The anticipated rapid shift in the life sciences from traditional stainless-steel bioreactors to new, disposable gamma-irradiated plastic bags for single-batch processing has been delayed by the problem of finding reliable, efficient sensors for vital liquid analysis.
Emerson has applied its deep sensor expertise to the creation of new single-use sensor technology that provides up to 10 times greater sensor stability, reducing risk in process quality and yield for biopharmaceutical manufacturers. The new technology also speeds time to market through shortened start-up time, greater ease of use and low maintenance.
The Rosemount 550pH single-use sensor and the 550DW dissolved oxygen single-use sensor adapter are designed to deliver the same proven stability and performance as Emerson’s stainless-steel sensors. The 550pH sensor offers the unique capability of being stored wet for immediate verification and standardisation, eliminating the initial stabilisation process, which can generally slow startup by 30 minutes to two hours.
The life sciences industry is in a transformational period adjusting to new trends and influences. As the number of blockbuster drugs decreases, many facilities are transitioning from dedicated to multi-product manufacturing facilities, requiring shorter production runs with faster changeovers. At the same time, many unit operations are switching from stainless-steel batch to single-use continuous production, which requires smaller equipment and more flexibility for product changeovers.
Responding to these trends puts pressure on plant design, equipment setup and utilisation to enable faster and more flexible production. The new Emerson single-use sensor technology responds to this market demand.
“Both end users and bioreactor equipment manufacturers are anxious to take advantage of the cost and quality benefits of single-use biopharmaceutical processing, including a smaller manufacturing footprint, fewer cleaning chemicals, less energy usage and more flexibility in a facility for producing multiple products,” says Michael Francis, Global Product Manager of Emerson Automation Solutions. “However, to achieve those benefits they can’t accept any compromises in the liquid analytical instrumentation that is inserted into the bioreactors.
“Emerson engineers have designed our new single-use sensors to perform as well as or better than those used in stainless-steel bioreactors. Wherever possible, we’ve maintained our industry-standard designs so that users and OEMs need no additional training to be up and running. At the same time, we’ve added features, like the wet storage, that overcome challenges that have been plaguing single-use processing since its advent. Our customers spoke, and we listened.”
The 550pH sensor is an electrochemical, fully disposable device with sensor stability of less than 0.005pH change per day verified by extensive testing. In a field marked by unstable sensors, the 550pH provides up to 10 times enhanced stability and requires no maintenance or calibration after initial one-point standardisation.
Since it is stored wet, it overcomes the problem of inserting a dry sensor into the single-use bioreactor only to discover it’s not working properly and having to discard the entire processing unit to start again. It is packaged with its own calibration fluid, giving it a two-year shelf life. Wet, one-point standardisation before startup means that the sensor’s characteristics and functionality are verified before any solutions or buffers are added to the bioreactor bag. It also means that the verified sensor begins measuring immediately after being introduced into the bag with no extensive wait time, thus reducing overall processing time and time to market.
The 550DW sensor adapter is compatible with standard stainless-steel dissolved oxygen sensors and enables placement into the bioreactor single-use bag. Only the gamma-irradiated adapter touches the process solution, meaning the sensor can be reused for multiple batches. The sensor can be air-calibrated prior to startup to verify functionality with no fill product needed in the bioreactor.
Both the 550pH and 550DW operate with the advanced Rosemount liquid analytical 56 transmitter, known for its intuitive ease of use. In addition, the new sensor technologies and the Rosemount 56 transmitter are fully compatible with the Emerson DeltaV control system, which is widely used in the life sciences industry.
“Emerson has delivered the level of sensor performance demanded by biopharmaceutical processing users in a single-use design that is efficient, highly stable, easy to use and cost effective,” Francis adds.
Emerson Automation Solutions
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