Standard Operating Procedure for Temperature Adjustment During Film Coating Process
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/163/2025 |
| Supersedes | SOP/TAB/163/2022 |
| 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 adjusting and maintaining the temperature during the film coating process of tablets, ensuring uniform coating application and product quality.
2. Scope
This SOP applies to the temperature control during the film coating process of tablets to ensure consistent coating thickness, prevent over-drying, and ensure product uniformity.
3. Responsibilities
- Production Operator: Responsible for monitoring and adjusting the temperature during the film coating process as per the SOP requirements. Notifies QC if the temperature goes out of range.
- Quality Control (QC): Responsible for verifying that the temperature adjustments during the coating process are within specified limits and for documenting the results.
- Quality Assurance (QA): Ensures that the temperature control process during film coating is compliant with the SOP and reviews documentation for compliance.
4. Accountability
The Production Supervisor is accountable for ensuring that the temperature adjustments are made according to this SOP and that all equipment is functioning properly. The QC Manager is responsible for verifying the temperature data and ensuring it is within acceptable limits.
5. Procedure
5.1 Preparation for Film Coating Process
- Ensure that the coating pan, sprayers, and drying system are calibrated and functioning properly before starting the film coating process.
- Check that the required coating solution and excipients are available and prepared according to the batch record.
- Ensure that the temperature control system is in place and has been calibrated to ensure the accurate measurement and adjustment of temperature.
- Verify that the desired coating temperature and drying conditions are set in accordance with the product specifications and batch record.
5.2 Monitoring Temperature During Coating
- Monitor the temperature inside the coating pan regularly during the coating process to ensure it remains within the specified range, typically between 40°C and 50°C (or as specified in the batch record).
- Use the in-built temperature sensors or manually measure the temperature at regular intervals using a calibrated thermometer.
- Document the temperature readings in the batch record (Annexure-2) including the time of measurement and any adjustments made.
- If automated temperature monitoring systems are in use, ensure that the system is functioning correctly and verify that the data is logged properly.
5.3 Temperature Adjustment
- If the temperature readings fall outside the acceptable range, immediately adjust the temperature control settings to bring the coating temperature back into the desired range.
- Increase or decrease the heater settings or adjust the airflow and humidity levels as necessary to achieve the desired temperature.
- Check the impact of adjustments on the temperature and make further changes if needed to stabilize the process conditions.
- Document the adjustments made to the temperature settings in the batch record and ensure that the adjustments are within the permissible limits defined in the SOP.
5.4 Documentation of Results
- Record all temperature measurements and adjustments in the batch record (Annexure-2), along with the time, date, and the person performing the adjustment.
- If the temperature is outside the acceptable range for a prolonged period, initiate a deviation report (Annexure-1) and investigate the root cause of the deviation.
- Ensure that all records are signed by the responsible personnel and reviewed by QA for compliance with product specifications.
5.5 Corrective Actions for Temperature Deviations
- If the temperature deviation persists, investigate the cause, such as equipment malfunction, improper calibration, or incorrect settings.
- Re-calibrate the temperature control system or adjust the system components, including the heating unit, cooling system, or air circulation system, to restore the desired temperature.
- Re-test the temperature after adjustments to confirm that it is within the specified limits. Continue monitoring until temperature stability is achieved.
- Document all corrective actions taken, including re-calibration and any adjustments made to the temperature control system.
5.6 Acceptance Criteria
- The batch is considered acceptable if the coating temperature is within the specified range throughout the entire coating process, with no significant deviations.
- If temperature deviations are corrected promptly and do not affect tablet quality, the batch may still be accepted, provided there is no adverse impact on the tablet coating.
- If the temperature is outside the acceptable range for a prolonged period, the batch should be reviewed for potential impact on product quality and corrective actions should be taken as necessary.
5.7 Post-Testing Actions
- If the batch passes the temperature control check, proceed with the next step in the tablet manufacturing process, such as drying or packaging.
- If the batch fails, take corrective actions as documented in the deviation report, and rework the batch if necessary. Re-test the temperature after the corrective measures are implemented.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- CAPA: Corrective and Preventive Action
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <701> – Film Coating Specifications
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Tablet Coating Guidelines
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 | Temperature outside acceptable range | Adjusted heating unit settings and recalibrated equipment | John Doe |
Annexure-2: Batch Record
| Time | Temperature (°C) | Action Taken | Tested By |
|---|---|---|---|
| 08:00 AM | 45°C | No action needed | Jane Smith |
| 12:00 PM | 55°C | Adjusted heating unit | 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 temperature control process | Improved temperature monitoring and documentation | QA Head |