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

Patent metadata

Field	Value
Publication number	US-10850873-B2
Application number	US-201715453615-A
Country	US
Kind code	B2
Filing date	Mar 8, 2017
Priority date	Aug 4, 2016
Publication date	Dec 1, 2020
Grant date	Dec 1, 2020

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 method for filling pharmaceutical containers with a fluid pharmaceutical product, the method comprising:
providing an aseptically sealable chamber comprising a robotic arm and a transfer wall capable of having aseptically mounted thereto a plurality of pharmaceutical containers pre-sealed with pierceable closures, wherein the aseptically sealable chamber is capable of maintaining an aseptic condition within an interior of the sealable chamber when the pharmaceutical containers are mounted to the transfer wall,
aseptically mounting to the transfer wall a plurality of pharmaceutical containers aseptically pre-sealed with corresponding pierceable pharmaceutical container closures, wherein the mounting of the plurality of pharmaceutical containers comprises mounting the plurality of pharmaceutical containers in locations and orientations wherein the corresponding pierceable pharmaceutical container closures are penetrable from within the interior of the sealable chamber, and the step of aseptically mounting to the transfer wall a plurality of pharmaceutical containers includes using at least one sealing structure to mount at least one container to the transfer wall, the sealing structure includes a flange having a recessed portion, and the recessed portion includes a vapor communication hole,
providing within the sealable chamber a first pharmaceutical syringe comprising a first syringe needle,
aseptically sealing the sealable chamber,
establishing an aseptic condition within the interior of the sealable chamber and on all portions of the plurality of pharmaceutical containers exposed to the interior of the sealable chamber, and
transferring a portion of the first fluid pharmaceutical product between the first syringe and at least one of the plurality of pharmaceutical containers through the corresponding pierceable pharmaceutical container closure via the first syringe needle.

2. The method of claim 1 , wherein the transferring comprises piercing the corresponding pierceable pharmaceutical container closure with the first syringe needle.

3. The method of claim 1 , wherein the transferring comprises operating the robotic arm.

4. The method of claim 1 , wherein providing an aseptically sealable chamber comprising a robotic arm comprises providing an aseptically sealable chamber comprising an articulated robotic arm and the transferring comprises operating the articulated robotic arm.

5. The method of claim 1 , wherein the transferring includes injecting a portion of the first pharmaceutical product into the one of the plurality of pharmaceutical containers, and wherein providing within the sealable chamber the first pharmaceutical syringe containing the first fluid pharmaceutical product comprises:
aseptically mounting to the transfer wall a first source pharmaceutical container aseptically pre-sealed with a corresponding pierceable first pharmaceutical container closure, wherein the mounting of the first source pharmaceutical container comprises disposing the first source pharmaceutical container in a location and orientation wherein the first pharmaceutical container closure is penetrable from within the interior of the sealable chamber,
piercing the closure of the first source pharmaceutical container with the first syringe needle, and
extracting a portion of the first fluid pharmaceutical product from the first source pharmaceutical container into the first pharmaceutical syringe.

6. The method of claim 5 , wherein at least one of the aseptically sealing, the establishing an aseptic condition, the transferring, and the extracting a portion of the first fluid pharmaceutical product is performed automatically.

7. The method of claim 5 , further comprising establishing within the sealable chamber a positive atmospheric pressure.

8. The method of claim 7 , wherein the establishing within the sealable chamber a positive atmospheric pressure is performed automatically after the aseptically sealing the sealable chamber.

9. The method of claim 5 , further comprising
injecting a portion of a second fluid pharmaceutical product from a second syringe into the at least one of the plurality of pharmaceutical containers through the corresponding pierceable pharmaceutical container closure via a second syringe needle.

10. The method of claim 9 , wherein the providing an aseptically sealable chamber comprises providing an aseptically sealable chamber comprising a syringe store, and wherein the second syringe is prepared by:
aseptically mounting to the transfer wall a second source pharmaceutical container aseptically pre-sealed with a corresponding pierceable second pharmaceutical container closure and containing the second fluid pharmaceutical, wherein the mounting of the second source pharmaceutical container comprises disposing the second source pharmaceutical container in a location and orientation wherein the second pharmaceutical container closure is penetrable from within the interior of the sealable chamber,
operating the robotic arm to place the first syringe in the syringe store,
operating the robotic arm to obtain from the syringe store the second pharmaceutical syringe comprising the second syringe needle,
operating the robotic arm to pierce the closure of the second source pharmaceutical container with the second syringe needle, and
operating the robotic arm to extract a portion of the second fluid pharmaceutical product from the second source pharmaceutical container into the syringe.

11. The method of claim 1 , wherein the establishing an aseptic condition comprises treating the interior of the sealable chamber and all portions of the at least one pharmaceutical container exposed to the interior of the sealable chamber with at least one of heated water vapor, gaseous hydrogen peroxide, ozone, nitrogen dioxide, ethylene oxide, and glutaraldehyde vapor.

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

13. The method of claim 12 wherein the at least one container is disposed within the flange and cap.

14. The method of claim 13 wherein a pierceable closure is aseptically sealed with the at least one container.

15. The method of claim 14 wherein the at least one container is aseptically sealed to the sealing structure by at least one o-ring.

16. The method of claim 1 wherein the step of providing within the sealable chamber a first pharmaceutical syringe comprising a first syringe needle includes removing a cap from the first syringe at a syringe capping station.

17. The method of claim 1 wherein the step of aseptically mounting to the transfer wall a plurality of containers aseptically pre-sealed with corresponding pierceable pharmaceutical container closures, involves mounting to a side of the transfer wall with is exterior of the sealable chamber prior to the step of providing an aseptically sealable chamber.

18. A method for filling pharmaceutical containers with a fluid pharmaceutical product, the method comprising:
providing an aseptically sealable chamber comprising a robotic arm and a transfer wall capable of having aseptically mounted thereto a plurality of pharmaceutical containers pre-sealed with pierceable closures, wherein the aseptically sealable chamber is capable of maintaining an aseptic condition within an interior of the sealable chamber when the pharmaceutical containers are mounted to the transfer wall,
aseptically mounting to the transfer wall a plurality of pharmaceutical containers aseptically pre-sealed with corresponding pierceable pharmaceutica

Assignees

• Vanrx Pharmasystems Inc

Inventors

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

Classifications

• 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

• B67C3/004

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

• B65B55/027

  Packaging in aseptic chambers · CPC title

• B65B3/003 Primary

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