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Increased Quality by Improving Data Collection Why It’s Worth Thinking about Intelligent Process Sensors

| Author / Editor: Volker Kupitz* / Dr. Jörg Kempf

Whether pH, dissolved oxygen, conductivity, viable cell density or redox, while analog sensors have been the product of choice in many areas and still are, modern intelligent sensors offer a range of advantages.

Related Companies

Hamilton offers intelligent sensor technology under the brand name “Arc”. This covers their complete range of pH, dissolved oxygen, conductivity, viable cell density and redox sensors, together with their “ArcAir” app, a comprehensive software that configures, calibrates, validates and troubleshoots these sensors.
Hamilton offers intelligent sensor technology under the brand name “Arc”. This covers their complete range of pH, dissolved oxygen, conductivity, viable cell density and redox sensors, together with their “ArcAir” app, a comprehensive software that configures, calibrates, validates and troubleshoots these sensors.
(Source: Hamilton)

Sensor technology has continuously improved over the last years. The sensor market has changed a lot since the FDA initiated the PAT (Process Analytical Technology) initiative, challenging the pharmaceutical industry to adopt quality innovations through real-time monitoring and control of their processes. While the initiative has indeed spurred valuable new technologies, the journey to a complete quality-by-design future is still in its early stages, with monitoring of many critical process parameters (CPPs) showing room for progress.

Intelligent Sensor Technology Facilitates Processes

While analog sensors have been, and still are, the product of choice in many areas, modern intelligent sensors offer a range of advantages that enable users to comply with the PAT framework. They demand in-line process sensors that allow for automated control of critical process parameters instead of documenting them by means of manual sampling and separate analytical devices. Intelligent sensors can communicate directly with the process control system (PCS) without the need for a separate transmitter. They not only send a compensating measurement value to process control but also a variety of diagnosis data that are automatically recorded and stored in the sensor.

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The data recording and transmission are further designed to not only comply with, but also to surpass, the FDA and GMP requirements. Hamilton, for example, offers intelligent sensor technology under the brand name “Arc”. This covers their complete range of pH, dissolved oxygen, conductivity, viable cell density and redox sensors, together with their “Arc Air” app, a comprehensive software that configures, calibrates, validates and troubleshoots these sensors.

Artificial Intelligence and Self-Diagnostics

The technology offers the advantage of an off-line calibration under defined conditions. Furthermore, configuration settings can easily be transferred to other sensors, which drastically reduces both the time requirement for employees and the error potential. Due to the Modbus communication, operators are able to fully use the comprehensive data from these smart sensors. It is also a two-way communication, so the sensor can be configured directly from the PCS without the need for a transmitter.

Possible sensor problems are detected immediately and not only at the end of a process. In case of an error, this feature can help to save an entire charge. The smart Arc sensors send alarms, information for debugging, quality indicators and diagnosis to the process control system as well as wirelessly to the Arc Air app that can be run on mobile devices. The data recording and transmission are designed to meet or exceed FDA and GMP regulatory guidelines. This way, the operator is able to see instantly when the sensor was used, and if calibration or interface errors or other warnings occurred. Arc Air also records possible hardware errors such as glass impedance. The information can be used immediately, as in the case of process deviations, or for future decisions, such as when to calibrate or replace the sensor.

Despite all of these advances, there are always hurdles to overcome. PAT encourages more and more data acquisition, and technology will need to continue to advance in order for operators to acquire, maintain, and use this influx of data (see expert interview below).

Additional Information
Expert Interview: “The Possibilities Are Almost Limitless”

Karen Henrich, Head of Marketing Hamilton Process Analytics and Dr. Philipp Arquint, Head of ­Innovations Process Analytics, are at the forefront of sensor innovation. Together with their teams, they work closely with the customers not only to develop products that the market requires, but to actually shape the future of modern bioproduction.

Karen Henrich, Head of Marketing Hamilton Process Analytics and Dr. Philipp Arquint, Head of Innovations Process Analytics
Karen Henrich, Head of Marketing Hamilton Process Analytics and Dr. Philipp Arquint, Head of Innovations Process Analytics
( Source: Hamilton )

PROCESS: What visions do you have when thinking about the future of sensor technology?

Henrich: Hamilton works ­continuously on possibilities to facilitate the PAT requirements — from the introduction of new measurement parameters up to an advanced data management. I see the future in the increasing integration of cloud computing and Internet of Things (IoT) services. The work of plant operators and technicians is further facilitated in this way. In this scenario, the process control system receives the data from the sensors and sends them instantly to the cloud.

Arquint: The cloud will store information for process analytics, preventive maintenance and asset management, enabling the efficiency of the processes to be significantly increased. Rather than manually tracking maintenance activities, the cloud can be used to automatically calculate when it is time for the next maintenance session to take place. In an industry where a batch of a product can be worth millions of dollars, plant managers can use this data to decide whether it is prudent, for instance, to replace a sensor e.g. after five uses or not.

PROCESS: This means that — as in many other fields — more and more data is being processed and evaluated. Does this not only concern the sensors itself, but also peripheral processes?

Henrich: The smart factory is no longer a futuristic vision. Efficiency improvements do not only concern the direct measurement process, but also the procurement. The cloud can also be used to monitor inventory and enable simple, GMP-compliant product documentation, as well as ordering a required sensor. The possibilities are almost limitless and it is most likely that this will be the working world of the future.

PROCESS: So it seems that lots of data goes along with high quality — does this apply to every field?

Arquint: I can only speak for process analytics — but yes. By using the ethernet protocol, we are able to ­handle the rich data needed for modern processes. With more and more data available, a variety of new and retrospective analyses will be possible that result in the continuous improvement of the end product. Quality-by-Design is the ultimate goal of companies in the biopharmaceutical industry that want to reach the smart factory level in the future. There is still a lot of innovation required to reach this goal, but our smart Arc sensors bring the future of biopharma production a step closer by improving process understanding and control. The array of measurable process parameters will also continue to increase in the future, along with the accuracy of the measurements. Process scientists will be able to learn more and more about their processes and require more sophisticated data transmission and management tools.

Henrich: Ethernet and cloud computing will empower process scientists to fully utilize smart sensors. This powerful combination will bring biopharma processes to an unprecedented level of efficiency, yield and quality as predicted by the PAT initiative.

* The author is Marketing Communication Manager at Hamilton Bonaduz AG, Switzerland.

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