17. SOP for Optimizing Particle Size in Nasal Suspensions
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SOP for Optimizing Particle Size in Nasal Suspensions

Standard Operating Procedure for Optimizing Particle Size in Nasal Suspensions

1) Purpose

The purpose of this SOP is to outline the procedure for optimizing the particle size in nasal suspensions to ensure uniform drug delivery and effective therapeutic action.

2) Scope

This SOP applies to all personnel involved in the preparation, optimization, and testing of nasal suspensions at [Company Name].

3) Responsibilities

Operators: Responsible for monitoring and optimizing particle size during formulation.
QA: Verifies the particle size and ensures that it meets formulation specifications.

4) Procedure

4.1 Selection of Equipment

4.1.1 Homogenizer or Milling Equipment

Select appropriate equipment (e.g., homogenizer, ball mill) to reduce particle size to the desired range (e.g., 1-10 microns).
Ensure that the equipment is calibrated and functioning correctly before use.

4.1.2 Particle Size Analyzer

Ensure the particle size analyzer is calibrated to measure the size distribution accurately.

4.2 Particle Size Reduction

4.2.1 Homogenization

Add the suspension ingredients into the homogenizer, and adjust the speed and pressure according to formulation guidelines.
Run the homogenizer for the required time to reduce the particle size.

4.2.2 Milling

If using a milling process, add the suspension to the ball mill or jet mill and run it at the recommended speed and time.

4.3 Particle Size Analysis

4.3.1 Measurement

Take a sample of the nasal suspension and measure the particle size distribution using a laser diffraction particle size analyzer or dynamic light scattering (DLS).
Ensure the particle size falls within the desired range specified in the formulation.

4.4 Stability Testing

4.4.1 Stability of Suspension

Monitor the suspension stability to ensure the particles remain evenly dispersed and do not aggregate over time.
Perform stability tests at regular intervals to check particle size, viscosity, and sedimentation.

4.5 Documentation

Document the particle size reduction process, equipment parameters, and results in the batch manufacturing record (BMR).
Record the particle size distribution values in the particle size log, including operator initials and QA approval.

5) Abbreviations, if any

DLS: Dynamic Light Scattering
QA: Quality Assurance
BMR: Batch Manufacturing Record

6) Documents, if any

Batch Manufacturing Record (BMR)
Particle Size Distribution Log

7) References, if any

USP 39 – Particle Size Analysis of Suspensions

8) SOP Version

Version 1.0

Annexure

Particle Size Distribution Log Template


  
    Date
    Formulation
    Particle Size (µm)
    Operator Initials
    QA Approval
  
  
    DD/MM/YYYY
    Formulation Name
    Size
    Operator Name
    QA Name