testing machine is correctly calibrated and that the test results meet the required specifications for aerosol valves.

Health and Safety Officer: Ensures that proper safety precautions are followed during calibration, particularly when dealing with pressurized equipment.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that the aerosol valve testing machine is properly calibrated. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Pre-Calibration Checks

1. Ensure that the valve testing machine is in a clean and operational state, free from any debris or contamination that could affect calibration accuracy.
2. Verify that all components, including the pressure regulator, valve fittings, and test chambers, are in place and functioning properly.
3. Check that the machine is receiving the correct power supply and that all control panels are functional.
4. Ensure that the testing machine is set to the correct temperature, pressure, and other relevant parameters for the valve type being tested.
5. Inspect the calibration equipment, such as reference pressure gauges and calibration standards, to ensure that they are accurate and within their calibration validity period.
6. Log the pre-calibration checks in the Calibration Check Log (Annexure-1).

5.2. Calibrating the Valve Testing Machine

1. Begin the calibration process by powering up the valve testing machine and accessing the calibration settings on the control panel.
2. Set the machine to the calibration mode and select the appropriate valve type and testing parameters (e.g., leak pressure, seal pressure, testing cycle duration).
3. Connect the reference calibration equipment, such as a calibrated pressure gauge or flow meter, to the test chamber or valve fitting to ensure accurate measurements during calibration.
4. Activate the machine and allow it to complete a test cycle for the valve. During the cycle, compare the test results to the reference equipment measurements. The valve testing machine’s readings should match or be within an acceptable tolerance of the reference measurements.
5. If discrepancies are found between the machine readings and the reference equipment, adjust the machine’s calibration settings according to the manufacturer’s instructions. Ensure that the calibration is within the acceptable tolerance limits as defined in the product specifications.
6. Repeat the test to verify that the machine is correctly calibrated and that the results are consistent with the reference measurements.
7. Document the calibration results, including the valve type, test conditions, any adjustments made, and the final calibration values in the Calibration Log (Annexure-2).

5.3. Post-Calibration Checks

1. After calibration is complete, conduct a series of test runs using sample valves to ensure that the machine is functioning properly and producing accurate results.
2. Check the consistency and quality of the test results to confirm that the machine is operating within the required specifications.
3. If any discrepancies or irregularities are found, investigate the issue and take corrective actions. If necessary, re-calibrate the machine and repeat the testing process.
4. Log all post-calibration checks and any corrective actions taken in the Post-Calibration Report (Annexure-3).

5.4. Routine and Preventive Calibration Checks

1. Perform routine calibration checks at specified intervals (e.g., monthly, quarterly) or whenever there is a significant change in the machine’s performance or environmental conditions that could affect calibration accuracy.
2. Follow the same calibration process as outlined in Section 5.2, ensuring that all relevant checks are performed and documented.
3. Perform preventive maintenance to ensure that the valve testing machine remains in good working condition and that all components remain calibrated. Preventive actions may include replacing worn parts, recalibrating sensors, or upgrading calibration equipment as necessary.
4. Record all routine and preventive maintenance activities in the Calibration Maintenance Log (Annexure-4).

5.5. Troubleshooting Calibration Issues

1. If the valve testing machine fails to calibrate properly or exhibits inconsistent results, follow the troubleshooting guidelines outlined in the machine’s manual.
2. Common issues may include:
   • Incorrect sensor readings
   • Pressure discrepancies
   • Leakage in the test chamber
3. If troubleshooting does not resolve the issue, contact the manufacturer’s support team or schedule an in-depth inspection by the Maintenance Team.
4. Document any issues encountered during calibration and the steps taken to resolve them in the Troubleshooting Log (Annexure-5).

5.6. Documentation and Record-Keeping

1. Ensure that all calibration activities are accurately documented, including pre-calibration checks, calibration results, post-calibration checks, and any corrective or preventive actions taken.
2. Maintain all calibration records according to the company’s document retention policy, ensuring that they are available for audits and regulatory inspections.
3. Review the calibration documentation regularly to ensure compliance with GMP standards and to identify any trends or recurring issues that may require further investigation.

6. Abbreviations

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

7. Documents

1. Calibration Check Log (Annexure-1)
2. Calibration Log (Annexure-2)
3. Post-Calibration Report (Annexure-3)
4. Calibration Maintenance Log (Annexure-4)
5. Troubleshooting Log (Annexure-5)

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: Calibration Check Log

Machine ID	Check Description	Operator Name	Date & Time	Remarks
VTM-001	Checked pressure sensor accuracy	Rajesh Patel	06/02/2025	Passed

Annexure-2: Calibration Log

Machine ID	Calibration Results	Operator Name	Calibration Date	Calibration Standards Used
VTM-001	Pressure: 5 bar, Flow Rate: 2L/min	Rajesh Patel	06/02/2025	ISO 9001 Certified

Annexure-3: Post-Calibration Report

Machine ID	Post Calibration Results	Test Parameters	Operator Name
VTM-001	Passed all test criteria	Pressure, Flow Rate	Rajesh Patel

Annexure-4: Calibration Maintenance Log

Maintenance Type	Details	Performed By	Date
Lubrication	Lubricated valve testing components	Rajesh Patel	06/02/2025

Annexure-5: Troubleshooting Log

Machine ID	Issue	Action Taken	Operator Name
VTM-001	Calibration error	Recalibrated pressure sensor	Rajesh Patel

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