(721h) Applying Batch Data Principles to Continuous Manufacturing for the Purposes of Data Management, Batch Reporting, Analytics and Traceability

It is often necessary to abstract continuous and semi-continuous processes into batch components for the purposes of reporting, analytics, and materials traceability. This is particularly true now in the pharmaceutical industry with the advent of continuous and semi-continuous manufacturing. Many processes that have been manufactured using traditional batch techniques are now evolving towards continuous manufacturing in order to improve manufacturing efficiency and product uniformity.  For example, there is intense research and development associated with applying continuous process technology to drug manufacturing that was previously batch oriented. The regulatory and traceability considerations are particularly critical in this area

There are substantial obstacles to overcome to enable batch functionality for continuous including: the aggregation of data from multiple data sources, analysis of poorly contextualized data, and traceability of materials characterized by complex residence time distributions. 

In drug manufacture each unit operation typically has its own process control system which has made it a long-standing challenge to bring the data together for reporting and analysis.  The data is typically poorly contextualized making it difficult to extract useful information from the data. 

Material traceability is also a challenge in continuous and semi-continuous manufacturing processes.  Since there is not discrete separation of materials at various stages of the process, it can be difficult or impossible to link incoming raw and intermediate materials to final product.  This is especially critical in industries where there are regulatory compliance, safety or efficacy considerations with respect to the manufactured goods.

This session demonstrates a Proof-of-Concept solution to integrate disparate process control systems into a centralized database in real-time with S88 contextualization, and built with Residence Time a Distribution (RTD) models to provide a single solution for batch reporting, analysis, and traceability of continuous processes. The RTD models also represent a possible solution for product traceability that is required with respect to regulatory and safety guidelines, as well as Current Good Manufacturing Practice (cGMP).