SOP Guide for Pharma

Tablets: SOP for Optimizing Surface Coating Uniformity – V 2.0

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Tablets: SOP for Optimizing Surface Coating Uniformity – V 2.0

Standard Operating Procedure for Optimizing Surface Coating Uniformity

Department Tablet
SOP No. SOP/TAB/063/2025
Supersedes SOP/TAB/063/2022
Page No. Page 1 of 7
Issue Date 25/12/2025
Effective Date 30/12/2025
Review Date 25/12/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for optimizing surface coating uniformity during tablet manufacturing. The goal is to ensure that the coating is applied evenly across all tablets, which is critical for consistent release and appearance.

2. Scope

This SOP applies to all tablet batches that undergo surface coating as part of the manufacturing process. It covers the optimization of coating parameters to ensure uniform application, including coating equipment setup, monitoring during the process, and post-coating quality checks.

3. Responsibilities

4. Accountability

The Production Manager is accountable for overseeing the tablet coating process, ensuring that the coating process is optimized for uniformity. The QA Manager is responsible for verifying that the coating process complies with this SOP and for approving any changes made to the coating parameters.

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5. Procedure

5.1 Preparing for Coating Process

  1. Ensure that the coating equipment, including the coating pan and spray nozzles, is clean and calibrated. Verify that all equipment is free of contamination from previous batches.
  2. Check that the coating solution is prepared according to the batch record, ensuring the correct concentration and viscosity. Filter the solution to remove any particulate matter.
  3. Ensure that all materials, including tablets and coating solutions, are within the required temperature range before starting the coating process.
  4. Verify that the tablet surface is prepared for coating, with the correct drying time and tablet hardness as per the specifications in the batch record.

5.2 Setting Up Coating Equipment

  1. Set the coating equipment to the specified parameters, including pan speed, spray rate, and atomization pressure, as indicated in the batch record.
  2. Ensure that the temperature of the air and the coating solution is within the required range to facilitate proper coating application and adhesion to the tablet surface.
  3. Ensure that the spray nozzles are properly aligned and that the coating solution is being evenly distributed across the tablets.
  4. Conduct a trial run with a small batch to verify that the coating is applied evenly. Make adjustments as needed to optimize the coating process.

5.3 Monitoring Coating Uniformity During the Process

  1. During the coating process, monitor key parameters such as pan speed, spray rate, and airflow to ensure they remain within the defined limits.
  2. Periodically stop the coating process and visually inspect the tablets for uniformity. Ensure that the coating is being applied evenly and that no tablet has excessive or insufficient coating.
  3. Check the coating weight on a sample of tablets at regular intervals throughout the process. Ensure that the weight increase is consistent across the batch, as per the batch record specifications.
  4. If any irregularities are detected, adjust the coating parameters, such as spray rate or pan speed, to achieve more uniform coating. Document all adjustments in the batch record.
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5.4 Post-Coating Quality Check

  1. Once the coating process is complete, remove a sample of tablets from the batch and conduct a quality check for coating uniformity. This includes checking the coating weight, appearance, and thickness of the coating.
  2. Perform visual inspection to check for defects such as uneven coating, drips, or streaks on the tablets. If any defects are found, the batch may need to be reworked or rejected.
  3. Conduct dissolution testing on a sample of coated tablets to ensure that the coating does not affect the tablet’s release profile.
  4. Ensure that the coated tablets meet all specified requirements for coating uniformity, appearance, and performance.

5.5 Documentation of Results

  1. Document all observations, adjustments, and test results in the batch record (Annexure-1), including coating weight, appearance, and any deviations observed during the coating process.
  2. Record any deviations in the deviation report (Annexure-2) and describe corrective actions taken to resolve them.
  3. Ensure that all documentation is complete, signed, and dated by the responsible personnel before the batch is moved to the next stage of production.

5.6 Calibration and Maintenance of Coating Equipment

  1. Ensure that the coating equipment is calibrated regularly according to the manufacturer’s specifications. This includes calibrating the spray nozzles, pan speed controls, and temperature settings.
  2. Perform routine maintenance checks to ensure that all parts of the coating equipment are in good working order. Replace any worn or damaged components as needed.
  3. Document all calibration and maintenance activities in the equipment maintenance log (Annexure-3).
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6. Abbreviations

7. Documents

  1. Batch Record (Annexure-1)
  2. Deviation Report (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 Coating Weight Tablet Appearance Coating Thickness Comments
Batch 001 5 mg Uniform 0.5 mm No defects

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
01/01/2025 Batch 002 Uneven coating Adjusted spray rate John Doe

Annexure-3: Equipment Maintenance Log

Maintenance Date Equipment Component Maintenance Performed Performed By Comments
12/12/2025 Coating Pan Calibration and 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 Coating Parameters Improved Process Efficiency QA Head
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