Standard Operating Procedure for Preparation of Nanoparticle-Based Lyophilized Formulations

1) Purpose

This SOP outlines the procedure for preparing nanoparticle-based formulations intended for lyophilization, ensuring the stability and uniform dispersion of nanoparticles.

2) Scope

This SOP applies to all personnel involved in the preparation of nanoparticle-based lyophilized formulations, including formulation scientists and operators.

3) Responsibilities

• Formulation Scientists: Responsible for designing the nanoparticle-based formulation and selecting appropriate stabilizers.
• Operators: Responsible for preparing the nanoparticle solution following the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying the preparation process and documentation.

4) Procedure

4.1 Preparation of Nanoparticle Solution

4.1.1 Equipment Setup

• 4.1.1.1 Ensure that all equipment (e.g., homogenizers, mixers) is cleaned, sanitized, and calibrated before use.
• 4.1.1.2 Prepare sterile containers for the nanoparticle solution.

4.1.2 Weighing and Dispensing of Nanoparticles

• 4.1.2.1 Weigh the nanoparticles and excipients using a calibrated balance according to the BMR.
• 4.1.2.2 Dispense the nanoparticles into a suitable solvent (e.g., water for injection, WFI).

4.1.3 Solubilization and Mixing

• 4.1.3.1 Use mechanical stirring to evenly disperse the nanoparticles throughout the solution.
• 4.1.3.2 Ensure that the nanoparticles are uniformly distributed without aggregation.

4.2 Filtration and Storage

4.2.1 Filtration

• 4.2.1.1 Filter the nanoparticle solution using a 0.22-micron sterile filter to remove particulates.

4.2.2 Storage

• 4.2.2.1 Transfer the filtered nanoparticle solution into sterile containers and store under the