Process Control, Automation, and PAT

Minimum disruption and maximum gain result when adopting a distributed process control and data management system for a cell culture and fermentation lab.

PAT can be defined as a collection of real-time data in-line to make decisions about product quality early in the production process.

...each day a product is delayed is estimated to cost upwards of $1 million to $100 million.

The methods used in most microbiological test laboratories originated in the laboratories of Koch, Lister, and Pasteur. While numerous changes have occurred in the chemistry laboratory, there have been limited improvements in methods used for microbiological testing.

A well-understood, validated, and correctly maintained BAS reduces the chance of a critical room parameter slipping out of specification.

Three meetings of the BioPharma Operations Excellence Consortium, facilitated by Tefen Operations Management Consulting, were held recently. The east coast meeting was hosted by Genzyme at its headquarters in Cambridge, MA; the west coast Chapter met at the Genentech campus in South San Francisco, CA; and the European forum held its meeting in Frankfurt, hosted by Aventis.

by Demetri Petrides, Alexandros Koulouris, and Charles Siletti, Intelligen, Inc. Bottlenecks are everywhere, from the freeway overpass during the morning commute to the long lines at the supermarket. But bottlenecks in a manufacturing process are bad for business. Computer models can help you eliminate those conditions or situations that retard your progress. Whether the goal is strategic planning, evaluating alternatives, purchasing equipment, appraising a facility, or optimizing production processes, simulation tools can improve your analysis.