Arrangement for the Contamination-Free Introduction of a Sterile Object from a Container into a Containment and Method Therefor

A method for the contamination-free introduction of a sterile object (3) from a vessel (2) into a containment (9), comprising the following sequence of process phases:

• a) removing the vessel (2), which has been closed by means of a cover (23) and which contains an object (3), from enclosures (21,22) under controlled clean-room conditions at an input station (8);
• b) providing the respectively individual vessel (2), which has been closed by means of the cover (23) and which has the sterile object (3) stored therein, for contamination-free introduction into a working chamber (90) of a containment (9);
• here:
• the passage (75) to the working chamber (90) is outwardly open but, into the containment (9), is closed by the door (5), the decontamination unit (4) is inactive, the repository (60) of the vessel receptacle (6) is open and empty, and the vessel receptacle (6) is detached from the portal unit (7);
• c) placing the provided individual vessel (2) into the repository (60);
• here:
• it remains the case that the passage (75) is outwardly open but, into the containment (9), is closed by the door (5), the decontamination unit (4) is inactive and the vessel receptacle (6) is detached from the portal unit (7), but now the repository (60) is filled with a vessel (2);
• d) moving the vessel receptacle (6) into abutment against the portal unit (7);
• here:
• the access flange (71) of the portal unit (7) and the flange (61) are sealed against one another;
• furthermore, the passage (75) into the containment (9) is closed by the door (5), the decontamination unit (4) is inactive and the repository (60) is filled with a vessel (2);
• and
• the passage (75) is also outwardly closed, specifically by the vessel receptacle (6) docked in a sealed manner to the portal unit (7);
• e) activating the decontamination unit (4) or bringing the latter into a state of action;
• here:
• it remains the case that the access flange (71) of the portal unit (7) and the flange (61) are sealed against one another, the passage (75) into the containment (9) is closed by the door (5), the repository (60) is filled with a vessel (2), and the passage (75) is also outwardly closed, specifically by the vessel receptacle (6) docked in a sealed manner to the portal unit (7);
• and now
• the outer surface, exposed to the door (5), of the cover (23) and the intermediate space (70) and all surfaces facing toward this are made sterile;
• f) deactivating the decontamination unit (4) or bringing the latter out of a state of action, and opening the door (5);
• here:
• it remains the case that the access flange (71) of the portal unit (7) and the flange (61) are sealed against one another, the repository (60) is filled with a vessel (2), the passage (75) is outwardly closed, specifically by the vessel receptacle (6) docked in a sealed manner to the portal unit (7), and the outer surface of the cover (23), the intermediate space (70) and all surfaces facing toward this are sterile;
• and now
• the passage (75) into the containment (9) is open;
• g) cutting open the cover (23) of the vessel (2);
• here:
• it remains the case that the access flange (71) of the portal unit (7) and the flange (61) are sealed against one another, the repository (60) is filled with a vessel (2), the passage (75) is outwardly closed, specifically by the vessel receptacle (6) docked in a sealed manner to the portal unit (7), the outer surface of the cover (23), the intermediate space (70) and all surfaces facing toward this are sterile, and the passage (75) into the containment (9) is open;
• and now
• the access to the object (3) situated in the vessel (2) is open;
• h) removing the object (3) from the vessel (2) and transferring the object (3) with the containers (30) stored therein into the working chamber (90) of the containment (9) for further processing;
• here:
• it remains the case that the access flange (71) of the portal unit (7) and the flange (61) are sealed against one another, the passage (75) is outwardly closed, specifically by the vessel receptacle (6) docked in a sealed manner to the portal unit (7), and the passage (75) into the containment (9) is open;
• and now
• the repository (60) is now filled only with the empty vessel (2);
• and
• i) returning the arrangement into the starting phase, that is to say moving the door (5) into the closed position, which is thus sealed against the access flange (71) again, pivoting the vessel receptacle (6) away from the access flange (71), and removing the empty vessel (2) from the repository (60).