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Applicability Of Manometric Temperature Measurement (Mtm) And Smart Freeze Dryer Technology To Development Of An Optimized Freeze Drying Cycle: Preliminary Investigation Of Two Amorphous Systems

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White Paper: Applicability Of Manometric Temperature Measurement (Mtm) And Smart Freeze Dryer Technology To Development Of An Optimized Freeze Drying Cycle: Preliminary Investigation Of Two Amorphous Systems

Rational development of a freeze drying cycle for a given product is often a trial and error approach and as a result time consuming, even for highly skilled personnel. To avoid a lack of quality and/or elegance of the final product, it is mandatory during the process that the product temperature (Tp) does not exceed a "critical" temperature, which usually refers to the collapse temperature (Tc) for amorphous systems. The product temperature, however, depends on many process variables, e.g. shelf temperature (Ts), chamber pressure (Pc), heat transfer coefficient of the container (Kv), product resistance to vapor flow (Rp), etc. [1]. Manometric temperature measurement (MTM) is a technique to determine the product temperature during primary drying by rapid closure of a separation valve in between the drying chamber and ice condenser. The subsequent chamber pressure rise during this period was analyzed in the original work by a "fit" to the MTM equation using the commercial software package Microcal Origin and utilizing the Levenberg-Marquardt method. This analysis yields product temperature and the mass transfer resistance of the dried product [2]. Thus, the shelf temperature required to achieve a given target product temperature can be calculated from product temperature and dried layer resistance by steady state heat and mass transfer theory.

The purpose of this study is to evaluate the new Smart™ Freeze Dryer Technology, which combines MTM and freeze dryer control algorithms to automatically optimize the freeze drying process during a single experiment, with regard to repeatability and limits in applicability for pure sucrose and trehalose solutions.

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White Paper: Applicability Of Manometric Temperature Measurement (Mtm) And Smart Freeze Dryer Technology To Development Of An Optimized Freeze Drying Cycle: Preliminary Investigation Of Two Amorphous Systems