Standard Operating Procedure for Heat Application during Sugar Coating Process
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/037/2025 |
| Supersedes | SOP/TAB/037/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 12/08/2025 |
| Effective Date | 17/08/2025 |
| Review Date | 12/08/2026 |
1. Purpose
This SOP defines the procedure for applying heat during the sugar coating process for tablets. The application of controlled heat ensures the proper drying and uniform coating of tablets, which is crucial for the integrity, appearance, and performance of the final product.
2. Scope
This SOP applies to the sugar coating process used in tablet production, with a focus on the controlled application of heat to ensure uniform coating and effective drying of the sugar layer.
3. Responsibilities
- Manufacturing Personnel: Responsible for setting up the coating machine, applying heat according to the SOP, and ensuring the process operates as per specifications.
- Quality Control (QC): Responsible for monitoring the temperature during the coating process, verifying that the sugar coating meets the required standards, and ensuring the heat application is in accordance with this SOP.
- Quality Assurance (QA): Ensures that the heat application during sugar coating is performed according to this SOP and monitors compliance with internal and external quality standards.
4. Accountability
The Production Manager is accountable for overseeing the heat application during the sugar coating process and ensuring adherence to this SOP. The QA Manager is responsible for reviewing the test results and ensuring compliance with required coating specifications.
5. Procedure
5.1 Pre-Coating Setup
- Ensure that the coating machine is properly cleaned and free from any residue from previous batches.
- Verify that the sugar coating solution is prepared according to the formulation and that all ingredients are properly mixed.
- Set up the coating pan and ensure that the heat application equipment (e.g., hot air blower, steam system) is ready for operation and calibrated according to the manufacturer’s specifications.
- Check the temperature control system to ensure that it is functioning within the required range for sugar coating (typically between 45°C to 55°C depending on the formulation).
5.2 Heat Application Process
- Begin the coating process by applying the first layer of the sugar coating solution to the tablets while gradually increasing the pan speed.
- Start the heat application by setting the desired temperature on the heating system. Begin with low heat and gradually increase it to the specified level.
- Maintain the temperature of the coating pan at a consistent level to ensure proper drying of the sugar coating without causing melting or over-drying. Typically, maintain the pan temperature between 45°C and 55°C, depending on the product requirements.
- Apply heat during each phase of the coating process, ensuring that the tablets are dried evenly. Use a thermometer or temperature sensor to monitor the temperature throughout the process.
- Ensure that the heat application system is evenly distributing heat across the coating pan. Adjust the system if any hotspots are detected.
5.3 Monitoring and Adjustments
- Monitor the temperature and humidity throughout the coating process. Adjust the heat application if the temperature exceeds the upper limit or if it drops below the lower limit.
- Check the coating process at regular intervals for uniformity in tablet coverage. If the coating is too thick or uneven, adjust the heat or spray rate to ensure an even coating.
- If any issues such as clumping or uneven coating are observed, reduce the heat slightly and allow the coating to dry uniformly before proceeding.
- Ensure that the tablets do not overheat or remain in contact with excess heat for prolonged periods, as this could lead to degradation of the coating material.
5.4 Post-Coating Inspection
- After the coating process is complete, inspect the tablets for uniformity, appearance, and adhesion of the sugar coating.
- Ensure that the tablets have the desired finish (e.g., glossy, smooth) and that the coating has been uniformly applied without cracks or peeling.
- Check the hardness of the coated tablets to ensure they are not too brittle or fragile, indicating that they may have been over-dried due to excessive heat.
- Document all findings in the batch record (Annexure-1) and record any issues encountered during the heat application process, along with corrective actions taken.
5.5 Documentation and Record-Keeping
- All process parameters, including temperature and humidity readings during the heat application, must be documented in the batch record (Annexure-1).
- Ensure that the batch record includes the start and stop times for heat application, the temperature settings, and any deviations or adjustments made during the process.
- Retain all records for future review and audit purposes to ensure compliance with internal and regulatory quality standards.
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-1)
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 | Temperature During Coating | Humidity During Coating | Coating Quality |
|---|---|---|---|---|
| Batch 001 | Tablet A | 50°C | 60% | Pass |
| Batch 002 | Tablet B | 52°C | 58% | Pass |
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 Heat Application Parameters | Improved Process Control | QA Head |