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A non-invasive multipoint product temperature measurement for pharmaceutical lyophilization
Xiaofan Jiang1, Petr Kazarin2,3, Michael D Sinanis1,4,3
1Elmore Family School of Electrical and Computer Engineering, Purdue University, West Lafayette, 47907, USA.
Scientific Reports
|July 14, 2022
Summary
This study introduces a novel, non-invasive method for monitoring product temperature during lyophilization. This approach accurately reconstructs the full temperature profile, optimizing the freeze-drying process and ensuring product quality.
Area of Science:
- Pharmaceutical Sciences
- Chemical Engineering
- Process Analytical Technology (PAT)
Background:
- Accurate product temperature monitoring during lyophilization is crucial for process development and final product integrity.
- Conventional invasive thermocouples offer limited single-point measurements and can disrupt the lyophilization process.
- In-situ monitoring enables closed-loop control for optimized lyophilization cycles.
Purpose of the Study:
- To develop a non-invasive methodology for comprehensive product temperature monitoring during lyophilization.
- To accurately reconstruct the complete temperature profile within the vial.
- To validate a novel approach using experimental data and multiphysics simulations.
Main Methods:
- Development of a flexible, wireless, multi-point temperature sensing probe using micro-manufacturing.
- Attachment of the probe externally to the lyophilization vial for non-invasive measurement.
- Integration of wirelessly collected sensor data with advanced multiphysics simulations for temperature profile reconstruction.
Main Results:
- Successful experimental validation of the non-invasive temperature monitoring methodology.
- Accurate reconstruction of the complete product temperature profile inside the vial during lyophilization.
- Demonstration of the probe's ability to extract product temperature without altering process dynamics.
Conclusions:
- The combined non-invasive sensing and modeling approach provides accurate, comprehensive temperature monitoring during lyophilization.
- This method overcomes the limitations of traditional invasive sensors, enabling better process understanding and control.
- The developed technology facilitates optimized lyophilization processes and ensures superior final product quality.
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