Kinda filtration has established large laboratory, which can offer 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 valication content is as follow:
|
Valication items |
Valication project 1 |
Valication project 2 |
|
Filter liquor sample+1 set filter element |
Filter liquor sample+3 set filter element |
|
|
Viability of bacteria |
√ |
√ |
|
Integnty of filter wetting |
√ |
√√√ |
|
Bacterial challenge test |
√ |
√√√ |
|
Chemical Compatiblity |
√ |
√ |
|
Particle releasing |
√ |
√√ |
|
Precipitates and adsorbate experiment |
evaluate |
evaluate |
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 product and sterilization products.
2. integnty 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 ASTIM F 838 which is a retention test for bacteria BREVUNDIMONAS DIMMINUTA(ATCC 19146). Sterilized water with minimum concentration 107 cfu/cm2 effective filtration area through filtration membrane or filters to test the intercept alility of microoganism under certain conditions. Different kinds of bacteria will be selected for testing differnt micron size filters.
4. Chemical Compatiblity
Under the specific condition of the process, test the chemical’s influence on appearamce and physical properties of the filter, bubble point changes,diffusion flow changes, to validates the cross-effects of filter and the process fluid.
5. Particle releasing
Particle releasing and gravimetric extractables,are directrly showed by quantitative analysis of no volatilization residue(NVR)
Post time: Feb-16-2021