Aerosol: SOP for Conducting Pre-Fill Leak Tests – V 2.0

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Aerosol: SOP for Conducting Pre-Fill Leak Tests – V 2.0

SOP for Conducting Pre-Fill Leak Tests

Department Aerosol
SOP No. SOP/Aerosol/033/2025
Supersedes SOP/Aerosol/033/2022
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) defines the process for conducting pre-fill leak tests on aerosol cans prior to the filling process. The purpose of this SOP is to ensure that cans are free of defects, such as leaks, which could lead to product loss, contamination, or malfunction during use. The goal is to identify defective cans before they are filled with product, ensuring that only properly sealed cans are used in production.

2. Scope

This SOP applies to all aerosol cans used in production at [Company Name]. It covers the procedures for performing pre-fill leak tests on cans before they are filled with product. This SOP does not cover the inspection of the cans after filling or during packaging, which are addressed in other procedures.

3. Responsibilities

  • Production Team: Responsible for performing pre-fill leak tests on aerosol cans, ensuring that they are free from defects, and properly recording the test results.
  • Quality Control (QC) Team: Responsible for verifying the effectiveness of the leak test process through sampling, visual inspection, and validation of test results.
  • Maintenance Team: Responsible for ensuring that the leak testing equipment is properly maintained, calibrated, and in good working condition.
  • Health and Safety Officer: Ensures that safety protocols are followed, particularly in relation to the handling of potentially hazardous chemicals, propellants, and equipment.

4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed and that pre-fill leak tests are conducted effectively. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

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5. Procedure

5.1. Preparation for Pre-Fill Leak Test

  1. Ensure that all aerosol cans are properly inspected before starting the pre-fill leak test. This includes verifying that the cans are free of visible damage (e.g., dents, cracks, or deformities) that could affect the leak testing process.
  2. Ensure that all necessary equipment for leak testing is available, including the leak tester, gas supply (if applicable), and PPE for operators (e.g., gloves, safety goggles).
  3. Check that the leak tester is calibrated and functioning according to the manufacturer’s instructions. If necessary, perform a test cycle using a known good can to verify the equipment’s accuracy.

5.2. Performing the Pre-Fill Leak Test

  1. Place each can into the leak testing equipment one at a time. Ensure that the can is correctly positioned and sealed in the test fixture to prevent any air or gas from escaping during the test.
  2. Activate the leak testing equipment. Common testing methods include:
    • Vacuum leak testing: A vacuum is created inside the can, and the equipment detects any change in pressure, which would indicate a leak.
    • Pressure leak testing: A small amount of pressurized air or gas is introduced into the can, and the equipment monitors for any drop in pressure that would indicate a leak.
    • Bubble leak testing: The can is submerged in a liquid solution, and the appearance of bubbles indicates a leak.
  3. Monitor the test results for each can. If the can shows any signs of leakage, remove it from the testing fixture and set it aside for rejection. Record the results in the Pre-Fill Leak Test Log (Annexure-1).
  4. For cans that pass the test, proceed to the next step in the filling process. For cans that fail, inspect them for possible causes of leakage, such as valve defects, improper can sealing, or structural issues.
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5.3. Handling Defective Cans

  1. If a can fails the leak test, remove it from the production line and place it in a designated rejection area.
  2. Investigate the cause of the defect, such as:
    • Improper sealing of the valve or can body
    • Defects in the can material
    • Improper handling during previous manufacturing stages
  3. Tag the defective can with the appropriate information (batch number, reason for rejection, etc.) and document it in the Defective Product Log (Annexure-2).
  4. Rework or dispose of the defective can according to company procedures and regulatory guidelines.

5.4. In-Process Monitoring and Quality Control

  1. During the leak testing process, perform periodic checks to ensure that the testing equipment is functioning properly and that all cans are being tested correctly.
  2. Verify that the test parameters (e.g., pressure, vacuum, or test time) are set according to the product’s specifications and that they are being maintained consistently throughout the test.
  3. Randomly sample a group of passed cans for additional testing, if necessary, to ensure that the leak test process is operating effectively.
  4. Record all test results, including any failed cans, corrective actions taken, and equipment performance, in the Pre-Fill Leak Test Log (Annexure-1) and the Defective Product Log (Annexure-2).

5.5. Post-Test Procedures

  1. Once the pre-fill leak test is complete, ensure that all equipment is properly shut down, cleaned, and stored according to the manufacturer’s guidelines and company procedures.
  2. Verify that all defective cans have been appropriately documented and either reworked or discarded.
  3. Transfer the passed cans to the next stage of the filling process, ensuring they are correctly labeled and handled to prevent any damage or contamination.
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5.6. Documentation and Record-Keeping

  1. Ensure that all pre-fill leak test results, including passed and failed cans, corrective actions, and equipment settings, are documented in the Pre-Fill Leak Test Log (Annexure-1).
  2. Maintain the Defective Product Log (Annexure-2) for any rejected cans, detailing the reason for rejection and corrective measures taken.
  3. Store all records according to the company’s document retention policy and ensure they are available for audits or inspections as required by regulatory agencies.

6. Abbreviations

  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • CAPA: Corrective and Preventive Actions
  • PPE: Personal Protective Equipment
  • R&D: Research and Development

7. Documents

  1. Pre-Fill Leak Test Log (Annexure-1)
  2. Defective Product 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
  • International Pharmacopoeia (Ph. Int.) – Aerosol Delivery

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Pre-Fill Leak Test Log

Batch No. Test Result Test Date Operator Name Test Method
12345 Pass 06/02/2025 Rajesh Patel Vacuum Test

Annexure-2: Defective Product Log

Batch No. Defect Description Action Taken Operator Name
12345 Leakage detected Reworked and resealed 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 leak testing procedures To comply with updated GMP regulations Anjali Sharma Page 1 [Ref Point] Updated procedures
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