(47a) Optimization of Primary and Secondary Clarification Using Failure Mode and Effect Analysis

From bench-scale to manufacturing, scientists and engineers are continually optimizing the purification train and scale-up strategies. Large-scale challenges are not always present during the small-volume investigations and may be overlooked. This may delay getting a product to the market and is undesirable. Using the Failure Mode and Effect Analysis (FMEA) approach, it is possible to identify potential failures in filtration unit operations, assess the consequences of these failures occurring, and rank them in order of criticality. Working from the bottom-up to prevent these failures from occurring, FMEA enables engineers to design the proper screening experiments at the beginning of the process development effort. The use of FMEA to discover robust solutions for upstream steps such as, centrifugation followed by clarification and sterile filtration, is discussed.