Process Analytical Technology
Researchers at PSI are active in the development of Process Analytical Technology (PAT) tools for a number of industries, including the important pharmaceutical and biotechnology industries. PSI pursues U.S. government research and development funding to develop new sensor technologies and applies existing PSI proprietary technologies to new industrial applications. Through this process PSI is able to leverage technologies developed for U.S. Department of Defense applications for industrial monitoring needs. PSI also works with industrial partners to develop sensors specifically targeted to their monitoring needs. Examples of PAT sensors that PSI has developed and their corresponding monitoring applications include:
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Monitoring water vapor (or other gas species) mass flow during pharmaceutical freeze drying (lyophilization) |
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PeroxyScan: |
Vapor phase hydrogen peroxide concentration monitor for barrier isolator decontamination |
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SolventScan: |
(a) Monitoring gas phase organic solvent concentrations during fluid bed spray coating; (b) Vial head space monitoring |
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WaterScan: |
(a) Monitoring water vapor concentrations during fluid bed drying and granulation processes; (b) Vial head space monitoring |
PSI LyoFlux Mass Flow Rate Monitor
LyoFlux optical diagnostic duct installation in a laboratory scale freezedryer
Library: (Papers, Presentations and Posters)
1. Henning Gieseler, William J. Kessler, Michael Finson, Steven J. Davis, Phillip A. Mulhall, Vincent Bons, David J. Debo and Michael J. Pikal, “Evaluation of Tunable Diode Laser Absorption Spectroscopy for In-Process Water Vapor Mass Flux Measurements During Freeze-Drying”, J. Pharm. Sci., Vol. 96, No. 7, 2007.
2. Stefan C. Schneid, Henning Gieseler, William J. Kessler and Michael J. Pikal, “Non-Invasive Product Temperature Determination during Primary Drying using Tunable Diode Laser Absorption Spectroscopy,“ J. Pharm. Sci., Vol. 98, No 9 2009.
3. Kessler, W.J., Caledonia, G., Finson, M., Cronin, J., Paulsen, D., Davis, S.J., Mulhall, P.A., Gieseler, H., Schneid, S., Pikal, M.J. and Schaepman, A. “TDLAS-Based Mass Flux Measurements: Critical Analysis Issues and Product Temperature Measurements,” oral presentation at the CPPR Freeze-Drying of Pharmaceuticals and Biologicals Conference, Breckenridge, CO, July 2008.
4. Kessler, W.J., Gieseler, H., Schneid, S. and Pikal, M.J., „Using TDLAS-Based Mass Flow Measurements to Determine Product Temperature during Lyophilization,” oral presentation at the International Forum on Process Analytical Chemistr Baltimore, MD, January 2009.
5. Shrake, J., Walsh, M., Kessler, W.J., Galbally-Kinney, K. and Hinds, M.F., “Development and Application of a PAT Vapor Phase Hydrogen Peroxide Sensor for Barrier Isolator Decontamination,” oral presentation at the International Forum on Process Analytical Chemistry, Baltimore, MD, January 2009.
6. Kessler, W.J., Sonnenfroh, D.M., Frish, M.B., Allen, M.G., Davis, S.J. and Becker, D.C., “Application of Diode Laser Absorption Spectroscopy for Process Monitoring: A Mature Tool for Green Engineering,” oral presentation at the International Forum on Process Analytical Chemistry, Baltimore, MD, January 2008.
7. Schneid, S., Gieseler, H., Kessler, W. and Pikal, M.J., „Position Dependent Vial Heat Transfer Coefficient Determination: A Comparison of Tunable Diode Laser Absorption Spectroscopy and Gravimetric Measurements,” CPPR Freeze-Drying of Pharmaceuticals and Biologicals, Garmisch-Partenkirchen, Germany, October 2006.
8. Schneid, S., Gieseler, H., Kessler, W., and Pikal, M.J., „Process Analytical Technology in Freeze Drying: Accuracy of Mass Balance Determination using Tunable Diode Laser Absorption Spectroscopy (TDLAS),” AAPS Annual Meeting, San Antonio, TX, November 2006.
Publications and Presentations Describing the use of PSI PAT Sensors:
1. Cook, G., “Wyeth Forges Ahead,”, European Pharmaceutical Review, Issue 5 2006.
2. Nail, S.L. and Searles, J.A., “Elements of Quality by Design in Development and Scale-up of Freeze-Dried Parenterals,” International BioPharm, January 2008.
3. Kuu, W.Y. and Nail, S.L., “Rapid freeze-drying cycle optimization using computer programs developed based on heat and mass transfer models and facilitated by tunable diode laser absorption spectroscopy (TDLAS),” J.Pharm.Sci., Vol.98, No.9, 2009.
4. Kuu, W.Y., “Freeze-Drying Cycle Optimization Facilitated by Mathematical Modeling and Tunable Diode Laser Absorption Spectroscopy (TDLAS),”
5. Kuu, W.Y., Nail, S.L. and Sacha, G., “Rapid determination of vial heat transfer parameters using tunable diode laser absorption spectroscopy (TDLAS) in response to step changes in pressure set-point during freeze-drying,” J. Pharm. Sci. Vol 98, No.3 2008.
6. Hardwick, L.M., Paunicka, C. and Akers, M.J., “Critical Factors in the Design and Optimisation of Lyophilisation Processes,” Innovations in Pharmaceutical Technology, 26, 2008, pp 70- 74.
Contact
William Kessler
Physical Sciences Inc.
20 New England Business Center
Andover, MA 01810-1077
Telephone: (978) 689-0003
Fax: (978) 689-3232
kessler@psicorp.com