# US 2014/0154671 A1 · Validation techniques for fluid delivery systems > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0154671 A1 - Document ID: US20140154671A1 - Status: Published application - Kind: A1 - Application number: 14/097,867 - Filed: 2013-12-05 - Published: 2014-06-05 - Earliest claimed: 2012-12-05 - Assignees: Bracco Imaging S.P.A. - Applicants: Bracco Imaging S.p.A - Inventors: Robert C. Williams, JR.; Patrice Marchildon - Web page: https://patentgrep.com/patent/US20140154671A1 ## CPC - G01M 3/2853: {for pipe joints or seals (G01M3/30 takes precedence)} - A61L 2/18: Liquid substances - A61L 2/28: Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour - A61M 5/00: Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests (tube connectors, tube couplings, valves or branch units, specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00) - A61M 5/1408: {in parallel, e.g. by manifolds or with sequencing valves} - A61M 5/1413: {Modular systems comprising interconnecting elements} - A61M 5/14232: {Roller pumps} - C12Q 1/18: Testing for antimicrobial activity of a material - C12Q 1/22: Testing for sterility conditions - G01N 31/226: {for investigating the degree of sterilisation} - G01N 33/50: Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing (measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q) - G01N 2013/003: {Diffusion; diffusivity between liquids} - Y10T 436/13: Tracers or tags - G01M: TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract 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. ## Claims ### Claim 1 A method comprising: providing a fluid delivery system that includes a medical fluid container, a fluid pressurizing unit having a discharge outlet, a fluid transfer set, and a discharge line, wherein the fluid transfer set is connected to transfer a fluid from the medical fluid container to the fluid pressurizing unit, and the discharge line is connect to the discharge outlet of the fluid pressurizing unit; filling the discharge line with a tracking agent; establishing a positive pressure that biases the tracking agent in the discharge line toward the fluid pressuring unit; extracting one or more samples of the fluid from at least one of the medical fluid container and the fluid transfer set; 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 and the fluid transfer set. ### Claim 2 (depends on 1) The method of claim 1, further comprising, prior to filling the discharge line with the tracking agent, filling the fluid transfer set and the fluid pressurizing unit with the fluid. ### Claim 3 (depends on 2) The method of claim 2, wherein the fluid comprises saline. ### Claim 4 (depends on 1) The method of claim 1, wherein the fluid pressurizing unit comprises a peristaltic pump. ### Claim 5 (depends on 4) The method of claim 4, wherein the peristaltic pump has a plurality of rollers that are configured to squeeze a compressible tube and convey the fluid from the fluid transfer set out through the discharge outlet, one of the plurality of rollers being positioned to squeeze the compressible tube adjacent the discharge outlet and thereby establish a fluid seal, and wherein filling the discharge line comprises filling the discharge line such that the tracking agent is positioned adjacent to the fluid seal. ### Claim 6 (depends on 5) The method of claim 5, wherein filling the discharge line comprises filling the discharge line such that the tracking agent impinges upon the fluid seal. ### Claim 7 (depends on 1) The method of claim 1, wherein the tracking agent includes one of a dye, a bacterium, and a virus. ### Claim 8 (depends on 7) The method of claim 7, wherein the tracking agent consists essentially of the dye. ### Claim 9 (depends on 1) The method of claim 1, further comprising maintaining the positive pressure that biases the tracking agent in the discharge line toward the fluid pressuring unit for at least 15 minutes prior to extracting the sample of the fluid. ### Claim 10 (depends on 1) The method of claim 1, wherein establishing the positive pressure that biases the tracking agent in the discharge line toward the fluid pressuring unit comprises orienting the discharge line vertically to establish a fluid head pressure. ### Claim 11 (depends on 10) The method of claim 10, wherein the pressure ranges from approximately 0.25 pounds per square inch gauge (psig) to approximately 1 psig. ### Claim 12 (depends on 1) The method of claim 1, wherein the medical fluid container is sized to provide multiple doses of the fluid to multiple different patients. ### Claim 13 (depends on 1) A product validated by the method of claim 1. ### Claim 14 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. ### Claim 15 (depends on 14) The method of claim 14, wherein activating the fluid pressurizing unit multiple times to discharge multiple portions of fluid comprises activating the fluid pressurizing unit a first time to discharge a first portion of fluid, ceasing operation of the fluid pressurizing unit, and activating the fluid pressurizing unit a second time to discharge a second portion of fluid. ### Claim 16 (depends on 14) The method of claim 14, wherein analyzing the plurality of samples comprises combining the plurality of samples to form a pooled sample and determining the concentration level of the pathogen in the pooled sample. ### Claim 17 (depends on 14) The method of claim 14, wherein each of the multiple portions of fluid discharged from the fluid pressurizing unit are drawn from a same medical fluid container or set of medical fluid containers connected to the fluid transfer set. ### Claim 18 (depends on 14) The method of claim 14, wherein activating the fluid pressurizing unit multiple times to discharge multiple portions of fluid comprises activating the fluid pressurizing unit a sufficient number of times to empty the medical fluid container and thereby provide an empty medical fluid container, and further comprising replacing the empty medical fluid container with a replacement medical fluid container and further activating the fluid pressurizing unit multiple times to draw fluid from the replacement medical fluid container and discharge multiple portions of fluid from the fluid pressurizing unit. ### Claim 19 (depends on 18) The method of claim 18, further comprising, during replacement of the empty medical fluid container with the replacement medical fluid container, applying the pathogen to the connection located between the replacement medical fluid container and the fluid pressurizing unit. ### Claim 20 (depends on 14) The method of claim 14, wherein at least one of the plurality of samples is obtained from fluid drawn from the medical fluid container and discharged during a first activation of the fluid pressurizing unit, and at least one other of the plurality of samples is obtained from another medical fluid container after replacement of the medical container. ### Claim 21 (depends on 14) The method of claim 14, further comprising, subsequent to applying the pathogen, assembling a fluid delivery system by at least placing the fluid transfer set in fluid communication with the fluid pressurizing unit and the medical fluid container so as to establish fluid communication between the medical fluid container and the fluid pressurizing unit via the fluid transfer set. ### Claim 22 (depends on 14) The method of claim 14, wherein the fluid transfer set comprises a polymeric tube that extends from a proximal end to a distal end and includes a bottle spike positioned on the proximal end of the polymeric tube and a mechanical connector positioned on the distal end of the polymeric tube, and wherein the pressurizing unit comprises a peristaltic pump. ### Claim 23 (depends on 14) The method of claim 14, wherein the connection located between the medical fluid container and the fluid pressurizing unit comprises at least one of a connection between the medical fluid container and the fluid transfer set and a connection between the fluid transfer set and the fluid pressurizing unit. ### Claim 24 (depends on 14) The method of claim 14, wherein the medical fluid container is sized to provide multiple doses of the fluid to multiple different patients. ### Claim 25 (depends on 14) A product validated by the method of claim 14.