Figure 1: System and data communication diagram; historical data available in the data historian are used as reference batches and to build the digital chromatogram project. During production, data ingested from the manufacturing SCADA system to the data historian (OSI PI) are transmitted to SIMCA Online through SimApi at real-time frequency. The visualization dashboards are made available to operators, quality assurance personnel reviewers, and the partner.

Chromatogram review is a monitoring method used to verify process performance in packed-bed chromatography processes. By observing key process parameters such as chromatography column outlet conductivity or UV absorbance, it is possible to identify the signs of a poorly packed column, resin degradation, or equipment malfunction. Therefore, chromatogram review is implemented as an in-process control (IPC) to decrease variability and identify suboptimal performance, thereby enhancing yield and ensuring high product quality.

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