SOP for Preparation of Nanoparticle Suspensions

Standard Operating Procedure for Preparation of Nanoparticle Suspensions

1) Purpose

This SOP outlines the procedure for preparing stable nanoparticle suspensions used in drug delivery, diagnostics, and other applications. The goal is to ensure that nanoparticles are uniformly dispersed in the suspension and maintain stability over time.

2) Scope

This SOP applies to laboratory personnel responsible for the preparation of nanoparticle suspensions in a sterile and controlled environment.

3) Responsibilities

Operators: Responsible for following the SOP to prepare stable nanoparticle suspensions.
QA: Ensures that nanoparticle suspensions meet the required size, stability, and quality parameters.

4) Procedure

4.1 Preparation of Nanoparticles

4.1.1 Nanoparticle Selection

4.1.1.1 Select the desired type of nanoparticles based on the specific application (e.g., polymeric, metallic, or lipid-based nanoparticles).

4.2 Preparation of Suspension Medium

4.2.1 Solvent Selection

4.2.1.1 Prepare a suspension medium using distilled water, saline solution, or a buffer depending on the application.

4.2.2 Stabilizers

4.2.2.1 Add a stabilizer (e.g., PVA, Tween 80) to the suspension medium to prevent nanoparticle aggregation.

4.3 Suspending the Nanoparticles

4.3.1 Dispersion

4.3.1.1 Add the nanoparticles to the suspension medium under gentle stirring.
4.3.1.2 Use an ultrasonic bath or homogenizer to ensure uniform dispersion of the nanoparticles in the suspension.

4.3.2 Monitoring Particle Size

4.3.2.1 Measure the particle size using dynamic light scattering (DLS) to ensure the nanoparticles remain in the desired size range (typically less than 200 nm).

4.4 Storage and Stability Testing

4.4.1 Storage

4.4.1.1 Store the nanoparticle suspension in sterile, sealed containers at 4°C.

4.4.2 Stability Testing

4.4.2.1 Periodically test the suspension for particle size, zeta potential, and any signs of aggregation or sedimentation.

5) Abbreviations, if any

DLS: Dynamic Light Scattering
PVA: Polyvinyl Alcohol

6) Documents, if any

Nanoparticle Suspension Preparation Logbook

7) References, if any

Relevant literature on the preparation and stabilization of nanoparticle suspensions

8) SOP Version

Version 1.0

Annexure

Nanoparticle Suspension Preparation Logbook Template


  
    Date
    Batch Number
    Particle Type
    Particle Size
    Stabilizer Used
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Type of Nanoparticles
    Size in nm
    Stabilizer Name
    Operator Name
    QA Name

Date	Batch Number	Particle Type	Particle Size	Stabilizer Used	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Type of Nanoparticles	Size in nm	Stabilizer Name	Operator Name	QA Name