System, device and method for receiving a disposable bag

Description

[0001] The invention relates to a system, a device and a method for receiving a disposable bag.

[0002] Bioreactors and pallet tanks serve as devices for the collection and storage of biological media, such as fluids. Biological media can be provided in disposable bags, which can have a volume ranging from a few liters to several hundred liters. The biological media are introduced into the bioreactor within a disposable bag, where they are maintained at a predeterminable temperature for a predetermined period of time, usually several hours. Furthermore, various tests can be conducted on the biological medium in such a bioreactor.

[0003] A bioreactor can be operated under cleanroom conditions, placing particularly high demands on quality assurance. This applies particularly to the temperature control of the biological medium, as particularly hazardous situations can arise during handling, for example, when using high-pressure temperature control fluids. Well-defined safety precautions must be implemented when handling temperature control fluids under high pressure.

[0004] From the documents US 2011 / 0310696 A1, WO 2015 / 039034 A1 and US 2005 / 0272146 A1 a bioreactor is known which can be tempered, for example, by means of a fluid.

[0005] Document US 2015 / 0299641 A1 discloses a heat exchanger module for use in a chemical, pharmaceutical, or biological reactor system. The heat exchanger module is configured for heat transfer to the reactor system, which comprises a flexible disposable container and at least one heat-conducting surface. The heat exchanger module has a fluid circulation path through which a heat exchange fluid can be circulated.

[0006] Document US 3,980,131 A discloses a vessel containing a culture medium or laboratory ware that is rapidly brought to a sterilization temperature by circulating a mixture of steam and superheated water through a narrow jacket. The mixture of steam and superheated water is generated in a part of the sterilizer outside the jacket and circulated without the use of a pump. The sterilization process can be carried out with an automatic control system.

[0007] The invention is based on the object of providing a possibility of the type mentioned at the outset for receiving a disposable bag with improved and / or simplified temperature control.

[0008] This object is achieved by the subject matter of the independent claims. Preferred embodiments are the subject matter of the dependent claims.

[0009] One aspect relates to a system for receiving a disposable bag with a receiving container having a container interior for receiving the disposable bag and a tempering cavity wall that at least partially surrounds the container interior of the receiving container.

[0010] The system can be designed as a bioreactor and / or pallet tank, which can be configured to accommodate disposable bags with a volume of approximately 1 liter to approximately 2000 liters, preferably with a volume of approximately 200 liters to approximately 1000 liters. The system can be designed, in particular, to accommodate disposable bags containing a biological medium such as a fluid that is to be stored, tempered, and / or otherwise examined in the system for a predetermined period of time. The system comprises a device.

[0011] The receptacle of the system provides the container interior, which is designed to accommodate the disposable bag. The container interior can be designed to accommodate a predeterminable type of disposable bag, for example, a disposable bag from a predeterminable manufacturer and / or with a predeterminable filling volume. Container walls of the receptacle define the container interior. The container walls of the receptacle do not have to completely surround and / or delimit the container interior. For example, the receptacle can have a stirring opening through which a stirring device can be connected to the disposable bag in the container interior. Such a stirring device is preferably formed at the upper end of the receptacle. The receptacle can thus, in particular, be designed without a lid and / or be open at the top.

[0012] The terms "top", "bottom", "lateral", "vertical", "horizontal", "height", etc., refer in the context of this invention to the Earth's reference system in which the system or device is arranged in an operating position.

[0013] The disposable bag is preferably introduced into the receiving container in such a way that it rests on a base of the receiving container and is in direct physical contact with the container walls of the receiving container, in particular in contact with the base of the receiving container and / or the container walls adjacent to the base.

[0014] The temperature control cavity wall is formed in the container walls of the receiving container in a closed temperature control circuit. The temperature control cavity wall can be formed as part of the container walls. The temperature control cavity wall can be designed as a double wall with an inner and an outer temperature control wall. The inner temperature control wall can face the container interior of the receiving container, and the outer temperature control wall can face away from the container interior.

[0015] The temperature control medium is formed in a cavity between the inner and outer temperature control walls. A temperature control unit can temperature-control the container interior, in particular the contents of the disposable bag, e.g., the biological medium, with the temperature control medium. For this purpose, a controller can be provided by means of which the temperature and / or pressure of the temperature control medium in the temperature control cavity wall can be controlled and / or adjusted. The controller can be formed as part of the temperature control unit. The temperature control unit can thus comprise the controller and / or the temperature control medium arranged in the temperature control cavity wall.

[0016] The interior of the temperature control cavity wall can be designed as a free cavity or with at least one flow guide element for guiding the flow of the temperature control medium through the temperature control cavity wall.

