FAT Checks for a Pharmaceutical Freeze Dryer
Buyers should define measurable pass or fail checks for shelf temperature control, ultimate vacuum, and drying performance before signing off a pharmaceutical freeze dryer at the factory acceptance test.
Before signing off a pharmaceutical freeze dryer, decide which acceptance checks will be pass or fail, not merely observed. A practical starting point is to require documented evidence for shelf temperature control across the stated −50 to +70 °C range and for ultimate vacuum at ≤1 Pa, treating the catalog values of 20.2 m² shelf area, −50 to +70 °C, and ≤1 Pa as reference specifications rather than guarantees for the supplied unit.
Ask the supplier in the request for quotation how each check will be run: which sensors are calibrated, where they sit, how long each condition is held, and what tolerance defines a pass. For a demonstration, request a temperature uniformity test at defined setpoints and a vacuum pull-down test with recorded time to target. For acceptance, agree on a written protocol with acceptance criteria, raw data, and a witnessed signature before shipment.
Before requesting a quote, confirm with the supplier which tests are included, the calibration status of instruments, the acceptance criteria and tolerances, and how deviations are resolved and documented.