March/April 2011
Volume 31, Number 2

 

    Articles

    Case Study: Genentech's ECP-1 Bacterial Manufacturing Facility, Overall Winner, 2010 Facility of the Year Awards
    by Rochelle Runas
    This article presents the story of how innovative project execution and strong teamwork overcame numerous challenges in the making of Genentech’s ECP-1 Bacterial Manufacturing Facility, Overall Winner of the 2010 Facility of the Year Awards.
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    Industry Interview Series: Timothy C. Tyson, Chairman and CEO, Aptuit, Inc.
    Tim Tyson discusses how his career has evolved since his first interview with Pharmaceutical Engineering 18 years ago; his current role as Chairman and CEO of a Contract Research, Development, and Manufacturing Organization; and his work with the ILF’s Factory of the Future initiative.
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    Alternative Methods for HEPA Filter Leak Detection
    by Jim Meek, Dan Milholland, and Laszlo Litauszki, PhD
    This article discusses HEPA filter leak detection methods that provide robust alternatives to current filter testing practices.
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    Single-Use Components for Flexible Biomanufacturing Processes
    by Thorsten Peuker and Jean-Marc Cappia
    This article presents the latest status of single-use technologies in biomanufacturing processes.
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    Optimizing the Design and Operation of Fill-Finish Facilities using Process Simulation and Scheduling Tools
    by Demetri Petrides, Charles Siletti, José Jiménez, Petros Psathas, and Yvonne Mannion
    This article presents examples and methodologies for optimizing the design and operation of fill-finish facilities using process simulation and scheduling tools.
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    Trends and Advances in Isolator Technology
    by Volker Sigwarth and Thomas Huber
    This article discusses the increasing use of isolator technology in modern aseptic processes and presents the latest developments and possibilities for this key equipment.
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    Standardizing Patient Safety Risk Management
    by Mark Cupryk
    This article presents the challenges in patient safety risk management for the Patient, US Food and Drug Administration (FDA), Healthcare Provider, and Sponsor. The article reviews specific risk management tools to show how audits can be leveraged by the Sponsor to provide additional patient safety focus and consistency across the medical product supply chain.
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    Business Process Management (BPM) Based Pharmaceutical Quality Management Systems: Win-Win Between Compliance and Competitiveness
    by François Versini
    This article shows how a BPM-based Quality Management System optimizes the way to comply with today’s evolving processes and stay competitive in the marketplace.
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    Departments

    ISPE Update
    - An Eastern Experience – Japan Affiliate on Tour in the US - Revision of EU Annex 11 and Chapter 4 - ISPE Releases GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems, Second Edition - What are the benefits of being a CPIP™?
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    Classified Advertising with Advertiser’s Index

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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 © 2011 ISPE. All rights reserved.)


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