Methodology of lyophilizers characterization to enable modeling of process parameters

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SP Scientific

To view the full webinar, please visit: http://www.spscientific.com/Methodology_Modeling/ Factory acceptance tests (FAT) are normally performed by manufacturer on “empty and dry” lyophilizers. Sometimes, manufacturers also perform “sublimation tests” to ensure that the condenser is capable of capturing the sufficient amount of water, specified by the user. These tests, however, might not generate enough meaningful data to enable a successful lyophilization process scale up. Drug product manufacturers often need information on heat transfer coefficients for the containers of use as well as information on capability of the dryer to maintain pressure set points at different loads. In this presentation, the methodology of measurement of vial heat transfer coefficient (Kv) and minimum controllable pressure as a function of sublimation rate (Pmin) will be described. Kv and Pmin are key inputs in primary drying models, application of which to process design and scale up will be discussed and demonstrated.