Agree the test conditions before the machine is built.
FAT and SAT become useful when the URS names the package, test product, utilities, runtime, measurements, acceptance values, responsibilities, and evidence to be delivered.
FAT
Factory acceptance
Approved drawings, P&ID, materials, instrument, valve, and software revision check
Specified bag and fitment presentation, opening, fill, recapping, and reject sequence
No-bag/no-fill and loss of the specified temperature, pressure, sterilant, or sterile-gas conditions
Agreed cleaning and pre-sterilization or decontamination sequence, including CIP/SIP where applicable, plus valve states, timers, alarms, reset permissions, and recipe control
Mass or flow measurement against an agreed method and product or substitute medium
Agreed bags/h and kg/h at stated fill mass, viscosity, temperature, handling, and runtime
Batch data, trends, alarm history, audit trail where required, and export format
Guarding, emergency stop, safe recovery, maintenance access, and open-item register
Upstream sterilizer, sterile hold, filler, conveyor, scale, and downstream interlocks
Actual customer bags, fitments, drums or bins, handling sequence, and filled-package movement
Specified field utilities, including power, air, water, drainage, sterilizing media, and CIP return where applicable, under peak-load conditions
Approved product or test medium at the agreed inlet condition and sustained runtime
On-site execution of the agreed cleaning and pre-sterilization or decontamination sequence, including CIP/SIP where applicable, with records, alarms, deviations, and restart procedure
Operator and maintenance training, spares, manuals, backups, and final document handover
Punch-list closure and responsibility for product/process/packaging validation
Important boundary
Passing FAT or SAT does not by itself prove commercial sterility.
Equipment and automation acceptance must be connected to—but not confused with—the product scheduled process, packaging sterilization, process authority work, microbiological qualification, and routine operating controls required for the intended product and market.