Start
Mar 12, 2012 - 15:00
End
Mar 12, 2012 - 16:00
Venue
Room 118 (Creativity Hall) Ground Floor Chemical Engineering Department
Event Type
Speaker
Dr. Bala Raghunath Director of Biomanufacturing Sciences Network for Asia
Title
Sizing of Robust & Cost Effective Filtration Processes Using Safety Factors
Abstract: In many biopharmaceutical filtration applications filter sizing safety factors of 1.5 are commonly used. This may lead to oversizing or undersizing of a process unit operation depending on the application and drug product. In this presentation we provide a rationale for assigning safety factor values based on designing a robust process that allows for scale differences process variability data extrapolation and process expansion.Analysis of a filtration cost model that includes process variability leads to a safety factor definition. Safety factors can vary from 1.2 to 2.5. They depend on the relative costs of failing to process a batch to base case cost and on the magnitude of process variability. Process models combined with variability data are used to determine the sources and magnitude of process variability. For the typical biopharmaceutical filtration applications these considerations indicate that process variability generally arises primarily from feedstock filter variability as well as process operating conditions.The application of the concept is illustrated through a case study for a typical biopharmaceutical filtration unit operation.