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Journal Article

Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods

Jayasree M. Srinivasan; Gregory A. Sacha; Vaibhav Kshirsagar; Alina Alexeenko; Steven L. Nail
AAPS PharmSciTech · Vol. 22, Issue 1 · 2021

Abstract

The objective of this investigation was to evaluate two methods for measuring the maximum sublimation rate that a freeze-dryer will support—the minimum controllable pressure method and the choke point method. Both methods gave equivalent results, but the minimum controllable pressure method is preferred, since it is easier, faster, and less subjective. The ratio of chamber pressure to condenser pressure corresponding to the onset of choked flow was considerably higher in this investigation (up to about 20:1) than in previously published reports. This ratio was not affected by the location of the pressure gauge on the condenser; that is, on the foreline of the vacuum pump versus on the body of the condenser itself. The total water loss due to sublimation as measured by tunable diode laser absorption spectroscopy was consistently within 5% of gravimetrically determined weight loss, regardless of whether the measurement took place during choked versus non-choked process conditions.

Bibliographic Information

JournalAAPS PharmSciTech
PublisherSpringer
Publication Date2021-01-01
Publication Year2021
Volume22
Issue1
Document TypeJournal Article
eISSN1530-9932
DOI10.1208/s12249-021-01921-2

Access Information

NARA Access Coverage2000-01-01~Current
Journal Homepagehttps://www.springer.com/journal/12249
Publisher PageOpen Publisher Page
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