Autoclave Operational Qualification Procedure verifies that an autoclave operates reliably within its specified parameters. This covers the OQ process, operational tests, acceptance criteria, and GMP documentation required for pharmaceutical microbiology laboratories.
Read Also => Installation Qualification for Autoclave – complete procedure
Objectives of the Autoclave Operational Qualification Procedure
The objective of Operational Qualification (OQ) is to verify and document that the Vertical Autoclave – 100/300/600 Liter operates as intended throughout all defined operating ranges such as temperature, pressure, and time cycles, in accordance with manufacturer specifications and GMP requirements.
To verify that the equipment operates in accordance with the design and user requirements as defined by set Acceptance Criteria and complies with relevant cGMP Requirements.
To verify the Operational features of Vertical Autoclave and to ensure that it produces desired Quality & rated output according to manufactures specifications.
To verify all the Operational features from user point of view of the Equipment, Cleaning Procedure, Start up & Shut down Procedure and Safety Features.
Scope where applicable
The scope of this operational qualification protocol cum report is limited to qualification of Vertical Autoclave – 100/300/600 Liter installed in between material receiving area & Sterilization area of Microbiology Section.
This Protocol will define the methods and documentation used to perform OQ activity the Vertical Autoclave for OQ. Successful completion of this Protocol will verify that Vertical Autoclave meets all acceptance criteria and ready for Performance Qualification.
Pre Approval Of Documents
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer Engineering |
Reviewed By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Warehouse | |||
| Head Quality Control | |||
| Head Production |
Approved by
| Designation | Name | Date | Signature |
| Head QA |
Scope of supply:
| Description | Specification |
| Make | |
| Model | |
| Control system | 230 V AC Single Phase |
Brief process description containing Autoclave Operational Qualification Procedure
The vertical autoclave sterilizes materials by generating saturated steam under pressure at preset temperature and time cycles (e.g., 121°C for 15–30 minutes).
OQ ensures that the control panel, sensors, and safety systems function properly during operation.
The Vertical Autoclave is used for sterilization of culture media, glassware, instruments, garments, and laboratory waste by applying saturated steam under pressure at predefined temperature and time cycles.
The process ensures effective destruction of microorganisms including bacterial spores to maintain contamination control in when the material is put inside pass box & the door is closed, UV light will turn on and material is placed under UV for some time to kill bacteria. Then the material can be taken out
Material of Construction
| Component | Material |
| Sterilization Chamber | SS 316L |
| Jacket | SS 304 / SS 316 |
| Outer Body | SS 304 Matt Finish |
| Door | SS 316L |
| Piping | SS316L |
| Frame | SS304 |
| Gasket | Silicone / EPDM (Food Grade) |
Chamber Specification
- Double wall construction
- Jacketed chamber
- Mirror polished internal surface (Ra ≤0.8 µm)
- Rounded corners for easy cleaning
- Complete condensate drainage
- Self-draining design
- No dead legs
Sterilization Parameters
| Parameter | Specification |
| Sterilization Temperature | 121°C & 134°C |
| Working Pressure | 15–30 psi |
| Maximum Temperature | 140°C |
| Cycle Time | Programmable |
| Holding Time | 1–99 Minutes |
| Drying Cycle | Automatic |
| Cooling Cycle | Automatic |
Control System
- PLC based controller
- 7–10 inch HMI Touch Screen
- Password protected access
- Recipe management
- User level access
- Alarm history
- Cycle history
- Data logging
- Real-time graphical display
- USB data export
- Ethernet communication
- Optional SCADA connectivity
Instrumentation
| Instrument | Requirement | Observation |
| Temperature Sensor | PT100 RTD | |
| Chamber Pressure Gauge | Digital | |
| Jacket Pressure Gauge | Digital | |
| Safety Valve | Yes | |
| Vacuum Sensor | If applicable | |
| Steam Pressure Indicator | Yes | |
| Door Interlock Sensor | Yes |
Utility Required
| Utility | Requirement | Observation |
| Power Supply | 415 V AC ±10%, 50 Hz, 3 Phase | |
| Steam | Plant Steam / Built-in Steam Generator | |
| Water | Purified Water / Soft Water | |
| Drain | Floor Drain Connection | |
| Compressed Air | 6–8 bar (if pneumatic door) | |
| Cooling Water | If required |
Instrumentation Required
| Instrument | Requirement | Observation |
| Temperature Sensor | PT100 RTD | |
| Chamber Pressure Gauge | Digital | |
| Jacket Pressure Gauge | Digital | |
| Safety Valve | Yes | |
| Vacuum Sensor | If applicable | |
| Steam Pressure Indicator | Yes | |
| Door Interlock Sensor | Yes |
Autoclave Operational Qualification Procedure:
Before initiating OQ, verify that:
- Installation Qualification (IQ) has been successfully completed and approved.
- All utilities (electrical power, steam, water, compressed air, and drain) are available and within specified limits.
- Calibration certificates for all critical instruments are valid.
- Standard Operating Procedures (SOPs) are approved and available.
- Preventive maintenance requirements have been completed.
- Validation master plan approval has been obtained.
- Test instruments used during qualification are calibrated and traceable to national standards.
