# US 11,443,866 B2 · Generator columns for elution systems loaded with pre-charged matrix > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,443,866 B2 - Document ID: US11443866B2 - Status: Granted - Kind: B2 - Application number: 16/799,154 - Filed: 2020-02-24 - Published: 2021-08-26 - Granted: 2022-09-13 - Earliest claimed: 2020-02-24 - Assignees: Jubilant Draximage Inc. - Applicants: Jubilant Draximage Inc. - Inventors: Robert William Riddoch - Web page: https://patentgrep.com/patent/US11443866B2 ## CPC - G21G 4/06: characterised by constructional features - A61L 2/20: Gaseous substances, e.g. vapours - B01D 15/20: relating to the conditioning of the sorbent material - B01D 15/22: relating to the construction of the column - B01D 15/361: {Ion-exchange} - G21G 1/0005: {Isotope delivery systems (use of radioisotopes as tracers G21H5/02)} - A61L 2/07: Steam - G21G 2001/0031: {Rubidium} - G21G: CONVERSION OF CHEMICAL ELEMENTS; RADIOACTIVE SOURCES (applications of radiation in general G21H5/00; handling particles, e.g. neutrons, or electromagnetic radiation not otherwise provided for G21K) - 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) - B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28) ## Abstract The present disclosure relates in general to nuclear medicine and generators for the production of radiopharmaceuticals for medical use. In particular, present disclosure relates to a generator column that resists high heat such as depyrogenation and sterilization. This allows some steps of the preparation of the column to be performed in a non-sterile environment. This also allows the generator column to be reusable. The present disclosure further describes methods for the preparation of a generator where a parent radioisotope is charged on the column matrix before or after the matrix is loaded in the column. ## Claims ### Claim 1 A generator column for eluting a radioactive solution comprising a desired radioisotope that is generated by the column and an eluant that has eluted through the column, wherein the column is prepared by the following steps: a. charging a parent radioisotope on a particulate ion exchange matrix, wherein the parent radioisotope is able to decay into the desired radioisotope; and b. loading the column with the charged matrix resulting from step (a). ### Claim 2 (depends on 1) The generator column of claim 1, further including a pre-loading step (c) that is performed before the loading step (b), and that comprises partially loading the column with a particulate ion exchange matrix that is not charged with a parent radioisotope. ### Claim 3 (depends on 1) The generator column of claim 1, wherein the column is made of a heat resistant material. ### Claim 4 (depends on 3) The generator column of claim 3, wherein the heat resistant material has the ability to resist to a heat of about 300° C. ### Claim 5 (depends on 3) The generator column of claim 3, wherein the heat resistant material comprises stainless steel, titanium tin, nickel, cadmium, tungsten, copper, aluminum, or any combination thereof. ### Claim 6 (depends on 5) The generator column of claim 5, wherein the heat resistant material comprises stainless steel. ### Claim 7 (depends on 1) The generator column of claim 1, further comprising a step of depyrogenation of the column, wherein the step of depyrogenation is performed before any matrix is loaded in the column. ### Claim 8 (depends on 7) The generator column of claim 7, wherein the step of depyrogenation comprises dry heating at a temperature of about 210° C. to about 280° C., for a period from about 3 hours to about 12 hours. ### Claim 9 (depends on 8) The generator column of claim 8, wherein the temperature is about 210° C. and the period is about 3 hours. ### Claim 10 (depends on 8) The generator column of claim 8, wherein the temperature is 260±5° C., and the period is from 3 hours to 6 hours. ### Claim 11 (depends on 1) The generator column of claim 1, wherein the particulate ion exchange matrix comprises alpha-stannic acid, zirconium oxide, titanium oxide, aluminum oxide, silica gel, other inorganic, organic ion exchange matrices, or any combination thereof. ### Claim 12 (depends on 1) The generator column of claim 1, wherein the parent radioisotope is strontium-82, and the desired radioisotope is rubidium-82. ### Claim 13 (depends on 1) The generator column of claim 1, wherein the column has an inlet port, a body, and an outlet port, and wherein the body has a length of about 3.0 cm to about 8.0 cm, an internal diameter of about 4 mm to about 12 mm, and a wall having a thickness of about 0.4 mm to about 1.2 mm. ### Claim 14 (depends on 1) The generator column of claim 1, further comprising a step of performing a phosphoric acid treatment of the column, wherein the step of phosphoric acid treatment is performed before any matrix is loaded in the column, and wherein the phosphoric acid treatment comprises soaking the column in a phosphoric acid solution having a concentration of about 5% to about 85%. ### Claim 15 (depends on 1) The generator column of claim 1, further comprising a step of performing a passivation treatment of the column wherein the step of passivation is performed before any matrix is loaded in the column and wherein the passivation treatment comprises soaking the column in a nitric acid solution, a citric acid solution, or a solution with nitric acid and sodium dichromate. ### Claim 16 (depends on 1) The generator column of claim 1, wherein the generator column is installed into a generator compartment, and the generator compartment and the column installed therein are sterilized. ### Claim 17 (depends on 16) The generator column of claim 16, wherein the sterilization is performed with steam at a temperature of about 110° C. to about 150° C., for a period that is from about 20 minutes to about 60 minutes. ### Claim 18 (depends on 17) The generator column of claim 17, wherein the sterilization is performed with steam at a temperature is about 121° C. ### Claim 19 (depends on 1) The generator column of claim 1, wherein the generator column was used in an elution system for the elution of the radioactive solution, and wherein the column is cleaned by a cleaning process that includes the steps of: a. emptying the used column by removing the used matrix therefrom; b. sterilizing the empty column resulting from step (a); and c. loading a new particulate ion exchange matrix into the sterilized column resulting from step (b). ### Claim 20 (depends on 19) The generator column of claim 19, wherein the sterilization step (b) uses steam at a temperature of about 110° C. to about 150° C., for a period of about 20 minutes to about 60 minutes.