Method for filling a medical packaging, filling device, and medical packaging formed as a pouch

Patent metadata

Field	Value
Publication number	US-11548665-B2
Application number	US-201816646837-A
Country	US
Kind code	B2
Filing date	Sep 21, 2018
Priority date	Sep 22, 2017
Publication date	Jan 10, 2023
Grant date	Jan 10, 2023

Abstract

The invention relates to a method and to a device for filling a medical packaging formed as a pouch. Preferably, the packaging is filled with liquid via a port, wherein the port is aerated with a protective gas, such as nitrogen, for example, during filling According to the invention, prior to filling with liquid, the packaging is filled with an inert gas, such as nitrogen, for example, which then provides the headspace of the filled and closed pouch. This results in a particularly low oxygen content in the headspace of the pouch.

First claim

The invention claimed is:

1. A method for filling a medical packaging, wherein the packaging is filled with a liquid via an entrance and the entrance, during the filling process, is provided in a protective atmosphere, wherein the packaging, prior to being filled with the liquid, is filled with an inert gas by means of a gas nozzle, wherein, for the provision of the protective atmosphere, at least one opening extends, at least in some sections, around the gas nozzle.

2. The method as claimed in claim 1 , wherein the packaging is filled with a volume of the inert gas which corresponds to at least the volume of a gas volume remaining after the filling of the packaging.

3. The method as claimed in claim 2 , wherein the packaging is filled with a volume of the inert gas which corresponds to at least the volume of a gas volume remaining after the filling of the packaging with a volume of the inert gas of 15 to 30 ml.

4. The method as claimed in claim 1 , wherein the packaging, prior to being filled with the inert gas, is evacuated.

5. The method as claimed in claim 4 , wherein the packaging, prior to being filled with the inert gas, is evacuated, by application of a pressure of below 100 mbar.

6. The method as claimed in claim 1 , wherein the packaging is filled with the liquid using a filling head, wherein the filling head has a gas nozzle and a liquid nozzle, and the packaging, after having been filled with the inert gas, is transferred from the gas nozzle to the liquid nozzle.

7. The method as claimed in claim 1 , wherein the entrance, upon transfer of the packaging from the gas to the liquid nozzle, is shut off and/or in that the packaging, after having been filled with the liquid, is moved to a sealing device, in which the entrance is sealed.

8. The method as claimed in claim 1 , wherein the entrance is provided by a port, wherein the port is shut off by two opposing foil walls of the packaging being clamped shut around a welded region of the port.

9. The method as claimed claim 1 , wherein the packaging, after having been filled with the liquid, is moved to a seal and is sealed by mounting of the seal onto the port, and/or in that the port and/or the seal, prior to and/or upon the mounting of the seal, is gassed with a protective gas.

10. The method as claimed in claim 1 , wherein, after the packaging has been filled with the liquid up to sealing of the entrance by mounting of the seal, the entrance of the packaging is shut off, and/or in that the entrance, at least from the filling of the packaging with the inert gas up to the filling with the liquid, is provided in the protective atmosphere.

11. The method as claimed in claim 1 , wherein the packaging is filled in hanging suspension, and/or in that the packaging, prior to being filled, under the application of a vacuum is checked for leak-tightness.

12. The method as claimed in claim 1 , wherein after the filling of the packaging, liquid present at a liquid nozzle is withdrawn, and/or in that the liquid is withdrawn such that, after the withdrawal of the liquid, a rim of the liquid nozzle is still in contact with the liquid, and/or in that the liquid nozzle is blown against from below with a protective gas.

13. The method as claimed in claim 1 , wherein the liquid is an oxygen-sensitive medical liquid to be administered intravenously, and/or in that the gas volume in the sealed packaging has an oxygen content of less than 1% by volume, and/or in that the packaging is enclosed and thermally sterilized with a secondary packaging comprising an oxygen barrier.

14. A device for a method for filling a medical packaging configured as a pouch, as claimed in claim 1 , comprising a filling head having a gas nozzle for feeding an inert gas into the packaging and having a liquid nozzle for filling the packaging, wherein at least one opening for the provision of a protective atmosphere extends, at least in some sections, around the liquid nozzle and/or the gas nozzle.

15. The device as claimed in claim 14 , wherein extending around the liquid nozzle and/or the gas nozzle are a plurality of openings for the provision of the protective atmosphere, wherein the openings extend in a circle around the gas nozzle and/or the liquid nozzle.

16. The device as claimed in claim 14 , wherein the gas nozzle and/or the liquid nozzle is or are arranged in a depression, wherein the gas nozzle and/or the liquid nozzle has or have an opening distanced from a rim of the depression, and/or in that the liquid nozzle and/or the gas nozzle protrudes or protrude within the depression, wherein the opening is arranged around the protruding liquid nozzle and/or the protruding gas nozzle.

17. Use of a device as claimed in claim 14 for filling a medical packaging configured as a pouch.

18. A pharmaceutical product comprising a medical packaging configured as a pouch, producible or produced with a method as claimed in claim 1 , wherein the medical packaging is filled with a liquid containing an active agent or with a liquid for parenteral feeding, and has a gas volume which has an oxygen content of less than 1% by volume.

19. The pharmaceutical product as claimed in claim 1 , wherein the packaging is arranged in a secondary packaging comprising an oxygen barrier.

20. The pharmaceutical product as claimed in claim 19 , wherein the oxygen barrier is a metal foil.

Assignees

• Fresenius Kabi Deutschland Gmbh

Inventors

• Wittorf Joern
• Wegner Gerald
• Klan Witali
• Ruffer Marius
• Faber Stefan
• Kosatsch Denis
• Zandnia Behnam

Classifications

• A61J1/1462

  Containers with provisions for hanging, e.g. integral adaptations of the container (accessories for hanging the container A61M5/1414) · CPC title

• A61J1/1481

  with connection retaining means, e.g. thread or snap-fit · CPC title

• A61J1/1431

  Permanent type, e.g. welded or glued · CPC title

• A61J1/1468

  Containers characterised by specific material properties · CPC title

• B65B3/003 Primary

  Filling medical containers such as ampoules, vials, syringes or the like · CPC title