Abstract: A method of manufacturing a flexible container housing a drug substance is disclosed that includes forming a first compartment from a flexible sheet-like material, filling a liquid into the first compartment, sealing the first compartment, forming a second compartment from the flexible sheet-like material, filling a dry drug formulation into the second compartment, and sealing the second compartment. The method further involves lyophilizing the drug formulation inside a tubular cartridge, filling the second compartment by introducing the tubular cartridge through an opening of the second compartment such that an open end of the tubular cartridge is positioned distant from the opening of the second compartment, providing the drug formulation from the open end of the tubular cartridge into the second compartment, and withdrawing the tubular cartridge from the second compartment. The first and second compartments are separated by a frangible seal which opens when the first compartment is compressed.

Abstract: A lyophilisate retainer for lyophilizing a substrate is disclosed that includes a three dimensional scaffold body having pores. The pores of the scaffold body are configured to receive and hold the substrate. The scaffold body is made of a scaffold material providing heat transfer properties in lyophilisation to induce heat transfer to the substrate held in the pores of the scaffold body.

Abstract: A method of generating a lyophilized drug formulation (2) comprises: preparing a substrate to be additive manufacturable, wherein the substrate comprises a drug; additive manufacturing the substrate such that a scaffold body (21) is formed of the substrate; and lyophilizing the scaffold body (21).

Abstract: A device for closing a chamber of a container having an opening for accessing the chamber comprises a plunger, a plunger seat, a container carrier and a spacer. The plunger seat releasably holds the plunger in a predefined alignment. The container carrier is arranged to be connected to the container in a predefined position and alignment in relation to the opening of the container. The spacer is arranged to position and align the plunger seat adjacent to and distant from the container carrier such that the opening of the container is open when the container is connected to the container carrier.

Abstract: A multi chamber syringe unit includes a longitudinal body with side wall, distal end side, proximal end side opposite to distal end side, an interior limited by side wall between distal end side and proximal end side and distal opening arranged in distal end side for providing a liquid out of the body. The syringe further includes a separating element arranged in the interior of the body such that distal chamber and proximal chamber are formed in the interior of the body, wherein the separating element seals the distal chamber from the proximal chamber. The syringe has a bypass arrangement provided in the side wall of distal chamber of the body. A first pharmaceutical liquid is arranged in distal chamber of the body and second pharmaceutical liquid in proximal chamber of the body. The multi chamber syringe unit allows for adequately administering plural pharmaceutical liquids by injection.

Abstract: A fluid analysis arrangement (1) comprises a particle quantifying device (4), a holder (6), a robot (3), a washing station (5) and a control unit (2). The particle quantifying device (4) has a sensor unit (42) with a sensing stick (421) to be arranged in a fluid to sense for particles in the fluid, and an evaluation unit (41). The holder (6) has a plurality of seats each configured to receive a container in which a sample fluid is arranged. The control unit (2) is connected to the particle quantifying device (4) and the robot (3). The sensor unit (42) is mounted to the robot (3).

Abstract: A process of assembling a filling system for low volume filling of a liquid into a container is disclosed. The process includes obtaining plural liquid forwarding devices configured to provide the liquid from a reservoir to the container, and simulating operation of each of the liquid forwarding devices by numerically modelling flow patterns of the liquid when being forwarded by the liquid forwarding devices, and by determining a shear stress rate for each of the liquid forwarding devices based on the modelled flow patterns. The process further includes determining an appropriateness for each of the liquid forwarding devices by comparing operation parameters of the liquid forwarding of the liquid forwarding devices, wherein the operation parameters include the determined shear stress rates, selecting the liquid forwarding device having the highest determined appropriateness, and installing the selected liquid forwarding device into the filling system.

Abstract: An inspection device (1) has a particle detector (3) adapted to detect particles (5) in a liquid, a seat (6) adapted to position a container (4) housing the liquid in an area of operation (311) of the particle detector (3) and a vibration arrangement (2) for vibrating the container (4). The vibration arrangement (2) comprises a frequency generator (21) adapted to provide an electrical signal and a transducer (22) adapted to transduce the electrical signal provided by the frequency generator (21) into an acoustic wave (221). The seat (6) is adapted to position the container (4) adjacent to the transducer (22). for inspecting a liquid inside a container (4) with respect to the existence of particles (5). The inspection device (1) allows for an accurate and gentle inspection of the liquid filled in the container and for detecting particles in the liquid.

Abstract: A multi chamber syringe unit includes a body, a separating element and a bypass arrangement. The body has a distal end side, a proximal end side opposite to the distal end side, an interior limited by a side wall between the distal end side and the proximal end side and a longitudinal axis centrally extending from the distal end side to the proximal end side through the body. The separating element is arranged in the interior of the body forming a distal chamber between the distal end side and the separating element and a proximal chamber between the proximal end side and the separating element. The bypass arrangement is a section of the body in which the interior has a constant noncircular cross section orthogonal to the longitudinal axis. The multi camber syringe unit allows for being efficiently prepared and for efficiently providing or administering high quality of prefilled products.

Abstract: An inspection device has a particle detector adapted to detect particles in a liquid, the particle detector preferably including a camera. The inspection device including a seat adapted to position a container housing the liquid in an area of operation of the particle detector and a vibration arrangement for vibrating the container. The vibration arrangement includes a frequency generator adapted to provide an electrical signal and a transducer adapted to transduce the electrical signal provided by the frequency generator into an acoustic wave. The seat is adapted to position the container adjacent to the transducer for inspecting a liquid inside a container with respect to the existence of particles. The inspection device allows for an accurate and gentle inspection of the liquid filled in the container and for detecting particles in the liquid.

Abstract: A lyophilisate container (39) comprising a compartment; a wall (3119, 3129) limiting the compartment; and a lyophilisate arranged inside the compartment. At least a portion of the wall (3119, 3129) is semipermeable allowing vapour permeation in one direction out of the compartment through the wall (3119, 3129) and preventing vapour permeation in an opposite direction into the compartment through the wall (3119, 3129).

Abstract: A method of manufacturing a flexible container (1) housing a drug substance, comprises: forming a first compartment (11) of the container (1) out of a flexible sheet-like material, filling a liquid (2) into the first compartment (11) of the container (1), sealing the first compartment (11), forming a second compartment (12) of the container (1) out of the flexible sheet-like material, filling a dry drug formulation (3) into the second compartment (12), and sealing the second compartment (12).

Abstract: A dosing system for transferring an aseptic fluid in dosages into a container, comprising a peristaltic pump configured such that the filling accuracy for fill volumes of the aseptic fluid <100 ?L is ±3 ?L.

Abstract: A method of preparing a double chamber container is disclosed that includes filling a substance into the container, freeze-drying the substance therein, inserting a middle plunger in the container to form distal and proximal chambers, wherein the middle plunger seals the distal chamber from the proximal chamber and the freeze-dried substance is inside the distal chamber. The method includes filling a reconstitution medium in the proximal chamber, and sealing distal and proximal openings of the container. The method includes providing a holder having a seat and arranging the container in the seat in an upright position wherein a distal end side of the container extends downwardly and a proximal end side of the container extends upwardly. The container is arranged in the seat while the substance is filled, the substance is freeze-dried, the middle plunger is inserted, the reconstitution medium is filled, and the proximal opening is sealed.

Abstract: A peristaltic dosing device for providing dosages of a fluid at a volume of less than one milliliter comprises: a flexible tube, a counter pressure element, a plurality of actors and a drive. The flexible tube is essentially straightly arranged along the counter pressure element thereby forming a longitudinal axis. The actors arranged parallel to each other along the longitudinal axis. They are moveable by the drive in relation to the flexible tube. The flexible tube is compressible between the actors and the counter pressure element by moving the actors. Each of the actors is independently and linearly moveable by the drive along an actuation axis essentially perpendicular to the longitudinal axis of the flexible tube from a home position in which the flexible tube is least compressed to an end position in which the flexible tube is compressed and sealed between the respective actor and the counter pressure element.

Abstract: A device for closing a chamber of a container having an opening for accessing the chamber comprises a plunger, a plunger seat, a container carrier and a spacer. The plunger seat releasably holds the plunger in a predefined alignment. The container carrier is arranged to be connected to the container in a predefined position and alignment in relation to the opening of the container. The spacer is arranged to position and align the plunger seat adjacent to and distant from the container carrier such that the opening of the container is open when the container is connected to the container carrier.

Abstract: A device (1) for closing a chamber of a container having an opening for accessing the chamber comprises a plunger, a plunger seat (11), a container carrier (13) and a spacer (12). The plunger seat (11) releasably holds the plunger in a predefined alignment. The container carrier (13) is arranged to be connected to the container in a predefined position and alignment in relation to the opening of the container. The spacer (12) is arranged to position and align the plunger seat (11) adjacent to and distant from the container carrier (13) such that the opening of the container is open when the container is connected to the container carrier (13).

Abstract: A method for providing a dried solid product containing an active pharmaceutical ingredient is disclosed and includes providing a primary packaging container, providing a drying cartridge different from the primary packaging container, the drying cartridge made of a material adapted to hold a liquid product to be dried, wherein the liquid product contains an active pharmaceutical ingredient and the drying cartridge is made of a material having a thermal conductivity higher than the thermal conductivity of glass. The method also includes filling the liquid product into the drying cartridge, drying the liquid product in the drying cartridge to form a dried solid product containing the active pharmaceutical ingredient, transferring the dried solid product into the primary packaging container.

Abstract: An inspection device has a particle detector adapted to detect particles in a liquid, a seat adapted to position a container housing the liquid in an area of operation of the particle detector and a vibration arrangement for vibrating the container. The vibration arrangement includes a frequency generator adapted to provide an electrical signal and a transducer adapted to transduce the electrical signal provided by the frequency generator into an acoustic wave. The seat is adapted to position the container adjacent to the transducer. for inspecting a liquid inside a container with respect to the existence of particles. The inspection device allows for an accurate and gentle inspection of the liquid filled in the container and for detecting particles in the liquid.

Abstract: A method for determining whether reconstitution of a solution in a container is completed comprises the steps of: selecting a predetermined amount of a solid substance and a predetermined amount of a liquid solvent from which the reconstituted solution is to be prepared, preparing a solution by solving the predetermined amount of the solid substance in the predetermined amount of the liquid solvent, measuring the impedance (Z) or the resistance (R) of the solution, determining whether the change of the measured impedance (Z) or the resistance (R) within a measuring time interval of a predetermined duration is below a defined threshold, and determining that reconstitution of the solution is completed when the change of the measured impedance (Z) is below the defined threshold.