝泰标签会首先确定已获准应用于制药的组分。
制药、医疗和食品领域的应用均受到同一法律的监管：我们的产品符合FDA对食品接触材料的要求（FDA 21 CFR 175.105和175.125对于胶粘剂的要求，FDA 21CFR 176.170和176.180对于纸张的要求，以及FDA 21 CFR part 177对于高分子聚合物的要求），和欧洲基于“食品框架性法规1935/2004”的有关食品接触方面的要求。
在研发制药用不干胶标签产品时，芬欧蓝泰标签遵循：EMEA（欧洲药物管理局），CPMP/QWP/4359/03-直接接触塑料包装材料指导原则-仅针对塑料制品IPAC-RS指导原则欧盟人用药品指令（2003/63/EC，即 2001/83/EC 修正案）4优化配方为防止渗透保驾护航全方位文件支持RP 31 Purus 胶粘剂是芬欧蓝泰标签研发团队历经长期努力，并在研发过程的每个阶段进行大量内部和外部测试后所打造出的优化洁净配方产品，具有创新、环保和低渗透性等特点。
这一高性能胶粘剂完全满足制药和医疗保健应用的要求，可将渗透风险降至最低。
RP 31 Purus 符合美国联邦法规及食品和药物监督管理局(FDA) 21 CFR Ch. I （2011 年4月1日版本）第175.105款的规定。
第三方权威测试实验室ISEGA 经过检验后，已认可RP 31 Purus 为可接触食品类标签。
在保护患者安全方面，本胶粘剂已通过渗透测试，可用于血袋贴标。
芬欧蓝泰标签可根据客户的要求提供支持文件，帮助制药公司进行初步风险评估和测试协议设计。
支持包中包括技术信息、RP 31 Purus 配方和可提取物特性的详细说明，并就执行渗透稳定性测试提供了建议。
此外，FDA 已为RP 31 Purus 派发了编号为 25392的第三类药物管理档案(DMF )：制药企业可在营销授权申请中以引用授权书 (Loa )的方式使用 RP31P DMF 数据。
RP 31 Purus 拥有欧盟符合标准声明(doc )。
RP 31 Purus 胶粘剂的生产过程符合制药标准。
此外，胶粘剂在提供最优性能的同时，也未违背芬欧蓝泰标签对于可持续性和全球环境与健康保护事业发展所作出的企业承诺：RP 31 Purus 的环保型配方不含烷基酚聚氧乙烯醚(APEO )，符合（化学品注册、评估、许可和限制，REACH ）指令 2003/53/EC 和1907/2006/EC 的规定。
5具有低渗透特性的RP 31 Purus 适用于要求最为严苛的制药包装应用中，能够有效抵御药品包装在LDPE 容器时常易发生的渗移风险。
RP 31 Purus 具备无与伦比的牢固胶粘力，即使在小口径容器和曲面上也能够粘贴牢固。
无论贴物底面材质为PP 、PE 或玻璃，还是低密度聚乙烯制成的耐挤压滴鼻液或滴眼液瓶，RP 31 Purus 均表现出色。
芬欧蓝泰标签已采取措施以确保长期稳定供货，并执行制药变更管理流程，防患于未然。
6 满足行业和监管要求潜在的渗透来源有油墨、瓶子、盖子、标签材料和其他用于保护和管理药物的组分。
所有制药企业均须证明其所使用的包装材料对药物无不良影响。
当制药企业为其包装选择标签材料时，以下机构会明确提取和渗透风险分析计划并提供指导，以确保产品安全。
1.EMEA2.FDA3.IPAC-R SIPAC-RS 制定了制药包装材料应遵守的其他重要指导原则。
RP 31 Purus 低渗透特性胶粘剂的名字源于拉丁文Purus ，意思是干净、纯粹、透明。
1.EMEA2.FDA3.IPAC-RS 欧洲药品管理局：营销授权申请中所需的信息有关材料的类型和性质的一般信息包装材料的规格萃取研究的结果-用于吸入型、注射或眼部给药的非固体药品-应在包装材料的规格中列出可提取化合物相互作用研究的结果-应证明包装材料与药品的兼容性-此外，还应证明容器外表面使用的油墨或胶粘剂不会渗移到药品中毒性文件-即使材料已获准可用于食品包装，也应对吸入型、注射或眼部用药提供药物可提取物和渗透物的毒性数据美国食品和药物监督管理局：人用药品和生物制品包装用容器密封系统指导原则 (1999)包装组分所采用的材料不得渗出有害或超量物质，以免对正在服用该药物的患者造成不良影响。
