1.0 Purpose

To describe the procedure for the operation, cleaning, and maintenance of the Multimill to ensure consistent performance and compliance with cGMP requirements.

2.0 Scope

This SOP applies to the Multimill installed in the production area of [Company Name], used for milling, granulation, pulverization, and particle size reduction.

3.0 Responsibility

• Production Operator: To operate and clean the Multimill as per SOP.

• Production Supervisor: To verify operations and logbook entries.

• Engineering: To carry out preventive maintenance and attend breakdowns.

• Quality Assurance (QA): To verify cleaning and compliance during line clearance.

4.0 Definitions

• Multimill: A self-contained portable unit for particle size reduction, using variable speed and interchangeable screens/knives.

5.0 Procedure

5.1 Operation

1. Ensure the equipment is labeled “Cleaned” and ready for use.

2. Verify assembly of rotor, blades/beaters, and suitable screen as per BMR.

3. Ensure all clamps and safety guards are properly fixed.

4. Switch ON the main power supply.

5. Start the Multimill at the required speed (low/medium/high) as per process requirement.

6. Feed material gradually into the hopper using a spatula or scoop, avoiding overfeeding.

7. Collect the processed material from the discharge chute into labeled containers.

8. After processing, switch OFF the machine and disconnect power supply.

9. Record operation details in the usage logbook.

5.2 Cleaning

Type A – Batch-to-Batch Cleaning

1. Switch OFF and unplug the machine.

2. Dismantle hopper, rotor assembly, screen, knives, and discharge parts.

3. Remove residual material using a nylon brush.

4. Wash contact parts with 1% detergent solution.

5. Rinse thoroughly with purified water.

6. Dry with a lint-free cloth or hot air.

7. Reassemble the equipment and affix “Cleaned” status label.

Type B – Product Changeover Cleaning

1. Perform all steps of Type A cleaning.

2. Wipe the external body with 70% IPA.

3. Perform line clearance verification by QA.

Type C – Weekly / Periodic Cleaning

1. Perform detailed cleaning of non-contact parts, motor housing, and frame.

2. Inspect screens and knives for damage or clogging.

5.3 Maintenance

1. Preventive maintenance shall be done as per schedule.

2. Inspect bearings, motor, and rotor for wear and lubrication.

3. Replace damaged screens, knives, or gaskets.

4. Maintain records in the equipment history logbook.

6.0 Safety Precautions

• Do not operate without proper guards.

• Never insert hands or tools into hopper during operation.

• Wear gloves, goggles, mask, and ear protection.

• Disconnect power before cleaning or maintenance.

• Avoid processing metallic objects or hard foreign materials.

7.0 Documentation

• Equipment usage logbook

• Cleaning record

• Preventive maintenance record

8.0 References

• Equipment manufacturer’s manual

• cGMP guidelines

• Batch Manufacturing Record (BMR)

9.0 Abbreviations

• SOP: Standard Operating Procedure

• BMR: Batch Manufacturing Record

• cGMP: Current Good Manufacturing Practices

• IPA: Isopropyl Alcohol

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