January/February 2005 Volume 25, Number 1



Automated Release of Water Using On-Line TOC Analysis and FDA Risk-Based cGMP, Inspection, and PAT Principles
by Richard Godec, Nissan Cohen
This article illustrates the advantages of automated on-line TOC analysis-based water release, discusses critical considerations and possible strategies to employ, and reviews TOC automation in light of the new FDA guidance.
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Equipment Cleaning-In-Place in Modern Biopharmaceutical Facilities: Engineering Concepts and Challenges
by Leonid Shnayder, Maria Khanina
This article reviews the major concepts of equipment CIP and issues related to the overall layout of modern biopharmaceutical facilities.
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The Vacuum Integrity Testing of Lyophilizers
by Charles D. Dern
This article summarizes and clarifies terms and issues related to the vacuum integrity testing of lyophilizers.
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Country Profile: Brazil - Jan/Feb 2005
This section takes a look at the pharmaceutical industry in Brazil
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