IFPAC ®- 2008
22nd International Forum
Process Analytical Technology - IFPAC
January 27-30, 2008
Baltimore, Maryland, U.S.A.
Welcome to IFPAC-2008
Partnership for Enhanced Quality & Manufacturing Excellence
WEDNESDAY, JANUARY 30, 2008
WEDNESDAY AM - I
PAT Implementation
David Radspinner and Carl Anderson
- Integrating Clinical Performance, Risk Analysis, and Multivariate Technologies for Robust Formulation, Process Development and Control
Robert P. Cogdill, James K. Drennen and Carl A. Anderson, Duquesne University, West Lafayette, IN
- Lyophilizer Heat Transfer Fluid Leak Monitoring via Gas Chromatographic Methods
John Kutney, Talecris Biotherapeutics, Clayton, NC
- Use of PAT tools in Solid Dosage Extrusion Processes
Manuel Hormaza, IBS Caribe Inc., San Juan, PR
- PharmaCon: Integrating Software and Hardware to Enable PAT.
Brad Swarbrick, SeerPharma Pty Ltd, New South Wales, Australia and David Marston, Process Analytics Group, Biolab Ltd., Lower Hutt, New Zealand
- Application of FT-NIR Spectroscopy for Monitoring of a Pilot Scale Fluid Bed Dryer
Peter J. Brush, Narmada Gunawardena and Albert Alexander, AstraZeneca Pharmaceuticals,Wilmington, DE
- Implementation of Control Systems for Fluid Bed Granulation and Blending
Carl A. Anderson, James K. Drennen, Robert P. Cogdill, Zhenqi Shi, Brian Zacour, Michael Moore and Steven Short, Duquesne University, West Lafayette, IN
- A Practical Process Control Solution for Absolute Moisture Determination in Fluid Bed Dryers
Dr Andrew Grady, NDC Infrared Engineering Ltd., Essex, UK
- PAT, Practical Applications
Thomas Buijs, ABB, Quebec, Quebec, Canada
WEDNESDAY AM - II
Pharmaceutical Waters and Real-Time Analysis
Chairs: Jeff Weber and Richard Godec
This session will review new technologies and applications for monitoring and controlling the quality of pharmaceutical waters and aqueous based equipment cleaning processes. The technologies to be examined include rapid bioburden detectors, rapid endotoxin detection, and applications of on-line total organic carbon analysis.
- A PAT Solution for Pharmaceutical Water Endotoxin Testing
Maribeth D. Janke, Ph.D. , Sr. Product Manager, Rapid Testing Systems and Kenneth E. Nichols, Jr., Scientist, Lonza Walkersville, Inc. , Walkersville, MD
- Rapid Equipment Cleaning Verification using TOC Analysis
Richard Godec, GE Analytical Instruments, Boulder, CO
- An FDA Perspective on the Use of Rapid Microbiological Methods for Testing Pharmaceutical Water
Bryan S. Riley, Ph.D., Senior Review Microbiologist, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD
- Rapid Detection of Microbial Contamination in Biotherapeutic Manufacturing
Martha Rook, Bioprocess Division, Millipore Corporation, Bedford, MA
- On line, Real time Monitoring for Microbiological Contamination in Pharmaceutical Waters Using MALS Technology
John A. Adams, Ph.D., Chief Scientist JMAR Technologies Sensor, Group; Steven Stephenson, Lab Manager/Microbiologist Sensor Products Group; David L. McCarty, VP Business Development, Technologies Sensor Group, JMAR, San Diego, CA
WEDNESDAY - AM - III
PAT and Green Chemistry
Chairs: Julie Manley and Chris Watts
- The Development and Application of Micro-Analytical Tools: Green Chemistry, the Competitive Edge
Mel Koch, Center for Process Analytical Chemistry, University of Washington, Seattle, WA
- Green Chemistry and Process Analytical in the Bowels of Ships and on the Battlefield
Suneet Chadha, Patrick Henning, Nese Orbey and Russ Newton, Foster-Miller, Inc., Waltham, MA
- Green nanomanufacturing: Enhanced control and efficiency through flow
synthesis and online analysis of nanoparticles
Lallie C. McKenzie and James E. Hutchison, Department of Chemistry, the Materials Science Institute, and the Oregon Nanoscience and Microtechnologies Institute, University of Oregon, Eugene, OR
- Application of Diode Laser Absorption Spectroscopy for Process Monitoring:
A Mature Tool for Green Engineering
William J. Kessler, David M. Sonnenfroh, MickeyB. Frish, Mark G. Allen
and Steven J. Davis, Physical Sciences Inc., Andover, MA and Douglas C. Becker, Wyeth Pharmaceuticals, Global Technology, Collegeville, PA
- Use of PAT (Process Analytical Technologies) in Continuous Chromatographic Processes (SMB/Varicol(R)
Jean Blehaut, Eric Valery, Christelle Bobier, Novasep Process
- Understanding the Process: Tracking the Process: Controlling the Process - Key Contributors to Green Chemistry and Green Engineering
Daniel J. Watts, Otto H. York Center for Environmental Engineering and Science, New Jersey Institute of Technology, University Heights, Newark, NJ
WEDNESDAY AM - IV
Process Understanding and Control
Chairs: Joe Andrisani and Troy Francisco
- Technology that Sets New Standards
Dirk Tillich, Hamilton Bonaduz AG, Bonaduz, Switzerland
- On-Line Hydrogen Specific Sensors for Process Monitoring
Prabhu Soundarrajan, H2scan Corporation, Valencia, CA
- Terahertz pulsed imaging as an analytical technique for tablet film coating during process scale-up
Louise Ho, University of Otago, Dunedin, New Zealand, University of Cambridge, Cambridge, UK & TeraView, Cambridge, UK, Ronny Mueller, Heinrich-Heine-University, Duesseldorf, Germany, Keith C. Gordon, University of Otago, Dunedin, New Zealand, Peter Kleinebudde, Heinrich-Heine-University, Duesseldorf, Germany, Michael Pepper, University of Cambridge, Cambridge, UK & TeraView, Cambridge, UK, Thomas Rades, University of Otago, Dunedin, New Zealand, Yaochun Shen, TeraView, Cambridge, UK & University of Liverpool, Liverpool, UK , Philip F. Taday, TeraView, Cambridge, UK, and J. Axel Zeitler, University of Cambridge, Cambridge, UK,
- Monitoring On-line Moisture Contents in Critical Recycle Gas Streams - Paraxylene Plant, Reliance Industries Limited, India
Keyur. G. Vora, Reliance Industries Limited, Maharastra, India and Christoph M. Mueller, Xentaur, USA
- Time-Domain Terahertz (TD-THz) On-line Measurement of Material Density Variations
Jeffrey White, Picometrix LLC, Ann Arbor, MI
- pH Measurement at High Temperature and Aging Mechanism of pH Sensing Glass
CD Feng, Rosemount Analytical Inc., Liquid Division, Emerson Process Management, Irvine, CA
- Gaining a Process Understanding of Blend Uniformity using on-line NIR spectroscopy
J.C. Richmond , Payal Roychoudhury, Bruker Optics Ltd, Coventry, United Kingdom
Process Characterization/Analysis - Nanotechnology
Chair: Paul Panetta
- Gold Nanoparticle Reference Materials and their Characterization
Dr. Debra Kaiser, Chief, Ceramics Division, NIST
- Electrospray Ion-Mobility Probes for Size Distribution, Surface Coatings and Colloidal Stability of Nanoparticles
De-Hao Tsai, Dept. of Mechanical Engineering, University of Maryland
- Ion-Mobility: An On-Line Method to Probe whole Virus Particles and their Interactions with Proteins
Dr. Leonard Pease, Process Measurements Division, NIST, Gaithersburg, MD
- Particle Characterization using Pattern Recognition
Lew Brown, Fluid Imaging Technologies, Inc., Yarmouth, ME
- Combination of Ultrasound and Electrical Resistance Tomography as a Basis for On-line Characterisation of Wet Particulate Systems.
