checks, and ensuring that the gas filling machine is properly maintained and repaired when necessary.

Health and Safety Officer: Ensures that the safety procedures are followed, particularly those related to handling pressurized gases, and verifies compliance with safety regulations.

Quality Control (QC) Team: Responsible for ensuring that the safety checks do not interfere with the product quality and that all filling processes meet the required standards.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that all gas filling machines are subject to the required safety checks. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Operation Safety Checks

1. Before operating the gas filling machine, ensure that the machine is clean and free from any debris or contaminants.
2. Inspect the gas supply system for any leaks, cracks, or damage to the hoses, valves, and connections. If any issues are found, repair or replace the damaged components before proceeding.
3. Check the pressure relief valves, ensuring that they are in proper working condition and set to the correct pressure limits as per the machine’s specifications.
4. Verify that the gas cylinders or supply tanks are securely fastened and that all connections are tight to prevent leaks.
5. Confirm that the filling machine’s emergency stop button and other safety features (e.g., gas shutoff valve) are functional and easily accessible.
6. Check that the gas filling machine is calibrated to the correct settings for the product being filled (e.g., volume, pressure, gas type).
7. Ensure that all personnel are wearing the appropriate personal protective equipment (PPE), including gloves, goggles, and face shields.
8. Log all pre-operation checks in the Gas Filling Machine Safety Check Log (Annexure-1).

5.2. Operating the Gas Filling Machine

1. Once all pre-operation checks have been completed, start the machine according to the standard operating procedure for the specific gas filling machine.
2. Monitor the gas filling process closely to ensure that it is operating within the specified pressure and volume ranges. Ensure that the pressure gauge readings are within acceptable limits.
3. If any abnormal sounds or behaviors (e.g., fluctuations in pressure, gas leaks, system malfunctions) are observed during operation, stop the machine immediately and investigate the issue.
4. Ensure that the gas filling process does not exceed the maximum allowable pressure to prevent overfilling or leakage. If an overpressure condition occurs, activate the emergency stop and report the issue to the Maintenance Team.
5. Record the operational data, including the batch number, start time, and operator name, in the Batch Production Log (Annexure-2).

5.3. Post-Operation Safety Checks

1. After completing the gas filling process, stop the machine and turn off the gas supply. Ensure that the machine is fully powered down and no residual pressure remains in the system.
2. Inspect the machine and all connections for any signs of leaks, particularly in the gas lines, valves, and filling chambers. Any leaks found must be addressed immediately by tightening connections or replacing damaged components.
3. Verify that all filled aerosol cans have been properly sealed and that there are no signs of leakage from the valves.
4. Ensure that the machine is cleaned and prepared for the next production run, including removing any residue or product buildup.
5. Record the completion of the post-operation checks in the Gas Filling Machine Post-Operation Report (Annexure-3).

5.4. Emergency Procedures

1. In case of a gas leak or overpressure situation, immediately activate the emergency stop button and shut off the gas supply to the machine.
2. Evacuate the area if there is a risk of exposure to toxic or flammable gases. Follow the company’s emergency evacuation procedure.
3. Report the incident to the Maintenance Team for further inspection and resolution. A root cause analysis must be conducted to prevent future occurrences.
4. Document the emergency incident in the Emergency Report Log (Annexure-4), including details of the incident, corrective actions taken, and any system adjustments required to prevent future occurrences.

5.5. Routine and Preventive Safety Checks

1. Perform routine safety checks on the gas filling machine at specified intervals (e.g., daily, weekly) as per the maintenance schedule.
2. Inspect the gas supply system, valves, pressure gauges, and machine components for wear and tear, and replace any worn parts to maintain safe operation.
3. Calibrate the gas filling machine regularly to ensure that it continues to operate within the specified pressure and volume parameters.
4. Log all routine checks and any actions taken in the Routine Safety Check Log (Annexure-5).

5.6. Documentation and Record-Keeping

1. Ensure that all safety checks, maintenance activities, and emergency responses are documented accurately and comprehensively.
2. Store all records in compliance with the company’s document retention policy to ensure traceability and regulatory compliance.
3. Ensure that records are available for internal audits and regulatory inspections as needed.

6. Abbreviations

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

7. Documents

1. Gas Filling Machine Safety Check Log (Annexure-1)
2. Batch Production Log (Annexure-2)
3. Gas Filling Machine Post-Operation Report (Annexure-3)
4. Emergency Report Log (Annexure-4)
5. Routine Safety Check Log (Annexure-5)

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: Gas Filling Machine Safety Check Log

Machine ID	Check Description	Operator Name	Date & Time	Remarks
GFM-001	Checked gas supply and connections	Rajesh Patel	06/02/2025	No issues

Annexure-2: Batch Production Log

Batch No.	Start Time	Operator Name	Gas Used	Test Results
12345	06/02/2025	Rajesh Patel	CO2	Pass

Annexure-3: Gas Filling Machine Post-Operation Report

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

Annexure-4: Emergency Report Log

Batch No.	Incident	Corrective Action	Operator Name
12345	Gas leak	Shut down system and repaired leak	Rajesh Patel

Annexure-5: Routine Safety Check Log

Machine ID	Check Type	Performed By	Date
GFM-001	Routine Pressure Check	Rajesh Patel	06/02/2025

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 safety checks procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures