Volume 26, Number 1

Table of Contents

Articles

Process Analytical Technology (PAT) and Scalable Automation for Bioprocess Control and Monitoring – A Case Study

by John Nichols, Stuart Preston, Joydeep Ganguly, Gerrit Vogel
This case study provides a comprehensive look at Talecris Biotherapeutics’ approach to PAT and automation followed by examples of PAT deployed on a bioprocess. It introduces the concept of integrated and scalable automation, provides a comparison of automation concepts, and explains how the selected automation effectively supports initiatives like PAT.

Pharmaceutical Facility Upgrades: The Containment Issues

by Martin Ryder
This article investigates the options for upgrading the containment performance of traditional pharmaceutical facilities using alternative (low cost) containment technologies.

On-line Particle Counters Provide Detection and Control in Water for Injection (WFI) and Purified Water (PW) Systems

by Hans-Walter Motzkus, Joe Gecsey
This case study presents early contamination detection in an established WFI and PW system through the use of on-line particle counters.

Interview with Emer Cooke, Head of Sector, Inspections, Veterinary Medicines and Inspections, EMEA

by Emer Cooke

GAMP® Traceability for GxP Regulated Applications

“Good traceability yields benefits” – guidance from the GAMP® Forum on achieving the correct level of traceability between requirements, design, and testing documents for regulated GxP applications.

Country Profile: Thailand - Jan/Feb 2006

This section takes a look at the pharmaceutical industry in Thailand.

A Hub Layout Concept for Oral Solid Dosage (OSD) Facilities

by M.P. Brocklebank, J. Lam, P. Mehta
This article describes a new configuration for the layout of an OSD facility that closely integrates all of the facility contents plus optional R&D and administration areas. It presents a number of operating and GMP advantages, as well as potential capital and operational cost savings.

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