Standard Operating Procedure for Cleaning of Storage Tanks

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the cleaning procedure for storage tanks used in pharmaceutical manufacturing to ensure product quality, safety, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the cleaning of storage tanks within the pharmaceutical manufacturing facility.

3. Responsibilities

• Production Operator: Responsible for initiating the cleaning process.
• Quality Assurance (QA) Inspector: Responsible for verifying the cleanliness of the storage tanks and approving them for further use.
• Supervisor: Oversees the cleaning process and ensures compliance with this SOP.

4. Procedure

4.1. Pre-Cleaning Preparations

1. Notify the Production Supervisor of the need for storage tank cleaning and obtain necessary approvals.
2. Ensure that the storage tank is not in operation and is safely isolated from the production process.
3. Wear appropriate personal protective equipment (PPE), including gloves and safety goggles.

4.2. Inspection

1. Visually inspect the storage tank for any visible residues, contaminants, or blockages.
2. If any residues, contaminants, or blockages are found, note their location and severity for documentation.

4.3. Draining and Ventilation

1. Drain any remaining contents from the storage tank into an approved container or designated disposal area.
2. Ensure adequate ventilation during the cleaning process to prevent the buildup of hazardous vapors or fumes.

4.4. Pre-Rinse

1. Rinse the interior of the storage tank with purified water to remove visible residues or contaminants.
2. Use a soft brush or sponge to gently clean any stubborn residues or deposits.

4.5. Cleaning Solution Preparation

1. Prepare a cleaning solution as per the approved formula and concentration. Refer to the Cleaning Solution Formulation document (if available) for details.
2. Ensure that the cleaning solution is suitable for the materials of construction of the storage tank.

4.6. Cleaning Process

1. Apply the prepared cleaning solution to the interior surfaces of the storage tank using suitable cleaning tools.
2. Scrub the surfaces to remove residues, contaminants, or deposits thoroughly.
3. Rinse the storage tank with purified water to remove residual cleaning solution.
4. Repeat the cleaning process as necessary until all residues, contaminants, or blockages are removed.

4.7. Post-Cleaning Inspection

1. Visually inspect the storage tank after cleaning to ensure that all residues, contaminants, or blockages have been effectively removed.
2. If any issues persist, repeat the cleaning process.

4.8. Final Inspection and Approval

1. Notify the QA Inspector that the storage tank is ready for inspection.
2. The QA Inspector will visually inspect the tank and document the inspection results.
3. If the tank meets cleanliness criteria, it is approved for further use. If not, the cleaning process is repeated.

4.9. Documentation

Properly document the cleaning process, including cleaning dates, personnel involved, cleaning solutions used, inspection results, and any deviations from the procedure.

5. Abbreviations

• GMP: Good Manufacturing Practices
• PPE: Personal Protective Equipment
• QA: Quality Assurance

6. Documents

• Cleaning Solution Formulation – Document specifying the approved cleaning solution formula and concentration.

7. Reference

No external references are used in this SOP.

8. SOP Version

Version 1.0