The equipment capability curve is one of two boundary conditions employed in the construction of a graphical design space to establish a relationship between process variables and product temperature. Scale-up of processes from laboratory to production equipment can be a challenge if the capability of the equipment is not well understood. In this presentation, we will discuss methods employed to determine the capability of both laboratory and production freeze-dryers and a comparison between to the two to determine their functional equivalencies. We will also discuss how the equipment capability influences the graphical design space for primary drying. Presented by Jayasree Srinivasan, PhD Researcher at R&D group at Baxter BioPharma Solutions
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