Sterile container comprising sterile barrier separate from primary package and method of manufacturing sterile container

Patent metadata

Field	Value
Publication number	US-10722428-B2
Application number	US-201715692092-A
Country	US
Kind code	B2
Filing date	Aug 31, 2017
Priority date	Sep 19, 2016
Publication date	Jul 28, 2020
Grant date	Jul 28, 2020

Abstract

A sterile container including at least one hollow fiber filter module, especially dialyzer, which is accommodated in a hermetically sealed holding volume of a primary package and includes a blood compartment delimited by a blood inlet opening and a blood outlet opening, wherein a plurality of hollow fiber filter modules is arranged in the primary package and the sterile barrier of the blood compartment of each hollow fiber filter module inside the primary package is implemented by caps which close the blood inlet opening and the blood outlet opening of each hollow fiber filter module. A method of manufacturing such sterile container is also disclosed.

First claim

The invention claimed is:

1. A sterile container comprising:
a primary package having a hermetically sealed holding volume;
a plurality of hollow fiber filter module accommodated in the hermetically sealed holding volume, each of the plurality of hollow fiber filter modules including: a blood compartment delimited by a blood inlet opening and a blood outlet opening, and respective caps including a respective first cap which closes the blood inlet opening and a respective second cap which closes the blood outlet opening to form a sterile barrier for the blood compartment.

2. The sterile container according to claim 1 , wherein at least one of the first cap is connected to the blood inlet opening or the second cap is connected to the blood outlet opening via a frictional connection.

3. The sterile container according to claim 1 , wherein the primary package is in the form of a puncture-proof film that prevents perforations from being introduced to the primary package.

4. The sterile container according to claim 3 , wherein an oxygen absorber is introduced to the primary package or to the holding volume so as to avoid oxidative material stress.

5. The sterile container according to claim 4 , wherein the oxygen absorber is integrated in the puncture-proof film.

6. The sterile container according to claim 4 , wherein the primary package is contracted due to oxygen absorption by the oxygen absorber and is adjacent to the plurality of hollow fiber filter modules disposed therein so as to fix the plurality of hollow fiber filter modules against each other.

7. The sterile container according to according to claim 1 , wherein an intermediate layer is interposed in the holding volume between at least two of the plurality of hollow fiber filter modules.

8. The sterile container according to according to claim 1 , further comprising:
a secondary package in the form of a container surrounding the primary package, the secondary package being relatively firm as compared to the primary package.

9. The sterile container according to claim 8 , further comprising:
an intermediate pad interposed between the secondary package and the primary package to dampen impacts acting on the plurality of hollow fiber filter modules.

10. The sterile container according to claim 1 , wherein each of the plurality of hollow filter modules is a dialyzer.

11. A method of producing a sterile container according to claim 1 , the method comprising:
arranging the plurality of hollow fiber filter modules in the primary package;
closing the primary package while forming the hermetically sealed holding volume;
absorbing oxygen present in the closed holding volume with an oxygen absorber;
sterilizing the closed primary package using gamma radiation; and
introducing the primary package including the hollow fiber filter modules packaged therein to a secondary package.

12. The method according to claim 11 , wherein the holding volume of the primary package is reduced due to the oxygen absorption so that the hollow fiber filter modules accommodated therein are fixed in a stable position by at least one of contacting the primary package or by mutual contact.

Assignees

• Braun Avitum Ag

Inventors

• Burkert Sina

Classifications

• A61M1/1682 Primary

  both machine and membrane module, i.e. also the module blood side · CPC title

• B65B55/19

  by adding materials intended to remove free oxygen or to develop inhibitor gases, e.g. vapour phase inhibitors · CPC title

• B65B55/16

  by irradiation · CPC title

• B65B55/20

  Embedding contents in shock-absorbing media, e.g. plastic foam, granular material · CPC title

• B65B2220/16

  Packaging contents into primary and secondary packaging · CPC title