Case studies
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CSL Behring H1N1 Vaccine Packaging Automation Case Study

Case study of ICONICS GENESIS32 deployment for FDA-compliant H1N1 vaccine bottling and packaging at CSL Behring's Marburg facility.

Published
June 4, 2026
Read time
3 min read
Source

Details the implementation of GENESIS32, DataWorX32, TrendWorX32, AlarmWorX32, WebHMI, and OPC DataStore to meet 21 CFR Part 11 electronic records and signature requirements. Covers real-time data collection from proximity sensors, production counting, alarm management, and long-term data retention for regulatory audits spanning 42 years. Includes system architecture with 23 servers supporting 109 concurrent users.

Key takeaways

GENESIS32 suite enabled FDA 21 CFR Part 11 compliant electronic records and signatures for vaccine packaging

TrendWorX32 and OPC DataStore handled enterprise data logging, charting, and production counts from bottling line sensors

AlarmWorX32 provided real-time abnormal condition detection and documentation for sterile filling operations

WebHMI delivered secure remote access to HMI applications across intranet and internet connections

23-server architecture on Windows Server 2003/SQL Server 2005 supported 109 simultaneous users

Market overview

SCR methodology note

Vendor landscape

Leaders

Implementation considerations

Important consideration