Tablets: SOP for Adjusting Compression Speed in High-Speed Tablet Machines – V 2.0
Standard Operating Procedure for Adjusting Compression Speed in High-Speed Tablet Machines
| Department |
Tablet |
| SOP No. |
SOP/TAB/019/2025 |
| Supersedes |
SOP/TAB/019/2022 |
| Page No. |
Page 1 of 7 |
| Issue Date |
14/05/2025 |
| Effective Date |
19/05/2025 |
| Review Date |
14/05/2026 |
1. Purpose
This SOP outlines the procedure for adjusting the compression speed in high-speed tablet machines to ensure optimal tablet quality, weight consistency, and operational efficiency during tablet production.
2. Scope
This SOP applies to all high-speed tablet machines used in the production of tablets, covering the adjustment of compression speed based on product specifications and process requirements.
3. Responsibilities
- Manufacturing Personnel: Responsible for adjusting the compression speed according to the process requirements and ensuring tablet quality during production.
- Quality Control (QC): Ensures that the compression speed settings meet the specifications and that tablets produced are within required quality parameters.
- Quality Assurance (QA): Ensures that the adjustment of compression speed follows this SOP and that proper documentation is maintained throughout the process.
4. Accountability
The Production Manager is accountable for ensuring the proper adjustment of compression speed and monitoring tablet quality. The QA Manager is responsible for reviewing and approving any adjustments to compression speed settings to ensure compliance with regulatory standards.
5. Procedure
5.1 Equipment Setup
- Ensure that the high-speed tablet machine is properly set up and calibrated before adjusting the compression speed.
- Check that all machine components, including punches, dies, and feeders, are properly installed and clean.
- Verify that the hopper is filled with the appropriate material for tablet production and is free from contaminants.
- Ensure that all relevant process parameters, such as tablet weight, hardness, and size, are defined in the batch record for reference.
5.2 Determining the Appropriate Compression Speed
- Refer to the product specifications to determine the recommended compression speed for the specific tablet formulation.
- Consider the properties of the tablet formulation (e.g., tablet size, hardness, excipient compatibility) to determine the ideal compression speed range.
- Consult with QC personnel to ensure that the compression speed aligns with the desired tablet quality, ensuring uniform weight and consistency.
- Adjust the compression speed based on the type of tablet being produced. For example, sustained-release tablets may require a slower compression speed to ensure uniformity in size and density, while immediate-release tablets may be compressed at a faster speed.
5.3 Adjusting Compression Speed on the Tablet Machine
- Locate the compression speed control panel on the tablet machine. This may include both manual and automated control settings.
- Adjust the compression speed by increasing or decreasing the settings based on the specifications for the batch.
- Ensure that the speed adjustment is gradual, and monitor the machine’s response to ensure that the change does not cause any issues such as excessive pressure, jamming, or inconsistent tablet formation.
- Record the adjusted speed settings in the batch record, including the reason for adjustment and any relevant observations (Annexure-1).
5.4 Monitoring Tablet Quality During Compression
- Monitor the tablet production closely after adjusting the compression speed, ensuring that the tablets produced meet the specified weight, hardness, and size criteria.
- Perform weight and hardness testing on a sample of tablets at regular intervals to ensure uniformity and consistency. Adjust the compression speed again if variations exceed acceptable limits.
- Conduct visual inspections for tablet defects such as cracks, chips, or uneven edges, which may indicate issues with compression speed settings.
- Document the results of all monitoring tests and inspections in the batch record (Annexure-2).
5.5 Adjusting Speed Based on Process Feedback
- If issues such as tablet breakage, over-compression, or under-compression are detected, adjust the compression speed accordingly to resolve the problem.
- In cases where the tablets are too soft or fragile, reduce the compression speed to allow for better compaction and tablet integrity.
- If tablets are being compressed too quickly, resulting in inconsistent tablet weight or hardness, reduce the speed to allow for more uniform compression.
- Work closely with QC to ensure that any adjustments are reflected in the product’s final specifications and do not impact the release profile or other tablet characteristics.
5.6 Final Check and Approval
- Once the compression speed has been adjusted and the tablet quality is within specification, approve the machine settings and allow production to continue.
- Ensure that any adjustments to the compression speed are documented in the batch record, including the rationale for the change and any quality checks performed.
- Ensure that the machine is regularly calibrated to avoid deviations in compression speed and tablet quality over time.
5.7 Documentation and Record-Keeping
- Document all changes to the compression speed settings in the batch record, including the date, time, reason for adjustment, and final speed settings (Annexure-1).
- Maintain records of tablet quality tests (weight, hardness, size) throughout the production process to track the impact of speed adjustments.
- Ensure that records are signed off by the responsible personnel and reviewed by QA for compliance with product specifications and regulatory requirements.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- RPM: Revolutions per Minute
7. Documents
- Batch Record (Annexure-1)
- Tablet Quality Monitoring 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
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Checked By |
Approved By |
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11. Annexures
Annexure-1: Batch Record
| Batch Number |
Compression Speed (RPM) |
Tablet Type |
Weight (mg) |
Hardness (kg) |
Remarks |
| Batch 001 |
45 RPM |
Tablet A |
500 |
8 |
Within specifications |
| Batch 002 |
50 RPM |
Tablet B |
510 |
7.5 |
Minor deviation, adjusted |
Annexure-2: Tablet Quality Monitoring Log
| Batch Number |
Tablet Type |
Tablet Weight (mg) |
Tablet Hardness (kg) |
Compression Speed (RPM) |
Remarks |
| Batch 001 |
Tablet A |
500 |
8 |
45 RPM |
Within specifications |
| Batch 002 |
Tablet B |
510 |
7.5 |
50 RPM |
Adjustment made |
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 Speed Settings |
Optimization of Compression Process |
QA Head |