APPARATUS AND METHODS FOR LEAK DETECTION IN BIOPROCESSING BAGS

Abstract

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.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of a mixing arrangement including a bag in a rigid support container for possible use with fluids under sterile conditions;

FIG. 2 is a schematic diagram of a leak detection apparatus forming one aspect of the present invention;

FIG. 3 is a schematic diagram illustrating an alternative embodiment of the leak detecting apparatus of FIG. 2;

FIG. 4 is a schematic diagram of a leak detection apparatus forming another aspect of the present invention.

Claims

1. An apparatus intended for use in at least temporarily holding an electrically conductive fluid in need of processing under sterile conditions, comprising: a plastic bag having a first interior compartment capable of receiving the conductive fluid for processing under sterile conditions;a rigid container having a second interior compartment for at least partially receiving and supporting the bag; anda sensor for sensing the presence of a leak of the conductive fluid from the first interior compartment.

2. The apparatus of claim 1, wherein the sensor comprises first and second electrodes, said second electrode arranged external to the first interior compartment and capable of being connected to the first electrode contacting the conductive fluid by the leak.

3. The apparatus of claim 2, wherein the sensor farther includes a generator of AC or DC voltage and a detector connected to the first and second electrodes for detecting the current in the resulting circuit when connected by the leak.

4. The apparatus of claim 2, wherein the first electrode projects through a hermetic seal associated with the sidewall of the bag.

5. The apparatus of claim 2, wherein the bag includes a tubular port for receiving the first electrode.

6. The apparatus of claim 5, wherein the tubular port includes a connector for allowing the first electrode to contact the conductive fluid under sterile conditions.

7. The apparatus of claim 2, wherein the rigid support container at least partially comprises a conductive material forming the second electrode.

8. The apparatus of claim 1, wherein the bag comprises a first layer of material arranged for forming the first interior compartment and a second layer of material adjacent the first layer of material.

9. The apparatus of claim 8, wherein the sensor comprises first and second electrodes for positioning at least partially between the first and second layers of material.

10. The apparatus of claim 8, wherein the sensor further comprises first and second electrodes, one of said first and second electrodes comprising the second layer of material of the bag.

11. An apparatus intended for use in at least temporarily holding an electrically conductive fluid in need of processing under sterile conditions and detecting a leak thereof comprising: a plastic processing bag having a first interior compartment capable of receiving the conductive fluid under sterile conditions;an at least partially conductive support structure having a second interior compartment for at least partially receiving the plastic processing bag; andan electrode connected to the conductive fluid in the first interior compartment and arranged to form an electrical circuit with the conductive support structure in the presence of the leak.

12. The apparatus of claim 11, further including a generator of AC or DC voltage and a detector connected to the electrode and the conductive support structure for detecting a current in the electrical circuit.

13. An apparatus intended for use in at least temporarily holding an electrically conductive fluid in need of processing and detecting a leak thereof, comprising: a processing bag comprising a first layer of flexible material creating an interior compartment capable of receiving the conductive fluid under sterile conditions and a second layer of flexible material adjacent the first layer;first and second electrodes arranged external to the interior compartment and capable of being connected by the leak, at least said first electrode extending at least partially between the first and second layers of flexible material.

14. The apparatus of claim 13, wherein both of said first and second electrodes are between the first and second layers of flexible material.

15. The apparatus of claim 13, wherein said second layer of flexible material and the second electrode are unitary.

16. The apparatus of claim 13, wherein said second electrode comprises a rigid container for receiving and supporting the bag.

17. A method of processing fluid under sterile conditions, comprising: providing a plastic processing bag having a first interior compartment creating a sterile environment;placing the bag in a support structure having a second interior compartment;providing an electrically conductive fluid in the interior compartment; andproviding a sensor for detecting the presence of a leak of the conductive fluid from the first interior compartment.

18. The method of claim 17, wherein the providing step Her includes providing first and second electrodes capable of being connected by the leak, creating an electrical potential difference across the electrodes, and detecting the current flowing through the circuit formed by the presence of the leak.

19. The method of claim 18, wherein the support structure is at least partially conductive, and the step of providing first and second electrodes comprises providing the first electrode in contact the conductive fluid in the first interior compartment and using the support structure as the second electrode.

20. The method of claim 18, wherein the bag comprises first and second layers of material, and the providing step comprises positioning the first and second electrodes external to the first interior compartment and at least partially between the first and second layers of material.