allow proper steam penetration.

Seal bags loosely to avoid rupture during sterilization.

Pre-Autoclave Inspection:

• Ensure waste does not contain volatile chemicals or materials incompatible with autoclaving.

4.3 Operating the Autoclave

1. Pre-Operation Checks:
   • Inspect the autoclave chamber, door seals, and pressure gauges for any visible issues.
   • Ensure water levels are sufficient for the sterilization cycle.
   • Verify that temperature and pressure sensors are calibrated.

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2. Loading Waste:
   • Place waste bags or containers in the autoclave tray, ensuring even spacing for proper steam circulation.
   • Avoid overloading the chamber to prevent inefficient sterilization.
3. Setting Sterilization Parameters:
   • Set the autoclave to the appropriate cycle based on waste type:
     • Temperature: 121°C to 134°C
     • Pressure: 15 to 30 psi
     • Duration: 30–60 minutes depending on load size
4. Running the Cycle:
   • Start the cycle and monitor parameters via the control panel.
   • Do not open the door until the cycle is complete and pressure has fully released.
5. Unloading the Autoclave:
   • Wear heat-resistant gloves and PPE while removing sterilized waste.
   • Inspect waste bags for intact seals and proper sterilization (e.g., color change on autoclave tape).

4.4 Post-Autoclave Handling

1. Inspection of Sterilized Waste:
   • Ensure all waste appears fully sterilized (e.g., no wet spots or unsterilized material).

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2. Disposal of Sterilized Waste:
   • Dispose of sterilized waste in designated bins for final incineration or landfill as per regulatory guidelines.

4.5 Maintenance and Calibration

1. Routine Maintenance:
   • Clean the autoclave chamber and drain regularly to prevent residue buildup.
   • Inspect and replace door seals as needed.

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2. Calibration:
   • Calibrate temperature and pressure sensors every 6 months.
   • Document calibration activities in the Autoclave Maintenance Log (Annexure 1).

4.6 Documentation and Record-Keeping

1. Sterilization Records:
   • Log each cycle in the Autoclave Sterilization Log (Annexure 2), including:
     • Date and time
     • Waste type and quantity
     • Sterilization parameters
     • Operator name

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2. Compliance Reports:
   • Retain sterilization records for at least 5 years for audits and regulatory inspections.

4.7 Emergency Response

1. Cycle Failures:
   • In the event of a sterilization failure (e.g., incomplete cycle), repeat the cycle with adjusted parameters.

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2. Spills or Leaks:
   • Contain spills immediately using absorbent materials and disinfectants.
   • Dispose of cleanup materials as hazardous waste.

5) Abbreviations, if any

• PPE: Personal Protective Equipment

6) Documents, if any

• Autoclave Maintenance Log
• Autoclave Sterilization Log

7) Reference, if any

• WHO Guidelines on Biomedical Waste Management
• ISO 17665 Sterilization Standards
• Biomedical Waste Management Rules, 2016

8) SOP Version

Version: 1.0

Annexure

Template 1: Autoclave Maintenance Log

 
 
 
Date
 
Maintenance Activity
 
Performed By
 
Remarks
 
 
 
DD/MM/YYYY
 
Calibrated pressure gauge
 
John Doe
 
No issues
 
 
 

Template 2: Autoclave Sterilization Log

 
 
 
Date
 
Time
 
Waste Type
 
Cycle Parameters
 
Operator Name
 
 
 
DD/MM/YYYY
 
10:00 AM
 
Microbial Cultures
 
121°C, 30 mins
 
Jane Smith