[0017] The two walls of the tempering cavity wall, i.e. an inner tempering wall and an outer tempering wall, can have a distance of a few millimeters from each other and can be spaced, for example, between 5 mm and 20 mm apart.

[0018] The inner side of the temperature control cavity wall, i.e., the temperature control inner wall facing the container interior, can be configured to directly border the container interior. In other words, no further system element can be configured between the container interior and the temperature control cavity wall. In other words, the temperature control cavity wall can thus at least partially directly surround and / or delimit the container interior.

[0019] "At least partially surrounded" means that the temperature control cavity wall surrounds the container interior on its outer surface by at least 40%, preferably at least 60%, particularly preferably at least 70%, particularly preferably at least 80%. In particular, this can mean that the container interior is completely surrounded and / or delimited and / or temperature-controlled by the temperature control cavity wall, except for an upper lid area and, if applicable, a viewing window and / or a door opening.

[0020] The temperature medium is set to a maximum pressure of approximately 1 bar in the temperature control cavity wall, preferably approximately 0.5 bar. With a maximum pressure of approximately 1 bar or 0.5 bar or less, the temperature medium is no longer considered a high-pressure medium, depending on the applicable pressure vessel directive. According to the ASME guideline ("American Society of Mechanical Engineers" for the American Economic Area), the maximum pressure is 1 bar; according to the PED guideline ("Pressure Equipment Directive" for the European Economic Area), the maximum pressure is 0.5 bar. The requirements for a high-pressure medium are particularly stringent, as handling and / or using a high-pressure medium poses particular safety risks. Using a temperature medium at such low pressure significantly reduces the safety risks associated with temperature control.In particular, the temperature control medium can also be under a pressure that is exactly 0.5 bar at the most, or that is always less than 0.5 bar.

[0021] In general, the temperature control medium can be a fluid, such as a liquid or a gas, located in a closed temperature control circuit. At least part of this temperature control circuit is formed by the cavity wall of the receiving container.

[0022] According to one embodiment, the temperature control unit adjusts the temperature control medium in the temperature control cavity wall in a closed temperature control circuit to a predetermined pressure of a maximum of approximately 1 bar or approximately 0.5 bar. The temperature control unit thus comprises adjustment means, such as a controller, for adjusting the pressure of the temperature control medium. In particular, the temperature control unit is designed and provided to adjust the pressure of the temperature control medium to a maximum of approximately 0.5 bar, thereby reducing a safety risk.

[0023] According to one embodiment, the temperature control unit regulates the temperature of the container interior with the temperature control medium, which has a pressure of approximately 0.20 bar to approximately 0.45 bar. In this pressure range, the temperature control medium is not yet a high-pressure medium with the associated safety risks, but nevertheless has a sufficiently high pressure to ensure sufficient performance for temperature control of the container interior.

[0024] The system comprises a device for receiving the disposable bag with the receiving container, which has the container interior for receiving the disposable bag. The temperature control cavity wall at least partially surrounds the container interior of the receiving container. The temperature control cavity wall is designed and provided to receive the temperature control medium for temperature control of the container interior at a maximum pressure of approximately 1 bar, preferably approximately 0.5 bar.

[0025] The device may be designed as a bioreactor which may be designed to accommodate disposable bags having a volume of several hundred liters, such as having a volume of 1 liter up to 2000 liters.

[0026] The device is designed as a component of the system. Thus, all embodiments described in connection with the device can also be implemented in the system.

[0027] In the device, the temperature control medium can be arranged in the temperature control cavity wall. The temperature control cavity wall is specifically designed and provided to accommodate a temperature control medium at a maximum pressure of approximately 0.5 bar. For this purpose, a controller can be provided by means of which the temperature and / or pressure of the temperature control medium in the temperature control cavity wall can be controlled and / or adjusted. The controller can be formed as part of the device. The device can thus comprise the controller and / or the temperature control medium arranged in the temperature control cavity wall.

[0028] By using a temperature medium under such low pressure, the safety risk during temperature control is significantly reduced.

[0029] According to one embodiment, the temperature control cavity wall is designed and provided to accommodate the temperature control medium for temperature control of the container interior at a pressure of approximately 0.20 bar to approximately 0.45 bar. The temperature control medium in the temperature control cavity wall can have a pressure of approximately 0.20 bar to approximately 0.45 bar during temperature control. In this pressure range, the temperature control medium is not yet a high-pressure medium with the associated safety risks, but nevertheless has a sufficiently high pressure to ensure sufficient performance for temperature control of the container interior.

