SOP Guide for Pharma

Tablets: SOP for Applying Protective Seal Coating for Sugar-Coated Tablets – V 2.0

Auditor

Tablets: SOP for Applying Protective Seal Coating for Sugar-Coated Tablets – V 2.0

Standard Operating Procedure for Applying Protective Seal Coating for Sugar-Coated Tablets

Department Tablet
SOP No. SOP/TAB/047/2025
Supersedes SOP/TAB/047/2022
Page No. Page 1 of 7
Issue Date 06/10/2025
Effective Date 11/10/2025
Review Date 06/10/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish the procedure for applying a protective seal coating on sugar-coated tablets. This coating helps to protect the sugar coating from environmental factors such as moisture and contamination, ensuring the stability and integrity of the tablets.

2. Scope

This SOP applies to the application of protective seal coating to all sugar-coated tablets produced in the tablet manufacturing facility. It covers the preparation of the coating solution, the application process, and quality checks to ensure uniformity and effectiveness of the protective coating.

3. Responsibilities

4. Accountability

The Production Manager is accountable for ensuring that the protective seal coating process is carried out in accordance with this SOP. The QA Manager is responsible for ensuring compliance with all quality standards and regulatory requirements and for reviewing the documentation for accuracy.

See also  Tablets: SOP for Using Multi-Tooling Tablet Press for High Volume Production - V 2.0

5. Procedure

5.1 Pre-Coating Setup

  1. Ensure that the sugar-coated tablets are properly dried before applying the protective seal coating to prevent uneven coating.
  2. Check all equipment, including the coating pan, spray guns, and air flow systems, to ensure they are clean, calibrated, and free from any residual coating material from previous batches.
  3. Prepare the protective seal coating solution according to the formulation. The solution should typically consist of film-forming agents, plasticizers, and solvents to create a uniform, protective layer over the sugar coating.
  4. Verify that the environmental conditions in the coating room, including temperature and humidity, are within the specified range to ensure proper application and drying of the coating.

5.2 Application of Protective Seal Coating

  1. Load the sugar-coated tablets into the coating pan, ensuring they are evenly distributed for uniform coating.
  2. Activate the spray system and begin applying the protective seal coating to the tablets. Monitor the spray rate to ensure that it remains consistent and that the coating is applied evenly over the surface of each tablet.
  3. Maintain the coating pan at the specified temperature (typically 40°C to 50°C) to facilitate proper drying of the applied coating.
  4. Ensure that the tablets rotate evenly in the coating pan during the coating process to prevent clumping and to allow uniform distribution of the coating solution.
  5. Apply additional layers of the seal coating as necessary to achieve the required thickness and coverage, allowing each layer to dry before applying the next.

5.3 Drying and Curing

  1. After the application of each layer of protective seal coating, increase airflow to facilitate drying. Maintain the temperature of the coating pan between 40°C and 50°C to ensure the coating dries properly.
  2. Allow the tablets to rotate in the pan for the required time to ensure that the coating dries completely without becoming too thick or uneven.
  3. Check the tablets for any signs of tackiness or moisture retention. If the coating has not dried properly, continue the drying process until the coating is fully hardened.
See also  Tablets: SOP for pH Stability Testing for Enteric-Coated Tablets - V 2.0

5.4 Quality Control Checks

  1. Once the protective seal coating has dried, visually inspect the tablets to ensure that the coating is uniform, free from cracks, and adheres well to the sugar coating.
  2. Measure the coating thickness using appropriate tools to ensure that it meets the required specifications. The coating should be uniform and within the acceptable thickness range.
  3. Perform moisture content testing on a sample of tablets to verify that the protective seal coating is effective in preventing moisture absorption.
  4. Ensure that the tablets meet all the required specifications for hardness and friability, and confirm that the coating has not negatively impacted the tablet’s mechanical properties.
  5. Document the results of all inspections and tests in the batch record (Annexure-1) and review any deviations or issues in the deviation report (Annexure-2).

5.5 Post-Coating Inspection

  1. After the seal coating process is complete, inspect the tablets for any defects, such as streaking, uneven coating, or residue left on the surface.
  2. Check the final appearance of the tablets to ensure that they have a smooth, glossy finish and that the protective seal coating has adhered well without any visible defects.
  3. Document any deviations found during the inspection in the deviation report (Annexure-2) and take corrective actions as necessary.

5.6 Documentation and Record-Keeping

  1. Record all details of the protective seal coating process, including solution preparation, equipment settings, inspection results, and any deviations from the SOP, in the batch record (Annexure-1).
  2. Document any deviations encountered during the process in the deviation report (Annexure-2) and outline the corrective actions taken to address the issues.
  3. Store all records securely for future audits, regulatory inspections, and traceability purposes.

5.7 Equipment Maintenance and Cleaning

  1. After each use, clean the coating equipment, including the spray guns, hoses, and coating pan, according to the equipment cleaning SOP to prevent contamination between batches.
  2. Inspect the coating equipment regularly for any signs of wear or damage. Perform routine maintenance on spray systems and ensure that all components are functioning optimally.
  3. Document all cleaning and maintenance activities in the maintenance log (Annexure-3).
See also  Tablets: SOP for Granule Bulk Density Determination - V 2.0

6. Abbreviations

7. Documents

  1. Batch Record (Annexure-1)
  2. Deviation Report (Annexure-2)
  3. 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 Coating Solution Application Parameters Coating Quality
Batch 001 Tablet A Seal coat solution: 5% HPMC Temperature: 45°C, Airflow: 2.0 m³/min Pass
Batch 002 Tablet B Seal coat solution: 7% PVA Temperature: 50°C, Airflow: 2.5 m³/min Pass

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
18/09/2025 Batch 003 Uneven coating observed Adjusted spray rate and reprocessed tablets John Doe

Annexure-3: Maintenance Log

Maintenance Date Equipment Component Maintenance Performed Performed By Comments
10/09/2025 Coating Pan Cleaning and Calibration Jane Smith Calibration completed, 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 QA Head
Exit mobile version