Lyophilized drug products are
sterile dosage forms manufactured through a series of unit operations, of which
lyophilization is one part of the process where adherence to aseptic handling
principles is required. The challenges
inherent in aseptic processing are many; when combined with the design of
processing technology required for lyophilization, a thorough understanding of
both are required to design Aseptic Process Simulation studies that provide
relevant oversight of the unit operation.
Recent advances in processing
technology for lyophilization have created additional challenges. Addition of new hardware components in the
lyophilizer system as well as changes in process execution have resulted in questions about the impact
of these changes on the performance of Aseptic Process Simulations.
This webinar reviews basic
elements of conducting Aseptic Process Simulations for lyophilized drug
products, and explores points to consider in study design.