Plenary Session: A Stimulus for Product Quality and Lifecycles...Facing Today's Challenges
Chair(s): Theodora Kourti, George Vickers and Vincent L. Vilker
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| Welcome, Overview IFPAC-2010 |
| Theodora Kourti, GlaxoSmithKline, George Vickers, BP, Naperville, IL and Vincent L. Vilker, FDA, CDER, OPS, OTR, Silver Spring, MD
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| Quality by Design (QbD) and Process Analytical Technology (PAT): Current Status and Future Directions |
| Helen N. Winkle, Director, Office of Pharmaceutical Science, FDA/CDER/OPS, Silver Spring, MD
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| Growth Strategies of Japan and the Global Pharmaceutical Market |
| Norikazu Eiki, Chairman, Bayer Yakuhin Ltd., Japan
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| Trends in Enterprise Data Warehousing and Information Consolidation |
| Rick Makos, Teradata, Dayton, OH
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| Challenges in Monitoring Food Safety, GMS Perspective |
| Glenn Black, Ph.D., Director of Science Operations, Grocery Manufacturers Association, Washington, DC
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| The Cycle of Innovation: What Other Manufacturers Can Learn from Automation in the Semiconductor Industry |
| Christopher Bode, Ph.D., Principal Member of the Technical Staff, Manufacturing Systems and Technology and Thomas Sonderman, Vice President, Manufacturing Systems and Technology, GLOBALFOUNDRIES
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| IFPAC Achievement Award, sponsored by ExxonMobil |
| Presenter, Jeff Gunnell, ExxonMobil Chemical, Beverkae House, Mossmorran, Cowdenbeath, Fife, UK
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| OnSite Analysis – Homeland Security, Forensics and Environmental Remediation |
| Sanjiv R. Shah, Ph.D., National Homeland Security Research Center of the EPA, Washington, DC
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| Research and Technology Directorate Overview |
| Joseph L. Corriveau, Director Research and Technology Directorate Edgewood Chemical Biological Center, Research and Technology Directorate, Aberdeen Proving Ground, MD
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QbD – I - New Directions & Modeling
Chair(s): Sharmista Chatterjee, FDA; Dora Kourti, GSK; and James Cheney, Novartis
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| Multivariate Models to Support Design Space and Process Control: A Regulatory Perspective |
| Sharmista Chatterjee, FDA, Silver Spring, MD
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| Implementation of Quality by Design for Analytical Methods during Development thru Technology Transfer |
| Rosario LoBrutto, Novartis Pharmaceuticals, East Hanover, NJ
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| Benefits from the Application of QbD to Analytical Methods – A GSK Manufacturing Perspective |
| Phil Nethercote and Jennifer Finnegan McCafferty, Quality Analytical Sciences, Global Manufacturing & Supply, GlaxoSmithKline
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| Taming the Unpredictability of Dosage Forms…-A Materials Science Approach to Design Space Definition |
| Paul. A. Trusty, GSK
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| Applying QbD Tools to Speed-up and Reduce Cost in Pre-clinical Vaccine Studies and to Develop the Quality Target Product Profile and Formulation of a Vaccine Product |
| Line Lundsberg, Per Vase, NNE Pharmaplan, Surrey UK and Keith Howard, Baxter BioScience
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| Stability in a QbD Framework |
| T. Kourti, S. Gonzalez, P. Balaguer, C. Frances and G. Paris, GlaxoSmithKline
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| Application of Quality by Design Principles to Legacy Products |
| Francois Yacoub, Wendy Banh, Paul Gasko, Julie lautens, Leo lucisano, GlaxoSmithKline
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| Multivariate Process Modeling Methods for Optimization and Control |
| Chris McCready, Umetrics, Inc., Kinnelon, NJ
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Bio-Processing (Industrial)
Chair(s): Ron Hoffman
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| Biodiesel Reactors: Raw Material Analysis, Process Control, and Product Quality |
| Michael Donahue, Real-Time Analyzers, Inc., Middletown, CT
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| Bioreactor Monitoring Using In Situ Near Infrared (NIR) |
| Robert Mattes and Denise Root, FOSS NIRSystems, Inc., Laurel, MD
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| The Evaluation of Performance of an Implemented Fourier Transform Near Infrared (FT-NIR) Spectrometer at a Fuel Ethanol Plant for In-line Monitoring of Corn Mash Fermentation Process |
| Yan Wang and Hui Li, Ph.D., Bruker Optics, Inc., Billerica, MA
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| A Dual Wavelength System for Process Understanding using NIR, IR Spectra, and Chemometrics |
| Masahiro Watari, Yokogawa Electric Corp., Tokyo, Japan
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| Complex Flows of Cellulosic Slurries visualized using Magnetic Resonance Imaging |
| Michael J. McCarthy, University of California, Davis, Davis, CA
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| Use of a Rugged and Portable Variable Filter Array IR Spectrometer for Biodiesel Analysis |
| Francisca Folque1, M. Joana Neiva Correia2, José C. Menezes2, Pedro Felizardo1, 1. 4TUNE Engineering Ltd, Lisbon, Portugal, 2. Technical University of Lisbon, Dept. Chemical & Biological Engineering, Lisbon, Portugal
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Advanced Instrumental Concepts for Process Analysis
Chair(s): Joe Andrisani and Troy Francisco
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| Industrial LIBS Advances |
| Steve Buckley, Photon Machines
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| FTIR Ambient Air Monitoring |
| Michael Kester, ABB, Houston, TX and Troy Francisco, DuPont, Wilmington, DE
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| Stationary Targeted Small Molecule Leak Detection Using EPIR Technology |
| Fred Baudais, Troy Francisco, Measurement Systems Technology, DuPont, Wilmington, DE
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| Impurity Monitoring in an Ethylene Plant using a Quantum Cascade Gas Sensor |
| Yann Hamonou and Simon Nicholson, Cascade Technologies, Stirling, UK
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| Long-Term Metrological Qualification of Optical Feedback Cavity Enhanced Absorption Spectroscopy (OFCEAS); Measurement of Dihydrogen Sulfur in Natural Gas. |
| Lucien Lonigro, AP2E and Bertrand Lanher, Polarmetrics Corporation
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| Ultimate PAT NIR Sensor Powered by MEMS Technology |
| Igor Nazarov and Dan Klevisha, Polychromix, Wilmington, MA
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| Robust TDL Analyzers for Measurement of PPB and Percentage Level Analytes for Process Applications |
| Wenhai Ji, Xiang (Sherry) Liu, Alfred Feitisch, SpectraSensors, Houston, TX
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| Enhanced Development of Batch and Continuous Chemical Processes Using Real-Time In Situ FTIR Analytics as a PAT Tool |
| Wes Walker, Mettler Toledo, Columbia, MD
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| Online Process Analysis of Mercury in Petrochemical Streams for the Evaluation of Mercury Adsorbents |
| Baco-antoniali Franck, Arnaud Cordier, Charles-Philippe Lienemann, Jean-Pierre Combrié, IFP-LYON, Solaize, France and Warren T Corns, Peter B Stockwell and Tony Rogers, PS Analytical Ltd, Kent, UK
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| Application of PAT in Freeze-drying : A Case Study |
