Bioprocess container, bioprocess container mixing device and method of use thereof

• US 20040062140A1
• Filed: 09/27/2002
• Published: 04/01/2004
• Est. Priority Date: 09/27/2002
• Status: Active Grant

• Current Assignee: ILC Dover IP, Inc., ILC Dover LP (Jetsolutions SA), Grayling Industries (Transdigm Group Incorporated)
• Original Assignee: ILC Dover IP, Inc.
• Inventors: Lin, John Kun Hung, Lloyd, Steven Michael, Cadogan, David Phillip, Edwards, Thomas Joseph, Davidson, Scott Lester, McKee, Tony Ray
• Granted Patent: US 6,837,610 B2
• Time in Patent Office: Days
• US Class Current: 366/144
• CPC Class Codes: B01F 2101/44 Mixing of ingredients for microbiology, enzymology, in vitro culture or genetic manipulation
• CPC Class Codes: B01F 2215/0431 Numerical size values, e.g. diameter of a hole or conduit, area, volume, length, width, or ratios thereof
• CPC Class Codes: B01F 27/90 with paddles or arms
• CPC Class Codes: B01F 31/31 using receptacles with deformable parts, e.g. membranes, to which a motion is imparted
• CPC Class Codes: B01F 33/452 using independent floating stirring elements
• CPC Class Codes: B01F 35/213 of the properties of the mixtures, e.g. temperature, density or colour
• CPC Class Codes: B01F 35/2131 Colour or luminescence
• CPC Class Codes: B01F 35/50 Mixing receptacles
• CPC Class Codes: B01F 35/513 Flexible receptacles, e.g. bags supported by rigid containers
• CPC Class Codes: B01F 35/5312 with vertical baffles mounted on the walls
• CPC Class Codes: B01F 35/92 for heating the outside of the receptacle, e.g. heated jackets or burners
• CPC Class Codes: C12M 23/14 Bags
• CPC Class Codes: C12M 27/02 Stirrer or mobile mixing elements
• CPC Class Codes: C12M 27/20 Baffles; Ribs; Ribbons; Auger vanes
• CPC Class Codes: C12M 41/18 Heat exchange systems, e.g. heat jackets or outer envelopes

Abstract

A bioprocess container consists of a flexible container, placed inside a heat exchanger. By providing a disposable agitation device inside the sealed container, a filled container can be stirred without having to open the container. Possible agitation elements include traditional stirrers, rotating magnetic rods, bladder devices integral with the structure of the container, as well as different devices for manipulating the shape of the sealed container. Finally, a containment disk is used to ensure that the magnetic rod is maintained in the magnetic field.

Claims

1. A bioprocess container (BPC) comprising:

a sealed flexible container having a size and a shape when at least partially filled, and

a rigid heat exchanger, having a cavity corresponding essentially to the shape of said container, said container disposed at least partially inside said cavity.

2. The BPC of claim 1, wherein said container is in the shape of a cylinder, having a rounded surface, a closed first end and a closed second end, said second end disposed inside said cavity.

3. A BPC mixing device comprising:

the BPC of claim 1 and

an agitator disposed at least partially inside said container.

4. The BPC mixing device of claim 3, wherein said agitator is a mixing device selected from the group consisting of:

a magnetic rod and a magnetic drive mechanism, adapted to rotate said rod; and

a shaft extending through said container and a mixing device disposed inside said container, at and end of said shaft.

5. The BPC mixing device of claim 4, wherein said magnetic rod is disposed inside a containment disk.

6. The BPC mixing device of claim 5, wherein said containment disk comprises:

a first ring,

a second ring secured to said first ring, defining a space therebetween, the space corresponding essentially to the shape of said magnetic rod.

7. The BPC of claim 5, wherein said containment disk comprises a baffle element positioned to disrupt vortex forming forces.

8. A BPC mixing device comprising:

the BPC of claim 1, and

means for manipulating the shape of said container.

9. The BPC mixing device of claim 8, wherein said manipulating means is selected from the group consisting of:

at least one bladder integral with the structure of said container and at least one inflating apparatus, in fluid communication with said at least one bladder;

a plurality of fluid-containing sleeves protruding from the interior of said container and a means for squeezing said plurality of fluid-containing sleeves;

a plurality of hinged plates, disposed on said container and a means for manipulating said plurality of hinged plates; and

means for displacing at least one edge or corner of said container.

10. A method for mixing comprising:

providing a bioprocess container (BPC), said BPC comprising;

a flexible container having a shape when at least partially filled, and

a rigid heat exchanger, having a cavity corresponding essentially to the shape of said container, said container disposed at least partially inside said cavity; and

agitating the contents of the container.

11. The method of claim 10, wherein said agitating is selected from the group consisting of:

manipulating the shape of the container, and

mixing the contents of the container.

12. The method of claim 11, wherein said mixing comprises generating a magnetic field to rotate a magnetic rod disposed inside said container.

13. The method of claim 11, wherein said manipulating is selected from the group consisting of

selectively inflating and/or deflating at least one bladder integral with the structure of said container;

selectively squeezing a plurality of fluid-containing sleeves protruding from the interior;

selectively moving a plurality of hinged plates, disposed on said container; and

displacing at least one edge or corner of said container.

14. A magnetic rod containment disk comprising:

a first ring;

a second ring, joined said first ring with a space therebetween; and

a magnetic rod disposed in said space.

15. The magnetic rod containment disk of claim 14, wherein said first ring and said second ring are joined with a plurality of bolts and spacers.

16. The magnetic rod containment disk of claim 15, wherein said first ring, said second ring, said plurality of bolts and said spacers are formed from high-density polyethylene.

17. The magnetic rod containment disk of claim 14, further comprising a baffle element, positioned to disrupt vortex forming forces.

18. The magnetic rod containment disk of claim 14, further comprising a low-friction surface disposed below said space.