Scope

This SOP applies to all autoclave operations conducted for sterilizing glassware, garments, equipment, and components used in the production of sterile injectable products.

3. Responsibilities

• Autoclave Operator: Performs pre-checks, loading, cycle execution, unloading, and documentation.
• Production Supervisor: Ensures readiness of materials and verifies the cycle parameters.
• QA Officer: Monitors sterilization records and ensures compliance with validated cycles.

4. Accountability

The Head of Production is accountable for ensuring that autoclaves are operated by trained personnel using approved and validated cycles.

5. Procedure

5.1 Pre-Operation Checklist

1. Ensure autoclave is labeled as “CLEANED” and free from previous load remnants.
2. Check integrity of door gaskets, chamber walls, and safety valves.
3. Verify availability of utilities like steam, water, and compressed air.
4. Record pre-use inspection in Autoclave Pre-Use Checklist (Annexure-1).

5.2 Loading the Autoclave

1. Wear sterile garments before loading.
2. Place items to be sterilized (e.g., vials, rubber stoppers, glassware) on perforated trays with proper spacing.
3. Do not overload or block steam circulation pathways.
4. Use sterilization indicators (Bowie-Dick or chemical) in each load.

5.3 Cycle Selection and Operation

1. Select validated sterilization cycle on PLC/HMI panel based on material type.
2. Typical parameters for porous load: 121°C for 30 minutes at 15 psi.
3. Start the cycle and monitor the chamber pressure, temperature, and time.
4. Record cycle start time, load details, and operator ID in the Sterilization Log (Annexure-2).

5.4 Monitoring During Sterilization

1. Check real-time graph trends on the HMI screen for temperature and pressure consistency.
2. Ensure no alarms or deviations occur. If triggered, abort and inform QA.

5.5 Unloading Post-Sterilization

1. Allow chamber pressure to normalize before opening the door.
2. Verify indicator color change or result to confirm sterilization efficacy.
3. Unload items using sterile gloves and place them on sterile transfer trolleys.
4. Complete unloading details in the record.

5.6 Post-Operation Cleaning

1. Wipe the autoclave interior with 70% IPA.
2. Drain condensate and log cleaning in Cleaning Record (Annexure-3).

6. Abbreviations

• SOP: Standard Operating Procedure
• HMI: Human Machine Interface
• QA: Quality Assurance
• IPA: Isopropyl Alcohol
• PLC: Programmable Logic Controller

7. Documents

1. Autoclave Pre-Use Checklist – Annexure-1
2. Sterilization Cycle Log – Annexure-2
3. Cleaning Record of Autoclave – Annexure-3

8. References

• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• WHO TRS 961 – Technical Report on Sterile Manufacturing
• ICH Q9 – Quality Risk Management

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: Autoclave Pre-Use Checklist

Date	Autoclave ID	Gasket OK	Steam Available	Checked By
18/06/2025	ACV-01	Yes	Yes	Rajesh Kumar

Annexure-2: Sterilization Cycle Log

Batch No.	Cycle ID	Start Time	End Time	Operator
STL/INJ/2025/034	ACV-121-30	09:00	10:00	Sunita Reddy

Annexure-3: Cleaning Record of Autoclave

Date	Cleaned By	Method Used	Remarks
18/06/2025	Ajay Verma	70% IPA Wipe	Completed

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/03/2022	1.0	Initial SOP Issue	New Process	QA Head
18/06/2025	2.0	Updated with validation references and annexures	Annual Review	QA Head