Apparatus and methods for leak detection in bioprocessing bags
An apparatus detects a leak of an electrically conductive fluid from a disposable plastic bag used in mixing applications, such as during bioprocessing in a sterile environment. In one embodiment, the bag is associated with a sensor for detecting a leak from an interior compartment. The sensor may be arranged to detect either a leak internal to the at least two material layers of the bag or external to the outer layer, or both. Related methods are also disclosed.
1. An apparatus for use with a sensor for sensing the presence of a leak of a fluid held under sterile conditions, comprising:
a vessel including a flexible portion, said vessel at least partially defining an interior compartment adapted for receiving the fluid under sterile conditions; and
at least one electrode integrally connected to the vessel, said electrode adapted for use with the sensor for sensing a leak of the fluid,
wherein the vessel includes a port for at least partially receiving the at least one electrode;
whereby sensing of the leak by the sensor using the electrode indicates a breach of the sterile conditions.
2. The apparatus of claim 1 , wherein the vessel includes a connector for connecting the electrode with the fluid under sterile conditions.
3. The apparatus of claim 1 , further including a fluid-agitating element positioned in the interior compartment of the vessel.
4. The apparatus of claim 1 , further including a support structure for supporting the vessel.
5. The apparatus of claim 4 , wherein the support structure comprises a second electrode adapted for use with the sensor for sensing a leak of the fluid.
6. The apparatus of claim 1 , wherein the at least one electrode comprises a first electrode connected to the flexible portion of the vessel.
7. The apparatus of claim 6 , further including a second electrode adapted to form an electrical connection with the first electrode in the presence of a leak.
8. The apparatus of claim 7 , wherein the second electrode is connected to the vessel.
9. The apparatus of claim 7 , wherein the second electrode is external to the interior compartment of the vessel.
10. An apparatus for use with a sensor for sensing the presence of a leak of a fluid held under sterile conditions, comprising:
a vessel including a flexible portion, said vessel at least partially defining an interior compartment adapted for receiving the fluid under sterile conditions; and
at least one electrode integrally connected to the vessel, said electrode adapted for use with the sensor for sensing a leak of the fluid,
wherein the electrode comprises a layer of the vessel,
whereby sensing of the leak by the sensor using the electrode indicates a breach of the sterile conditions.
11. The apparatus of claim 10 , further including a sterile connector associated with the vessel.
12. The apparatus of claim 10 , further including a second electrode adapted to form an electrical connection with the first electrode in the presence of a leak.
13. An apparatus for at least temporarily holding a fluid for processing under sterile conditions, comprising:
an at least partially flexible vessel having a first interior compartment capable of receiving the fluid for processing under sterile conditions; and
a sensor comprising a first electrode connected to the vessel and a second electrode arranged external to the interior compartment to form an electrical connection with the first electrode,
wherein the first electrode is arranged at least partially in contact with the fluid;
whereby the electrical connection between the first and second electrodes may be used to detect the presence of a leak of the fluid from the interior compartment of the flexible vessel.
14. The apparatus of claim 13 , wherein the first electrode is arranged to at least partially form a wall of the flexible vessel.
15. The apparatus of claim 13 , wherein the second electrode is arranged to at least partially form a wall of the flexible vessel.
16. The apparatus of claim 13 , wherein the first electrode extends at least partially within the interior compartment.
17. The apparatus of claim 13 , wherein the first electrode comprises a layer of the vessel.
18. The apparatus of claim 13 , further including a sterile connector associated with the vessel.
19. An apparatus for use with a sensor for sensing the presence of a leak of a fluid held under sterile conditions, comprising:
a vessel including a flexible portion, said vessel at least partially defining an interior compartment adapted for receiving the fluid under sterile conditions; and
at least one electrode integrally connected to the vessel, said electrode adapted for use with the sensor for sensing a leak of the fluid,
wherein the vessel includes a connector for connecting the electrode with the fluid under sterile conditions;
whereby sensing of the leak by the sensor using the electrode indicates a breach of the sterile conditions.
20. The apparatus of claim 19 , further including a second electrode adapted to form an electrical connection with the first electrode in the presence of a leak.
21. An apparatus for at least temporarily holding a fluid for processing under sterile conditions, comprising:
an at least partially flexible vessel having a first interior compartment capable of receiving the fluid for processing under sterile conditions; and
a sensor comprising a first electrode connected to the vessel and a second electrode arranged external to the interior compartment to form an electrical connection with the first electrode,
wherein the first electrode extends at least partially within the interior compartment;
whereby the electrical connection between the first and second electrodes may be used to detect the presence of a leak of the fluid from the interior compartment of the flexible vessel.
22. The apparatus of claim 21 , further including a sterile connector associated with the vessel.
23. An apparatus for at least temporarily holding a fluid for processing under sterile conditions, comprising:
an at least partially flexible vessel having a first interior compartment capable of receiving the fluid for processing under sterile conditions; and
a sensor comprising a first electrode connected to the vessel and a second electrode arranged external to the interior compartment to form an electrical connection with the first electrode,
wherein the first electrode comprises a layer of the vessel; and
whereby the electrical connection between the first and second electrodes may be used to detect the presence of a leak of the fluid from the interior compartment of the flexible vessel.
24. The apparatus of claim 23 , further including a sterile connector associated with the vessel.