Standard Operating Procedure for High-Pressure Homogenization in Nanoparticle Production

1) Purpose

This SOP outlines the high-pressure homogenization method used for reducing particle size in nanoparticle production, a technique commonly employed to achieve nanoparticles for drug delivery and other applications.

2) Scope

This SOP applies to all operators using high-pressure homogenizers to reduce the particle size of nanoparticles in formulations.

3) Responsibilities

• Operators: Responsible for setting up and operating the high-pressure homogenizer.
• QA: Ensures the final nanoparticles meet quality and size specifications.

4) Procedure

4.1 Preparation of Sample

4.1.1 Sample Preparation

• 4.1.1.1 Prepare the nanoparticle suspension as per formulation guidelines, ensuring that the starting particle size is suitable for homogenization.
• 4.1.1.2 Transfer the suspension into the homogenizer feed tank.

4.2 High-Pressure Homogenization

4.2.1 Equipment Setup

• 4.2.1.1 Calibrate the high-pressure homogenizer according to the manufacturer’s instructions.
• 4.2.1.2 Set the operating pressure between 500 and 1500 bar, depending on the formulation needs.

4.2.2 Particle Size Reduction

• 4.2.2.1 Pass the nanoparticle suspension through the homogenizer for multiple cycles (usually 3–5 passes) until the desired particle size is achieved.
• 4.2.2.2 Monitor the particle size during the process using dynamic light scattering (DLS) or a similar technique.

4.3 Cleaning and Maintenance

4.3.1 Cleaning of Equipment

• 4.3.1.1 Clean the homogenizer thoroughly after each batch using sterile water and a cleaning solution to remove