Standard Operating Procedure for Adhesion Monitoring in Sugar-Coated Tablets
| Department | Quality Control |
|---|---|
| SOP No. | SOP/TAB/132/2025 |
| Supersedes | SOP/TAB/132/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedure for monitoring the adhesion of sugar coating on tablets during the coating process, ensuring uniform and effective coating adhesion for product quality and stability.
2. Scope
This SOP applies to the adhesion monitoring of sugar-coated tablets during the coating process. It ensures that the sugar coating adheres properly to the tablets, preventing peeling, cracking, or detachment during subsequent processing steps.
3. Responsibilities
- Quality Control (QC): Responsible for monitoring the adhesion of the sugar coating during and after the coating process, and ensuring that it meets the required specifications.
- Coating Operator: Responsible for applying the sugar coating to tablets according to specified parameters and ensuring that the adhesion meets the required standards.
- Quality Assurance (QA): Ensures that adhesion monitoring is conducted according to this SOP and reviews the results for compliance with product specifications.
4. Accountability
The QC Manager is accountable for ensuring proper adhesion monitoring of the sugar coating on tablets. The QA Manager is responsible for reviewing the results and ensuring compliance with the established quality standards.
5. Procedure
5.1 Adhesion Monitoring Method
- After sugar coating is applied to the tablets, perform a visual inspection to check for uniform coating coverage and adhesion. The coating should be smooth, uniform, and free of cracks or peeling.
- Perform adhesion testing by placing the tablets in a mechanical tester that simulates handling and storage conditions. The test should assess the ability of the coating to stay intact without delaminating or peeling off under simulated stress.
5.2 Adhesion Test Methods
- One common method is the “Tape Test” where adhesive tape is applied to the surface of the coated tablet and quickly removed. If the coating adheres to the tape, the adhesion is considered insufficient.
- Alternatively, a “Fingernail Scratch Test” can be used, where a fingernail or similar object is used to gently scratch the coating. The coating should not peel or flake off under light pressure.
- The “Peel Test” can also be used, where a tablet is subjected to a gradual force to peel the coating off. The coating should resist detachment until the test exceeds a set threshold of force.
5.3 Sampling
- Collect a representative sample of tablets after coating (typically at least 10 tablets per batch).
- Ensure the sample represents the entire batch by collecting tablets from different locations (top, middle, and bottom of the batch). This helps to evaluate the consistency of adhesion throughout the batch.
5.4 Monitoring Frequency
- Perform adhesion testing on the first 10 tablets after the sugar coating process and then at regular intervals (e.g., every 100 tablets) during production.
- If any tablet fails the adhesion test, increase the frequency of monitoring to identify and resolve potential issues promptly.
5.5 Adjustments and Corrective Actions
- If the adhesion test fails, immediately inspect the coating process for potential issues such as inadequate coating solution viscosity, coating pan settings, or drying parameters.
- Adjust the coating parameters as necessary, such as increasing the coating pan speed or modifying the spray rate, and perform another round of adhesion testing after adjustments.
5.6 Documentation
- Record the results of the adhesion tests, including the sample number, test method, results, and any corrective actions taken, in the batch record (Annexure-2).
- Document any deviations from the acceptance criteria and corrective actions in the deviation report (Annexure-1).
- Ensure that all records are signed, dated, and reviewed by QA for compliance with quality standards.
5.7 Acceptance Criteria
- The sugar coating should adhere properly to the tablet without any peeling, cracking, or detachment under normal handling and storage conditions.
- Tablets with failed adhesion should be rejected, and the batch may need to be reworked depending on the severity of the issue.
5.8 Post-Coating Actions
- Once the tablets pass the adhesion test, proceed with the next stages of tablet manufacturing, such as drying, packaging, and storage.
- Ensure that the coating equipment is cleaned and maintained according to the preventive maintenance schedule after each batch.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <701> – Stability Testing of Pharmaceutical Products
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Sugar-Coating Specifications
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 | Poor adhesion in 4% of tablets | Adjusted coating solution viscosity and drying time | Jane Doe |
Annexure-2: Batch Record
| Sample Number | Adhesion Test Result | Action Taken |
|---|---|---|
| Sample 1 | Pass (No peeling or cracking) | 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 monitoring process | Improved monitoring standards | QA Head |