完整性测试2.pptVIP

* Key difference between a manual bubble point test and a manual diffusion test is bubble point is observed gas flow and diffusion is measured gas flow. We run the diffusion test at a pressure below the bubble point of the expected largest pores in the filter. If the measured gas flow exceeds the diffusion specification, we conclude the extra flow comes from pores that have been “bubble pointed” and must therefore be larger than expected, and less retentive than expected. * The problem with alcohol is there is a high risk of getting alcohol into the system when you try to test the filters in place. When testing with alcohol, in most cases the filter and housing are removed from the manufacturing area to a prep area to be tested and dried. Using alcohol can also create safety issues. * At Millipore we call the water intrusion test “HydroCorr” The test name comes from ‘Hydro” for water and “Corr” because the test specifications are correlated to bacterial retention. During the test, the upstream of the dry filter is pressurized with water. If all the pores are as small as they are supposed to be, water will not flow into the filter. If there are any defects, water will intrude these openings and water will flow through. If the filter is integral, at the end of the test the upstream can be drained and filter is ready to use. * * * * Remember the important points of the presentation are to get a mental picture of what is occurring inside the filter when running an integrity test and what it means. These tests are closely scrutinized by regulatory agencies because of the critical nature of the filter application. Knowing what you are doing and why is critical to achieving the correct result. * * * * * * * * * * * Diffusion Test Applicability 扩散测试适用性 For filters with gas flowrate of 100 ml/min 过滤器扩散流速大于100ml/min high surface area filters大表面积过滤器 thin membranes薄的膜 organic solvent wetted filters有机溶剂湿润的过滤器 Diffusional flow specifications (and the S.O.P.) should