Abstract: A multilayer film for manufacturing a pouch, includes: a core layer, and an outer layer, wherein: the outer layer and the core layer are made integral with a tie layer, the core layer includes an ethylene vinyl alcohol copolymer having an ethylene content ranging from 25 to 48 mol %, alone or in mixture with an ionomer acid ethylene copolymer, the outer layer includes a polyolefin having a density ranging from 0.910 g/cm3 to 0.940 g/cm3 or a copolymer of ethylene and ?-olefin having a density ranging from 0.870 g/cm3 to 0.910 g/cm3, or a mixture thereof, the tie layer includes a copolymer of polyolefin grafted with a carboxylic acid or an anhydride of carboxylic acid, alone or in mixture with (H) a copolymer of polyolefin. The process for manufacturing such a film, and the single-use pouch manufactured from that film are also described.

Abstract: A film for manufacturing a pouch includes a contact layer including (A) a copolymer of ethylene and ?-olefin having a density in the range of 0.870 g/cm3 to 0.910 g/cm3, alone or in mixture with (B) a polyolefin having a density in the range of 0.910 g/cm3 to 0.940 g/cm3, the contact layer including less than 0.10 wt %, preferably less than 0.07 wt %, of additives able to release a degradation compound further to gamma irradiation in the range of 25 kGy-50 kGy that can slow down or delay cellular growth. The process for manufacturing such a film, as well as the single-use pouch manufactured from that film are also described.

Abstract: A bioreactor system for receiving a disposable bioreactor bag comprises a receiving container having a container wall which defines a receiving space in which the disposable bioreactor bag is received in an operating state of the bioreactor system. A stirring system projects at least partially into the receiving space and is designed and configured to stir a biomedium present in the disposable bioreactor bag in the operating state of the bioreactor system. At least one baffle, which makes the receiving space smaller and differs from the container wall, serves to reduce a laminar flow of the biomedium. A temperature control medium flows through at least part of the at least one baffle, said temperature control medium controlling the temperature of the baffle.

Abstract: The present invention relates to an operation process for a cell cultivation system, the cultivation system comprising two or more cultivation vessels for the production of at least one biologic agent and/or cell, which cultivation vessels comprise cells in a suitable cultivation medium, the process comprising the steps of taking two or more liquid samples from two or more or cultivation vessels, optionally, purifying the liquid samples, analyzing at least one sample to acquire data relating to at least one system parameter indicative for at least one of nutrient status and/or medium quality of the cultivation medium, or cell density, or cell viability and/or one product parameter indicative for biologic agent quality and/or cell quality, and, adjusting, preferably in real-time, at least one process parameter and/or at least one feeding input in at least one cultivation vessel of the cultivation system, or of a subsequent cultivation system.

Abstract: A bioprocess device assembly includes at least a first bioreactor and a second bioreactor, and a transfer system for transferring a certain volume of a medium contained in the first bioreactor into the second bioreactor. A biomass sensor is associated to the first bioreactor. A control unit is configured for receiving measurement data from the biomass sensor and controlling the transfer system. An inoculation method makes use of such a device assembly wherein the biomass sensor measures at least one parameter of biomass contained in the first bioreactor; the biomass sensor sends measurement data to the control unit; and the control unit evaluates the measurement data and, based on an evaluation of the measurement data decides whether the viable cell density is sufficient for inoculation, determines a necessary inoculation volume, and controls the transfer system to transfer the determined inoculation volume from the first bioreactor into the second bioreactor.

Abstract: A method is provided for measuring parameters of state of a fluid contained in a container (10, 10?) that has a sensor carrier plate with plural sensors (S01-S10, S01?-S10?). Each sensor has a sensor head in operative contact with the interior of the container (10, 10?) and in operative contact with an external control unit (12). The external control unit (12) receives measurement data generated by the sensor heads of active sensors via their communication link and processes the data. An activation data record (24, 24?) is assigned to each sensor (S01-S10, S01?-S10?) and is recorded in a manner that is accessible for the external control unit (12). The external control unit (12) first accesses the activation data records (24, 24?), then classifies the sensors (S01-S10, S01?-S10?) as activatable or nonactivatable sensors, and subsequently activates only those sensors classified as activatable sensors.

Abstract: A method is provided for measuring status parameters of a fluid contained in a container (10). The container (10) is configured for single use and has a wall on which a sensor-carrier plate is fixed in a fluid-tight manner. The plate carries sensors (S1-S5) that are in operative contact with the internal chamber of the container (10) and connected for data exchange (14) with an external control unit (16) that receives and processes the measurement data from the sensors (S1-S5). The sensor plate also carries a temporarily inactive duplicate (D1-D5) of at least one of the sensors (S1-S5) that is activated if measurement data of the sensor (S1-S5) is classified as atypical in the context of an integrity or plausibility test carried out by the external control unit (16).

Abstract: A container (1) has a flexible wall (2) and at least one emptying tube (4, 4?, 4?) that projects through a wall aperture (7) into the container interior (3) surrounded by the flexible wall (2). The free end (12) of the emptying tube has an emptying opening (13) that can be set in position vertically to different emptying heights (14). The container (1) is distinguished in that an adapter piece (8), in which the emptying tube (4, 4?, 4?) is held in a longitudinally displaceable manner, is arranged in the wall aperture and in that a portion of the emptying tube (4, 4?, 4?) is surrounded by a flexible sheath (5) that is connected at a first end (11) to the emptying tube (4, 4?, 4?) and at its second end (10), which is remote from the first end (11), to the wall (2) or the adapter piece (8).

