Standard Operating Procedure (SOP)

1. Objective

To define the procedure for cleaning the Automatic Cartoning Machine to ensure product integrity, prevent cross-contamination, and maintain GMP compliance.

2. Scope

This SOP is applicable to the cleaning of the Automatic Cartoning Machine used in the packing area.

3. Responsibility

• Machine Operator / Technician: Perform cleaning according to this SOP.

• Production Supervisor: Supervise and verify cleaning.

• QA/QC Personnel: Inspect and approve the equipment post-cleaning.

4. Materials and Equipment Required

• Clean lint-free cloths

• Soft-bristle brush

• Approved cleaning agent (if applicable)

• Vacuum cleaner (if dry cleaning)

• PPE (gloves, apron, mask, goggles)

• Cleaning checklist/logbook

5. Procedure

5.1 Pre-Cleaning Steps

1. Ensure the machine is switched off and disconnected from the power supply.

2. Display “Under Cleaning” label on the machine.

3. Wear appropriate personal protective equipment (PPE).

4. Remove any product remnants, cartons, leaflets, and debris manually.

5.2 Cleaning Steps (Routine/Batch Changeover)

1. Open all guards, panels, and covers carefully.

2. Use a vacuum cleaner or brush to remove dust, carton particles, and loose debris.

3. Wipe accessible surfaces, belts, and guides using a lint-free cloth.

4. If applicable, use a mild detergent solution on non-sensitive parts and wipe with a damp cloth.

5. Dry all surfaces thoroughly to prevent moisture build-up.

6. Clean the carton feeding area, leaflet insertion unit, and printing unit (if installed).

7. Clean the sensors and vision system lenses carefully using a dry lens-safe cloth or air blower (if applicable).

8. Visually inspect the machine for cleanliness.

5.3 Cleaning After Maintenance or Periodic Deep Cleaning

1. Dismantle removable parts as per machine manual.

2. Clean individual parts and dry completely.

3. Reassemble and ensure all safety guards are in place.

4. Perform a function check (dry run) if required before resuming operation.

6. Post-Cleaning

1. Affix “Cleaned” status label on the machine with date, time, and cleaned by information.

2. Record the cleaning activity in the logbook or relevant cleaning checklist.

3. Notify QA for line clearance.

7. Precautions

• Do not spray water or cleaning agent directly on electrical/electronic components.

• Avoid using abrasive materials that may scratch or damage machine surfaces.

• Ensure all machine parts are properly secured after reassembly.

8. References

• Equipment Operating Manual

• GMP Guidelines

• Cleaning Validation Protocols

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