May / June 2017

Pharmaceutical Engineering May / Jun 2017 Issue Cover

Downloads

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.

A Matter of Well-Being

Cover: 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.

Continuous Manufacturing

Special Report:  PE contributors discus findings, outcomes, and the regulatory Q&A session from the ISPE Continuous Manufacturing Conference held 20–21 April 2016 in Baltimore, Maryland.

Corrosion Investigation of Pharmaceutical Clean Steam Systems

Facilities and Equipment:  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.

In This Issue

Insights
A country best known for its artists, food, and fashion designers, Italy is also home to a thriving pharmaceutical industry. Along the country roads that stretch from Milan to Bologna, Florence, deep into Rome and Naples, idyllic hillsides are dotted...
Insights
Megan was diagnosed with Type 1 diabetes in 2007 when she was five months pregnant with her first child. She began the routine, familiar to many of the 415 million diabetics worldwide, of measuring her blood glucose levels with finger pricks, followed by...
Insights
Michael Schmitz is Vice President, Planning and Logistics, of Vetter Pharma- Fertigung GmbH & Co. KG. In this position he is focused on logistics operations, production resources, OEE measures and customer service levels,...
Insights
Already in its 26th year, ISPE’s annual Aseptic Conference continues to be the place to go to for the latest and greatest in barrier/isolation technology, small- and large scale aseptic manufacturing, and disposables. The conference presents fantastic...
Technical
With the integration of single-use systems (SUS)* into downstream processing and thus closer to the final drug product, considerations of extractables and leachables (E&L) have become a critical issue within the industry. Lack of standardization,...
Insights
Manufacturing therapeutic proteins such as monoclonal antibodies, while potentially lucrative, is fraught with uncertainty. A company can have a number of biologics in the pipeline, each requiring an estimate of future need for a variety of indications,...
Insights
“Industry 4.0” is the networking of information that became possible after several years of disruptive technological innovation. You may have heard related terms such as big data, real-time data, patient data, knowledge management, data analytics, and...
Special Reports
This paper discusses the findings and outcome of the ISPE Continuous Manufacturing Conference held 20–21 April 2016 in Baltimore, Maryland. While the ideas captured below reflect presentations and discussions both during the main conference and in breakout sessions, they are not necessarily the...
Technical
Much has been published on advantages of predictive maintenance, yet many do not realize that it is a tool to help achieve their facility's goals and objectives. If you need to convince management of the need for PredM, this article contains information that you can use as an "elevator speech."
Insights
Leaving the familiarity of a college environment, and beginning your career can be both exciting and intimidating. It’s a time when you are expected to put your years of education into practical use. However, even with a degree in hand, you still face a...
Features
Maintaining a robust supply of high-quality medicine is neither easy nor inexpensive. It depends on reliable processes, a secure supply chain, and a skilled workforce. Yet even when good medicines exist to treat an illness, delivery of these drugs could...
Technical
This article presents current research on the problem of rouge in clean steam generators and their distribution systems, as well as possible deleterious effects on capital equipment and final drug products.
Insights
Imagination is more important than knowledge. Knowledge is limited. Imagination encircles the world. —Albert Einstein
Technical
This article presents the work of the newly formed ISPE Holistic Production Control Strategy Working Group, which has identified and summarized the need for a redefined control strategy implementation methodology.
Insights
The importance of ensuring data integrity is reflected in guidance, citations, and public comments of regulators and health agencies. A number of companies have suffered serious regulatory and financial consequences as a result of unacceptable...