SOP Guide for Pharma

Tablets: SOP for Bulk Density Testing for Granules – V 2.0

Auditor

Tablets: SOP for Bulk Density Testing for Granules – V 2.0

Standard Operating Procedure for Bulk Density Testing for Granules

Department Quality Control
SOP No. SOP/TAB/112/2025
Supersedes SOP/TAB/112/2022
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 performing bulk density testing of granules used in tablet formulations, ensuring that the granules meet the required specifications for quality and consistency.

2. Scope

This SOP applies to the testing of bulk density of granules, which is an important parameter to assess the flowability and compressibility of the granules in tablet manufacturing.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that bulk density testing is performed accurately, and the results meet the quality standards. The QA Manager is responsible for reviewing the results and ensuring compliance with regulatory standards.

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5. Procedure

5.1 Sample Preparation

  1. Weigh approximately 50-100 g of granules for bulk density testing, ensuring a homogeneous sample.
  2. Transfer the granules into a clean, dry graduated cylinder or container with known volume (typically 100 mL or 250 mL).
  3. Ensure there is no moisture or dust contamination in the sample container.

5.2 Performing the Bulk Density Test

  1. Tap the graduated cylinder gently on a flat surface or use a tapping apparatus for consistent tapping (e.g., 100 taps) to settle the granules.
  2. Record the final volume of the granules after tapping, ensuring it is stable and consistent.
  3. Calculate the bulk density using the following formula:
    • Bulk Density (g/mL) = Mass of the sample (g) / Volume of the granules (mL)

5.3 Repeat Testing

  1. Repeat the bulk density testing for a minimum of three different samples from the same batch to ensure reproducibility of the results.
  2. Ensure that all samples are tested under the same conditions and using the same volume measurement method.

5.4 Data Analysis and Calculation

  1. Calculate the average bulk density from the three measurements and report the final value.
  2. If any measurement deviates significantly (more than ±5%) from the others, investigate and perform re-testing.
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5.5 Acceptance Criteria

  1. The bulk density of the granules should fall within the predefined limits based on the formulation’s requirements (e.g., 0.5–1.0 g/mL for most tablet formulations).
  2. If the bulk density falls outside the acceptable range, investigate potential causes such as particle size distribution, moisture content, or compaction issues in the granulation process.
  3. Document any deviations and corrective actions taken (Annexure-1).

5.6 Documentation and Record-Keeping

  1. Record all bulk density test results, including the mass, volume measurements, and final bulk density calculations, in the batch record (Annexure-2).
  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, including weighing logs and any additional testing results, for regulatory compliance and future reference.

5.7 Post-Test Actions

  1. Clean the graduated cylinders or containers used for bulk density testing to remove any residual granules or powder.
  2. Dispose of used samples, solvents, and reagents according to the company’s waste disposal procedures.
  3. Ensure that laboratory instruments are maintained and calibrated according to the instrument SOP.

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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 Bulk density outside acceptable range Adjusted granulation process and re-tested John Doe

Annexure-2: Batch Record

Batch Number Sample Weight (g) Volume (mL) Bulk Density (g/mL) Result
Batch 001 100 g 150 mL 0.67 g/mL Pass

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 Acceptance Criteria Improved granule flowability requirements QA Head
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