Standard Operating Procedure for Tablet Compression Force Monitoring and Adjustments
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/053/2025 |
| Supersedes | SOP/TAB/053/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 05/11/2025 |
| Effective Date | 10/11/2025 |
| Review Date | 05/11/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for monitoring and adjusting tablet compression force during the tablet manufacturing process. Proper compression force ensures that tablets are formed with the desired hardness, weight, and consistency, meeting quality specifications.
2. Scope
This SOP applies to all tablet compression machines used in tablet production. It includes guidelines for monitoring compression force during tablet compression, making necessary adjustments, and ensuring that the tablet’s physical properties meet the required standards.
3. Responsibilities
- Manufacturing Personnel: Responsible for setting up and operating the tablet compression machine, monitoring compression force, and making adjustments as needed.
- Quality Control (QC): Responsible for performing in-process checks of tablet compression force, tablet hardness, and ensuring the batch complies with quality standards.
- Quality Assurance (QA): Ensures compliance with the SOP, verifies documentation, and approves any changes to the compression force parameters.
- Maintenance Personnel: Responsible for ensuring that the tablet compression machine is functioning properly, calibrated, and maintained in good working condition.
4. Accountability
The Production Manager is accountable for ensuring that the tablet compression process is conducted according to this SOP. The QA Manager is responsible for reviewing the monitoring results and approving any adjustments made to the compression force during production.
5. Procedure
5.1 Pre-Compression Setup
- Verify that the tablet compression machine is clean and free of any previous batch residues. Follow the equipment cleaning SOP if necessary.
- Ensure that all necessary tooling, including punches and dies, is available and in good condition. Inspect tooling for wear and tear and replace if necessary.
- Load the appropriate material for compression, ensuring that the powder blend or granules meet the required specifications for tablet formation.
- Set up the tablet compression machine according to the batch record, including specifying the compression force range and tablet specifications (weight, thickness, hardness).
5.2 Monitoring Compression Force
- Start the tablet compression machine and begin the compression process.
- Monitor the compression force in real-time using the machine’s compression monitoring system. The compression force should fall within the range specified in the batch record.
- Periodically check the tablet hardness to ensure it corresponds with the compression force and meets product specifications.
- If the compression force deviates from the specified range, stop the machine and inspect the settings to ensure they are correct. Check for any blockages or equipment malfunctions that may be affecting the force application.
- Record the monitoring results in the batch record (Annexure-1), including compression force measurements, tablet weight, and hardness for each sampling interval.
5.3 Adjusting Compression Force
- If tablet hardness or other physical properties do not meet the specifications, adjust the compression force as follows:
- If tablets are too soft or breaking easily, increase the compression force.
- If tablets are too hard, causing excessive breakage or poor dissolution, decrease the compression force.
- After making an adjustment, re-test the tablets to verify the new compression force is within the acceptable range and that the tablets meet the desired specifications.
- Document all adjustments to the compression force in the batch record (Annexure-1), noting the reason for the adjustment and the changes made.
5.4 Compression Force Calibration
- Perform routine calibration of the tablet compression machine to ensure the force application mechanism is functioning correctly.
- Use a calibrated force gauge to verify that the machine’s compression force matches the applied force readings. If discrepancies are found, recalibrate the machine or perform maintenance to correct the issue.
- Ensure that calibration is performed at regular intervals as part of the preventive maintenance schedule and after any significant adjustments or repairs to the equipment.
5.5 In-Process Tablet Testing
- During production, perform in-process tests on the tablets, including tablet weight, thickness, and hardness, at regular intervals as per the batch record.
- Verify that the tablets meet the required specifications for tablet weight and hardness. Record the results in the batch record (Annexure-1).
- If any tablets fail to meet the specifications, investigate the cause and adjust the compression force or other parameters as needed. Document any deviations and corrective actions in the deviation report (Annexure-2).
5.6 Post-Compression Inspection
- After the compression process is completed, inspect the tablets for defects such as capping, lamination, or chips, which may indicate that the compression force was improperly set.
- If defects are observed, adjust the compression force and perform a re-test to ensure that the issue has been resolved.
- Verify that the tablets meet all quality criteria, including uniformity of weight, hardness, and appearance. Approve the batch for the next stage of production (e.g., coating or packaging) once the tablets meet the required specifications.
5.7 Documentation and Record-Keeping
- Document all compression force monitoring data, adjustments made, tablet testing results, and any deviations in the batch record (Annexure-1).
- Ensure that the batch record is reviewed by QA personnel for compliance with the SOP and regulatory requirements before proceeding with the next production step.
- Maintain all records for the required retention period, ensuring they are easily accessible for future audits and regulatory inspections.
5.8 Equipment Maintenance and Calibration
- Ensure that the tablet compression machine is regularly maintained and calibrated according to the equipment’s maintenance schedule.
- Perform periodic checks of the compression force monitoring system to verify that it is functioning correctly. Document all maintenance activities in the maintenance log (Annexure-3).
- If any equipment malfunction is detected during the compression process, stop production immediately and perform corrective maintenance before resuming the process.
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)
- Deviation Report (Annexure-2)
- Maintenance Log (Annexure-3)
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 | Compression Force | Tablet Hardness | Tablet Weight | Comments |
|---|---|---|---|---|
| Batch 001 | 10 kN | 7 kg | 500 mg | No deviations |
| Batch 002 | 12 kN | 8 kg | 500 mg | Minor adjustment to force |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 10/10/2025 | Batch 003 | Tablet hardness outside specification | Increased compression force | John Doe |
Annexure-3: Maintenance Log
| Maintenance Date | Equipment Component | Maintenance Performed | Performed By | Comments |
|---|---|---|---|---|
| 15/09/2025 | Tablet Compression Machine | Lubrication, Calibration | Jane Smith | Calibration verified and machine lubricated |
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 Compression Force Parameters | Improved Tablet Quality Control | QA Head |