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Full process control through integrated PAT

Partner content | dinsdag 27 oktober 2020

Hamilton’s Arc Air interface enables GMP workflows, with its single-use intelligent sensors combined with the latest generation of process analytical technology (PAT).

Upon the celebration of its 30th anniversary, Hamilton is taking stock of its achievements and ambitions. “In our PAT, we constantly aim to increase the number of performance parameters that we can measure”, says Senior Product Manager Jahir Kololli. “The more parameters you measure, the more data you get, and the more precisely you can control your process. This is exactly as suggested by the PAT Guidance published by the U.S. Food and Drug Administration (FDA).”

Process control

Of course it is not enough to just collect data. Companies need smart systems that can manage the abundance of available information in order to better control their processes. Hamilton’s Arc platform is such a smart system. Kololli explains: “Its main benefit is the fact that you don’t need an additional device between sensor and process control system. The sensor connects directly to your Biomonitor or process control system.”

The ArcAir software can be accessed on a computer or any mobile device. It gives its user full control of the sensors: it allows for configuration, calibration, validation and troubleshooting from any of those devices at any time. The dashboard view shows the status and important information of all sensors on a single screen. Simplified colour coding on the sensor and ArcAir software indicates when sensors are working fine or may have error messages or warnings.

“The sensor connects directly to your Biomonitor or process control system” 

At the same time, the Arc Air software automatically documents all steps within a GMP production process, while allowing for data to be shared across devices and stored in a centralised database. “This automatic reporting saves time and avoids costly data entry errors”, says Kololli. “The documentation can be signed electronically, allowing for a complete paperless workflow.” Data from all devices are logged into an audit trail report, which ensures full traceability of all user actions. This makes this system ready to comply with the FDA’s GMP standards.

Single-use

The Arc platform is fully compatible with single-use systems, as Kololli emphasises. “Hamilton is a trusted supplier of sensors that are designed specifically for the special single-use requirements as well. Many pharmaceutical companies working with living cells use conventional sensors in their bioreactors, but this entails some disadvantages such as the risk of contamination. With this in mind, we adapted our trusted sensor designs into single-use versions that are incorporated directly into a bag.”

The result is a complete system that elimi­nates the need for manual intervention, avoids contamination, saves costs, and is more reliable. “It offers the best of both worlds”, concludes Kololli. “Especially when you combine single-use sensors and smart technologies, such as Arc.”