Abstract: PAT for Freeze-Drying - Determination of End Point of Primary Drying

One of the critical product quality attributes for freeze dried product is elegance (i.e., no collapse). Increasing the shelf temperature for secondary drying before all the ice is removed from the vial results in product collapse or eutectic melt. A collapsed vial is rejected because of lack of appearance. Also, typically collapse results in high residual water content and hence poor drug product stability. Thus, it is very critical to determine the end point of primary drying from process economics as well as product quality stand point. This webinar will compare the various techniques that are currently available to determine the end point of primary drying.



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