November/December 2004
Volume 24, Number 6

Theme: Automation, Information, and Business Systems

Table of Contents

Articles

A New Suite of Automated Bioreactors at Genentech: A Case Study Employing Standards, Guidelines, and Software: From Requirements to Validation
by Ronald E. Menéndez
This case study reports on one effort to design and automate a suite of bioreactors employing ISA-S88.01, Batch Control, Part 1: Models and Terminology standard, GAMP 4 guidance, and S88-based batch management software widely used in the manufacturing industry.
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Case Study: Robot-Based Inspection and Packaging System for Radiopharmaceuticals by PhD, James E. Akers, Yoshifumi Yabuuchi, and Kenji Yoneda This article describes an automated packaging line for pre-filled syringes. It discusses the process from inserting syringes into lead containers for shipping to loading the containers onto shipping trays. Download Article...

Establishing Compliance of a Company’s IT Infrastructure - A Practical Guide to Meeting GxP Requirements by John Andrews and Richard Labib This article describes a pragmatic and effective approach to network qualification compliance. Download Article...

Design, Simulation, and Optimization of a Large-Scale Monoclonal Antibody Production Plant: Upstream Design by Steve K.W. Oh, K.H. Kuek, and Victor V.T. Wong This article presents a commercial software to design, simulate, and optimize the production of a large-scale monoclonal antibody. Download Article...

How Object-Oriented Design Can Drive Down the Cost of Implementing and Validating Automated Processes by Phillip Maderia This article presents a software design methodology that reduces the time it takes to develop, test, and document application software and enables testing to occur before the automation is installed. Download Article...

Regulations Governing Gas Used in Pharmaceutical Production by Catharina Nilsson, Katrin Åkerlindh, and Anders Ernblad This article discusses the gases that are used in production processes in the pharmaceutical industry. Download Article...

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