Sterile probe sampling for a single-use vessel

Patent metadata

Field	Value
Publication number	US-12325025-B2
Application number	US-201816646538-A
Country	US
Kind code	B2
Filing date	Apr 20, 2018
Priority date	Sep 22, 2017
Publication date	Jun 10, 2025
Grant date	Jun 10, 2025

Abstract

A system and method for transferring chemical, pharmaceutical, and/or biological material into or out of a container are provided. Further, a use of a transfer interface for accessing the interior of a disposable container is provided. The system comprises a disposable container having at least one port for accessing the interior of the container. The system further comprises a transfer interface connectable to the at least one port. The transfer interface comprises a plurality of extendable transfer elements for collecting samples from the disposable container in a sterile manner. The transfer elements may also be referred to as sampling elements, extractors, or probes. Each of the transfer elements has a corresponding biasing element for retracting the transfer element. The biasing element may be implemented as a spring or as another device capable of applying a biasing force.

First claim

The invention claimed is:

1. A system for transferring chemical, pharmaceutical, and/or biological material into or out of a container, the system comprising:
a disposable container having at least one port for accessing an interior of the disposable container;
a transfer interface connectable to the at least one port, the interface comprising a plurality of extendable transfer elements for extracting samples from the disposable container in a sterile manner;
a locking mechanism for locking one of the transfer elements, the locking mechanism being configured such that, after locking the locking mechanism, it is not possible to unlock the locking mechanism; and
a switch for the transfer interface, wherein activation of the switch causes one of the transfer elements to extend from the transfer interface to collect a sample from the container, and deactivation of the switch causes the extended transfer element to retract into the transfer interface,
wherein the switch is configured such that activation of the switch occurs when a user presses a button on the transfer interface and the deactivation of the switch occurs when the user releases the button.

2. The system of claim 1 , wherein the locking mechanism prevents the locked transfer element from being extended.

3. The system of claim 1 , wherein the transfer interface further comprises a septum,
wherein the transfer elements extend beyond the septum when fully extended, and
wherein the transfer elements retreat behind the septum when retracted.

4. The system of claim 3 , wherein the transfer interface further comprises a plate covering the septum, the plate having holes corresponding to each of the transfer elements,
wherein the plate is between the septum and the container when the interface is connected to the port.

5. The system of claim 1 , wherein the at least one port includes a sensor port for arranging a sensor on the container in order to sense at least one parameter of the content of the container.

6. The system of claim 5 , wherein the sensor port is a pH port for measuring a relative amount of hydrogen and hydroxide ions within the container.

7. The system of claim 1 , wherein the transfer interface further comprises a crescent shaped grip arranged such that the tips of the crescent protrude from opposing sides of the interface.

8. The system of claim 1 , wherein the transfer interface is connectable to the at least one port via a bayonet connection.

9. The system of claim 8 , wherein the bayonet connection is one-way, such that fluid can exit the container through the interface, but fluid cannot pass through the interface into the container.

10. The system of claim 1 , wherein the interface comprises a plurality of tubes extending away from the transfer elements.

11. The system of claim 1 , further comprising a housing, wherein the container is provided within the housing and the housing supports the container.

12. The system of claim 11 , further comprising a mounting bracket attached to the housing,
wherein components of the mounting bracket are arranged in front of the at least one port so as to support the interface when the interface is connected to the port.

13. A method for transferring chemical, pharmaceutical, and/or biological material into or out of a container, the method comprising:
providing a disposable container having at least one port, the at least one port being suitable for accessing an interior of the container;
connecting a transfer interface to the at least one port, the transfer interface comprising a plurality of transfer elements, the connecting comprising extending one of the transfer elements from the transfer interface to the container to extract a sample from the container in a sterile manner;
retracting the extended transfer element from the container by means of a biasing element corresponding to the extended transfer element; and
permanently locking the retracted transfer element, such that the locked transfer element cannot be unlocked and reused,
wherein the transfer interface comprises a switch that is operable by a button on the transfer interface,
wherein the extending one of the transfer elements occurs when the button is pressed and the switch is activated, and
wherein the retracting the extended transfer element occurs when the button is released and the switch is deactivated.

14. A method of connecting a transfer interface for accessing an interior of a disposable container, the method comprising:
connecting the transfer interface to a port of the disposable container by extending one of a plurality of extendable transfer elements from the transfer interface to the disposable container to extract a sample from the disposable container in a sterile manner; and
after retracting the extended transfer element, permanently locking the retracted transfer element, such that the locked transfer element cannot be unlocked and reused,
wherein the transfer interface comprises a switch that is operable by a button on the transfer interface,
wherein the extending one of the transfer elements occurs when the button is pressed and the switch is activated, and
wherein the retracting the extended transfer element occurs when the button is released and the switch is deactivated.

Assignees

• Sartorius Stedim Biotech Gmbh

Inventors

• Reinert Inga
• Gay Isabelle
• Meadows Charles
• Zumbrum Michael

Classifications

• B01F2101/44

  Mixing of ingredients for microbiology, enzymology, in vitro culture or genetic manipulation · CPC title

• C12M23/40

  Manifolds; Distribution pieces (fluid transfer means B01L3/563) · CPC title

• C12M23/28 Primary

  disposable or single use · CPC title

• B01L2200/141

  Preventing contamination, tampering · CPC title

• B01L2200/026

  Fluid interfacing between devices or objects, e.g. connectors, inlet details · CPC title