| Rebecca Vangenechten/Dr. Thomas De Beer, Siemens Industry & Automation/Ghent University Belgium, Antwerp, Belgium
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Process Analysis/Spectroscopy - I
Chair(s): George Vickers
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| In situ Monitoring of Liquids Using Mid Infrared Spectrometry |
| Alison Nordon,1 Megan Holden,1 Lynsey Anderson,1 Jaclyn Dunn,1 Stuart Forrest,1 Allyson McIntyre,1 Nichola Townshend,1 Gemma Griffen,1 Anna Jawor-Baczynska,2 Pamela Allan,1 Jan Sefcik,2 David Littlejohn,1 Gary Colquhoun3 and Viacheslav Artyushenko3,1. WestCHEM, Department of Pure and Applied Chemistry and CPACT, University of Strathclyde, Glasgow, UK 2. Department of Chemical and Process Engineering, University of Strathclyde, Glasgow, UK, 3. Fibre Photonics Ltd., West Lothian, UK
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| The Application of IR Spectroscopy to Monitor Biotransformations |
| Peter Gardner, University of Strathclyde, Glasgow, United Kingdom
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| Combining Photometric Data for Multi-component Process Analysis |
| Anthony Myles, AMETEK Process Instruments, Newark, DE
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| Dynamic Orthogonal Projection method used for Spectroscopic Calibration models Update, Transfer and Maintenance - Pharmaceutical Applications |
| Dr. Magida Zeaiter, GlaxoSmithKline R&D UK, Hertfordshire, UK
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| Calibration Transferability: Case Studies for Mid-IR and NIR Spectrometers |
| Stephen Medlin and John Richmond, Bruker Optics, The Woodlands, TX
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| Analysis of a Hot Melt Extrusion Process Using Near Infrared Spectroscopy |
| Thomas S. Chirkot Ph. D., P. E., ThermoFisher Scientific, Lanham, MD
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| Chemical Process Monitoring using Quantum Cascade Laser Spectroscopy |
| Yann Hamonou and Simon Nicholson, Cascade Technologies, Stirling, UK
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| Improved Solid-State Hydrogen Specific Analyzing Systems with %CO and H2S Tolerance |
| Prabhu Soundarrajan, H2scan Corporation, Valencia, CA
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| Development of H2S, HCl, H2O, CO2 and NH3 TDL Analyzers for Petrochemical Applications in Optically Interfering Hydrocarbon Streams |
| Xiang (Sherry) Liu, Wenhai Ji, Alfred Feitisch, SpectraSensors, Houston, TX
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Process Raman Symposium
Chair(s): Brian J. Marquardt
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| Process Raman Understanding |
| Ian R. Lewis, Kevin L. Davis, Sean J. Gilliam, Pat Weigand, Maryann, Cuellar, David Strachan, Carsten Uerpmann, Herve Lucas and Bruno Lenain, Kaiser Optical Systems, Inc., Ann Arbor, MI
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| Characterization of Petroleum Products Using the Data Fusion of Process Raman and IR Spectra |
| Thomas I. Dearing, Applied Physics Laboratory, University of Washington, Seattle, WA, Carl Rechsteiner, Jr., Chevron ETC, Richmond, CA and Brian Marquardt, Applied Physics Laboratory, University of Washington, Seattle, WA
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| Transmission Raman: Just what the doctor ordered! |
| Andrew Whitley, HORIBA Jobin Yvon Inc., Edison, NJ
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| PhAT Raman Analysis of Pharmaceutical Powders and Tablets |
| Nichola Townshend,1 Pamela Allan,1 Luke Bellamy,1 Alison Nordon,1 David Littlejohn,1 John Andrews,2 Paul Dallin2 and Michael Myrick3 , 1. WestCHEM, Department of Pure and Applied Chemistry and CPACT, University of Strathclyde, Glasgow, UK, 2. Clairet Scientific, Northampton, UK, 3. Department of Chemistry and Biochemistry, University of South Carolina, Columbia, SC
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| Rapid Non-invasive Quantification of Pharmaceutical Formulations by Transmission Raman Spectroscopy |
| Darren Andrews, Cobalt Light Systems, Cheshire, UK
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| Spectroscopic Characterization of Tablets with Low MgSt Concentration and Different Shear History |
| Michael L. Ramirez, J.I. Jerez Rozo, A. Rivera, A. Vanarase, M. Llusa, F.J. Muzzio and R.J. Romañach, Engineering Research Center for Structured Organic Particulate Systems, Department of Chemistry University of Puerto Rico –Mayagüez Campus, Mayaguez, PR and Department of Chemical and Biochemical Engineering, Rutgers University
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| Accurate Identification of Powders: the power of x-axis stability |
| Stuart Farquharson, Real-Time Analyzers, Inc., Middletown, CT
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| Handheld Raman Method Transfer on a Large Scale and Associated Assessments of Robustness |
| Chris Brown, Ahura, Wilmington, MA
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Chemometrics and Process Analytics - I
Chair(s): Brian J. Rohrback
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| Overview: Chemometrics for On-Line Process Analytics |
| Brian Rohrback, Infometrix, Inc., Bothell, WA
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| Chemometrics for Microhotplate Sensor Arrays- Exploiting the Additional Data Order |
| Robert T. Roginski, Barry M. Wise, Eigenvector Research, Inc., Wenatchee WA and Kurt D. Benkstein and Steve Semancik, National Institute of Standards and Technology, Gaithersburg MD
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| Real-Time Chemometric Alignment for Process Gas Chromatography |
| Rob Synovec, Center for Process Analytical Chemistry, Department of Chemistry, University of Washington, Seattle, WA
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| Integrating Chemometrics and Statistical Process Monitoring |
| Louis Halvorsen, Northwest Analytical, Inc., Portland, OR
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| Batch Monitoring with End-point Detection Models |
| Katherine Bakeev and Frank Westad, CAMO Software, Woodbridge, NJ
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| The Value of Peak Alignment in Chromatography |
| Jeff Gunnell, FRSC, ExxonMobil Chemical, Cowdenbeath, Fife, UK
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| Real-Time Alignment to Assist Process Measurements |
| Carl E. Rechsteiner, Chevron Energy Technology Company, Richmond, CA
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| Measuring the Homogeneity in a Continuous Blending Process with a Multipoint NIR System |
| Janne Paaso, Rutgers University / VTT, Piscataway, NJ
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QbD – II - PAT
Chair(s): James Cheney and Dora Kourti
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| PAT -an enabler of Quality throughout the product lifecycle |
| Vibhakar Shah, Ph.D. and Steven Wolfgang, Ph.D., US FDA, Division of Manufacturing & Product Quality, Office of Compliance, CDER, USFDA, Silver Spring, MD
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| Real Time End Point Detection for Powder Blends in a Compliant Environment using NIR and Chemometrics |
| Geir Rune Flåten, Ana Patricia Ferreira, Luke Bellamy and Paul Frake, GlaxoSmithKline
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| New Approaches for Timely Process Monitoring in Sugar Production |
| Rasmus Bro, Faculty of Life Sciences, University of Copenhagen, Denmark
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| Spectroscopic Process Monitoring in Cheese Production |
| Christian Lyndgaard Hansen, Faculty of Life Sciences, University of Copenhagen, Denmark
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| A PAT Study at Industrial Scale of a Fluidized Bed Drying Granulation process with a Microwave Resonance Sensor |
