Standard Operating Procedure for Primary Drying Process in Lyophilization

1) Purpose

This SOP outlines the steps for managing the primary drying (sublimation) phase of lyophilization, ensuring efficient ice removal while maintaining the product’s physical and chemical integrity.

2) Scope

This SOP applies to all operators and QA personnel involved in monitoring and controlling the primary drying stage of the lyophilization process.

3) Responsibilities

• Operators: Responsible for initiating and monitoring the primary drying phase as per the Batch Manufacturing Record (BMR).
• QA Personnel: Responsible for verifying that the process parameters for temperature, pressure, and drying time are adhered to and documented correctly.

4) Procedure

4.1 Setup and Pre-Drying Checks

4.1.1 Initial Setup

• 4.1.1.1 Confirm that the shelves have been pre-cooled to the specified temperature.
• 4.1.1.2 Ensure the vacuum system is operational and capable of maintaining the required pressure.

4.2 Monitoring Sublimation

4.2.1 Temperature and Pressure Control

• 4.2.1.1 Monitor shelf temperature to ensure it is kept within the required range to avoid collapse of the product structure.
• 4.2.1.2 Ensure the vacuum level remains stable to promote efficient ice sublimation without damaging the product.

4.2.2 Sublimation Rate Monitoring

• 4.2.2.1 Adjust shelf temperature and pressure if necessary to control sublimation rate. A slow, steady sublimation process is preferable to maintain product quality.

4.3