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TS Filter has established large laboratory, which can offer a complete set of test and validation service for pharmaceuticals, food&beverage and filter housing industry, as well as accurate filtration solutions and documents which conform to laws and regulations.
The specific validation content is as follow:
validation project 1
validation project 3
filter liquor sample + 1 set filter element
filter liquor sample + 3 set filter element
viability of bacteria
integrity of filter’s wetting
bacterial challenge test
precipitates and adsorbate experiment
Note: √ stand for the validation times,according to《Good Manufacturing Practice for Pharmaceutical Products》(Amended in 2010)
The service items of performance verification of filter housing:
1、viability of bacteria
Confirming the survival of organism in drugs under our technological conditions, to determine reasonable method for bacteria challenge test.Including non sterilization products,neutral sterilization products and sterilization products.
2、integrity of filter wetting
Under designated temperature, determine the diffusion flow, pressure decay test, bubble point test after the filter was 100% wetting.
3、Bacterial challenge test
The procedure is based on the ASTM F 838 which is a retention test for bacteria BREVUNDIMONAS DIMINUTA(ATCC 19146).Sterilized water with minimum concentration 107cfu/cm2 effective filtration area through filtration membrane or filters to test the intercept ability of microorganism under certain conditions. Different kinds of bacteria will be selected for testing different micron size filters.
Under the specific condition of the process ,test the chemical’s influence on appearance and physical properties of the filter, bubble point changes, diffusion flow changes, to validates the cross-effects of filter and the process fluid.
Particle releasing and gravimetric extractables, are directly showed by quantitative and qualitative analysis of no volatilization residue(NVR).