May/June 2010
Volume 30, Number 3



    Simple Strategies to Improve Bioprocess Pure Culture Processing
    by Michael Hines, Chris Holmes, and Ryan Schad
    This article presents strategies to improve bioreactions by reducing contaminations by adventitious agents.
    Download Article... (,2.Mb)

    A Methodology for Knowledge Management in Biopharmaceutical Production
    by Jennifer Coakley, Nicola Hogan, Linda McGuire, Brendan Griffin, Colman Casey, Cliff Campbell, and Abina Crean
    This article presents a novel ontological, stepwise approach undertaken to itemize and standardize a biopharmaceutical manufacturing process into a multidisciplinary plant and process knowledge model.
    Download Article... (,4.Mb)

    An Exhausting Solution for Fermentors
    by Ernest L. Stadler
    This article provides various solutions from simple to complex that deal with the removal of water vapor, liquid particles, and solid particles that can escape a fermentor exhaust nozzle and clog the sterile exhaust filter.
    Download Article... (,3.Mb)

    Guide for using Open Source Software (OSS) in Regulated Industries based on GAMP
    by Markus Kaufmann, Marcus Ciolkowski, Andreas Hengstberger, Till Jostes, Erwin Kruschitz, Thomas Makait, Karl-Heinz Menges, Stefan Münch, and Martín Soto
    This article demonstrates the benefits of employing Open Source Software (OSS) in compliance with GAMP for the validation of computerized pharmaceutical applications.
    Download Article... (,2.Mb)

    Successful Use of Simulation as a Tool in a Lean Six Sigma Program
    by Bruce Sawyer, Johnny Muñoz, and Jim Curry
    This article presents the role of simulation in Johnson & Johnson’s process excellence program. It uses a case study of a large pharmaceutical plant to describe how simulation evolved from improvement and capacity projects to the ongoing planning and management process.
    Download Article... (,4.Mb)

    A Simplified Statistical Model to Assess Product Capability
    by Selim Seyhan, Tolga Özcan, and Merve Öktem
    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.
    Download Article... (,2.Mb)

    Systems Turnover Coordination: Effective Application and Integration of the Supplier-Provided Engineering Turnover Package (ETOP)
    by 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.
    Download Article... (,392.Kb)


    2010 May/June FOYA Supplement

    Download Article... (,28.Mb)


    ISPE Update
    - ISPE Milan Congress Report: Cooperation, Collaboration, and Harmonization - ISPE Launches Career Solutions - ISPE International Board Member Appointed VP with GMS - Philippines Affiliate Welcomes Best - India Affiliate’s Young Pharmaceutical Professionals’ Educational Program a Success
    Download Article... (,3.Mb)

    Classified Advertising with Advertiser’s Index

    Download Article... (,149.Kb)

    Online Exclusive Articles

    Global Regulatory News

    Download Article... (,186.Kb)

    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.)

     Get the Pharmaceutical Engineering App
    Available for
    Available at the App Store
    Available on Google Play
    Available for Amazon Kindle