| Dr. Dirk Lochmann, MERCK SERONO, Darmstadt, Germany
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| Regulatory Considerations for Utilization of Near-Infrared (NIR) Spectroscopy in Process Monitoring and Control |
| Bogdan Kurtyka, Food and Drug Administration, Silver Spring, MD
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| Raman Spectroscopy to Analyze Intact Pharmaceutical Tablets: factors influencing MVPM-based PAT methods |
| J. Salvas, J.-S. Simard, Nicolas Abatzoglou,(*), Université de Sherbrooke, Department of Chemical & Biotechnological Engineering, Sherbrooke, Quebec, Canada
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| Mechanistic Modeling for Systematic Design and Analysis of PAT Systems |
| Ravendra Singh, Krist V. Gernaey, John M. Woodley and Rafiqul Gani, Department of Chemical and Biochemical Engineering, Technical University of Denmark, Lyngby, Denmark
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| PAT Particle Size Analyzer (PSA) Application for API Milling Manufacturing Process |
| Eric J. Correa, Abbott Labs, North Chicago, IL
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Food Safety – Microbiological Contaminants
Chair(s): Joseph E. LeClerc, Ph.D. and John Steichen
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| Overview: Microbiological Safety of Foods |
| Joseph E. LeClerc, Ph.D., Center for Food Safety and Applied Nutrition, FDA
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| Technologies for the Microbiological Safety of Foods – Where we are |
| CDC Speaker
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| Cell Sorting for Detection of Microbial Contaminants in Foods |
| Thomas Flammang, Ph.D., National Center for Toxicological Research (NCTR), FDA
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| Mass Spectrometry of Genetic Signatures using the Ibis T6000 System |
| Ranga Sampath, Ph.D., Ibis BioSciences
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| DNA Microarray of Foodborne Contaminants using an Affymetrix Microarray |
| Scott A. Jackson, Center for Food Safety and Applied Nutrition, FDA
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| Remote Detection of Marine Microbes, Their Genes and Gene Products Using the Environmental Sample Processor (ESP) |
| Christopher A. Scholin, Ph.D., President and Chief Executive Officer Monterey Bay Aquarium Research Institute
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| Systems and Assays for Food Evaluation |
| Jon Mogford, Ph.D., Program Manager-DSO, DARPA
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NeSSI-I
Chair(s): Jeff Gunnell and Mel Koch
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| Future Directions in Process Analytics |
| Jeff Gunnell, ExxonMobil Chemical, Cowdenbeath, Fife, UK and Mel Koch, CPAC, University of Washington, Seattle, WA
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| SP76 Standard Revision Updates |
| Steve Doe, Parker Hannifin, Jacksonville, AL
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| New Astute Field Applications |
| Philippe Coric and Michel Josseau, EIF Filter, Montrevil, France
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| Leveraging New Intrinsically-Safe Digital CANbus Technology for Simultaneous, Multi-Analyzer Sample Conditioning Using a Single System Methodology for Halo-Butyl Moisture and GC Analysis |
| Paul Bartel and Patrick Lowery, ExxonMobil Chemical Company and CIRCOR International, (respectively), Spartanburg, SC
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| Current Status of CIRCOR Tech’s Platform Development |
| Patrick Lowery P.E., CIRCOR Technologies, Spartanburg, SC
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| Matching NeSSI™ System Solutions to Process Criticality: Realizing the Value Proposition |
| Tracy Dye, ABB, Lewisburg, WV
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| A Commercial Implementation of NeSSI-Based Tools for Smart Process Sampling Systems |
| Bob Farmer, Siemens Industry, Inc., Bartlesville, OK
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| SAM Functionality Considerations |
| Peter van Vuuren, Process Analytics Consultant
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| Updates on the Swagelok Platform (TBC) |
| TBA, Swagelok, Solon, OH (TBC)
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Advanced Separations- I (MS/HPLC/Components/GC)
Chair(s): Rick Cooley and John Crandall
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| On-line analysis of Autothermal Reforming processes by Process Mass Spec |
| Todd Colin, Colin Consulting, Macedon, NY
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| Improvements in the Analysis Accuracy of Complex Gases by Process Mass Spectrometry |
| Peter J Traynor, Thermo Fisher Scientific, Scottsdale, AZ
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| Gasification: SynGas Analysis by Quadrupole Mass Spectrometry |
| Jim Brenner, Extrel CMS, Pittsburgh, PA
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| A Unified and Flexible Platform for the Analysis of Inprocess Samples by UPLC |
| Tanya Jenkins, Waters Corporation, Milford, MA
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| New Developments in Capillary Ion Chromatography Applications |
| Mike Doyle and Jason Wood, Dionex Corporation, Sunnyvale, CA
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| Innovations in Diaphragm Valve Technology |
| Gordon McFarland, Analytical Flow Products, Thetford Mines, Canada
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| Achieving Improved Sensitivity Of A Gas Chromatograph's Thermal Conductivity Detector Through Optimization Of Thermal Design Characteristics |
| Al Kania, Yokogawa Corporation, Houston, TX
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| Using the Dielectric Barrier Discharge Detector in an Electron Capture Mode |
| Jerry Clemons,Ph.D. ABB, Lewisburg, WV
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| Process Gas Chromatography - Simplified Maintainability by using Modular and Standardized Analytics |
| Ulrich Gokeler, Siemens Industries, Inc., Houston, TX
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| A Mathematical Alignment Technique Used With On-line Process Chromatography |
| Bob Farmer (Siemens); Brian Rohrback (Infometrix), Siemens Industry, Inc., Bartlesville, OK
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Imaging: Data Analysis and Emerging Techniques
Chair(s): Steve Hammond
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| Correlating Raman and EDXRF Hyperspectral Imaging using Chemometrics to Achieve Comprehensive Material Characterization |
| Eunah Lee, HORIBA Scientific, Edison, NJ
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| High-Speed Vibrational Imaging of Tablets by Epi-detected Stimulated Raman Scattering Microscopy |
| Ji-Xin Cheng, Purdue University, West Lafayette, IN
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| Imaging Methods to Support PAT Development |
| Jordan Cheyne, Pfizer, Sandwich, Kent, UK
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| Complementary Spectroscopic Imaging Tools for Pharmaceutical Authenticity Testing |
| Thomas W. Brueggemeyer, Mark Witlowski, Adam Lanzarotta, Nico Ranieri, Doug Albright, Forensic Chemistry Center - U.S. Food and Drug, Administration, Cincinnati, OH
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| Vibrational Spectroscopy and Chemical Imaging Coupled with Multivariate Analysis as a Multidisciplinary Tool Set to Support Early Stage Formulation and Process Development |
| Hua (May) Ma, Ph.D., Pharmaceutical and Analytical Research and Development (PARD), Roche, Nutley, NJ
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| Morphologically Directed Raman Microscopy: A Novel Approach for the Characterization of Pharmaceutical Products |
