Standard Operating Procedure for Cleaning of Mixing Tanks

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the cleaning procedure for mixing 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 mixing 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 mixing tank and approving it 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 tank cleaning and obtain necessary approvals.
2. Ensure that the tank is empty and free from any product residues.
3. Check that all valves and outlets on the tank are closed.
4. Wear appropriate personal protective equipment (PPE), including gloves and safety goggles.

4.2. Disassembly (if applicable)

If the tank has removable parts (e.g., agitators, filters), follow the manufacturer’s instructions for disassembly before cleaning.

4.3. Pre-Rinse

1. Rinse the interior of the tank with warm water to remove visible residues.
2. Use a soft brush or sponge to gently scrub any stubborn residues.

4.4. 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 tank.

4.5. Cleaning Process

1. Fill the tank with the prepared cleaning solution, ensuring all interior surfaces are covered.
2. Close the tank and agitate the solution for a minimum of [insert duration] at [insert speed or intensity].
3. Periodically check the solution for signs of contamination or discoloration. If observed, stop the cleaning process and notify QA.

4.6. Rinse

1. Drain the cleaning solution from the tank completely.
2. Rinse the tank with purified water to remove any remaining cleaning solution.

4.7. Post-Cleaning Inspection

1. Inspect the tank visually for cleanliness. Ensure there are no visible residues or particles.
2. If any residues are found, repeat the cleaning process.

4.8. Reassembly (if applicable)

If disassembled, follow the manufacturer’s instructions for reassembling the tank and its components.

4.9. Final Inspection and Approval

1. Notify the QA Inspector that the 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.

4.10. Documentation

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

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

[Insert any relevant references or standards applicable to tank cleaning in the pharmaceutical industry]

8. SOP Version

This is version 1.0 of the “Cleaning of Mixing Tanks SOP,” issued on [insert issuance date].