Procedure for Cleaning Validation of Storage Tanks in Aerosol Manufacturing
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/187/2025 |
| Supersedes | SOP/Aerosol/187/2022 |
| 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 cleaning procedure for storage tanks used in aerosol product manufacturing. The cleaning validation ensures that no residual contaminants remain that could compromise product quality and safety.
2. Scope
This SOP applies to all storage tanks used for storing raw materials, excipients, and propellants in aerosol manufacturing.
3. Responsibilities
- Production Team: Responsible for performing routine cleaning of storage tanks.
- Quality Control (QC) Team: Responsible for verifying and sampling after cleaning.
- Quality Assurance (QA) Team: Responsible for approving the cleaning validation process.
- Maintenance Team: Responsible for maintaining cleaning equipment and ensuring its functionality.
4. Accountability
The Quality Assurance Manager is accountable for ensuring that all storage tanks meet cleaning validation requirements.
5. Procedure
5.1. Cleaning Procedure for Storage Tanks
- Ensure all product residues are drained from the storage tank.
- Use an approved cleaning agent to clean internal surfaces.
- Rinse the tank with purified water to remove any detergent residues.
- Perform a final rinse with deionized water.
- Record all cleaning activities in the Tank Cleaning Log (Annexure-1).
5.2. Cleaning Validation Process
- After cleaning, collect swab samples from
different areas of the tank.
Test swab samples for residual contaminants.
Ensure that no detectable residue remains within specified limits.
Document validation results in the Cleaning Validation Report (Annexure-2).
5.3. Frequency of Cleaning
- Conduct routine cleaning after each batch.
- Perform deep cleaning at least once a month.
- Maintain a record of all cleaning schedules in the Cleaning Schedule Log (Annexure-3).
5.4. Equipment and Cleaning Agents
- Use validated cleaning solutions as per approved SOPs.
- Ensure cleaning tools are decontaminated before use.
- Record the details of cleaning agents in the Cleaning Agent Log (Annexure-4).
5.5. Corrective Actions for Cleaning Failures
- In case of failed validation results, repeat the cleaning procedure.
- Investigate the root cause of the failure.
- Document corrective measures in the Cleaning Failure Log (Annexure-5).
6. Abbreviations
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- QC: Quality Control
- SOP: Standard Operating Procedure
7. Documents
- Tank Cleaning Log (Annexure-1)
- Cleaning Validation Report (Annexure-2)
- Cleaning Schedule Log (Annexure-3)
- Cleaning Agent Log (Annexure-4)
- Cleaning Failure Log (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- FDA Cleaning Validation Guidelines
- 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: Tank Cleaning Log
| Tank ID | Cleaning Date | Cleaning Agent Used | Checked By |
|---|---|---|---|
| T-201 | 07/02/2025 | Sodium Hydroxide | Rahul Mehta |
Annexure-2: Cleaning Validation Report
| Tank ID | Validation Date | Residual Contaminant (PPM) | Approved By |
|---|---|---|---|
| T-202 | 07/02/2025 | <0.1 PPM | QA Team |
Annexure-3: Cleaning Schedule Log
| Tank ID | Routine Cleaning Date | Deep Cleaning Date | Responsible Person |
|---|---|---|---|
| T-203 | 06/02/2025 | 01/02/2025 | Priya Sharma |
Annexure-4: Cleaning Agent Log
| Cleaning Agent | Batch No. | Expiration Date | Checked By |
|---|---|---|---|
| Hydrogen Peroxide | HP-567 | 12/2026 | QA Team |
Annexure-5: Cleaning Failure Log
| Tank ID | Issue Identified | Corrective Action | Approved By |
|---|---|---|---|
| T-204 | Residue above limit | Repeat cleaning | 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 validation frequency and testing methods | GMP Compliance | Anjali Sharma |