March/April2009 Volume 29, Number 2 Theme:Automation Solutions/PAT/Operational Excellences Includes:2009 Facility of the Year Awards Supplement
PDF Version (,20.Mb) Digital Edition Digital Edition FAQ	PDF Version (,16.Mb) Digital Edition

NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2009 ISPE. All rights reserved.)

Articles

PAT and Green Chemistry: The Intersection of Benign by Design and Quality by Design
by Berkeley W. Cue, John Berridge, Julie B. Manley
This article will illustrate the application of Process Analytical Technology (PAT) as an important contributor to the “triple bottom line,” a measure of a company’s economic, environmental, and social performance, and the sustainability of the pharmaceutical industry.
Download Article... (,5.Mb)

Introduction to PAT Data Management Solutions
by Mark N. Reed
This article discusses the critical requirements for a Process Analytical Technology (PAT) data management solution and how these requirements contribute to the successful operation of the PAT solution.
Download Article... (,5.Mb)

Considerations for Transferring a Bulk Freeze-Drying Process from a Glass Container to a Tray
by Yves Mayeresse, Vinciane de Cupere, Romain Veillon, Joseph Brendle
This article presents the transfer of a freeze-drying process from a glass bottle to a freeze-drying tray.
Download Article... (,6.Mb)

Clinical Manufacturing Efficiency
by Beth H. Junker, Kay Hunsberger, Vicky Griffin, Kent Hamaker, Carl Holz, Amy Caparoni, Kelly Kistler, Jeffrey Graczyk, Marshall Gayton
This article presents a description of an operational effectiveness project to improve clinical material manufacturing efficiency of a biologics pilot plant. It utilizes lean and Kaizen principles to identify root causes, then brainstorm/evaluate potential solutions.
Download Article... (,3.Mb)

Using GAMP 5 for Rapid Deployment
by Markus Roemer, Hermann Schaefer
This article presents the implementation of a risk-based approach into a supplier’s Software Development Workflow and Product’s Release Management according to GAMP® 5.
Download Article... (,2.Mb)

Departments

Classified Advertising with Advertiser’s Index (,3.Mb)

ISPE Update (,2.Mb)

Online Exclusive Articles

Global Regulatory News (,0.Kb)