Standard Operating Procedure for Supercritical Fluid Techniques in Nanoparticle Preparation

1) Purpose

This SOP outlines the use of supercritical fluid techniques for the preparation of nanoparticles, which allow for controlled particle size and purity. The supercritical fluid method is commonly used to prepare drug nanoparticles with enhanced solubility.

2) Scope

This SOP applies to all laboratory personnel involved in the use of supercritical fluids for the preparation of nanoparticles.

3) Responsibilities

• Operators: Responsible for following the supercritical fluid technique protocol accurately.
• QA: Ensures that nanoparticles prepared using supercritical fluids meet the required quality standards.

4) Procedure

4.1 Setup of Supercritical Fluid Apparatus

4.1.1 Equipment Preparation

• 4.1.1.1 Ensure that the supercritical fluid apparatus is cleaned, calibrated, and properly set up according to the manufacturer’s guidelines.
• 4.1.1.2 Check for leaks and ensure that all safety protocols are in place for handling supercritical CO₂ or other fluids.

4.1.2 Solvent and Drug Preparation

• 4.1.2.1 Dissolve the drug or active ingredient in a solvent appropriate for the supercritical fluid process (e.g., ethanol, acetone).
• 4.1.2.2 Set up the drug solution and supercritical fluid for introduction into the apparatus.

4.2 Supercritical Fluid Process

4.2.1 Introduction of Supercritical Fluid

• 4.2.1.1 Slowly introduce the supercritical fluid (e.g., CO₂) into the system at the specified temperature and pressure conditions.
• 4.2.1.2 Ensure that the flow rates of both the drug solution and supercritical fluid are consistent and as per the process requirement.

4.2.2 Particle Formation

• 4.2.2.1 As the supercritical fluid expands, nanoparticles are formed as the solvent evaporates and the drug precipitates.
• 4.2.2.2 Collect the formed nanoparticles in the collection chamber.

4.3 Washing and Drying

4.3.1 Washing with Solvent

• 4.3.1.1 Wash the nanoparticles using a suitable solvent to remove any residual supercritical fluid or impurities.

4.3.2 Drying of Nanoparticles

• 4.3.2.1 Dry the nanoparticles under vacuum or in a desiccator to ensure complete removal of solvent residues.

4.4 Characterization

4.4.1 Particle Size Analysis

• 4.4.1.1 Use dynamic light scattering (DLS) or similar techniques to measure the particle size of the nanoparticles.
• 4.4.1.2 Record the particle size and ensure it meets the required specifications.

4.5 Storage of Nanoparticles

4.5.1 Storage Conditions

• 4.5.1.1 Store the nanoparticles in sterile, sealed containers and maintain them at room temperature or 4°C depending on the stability of the formulation.

5) Abbreviations, if any

• DLS: Dynamic Light Scattering
• CO₂: Carbon Dioxide
• QA: Quality Assurance

6) Documents, if any

• Supercritical Fluid Process Logbook

7) References, if any

• Relevant literature on supercritical fluid techniques in nanoparticle preparation

8) SOP Version

Version 1.0

Annexure

Supercritical Fluid Process Logbook Template

  

    
Date
    
Batch Number
    
Fluid Used
    
Particle Size
    
Encapsulation Efficiency
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Fluid (e.g., CO2)
    
Size in nm
    
% Encapsulation
    
Operator Name
    
QA Name