Standard Operating Procedure for Compression Force Impact Analysis on Tablet Hardness
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/099/2025 |
| Supersedes | SOP/TAB/099/2022 |
| 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 analyzing the impact of compression force on tablet hardness, ensuring that tablets meet the required hardness specifications for product quality and performance.
2. Scope
This SOP applies to the compression force impact analysis on tablets during manufacturing, ensuring that the compression process does not adversely affect the tablet hardness, which is critical for handling, storage, and dissolution.
3. Responsibilities
- Manufacturing Personnel: Responsible for adjusting compression force during the tablet compression process and ensuring that the tablet hardness meets the specified criteria.
- Quality Control (QC): Responsible for conducting the compression force impact analysis, testing tablet hardness, and ensuring that the tablets comply with hardness specifications.
- Quality Assurance (QA): Ensures that the compression force impact analysis procedure is followed, reviews the test results, and approves the batch for release based on the tablet hardness data.
4. Accountability
The QC Manager is accountable for ensuring the proper execution of compression force impact
analysis. The QA Manager is responsible for reviewing and approving the batch release based on hardness test results.
5. Procedure
5.1 Sample Collection
- Collect a representative sample of tablets from the batch, as specified in the batch record or pharmacopeial guidelines (usually a minimum of 10 tablets or as specified).
- Ensure that the tablets are free from defects such as cracks, chips, or discoloration that could affect the analysis.
- Label the sample appropriately for identification during testing.
5.2 Preparation of Compression Force Testing Apparatus
- Ensure that all testing equipment, such as hardness testers, compression machines, and load cells, are calibrated and functioning properly.
- Set up the compression machine to the specified compression force ranges, based on the tablet formulation and the batch record specifications.
- Verify that the testing environment (e.g., temperature and humidity) meets the specifications for the compression force impact test.
5.3 Performing Compression Force Impact Test
- Set the compression machine to a predetermined compression force based on the tablet formulation and product specifications.
- Compress a set of tablets at varying compression forces to evaluate the relationship between the compression force and tablet hardness.
- Measure the tablet hardness using an appropriate hardness tester (e.g., Pfizer hardness tester, or a similar device) at each compression force setting.
- Record the tablet hardness values for each compression force level (Annexure-1).
5.4 Data Recording and Calculation
- Record the compression force and corresponding tablet hardness values in the batch record (Annexure-1).
- Analyze the data to determine the correlation between compression force and tablet hardness. The goal is to identify the optimal compression force that results in the desired tablet hardness without causing any defects.
- Calculate the average tablet hardness for each compression force setting and identify the optimum force range that meets the product specifications for hardness.
5.5 Acceptance Criteria
- The tablet hardness must fall within the specified range outlined in the batch record or product specifications, which is typically in the range of 4–8 kg (or as specified).
- If the tablet hardness falls outside the specified range, investigate and document the findings in the deviation report (Annexure-2).
- Adjust the compression force settings and perform re-testing if necessary to meet the acceptance criteria.
5.6 Documentation and Record-Keeping
- Document all test results, including compression force, tablet hardness, and any deviations, in the batch record (Annexure-1).
- Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
- Maintain raw data, test results, and supporting documentation for future reference and regulatory compliance.
5.7 Post-Test Cleanup
- Clean all equipment used for compression force testing, including the hardness tester, compression machine, and sample containers, according to the cleaning SOP to prevent cross-contamination between tests.
- Ensure that all testing equipment is properly maintained and calibrated for future use.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
- Kg: Kilogram
7. Documents
- Batch Record (Annexure-1)
- Deviation Report (Annexure-2)
8. References
- USP <1216> – Tablet Hardness Testing
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Tablet Hardness Standards
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 Sample | Compression Force (kg) | Hardness (kg) | Result |
|---|---|---|---|---|
| Batch 001 | Tablet Sample | 5 | 6.2 | Pass |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | Batch 001 | Tablet hardness outside specification | Adjusted compression force and re-tested | John Doe |
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 Ranges | Refined tablet compression process | QA Head |