Procedure for Monitoring Propellant Loss in Stored Aerosol Products
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/196/2025 |
| Supersedes | SOP/Aerosol/196/2022 |
| 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 systematic approach for checking and monitoring propellant loss in stored aerosol products to ensure product stability, efficacy, and compliance with regulatory requirements.
2. Scope
This SOP applies to all aerosol products stored under controlled conditions, including batch stability studies and routine storage monitoring.
3. Responsibilities
- Quality Control (QC) Analysts: Responsible for conducting propellant loss testing.
- Quality Assurance (QA) Team: Responsible for reviewing and approving test results.
- Warehouse Team: Responsible for ensuring proper storage conditions.
- Regulatory Affairs Team: Responsible for ensuring compliance with storage stability regulations.
4. Accountability
The Quality Control Manager is accountable for ensuring proper monitoring of propellant loss and compliance with stability requirements.
5. Procedure
5.1. Sample Selection and Storage Conditions
- Select aerosol cans from different production batches.
- Store them under standard and accelerated stability conditions (e.g., 25°C/60% RH, 40°C/75% RH).
- Record details in the Propellant Stability Sample Log (Annexure-1).
5.2. Initial Weight Measurement
- Weigh each selected aerosol container before storage.
- Record initial weights in the Initial Weight Log (Annexure-2).
5.3. Periodic Weight Monitoring
- Weigh stored samples at predefined intervals (e.g., 1 month, 3 months, 6
months).
Compare the recorded weights with initial measurements.
Record weight changes in the Propellant Loss Monitoring Log (Annexure-3).
5.4. Propellant Leakage Testing
- Perform leakage testing using gas chromatography or pressure decay methods.
- Identify cans with significant loss (>2% of initial weight).
- Document findings in the Propellant Leakage Test Log (Annexure-4).
5.5. Corrective Actions for High Propellant Loss
- Investigate the root cause (e.g., valve defects, improper crimping).
- Implement corrective actions such as improved sealing or formulation adjustments.
- Record corrective measures in the Propellant Loss Corrective Action Log (Annexure-5).
6. Abbreviations
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- RH: Relative Humidity
- SOP: Standard Operating Procedure
7. Documents
- Propellant Stability Sample Log (Annexure-1)
- Initial Weight Log (Annexure-2)
- Propellant Loss Monitoring Log (Annexure-3)
- Propellant Leakage Test Log (Annexure-4)
- Propellant Loss Corrective Action Log (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- ICH Q1A Stability Testing Guidelines
- FDA Aerosol Product Stability Requirements
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 Stability Sample Log
| Batch No. | Sample ID | Storage Condition | Checked By |
|---|---|---|---|
| BN-240 | SPL-301 | 25°C/60% RH | QA Team |
Annexure-2: Initial Weight Log
| Sample ID | Initial Weight (g) | Weighed By | Date |
|---|---|---|---|
| SPL-301 | 150.5 | QA Team | 07/02/2025 |
Annexure-3: Propellant Loss Monitoring Log
| Sample ID | Time Point | Weight (g) | Change (%) | Reviewed By |
|---|---|---|---|---|
| SPL-301 | 3 Months | 149.8 | -0.46% | QA Team |
Annexure-4: Propellant Leakage Test Log
| Sample ID | Test Method | Leakage Detected | Reviewed By |
|---|---|---|---|
| SPL-302 | Gas Chromatography | No | QA Team |
Annexure-5: Propellant Loss Corrective Action Log
| Issue Identified | Corrective Action | Implementation Date | Approved By |
|---|---|---|---|
| Excessive Propellant Loss | Valve Redesign | 08/02/2025 | Anjali Sharma |
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 monitoring procedures | GMP Compliance | Anjali Sharma |