# US 2025/0144261 A1 · Arrangement for the contamination-free introduction of a sterile object from a container into a containment and method therefor

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- Number: US 2025/0144261 A1
- Document ID: US20250144261A1
- Status: Published application
- Kind: A1
- Application number: 18/947,225
- Filed: 2024-11-14
- Published: 2025-05-08
- Earliest claimed: 2018-07-18
- Assignees: Pharma Integration S.R.L.
- Applicants: Pharma Integration S.R.L.
- Inventors: Robert Landes; Mathieu Müller; Kathrin Sprecher; Mike Zeller
- Web page: https://patentgrep.com/patent/US20250144261A1

## CPC

- A61L 2/26: Accessories
- B08B 15/02: using chambers or hoods covering the area {(B08B15/002 takes precedence)}
- A61L 2/08: Radiation
- A61L 2/084: Visible light
- A61L 2/087: Particle radiation, e.g. electron-beam, alpha or beta radiation
- A61L 2/10: Ultraviolet [UV] radiation
- A61L 2/20: Gaseous substances, e.g. vapours
- A61L 2/208: Hydrogen peroxide
- B25J 21/005: {Clean rooms}
- A61L 2103/05: Living organisms or biological materials
- A61L 2103/23: {Containers other than laboratory or medical, e.g. bottles or mail}
- A61L 2202/121: Sealings, e.g. doors, covers, valves, sluices
- A61L 2202/122: Chambers for sterilisation
- B08B 7/0057: {by ultraviolet radiation}
- B65B 69/00: Unpacking of articles or materials, not otherwise provided for
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- B08B: CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
- B25J: MANIPULATORS; CHAMBERS PROVIDED WITH MANIPULATION DEVICES ({manipulators specially adapted for use in surgery A61B34/70; manipulators used in cleaning hollow articles B08B9/04}; manipulators associated with rolling mills B21B39/20; manipulators associated with forging machines B21J13/10; {manipulators associated with picking-up and placing mechanisms B23P19/007}; means for holding wheels or parts thereof B60B30/00; {vehicles with ground-engaging propulsion means, e.g. walking members B62D57/02, B62D57/032; devices for picking-up and depositing articles or materials between conveyors B65G47/90, B65G47/91; manipulators with gripping or holding means for transferring packages B65H67/065}; cranes B66C; {manipulators used in the protection or supervision of pipe-line installations F17D5/00; walking equipment adapted for nuclear steam-generators F22B37/006}; manipulators specially adapted for, or associated with, nuclear reactors G21C; {apparatus used for handling wafers during manufacture or treatment of semiconductor H10P72/50})
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)

## Abstract

The contamination-free introduction of a sterile object from a vessel, which has been closed by means of a semipermeable cover, into a working chamber, which is surrounded by a wall, of a containment firstly comprises a portal unit having an access flange which is arranged in the wall and which forms a passage from the outside into the working chamber, and a door which sealingly closes the passage and which, in order to be opened, can be moved into the working chamber. A vessel receptacle has a repository for holding a vessel that has been introduced into the vessel receptacle, an opening for the introduction of the vessel into the repository, and a flange for interacting with the access flange. A decontamination unit is designed to decontaminate an outer surface of the cover when the door has been closed. Based on this arrangement, a method for introduction is also disclosed.

## Claims

### Claim 1

An arrangement for the contamination-free introduction of a sterile object from a vessel, which has been closed by means of a cover, into a working chamber, which is surrounded by a wall, of a containment comprising:
a) a portal unit having:
aa) an access flange which is arranged in the wall and which forms a passage from the outside into the working chamber; and
ab) a door which sealingly closes the passage and which, in order to be opened, can be moved into the working chamber; and
b) a vessel receptacle having:
ba) a repository for holding a vessel that has been introduced into the vessel receptacle;
bb) an opening for the introduction of the vessel into the repository; and
bc) a flange for interacting with the access flange, wherein
c) a decontamination unit is designed to, when the door has been closed, the vessel receptacle has been docked to the access flange and the vessel has been stored in the vessel receptacle, decontaminate an outer surface, facing toward the door, of the cover.