| Linda Kidder, Malvern Instruments, Columbia, MD
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| NIR Chemical Imaging Studies for Tablets during Manufacturing Platform Selection |
| Saly Romero-Torres, Pfizer, Pearl River, NY
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| Laser Induced Breakdown Spectroscopy as an Imaging Technique |
| Fernando Muzzio, Rutgers University, Piscataway, NJ
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| Pharmaceutical Imaging Application (TBA) |
| Jurgen Perin, PPD Freiburg – Product and Process Development, GMX – New Products Group, Freiburg, Germany
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Chemometrics and Process Analytics - II
Chair(s): Brian J. Rohrback
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| NIR and NIR-CI Determination of Drug Concentration and Homogeneity in Novel Gel Strips |
| J.I. Jerez Rozo, M.L. Ramírez, K. Laboy, J. Torres, B. Zhou, R. Pinal and R.J. Romañach, Engineering Research Center for Structured Organic Particulate Systems, Department of Chemistry University of Puerto Rico -Mayagüez Campus and Purdue University Department of Industrial and Physical Pharmacy
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| A Locked-down Approach to Process Analytical Deployment |
| Mike A. Power and Mike Doyle, Symbion Systems, Inc., Tustin, CA
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| A Portable Fuel Analyzer |
| Stuart Farquharson, Real-Time Analyzers, Inc., Middletown, CT
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| Laser Induced Breakdown Spectroscopy of Steel: A Comparison of Univariate and Multivariate Calibration Methods |
| Christopher B. Stipe and Brian D. Hensley, Seattle University, Mechanical Engineering Dept., Seattle, WA, Jeffrey L. Boersema, Seattle University, Mathematics Dept., Seattle, WA and Steven G. Buckley, PhotonMachines
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| Chemometrics: Speed up Process Development |
| Nilesh Shah, Mettler Toledo, Columbia, MD
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| Diversification of the World's Energy Sources and its Challenges for the Technical Professions |
| Jeffry T. Donner and Kurt M. VandenBussche, UOP LLC, Des Plaines, IL (Double time slot)
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QbD – III – Applications
Chair(s): Dora Kourti, GSK and James Cheney, Novartis
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| Smart Process Analytics and Process Systems Engineering - Contributions to Quality by Design |
| Professor Dr Julian Morris, Centre for Process Analytics and Control Technology (CPACT), Dept of Pure and Applied Chemistry, University of Strathclyde, Glasgow, UK
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| Multivariate Analysis (MVA): A structured approach for Chemical Development data |
| Christian Airiau1, Tom Thurston2 and Vern de Biasi1, 1GlaxoSmithKline, PAT & Chemometrics, Hertfordshire, UK, 2GlaxoSmithKline, PAT & Chemometrics, Kent, UK
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| QbD Approach to Developing a Parenteral Formulation for a Small Molecule |
| Linas Mockus, Prabir K. Basu, Nancy J. Harper, Steven L. Nail, Nathan Pease, Tim Paul, Michael J. Pikal, David LeBlond, Mansoor A. Khan, Agnes A Nguyenpho, The National Institute for Pharmaceutical Technology and Education, West Lafayette, IN
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| Injection Moulding Process Understanding and Control Using Design of Experiments and Cavity Sensor Technology: application to Pharmaceutical Device Components |
| Dr. Magida Zeaiter, Wendy Knight and Brett Blackwell, GlaxoSmithKline R&D, Ware, UK
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| PAT Platform Implementation for the Roller Compaction Process to Support Attribute-Based Technology Transfer, QbD Control Strategies, and Real-Time Release Testing |
| Mano Ramasamy, Merck & Co, Inc., West Point, PA
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| Implementation of SIPAT in an Oral Solid Dose Plant: Key Elements for Success |
| Kjell Francois, Siemens
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| Applying PAT to Cleaning and Cleaning Validation |
| Mario Hellings, Johnson & Johnson Pharmaceutical Research & Development, Beerse, Belgium
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| MSPC in the Food Industry |
| Frans van den Berg, University of Copenhagen, Denmark
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| Real-Time Smart Sensor Platform Aids in Delivering Quality by Design via PAT |
| Crystal Dixon, Sara Mohre and Mike Ponstingl, Custom Sensors & Technology, Fenton, MO and Jason Dickens, PhD, GlaxoSmithKline, Durham, NC
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| Multivariate Statistical Process Monitoring (MSPM) Outside and Within the Design Space Concept |
| Ing-Marie Olsson, Umetrics AB, Malmö, Sweden
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| Quality by design case study: An integrated multivariate approach to drug product and process development |
| Jun Huang, Pfizer, Pearl River, NY
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Challenges in Monitoring Food Safety – Chemical Safety of Foods
Chair(s): John Callahan, Ph.D., CFSAN and John Steichen
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| Overview: Chemical Safety of Foods |
| John Callahan, Ph.D., Center for Food Safety and Applied Nutrition
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| Food Contaminants: Fresh Mass Spectrometry Methods of Analysis |
| R. Graham Cooks,1 Guangming Huang,1 Juan Garcia Reyes,2 Joshua S. Wiley,1 Ayanna U. Jackson,1 Robert J. Noll,1 Santosh Soparawalla1 and Zheng Ouyang3 , 1Department of Chemistry and Center for Analytical Instrumentation Development, Purdue University, West Lafayette, IN, 2Analytical Chemistry Research Group, University of Jaén, Department of Physical and Analytical Chemistry, Campus Las Lagunillas, 23071 Jaén, Spain 3 Weldon School of Biomedical Engineering, and Center for Analytical Instrumentation Development, Purdue University, West Lafayette, Indiana (Double Time Slot)
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| Untargeted Screening Methods for Identification of Chemical Contaminants in Foods |
| Steven Musser, Center for Food Safety and Applied Nutrition, U.S. FDA
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| Fast Extraction and Analysis for Hundreds of Pesticide Residues in Foods |
| Steven J. Lehotay, USDA Agricultural Research Service, Eastern Regional Research Center, Wyndmoor, PA
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| Definitive Elemental Composition Information in a Minute or Less - Recent Advances and Applications of Field Portable XRF |
| P.T. Palmer1,2, R. Jacobs2, P. Baker2, H. Gregory1, A. Trinh1, D. Luong1, J. Hamdani1, R. Johnson1, K. Yamamoto1, 1Dept. of Chemistry and Biochemistry, San Francisco State University, 2San Francisco District Laboratory, U.S. Food and Drug Administration (FDA)
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| Fluidic Force Discrimination Assays: an Alternative Technology for Rapid and Sensitive Food Monitoring |
| Shawn P. Mulvaney1*, Betsy J. Yakes2, Stacey Etheridge2, and Cy R. Tamanaha1, 1 U.S. Naval Research Laboratory; 2 Food and Drug Administration
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| Yesterday, Today, and Tomorrow: Detecting Food Allergens Using Single Analyte and Multiplex Technology |
| Eric A.E. Garber*, Sabine Hildebrandt, Chung Y. Cho, Benjamin J. Canas, Anne C. Eischeid, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD, USA
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| Panel Discussion: Food Safety – Chemical Contaminants |
| John Callahan, Ph.D., CFSAN, John Steichen, et al.
