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Overview of Heat and Mass Transfer Modeling in Lyophilization to Create Design Spaces and Improve Process Analytical Technology (PAT) Capability

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Principles and Practices of Lyophilization in Product Development and Manufacturing

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 59))

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Abstract

Lyophilization or freeze-drying is a process of removing water by sublimation. It is commonly used to extend the shelf life of drugs in the pharmaceutical industries. Due to a relatively high operational cost and long process time compared with other typical drying approaches, lyophilization process conditions including the pressure and temperature need to be optimized with the help of process analytical technology.

In this chapter, we present an overview of the steady state heat and mass transfer modeling of the drying process both in the vial and in the lyophilizer. The quasi-1D steady state heat and mass transfer modeling for drying in the vial is first reviewed, and then we presented the CFD-based modeling of choked flow limiting conditions to obtain equipment capability of lyophilizers as well as a detailed procedure to create the various types of primary drying design spaces. In addition, CFD modeling is used to find the sublimation rate as a function of pressure drop across the pipe connecting the chamber and the condenser for a wide range of operating conditions, which can be used as an advanced PAT tool for process monitoring and optimization.

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Acknowledgment

The authors would like to sincerely thank Drs. Steve Nail and Greg Sacha from Baxter, Bloomington, IN for their insights, discussion, and help during experimental data collection. This work was supported in part through a grant offered to the Purdue-Baxter collaboration by the Indiana Manufacturing Competitiveness Center (IN-MAC).

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Authors and Affiliations

  1. Drug Product Development, AbbVie Inc., North Chicago, IL, USA

    Tong Zhu

  2. School of Aeronautics and Astronautics, College of Engineering, Purdue University, West Lafayette, IN, USA

    Tong Zhu, Pasita Pibulchinda, Vaibhav Kshirsagar & Alina Alexeenko

  3. Nimble BioSolutions, Gurnee, IL, USA

    Feroz Jameel

Authors
  1. Tong Zhu
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  2. Feroz Jameel
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  3. Pasita Pibulchinda
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  4. Vaibhav Kshirsagar
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  5. Alina Alexeenko
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Corresponding author

Correspondence to Tong Zhu .

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Editors and Affiliations

  1. Nimble BioSolutions, Gurnee, IL, USA

    Feroz Jameel

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Zhu, T., Jameel, F., Pibulchinda, P., Kshirsagar, V., Alexeenko, A. (2023). Overview of Heat and Mass Transfer Modeling in Lyophilization to Create Design Spaces and Improve Process Analytical Technology (PAT) Capability. In: Jameel, F. (eds) Principles and Practices of Lyophilization in Product Development and Manufacturing . AAPS Advances in the Pharmaceutical Sciences Series, vol 59. Springer, Cham. https://doi.org/10.1007/978-3-031-12634-5_22

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