Apparatus and method for the integrity testing of flexible containers

1. An apparatus for use in detecting a detectable gas in a hermetically sealed detection chamber, comprising:

a sterilized first container for positioning in the detection chamber, said first container having a flexible body at least partially defining a first interior chamber for receiving and holding the detectable gas in the absence of a leak;

a sensor associated with the detection chamber and capable of sensing the detectable gas external to the first interior chamber as the result of the leak;

a pump for creating a pressure differential between the first interior chamber and the detection chamber; and

a connector for delivering the detectable gas to the first interior chamber under sterile conditions.

2. The apparatus of claim 1 , further including a valve for controlling the flow of the detectable gas from a source of the detectable gas to the first interior chamber.

3. The apparatus of claim 1 , wherein the connector comprises a sterilizing filter.

4. The apparatus of claim 1 , further including a rigid container forming the detection chamber for receiving the first container.

5. The apparatus of claim 4 , wherein the rigid container includes a port adapted for delivering the detectable gas from a source external to the first interior chamber.

6. The apparatus of claim 4 , wherein the rigid container further includes a cover for hermetically sealing the detection chamber.

7. The apparatus of claim 6 , wherein the cover includes a port adapted for permitting the delivery of the detectable gas from a source external to the detection chamber.

8. The apparatus of claim 6 , wherein the first container comprises a fluid processing bag including a fluid-agitating element.

9. The apparatus of claim 6 , further including a spacer for promoting the escape of the detectable gas from any leak in the first container.

10. An apparatus for use in detecting a detectable gas in a detection chamber, comprising:

a sterilized first container for positioning in the detection chamber, said first container having a flexible body at least partially defining a first interior chamber for receiving and holding the detectable gas under sterile conditions;

a conduit connected to the sterilized first container for delivering the detectable gas to the interior compartment;

a sensor associated with the detection chamber and capable of sensing the detectable gas external to the first interior chamber as the result of the leak; and

a pump for creating a pressure differential between the first interior chamber and the detection chamber.

11. The apparatus of claim 10 , further including a valve associated with the conduit for controlling the flow of the detectable gas from a source of the detectable gas to the first interior chamber.

12. The apparatus of claim 10 , wherein the conduit comprises a sterilizing filter.

13. The apparatus of claim 10 , further including a rigid container forming the detection chamber for receiving the first container.

14. The apparatus of claim 13 , wherein the rigid container includes a port adapted for delivering the detectable gas from a source external to the first interior chamber.

15. The apparatus of claim 14 , wherein the conduit passes through the port of the rigid container.

16. The apparatus of claim 14 , wherein the rigid container further includes a cover for hermetically sealing the detection chamber.

17. The apparatus of claim 16 , wherein the cover includes a port adapted for permitting the delivery of the detectable gas from a source external to the detection chamber.

18. The apparatus of claim 16 , wherein the first container comprises a fluid processing bag including a fluid-agitating element.

19. The apparatus of claim 10 , further including a spacer for promoting the escape of the detectable gas from any leak in the first container.

20. An apparatus for use in detecting a detectable gas in a detection chamber, comprising:

a sterilized fluid processing bag including a fluid-agitating element, said processing bag having a flexible body at least partially defining a first interior chamber for receiving and holding the detectable gas in the absence of a leak;

a sensor associated with the detection chamber and capable of sensing the detectable gas external to the first interior chamber as the result of the leak; and

a pump for creating a pressure differential between the first interior chamber and the detection chamber.

21. The apparatus of claim 20 , further including a valve for controlling the flow of the detectable gas from a source of the detectable gas to the first interior chamber.

22. The apparatus of claim 20 , further including a connector for delivering the detectable gas to the first interior chamber under sterile conditions.

23. The apparatus of claim 22 , wherein the connector comprises a sterilizing filter.

24. The apparatus of claim 20 , further including a rigid container forming the detection chamber for receiving the first container.

25. The apparatus of claim 24 , wherein the rigid container includes a port adapted for delivering the detectable gas from a source external to the first interior chamber.

26. The apparatus of claim 24 , wherein the rigid container further includes a cover for hermetically sealing the detection chamber.

27. The apparatus of claim 26 , wherein the cover includes a port adapted for permitting the delivery of the detectable gas from a source external to the detection chamber.

28. The apparatus of claim 20 , further including a spacer for promoting the escape of the detectable gas from any leak in the first container.

29. The apparatus of claim 24 , further including a spacer positioned between the sterilized fluid processing bag and a wall of the rigid container.

30. An apparatus for use in detecting a detectable gas in a hermetically sealed detection chamber, comprising:

a sterilized first container for positioning in the detection chamber, said first container having a flexible body at least partially defining a first interior chamber for receiving and holding the detectable gas in the absence of a leak;

a sensor associated with the detection chamber and capable of sensing the detectable gas external to the first interior chamber as the result of the leak;

a pump for creating a pressure differential between the first interior chamber and the detection chamber; and

a rigid container forming the detection chamber for receiving the first container, said rigid container including a port adapted for delivering the detectable gas from a source external to the first interior chamber.

31. The apparatus of claim 30 , further including a valve for controlling the flow of the detectable gas from a source of the detectable gas to the first interior chamber.

32. The apparatus of claim 30 , further including a connector for delivering the detectable gas to the first interior chamber.

33. The apparatus of claim 32 , wherein the connector comprises a sterilizing filter.

34. The apparatus of claim 30 , wherein the rigid container includes a port adapted for delivering the detectable gas from a source external to the first interior chamber.

35. The apparatus of claim 30 , wherein the rigid container further includes a cover for hermetically sealing the detection chamber.

36. The apparatus of claim 35 , wherein the cover includes a port adapted for permitting the delivery of the detectable gas from a source external to the detection chamber.

37. The apparatus of claim 30 , wherein the first container comprises a fluid processing bag including a fluid-agitating element.

38. The apparatus of claim 30 , further including a spacer for promoting the escape of the detectable gas from any leak in the first container.