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

1. Ensure the tank is clean and free from any residual material. Verify the line clearance before initiating batch processing.
2. Check the integrity of gaskets, valves, agitators, and temperature probes.
3. Load raw materials as per Batch Manufacturing Record (BMR) instructions under supervision.
4. Start mixing operation according to specified RPM and time in the BMR. Record parameters.
5. Monitor temperature if heating is required and maintain within defined limits.
6. Record critical processing parameters in the Equipment Logbook.

5.2 Post-Operation Cleaning

1. Immediately after use, drain the residual product from the mixing tank completely.
2. Rinse the interior with purified water to remove loose particles.
3. Prepare a 1% non-ionic detergent solution and perform scrubbing using lint-free mop or scrubber.
4. Rinse thoroughly with potable water followed by purified water until detergent residues are removed.
5. 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

1. Perform visual inspection for absence of product residue, foam, and water spots.
2. Ensure no water droplets are left in valves or piping post-cleaning.
3. 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

1. Batch Manufacturing Record
2. Equipment Cleaning Logbook – Annexure-1
3. 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