Standard Operating Procedure for Cleaning of High Shear Mixer

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the cleaning procedure for a high shear mixer 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 high shear mixers 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 high shear mixer 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 high shear mixer cleaning and obtain necessary approvals.
2. Ensure that the high shear mixer 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 high shear mixer 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. Disassembly (if applicable)

If the high shear mixer has removable parts (e.g., blades, screens), follow the manufacturer’s instructions for disassembly before cleaning.

4.4. Pre-Rinse

1. Rinse the interior and exterior of the high shear mixer with purified water to remove visible residues, contaminants, or product remnants.
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 high shear mixer and any removable parts.

4.6. Cleaning Process

1. Apply the prepared cleaning solution to the surfaces of the high shear mixer, including any disassembled components, using suitable cleaning tools.
2. Operate the high shear mixer according to manufacturer’s specifications for a minimum of [insert duration] to ensure that the cleaning solution reaches all surfaces.
3. Rinse the high shear mixer and its components with purified water to remove residual cleaning solution.
4. Reassemble the high shear mixer if it was disassembled.
5. Repeat the cleaning process as necessary until all residues, contaminants, and blockages are removed.

4.7. Post-Cleaning Inspection

1. Visually inspect the high shear mixer after cleaning to ensure that all residues, contaminants, and 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 high shear mixer is ready for inspection.
2. The QA Inspector will visually inspect the high shear mixer and document the inspection results.
3. If the mixer 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

[Insert any relevant references or standards applicable to the cleaning of high shear mixers in the pharmaceutical industry]

8. SOP Version

This is version 1.0 of the “Cleaning of High Shear Mixer SOP,” issued on [insert issuance date].