这一点对于直接接触药剂的包装组分尤其重要，也同样适用于任何可能会渗移到剂型中的组分。
针对科学和法规的国际药用气雾剂联盟。
对于口服吸入和鼻用药品材料的要求：对于存在渗移风险的产品，制药企业需确保：在不更换材料的情况下最少可连续使用36个月，其中-根据监管要求，新材料欲投入使用需至少提前12个月予以通知-材料保存期限的相关信息-最后通知选项，以供客户在停止生产前进行大批量采购食品添加剂合规性具备原料药DMF(USA)编号通过重金属测试材料/工艺产生异物微粒（污染）的可能性应尽量降到最低符合1907/2006/EC(REACH)成分、流程和质量体系的相关信息受控提取研究数据的可用性RP 31 Purus完全满足IPAC-RS制定的所有要求。
7风险评估流程为了对药品中可提取物和渗透物进行控制，需要执行风险评估。
第一步是根据整体材料供应链流程图，确定所有容器密封系统和其他接触药品的材料。
下一步，为进行风险评估，需要确定哪些材料和组分存在突出的潜在风险，要求进一步获取更多可提取物和渗透物相关信息。
风险评估的范围应考虑到：药剂和包装组分之间的相互作用包装材料和药品之间的化学兼容性可提取物的毒性评估接触时间和温度溶剂酸碱度保存期限产品接触面的面积给药方式和剂量可提取物是指在浸染条件下，可在具备不同理化性质的溶剂中提取于材料的化合物。
渗透物是指材料在保存期限内于正常使用条件下渗透到实际药品中的化合物。
由于渗透物属于可提取物的一部分，所以应预先确定可提取物的特性。
8可提取物和渗透物的定义可提取物使用选定溶剂或通过特定流程可从包装（即容器和封闭系统上的合成橡胶、塑料组分或涂层）中提取的化合物。
渗透物因直接接触药物产品的配方而从包装中渗透出的化合物，因此可能随药物一起用于患者。
还可能与产品组分发生相互作用而产生杂质，因此需要对其稳定性进行监控。
保存期限和有效期限始终取决于储藏条件和有效药物成分的稳定性。
根据收集到的包装材料的相关信息制定受控的定性和定量提取研究计划。
因此，务必确保所有包装材料均选用满足官方要求的组分。
出众性能，长期稳定供应及全方位支持合规性、批准认可和组分安全性具备低渗透特性，胶粘性能出众。
医药行业要求药品质量和产品稳定性应始终如一：长期原材料供应已得到保证。
制药变更管理要求任何变更均需提前12个月予以通知。
加上RP 31 Purus 标签材料自生产之日起的 2年保存期限，可以给予3年的操作期重FDA 已为RP 31 Purus 派发了编号为25392 的第三类药物管理档案(DMF )。
制药企业可在营销授权申请中以引用授权书(LoA ) 的方式使用RP31P DMF 数据。
在保护患者安全方面，已获得ISEGA 的批准和认可，可用于血袋标签（已通过渗移测试）。
ISEGA 已根据欧盟对于直接接触非脂肪干、湿食品（牛奶和乳制品除外）的材料要求对RP 31 Purus 予以认可；根据FDA 规定，本胶粘剂可直接接触干燥食品，而其他胶粘剂必须通过功能性包装与食品隔离。
RP 31 Purus 符合美国联邦法规及食品和药 9RP 31 Purus –要点概述新进行资格认证。
在玻璃、PE 、PP 和COC/COP 小口径容器上具有良好的胶粘性能。
作为RP 31 C 胶粘剂的替代产品，RP 31 Purus 具备最新的认证书和文件。
为制药企业提供详细的文件包，为其进行可提取物/渗透物研究提供全方位支持。
物监督管理局(FDA )21 CFR Ch.I （2011 年4月1日版本）第175.105款的规定。
环境友好：不含带有烷基酚聚氧乙烯醚 (APEO ) 的组分。
我们已对RP 31 Purus 进行重金属测试。
生产工艺符合制药领域对于品质和安全性的要求；RP 31 Purus 采用专门的不干胶标签制造流程。
RP 31 Purus 不含反刍动物衍生原材料。
根据EN 1230-2（Robinson 试验），在感官分析中，RP 31 Purus 复合产品的味觉觉察值 < l ；它不会改变食品的味道或气味。
有所权版签标泰蓝欧芬8 2 2 1 N H C 3 1 0 2 / 9 0。
