Apparatus for asepticaly filling pharmaceutical containers with a pharmaceutical fluid using rotary stage

Patent metadata

Field	Value
Publication number	US-10967994-B2
Application number	US-201916431549-A
Country	US
Kind code	B2
Filing date	Jun 4, 2019
Priority date	Aug 4, 2016
Publication date	Apr 6, 2021
Grant date	Apr 6, 2021

Abstract

Systems and methods for aseptically filling pharmaceutical containers with pharmaceutical fluid are disclosed. In one general aspect, these are based on an aseptically sealable chamber that includes a transfer wall to which pre-sealed pharmaceutical source and receiving containers are mounted aseptically. A robotic arm and a syringe store are disposed within the chamber along with a sterilizing facility for establishing in the chamber an aseptic condition. The robotic arm can grip and operate syringes to inject and/or extract pharmaceutical products from the containers by piercing their closures with the needles of the syringes.

First claim

What is claimed is:

1. A system for aseptically filling pharmaceutical containers with pharmaceutical fluid, the system comprising:
an aseptically sealable chamber,
wherein the aseptically sealable chamber includes a transfer wall including a plurality of openings, corresponding portions of the transfer wall defining each of the openings, each corresponding portion providing a sealing surface being aseptically sealable to a container,
a robotic arm disposed within the sealable chamber and having a range of motion that allows it to move a fluid transfer conduit to each of the openings,
a fluid transfer actuator to drive fluid through the fluid transfer conduit, a controller that includes:
three-dimensional arm control logic to move the fluid transfer conduit to a selected container that sealably passes through one of the openings, and
fluid transfer actuation logic to operate the fluid transfer actuator to transfer fluid between a fluid transfer vessel and the selected container, and
a sterilizing facility for establishing an aseptic condition within the sealable chamber
and further comprising at least one sealing structure to mount a container to the transfer wall, the sealing structure including a flange having a recessed portion, the recessed portion including a vapor communication hole.

2. The system of claim 1 wherein the fluid transfer conduit is a syringe needle mounted on a syringe that includes a body and a plunger and wherein the fluid transfer actuator is a linear actuator that moves the plunger relative to the body.

3. The system of claim 2 further including at least one container with a pierceable closure sealably passing through one of the openings with the pierceable closure
positioned inside the sealable chamber and wherein the three-dimensional arm control logic is operative to cause the syringe needle to pierce the pierceable closure.

4. The system of claim 3 , wherein the three-dimensional arm control logic and the fluid transfer actuation logic are operative to transfer fluids from one container to another.

5. The system of claim 3 , further comprising a syringe store disposed in the interior of the sealable chamber and wherein the three-dimensional arm control logic is operative to transfer syringes to and from the syringe store.

6. The system of claim 1 , wherein the robotic arm is an articulated robotic arm.

7. The system of claim 1 , wherein the sealable chamber is capable of being operated under a positive pressure when sealed.

8. The system of claim 1 wherein the sealing structure further includes a cap connected to the flange.

9. The system of claim 8 wherein the container is disposed within the flange and cap.

10. The system of claim 9 wherein a pierceable closure is aseptically sealed with the container.

11. The method of claim 10 wherein the at least one container is aseptically sealed to the sealing structure by at least one o-ring.

12. The system of claim 1 further including at least one sealing structure to mount at least one intra-venous bag to the transfer wall.

13. The system of claim 12 wherein the intra-venous bag includes a tube aseptically sealed to a pierceable closure.

14. The system of claim 1 wherein the fluid transfer conduit includes a syringe, and the fluid transfer actuator includes a plunger mechanism of the syringe.

15. The system of claim 14 further comprising a syringe carousel adapted to mount a plurality of syringes.

16. The system of claim 15 further comprising a capping station for removing a cap from the syringe.

17. The system of claim 1 further comprising at least one container with a pierceable closure sealably passing through one of the openings with the pierceable closure positioned inside the sealable chamber.

18. The system of claim 17 wherein the three-dimensional arm control logic is adapted to cause the fluid transfer conduit to pierce the pierceable closure.

19. The system of claim 1 wherein the sealing structure includes two half-annular caps holding the pierceable closure of the intra-venous bag.

20. The system of claim 19 wherein at least two sealing structures are disposed on a mounting plate and aseptically sealed to the transfer wall.

21. A system for aseptically filling pharmaceutical containers with pharmaceutical fluid, the system comprising:
an aseptically sealable chamber,
wherein the aseptically sealable chamber includes a transfer wall including a plurality of openings, corresponding portions of the transfer wall defining each of the openings, each corresponding portion providing a sealing surface being aseptically sealable to a container,
a robotic arm disposed within the sealable chamber and having a range of motion that allows it to move a fluid transfer conduit to each of the openings,
a fluid transfer actuator to drive fluid through the fluid transfer conduit, a controller that includes:
three-dimensional arm control logic to move the fluid transfer conduit to a selected container that sealably passes through one of the openings, and
fluid transfer actuation logic to operate the fluid transfer actuator to transfer fluid between a fluid transfer vessel and the selected container, and
a sterilizing facility for establishing an aseptic condition within the sealable chamber;
further including at least one sealing structure to mount at least one intra-venous bag to the transfer wall, wherein the intra-venous bag includes a tube aseptically sealed to a pierceable closure, and the sealing structure includes two half-annular caps holding the pierceable closure of the intra-venous bag.

22. The system of claim 21 wherein at least two sealing structures are disposed on a mounting plate and aseptically sealed to the transfer wall.

23. The system of claim 21 wherein the fluid transfer conduit includes a syringe, and the fluid transfer actuator includes a plunger mechanism of the syringe.

24. The system of claim 23 further comprising a syringe carousel adapted to mount a plurality of syringes.

25. The system of claim 24 further comprising a capping station for removing a cap from the syringe.

26. The system of claim 21 wherein the fluid transfer conduit includes a syringe, and the fluid transfer actuator includes a plunger mechanism of the syringe.

27. The system of claim 26 further comprising a syringe carousel adapted to mount a plurality of syringes.

28. The system of claim 27 further comprising a capping station for removing a cap from the syringe.

29. The system of claim 21 wherein the fluid transfer conduit is a syringe needle mounted on a syringe that includes a body and a plunger and wherein the fluid transfer actuator is a linear actuator that moves the plunger relative to the body.

30. The system of claim 29 further including at least one container with a pierceable closure sealably passing through one of the openings with the pierceable closure
positioned inside the sealable chamber and wherein the three-dimensional arm control logic is operative to cause the syringe needle to pierce the pierceable closure.

31. The system of claim 30 , wherein the three-dimensional arm control logic and the fluid transfer actuation logic are operative to transfer fluids from one container to another.

32. The system of claim 30 , further comprising a syringe store dispose

Assignees

• Vanrx Pharmasystems Inc

Inventors

• Procyshyn Christopher A
• Naing Juvenal
• Senger John
• Cichy Marcin Czeslaw

Classifications

• B65B3/003 Primary

  Filling medical containers such as ampoules, vials, syringes or the like · CPC title

• B65B55/027

  Packaging in aseptic chambers · CPC title

• B65B55/022

  of flexible containers having a filling and dispensing spout, e.g. containers of the "bag-in-box"-type (B65B55/025, B65B55/027 take precedence) · CPC title

• A61M5/1782

  Devices aiding filling of syringes in situ (combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003) · CPC title

• B67C3/004

  permanently attached to the filling machine and movable between a rest and a working position · CPC title