Volume 28, Number 4
by Kurt Yanagimachi, Corey Dodge, Marisa Hewitt
This article presents a case study demonstrating the use of detailed process monitoring and scale-down modeling in determining the root causes of yield losses in the manufacture of a therapeutic enzyme and identifying alternative technologies to improve the manufacturing process.
by Keith Weseli, Michael DiGiovanni
This article presents a case study illustrating project management and commissioning and qualification processes that allowed for accelerated completion of a renovation project.
by Valerie Maier-Speredelozzi, Cyrus Agarabi, Thomas Needham, Sirine A. Saleem
This article presents the application of industrial engineering and lean techniques to a contract pharmaceutical manufacturing facility.
by Nigel A. Fletcher
This article describes the physical modifications and additions retrofitted into existing plants to incorporate CIP technology and some of the techniques that can be used to ‘stretch’ the existing CIP systems for best effect.
by Robert Adamson, Nuala Calnan, Robert E. Chew, Steven J. Wisniewski
This article discusses the terms “commissioning,” “qualification,” and “verification.” Do the terms refer to the same or different ideas? How should the pharmaceutical and biotechnology industries use these terms in a consistent and meaningful way? This article provides a compilation of how these terms are used in regulations and by various industries, and provides a proposal for clear definitions to be used as ISPE updates and creates Baseline® Guides.
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