and reviewing testing results to verify product quality.

Maintenance Team: Ensures that the leak testing equipment is in proper working condition and performs routine maintenance and calibration of the testing devices.

Health and Safety Officer: Ensures that leak testing procedures are conducted following safety guidelines and that the proper PPE is worn during testing.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the leak testing procedure is followed and that aerosol cans are tested according to the specified criteria. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Testing Preparation

1. Before conducting leak tests, ensure that all aerosol cans are fully filled, crimped, and sealed according to the specified production standards.
2. Ensure that the leak testing equipment is properly calibrated and in good working condition. Check for any malfunctions or inaccuracies in the testing system.
3. Gather the necessary tools and equipment for testing, including the leak tester, air pressure system, and any required PPE such as gloves, goggles, and protective aprons.
4. Ensure that the testing area is clean and free of any obstructions to avoid contamination or interference during testing.

5.2. Conducting the Leak Test

1. Place the filled aerosol can into the leak testing machine according to the manufacturer’s instructions. If performing manual testing, ensure the correct positioning of the can for accurate results.
2. For pressure-based leak tests:
   • Apply a specified air pressure to the can using the testing system.
   • Monitor the can for any signs of pressure loss or hissing sounds indicating a leak in the can, valve, or seal.
   • For automated systems, ensure that the system records the pressure and any variations in pressure over a specified duration to detect leaks.
3. For bubble-based leak tests:
   • Submerge the sealed aerosol can in a water or liquid bath, applying pressure to the can.
   • Look for the presence of bubbles forming around the seal, valve, or other components of the can. The presence of bubbles indicates a leak.
4. If the can passes the test, proceed with the next step in the production process. If the can fails the test, it must be removed from the production line for further inspection and corrective action.

5.3. Post-Testing Actions

1. For failed cans, remove them from the production line immediately and tag them for further investigation or disposal.
2. Document the results of the leak tests, including the number of cans tested, the number of passed and failed tests, and the actions taken on failed cans in the Leak Testing Log (Annexure-1).
3. For automated testing systems, ensure that the results are automatically recorded and stored in the system for future reference and analysis.

5.4. Documentation and Record-Keeping

1. Document all leak testing activities in the Leak Testing Log (Annexure-1), including the date of testing, operator name, test results, and corrective actions taken for failed cans.
2. Ensure that the records are reviewed by the QC team and signed off for compliance verification.
3. Store all leak testing records in the document management system for future reference and audits.

5.5. Calibration and Maintenance of Leak Testing Equipment

1. Perform routine calibration of leak testing equipment to ensure accurate readings. Calibration should be done according to the manufacturer’s instructions and at regular intervals.
2. Conduct preventive maintenance on the leak testing equipment, including cleaning, replacing worn components, and checking for functionality, as outlined in the maintenance schedule.
3. Keep a record of all calibration and maintenance activities in the Equipment Maintenance Log (Annexure-2).

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in the leak testing process wear the appropriate PPE, including gloves, goggles, and protective aprons, to prevent exposure to pressurized cans and potential chemicals.
2. Follow all safety protocols for handling pressurized containers and gas propellants, including proper disposal procedures for failed cans or those with potential safety hazards.
3. Dispose of any waste generated during the leak testing process, such as failed cans or cleaning materials, according to environmental and safety regulations.

6. Abbreviations

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

7. Documents

1. Leak Testing Log (Annexure-1)
2. Equipment Maintenance 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

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Leak Testing Log

Can ID	Test Date	Test Type	Result	Operator Name	Remarks
C-12345	06/02/2025	Pressure Test	Pass	Rajesh Patel	No issues found

Annexure-2: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
LT-123	06/02/2025	Calibrated leak tester	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 leak testing procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures