Flexible mixing bag for mixing solids, liquids and gases

• US 7,249,880 B2
• Filed: 10/14/2003
• Issued: 07/31/2007
• Est. Priority Date: 10/14/2003
• Status: Active Grant

• Current Assignee: Pall Life Sciences Belgium BVBA (Danaher Corporation)
• Original Assignee: Advanced Technology Materials, Inc. (Entegris Incorporated)
• Inventors: Zambaux, Jean-Pascal
• Primary Examiner(s): SOOHOO, TONY GLEN
• Application Number:
  US10/684,932
• Publication Number:
  US 20050078552A1
• Time in Patent Office: 1,386 Days
• Field of Search: 366/279, 366/276, 366/277, 366/278, 366/349, 383/127, 383/105, 383/121
• US Class Current: 366/277
• CPC Class Codes: B01F 2101/06 Mixing of food ingredients
• CPC Class Codes: B01F 2101/22 Mixing of ingredients for pharmaceutical or medical compositions
• CPC Class Codes: B01F 2101/2202 Mixing compositions or mixers in the medical or veterinary field
• CPC Class Codes: B01F 2101/58 Mixing semiconducting materials, e.g. during semiconductor or wafer manufacturing processes
• CPC Class Codes: B01F 27/88 with a separate receptacle-stirrer unit that is adapted to be coupled to a drive mechanism
• CPC Class Codes: B01F 31/80 Mixing by means of high-frequency vibrations above one kHz, e.g. ultrasonic vibrations
• CPC Class Codes: B01F 35/146 Working under sterile conditions; Sterilizing the mixer or parts thereof
• 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 35/514 the mixing receptacle or conduit being transparent or comprising transparent parts
• CPC Class Codes: C12M 23/14 Bags
• CPC Class Codes: C12M 23/28 disposable or single use
• CPC Class Codes: C12M 27/00 Means for mixing, agitating or circulating fluids in the vessel by introduction of gas C12M29/06, C12M29/14, mixing in general or mixers per se B01F; mixing in apparatus for chemical or physical processes B01J
• CPC Class Codes: C12M 27/02 Stirrer or mobile mixing elements

Abstract

In an embodiment, an apparatus includes a disposable and flexible mixing tank having a sealed sleeve therein for arrangement of a mixing device. The volume of the mixing tank is defined by an inner wall of the mixing tank and an inner wall of the sleeve. The mixing tank may be used to mix, store, reconstitute and/or dispense materials therein.

Claims

1. A mixing container comprising:

a hollow mixing bag having at least one interior wall;

a mixing paddle adapted to engage a support rod mechanically coupleable to receive kinetic energy from a kinetic energy source, the mixing paddle having at least one widened paddle portion that is wider than a nominal diameter or cross-sectional width of the support rod;

a coupling guide joined to the mixing bag, the coupling guide defining an aperture sized to permit pivotal arrangement of the support rod between the kinetic energy source and the mixing bag; and

an integral sleeve sealingly and permanently welded proximate the coupling guide aperture to any of the bag and the coupling guide, the sleeve having a closed end protruding into the interior of the hollow bag, having at least one exterior wall, and defining a cavity containing the mixing paddle, the cavity having at least one widened cavity portion disposed about the at least one widened paddle portion;

wherein the at least one interior wall of the mixing bag and the at least one exterior wall of the sleeve encloses a volume, and the sleeve serves as an isolation barrier between the volume and the mixing paddle.

2. The mixing container of claim 1, wherein the mixing paddle includes a narrow paddle portion that is narrower than the at least one widened paddle portion and extends from the at least one widened paddle portion toward the coupling guide.

3. The mixing container of claim 2, wherein the cavity includes a narrow cavity portion that is narrower than the widened cavity portion and is disposed about the narrow paddle portion.

4. The mixing container of claim 1, wherein the sleeve is sized and shaped to be substantially form-fitting around the mixing paddle.

5. The mixing container of claim 1, wherein the mixing paddle is permanently retained by the sleeve.

6. The mixing container of claim 1, wherein any of the mixing bag and the sleeve comprises a material characterized by any of a stretchable, collapsible, pliable, and elastic property.

7. The mixing container of claim 1, wherein any of the mixing bag and the sleeve comprises a polymeric film.

8. The mixing container of claim 7, wherein the polymeric film is substantially transparent.

9. The mixing container of claim 1, wherein each of the mixing bag and the sleeve comprises a polymeric film, and the polymeric film of the mixing bag has substantially the same composition as the polymeric film of the sleeve.

10. The mixing container of claim 1, wherein the mixing bag defines at least one resealable access port.

11. A mixing container comprising:

a hollow mixing bag having at least one interior wall, the mixing bag comprising a substantially transparent polymeric film material and having a resealable access port;

a mixing paddle adapted to engage a support rod mechanically coupleable to receive kinetic energy from a kinetic energy source, the mixing paddle having at least one widened paddle portion that is substantially broader than a nominal diameter or cross-sectional width of the support rod;

a coupling guide joined to the mixing bag, the coupling guide defining an aperture sized to permit pivotal arrangement of the support rod between the kinetic energy source and the mixing bag; and

an integral sleeve comprising a substantially transparent polymeric film material, the sleeve (1) being sealingly and permanently welded proximate the coupling guide aperture to any of the bag and the coupling guide, (2) having a closed end protruding into the interior of the hollow bag, having at least one exterior wall, and (3) defining a cavity containing the mixing paddle, the cavity having at least one widened cavity portion disposed about the at least one widened paddle portion;

wherein the polymeric film material of the mixing bag has substantially the same composition as the polymeric film material of the sleeve, the at least one interior wall of the mixing bag and the at least one exterior wall of the sleeve encloses a volume, and the sleeve serves as an isolation barrier between the volume and the mixing paddle.

12. A mixing apparatus comprising:

a kinetic energy source;

a hollow mixing bag having at least one interior wall and a substantially central vertical axis;

a support rod mechanically coupleable to receive kinetic energy generated by the kinetic energy source;

a mixing paddle;

a flexible integral sleeve protruding into the interior of the hollow mixing bag, having at least one exterior wall, and defining a cavity containing the mixing paddle and at least a portion of the support rod;

wherein the at least one interior wall of the mixing bag and the at least one exterior wall of the sleeve encloses a volume, with the sleeve serving as an isolation barrier to isolate the volume from the mixing paddle and the support rod; and

wherein the mixing paddle contained within the sleeve is driven by the support rod when coupled to the kinetic energy source and, when so coupled, is adapted to travel within the bag through a defined path at a nonzero angle relative to the central vertical axis without continuous rotation of the support rod about a longitudinal axis defined by the support rod.

13. The mixing apparatus of claim 12, wherein the mixing paddle includes at least one widened paddle portion having a width greater than a nominal width or diameter of the support rod.

14. The mixing apparatus of claim 13, wherein the cavity has at least one widened cavity portion disposed about the at least one widened paddle portion.

15. The mixing apparatus of claim 13, wherein the mixing paddle includes a narrow paddle portion extending above the widened paddle portion.

16. The mixing apparatus of claim 15, wherein the cavity has at least one widened cavity portion disposed about the at least one widened paddle portion, and a narrow cavity portion disposed about the narrow paddle portion.

17. The mixing apparatus of claim 12, wherein the sleeve is sized and shaped to be substantially form-fitting around the mixing paddle.

18. The mixing apparatus of claim 12, wherein the mixing paddle is permanently retained by the sleeve.

19. The mixing apparatus of claim 12, wherein the mixing bag comprises a coupling guide defining an aperture sized and shaped to permit pivotal arrangement of the support rod between the kinetic energy source and the mixing bag.

20. The mixing apparatus of claim 12, wherein any of the mixing bag and the sleeve comprises a material characterized by any of a stretchable, collapsible, pliable, and elastic property.

21. The mixing apparatus of claim 12, wherein any of the mixing bag and the sleeve comprises a polymeric film.

22. The mixing apparatus of claim 21, wherein the polymeric film is substantially transparent.

23. The mixing apparatus of claim 12, wherein each of the mixing bag and the sleeve comprises a polymeric film, and the polymeric film of the mixing bag has substantially the same composition as the polymeric film of the sleeve.

24. The mixing apparatus of claim 12, wherein the mixing bag defines at least one resealable access port.

25. The mixing apparatus of claim 12, wherein the kinetic energy source comprises a motor.

26. The mixing apparatus of claim 12, wherein the defined path comprises a closed curvilinear path.

27. The mixing apparatus of claim 12, wherein the defined path comprises a substantially circular path.

28. The mixing apparatus of claim 12, further comprising a support frame adapted to support the mixing bag.

29. The mixing apparatus of claim 28, wherein the support frame is substantially open with a plurality of apertures or windows, and the support frame is coupled to the mixing bag with at least one coupling element.

30. A mixing method employing a mixing apparatus including (1) a kinetic energy source, (2) a hollow mixing bag having a flexible integral sleeve joined thereto with a closed end of the sleeve protruding into the mixing bag, and (3) a mixing paddle enveloped by the sleeve and adapted to receive a support rod coupleable to the kinetic energy source, wherein at least one interior wall of the bag and an exterior wall of the sleeve defines an interior volume, and the sleeve serves as an isolation barrier between the interior volume and the mixing paddle, the method comprising the steps of:

supplying at least two components of a mixture to the interior volume;

engaging the support rod between the kinetic energy source and the mixing paddle;

mixing the at least two components by moving the enveloped mixing paddle in a closed curvilinear path within the interior volume without continuous rotation of the support rod about a longitudinal axis defined by the support rod to combine the at least two components and form said mixture.

31. The method of claim 30, wherein the moving step comprises moving the mixing element within the tank through a defined path at a nonzero angle relative to a substantially central vertical axis of the tank.

32. The method of claim 30, further comprising the step of storing the mixture inside the bag.

33. The method of claim 30, further comprising the steps of:

extracting at least a portion of the mixture from the tank; and

disposing of the tank.

34. The method of claim 30, wherein the mixing bag comprises a resealable access port, and the supplying step comprises supplying the at least two components through the resealable access port to the interior volume, and sealing the resealable access port.

35. The method of claim 30, wherein the mixing paddle includes (1) a widened paddle portion that is substantially wider than a nominal diameter or cross-sectional width of the support rod, and (2) a narrow paddle portion extending above the widened paddle portion, and wherein the engaging step includes engaging the support rod to the narrow paddle portion.

36. The method of claim 30, wherein the closed curvilinear path comprises a substantially circular path.

37. The method of claim 30, wherein the mixing bag comprises a coupling guide defining an aperture sized and shaped to permit pivotal arrangement of the support rod between the kinetic energy source and the mixing bag, and the mixing step includes pivotally moving support rod through the coupling guide to direct the mixing paddle in the closed curvilinear path.