Standard Operating Procedure for Spray Drying for Nasal Powder Formulations
1) Purpose
The purpose of this SOP is to outline the process for using spray drying techniques to prepare nasal powder formulations, ensuring uniform particle size and optimal drug delivery.
2) Scope
This SOP applies to all personnel involved in the spray drying process for nasal powder formulations at [Company Name].
3) Responsibilities
- Operators: Responsible for operating the spray dryer and ensuring correct parameters are followed.
- QA: Verifies that the powder meets the required specifications for particle size and uniformity.
4) Procedure
4.1 Equipment Setup
4.1.1 Spray Dryer Inspection
- Inspect the spray dryer to ensure it is clean and ready for use.
- Check that the nozzles and other components are correctly installed.
4.1.2 Calibration
- Calibrate the spray dryer according to the manufacturer’s specifications.
4.2 Solution Preparation
4.2.1 Dissolving and Mixing
- Dissolve the API and excipients in purified water or another suitable solvent.
- Ensure that the solution is homogenous before feeding it into the spray dryer.
4.3 Spray Drying Process
4.3.1 Process Parameters
- Set the spray dryer to the appropriate parameters, including inlet temperature, outlet temperature, and feed rate.
- Start the
spray drying process, ensuring that the feed solution is atomized properly into the drying chamber.
4.3.2 Monitoring
- Monitor the spray drying process continuously to ensure consistent particle size and drying.
- Make adjustments as necessary to the feed rate, air flow, and temperature to optimize the drying process.
4.4 Post-Spray Drying Testing
4.4.1 Particle Size Analysis
- After spray drying, collect a sample of the powder and test the particle size distribution using a particle size analyzer.
4.4.2 Moisture Content Testing
- Test the moisture content of the powder to ensure it meets the target specifications.
4.5 Packaging
4.5.1 Powder Collection
- Collect the spray-dried powder into sterilized containers.
4.5.2 Storage
- Store the collected powder in a controlled environment to maintain its stability.
4.6 Documentation
- Document all process steps, including the parameters used, particle size, and moisture content, in the batch manufacturing record (BMR).
5) Abbreviations, if any
- API: Active Pharmaceutical Ingredient
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
6) Documents, if any
- Batch Manufacturing Record (BMR)
- Particle Size and Moisture Content Log
7) References, if any
- FDA Guidance for Industry – Nasal Drug Products
8) SOP Version
Version 1.0
Annexure
Particle Size and Moisture Content Log Template
| Date | Formulation | Particle Size Range (µm) | Moisture Content (%) | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Formulation Name | Size Range | Moisture | Operator Name | QA Name |