Method, device and system for filling pharmaceutical containers

Patent metadata

Field	Value
Publication number	US-2016200461-A1
Application number	US-201414912145-A
Country	US
Kind code	A1
Filing date	Aug 15, 2014
Priority date	Aug 16, 2013
Publication date	Jul 14, 2016
Grant date	—

Abstract

In one general aspect, a method for filling multiple containers with a pharmaceutical product is disclosed, which comprises decontaminating sealed nested materials in a transfer chamber, removing from the sealed nested materials one or both of a container nest holding the multiple containers and a closure nest holding multiple closures, transferring from the transfer chamber to a controlled environment enclosure the removed nest, aseptically filling the containers with the pharmaceutical product, and closing the containers with the multiple closures. The nests are configured to allow multiple closures and containers to be simultaneously aligined concentrically, and closed simultaneously. Spring-loaded retaining structures on the closure nest allow it to releasably retain multiple closures above the corresponding multiple containers. In some embodiments the spring-loaded features are monolithically integrated with the closure nest. The product may be lyophilized in partially sealed containers while the sealing closures are releasably retained by the closure nest.

First claim

What is claimed is:

1 . A method for aseptically filling a first plurality of containers with a pharmaceutical product in a first controlled environment enclosure, the method comprising:
decontaminating at least one of first and second sealed nested materials in a first transfer chamber; placing the first controlled environment enclosure in spatial communication with the first transfer chamber; aseptically gripping the at least one of first and second sealed nested materials; transferring the at least one of first and second sealed nested materials to the controlled environment enclosure; removing from one of the first and second sealed nested materials a container nest holding the first plurality of containers and removing from the other of the first and second sealed nested materials a closure nest releasably retaining a plurality of closures; filling the first plurality of containers with the pharmaceutical product in the first controlled environment enclosure; and at least partially closing the first plurality of containers with the plurality of closures.

2 . The method of claim 1 , wherein the first plurality of containers is in the closure nest during the at least partially closing.

3 . The method of claim 1 , wherein the aseptically gripping comprises manipulating a first articulated arm apparatus.

4 . The method of claim 3 , wherein the filling comprises manipulating a second articulated arm apparatus.

5 . The method of claim 1 , wherein the filling the first plurality of containers comprises filling simultaneously at least a portion of the first plurality of containers.

6 . The method of claim 1 , wherein the filling the first plurality of containers comprises manipulating an articulated arm apparatus to move one of the container nest and a fill needle system dispensing the pharmaceutical product.

7 . The method of claim 6 , wherein dispensing the pharmaceutical product comprises dispensing the pharmaceutical product simultaneously from a plurality of fill needles.

8 . The method of claim 6 , wherein the removing the container nest holding the first plurality of containers is by manipulating a second articulated arm apparatus.

9 . The method of claim 1 , wherein the at least partially closing the first plurality of containers comprises:
a. partially inserting the plurality of closures in the first plurality of containers; b. lyophilizing the pharmaceutical product in the first plurality of containers; and c. at least partially sealing the first plurality of containers by exerting pressure on at least a portion of a plurality of caps associated with the plurality of stoppers.

10 . The method of claim 9 , wherein the lyophilizing the pharmaceutical product comprises lyophilizing the pharmaceutical product in a stoppering apparatus having an interior that may be isolated from the interior of the first controlled environment enclosure.

11 . The method of claim 1 , wherein the partially closing the first plurality of containers comprises simultaneously partially closing at least a portion of the first plurality of containers.

12 . The method of claim 1 , wherein the partially closing the first plurality of containers comprises partially closing all the containers in the container nest simultaneously.

13 . The method of claim 1 , wherein the closing the first plurality of containers comprises manipulating an articulated arm apparatus to place the first plurality of containers in a stoppering apparatus.

14 . The method of claim 1 , further comprising returning the filled containers to the transfer chamber and terminating the spatial communication between the transfer chamber and the first controlled environment chamber.

15 . The method of claim 1 , wherein the at least partially closing comprises completely closing and the method further comprises transferring the filled containers to a second controlled environment enclosure.

16 . The method of claim 1 , further comprising transferring the partially sealed first plurality of containers to a second controlled environment chamber.

17 . The method of claim 1 , further comprising maintaining aseptic conditions in the first controlled environment chamber.

18 . The method of claim 1 , wherein the at least partially closing the first plurality of containers with the plurality of closures is at least partially closing the first plurality of containers while the first plurality of containers is in the closure nest.

19 . The method of claim 1 , wherein the decontaminating is at least one of electron beam decontamination and ultraviolet radiation decontamination.

20 . The method of claim 1 , wherein the decontaminating is by means of at least one of steam and chemical exposure.

21 . The method of claim 1 , wherein the decontaminating the at least one of first and second sealed nested materials comprises covering the at least one of first and second sealed nested materials with an impermeable cover.

22 . The method of claim 1 , further comprising weighing the first plurality of containers while the first plurality of containers is in the container nest.

23 . A method for aseptically sealing a pharmaceutical product into a plurality of containers, the method comprising:
a. introducing a first plurality of containers into a controlled environment enclosure; b. releasably suspending from a closure nest in the controlled environment a plurality of aseptic closures; c. filling at least a first portion of the first plurality of containers with the pharmaceutical product; and d. sealing simultaneously at least partially a second portion of the first plurality of containers with a portion of the plurality of aseptic closures while releasably retaining the aseptic closures in the closure nest.

24 . The method of claim 23 , wherein the releasably suspending comprises releasably engaging with a holding feature of each of the plurality of aseptic closures.

25 . The method of claim 24 , wherein the releasably engaging with the holding feature comprises elastically engaging with the holding feature.

26 . The method of claim 25 , wherein the elastically engaging with the holding feature comprises engaging the holding feature with a spring-loaded retaining structure portion of the closure nest.

27 . The method of claim 23 , wherein the releasably retaining comprises releasably engaging with a holding feature of each of the plurality of aseptic closures.

28 . The method of claim 27 , wherein the releasably engaging with the holding feature comprises elastically engaging with the holding feature.

29 . The method of claim 28 , wherein the elastically engaging with the holding feature comprises engaging the holding feature with a spring-loaded retaining structure portion of the closure nest.

30 . The method of claim 23 , wherein the portion of the plurality of the aseptic closures is all the closures in the plurality of closures.

31 . The method of claim 30 , wherein the first portion of the first plurality of containers equals in number the number of closures in the plurality of closures.

32 . The method of claim 30 , wherein the number of closures in the plurality of closures is all the closures the closure nest is configured to retain.

33 . The method of cl

Assignees

• Vanrx Pharmasystems Inc

Inventors

• Broadbent Nick
• Immerzeel Jeroen
• Procyshyn Christopher
• Gold Ross M
• Park Steve Sang Joon

Classifications

• B65D41/28

  Caps combined with stoppers · CPC title

• B65B55/10

  by liquids or gases · CPC title

• B65B55/08

  by irradiation · CPC title

• B65B7/161 Primary

  Sealing filled ampoules · CPC title

• B65B55/027

  Packaging in aseptic chambers · CPC title