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Tunable Diode Laser Absorption Spectroscopy in Lyophilization

  • William J. KesslerEmail author
  • Emily Gong
Protocol
Part of the Methods in Pharmacology and Toxicology book series (MIPT)

Abstract

Chapter  5 provides a description of a tunable diode laser absorption spectroscopy-based sensor that provides real-time, non-contact measurements of the gas temperature, water vapor concentration, and gas flow velocity in the duct connecting the lyophilizer product chamber and condenser. These measurements are used to calculate the water vapor mass flow rate throughout the primary and secondary drying phases of freeze-drying. The instantaneous mass flow values are integrated to provide a continuous determination of the total amount of water removed during the lyophilization process. Permanent sensor calibration is performed using an interferometric technique leveraging the wave characteristics of light. The sensor calibration is verified using ice slab sublimation tests with direct comparisons of the integrated measurements to gravimetric determinations of total water removed. Direct use of the measured values and the calculated mass flow rate combined with a heat and mass transfer model of vial based freeze-drying have been used to demonstrate numerous applications that will be described in this chapter.

Key words

Tunable diode laser absorption spectroscopy Water vapor mass flow Freeze drying Lyophilization Heat and mass transfer model Quality by design process development 

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Physical Sciences Inc.AndoverUSA

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