March/April 2009
Volume 29, Number 2



    PAT and Green Chemistry: The Intersection of Benign by Design and Quality by Design
    by Berkeley W. Cue, John Berridge, Julie B. Manley
    This article will illustrate the application of Process Analytical Technology (PAT) as an important contributor to the “triple bottom line,” a measure of a company’s economic, environmental, and social performance, and the sustainability of the pharmaceutical industry.
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    Introduction to PAT Data Management Solutions
    by Mark N. Reed
    This article discusses the critical requirements for a Process Analytical Technology (PAT) data management solution and how these requirements contribute to the successful operation of the PAT solution.
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    Considerations for Transferring a Bulk Freeze-Drying Process from a Glass Container to a Tray
    by Yves Mayeresse, Vinciane de Cupere, Romain Veillon, Joseph Brendle
    This article presents the transfer of a freeze-drying process from a glass bottle to a freeze-drying tray.
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    Clinical Manufacturing Efficiency
    by Beth H. Junker, Kay Hunsberger, Vicky Griffin, Kent Hamaker, Carl Holz, Amy Caparoni, Kelly Kistler, Jeffrey Graczyk, Marshall Gayton
    This article presents a description of an operational effectiveness project to improve clinical material manufacturing efficiency of a biologics pilot plant. It utilizes lean and Kaizen principles to identify root causes, then brainstorm/evaluate potential solutions.
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    Using GAMP 5 for Rapid Deployment
    by Markus Roemer, Hermann Schaefer
    This article presents the implementation of a risk-based approach into a supplier’s Software Development Workflow and Product’s Release Management according to GAMP® 5.
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    2009 March/April FOYA Supplement

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    Classified Advertising with Advertiser’s Index

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    ISPE Update

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    Online Exclusive Articles

    Global Regulatory News

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    NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2009 ISPE. All rights reserved.)

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