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.

Abstract: A containment system for placement in an installation space includes a housing which encloses a process chamber, a dosing station for the aseptic filling of vessels with a liquid, positioned in the process chamber, a transfer port leading into the process chamber, and a functional module which can be moved up to the dosing station, The module includes an element carrier, functional elements installed on the element carrier, and media feed lines connected to the functional elements. The functional module with the element carrier, the functional elements, and the media feed lines is movable from an initial position, through a transfer port leading into the process chamber, to an operating position at the dosing station.

Abstract: Provided herein are systems and methods for sampling of controlled environments, including automated and/or robotically controlled sampling. The present systems and methods are useful for determining the presence of, quantity, size, concentration, viability, species or characteristics of particles, including viable biological particles, within a controlled environment. The described systems and methods may utilize rotational motion via robotics, automation and/or control systems to reduce, or eliminate, some or all of the steps carried out by human operators in traditional particle collection and/or analysis methodologies. The described systems and methods may rotational motion via robotics, automation and/or control systems to provide for particle sampling over time periods that are well-defined for an individual impactor and/or sequential sampling via a plurality of impactors.

Abstract: Devices and methods for sampling, detecting and/or characterizing particles, for example, via collection, growth and analysis of viable biological particles such as microorganisms. Devices and methods of the invention include particle samplers and impactors including a sampling head comprising one or more intake apertures, a selectively removable cover, an impactor base connected to the sampling head, and one or more magnets fixed to the sampling head, the selectively removable cover and/or the impactor base. The one or more magnets allow for robotic manipulation of the impactor devices.

Abstract: A containment system and assembly for the automated production of pharmaceutical or biotechnical articles is provided. The containment system has a housing within which there is an inner chamber having at least one through opening. One or more robots are installed in the chamber, which have a manipulating element on the pivotable arms, which can move within a pivot range. One or more process units are installed in the chamber for the production of the articles. The chamber includes a process space for the production of the articles and a tub-shaped base space for anchoring the feet of the robots to the side surfaces inside the base space. The manipulating element functions as a gripping and transportation device for inspecting the articles or article parts and/or for the production of the articles.

Abstract: The arrangement for the contamination-free introduction of a sterile object (3) from a vessel (2), which has been closed by means of a semipermeable cover (23), into a working chamber (90), which is surrounded by a wall (91), of a containment (9) firstly comprises a portal unit (7) having an access flange (71) which is arranged in the wall (91) and which forms a passage (75) from the outside into the working chamber (90), and a door (5) which sealingly closes the passage (75) and which, in order to be opened, can be moved into the working chamber (90). The arrangement furthermore comprises a vessel receptacle (6) having a repository (60) for holding a vessel (2) that has been introduced into the vessel receptacle (6), an opening for the introduction of the vessel (2) into the repository (60), and a flange (61) for interacting with the access flange (71).

Abstract: A mobile monitoring device for monitoring controlled contamination areas may include a motorized mobile structure, a sampling unit, and a central management and control unit. The motorized mobile structure is configured to move within an area to be monitored. The sampling unit is positioned on said mobile structure, and configured to perform sampling operations of air and/or surfaces of said area and obtain sampling data. The central management and control unit is operatively connected to the mobile structure and to said sampling unit. The mobile structure may be controlled by the central unit to reach predefined points of the area to be monitored. The sampling unit may be selectively activated and/or deactivated by said central unit in correspondence with said predefined starting points of said sampling operations.

Abstract: The constructive assembly of the containment means (9) is intended for the automated production of pharmaceutical or biotechnical articles (6). As an end product, a respective article (6) comprises multiple article parts (7). The containment means (9) has a housing (90) within which there is an inner chamber (91) having at least one through opening (917, 919). At most, multiple robots (1, 2) are installed in the chamber (91), which generally have a manipulating element (12, 22) on the pivotable arms (11, 21) thereof, which can move within a pivot range (R1,R2). At most, multiple process units (3) are installed in the chamber (91) for the production of the articles (6). The chamber (91) is formed by a process space (93) for the production of the articles (6) and a tub-shaped base space (92) for anchoring the feet (10, 20) of the robots (1, 2) to the side surfaces (910,912,916,918) inside the base space (92).