# US 2021/0276740 A1 · Method and machine for producing sterile solution product bags > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2021/0276740 A1 - Document ID: US20210276740A1 - Status: Published application - Kind: A1 - Application number: 17/327,527 - Filed: 2021-05-21 - Published: 2021-09-09 - Earliest claimed: 2016-01-22 - Assignees: Baxter International Inc.; Baxter Healthcare S.A. - Applicants: Baxter International Inc.; Baxter Healthcare SA - Inventors: Grant Anthony Bomgaars; Joseph Vincent Ranalletta; Yuanpang Samuel Ding; Ying-Cheng Lo; Mark Edward Pasmore; Michael Joseph Sadowski; Anastasios Hristakos; Thomas Edward Dudar; Bernd Krause - Web page: https://patentgrep.com/patent/US20210276740A1 ## CPC - B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like} - B01D 63/08: Flat membrane modules - B01D 65/10: Testing of membranes or membrane apparatus; Detecting or repairing leaks - B65B 3/28: by weighing - B65B 31/024: {specially adapted for wrappers or bags (B65B31/021, B65B31/022 take precedence)} - B65B 43/60: rotatable - B65B 51/30: Devices, e.g. jaws, for applying pressure and heat, e.g. for subdividing filled tubes - B65B 57/00: Automatic control, checking, warning, or safety devices (registering wrapping or container-forming material fed from rolls B65B41/18) - B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00) - 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 A method of providing a plurality of filled product bags of sterile fluid includes positioning a bag assembly onto a filling machine. The bag assembly includes a tube, a filter assembly, bladders, and stems. A stem is attached to a bladder, forms a fluid passageway, fluidly connects to the tube, and provides fluid communication into the bladders. The method includes fluidly coupling an inlet of the filter assembly to a connection line in fluid communication with a fluid source, and filling the bag assembly with a fluid. Filling the bag assembly includes passing the fluid through the filter assembly, the fluid passageway, and into the bladder. The method includes sealing the fluid passageway at a location between the tube and the bladders. The method includes cutting the stem to form a partially filled product bag having the sealed passageway. The method includes performing an integrity test on the filter assembly. ## Claims ### Claim 1 A method of providing a plurality of filled product bags of sterile fluid, the method comprising: positioning a bag assembly onto a filling machine, wherein the bag assembly includes a tube, a filter assembly in fluid communication with the tube, a plurality of bladders, and a plurality of stems, wherein a stem is attached to a bladder, forms a fluid passageway, fluidly connects to the tube, and provides fluid communication into an interior of the plurality of bladders; fluidly coupling an inlet of the filter assembly to a connection line in fluid communication with a fluid source; filling the bag assembly with a fluid to create an at least partially filled bag assembly, wherein filling the bag assembly includes passing the fluid through the filter assembly, the fluid passageway of the stem, and into the bladder; after filling, sealing the fluid passageway of the stem of the at least partially filled bag assembly at a location between the tube and the bladders, thereby creating a sealed passageway in the stem; after sealing the stem, cutting the stem to form an at least partially filled product bag having the sealed passageway; and performing an integrity test on the filter assembly. ### Claim 2 (depends on 1) The method of claim 1, wherein sealing the fluid passageway includes pressing the passageway closed. ### Claim 3 (depends on 1) The method of claim 1, further including correlating an integrity of the contents of the at least partially filled product bag to an integrity of the filter assembly based on an outcome of the integrity test. ### Claim 4 (depends on 1) The method of claim 1, wherein cutting the stem includes severing the stem with a blade to irreversibly separate the at least partially filled product bag from a remainder of the bag assembly. ### Claim 5 (depends on 1) The method of claim 1, further including measuring an amount of fluid in the bladder of the bag assembly with a load cell, and discontinuing filling the bag assembly when the bladder contains a predetermined amount of fluid. ### Claim 6 (depends on 1) The method of claim 1, wherein performing the integrity test includes performing at least one of a bubble test and a pressure degradation test. ### Claim 7 (depends on 1) The method of claim 1, wherein performing the integrity test includes sensing a pressure applied to the filter assembly with a pressure sensor. ### Claim 8 (depends on 1) The method of claim 1, wherein performing the filter integrity test includes assessing the filter assembly for structural flaws. ### Claim 9 (depends on 1) The method of claim 1, wherein passing the fluid through the filter assembly includes passing the fluid through a sterilizing grade filter. ### Claim 10 (depends on 1) The method of claim 1, wherein passing the fluid through the filter assembly includes passing the fluid through a 0.2 micron filter. ### Claim 11 A method of providing filled product bags of sterile fluid using a machine, the method comprising: loading a plurality of product bags onto a machine, a product bag including a bladder and a stem fluidly connected to an opening of the bladder; coupling the machine to a connection line in fluid communication with a fluid source; at least partially filling the bladder associated with the plurality of product bags by pumping fluid from the fluid source and through the connection line, a filter assembly disposed in-line with the stem, the stem, and into the bladder, thereby creating one or more at least partially filled product bags; sealing the stem of the one or more at least partially filled product bags to create a seal at a location between the connection line and the bladder, thereby creating one or more at least partially filled and sealed product bags; and after sealing the stem, cutting the stem between the filter assembly and at least a portion of the seal to form a sealed stem of the one or more at least partially filled product bags. ### Claim 12 (depends on 11) The method of claim 11, wherein filling the bladder includes passing the fluid through the filter assembly, the filter assembly including a sterilizing grade filter. ### Claim 13 (depends on 11) The method of claim 11, wherein sealing includes sealing the stem of the one or more at least partially filled product bags at a location downstream from the filter assembly to create the seal. ### Claim 14 (depends on 11) The method of claim 11, wherein cutting includes cutting the stem between the filter assembly and at least a portion of the seal to separate a portion of the stem from a partially filled and sealed product bag thereby creating a sealed stem connected to the partially filled and sealed product bag. ### Claim 15 (depends on 14) The method of claim 14, wherein cutting includes cutting the stem to create the sealed stem connected to the partially filled and sealed product bag and an opposite sealed end. ### Claim 16 (depends on 11) The method of claim 11, wherein at least partially filling the bladder includes drawing the fluid from the fluid source through a fill tube, and dispensing the fluid from the fill tube through the connection line and into the stem. ### Claim 17 (depends on 11) The method of claim 11, wherein creating the one or more at least partially filled product bags includes measuring an amount of fluid in the bladder with a load cell, and discontinuing filling the bladder when the bladder contains a predetermined amount of fluid. ### Claim 18 (depends on 11) The method of claim 11, further comprising performing an integrity test by performing at least one of a bubble test and a pressure degradation test. ### Claim 19 (depends on 18) The method of claim 18, wherein performing the integrity test includes sensing a pressure applied to the filter assembly with a pressure sensor. ### Claim 20 (depends on 11) The method of claim 11, wherein sealing the stem includes pressing a passageway defined in the stem closed.