SOP for Cleaning of Fluidised Bed Dryer (FBD)

Standard Operating Procedure (SOP) for Cleaning of Fluidised Bed Dryer (FBD)

1.0 OBJECTIVE:
To lay down the cleaning procedure for Fluidised Bed Dryer (FBD) to ensure proper hygiene and avoid cross-contamination.

2.0 SCOPE:
This SOP shall be applicable for the cleaning of the Fluidised Bed Dryer (FBD) in the Granulation Area of the Production Department.

3.0 RESPONSIBILITY:
3.1 Execution: Operator
3.2 Checking: Pharmacist and Above

4.0 ACCOUNTABILITY:
HOD – Production

5.0 PROCEDURE:

5.1 Type of Cleaning:

• Batch-to-batch cleaning (Product changeover within the same product category).
• Product changeover cleaning (When switching between different products).
• Periodic cleaning (Scheduled deep cleaning at regular intervals).

5.2 Cleaning Procedure:

5.2.1 Precautions:

• Ensure that the machine is switched off and electrically isolated before cleaning.
• Use personal protective equipment (PPE) like gloves, masks, and safety goggles.
• Ensure no residual material is left inside before starting the cleaning process.

5.2.2 Batch-to-Batch Cleaning:

1. Switch off the main power supply.
2. Open the air filter and remove any accumulated dust.
3. Clean the inner surfaces of the drying chamber using a vacuum cleaner.
4. Wipe the inner surface with a clean, dry lint-free cloth.
5. Clean the filters and sieves with a dry brush.
6. Reassemble all the parts and ensure they are properly fixed.
7. Record the cleaning activity in the logbook.

5.2.3 Product Changeover Cleaning:

1. Ensure that the FBD is turned off and locked out.
2. Dismantle the product container, filter bag, and air distribution plate.
3. Remove residual product using a vacuum cleaner.
4. Wash all dismantled parts with purified water and a non-reactive cleaning agent.
5. Scrub and rinse thoroughly with purified water.
6. Wipe all components with a clean, dry lint-free cloth.
7. Reassemble the FBD and conduct a visual inspection.
8. Record the cleaning details in the cleaning log.

5.2.4 Periodic Cleaning:

1. Perform complete dismantling of all removable parts.
2. Conduct deep cleaning using an approved detergent and purified water.
3. Check and clean air filters, nozzles, and ducts thoroughly.
4. Allow all cleaned parts to dry completely before reassembly.
5. Verify cleanliness using a swab test (if applicable).
6. Document the cleaning procedure in the logbook.

6.0 CLEANING VALIDATION:

• Visual Inspection: Ensure no visible residues are left after cleaning.
• Swab Testing: Conduct periodic swab tests to verify cleanliness.
• pH Testing: Check the pH of the final rinse water to ensure no detergent residues remain.

7.0 DOCUMENTATION:

• Maintain a cleaning record in the logbook with the date, time, and signature of the responsible person.
• Ensure that all executed cleaning processes are documented and approved.

8.0 REFERENCES:

• Equipment manufacturer’s cleaning guidelines.
• cGMP guidelines for equipment cleaning procedures.
• Internal quality assurance policies.

9.0 ANNEXURES:

• Annexure 1: Cleaning Log Sheet
• Annexure 2: Swab Test Report Format

This SOP for Fluid Bed Dryer ensures compliance with cGMP guidelines and maintains product integrity while preventing cross-contamination.

© 2024 Crivva - Business Promotion. All rights reserved.