Filtration system for preparation of fluids for medical applications

Patent metadata

Field	Value
Publication number	US-10926016-B2
Application number	US-201715474849-A
Country	US
Kind code	B2
Filing date	Mar 30, 2017
Priority date	Apr 7, 2006
Publication date	Feb 23, 2021
Grant date	Feb 23, 2021

Abstract

A system that fills multiple containers includes a filter with an inlet port and multiple outlet ports. The outlet ports are pre-attached to containers by respective filling lines of each container. Each container has an interior and each of the respective filling lines is connected to a respective container interior. All of the respective filling lines are sealed to the outlet ports and the containers such that the container interiors are isolated from an external environment except the inlet port, via the filter, forming a combined interior volume which is sterile. The system can produce batches of multiple sterile containers with sterile medicament in the containers.

First claim

The invention claimed is:

1. A method of filling multiple empty containers with a concentrated dialysate fluid, each of the multiple empty containers having a first volume, the method comprising:
providing a filter with an inlet port and multiple outlet ports;
sealingly attaching each of the multiple outlet ports of the filter to a respective one of the multiple empty containers to form a combined internal volume that includes an interior of the multiple empty containers, the interior of the filter, and the multiple outlet ports, the combined internal volume being sealed from an external environment;
after the attaching, sterilizing the filter and the multiple empty containers simultaneously to sterilize said combined internal volume;
after the sterilizing, passing through the filter and into each of the multiple empty containers a second volume of the concentrated dialysate fluid that is less than the first volume, wherein the first volume is a quantity that permits addition of water to dilute the second volume of the concentrated dialysate fluid into dialysate fluid;
measuring a conductivity of the concentrated dialysate fluid to determine an actual concentration of the concentrated dialysate fluid;
calculating an amount of water needed to dilute the second volume of the concentrated dialysate fluid to a final concentration based on the measured conductivity of the concentrated dialysate fluid; and
recording the calculated amount of water needed on a data storage device of at least one of the containers.

2. The method according to claim 1 , further comprising:
breaking a connection between the filter and each of the multiple containers while simultaneously sealing each broken connection.

3. The method according to claim 2 , further comprising:
halting the passing of the concentrated dialysate fluid through the filter when a fill condition is satisfied.

4. The method according to claim 2 , further comprising:
testing integrity of the filter after the multiple containers are sealed.

5. The method according to claim 4 , wherein the testing includes measuring an input pressure decay versus a time profile following forcing of the concentrated dialysate fluid through the filter at a specified rate, and comparing the measured input pressure decay to a predicted profile for an intact filter membrane.

6. The method according to claim 1 , further comprising:
recording in the data storage device the measured conductivity or a value derived therefrom.

7. The method according to claim 6 , further comprising:
reading data from the data storage device; and
determining an amount of purified water to mix with the concentrated dialysate fluid based on said data.

8. The method according to claim 2 , further comprising:
recording in the data storage device the measured conductivity or a value derived therefrom.

9. The method according to claim 8 , further comprising:
reading data from the data storage device; and
determining an amount of purified water to mix with the concentrated dialysate fluid based on said data.

Assignees

• Nxstage Medical Inc

Inventors

• Burbank Jeffrey H
• Brugger James M

Classifications

• B01D61/146

  comprising multiple ultrafiltration steps · CPC title

• A61M1/1656

  Apparatus for preparing dialysates · CPC title

• A61M2205/273

  preventing reuse, e.g. of disposables · CPC title

• A61M1/1672

  using membrane filters, e.g. for sterilising the dialysate · CPC title

• C02F1/444

  by ultrafiltration or microfiltration · CPC title