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17. SOP for Optimizing Particle Size in Nasal Suspensions
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Standard Operating Procedure for Optimizing Particle Size in Nasal Suspensions
1) Purpose
The purpose of this SOP is to outline the procedure for optimizing the particle size in nasal suspensions to ensure uniform drug delivery and effective therapeutic action.
2) Scope
This SOP applies to all personnel involved in the preparation, optimization, and testing of nasal suspensions at [Company Name].
3) Responsibilities
- Operators: Responsible for monitoring and optimizing particle size during formulation.
- QA: Verifies the particle size and ensures that it meets formulation specifications.
4) Procedure
4.1 Selection of Equipment
4.1.1 Homogenizer or Milling Equipment
- Select appropriate equipment (e.g., homogenizer, ball mill) to reduce particle size to the desired range (e.g., 1-10 microns).
- Ensure that the equipment is calibrated and functioning correctly before use.
4.1.2 Particle Size Analyzer
- Ensure the particle size analyzer is calibrated to measure the size distribution accurately.
4.2 Particle Size Reduction
4.2.1 Homogenization
- Add the suspension ingredients into the homogenizer, and adjust the speed and pressure according to formulation guidelines.
- Run the homogenizer for the required
time to reduce the particle size.
4.2.2 Milling
- If using a milling process, add the suspension to the ball mill or jet mill and run it at the recommended speed and time.
4.3 Particle Size Analysis
4.3.1 Measurement
- Take a sample of the nasal suspension and measure the particle size distribution using a laser diffraction particle size analyzer or dynamic light scattering (DLS).
- Ensure the particle size falls within the desired range specified in the formulation.
4.4 Stability Testing
4.4.1 Stability of Suspension
- Monitor the suspension stability to ensure the particles remain evenly dispersed and do not aggregate over time.
- Perform stability tests at regular intervals to check particle size, viscosity, and sedimentation.
4.5 Documentation
- Document the particle size reduction process, equipment parameters, and results in the batch manufacturing record (BMR).
- Record the particle size distribution values in the particle size log, including operator initials and QA approval.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
6) Documents, if any
- Batch Manufacturing Record (BMR)
- Particle Size Distribution Log
7) References, if any
- USP 39 – Particle Size Analysis of Suspensions
8) SOP Version
Version 1.0
Annexure
Particle Size Distribution Log Template
| Date | Formulation | Particle Size (µm) | Operator Initials | QA Approval | |
|---|---|---|---|---|---|
| DD/MM/YYYY | Formulation Name | Size | Operator Name | QA Name | |