Volume 25, Number 1

Table of Contents

Articles

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.

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.

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.

Country Profile: Brazil - Jan/Feb 2005

This section takes a look at the pharmaceutical industry in Brazil

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