March/April 2013
Volume 33, Number 2



    Mitigate Risk, Facilitate Project Delivery, Integrate Sustainability, and Improve Maintainability for Advanced Technology Facilities
    by Allan Chasey, PhD, PE
    This article presents a project management vision that uses the reduction of risk, value-added sustainability, and improved operations and maintenance to minimize conflicts, waste, and costs.
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    Advances in Vapor Compression Technology for the Production of USP Purified Water and Water For Injection
    by George V. Gsell, Chet Nunez, and Michael Smith-Palmer
    This article presents the advancements in vapor compression technology and how these advancements affect the efficiency and reliability of the equipment.
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    Facility of the Future: Next Generation Manufacturing Forum Part II: Tools for Change – Enabling Technologies and Business and Regulatory Approaches
    by Mark Witcher, PhD, Ruben Carbonell, PhD, Jeff Odum, CPIP, Peter Bigelow, Patricia Lewis, and Michael Zivitz
    This article is the second 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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    Engineering Practices During Manufacturing Process Development for New Products
    by David Rich, Mark Blanchard, Salvatore Giglia, Greg Straeffer, Amy Cazeault, Shannon Cleveland, Rebecca Bartkus, and Matthew Desmarais
    This article presents a structure and methodology for designing quality into new manufacturing processes for new filtration products.
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    Index of Refraction as a Quality Control Metric for Liquids in Pharmaceutical Manufacturing
    by Brent Schreiber, Christopher Wacinski, and Ron Chiarello, PhD
    This article presents a case study comparison of four analysis system technologies: pH, conductivity, osmolality, and refractive index for nine buffer chemical mixtures.
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    Follow-on Biologics: Will the New Biologics Price Competition and Innovation Act Live Up to the Waxman-Hatch 1984 Expectations?
    by Michael R. Goodman
    This opinion article presents a candid look at the motivations behind the new biosimilar legislation and if it really will be as influential as the Drug Price Competition and Patent Term Restoration Act of 1984.
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    Global Regulatory News

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    Ultrasonic-Assisted Extraction of Berberine in Ionic Liquid
    by Yang Chang
    This editorial presents a poster presentation from a graduate student at Sichuan University in Chengdu, China.
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    ISPE is Changing with the Industry
    ISPE’s President and CEO Nancy S. Berg discusses changes at ISPE to better understand and act on the issues important to Members, their companies, regulators, and patients.
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    ISPE Update
    - ISPE Drug Shortage Initiative Supports Global Efforts to Understand Drug Shortages
    - ISPE’s Critical Utility Community to Develop Good Practice Guide on Sampling
    - A View to Pharma Excellence in US – Japan Affiliate on the Road Again
    - ISPE QbD Conference Endorsed by CASSS
    - An Interview with Sadayoshi Tomita, CPIP
    - ISPE Approved as a Registered Education Provider by PMI®
    - 2013 Facility of the Year Awards (FOYA) Winners Announced
    - Contribute Your Expertise on Decommissioning
    - Pharmaceutical Engineering Expands Technical Focus, Seeks Contributors

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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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