SOP Guide for Pharma

Aerosol: SOP for Valve Placement and Crimp Testing – V 2.0

Auditor

Aerosol: SOP for Valve Placement and Crimp Testing – V 2.0

SOP for Valve Placement and Crimp Testing

Department Aerosol
SOP No. SOP/Aerosol/072/2025
Supersedes SOP/Aerosol/072/2022
Page No. Page 1 of Y
Issue Date 06/02/2025
Effective Date 16/02/2025
Review Date 06/02/2028

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for valve placement and crimp testing of aerosol products. The objective is to ensure that the valve is correctly positioned and securely crimped onto the aerosol can, preventing leakage and ensuring the product functions as intended. Valve placement and crimp testing are critical to product safety and performance, as they ensure proper dispensing and the integrity of the product packaging.

2. Scope

This SOP applies to all aerosol cans and products filled at [Company Name]. It covers the procedures for valve placement, crimping, and testing to verify that the valves are correctly attached and that the crimping process meets the required specifications for pressure and seal integrity.

3. Responsibilities

4. Accountability

The Manufacturing Manager is accountable for ensuring that valve placement and crimp testing are performed as part of the aerosol filling 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 the aerosol cans are filled and ready for valve placement.
  2. Check that the crimping machine and other equipment are set up properly, according to the required specifications for the can type and valve design.
  3. Prepare the valves and ensure that they meet the required specifications for size, material, and functionality.
  4. Ensure that all testing equipment (e.g., pressure testers) is calibrated and in proper working condition.
  5. Verify that the production line is free from obstructions and that safety measures are in place for handling pressurized cans and operating the crimping equipment.
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5.2. Valve Placement

  1. Place the valve on the aerosol can, ensuring that it is positioned properly according to the design specifications.
  2. Verify that the valve orientation is correct, ensuring that the dispensing nozzle is facing the proper direction for the end user.
  3. Ensure that the valve seating is aligned with the can opening to avoid misalignment during crimping.
  4. Visually inspect the placement of the valve to ensure it is secure and free from defects or contamination.

5.3. Crimping Process

  1. Activate the crimping machine to secure the valve onto the can.
  2. Monitor the crimping operation to ensure that the crimping tool applies uniform pressure to seal the valve onto the can.
  3. Ensure that the crimping force is within the required range to avoid over-crimping (which may cause deformation) or under-crimping (which may result in leakage).
  4. For automated systems, ensure that the system performs the crimping consistently with the correct pressure and alignment.
  5. Perform a visual inspection of the crimped valve to ensure that there are no visible defects, such as incomplete seals or crooked valves.

5.4. Crimp Testing

  1. Perform crimp testing on a sample of the crimped cans to verify that the valve is securely attached to the can and that there are no leaks. This can be done using a pressure test or by applying a specified torque to the valve.
  2. If performing a pressure test:
    • Seal the can in a pressure testing chamber and increase the internal pressure to the specified test value.
    • Monitor the can for any signs of leakage or deformation, which would indicate that the crimping process was unsuccessful.
    • Record the results of the pressure test in the Crimp Test Log (Annexure-1).
  3. If performing a torque test:
    • Apply a torque to the crimped valve and measure the amount of force required to loosen it. This test ensures that the crimping process has achieved the required seal strength.
    • Record the torque values and compare them against the specified acceptable range.
  4. If the can fails the crimp test (e.g., leakage or inadequate seal strength), remove the can from the production line and label it as “non-conforming.” Investigate the cause of the failure and take corrective actions as necessary.
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5.5. Post-Test Actions

  1. If the crimping test results are within acceptable limits:
    • Proceed with the next step in the production process, ensuring that all cans meet the crimping and sealing requirements.
    • Document the test results, including the can ID, test date, operator name, and crimp test results, in the Crimp Test Log (Annexure-1).
  2. If the crimping test results are outside the acceptable limits:
    • Investigate the root cause of the failure (e.g., improper machine settings, incorrect valve placement, or defective valves).
    • Take corrective action, such as adjusting the machine settings, replacing faulty components, or improving operator training.
    • Document the corrective actions taken and the test results in the Corrective Action Log (Annexure-2).

5.6. Calibration and Maintenance of Equipment

  1. Ensure that the crimping machine and pressure testing equipment are calibrated regularly, according to the manufacturer’s recommendations and company procedures.
  2. Perform routine maintenance on crimping machines and pressure testing systems, including cleaning, checking for wear, and replacing any faulty components that could affect the accuracy and consistency of the tests.
  3. Document all calibration and maintenance activities in the Equipment Calibration Log (Annexure-3) and the Equipment Maintenance Log (Annexure-4).

5.7. Documentation and Record-Keeping

  1. Document all valve placement and crimp testing activities, including the can ID, test date, test results, and operator name, in the Crimp Test Log (Annexure-1).
  2. Ensure that all records are reviewed by the QC team to confirm that the aerosol products meet the required crimping specifications and safety standards.
  3. Store all records in the document management system, ensuring they are available for future reference and audits.
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5.8. Safety and Environmental Considerations

  1. Ensure that all personnel involved in valve placement and crimping wear appropriate PPE, including gloves, goggles, and lab coats, to prevent exposure to aerosol products and equipment.
  2. Follow safety guidelines for handling pressurized aerosol cans and crimping machinery to avoid accidents during the testing process.
  3. Ensure proper disposal of any waste generated during the testing process, including non-conforming cans and used materials, according to environmental and safety regulations.

6. Abbreviations

7. Documents

  1. Crimp 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:

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Crimp Test Log

Can ID Test Date Test Method Result Operator Name Remarks
C-12345 06/02/2025 Pressure Test 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 Leaking valve Replaced valve and recalibrated machine Rajesh Patel

Annexure-3: Equipment Calibration Log

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

Annexure-4: Equipment Maintenance Log

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