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.
Madhav Kamat, PhD, RPh, is a senior principal scientist at Biopharmaceutics R&D, Drug Product Processing and Packaging Technologies, Bristol-Myers Squibb Company, One Squibb Drive, New Brunswick, NJ 08993.
Articles by Madhav Kamat
How does your company apply quality-by-design (QbD) principles to manufacturing processes?
To all processes for both new and legacy products
To all process for new products only
To select process for new products only
To select processes for both new and legacy products