Procedure for Maintaining Propellant Purity in Aerosol Manufacturing
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/186/2025 |
| Supersedes | SOP/Aerosol/186/2022 |
| 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 define measures for ensuring the purity of propellants used in aerosol manufacturing. This includes proper storage, handling, and testing to prevent contamination and maintain compliance with industry standards.
2. Scope
This SOP applies to all propellants used in aerosol manufacturing, including liquefied gases and compressed gases, and their storage and handling in production areas.
3. Responsibilities
- Quality Assurance (QA) Team: Responsible for verifying propellant purity compliance.
- Warehouse Team: Responsible for ensuring proper storage conditions.
- Production Team: Responsible for handling and using propellants correctly.
- Quality Control (QC) Team: Responsible for performing analytical testing on propellants.
4. Accountability
The Production Manager is accountable for ensuring propellant purity during storage and manufacturing.
5. Procedure
5.1. Storage Requirements for Propellants
- Store propellants in designated, temperature-controlled areas.
- Ensure propellant storage tanks are sealed and free from contamination.
- Maintain records in the Propellant Storage Log (Annexure-1).
5.2. Handling of Propellants
- Ensure proper grounding and bonding to prevent static discharge.
- Use dedicated pipelines and fittings to transfer propellants.
- Record handling details in the Propellant Handling Log (Annexure-2).
5.3. Testing and Purity Verification
- Perform incoming QC tests for purity, moisture
content, and contaminants.
Conduct periodic sampling as per defined schedules.
Document test results in the Propellant Purity Test Log (Annexure-3).
5.4. Preventing Contamination
- Regularly inspect storage tanks and transfer lines for leaks.
- Ensure all valves and fittings are securely closed when not in use.
- Record contamination checks in the Contamination Prevention Log (Annexure-4).
5.5. Corrective Actions for Impurity Detection
- Segregate and label non-compliant batches.
- Investigate the root cause of impurity and implement corrective measures.
- Record actions taken in the Corrective Action Log (Annexure-5).
6. Abbreviations
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- QC: Quality Control
- SOP: Standard Operating Procedure
7. Documents
- Propellant Storage Log (Annexure-1)
- Propellant Handling Log (Annexure-2)
- Propellant Purity Test Log (Annexure-3)
- Contamination Prevention Log (Annexure-4)
- Corrective Action Log (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- FDA Regulations for Aerosol Propellant Purity
- ISO 9001 – Quality Management Systems
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 Storage Log
| Storage Tank ID | Propellant Type | Inspection Date | Checked By |
|---|---|---|---|
| T-101 | Butane | 07/02/2025 | Rahul Mehta |
Annexure-2: Propellant Handling Log
| Operator Name | Propellant Type | Handling Date | Remarks |
|---|---|---|---|
| Priya Sharma | Propane | 07/02/2025 | Transfer completed |
Annexure-3: Propellant Purity Test Log
| Batch No. | Purity (%) | Moisture Content | Tested By |
|---|---|---|---|
| BN-150 | 99.8% | 0.02% | QA Team |
Annexure-4: Contamination Prevention Log
| Inspection Date | Storage Tank | Observations | Reviewed By |
|---|---|---|---|
| 07/02/2025 | T-102 | No leaks detected | QA Team |
Annexure-5: Corrective Action Log
| Issue Identified | Action Taken | Implementation Date | Approved By |
|---|---|---|---|
| Moisture contamination detected | Filter replacement | 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 testing and contamination prevention measures | GMP Compliance | Anjali Sharma |