Standard Operating Procedure (SOP)

1. Purpose

The purpose of this SOP is to outline the procedure for cleaning the tablet counter, ensuring that it operates efficiently, maintains product quality, and prevents contamination. Regular cleaning minimizes downtime, reduces contamination risks, and helps to maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in cleaning the tablet counter, including machine operators, cleaning personnel, maintenance staff, and supervisors. It is applicable after each production run, as well as during routine cleaning and maintenance checks.

3. Responsibilities

• Machine Operators: Ensure the tablet counter is powered down and properly prepared for cleaning. Assist in disassembling any components if necessary.

• Cleaning Personnel: Perform the cleaning tasks following this SOP, ensuring that all parts are thoroughly cleaned using approved cleaning agents.

• Supervisors: Oversee the cleaning process, ensuring it is carried out per the SOP and verifying that the machine is ready for operation before resuming production.

• Maintenance Personnel: Inspect the tablet counter for any mechanical issues during the cleaning process and address any problems found.

4. Definitions

• Tablet Counter: A machine used for counting and filling tablets into bottles, blister packs, or other containers.

• Cleaning Validation: A process to ensure that cleaning methods effectively remove residues and contaminants from the equipment without affecting product quality.

5. Procedure

5.1. Preparation

• 5.1.1. Shut Down the Tablet Counter:

  • Ensure that the tablet counter is powered off and disconnected from the electrical supply.

  • Lock-out and tag-out (LOTO) procedures must be followed to ensure safety.

• 5.1.2. Safety Precautions:

  • Ensure all personnel wear the necessary Personal Protective Equipment (PPE), including gloves, goggles, and protective aprons.

  • Post safety signage in the area to prevent unauthorized access during the cleaning process.

• 5.1.3. Remove All Product:

  • Remove any remaining tablets, packaging materials, or other products from the tablet counter.

  • Dispose of any product waste and packaging material according to the company’s waste disposal policies.

5.2. Cleaning the Tablet Counter

• 5.2.1. Disassemble Removable Parts:

  • Remove any parts that can be disassembled, such as trays, containers, feeders, or tablet conveyors.

  • Follow the manufacturer’s instructions for proper disassembly and handling of each component.

• 5.2.2. Dry Cleaning:

  • Use a clean, dry cloth or compressed air to remove any loose tablets, powder, or debris from all external and internal parts of the tablet counter.

  • Pay special attention to hard-to-reach areas, such as under trays, around counters, and between rollers.

• 5.2.3. Wet Cleaning:

  • Prepare a cleaning solution with warm water and a mild detergent approved by the manufacturer.

  • Use a soft cloth or sponge to wipe down the entire tablet counter, focusing on areas where product residue or dust may accumulate.

  • For stubborn residue, use a soft brush to clean corners, rollers, and feed areas without damaging the machine.

  • Do not allow water or cleaning solution to enter electrical components or other areas where moisture could cause damage.

• 5.2.4. Cleaning the Tablet Counter Surfaces:

  • Use a lint-free cloth to wipe down all surfaces, including the control panels, feed areas, tablet trays, and conveyors.

  • Pay special attention to areas that come into direct contact with the tablets, as these must be thoroughly cleaned to avoid contamination.

• 5.2.5. Rinse:

  • After cleaning with the detergent solution, rinse all cleaned parts with clean water to remove any detergent residues.

  • Ensure all cleaning agents are thoroughly removed, as residual chemicals may affect product quality.

5.3. Drying and Reassembly

• 5.3.1. Drying:

  • Use clean, dry towels or a lint-free cloth to thoroughly dry all machine components.

  • Allow all parts to air dry completely before reassembling, ensuring that moisture does not remain in hard-to-reach areas.

• 5.3.2. Reassemble the Machine:

  • Once all components are dry, carefully reassemble the tablet counter according to the manufacturer’s guidelines.

  • Ensure all parts are properly aligned and secured before starting the machine.

5.4. Post-Cleaning Inspection

• 5.4.1. Visual Inspection:

  • Inspect the cleaned areas to ensure no residues, cleaning agents, or foreign particles are present.

  • Check that all parts have been properly reassembled and are functioning correctly.

• 5.4.2. Functionality Test:

  • Perform a quick operational test to ensure the tablet counter operates smoothly.

  • Observe the machine for any unusual noises, malfunctions, or issues that may have occurred during cleaning or reassembly.

5.5. Documentation and Verification

• 5.5.1. Cleaning Log:

  • Record the cleaning process, including the date, time, personnel involved, and any issues encountered during cleaning.

  • Document the batch number, machine number, and any relevant details for traceability.

• 5.5.2. Quality Control Verification:

  • A supervisor should verify the cleanliness and functionality of the machine before resuming production.

  • If any discrepancies or issues were identified during the inspection, corrective actions should be taken before the machine is used again.

6. Health, Safety, and Environmental Considerations

• 6.1. PPE: Always wear gloves, goggles, and any other necessary PPE to protect against cleaning agents and residues.

• 6.2. Chemical Safety: Ensure that all cleaning agents used are compatible with the tablet counter’s materials and are safe to handle. Always follow safety data sheets (SDS).

• 6.3. Waste Disposal: Dispose of waste products, cleaning agents, and packaging materials in accordance with company waste disposal protocols and environmental regulations.

7. Monitoring and Auditing

• 7.1. Audits: Regular audits should be conducted to ensure the cleaning procedure is followed properly and the tablet counter is in optimal working condition.

• 7.2. Corrective Actions: Any issues identified during audits or inspections should be addressed with corrective actions, including retraining or updates to the SOP.

8. Documentation

• 8.1. Cleaning Logs: Maintain detailed records of the cleaning process, including personnel involved, time, and any observations made during the cleaning.

• 8.2. Maintenance Reports: Any issues identified during cleaning should be documented and communicated to the maintenance team for immediate attention.

9. Appendices

• Appendix A: Tablet Counter Cleaning Checklist

• Appendix B: List of Recommended Cleaning Agents and Tools

• Appendix C: Cleaning Log Template

This SOP ensures that the tablet counter is cleaned thoroughly and safely, maintaining both the machine’s performance and product quality. Regular cleaning and proper documentation help comply with GMP and ensure the machine is ready for future production runs.

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