Standard Operating Procedure for Lamination and Stress Testing in Film Coating Process

Department	Tablet
SOP No.	SOP/TAB/038/2025
Supersedes	SOP/TAB/038/2022
Page No.	Page 1 of 7
Issue Date	17/08/2025
Effective Date	22/08/2025
Review Date	17/08/2026

1. Purpose

The purpose of this SOP is to describe the procedure for conducting lamination and stress testing during the film coating process of tablets. The test ensures that the film coating adheres properly to the tablet core and can withstand the physical stresses encountered during handling, storage, and transport.

2. Scope

This SOP applies to the film coating process for all tablet formulations that require lamination and stress testing. It covers the testing of coated tablets for their ability to resist cracking, delamination, or other physical defects.

3. Responsibilities

• Manufacturing Personnel: Responsible for preparing the coated tablets for testing, ensuring that the correct formulation and film-coating parameters are followed.
• Quality Control (QC): Responsible for conducting the lamination and stress tests, recording the results, and ensuring that the coating meets the required specifications.
• Quality Assurance (QA): Ensures that the testing is conducted in accordance with this SOP and reviews all test results to verify compliance with quality standards.

4. Accountability

The QC Manager is accountable for overseeing the lamination and stress testing procedure and ensuring that the tests are performed properly. The QA Manager is responsible for reviewing the test results and ensuring compliance with internal and regulatory standards.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that the tablets have completed the film coating process and are fully cured. Allow the tablets to cool to room temperature before testing to avoid any moisture or temperature-related issues.
2. Verify that the coating machine and other equipment used for the lamination process are cleaned and calibrated according to the maintenance SOP.
3. Prepare the necessary test equipment, including a universal testing machine or other stress-testing apparatus, to measure the resistance of the coated tablets to stress and lamination.
4. Label the samples for testing with the batch number, formulation, and sample identification.

5.2 Lamination Testing

1. Take a representative sample of tablets (at least 10 tablets per batch) for testing to ensure accurate results.
2. Place each tablet on the testing apparatus, ensuring that it is aligned correctly to avoid false readings.
3. Perform the lamination test by applying a controlled force to the tablet to simulate conditions such as handling or transportation. The force applied should be in accordance with the specifications outlined in the product’s quality standard.
4. Record the force at which the coating begins to crack or delaminate, ensuring that the values are within the acceptable range defined by the formulation’s specifications.
5. Repeat the test for each tablet in the sample. If any tablets fail the lamination test, investigate the cause of the failure, which may include coating thickness, formulation, or machine settings.

5.3 Stress Testing

1. Perform the stress testing on each tablet to assess the durability of the film coating under simulated mechanical stress.
2. Using the universal testing machine or appropriate stress-testing equipment, apply controlled pressure or mechanical stress to the tablet to measure its ability to withstand external force without breaking or causing the coating to peel.
3. Ensure that the stress levels applied during the test are consistent with the anticipated stress the tablets will experience during normal use and handling.
4. Record the maximum force that the tablet can withstand before breaking or cracking. Compare this with the required specifications for the tablet’s coating to ensure that it is within acceptable limits.

5.4 Post-Test Evaluation

1. After conducting the tests, examine the tablets for any visible defects, including cracks, chips, or delamination.
2. Document the results of the lamination and stress tests in the batch record (Annexure-1), noting the force values, any observed failures, and the overall performance of the coating.
3. If any tablets fail the test, investigate the cause and adjust the coating formulation or process as needed to improve the film adhesion and durability. Document all findings and corrective actions in the deviation report (Annexure-2).

5.5 Corrective Actions for Failed Tablets

1. If a tablet batch fails the lamination or stress test, identify the root cause of the failure, which may include coating defects, formulation issues, or equipment malfunctions.
2. Take corrective actions such as adjusting the coating formulation, increasing the curing time, or modifying the application process parameters (e.g., temperature, spray rate, or coating thickness).
3. Retest the batch after making the necessary adjustments to ensure that the tablets pass the lamination and stress tests. Document the re-testing results in the batch record (Annexure-1).

5.6 Documentation and Record-Keeping

1. Ensure that all results from the lamination and stress tests are documented in the batch record (Annexure-1), including force values and any observed defects in the coating.
2. Any deviations or failures must be recorded in the deviation report (Annexure-2), and the corrective actions taken must be documented in the corrective action report (Annexure-3).
3. Ensure that all records are signed by the responsible personnel and stored for future reference, quality reviews, and regulatory audits.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

1. Batch Record (Annexure-1)
2. Deviation Report (Annexure-2)
3. Corrective Action Report (Annexure-3)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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	Lamination Test Result	Stress Test Result	Remarks
Batch 001	Tablet A	Pass	Pass	No defects found
Batch 002	Tablet B	Fail	Pass	Coating delaminated under stress

Annexure-2: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
20/07/2025	Batch 002	Coating delaminated during stress testing	Adjusted coating formulation	John Doe

Annexure-3: Corrective Action Report

Action Date	Action Number	Corrective Action Taken	Verification Date	Verified By
22/07/2025	CA-001	Revised coating formulation and process parameters	23/07/2025	Jane Smith

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 Lamination and Stress Testing Procedure	Improved Testing Protocol	QA Head