Process Events for the Life Science Industry - Information Model Concept on OPC UA for Alarms and Audit Trails

Abstract

Plug & play in general describes a piece of equipment that is ready to use upon connecting to a computer without any configuration, like a home printer. Plug & Produce has the same vision for manufacturing and aims to enable straightforward integration of new production equipment or a device to substitute or adapt assembly line parts.

Concepts like OPC UA and Modular Type Package (MTP) are the groundwork for the standardization of interfaces and data formats for shop floor manufacturing equipment to enable Plug & Produce. However, current standards focus either on technical integration concepts or information structures. To fully realize Plug & Produce, technical integration, information structure, and biopharmaceutical-specific elements and documentation need to be in place.

This Concept Paper proves that a standard model within OPC UA Alarms and Conditions (OPC UA Part 9) can be leveraged to realize Plug & Produce for exchanging pharmaceutical alarms and audit trails between OT manufacturing equipment and Orchestration Platforms or IT Services like EBR or Historian.