# US 2014/0193897 A1 · Bioreactor container and integrity check method for bioreactor containers

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2014/0193897 A1
- Document ID: US20140193897A1
- Status: Published application
- Kind: A1
- Application number: 14/130,061
- Filed: 2012-06-15
- Published: 2014-07-10
- Earliest claimed: 2011-06-30
- Assignees: Sartorius Stedim Biotech GmbH
- Inventors: Martin Dahlberg; Isabelle Gay; Lars Boettcher; Stefan Obermann; Rainer Sandrock
- Web page: https://patentgrep.com/patent/US20140193897A1

## CPC

- C12M 23/14: {Bags}
- A61J 1/10: Bag-type containers
- B32B 1/00: Layered products having a non-planar shape
- B32B 3/30: characterised by a layer formed with recesses or projections, e.g. {hollows, grooves, protuberances, ribs (apertured layer B32B3/266; layer with cavities or internal voids B32B3/26)}
- B32B 5/022: {Non-woven fabric}
- B32B 5/024: {Woven fabric}
- B32B 5/18: characterised by features of a layer {of} foamed material
- C12M 23/02: {Form or structure of the vessel (large containers B65D88/00)}
- C12M 23/26: {flexible (flexible containers for laboratory use B01L3/505)}
- G01M 3/04: by detecting the presence of fluid at the leakage point
- G01M 3/22: for pipes, cables or tubes; for pipe joints or seals; for valves; {for welds; for containers, e.g. radiators}
- G01M 3/3218: {for flexible or elastic containers}
- G01M 3/3272: {for verifying the internal pressure of closed containers}
- A61J 1/16: Holders for containers
- B32B 2307/726: Permeability to liquids, absorption
- B32B 2307/7265: Non-permeable
- F04C 2270/0421: Controlled or regulated
- C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS}
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- B32B: LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- G01M: TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
- F04C: ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS (engines F03C); ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS

## Abstract

A bioreactor container comprising has an at least locally flexible wall and at least one container opening. The wall of the bioreactor container has a fluid-tight inner sheet, and an at least locally fluid-permeable or structured outer sheet. A method for testing the integrity of the bioreactor container also is provided.

## Claims

### Claim 1

A bioreactor container (1) comprising:
an at least locally flexible wall (3);
at least one container opening (9a, 9b, 9c, 9d),
wherein the wall (3) of the bioreactor container (1) has a fluid-tight inner sheet (5), and
wherein the wall (3) of the bioreactor container (1) has an at least locally fluid-permeable outer sheet (7).

### Claim 2 (depends on 1)

The bioreactor container (1) of claim 1, wherein the fluid-permeable outer sheet (7) comprises at least one of a woven textile, a nonwoven textile and a foam material.

### Claim 3 (depends on 1)

The bioreactor container (1) of claim 1, wherein the fluid-permeable outer sheet (7) has a direction-dependent fluid permeability.

### Claim 4

A bioreactor container (1) comprising:
an at least locally flexible wall (3);
at least one container opening (9a, 9b, 9c, 9d),
wherein the wall (3) of the bioreactor container (1) has a fluid-tight inner sheet (5), and
wherein the wall (3) of the bioreactor container (1) has an at least locally structured outer sheet (7).

### Claim 5 (depends on 4)

The bioreactor container (1) of claim 4, wherein the structured outer sheet (7) has depressions which are at least about 200 μm deep.

### Claim 6 (depends on 5)

The bioreactor container (1) of claim 5, wherein the structured outer sheet (7) has elevations that are at most about 200 μm wide.

### Claim 7 (depends on 6)

The bioreactor container (1) of claim 6, wherein the elevations and depressions of the structured outer sheet (7) are oriented along a preferential direction V.

### Claim 8 (depends on 4)

The bioreactor container (1) of claim 4, wherein the fluid-permeable outer sheet (7) or the structured outer sheet (5) is connected releasably or nonreleasably to the fluid-impermeable inner sheet (5), and
wherein the outer sheet (7) is formed as a sterile barrier.

### Claim 9 (depends on 4)

The bioreactor container (1) of claim 4, wherein the at least one container opening (9a, 9b, 9c, 9d) of the bioreactor container (1) is enclosed in a first state by the outer sheet (7), wherein the at least one container opening (9a, 9b, 9c, 9d) is freely accessible in a second state, and wherein the bioreactor container (1) can be converted from the first state to the second state by local tearing and removal of the outer sheet (7).

### Claim 10 (depends on 1)

A method for testing the integrity of a bioreactor container (1), having the steps:
providing the bioreactor container (1) of claim 1;
providing a bioreactor apparatus having a bioreactor container compartment (25);
arranging the bioreactor container (1) at least partially in the bioreactor container compartment (25);
connecting the at least one container opening (9a, 9b, 9c, 9d) of the bioreactor container to a fluid source (27);
filling the bioreactor container (1) with a fluid from the fluid source (27) in order to generate a predetermined positive pressure Pi in the bioreactor container (1) at a first time Ti, the outer sheet (7) of the bioreactor container (1) bearing at least locally on an inner wall of the bioreactor container compartment (25); and
determining whether the bioreactor container (1) is sufficiently leaktight.
