Single-use biopharmaceutical manufacturing systems require gamma-sterilizable, highly stable, accurate, and simple-to-use single-use pH sensors with a long shelf life. Herein we report the design and performance of a single-use pH sensor technology optimized for single-use bag applications such as those found in bioreactor and mixing applications. This technology is the basis of Emerson’s Rosemount 550pH Single-Use Sensor. The sensor is compatible with gamma irradiation and can be attached to a single-use bioreactor bag via industry accepted ports. With the incorporation of a unique storage buffer solution, the sensor has a long shelf life of two years and offers a startup one-point standardization and validation capability without the need for filling the bag.

Sensor prototypes were constructed and tested through real-time aging. It was demonstrated that the sensors remained high performance after two years of storage, with a startup accuracy of ± 0.1 pH at pH 7, a wide pH sensing range between pH 2 and pH 12, a high sensitivity with a response slope higher than 57 mV/pH, and an outstanding sensor stability with drift less than 0.005 pH/day.

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This special report will be published in BPI’s September 2021 print edition.