Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying

10.1520/e3250 ◽  
2021 ◽  
Author(s):  
Keyword(s):  
Freeze Drying ◽  
Standard Practice ◽  
Product Temperature

scholarly journals Thermal Imaging as a Noncontact Inline Process Analytical Tool for Product Temperature Monitoring during Continuous Freeze-Drying of Unit Doses

2018 ◽  
Vol 90 (22) ◽  
pp. 13591-13599 ◽  
Author(s):  
Pieter-Jan Van Bockstal ◽  
Jos Corver ◽  
Laurens De Meyer ◽  
Chris Vervaet ◽  
Thomas De Beer
Keyword(s):  
Thermal Imaging ◽  
Freeze Drying ◽  
Temperature Monitoring ◽  
Analytical Tool ◽  
Product Temperature

scholarly journals How Vial Geometry Variability Influences Heat Transfer and Product Temperature During Freeze-Drying

2017 ◽  
Vol 106 (3) ◽  
pp. 770-778 ◽  
Author(s):  
Bernadette Scutellà ◽  
Stéphanie Passot ◽  
Erwan Bourlés ◽  
Fernanda Fonseca ◽  
Ioan Cristian Tréléa
Keyword(s):  
Heat Transfer ◽  
Freeze Drying ◽  
Product Temperature

On the Design of an In-Line Control System for a Vial Freeze-Drying Process: The Role of Chamber Pressure

2009 ◽  
Vol 4 (2) ◽  
Author(s):  
Davide Fissore ◽  
Roberto Pisano ◽  
Antonello A. Barresi
Keyword(s):  
Control System ◽  
Freeze Drying ◽  
Pressure Rise ◽  
Open Loop ◽  
Parameters Estimation ◽  
Chamber Pressure ◽  
Fluid Temperature ◽  
Drying Process ◽  
Product Temperature ◽  
Drying Chamber

This paper is focused on the design of an in-line control system for the freeze-drying process of pharmaceuticals in a vial. The goal is to minimize the duration of the primary drying, when most of the water is removed by sublimation while maintaining the product temperature below the maximum value allowed by the product. The pressure in the drying chamber and the temperature of the fluid that is used to heat (or to cool) the product can be manipulated; the pressure rise test and the DPE (Dynamic Parameters Estimation) algorithm are used to estimate the product temperature and the residual ice fraction, i.e. the controlled variables. Both an open-loop controller, using constant values of fluid temperature and chamber pressure, and a closed-loop controller, based on the in-line optimization of the fluid temperature, will be described and tested. Finally, the possibility of manipulating in-line the pressure in the drying chamber will be discussed.

scholarly journals Cycle Development in a Mini-Freeze Dryer: Evaluation of Manometric Temperature Measurement in Small-Scale Equipment

2021 ◽  
Vol 22 (4) ◽  
Author(s):  
Tim Wenzel ◽  
Margit Gieseler ◽  
Ahmad M. Abdul-Fattah ◽  
Henning Gieseler
Keyword(s):  
Temperature Measurement ◽  
Temperature Control ◽  
Process Parameters ◽  
Wall Temperature ◽  
Freeze Drying ◽  
Small Scale ◽  
Residual Moisture ◽  
Product Temperature ◽  
Manometric Temperature Measurement ◽  
Freeze Dryer

AbstractThe objective of this research was to assess the applicability of manometric temperature measurement (MTM) and SMART™ for cycle development and monitoring of critical product and process parameters in a mini-freeze dryer using a small set of seven vials. Freeze drying cycles were developed using SMART™ which automatically defines and adapts process parameters based on input data and MTM feedback information. The freeze drying behavior and product characteristics of an amorphous model system were studied at varying wall temperature control settings of the cylindrical wall surrounding the shelf in the mini-freeze dryer. Calculated product temperature profiles were similar for all different wall temperature settings during the MTM-SMART™ runs and in good agreement with the temperatures measured by thermocouples. Product resistance profiles showed uniformity in all of the runs conducted in the mini-freeze dryer, but absolute values were slightly lower compared to values determined by MTM in a LyoStar™ pilot-scale freeze dryer. The resulting cakes exhibited comparable residual moisture content and optical appearance to the products obtained in the larger freeze dryer. An increase in intra-vial heterogeneity was found for the pore morphology in the cycle with deactivated wall temperature control in the mini-freeze dryer. SMART™ cycle design and product attributes were reproducible and a minimum load of seven 10R vials was identified for more accurate MTM values. MTM-SMART™ runs suggested, that in case of the wall temperature following the product temperature of the center vial, product temperatures differ only slightly from those in the LyoStar™ freeze dryer.

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