Standard Operating Procedure for Freeze Drying in Powders Production

1) Purpose

The purpose of this SOP is to provide guidelines for the freeze drying (lyophilization) process in pharmaceutical manufacturing, specifically for converting liquid formulations into dry powders under low temperature and pressure conditions.

2) Scope

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

3) Responsibilities

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

4) Procedure

1. Preparation Before Freeze Drying:
   1. Verify cleanliness and operational status of the freeze dryer.
   2. Prepare the liquid formulation according to batch specifications.
2. Freeze Drying Process:
   1. Load the liquid formulation into the freeze drying chamber.
   2. Initiate freezing of the product to form ice crystals.
   3. Apply vacuum to sublimate the frozen solvent directly from ice to vapor, leaving behind dry powder particles.
3. Post-Drying Checks:
   1. Monitor drying parameters such as shelf temperature, chamber pressure, and drying time to ensure product quality.
   2. Collect samples for moisture content analysis and verify particle size distribution.
4. Cleaning and Maintenance:
   1. Clean the freeze 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 freeze drying in pharmaceutical manufacturing.

8) SOP Version

Version 1.0