About This Project

 

B. Braun Medical

APEX TPN Compounding System

B. Braun Medical has integrated both macro- and micro-fluidic handling into one TPN compounding system. The APEX Compounding System is designed to provide exceptional precision in delivering micro ingredients while increasing compounding speed. Key Tech was engaged to invent, design, develop and verify a critical dual peristaltic pumping system to meet these goals in outpatient hospital care markets. Leveraging early user observations and collaborating on a product requirements document, Key Tech designed a user-centric device with hardware complying with IEC 60601-1 and embedded firmware complying with IEC 62304. In parallel, B. Braun designed and developed the transfer set. A cross-functional team managed the pump/transfer set interface. Key successes include characterizing and optimizing integrated system performance, reducing solution cross contamination and user errors, and developing a smart bubble detection algorithm that allows the pump to continue when measured bubble volumes are insignificant. This initiative benefited from persistent and seamless teamwork throughout the development and transition to B. Braun manufacturing, including verification and validation phases.

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