Standard Operating Procedure (SOP) 

1. Objective

To establish a standardized method for the safe and efficient operation of the 27-station double rotary tablet compression machine, ensuring consistent tablet quality and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the operation of the 27-station double rotary tablet compression machine within the tablet manufacturing area.

3. Responsibilities

• Machine Operator: Execute the operation as per this SOP.

• Production Supervisor/Pharmacist: Supervise operations and ensure adherence to the SOP.

• Quality Assurance (QA): Monitor compliance and review documentation.

• Head of Production: Overall accountability for compliance and performance.

4. Procedure

4.1 Pre-Operational Checks

• Area and Equipment Cleanliness: Ensure the machine and surrounding area are clean and free from any residual materials.

• Status Labeling: Verify that the machine is labeled appropriately (e.g., “Cleaned” or “Ready for Use”).

• Safety Guards: Confirm that all safety guards are in place and functional.

• Tool Availability: Check the availability and condition of required tools and accessories.

• Power Supply: Ensure the main power supply is switched off before starting any setup activities.

4.2 Machine Setup

• Die and Punch Installation:

  • Select the appropriate set of dies and punches as per the batch manufacturing record (BMR).

  • Inspect dies and punches for cleanliness and integrity.

  • Install dies into the turret, ensuring they are flush with the turret surface.

  • Insert lower punches into the lower punch bores, ensuring smooth movement.

  • Insert upper punches into the upper punch bores, aligning them correctly.

• Feed Frame and Hopper:

  • Install the feed frame securely onto the machine.

  • Attach the hopper and ensure it is properly aligned and fixed.

• Cam Tracks and Rollers:

  • Inspect cam tracks and pressure rollers for wear and cleanliness.

  • Lubricate as necessary with food-grade lubricant.

4.3 Operational Steps

• Startup:

  • Switch on the main power supply.

  • Engage the main drive and allow the machine to run in ‘jog’ mode to check for any abnormalities.

• Feeding Material:

  • Load the pre-lubricated granules into the hopper.

  • Ensure the hopper lid is closed to prevent contamination.

• Tablet Compression:

  • Adjust tablet weight and thickness settings as per BMR specifications.

  • Start the machine in continuous mode.

  • Monitor tablet quality parameters (weight, thickness, hardness) at regular intervals.

  • Record observations and any adjustments made during the run.

4.4 Post-Operational Activities

• Shutdown:

  • Stop the machine and switch off the main power supply.

• Cleaning:

  • Remove residual granules from the hopper and feed frame.

  • Clean the machine surfaces with a lint-free cloth and appropriate cleaning agents.

  • Dismantle dies and punches, clean with 70% Isopropyl Alcohol (IPA), dry, and store properly.

• Documentation:

  • Record the operation details, observations, and any deviations in the equipment logbook.

  • Label the machine status appropriately (e.g., “To Be Cleaned” or “Cleaned”).

5. Precautions

• Do not operate the machine without all safety guards in place.

• Ensure proper lubrication to prevent equipment wear.

• Use only designated tools for adjustments to avoid equipment damage.

• Discard the initial tablets produced at the start of the run as per quality guidelines.

6. References

• Batch Manufacturing Record (BMR)

• Equipment Cleaning SOP

• Equipment Maintenance Log

7. Abbreviations

• SOP: Standard Operating Procedure

• BMR: Batch Manufacturing Record

• IPA: Isopropyl Alcohol

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