Standard Operating Procedure for Preparation of Lyophilizer Chambers

1) Purpose

The purpose of this SOP is to outline the steps required to clean, set up, and verify the readiness of lyophilizer chambers prior to the freeze-drying process. This ensures that the chambers are free of contaminants and that all equipment functions are prepared for a successful lyophilization cycle.

2) Scope

This SOP applies to operators, maintenance staff, and QA personnel involved in the preparation of lyophilizer chambers for product loading and lyophilization.

3) Responsibilities

• Operators: Responsible for chamber cleaning, disinfection, and setup as outlined in the Batch Manufacturing Record (BMR).
• Maintenance Personnel: Responsible for inspecting and verifying the proper operation of sensors, refrigeration, and vacuum systems.
• QA Personnel: Responsible for verifying cleanliness and setup prior to initiating the lyophilization cycle.

4) Procedure

4.1 Cleaning and Disinfection

4.1.1 Cleaning Frequency

• 4.1.1.1 Clean and disinfect the lyophilizer chamber before every batch to ensure sterile conditions and prevent contamination.

4.1.2 Cleaning Procedure

• 4.1.2.1 Use a cleaning solution suitable for sterile environments to wipe down internal surfaces, including shelves, walls, and door seals.
• 4.1.2.2 Inspect for and remove any residue from previous batches.
• 4.1.2.3 Allow surfaces to air dry before proceeding to equipment setup.

4.2 Chamber Setup

4.2.1 Temperature and Pressure Checks

• 4.2.1.1 Verify that temperature and pressure