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Table of Contents: Articles Increased Process Understanding Through Monitoring and Scale-Down Models: Case Study of a Cell Culture Harvest Fluid Titration and Filtration Process

by Kurt Yanagimachi, Corey Dodge, and 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.

Case Study: Parenteral Facility Upgrade Project with Fill Line Install

by Keith Weseli and 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.

Integrating Industrial Engineering and Lean Techniques at a Contract Pharmaceutical Manufacturer

by Valerie Maier-Speredelozzi, Cyrus Agarabi, Thomas Needham, and Sirine A. Saleem

This article presents the application of industrial engineering and lean techniques to a contract pharmaceutical manufacturing facility.

Retrofitting CIP into API Plants

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.

Solving the Terminology Conundrum

by Robert Adamson, Nuala Calnan, Robert E. Chew, and 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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