The Ongoing Transformation of Process Controls

BioPharm International, BioPharm International, April 2022 Issue, Volume 35, Issue 4
Pages: 26-27

As process controls adjust to a continuously shifting manufacturing landscape, implementation of information gathered from novel data analysis techniques has become a priority.

While discussing the state of process controls, industry professionals have an overarching message: the pronounced, ever-increasing importance of data. While data have always been instrumental in the development process, transformative new advances in what data can be used for are further increasing its prominence within manufacturing.

What’s the deal with data?

According to Doan Chau, global industry technical consultant, Rockwell Automation, while goals such as improving overall equipment effectiveness and batch yield optimization are not new, what can be done with the information gained is changing. For instance, key performance indicators can now be easily visualized and analyzed in real-time, granting expedient access to critical information for decision makers directing their companies.

“The latest innovations in process control technology have stemmed from better utilizing the large amounts of data that’s generated on the shop floor and using information technology tools that were not typically seen on the shop floor,” says Chau. “This effectively gives production teams, in real time, a better understanding of the current and future state of the process of equipment.”

Chau also notes how Industrial Internet of Things platforms can be used to leverage from other systems (e.g., manufacturing execution systems, computerized maintenance management systems, laboratory information management systems, enterprise resource planning systems) so that machine learning and artificial intelligence can be applied to various outcomes, which include predictive maintenance, production schedule optimization, or automated verification of manual process steps.

Kristel Biehler, the vice-president of Life Sciences at Emerson’s process systems and solutions business, echoes Chau’s thesis, stating that the industry is “all about data.” Biehler stresses, however, that the concern should not only be about creating that data, but in how it’s utilized.

“Once you have the data, how do you contextualize it? How do you make it useful to third-party applications with advanced analytics? Are you able to make decisions [using] the information?” says Biehler. “I think the biggest horizon is our ability to unlock the power that’s inside of that data.”

The rise of data-integrated technologies

Data-integrated technologies have been instrumental in recent innovations in the process controls sphere. For instance, Biehler noted how one of her company’s newer products, the DeltaV Spectral Process Analytical Technology (PAT), was designed to integrate chemometric models within the control system. The technology allows Emerson to take spectral data from on-line analyzers and analyze it with the embedded chemometric models. “You’re exposing parameters that weren’t previously available, and now they can be used for closed-loop control,” explains Biehler. For example, glucose can’t be measured directly, but you can build a model for this important parameter using the data from a spectral analyzer. You can also use other measurement parameters in addition to glucose, inside the control system, to close the loop and even optimize control settings for multiple controlled variables.

Another type of real-time data interfacing is the module type packaging (MTP) protocol that enables “plug and play” functionality. According to Biehler, MTP automatically recognizes features or definitions around what a piece of equipment is, allowing for quick changes to a system.

“Emerson is creating innovative solutions in the manufacturing automation management space by getting back to that data,” says Biehler. “We are automatically collecting data, understanding data during the process, and making corrections in real time. There’s no need to have to wait to clear up deviations at the end of the manufacturing cycle; we check and validate during the process.”

Similarly, Chau notes how the rise of continued process verification allows operators to monitor the process in real time via statistical process control methods. This either gives the operator confidence that the process is adhering to control parameters or notifies them that it is trending in an out-of-specification direction so that they can take additional actions, which could be invaluable in preventing a lost batch.

In a different vein, Chau cites how training technologies are being used as a solution to address the industry’s “aging workforce gap.” While much of the workforce has significant experience and knowledge regarding these systems, many are retiring without all members of the younger generation getting a chance to directly learn from their seniors.

“Digital work instructions and knowledge transfer are indispensable in capturing the knowledge of employees exiting the industry and relaying it to the new workforce,” says Chau. “Moreover, the use of extended reality (augmented or virtual reality) to relay the information has been tremendous in decreasing new hire time-to-value, especially in tough to train environments like a [good manufacturing practice] cleanroom. It also has the added benefit of reducing human error, which is the primary cause of most pharma manufacturing failures.”

The future of process controls

With the two-year anniversary of the COVID-19 pandemic officially in the rear-view mirror, a clearer picture is emerging of not only its impact on the current market, but also of what measures that might be desired long-term.

“Utilizing remote connectivity to support manufacturing was typically considered and included in the conversation because it does provide many benefits, such as improved response time, reduced costs, and increased up time,” says Chau. “[However], the pandemic added another critical factor into that equation, which is safety, and that was the major driving force in adopting remote connectivity in the industry during the pandemic.”

According to Chau, strict restrictions were already placed on who can access the plant prior to the pandemic. These restrictions impacted contractors, original equipment manufacturers, or vendors, all of whom had to undergo qualifications and training to work in a cleanroom environment. This issue was further exacerbated by the pandemic, which shifted the issue of entering the shop floor onto the end user, presenting a major challenge to productivity that remote connectivity solved. In the process, however, this shift also served to demonstrate the longitudinal efficacy of such systems.

“Continuous improvement is always happening in the industry, and remote access is certainly an enabler of that,” says Chau. “While it may not see the same demands as during the pandemic, remote connectivity will have an increased demand than prior to the pandemic because of the push for remote office work as a standard in the world.”

Meanwhile, Biehler stresses the ongoing changes that are occurring due to pandemic stresses on the supply-chain., which have ushered in a sustained effort to localize manufacturing.

“New facilities are popping up in places where we typically have not seen a lot of life sciences, like Africa and in Canada,” says Biehler. “[When] those investments are made, that obviously brings in a need for automation.”

Furthermore, Biehler states the emphasis on mRNA and therapies and drugs derived from it, which are frequently being fast tracked, could lead to less bulk manufacturing and more personalized medicine and gene therapies. Biehler believes that more personalized medicine would further stress the need for automation tools that integrate quality into product manufacturing.

“The requirements for automation are changing, because the industry is moving from large batches to small batches and it’s becoming even more important to be able to make changes quickly in your process,” says Biehler. “From that regard, I think that there’s a change that’s happening in the industry that’s having us rethink how we work with our customers to change our technologies and innovations.”

About the author

Grant Playter is the Assistant Editor for BioPharm International.

Article Details

BioPharm International
Vol. 35, No. 4
April 2022
Pages: 26–27

Citation

When referring to this article, please cite it as G. Playter, “The Ongoing Transformation of Process Controls,” BioPharm International 35 (4) 26–27 (2022).