SOP Guide for Pharma

Tablets: SOP for Preventing Picking and Sticking in Coated Tablets – V 2.0

Auditor

Tablets: SOP for Preventing Picking and Sticking in Coated Tablets – V 2.0

Standard Operating Procedure for Preventing Picking and Sticking in Coated Tablets

Department Tablet
SOP No. SOP/TAB/022/2025
Supersedes SOP/TAB/022/2022
Page No. Page 1 of 8
Issue Date 29/05/2025
Effective Date 03/06/2025
Review Date 29/05/2026

1. Purpose

This SOP outlines the preventive measures and techniques for minimizing picking and sticking during the coating of tablets, ensuring high-quality coating with no defects in the final product.

2. Scope

This SOP applies to the coating process of tablets, focusing on preventing picking (tablet surface material adhering to the coating machine) and sticking (tablets adhering to one another) during the film coating process.

3. Responsibilities

4. Accountability

The Production Manager is accountable for ensuring that all coating processes are conducted per this SOP, and the QA Manager is responsible for reviewing and approving all process steps to ensure compliance with quality standards.

5. Procedure

5.1 Pre-Coating Preparation

  1. Ensure that the coating machine and all associated equipment are clean and free of residues from previous batches, following the cleaning SOP.
  2. Check that the film coating pan is properly aligned, and ensure the spray nozzles are calibrated to prevent uneven application of the coating.
  3. Verify that the tablets have been properly compressed and are free of any defects that could cause sticking or picking during coating.
  4. Ensure the coating solution is well-mixed and filtered to prevent particle contamination, which could lead to coating defects.
  5. Check the temperature and humidity levels in the coating environment to ensure they are within the specified range to prevent excessive moisture in the tablets.
See also  Tablets: SOP for Process Troubleshooting in Tablet Manufacturing - V 2.0

5.2 Adjusting the Coating Pan Speed

  1. Set the coating pan speed to the optimal range, ensuring a gentle rotation to prevent excessive tablet-to-tablet contact, which could lead to sticking.
  2. If tablets are sticking together during rotation, reduce the pan speed and check the process parameters.
  3. Ensure the tablet loading into the pan is consistent to avoid overloading, which could cause tablets to collide with one another, leading to sticking.

5.3 Controlling the Coating Solution Application

  1. Set the spray pressure and atomization parameters to ensure an even coating distribution over the tablets. The solution should be sprayed as a fine mist to avoid pooling on tablet surfaces, which can lead to picking.
  2. Apply the coating solution in multiple thin layers rather than one thick layer to ensure uniform application and prevent the coating from sticking to the pan or nozzle.
  3. Monitor the tablet surface during spraying to ensure that each tablet receives an even coating layer without pooling or excessive accumulation of the coating material.
  4. If picking or sticking occurs, stop the machine immediately and inspect the spray system to adjust the pressure or nozzle settings.

5.4 Drying Process and Airflow Control

  1. Ensure that the drying system is set to the appropriate temperature and airflow to prevent the tablets from becoming too moist or excessively dry.
  2. Maintain a controlled airflow over the tablets during the drying phase to ensure that the coating adheres evenly and does not cause tablets to stick to one another.
  3. Ensure that the temperature and humidity are consistent in the drying environment to maintain proper coating integrity without excessive moisture accumulation.
  4. If sticking or picking occurs due to insufficient drying, increase airflow or adjust the temperature settings to ensure proper drying.
See also  Tablets: SOP for Particle Size Analysis in Slow-Release Tablets - V 2.0

5.5 Tablet Inspection and In-Process Quality Control

  1. Inspect the coated tablets at regular intervals during the coating process to check for signs of sticking, picking, or irregular coating.
  2. If any signs of picking or sticking are found, immediately adjust the coating process parameters, including pan speed, spray pressure, or drying temperature, to rectify the issue.
  3. Perform a uniformity test for coating thickness and ensure that the tablets have a consistent coating layer, free from defects such as clumping or uneven coating.
  4. Document the results of the inspections, including any corrective actions taken, in the batch record (Annexure-1).

5.6 Final Coated Tablet Inspection

  1. Once the coating process is complete, perform a final inspection to ensure that the tablets are free from picking or sticking defects.
  2. Check the appearance, coating uniformity, and tablet integrity. Ensure that the tablets are smooth, shiny, and free from any sticking or surface material transfer.
  3. Conduct dissolution testing to verify that the film coating does not interfere with the tablet’s intended release profile.
  4. If any tablets are found with defects, segregate them for further examination or rework and document the findings in the batch record.

5.7 Packaging and Storage

  1. Once the coated tablets pass the final inspection, package them in appropriate containers to protect them from moisture and air that could affect the coating quality.
  2. Ensure that the packaging material used is suitable for coated tablets, providing protection from environmental factors such as light and humidity.
  3. Store the coated tablets in a controlled environment with proper temperature and humidity levels to prevent degradation of the coating or sticking between tablets.
See also  Tablets: SOP for Uniformity of Dosage Units Testing in Tablets - V 2.0

5.8 Documentation and Record-Keeping

  1. Document all process parameters, including spray settings, drying conditions, and tablet inspection results in the batch record (Annexure-2).
  2. Ensure that any corrective actions taken during the process are properly recorded, including changes in pan speed, spray pressure, or drying temperature.
  3. Review all records for compliance with internal and regulatory standards, ensuring that the batch meets the required specifications for coating quality and tablet integrity.

6. Abbreviations

7. Documents

  1. Batch Record (Annexure-1)
  2. Coating Process Log (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: Batch Record

Batch Number Tablet Type Spray Pressure Coating Thickness Drying Temperature Remarks
Batch 001 Tablet A 3 bar 2.5% 50°C Within specifications
Batch 002 Tablet B 3.5 bar 2.8% 52°C Minor adjustment, resolved

Annexure-2: Coating Process Log

Batch Number Tablet Type Spray Pressure Atomization Drying Temperature Remarks
Batch 001 Tablet A 3 bar Fine mist 50°C Within specifications
Batch 002 Tablet B 3.5 bar Medium mist 52°C Adjusted for coating thickness

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 Process Parameters Optimization of Coating Process QA Head
Exit mobile version