Standard Operating Procedure for Operation and Cleaning of Mixing Tanks in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/123/2025 |
| Supersedes | SOP/GM/123/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To describe the procedure for the proper operation and cleaning of mixing tanks used in the manufacturing of gel formulations to ensure product quality, hygiene, and compliance with GMP requirements.
2. Scope
This SOP applies to all stainless steel or glass-lined mixing
tanks used in the Gel Manufacturing area for compounding and mixing operations.
3. Responsibilities
- Production Operator: Responsible for executing the operation and cleaning steps.
- Line Supervisor: Ensures compliance with SOP during operation and cleaning activities.
- QA Executive: Verifies cleanliness and approves line clearance post-cleaning.
4. Accountability
Production Manager and QA Manager
5. Procedure
5.1 Operation of Mixing Tanks
- Ensure the tank is clean and free from any residual material. Verify the line clearance before initiating batch processing.
- Check the integrity of gaskets, valves, agitators, and temperature probes.
- Load raw materials as per Batch Manufacturing Record (BMR) instructions under supervision.
- Start mixing operation according to specified RPM and time in the BMR. Record parameters.
- Monitor temperature if heating is required and maintain within defined limits.
- Record critical processing parameters in the Equipment Logbook.
5.2 Post-Operation Cleaning
- Immediately after use, drain the residual product from the mixing tank completely.
- Rinse the interior with purified water to remove loose particles.
- Prepare a 1% non-ionic detergent solution and perform scrubbing using lint-free mop or scrubber.
- Rinse thoroughly with potable water followed by purified water until detergent residues are removed.
- If disinfectant treatment is required, use an approved disinfectant (e.g., 70% IPA) and allow to air dry.
5.3 Visual Inspection and Line Clearance
- Perform visual inspection for absence of product residue, foam, and water spots.
- Ensure no water droplets are left in valves or piping post-cleaning.
- Get QA verification before tagging the tank as “CLEANED.”
5.4 Frequency of Cleaning
- Routine Cleaning: After every batch
- Changeover Cleaning: Before processing a new product
- Monthly Deep Cleaning: With complete dismantling and inspection
5.5 Precautions
- Always wear PPE during cleaning and operation.
- Do not use abrasive materials that may damage tank surfaces.
- Handle electrical controls with dry hands and in proper condition.
6. Abbreviations
- BMR: Batch Manufacturing Record
- GMP: Good Manufacturing Practice
- IPA: Isopropyl Alcohol
- PPE: Personal Protective Equipment
7. Documents
- Batch Manufacturing Record
- Equipment Cleaning Logbook – Annexure-1
- Tank Visual Inspection Checklist – Annexure-2
8. References
- Schedule M – Good Manufacturing Practices
- FDA Guidance for Cleaning Validation
- WHO TRS No. 986 – Annex 2
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 Logbook
| Date | Tank ID | Product Name | Cleaned By | Checked By | QA Verified |
|---|---|---|---|---|---|
Annexure-2: Tank Visual Inspection Checklist
| Inspection Item | Pass/Fail | Remarks |
|---|---|---|
| No product residue | ||
| No water spots or foam | ||
| Valves and agitators cleaned | ||
| Gaskets intact | ||
| Tank tag updated |
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 15/03/2022 | 1.0 | Initial version | New SOP | QA Head |
| 09/06/2025 | 2.0 | Included new annexures and deep cleaning steps | Periodic review | QA Head |