Standard Operating Procedure for Temperature and Humidity Control in Coating Areas
| Department | Quality Control |
|---|---|
| SOP No. | SOP/TAB/128/2025 |
| Supersedes | SOP/TAB/128/2022 |
| 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 controlling and monitoring temperature and humidity levels in the coating areas during the tablet manufacturing process to ensure uniform and high-quality coating.
2. Scope
This SOP applies to the temperature and humidity control systems in the coating areas used for the production of film-coated tablets. Proper environmental conditions are essential for achieving uniform coating.
3. Responsibilities
- Quality Control (QC): Responsible for monitoring the temperature and humidity levels in the coating areas and ensuring they meet the required specifications.
- Coating Operator: Responsible for ensuring that the coating process is carried out under the specified temperature and humidity conditions.
- Facilities/Engineering Department: Responsible for maintaining and calibrating the temperature and humidity control systems in the coating area.
- Quality Assurance (QA): Ensures that temperature and humidity control procedures are followed and reviews monitoring data for compliance.
4. Accountability
The QC Manager is accountable for ensuring that the temperature and humidity levels are maintained
within specified ranges. The Facilities Manager is responsible for the maintenance and calibration of the environmental control systems.
5. Procedure
5.1 Temperature and Humidity Range Specifications
- Temperature in the coating area should be maintained within the range of 20°C to 25°C (68°F to 77°F).
- Relative humidity should be controlled between 40% and 60% to ensure consistent coating quality.
- Any deviation from these ranges must be immediately corrected, and corrective actions should be documented in the deviation report (Annexure-1).
5.2 Monitoring Frequency
- Temperature and humidity should be continuously monitored throughout the coating process.
- Data should be recorded at regular intervals (e.g., every 30 minutes) to ensure that environmental conditions remain within the specified limits.
- For manual recording, ensure that readings are logged in the temperature and humidity log (Annexure-2).
- For automated systems, ensure that the data is saved and stored electronically for traceability.
5.3 Equipment Calibration and Maintenance
- Temperature and humidity control equipment should be calibrated at regular intervals, typically every six months or according to the manufacturer’s instructions.
- Ensure that calibration records are maintained and reviewed by QA for compliance with internal standards (Annexure-3).
- Perform maintenance of the environmental control systems as per the scheduled preventive maintenance plan to ensure proper functioning.
5.4 Adjustment of Temperature and Humidity
- If temperature or humidity deviates from the acceptable range, corrective actions must be taken immediately:
- Adjust air conditioning, heating, or humidifying systems to bring temperature and humidity levels within the specified range.
- If the adjustment is not successful, document the issue, and notify the Facilities/Engineering Department for further troubleshooting.
- Monitor the levels continuously after making adjustments to confirm that the environmental conditions remain within specifications.
5.5 Documentation
- Record all temperature and humidity readings in the temperature and humidity log (Annexure-2), including the time of reading, the measured values, and any corrective actions taken.
- Document any deviations from the required temperature and humidity ranges in the deviation report (Annexure-1), along with corrective actions.
- Ensure all records are signed and dated by the responsible personnel and reviewed by QA.
5.6 Acceptance Criteria
- The temperature and humidity levels must remain within the specified ranges of 20°C to 25°C and 40% to 60% relative humidity, respectively, for the entire duration of the coating process.
- If any reading falls outside the acceptable range, the batch should not proceed until the issue is resolved, and corrective actions are documented.
5.7 Post-Coating Actions
- Once the coating process is completed and the environmental conditions are stable, proceed with the drying, packaging, and storage of tablets as per the next steps in production.
- Ensure that the temperature and humidity control equipment is cleaned, calibrated, and maintained regularly.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
7. Documents
- Temperature and Humidity Log (Annexure-2)
- Deviation Report (Annexure-1)
- Calibration Record (Annexure-3)
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) – Temperature and Humidity Specifications for Tablet Coating
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 | Humidity > 60% for 30 minutes | Adjusted humidifier settings and rechecked | John Doe |
Annexure-2: Temperature and Humidity Log
| Time | Temperature (°C) | Humidity (%) | Action Taken |
|---|---|---|---|
| 10:00 AM | 22°C | 50% | No action needed |
Annexure-3: Calibration Record
| Equipment | Calibration Date | Next Calibration Due | Calibration Status |
|---|---|---|---|
| Temperature Controller | 01/02/2025 | 01/08/2025 | Calibrated |
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 calibration and control processes | Improved control measures | QA Head |