SOP for High-Pressure Homogenization for Nanoparticle Production

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

any residual particles or contaminants.

4.4 Storage of Nanoparticles

4.4.1 Storage Conditions

4.4.1.1 Store the nanoparticle suspension in sealed, sterile containers at 4°C, or freeze-dry for long-term storage if necessary.

5) Abbreviations, if any

DLS: Dynamic Light Scattering
QA: Quality Assurance

6) Documents, if any

High-Pressure Homogenization Process Logbook

7) References, if any

Manufacturer’s instructions for high-pressure homogenizer

8) SOP Version

Version 1.0

Annexure

High-Pressure Homogenization Process Logbook Template


  
    Date
    Batch Number
    Pressure (bar)
    Particle Size
    Encapsulation Efficiency
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Pressure Used (e.g., 1000 bar)
    Size in nm
    % Encapsulation
    Operator Name
    QA Name

Date	Batch Number	Pressure (bar)	Particle Size	Encapsulation Efficiency	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Pressure Used (e.g., 1000 bar)	Size in nm	% Encapsulation	Operator Name	QA Name