January/February 2013
Volume 33, Number 1



    Accelerating the Fight Against Chickenpox and Shingles
    by Rochelle Runas
    This is a case study on Merck’s Vaccine Bulk Manufacturing Facility (VBF) Program of Projects, Overall Winner of the 2012 Facility of the Year Awards.
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    Why Conduct Pilot Studies for Agitated Gas-Liquid Mass Transfer?
    by Gregory T. Benz
    This article presents the rationale for conducting detailed mass transfer correlation studies in aerobic fermenters, in order to minimize power consumption in full scale design and maximize the chance of having correctly designed equipment.
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    Facility of the Future: Next Generation Manufacturing Forum Part I: “Why We Cannot Stay Here” – The Challenges, Risks, and Business Drivers for Changing the Paradigm
    by Mark F. Witcher, PhD, Ruben Carbonell, PhD, Jeff Odum, CPIP, Peter Bigelow, Patricia Lewis, and Michael Zivitz
    This article is the first of a three-part series focused on defining the facility of the future required for manufacturing biopharmaceuticals in the 21st Century.
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    A Science-Based Approach to Selecting Air Filters
    by Steve Devine, Sean O’Reilly, Andy Stillo, and Don Thornburg
    This article provides an overview of science-based factors to consider when selecting HEPA filters.
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    Pharmaceutical Engineering Interviews
    George Gsell, President, MECO, Inc.
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    Global Regulatory News

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    ASEAN Harmonization on GMP Inspection and Training of Inspectors
    by Sia Chong Hock, Robert Tribe, and Dr. Chan Lai Wah
    This article provides a progress report on the harmonization of GMP inspection and training of inspectors being led by the Association of Southeast Asian Nations (ASEAN).
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    Automating a Manual Cleaning Program in a Multi-Product Biopharmaceutical Manufacturing Operation
    by Gordon Leichter, PhD, and John Spohn, CPIP
    This article discusses how to implement automatic washing in facilities where manual washing is conducted and provides valuable insight into lessons learned and key considerations in the planning for their future-state process.
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    Expanding the Process Validation Paradigm and Applying it to the Biopharmaceutical Product Lifecycle from Development to Commercial Manufacturing
    by Mark F. Witcher, PhD
    This article presents a combination of critical process and product definition issues with a QbD approach to define the Validation Lifecycle Matrix (VLM) used to build a Validation Master Plan (VMP) that guides development of the product through its complete lifecycle.
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    President's Message: The Year Ahead: New Initiatives to Achieve ISPE’s Mission
    by Nancy Berg, ISPE President/CEO
    Berg reviews what’s on the horizon in 2013, including surveys, relationship-building, technical study initiatives and new events that will position the Society to become the leading technical organization for professionals engaged in producing quality medicines and pharmaceutical delivery devices throughout the lifecycle.
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    ISPE Update
    Report of QbD-Related Regulatory Sessions from ISPE Annual Meeting; ISPE Developing Biotechnology Guides; ISPE Updates Guidance for GxP Compliant Laboratory Computerized Systems; ISPE Announces 2012 Award Winners at Global Annual Meeting
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    Buyers Guide - Jan/Feb 2013

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    Classified Advertising with Advertiser’s Index

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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 © 2012 ISPE. All rights reserved.)

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