文档介绍：AAPS PharmSciTech 2006; 7 (2) Article 39 ().
Heat and Mass Transfer Scale-Up Issues During Freeze-Drying, III: Control
and Characterization of Dryer Differences via Operational Qualification Tests
Submitted: January 15, 2004; Accepted: February 9, 2006; Published: April 21, 2006
S. Rambhatla,1,2 S. Tchessalov,1,3 and Michael J. Pikal1
1School of Pharmacy, University of Connecticut, Storrs, CT 06269
2Present address: Talecris Biotherapeutic, Inc., Clayton, NC
3Present address: Wyeth BioPharma, Drug Products Development, Andover, MA
ABSTRACT of size and design. To be fully transferable, the process
should be equivalent—that is, the product temperature:time
The objective of this research was to estimate differences in
profile should be identical—when the same freeze-drying
heat and mass transfer between freeze dryers due to
process is performed on different freeze dryers. Achieving
inherent design characteristics using data obtained from
this objective poses some challenges. First, the freeze dryer
sublimation tests. This study also aimed to provide guide-
under consideration must be tested for performance under
lines for convenient scale-up of the freeze-drying process.
conditions of thermal load that it would typically experi-
Data obtained from sublimation tests performed on labo-
ence during the process. This requirement means that the
rator