Standard Operating Procedure for Preparation of Polymer-Based Nanoparticles
1) Purpose
This SOP describes the process for preparing polymer-based nanoparticles, commonly used for drug delivery and other biomedical applications. It aims to ensure a consistent and high-quality preparation process.
2) Scope
This SOP applies to laboratory personnel involved in the preparation and processing of polymer-based nanoparticles in the research or production setting.
3) Responsibilities
- Operators: Responsible for the accurate preparation and processing of polymer-based nanoparticles according to this SOP.
- QA: Ensures compliance with protocols and verifies the quality of prepared nanoparticles.
4) Procedure
4.1 Polymer Preparation
4.1.1 Polymer Selection
- 4.1.1.1 Select appropriate polymers (e.g., PLGA, PEG) based on the desired properties of the nanoparticles (e.g., size, degradation rate).
- 4.1.1.2 Verify the quality of the polymer by reviewing certificates of analysis and performing any necessary pre-processing checks.
4.1.2 Polymer Dissolution
- 4.1.2.1 Dissolve the polymer in an appropriate solvent (e.g., acetone or ethanol) under continuous stirring until fully solubilized.
- 4.1.2.2 If heating is required, ensure the temperature does not exceed the polymer’s thermal stability.
4.2 Nanoparticle Formation
4.2.1 Emulsification
- 4.2.1.1 Slowly add the polymer solution to an aqueous phase containing stabilizers under high-speed homogenization to form an emulsion.
- 4.2.1.2 Continue mixing for 10–15 minutes to stabilize the emulsion.
4.2.2 Solvent Evaporation
- 4.2.2.1 Allow the solvent to evaporate under reduced pressure or by stirring at room temperature, leading to nanoparticle formation as the polymer precipitates.
- 4.2.2.2 Monitor particle size using dynamic light scattering (DLS) or other particle-sizing methods.
4.3 Collection and Washing of Nanoparticles
4.3.1 Centrifugation
- 4.3.1.1 Centrifuge the nanoparticle suspension at 10,000–20,000 g for 20–30 minutes to collect the nanoparticles.
- 4.3.1.2 Discard the supernatant and wash the nanoparticles by resuspending them in distilled water and repeating the centrifugation process.
4.4 Storage of Nanoparticles
4.4.1 Storage Conditions
- 4.4.1.1 Store the polymer-based nanoparticles in sterile, sealed containers at 4°C or freeze them for long-term storage, depending on the stability of the formulation.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
- PLGA: Poly(lactic-co-glycolic acid)
- PEG: Polyethylene glycol
- PPE: Personal Protective Equipment
6) Documents, if any
- Polymer-Based Nanoparticle Preparation Logbook
7) References, if any
- Polymer Material Safety Data Sheets (MSDS)
8) SOP Version
Version 1.0
Annexure
Polymer-Based Nanoparticle Preparation Logbook Template
| Date | Batch Number | Polymer Type | Particle Size | Encapsulation Efficiency | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Polymer Name | Size in nm | % Encapsulation | Operator Name | QA Name |