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Suzhou Aitesen Pharmaceutical Equipment Co., Ltd.
2
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Product Description
切向流过滤
简介
答：伊特森LDS系列切向流过滤主要应用于微纳米药物和生物制品的切向流超滤技术研究，提供优良的技术服务和解决方案。
该设备可用于小规模样品的工艺研究实验，以及大规模的工艺验证实验。该设备配备触摸屏操作系统和软件程序，用于自动数据记录，支持数据追溯和导出。该过程可靠，适用于程序化放大。这些组件符合制药行业标准，安全可靠。
TFF：
切向流过滤（TFF）是目前广泛使用的膜分离技术。样品在压力驱动下，根据不同的分子大小通过膜过滤分离内容物，达到除热、置换溶液环境、纯化、浓缩的目的。
原则：
TFF的实施过程与死胡同过滤有着根本的不同。当滤液通过膜组件时，样品溶液沿垂直方向连续穿过膜表面。
膜部件：
用于切向流过滤的膜组件通常是膜组件或中空纤维柱，两者都有多种型号，以满足不同的使用需求。膜材料的种类和孔径、溶液循环流速、膜两侧压力、样品温度、膜两侧工艺、样品温度、工艺时间等参数对于切向流过滤非常重要。他们决定了最终的工艺效果，以及大规模生产的可行性和具体计划。实验室规模的切向流过滤设备致力于获得可行的工艺方案和可靠的工艺参数，确定适合大规模实验和生产的工艺参数，为设备或系统选型提供有效依据。
T FF流程图
应用领域
核酸药物和疫苗
mRNA-LNP、siRNA、聚合物纳米颗粒等
化疗脂质体
盐酸阿霉素脂质体
盐酸伊立替康脂质体
柔红霉素脂质体
复合脂质体等
解决方案系统位移
替代缓冲溶液
纳米药物溶液的外置水相置换
细胞产物分离纯化
发酵液细胞的收集和纯化
澄清过程
质粒、单克隆抗体、蛋白纯化
质粒、mRNA、siRNA等
L DS-L2切向流过滤
技术参数：
|
Model |
LDS-L2型 |
|
最小 S充足的 Volume |
≤30毫升 |
|
压力R ange |
-1-5BAR（系统配备压力传感器） |
|
最大 F低 R吃 |
≥2200mL/min |
|
一个ccuracy |
±0.5% |
|
重量范围 |
0–4100克 |
|
控制 P参数 |
P f（进料压力）、P r（回流压力）、Pp（渗透压力）、TMP（跨膜压力）、△P（压降）等。 |
|
M行动颂歌 |
自动实现TFF过程，通过在集成PLC软件平台内对用户指定设置进行集成监控，可以执行复杂的TFF过程。
|
|
软件 |
用于自动化TFF系统的专用软件，具有简单的操作逻辑、实时跟踪、实时数据分析，并符合FDA 21 CFR Part 11数据审计跟踪。 |
|
软件功能说明 |
密码权限分为三个级别：操作员、技术人员、管理员、功能操作，按权限不同划分; 在过程中可监测流量、流量、压力等工艺参数; 在过程中可监测流量、流量、压力等工艺参数; 当采样或过滤端压力达到或超过预设值时，系统将触发报警和/或停机功能; 可以记录和导出过程中的关键参数（如样品体积、流速、流速、压力和每个工艺段的时间）。 数据展示、记录和导出可以同时以趋势图、表格和批量记录报告的形式进行。 在设备运行过程中，操作画面主界面可实时显示样品量、当前样品流向、各部件运行状态等动态变化。 |
|
适用 M embrane Materials |
PES/纤维素膜包装，中空纤维 |
|
薄膜包装规格 |
5~1000kD;0.01~0.1m2 |
设备特点：
自动 Ultrafiltration S系统
它可以实现无人化的自动化TFF过程，并通过在集成PLC软件平台内对用户指定设置进行集成监控来执行复杂的TFF过程。
专业 Operating System
具有简单操作逻辑、实时跟踪、实时数据分析以及符合 FDA 21 CFR PART 11 数据审计跟踪的专用软件。
药物研发
设备设计基于药物研发生产的工艺要求和监管规范，可用于脂质体、脂质纳米颗粒等制剂的纯化、溶剂去除、浓缩等工艺的实施。
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