Standard Operating Procedure for Preparation of Nanoparticles for Intravenous Administration
1) Purpose
This SOP outlines the procedure for preparing sterile nanoparticles for intravenous (IV) administration, ensuring the formulation is suitable for direct injection into the bloodstream for therapeutic use.
2) Scope
This SOP applies to laboratory personnel responsible for the preparation of nanoparticles designed for IV administration, with a focus on maintaining sterility, particle size, and drug release properties.
3) Responsibilities
- Operators: Responsible for preparing nanoparticles under aseptic conditions and ensuring that the formulation meets IV administration standards.
- QA: Verifies that the nanoparticle formulations are sterile and meet size and safety specifications for IV use.
4) Procedure
4.1 Preparation of Nanoparticles
4.1.1 Selection of Materials
- 4.1.1.1 Select biocompatible materials (e.g., PLGA, lipids) suitable for IV use to form the nanoparticles.
- 4.1.1.2 Ensure that all materials are sterile or can be sterilized without degradation.
4.2 Sterilization Process
4.2.1 Sterilization of Nanoparticles
- 4.2.1.1 Prepare the nanoparticle formulation under aseptic conditions in a cleanroom environment or laminar flow hood.
- 4.2.1.2 Sterilize the formulation using either filtration (0.22 μm filter) or autoclaving, depending on the stability of the nanoparticles.
4.3 Particle Size and Drug Release Testing
4.3.1 Dynamic Light Scattering (DLS)
- 4.3.1.1 Measure the particle size of the nanoparticles using DLS to ensure they are within the appropriate size range (typically 50–200 nm) for IV administration.
4.3.2 Drug Release Assay
- 4.3.2.1 Conduct in vitro drug release studies to ensure the drug is released at the desired rate for therapeutic efficacy after IV administration.
4.4 Storage of Nanoparticles
4.4.1 Storage Conditions
- 4.4.1.1 Store the sterile nanoparticle formulation in sealed, sterile containers at 4°C or room temperature, depending on the formulation stability.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
- IV: Intravenous
- QA: Quality Assurance
6) Documents, if any
- IV Nanoparticle Preparation Logbook
7) References, if any
- Guidelines for sterile preparation of pharmaceuticals for IV use
8) SOP Version
Version 1.0
Annexure
IV Nanoparticle Preparation Logbook Template
| Date | Batch Number | Material Used | Particle Size | Drug Release Rate | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Polymer/Lipid Type | Size in nm | Rate (mg/hr) | Operator Name | QA Name |
