SOP Guide for Pharma

Tablets: SOP for Inspection of Granule Flow Properties During Compression – V 2.0

Auditor

Tablets: SOP for Inspection of Granule Flow Properties During Compression – V 2.0

Standard Operating Procedure for Inspection of Granule Flow Properties During Compression

Department Quality Control
SOP No. SOP/TAB/131/2025
Supersedes SOP/TAB/131/2022
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 inspecting the flow properties of granules during the compression process to ensure uniform and efficient tablet formation.

2. Scope

This SOP applies to the inspection of granule flow properties during tablet compression. It ensures that granules have appropriate flow characteristics for consistent tablet compression and quality.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that the granule flow properties are inspected accurately during the compression process. The QA Manager is responsible for reviewing and ensuring compliance with the inspection results.

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5. Procedure

5.1 Granule Flow Property Assessment

  1. Inspect the granules before and during the compression process to evaluate their flowability, which is crucial for consistent tablet formation.
  2. Granules should be free-flowing without clumping, bridging, or poor flow, which could cause irregular tablet weight or formation issues.

5.2 Flow Property Testing Methods

  1. Perform a flowability test using methods such as the “angle of repose” test, “Hausner ratio,” or “Carr index” to evaluate the granule’s flow characteristics.
  2. For the angle of repose test:
    • Place the granules in a funnel and allow them to flow freely onto a flat surface.
    • Measure the angle formed between the surface of the pile and the horizontal plane. A typical acceptable angle of repose range for granules is 25°–35°.
  3. For Hausner ratio or Carr index:
    • Calculate the bulk and tapped density of the granules to assess flowability. The Hausner ratio should ideally be between 1.2 and 1.5 for good flow.
    • The Carr index should ideally be below 15% for good flow.

5.3 Sample Collection

  1. Collect representative samples of granules at regular intervals during the granulation process, typically every 100 grams of granules produced or after each major granulation stage.
  2. Ensure that the sample is representative of the entire batch by collecting from different locations (top, middle, and bottom of the batch).
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5.4 Monitoring and Adjustments

  1. Monitor the flow properties during the compression process. If any issues, such as poor flow or clogging, are detected, adjust the compression machine settings or the granulation process.
  2. For poor flow, consider adjusting the granule size distribution, moisture content, or binder levels in the granulation process.
  3. If issues persist, perform additional granulation to optimize flow properties.

5.5 Documentation

  1. Record all granule flow property results, including test methods, values, and any corrective actions taken, in the batch record (Annexure-2).
  2. Document any deviations or corrective actions in the deviation report (Annexure-1).
  3. Ensure that all records are signed, dated, and reviewed by QA for compliance.

5.6 Acceptance Criteria

  1. Granules should exhibit good flowability with an angle of repose between 25° and 35° and a Hausner ratio between 1.2 and 1.5.
  2. If the flow properties fall outside the specified range, corrective actions should be taken, such as modifying the granulation parameters or reprocessing the granules.

5.7 Post-Compression Actions

  1. Once the granule flow properties are acceptable, proceed with the compression process and continue to monitor flow properties as needed during subsequent batches.
  2. Ensure that all monitoring equipment is cleaned and calibrated as required after each inspection.
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6. Abbreviations

7. Documents

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

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: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/12/2025 Batch 001 Poor granule flow resulting in uneven tablet weight Adjusted granule binder content and compression settings Jane Doe

Annexure-2: Batch Record

Sample Number Flow Property Test Result Action Taken
Sample 1 Good flowability (Hausner ratio 1.3) 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 flow testing methodology Improved testing procedure QA Head
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