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Tunable Diode Laser Absorption Spectroscopy in Lyophilization

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Lyophilization of Pharmaceuticals and Biologicals

Part of the book series: Methods in Pharmacology and Toxicology ((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.

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Author information

Authors and Affiliations

  1. Physical Sciences Inc., Andover, MA, USA

    William J. Kessler & Emily Gong

Authors
  1. William J. Kessler
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  2. Emily Gong
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Corresponding author

Correspondence to William J. Kessler .

Editor information

Editors and Affiliations

  1. Biopharma Process Systems Ltd., Winchester, UK

    Kevin R. Ward

  2. National Institute for Biological Standards & Control (NIBSC), Potters Bar, Hertfordshire, UK

    Paul Matejtschuk

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Kessler, W.J., Gong, E. (2019). Tunable Diode Laser Absorption Spectroscopy in Lyophilization. In: Ward, K., Matejtschuk, P. (eds) Lyophilization of Pharmaceuticals and Biologicals. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-8928-7_5

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  • DOI: https://doi.org/10.1007/978-1-4939-8928-7_5

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  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-8927-0

  • Online ISBN: 978-1-4939-8928-7

  • eBook Packages: Springer Protocols

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