疏水过滤器完整性测试
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• 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
• 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
Automated HydroCorr Test自动化测试
• 典型的润湿液是异丙醇,甲 醇或他们与水的混合物
compressed air
• 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 酒精/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
For integral filter there is no “actual” water flow 实际上完整膜,没有实际的水流
– 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
– 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 用酒精测试的优点
• No special equipment required 不需特定的设备 • Follows similar procedures to hydrophilic membranes. Operator
Hydrophobic Integrity Testing 疏水性过滤器完整性测试
过滤/完整性测试培训课程
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
Integrity Tester
Air / N2
WFI
apply pressure
Measure pressure
and hold加压并保持 Decay测量压力衰减
2.6
2.6
2.6
2.6
0 bar
0 bar
0 bar
0 bar
Pressure causes pleats to compact -
• 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
– 水浸入压的定义为:把水挤入疏 水性膜最大孔的最小压力
P1 Water
GPa2 s
d
- 4 . k . . cos
IP = ------------------d
where: 其中 k = shape correction factor = surface tension = contact angle d = pore diameter
– "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
Particle Distribution must be uniform颗粒分布必须是均一的 Must have correlation of particles vs microorganisms 颗粒与微生物之间需要有相关性 High equipment cost设备成本高 Difficult to perform in-situ很难在线测试
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
1.0
Water 0.5 Flow 0.4
0.3
ml/min 0.2
0.1
0
20 minutes
10
Time
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
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
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
Alternatives to Alcohol Based Integrity Testing 代替酒精进行完整性测试
• 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
• 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
resulting in apparent water flow
P atm
压力导致折叠式滤膜进一步压缩—现
象是有一定的水流
0 Time (min.)
10
P atm
20
HydroCorr Test Results测试结果
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
– 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
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
• Automatically自动操作 – Use a pressure transducer to measure upstream gas pressure loss 使用压力传感器来测量上游气体压力的损失
• Bothห้องสมุดไป่ตู้need 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分钟的测试时间
– 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
– Water Intrusion Pressure is the minimum pressure necessary to force water into the largest pores of a hydrophobic membrane.
training time 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
– 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
• 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 – 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
• 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
Particle Based Integrity Testing 测试所用的颗粒
• Microorganism - Destructive Test • 微生物测试---破坏性测试
• 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
Automated HydroCorr Test自动化测试
• 典型的润湿液是异丙醇,甲 醇或他们与水的混合物
compressed air
• 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 酒精/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
For integral filter there is no “actual” water flow 实际上完整膜,没有实际的水流
– 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
– 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 用酒精测试的优点
• No special equipment required 不需特定的设备 • Follows similar procedures to hydrophilic membranes. Operator
Hydrophobic Integrity Testing 疏水性过滤器完整性测试
过滤/完整性测试培训课程
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
Integrity Tester
Air / N2
WFI
apply pressure
Measure pressure
and hold加压并保持 Decay测量压力衰减
2.6
2.6
2.6
2.6
0 bar
0 bar
0 bar
0 bar
Pressure causes pleats to compact -
• 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
– 水浸入压的定义为:把水挤入疏 水性膜最大孔的最小压力
P1 Water
GPa2 s
d
- 4 . k . . cos
IP = ------------------d
where: 其中 k = shape correction factor = surface tension = contact angle d = pore diameter
– "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
Particle Distribution must be uniform颗粒分布必须是均一的 Must have correlation of particles vs microorganisms 颗粒与微生物之间需要有相关性 High equipment cost设备成本高 Difficult to perform in-situ很难在线测试
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
1.0
Water 0.5 Flow 0.4
0.3
ml/min 0.2
0.1
0
20 minutes
10
Time
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
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
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
Alternatives to Alcohol Based Integrity Testing 代替酒精进行完整性测试
• 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
• 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
resulting in apparent water flow
P atm
压力导致折叠式滤膜进一步压缩—现
象是有一定的水流
0 Time (min.)
10
P atm
20
HydroCorr Test Results测试结果
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
– 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
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
• Automatically自动操作 – Use a pressure transducer to measure upstream gas pressure loss 使用压力传感器来测量上游气体压力的损失
• Bothห้องสมุดไป่ตู้need 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分钟的测试时间
– 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
– Water Intrusion Pressure is the minimum pressure necessary to force water into the largest pores of a hydrophobic membrane.
training time 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
– 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
• 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 – 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
• 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