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BioPAT® SIMCA-Online

Source: Sartorius Stedim Biotech

BioPATĀ® SIMCA-online

Continuous real-time quality control and assurance is a highly desired state in biopharmaceutical manufacturing, which can be achieved by sophisticated process control strategies that use multivariate monitoring techniques to prevent or mitigate the risk of producing a poor quality product.

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  • Early detection of process deviations with guidance to potential root cause reduces the risk of costly downtimes
  • Real-Time Multivariate Statistical Process Monitoring (RT-MSPM) with easy understandable graphics leads to enhanced process safety
  • Process trajectories for real-time cultivation monitoring with BioPAT® Spectro
  • Real-Time Release (RTR) testing
  • Classification and process predictions for control and assurance of overall process and product quality

Continuous real-time quality control and assurance is a highly desired state in biopharmaceutical manufacturing, which can be achieved by sophisticated process control strategies that use multivariate monitoring techniques to prevent or mitigate the risk of producing a poor quality product. Multivariate monitoring is based on models representing the relationship between parameters, whereas traditional process monitoring is based on univariate rules incapable of revealing correlation patterns and sometimes resulting in misleading conclusions.

BioPAT® SIMCA-online is a highly efficient software release for real-time multivariate statistical process monitoring and control of previously established Design Spaces based on current process parameters and (spectro) analytical data.

The software permits early detection of process deviations and provides user guidance for identifying potential root causes by displaying easy-to-understand graphics. This not only results in improved health, safety and environmental (HSE) performance, but also in enhanced control and assurance of the overall process and product quality.

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