Volume 24, Number 6

Table of Contents

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.

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.

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.

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.

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.

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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