01
Clearance objective and challenge model
Define the virus-clearance objective, regulatory strategy, target
and model viruses, morphology and challenge design.
02
Feed composition and product interaction
Provide protein concentration, viscosity, product-interaction risk
and required recovery.
03
Aggregate and foulant burden
Characterize aggregate, colloid and particulate loading and the
need for nylon or depth prefiltration.
04
Throughput and operating limits
Confirm expected throughput, processing time, flux, differential
pressure and temperature.
05
Scale-down and integrity strategy
Define the representative model, membrane-area scaling basis, and
pre-use and post-use integrity-test criteria.
06
Recovery, flush and compatibility
Assess acceptable yield loss, flush volume, hold-up volume,
extractables and material compatibility.