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 |