Example of batch analysis management for biopharmaceuticals using process factors with an integrated system.

It is possible to analyze batches with different process times for biopharmaceuticals in relative time. Centralized management contributes to data integrity.

It is possible to manage and integrate complex data in bulk. By integrating and managing big data and performing analysis, early event detection of process errors and other issues can be achieved! Optimal's synTQ is a QbD/PAT integrated management system that is useful for quality control and product development. It can seamlessly connect with various devices and systems, allowing for bulk management and integration of data. Additionally, by integrating and analyzing the big data obtained from the process, early event detection of process errors can be realized. System demonstrations are also available. ◎ There are many achievements in major pharmaceutical companies in Europe and the United States. 【Features】 ■ Various multivariate statistical analysis models can be used regardless of the manufacturer. ■ Connects with various PAT tools such as near-infrared, Raman, particle size analyzers, and UHPLC, regardless of the manufacturer. ■ Captures and analyzes various process data such as temperature, pressure, and airflow obtained from the process for monitoring. ■ Interfaces with upper systems and databases such as MES and LIMS via OPC and ODBC. ■ Connects with various sequencers, including Mitsubishi Electric's MELSEC series, for data input and output. *For more details, please refer to the PDF. Feel free to contact us with any inquiries.

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