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NeSSI - II
Chair(s): Mel Koch and Jeff Gunnell
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| Use of MicroGCs |
| Carl E. Rechsteiner, Chevron Energy Technology Company, Richmond, CA
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| OPC Unified Architecture (UA) Analyzer Device Integration (ADI) and Application to NeSSI™ Systems |
| Tracy Dye, ABB, Lewisburg, WV
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| Water Security: Detecting Chemical Agents by SERS using NeSSI |
| Stuart Farquharson, Real-Time Analyzers, Inc., Middletown, CT
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| Vision of Micro-Analytics on NeSSI™ |
| Brian J. Marquardt, Ph.D., Director, Applied Optical Sensing Laboratory at the Applied Physics Laboratory, University of Washington, Seattle, WA
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| Real-Time In-Line Density Analysis of Gas & Liquid Hydrocarbons Using Smart Microsystems - Application to Process Intensification |
| Franck Baco-Antoniali+, Arnaud Cordier+, Philippe Rocher+, François Chaudoreille*, Emmanuel Tavernier*+ IFP-LYON, Process Experiments Division, Vernaison – France, * , Memschulumberger, Parc Euclide, Elancourt - France
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| The NeSSI Session - II will now move and be combined with Advanced Separations – II (see below) |
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Advanced Separations - II (Smart & microGC)
Chair(s): John Crandall
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| Sorting Sources: Apportionment by GC |
| Brian Rohrback, Infometrix, Inc., Bothell, WA
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| Rethinking Process Gas Chromatography |
| John A. Crandall, Falcon Analytical, Ronceverte, WV, Carl Rechsteiner, Chevron, Richmond, CA and Ned J. Roques, Falcon Analytical, Ronceverte, WV
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| Fundamental Advances for Process Gas Chromatography Instrumentation |
| Rob Synovec, Center for Process Analytical Chemistry, Department of Chemistry, University of Washington, Seattle, WA
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| Advanced, Smart & Fast microGC Technologies |
| Carl Rechsteiner, Chevron, Richmond, CA, Ned Roques, Falcon Analytical, Ronceverte, WV, Brian Morlan, Chevron, Richmond, CA and Molly Carlson, Chevron, Richmond, CA
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| New Applications on a Revolutionary Point-of-Use Micro-Chromatograph |
| Bob Cook, Research Chemist, ABB Totalflow, Bartlesville, OK
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| The NeSSI Session - II will move and be combined with Advanced Separations – II at this time. |
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| SP76 Sample Conditioning Systems: Form, Function and Benefits for Analytical Measurement |
| Mike Cost, Parker Hannifin, Huntsville, AL
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| Is NESSI Necessary? |
| Bob Cook, Research Chemist, ABB Totalflow, Bartlesville, OK
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| The Micro Gas Chromatograph Experience |
| Carl E. Rechsteiner, Chevron Energy Technology Company, Richmond, CA
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| Advanced Separations Panel Discussion: Small, Smart, NeSSI? |
| John A. Crandall, “The Panel”, Falcon Analytical, Ronceverte, WV, Mike Cost, Parker Hannifin, Huntsville, AL, Bob Cook, Research Chemist, ABB Totalflow, Bartlesville, OK, Carl E. Rechsteiner, Chevron Energy Technology Company, Richmond, CA, Jeff Gunnell, FRSC, ExxonMobil Chemical, Cowdenbeath, Fife, UK And two others to be announced.
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Imaging for Quality & Process Understanding
Chair(s): Carl Anderson and Steve Hammond
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| Evaluation of a Novel Pharmaceutical Formulation by NIR -Chemical Imaging and Multivariate Image Analysis |
| José Manuel Prats-Montalbán1, J.I. Jérez-Rozo2, R.J. Romañach2, and A. Ferrer1, 1Multivariate Statistical Engineering Group, Departamento de Estadísticae, Universidad Politécnica de Valencia (Spain), 2NSF-Engineering Research Center for Structured Organic Particulate Systems, Department of Chemistry, Universidad Politécnica de Valencia, Valencia, Spain
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| Improved Insight into Spatial Distribution of Tablet Components |
| Ralf Marbach, VTT, Oulu, Finland
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| Successful Multivariate Imaging Applications in the Process Industry |
| Ryan Gosselin, Jayson Tessier, Myriam Cousineau Pelletier, and Carl Duchesne*, Department of Chemical Engineering, Université Laval, Québec (Qc), Canada
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| Characterization of post-compression expansion in pharmaceutical tablets by NIR Chemical Imaging |
| Benoit Igne, Carl A. Anderson, James K. Drennen III, Duquesne University Center for Pharmaceutical Technology, Pittsburgh, PA
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| Two-dimensional (2-D) Localization in Hyperspectral Imaging Analysis |
| Zhenqi (Pete) Shi and Carl A. Anderson*, Graduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA
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| Imaging (TBA) |
| Carl A. Anderson, Ph.D., Duquesne University, Pittsburgh, PA
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| Advances in Hyperspectral Imaging Technologies and Multi-channel Fiber Sensing |
| Jay Zakrzewski, Headwall Photonics, Inc., Fitchburg, MA
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| Push-broom Hyperspectral Imaging with real time Chemometrics |
| Timo Hyvärinen 1, Harri Karjalainen 1, Oskar Johnson 2, and Susanne Wiklund Lindström 2, 1 SPECIM, Spectral Imaging Ltd, Oulu, Finland, 2 Umbio AB, Umeå, Sweden
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| SAM-Spec® VIS-NIR Spectroscopy for the Pharmaceutical Industry Example: Simultaneous prediction of API concentration and Particle size distribution on drug layering process. |
| Fabien Chauchard1 , Anil Asokan, 1, Hamid Dehghani 2 , Jerome Revel 3 , Magida Zeaiter4, 1 Indatec, Prades le Lez, France, 2 The University of Birmingham , School of Computer Science, Birmingham, United Kingdom, 3 2 Flamel Technologies, Pessac, France, 4 GlaxoSmithKline, R & D, Hertfordshire, UK
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Life Cycle Management of Analyzer and Method Reliability
Chair(s): Gert Thurau and Stephen Jacobs
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| Intelligent Chemical Microsensor Systems as a Potential Enabling Technology for Aeronautic and Commercial Applications |
| Gary W. Hunter, NASA Glenn Research Center, Cleveland, OH
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| Fault Monitoring in Sensor Networks and Sensor Placement Strategy for Nuclear Desalination Systems |
| Belle R. Upadhyaya and J. Wesley Hines, University of Tennessee, Knoxville
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| Building Technology into Process Analytics |
| Ken Queeney, Mettler-Toledo Ingold, Inc., Bedford, MA
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| Using Instrument Capability Determination to Ensure Application Suitability |
| Martin Warman, Vertex Pharmaceuticals, Inc., Nuno Matos and Ligia Bras, Hovione FarmaCiencia SA
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| The use of MVDA Models Supporting Time Resolved Quality Assurance for Chemical and Pharmaceutical Processes |
