Standard Operating Procedure for Cleaning of Case Packer

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for the proper cleaning of a case packer machine in pharmaceutical manufacturing. This ensures the maintenance of cleanliness, prevents cross-contamination, and promotes the proper functioning of the equipment while adhering to Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the cleaning and maintenance of case packer machines within the pharmaceutical manufacturing facility.

3. Responsibilities

• Cleaning Operator: Responsible for following the procedures outlined in this SOP during cleaning operations.
• Supervisor: Oversees and verifies compliance with this SOP, including training and documentation.

4. Procedure

4.1. Pre-Cleaning Preparations

1. Ensure that the case packer machine is not in operation and is safely powered off.
2. Gather all necessary cleaning equipment and materials, including cleaning agents, brushes, cloths, and personal protective equipment (PPE) such as gloves and safety goggles.

4.2. Dismantling and Disassembly

1. Refer to the manufacturer’s manual for specific instructions on disassembly and dismantling of machine parts.
2. Carefully remove and disassemble components such as conveyor belts, guides, chutes, and other parts that come into contact with products or packaging materials.
3. Follow a systematic procedure to ensure that each component is removed without causing damage.

4.3. Cleaning Process

1. Start by removing loose debris and product residues from the machine using brushes or vacuum cleaners.
2. Prepare a cleaning solution as per the manufacturer’s recommendations or facility-specific procedures.
3. Clean all machine parts, surfaces, and components thoroughly, paying close attention to areas that come into direct contact with products or packaging materials.
4. Rinse all cleaned surfaces with clean, potable water to remove any traces of cleaning agents.
5. Dry the machine and its components using clean, lint-free cloths or compressed air.

4.4. Reassembly

1. Reassemble the machine components in the reverse order of disassembly, ensuring that each part is correctly aligned and securely fastened.
2. Verify that all connections, belts, and fasteners are properly tightened.

4.5. Post-Cleaning Checks

1. Inspect the machine for any residual cleaning agents, foreign particles, or defects.
2. Ensure that no tools or equipment have been left inside the machine.

4.6. Documentation

Properly document the cleaning process, including the date, time, personnel involved, cleaning agents used, and any deviations from the standard procedure. Maintain records in a secure and accessible location for regulatory inspection.

5. Personal Protective Equipment (PPE)

Wear appropriate PPE, including gloves and safety goggles, during the cleaning process to protect against chemical exposure and potential hazards.

6. Abbreviations

• GMP: Good Manufacturing Practices

7. Reference

No external references are used in this SOP.

8. SOP Version

Version 1.0