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Integrated Safety System
CSL Behring is committed to maintaining the highest standards of quality and safety throughout the production process. Our integrated safety system ensures that only the highest quality plasma is selected for use in manufacturing and only safe and effective therapies are released. Quality control measures, including dozens of inspections, tests and cross-checks are performed by highly trained personnel at each stage in the manufacturing process.
The foundation of our integrated safety system is quality. The four pillars of safety are selection, manufacturing, quality control and monitoring. The result of this system is safe products. In particular, virus safety is one essential aspect of product quality. Strict donor selection criteria have been implemented, and many tests are performed to minimize the presence of either viruses or prions in the basic raw material. Methods for clearing viruses from plasma are also implemented. These processes include both inactivation (e.g. pasteurization) and removal (e.g. nanofiltration, monoclonal purification, precipitation and chromatography). The result is a safe, potent, pure product. Even after lot release and distribution, our products continue to be monitored through a process called pharmacovigilance.
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