04 / Acceptance and handover
Prove the result under a representative production condition
Inspect and instrument controlling locations and verify drainage during sterilise, hold, cool and production transitions. Retain measured evidence for steam and cooling sequence and temperature, removal and inspection proof 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.