[0030] According to one embodiment, at least one flow guide element is arranged in the temperature control cavity wall for guiding the flow of the temperature control medium through the temperature control cavity wall. In particular, a plurality of flow elements can be provided for this purpose. The flow element can be designed as a partition wall that runs essentially rectilinearly at least in sections and that defines and / or determines a flow path inside the temperature control cavity wall, at least in sections. The flow element can be designed, for example, as a guide spiral through the temperature control cavity wall. The flow element can prevent the formation of an unevenly distributed flow pattern in the temperature control cavity wall. Without a flow element, the temperature control medium in the temperature control cavity wall could flow essentially rectilinearly from a temperature control medium inlet to a temperature control medium outlet. The flow through the temperature control cavity wall can be redirected by the flow element.In particular, the flow element(s) can improve the temperature control by the temperature control medium in that the guided, freshly tempered temperature control medium passes essentially uniformly through the entire temperature control cavity wall.

[0031] According to one embodiment, the at least one flow guide element is designed and / or arranged at an angle such that the flow of the temperature control medium through the temperature control cavity wall is continuously guided with a vertical directional component. "Oblique" here means that the flow guide element is not designed exclusively horizontally, which would result in a substantially horizontal section of the flow guide, but that the flow guide element also has at least a vertical extension. This results in flow guidance through the temperature control cavity wall with at least one vertical component. Preferably, the flow guide is designed with both a vertical and a horizontal directional component in order to guide the temperature control medium through the temperature control cavity wall as evenly and efficiently as possible.The horizontal component of the flow guide can be larger than the vertical component, preferably even at least twice or at least three times as large. In particular, the flow guide can be guided from a temperature control medium inlet arranged at a lower end of the temperature control cavity wall to a temperature control medium outlet arranged at the upper end of the temperature control cavity wall and / or vice versa. To prevent the formation of air bubbles in the flow guide, the flow guide essentially has a vertical directional component throughout. This can reduce disruption to the temperature control due to air inclusions, in particular regardless of a flow and / or flow direction of the temperature control medium. This can improve the temperature control effect.

[0032] According to one embodiment, a collecting chamber with a vent outlet and a separate temperature control medium outlet is arranged at an upper end of the temperature control cavity wall. The separate temperature control medium outlet can be designed, for example, as an overflow and / or return line through which the temperature control medium is led out of the temperature control cavity wall. The vent outlet can be arranged at an upper end of the collecting chamber and thus start at a position where air collects in the temperature control cavity wall. This means that any air present in the circuit is not repeatedly passed through the entire cooling circuit, but can be vented as easily as possible. The vent outlet can be adjusted to the pressure set in the temperature control cavity wall. A target pressure in the temperature control cavity wall can also be controlled and / or regulated via the vent outlet.

[0033] According to one embodiment, the temperature control cavity wall is designed such that it substantially completely surrounds and / or delimits at least a lower third of the container interior. The bottom of the receiving container and the container walls adjacent to the bottom are located in the lower third of the container interior. At least in this lower third, the temperature control cavity wall is formed in the container walls of the receiving container. A stable container trough can be formed in the lower third. Thus, at least the lower third of the container interior is temperature-controlled by the temperature control medium over its entire circumference, i.e. along the entire side wall circumference of the receiving container, and substantially completely except for any bottom viewing windows arranged in the container wall.

[0034] According to one embodiment, the temperature control cavity wall is designed to control the temperature of the container interior and / or surround and / or delimit it above a predetermined fill level in the receiving container. The device and, in particular, the receiving container are designed to accommodate a predeterminable disposable bag. This disposable bag contains a predeterminable volume of a biological medium. Thus, the predetermined fill level in the receiving container corresponds to the fill level of the biological medium in the receiving container when one of the predeterminable disposable bags with biological medium is arranged in the container interior.

[0035] The temperature control cavity wall therefore surrounds and / or limits the container interior not only up to this predetermined fill level, but also upwards above this fill level. Typically, the upper part, such as the lid of a bioreactor, is no longer temperature-controlled because the biological medium is not filled up to the lid of the bioreactor and therefore does not rest against the lid. Thus, if the lid or the upper part of the bioreactor were temperature-controlled, it would not be the biological medium that would be temperature-controlled, but only the air inside the device, which could possibly escape through an opening in the container. For this reason, temperature control of air inside the bioreactor is conventionally avoided and the temperature is only controlled up to a maximum of the fill level. However, particularly when the biological medium in the bioreactor is stirred, the biological medium can rise in the receiving container above the predetermined fill level.This occurs particularly when a funnel is formed due to centrifugal forces during a stirring motion. In this embodiment of the device, the temperature control cavity extends well beyond the predetermined fill level and is thus capable of controlling the temperature of the biological medium inside the disposable bag even during a stirring motion, even beyond the predetermined fill level. This improves temperature control.

