Standard Operating Procedure (SOP)

Here is a complete Standard Operating Procedure (SOP) for Cleaning of a Tablet Compression Machine, commonly used in pharmaceutical production environments to ensure hygiene, prevent cross-contamination, and comply with GMP.

1. Objective

To lay down the procedure for proper and consistent cleaning of the tablet compression machine to ensure cleanliness and prevent cross-contamination.

2. Scope

Applicable to all tablet compression machines used in the production department for the manufacture of oral solid dosage forms.

3. Responsibility

• Machine Operator: Perform cleaning as per this SOP.

• Production Supervisor: Ensure cleaning is done and documented properly.

• QA Personnel: Verify and approve post-cleaning condition of the machine.

4. Materials and Equipment Required

• Purified water

• Approved cleaning agent (detergent)

• Soft nylon brushes

• Lint-free cloths

• Clean dry air supply

• PPE (gloves, goggles, apron, face mask)

• Vacuum cleaner (if required)

• Cleaning checklist/logbook

5. Procedure

5.1 Pre-Cleaning Activities

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

2. Display “UNDER CLEANING” status board.

3. Wear appropriate PPE.

4. Remove any leftover tablets, granules, or powder from the hopper and die table.

5.2 Cleaning Procedure (Product-to-Product or Batch Changeover Cleaning)

1. Dismantle Machine Parts:

   • Remove feeding hopper, turret cover, dust extraction pipes, scrapers, punches, and dies.

   • Handle tooling carefully to avoid damage.

2. Dry Cleaning (if applicable):

   • Use a vacuum or brush to remove powder residues.

3. Wet Cleaning:

   • Wash parts with approved detergent and purified water.

   • Use soft brushes to clean crevices and hard-to-reach areas.

   • Rinse thoroughly with purified water.

4. Cleaning the Main Machine Body:

   • Wipe the turret, guards, and external surfaces with a damp cloth using purified water.

   • Do not use excessive water on electrical or motor components.

5. Drying:

   • Use clean dry lint-free cloths and/or filtered compressed air to dry parts completely.

   • Ensure no moisture is retained on any part.

6. Visual Inspection:

   • Check for any residue, stains, or contamination visually.

   • Re-clean if needed.

7. Reassembly:

   • Reassemble the cleaned and dried parts.

   • Ensure proper fitment and function.

6. Post-Cleaning Activities

1. Affix a “CLEANED” status label on the machine.

2. Enter the details in the Equipment Cleaning Log.

3. Inform QA for line clearance before the next use.

7. Precautions

• Avoid using metal brushes or abrasive materials.

• Ensure all detergent is rinsed off thoroughly.

• Do not allow water to contact electrical components.

• Handle punches and dies with care.

8. References

• Equipment Operation Manual

• Cleaning Validation Protocol

• cGMP Guidelines

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