November/December 2011
Volume 31, Number 6



    Applying Predictive Maintenance Techniques to Utility Systems
    by Padraig Liggan and David Lyons
    This article discusses how Predictive Maintenance (PdM) technologies can be successfully applied to both GMP and non-GMP utility systems in the pharmaceutical industry. The discussion also demonstrates the clear benefits of PdM, including the use of a proactive approach to maintenance.
    Download Article... (,5.Mb)

    Online Rouge Monitoring: A Science-Based Technology to Measure Rouge Rates
    by Nissan Cohen and Allan Perkins
    This article presents the implementation and installation of an online rouge monitor which measures in near real-time the rouge rate and rouge accumulation (metal loss) over time helping to determine derouging and passivation frequency based on empirical data.
    Download Article... (,2.Mb)

    Determining Acceptable Levels of Weld Discoloration on Mechanically Polished and Electropolished Stainless Steel Surfaces
    by Ken Kimbrel
    This article will identify acceptable levels of weld discoloration on mechanically polished and electropolished stainless steel surfaces and also show proven shop and field remediation practices to removes excessive heat tint. Additionally, we will show the effect of various oxygen levels and the impact heat tint has on corrosion resistance. The information herein is based on actual field experiences and successful methods of field remediation.
    Download Article... (,7.Mb)

    Engineering and Design Considerations for Thermal Inactivation of Bio-Hazardous Waste Streams
    by Juha Mattila
    This article presents important considerations when designing thermal inactivation systems for bio-hazardous applications, and provides a comparison between properties of batch and continuous decontamination systems.
    Download Article... (,4.Mb)

    Survey of Pharmaceutical Water System Users on the Use of Non-Distillation Systems for the Production of WFI
    by Dr. Anthony Bevilacqua and Dr. Teri C. Soli
    This article presents the results of a jointly sponsored USP/ISPE survey of the pharmaceutical industry and analyzes the potential to use alternative methods of production (other than distillation) as the final purification in the preparation of Water for Injection (WFI).
    Download Article... (,4.Mb)

    Industry Interview Series: Efraim Cohen-Arazi, CEO and Co-Founder, Rainbow Medical
    by Nissan Cohen
    Efraim Cohen-Arazi discusses the business side of the life sciences industry. He offers a look into the R&D and investment strategy of his own venture investment firm, Rainbow Medical.
    Download Article... (,503.Kb)

    Alternative Test Methodology for In-Situ Testing of ePTFE HEPA Filters for Pharmaceutical Applications
    by Eugene Bryan, Bill Kitch, Jim Meek, Dan Milholland, and Nathaniel Nance
    This article presents the study results of using an ultra low poly-alpha-olefin (PAO) challenge and a particle counter to preform leak sizing on an expanded polytetra- fluoroethylene (ePTFE) filter.
    Download Article... (,2.Mb)

    Understanding Operational Waste from a Lean Biopharmaceutical Perspective
    by Richard Benson and Niranjan S. Kulkarni
    This article presents different types of operational wastes (non-value adding activities), provides examples of wastes common to pharmaceutical and biotech manufacturing, and lists commonly used techniques to analyze and reduce waste.
    Download Article... (,753.Kb)

    Cleaning Validation for the 21st Century: Overview of the New ISPE Cleaning Guide
    by Andrew Walsh
    This article provides an overview of an ISPE Cleaning Guide currently under development. The Guide will provide a framework for a scientific, risk-based approach to cleaning processes and validation.
    Download Article... (,470.Kb)


    Global Regulatory News

    Download Article... (,212.Kb)

    ISPE Update
    - Introducing the 2011-2012 Board of Directors - An Expression of Gratitude from the Japan Affiliate - Pharmaceutical Engineering Announces Winner of the Article of the Year Award - ISPE Launches New Website
    Download Article... (,416.Kb)

    Classified Advertising with Advertiser’s Index

    Download Article... (,758.Kb)

    Online Exclusive Articles

    Inhibitory Effect of Silkworm Extract on Alpha-Glucosidase Activity and Postprandial Blood Glucose in Mice
    by Juan Cueva, Patricio Castillo, Giovanna Allara-Salice, and Angel Guevara
    This article was developed from the presentation by a finalist in the ISPE 2010 Undergraduate International Student Poster Competition.
    Download Article... (,908.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 © 2011 ISPE. All rights reserved.)

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