Insertable components for single-use containers

Patent metadata

Field	Value
Publication number	US-12384995-B2
Application number	US-202017070060-A
Country	US
Kind code	B2
Filing date	Oct 14, 2020
Priority date	Dec 20, 2017
Publication date	Aug 12, 2025
Grant date	Aug 12, 2025

Abstract

An assembly includes a single-use sterilizable bag for containing a biological material. The single-use sterilizable bag has at least one insertion opening; and at least one insertable component configured to be inserted into the single-use sterilizable bag via the at least one insertion opening. The at least one insertable component includes a positioning unit for positioning the insertable component with respect to the single-use sterilizable bag and at least one of a processing unit and a sensing unit for handling the biological material.

First claim

What is claimed is:

1. An assembly comprising:
a single-use sterilizable bag for containing a biological material, the single-use sterilizable bag having at least one insertion opening; and
at least one insertable component configured to be inserted entirely into the single-use sterilizable bag via the at least one insertion opening and to perform one or more specified tasks with respect to the biological material in the single-use sterilizable bag, wherein the at least one insertable component comprises:
a positioning unit comprising a dynamic element configured to move the insertable component into a specific position in the single-use sterilizable bag at which the one or more specified tasks is to be carried out;
a sensing unit and a processing unit for handling the biological material, the processing unit being at least one of a mixing device, a filtration device, an aeration device, a purification device, a centrifugation device and a cell cultivation device that manipulates the biological material in the single-use sterilizable bag to mechanically or chemically modify the biological material; and
a controlling unit configured to autonomously control all operations of the sensing unit and the processing unit without input from outside the single-use sterilizable bag, wherein the controlling unit controls the processing unit based on whether a measured parameter received from the sensing unit has exceeded a predetermined threshold.

2. The assembly of claim 1 , wherein the insertion opening is provided with an aseptic connector configured to enable an aseptic transfer of the at least one insertable component into the single-use sterilizable bag.

3. The assembly of claim 1 , wherein the at least one insertable component further comprises a communication unit configured to enable communication between the at least one insertable component and at least one device external to the assembly.

4. The assembly of claim 1 , wherein the at least one insertable component is a plurality of insertable components.

5. The assembly of claim 4 , wherein at least two of the plurality of insertable components further comprise a communication unit configured to enable communication between the insertable components.

6. The assembly of claim 1 , wherein the single-use sterilizable bag further comprises an attachment unit and the at least one insertable component further comprises a connecting unit configured to engage with the attachment unit.

7. The assembly of claim 6 , wherein the attachment unit is configured to provide one or more sterile connections for the insertable components to the outside of the assembly.

8. The assembly of claim 1 , wherein the positioning unit further comprises at least one static element configured to maintain the insertable component at the specific position to which the insertable component has been moved by the dynamic element.

9. The assembly of claim 8 , wherein the static element is a buoyancy device filled with a compressed gas.

10. The assembly of claim 8 , wherein the at least one static element comprises at least one buoyancy device that receives compressed gas to hold the insertable component at a specified depth in the biological material in the single-use sterilizable bag.

11. The assembly of claim 1 , wherein the positioning unit is configured to position the insertable component autonomously.

12. The assembly of claim 1 , wherein the dynamic unit comprises an impeller configured for moving the insertable component.

13. The assembly of claim 1 , wherein the insertable component is sterilizable and the single-use sterilizable bag is configured to be sterilized using a first sterilization method.

14. The assembly of claim 13 , wherein the insertable component is configured to be sterilized separately from the single-use bag using a second sterilization method, the second sterilization method being different from the first sterilization method.

15. The assembly of claim 13 , wherein the insertable component further comprises a body configured to be sterilized using the first sterilization method and at least one compartmentalized container configured to be sterilized using a second sterilization method, and wherein:
the second sterilization method is different from the first sterilization method;
the at least one compartmentalized container is configured to enclose an element sensitive to the first sterilization method;
the at least one compartmentalized container is configured to be embedded in the insertable component after sterilization by being aseptically inserted therein.

16. The assembly of claim 14 , wherein the at least one compartmentalized container is configured to be re-used.

Assignees

• Sartorius Stedim Biotech Gmbh

Inventors

• Maggiore Frank

Classifications

• C12M41/48

  Automatic or computerized control (automatic analysis G01N35/00) · CPC title

• C12M23/56

  Floating elements · CPC title

• C12M27/02

  Stirrer or mobile mixing elements · CPC title

• C12M23/14

  Bags · CPC title

• C12M29/00

  Means for introduction, extraction or recirculation of materials, e.g. pumps (pumps per se F04B) · CPC title