The TDLAS-based LyoFlux™ sensor provides batch average, real-time measurements of the water vapor flow rate between the lyophilizer drying chamber and the condenser. Measurements linked to a heat and mass transfer model of lyophilization enable determination of key process parameters, including product temperature (Tb & Tp), vial heat transfer (Kv) and product resistance to drying (Rp) coefficients and dry layer thickness. Supports QbD cycle development.
- Instantaneous mass flow and integrated water removed measurements
- Primary & secondary drying endpoint determinations
- Efficient determination of vial heat transfer, Kv, and product resistance to drying, Rp coefficients
- Efficient determination of lyophilizer equipment capability curve (choked flow determination vs pressure)
- Enables efficient QbD process design development
- 24/7 unattended operation
- Direct communication with lyophilizer;
- Enables automated process development and control
Enables lyophilization cycle monitoring, development and process control