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 |