May/June 2017
Volume 37, Number 3

    Bonus content
    2017 Facility of the Year Awards Supplement


     

    IN THIS ISSUE

    Cover: A Matter of Well-Being
    Recently retired Pfizer Executive Vice President Anthony Maddaluna sat down with Pharmaceutical Engineering to discuss his 42 years in the industry, his passion for excellence, and the complexities of supply chain organizational structure.

    Special Report: Continuous Manufacturing
    While both industry and regulators recognize that continuous manufacturing offers significant quality and cost advantages, barriers and challenges to adoption and implementation remain. This report discusses findings, outcomes, and the regulatory Q&A session from the ISPE Continuous Manufacturing Conference held 20–21 April 2016 in Baltimore, Maryland.

    Facilities and Equipment: Corrosion Investigation of Pharmaceutical Clean Steam Systems
    Corrosion byproducts encountered in clean and pure steam systems are present to some degree in every system, but many lack routine inspection and maintenance that could control corrosion and particulate migration from oxide deposit exfoliation. Drew Coleman and Daryl Roll report on four case studies that tested condensate for metals and particles and conducted a risk assessment of potential corrosion effects on process and critical utility systems.

    BONUS CONTENT
    Special Supplement—2017 Facility of the Year Awards
    ISPE’s Facility of the Year awards recognize projects that demonstrate cutting-edge engineering, innovative new technology, and advanced applications of existing technology. We profile this year’s category winners and honorable mentions.

    TABLE OF CONTENTS

    Message from the Chair

    A YP State of Mind

    COVER STORY

    A Matter of Well-Being
    Anthony Maddaluna started his career at Pfizer in 1975 and has seen incredible changes in the industry during his 42-year career. He talked to us about his vision, his purpose, and what he likes to call the “well-being industry.”

    PEOPLE + EVENTS

    • 26th Annual Aseptic Conference
    • CaSA Life Sciences Technology Conference
    • 2017 ISPE Training: July­­­­–October
    • ISPE GAMP® Guide: Records and Data Integrity
    • ISPE Italy, Poised for Leadership
    • MECO Vice President Bob Gray Retires After 48 Years
    • Letter to the Editor

    CAREER Q&A

    Prepare. Prepare. Prepare. Repeat.
    David G. Smith, Principle Recruiting Partner, Biogen

    IN YOUR OPINION

    Mastering the Art of Supply Chain Management
    Michael Schmitz, PhD, Vice President, Planning & Logistics, Vetter Pharma-Fertigung GmbH & Co. KG

    SPECIAL REPORT: CONTINUOUS MANUFACTURING

    ISPE 2016 Continuous Manufacturing Conference Highlights

    Highlights, findings, and outcomes from the ISPE Continuous Manufacturing Conference and regulatory panel Q&A, held 20–21 April 2016 in Baltimore, Maryland.

    TECHNICAL ARTICLES

    A Holistic Approach to Production Control
    Prof. Dr. Christoph Herwig, Christian Wölbeling, and Thomas Zimmer, PhD

    Corrosion Investigation of Pharmaceutical Clean Steam Systems
    Drew C. Coleman and Daryl L. Roll

    Extractables and Leachables: Not the Same
    Nassrine Lablack, Mathieu Tricot, and Malik Belattar

    An Introduction to Predictive Maintenance
    James Butler and Christopher Smalley

    Embrace Special Cause Variation during CPV
    Tara Scherder

    POSITION STATEMENT

    Diabetes and the Internet of Things


    NOTE: Pharmaceutical Engineering articles are not to be posted on any website, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2016 ISPE. All rights reserved.)

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