Abstract: Container system with one container (1) with a flexible partition, in particular a disposable container, that can be inserted into a carrying container that supports its lateral container partition (10) and in which liquid medium (8) that has been poured in can be mixed, with the carrying container (4) featuring at least one baffle (15, 15?, 15?, 15??) on the internal support partition (11) that forms the lateral container partition.

Abstract: A mixing device (10) comprises a flexible container (14), at least one stirring element (22) and at least one baffle (24). The baffle (24) is formed on the inside on a circumferential side wall (16) of the flexible container (14) and has a free end protruding into the interior of the container (14). A main application of the mixing device (10) is considered to be the use as disposable bioreactor.

Abstract: A method is provided for measuring parameters of state of a fluid contained in a container (10, 10?) that has a sensor carrier plate with plural sensors (S01-S10, S01?-S10?). Each sensor has a sensor head in operative contact with the interior of the container (10, 10?) and in operative contact with an external control unit (12). The external control unit (12) receives measurement data generated by the sensor heads of active sensors via their communication link and processes the data. An activation data record (24, 24?) is assigned to each sensor (S01-S10, S01?-S10?) and is recorded in a manner that is accessible for the external control unit (12). The external control unit (12) first accesses the activation data records (24, 24?), then classifies the sensors (S01-S10, S01?-S10?) as activatable or nonactivatable sensors, and subsequently activates only those sensors classified as activatable sensors.

Abstract: A receptacle has a wall defining a receptacle interior and a shaft housing for guiding a shaft through the wall into the receptacle interior. The shaft housing defines an annular cap with spaced apart inner and outer walls connected by an inner end face facing the receptacle interior. A shaft guide part has an end facing the receptacle interior and an outer surface that defines a gap relative to the inner wall of the shaft housing. The shaft guide part has an annular wall spaced apart from and parallel to its outer surface. The annular wall extends over the free end of the inner wall of the shaft housing and is sealed to the inner and outer walls of the shaft housing by at least one seal each. The shaft guide part is mounted in the shaft housing by a radial ball bearing and by an axial ball bearing.

Abstract: A method is provided for measuring status parameters of a fluid contained in a container (10). The container (10) is configured for single use and has a wall on which a sensor-carrier plate is fixed in a fluid-tight manner. The plate carries sensors (S1-S5) that are in operative contact with the internal chamber of the container (10) and connected for data exchange (14) with an external control unit (16) that receives and processes the measurement data from the sensors (S1-S5). The sensor plate also carries a temporarily inactive duplicate (D1-D5) of at least one of the sensors (S1-S5) that is activated if measurement data of the sensor (S1-S5) is classified as atypical in the context of an integrity or plausibility test carried out by the external control unit (16).

Abstract: A bioreactor has a stirrer shaft that is driveable by a drive and on which a stirrer element is positioned. The position of the stirrer element is determined by a stirrer installation aid. The stirrer installation aid has a free end with an abutment surface on which the free end of the stirrer element abuts. The stirrer installation aid is designed as a sleeve that comprises a slot extending between the axial ends of the sleeve. The slot is delimited by opposite flanks of a wall, and the sleeve is placed on the stirrer shaft. The stirrer installation aid can be pulled off laterally from the stirrer shaft. A method for installing the stirrer element on the stirrer shaft arranged in the bioreactor also is provided.

Abstract: The invention relates to a device for culturing cells in a bioreactor, the waste-air line of which leading out of the reactor interior comprises a waste-air filter having a sterile-filtration microfilter membrane, wherein at least one prefilter having a hydrophobic filter material is placed upstream of the waste-air filter toward the reactor interior.

Abstract: A device and a method for adjusting stirring blades on a stirring blade receptacle of a stirrer, wherein the stirring blades can be fixed with a stirring blade axis in receiving bores, which are arranged transversely to an axis of rotation and are a part of the stirring blade receptacle, at intended predetermined angle of attack relative to a virtual plane that is arranged transversely to the axis of rotation of the stirrer. An associated device body is provided with a receiving element for receiving the stirring blade receptacle with unfixed stirring blades. A stop is arranged on the device body for each lower face, which faces the receiving element and is a part of the stirring blades, outside the respective stirring blade axis. Each respective stirring blade is then brought into abutment against its associated stop, to place it into the predetermined angle of attack.

Abstract: A mixing device (10) comprises a flexible container (14), at least one stirring element (22) and at least one baffle (24). The baffle (24) is formed on the inside on a circumferential side wall (16) of the flexible container (14) and has a free end protruding into the interior of the container (14). A main application of the mixing device (10) is considered to be the use as disposable bioreactor.

Abstract: A bioreactor has a reactor bag (12) with a predominantly flexible bag wall (121) that has a rigid bearing area. A stirrer arrangement (14) is in the bearing area and includes rigid profile ring (16) made of a non-magnetic material and fixed in the bearing area. The stirrer arrangement (14) also includes a shaftless stirrer (18) rotatably engaged with the profile ring (16) and having parts that are permanently magnetic. An electric coil arrangement (20) is outside the reactor bag (12) and can produce a rotating magnetic field that interacts with the permanent-magnetic areas of the stirrer (18) to produce a torque that rotates the stirrer (18) and circulates the contents of the bag (12).

Abstract: A mixing system has a single-use container (1) with flexible walls and a mixing device. The mixing device has at least one encapsulated drive (5) and a mixer shaft (3). The drive (5) can be disposed of after use together with the mixer shaft (3) and the single-use container (1). The mixing system can be used in biotechnology and the pharmaceutical industry for mixing liquids, dissolving solids or cultivating cells and microorganisms.

Abstract: Aeration device for bioreactors with a first aeration element with gas outlet openings of a first size and with at least one second aeration element with gas outlet openings of a second size, the aeration elements being formed by a common housing with separate aeration channels.