- DeltaV lets manufacturers meet the goals of PAT and Pharma 4.0
DeltaV lets manufacturers meet the goals of PAT and Pharma 4.0
“Many people with experience in process automation are wondering what is new about this [Pharma 4.0 and IIoT] – it seems that we’ve been doing this for a while now.” – Mike Bourdreaux, Director of Performance and Reliability Monitoring at Emerson Process Management
“Industry 4.0” is a term that gets thrown around a lot (often either pervasive at a company or fully avoided), loosely defined as “the convergence of people, physical systems, and data within an industrial process to increase quality, productivity, and profit by using the power of advanced data analytics.”
In other words: Industry 1.0 was defined by steam power and the Industrial Revolution, Industry 2.0 by electricity, and Industry 3.0 by the internet – with Industry 4.0 emerging from new capabilities to manage big data (notably machine learning and artificial intelligence) and the Industrial Internet of Things (IIoT). Pharma 4.0 applies big data to manufacturing medicinal products.
Process automation: steadily moving toward Pharma 4.0
Process analytical technology (PAT), quality by design, operational excellence, online sensors – all of these are tools that allow manufacturers to take advantage of automation and the increase in available data, and to relate them directly to tighter process control and improved manufacturing outcomes.
While Pharma 4. 0 is a newer term, the overall move toward automation and PAT have simply made Pharma 4.0 achievable and realistic, at a much lower cost than ever before. Meanwhile, the same tools manufacturers have been using for years are continually providing greater benefits in the form of increased reliability, uptime, data security, and system control.
Addressing the data transfer challenge
Despite the industry trend toward greater automation and online equipment, technology transfer is still a major risk point which must often be done several times over when scaling a bioprocess. Twenty years ago, each new phase of pharmaceutical research or production required moving data to a new platform: from lab-based systems to pilot systems, from systems designed for clinical trials to SCADAs for commercial-scale production. Each of those data transfers presented a risk of lost or compromised data.
Newer systems, particularly those designed with Pharma 4.0 in mind, are designed to scale with a process as it moves from scientists and researchers through to manufacturers and operations groups. Limiting the number of platforms necessary for effective data management through the lifecycle of pharmaceutical research, development, and production means fewer data transfers – and a lowered chance of compromised data.
Emerson’s DeltaV is a key example of a data system that can scale with a process. The platform originated in the petrochemical and nuclear industries, which, much like pharma, are highly regulated and require end-to-end data management and control – laying a strong foundation for the platform’s transition into pharma.
Integrating various data systems to provide closed-loop, end-to-end system control from early-stage lab experiments to commercial production environments is the overarching goal of Pharma 4.0. Modifying data transfers so they pose less risk substantially increases productivity and efficiency, and DeltaV has provided an effective solution to the problem of risky and time consuming data transfers.
Fitting DeltaV in to Pharma 4.0 and IIoT
While there has been a lot of buzz around Pharma 4.0, it is a very natural extension of the FDA’s PAT directive: increased sensorization gives more data, which you can analyze through new methods to better understand and control systems in real-time, leading directly to advances in productivity.
DeltaV works explicitly within this framework, reducing the complexity of connecting automation systems with low-level measurement devices. Redundant sensors and data backups limit errors, provide data integrity, and create an easy means of transferring data between research, development, pilot, and production phases.
Process intensification through smart control and data management
Emerson Process Management (now the Automation Solutions Division) and GE Healthcare’s Life Sciences business (now Cytiva) teamed up in 2015 to integrate the DeltaV distributed control system (DCS) with GE’s end-to-end single-use systems. They created FlexFactory – GE’s integrated manufacturing platform for single-use technology.
Emerson’s strength in remote monitoring of facilities across the country combined well with GE’s specialty in single-use systems. FlexFactory has successfully increased the productivity and overall efficiency of biopharmaceutical production, appealing to pharmaceutical companies looking toward automation as a means of cost reduction. The automation and additional data, combined with the increased flexibility and reduced setup times of single-use systems, enabled those companies to significantly shorten time to market for monoclonal antibodies and vaccines.
Risk mitigation through standardization
Historically, DeltaV was only financially feasible at the scale of commercial manufacturing, with some spillover into pilot runs. But as companies are now beginning to standardize their benchtop controllers on DeltaV, taking advantage of its open architecture, it has become more available to research scientists using those control systems. Universities are also beginning to use DeltaV, making it into a tool that students learn and take with them into industry.
This makes DeltaV a tool which integrates smoothly with existing systems, streamlines process control, and manages data at every phase of the drug development process. Its key features of mitigating the risks associated with multiplatform frameworks and providing data scalability from research to commercial-scale operators have led leading manufacturers such as Thermo Scientific and Applikon to build control systems based on DeltaV.
Very simply – by providing pharmaceutical companies with the ability to simplify their tech transfers, configure control schemes, and easily merge data libraries, DeltaV significantly reduces time to market for lifesaving biologic drugs and treatments.