SOP for Spray Drying for Nasal Powder Formulations

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