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 temperature and pressure throughout the cycle.
4.3.4 Monitor for any issues (e.g., temperature deviations) and address them immediately.
4.4 Quality Control Checks
4.4.1 Take samples of lyophilized product for quality control testing.
4.4.2 Perform tests to verify that the product meets specified quality criteria (e.g., moisture content, sterility).
4.4.3 Record test results and compare them with established acceptance criteria.
4.4.4 If the product fails to meet quality criteria, investigate the cause and take corrective actions.
4.5 Shutdown and Cleanup
4.5.1 Once lyophilization is complete, shut down the lyophilizer according to the manufacturer’s instructions.
4.5.2 Clean and disinfect the lyophilizer and surrounding area.
4.5.3 Perform a post-use check to ensure the lyophilizer is ready for the next operation.
4.6 Documentation
4.6.1 Maintain records of all lyophilization operations, including setup, cycle parameters, quality control checks, and maintenance activities.
4.6.2 Ensure all records are signed and dated by the responsible personnel.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Lyophilization Operation Records
– Quality Control Test Records
– Maintenance Logs

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
– Lyophilizer Manufacturer’s Manual

8) SOP Version

Version 1.0