Standard Operating Procedure for Preparation of Nanoparticles for Intravenous Administration
1) Purpose
This SOP outlines the procedure for preparing nanoparticles intended for intravenous (IV) administration, focusing on producing nanoparticles with appropriate size, sterility, and biocompatibility for safe administration via the bloodstream.
2) Scope
This SOP applies to personnel involved in the formulation, sterilization, and quality testing of nanoparticles for IV administration in pharmaceutical or clinical settings.
3) Responsibilities
- Operators: Responsible for preparing and sterilizing nanoparticles for IV use as per this SOP.
- QA: Ensures that nanoparticles meet sterility and biocompatibility specifications for intravenous administration.
4) Procedure
4.1 Selection of Materials
4.1.1 Polymer or Lipid Selection
- 4.1.1.1 Use biocompatible and biodegradable materials such as PLGA, PEGylated lipids, or other approved polymers that can circulate in the bloodstream without causing toxicity or immune reactions.
4.2 Nanoparticle Preparation
4.2.1 Nanoprecipitation or Emulsification Method
- 4.2.1.1 Prepare nanoparticles using a nanoprecipitation or emulsification method, optimizing the formulation to achieve particle sizes between 100–200 nm, suitable for IV administration.
4.3 Sterilization
4.3.1 Filtration Method
- 4.3.1.1 Sterilize the nanoparticle suspension by passing it through a 0.22-micron sterile filter to remove any microbial contamination.
4.4 Characterization
4.4.1 Particle Size and Zeta Potential
- 4.4.1.1 Measure the particle size using dynamic light scattering (DLS) and assess zeta potential to ensure nanoparticle stability and
appropriate charge for circulation in the bloodstream.
4.5 Biocompatibility and Sterility Testing
4.5.1 In Vitro and In Vivo Testing
- 4.5.1.1 Perform in vitro cytotoxicity assays and in vivo testing (where applicable) to confirm the biocompatibility of the nanoparticles for IV use.
- 4.5.1.2 Conduct sterility testing according to standard protocols to confirm the absence of microbial contamination.
4.6 Storage
4.6.1 Storage Conditions
- 4.6.1.1 Store the sterilized nanoparticle suspension in sterile, sealed vials at 4°C to maintain stability until administration.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
- PLGA: Poly(lactic-co-glycolic acid)
- PEG: Polyethylene Glycol
6) Documents, if any
- Intravenous Nanoparticle Formulation Logbook
7) References, if any
- Guidelines for nanoparticle formulations for intravenous administration
8) SOP Version
Version 1.0
Annexure
Intravenous Nanoparticle Formulation Logbook Template
| Date | Batch Number | Polymer/Lipid Type | Particle Size | Zeta Potential | Sterility Test Results | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Polymer/Lipid Type | Size in nm | Zeta Potential (mV) | Pass/Fail | Operator Name | QA Name |