and ensuring that the cans meet the required specifications.

Maintenance Team: Responsible for maintaining and calibrating the gas-filling equipment to ensure it functions properly and accurately.

Health and Safety Officer: Ensures that safety protocols are followed during the gas filling process, including proper ventilation, PPE, and handling of gas-filled cans.

4. Accountability

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

5. Procedure

5.1. Preparation for Gas Filling

1. Ensure that all equipment needed for the gas-filling process is available, including:
   • Aerosol cans
   • Propellants (gas) required for the formulation
   • Gas filling equipment (e.g., automated gas filling machines)
   • Personal protective equipment (PPE) for operators
2. Inspect all aerosol cans for defects such as dents, cracks, or other physical damage that could cause leakage or affect the sealing process.
3. Ensure that the propellant gas is stored in a secure, controlled environment and is compatible with the formulation in the aerosol can.
4. Ensure that the filling equipment is calibrated and tested according to the required specifications to accurately fill the aerosol cans with the correct volume of propellant.

5.2. Gas Filling Process

1. Place the aerosol cans into the gas filling machine, ensuring that they are properly aligned with the filling nozzles.
2. Start the gas filling machine, which will automatically charge the cans with the correct volume of propellant. The volume should be measured and controlled based on the product specifications.
3. Ensure that the gas is filled at the correct pressure to maintain the integrity of the can and formulation. Overfilling or underfilling should be avoided to prevent leakage or malfunction during use.
4. Monitor the filling machine for consistency in the gas filling process, ensuring that the pressure and flow are within the specified range.

5.3. In-Process Checks

1. Perform regular checks during the gas filling process to ensure the correct amount of propellant is filled. Common checks include:
   • Weight check of the filled cans to ensure the correct propellant amount
   • Visual inspection of the can and valve area to ensure no leakage or improper sealing
   • Pressure checks to ensure the cans are filled to the correct pressure levels
2. Record the results of the in-process checks in the In-Process Testing Log (Annexure-1). If any discrepancies are found (e.g., overfilling, underfilling), halt the process and adjust the equipment settings as necessary.

5.4. Post-Filling Procedure

1. After the gas is filled, check the aerosol cans for defects such as improper sealing, leakage, or valve misalignment.
2. Inspect the filled cans for proper sealing. Ensure that the valve is correctly crimped and securely attached to prevent any gas leakage.
3. If any defects are found, reject the defective cans and document the issue in the Defective Product Log (Annexure-2).
4. Once the cans pass inspection, transfer them to the next stage of the manufacturing process, which may include labeling, packaging, or further testing.

5.5. Safety and Environmental Considerations

1. Ensure that the gas filling process is conducted in a well-ventilated area to prevent the accumulation of flammable vapors from propellants.
2. Operators must wear appropriate PPE, including gloves, safety goggles, and lab coats, to minimize exposure to hazardous materials.
3. Ensure that all safety protocols are followed when handling propellants, including proper storage, transport, and disposal procedures.
4. Ensure that the gas filling machine is maintained regularly and is checked for compliance with safety standards to prevent accidents during operation.

5.6. Documentation and Record-Keeping

1. Document all gas filling activities in the Gas Filling Log (Annexure-3), including the batch number, operator name, gas lot number, and any deviations or corrective actions taken during the process.
2. Ensure that all in-process checks, including weight checks and pressure measurements, are recorded in the In-Process Testing Log (Annexure-1).
3. Store all batch records and logs in compliance with the company’s document retention policy and ensure they are 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. Gas Filling Log (Annexure-3)
2. In-Process Testing Log (Annexure-1)
3. Defective Product 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: In-Process Testing Log

Test Parameter	Test Result	Test Date	Tested By
Weight Check	Pass	06/02/2025	Rajesh Patel

Annexure-2: Defective Product Log

Batch No.	Defect Description	Action Taken	Operator Name
12345	Leakage from valve	Rejected and reprocessed	Rajesh Patel

Annexure-3: Gas Filling Log

Batch No.	Gas Lot No.	Amount of Gas Filled	Operator Name	Comments
12345	Propellant Lot A	150g	Rajesh Patel	No issues

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