Standard Operating Procedure for Surfactant Use in Nanoparticle Formulations
1) Purpose
This SOP provides guidelines for the appropriate selection, handling, and use of surfactants in nanoparticle formulations to ensure proper stabilization of particles and consistency in product quality.
2) Scope
This SOP applies to all laboratory staff involved in the preparation of nanoparticle formulations requiring surfactants for stabilization or formulation purposes.
3) Responsibilities
- Operators: Responsible for the proper selection and use of surfactants in nanoparticle formulations.
- QA: Ensures surfactant usage complies with the formulation protocol and meets quality standards.
4) Procedure
4.1 Selection of Surfactants
4.1.1 Criteria for Surfactant Selection
- 4.1.1.1 Select surfactants based on their compatibility with the nanoparticle material, type of formulation, and intended application (e.g., Tween 80, SDS).
- 4.1.1.2 Review the Material Safety Data Sheets (MSDS) for each surfactant to ensure safe handling and usage.
4.2 Surfactant Handling
4.2.1 Weighing and Dispensing
- 4.2.1.1 Accurately weigh the required amount of surfactant using a calibrated balance, as per the formulation guidelines.
- 4.2.1.2 Dispense the surfactant into clean, labeled containers for use in the formulation.
4.2.2 Solubilization of Surfactants
- 4.2.2.1 Dissolve the surfactant in water or the relevant solvent under gentle stirring to ensure proper solubilization before adding it to the nanoparticle formulation.
- 4.2.2.2 Ensure the temperature does not exceed the stability
limits of the surfactant during solubilization.
4.3 Addition of Surfactants to Nanoparticle Formulations
4.3.1 Incorporation of Surfactants
- 4.3.1.1 Add the dissolved surfactant slowly into the nanoparticle formulation under continuous stirring to avoid clumping or aggregation.
- 4.3.1.2 Continue stirring for at least 15–30 minutes to ensure uniform distribution of the surfactant throughout the formulation.
4.4 Safety and Handling
4.4.1 Safety Guidelines
- 4.4.1.1 Wear appropriate PPE, including gloves, goggles, and lab coats, when handling surfactants.
- 4.4.1.2 Work in a fume hood or well-ventilated area if the surfactant is volatile or hazardous.
5) Abbreviations, if any
- SDS: Sodium Dodecyl Sulfate
- PPE: Personal Protective Equipment
6) Documents, if any
- Surfactant Usage Logbook
7) References, if any
- MSDS for surfactants
8) SOP Version
Version 1.0
Annexure
Surfactant Usage Logbook Template
| Date | Surfactant Name | Batch Number | Amount Used | Operator Initials | QA Initials |
|---|---|---|---|---|---|
| DD/MM/YYYY | Surfactant Name | Batch Number | Amount in grams | Operator Name | QA Name |