Automated Facility: Stirred tank unit interface specification

Equipment skids usually need to be treated as bespoke units when they are connected to control systems, which places automation on the critical path for facility design, build and reconfiguration. Any problems can clearly have major implications for a facility project – builds and reconfigurations would be much easier and quicker if equipment interfaces were standardized and offered interoperability. This paper helps address this issue perfectly by defining a standardized specification for automated equipment interfaces.

Written by the BioPhorum Plug and Play project team, the specification targets the stirred tank unit (STU) class of equipment that includes single-use bioreactors. These are central to the manufacturing operations of many companies producing biopharmaceuticals using a batch process at small- to intermediate-scales.

This document describes the capabilities of the interface specification for controlling STUs used in the batch-mode production of monoclonal antibodies (mAbs), recombinant proteins or other biotherapeutics, for example, how to adjust a pH in a mixer or bioreactor. It is not intended to describe how companies implement and test the PEA or the detailed specifications of the PEA, e.g. agitator control module capabilities such as the range of revolutions per minute (RPM) supported.

The BioPhorum Plug-and-play team anticipates that this document will be maintained in future through the governance of a relevant standards agency. Additional equipment and other equipment classes are expected to be added as a suite of documents maintained in the same way. At the time of writing, the team favored the creation of an International Electrotechnical Commission (IEC) publicly available specification based on this document. It is possible it will become a full IEC standard in time.

 Operation overview 

This interface specification defines the services and principles for controlling intelligent PEA STUs used in batch-mode from an overlying POL executing a procedural recipe. The PEA vendor is responsible for the mechanical, instrumentation and automation components on the PEA. The mechanism for accomplishing the required functionality is not within the scope of this document or the MTP Standard. The specification is defined at the interface level, with required parameter sets and expected functionality in which STU services are employed in a way philosophically similar to ANSI/ISA-88 equipment phases.

An evolving document

Although the specification has been extensively discussed and developed in a collaborative partnership between end-users and suppliers, it is open for comment and the team plans to submit the final version to a standards body for governance and maintenance.

Interface specifications for filtration and chromatography unit operations in a drug substance manufacturing facility should be published in the next six months or so, and there are also plans to expand the work downstream and into drug product manufacturing.

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