SOP for Preparation of Polymer-Based Nanoparticles

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

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