respect to handling pressurized cans and avoiding accidents during testing.

Maintenance Team: Responsible for ensuring that the testing equipment, such as pressure testing machines or chambers, is calibrated and properly maintained for accurate results.

4. Accountability

The Manufacturing Manager is accountable for ensuring that pressure testing is conducted on all aerosol cans. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Test Preparation

1. Ensure that the aerosol cans to be tested are fully filled and crimped according to product specifications.
2. Prepare the testing equipment, including:
   • Pressure testing chamber or pressure gauge system
   • Control valves for pressurization
   • Appropriate PPE, such as gloves, goggles, and lab coats
3. Inspect the pressure testing equipment to ensure it is clean, calibrated, and in good working condition. Verify that all safety features of the testing equipment are functioning properly.
4. Ensure that the testing area is free from obstructions and that proper ventilation is in place to handle potential accidents or leaks during testing.

5.2. Conducting the Pressure Test

1. Place the aerosol can securely inside the pressure testing chamber or connect it to the pressure testing system.
2. Apply the specified pressure to the can using the testing system, typically increasing the pressure to a level that is higher than the normal operating pressure but within the can’s safe tolerance limits.
3. Monitor the can for any signs of deformation, leakage, or failure during the test. Common failure points include the can’s seams, valve, and crimping areas.
4. For automated systems, ensure that the system automatically records the test data, including the applied pressure, time duration, and the results (pass or fail).
5. If performing manual testing, use a pressure gauge to verify that the pressure is stable and monitor for any loss of pressure that could indicate a leak or failure in the can.
6. After reaching the test pressure, hold the pressure for a specified time (e.g., 10 seconds) and then gradually release the pressure to observe the can’s ability to return to its normal state without any permanent deformation or damage.

5.3. Post-Test Actions

1. If the can passes the test:
   • Proceed with the next step in the production process, ensuring that all cans are within the required pressure tolerance.
   • Document the test results, including the can ID, test pressure, time, and operator name, in the Pressure Test Log (Annexure-1).
2. If the can fails the test (e.g., leakage, excessive deformation, rupture), remove the can from the production line and label it as “non-conforming.” The failed can should be set aside for further investigation to determine the cause of the failure.
3. Notify the Quality Control (QC) team and relevant personnel if a failure occurs, and take corrective action as needed. Document the corrective actions taken to address the failure in the Corrective Action Log (Annexure-2).

5.4. Calibration and Maintenance of Equipment

1. Ensure that the pressure testing equipment is calibrated at regular intervals according to the manufacturer’s specifications and company procedures.
2. Perform routine maintenance on pressure testing machines, including cleaning, checking for wear, and replacing any faulty components to maintain the accuracy and reliability of the test results.
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 pressure testing activities, including the test results, can ID, test pressure, operator name, and any deviations or corrective actions taken, in the Pressure Test Log (Annexure-1).
2. Ensure that all records are reviewed by the QC team to confirm that all cans have passed the pressure test and are safe for use in production.
3. Store all records in the document management system, ensuring that they are available for future reference and audits.

5.6. Safety and Environmental Considerations

1. Ensure that all personnel involved in pressure testing wear the appropriate PPE, including gloves, goggles, and lab coats, to prevent injury during testing.
2. Conduct all pressure testing in a well-ventilated area, preferably with a fume hood or proper exhaust system to manage any hazardous gas release.
3. In case of any leakage or rupture, ensure proper emergency procedures are in place to handle potential safety risks, such as using fire extinguishers or isolating the area as needed.
4. Dispose of any waste materials, such as failed cans or hazardous materials from the testing process, 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. Pressure Test 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: Pressure Test Log

Can ID	Test Date	Test Pressure (psi)	Result	Operator Name	Remarks
C-12345	06/02/2025	100 psi	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	Leak detected	Returned to production for inspection	Rajesh Patel

Annexure-3: Equipment Calibration Log

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

Annexure-4: Equipment Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Operator Name	Remarks
PRESS-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 container pressure testing procedure	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures