Standard Operating Procedure for Tablet Drying Process
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/014/2025 |
| Supersedes | SOP/TAB/014/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 19/04/2025 |
| Effective Date | 24/04/2025 |
| Review Date | 19/04/2026 |
1. Purpose
This SOP defines the procedures for drying tablets after processing, ensuring that moisture content is controlled to prevent degradation, enhance stability, and meet product specifications.
2. Scope
This SOP applies to the tablet drying process following compression or coating, covering drying equipment setup, monitoring, and quality control procedures.
3. Responsibilities
- Manufacturing Personnel: Responsible for operating the drying equipment, ensuring proper drying times, temperatures, and air circulation.
- Quality Control (QC): Ensures that tablets are dried to the appropriate moisture content and meets quality standards by conducting moisture content testing.
- Quality Assurance (QA): Oversees compliance with this SOP and ensures that drying parameters meet the specifications.
4. Accountability
The Production Manager is accountable for the effective operation of the drying process. The QA Manager ensures compliance with regulatory standards and internal specifications.
5. Procedure
5.1 Drying Equipment Setup
- Ensure that the drying equipment (e.g., tray dryer, fluidized bed dryer) is clean and free from residue of previous batches.
- Verify that all components of the dryer, including air filters and temperature controls, are in good working order.
- Set the temperature and airflow parameters according to the product specifications for optimal drying. Typical settings range between 40°C to 60°C, depending on the tablet formulation.
- Ensure that the drying trays or baskets are appropriately loaded, ensuring even spacing between tablets to allow proper air circulation.
5.2 Loading Tablets into the Drying Equipment
- Ensure that tablets are properly inspected and free from cracks, chips, or defects before loading into the drying trays or baskets.
- Load the tablets evenly, ensuring they are not overcrowded and have adequate spacing between them for uniform airflow.
- Do not exceed the maximum load capacity of the dryer to avoid compromising airflow and drying efficiency.
5.3 Drying Process
- Start the drying equipment and allow the tablets to dry according to the set parameters (temperature, airflow, and time).
- Monitor the drying process periodically to ensure that tablets are drying evenly. If tablets are sticking together or show signs of excessive moisture, adjust the airflow or temperature settings accordingly.
- Ensure that the drying process is continuous, and that tablets are evenly exposed to airflow to prevent any accumulation of moisture.
- Check that the drying process is completed within the designated time and that the tablets do not overheat, which could affect tablet integrity or cause coating issues.
5.4 In-Process Quality Control
- Conduct moisture content testing at regular intervals during the drying process to ensure tablets meet the required specifications.
- Use methods such as Loss on Drying (LOD) or a moisture analyzer to determine the moisture content of the tablets.
- Record moisture content results in the batch record (Annexure-1). If the moisture content exceeds the acceptable limit, extend the drying process until the target moisture level is achieved.
5.5 Final Inspection
- After completing the drying process, perform a final inspection to ensure that the tablets are free from excess moisture and do not exhibit signs of damage, such as stickiness or warping.
- Verify the moisture content of the tablets using a moisture analyzer to confirm that they meet the required specifications.
- If tablets are not within the acceptable moisture range, return them to the dryer and continue drying until the target moisture level is achieved.
5.6 Cooling and Storage
- After drying, allow the tablets to cool to room temperature before transferring them to storage containers or the next stage in the manufacturing process.
- Store the dried tablets in a dry, cool environment to prevent them from absorbing moisture or being affected by humidity.
- Ensure that storage containers are clean and tightly sealed to protect tablets from moisture and contamination.
5.7 Equipment Shutdown and Cleaning
- After the drying process is complete, shut down the equipment and clean it according to the cleaning SOP.
- Ensure that all components in contact with the tablets (e.g., trays, baskets, airflow ducts) are thoroughly cleaned to prevent contamination between batches.
- Record the cleaning activities in the equipment cleaning log (Annexure-2) and ensure all records are completed for regulatory compliance.
5.8 Documentation and Record-Keeping
- Document all drying process parameters, including temperature, airflow rate, drying time, and moisture content results, in the batch record.
- Ensure that all records are reviewed, signed off, and stored for regulatory compliance.
- Document any deviations from the standard process and the corrective actions taken.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- LOD: Loss on Drying
7. Documents
- Batch Record (Annexure-1)
- Equipment Cleaning Log (Annexure-2)
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 | Moisture Content | Drying Time | Temperature | Remarks |
|---|---|---|---|---|---|
| Batch 001 | Tablet A | 1.5% | 4 hours | 50°C | Within specifications |
| Batch 002 | Tablet B | 2.0% | 4.5 hours | 55°C | Minor adjustment needed |
Annexure-2: Equipment Cleaning Log
| Equipment | Cleaning Date | Cleaning Method | Personnel |
|---|---|---|---|
| Tray Dryer 1 | 18/04/2025 | Washing with detergent and rinsing with water | John Doe |
| Tray Dryer 2 | 19/04/2025 | Washing with detergent and rinsing with water | 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 Drying Process Parameters | Optimization of Drying Process | QA Head |