LyoPRONTO

LyoPRONTO optimizes lyophilization processes by simulating freezing and primary drying using 0D lumped capacitance and 1D heat and mass transfer models to predict product temperature, drying time, and design spaces for chamber pressure and shelf temperature.


Key Features:

  • Freezing Calculator: Employs 0D lumped capacitance modeling to predict product temperature variations over time with good alignment to experimental data.
  • Primary Drying Calculator: Performs 1D heat and mass transfer analysis within a vial to predict drying time with an average deviation of 3% from experimental results.
  • Design-Space Generator: Generates design spaces across chamber pressures and shelf temperatures to identify optimal operational setpoints.
  • Primary Drying Optimizer: Dynamically adjusts chamber pressure and shelf temperature profiles over time while accounting for continuously varying product resistance, reducing primary drying times by 62% for 5% mannitol and 50% for 5% sucrose compared to typical cycle conditions.

Scientific Applications:

  • Primary Drying Time Reduction: Minimizes primary drying time to improve process efficiency and reduce operational costs.
  • Cycle and Equipment Design: Informs selection of chamber pressure and shelf temperature setpoints and supports next-generation lyophilizer and cycle design.
  • Automated Control Integration: Enables integration with sensor networks and control systems to support automated or self-driving freeze-dryer operation.

Methodology:

Uses 0D lumped capacitance modeling for freezing, 1D heat and mass transfer analysis for primary drying, design-space generation across chamber pressures and shelf temperatures, and dynamic optimization that adjusts chamber pressure and shelf temperature profiles accounting for continuously varying product resistance and utilizing real-time data.

Topics

Details

Tool Type:
command-line tool
Added:
1/14/2020
Last Updated:
1/14/2021

Operations

Publications

Shivkumar G, Kazarin PS, Strongrich AD, Alexeenko AA. LyoPRONTO: an Open-Source Lyophilization Process Optimization Tool. AAPS PharmSciTech. 2019;20(8). doi:10.1208/s12249-019-1532-7. PMID:31673810. PMCID:PMC6823652.

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