Standard Operating Procedure (SOP)

Here’s a comprehensive Standard Operating Procedure (SOP) for the Multimill, widely used in pharmaceutical, food, and chemical manufacturing industries for granulation, pulverization, and particle size reduction.

1. Purpose

To describe the procedure for the safe operation and effective cleaning of the multimill used for reducing particle size during manufacturing.

2. Scope

This SOP is applicable to the multimill installed in the production department for wet and dry granulation processes.

3. Responsibility

• Machine Operator: To operate and clean the multimill according to this SOP.

• Production Supervisor: To verify the correct operation and cleaning.

• QA/QC Department: To ensure compliance with GMP standards.

4. Equipment/Materials Required

• Multimill

• Cleaning accessories and approved cleaning agents

• PPE (gloves, mask, goggles, apron)

• Collection container (lined with polybag if required)

5. Procedure

5.1 Pre-Startup Check

• Ensure the equipment is clean, dry, and labeled “Cleaned.”

• Check for the correct assembly of screen, blades, and rotor.

• Inspect for any damage or wear on parts.

• Confirm the area is clean and clear of any obstructions.

• Ensure that all safety guards are in place.

5.2 Operation Procedure

1. Wear required PPE before starting.

2. Switch ON the main power and then the multimill.

3. Feed material slowly into the hopper.

4. Control the speed as per process requirement (if variable speed model).

5. Collect the processed material in a clean, labeled container.

6. Avoid overloading or pushing material with hands.

7. After processing, stop the machine and switch OFF the power.

5.3 Post-Operation

• Discharge any remaining material.

• Record the usage in the equipment logbook.

• Attach “To be Cleaned” status label if not cleaned immediately.

5.4 Cleaning Procedure

1. Ensure the machine is switched OFF and disconnected from power.

2. Dismantle all contact parts (hopper, blade, screen, rotor).

3. Wash all parts with purified water and approved detergent.

4. Rinse thoroughly and allow to dry completely.

5. Wipe the exterior of the machine with a clean, damp cloth.

6. Reassemble parts after drying or store them properly if not in use.

7. Record cleaning activity in the logbook.

6. Safety Precautions

• Do not operate without safety guards.

• Use tools to dismantle sharp parts—avoid direct hand contact.

• Never insert hands or tools into the hopper during operation.

• Always wear PPE.

• Use caution with electrical components.

7. Documentation

• Equipment usage and cleaning log

• Batch manufacturing records

• Cleaning checklist

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