SOP Guide for Pharma

Aerosol: SOP for Quality Check During Propellant Filling – V 2.0

Auditor

Aerosol: SOP for Quality Check During Propellant Filling – V 2.0

SOP for Quality Check During Propellant Filling

Department Aerosol
SOP No. SOP/Aerosol/026/2025
Supersedes SOP/Aerosol/026/2022
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 quality checks during the propellant filling stage of aerosol manufacturing. The objective is to ensure that the correct amount of propellant is accurately filled into each can while maintaining product quality, consistency, and safety. This procedure ensures that the gas filling process is monitored, deviations are detected, and corrective actions are implemented as necessary to comply with GMP standards.

2. Scope

This SOP applies to all aerosol products manufactured at [Company Name] that require propellant filling. It includes the quality checks to be performed during the gas filling process, ensuring that the propellant is accurately filled and that the aerosol cans are free from defects. This SOP does not cover the preparation or storage of propellants or the post-filling inspection, which are addressed in separate procedures.

3. Responsibilities

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4. Accountability

The Manufacturing Manager is accountable for ensuring that this SOP is followed during the propellant filling process. The overall compliance with this SOP is under the supervision of the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparation for Quality Check

  1. Ensure that all materials, equipment, and tools required for the quality checks are available:
    • Filled aerosol cans
    • Propellant gases (according to formulation specifications)
    • Weighing scales, measurement tools, and testing equipment (e.g., pressure gauges, spray pattern testers)
    • Personal protective equipment (PPE) for operators
  2. Verify that the filling equipment is calibrated and functioning properly. Ensure that the gas supply, filling machine, and valve crimping systems are operating according to specifications.
  3. Confirm that the operator is trained and understands the importance of accurate filling, proper crimping, and the use of safety measures during propellant handling.

5.2. Quality Check During Propellant Filling

  1. During the propellant filling process, perform the following quality checks:
    • Weight Check: Measure the weight of a sample of filled aerosol cans to verify that the correct amount of propellant has been added. The weight should meet the product’s specified fill volume.
    • Pressure Check: Measure the internal pressure of the filled cans to ensure it falls within the acceptable range for the formulation and propellant type.
    • Seal Integrity Check: Visually inspect the cans to ensure the valve is securely crimped and there are no signs of leakage around the valve.
    • Spray Pattern and Actuation Check: Check the spray pattern and actuation of a sample of cans to verify that the valve functions correctly and that the aerosol is dispensed properly.
  2. Record all test results in the In-Process Testing Log (Annexure-1). If any discrepancies are detected, investigate the root cause and take corrective actions immediately.
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5.3. Handling Deviations

  1. If any deviation is found during the quality check (e.g., underfilling, overfilling, leakage), stop the filling process and take the following actions:
    • Identify the root cause of the deviation, which could include equipment malfunction, incorrect settings, or improper filling procedures.
    • Adjust the equipment settings (e.g., filling pressure, speed) or re-calibrate the filling machine as needed.
    • Perform additional checks to verify that the issue has been corrected before resuming production.
    • Document the deviation and corrective actions taken in the Filling Deviation Log (Annexure-2).

5.4. Post-Filling Quality Checks

  1. Once the propellant has been filled, conduct a final inspection to verify that the cans are sealed properly and that there is no evidence of leakage or misalignment of the valve system.
  2. Perform final checks on a sample of filled cans, including weight checks, spray pattern testing, and valve inspection.
  3. Document the results of the final quality checks in the Final Quality Check Log (Annexure-3).
  4. Approved cans should be transferred to the next stage of production for labeling or packaging. Reject any defective cans and document the issue in the Defective Product Log (Annexure-4).

5.5. Safety and Environmental Considerations

  1. Ensure that the propellant filling process is carried out in a well-ventilated area to prevent the accumulation of potentially hazardous fumes.
  2. Operators should wear appropriate PPE, including gloves, goggles, and lab coats, to minimize exposure to propellant gases and any other potentially hazardous materials.
  3. Ensure that the filling area is free from any potential ignition sources and that all safety protocols are followed to prevent accidents or spills.

5.6. Documentation and Record-Keeping

  1. Document all quality checks performed during the propellant filling process in the In-Process Testing Log (Annexure-1), including the weight, pressure, and spray pattern test results.
  2. Record any deviations and corrective actions in the Filling Deviation Log (Annexure-2) and the Defective Product Log (Annexure-4).
  3. Store all batch records and logs according to the company’s document retention policy, ensuring they are available for future audits or inspections.
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6. Abbreviations

7. Documents

  1. In-Process Testing Log (Annexure-1)
  2. Filling Deviation Log (Annexure-2)
  3. Final Quality Check Log (Annexure-3)
  4. Defective Product 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: In-Process Testing Log

Test Parameter Test Result Test Date Tested By
Weight Check Pass 06/02/2025 Rajesh Patel

Annexure-2: Filling Deviation Log

Batch No. Deviation Description Corrective Action Operator Name
12345 Overfill detected Adjusted filling machine settings Rajesh Patel

Annexure-3: Final Quality Check Log

Batch No. Test Parameter Test Result Operator Name Comments
12345 Spray Pattern Pass Rajesh Patel No issues

Annexure-4: Defective Product Log

Batch No. Defect Description Action Taken Operator Name
12345 Leakage from valve Rejected and reprocessed 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 quality check process To comply with updated GMP regulations Anjali Sharma Page 1 [Ref Point] Updated procedures
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