ABSTRACT
This case study provides guidance on considerations when installing and validating a Distributed Control System (DCS) for a pharmaceutical batch process.
Most pharmaceutical manufacturing facilities designed and constructed in the mid-to late 1980s are likely to have taken advantage of the automation offered by the DCSs or PLCs available at the time. Such systems are often seen as being inflexible, and any recipe/reporting and data collection (alarms, trends, operator actions) are unlikely to be technically compliant with the FDA regulatory requirements on electronic records and electronic signatures.1 Therefore this case study also considers the options for implementing a replacement DCS system on an existing facility.
