Manufacturing and Bioprocessing – Chemical
2019 PharmSci 360
Lyophilization or Freeze drying is an energy intensive and usually extremely long process, where the monitoring of process parameters is of utmost importance. Although a number of Process Analytics Technologies are currently available for lab scale freeze drying cycle monitoring, there are many restrictions in the implementations of most of these in production environments. Further, not many of these PAT tools can effectively monitor all the stages of a freeze drying cycle.
Two approaches that are discussed here to monitor pharmaceutical freeze drying focus on - product/process characterization with the help of mass spectrometers and process/equipment monitoring with a data analytics sensor framework.
Mass Spectrometry has been at the forefront of PATs in freeze drying. Critical process parameters such as sublimation rate, gas composition, end point determination and measurements affecting product quality attributes such as residual moisture or presence of trace contaminants can be extrapolated from the data measured by a mass spectrometer.
In addition, correlating equipment performance with data gathered from a network of sensors can provide a wealth of information including process parameter deviations, prediction of certain events critical to the product cycle and tremendous potential to prevent failures leading to batch rejections.