into each aerosol can and that the charging process is consistent with the product specifications.

Health and Safety Officer: Ensures that all safety measures are followed, particularly in relation to the handling of pressurized gases and the potential hazards associated with propellant charging.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed, and that propellant charging equipment operates effectively and safely. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Operation Checks

1. Before starting the propellant charging process, ensure that all equipment is clean and free of any debris, contamination, or residue from previous batches.
2. Verify that the propellant charging machine is calibrated to the correct pressure and volume settings, based on the batch requirements and product specifications.
3. Check the condition of all hoses, connections, and valves for signs of wear, leaks, or damage. Replace any damaged components before use.
4. Ensure that the propellant supply system is fully stocked with the required propellant type and that all connections are secure.
5. Confirm that all safety features, such as pressure relief valves and emergency shutoff systems, are functioning correctly and have been tested prior to use.
6. Record the completion of the pre-operation check in the Propellant Charging Equipment Pre-Operation Log (Annexure-1).

5.2. Operating the Propellant Charging Equipment

1. Start the machine by activating the power supply and initiating the propellant charging cycle through the control panel.
2. Place the aerosol cans in the machine’s charging station, ensuring that they are properly aligned and securely held in place.
3. Initiate the charging process. The machine will automatically fill the cans with the pre-determined amount of propellant. Monitor the machine closely to ensure that the charging is consistent and that no can is overfilled or underfilled.
4. Check the pressure gauges to ensure that the propellant is being charged at the correct pressure. If the pressure exceeds the upper limit, stop the process immediately and investigate the issue.
5. If there is any malfunction during the charging process, stop the machine using the emergency stop button and troubleshoot according to the machine’s manual.
6. Record the batch number, start time, and operator name in the Batch Production Log (Annexure-2) as the charging process begins.

5.3. Post-Operation Checks

1. After the propellant charging cycle is complete, turn off the machine and ensure that all remaining propellant is safely contained or released according to safety procedures.
2. Remove the charged aerosol cans from the machine and inspect them for any signs of leakage or improper sealing.
3. Check the accuracy of the filled cans by performing a sample check on the propellant weight or volume, based on the product specifications.
4. If any cans are found to be improperly filled, initiate the corrective action process and document the issue in the Deviation Report (Annexure-3).
5. Record the completion of the propellant charging process in the Post-Operation Report (Annexure-4), noting the total number of cans filled and any anomalies encountered during the process.

5.4. Routine Maintenance

1. Perform daily maintenance tasks as specified by the manufacturer and the company’s maintenance schedule, including lubrication of moving parts, checking for wear on seals and hoses, and cleaning the machine components.
2. Inspect the propellant charging system regularly for leaks, damage, or any malfunctioning parts. Replace any worn or damaged components immediately.
3. Ensure that the machine is recalibrated periodically to maintain accurate propellant charging measurements.
4. Document all maintenance activities in the Propellant Charging Equipment Maintenance Log (Annexure-5).

5.5. Troubleshooting

1. If the propellant charging machine fails to function as expected, follow the troubleshooting steps outlined in the machine’s manual. Common issues may include:
   • Pressure fluctuations
   • Underfilling or overfilling of cans
   • Leaking valves or hoses
   • Electrical failures or malfunctions
2. Log any issues encountered during the operation and troubleshooting in the Troubleshooting Log (Annexure-6), including the steps taken to resolve the issue.
3. If the issue cannot be resolved in a timely manner, notify the Maintenance Team to conduct a detailed inspection and repair.

5.6. Documentation and Record-Keeping

1. Ensure that all logs related to the operation, maintenance, and troubleshooting of the propellant charging equipment are accurately completed and stored in accordance with the company’s document retention policy.
2. Ensure that all records, including the Pre-Operation Log, Batch Production Log, Deviation Report, and Maintenance Log, are readily available for audits and regulatory inspections.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Propellant Charging Equipment Pre-Operation Log (Annexure-1)
2. Batch Production Log (Annexure-2)
3. Deviation Report (Annexure-3)
4. Post-Operation Report (Annexure-4)
5. Propellant Charging Equipment Maintenance Log (Annexure-5)
6. Troubleshooting Log (Annexure-6)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• ISO 9001:2015 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Propellant Charging Equipment Pre-Operation Log

Machine ID	Check Description	Operator Name	Date & Time	Remarks
PC-001	Checked valves and hoses	Rajesh Patel	06/02/2025	No issues found

Annexure-2: Batch Production Log

Batch No.	Start Time	Operator Name	Propellant Used	Test Results
12345	06/02/2025	Rajesh Patel	50L	Pass

Annexure-3: Deviation Report

Batch No.	Deviation Description	Corrective Action	Operator Name
12345	Low pressure in propellant	Replaced pressure valve	Rajesh Patel

Annexure-4: Post-Operation Report

Batch No.	Stop Time	Operator Name	Issues Encountered	Corrective Actions
12345	06/02/2025	Rajesh Patel	None	None

Annexure-5: Propellant Charging Equipment Maintenance Log

Maintenance Type	Details	Performed By	Date
Lubrication	Lubricated valves and seals	Rajesh Patel	06/02/2025

Annexure-6: Troubleshooting Log

Batch No.	Issue	Action Taken	Operator Name
12345	Low propellant flow	Adjusted pressure settings	Rajesh Patel

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated equipment operation and maintenance procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures