Operate and monitor autoclave systems for sterilization of production equipment, rubber stoppers, glassware, garments, and materials used in injectable manufacturing.
Execute sterilization cycles as per approved Batch Manufacturing Records (BMR) and validated cycle parameters.
Ensure correct loading, unloading, and arrangement of materials inside autoclaves to achieve effective sterilization.
Monitor critical parameters such as temperature, pressure, exposure time, and F0 value during sterilization cycles.
Maintain autoclave operation logs, sterilization records, and batch documentation as per GMP requirements.
Perform routine checks and ensure calibration status of autoclave instruments and sensors.
Coordinate with QA for cycle approval, validation activities, and sterilization cycle qualification.
Ensure compliance with aseptic practices and contamination control procedures.
Report deviations, cycle failures, and equipment malfunctions to supervisors and initiate corrective actions.
Support validation activities such as heat distribution studies and heat penetration studies.
Maintain cleanliness and housekeeping of autoclave area as per cGMP and EHS guidelines.
Ensure proper segregation of sterile and non-sterile materials.
Coordinate with Production, QA, QC, and Engineering teams for smooth sterilization operations.
Follow safety procedures for handling high-pressure and high-temperature equipment.
