Bioreactor exhaust

• US 9,005,959 B2
• Filed: 05/01/2011
• Issued: 04/14/2015
• Est. Priority Date: 05/01/2011
• Status: Expired due to Fees

• Current Assignee: Adello Biologics, LLC
• Original Assignee: Therapeutic Proteins International, LLC (Amneal Pharmaceuticals, LLC)
• Inventors: Niazi, Sarfaraz
• Primary Examiner(s): HOBBS, MICHAEL L
• Application Number:
  US13/098,462
• Publication Number:
  US 20110207170A1
• Time in Patent Office: 1,444 Days
• Field of Search: 435/41, 435/284.1, 137/334
• US Class Current: 435/284.1
• CPC Class Codes: C12M 23/26 flexible flexible containers for laboratory use B01L3/505
• CPC Class Codes: C12M 23/28 disposable or single use
• CPC Class Codes: C12M 29/20 Degassing; Venting; Bubble traps means for collection or storage of gas C12M23/36; gas collection apparatus for laboratory use B01L5/02
• CPC Class Codes: C12M 41/40 of pressure
• CPC Class Codes: Y10T 137/0379 By fluid pressure
• CPC Class Codes: Y10T 137/6416 With heating or cooling of the system

Abstract

An exhaust system suitable for high volume exhaust from flexible disposable bags is described that prevents nutrient media volume loss and prevents cross-contamination without using any filters. The invention described here allows the use of disposable two-dimensional bioreactors for the cultivation of bacterial and other organisms and cells require high aeration.

Claims

1. A bioreactor exhaust assembly comprising:

(a) an exhaust tube with an inner volume and a lower end connected to a bioreactor and an upper end connected to a low pressure relief valve and a plurality of sensors including at least a pressure sensor and a temperature sensor;

(b) wherein the exhaust tube is cooled to maintain a temperature below the dew point of a gas in the exhaust tube; and

wherein the exhaust tube is attached to a vertical surface, held up by a hook at a higher elevation or winding it upward around a vertical cylindrical block with an outer surface.

2. The bioreactor exhaust assembly according to claim 1, wherein the exhaust tube is made from a polymer or a metal or a combination thereof.

3. The bioreactor exhaust assembly according to claim 1, wherein the exhaust tube is at least one-half inch in diameter.

4. The bioreactor exhaust assembly according to claim 1, wherein the exhaust tube has such length that the inside volume of the exhaust tube is 1% to 50% of a volume of gas exhausted per minute.

5. The bioreactor exhaust assembly according to claim 1, wherein the exhaust tube is flexible.

6. The bioreactor exhaust assembly according to claim 1, wherein the vertical cylindrical block is made of a metal, preferably aluminum.

7. The bioreactor exhaust assembly according to claim 6, wherein the cylindrical block has a groove on the outer surface to completely seat the exhaust tube inside the groove.

8. The bioreactor exhaust assembly according to claim 6, wherein the cylindrical block further comprises a temperature sensor to measure the temperature of the cylindrical block.

9. The bioreactor exhaust assembly according to claim 1, wherein the cooling of the exhaust tube comprises blowing cold air over it, enclosing it in a cold box, by submerging it in a cold liquid.

10. The bioreactor exhaust assembly according to claim 6, wherein the cooling of the cylindrical block comprises circulating a cold liquid in the cylindrical block.

11. The bioreactor exhaust assembly according to claim 1, wherein the low pressure relief valve is a mechanical or electro-mechanical device.

12. The bioreactor exhaust assembly according to claim 1, wherein the low pressure relief valve provides an instant hermetic seal when closed.

13. The bioreactor exhaust assembly according to claim 1, wherein the pressure sensor is electronically or mechanically connected to the low pressure relief valve to open or close the low pressure relief valve.

14. The bioreactor exhaust assembly according to claim 1, wherein the low pressure relief valve opens when the pressure in the exhaust tube reaches above a pressure of 0.05-inch (±

10%) water gauge and closes when the pressure in the exhaust tube reaches below a pressure of 0.05-inch (±

10%) water gauge in the exhaust tube.

