Pharma 4.0 – Towards IT/OT Architectures for Prescriptive Maintenance


Faced with global competition and shrinking margins, (bio)pharmaceutical manufacturers worldwide are urged to increase production efficiency by making better use of time and resources. This is in addition to addressing the unique challenges faced by pharmaceutical manufacturers such as a strictly regulated environment, heterogeneous equipment suppliers, and long adaptation times. Digitalization and Industry 4.0 [1] are two concepts that support the achievement of these goals.

Within the framework of Industry 4.0 [1], the Industrial Internet of Things (IIoT) offers major opportunities for improved asset performance and operational efficiency, new service offerings, and completely new ways of offering value to customers. The IIoT harnesses the power of smart devices and real-time analytics to leverage the data that is constantly produced in industrial environments. The idea behind IIoT is that smart equipment is not only better than humans at collecting and analyzing data in real time, but also at communicating important information. This information can be used to make faster and more accurate business decisions during operations, maintenance, and calibration strategies.

Through a network of sensors, instruments, and other devices connected into systems that monitor, collect, share, and analyze data, the IIoT leverages smart technology such as machine learning, Artificial Intelligence (AI), and other technologies that can impact every level of the manufacturing ecosystem. An enormous potential for greater efficiency in manufacturing, operation, and maintenance management lies in the orchestration of smart devices’ capabilities with user-oriented software applications. What exactly are the benefits IIoT technologies can bring to biopharmaceutical manufacturers? Which application fields are the most promising? How can maintenance activities be supported?