all vertical and horizontal autoclaves used for sterilizing product contact equipment, garments, accessories, media, and components in the sterile injectable manufacturing department.

3. Responsibilities

• Operator: Identifies the issue and immediately informs maintenance and QA.
• Engineering Technician: Diagnoses and rectifies autoclave malfunctions.
• QA Officer: Reviews deviation reports and authorizes resumption of sterilization.

4. Accountability

The Engineering Head and Production Head are jointly accountable for minimizing autoclave downtime and ensuring sterilization reliability per GMP requirements.

5. Procedure

5.1 Types of Autoclave Issues and Troubleshooting

1. Temperature Deviation
   • Check if the temperature probe is calibrated and properly placed.
   • Ensure steam inlet valve is open and steam generator is functional.
   • Rectify insulation or jacket pressure issues if the chamber is not heating uniformly.
2. Pressure Build-up Failure
   • Check for gasket integrity and chamber door lock mechanism.
   • Inspect air removal vacuum pump for leaks or blockage.
   • Ensure there are no obstructions in steam traps or vent filters.
3. Cycle Abort or Alarm Triggered
   • Read the alarm message on the HMI display panel.
   • Cross-check with the SOP-defined alarm codes (Annexure-1).
   • Reset alarm only after identifying and rectifying the root cause.
4. Incomplete Drying
   • Check dryer fan operation and exhaust temperature settings.
   • Ensure load is not exceeding capacity and arranged properly.
5. Water Leakage or Drain Issues
   • Inspect drain line and check for valve blockages.
   • Ensure no condensate accumulation inside the chamber.

5.2 Documentation of Issues

1. All issues shall be logged in the Autoclave Trouble Log (Annexure-2).
2. Engineering must fill the Maintenance and Rectification Record (Annexure-3).
3. QA shall review and sign off after verifying corrective actions.

5.3 Preventive Measures

1. Follow routine preventive maintenance as per the Autoclave Maintenance SOP.
2. Check and calibrate critical parameters quarterly (pressure, temperature, time).
3. Train operators on recognizing early signs of malfunction.

5.4 Emergency Protocol

1. In case of sudden shutdown or major breakdown, press the EMERGENCY STOP button.
2. Inform the engineering and QA departments immediately.
3. Isolate the autoclave using lock-out/tag-out (LOTO) procedures.
4. Raise a deviation report and perform impact assessment for loads inside (if any).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• HMI: Human Machine Interface
• LOTO: Lock-Out Tag-Out

7. Documents

1. Alarm Code Sheet – Annexure-1
2. Autoclave Trouble Log – Annexure-2
3. Maintenance and Rectification Record – Annexure-3

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• WHO Technical Report Series, No. 1010

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Alarm Code Sheet

Code	Description	Action
E01	Temperature deviation	Check probe calibration
E02	Vacuum pump failure	Inspect pump and filters

Annexure-2: Autoclave Trouble Log

Date	Issue	Detected By	Remarks
23/06/2025	Door not sealing	Kiran Yadav	Gasket replaced

Annexure-3: Maintenance and Rectification Record

Date	Action	Performed By	Verified By
23/06/2025	Replaced steam trap	Ajay Kumar	QA – Rajeev R.

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial issue	New SOP	QA Head
24/06/2025	2.0	Added alarm codes and emergency protocol	Annual Review	QA Head