Standard Operating Procedure for Lyophilization Process

1) Purpose

The purpose of this SOP is to define the procedures for the lyophilization (freeze-drying) process to ensure the stability and sterility of injection products.

2) Scope

This SOP applies to all personnel involved in the lyophilization process at [Company Name] for the production of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Production Department: Performing the lyophilization process.
– Maintenance Personnel: Ensuring the lyophilizer is in good working condition.
– Quality Assurance (QA) Department: Reviewing and approving lyophilization procedures and records.

4) Procedure

4.1 Preparation for Lyophilization
4.1.1 Ensure the lyophilizer and surrounding area are clean and disinfected.
4.1.2 Verify that the product to be lyophilized has passed all preliminary quality control tests.
4.1.3 Ensure all materials (e.g., vials, stoppers) are sterilized and ready for use.
4.2 Lyophilizer Setup
4.2.1 Set up the lyophilizer according to the manufacturer’s instructions.
4.2.2 Perform a pre-use check to ensure the lyophilizer is functioning correctly.
4.2.3 Calibrate the lyophilizer to ensure accurate temperature and pressure settings.
4.3 Lyophilization Process
4.3.1 Load the product into the lyophilizer.
4.3.2 Start the lyophilization cycle and monitor its progress.
4.3.3 Ensure the product is maintained at the specified