SOP Guide for Pharma

Aerosol: SOP for Propellant Compatibility Testing with Container Materials – V 2.0

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Aerosol: SOP for Propellant Compatibility Testing with Container Materials – V 2.0

Procedure for Propellant Compatibility Testing with Aerosol Container Materials

Department Aerosol
SOP No. SOP/Aerosol/195/2025
Supersedes SOP/Aerosol/195/2022
Page No. Page 1 of Y
Issue Date 06/02/2025
Effective Date 16/02/2025
Review Date 06/02/2028

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a validated procedure for assessing the compatibility of propellants with aerosol container materials to prevent degradation, contamination, or loss of product integrity.

2. Scope

This SOP applies to all propellant-container combinations used in aerosol formulations, including aluminum, tinplate, stainless steel, and coated containers.

3. Responsibilities

  • Quality Control (QC) Analysts: Responsible for performing compatibility testing.
  • Quality Assurance (QA) Team: Responsible for reviewing and approving test results.
  • Research and Development (R&D) Team: Responsible for developing compatibility study protocols.
  • Regulatory Affairs Team: Responsible for ensuring compliance with global safety and material compatibility standards.
See also  Aerosol: SOP for Safety Measures in Handling Aerosol Propellants - V 2.0

4. Accountability

The Quality Control Manager is accountable for ensuring the accuracy, reliability, and documentation of compatibility testing.

5. Procedure

5.1. Selection of Test Samples

  1. Select representative propellant and container samples for testing.
  2. Ensure containers are free from surface defects or pre-existing corrosion.
  3. Record sample details in the Propellant-Container Selection Log (Annexure-1).

5.2. Accelerated Compatibility Testing

  1. Fill containers with propellant and store them at controlled conditions (e.g., 40°C, 75% RH).
  2. Conduct periodic visual inspections for corrosion, swelling, or discoloration.
  3. Record findings in the Accelerated Compatibility Test Log (Annexure-2).

5.3. Chemical

Interaction Analysis
  1. Analyze container material for leachable substances using GC-MS.
  2. Test propellant composition before and after exposure to the container.
  3. Record analytical results in the Chemical Interaction Report (Annexure-3).

5.4. Mechanical Integrity Testing

  1. Evaluate container pressure retention over time.
  2. Conduct burst pressure testing to assess structural integrity.
  3. Record test results in the Mechanical Integrity Test Log (Annexure-4).

5.5. Risk Assessment and Conclusion

  1. Compare findings against predefined acceptance criteria.
  2. Identify potential risks such as corrosion, leachables, or loss of pressure.
  3. Document final conclusions in the Compatibility Study Report (Annexure-5).

6. Abbreviations

  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • GC-MS: Gas Chromatography-Mass Spectrometry
  • RH: Relative Humidity
  • SOP: Standard Operating Procedure

7. Documents

  1. Propellant-Container Selection Log (Annexure-1)
  2. Accelerated Compatibility Test Log (Annexure-2)
  3. Chemical Interaction Report (Annexure-3)
  4. Mechanical Integrity Test Log (Annexure-4)
  5. Compatibility Study Report (Annexure-5)

8. References

  • Good Manufacturing Practice (GMP) Guidelines
  • ISO 10993 – Biocompatibility Testing for Materials
  • FDA Guidelines on Aerosol Propellant Compatibility

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Propellant-Container Selection Log

Propellant Type Container Material Batch No. Checked By
HFA-134a Aluminum PC-101 QA Team

Annexure-2: Accelerated Compatibility Test Log

Sample ID Storage Condition Observation Period Reviewed By
PC-101 40°C, 75% RH 30 Days QA Team

Annexure-3: Chemical Interaction Report

Propellant Type Leachable Detected Regulatory Limit Approved By
HFA-152a None Below Limit QA Team

Annexure-4: Mechanical Integrity Test Log

Container Type Initial Pressure (PSI) Final Pressure (PSI) Reviewed By
Aluminum 120 118 QA Team

Annexure-5: Compatibility Study Report

Propellant Type Container Material Compatibility Status Approved By
HFA-134a Aluminum Compatible QA Team

12. Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 V 1.0 Initial Release First Issue Anjali Sharma
01/01/2025 V 2.0 Updated compatibility test parameters GMP Compliance Anjali Sharma
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