| Dr. Lorenz Liesum, Novartis Pharma AG, Basel, Switzerland
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| Challenges in Selecting the Right Control Strategy for Content Uniformity |
| Mette Bryder and Morten Allesoe, H. Lundbeck, Copenhagen, Denmark
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| Process Analyzer System Monitoring, enhanced with Remote Support |
| Michael Hoffman, Siemens, Houston, TX
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PAT Applied for Biologics Manufacturing
Chair(s): Jose Cardoso de Menezes and Deshmukh Ranjit
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| Enabling PAT over Multiple Scales using Non-invasive Sensor Technology |
| Govind Rao, Center for Advanced Sensor Technology and Department of Chemical & Biochemical Engineering, UMBC, Baltimore, MD
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| Development of Process Analytical Technology (PAT) Methods for Online Control of Glycosylation Profiles during Monoclonal Antibody Production |
| Melissa St. Amand, P. Millili, M. McCabe and B.A. Ogunnaike, University of Delaware, Newark, DE
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| PAT-based In-line-Buffer dilution: Serving the paradigm of Quality by Design |
| Michael Li, Asahi Kasei, TechniKrom, Glenview, IL
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| Automated Bioreactor Feeding, Sampling, and Analysis - A PAT Proof Statement |
| George Barringer(1), Karl Rix(2), David Lau(1), and Falk Schneider(2), 1. Groton Biosystems, Boxborough, MA, 2. DASGIP AG, Juelich, Germany
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| Innovative Methods for Bioprocess Modeling, Monitoring and Controlling |
| Barbara Spangl-Kavsek & Rebecca Vangenechten, Siemens Corporate Technology & Siemens Industry and Automation, Anwterp, Belgium
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| Use of FT-NIR for Biomanufacturing Processes |
| Frederic Despagne, ABB Analytical, Bordeaux, France
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| Monitoring Mammalian Cell Cultivations for Monoclonal Antibody Production Using In-Situ FT-NIR |
| Stefan Buziol, Elena Stocker, Arthur Voogd, Joao G Henriques and Jose C Menezes, Technical Univ Lisbon – Portugal, Dept Chemical & Biological, Engineering, Lisbon, Portugal
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| Controlling a Cell Culture Process by NIRS Process Fingerprinting |
| Mariana Fazenda, Strathclyde University, Glasgow, United Kingdom
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| Strategies to Combine Spectroscopic Data for Raw Material Analysis |
| Maureen Lanan, Biogen Idec, Cambridge, MA
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| Controlling Variability in Bioprocess |
| Rick Baggio, Millipore Corp.
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| PAT for Vaccines: Real-Time Multivariate Data Analysis for Bulk Production |
| John Higgins, Merck Sharp and Dohme Corporation, West Point, PA
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| PANEL DISCUSSION-WHAT ARE LIMITS ON USING PAT FOR BIOLOGICS? |
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Poster Session
Chair(s): Jerry Clemons
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| Evaluation Method Robustness to Physical and Batch to Batch Variances of a Handheld Raman Spectrometer for Bulk Raw Material Authentication |
| Jeremy A. Linoski, Ahura Scientific Inc., Wilmington, MA
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| Best Practices for Implementation of Handheld NIR for Rapid Raw Material Identification in Your Warehouse |
| Dan Klevisha, Polchromix, Wilmington, MA
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| Comparison of the Three Existing Approaches for On-line Calibration Model transfer, Update and Maintenance |
| Jordane Lallemand, Sebastien Preys (1) Magida Zeaiter, Simon Holland(2), 1 Ondalys, Prades le Lez, France, 2 GlaxoSmithKline, R & D, Hertfordshire, UK
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| Metal-Organic Synthesis of Single-Crystalline Cobalt Phosphide 1-D Nanostructure with Controllable Size |
| Zhang Shuangyuan, National University of Singapore, Singapore
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| Evolution of Valve Technology from the Lab Bench to the Process Analyzer |
| Gordon McFarlane, Analytical Flow Products, Thetford Mines, Canada
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| Physical-Chemical Sensors: Application to Bioreactor Monitoring and Control |
| Rick Baggio, L. Mullin*, M. Blanchard^, M. Zillmann*, J. Dufour** and C. Martin*, Technology and Pre-Development* , Filtration Product Development^, Industrialization and Process Transfer**, Millipore Corporation, Bedford, MA
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| Extending Calibrations for Near-Infrared Assay of Tablets Using Synthetic Modeling and Variance from Placebos |
| Robert Mattes, FOSS NIRSystems, Inc., Laurel, MD
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| Wide Dynamic Range Non-Contact In-Process Wet Coating Measurement Applications |
| Jeffrey White, Irl Duling, David Zimdars, Greg Fichter, Chris Megdanoff and John Duquette
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| From Model Building to Routine Analyses – a new approach to calibration transfer |
| E. Hilscher,1* S. Busche,2 and J. Nolte,2, Einbeck, Germany, 2 Polytec GmbH, Waldbronn, Germany
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| Avoidance of Technical Transfer Issues by Building a Quantitative PLS Model from UV Spectroscopic Data Generated in-situ in a Plant Vessel with no Sacrifice of Clinical Grade Material |
| Peter Skett, GlaxoSmithKline, Medicines Research Centre, Stevenage, Herts, UK
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| A Systematic Approach to PAT Deployment for API Development and Manufacturing |
| Eric Ahuja, Tseng-En Hu, John Higgins, Merck Sharp and Dohme Corporation, West Point, PA
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Continuous Processes
Chair(s): Vibhakar Shah, FDA; Dora Kourti, GSK; and James Cheney, Novartis
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| Continuous, Bottom-Up Production of Nanosuspensions for Pharmaceutical and Chemical Applications |
| T. Panagiotou, Microfluidics Corporation, Newton, MA and R.J. Fisher, Massachusetts Institute of Technology, Cambridge, MA (Double Time Slot)
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| Regulatory Perspective on Continuous Processing |
| Vibhaker Shah, Ph.D., Senior Policy Advisor, Div. of Manufacturing and Product Quality, Office of Compliance, CDER, USFDA
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| The Continuous Manufacture of API |
| Simon Hayes, GSK
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| The Enabling Role of PAT in Continuous API Processes |
| Mojgan Moshgbar, Ph.D., Senior Manager/TL-Innovative Processes team, PASG, GMS, Pfizer Global Manufacturing, Kalamazoo, MI
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| Continuous Processes (TBA) |
| Steve Hammond, Director/Team Leader, Process Analytical Sciences Group, Pfizer, Morris Plains, NJ
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| The Development of Technology for Enabling Optimization of Continuous Processing |
| Mel Koch CPAC/University of Washington, Seattle, WA and Brian Marquardt, APL/University of Washington, Seattle, WA
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| Roundtable Discussion on Continuous Processes |
| Vibhakar Shah, Dora Kourti, James Cheney et al.
