Single use sensors: Sensing a need for change

Single use sensors are vital for the advancement of bioprocess monitoring and control. The application of process analytical technology is gaining momentum to drive process control and improve process consistency. The data is being combined into MVDA parametric models to apply real time release strategies with the intent to reduce the QC burden. Progress has been hindered by inadequate sensing tools that struggle to meet the user requirements. End users have resorted to using conventional probes via insertion ports with separate steam sterilization. Some of the existing single use sensor offerings have been plagued with inaccuracy , drift and reliability concerns that have tainted the confidence in the sensor arena. This situation has been compounded by end users not providing clear expectations for SU sensor performance. This talk will define the user specifications for single use sensors that will include case studies for key areas including pH, pressure, and flow. This will be include a discussion on guidance for GMP implementation and calibration testing. Encouraging developments of improved sensor technology are emerging. Case study examples of potential new single use technology sensors currently in development will be presented. This includes solid state pH, ultrasonic sensing for flow and single use NIR approaches for analyte monitoring. Applying these technologies to a number of bioprocess applications will be described. This includes disposable sensor applications for the next generation continuous mAb production enabled by single use technology