[0036] In a further development of this embodiment, the temperature control cavity wall is designed such that it controls and / or surrounds and / or delimits the container interior by at least about 1 cm and a maximum of about 20 cm, preferably from about 5 cm to about 12 cm, above the predetermined fill level in the receiving container. This height has proven to be a suitable average value both with regard to the most efficient temperature control of the biological medium and with regard to minimizing power losses due to temperature control of air in the upper region of the receiving container.

[0037] According to one embodiment, the device has at least one relief valve for adjusting and / or limiting the pressure of the temperature control medium in the temperature control cavity wall. The relief valve can be designed as a component of a controller and / or a temperature control unit. The at least one relief valve ensures that the temperature control medium in the temperature control cavity wall does not exceed a predeterminable target pressure, e.g., the target pressure of approximately or exactly 0.5 bar.

[0038] According to one embodiment, the device comprises an electric heater in heat exchange with the temperature control medium. The electric heater can be controlled and / or adjusted via a controller for the temperature control medium. The electric heater can be designed as an internal heater, which can be located, for example, directly adjacent to the temperature control cavity wall, inside the temperature control cavity wall, and / or in the temperature control circuit of the temperature control medium. The electric heater can be designed, for example, as a heating cartridge. The electric heater serves to adjust the temperature of the temperature control medium and thus to set a target temperature for the container interior.

[0039] According to one embodiment, the temperature control medium can be passed through an external heat exchanger. The heat exchanger can be designed as a separate component or as a part of the device. The heat exchanger can be designed and provided to both cool and heat the temperature control medium. Heat exchange with an external temperature control medium, which can be under high pressure, for example, can be provided and / or carried out in the heat exchanger. By using the heat exchanger, external temperature control media can also be used that would be too aggressive, for example, to be passed through the receiving container. Special safety precautions must only be taken to monitor and / or control the external temperature control medium, but not to monitor the internal temperature medium in the temperature control cavity wall. This simplifies the handling of the internal temperature control medium.The external temperature control medium can be present at high pressures of up to 10 bar to ensure high heat exchange efficiency. In this embodiment, one or more insulated temperature control lines can be provided, through which the internal temperature control medium can be directed to the external heat exchanger and from there back to the temperature control cavity wall.

[0040] According to one embodiment, insulation is at least partially formed on the side of the temperature control cavity wall facing away from the container interior, i.e., for example, on the temperature control outer wall, which insulates the temperature control cavity wall from the outside. Preferably, the insulation is designed such that it completely insulates the temperature control cavity wall from the outside. This reduces energy loss due to heat transfer from the temperature control medium to the outside air, i.e., air outside the container interior. At the same time, it is ensured that the temperature of the temperature control medium is released essentially exclusively to the inside, i.e., into the container interior and thus to the biological medium located in the disposable bag. The insulation can be designed as an air layer, as a vacuum, or as an insulating material such as, for example, insulating wool. The insulation can be designed such that at least the temperature control cavity wall is completely insulated from the outside.

[0041] In a further development of this embodiment, the insulation is at least partially arranged in an insulating hollow wall formed on the side of the temperature control hollow wall facing away from the container interior. The container wall of the receiving container thus at least partially has a double cavity, in other words, three consecutive partition walls in the direction from the inside to the outside. The temperature control medium is arranged in the first cavity, as viewed from the container interior, the temperature control hollow wall. The insulation is arranged in the second cavity, as viewed from the container interior, the insulating hollow wall. From the inside to the outside, the following can thus be arranged: 1. an inner temperature control wall adjacent to the container interior, 2. adjacent to this the temperature control medium in the temperature control cavity wall, 3. adjacent to this the temperature control outer wall, which can also be designed as an insulating inner wall, 4. adjacent to this the insulation in the insulating cavity wall, and 5. adjacent to this an insulating outer wall.

[0042] This provides particularly efficient temperature control and insulation of the container interior.

[0043] According to one embodiment, the receptacle has an openable door through which the disposable bag can be inserted into the container interior in a substantially horizontal direction. The door has at least one door hinge on which the door is rotatably mounted. The door can be opened and, when opened, provides access to the container interior. The door is formed as part of the container wall of the receptacle. The door is formed in a side wall of the receptacle and therefore provides access into the container interior in a substantially horizontal direction. This allows the disposable bag to be inserted into the container interior or removed from the container interior in a substantially horizontal direction. The remainder of the receptacle can be solid. In particular, the remaining side walls of the receptacle can be dimensionally stable without further opening options.This increases the overall stability of the receiving vessel compared to previously known, conventional bioreactors, which are completely split in half when inserting the disposable bag. It has been shown that a single door is sufficient for inserting a disposable bag comfortably and safely into the receiving vessel. In fact, the door actually facilitates the insertion of the disposable bag. The door can be designed as a single-leaf or double-leaf door.

