01
Filtration objective
Define the required particle or bioburden reduction and the position
of the filter in the process.
02
Fluid compatibility
Provide composition, pH, temperature, contact time, viscosity and
chemical-compatibility requirements.
03
Contaminant and product load
State particle concentration, size distribution, and protein or
active-ingredient concentration.
04
Batch and processing target
Confirm batch volume, desired processing time, acceptable product
loss and required recovery.
05
Operating limits
Define maximum allowable differential pressure and other
process-specific operating constraints.
06
Equipment and use strategy
Identify connections, housing interfaces and the cleaning,
sterilization or single-use strategy.