Abstract: A distributor assembly, which is provided in particular for a separation unit of a modular process device arrangement, including a fluid distributor device having a plurality of fluid ports, wherein the fluid distributor device can selectively establish and block fluid communications between the fluid ports. The distributor assembly further includes a connecting element and a retaining element. The connecting element is adapted to be attached to one of the fluid ports, and the distributor assembly includes an associated mounting slot at the fluid port. The mounting slot is adapted to the shape of the retaining element such that the retaining element can be inserted into the mounting slot up to a defined retaining position, in which the retaining element engages the connecting element and fixes it in place.

Abstract: A filtering system (10) includes a filtering apparatus having a filter unit for receiving liquid to be filtered, a receptacle for receiving filtered liquid, and an adapter (14) for coupling the filter unit to the receptacle, and also includes a base (12) having a cradle (26) for receiving the filtering apparatus and a base vacuum delivery port (28). The adapter includes an adapter vacuum receiving port (22) coupled to the vacuum delivery port for driving the liquid through the filter and—as filtered liquid—into the receptacle. The cradle and the adapter have an interlocking mechanism (52, 54) that locks the filtering apparatus to the cradle in a locking position in which the vacuum receiving port is sealingly coupled to the base vacuum delivery port. The base vacuum delivery port has a vacuum valve (30) constituted as a normally-closed valve automatically forced open when the filtering apparatus locks to the cradle.

Abstract: A bioreactor having a filter unit and a method for treating a cell broth. The filter unit has a supply channel (2), a first filter medium (4), a retentate channel (1), a second filter medium (5) and a permeate channel (3), arranged so that the first filter medium delimits the supply channel and the retentate channel from one another; and the second filter medium delimits the retentate channel and the permeate channel from one another. The supply channel is connected to an inlet for a supply medium; the retentate channel is connected to an inlet for a cell broth and to an outlet for the cell broth; the permeate channel is connected to an outlet for a permeate; and the interior of the bioreactor is connected to the inlet for the cell broth and to the outlet for the cell broth.

Abstract: A device for compensating short-term pressure or volume fluctuations of a medium in a continuously managed biopharmaceutical process including a receiving space in fluid communication with a process line through which a medium flows, an equalizing space, which is separated from the receiving space by a deflectable element, and a counter-pressure mechanism in the equalizing space for applying a counter-pressure to the deflectable element towards the receiving space. A method of compensating short-term pressure or volume fluctuations of a medium in a continuously managed biopharmaceutical process including providing a receiving space in fluid communication with a process line through which a medium flows, receiving an excess amount of the medium flowing into the receiving space, charging an energy storage device by the medium flowing into the receiving space, and expelling at least part of the excess amount if the pressure or flow rate falls below a set amount.

Abstract: A safety device for a single-use mixing or storage system (10), especially for use in a biopharmaceutical process, includes a flexible bag (12) made from a film material and a support structure (14) receiving and supporting the bag (12) in several directions. The support structure (14) allows an expansion of the bag (12) in an expansion direction. The safety device further includes a detection unit (20) adapted to detect an expansion of the bag (12) in the expansion direction, and a control unit (28) connected to the detection unit (20) and adapted to initiate a safety measure in response to the expansion of the bag (12) in the expansion direction that exceeds a given threshold.

Abstract: A bioreactor for cultivating microorganisms and cells of animal or plant origin includes a filter pocket which is arranged on the inner surface of a flexible wall of the bioreactor and which is delimited on the outside by the wall of the bioreactor and on the inside by a filter pocket wall. The inside filter pocket wall is formed at least partially by a filter medium. A spacer is arranged in the filter pocket between the wall of the bioreactor and the filter medium. The spacer has at least one through opening. A connecting portion of the filter medium protrudes through the through opening and is directly connected to the wall of the bioreactor. A method of manufacturing a filter pocket in a bioreactor for cultivating microorganisms and cells of animal or plant origin is also provided herein.

Abstract: A configurable device arrangement for performing at least one unit operation in a biopharmaceutical process includes a base rack and a plurality of holders for releasable direct or indirect attachment of process components, in particular single-use process components, for the unit operation. The holders are in turn adapted to be releasably attached directly or indirectly to the base rack. The device arrangement further includes a positioning system which defines specific positions for the holders relative to the base rack.

Abstract: A valve block for single use in a bioprocess, having a plurality of valve units and a one-piece block body having a main conduit. Each valve unit includes a secondary conduit, a valve seat between the secondary conduit and the main conduit, a closure part having a gripping portion, and an actuator coupled to the gripping portion which can transfer the closure part from a first switching position, in which the closure part is pressed against the valve seat and blocks a fluid communication between the secondary conduit and the main conduit, to a second switching position, in which the closure part is lifted from the valve seat and unblocks the fluid communication between the secondary conduit and the main conduit. The gripping portion is sealed against both the main conduit and the secondary conduit in both switching positions of the valve unit.

Abstract: A method for degassing a cross-flow diafiltration unit, a cross-flow diafiltration method and a cross-flow diafiltration unit. The degassing method includes (i) providing a cross-flow diafiltration unit having a diafiltration channel, a retentate channel and a permeate channel, a first filter material that delimits the diafiltration channel from the retentate channel, and a second filter material that delimits the retentate channel from the permeate channel; and thereafter (ii) feeding a liquid into the retentate channel so that the liquid flows in a flow direction through the retentate channel and penetrates through the first filter material into the diafiltration channel, whereby the retentate channel and the diafiltration channel are filled with and degassed by the liquid.