[0044] In a further development of the embodiment, the receiving container is essentially in the form of a vertically arranged cylinder, wherein the door is formed in the cylinder jacket of the receiving container over a cylinder sector of approximately 80° to approximately 150°. The cylinder axis of the receiving container is arranged essentially vertically in the earth's reference system. Forming the door and thus a door opening of the same size over the angular range of approximately 80° to approximately 150° is particularly advantageous in several respects. The door size extends over less than half the cylinder circumference, i.e. is smaller than a cylinder sector with 180°. On the one hand, this ensures a high static stability of the receiving container. On the other hand, this door dimensioning enables supply lines, etc., to be fixed in a vertical orientation to opposite, static container walls, e.g. for fastening, supplying and / or controlling a stirring device.On the other hand, the door, with the dimensions mentioned, is large enough to ensure sufficiently comfortable access to the interior of the container. Preferably, the door, and thus a door opening of the same size, extends over a cylinder sector of 90° to 120° in the container wall of the receiving container.

[0045] In the embodiment with the door, the temperature control cavity wall and / or the insulation can also be formed in the door. For example, the temperature control cavity wall may not be formed inside the door, but only the insulation. Alternatively, in addition to being formed in the container wall of the receiving container, the temperature control cavity wall can also be formed in the door, specifically on the side of the door facing the container interior. This means that the container interior can also be temperature controlled at the door. The insulation can also be formed on the outside of the door, for example, as described above inside an insulating cavity wall. Alternatively, only insulation can be formed in the door without a temperature control cavity wall. For example, one or more temperature control lines for introducing the temperature control medium into the temperature control cavity wall of the door can be provided in or on the door hinge (or possibly the door hinges) of the door.This enables temperature control not only on the container walls but also on the door itself, which overall increases the temperature control effect and improves the temperature control and / or insulation of the container interior.

[0046] A third aspect relates to a method for picking up a disposable bag comprising the steps: Receiving a disposable bag in a container interior of a receiving container, and tempering the disposable container received in the container interior by means of a tempering medium arranged in a tempering cavity wall at least partially surrounding the container interior of the receiving container, wherein the tempering medium in the tempering cavity wall has a pressure of at most about 1 bar, preferably about 0.5 bar.

[0047] The method can be carried out, for example, using a device according to the second aspect and / or using a system according to the first aspect. Thus, all statements made in connection with the first and second aspects, and in particular the listed embodiments, also relate to the method according to the second and third aspects.

[0048] The invention is described in more detail below with reference to exemplary embodiments shown in the figures. Individual features of the embodiments shown in the figures can be implemented in other embodiments. The same reference numerals indicate the same or similar features of the embodiments. In the figures: Figure 1 shows a perspective view of a device for receiving a disposable bag; Figure 2A shows a first side view of a device for receiving a disposable bag; Figure 2B shows a second side view of a device for receiving a disposable bag; Figure 3 shows a perspective view of a vertical sectional view through a device for receiving a disposable bag; Figure 4A shows a first vertical cross-section through a device for receiving a disposable bag; Figure 4B shows a second vertical cross-section through a device for receiving a disposable bag; Figure 5A shows a first horizontal cross-section through a device for receiving a disposable bag; Figure 5B shows a second horizontal cross-section through a device for receiving a disposable bag; Figure 6 shows a side view of a first receiving container for receiving a disposable bag without a door and without an outer wall;Figure 7 shows a side view of a second receptacle for receiving a disposable bag without a door and without an outer wall; and Figure 8 shows a perspective view of a receptacle for receiving a disposable bag without a door and without an outer wall.

[0049] Figure 1 shows a perspective view of a device 1 for receiving a disposable bag. The device 1 shown in the figures can be designed as a component of a system for receiving a disposable bag.

[0050] The device 1 has a receiving container 10 which essentially has the shape of a vertically arranged cylinder, i.e. whose cylinder axis is arranged essentially vertically. The receiving container 10 has an interior into which a disposable bag can be inserted, which bag can contain, for example, a biological medium. The biological medium in the disposable bag is stored in the interior of the receiving container 10 for a predetermined period of time. While the disposable bag with the biological medium is located inside the receiving container 10, various reactions can occur with or on the biological medium. Thus, the device 1 can also be designed as a bioreactor.

[0051] To observe the biological medium, one or more viewing windows are formed in the side walls, through which one can look from the outside through the container wall into the interior of the receiving container 10 in order to observe the biological medium. For this purpose, the device 1 has two bottom viewing windows 12 in the lower third, as well as a door viewing window 32. The bottom viewing windows 12 are essentially in the shape of an elongated oval, the long oval axis of which is aligned essentially horizontally along the curved cylindrical outer wall of the receiving container 10. The door viewing window 32 is essentially in the shape of an elongated rectangle, the longer sides of which are aligned essentially vertically and are formed in the center of a single-leaf door 30 in the container wall of the receiving container 10.

[0052] Figures 2A and 2B show together with Figure 1different views of the device 1. For example, Figure 2BA frontal side view of the single-leaf door 30. The single-leaf door 30 extends in width, i.e., in the horizontal direction, approximately over a cylinder segment of the receptacle 10 of approximately 100°. In the horizontal direction, the single-leaf door 30 extends from two door hinges 34 along the cylinder jacket to a door handle 35 at the opposite end of the door. The single-leaf door 30 is essentially formed in the upper two-thirds of the receptacle 10, while the lower third of the receptacle 10 is essentially designed in the form of a rigid base shell, which itself is not designed to be openable. The single-leaf door 30 is rotatable about the door hinges 34 and can thus be opened. When the single-leaf door 30 is open, a door opening is formed in the receptacle 10 at a lateral position, through which door opening access to the interior of the receptacle 10 is possible.For example, the disposable bag can be inserted through the door opening into the interior of the receiving container 10 from a lateral direction, i.e. essentially in a horizontal direction of movement.

[0053] The device 1 is mounted on rollers 18, allowing it to be moved through a room. In addition to the rollers 18, the device 1 can have fixing feet 19 at its lower end, which serve to secure and correctly align the device 1 on uneven floors.

[0054] The receiving container 10 is open at the top. Instead of a cylindrical lid, the receiving container 10 has a stirring opening. Above the upwardly open receiving container 10, a stirring device 14 is formed, via which a stirring rod can be connected to the disposable bag through the stirring opening so that the interior of the disposable bag can be thoroughly mixed. The stirring rod can be arranged inside the disposable bag and connected to the stirring device 14 via a coupling. The stirring device 14 is formed centrally above the receiving container 10 and is carried by a support bridge, which rests on an upper edge of the receiving container 10 on opposite side walls of the receiving container 10.

[0055] Figure 2Ashows a side view directly onto one of the two cable guides 13. The second of the two cable guides 13 is arranged on the opposite outer wall of the receptacle 10. The side view of the Figure 2A shows the device 1 in a position which is different from the side view of the Figure 2B rotated 90°.

[0056] Figure 3 shows a perspective view of a vertical section through the device 1. In Figure 3Shown, for example, is a disposable bag 44, or more precisely, a section through this disposable bag 44, which is arranged in the interior of the receiving container 10. A biological medium 42, which is filled up to a predetermined fill level 40, is arranged in the interior of the receiving container 10 and simultaneously also in the interior of the disposable bag 44. The biological medium 42 extends from the bottom of the receiving container 10 up to the fill level 40 and thus fills the entire internal volume of the receiving container 10 up to the fill level 40, minus the volume of the walls of the disposable bag 44, which, however, are very thin and hardly noticeable.

[0057] The disposable bag 44 is held in shape by a container wall 16 of the receiving container 10, which extends upwards from the rounded bottom of the receiving container 10 to above the filling level 40. At least along the upper half, preferably along the upper two-thirds of the receiving container 10, the container wall 16 can extend substantially vertically upwards.

[0058] Figures 4A and 4B each show a cross-section vertically through the device 1. A section plane AA, which is Figure 4A shown is in Figure 2A and extends vertically through the upper part of the cable guide 13 and through the cylinder center of the receiving container 10. The Figure 4B The cross-section shown is in a section plane BB, which is Figure 2BThe section plane BB is arranged perpendicular to the section plane AA, in a vertical direction through the cylinder axis of the receiving container 10 and through the center of the single-leaf door 30.

[0059] In the Figures 4A and 4B The interior of the container walls 16 is shown in more detail. A temperature control cavity wall 20 is arranged on the inner walls of the receiving container 10, in which a temperature control medium (not shown in the figures) is arranged. The temperature control medium is regulated to a low pressure of less than 0.5 bar. The temperature control cavity wall 20 extends over the entire bottom of the receiving container 10 and along the container walls from the container bottom upwards beyond the fill level 40 to a temperature control height 41. The temperature control height 41 is arranged essentially 1 cm to 20 cm vertically above the fill level 40.

