Standards for process automation would save drug makers money, allow them to adopt innovative technologies, and reduce cybersecurity risks, reports a new study. Biopharmaceutical manufacturing lines can comprise tens of different technologies, supplied by a range of suppliers. While efforts to ensure the separate systems can be linked have increased in recent years, interoperability is still a challenge.

What the bioindustry needs are standards, particularly for process control technologies, according to Don Bartusiak PhD, is president of Collaborative Systems Integration and a part of the Open Process Automation (OPA) initiative.

“The root cause of these pain points is the closed, proprietary nature of currently available industrial control system (ICS) products,” says Bartusiak. “The Open Process Automation initiative is defined by the vision to transform the ICS from its current state to a standards-based, open, secure, interoperable process automation architecture.”

The OPA initiative was set up in 2016 by the Open Group, a consortium of 800 tech firms, tool vendors, academics, and consultants across multiple industries. The aim is to define standards and catalyse the transformation of industrial control systems.

Part of the problem with current systems, Bartusiak continues, is that the lack of interoperability means it is difficult to reuse applications software, which limits data exchange and hampers monitoring. The inability to connect systems also results in “excess cost to upgrade or replace because of close, proprietary couplings between components that makes for whole-system, instead of modular, replacement,” he says.

The lack of standards and the closed nature of current systems also results in lost business opportunities because it makes it harder to introduce innovative third-party hardware and software, notes Bartusiak, citing cybersecurity technologies as an example.

Standards architecture

Bartusiak and colleagues looked at three potential standards solutions in the Control Engineering Practice journal article previously cited. And the conclusion was that all industries, including the biopharmaceutical sector, stand to benefit.

“The biopharmaceutical industry will benefit from faster time-to-market of its products by the elimination of continual re-engineering of the control systems for new product manufacturing lines. It will benefit by reduced time and cost to recertify the control configurations, software, and other Process Analytical Technology (PAT) mechanisms between manufacturing line duplications or upgrades because of the interoperability, interchangeability, and software re-use enabled by Open Process Automation Standard (O-PAS),” says Bartusiak.

“Biopharmaceutical and other ICS-using industry vertical segments will benefit from easier, faster innovation and reduced total cost of ownership of their ICS systems by reduction of vendor lock-in.”

Whether technology suppliers fully embrace the standards remains to be seen, but it is likely customers in the biopharmaceutical industry will hope they do, notes Bartusiak.

“It is a universal truth that well-performing control systems reduce unwanted variability and increase manufacturing productivity in the processes to which they are applied,” he points out. “I think any biopharmaceutical manufacturer who is using PAT, recent innovations in multi-variate data analytics for monitoring and control, or other batch control technology solutions can attest to the benefits of process control. O-PAS will bring these benefits faster, cheaper, and better than the status quo.”


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