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默克密理博 王斌

Filtration Principle and Application 过滤原理及应用. 默克密理博 王斌. Outline 讲座主要内容. Filtration Technology and Principles 过滤知识及原理 Filtration usage and maintains 过滤器的使用及维护 Typical Sterile filtration process 典型除菌过滤流程. 5. 0.22 µm. 4. 1. 2. 3. Introduction to Filtration 过滤基本知识.

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默克密理博 王斌

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  1. Filtration Principle and Application 过滤原理及应用 默克密理博 王斌

  2. Outline 讲座主要内容 • Filtration Technology and Principles • 过滤知识及原理 • Filtration usage and maintains • 过滤器的使用及维护 • Typical Sterile filtration process • 典型除菌过滤流程

  3. 5 0.22 µm 4 1 2 3 Introduction to Filtration 过滤基本知识

  4. Size Exclusion大小排除 • Particles are too large to pass through the "pore“ • 基于大小来分离 • Examples are termed entrapment, sieving, surface capture • 例如拦截,筛分,表面捕获 • Adsorption吸附 • Particles stick to the filter by chemical / electrical attraction • 颗粒由于化学/电荷作用粘附在滤器上 How do Filters Work? 过滤机理

  5. Main content主要内容 • Important differences in the types of filters used in Bioprocesses. • 生物制药中使用的不同类型过滤器及其特性 • Why we use membrane filters for critical application • 关键应用中为什么使用膜过滤器 • How to recognize filtration problems and perform basic troubleshooting • 怎样理解过滤中的问题和解决简单故障

  6. Filter media type 过滤介质种类 • 深层滤膜 Depth filter • 表面滤膜 Surface filter • 绝对膜 Membrane filter

  7. Typical filter device 常见过滤装置

  8. Install filter 安装滤芯 Autoclave 高温高压/SIP Flushing/wetting 冲洗/润湿 Sterile filtration 除菌过滤 Integrity test 完整性测试 Flushing/wetting冲洗/润湿 Air blow down 空气吹干 DP < 5 psi Integrity test 完整性测试 Typical sterile filtration process除菌过滤基本流程

  9. Sterile Filtration 除菌过滤

  10. Filter Cleaning 滤芯的清洗 • 1．Forward cleaning 正向清洗： • Cleaning agent or water clean from upstream to downstream, pressure could be higher than process.清洗剂或清洗水从膜的上游到下游的清洗方法，可以用稍大于过滤产品的压力来进行。 • 2．Reverse cleaning 反向清洗： • Cleaning agent or water clean from downstream to upstream, pressure should be less than specification.清洗剂或清洗水从膜的下游到上游的清洗方法； • 压力要严格按照产品说明书给定的参数来执行； • 3．Cleaning agent selection 清洗剂的选择 • We should consider 选择清洗剂时，必须考虑下列因素 • 1、Fouling type堵塞的类型 • 2、Membrane type, Chemical compatibility 膜的类型，化学兼容性（如PVDF不能用NaOH清洗，但是蛋白吸附极低，可以用40~50度250~300ppm 活性氯的NaCIO清洗） • 3、Application requirement应用的要求

  11. There are two major retention mechanisms in liquids • 在流体过滤中有两类过滤机理 • Adsorption, Size Exclusion吸附,大小排除 • Three types of filters are commonly used in biopharmaceutical filtration • 三类过滤器普遍使用在生物制药 • Depth, Surface, Membrane深层,表面,膜过滤 • Filter materials are supplied as either过滤介质以下列形式提供 • Disc, Stacked Disc, Pleated Cartridge圆盘,层叠式,柱式 • Filters block by either过滤堵塞可以是 • Gradual, Total or Cake逐渐堵塞,完全堵塞 • Filtration problems can be solved过滤问题可以被解决 • Monitoring and optimizing are key techniques监测和优化是关键技术 Filtration Summary总结

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