Biomanufacturing Automation Plug & Play

Abstract

In the biopharmaceutical industry today, the software of manufacturing equipment requires custom coding and lengthy efforts to integrate any new piece of equipment with others in a process. Plug-and-play is an evolving concept that would enable new equipment to quickly connect and seamlessly integrate with the existing automation control system, saving precious time when developing processes for new drugs and enabling unprecedented operational flexibility. Through a variety of biopharma and process industry consortia, efforts toward this goal are well underway using a standardized data file called the Module Type Package (MTP). Most reports of plug-and-play development focus on using MTP to facilitate connection of whole equipment assemblies. However, the plug-and-play concept might also be applied to individual components, such as sensors, within those assemblies. The interchangeability of individual components, while related to the integration of whole assemblies with MTP, represents a distinct capability that is not widely addressed in existing industry literature. This thesis proposes a framework to differentiate the two capabilities as Reconfigurability and Interchangeability and broadly studies the possible use cases associated with each. After establishing the framework, this thesis focuses specifically on Interchangeability and investigates the design considerations for, and the potential business value of, an interchangeable sensor.