Standard Operating Procedure for Loading Product Vials into Lyophilizers

1) Purpose

This SOP outlines the procedure for safely and accurately loading product vials into lyophilizers to ensure proper freeze-drying, uniform product exposure, and contamination prevention.

2) Scope

This SOP applies to all operators involved in the loading and arranging of product vials into lyophilizers for freeze-drying processes in accordance with the Batch Manufacturing Record (BMR).

3) Responsibilities

• Operators: Responsible for loading vials into the lyophilizer according to the product’s specific lyophilization cycle requirements.
• QA Personnel: Responsible for verifying that vials are properly arranged and ensuring compliance with contamination control measures.

4) Procedure

4.1 Preparing Product Vials

4.1.1 Pre-Loading Inspection

• 4.1.1.1 Inspect each vial for damage, contamination, or improper filling before loading. Reject any vials that show signs of defects.
• 4.1.1.2 Ensure that each vial has been sealed with a rubber stopper but is not fully crimped to allow for vapor exchange during freeze-drying.

4.2 Loading the Vials

4.2.1 Placement on Shelves

• 4.2.1.1 Arrange vials on the lyophilizer shelves in neat, evenly spaced rows, ensuring there is enough space between vials for uniform freeze-drying.
• 4.2.1.2 Load the shelves evenly to avoid temperature gradients and ensure consistent drying across the batch.

4.2.2 Monitoring Shelf Temperature

• 4.2.2.1 Ensure the shelf temperature is