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