to hold intermediate or finished bulk gel products prior to packaging in the Gel Manufacturing Department.

3. Responsibilities

• Production Operator: Responsible for performing the cleaning activities as per procedure.
• Maintenance Team: To assist in disconnection and utility checks during cleaning.
• Quality Assurance: Verifies cleaning effectiveness and ensures compliance.

4. Accountability

The Department Head of Gel Manufacturing and the Head of QA are jointly accountable for adherence to this SOP.

5. Procedure

5.1 Pre-Cleaning Preparation

1. Ensure that the storage tank is empty and disconnected from filling lines if applicable.
2. Check for any physical damage, residues, or spills around the tank.
3. Wear the appropriate PPE: gloves, goggles, and chemical-resistant aprons.
4. Place “Cleaning in Progress” signage near the work area.

5.2 Manual Cleaning Steps

1. Rinse the tank with ambient temperature purified water to remove bulk residues.
2. Apply a validated cleaning solution (e.g., 2% NaOH) using a spray ball or manually with soft brushes.
3. Allow the solution to circulate for a minimum of 15 minutes or as per cleaning protocol.
4. Drain the cleaning solution completely and inspect the tank surface.
5. Rinse thoroughly with purified water until rinse water conductivity is within acceptable range (<10 µS/cm).

5.3 Final Rinse and Drying

1. Use Water for Injection (WFI) for a final rinse if product requires higher cleanliness level.
2. Dry the tank using filtered air or allow it to air dry in a controlled environment.

5.4 Cleaning Frequency

• After each batch transfer to filling or packing.
• After product changeover.
• If idle for more than 72 hours without nitrogen blanketing.

5.5 Cleaning Verification

1. Swab samples to be collected from internal tank walls, nozzles, and manholes.
2. Perform Total Organic Carbon (TOC) or visual inspection as per cleaning validation protocol.
3. QA to review and sign off the results prior to reuse of the tank.

6. Abbreviations

• SOP: Standard Operating Procedure
• PPE: Personal Protective Equipment
• QA: Quality Assurance
• WFI: Water for Injection
• TOC: Total Organic Carbon

7. Documents

1. Tank Cleaning Log – Annexure-1
2. Swab Sampling and Verification Form – Annexure-2

8. References

• WHO GMP Guidelines
• Schedule M – Cleaning Procedures
• Internal Cleaning Validation Protocol

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: Tank Cleaning Log

Date	Tank ID	Cleaning Agent	Rinse Conductivity (µS/cm)	Drying Method	Operator	QA Verified

Annexure-2: Swab Sampling and Verification Form

Sample Point	Swab No.	Result (TOC/Visual)	Limit	Pass/Fail	QA Sign
Tank Wall			<2.0 µg/cm²
Nozzle			<2.0 µg/cm²
Manhole			<2.0 µg/cm²

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial version	New SOP Creation	QA Head
02/06/2025	2.0	Added TOC limits and detailed annexures	Regulatory Alignment	QA Head