Standard Operating Procedure for Homogenization Techniques in Nasal Spray Formulation

1) Purpose

The purpose of this SOP is to provide guidelines for using homogenization techniques to ensure even distribution of active ingredients in nasal spray formulations.

2) Scope

This SOP applies to all personnel involved in the homogenization of nasal spray formulations at [Company Name].

3) Responsibilities

• Operators: Responsible for homogenizing formulations according to SOP guidelines.
• QA: Verifies that homogenization is performed properly to ensure product uniformity.

4) Procedure

4.1 Homogenizer Setup

4.1.1 Equipment Inspection

• Inspect the homogenizer to ensure it is clean and functioning properly before use.

4.1.2 Calibration

• Ensure the homogenizer is calibrated and documented in the equipment log before use.

4.2 Homogenization Process

4.2.1 Pre-Homogenization Steps

• Mix the formulation components in a suitable container before homogenization.

4.2.2 Homogenization

• Run the homogenizer at the specified speed and duration according to the formulation requirements.
• Ensure continuous mixing during homogenization to avoid settling or separation of components.

4.3 Post-Homogenization Testing

4.3.1 Particle Size Testing

• After homogenization, test the particle size distribution using a particle size analyzer to ensure uniformity.

4.3.2 pH and Viscosity Testing

• Test the pH and viscosity of the homogenized solution to ensure they meet formulation specifications.

4.4 Documentation

• Document the homogenization process, including the speed, duration, and test results in the batch manufacturing record (BMR).

5) Abbreviations, if any

• QA: Quality Assurance
• BMR: Batch Manufacturing Record

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Particle Size Distribution Log

7) References, if any

• ICH Q6A – Specifications: Test Procedures for New Drug Substances

8) SOP Version

Version 1.0

Annexure

Particle Size Distribution Log Template

  

    
Date
    
Formulation
    
Particle Size Range (µm)
    
Operator Initials
    
QA Approval
  
  

    
DD/MM/YYYY
    
Formulation Name
    
Size Range
    
Operator Name
    
QA Name