15. The bioreactor exhaust assembly according to claim 1, wherein the bioreactor exhaust assembly is connected to a two-dimensional soft wall container, a three-dimensional soft-wall container or a three-dimensional hard-walled container.

16. A bioreactor exhaust assembly comprising:

(a) an exhaust tube with an inner volume and a lower end connected to a bioreactor and an upper end connected to a condenser box, wherein the exhaust tube is held upright;

(b) a cooling element attached to the exhaust tube to maintain a temperature below the dew point of a gas in the exhaust tube;

(c) a plurality of sensors with at least a pressure sensor and a temperature sensor;

(d) a condenser box with a top and a bottom and an inner volume, a connector to the exhaust tube, a condenser coil, an inlet for cold liquid to cool the condenser coil, an outlet for recirculating the cold liquid in the condenser coil, a pressure sensor, a low pressure relief valve, an exhaust outlet, a plurality of sensors with at least a pressure sensor and a temperature sensor, a bottom drain and a stopcock to operate the drain.

17. The bioreactor exhaust assembly according to claim 16, wherein the exhausts tube is made from a polymer or a metal material or a combination thereof.

18. The bioreactor exhaust assembly according to claim 16, wherein the exhaust tube is at least one-half inch in diameter.

19. The bioreactor exhaust assembly according to claim 16, wherein the exhaust tube is flexible.

20. The bioreactor exhaust assembly according to claim 16, wherein the exhaust tube has such length that the inside volume of the exhaust tube is 1% to 50% of a volume of gas exhausted from the bioreactor per minute.

21. The bioreactor exhaust assembly according to claim 16, wherein the exhaust tube is attached to a vertical surface, held up by a hook at a higher elevation or winding it upward around a vertical cylindrical block.

22. The bioreactor exhaust assembly according to claim 21, wherein the vertical cylindrical block is made of a metal, preferably aluminum and has an outer surface.

23. The bioreactor exhaust assembly according to claim 22, wherein the cylindrical block has a groove on the outer surface of the cylinder block to completely seat the exhaust tube inside the groove.

24. The bioreactor exhaust assembly according to claim 22, wherein the cylindrical block further comprises a temperature sensor to measure the temperature of the cylindrical block.

25. The bioreactor exhaust assembly according to claim 16, wherein the cooling of the exhaust tube comprises blowing cold air over it, enclosing it in a cold box, or by submerging it in a cold liquid.

26. The bioreactor exhaust assembly according to claim 22, wherein the cooling of the exhaust tube comprises circulating a cold liquid in the cylindrical block.

27. The bioreactor exhaust assembly according to claim 16, wherein the condenser box is kept at a lower height than the upper end of the exhaust tube.

28. The bioreactor exhaust assembly according to claim 16, wherein the condenser coil in the condenser box is kept at a temperature between 5°

C. and 8°

C. by circulating a cold liquid through the condenser coil.

29. The bioreactor exhaust assembly according to claim 16, wherein the condenser box further comprises a plurality of sensors including at least a temperature sensor to measure the temperature inside the condenser box.

30. The bioreactor exhaust assembly according to claim 16, wherein the low pressure relief valve is a mechanical or electro-mechanical device.

31. The bioreactor exhaust assembly according to claim 16, wherein the low pressure relief valve provides an instant hermetic seal when closed.

32. The bioreactor exhaust assembly according to claim 16, wherein the pressure sensor is electronically or mechanically connected to the low pressure relief valve to open or close the low pressure relief valve automatically according to conditions programmed in the pressure sensor.

33. The bioreactor exhaust assembly according to claim 16, wherein the low pressure relief valve opens when the pressure in the condenser box reaches above 0.05-inch (±

10%) water gauge and closes when the pressure in the condenser box reaches below a pressure of 0.05-inch (±

10%) water gauge in the condenser box.

34. The bioreactor exhaust assembly according to claim 16, wherein the bioreactor exhaust assembly is connected to a two-dimensional soft wall container, a three-dimensional soft-wall container or a three-dimensional hard-walled container.