Abstract: A filter system (100) for biopharmaceutical processes includes: at least one filter unit (10); and at least one distributor plate (200), against which the filter unit rests. A tubeless distributor unit (202) is arranged within the distributor plate and is fluidically connected to the filter unit. The distributor unit guides the fluid to be filtered to the filter unit and/or receives and discharges the filtered fluid from the filter unit. The distributor unit includes at least one active control element (232; 238), with which a fluid flow (14) through the distributor unit) and the filter unit is controlled in an open loop flow or a closed loop flow. The fluid connection between the filter unit and the distributor plate is tubeless. Also provided are a distributor plate (200) for a filter system (100) for biopharmaceutical processes and a method for producing a filter system (100) for biopharmaceutical processes.

Abstract: A disposable filter capsule for a filtration device comprises only one housing, which has an inflow connection for a fluid to be filtered and an outflow connection for filtrate. The disposable filter capsule also comprises at least two separate filter means, which are fixed in the housing and together with the housing form an inseparable structural unit. All the components of the disposable filter capsule consist of sterilizable, in particular gamma-sterilizable, materials.

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: A bioreactor for use on a moving platform including a bag. According to a first aspect, the bag defines a three-dimensional geometrical shape including at least one lower collecting vertex in which at least two edges of the geometrical shape meet at an angle not greater than 90°. The bioreactor further includes at least one port or sensor arranged in the vicinity of the collecting vertex. According to a second aspect, the bag defines a two-dimensional geometrical shape or a three-dimensional geometrical shape. The geometrical shape includes at least one edge, in which at least two faces of the geometrical shape meet at an angle not greater than 90°. A longitudinal port/sensor element is arranged along the edge and includes several ports and/or sensors. A bioreactor motion system including a moving platform and a bioreactor according to the first or second aspect. A method of performing a bioprocess.

Abstract: A configurable device for the flexible provision of connections and/or functions in a biopharmaceutical process includes a body in which predefined pipe sections and plug-in locations are formed by recesses in the material of the body. The configurable device further includes a plurality of functional elements which are adapted to be inserted into the plug-in locations.

Abstract: A modular processing system (100) for biopharmaceutical processes includes (i) at least one first and at least one second processing unit (30, 32), which can be fluidically connected to each other; and (ii) at least one adapter plate (200), through which at least one fluid flow (14), flowing from the first processing unit (30) to the second processing unit (32), can flow. The adapter plate deflects the fluid flow between the first processing unit and the second processing unit at least partially; and/or controls the fluid flow, preferably, the pressure thereof, in an open loop or closed loop manner. A method for the modular construction of a processing system (100) for biopharmaceutical processes is also disclosed.

Abstract: A packaging for a flexible container, in particular for a disposable bag for use in a bioreactor, including a bottom part for fixing a first portion of the container, a ceiling part for fixing an opposite second portion of the container, a receiving space which on a first side is defined by the bottom part and on an opposite second side is defined by the ceiling part, and struts arranged between the bottom part and the ceiling part, which fix a defined distance between the bottom part and the ceiling part.

Abstract: The present invention relates to a method of expanding stem cells cultured as cell aggregates in a suspension culture changing culture medium and a method of medium exchange for the same cells characterized in the use of a rotating mesh such as a spinfilter device. The present invention further relates to a use of a rotating mesh for medium exchange in a suspension culture of stem cells.

Abstract: A device (1) and method for media filtration with a preparation container (2). A chamber (5) containing a dissolvable medium (29) is situated between the container inflow and outflow, and has a filter (22). A mixing arm (6, 7), connected to the inflow, protrudes into the medium in the chamber with at least one mixing nozzle (19, 20), disposed at the free end (17, 18) of the mixing arm for generating a directed jet of solvent. The preparation container has bottom (10) and top (8) parts bracketing the chamber. The filter is a sterile, has on the filtrate side facing the outflow, a circumferential outer edge (23) resting on a circumferential rest edge (37) of the bottom part of the preparation container and is connected fixedly thereto. A sterilised filtrate space (39) is formed between the filtrate side (38) of the filter and the outflow situated in the bottom part.

Abstract: A single-use filtration device including a plurality of single-use filter capsules connected with each other by rigid lines, of which at least a part is firmly mounted in a raster universally specified by a holder. The filter capsules, in particular as regards the type of filter, type of construction and/or size, and/or the connections of the filter capsules, are preconfigured for a desired filtration process.

Abstract: A mixing apparatus (1) for mixing a fluid and/or solid. The mixing apparatus includes a mixing container (100) having an interior in which the fluid and/or solid can be arranged. A feed-through passage (10) extends through a container wall (101) of the mixing container. A drive shaft (50) is fed through the feed-through passage, to drive a stirring element (30) arranged at least partly in the interior of the mixing container. The stirring element is used to mix the fluid and/or solid arranged in the mixing container. A drive-side shaft end (51) of the drive shaft couples the drive shaft to a drive (120) arranged outside of the mixing container. An adjustable seal (70) seals off the feed-through passage. A setting apparatus (80) is provided to switch the adjustable seal into at least two sealing operation states having different sealing effects.