January/February 2005
Volume 25, Number 1

Theme: Process Development

Table of Contents

Articles

The Four Steps of PAT Implementation
by John R. Davis, PE and John Wasynczuk, PhD
This article presents a blueprint for implementing Process Analytical Technology (PAT) using a practical, four-step methodology consistent with the FDA’s Guidance.
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Automated Release of Water Using On-Line TOC Analysis and FDA Risk-Based cGMP, Inspection, and PAT Principles by Richard Godec and 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. Download Article...

Ozonization of Purified Water Systems by Dr. Samuel Stucki, Dirk Schulze, Dieter Schuster, and Christian Stark This article describes the suitability of ozone for the protection of purified water systems against microbiological contamination. It also describes the process of electrolytical ozone generation, as well as an ozone application with the aid of an example from the pharmaceutical industry. Download Article...

Equipment Cleaning-In-Place in Modern Biopharmaceutical Facilities: Engineering Concepts and Challenges by Leonid Shnayder, PhD, PE and Maria Khanina This article reviews the major concepts of equipment CIP and issues related to the overall layout of modern biopharmaceutical facilities. Download Article...

The Vacuum Integrity Testing of Lyophilizers by Charles D. Dern, PE This article summarizes and clarifies terms and issues related to the vacuum integrity testing of lyophilizers. Download Article...

Country Profile: Brazil by ISPE Brazil Affiliate This section takes a look at the pharmaceutical industry in Brazil Download Article...