November/December2004
Volume 24, Number 6
Articles
A New Suite of Automated Bioreactors at Genentech: A Case Study Employing Standards
by Ronald E. Men
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 James E. Akers, Yoshifumi Yabuuchi, 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.
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Establishing Compliance of a Company’s IT Infrastructure - A Practical Guide to Meeting GxP Requirements
by John Andrews, Richard Labib
This article describes a pragmatic and effective approach to network qualification compliance.
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Design
by Steve K.W. Oh, K.H. Kuek, Victor V.T. Wong
This article presents a commercial software to design, simulate, and optimize the production of a large-scale monoclonal antibody.
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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.
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Regulations Governing Gas Used in Pharmaceutical Production
by Catharina Nilsson, Anders Ernblad
This article discusses the gases that are used in production processes in the pharmaceutical industry.
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