Method, system, and apparatus for pharmaceutical container filing and lyophilizing

Patent metadata

Field	Value
Publication number	US-10781003-B2
Application number	US-201615171015-A
Country	US
Kind code	B2
Filing date	Jun 2, 2016
Priority date	Aug 16, 2013
Publication date	Sep 22, 2020
Grant date	Sep 22, 2020

Abstract

In one general aspect, a method is disclosed for processing a pharmaceutical substance in a pharmaceutical processing system that includes lyophilizing a plurality of containers provided in a nest. A first controlled environment enclosure in the pharmaceutical processing system is isolated against an external environment, and a controlled environmental condition is established in the first controlled environment enclosure. The pharmaceutical substance is deposited into at least a portion of the plurality of containers in the first container nest at a filling station within the first controlled environment enclosure. The deposited pharmaceutical substance is lyophilized in the first container nest.

First claim

What is claimed is:

1. A method for processing a pharmaceutical substance in a pharmaceutical processing system, the method of comprising:
providing a plurality of pharmaceutical containers held in at least a first container nest,
isolating a first controlled environment enclosure in the pharmaceutical processing system against an external environment,
establishing in the first controlled environment enclosure of the pharmaceutical processing system a controlled environment condition within the processing system, and
after establishing the controlled environment condition in the first controlled environment enclosure within the pharmaceutical processing system, performing the following steps in the first controlled environment enclosure:
depositing the pharmaceutical substance into at least a first portion of the plurality of containers in the first container nest;
placing a closure nest, having a plurality of closures, over the plurality of pharmaceutical containers such that at least a portion of the plurality of closures is disposed upon at least a second portion of the plurality of containers such that the at least a portion of the plurality of closures engage upper portions of the at least a second portion of the plurality of containers, wherein the closure nest comprises closure retaining features capable of releasably suspending each closure from the closure nest, the retaining features of the closure nest each having a spring-loaded retaining structure, wherein each closure comprises a stopper, a cap, and a holding feature above and extending radially outward relative to the cap;
lyophilizing the pharmaceutical substance contained in the at least a first portion of the plurality of containers in the first container nest; and
pushing the closure nest so that at least one of the stoppers seals at least one of the at least a second portion of the plurality of containers while the closures are held within the closure nest by the spring-loaded retaining structures engaging corresponding closure holding features of each closure.

2. The method of claim 1 , further including:
decontaminating the first container nest in a first transfer chamber,
placing the first controlled environment enclosure in spatial communication with the first transfer chamber,
aseptically gripping the first container nest, and
transferring the first container nest to the controlled environment enclosure.

3. The method of claim 2 , wherein the aseptically gripping comprises manipulating a first articulated arm apparatus and wherein the transferring comprises manipulating the first articulated arm apparatus.

4. The method of claim 3 , wherein the step of lyophilizing the pharmaceutical product takes place while releasably retaining aseptic closures in the closure nest.

5. The method of claim 3 , wherein the establishing of a controlled environmental condition includes establishing an aseptic condition.

6. The method of claim 2 , wherein the depositing comprises manipulating a second articulated arm apparatus.

7. The method of claim 2 , wherein the step of lyophilizing the pharmaceutical product takes place while releasably retaining aseptic closures in the closure nest.

8. The method of claim 2 , wherein the establishing of a controlled environmental condition includes establishing an aseptic condition.

9. The method of claim 2 , wherein the decontaminating is at least one of electron beam decontamination and ultraviolet radiation decontamination.

10. The method of claim 2 , wherein the decontaminating is by means of at least one of steam and chemical exposure.

11. The method of claim 1 , wherein the lyophilizing the pharmaceutical product comprises lyophilizing the pharmaceutical product in a stoppering apparatus having an interior that is adapted to be isolated from an interior of the first controlled environment enclosure.

12. The method of claim 1 , wherein the step of lyophilizing the pharmaceutical product takes place while releasably retaining aseptic closures in the closure nest.

13. The method of claim 12 , wherein the establishing of a controlled environmental condition includes establishing an aseptic condition.

14. The method of claim 1 , wherein the establishing of a controlled environmental condition includes establishing an aseptic condition.

15. The method of claim 1 , wherein the depositing of the pharmaceutical substance comprises filling simultaneously containers of the at least a first portion of the first plurality of containers.

16. The method of claim 1 , further comprising additional steps of partially closing at least a third portion of the first plurality of containers and transferring the at least a third portion of the first plurality of containers partially closed to a second controlled environment chamber.

Assignees

• Vanrx Pharmasystems Inc

Inventors

• Procyshyn Christopher
• Gold Ross M

Classifications

• B65D51/002

  Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means · CPC title

• B65D1/0246

  Closure retaining means, e.g. beads, screw-threads · CPC title

• B65B55/04

  Sterilising wrappers or receptacles prior to, or during, packaging {(sterilising bottles B67C7/00)} · CPC title

• B65B3/003

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

• B65B55/027

  Packaging in aseptic chambers · CPC title