Standard Operating Procedure (SOP)

Here’s a detailed Standard Operating Procedure (SOP) for a Sizoner Mixer Granulator, used in pharmaceutical manufacturing for mixing and wet granulation of powders.

1. Purpose

To outline the procedure for safe and efficient operation and cleaning of the Sizoner Mixer Granulator used in the granulation process.

2. Scope

Applicable to all production personnel operating the Sizoner Mixer Granulator for wet granulation in the manufacturing area.

3. Responsibility

• Machine Operator: Operate and clean the equipment as per SOP.

• Production Supervisor: Monitor adherence to SOP and ensure documentation.

• QA/QC: Verify cleaning and approve batch records.

4. Equipment/Materials Required

• Sizoner Mixer Granulator

• Raw materials for granulation

• Binder solution (if applicable)

• Cleaning tools and approved detergent

• PPE (gloves, mask, apron, goggles)

5. Procedure

5.1 Pre-Operation Checks

• Verify the machine is cleaned, dried, and labeled “Cleaned.”

• Inspect mixing blades, chopper, and vessel for wear or damage.

• Ensure all safety guards and interlocks are functional.

• Check availability of raw materials and binder solution.

• Confirm the area is clean and power supply is stable.

5.2 Operation Procedure

1. Wear appropriate PPE.

2. Switch ON the main power supply.

3. Load raw materials into the mixing vessel as per batch formulation.

4. Start the mixer at low speed to mix powders uniformly.

5. Add binder solution gradually while mixing.

6. Increase mixing speed as per process parameters.

7. Operate the chopper to achieve desired granule size.

8. Monitor mixing time and process variables according to batch record.

9. Once granulation is complete, stop the mixer and chopper.

10. Discharge wet granules into a clean container for drying.

11. Record process parameters in the batch manufacturing record.

5.3 Post-Operation

• Switch OFF the machine and power supply.

• Attach “To Be Cleaned” status label.

• Clean the equipment immediately or store in a controlled environment if cleaning is delayed.

5.4 Cleaning Procedure

1. Disconnect the machine from power.

2. Dismantle removable parts: blades, chopper, vessel lid.

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

4. Rinse thoroughly and dry completely.

5. Wipe exterior surfaces with a clean, damp cloth.

6. Reassemble the machine or store cleaned parts properly.

7. Label the equipment as “Cleaned.”

8. Document cleaning activities in the logbook.

6. Safety Precautions

• Always wear PPE during operation and cleaning.

• Never insert hands or tools inside the vessel while the machine is running.

• Ensure safety interlocks are engaged before operation.

• Report any unusual noises or malfunctions immediately.

• Handle binder solutions carefully as per MSDS guidelines.

7. Documentation

• Equipment usage log

• Cleaning log

• Batch manufacturing record

• Maintenance records

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