Standard Operating Procedure for Cleaning of Manufacturing Vessels and Accessories in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/119/2025 |
| Supersedes | SOP/GM/119/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To define the procedure for cleaning gel manufacturing vessels and accessories such as mixers, transfer pipes, spatulas, and sampling tools to maintain hygiene and eliminate contamination risks.
2. Scope
This SOP applies to all production vessels and accessories used for the manufacturing of gel formulations
at the facility.
3. Responsibilities
- Production Operator: Performs cleaning as per approved method.
- QA Executive: Verifies cleanliness and approves equipment for reuse.
- Maintenance Personnel: Assists in dismantling and reassembling as required.
4. Accountability
Head – Manufacturing
5. Procedure
5.1 Cleaning Types
- Batch-to-Batch Cleaning: For same product, similar strength.
- Product-to-Product Cleaning: Required when changing product or strength.
- Periodic Cleaning: Weekly or after extended equipment idling.
5.2 Cleaning Agents
- Use purified water, 2% non-ionic detergent, and 70% IPA as applicable.
- Ensure all cleaning agents are approved and within expiry.
5.3 Cleaning Process
- Disconnect all accessories and dismantle detachable parts.
- Rinse vessels and parts with lukewarm purified water to remove residues.
- Apply 2% detergent solution and scrub using nylon brushes.
- Rinse thoroughly with purified water until no foam remains.
- Perform a final rinse with purified water and allow to drain completely.
- Spray 70% IPA on surface contact areas and allow to air dry.
- Reassemble all parts after verification of dryness.
5.4 Cleaning of Accessories
- Clean sampling tools, spatulas, and pipe connectors as per steps in section 5.3.
- Use designated cleaning area for small parts to avoid cross-contamination.
5.5 Post-Cleaning Checks
- Inspect equipment visually for cleanliness.
- Record cleaning activity in the Equipment Logbook.
- QA to perform swab test (if required) and release for next use.
5.6 Documentation
- Fill Cleaning Record – Annexure-1 after each cleaning activity.
- Attach checklist and QA clearance – Annexure-2.
6. Abbreviations
- IPA: Isopropyl Alcohol
- QA: Quality Assurance
- SOP: Standard Operating Procedure
7. Documents
- Cleaning Record – Annexure-1
- QA Clearance Checklist – Annexure-2
- Detergent Certificate of Analysis
8. References
- WHO TRS 986 Annex 2: GMP for Pharmaceutical Products
- 21 CFR Part 211 – US FDA CGMP Guidelines
- ICH Q7: GMP for Active Pharmaceutical Ingredients
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: Equipment Cleaning Record
| Equipment Name | |
|---|---|
| Equipment ID | |
| Product | |
| Cleaning Type | Batch-to-Batch / Product Change |
| Date of Cleaning | |
| Cleaned By | |
| Verified By (QA) |
Annexure-2: QA Clearance Checklist
| Checklist Item | Status (Yes/No) | Remarks |
|---|---|---|
| No visible residue | ||
| Swab test results (if applicable) | ||
| Dryness verified | ||
| Ready for next use |
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 20/06/2022 | 1.0 | Initial release | New SOP | QA Head |
| 09/06/2025 | 2.0 | Revised cleaning steps, added annexures | GMP update | QA Head |