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 conditions specified by the formulation.
4.3 Documentation
All steps involved in nanoparticle preparation, including weights, mixing times, and filtration, must be recorded in the Nanoparticle Preparation Logbook and verified by QA.
5) Abbreviations
- BMR: Batch Manufacturing Record
- WFI: Water for Injection
6) Documents
- Nanoparticle Preparation Logbook
7) References
- Research articles on nanoparticle formulations and lyophilization techniques
8) SOP Version
Version 1.0
Annexure
Nanoparticle Preparation Logbook Template
| Date | Nanoparticle Name | Batch No. | Quantity | Mixing Time | Operator Initials | QA Verification |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Nanoparticle Name | Batch Number | Quantity (grams) | Mixing Time (minutes) | Operator Name | QA Initials |