SOP for Sieve Analysis of Pharmaceutical Samples

Shahzaib Aftab

Step-by-step SOP for sieve analysis of granules and in-process samples, including mesh sizes, procedure, calculations, and best practices.

🧠 Definition

Sieve analysis is a laboratory method used to determine particle size distribution by passing a sample through a series of sieves with decreasing mesh sizes, ensuring uniformity and quality in pharmaceutical granules.

📊 Mesh Size Distribution

Mesh SizeParticle Category
16 MeshCoarse granules
20 MeshMedium coarse particles
40 MeshFine granules
60 MeshVery fine particles

📋 Quick SOP Steps

Steps for Sieve Analysis:

  1. Arrange sieves in ascending order
  2. Weigh sample (10–15 g)
  3. Place sample on top sieve
  4. Separate particles using spatula
  5. Collect fractions on each sieve
  6. Weigh and record each fraction
  7. Calculate percentage distribution

Introduction

Particle size distribution plays a crucial role in pharmaceutical manufacturing, influencing flow properties, dissolution rate, and product uniformity. This sieve analysis SOP provides a standardized method to evaluate granule size distribution for quality control and process optimization.

🧬 Semantic Content Layer

Sieve analysis in pharmaceutical quality control involves separating particles using standardized mesh sizes to determine particle size distribution. This ensures analytical accuracy, process consistency, and compliance with GMP guidelines while supporting product quality and performance.

1. Objective

To lay down the procedure for sieve analysis.

2. Scope

Applicable for sieve analysis of granules and in-process samples.

3. Responsibility

  • Execution: Technical Assistant
  • Checking: Executive / Manager

4. Accountability

  • Head of Department

⚙️ 5. SOP Procedure

5.1 Operation (Sieve Analysis Procedure)

Step-by-Step Procedure

  1. Use 16, 20, 40, and 60 mesh sieves.
  2. Arrange sieves in ascending order (coarse to fine).
  3. Weigh 10–15 g of sample.
  4. Place sample on top (16 mesh sieve).
  5. Stir granules with stainless steel spatula.
  6. Allow finer particles to pass through successive sieves.
  7. Collect and weigh particles retained on each sieve.

5.2 Measurement & Calculation

  1. Record weights retained on:
    • 20 mesh
    • 40 mesh
    • 60 mesh
    • below 60 mesh
  2. Calculate percentage distribution:
    • Below 16 mesh
    • 16–20 mesh
    • 20–40 mesh
    • 40–60 mesh
    • Below 60 mesh
  3. Record results in log sheet

5.3 Calibration of Sieves

  • Verify mesh integrity before use
  • Ensure sieve cleanliness
  • Use calibrated weighing balance
  • Replace damaged sieves

5.4 Cleaning Procedure

  1. Remove residual particles from sieves
  2. Clean using brush or air
  3. Avoid damage to mesh
  4. Store in clean, dry condition

⚠️ Safety Precautions

  • Use gloves and mask
  • Avoid dust inhalation
  • Handle sieves carefully

❌ Common Mistakes

  • Incorrect sieve order
  • Overloading sample
  • Improper cleaning
  • Inaccurate weighing

✅ Best Practices

  • Use standardized mesh sizes
  • Maintain calibration records
  • Perform analysis consistently
  • Record data accurately

📘 Abbreviations

  • SOP – Standard Operating Procedure

❓ FAQs

  1. What is sieve analysis?
    A method to determine particle size distribution.
  2. Why is it important?
    Ensures uniformity and product quality.
  3. What mesh sizes are used?
    16, 20, 40, and 60 mesh.
  4. What sample size is used?
    10–15 grams.
  5. How is distribution calculated?
    By percentage weight retained.
  6. Is it GMP compliant?
    Yes.
  7. What tools are required?
    Sieves, balance, spatula.
  8. What errors affect results?
    Improper sieve arrangement.
  9. How often should sieves be checked?
    Before each use.
  10. Can it be automated?
    Yes, using sieve shaker.