Standard Operating Procedure for Lyophilization of Nanoparticle-Based Formulations
1) Purpose
This SOP outlines the procedure for lyophilizing nanoparticle-based formulations, which is used to improve the stability and shelf life of the nanoparticles by removing water through freeze-drying.
2) Scope
This SOP applies to personnel involved in the formulation, preparation, and lyophilization of nanoparticle-based products in pharmaceutical or research laboratories.
3) Responsibilities
- Operators: Responsible for performing the lyophilization process following this SOP.
- QA: Ensures the process parameters meet required specifications for nanoparticle stability and quality.
4) Procedure
4.1 Preparation of Nanoparticles
4.1.1 Nanoparticle Formulation
- 4.1.1.1 Prepare the nanoparticles using solvent evaporation, nanoprecipitation, or other standard methods suitable for the type of nanoparticles being lyophilized.
4.1.2 Addition of Cryoprotectants
- 4.1.2.1 Add cryoprotectants such as trehalose or mannitol to the nanoparticle suspension to prevent aggregation and damage during freeze-drying.
- 4.1.2.2 Ensure the concentration of the cryoprotectant is optimized based on the type of nanoparticle and its stability requirements.
4.2 Lyophilization Process
4.2.1 Freezing Step
- 4.2.1.1 Freeze the nanoparticle suspension by placing it in a lyophilizer at a temperature below -40°C to ensure the nanoparticles are completely frozen.
4.2.2 Primary Drying
- 4.2.2.1 Initiate the primary drying phase by applying a vacuum to the frozen sample to sublimate the water directly from ice to vapor.
4.2.3 Secondary Drying
- 4.2.3.1 Perform the secondary drying phase by gradually raising the temperature to remove any bound water, ensuring the nanoparticles remain stable without degradation.
4.3 Post-Lyophilization Testing
4.3.1 Reconstitution and Stability Testing
- 4.3.1.1 After lyophilization, reconstitute a portion of the nanoparticles in water to test for particle size and zeta potential stability using dynamic light scattering (DLS).
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
6) Documents, if any
- Lyophilization Process Logbook
7) References, if any
- Protocols for freeze-drying of nanoparticles
8) SOP Version
Version 1.0
Annexure
Lyophilization Process Logbook Template
| Date | Batch Number | Cryoprotectant Used | Freezing Temperature | Particle Size | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Cryoprotectant Used | Temperature (°C) | Size in nm | Operator Name | QA Name |