Arrangement for the contamination-free introduction of a sterile object from a container into a containment and method therefor
Inventors
Landes, Robert • Müller, Mathieu • Sprecher, Kathrin • Zeller, Mike
Assignees
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Publication Number
US-12168080-B2
Publication Date
2024-12-17
Expiration Date
Abstract
The arrangement for contamination-free introduction of a sterile object from a vessel, closed by means of a semipermeable cover, into a working chamber, surrounded by a wall, of a containment comprising a portal unit having an access flange arranged in the wall and forming a passage 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. The arrangement comprises a vessel receptacle having a repository for holding a vessel, an opening for introducing the vessel into the repository, and a flange for interacting with the access flange. A decontamination unit designed to, when the door is closed, the vessel receptacle is docked to the access flange and the vessel is stored in the vessel receptacle, decontaminate an outer surface of the cover. Based on this arrangement, a method for introduction is also disclosed.
Core Innovation
The invention provides an arrangement and a method for the contamination-free introduction of a sterile object stored in a vessel with containers into a containment working chamber. The arrangement includes a portal unit that has an access flange arranged in a wall to form a passage into the working chamber, and a door sealingly closing the passage. The door can be moved into the working chamber in order to be opened, thereby controlling communication between the outside and the containment working chamber.
A vessel receptacle is provided that has a repository for holding a vessel that has been introduced into the vessel receptacle, an opening for introduction of the vessel into the repository, and a flange for interacting with the access flange. 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 a cover of the vessel.
The method includes removing the vessel closed by the cover from enclosures under controlled clean-room conditions at an input station, providing the individual vessel for contamination-free introduction, placing the vessel into the repository, and moving the vessel receptacle into abutment against the portal unit with sealed access flange interaction. The decontamination unit is activated to sterilize the outer surface exposed to the door of the cover and an intermediate space and all surfaces facing toward this, then deactivated before opening the door so that the passage into the containment becomes open.
The cover is then cut open, the object is removed from the vessel and transferred into the working chamber of the containment, and finally the arrangement is returned to the starting phase by closing and resealing the door and moving the vessel receptacle away while removing the empty vessel.
Claims Coverage
The partial content identifies one independent claim for contamination-free introduction, with multiple dependent refinements. The inventive features are grouped by the independent claim and the key additional limitations in the dependent claims.
Sealed portal unit with movable sealing door and access flange passage
A portal unit having an access flange arranged in the wall that forms a passage from the outside into a working chamber, and a door which sealingly closes the passage and which, in order to be opened, can be moved into the working chamber.
Vessel receptacle repository for holding the covered vessel and flange docking to the access flange
A vessel receptacle having a repository for holding a vessel, an opening for the introduction of the vessel into the repository, and a flange for interacting with the access flange.
Decontamination of the outer door-facing cover surface during docked and closed-door state
A decontamination unit 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.
Defined process sequence with staged activation and deactivation of the decontamination unit
Removing the vessel from enclosures under controlled clean-room conditions at an input station; placing the vessel into the repository and moving the vessel receptacle into abutment with the access flange sealed against the flange; activating the decontamination unit; deactivating the decontamination unit and opening the door; cutting open the cover; removing the object and transferring the object into the working chamber of the containment; and returning the arrangement into the starting phase by closing and resealing the door and moving the vessel receptacle away and removing the empty vessel.
Pre-decontamination integrity test with conditional removal of defective vessel
Performing an integrity test on the content of the vessel and, if the integrity test yields a negative result, pivoting the vessel receptacle away from the portal unit to remove the defective vessel from the repository.
In-working-chamber transfer apparatus for cutting open, removing and transferring the object
Performing cutting open the cover, removing the object, and transferring the object into the working chamber by a transfer apparatus located in the working chamber.
Moving a cut-away portion of the cover into the working chamber
Moving a cut-away portion of the cover into a working chamber using a transfer apparatus located in the working chamber.
Package and enclosure handling with release at an input station under controlled clean-room conditions
A method in which a sterile, covered individual vessel is packaged with containers as a delivered package and, before placement into a vessel receptacle, the vessel is released from the package at an input station under controlled clean-room conditions.
Across the independent claim and dependent refinements, coverage centers on a sealed portal unit with a movable sealing door, a docking vessel receptacle, and a decontamination unit that decontaminates an outer door-facing cover surface while the door is closed and interfaces are sealed. The claims further define a staged sequence with activation and deactivation around door opening, and add optional integrity testing and in-working-chamber transfer with a cut-away cover portion, plus package and release handling at an input station.
Stated Advantages
Contamination-free introduction of a sterile object into a containment working chamber.
Documented Applications
Transferring a sterile object with containers stored therein from a vessel into a containment working chamber using a covered vessel arrangement and a portal unit.
Introducing a sterile, covered individual vessel that is packaged with containers, with release at an input station under controlled clean-room conditions prior to placement into a vessel receptacle.
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