Thursday, November 12, 2015: 9:54 AM
252A/B (Salt Palace Convention Center)
Although the commercial process was successfully qualified, Shire determined that there was further opportunity to reduce the risk of segregation and potential for content uniformity (CU) variation to further improve process robustness. Jenike & Johanson, Inc. was enlisted to characterize the flow properties and segregation potential of the final blend. Then, Shire, Jenike, and Patheon jointly conducted a root cause assessment of the CU concerns and developed corrective process and equipment modifications to reduce the risk of segregation in the gravity transfer steps. This presentation will provide an overview of the process data that provided signals of segregation, the various blend characterization testing completed to evaluate different modes of segregation, and the resulting modifications to the encapsulator feed chute.