The anticipated rapid shift in the life sciences arena from traditional stainless steel bioreactors to new, disposable gamma-irradiated plastic bags used for single-batch processing, has been delayed by the problem of finding reliable, efficient sensors required for vital liquid analysis. Now, 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 sensor 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 Rosemount 550DW dissolved oxygen single-use sensor adapter are designed to deliver the same proven stability and performance as Emerson's stainless steel sensors. The Rosemount 550pH sensor offers the apability of being stored wet for immediate verification and standardisation, eliminating the initial stabilisation process, which can generally slow start-up 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 set-up, and utilisation to enable more flexible and faster production. The new 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. However, to achieve those benefits they can't accept any compromises in the liquid analytical instrumentation that is inserted into the bioreactors,' said Michael Francis at Emerson Automation Solutions. "Our 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."
The Rosemount 550pH sensor is an electrochemical, fully disposable device with sensor stability of less than 0.005 pH change per day, verified by extensive testing. In a field marked by unstable sensors, the new sensor provides up to 10 times enhanced stability and requires no maintenance or calibration after initial one-point standardisation.
Since the sensor 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. The new sensor is packaged with its own calibration fluid, giving it a two-year shelf life. Wet, one-point standardisation before start-up means that the sensor¹s 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.