Accomodating Filter Variability in Process Design
Accelerating Biopharmaceutical Development ABD
2013
3rd AccBio / QbD Proceedings
Poster Session
Rapid Fire Poster Sesssion
Sunday, February 24, 2013 - 6:05pm to 6:15pm
Lot variability in raw materials and differences in performance at different scales of operation may impact manufacturing scale operation. This talk will characterize and identify the magnitude and sources of process variability and scaling differences for a variety of filtration unit operations using performance models and test data. This variability can be accomodated through operating practices and the use of both a scaling factor and a safety factor in sizing. Values for these factors will be derived for a variety of filters and the implications for process risk identified.