04 / Acceptance and handover
Prove the result under a representative production condition
Calibrate through the usable range and challenge high, low, signal-loss and disagreement scenarios with safe product response. Retain measured evidence for tank geometry and usable range and alarm, interlock and proof-test plan with method, state, limit, deviation, witness, approval and requalification trigger. Use qualified process and aseptic validation, calibrated critical instruments, boundary and intervention challenges, sterile-utility evidence, package-treatment verification, representative hold and stop scenarios, environmental or product monitoring and documented deviation disposition. Final commercial-sterility and regulatory responsibility remains project- and jurisdiction-specific. Put the sample or test material, method, instrument, production state, duration, limit, witnesses, retained record and deviation authority in the protocol before testing begins. Requalify when a product, package, site, speed or connected system invalidates the accepted basis.