to handling pressurized cans and hazardous propellants.

Maintenance Team: Responsible for ensuring that the equipment used for propellant filling, such as filling machines and pressure gauges, is calibrated and maintained for accurate results.

4. Accountability

The Manufacturing Manager is accountable for ensuring that propellant-filling checks are performed during the aerosol manufacturing process. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Test Preparation

1. Ensure that all aerosol cans are properly positioned and secured on the filling line before propellant filling begins.
2. Verify that the correct type and amount of propellant are available for filling, and that the propellant storage tank is properly pressurized and free from contamination.
3. Prepare necessary equipment, including:
   • Filling machine
   • Propellant storage tank
   • Pressure gauges and monitoring systems
   • PPE, including gloves, goggles, and lab coats
4. Ensure that the production line is free from obstructions and that all safety measures are in place to handle pressurized aerosol cans and propellants.

5.2. Conducting Propellant-Filling Checks

1. Start the propellant-filling process and monitor the filling machine to ensure that each aerosol can is filled with the correct amount of propellant.
2. For automated systems:
   • Ensure that the automated system correctly measures and adjusts the amount of propellant filled in each can.
   • Monitor the system’s display to ensure that the propellant level is within the acceptable range.
3. For manual systems:
   • Use a calibrated pressure gauge or scale to monitor the amount of propellant being filled into each can.
   • Weigh or measure the propellant amount for each can and compare it with the specified target fill amount.
4. Perform random checks on filled cans to ensure that the propellant levels meet the required specifications. Typically, one in every ten cans should be tested to verify consistency.
5. If a can is found to have too little or too much propellant, document the result and investigate the cause of the discrepancy.

5.3. Post-Test Actions

1. If the propellant levels are within acceptable tolerance limits:
   • Continue the filling process and document the results in the Propellant-Filling Log (Annexure-1).
   • Ensure that the records are reviewed by the QC team for accuracy and compliance.
2. If the propellant levels are outside the acceptable limits (e.g., overfilled or underfilled):
   • Remove the affected cans from the production line and label them as “non-conforming.”
   • Investigate the cause of the deviation (e.g., malfunctioning filling equipment, incorrect machine settings).
   • Take corrective actions as necessary, such as adjusting the machine settings or recalibrating the filling equipment.
   • Document the corrective actions in the Corrective Action Log (Annexure-2).

5.4. Calibration and Maintenance of Equipment

1. Ensure that the filling equipment, pressure gauges, and other measurement instruments are calibrated according to the manufacturer’s specifications and company procedures.
2. Perform routine maintenance on filling machines and pressure monitoring equipment to ensure that they remain in good working condition and continue to provide accurate readings.
3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-3) and the Equipment Maintenance Log (Annexure-4).

5.5. Documentation and Record-Keeping

1. Document all propellant-filling activities, including the can ID, test date, propellant fill level, operator name, and any corrective actions taken, in the Propellant-Filling Log (Annexure-1).
2. Ensure that all records are reviewed by the QC team to confirm that the aerosol products meet the required propellant fill specifications.
3. Store all records in the document management system, ensuring they are available for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in the propellant-filling process wear the appropriate PPE, including gloves, goggles, and lab coats, to prevent exposure to pressurized propellants.
2. Conduct all propellant-filling activities in a well-ventilated area, preferably with an exhaust system to handle propellant vapors.
3. Ensure proper disposal of any waste generated during the filling process, including non-conforming cans and excess propellant, according to safety and environmental regulations.

6. Abbreviations

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

7. Documents

1. Propellant-Filling Log (Annexure-1)
2. Corrective Action Log (Annexure-2)
3. Equipment Calibration Log (Annexure-3)
4. Equipment Maintenance Log (Annexure-4)

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-Filling Log

Can ID	Test Date	Propellant Fill Level (ml)	Result	Operator Name	Remarks
C-12345	06/02/2025	100 ml	Pass	Rajesh Patel	No issues found

Annexure-2: Corrective Action Log

Can ID	Issue Date	Issue Description	Corrective Action	Operator Name
C-12346	06/02/2025	Underfilled	Adjusted machine settings	Rajesh Patel

Annexure-3: Equipment Calibration Log

Equipment ID	Calibration Date	Calibration Results	Operator Name	Remarks
FILL-001	06/02/2025	Pass	Rajesh Patel	No adjustments required

Annexure-4: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
FILL-001	06/02/2025	Cleaned and calibrated	Rajesh Patel	No issues found

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-filling check procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures