Abstract: A sterile filling unit, of a basic container with contents that can be distributed in a fluid form and that is originally located in a source container in a sterile manner, includes a sterile chamber with at least one sterile entry port and/or outlet; a sterile fluid transfer and filling line with an intake and an outlet, such that for a filling stage the line passes through the wall of the sterile chamber in a sterile manner, with the intake located outside of the sterile chamber in sterile fluid communication with the source container, with the filling element at the outlet located inside the sterile chamber and positioned to be operating; and a unit that can introduce the disposable internal elements that, in a stage prior to the filling stage, were located outside of the sterile chamber, into the interior of the sterile chamber in a sterile manner.

Abstract: A sterile filling unit, of a basic container with contents that can be distributed in a fluid form and that is originally located in a source container in a sterile manner, includes a sterile chamber with at least one sterile entry port and/or outlet; a sterile fluid transfer and filling line with an intake and an outlet, such that for a filling stage the line passes through the wall of the sterile chamber in a sterile manner, with the intake located outside of the sterile chamber in sterile fluid communication with the source container, with the filling element at the outlet located inside the sterile chamber and positioned to be operating; and a unit that can introduce the disposable internal elements that, in a stage prior to the filling stage, were located outside of the sterile chamber, into the interior of the sterile chamber in a sterile manner.

Abstract: A device (1; 2; 3; 4; 5) is provided for carrying out an integrity test on a sample of disposable components. The device has a medium chamber (10) with an inner chamber (11) that is bounded to the outside, for the purpose of receiving a culture medium. The device also has a sample holder (20) in which the sample (100) can be arranged in such a way that the sample (100) at least partially bounds the medium chamber (10) to the outside. The medium chamber (10) has a vent line (19) that is arranged on a side of the medium chamber (10) facing away from the sample holder (20).

Abstract: A method for producing a single-use container, particularly a single-use bioreactor, an assembly system, and a single-use container particularly a single-use bag such as a single-use bioreactor comprising: a base material; and at least one functional element being at least partially connected with the base material, wherein the functional element is obtained by a three dimensional printing technique from at least one printable material, wherein the printable material is heated during the three dimensional printing thereby at least partly connecting the printed functional element to the base material.

Abstract: A disposable port device for connecting a functional unit to a flexible wall of a disposable container includes a flange to be connected to the flexible wall of the disposable container and an insert providing or receiving the functional unit. The flange and the insert are separate parts made from different materials with different material characteristics. A method of manufacturing such a disposable port device includes the steps of producing the flange from a first material, producing the insert from a different second material, the first and second materials having different material characteristics, and connecting the insert to the flange.

Abstract: Disclosed is a fluid connection system including a sleeve, a pipe and a fluid connector, the fluid connector including at least one rigid body made from a sterilizable biocompatible material, and the pipe including a flexible connection portion made from a sterilizable biocompatible material that is at least partially elastomeric. The fluid connector and the flexible connection portion of the pipe are assembled to one another, with the flexible connection portion of the pipe surrounding the rigid body, and the sleeve being shrunk tightly, but with free movement, on the pipe.

Abstract: Disclosed is a fluid connection system including a sleeve, a pipe and a fluid connector, the fluid connector including at least one rigid body made from a sterilizable biocompatible material, and the pipe including a flexible connection portion made from a sterilizable biocompatible material that is at least partially elastomeric. The fluid connector and the flexible connection portion of the pipe are assembled to one another, with the flexible connection portion of the pipe surrounding the rigid body, and the sleeve being shrunk tightly, but with free movement, on the pipe.

Abstract: A sterile filling unit, of a basic container with contents that can be distributed in a fluid form and that is originally located in a source container in a sterile manner, includes a sterile chamber with at least one sterile entry port and/or outlet; a sterile fluid transfer and filling line with an intake and an outlet, such that for a filling stage the line passes through the wall of the sterile chamber in a sterile manner, with the intake located outside of the sterile chamber in sterile fluid communication with the source container, with the filling element at the outlet located inside the sterile chamber and positioned to be operating; and a unit that can introduce the disposable internal elements that, in a stage prior to the filling stage, were located outside of the sterile chamber, into the interior of the sterile chamber in a sterile manner.

Abstract: A method for the sterile filling of at least one final basic container, includes: providing at least one sterile chamber having at least one sterile entrance port and providing a source container containing the content, located outside the chamber; providing a communication element, a dispensing element and at least one filling member, to form when all are assembled, a sterile fluid filling and transfer line; inserting at least one final container into the chamber; structurally combining at least one final container with at least one filling member; providing inner members and elements in sterile condition for a single-use; inserting the inner element and members which were previously outside the chamber in the chamber in a sterile manner, such that after filling, a new filling process can be performed without sterilizing the inside of the chamber; transferring in a filling step content from the source container into the final container.

Abstract: A presterilizable filtration system is provided and is to be disposed of after a single use. The system has a recirculation tank and a filtration module that are connected to each other in a circuit via a hose system that can be regulated by at least one valve. The valve has a disposable separate valve part that can be integrated in the hose system and a reusable actuator.

Abstract: A system and method for transferring chemical, pharmaceutical, and/or biological material into or out of a container are provided. Further, a use of a transfer interface for accessing the interior of a disposable container is provided. The system comprises a disposable container having at least one port for accessing the interior of the container. The system further comprises a transfer interface connectable to the at least one port. The transfer interface comprises a plurality of extendable transfer elements for collecting samples from the disposable container in a sterile manner. The transfer elements may also be referred to as sampling elements, extractors, or probes. Each of the transfer elements has a corresponding biasing element for retracting the transfer element. The biasing element may be implemented as a spring or as another device capable of applying a biasing force.

Abstract: Systems and a method for transferring chemical, pharmaceutical, and/or biological material into or out of a container are provided. One system comprises a disposable container having at least one port for accessing the interior of the container, the port comprising at least one connecting protrusion extending parallel to the container. The system further comprises a transfer interface connectable to the port. The transfer interface comprises a plate, and at least one connecting flange extending from the plate, the connecting flange to be arranged under the respective connecting protrusion to connect the transfer interface to the port, such that when the transfer interface is connected to the port the plate is parallel to a surface of the container.

Abstract: Disclosed is a fluid-connection device for connecting a first wall defining a first fluid space, in the form of a flexible pipe, to a second wall defining a second fluid space, in the form of a flexible or rigid disposable pipe or enclosure, in a biopharmaceutical assembly, including a first connector in fluid communication with the first space, the first connector including a tubular nozzle for receiving the pipe by insertion along the axis A, a pipe clamp arranged around the end of the pipe in order to clamp the pipe onto the tubular nozzle of the first connector, a protective cover forming a separate part, capable of being snap-fit in an operative position in which the cover is at least partially surrounding the first connector and the pipe clamp thereof, by way of which the pipe clamp cannot come into direct contact with external elements.

Abstract: Disclosed is a device for transporting a biopharmaceutical fluid, including an inner bag forming an inner chamber adapted and intended for receiving a biopharmaceutical fluid, an outer container including an outer receptacle, the outer receptacle including a wall forming an outer chamber, an expandable protective element arranged at least partially between the outer receptacle and the inner bag and adapted to receive the inner bag, the expandable protective element being adapted to expand in volume to an expanded state so as to be interposed between the outer receptacle and the inner bag, the expandable protective element in the expanded state surrounding the inner bag and filling the space between the wall of the outer receptacle and the inner bag.

Abstract: A bioreactor container comprising has an at least locally flexible wall and at least one container opening. The wall of the bioreactor container has a fluid-tight inner sheet, and an at least locally fluid-permeable or structured outer sheet. A method for testing the integrity of the bioreactor container also is provided.

Abstract: A coupling device for sealingly coupling a first wall defining a flexible pipe (11) to a tubular nozzle (9) of a connector (1) in a biopharmaceutical assembly, the coupling device including the connector (1) including the tubular nozzle (9), on which one end of the pipe can be inserted along an axis A, a plurality of flexible tabs (3) extending from an intermediate area (7) of the coupling body toward the free end (1a) of the nozzle, an abutment clamp (16), a connection interface (6), a separate ring (2), axially movable between an inoperative position and an operative position, for covering the flexible tabs (3) such as to push same radially inward in order to press the pipe onto the nozzle in the operative position, the tabs extending substantially parallel to the axis (A) when the ring (2) is in the operative position.

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: A device (1; 2; 3; 4; 5) is provided for carrying out an integrity test on a sample of disposable components. The device has a medium chamber (10) with an inner chamber (11) that is bounded to the outside, for the purpose of receiving a culture medium. The device also has a sample holder (20) in which the sample (100) can be arranged in such a way that the sample (100) at least partially bounds the medium chamber (10) to the outside. The medium chamber (10) has a vent line (19) that is arranged on a side of the medium chamber (10) facing away from the sample holder (20).

Abstract: A system for using freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The holder has a cavity and the container is received in the cavity. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior cradle having a bottom and edges extending from the bottom. The cradle bounds the cavity. An outer rim is connected to the cradle and separated from the cavity. The bottom includes an inner surface facing the cavity receiving the container and an outer surface. The outer surface of the bottom is recessed relative to an outer surface of the outer rim.

Abstract: Disclosed is a device for transporting a biopharmaceutical fluid, including an inner bag forming an inner chamber adapted and intended for receiving a biopharmaceutical fluid, an outer container including an outer receptacle, the outer receptacle including a wall forming an outer chamber, an expandable protective element arranged at least partially between the outer receptacle and the inner bag and adapted to receive the inner bag, the expandable protective element being adapted to expand in volume to an expanded state so as to be interposed between the outer receptacle and the inner bag, the expandable protective element in the expanded state surrounding the inner bag and filling the space between the wall of the outer receptacle and the inner bag.