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Food Applications – PAT
Chair(s): Michael McCarthy
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| PAT's 9 Lives: Impact of Technology, Risk and ROI on PAT / QbD Projects |
| Joe Smith, ABB Inc., Automation Technology - Process Industries Products Process Analytical, Philadelphia PA
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| Impact of Processing on Fruit and Vegetable Cell Membrane Integrity |
| Michael J McCarthy, Mecit Halil Oztop, Seda Ersus and Diane M. Barrett, Department of Food Science and Technology, University of California, Davis, CA
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| Online Quality Analysis of High Value Food Processing Streams |
| J. Bruce German, David A Mills and Carlito B Lebrilla, University of California, Davis
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| Sophisticated Wireless Monitoring System which Elevate Food Safety (HACCP) Performance, Operations Efficiencies and Productivity and Management Decision Making Capabilities in Food and Agriculture |
| Gideon Zeidler, University of California, Riverside, CA
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Process Understanding & Control
Chair(s): Joseph Andrisani and Troy Francisco
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| Implementation of a Global Program for Ambient Gas Monitoring – A Case Study |
| Matthew H. MacConnell, Analyzer Technology Manager, Air Products, Allentown, PA
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| On-line Production Time-Domain Terahertz Measurements of Multilayered Materials |
| Jeffrey White, Picometrix LLC, Ann Arbor, MI
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| Critical Safety Analyzer; Trace Acetylene in Cryogenic System Feed Gas |
| Matthew H. MacConnell, Analyzer Technology Manager, Air Products, Allentown, PA
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| Environmental Monitoring of Total Reduced Sulfur and High Heating Value of Refinery Flare Vent Gas |
| Timothy Davidson, John Shao, Nand Khindkikar, Jeromy Jorgenson and Rodelio Limfueco, BP West Coast Products, Carson, CA
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| 100% Inline Measurement of Dosed Mass on the Flight During Liquid and Solid Filling |
| Dr. Heino Prinz, Uhlmann VisioTec GmbH, Laupheim, Germany
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| High-Speed Residual Moisture Determination of Lyophilized End-Products |
| Angelina Hartini and Evan Ramer, Brimrose Corporation of America, Sparks – Glencoe, MD
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| Utilization of an Optical Oxygen Analyzer for Process Control |
| Deru Qin, James Airey, and Kirby Goss, ExxonMobil Chemical Company, Beaumont, TX
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Pharma Waters and Real-Time Analysis
Chair(s): Richard Godec and Jeffrey Weber
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| Sensitivity and Transient-Response Performance of a Multi-Angle Light Scattering System for Real-Time Microbial Monitoring of Pharmaceutical-Grade Waters |
| Dr. Peter Gallant, Pathogen Detection Systems Inc. / Veolia Water Solutions & Technologies, Queen's University, Kingston, Ontario, Canada
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| Pharmaceutical Waters and Real-Time Release |
| Michael Goetter, VP of Product Strategy, MODA Technology Partners, Wayne, PA and Robert Lutskus, Imclone Systems, a wholly owned subsidiary of Eli Lilly and Co. (Double Time Slot)
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| Instantaneous Microbial Detection Technology and its relevancy to Process Analysis and Control |
| Dr. J.P. Jiang, Chief Technology Officer, BioVigilant, Tucson, AZ
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| Rapid ATP BioBurden Testing for Purified Water Systems |
| Robert Salter, Vice President of Regulatory Affairs, Charm Sciences Inc., Lawrence, MA
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| Low Level Sodium On-line analysis with Ion-Seletive Electrode (ISE) |
| Robert Hoogendijk, Applikon Analytical b.v., Zuid-Holland, Netherlands
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| Application of Process Analytical Technologies (PAT) for Effective Cleaning Validation Risk Management |
| Keith Bader, Hyde Engineering + Consulting, Inc., Boulder, CO
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| Progress Report: International Real-time Release Online TOC Standard |
| Richard Godec, New Product and Market Development Manager, GE Energy and Water, Analytical Instrumentation, Boulder Colorado, USA
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Screening and Surveillance Techniques using Handheld Instrumentation
Chair(s): Paul Vahey
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| Pharmaceutical Surveillance with Rapid Spectroscopic Screening Technologies |
| John F. Kauffman, Connie Gryniewicz-Ruzicka, John A. Spencer, Jamie Dunn, Sergey Arzhantsev, Lillian Li, Lindsey Pelster, Laura Mecker, Jason Rodriguez, Brendon Lyons, Benjamin J. Westenberger and Lucinda F. Buhse, FDA Center for Drug Evaluation and Research, Division of Pharmaceutical Analysis, St. Louis, MO
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| Rugged, Portable NIR Fuel Analyzer |
| Stephen Medlin, John Cooper, Bruker Optics, The Woodlands, TX
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| Hand-held FTIR for Cleaning Validation & Verification |
| Ben Lyons, Pfizer
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| Using Handheld NIR in Customs and Security Applications |
| Fred Haibach, Polychromix, Wilmington, DE
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| Non-Destructive Analysis of Composites by Infrared Spectroscopy |
| Paul Vahey, Boeing, Seattle, WA
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| Using Quantum Cascade Lasers to Develop Handheld Gas Sensors with FTIR Capabilities |
| Miles Weida, Daylight Solutions, Poway, CA
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| On-Site Material Verification with a Portable Variable Filter Array (VFA) Mid Infrared Analyzer |
| Sandra Rintoul, Wilks Enterprise, Inc., South Norwalk, CT
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| Portable Hand-Held Near-Infrared Analyzer for Biodiesel Feedstocks Qualification and Quality Control |
| Pedro Felizardo1, Francisca Folque1, José C. Menezes2, M. Joana Neiva-Correia2, 1. 4TUNE Engineering Ltd, Lisbon, Portugal, 2. Technical University of Lisbon, Dept. Chemical & Biological Engineering, Lisbon, Portugal
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| Discussion on Portable Handheld Analyzers |
| Paul Vahey et al.
