SOP Guide for Pharma

Tablets: SOP for Particle Size Analysis in Slow-Release Tablets – V 2.0

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Tablets: SOP for Particle Size Analysis in Slow-Release Tablets – V 2.0

Standard Operating Procedure for Particle Size Analysis in Slow-Release Tablets

Department Tablet
SOP No. SOP/TAB/086/2025
Supersedes SOP/TAB/086/2022
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 particle size analysis in slow-release tablets, ensuring that the particle size of the active pharmaceutical ingredient (API) and excipients is within the desired range to ensure the intended release profile.

2. Scope

This SOP applies to the particle size analysis of granules and powders used in the manufacture of slow-release tablets to ensure that the particle size distribution meets the specifications required for the formulation and performance of the tablets.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that particle size analysis is performed in compliance with this SOP and for reporting the results. The QA Manager is responsible for reviewing the results and approving the batch for release.

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5. Procedure

5.1 Sample Collection

  1. Collect a representative sample of granules or powders from the batch, as specified in the batch record.
  2. The sample should consist of an appropriate amount of granules or powder (typically 10–20 grams, or as specified in the batch record or pharmacopeial guidelines).
  3. Ensure that the sample is free from defects, contamination, or other visible issues.
  4. Label the sample appropriately for identification during testing.

5.2 Preparation of Particle Size Analysis Apparatus

  1. Ensure that the particle size analysis equipment, such as a sieve shaker, laser diffraction analyzer, or other suitable instruments, is calibrated and functioning properly.
  2. Prepare any required calibration standards or reference materials according to the manufacturer’s instructions and company procedures.

5.3 Performing the Particle Size Analysis

  1. For sieve analysis, weigh the required amount of granules or powder and place them in the sieve stack with the appropriate mesh sizes.
  2. Operate the sieve shaker for the specified time or until the particles have been adequately separated.
  3. For laser diffraction analysis, prepare the sample by dispersing it in an appropriate solvent, ensuring that the sample concentration is within the operating range of the instrument.
  4. For both methods, record the particle size distribution and the percentage of particles falling within the defined size ranges.

5.4 Data Recording and Calculation

  1. Record the particle size distribution data, including the median particle size (D50), the size at 10% (D10), and the size at 90% (D90) of the cumulative distribution, as well as any other relevant parameters.
  2. Ensure that the particle size distribution falls within the specifications set in the batch record or pharmacopeial guidelines (e.g., D50 should be within a specific range for the formulation to ensure proper release characteristics).
  3. Document the calculated results, including any observations, in the batch record (Annexure-1).
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5.5 Acceptance Criteria

  1. Ensure that the particle size distribution of the granules or powder meets the required specifications. Typically, the target particle size range will be specified in the batch record or pharmacopeial guidelines, based on the intended dissolution and release profile.
  2. If the particle size distribution does not meet the acceptance criteria, the batch should be investigated, and corrective actions should be documented in the deviation report (Annexure-2).

5.6 Documentation and Record-Keeping

  1. Document the particle size analysis results, including the individual particle size data, the mean particle size, and the distribution profile, in the batch record (Annexure-1).
  2. Record any deviations from the particle size specifications in the deviation report (Annexure-2), along with corrective actions taken.
  3. Ensure all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.

5.7 Post-Test Cleanup

  1. Clean the particle size analysis equipment, including sieves or laser diffraction apparatus, according to the manufacturer’s instructions and the company’s cleaning SOP.
  2. Ensure that all equipment is properly stored and maintained in good working condition 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 Sample Name Particle Size (D50) Particle Size (D10) Particle Size (D90) Result
Batch 001 Granules 250 µm 150 µm 400 µm Pass

Annexure-2: Deviation Report

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Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/12/2025 Batch 001 Particle size distribution out of specification Re-processed granules and adjusted milling process 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 Particle Size Testing Parameters Improved test methodology QA Head
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