Multi-Point Wireless Temperature Sensing System for Monitoring Pharmaceutical Lyophilization
This work presents the design and evaluation of a fully wireless, multi-point temperature sensor system as a Process Analytical Technology (PAT) for lyophilization. Each sensor contains seven sensing elements which measure the product temperature at various positions of the contents of a glass vial....
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2018-07-01
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| Series: | Frontiers in Chemistry |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fchem.2018.00288/full |
| _version_ | 1828450632570241024 |
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| author | Xiaofan Jiang Tong Zhu Tatsuhiro Kodama Nithin Raghunathan Alina Alexeenko Dimitrios Peroulis |
| author_facet | Xiaofan Jiang Tong Zhu Tatsuhiro Kodama Nithin Raghunathan Alina Alexeenko Dimitrios Peroulis |
| author_sort | Xiaofan Jiang |
| collection | DOAJ |
| description | This work presents the design and evaluation of a fully wireless, multi-point temperature sensor system as a Process Analytical Technology (PAT) for lyophilization. Each sensor contains seven sensing elements which measure the product temperature at various positions of the contents of a glass vial. The sensor performance was studied by freeze drying experiments with sensor placement in both center and edge of full shelf of 6R glass vials with 4 ml fill volume. Product temperature profile and primary drying time measured at the bottom center position in the glass vial by the wireless sensor as well as the primary drying time are in close comparison with the thermocouple data. The drying times during primary drying were determined at the top, higher middle, lower middle and bottom positions which are 3.26 mm apart vertically in the vial by the wireless sensor based on the temperature profile measured at different positions. For a center vial, the drying time from the start of primary drying to each layer was measured at 3.9, 9.3, 14.2, and 21 h respectively, allowing to track the sublimation interface during primary drying phase. In addition, sublimation rate at each layer was calculated based on the drying time and theoretical weight loss of ice in the product. The sublimation rate at the beginning of the primary drying was similar to the sublimation rate by gravimetric method. Furthermore, the vial heat transfer coefficient (Kv) was also calculated based on the sublimation rate. Thus, allowing the use of the multi-point wireless sensor to rapidly monitor the sublimation rate and Kv for every batch as continuous process verification. Similar tests were also conducted with 3% w/v mannitol solutions and the results were consistent demonstrating potential for real-time monitoring, process verification and cycle optimization for pharmaceutical lyophilization. |
| first_indexed | 2024-12-10T23:26:19Z |
| format | Article |
| id | doaj.art-76b412590d6040f7807707bee52a358d |
| institution | Directory Open Access Journal |
| issn | 2296-2646 |
| language | English |
| last_indexed | 2024-12-10T23:26:19Z |
| publishDate | 2018-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Chemistry |
| spelling | doaj.art-76b412590d6040f7807707bee52a358d2022-12-22T01:29:35ZengFrontiers Media S.A.Frontiers in Chemistry2296-26462018-07-01610.3389/fchem.2018.00288388025Multi-Point Wireless Temperature Sensing System for Monitoring Pharmaceutical LyophilizationXiaofan Jiang0Tong Zhu1Tatsuhiro Kodama2Nithin Raghunathan3Alina Alexeenko4Dimitrios Peroulis5School of Electrical and Computer Engineering-Birck Nanotechnology Center, Purdue University, West Lafayette, IN, United StatesSchool of Aeronautics and Astronautics, Purdue University, West Lafayette, IN, United StatesFormulation Technology Research Laboratories, Daiichi Sankyo Co., Ltd., Hiratsuka-shi, Kanagawa, JapanSchool of Electrical and Computer Engineering-Birck Nanotechnology Center, Purdue University, West Lafayette, IN, United StatesSchool of Aeronautics and Astronautics, Purdue University, West Lafayette, IN, United StatesSchool of Electrical and Computer Engineering-Birck Nanotechnology Center, Purdue University, West Lafayette, IN, United StatesThis work presents the design and evaluation of a fully wireless, multi-point temperature sensor system as a Process Analytical Technology (PAT) for lyophilization. Each sensor contains seven sensing elements which measure the product temperature at various positions of the contents of a glass vial. The sensor performance was studied by freeze drying experiments with sensor placement in both center and edge of full shelf of 6R glass vials with 4 ml fill volume. Product temperature profile and primary drying time measured at the bottom center position in the glass vial by the wireless sensor as well as the primary drying time are in close comparison with the thermocouple data. The drying times during primary drying were determined at the top, higher middle, lower middle and bottom positions which are 3.26 mm apart vertically in the vial by the wireless sensor based on the temperature profile measured at different positions. For a center vial, the drying time from the start of primary drying to each layer was measured at 3.9, 9.3, 14.2, and 21 h respectively, allowing to track the sublimation interface during primary drying phase. In addition, sublimation rate at each layer was calculated based on the drying time and theoretical weight loss of ice in the product. The sublimation rate at the beginning of the primary drying was similar to the sublimation rate by gravimetric method. Furthermore, the vial heat transfer coefficient (Kv) was also calculated based on the sublimation rate. Thus, allowing the use of the multi-point wireless sensor to rapidly monitor the sublimation rate and Kv for every batch as continuous process verification. Similar tests were also conducted with 3% w/v mannitol solutions and the results were consistent demonstrating potential for real-time monitoring, process verification and cycle optimization for pharmaceutical lyophilization.https://www.frontiersin.org/article/10.3389/fchem.2018.00288/fullfreeze dryinglyophilizationPATwireless sensor networksenergy harvestingsublimation tracking |
| spellingShingle | Xiaofan Jiang Tong Zhu Tatsuhiro Kodama Nithin Raghunathan Alina Alexeenko Dimitrios Peroulis Multi-Point Wireless Temperature Sensing System for Monitoring Pharmaceutical Lyophilization Frontiers in Chemistry freeze drying lyophilization PAT wireless sensor networks energy harvesting sublimation tracking |
| title | Multi-Point Wireless Temperature Sensing System for Monitoring Pharmaceutical Lyophilization |
| title_full | Multi-Point Wireless Temperature Sensing System for Monitoring Pharmaceutical Lyophilization |
| title_fullStr | Multi-Point Wireless Temperature Sensing System for Monitoring Pharmaceutical Lyophilization |
| title_full_unstemmed | Multi-Point Wireless Temperature Sensing System for Monitoring Pharmaceutical Lyophilization |
| title_short | Multi-Point Wireless Temperature Sensing System for Monitoring Pharmaceutical Lyophilization |
| title_sort | multi point wireless temperature sensing system for monitoring pharmaceutical lyophilization |
| topic | freeze drying lyophilization PAT wireless sensor networks energy harvesting sublimation tracking |
| url | https://www.frontiersin.org/article/10.3389/fchem.2018.00288/full |
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