Standard Operating Procedure for Tablet Temperature Control During Compression
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/141/2025 |
| Supersedes | SOP/TAB/141/2022 |
| 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 tablet temperature during the compression process to ensure proper tablet formation and avoid damage to the active ingredients or excipients.
2. Scope
This SOP applies to the compression process in tablet manufacturing, specifically focusing on controlling the temperature of tablets during compression to ensure uniformity, quality, and stability of the final product.
3. Responsibilities
- Quality Control (QC): Responsible for monitoring tablet temperature during the compression process and verifying that the temperature remains within the specified range.
- Tablet Compression Operator: Responsible for maintaining and adjusting the compression parameters to control tablet temperature during compression.
- Quality Assurance (QA): Ensures compliance with the SOP, reviews temperature control data, and confirms that tablet temperature remains within the acceptable limits during the compression process.
4. Accountability
The QC Manager is accountable for ensuring that tablet temperature is monitored and controlled during the compression process. The QA Manager is responsible for reviewing the temperature control records
and ensuring compliance with quality standards.
5. Procedure
5.1 Temperature Control Setup
- Before starting the compression process, check and set up the tablet press machine to ensure proper temperature control mechanisms are in place, including cooling systems and temperature sensors.
- Verify that the temperature sensors are calibrated and functioning correctly. These sensors should be able to monitor tablet temperature in real-time during compression.
- Set the target temperature for tablet compression according to the formulation’s requirements. Typical target temperatures range from 20°C to 30°C, but these can vary based on the formulation’s sensitivity to heat.
5.2 Monitoring Tablet Temperature During Compression
- During the compression process, continuously monitor the temperature of the tablets using the installed sensors and temperature monitoring system.
- Record the tablet temperature at regular intervals, such as every 5 minutes or after every 1000 tablets, depending on the production batch size and the equipment being used.
- If the temperature exceeds the set threshold, halt the compression process and investigate the cause of the temperature rise.
- Adjust the compression machine’s cooling system or air circulation to bring the temperature back within the acceptable range.
5.3 Corrective Actions
- If the tablet temperature is found to be outside the acceptable range, immediately stop the compression process to prevent potential damage to the tablets or active ingredients.
- Investigate the root cause of the temperature deviation, such as insufficient cooling, equipment malfunction, or improper compression speed.
- Make necessary adjustments to the machine settings, such as reducing the compression speed, increasing the cooling system capacity, or modifying other machine parameters.
- Once the issue is addressed, resume the compression process and monitor the temperature continuously to ensure it remains within the specified range.
5.4 Documentation
- Document the temperature settings, monitoring results, and any corrective actions taken during the compression process in the batch record (Annexure-2).
- Record the temperature deviations and the corresponding corrective actions in the deviation report (Annexure-1).
- Ensure that all records are signed, dated, and reviewed by QA to verify compliance with quality standards.
5.5 Acceptance Criteria
- The tablet temperature should remain within the specified range during compression, typically between 20°C and 30°C, unless otherwise specified by the formulation or product requirements.
- If the tablet temperature exceeds the defined limits, corrective actions must be taken, and the batch may need to be stopped or reprocessed.
5.6 Post-Compression Actions
- Once the compression process is complete and the tablet temperature is verified to be within the required range, proceed with the next steps in tablet manufacturing, such as drying, coating, and packaging.
- Ensure that the tablet press machine is cleaned and calibrated according to the preventive maintenance schedule after each use to ensure proper functionality for the next batch.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- USP <701> – Tablet Compression Process
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Tablet Compression 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 | Tablet temperature exceeded 30°C | Adjusted compression speed and cooling system | John Doe |
Annexure-2: Batch Record
| Sample Number | Tablet Temperature | Deviation | Action Taken |
|---|---|---|---|
| Sample 1 | 28°C | Pass (Deviation: 2%) | Accepted |
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 procedure | Improved monitoring process | QA Head |