Validation techniques for fluid delivery systems

摘要

A fluid delivery system may include a container that houses a medical fluid, a fluid pressurizing unit, and a fluid transfer set that transfers the medical fluid from the container to the fluid pressurizing unit. To validate the integrity and sterility of the fluid delivery system, the system may undergo testing protocols to evaluate the susceptibility of the system to pathogenic ingress, chemical degradation, and/or fluid cross-contamination between patient fluid delivery procedures. The testing protocols may help ensure that delivery system components used during multiple different fluid delivery procedures perform as well as if the components were replaced after each fluid delivery procedure.

主权项

1. A method comprising:
providing a fluid delivery system that includes a medical fluid container, a fluid pressurizing unit, and a fluid transfer set, wherein the fluid transfer set is connected to transfer a fluid from the medical fluid container to the fluid pressurizing unit; drawing the fluid from the medical fluid container, through the fluid transfer set, and into the fluid pressurizing unit so that the fluid transfer set and fluid pressurizing unit are filled with the fluid; placing a discharge outlet of the fluid pressurizing unit in fluid communication with a fluid reservoir containing a tracking fluid, wherein the tracking fluid contains a tracking agent, and wherein the fluid reservoir is closed so that the fluid pressurizing unit cannot draw the fluid from the medical fluid container and discharge the fluid into the fluid reservoir; operating the fluid pressurizing unit so as to pressurize a portion of the fluid in the fluid pressurizing unit; extracting one or more samples of the fluid from at least one of the medical fluid container, the fluid transfer set, and the fluid pressurizing unit; and analyzing the one or more samples to determine a concentration of the tracking agent in the at least one of the medical fluid container, the fluid transfer set, and the fluid pressurizing unit.