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:
applying one or more pathogens to a connection located between a medical fluid container and a fluid pressurizing unit, wherein a fluid transfer set is configured to transfer a fluid from the medical fluid container to the fluid pressurizing unit; activating the fluid pressurizing unit multiple times to discharge multiple portions of fluid from the fluid pressurizing unit; obtaining a plurality of samples from the multiple portions of fluid discharged from the fluid pressurizing unit, each of the plurality of samples comprising a different portion of fluid; and analyzing the plurality of samples to determine a concentration level of the pathogen in the plurality of samples.