SOP Guide for Pharma

Tablets: SOP for Compression Force Impact Analysis on Tablet Hardness – V 2.0

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Tablets: SOP for Compression Force Impact Analysis on Tablet Hardness – V 2.0

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

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.

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5. Procedure

5.1 Sample Collection

  1. 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).
  2. Ensure that the tablets are free from defects such as cracks, chips, or discoloration that could affect the analysis.
  3. Label the sample appropriately for identification during testing.

5.2 Preparation of Compression Force Testing Apparatus

  1. Ensure that all testing equipment, such as hardness testers, compression machines, and load cells, are calibrated and functioning properly.
  2. Set up the compression machine to the specified compression force ranges, based on the tablet formulation and the batch record specifications.
  3. 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

  1. Set the compression machine to a predetermined compression force based on the tablet formulation and product specifications.
  2. Compress a set of tablets at varying compression forces to evaluate the relationship between the compression force and tablet hardness.
  3. Measure the tablet hardness using an appropriate hardness tester (e.g., Pfizer hardness tester, or a similar device) at each compression force setting.
  4. Record the tablet hardness values for each compression force level (Annexure-1).
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5.4 Data Recording and Calculation

  1. Record the compression force and corresponding tablet hardness values in the batch record (Annexure-1).
  2. 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.
  3. 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

  1. 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).
  2. If the tablet hardness falls outside the specified range, investigate and document the findings in the deviation report (Annexure-2).
  3. Adjust the compression force settings and perform re-testing if necessary to meet the acceptance criteria.

5.6 Documentation and Record-Keeping

  1. Document all test results, including compression force, tablet hardness, and any deviations, in the batch record (Annexure-1).
  2. Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
  3. Maintain raw data, test results, and supporting documentation for future reference and regulatory compliance.

5.7 Post-Test Cleanup

  1. 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.
  2. Ensure that all testing equipment is properly maintained and calibrated for future use.
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6. Abbreviations

7. Documents

  1. Batch Record (Annexure-1)
  2. Deviation Report (Annexure-2)

8. References

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
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