### Claim 2 (depends on 1)

The arrangement as claimed in claim 1, wherein:
a) the door, in a closed position, is attached in a sealed manner to the access flange from the side of the working chamber, and the access flange borders an intermediate space which is situated in the passage; and
b) the cover of the vessel which has been placed in the vessel receptacle is sealed between the flange and the access flange when the vessel receptacle has been pivoted into abutment against the access flange.

### Claim 3 (depends on 2)

The arrangement as claimed in claim 2, wherein the decontamination unit is furthermore utilizable for decontamination of the outwardly facing surface of the door, of the intermediate space and of that surface of the access flange which faces toward the intermediate space.

### Claim 4 (depends on 2)

The arrangement as claimed in claim 2, wherein the decontamination unit, with a direction of action into the passage, is installed directly on the door.

### Claim 5 (depends on 2)

The arrangement as claimed in claim 2, wherein the decontamination unit, with a direction of action into the passage, is installed laterally with respect to the portal unit which has the door and the access flange.

### Claim 6 (depends on 2)

The arrangement as claimed in claim 2, wherein the access flange has a first seal.

### Claim 7 (depends on 2)

The arrangement as claimed in claim 2, wherein the door is equipped with a second seal which is sealed against the access flange in the closed position.

### Claim 8 (depends on 2)

The arrangement as claimed in claim 2, comprising a common seal arranged on the access flange and said common seal encompasses the access flange at its inner surfaces facing toward the intermediate space.

### Claim 9 (depends on 2)

The arrangement as claimed in claim 2, wherein a transfer apparatus which is equipped, in the working chamber, with a tool head is designed to, when the door has been opened, the vessel receptacle has been docked to the access flange and the vessel has been stored in the vessel receptacle:
a) detach a decontaminated part of the cover from the vessel and move it into the working chamber;
and
b) move the object resting in the vessel situated in the vessel receptacle from said vessel into the working chamber.

### Claim 10 (depends on 1)

The arrangement as claimed in claim 1, wherein the decontamination unit, with a direction of action into the passage, is installed directly on the door.

### Claim 11 (depends on 1)

The arrangement as claimed in claim 1, wherein the decontamination unit is a radiation source.

### Claim 12 (depends on 11)

The arrangement as claimed in claim 11, wherein the radiation source is UVC.

### Claim 13 (depends on 1)

The arrangement as claimed in claim 1, wherein a transfer apparatus which is equipped, in the working chamber, with a tool head is designed to, when the door has been opened, the vessel receptacle has been docked to the access flange and the vessel has been stored in the vessel receptacle:
a) detach a decontaminated part of the cover from the vessel and move it into the working chamber;
and
b) move the object resting in the vessel situated in the vessel receptacle from said vessel into the working chamber.

### Claim 14 (depends on 13)

The arrangement as claimed in claim 13 wherein the transfer apparatus is equipped with a cutting tool for cutting-open the cover.

### Claim 15 (depends on 13)

The arrangement as claimed in claim 13 wherein the transfer apparatus is equipped with a gripping tool for gripping the detached decontaminated part of the cover.

### Claim 16 (depends on 1)

The arrangement as claimed in claim 1, wherein:
a) the vessel has the form of a trough-shaped tub; and
b) the object has the form of a nest with a raster of depression-like receiving contours for the storage of containers.

### Claim 17 (depends on 1)

The arrangement as claimed in claim 1, wherein:
a) the arrangement is assigned an input station with an air stream flowing through a filter, which stream is intended for releasing the vessels from packages provided with at least an enclosure and for providing the vessels, under controlled clean-room conditions, before these are placed into the vessel receptacle; and
b) the cover which closes the vessel maintains the sterile state of the object, situated in the interior space of the vessel, with the containers.

### Claim 18 (depends on 17)

The arrangement as claimed in claim 17 wherein the cover which closes the vessel is semipermeable and sealed against a vessel edge of the vessel.

### Claim 19 (depends on 1)

The arrangement as claimed in claim 1, wherein the decontamination unit, with a direction of action into the passage, is installed laterally with respect to the portal unit which has the door and the access flange.

### Claim 20 (depends on 1)

The arrangement as claimed in claim 1, wherein the decontamination unit is a fumigation device.