Ken Primrose, Industrial Tomography Systems Ltd., Manchester, UK
- On-line Monitoring of Crystallisation by Electrical Tomography as an Aid to Process Understanding, Scale-up and Control
Ken Primrose, Industrial Tomography Systems Ltd., Manchester, UK
- Terahertz Pulsed Imaging for Non-Destructive and Non-Invasive Analysis of Key Quality Attributes of Theopylline Tablets
Jelena Obradovic, Jelena Obradovic, Alessia Portieri, Philip F. Taday TeraView Limited, Platinum Building, St. John's Innovation Park, Cambridge, UK and Phil Hadfield, ISP Europe, Waterfield, Tadworth, Surrey, UK
- Real-Time Particle Size And Shape Characterization Using In-Process Video Imaging
Paul Barrett, PhD, Mettler Toledo Lasentec, 7075 Samuel Morse Dr., Columbia, MD
WEDNESDAY AM - V
PAT/Pharma/Biotech
Chairs: Tim Stevens, Rick Cooley
- Quick Fixes Won't Work Anymore - A Proactive Approach Will
How to Build in Quality to Achieve Operational Excellence
Wylene Lengel, Clarkston Consulting, Carlsbad, CA
- Future Trends in Haromonization, FDA and EMEA
Dr. Sandy Weinberg, Tikvah Therapeutics, Atlanta, GA
- Rapid and Non-destructive Identification of Pharmaceutical Excipients for 21 CFR 211 Compliance
Suzanne Schreyer, Polychromix, Wilmington, MA
- Terahertz Spectroscopy Pharmaceutical PAT Application and its Regulatory Considerations
Huiquan Wu, FDA CDER, Division of Product Quality Research, Silver Spring, MD
- Applications of Spray Drying in the Pharmaceutical Industry
Andrew P. Birkmire, Niro Pharma Systems, Columbia, MD
- Statistical Results for Time-Domain Terahertz (TD-THz) Measurement of Whole Pharmaceutical Tablet Weight for On-line Process Control
Jeffrey White, Picometrix LLC, Ann Arbor, MI
WEDNESDAY AM - VI
Process Analysis/Spectroscopy/Plus LIBS
Chairs: George Vickers & Andre Blain
- Process Monitoring by FTIR and NIR: Two Decades and Counting
Larry McDermott and Norman Wright, Hamilton Sundstrand; Applied Instrument Technologies, Pomona, CA
- Broad Band Fiber Spectroscopy in 0.18-18um Range for PAT
Dr. Viacheslav Artyushenko, Fibre Photonics, Ltd., West Lothian, Scotland
- Online Monitoring of the Drying of a Drug Product by an ABB FT-NIR Dryer Monitor
Jeremy A Linoski, ABB, Houston TX
- On-Line Measurement of H2S Using Tunable Diode Laser (TDL) Analyzers
Al Kania, SpectraSensors, Inc., Houston, TX
- Real Time Reaction Measurement of Polypeptide Reactions on a Solid Substrate using NIR Spectroscopy
Susan J. Foulk, Guided Wave, Inc., Rancho Cordova, CA
- Estimation of Pregabalin in bulk and its Dosage Form by Visible Spectrophotometric Method
Urvisha V. Bangoriya, S.J.Thakkar Pahrmacy college,Rajkot, Gujarat, India
LIBS
Brian Marquardt and Andre Blain
- Predicting Pharmaceutical Manufacturing Changes using Molecular
Laser-Induced Breakdown Spectroscopy and Chemometrics
Francois R. Doucet1, Patrick J. Faustino2, Martine Tourigny3, Robbe C. Lyon2 and Mohamad Sabsabi1 1 National Research Council of Canada (IMI), Boucherville (QC), Canada
2 Division of Product Quality Research, CDER, US FDA, Silver Spring, MD, USA
3 Pharma Laser, Boucherville (QC), Canada
- A powerful plug and play 3D analytical instrument: PharmaLIBS(TM)250
Andre Blain, Pharma Laser, Boucherville (QC), Canada
- Recent trends in Laser-induced breakdown spectroscopy for real time analysis and process control
Mohamad Sabsabi, Ph.D., Senior Research Officer, Paul Bouchard, Francois Doucet, and Rene Heon, National Research Council Canada, Industrial Materials Institute, Boucherville (Quebec), CANADA
WEDNESDAY PM - I
Knowledge Management & Continuous Improvement
Chair: Gawayne Mahboubian-Jones
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.
