System and method for interfacing sensors to a sterile flow stream

• US 8,640,560 B2
• Filed: 03/26/2008
• Issued: 02/04/2014
• 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:
  US12/079,323
• Publication Number:
  US 20090247989A1
• Time in Patent Office: 2,141 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 method of interfacing a non-sterile sensor to a sterile flow stream, comprising:

a. providing at least one component defining a flow path adapted to be in communication with said flow stream, one of said at least one components having a port and a receptacle for attachment of said sensor;

b. permanently affixing a separation membrane to said port located on said at least one component so that it is an integral and permanent part of said flow path;

c. sterilizing a surface of said permanently affixed membrane facing said flow path with said at least one component; and

d. attaching said non-sterile sensor to said receptacle while leaving said separation membrane in place, such that said separation membrane does not permit the passage of contaminants present on said sensor to said flow path.

2. The method of claim 1, whereby said membrane is impermeable.

3. The method of claim 1, whereby said membrane is semi-permeable.

4. The method of claim 1, whereby said membrane is durable against gamma sterilization.

5. The method of claim 1, whereby at least one of said at least one components defining said flow path is selected from the group consisting of a filter, a bioreactor bag, a tube and a container.

6. The method of claim 1, whereby said sterilization step is performed using gamma irradiation.

7. The method of claim 2, whereby said sensor comprises a temperature sensor.

8. The method of claim 2, whereby said sensor comprises a pressure sensor.

9. The method of claim 3, whereby said sensor comprises an oxygen sensor.

10. The method of claim 3, whereby said sensor comprises a pH sensor.

11. The method of claim 3, whereby said sensor comprises a conductivity sensor.

21. The method of claim 1, whereby said sterile flow stream comprises biocomponents.

12. A system for sensing a characteristic of a sterile flow stream, comprising:

a. at least one component defining a flow path in communication with said sterile flow stream;

b. a port and a receptacle located on one of said at least one components in said flow path for attachment to a sensor;

c. a separation membrane permanently affixed to said port located on said at least one component so as to be an integral and permanent part of said flow path; and

d. a non-sterilized sensor attached to said receptacle and separated from said sterile flow stream by said membrane, such that said separation membrane does not permit the passage of contaminants present on said sensor to said flow path.

13. The system of claim 12, wherein said sensor comprises a pH sensor.

14. The system of claim 12, wherein said sensor comprises a temperature sensor.

15. The system of claim 12, wherein said sensor comprises an oxygen sensor.

16. The system of claim 12, wherein said sensor comprises a pressure sensor.

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

18. The system of claim 12, wherein said separation membrane is impermeable.

19. The system of claim 12, wherein said separation membrane is semi-permeable.

20. The system of claim 12, wherein at least one of said at least one components defining said flow path is selected from the group consisting of a filter, a bioreactor bag, a tube and a container.

22. The system of claim 12, wherein said sterile flow stream comprises biocomponents.