Most pH adjustment process steps in single-use biomanufacturing require manual manipulation of the product and vessel, including off-line sampling, pH measurement, and the addition of acid and base. Manual processes increase risk to the process from operator error, microbial or virus contamination, pH overshoot and time-to-process deviations. A lack of electronic batch records and data storage and trending in manual processing introduces further complications in documentation and regulatory compliance.
The XDUOTM (Xcellerex Disposable Unit Operation) single-use mixing system is enabled with powerful onboard automation that is capable of controlling precise and accurate pH adjustment and capturing process data to a historian platform. The following study details how integrating a robust single-use mixing system with an onboard automation platform enables process excellence in the following ways: