Lyophilization For Biologics

This module, provides the basic physicochemical foundations of lyophilization and the engineering aspects of an industrial lyophilization process. Most industrial freeze-drying used to manufacture stable drug products, is accomplished using four (4) sub-processes: Refrigeration, Vacuum, Drying (Primary & Secondary), & Final Stoppering. The module discusses each of these sub-processes in detail and demonstrates their sequence in an industrial lyophilizer to produce an acceptable final product. The module addresses steps taken to qualify a typical industrial lyophilizer from installation (IQ), operation (OQ) through Performance (PQ). The module discusses sterilization and cleaning processes used to maintain the lyophilizer in a validated state during production. After completing this module, the trainee should have a basic understanding of lyophilization as well as be able to participate in a team for operation and qualification of a cGMP Lyophilizer.