System and method for interfacing sensors to a sterile flow stream

• US 8,844,388 B2
• Filed: 11/14/2013
• Issued: 09/30/2014
• Est. Priority Date: 03/26/2008
• Status: Active Grant

• Current Assignee: EMD Millipore Corporation (Merck & Co., Inc.)
• Original Assignee: EMD Millipore Corporation (Merck & Co., Inc.)
• Inventors: Burke, Aaron
• Primary Examiner(s): Raevis, Robert R
• Application Number:
  US14/080,466
• Publication Number:
  US 20140073040A1
• Time in Patent Office: 320 Days
• Field of Search: None
• US Class Current: 73/866.5
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: B01D 63/00 Apparatus in general for separation processes using semi-permeable membranes
• CPC Class Codes: C12M 23/14 Bags
• CPC Class Codes: C12M 29/00 Means for introduction, extraction or recirculation of materials, e.g. pumps pumps per se F04B
• CPC Class Codes: C12M 37/02 Filters
• CPC Class Codes: C12M 41/00 Means for regulation, monitoring, measurement or control, e.g. flow regulation controlling or regulating chemical, physical or physicochemical processes B01J19/0006; heating or cooling apparatus for laboratory use B01L7/00; electro optical investigation of individual particles, flow cytometers G01N15/14; automatic analysis G01N35/00; controlling or regulating in general G06N
• CPC Class Codes: G01L 19/0645 using isolation membranes, specially adapted for protection

Abstract

A system and method for interfacing non-sterile sensors to a sterile flow stream is disclosed. Typically, sensors cannot be sterilized in the same manner as other components of the flow stream. This results in complex processes to incorporate a sterilized sensor into a sterilized flow stream. By introducing a separation membrane, the desired sensor can be interfaced to the sterile flow stream. By doing so, the sensor need not be sterile, only sufficiently clean. The membrane separates the sterile environment within the flow stream from the sensor, while still permitting the sensor to function.

Claims

1. A bioreactor system, comprising:

a bioreactor bag;

a separation membrane integrated into and permanently affixed to said bioreactor bag, so as to separate an interior of said bioreactor bag from an external environment; and

a non-sterilized sensor disposed outside of said bioreactor bag proximate to said separation membrane, such that said separation membrane does not permit passage of contaminants present on said sensor into said bioreactor bag.

2. The bioreactor system of claim 1, wherein said separation membrane is thermally welded to said bioreactor bag.

3. The bioreactor system of claim 1, wherein said separation membrane is adhered to said bioreactor bag.

4. The bioreactor system of claim 1, further comprising a supporting structure configured to hold said bioreactor bag, said supporting structure comprising a passage, aligned with said separation membrane, wherein said sensor is disposed in said passage.

5. The bioreactor system of claim 4, wherein a body of said sensor is threaded, such that said sensor body is screwed into said passage.

6. The bioreactor system of claim 4, further comprising a locking mechanism in communication with said passage, said locking mechanism used to hold said sensor in said passage.

7. The bioreactor system of claim 4, wherein said sensor is held in said passage using a clamping mechanism.

8. The bioreactor system of claim 1, wherein said sensor comprises a pH sensor.

9. The bioreactor system of claim 1, wherein said sensor comprises a temperature sensor.

10. The bioreactor system of claim 1, wherein said sensor comprises an oxygen sensor.

11. The bioreactor system of claim 1, wherein said sensor comprises a pressure sensor.

12. The bioreactor system of claim 1, wherein said sensor comprises a conductivity sensor.

13. The bioreactor system of claim 1, wherein said separation membrane is impermeable.

14. The bioreactor system of claim 1, wherein said separation membrane is semi-permeable.

15. A system comprising:

a bioreactor bag, having an inlet conduit;

a filtering element, having a downstream side through which filtered material passes, and an unfiltered upstream side;

a tube in communication with said downstream side of said filtering element and said inlet conduit of said bioreactor bag; and

a separation membrane, where said separation membrane is disposed in a position such that an unsterilized sensor can monitor a characteristic of said filtered material and said separation membrane does not permit passage of contaminants present on said sensor into said filtered material.

16. The system of claim 15, wherein said separation membrane is integrated into and permanently affixed to said tube.

17. The system of claim 15, wherein said separation membrane is integrated into and permanently affixed to said bioreactor bag, so as to separate an interior of said bioreactor bag from said unsterilized sensor.

18. The system of claim 15, wherein said separation membrane is disposed in an outlet conduit of said bioreactor bag.

19. The system of claim 15, wherein said separation membrane is impermeable.

20. The system of claim 15, wherein said separation membrane is semi-permeable.

21. The system of claim 15, wherein said sensor is selected from the group consisting of a pH sensor, a temperature sensor, an oxygen sensor, a pressure sensor, and a conductivity sensor.