Biopharmaceutical Single Use Measurement and Control

A recent Biopharm International article, Single-Use Bioprocessing Equipment Trends and Adoption by CMOs highlighted this trend:

Single-use systems (SUS)—bioprocessing equipment designed for one-time use or a single product manufacturing campaign—has become the leading paradigm for pre-commercial (preclinical and clinical supplies) manufacturing of biopharmaceutical products (1).

At this past autumn’s Emerson Exchange conference in San Antonio, Texas, Emerson’s Michalle Adkins demonstrated single use manufacturing measurement and control devices and how they could be used to measure and control biomanufacturing operations in a single use environment.

Michalle opens this 5:36 video explaining how the capital expenditures for a biopharmaceutical manufacturing operation is extensive. Projects timelines based on the traditional approach of fixed stainless-steel vessels and piping are also long.

With SUS, plastic bags and tubing is used in the manufacturing processes instead of stainless steel vessels and pipes. Instead of needing to perform clean-in-place (CIP) or steam-in-place (SIP) operations, the bags with sensors and the plastic tubing are discarded and replaced with new ones. Greater flexibility in processing different products is possible with SUS, and less capital is required for initial installation.

This also requires a new approach for process sensors and control. Rosemount disposable pressure, pH and conductivity sensors and ASCO pinch valves meet the demanding requirements of bioproduction manufacturing SUS.

Michalle explained how Syncade Workflow can provide setup instructions, track the proper performance of the setup, and track the use and consumption of disposable devices as part of an order. She demonstrated how to setup a bioreactor bag containing a disposable dissolved oxygen sensor—first scanning the barcode on the bag. Next step is to confirm that the dissolved oxygen sensor has been calibrated. Finally, the bag is added to the SUS.

Watch the video for the rest of the sensors that Michalle reads with the barcode and installs as part of the setup operation. This shows how these sensors and steps can be full recorded as part of the electronic batch record for production by single-use systems.

You can also connect and interact with other biopharmaceutical industry experts in the Life Sciences group in the Emerson Exchange 365 community.

Posted Friday, January 18th, 2019 under Life Sciences.

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