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Single Pharmaceutical Vial TDLAS Water Vapor Mass Flow Rate Monitor

Tunable Diode Laser Absorption Spectroscopy (TDLAS)

Assessing Pharmaceutical Freeze-Drying Process Heterogeneity

PSI is developing a single pharmaceutical vial TDLAS water vapor mass flow monitor which provides real-time measurements of water vapor concentration and flow velocity emanating from the head space of a vial with product undergoing ice sublimation. These measurements enable determination of the water vapor mass flow rate to assess vial location specific intra-batch drying heterogeneity.

Key Features

  • [H2O] measurements (molecules cm-3)
  • Flow velocity measurements (m/s)
  • Calculated dm/dt (g/s) determinations
  • dm/dt linkage to lyophilization heat and mass transfer model
  • Time division multiplexed measurements of up to eight vials
  • Continuous measurements throughout primary drying
  • Assessment of drying heterogeneity during pharmaceutical lyophilization
Photo of TDLAS single vial measurement cap and data for center and edge vials during 5% dextran lyophilization

Benefit to Customer

Lyophilization cycle development using a direct assessment of vial drying heterogeneity

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