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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Winner of the 2016 Article of the Year Award