Standard Operating Procedure for Cleaning of Cartoning Machine

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the cleaning procedure for a cartoning machine 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 cartoning machines 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 cartoning machine 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 cartoning machine cleaning and obtain necessary approvals.
2. Ensure that the cartoning machine 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 cartoning machine 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 cartoning machine has removable parts (e.g., belts, chutes), follow the manufacturer’s instructions for disassembly before cleaning.

4.4. Pre-Rinse

1. Rinse the exterior of the cartoning machine with purified water to remove visible residues or contaminants.
2. Use a soft brush or sponge to gently clean any stubborn residues or deposits on the exterior surfaces.

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 cartoning machine and any removable parts.

4.6. Cleaning Process

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

4.7. Post-Cleaning Inspection

1. Visually inspect the cartoning machine 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 cartoning machine is ready for inspection.
2. The QA Inspector will visually inspect the machine and document the inspection results.
3. If the machine 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