Aseptic connectors for bio-processing containers

1. An aseptic peripheral connection assembly for installing a sterilized peripheral in a bio-processing vessel via an aseptic connector affixed to the vessel, the peripheral connection assembly comprising:

a. a carrier within an applicator sleeve, the carrier comprising the sterilized peripheral and a first sealing member configured to form a leak-tight seal with the aseptic vessel connector on the bio-processing vessel at a location where the carrier is to be installed;

b. an applicator comprising the applicator sleeve and a vessel-facing opening adjacent to an applicator connector configured to temporarily connect to the aseptic vessel connector on the bio-processing vessel;

c. a plunger within the applicator sleeve and configured to plunge the carrier from a position within the applicator sleeve to a position engaged with the aseptic vessel connector to form the leak-tight seal, wherein the plunger comprises a second sealing member; and

d. a removable hermetic sealing tab covering the vessel-facing opening of the applicator sleeve to maintain the sterilized peripheral in aseptic condition prior to installation in the bio-processing vessel.

2. The aseptic peripheral connection assembly of claim 1 , wherein the bio-processing vessel is a self-contained container or a flow path.

3. The aseptic peripheral connection assembly of claim 1 , wherein the bio-processing vessel is a bioreactor or a filter flow path.

4. The aseptic peripheral connection assembly of claim 1 , wherein the peripheral is a single use sensor.

5. The aseptic peripheral connection assembly of claim 1 , wherein the carrier comprises two or more sensors.

6. The aseptic peripheral connection assembly of claim 1 , wherein the carrier is disk shaped with a sensor having an exposed sensing surface on a flat side of the carrier.

7. The aseptic peripheral connection assembly of claim 6 , wherein the carrier comprises two or more sensors having exposed sensing surfaces on a flat side of the carrier.

8. The aseptic peripheral connection assembly of claim 1 , wherein the carrier is generally sheath shaped and comprises a sensor having an exposed sensing surface on an end of the carrier.

9. The aseptic peripheral connection assembly of claim 1 , wherein the first sealing member comprises a clip or a ledge.

10. The aseptic peripheral connection assembly of claim 1 , wherein the first sealing member comprises an o-ring.

11. The aseptic peripheral connection assembly of claim 1 , wherein the applicator sleeve is constructed of a rigid material.

12. The aseptic peripheral connection assembly of claim 1 , wherein the applicator is configured to be removed from the carrier and the bio-processing vessel after the carrier is installed in the bio-processing vessel.

13. The aseptic peripheral connection assembly of claim 1 , wherein the applicator sleeve has a tubular shape and the plunger has a substantially circular shape comprising the second sealing member that forms a seal with an interior surface of the applicator.

14. The aseptic peripheral connection assembly of claim 1 , wherein the applicator connector comprises a clip or a ledge.

15. The aseptic peripheral connection assembly of claim 1 , wherein the applicator connector comprises an o-ring.

16. The aseptic peripheral connection assembly of claim 1 , wherein the applicator connector is configured to provide a hermetic seal with the aseptic vessel connector while the plunger inserts the carrier into the aseptic vessel connector.

17. The aseptic peripheral connection assembly of claim 1 , wherein the applicator is composed of a polycarbonate, polysulfone, polyvinylidene fluoride, co-polyester, or a combination of any of these.

18. The aseptic peripheral connection assembly of claim 1 , wherein the applicator is composed of USP Class VI material that is animal derived component free, latex free, phthalate free, and gamma and e-beam stable.

19. The aseptic peripheral connection assembly of claim 1 , wherein the second sealing member comprises an o-ring for forming a hermetic seal with the applicator sleeve while plunging the carrier into position with the aseptic vessel connector.

20. The aseptic peripheral connection assembly of claim 1 , wherein the removable hermetic sealing tab is configured to be removed from the aseptic peripheral connection assembly after connecting the applicator to the aseptic vessel connector on the bio-processing vessel at a location where the sterilized peripheral is to be installed, and before plunging the carrier from a position within the applicator sleeve to a position engaged with the aseptic vessel connector.

21. The aseptic peripheral connection assembly of claim 1 , wherein the removable hermetic sealing tab comprises a film or sheet having a thickness of between about 1 mil and 20 mil.

22. The aseptic peripheral connection assembly of claim 1 , wherein the removable hermetic sealing tab comprises a USP Class VI, latex free, phthalate free animal derived component free polymeric plate.

23. The aseptic peripheral connection assembly of claim 1 , wherein the removal hermetic sealing tab is coated with an adhesive.

24. A bio-processing vessel kit comprising:

a. the aseptic peripheral connection assembly of claim 1 ; and

b. a bio-processing vessel housing with the aseptic vessel connector affixed.

25. The bio-processing vessel kit of claim 24 , wherein the bio-processing vessel housing is a single use bio-processing vessel housing or a flow path.

26. The bio-processing vessel kit of claim 24 , wherein the bio-processing vessel housing is configured or designed as a bioreactor or a filter with a flow path.

27. The bio-processing vessel kit of claim 26 , wherein the bio-processing vessel housing comprises a container packed with material for product separation.

28. A method of fabricating an aseptic peripheral connection assembly for installing a sterilized peripheral in a bio-processing vessel via an aseptic connector affixed to the vessel, wherein the aseptic peripheral connection assembly comprises (i) a carrier within an applicator sleeve, the carrier comprising the peripheral and a sealing member configured to form a leak-tight seal with the aseptic vessel connector on the bio-processing vessel at a location where the carrier is to be installed; and (ii) an applicator comprising the applicator sleeve and vessel-facing opening adjacent to an applicator connector configured to temporarily connect to the aseptic vessel connector on the bio-processing vessel, the method comprising:

a. placing the carrier in the applicator;

b. packaging the aseptic peripheral connection assembly in a hermetically sealed package; and

c. sterilizing the aseptic peripheral connection assembly, wherein the sterilizing does not employ exposure to radiation at a level of greater than about 15 kGy.

29. A method of using an aseptic peripheral connection assembly for installing a sterilized peripheral in a bio-processing vessel via an aseptic connector affixed to the vessel, wherein the aseptic peripheral connection assembly comprises (i) a carrier within an applicator sleeve, the carrier comprising the peripheral and a sealing member configured to form a leak-tight seal with the aseptic vessel connector on the bio-processing vessel at a location where the carrier is to be installed; and (ii) an applicator comprising the applicator sleeve and vessel-facing opening adjacent to an applicator connector, the method comprising:

a. connecting the applicator connector of the applicator to the aseptic vessel connector on the bio-processing vessel;

b. removing a hermetic sealing tab covering the vessel-facing opening of the applicator sleeve; and

c. plunging the carrier from a position within the applicator sleeve to a position engaged with the aseptic vessel connector, and forming the leak-tight seal therewith.