SOP Guide for Pharma

Tablets: SOP for Optimizing Coating Suspension Viscosity – V 2.0

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Tablets: SOP for Optimizing Coating Suspension Viscosity – V 2.0

Standard Operating Procedure for Optimizing Coating Suspension Viscosity

Department Tablet
SOP No. SOP/TAB/034/2025
Supersedes SOP/TAB/034/2022
Page No. Page 1 of 6
Issue Date 28/07/2025
Effective Date 02/08/2025
Review Date 28/07/2026

1. Purpose

This SOP defines the procedure for optimizing the coating suspension viscosity during tablet coating processes. Optimizing the viscosity ensures uniform coating application, prevents coating defects, and improves tablet quality by controlling the flow characteristics of the coating suspension.

2. Scope

This SOP applies to the tablet coating process and focuses on optimizing the coating suspension viscosity. The procedure covers the preparation, mixing, and adjustments required to achieve the desired viscosity for the coating solution used in the production of tablets.

3. Responsibilities

4. Accountability

The Production Manager is accountable for ensuring the correct preparation and optimization of the coating suspension. The QA Manager is responsible for ensuring that the process follows this SOP and that all quality checks are performed properly.

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5. Procedure

5.1 Coating Suspension Preparation

  1. Prepare the coating suspension by mixing the specified ingredients, such as the film-forming agent, solvents, plasticizers, and other excipients, according to the formulation.
  2. Ensure that the ingredients are mixed thoroughly to avoid clumping or uneven dispersion of materials.
  3. Use a high-shear mixer or other suitable equipment to ensure uniform mixing of the coating suspension components.
  4. Check the temperature of the suspension during mixing to ensure it is within the recommended range for the ingredients used.

5.2 Initial Viscosity Measurement

  1. After the suspension is prepared, measure the viscosity using a viscometer or rheometer to determine the initial viscosity of the coating solution.
  2. Record the viscosity value in the viscosity log (Annexure-1) and compare it to the desired range as per the product specifications.
  3. If the viscosity is outside the acceptable range, proceed with the adjustment process outlined in section 5.3.

5.3 Adjusting Coating Suspension Viscosity

  1. If the viscosity is too high or too low, adjust the coating suspension by adding a suitable solvent or thickener, depending on whether the suspension needs to be thinned or thickened.
  2. For thinning the suspension, add the specified solvent in small increments while mixing continuously. Monitor the viscosity after each addition to avoid over-thinning.
  3. If the suspension needs thickening, add the appropriate thickening agent or binder, mixing thoroughly to ensure it dissolves completely and evenly in the solution.
  4. Adjust the mixing speed, temperature, and time as necessary to achieve the desired viscosity.
  5. After each adjustment, measure the viscosity again to ensure that it is within the desired range and that the coating suspension is consistent.
  6. Record all viscosity adjustments and final viscosity values in the batch record (Annexure-2).
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5.4 Monitoring Viscosity During Production

  1. During tablet coating, continuously monitor the viscosity of the coating suspension to ensure that it remains within the acceptable range.
  2. Use in-line viscosity sensors or take periodic samples to measure viscosity during the coating process.
  3. If any fluctuations in viscosity are detected, stop the coating process and make necessary adjustments as outlined in section 5.3.
  4. Ensure that the coating process is stopped if viscosity exceeds the upper limit or drops below the lower limit, as this could lead to coating defects such as uneven distribution or poor adhesion.

5.5 Post-Coating Suspension Testing

  1. Once the coating process is completed, measure the final viscosity of the coating suspension to ensure that it matches the target viscosity.
  2. Document the final viscosity in the batch record (Annexure-2) and include any corrective actions taken during the coating process if viscosity was adjusted.
  3. Ensure that all unused coating suspension is properly stored or disposed of according to the waste management SOP.

5.6 Documentation and Record-Keeping

  1. All viscosity measurements, adjustments, and final results must be documented in the viscosity log (Annexure-1) and batch record (Annexure-2).
  2. Any deviations from the desired viscosity range must be recorded, along with the corrective actions taken.
  3. Ensure that all records are signed off by the responsible personnel and are retained for future reference and audits.
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6. Abbreviations

7. Documents

  1. Viscosity Log (Annexure-1)
  2. Batch Record (Annexure-2)

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: Viscosity Log

Batch Number Tablet Type Viscosity Initial (cP) Viscosity Adjusted (cP) Remarks
Batch 001 Tablet A 350 360 Added solvent to achieve optimal viscosity
Batch 002 Tablet B 340 330 Added thickener to adjust viscosity

Annexure-2: Batch Record

Batch Number Tablet Type Coating Suspension Viscosity Final Tablet Quality Remarks
Batch 001 Tablet A 360 cP Pass Coating applied successfully
Batch 002 Tablet B 330 cP Pass Adjustment made to viscosity during production

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 Viscosity Adjustment Procedures Improved Adjustment Techniques QA Head
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