Evaluating Functional Equivalency as a Lyophilization Cycle Transfer Tool - Pharmaceutical Technology

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Evaluating Functional Equivalency as a Lyophilization Cycle Transfer Tool
The authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers.


Pharmaceutical Technology
Volume 33, Issue 9, pp. 54-70


Figure 3: Lyophilizer performance (partial load): chamber pressure, shelf temperature, mean product temperature, and condenser temperature for FD-104 (B420FT) and FD-105 (C220FT). (FIGURE IS COURTESY OF THE AUTHOR)
Tables IV and V show that even during this early period of drying, the rates of drying among various units were quite close to each other (i.e., 1.79% and 3.21%) in fully loaded and partially loaded conditions, respectively. These results were irrespective of the locations of the trays within the units. The differences in the drying rates among vials located at corresponding locations were slightly more variable but within 10% of each other.


Table VI: Comparison of lyophilization process parameters (partial load): shelf temperature, condenser temperature, and chamber pressure in B420FT and C220FT.
Comparison of process parameters during cycles. The equipment parameter data from the drying rate studies conducted under partial- and full-load conditions were analyzed for this comparison. Under full-load conditions (i.e., 210 trays), a large amount of solution (~800 kg) is subjected to the lyophilization process. Under such a large load, the system capabilities are fully challenged. In spite of such a full-load condition, the flawless execution of the lyophilization cycles while maintaining all the independent and dependent parameters within the narrow limits clearly confirms that these units are capable of performing according to the set parameters and that the profiles generated are comparable with each other.


Table VII: Comparison of lyophilization process parameters (full load): shelf temperature, condenser temperature, and chamber pressure in A420FT, B420FT, and C220FT.
The temperature-pressure rate profiles reflect close agreement of the lyophilization parameters during the entire run (see Figures 2, 3). (Note: lyophilizer units A420FT, B420FT, and C220FT are referred to as FD-103, FD-104, FD-105, respectively) The independent parameters (i.e., the shelf temperature, chamber pressure, and the condenser temperature) were within the overlapping range throughout the course of the cycle in all three lyophilizers (see Tables VI and VII). Moreover, the mean product temperatures were within the overlapping range throughout the course of the cycle in all three lyophilizers (see Figures 2 and 3). These parameters are the actual indicators of equipment performance under stress conditions and their close agreement with the programmed recipe confirms excellent capability of these units.


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