Plug and play bioreactor interface development

The BioPhorum Plug and Play team is creating a number of specifications needed to address the problems associated with automating equipment that lacks interoperability in the Biopharmaceutical industry. Typically, equipment skids (Process Equipment Assemblies, or PEAs) need to be treated as bespoke units when they are connected to control systems (Process Orchestration Layers or POLs).

This places automation on the critical path for facility design, build and reconfiguration. Here, the example of a Stirred Tank Unit (STU) interface specification is presented. The STU class of equipment includes single use bioreactors, which are central to the manufacturing operations of many companies producing biopharmaceuticals using a batch process at intermediate scales. By combining this specification with NAMUR’s Module Type Package (MTP) approach to interoperability, equipment and control systems providers can reduce the equipment installation time from weeks to days. And by providing good documentation from their quality systems, vendors and suppliers of these systems will enable their customer to benefit from a reduction in validation time.