Standard Operating Procedure (SOP)

Here is a detailed Standard Operating Procedure (SOP) for Fluidized Bed Dryer (FBD), widely used in pharmaceutical and chemical manufacturing for drying granulated materials.

1. Purpose

To define the procedure for operation and cleaning of the Fluidized Bed Dryer (FBD) used in the drying of wet granules in the manufacturing area.

2. Scope

Applicable to all FBD operations in the production department for drying granules during tablet or capsule production.

3. Responsibility

• Operator: Operate and clean the FBD according to this SOP.

• Production Supervisor: Ensure SOP adherence and proper documentation.

• QA/QC: Verify cleaning and release of equipment for use.

4. Equipment/Materials Required

• Fluidized Bed Dryer

• Granules for drying

• Inlet and exhaust filters

• Temperature and airflow settings

• Cleaning tools and approved detergent

• Personal Protective Equipment (PPE)

5. Procedure

5.1 Pre-Operation Checks

• Ensure the FBD is cleaned, dried, and labeled as “Cleaned.”

• Check that all filters (inlet, exhaust, finger bag) are intact and properly installed.

• Verify that the bowl, product container, and mesh are clean and undamaged.

• Check the power supply and emergency stop functionality.

5.2 Operation Procedure

1. Wear appropriate PPE before starting.

2. Place the wet granules in the FBD bowl and position it properly.

3. Clamp the bowl securely to the FBD unit.

4. Set drying parameters (inlet temperature, airflow, timer) as per batch manufacturing record (BMR).

5. Start the blower and then the heater.

6. Monitor the drying process continuously—record inlet/outlet temperature and drying time.

7. Perform Loss on Drying (LOD) tests periodically to determine endpoint.

8. Once LOD is within specified limits, stop the heater and then the blower.

9. Allow the product to cool before removing.

10. Discharge dried granules into a clean, labeled container.

5.3 Post-Operation

• Switch off the equipment and main power supply.

• Affix “To Be Cleaned” status label.

• Record batch number, drying time, and other operational parameters in the logbook.

5.4 Cleaning Procedure

1. Disconnect the machine from the power source.

2. Dismantle detachable parts: bowl, mesh, finger bags (if applicable).

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

4. Rinse and dry thoroughly in a controlled area.

5. Wipe external surfaces with a clean cloth.

6. Replace and secure clean filters as needed.

7. Reassemble parts or store them properly.

8. Label the equipment as “Cleaned.”

9. Record the cleaning activity in the equipment logbook.

6. Safety Precautions

• Always wear gloves, mask, and goggles during operation and cleaning.

• Do not operate without proper filters in place.

• Avoid opening the bowl during operation.

• Use caution while handling hot surfaces after drying.

7. Documentation

• Equipment usage log

• Cleaning log

• BMR drying records

• LOD test results

• Filter cleaning/replacement log

🎓 Discover one of the best Pharmaceutical Production courses available — click below to explore the course that’s shaping future Production skills.

https://trcjw.on-app.in/app/oc/338669/trcjw