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Customer Success Story: CSL Behring and CSL Limited
Technology Category
- Analytics & Modeling - Real Time Analytics
- Application Infrastructure & Middleware - Data Exchange & Integration
Applicable Industries
- Healthcare & Hospitals
- Pharmaceuticals
Applicable Functions
- Discrete Manufacturing
- Quality Assurance
Use Cases
- Process Control & Optimization
- Track & Trace of Assets
Services
- Software Design & Engineering Services
- System Integration
The Challenge
CSL Behring, a subsidiary of CSL Limited, is a pioneer in the field of immunology and operates some of the world’s largest flu vaccine manufacturing facilities. In 2009, following the announcement of an influenza pandemic by the World Health Organization, CSL developed a pandemic vaccine (H1N1) and signed a 180 million dollar contract with the US Department of Health and Human Services (HHS) to provide bulk H1N1 influenza antigen. The challenge was to ensure rapid and safe production of the H1N1 flu vaccine for the US market in CSL Behring’s FDA-approved filing and packaging facility in Marburg, Germany. The company needed a system where production data could be logged reliably and stored safely, meeting the recording requirements of the FDA, specifically the 21 CFR Part 11, which outlines the controls necessary for the regulated industry to utilize electronic records and electronic signatures.
About The Customer
CSL Behring, a subsidiary of CSL Limited since 2004, traces its corporate roots to Emil von Behring, the first Nobel Prize recipient for Medicine and Physiology in 1901. As a pioneer in the field of immunology, Behring’s ground-breaking work resulted in the development of vaccinations against diphtheria and tetanus. CSL Biotherapies, also a subsidiary of CSL, operates some of the world’s largest flu vaccine manufacturing facilities for the global market. With more than 80 years of experience in the development and manufacturing of vaccines, and nearly 40 years with flu vaccines, CSL is committed to reliability, safety and quality. Following the June 2009 World Health Organization announcement of an influenza pandemic, CSL developed a pandemic vaccine (H1N1) and signed a 180 million dollar contract with the US Department of Health and Human Services (HHS) to provide bulk H1N1 influenza antigen.
The Solution
ICONICS’ GENESIS32 software suite was deployed to enable rapid and safe production of the H1N1 flu vaccine. The suite includes DataWorX™32, TrendWorX™32, WebHMI™, AlarmWorX™32 and ICONICS OPC DataStore, which combine to create the solution bridging the gap between industrial automation and the medical field. The H1N1 vaccine is dispensed into single use syringes or multi-dose vials in a sterile conveyor line, and then packaged and sent to CSL’s Illinois site for distribution across the US. TrendWorX32 facilitates enterprise-wide data collection, logging, charting, reporting and analysis. A DataStore OPC Server stores collected information from proximity sensors, such as bottles in and out, rejects, and total production counts. AlarmWorX32 improves CSL’s ability to identify, quickly respond to and to document abnormal conditions throughout the bottling process. Internet and Intranet connectivity is provided to GENESIS32 applications securely through WebHMI.
Operational Impact
Quantitative Benefit
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