Integrated Control Systems:A hierarchical multi-level IT/OT infrastructure and an integrated process control system are the main pillars to the operation of ICM facilities. Granularity is a key component to support the process control demands stemming from field equipment/instrument devices, modular unit operation, drug substance synthesis suites, and drug product manufacturing lines. In this manner, the concept of plug-and-play of the ICM technology is possible to produce multiple active pharmaceutical ingredient (API) drug substances and drug products.

At CONTINUUS, the integrated control systems feature a systematic deployment of remote I/O modules, virtual I/O modules, programable logical controllers (PLCs), supervisory control and data acquisition (SCADA), and a distributed control system (DCS), etc., to achieve the granularity at different scales of process control demands. This holistic approach allows for using remote I/O modules to acquire process data from field equipment/instrument devices located in plug-and-play unit operation modules, such as afive-stage continuous stirred tank reactors (CSTRs) array. Process data from remote I/O modules can be processed and monitored by the DCS system at a specific API suite to detect events and alarms or other significant process/data changes, as well as implementing control actions or required interlocks, etc. The integrated control system also includes the implementation of process analytical technologies (PAT) tools to maintain the process in a “state of control” for critical process parameters (CPPs) and critical quality attributes (CQAs), supporting the real-time release from upstream to downstream processing units and achieving the goal of end-to-end pharmaceutical integrated continuous manufacturing.

Our overall integrated control strategy is to (1) provide an intuitive and easy-to-use automation system that simplifies operational complexity and reduces risks to safety and quality; (2) provide an adaptive control system integration solution that facilitates a flexible and scalable process configuration to support the manufacture of multiple API drug substances and drug products using an ICM facility; (3) provide an effective and efficient manufacturing process management platform for process performance monitoring, evaluation, and analysis.