SOP Guide for Pharma

Tablets: SOP for Adhesion Testing of Coated Tablets During Production – V 2.0

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Tablets: SOP for Adhesion Testing of Coated Tablets During Production – V 2.0

Standard Operating Procedure for Adhesion Testing of Coated Tablets During Production

Department Tablet
SOP No. SOP/TAB/147/2025
Supersedes SOP/TAB/147/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To establish the procedure for performing adhesion testing of coated tablets during production to ensure that the film coating adheres properly and meets the required specifications for tablet durability and drug release.

2. Scope

This SOP applies to the testing of adhesion properties of the coating on tablets during the coating process to ensure that the tablets meet the required quality standards.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that adhesion tests are performed regularly during the tablet coating process. The QA Manager ensures that the testing process follows the SOP and verifies the results for compliance with the required specifications.

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5. Procedure

5.1 Sample Collection

  1. During the coating process, collect random samples of coated tablets from the production batch at defined intervals (e.g., after every 100 kg or batch).
  2. Ensure that the samples are representative of the entire batch and are collected according to the sampling procedure.

5.2 Adhesion Testing Method Selection

  1. Choose the appropriate adhesion testing method based on the type of coating used (e.g., tape test, peel test, or crosshatch test).
  2. Ensure that the selected testing method is suitable for the type of coating and complies with internal or regulatory specifications.

5.3 Performing Adhesion Testing

  1. For the tape test: Apply a piece of adhesive tape firmly to the surface of the coated tablet, then quickly remove it. Examine the amount of coating that is removed along with the tape.
  2. For the peel test: Place the tablet on a flat surface, and using a suitable tool, apply a force to peel the coating from the tablet. Measure the amount of coating that is removed and record the result.
  3. For the crosshatch test: Use a scalpel or similar tool to make a series of intersecting cuts on the coated surface, then apply adhesive tape as described above and record the amount of coating that is removed.
  4. Record the results of the adhesion test in the batch record (Annexure-2) and note any deviations or issues observed.
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5.4 Documentation and Records

  1. Document the adhesion test results, including the type of test performed, the results, and any deviations, in the batch record (Annexure-2).
  2. If the adhesion test fails, generate a deviation report (Annexure-1) and take corrective action, such as adjusting the coating process or formulation.
  3. Ensure that all records are signed, dated, and reviewed by QA personnel.

5.5 Acceptance Criteria

  1. The adhesion of the coating to the tablet must meet the predefined specifications, such as a minimum percentage of coating remaining after the adhesion test, or specific guidelines for peeling or tape removal.
  2. If the coating adhesion is below the specified threshold, the batch may need to be rejected, reprocessed, or further investigated.

5.6 Post-Testing Actions

  1. Once testing is complete, continue with subsequent production steps if the results meet the required specifications.
  2. If the adhesion test fails, evaluate the root cause, adjust the coating process or formulation, and retest the batch for adhesion before proceeding with further processing.
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6. Abbreviations

7. Documents

  1. Batch Record (Annexure-2)
  2. Deviation Report (Annexure-1)

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: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/12/2025 Batch 001 Coating adhesion failed the tape test Reformulated coating and reprocessed the batch John Doe

Annexure-2: Batch Record

Sample Number Adhesion Test Result Action Taken
Sample 1 Passed Accepted

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 adhesion test procedure Improved coating quality control QA Head
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