Filtration process validation refers to the validation process implemented for the specific medium to be filtered, in combination with the specific process conditions, and includes two parts, performance confirmation and filtration process validation, both of which are difficult to replace each other and should be done independently. Filtration process validation generally includes bacterial entrapment test, chemical compatibility test, extractable or leachables test, safety assessment and adsorption assessment. The sunitinib test enables cartridge compatibility studies, chemical compatibility tests, integrity tests, etc.
● Detection items:
Cartridge compatibility study
Extractable assays
Elements (ICP-MS / ICP-OES)
Non volatile compounds (uplc-dad-ms)
Volatile and semi volatile compounds (GC-MS / FID)
Small molecule volatiles (hs-gc-ms)
Special compounds (18 PAHs, 12 nitrosamines, 2-mbt)
Elemental and organic matter methodological validation
Elemental and organic matter testing
Chemical compatibility test
Visual inspection before and after filter cartridges contact the medium to be filtered
Flow rate changes during filtration
Variation of filter membrane weight / thickness
Changes in integrity test values such as blistering point before and after filtration
Variation in tensile strength of filter membranes
Integrity testing
Bubble point method method development, validation
Diffusion flow method development, validation
Method development, validation by pressure holding method