- A Systems Approach to Process Understanding
Tom Cochrane, Napp Pharmaceuticals, Cambridge, UK
- Datacentric Lifecycle Integration
Vincent Walshe, Campbell Informatics, Cork, Ireland
- PAT / Quality by Design IT architecture: experiences and future directions
Frederik Jaenen, Team Manager Consulting & Projects, Siemens, Ninove, Belgium
WEDNESDAY PM - II
Water Quality/Analysis/Ecco-Terrorism (General Water Systems)
Chair: Wayne Einfeld
- Advances in Analytical Chemistry Instrumentation for Water Monitoring
David M. Simko, Swagelok Company, Solon, OH
- Terahertz Pulsed Imaging (TPI) Study of Water Diffusion in Different Viscosity Grades HPMC Samples
Alessia Portieri, TeraView Ltd, Cambridge, UK
- Comprehensive and Fully Automated Water Analysis
Heike Risse, Metrohm Ltd., Herisau, Switzerland
- Determination of Alkalinity, pH Value and Total Hardness in Water Samples
Anja Zimmer, Metrohm Ltd., Herisau, Switzerland
- An Electronic Nose Microsystem as Safe Water Monitor in Drinking Water Networks
J. Goschnick, M. Sommer, Forschungszentum Karlsruhe, Hermann-von-Helmholtz, Germany
- Water Security: Chemical Agent Detection by SERS
Frank Inscore and Stuart Farquharson, Real-Time Analyzers, Inc., Middletown, CT
- Taking Off the Blinders. Using On-line Instrumentation for Process
Improvement in the Water Distribution System
Dan Kroll, Hach Company, Loveland, CO
- Rapid Isolation of Viruses from Water with the Use of Anionic Exchange Resins
Lawrence Goodridge, Colorado State University, Fort Collins, CO
WEDNESDAY PM - III
Process Analysis/Spectroscopy-II
Joe Sung and Joe Patrick Smith
- TDL Analyzers for Ethylene Production and Quality Control
Xiang (Sherry) Liu, Xin Zhou and Alfred Feitisch, SpectraSensors, Inc., Rancho Cucamonga, CA
- Advanced TDL Gas Analyzers for Petrochemical Process Industries
Xin Zhou, Xiang (Sherry) Liu, Alfred Feitisch, SpectraSensors, Inc., Rancho Cucamonga, CA
- A Comparison of Surface Adsorption Effects in Mercury and Sulfur Sampling Systems
Gary Barone, Restek Corporation, Bellefonte, PA
- Modeling in Personal Exposure Area
Khalid A. Al-Raihan, Bader M. Al-Braik & Athar Waseem, Analyzer Section, Quality Assurance Department), PETROKEMYA, Jubail, Kingdom of Saudi Arabia
Athar Waseem, Process Analyzer Specialist, Quality Assurance Department.
Arabian Petrochemical Company (PETROKEMYA), Jubail - Saudi Arabia
- Trace Element Analysis of Pharmacological, Medical and Biological Samples by Means of Total Reflection X-ray Fluorescence (TXRF) Analysis
Hagen Stosnach, Armin Gross and Alexander Seyfarth, Bruker AXS Microanalysis GmbH, Berlin, Germany
- Ozone sensor and calibrator
Daniel Ebeling,Wisconsin Lutheran College; KWJ Engineering, Newark, CA
WEDNESDAY PM - IV
Development and Best Practices Approach to Technical Standards
Chairs: Duncan Low, David Radspinner and Chris Watts
Global Standards - An Agency Perspective (TBA)
Including ASTM
Don Marlow, FDA et al.
IPAC-RS Perspective (TBA)
Barbara Falco, Abbott Labs, N. Chicago, IL
PDA Perspective (TBA)
Rich Levy, Walt Morris et al., PDA, Bethesda, MD
ASME Perspective (TBA)
Jay Ankers, Lifetek, Blue Bell, PA (representing ASME)
ISPE Perspective (TBA)
Bruce Davis, for ISPE
Technical Standards Roundtable Discussion
Duncan Low, David Radspinner, and Chris Watts, Don Marlow, Barbara Falco, Walt Morris et al., Gerry Eisenbert et al., and Bruce Davis.
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Registration Form for IFPAC-08
Last updated Monday, 31-Dec-2007 10:55:19 CST