US 12,292,487 B2
Cleaning of a fluid path for hyperpolarization of a pharmaceutical product
Jan Ardenkjær-Larsen, Frederiksberg C (DK)
Assigned to Danmarks Tekniske Universitet, Kgs. Lyngby (DK)
Appl. No. 17/436,352
Filed by Danmarks Tekniske Universitet, Kgs. Lyngby (DK)
PCT Filed Mar. 4, 2020, PCT No. PCT/EP2020/055639
§ 371(c)(1), (2) Date Sep. 3, 2021,
PCT Pub. No. WO2020/178310, PCT Pub. Date Sep. 10, 2020.
Claims priority of application No. 19160525 (EP), filed on Mar. 4, 2019.
Prior Publication US 2022/0163608 A1, May 26, 2022
Int. Cl. G01R 33/28 (2006.01); G01R 33/30 (2006.01)
CPC G01R 33/282 (2013.01) [G01R 33/30 (2013.01)] 16 Claims
OG exemplary drawing
 
1. A method for ensuring sterility or low bioburden of a reusable fluid path system for hyperpolarization of a pharmaceutical product, the fluid path system comprising an inlet tube having a first inlet tube end adapted for communicating with a fluid vessel and a second inlet tube end adapted for communicating with a vial, for holding the pharmaceutical product during hyperpolarization; and an outlet tube having a first outlet tube end configured for receiving the vial and a second outlet tube end for connecting to a receiving vessel, while said fluid path system is continuously at least partly contained by a polarizer during multiple consecutive uses; the method comprising:
sealing the second inlet tube end with the first outlet tube end;
fluidly connecting a medium vessel to the first inlet tube end;
fluidly connecting a collector vessel to the second outlet tube end;
transferring a cleaning medium from the medium vessel into the reusable fluid path and subjecting an inside of the reusable fluid path system to cleaning conditions selected for ensuring sterility or low bioburden;
ejecting the cleaning medium from the reusable fluid path system into a collector vessel; and
drying the reusable fluid path system.