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.
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
- Select representative propellant and container samples for testing.
- Ensure containers are free from surface defects or pre-existing corrosion.
- Record sample details in the Propellant-Container Selection Log (Annexure-1).
5.2. Accelerated Compatibility Testing
- Fill containers with propellant and store them at controlled conditions (e.g., 40°C, 75% RH).
- Conduct periodic visual inspections for corrosion, swelling, or discoloration.
- Record findings in the Accelerated Compatibility Test Log (Annexure-2).
5.3. Chemical
Interaction Analysis
- Analyze container material for leachable substances using GC-MS.
- Test propellant composition before and after exposure to the container.
- Record analytical results in the Chemical Interaction Report (Annexure-3).
5.4. Mechanical Integrity Testing
- Evaluate container pressure retention over time.
- Conduct burst pressure testing to assess structural integrity.
- Record test results in the Mechanical Integrity Test Log (Annexure-4).
5.5. Risk Assessment and Conclusion
- Compare findings against predefined acceptance criteria.
- Identify potential risks such as corrosion, leachables, or loss of pressure.
- 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
- Propellant-Container Selection Log (Annexure-1)
- Accelerated Compatibility Test Log (Annexure-2)
- Chemical Interaction Report (Annexure-3)
- Mechanical Integrity Test Log (Annexure-4)
- 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 |