5-疏水过滤器完整性测试

Performing HydroCorr Tests 进行疏水性测试
Manually手动操作 Use a flow meter to measure actual upstream water displacement
使用流量计来测量上游水的水流 Automatically自动操作 Use a pressure transducer to measure upstream gas pressure loss
How we can test hydrophobic filters with the same liquid properties we used to test hydrophilic filters 如何利用测试亲水性滤膜的液体来测试疏水性滤膜
What new tests are available to address the limitations of alcohol based testing – HydroCorr 新的测试方法可以去除使用酒精---Hydrocorr
compressed air
典型的润湿液是异丙醇,甲醇或他 们与水的混合物
Uses same principles as a hydrophilic test
使用与亲水性滤膜测试相同的原理
Alcohol / Water Gas Flow Curve 异丙醇/水 气体流速曲线
Don't use 100% solvent, check gauges, set pressure accurately, check for correct test gas, look for distinctive change in gas flowrate
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Pressure causes pleats to compact -
resulting in apparent water flow
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压力导致折叠式滤膜进一步压缩—现
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象是有一定的水流
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HydroCorr Test Results测试结果
Alcohol Testing Issues 采用酒精测试的问题
Alcohol / Water mixtures are often used due to: 酒精/水的混合物使用经常会导致
• Cost成本高 • Flammability有燃烧的危险 • high diffusion高的扩散流
– 在测试后,测试液体会残存在过滤器/管路中 – Residual solution should be removed before filter sterilization – 灭菌前需要去除残存的液体
Alternatives to Alcohol Based Integrity Testing 代替酒精进行完整性测试
The water pressure is maintained but not increased. 压力维持但不再加压
Pleated structure compacts 折叠式结构进一步压缩
If integral, the upstream pressure will not drop below a preset value. 膜如果是完整的,上游的压力不会太快下降
is reduced 可以采用与亲水性滤膜相同的步骤.操作者培训时间可以省去. Traditional 是传统的方法 Widely accepted 广泛被接受 Well understood 很好理解 Correlated to bacterial challenge与细菌挑战有相关性 Can be performed easily & quickly 能非常容易及快速的进行测试
Water-Based Integrity Tests have been developed to overcome these issues 用水来测试可以克服以上问题
– Ease of validation容易验证
Water-Based Integrity Test Theory 用水作完整性测试的原理
HydroCorr Testing Hydrocorr测试
Force water under pressure onto the surface of the filter. 把水灌在膜表面
Applied pressure is < integral filter intrusion pressure 加压至小于膜的水浸入压
Changes in water level in the pipette can be read through the cylinder 水流的变化可通过 圆柱管来读出
Needed primarily due to: 改变的主要原因是
– Issues with alcohol contamination of processes residues – 酒精残留的问题 – Risks inherent with the use of solvents
使用有机溶剂的问题
How and when to use HydroCorr to it’s maximum advantage 如何及合适使用Hydrocorr方法更能体现其优点
Particle Based Integrity Testing 测试所用的颗粒
Microorganism - Destructive Test 微生物测试---破坏性测试
Filter remains dry and does not require drying between testing and use 在测试与使用中,过滤膜维持干燥也不需要干燥
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Air pressure below the expected intrusion pressure is applied 缓慢加压,不超过水浸入测 试压力
After stabilization, valve is closed so all water flow into housing is through the pipette 稳定 好后,关闭阀门以使水通过管路流至外壳中
Manual HydroCorr Test 手动测试
Clear cylinder with pipette inside is attached to the top of the filter housing 把洗干净的圆 柱管与过滤器上游相连
Housing and cylinder are filled with water 过 滤器外壳及圆管中加满水
After initial stabilization, “apparent” water flow for an integral filter is very low 在最初的稳定后,对于完整膜来说,水流是非常小的 Specifications are correlated to bacterial challenge 水流指标是与细菌挑战有关 For integral filter there is no “actual” water flow 实际上完整膜,没有实际的水流
Traditional Testing Principles 传统测试原理
Typical wetting liquids are Isopropyl Alcohol (I.P.A.), Methanol, Tert-butyl Alcohol, or a mixture of one of these and water
Hydrophobic Integrity Testing 疏水性过滤器完整性测试
What you will learn 主要内容
The types of particles and microorganisms used for testing hydrophobic filters 测试疏水性滤膜所用的颗粒及微生物的种类
"Smoke" (D.O.P., Glycerol, Corn oil, etc) 烟雾 Methylene Blue, Sodium Flame 亚甲基蓝,钠火焰 Issues注意点
z Particle Distribution must be uniform颗粒分布必须是均一的 z Must have correlation of particles vs microorganisms z 颗粒与微生物之间需要有相关性 z High equipment cost设备成本高 z Difficult to perform in-situ很难在线测试
Aerosol microorganisms or liquid bacterial challenge 气雾型微生物或者使用液状细菌进行挑战 Phage (T1, T3, phiX)噬菌体 Bacteria (B. diminuta) 细菌(缺陷型假单孢杆菌)
Aerosol Based - Non-destructive Test 气雾测试----非破坏性测试
Hydrophobic polymers repel water
疏水膜抗拒水
Pleated structures compact under pressure 在压力下,折叠式结构进一步压缩
P1 Water
Water Intrusion Pressure is the minimum pressure necessary to force water into the largest pores of a hydrophobic membrane.
水浸入压的定义为:把水挤入疏水性膜最大孔的 最小压力
IP =
GPa2s
d
θ
φ
- 4 . k . γ . cos θ
------------------d
where: 其中
k = shape correction factor γ = surface tension θ = contact angle d = pore diameter
Secure areas and equipment needed 需要可靠的区域及设备
Can be difficult to perform in-situ 很难在线操作
– Some concerns with residual test solution remaining in filter holder / pipework after testing
使用压力传感器来测量上游气体压力的损失 Both need long stabilization & test time
都需要长时间的稳定及测试时间 Typically 10 minute stabilization & 10 minute test
一般需要10分种的稳定时间及10分钟的测试来自百度文库间
不要使用100%的溶剂.核实压力表.正确设定压力.核实正确的测试气体.寻找在气体流速 中特别的现象
Alcohol Testing Advantages 采用有机溶剂测试的优点
No special equipment required 不需特定的设备 Follows similar procedures to hydrophilic membranes. Operator training time
Integrity Tester
Air / N2
WFI
装 In上st干all的dr滤y芯cartridge 水watFiellr u在ps上tre游a充m满w/
apply pressure
Measure pressure
and hold加压并保持 Decay测量压力衰减
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