On-site Commissioning and Acceptance Checklist for New Installed Industrial Lyophilizer
Complete testing items of mechanical, refrigeration, vacuum, control and safety systems during lyophilizer on-site acceptance.
After lyophilizer delivery and on-site assembly, systematic commissioning and acceptance are critical procedures before formal production. Comprehensive testing confirms all functions and technical indexes conform to contract specifications, avoiding potential hidden faults entering commercial production. This acceptance checklist applies to pharmaceutical, food and material industrial lyophilizer models.
Mechanical system inspection includes chamber door sealing performance, shelf lifting operation, vacuum stoppering mechanism (if equipped), tray-free flipping action and all transmission components. Check whether movement is smooth without abnormal noise, and verify travel limit and safety interlock function.
Refrigeration system commissioning tests cooling speed, ultimate low temperature achievement and temperature uniformity. Complete temperature mapping test under simulated loading condition, record hot zones and cold zones inside the chamber to confirm deviation within allowable range.
Vacuum system acceptance covers ultimate vacuum test and vacuum holding leakage test. Record pressure rising rate to judge chamber and pipeline tightness. Test stable vacuum maintaining capacity under simulated drying working condition.
Control system verification includes lyophilization recipe storage, automatic operation sequence, data recording, alarm triggering and authority management. For pharmaceutical models, verify audit trail and electronic signature functions satisfy 21 CFR Part 11 requirements.
Auxiliary system test: CIP flushing coverage test, SIP sterilization temperature distribution test for pharmaceutical versions; check cleaning pressure, steam temperature and holding time meet design standard.
Safety function test contains over-temperature protection, over-pressure interlock, emergency stop button, power failure protection and refrigeration system fault alarm.
All test data are recorded in acceptance documents. Only after all items pass inspection can formal equipment handover be completed. Unqualified indicators require supplier adjustment and re-testing.
LYOMAC provides standardized on-site commissioning acceptance workflow, and professional engineers conduct global on-site startup service for customers.