[0060] The biological medium 42 is in direct thermal contact with the temperature control cavity wall 20, from which it is separated only by the thin bag wall of the disposable bag 44. The biological medium can be regulated to a predeterminable temperature via the temperature control medium.

[0061] The device 1 can in particular be designed and provided to temper the container interior to a predeterminable target temperature of approximately 0°C to approximately 80°C, preferably of approximately 20°C to approximately 40°C.

[0062] The temperature control cavity wall 20 almost completely surrounds the container interior of the receiving container 10 up to and above the fill level 40. "Almost completely surrounded" in the exemplary embodiment shown in the figures means that the temperature control cavity wall 20 completely surrounds the container interior up to the temperature control level 41, except for those positions where the bottom viewing windows 12 are located and where the single-leaf door 30 is located. A glass pane can be arranged at the positions of the bottom viewing windows, providing a view of the container interior and, in particular, the biological medium located in the receiving container 10 (and, if necessary, corresponding darkening without temperature control). At the position of the single-leaf door 30, there is a recess in the shape of the door opening in the temperature control cavity wall 20.In an alternative embodiment, a temperature control cavity wall can also be formed on the inside of the single-leaf door 30, which is supplied with the temperature control medium via temperature control lines arranged on the door hinges 34.

[0063] In general, "almost completely surrounded" can mean that the temperature control cavity wall 20 completely surrounds the container interior up to the temperature control height 41, except for a few predetermined positions. These few positions can be the positions where viewing windows are arranged in the container wall of the receiving container 10 and, if appropriate, where the single-leaf door 30 is arranged. Generally, the temperature control cavity wall 20 does not delimit the container interior at its upper end.

[0064] The temperature control cavity wall 20 is surrounded on its outside by an insulating cavity wall 25, in which an insulation is located. The insulating cavity wall 25 almost completely surrounds the interior of the receiving container 10 from the bottom of the receiving container 10 up to the upper end of the container wall 16 (see also Figure 3 The insulating hollow wall 25 insulates both the container interior and, in particular, the temperature control hollow wall 20 from the outside. The insulation arranged in the insulating hollow wall 25 provides directed temperature control by means of the temperature control medium inward toward the container interior, which increases the energy efficiency of the device 1.

[0065] In Figure 4B Tempering lines 26 are shown, which are connected to the interior of the tempering cavity wall 20. Connections or insulating lines for providing a vacuum in the insulating cavity wall are not shown in the figures.

[0066] Figures 5A and 5Beach show a cross section through the device 1 in a horizontal cutting direction, namely through different high cutting planes DD and CC, which are in Figure 4B are marked.

[0067] Figure 5A shows a horizontal cross-section through the lower third of the receiving container 10, in which the temperature control cavity wall 20 completely surrounds and tempers the container interior and thus the biological medium 42 arranged therein from the outside (except for the bottom viewing windows). Figure 5A thus shows a horizontal cross section through the lower, non-openable bottom tray of the receiving container 10. The temperature control cavity wall 20 is in the Figure 5A shown cross-section is completely surrounded by the insulating cavity wall 25 and thus insulated from the insulation located therein.

[0068] The Figure 5B The horizontal cross section CC shown is above the Figure 5Ashown cross-section DD. At the height of cross-section CC, the single-leaf door 30 is already formed. At the position of the single-leaf door 30, i.e., at the position of the door opening in the container wall 16, the temperature control cavity wall 20 is interrupted. Therefore, no temperature control of the biological medium 42 takes place at the single-leaf door 30 itself. However, at the location of the single-leaf door 30, insulation is formed in the insulating cavity wall 25, which insulates the biological medium 42, i.e., the container interior of the receiving container 10, from the outside. The insulating cavity wall 25 is interrupted only at the position of the door viewing window 32, where the container interior is merely delimited by a glass pane.

[0069] The insulation thus insulates the receiving container 10 almost completely, in particular from the container bottom up to above the fill level completely up to the viewing windows arranged in the receiving container, in the exemplary embodiment the bottom viewing windows 12 and the door viewing window 32. The insulation can be formed in particular up to the temperature control height 41, preferably up to the upper edge of the container walls 16.

[0070] The tempering height 41 exceeds both the predetermined filling level 40 and the contact area of ​​the disposable bag 44 with the container walls 16 of the receiving container 10.

[0071] The disposable bag 44 is emptied after use, for example, via an outlet located below the device 1, and can then be completely disposed of. By using the disposable bag 44, cleaning of the device 1 can be avoided or completed much more quickly.

