Method for sterilizing water-filled devices

Patent metadata

Field	Value
Publication number	US-11833258-B2
Application number	US-201816638671-A
Country	US
Kind code	B2
Filing date	Aug 16, 2018
Priority date	Aug 17, 2017
Publication date	Dec 5, 2023
Grant date	Dec 5, 2023

Abstract

The present disclosure relates to a method of steam-sterilizing liquid-filled medical devices, e.g., filtration and/or diffusion devices like ultrafilters and capillary dialyzers.

First claim

The invention claimed is:

1. A process for steam-sterilizing a liquid-filled medical device, the process comprising the steps of: closing at least one open liquid port of the liquid-filled medical device with a stopper; closing any remaining open ports of the liquid-filled medical device; and steam-sterilizing the closed liquid-filled medical device,
characterized in that the stopper is obtainable by piercing a non-cannulated stopper comprised of an elastomeric material with a cannula having an outer diameter in the range of from about 0.4 mm to about 1.0 mm,
wherein the liquid-filled medical device is a filtration device.

2. The process of claim 1 , wherein the filtration device is a dialyzer.

3. The process of claim 1 , wherein the elastomeric material comprises silicone rubber.

4. The process of claim 1 , wherein the outer diameter the cannula is in the range of from about 0.6 mm to about 0.8 mm.

5. The process of claim 1 , wherein the filtration device is filled with water or physiological saline, and wherein the filtration device comprises hollow fiber membranes.

6. The process of claim 1 , wherein the filtration device comprises hollow fiber membranes and particulate material.

7. The process of claim 6 , wherein the particulate material is located in a space surrounding the hollow fiber membranes.

8. The process of claim 6 , wherein the particulate material comprises polymer beads, carbon particles, or a combination thereof.

9. The process of claim 1 , wherein the elastomeric material is selected from the group consisting of silicone rubber, natural rubber (NR), butadiene rubber (BR), chloroprene rubber (CR), butyl rubber (IIR), styrene-butadiene rubber (SBR), nitrile rubber (NBR), ethylene propylene diene rubber (EPDM), a polyurethane elastomer, and any combination thereof.

10. The process of claim 1 , wherein the liquid-filled medical device is sterilized with steam at a temperature in the range of from about 119° C. to about 121° C. for a time period of at least 20 minutes.

Assignees

• Gambro Lundia Ab

Inventors

• Flieg Ralf
• Freudemann Wolfgang
• Knoer Torsten

Classifications

• A61L2103/15

  Laboratory, medical or dentistry appliances, e.g. catheters or sharps · CPC title

• A61L2103/05

  Living organisms or biological materials · CPC title

• A61L2/12

  Microwaves · CPC title

• A61L2/07 Primary

  Steam · CPC title

• A61M1/1686

  by heat · CPC title