Standard Operating Procedure (SOP)

Here is a Standard Operating Procedure (SOP) for operating a Cad Mill (also known as a Co-Mill or Cone Mill), commonly used in pharmaceutical and related industries for granule sizing and milling.

1. Purpose

To define the procedure for the operation and cleaning of the Cad Mill used for sizing and granule milling during pharmaceutical manufacturing.

2. Scope

This SOP applies to all operators responsible for using the Cad Mill in the production department.

3. Responsibility

• Machine Operator: To operate and clean the cad mill as per SOP.

• Production Supervisor: To ensure adherence and training.

• QA/QC: To verify cleanliness and compliance.

4. Equipment/Materials Required

• Cad Mill machine

• Personal Protective Equipment (PPE)

• Cleaning tools and approved detergent

• Granules or material to be milled

5. Procedure

5.1 Pre-Start Checks

• Ensure the equipment is clean and dry.

• Check that the sieve/screen is properly fixed.

• Inspect blades, impellers, and seals for damage or wear.

• Ensure power supply is switched off before any setup.

5.2 Operation

1. Assemble the mill with appropriate screen and impeller as per batch requirement.

2. Ensure all parts are secured.

3. Switch ON the main power supply and then the machine.

4. Feed material gradually into the hopper.

5. Control speed (if applicable) based on product characteristics.

6. Collect milled product into clean, labeled containers.

7. Avoid overloading or forcing material into the hopper.

5.3 Shutdown Procedure

• Switch OFF the mill after completion.

• Disconnect from power source.

• Record operational details in the logbook.

5.4 Cleaning Procedure

• Ensure machine is powered off and disconnected.

• Dismantle screen, blades, and hopper carefully.

• Wash all dismantled parts with purified water and detergent.

• Rinse thoroughly and allow to dry.

• Sanitize if required and reassemble or store parts properly.

• Record cleaning activity in equipment logbook.

6. Safety Precautions

• Do not operate without safety guards in place.

• Always wear gloves, masks, and safety goggles.

• Never insert hands into the hopper during operation.

• Handle sharp components (screens/blades) with care.

7. Documentation

• Equipment logbook (operation & cleaning)

• Batch Manufacturing Record (BMR)

• Cleaning checklist/record

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