微流控纳米药物脂质纳米颗粒LNPs仪碰撞喷射混合器碰撞喷射混合器IJM纳米药物制造LNPsLipid nanoparticles (LNPs) Impingement Jets Mixing Small Scale德国/KNAUER基于 mRNA 新冠病毒疫苗的研发,脂质纳米颗粒(LNPs)已经被证实是用来递送 RNA 药物、疫苗的有效载药方式。LNPs 封装包裹易降解活性成分,模拟低密度脂蛋白 (LDLs),由内源性途径摄取。LNPs 对 pH 值敏感,其设计目的是将其有效载荷释放到细胞质中。这将是接种疫苗历史上首次大规模使用核酸脂质纳米颗粒。新的医学发展使药物及其活性成分日益复杂,并带来了新的挑战。例如,寡核苷酸很容易在人体内降解。zui新研究表明 LNPs 可以形成一个用来保护活性成分(如:RNA、mRNA、siRNA 或基于 DNA 的 API)的稳定环境。像核酸类药物和向靶细胞运送途径的优化是当下非常热门的研究领域。总部位于德国柏林的高科技实验室仪器制造商 KNAUER,主要以液相色谱系统、SMB、连续流层析闻名。通过结合在高压加料和实验室系统工程方面的丰富经验,成功开发生产制药脂质纳米颗粒的合成设备 —— LNPs 制药生产装置。详情介绍KNAUER 的喷射混合技术在小规模和大规模的疫苗脂质纳米颗粒生产中表现出优异的性能。可为研发用户提供小型桌面设备,并为制药行业提供完整的 LNPs 装置。LNPs 生产系统,也称为 IJM 设备(冲击喷射混合)经过设计和优化,满足客户性能要求及法规要求。并成功在洁净间(C 级)内进行了安装及验收。该系统预留了所有必须的接口,用于集成到客户自己的 PLC(可编程逻辑控制器)系统中。不同型号的技术参数:Pilot Scale UnitSmall Production Scale Unit(Customized) Large Production Scale Units*Number of impingement jets mixers12up to 8Number of pumps48up to 16Number of flow meters48up to 16Number of valves12—Process connection inlet**1/2" Tri-clamp (4 inlets)3/8" and 1/4" barbed fitting (6 inlets)Sanitary Clamp Connector (2 inlets)Process connection outlet**1/2" Tri-clamp (1 outlet)1/4" barbed fitting (2 outlets)Sanitary Clamp Connector (1 outlet)Volumetric flow rateup to 1 l/minup to 2 l/mindepending on configurationVolumetric flow rateup to 60 l/hup to 120 l/hdepending on configurationMaximum operating pressure***100 bar100 bar50?70 barLiquid temperature range4?60 °C (39.2?140 °F)4?60 °C (39.2?140 °F)4?60 °C (39.2?140 °F)Wetted materialsstainless steel, PEEK, titanium, FFKM, PTFE (GFP 55), aluminum oxide, ruby, sapphire, EPDMstainless steel, PEEK, titanium, FFKM, PTFE (GFP 55), aluminum oxide, ruby, sapphirestainless steel, PEEK, titanium, FFKM, PTFE (GFP 55), aluminum oxide, ruby, sapphire, EPDMSoftwareCDS, 21 CFR part 11compliantCDS, 21 CFR part 11compliantnot included, necessary interfaces for the integration into PLCInterfacespump: LAN, RS-232, pin header connectors flow meter: RS-232 + FLOW-BUS™ valve drive: LANpump: LAN, RS-232, pin header connectors flow meter: RS-232 + FLOW-BUS™ valve drive: LANpump: LAN, RS-232, pin header connectors flow meter: RS-232 + industrial interfacesPower supplypump: 100–240 V, 50–60 Hz flow meter: +15… 24 V DC, valve drive: 24 V DCpump: 100–240 V, 50–60 Hz flow meter: +15… 24 V DC, valve drive: 24 V DCpump: 100–240 V, 50–60 Hz flow meter: +15… 24 V DCPower consumption (per device)pump: maximum 320 W flow meter: 3 W valve drive: 65 Wpump: maximum 320 W flow meter: 3 W valve drive: 65 Wpump: maximum 320 W flow meter: 3 WAmbient conditionstemperature range: 4–40 °C 39.2?104 °F below 90 %humidity (non-condensing)temperature range: 4–40 °C 39.2?104 °F below 90 %humidity (non-condensing)temperature range: 4–40 °C 39.2?104 °F below 90 % humidity (non-condensing)Dimensions (W x H x D)900 x 915 x 700 mm1000 x 1290 x 700 mmdepending on configurationNet weight (approx.)150 kg250 kgdepending on configurationAPI-predilution and quenchingYesYesdepending on configurationGMP-ready documentationYesYesYesFactory acceptance testYesYesYesSite acceptance testYesYesYesPurchase order lead timeabout 3 monthsabout 3 monthsminimum 5 months, depending on customer requirements深圳市富彻尔生物科技有限公司地址:深圳市龙岗区横岗街道深华街1号林展财富大厦315室,广东省客服:销售:手机:邮箱:官网:
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