Standard Operating Procedure for Cleaning of Gel Manufacturing Tanks in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/130/2025 |
| Supersedes | SOP/GM/130/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To establish a standard procedure for the cleaning of gel manufacturing tanks, ensuring compliance with regulatory standards and preventing contamination and cross-contamination of gel products.
2. Scope
This procedure is applicable to all gel manufacturing tanks used in compounding, storage, and transfer within the gel production
department.
3. Responsibilities
- Production Operator: Performs cleaning and documents activity in logbook.
- Line Supervisor: Verifies cleaning and signs off in records.
- QA Executive: Conducts visual and microbiological inspections post-cleaning.
4. Accountability
Department Head – Gel Manufacturing and Department Head – Quality Assurance
5. Procedure
5.1 Pre-Cleaning Checks
- Ensure the tank is emptied and residual material is drained completely.
- Verify that all valves are in closed position and power supply is off.
- Attach “Under Cleaning” label on the tank.
5.2 Cleaning Steps
- Rinse the tank with potable water to remove bulk residue.
- Prepare 0.5% non-ionic detergent solution and fill the tank to 25% capacity. Circulate the solution through the internal loop for 15 minutes.
- Scrub the inner surfaces using sterile brushes where needed.
- Drain detergent solution and rinse twice with purified water.
- Perform a final rinse with Water for Injection (WFI) for critical applications.
5.3 Visual and Swab Inspection
- Inspect the tank interior for absence of residue, stains, and watermarks.
- QA personnel to perform swab test on contact surfaces (Annexure-1) and submit for microbiological analysis.
- Record inspection findings in Annexure-2 and cleaning logbook.
5.4 Drying and Storage
- Allow the tank to air-dry under LAF (Laminar Air Flow) or with filtered compressed air.
- Ensure no water droplets remain in crevices or outlet valves.
- Affix “Cleaned and Ready for Use” status label once QA clearance is received.
5.5 Cleaning Frequency
- After every batch or before product changeover.
- Every 48 hours if not used after cleaning.
5.6 Precautions
- Ensure PPE (gloves, goggles, mask, apron) is worn during cleaning.
- Do not mix equipment-specific cleaning accessories.
- Follow safety measures for handling detergents and WFI.
6. Abbreviations
- WFI: Water for Injection
- PPE: Personal Protective Equipment
- QA: Quality Assurance
7. Documents
- Cleaning Checklist – Annexure-1
- Visual Inspection Report – Annexure-2
- Microbial Swab Test Report – Annexure-3
8. References
- WHO TRS 986 Annex 2 – GMP Guidelines
- Schedule M – Requirements for Pharmaceutical Manufacturing
- Internal Equipment Cleaning SOPs
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Cleaning Checklist
| Step | Done (Y/N) | Initials | Remarks |
|---|---|---|---|
| Detergent Cleaning | |||
| Potable Water Rinse | |||
| WFI Rinse | |||
| Drying |
Annexure-2: Visual Inspection Report
| Date | Inspected By | Observation | Initials |
|---|---|---|---|
| Clean / Not Clean |
Annexure-3: Microbial Swab Test Report
| Sample ID | Location | Result (CFU/cm²) | Limits | Approved By |
|---|---|---|---|---|
| <10 CFU/cm² |
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 01/02/2022 | 1.0 | Initial Release | New SOP | QA Head |
| 09/06/2025 | 2.0 | Updated procedure and added Annexure-3 | Regulatory Alignment | QA Head |