March/April 2010
Volume 30, Number 2



    Just in Time. An Approach for a cGMP Fill-Finish Facility
    by Andrew Cunningham
    This article presents a detailed narrative on the design drivers and delivery methodology for Genentech’s recently completed fill-finish facility in Hillsboro, Oregon.
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    Design and Optimization of a Large Scale Biopharmaceutical Facility Using Process Simulation and Scheduling Tools
    by Abdelaziz Toumi, Carmen Jungo, Mr. Victor Papavasileiou, Mr. Demetri Petrides, Christian Jürgens, Bernd Maier
    This article presents a case study focusing on the design and optimization of a large scale biopharmaceutical facility using process simulation and scheduling tools.
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    “East is East and West is West” – Managing Capital Investment Projects in China
    by Jerry Hourihan, Gordon Lawrence
    This article presents some helpful “tips and suggestions” regarding building capital projects in China.
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    PQLI Roadmap: Product Design, Development, and Realization, a Science- and Risk-Based Approach to Implementation – An Overview of ISPE’s First PQLI Guide
    by Dr. Christopher Potter, Dr. John Berridge, Contributing Team
    This article provides the background and current status of ISPE’s Product Quality Lifecycle Implementation (PQLI®) initiative, including the development of an ISPE PQLI Guide Series.
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    Improving the Facility Design Engineering Process for Major Capital Projects
    by Mr. Joseph Hettenbach, PE
    This article discusses design tools for the design of pharmaceutical facilities, management of the design engineering process, and ways to potentially improve the design process, including the application of a “strong front-end design approach.”
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    Life-Enhancing Biotherapeutics Company Nets Healthier Equipment
    by Mr. Kevin Pait, Preston Ingalls
    This article shows the impact of an organized and focused continuous improvement effort using teamwork on equipment reliability.
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    Streamlining of Raw Material and Culture Media Testing and Release for Clinical Manufacturing
    by Susan Gibbons, Jocelyn Lazor, Monica Storz, Kelli Pardue, Marshall Gayton, Dr. Beth Junker, Vicky Griffin, Raymond Kaiser
    This article presents a Lean/Kaizen team effort to improve raw material and culture media testing and release cycle times for clinical manufacturing campaigns.
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    ISPE Update
    - Japan Affiliate’s 2009 US Plant Tour - ISPE Co-sponsors ICH Q-IWG Workshops - ISPE Launches Electronic Document Delivery - ISPE/PDA White Paper on Use of IVR - Two New ISPE GAMP Good Practice Guides
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    Classified Advertising with Advertiser’s Index

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    Online Exclusive Articles

    Design, Validation, and Control of Sterile Manufacturing Facilities: A Brief Overview from the Perspective of Risk Management and Existing Regulations
    by Ana Quinto , Prof. Jose Menezes
    This article presents the design, validation, and control of sterile manufacturing facilities; discusses the implementation of risk management, and provides an overview of existing regulations.
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    A Simplified Statistical Model to Assess Product Capability
    by Mr. Selim Seyhan, Mr. Tolga Ozcan, Mrs. Merve Oktem
    This article presents a simplified model that can be used after future refinements to identify the specific process capability in pharmaceutical manufacturing. Data for a concrete production stage of a solid product is presented. Technologies, present and future, are identified.
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    Systems Turnover Coordination: Effective Application and Integration of the Supplier-Provided Engineering Turnover Package (ETOP)
    by Ms. Carol Susla
    This article presents the process for leveraging supplier knowledge and documentation in the context of applying a risk-based approach to compliant commissioning and qualification programs.
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    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 © 2010 ISPE. All rights reserved.)

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