Functional Description
| Description | Function |
| Chamber | Provides the sterilization space where media, glassware, instruments, and materials are placed and exposed to steam. |
| Lid / Door with Gasket | Ensures airtight sealing to prevent steam leakage and maintain required pressure. |
| Heater Element | Heats the water to generate steam for sterilization. |
| Temperature Sensor (PT-100) | Measures chamber temperature and sends signal to the controller. |
| Pressure Gauge | Displays the internal chamber pressure during operation. |
| Digital / PID Controller | Controls temperature, time, and cycle parameters of the autoclave. |
| Safety Valve | Automatically releases excess pressure to ensure safety. |
| Drain Valve | Used to drain used water or condensate from the chamber. |
| Basket / Tray | Supports and arranges sterilization materials properly inside the chamber. |
| Alarm | Indicates cycle completion, faults, or abnormal operating conditions. |
Autoclave Operational Qualification Procedure-Parameters verification
Power Supply Verification
Procedure
- Switch ON the main power supply.
- Verify that the HMI/PLC powers up correctly.
- Check for abnormal indications or error messages.
Acceptance Criteria
- Equipment powers up without errors.
- Control panel functions normally.
HMI/PLC functional verification
Procedure
- Verify touch screen operation.
- Check menu navigation.
- Verify user login functions.
- Verify password levels.
- Check date and time settings.
Acceptance Criteria
- All functions operate correctly.
- User access levels function as specified.
Temperature control verification
Procedure
- Select a sterilization cycle.
- Set temperature to 121°C.
- Start the cycle.
- Observe chamber temperature during heating.
Repeat the test at 134°C.
Pressure Control Verification
Procedure
- Run a sterilization cycle.
- Observe chamber pressure.
- Compare displayed pressure with calibrated reference gauge.
Acceptance Criteria
- Pressure corresponds to sterilization temperature.
- Pressure variation within manufacturer’s specification.
Cycle Operation Verification
Verify operation of each programmed cycle.
Typical cycles include:
- Glassware
- Media
- Instruments
- Liquids
- Waste
- User Defined Cycle
Acceptance Criteria
- Selected cycle executes correctly.
- All programmed stages complete successfully.
Timer Verification
Procedure
- Set holding time (e.g., 15 minutes).
- Compare displayed time with calibrated stopwatch.
Acceptance Criteria
- Timer accuracy within ±1 minute.
Steam Generation Verification
Procedure
For autoclaves with built-in steam generators:
- Fill water reservoir.
- Start steam generation.
- Observe steam pressure.
Acceptance Criteria
- Steam generated without interruption.
- Steam pressure remains stable.
Door Interlock Verification
Procedure
Attempt to open the door:
- During heating
- During sterilization
- Under pressure
Acceptance Criteria
- Door shall remain locked.
- Door opens only after chamber pressure reaches zero.
Chamber Leak Test
Procedure
- Pressurize chamber.
- Observe pressure for specified holding period.
Acceptance Criteria
- No visible leakage.
- Pressure loss within manufacturer’s specification.
Alarm Verification
Verify each alarm individually.
| Alarm | Expected Result |
| High Temperature | Alarm generated |
| High Pressure | Alarm generated |
| Low Water Level | Alarm generated |
| Door Open | Alarm generated |
| Sensor Failure | Alarm generated |
| Cycle Failure | Alarm generated |
| Power Failure | Alarm generated |
Acceptance Criteria
- Correct alarm displayed.
- Audible alarm activates.
- Cycle response as designed.
Component Veriifcation
Record the results in below table.
| Component Description | Acceptance Criteria | Observations (Ok/Not Ok) | Observed By (Sign & date) |
| Chamber | Clean, No Damage, Proper Finish | ||
| Lid / Door with Gasket | Proper Sealing, No Leakage | ||
| Heater Element | Heating Properly | ||
| Temperature Sensor (PT-100) | Accurate Reading ±2°C | ||
| Pressure Gauge | Correct Display ±2 PSI | ||
| Digital / PID Controller | Display & Keys Working | ||
| Safety Valve | Functional on High Pressure | ||
| Drain Valve | Smooth Operation, No Leakage |
Safety Features & Alarms
| Safety feature | Function | Identified by/Date |
| Electrical Insulation | Safety | |
| Earthing | To avoid the shock | |
| Over-Temperature | Cut-off | |
| Alarm | Audio/Visual Alarm Emergency Power Cut Switch Low Water Level Protection Pressure Release Valve |
Acceptance Criteria
Operational Qualification shall be considered satisfactory if:
- All operational tests meet predefined acceptance criteria.
- No critical deviations remain unresolved.
- All alarms and safety interlocks function correctly.
- Control system performs as intended.
- Temperature, pressure, and timing remain within specified limits.
- Required documentation is complete and approved.
Deviations
Any deviation observed during Operational Qualification shall be documented, investigated and assessed.
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Conclusion
Upon successful completion of all Operational Qualification tests, the laboratory autoclave shall be considered qualified for operational use and suitable to proceed to Performance Qualification (PQ), where sterilization performance is verified using representative loads and biological indicators.
Post Approval Of Documents
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer Engineering |
Reviewed By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Warehouse | |||
| Head Quality Control | |||
| Head Production |
Approved by
| Designation | Name | Date | Signature |
| Head QA |
List Of Abbreviations
| PSI | Pound per Square Inch |
| MCB | Miniature Circuit Board |
| ISO | Indian Standardized Organisation |
| GMP | Good Manufacturing practices |
| MM | Millimetre |
| V | Voltage |
| AC | Alternate Current |
| PID | Proportional Integral Derivative |