followed during the propellant charging process, including proper ventilation and protective equipment.

Packaging Team: Responsible for ensuring that the charged aerosol cans are properly sealed, labeled, and ready for further processing or testing.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed during the propellant charging process. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation of Equipment and Materials

1. Before starting the propellant charging process, verify that all equipment is calibrated and functioning properly. This includes checking the filling machine, propellant charging system, and any associated equipment.
2. Ensure that the aerosol cans to be filled are clean, dry, and free of any contamination. The cans should be visually inspected for any defects such as dents, scratches, or damage to the valve.
3. Prepare the propellant according to the formulation requirements. Verify the propellant type, lot number, and specifications to ensure consistency with the product formulation.
4. Ensure that all required personal protective equipment (PPE) is available and that the work area is properly ventilated to avoid exposure to any propellant fumes.

5.2. Charging Propellants into Aerosol Cans

1. Position the aerosol cans into the filling machine, ensuring they are correctly aligned with the charging system.
2. Activate the propellant charging system to begin the filling process. The amount of propellant charged should be consistent with the formulation specifications, and the system should ensure that no overcharging or undercharging occurs.
3. During the charging process, monitor the pressure and flow rates to ensure that the propellant is added at the correct pressure. The pressure should be maintained within the required range to avoid any leakage or system malfunction.
4. Once the propellant has been charged into the can, ensure that the valve is securely crimped and that the can is sealed properly. Verify that the can does not show any signs of leakage.
5. Record the batch number, propellant lot number, and other relevant details in the Charging Propellant Log (Annexure-1). This log should include the date and time of the charge, the operator’s name, and the number of cans charged.

5.3. In-Process Testing and Monitoring

1. Conduct in-process testing to verify that the correct amount of propellant has been charged into each can. This may include measuring the weight of the charged can or performing an internal pressure test.
2. During the charging process, monitor the following:
   • The uniformity of the spray pattern
   • Can weight or fill volume consistency
   • The proper functioning of the valve system
   • Integrity of the can seal and valve crimp
3. If any discrepancies are detected (e.g., overfill, underfill, leakage), immediately stop the process and investigate the root cause. Take corrective actions as needed, such as adjusting the filling machine settings or recalibrating the propellant charging system.
4. Record all in-process test results in the In-Process Testing Log (Annexure-2).

5.4. Safety and Environmental Considerations

1. Ensure that the area is well-ventilated during the charging process to prevent the accumulation of potentially hazardous vapors.
2. Operators should wear appropriate PPE, including gloves, safety goggles, and respiratory protection, as required by the safety protocols.
3. Verify that emergency safety equipment, such as fire extinguishers and first aid kits, are easily accessible in case of an emergency.
4. Monitor the propellant levels in the storage tanks to prevent overfilling and ensure that the storage area complies with safety regulations regarding flammable materials.

5.5. Post-Charging Procedure

1. After the propellant charging process is complete, inspect the filled aerosol cans for any defects, such as leakage or improper sealing. Perform a final visual inspection of the valve and actuator system to ensure proper function.
2. Transfer the filled cans to the packaging area for further processing, including labeling and sealing. Ensure that the cans are stored in a safe, stable environment until they are ready for shipment or further testing.
3. Ensure that all documentation is completed, including the charging log, in-process testing log, and any deviations or corrective actions taken during the process.

5.6. Documentation and Record-Keeping

1. Document all steps in the Charging Propellant Log (Annexure-1), including the batch number, operator details, and any discrepancies or corrective actions taken during the process.
2. Ensure that the In-Process Testing Log (Annexure-2) is completed with all test results, including pressure readings, weight measurements, and spray pattern consistency.
3. All records must be stored in compliance with the company’s document retention policy and made available for review during audits or inspections.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QC: Quality Control
• CAPA: Corrective and Preventive Actions
• PPE: Personal Protective Equipment
• R&D: Research and Development

7. Documents

1. Charging Propellant Log (Annexure-1)
2. In-Process Testing Log (Annexure-2)

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
• International Pharmacopoeia (Ph. Int.) – Aerosol Delivery

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Charging Propellant Log

Batch No.	Propellant Lot No.	Charge Amount	Operator Name	Comments
12345	Propellant Lot A	100g	Rajesh Patel	No issues

Annexure-2: In-Process Testing Log

Test Parameter	Test Result	Tested By	Comments
Pressure	2.5 bar	Rajesh Patel	Within specifications

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 propellant charging process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures