In a typical filling line involving freeze-drying, the lyophilizer is located away from the filling machine, in a separate room or even another part of the facility. As a result, it requires special transfer and isolation considerations. A recent project was completed by Walker Barrier Systems for an H1N1 vaccine filling line running at 80 – 100 vials/min. In this project, the filling machine and lyophilizer were integrated into the same isolator, which is unique in the industry.
The requirement for this project was to provide an aseptic environment for vaccine filling using isolators for vial depryogenation, vial filling and lyophilization in an existing small room measuring 22' long x 13' wide x 10' high. A positive pressure, non uni-directional airflow isolator was interfaced to a Gruenberg Oven. A positive pressure, non unidirectional airflow transfer isolator was to be used to transfer vials from the oven to the fill machine isolator. Due to the room constraints, a uniquely shaped isolator was designed to interface with both the M&O Perry liquid fill machine and the SP Systems Lyophilizer.
The Filler/Lyophilizer isolator was L shaped with two 450 angles in which 350mm RTP flanges were placed. This allowed docking of the transfer isolator and provided space for operators to walk around the equipment. This isolator also operated under positive pressure but included uni-directional airflow at 45fpm.