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