Production Sterile: Autoclave Operator
- Autoclave Setup & Loading: Prepare, assemble, and load terminal steam sterilizers (autoclaves) with cleanroom garments, equipment parts, tubing, and filling line change parts per validated loading patterns.
- Cycle Execution & Control: Operate moist heat sterilization cycles (gravity, prevacuum, air-overpressure) using automated PLC/SCADA terminals following validated recipe parameters.
- In-Process Cycle Monitoring: Monitor critical sterilization parameters, including chamber temperature, exposure time, F0 values, pressure differential, and vacuum hold performance.
- Sterility Assurance & Indicators: Place and verify physical, chemical, and Biological Indicators (BIs) across loads to validate cycle efficacy and release sterilized components.
- Post-Sterilization Aseptic Transfer: Unload sterilized loads using proper aseptic handling techniques and transfer components into Grade A/B cleanrooms through double-ended pass-through airlocks.
- Line Clearance & Sanitization: Perform line clearance routines,



equipment surface sanitization, and chamber cleanings between sterilization runs to prevent cross-contamination.
- Sterilization BMR & Logbook Entries: Log real-time process data, cycle printouts, temperature recorder charts, and equipment status updates in Batch Manufacturing Records (BMR) following ALCOA+ rules.
- Preventive Maintenance & Leak Testing: Perform daily/weekly routine maintenance checks, door gasket inspections, air detector tests, and Bowie-Dick steam penetration tests.
- Audit & Compliance Readiness: Maintain autoclave logbooks, Bowie-Dick test records, and cycle trend graphs in an organized, audit-ready state for regulatory inspections (USFDA, EU Annex 1).
- EHS & Safety Enforcement: Strictly enforce steam plant safety protocols, wear heat-resistant thermal PPE, inspect pressure safety valves, and observe hot-surface safety guidelines.

📌 Production Sterile (Diu)
🏢 USV
📍 Diu