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Analyzer Integration
Chair(s): George Vickers
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| Analytical Integration at the Process Level |
| M. A. Power and W. M. Doyle, Symbion Systems, Inc., Tustin, CA
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| Process Analyzer Sensor Integration - The Development of Novel QbD Instrumental Solutions |
| Crystal Dixon, Sara Mohre, Mike Ponstingl,Custom Sensors & Technology and Jason Dickens, GlaxoSmithKline
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| Analyzer Project Up-Grade |
| Nick Valasek and John Burkland, TASC, Seabrook, TX
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| Delivering an Integrated Project; A Value Structured Approach |
| Michael Hoffman, Siemens, Houston, TX
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| Design and Fabrication of a Custom Two Room Analyzer Shelter |
| Jim Cronin and Larry Bonam, DuPont, Wilmington, DE
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| Analyzer Integration – spotlight use of NeSSi hardware and successes/opportunities with analyzer building, field NEMA options, and bus integration (Profibus, Ethernet) |
| Matt MacConnell, Analyzer Technology Manager, Air Products, Allentown, PA
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Shelter Safety
Chair(s): Dan Podkulski
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| Tools to Assure Safety in the Design of Analyser Shelters |
| Jeff Gunnell, FRSC, ExxonMobil Chemical, Cowdenbeath, Fife, UK
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| A Continuous Process to Assess Analyzer Shelter Safety |
| Dan E. Podkulski, ExxonMobil Chemical, Baytown, TX
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| Creating a Safe Environment for Your Analyzers |
| Wayde Wong, ABB Inc. Process Automation, Houston, TX
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| Shelter Safety Panel Discussion |
| Dan E. Podkulski, ExxonMobil Chemical, Baytown, TX, Jeff Gunnell, ExxonMobil Chemical, Cowdenbeath, Fife, UK and Wayde Wong, ABB Inc. Process Automation, Houston TX
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Process Analysis
Chair(s): Walter Henslee
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| Gas Analysers based on Tuneable Diode Laser Spectroscopy: Oxygen Measurement with a new compact, digital, low-power analyser design |
| Christian Heinlein and Peter Kaspersen, NEO Monitors AS, Loerenskog, Norway
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| Utilizing Headspace Sampling and UV Absorbance for Online Measurement of Volatile Components in Liquid Process Streams |
| Andy Burgess, Dan Murphy, Applied Analytics, Inc., Concord, MA
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| Analyzers in the Year 2020 – the Technology Evolution and the Challenges |
| Jon Gethner, Ph.D., Adaptive Analyzer Technologies, New York, NY
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| Pharmaceutical Manufacturing for Reduced Environmental Impact |
| Alberto Cuitino, Professor of Mechanical and Aerospace Engineering, Rutgers University
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QbD – IV- Knowledge Management & Continuous Improvement
Chair(s): Gawayne Mahboubian-Jones
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| This session will clearly define how we need to approach implementation, in theory and in practice. This is essentially systems information. Examples will be shown of current best practice within the industry, as well as academic. In addition, practical examples will be shown of how far we can push the envelope and what benefits we might expect. We will demonstrate how other, closely related industries have adopted, and benefited from this approach. |
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| Effective Data Processing: Using QbD to Improve Process and Product Understanding |
| Martin Warman, Vertex, USA
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| Knowledge management and continuous improvement in upscaling from lab to production |
| Tomas Vermeire, GEA, Belgium
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| Information Visibility in Pharmaceutical Manufacturing |
| Chris Am Stutz/Dave Rehbein, Emerson, USA
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| Coordinating Multiple Process Sensors and Information for Improved Process Understanding and Control |
| Carl Anderson, Duquesne University, USA
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| Innovation in a Regulated Environment |
| Ali Afnan, CDER, FDA, USA
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PAT/Pharma/Biotech
Chair(s): Walter Henslee
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| Diverse Efficiency of a Portable AOTF-NIR Analyzer in a Pharmaceutical Plant |
| Shana Middleton, Brimrose Corporation of America, Sparks Glencoe, MD
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| Perspectives on the use of Global Uncertainty and Sensitivity Analysis Methods in a PAT Context |
| Gürkan Sina1, Anna Eliasson Lantz2, Krist V. Gernaey3, 1CAPEC-Department of Chemical and Biochemical Engineering, Technical University of Denmark, Lyngby, Denmark, 2Center for Microbial Biotechnology, Department of Systems Biology, Technical University of Denmark, Lyngby, Denmark, 3Department of Chemical and Biochemical Engineering, Technical University of Denmark, Lyngby, Denmark
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| Process Signature - Monitoring Heartbeat of the Process |
| Samir Gami, Director - Advanced Technology & Process Engineering, Warren, NJ
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Particle Characterization/Analysis-Ultrasound Spectroscopy
Chair(s): Paul Panetta and David Scott
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| Investigating Molecular Conjugation and Aggregation of Nanoscale Particles Using Multiple Physical Characterization Methods |
| De-Hao Tsai 1, Tae Joon Cho 1, Frank DelRio 1, Robert I. MacCuspie 1, Michael R. Zachariah 2,3, Vincent A. Hackley 1, National Institute of Standards and Technology, Gaithersburg, MD 1: Ceramic Division, National Institute of Standards & Technology, 2: Process Measurement Division, National Institute of Standards & Technology, 3: Departments of Mechanical Engineering & Chemistry, University of Maryland
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| PAT Application of Particle Size, Shape and Color using Dyanmic in Process Imaging |
| Tod Canty P.E., Canty Inc., Buffalo, NY
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| Improving Control of Particulate Processes via Ultrasonic Spectroscopy |
| David M. Scott, DuPont, Wilmington, DE
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Process Analysis/Spectroscopy – II
Chair(s): George Vickers
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| The Effect of Deadlegs on Sample Purity in Analytical Systems |
| Doug Nordstrom, Swagelok, Solon, OH
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| Online FT-NIR Analysis of HF Acid in the Refining Industry: A Decade of Development in Analyzer Design |
| Michael Kester, Serge Godin, Jean-Luc Flandin, ABB, Quebec, Canada
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| New Experiences during Implementation of On-Line FTNIR in an industrial Isocyanatoalkylsilane Plant |
| Wolfgang Münzer, Wacker Chemie AG, Bavaria, Germany
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| Current Developments in O2 Measurement |
| Dr Sam Langridge, Ametek Process and Analytical Instruments, Pittsburgh, PA
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| Application of Online Process Analyzer to Monitor the Efficiency of Nitrogen Reduction using a Membrane based Process from sweet and Sour Natural Gas |
| Naim Akmal, Milind Vaidya, Sebastian Duval, and Jean-Pierre Ballaguet, Saudi Aramco, Dhahran, Saudi Arabia
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