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.
BioPhorum’s new Stirred tank unit: interface specification 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.
“The release of the Stirred tank unit: interface specification represents a step forward for the industry in the seamless integration of data and information between single-use systems and supervisory control systems,” said Eugene Tung, Executive Director of Manufacturing IT at Merck. “The specification promotes data sharing for continuous manufacturing and the flow of data into batch release systems and process analytics platforms. By eliminating the need for custom interfaces, the specification will enable manufacturers to more rapidly qualify new facilities, allowing medicines to get to patients faster and at lower cost.”
Benefits and standards
Combining this BioPhorum specification with NAMUR’s Module Type Package (MTP) approach to system integration has lots of benefits for users. For example, equipment and control system providers can enhance interoperability and reduce installation times from months to weeks or even days, depending on the installation scenario. And by providing sound documentation for their customers’ quality systems, suppliers can help their customers reduce their internal validation effort.
It is the first specification of this type published by BioPhorum and contains several introductory sections describing the principles on which it and future specifications are based. These principles relate to the established standards of ANSI/ISA-88, ANSI/ISA-95 and OPC-UA, and the developing ‘plug and play’ approach represented by NAMUR’s MTP.
An industry-specific standard
MTP and OPC UA are standards designed for general automation – this BioPhorum specification supplements those with the details required for the biopharmaceutical manufacturing industry, such as events, alarms, audit trail and the specific parameters for controlling process equipment assemblies.
It describes the capabilities of the interface specification for controlling STUs used in the batch mode production of monoclonal antibodies or other proteins; for example, how to adjust the pH in a mixer or bioreactor.
End-user members intend to deploy prototype equipment using this specification through 2021, and it is expected that adoption will grow across the industry as the approach is proven and case studies are communicated. In just a few years, it is likely to be the way the industry does automation.
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. This is an exciting development for BioPhorum and the Plug and Play project team – the first of a series of specifications that will encourage a step-change in our industry.