Standard Operating Procedure for Spray Drying in Powders Production

1) Purpose

The purpose of this SOP is to provide guidelines for the spray drying process in pharmaceutical manufacturing, specifically for converting liquid formulations into dry powders through controlled evaporation.

2) Scope

This SOP applies to all personnel involved in the spray drying operations within the pharmaceutical manufacturing department.

3) Responsibilities

Production Operator: Responsible for operating the spray dryer and following SOPs.
Quality Control (QC) Analyst: Responsible for monitoring drying parameters and conducting quality checks.

4) Procedure

1. Preparation Before Spray Drying:
   1. Verify cleanliness and operational status of the spray dryer.
   2. Prepare the liquid formulation according to batch specifications.
2. Spray Drying Process:
   1. Feed the liquid formulation into the spray dryer.
   2. Atomize the liquid into fine droplets using a suitable nozzle under controlled conditions.
   3. Dry the droplets by passing hot air through the spray chamber, evaporating the solvent and leaving behind dry powder particles.
3. Post-Drying Checks:
   1. Monitor drying parameters such as inlet air temperature, outlet air temperature, and spray rate to ensure product quality.
   2. Collect samples for moisture content analysis and particle size distribution.
4. Cleaning and Maintenance:
   1. Clean the spray dryer thoroughly after use to prevent cross-contamination.
   2. Perform routine maintenance as per equipment manufacturer’s guidelines.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Batch Records, Drying Logs, Quality Inspection Reports

7) Reference, if any

Pharmacopoeial guidelines (e.g., USP, EP) for spray drying in pharmaceutical manufacturing.

8) SOP Version

Version 1.0