scholarly journals Evaluation of manometric temperature measurement, a process analytical technology tool for freeze-drying: Part I, product temperature measurement

2006 ◽  
Vol 7 (1) ◽  
pp. E95-E103 ◽  
Author(s):  
Xiaolin Tang ◽  
Steven L. Nail ◽  
Michael J. Pikal
Keyword(s):  
Temperature Measurement ◽  
Freeze Drying ◽  
Process Analytical Technology ◽  
Product Temperature ◽  
Manometric Temperature Measurement ◽  
Technology Tool ◽  
Analytical Technology

Potential of Near-Infrared Chemical Imaging as Process Analytical Technology Tool for Continuous Freeze-Drying

2018 ◽  
Vol 90 (7) ◽  
pp. 4354-4362 ◽  
Author(s):  
Davinia Brouckaert ◽  
Laurens De Meyer ◽  
Brecht Vanbillemont ◽  
Pieter-Jan Van Bockstal ◽  
Joris Lammens ◽  
...  
Keyword(s):  
Freeze Drying ◽  
Near Infrared ◽  
Process Analytical Technology ◽  
Chemical Imaging ◽  
Technology Tool ◽  
Analytical Technology

Temperature Measurement by Sublimation Rate as a Process Analytical Technology Tool in Lyophilization

2019 ◽  
Vol 108 (7) ◽  
pp. 2305-2314 ◽  
Author(s):  
Hidenori Kawasaki ◽  
Toshinori Shimanouchi ◽  
Hiroyuki Sawada ◽  
Hiroshi Hosomi ◽  
Yuta Hamabe ◽  
...  
Keyword(s):  
Temperature Measurement ◽  
Process Analytical Technology ◽  
Sublimation Rate ◽  
Technology Tool ◽  
Analytical Technology

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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