Case Study: CSL Behring and CSL Limited improve FDA-compliant vaccine bottling with Mitsubishi Electric Iconics Digital Solutions

CSL Behring and CSL Limited secures H1N1 production with Mitsubishi Electric Iconics Digital Solutions and a $180 million HHS contract

CSL Behring, a subsidiary of CSL Limited, faced the challenge of adhering to strict US FDA 21 CFR Part 11 requirements for its vaccine packaging facility in Marburg, Germany. They needed to reliably log and safely store production data for 42 years and bridge the gap between industrial automation and the medical field. To meet this challenge, they implemented the GENESIS software suite from Mitsubishi Electric Iconics Digital Solutions.

The solution from Mitsubishi Electric Iconics Digital Solutions utilized applications like TrendWorX for data collection and AlarmWorX to identify and document abnormal conditions. This provided secure data logging, enterprise-wide reporting, and improved process response times. The implementation successfully supported CSL's fulfillment of a $180 million contract with the US Department of Health and Human Services to provide H1N1 influenza antigen, ensuring efficient and safe vaccine bottling for distribution.

CSL Behring and CSL Limited