Method and machine for producing sterile solution product bags

Patent metadata

Field	Value
Publication number	US-11623773-B2
Application number	US-202117327527-A
Country	US
Kind code	B2
Filing date	May 21, 2021
Priority date	Jan 22, 2016
Publication date	Apr 11, 2023
Grant date	Apr 11, 2023

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.

First claim

What is claimed is:

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 having a head at a proximal end thereof comprising a fitting, 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;
coupling the fitting of the tube to a fitting fixture of the filling machine, thereby sealingly engaging a nozzle of the filling machine in fluid communication with a fluid source to the head of the tube;
filling the bag assembly with a fluid from the fluid source 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.

2. The method of claim 1 , wherein sealing the fluid passageway includes pressing the passageway closed.

3. 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.

4. 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.

5. 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.

6. The method of claim 1 , wherein performing the integrity test includes performing at least one of a bubble test and a pressure degradation test.

7. The method of claim 1 , wherein performing the integrity test includes sensing a pressure applied to the filter assembly with a pressure sensor.

8. The method of claim 1 , wherein performing the integrity test includes assessing the filter assembly for structural flaws.

9. The method of claim 1 , wherein passing the fluid through the filter assembly includes passing the fluid through a sterilizing grade filter.

10. The method of claim 1 , wherein passing the fluid through the filter assembly includes passing the fluid through a 0.2 micron filter.

11. The method of claim 1 , wherein performing the integrity test on the filter assembly comprises performing the integrity test on the filter assembly after cutting the stem.

12. The method of claim 1 , wherein performing the integrity test on the filter assembly comprises performing the integrity test on the filter assembly after sealing the stem.

Assignees

• Baxter Int
• Baxter Healthcare Sa

Inventors

• Bomgaars Grant Anthony
• Ranalletta Joseph Vincent
• Ding Yuanpang Samuel
• Lo Ying-Cheng
• Pasmore Mark Edward
• Sadowski Michael Joseph
• Hristakos Anastasios
• Dudar Thomas Edward
• Krause Bernd

Classifications

• B01D65/10

  Testing of membranes or membrane apparatus; Detecting or repairing leaks · CPC title

• B01D63/08

  Flat membrane modules · CPC title

• B65B43/60

  rotatable · CPC title

• B65B31/021

  the containers or wrappers being interconnected · CPC title

• B65B3/28

  by weighing · CPC title