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Tablets: SOP for Using Fluidized Bed Processor in Tablet Manufacturing – V 2.0

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Tablets: SOP for Using Fluidized Bed Processor in Tablet Manufacturing – V 2.0

Standard Operating Procedure for Using Fluidized Bed Processor in Tablet Manufacturing

Department Tablet
SOP No. SOP/TAB/024/2025
Supersedes SOP/TAB/024/2022
Page No. Page 1 of 8
Issue Date 08/06/2025
Effective Date 13/06/2025
Review Date 08/06/2026

1. Purpose

This SOP outlines the procedures for using a fluidized bed processor (FBP) in tablet manufacturing. The FBP is used for processes such as granulation, coating, and drying, ensuring that tablet quality meets the required specifications for uniformity, strength, and appearance.

2. Scope

This SOP applies to the operation of the fluidized bed processor in the granulation and coating processes in tablet manufacturing. It includes setup, operation, and cleaning procedures to ensure effective and efficient use of the equipment.

3. Responsibilities

4. Accountability

The Production Manager is accountable for ensuring that the FBP is operated according to this SOP. The QA Manager is responsible for ensuring compliance with SOPs and verifying that all process steps are properly documented and reviewed.

5. Procedure

5.1 Pre-Operation Setup

  1. Ensure that the fluidized bed processor is cleaned and sanitized according to the cleaning SOP before use. Verify that there is no residue from previous batches.
  2. Check that all components of the FBP are properly assembled, including the air supply, fluidizing bed, spray nozzles, and collection filters.
  3. Inspect the fluidizing air system to ensure that it is operating at the required air flow rate and pressure to properly fluidize the tablet granules or coating material.
  4. Verify that the required product formulation and raw materials are ready and meet the specifications for the process. Check the composition of the granulation binder or coating solution to ensure uniformity and consistency.
  5. Prepare all required equipment for granulation or coating, including spray nozzles, temperature control systems, and drying units, and ensure they are calibrated correctly.
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5.2 Granulation Process Using FBP

  1. Load the pre-weighed dry powder mixture into the fluidized bed processor hopper, ensuring that the material is free of contamination and evenly distributed.
  2. Activate the fluidizing air system to create a fluidized bed, ensuring the granules are suspended in the air and are subjected to constant agitation for uniform mixing.
  3. Spray the binder solution onto the dry powder mixture using the spray nozzles. Control the spray rate, pressure, and droplet size to achieve uniform coating.
  4. Monitor the moisture content of the granules during the process. Use in-process sampling and testing to ensure that the moisture level does not exceed the specified limits (typically 3% to 8%).
  5. Once the required granule size and moisture content are achieved, stop the spray process and continue fluidizing until the granules are dried to the specified moisture level (typically < 5%).
  6. After drying, collect and sample the granules for particle size distribution, uniformity, and moisture content tests.
  7. Document all granulation process parameters in the batch record (Annexure-1), including fluidizing air pressure, spray rate, and moisture content.

5.3 Coating Process Using FBP

  1. After granulation, transfer the granules to the fluidized bed processor for coating, ensuring that the pan is properly cleaned and ready for coating.
  2. Prepare the coating solution by dissolving film-forming agents, plasticizers, and colorants in the appropriate solvent. Ensure the solution is filtered to remove any solid particles.
  3. Start the fluidizing air system to create the fluidized bed. Ensure the granules are evenly suspended in the air, allowing uniform coating application.
  4. Spray the coating solution onto the granules using the spray nozzles. Adjust the spray rate, pressure, and atomization to ensure a uniform layer of coating.
  5. Monitor the coating thickness regularly using a coating thickness gauge or visual inspection to ensure the tablets meet the specified weight and coating thickness limits.
  6. Ensure proper drying of the coated tablets during the process by adjusting the temperature and airflow to prevent excessive moisture buildup, which could lead to sticking or uneven coating.
  7. Continue spraying and drying until the required coating thickness is achieved, and then stop the process.
  8. Document all coating process parameters, including spray rate, air flow, drying temperature, and coating thickness, in the batch record (Annexure-2).
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5.4 Post-Operation Procedures

  1. After the granulation or coating process is complete, stop the fluidizing air system and allow the granules or coated tablets to cool.
  2. Remove the granules or coated tablets from the fluidized bed processor and inspect them for defects such as over-coating, under-coating, or uneven drying.
  3. Perform final checks on the granules or coated tablets, including particle size, weight variation, and dissolution testing, to ensure they meet the specified product quality standards.
  4. Record the final inspection results in the batch record, including any defects or deviations encountered during the process.
  5. Shut down the fluidized bed processor, following the equipment shutdown and cleaning SOP to ensure proper cleaning before the next use.

5.5 Equipment Cleaning and Maintenance

  1. Clean the fluidized bed processor thoroughly after each batch, following the cleaning SOP to prevent cross-contamination and ensure equipment integrity.
  2. Perform regular maintenance on the equipment, including inspection of spray nozzles, fluidizing bed components, and air pressure systems to ensure proper operation and performance.
  3. Document all maintenance and cleaning activities in the equipment maintenance log (Annexure-3), ensuring compliance with regulatory requirements.

5.6 Documentation and Record-Keeping

  1. Ensure that all process parameters, including granulation or coating parameters, are documented in the batch record for traceability and regulatory compliance.
  2. Review all records and ensure that the granulation and coating processes are carried out according to the established specifications and any deviations are appropriately addressed.
  3. Store the batch records, equipment maintenance logs, and cleaning records as per company policy and regulatory requirements for audit purposes.
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6. Abbreviations

7. Documents

  1. Batch Record (Annexure-1)
  2. Coating Process Log (Annexure-2)
  3. Equipment Maintenance Log (Annexure-3)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number Tablet Type Granulation Method Coating Type Moisture Content (%) Remarks
Batch 001 Tablet A Wet Granulation Film Coating 3.2% Within specifications
Batch 002 Tablet B Dry Granulation Film Coating 4.1% Adjustment made

Annexure-2: Coating Process Log

Batch Number Tablet Type Spray Pressure Atomization Drying Temperature Remarks
Batch 001 Tablet A 3 bar Fine mist 50°C Within specifications
Batch 002 Tablet B 3.5 bar Medium mist 52°C Adjusted for coating thickness

Annexure-3: Equipment Maintenance Log

Maintenance Date Equipment Maintenance Type Performed By Remarks
01/03/2025 Fluidized Bed Processor Cleaning and Calibration John Doe Performed according to SOP
15/04/2025 Fluidized Bed Processor Inspection Jane Smith No issues found

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Creation QA Head
01/02/2025 2.0 Updated Fluidized Bed Processor Operation Optimization of Granulation and Coating Process QA Head
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