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

Patent metadata

Field	Value
Publication number	US-12528615-B2
Application number	US-201916370526-A
Country	US
Kind code	B2
Filing date	Mar 29, 2019
Priority date	Sep 13, 2016
Publication date	Jan 20, 2026
Grant date	Jan 20, 2026

Abstract

A system for filling nested pharmaceutical containers with a pharmaceutical fluid is disclosed. In one general aspect, it comprises a sterilizable chamber containing a planar rotary stage with a fiducial locating structure for holding a pharmaceutical container nest. The chamber has a rotatable cover removal station, a rotatable filling station with a dispenser head, and camera guided vacuum pickup facilities for handling container and closure nests. An associated method for filling the containers comprises establishing an aseptic condition within the chamber; removing covers from a container tub and a container closure tub by operating both the rotary stage and the cover removal station. The vacuum pickup facility transfers into the fiducial locating structure a container nest bearing pharmaceutical containers. The fluid is dispensed into the containers by operating both the rotary stage and the filling station. A container closure nest is placed on the container nest in the fiducial locating structure with closures in correspondence with containers. A ram in the chamber forces the closures into the containers.

First claim

What is claimed is:

1 . A container tub assembly of for holding nested and sterilized pharmaceutical container parts, comprising:
a container tub defining an interior adapted to hold the nested and sterilized pharmaceutical container parts, comprising:
a bottom,
a lip having a sealing surface with a peripheral outline, and
sidewalls located between the bottom and the lip,
a gas impermeable peelable container cover consisting of a sheet of flexible material sealed to the sealing surface of the lip of the container tub to seal the nested and sterilized pharmaceutical container parts, and a cover removal fixture on the container cover, the cover removal fixture having an appendage that is structured and arranged to be engageable by a forked engagement tool; wherein the cover removal fixture is detachably clipped to a portion of the peelable container cover that extends outside of the peripheral outline of the sealing surface of the container.

2 . The container tub assembly of claim 1 wherein the gas impermeable container cover includes a portion that extends outside of the peripheral outline of the sealing surface of the container tub, and the cover removal fixture is on the portion of the gas impermeable container cover that extends outside of the peripheral outline of the top sealing surface of the container tub.

3 . The container tub assembly of claim 1 wherein the container tub is rectangular and includes four sidewalls.

4 . The container tub assembly of claim 1 wherein the gas impermeable container cover is heat sealed to the sealing surface of the lip of the container tub to seal the contents of the container against a decontamination process.

5 . The container tub assembly of claim 4 wherein the container tub assembly is configured for the decontamination process to be effected by a decontamination agent, the decontamination agent being one of a decontamination gas, a decontamination irradiation, and a decontamination plasma.

6 . The container tub assembly of claim 4 wherein the gas impermeable container cover is sealed to the sealing surface of the lip of the rectangular container to seal the contents of the container against the decontamination process using a chemical agent including at least one of heated water vapor, hydrogen peroxide vapor, ozone, nitrogen dioxide, chlorine dioxide, ethylene oxide and glutaraldehyde vapor.

7 . The container tub assembly of claim 4 wherein the gas impermeable container cover is sealed to the sealing surface of the lip of the container tub to seal the contents of the container tub against the decontamination process using an irradiation including at least one of at least one of ultraviolet irradiation and electron beam irradiation.

8 . The container tub assembly of claim 4 wherein the gas impermeable container cover is sealed to the sealing surface of the lip of the container tub to seal the contents of the container against the decontamination process using plasma.

9 . The container tub assembly of claim 1 wherein the peelable gas impermeable container cover is made of a plastic material.

10 . The container tub assembly of claim 1 wherein the peelable gas impermeable container cover is made of an impermeable laminated foil.

11 . The container tub assembly of claim 1 wherein the peelable gas impermeable container cover is made of a polymeric membrane.

12 . The container tub assembly of claim 1 wherein the sealed container tub holds sterilized pharmaceutical containers or closures.

13 . The container tub assembly of claim 1 wherein the sealed container tub holds a plurality of containers disposed in a container nest.

14 . The container tub assembly of claim 1 wherein the sealed container tub holds a plurality of container nests, each of the container nests holding a plurality of containers.

15 . The container tub assembly of claim 1 wherein the sealed container tub holds a plurality of closures disposed in a closure nest.

16 . The container tub assembly of claim 1 wherein the sealed container tub holds a plurality of closure nests, each of the closure nests holding a plurality of closures.

17 . A container tub assembly for holding nested and sterilized pharmaceutical container parts, comprising:
a container tub defining an interior adapted to hold the nested and sterilized pharmaceutical container parts, comprising:
a bottom,
a lip having a sealing surface with a peripheral outline, and
sidewalls located between the bottom and the lip,
a gas impermeable peelable container cover consisting of a sheet of flexible material sealed to the sealing surface of the lip of the container tub to seal the nested and sterilized pharmaceutical container parts held in the container, and
a cover removal fixture clipped on the container cover and extending above the container cover, the cover removal fixture having an appendage that is structured and arranged to be engageable by a forked engagement tool above the container cover.

18 . A container tub assembly for holding nested and sterilized pharmaceutical container parts, comprising:
a container tub defining an interior adapted to hold the nested and sterilized pharmaceutical parts, comprising:
a bottom,
a lip having a sealing surface with a peripheral outline, and
sidewalls located between the bottom and the lip,
gas impermeable peelable container cover consisting of a sheet of flexible material sealed to the sealing surface of the lip of the container tub to seal the nested and sterilized pharmaceutical container parts held in the container, and
a cover removal fixture on the container cover, the cover removal fixture having an engagement portion clipped to the container cover, the cover removal fixture having an appendage that is structured and arranged to be engageable by a forked engagement tool.

19 . The container tub assembly of claim 17 wherein the gas impermeable peelable container cover includes a portion that extends outside of the peripheral outline of the sealing surface of the container tub, and the cover removal fixture is on the portion of the gas impermeable container cover that extends outside of the peripheral outline of the top sealing surface of the container tub.

20 . The container tub assembly of claim 17 wherein the container tub is rectangular and includes four sidewalls.

21 . The container tub assembly of claim 17 wherein the container tub assembly is configured for the decontamination process to be effected by a decontamination agent, the decontamination agent being one of a decontamination gas, a decontamination irradiation, and a decontamination plasma.

22 . The container tub assembly of claim 21 , wherein the gas impermeable peelable container cover is heat sealed to the sealing surface of the lip of the container tub to seal the contents of the container against a decontamination process.

23 . The container tub assembly of claim 22 wherein the gas impermeable peelable container cover is sealed to the sealing surface of the lip of the rectangular container to seal the contents of the container against the decontamination process using a chemical agent including at least one of heated water vapor, hydrogen peroxide vapor, ozone, nitrogen dioxide, chlorine dioxide, ethylene oxide and glutaraldehyde vapor.

24 . The container tub assembly of claim 22 wherein the gas impermeable peelable container cover is sealed to the sealing surface of the lip of th

Assignees

• Vanrx Pharmasystems Inc

Inventors

• Naing Juvenal
• Gofman Yacov
• Cichy Marcin

Classifications

• B65B55/06

  by heat · CPC title

• B65B43/50

  using rotary tables or turrets {(B65B43/46 takes precedence)} · CPC title

• B65B3/003

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

• B65B55/10

  by liquids or gases · CPC title

• B65B55/027 Primary

  Packaging in aseptic chambers · CPC title