[0072] The collecting container 15 serves as a collecting element in case biological medium should escape from the device 1, e.g. due to a leak in the disposable bag.

[0073] Air, a vacuum, insulating wool, glass wool, rock wool or a similar insulating material can be used as insulation in the insulated cavity wall.

[0074] Device 1 has as few thermal bridges as possible, i.e., continuous metal connections from the container interior to the exterior, which would slow down the temperature control of the container interior. Device 1 only has thermal bridges that are absolutely necessary for structural reasons.

[0075] The temperature control medium is located inside a sealed temperature control system, which encompasses the interior of the temperature control cavity wall 20. The temperature of the temperature control medium can be regulated and / or controlled via an internal, electrically operated heating device or, optionally or alternatively, via an external heat exchanger. The external heat exchanger can be used to both cool and heat the temperature control medium independently of the internal electrical heating device of the temperature control system.

[0076] Figure 6 shows a side view of a first embodiment of the receiving container 10 for receiving a disposable bag without a single-leaf door 30 and without an outer wall. In other words, Figure 6a view of the interior of the temperature control cavity wall 20. Thus, only an inner wall of the receiving container 10 is shown, without its outer wall, which delimits and closes the temperature control cavity wall 20 to the outside. Also not shown is the insulating cavity wall 25, which can delimit the temperature control cavity wall 20 from the outside.

[0077] Inside the temperature control cavity wall 20, the receiving container 10 has a plurality of flow guide elements 22, which, in the side view shown, are arranged to extend in a substantially horizontal direction through the temperature control cavity wall 20. The flow guide elements 22 are designed such that they tightly adjoin both the inner and outer walls of the temperature control cavity wall 20. The flow guide elements 22 can, for example, be welded to both the inner and outer walls of the temperature control cavity wall 20.

[0078] As a result, the flow guide elements 22 define a flow channel and / or a flow guide for the temperature control medium inside the temperature control cavity wall 20, which in Fig. 6 marked by arrows.

[0079] At a lower end, the temperature control cavity wall 20 has a temperature control medium inlet 27, which can be designed in the form of a connecting pipe. The temperature control medium can be introduced and / or admitted into the interior of the temperature control cavity wall 20 via the temperature control medium inlet 27. The temperature control medium is guided from the lower end of the temperature control cavity wall 20 along the flow guide elements 22, which delimit a plurality of essentially horizontally extending flow sections of the flow channel.

[0080] In this case, the temperature control cavity wall 20 can, for example, have a flow guide element running spirally around the interior of the receiving container 10. Alternatively, as shown in the Figures 6, 7 and 8As shown, the temperature control cavity wall 20 comprises a plurality of flow guide elements 22 and / or 21, which provide a plurality of individual, substantially horizontally extending flow sections of the flow channel arranged one above the other. In transition regions between these individual, substantially horizontally extending flow sections of the flow channel, the temperature control medium flows in a substantially vertical direction (in the example shown, substantially vertically upward) up to the next higher, substantially horizontally extending flow section of the flow channel.

[0081] The temperature control medium thus flows along the flow guide elements 22 into a collection chamber 23 located at the upper end of the receiving container 10. The collection chamber 23 has a temperature control medium outlet 28, from which the temperature control medium can be drained from the temperature control cavity wall 20. The temperature control medium outlet 28 can be substantially tubular. An upper end of the temperature control medium outlet 28 can be designed as an overflow for the temperature control medium and define a maximum gradient of the temperature control medium inside the collection chamber 23.

[0082] Above the upper end of the temperature control medium, air can collect in the collection chamber 23. The air can be discharged via a vent outlet 24, which can also be arranged on the collection chamber 23, separate from the temperature control medium outlet 28.

[0083] This design prevents or at least reduces the possibility of air being sucked out via the temperature control medium outlet 28 and being led back into the temperature control circuit, which can cause malfunctions and disruptions in the temperature control.

[0084] The individual flow guide elements 22 are arranged as essentially rectilinear separating elements in side view. The flow guide elements 22 are aligned essentially horizontally, but in side view point upwards from a lower end to an upper end of the respective flow guide element 22 at an angle greater than 0° and up to 30°, preferably from 1° to 10°, particularly preferably from 3° to 8°. In other words, the flow guide elements 22 (viewed in side view and from the lower end to the upper end) have an upward gradient from the horizontal. This beveled or inclined design of the flow guide elements 22 results in the flow channel or flow guide having a continuous vertically upward directional component from the temperature control medium inlet 27 to the temperature control medium outlet 28.The flow channel thus runs neither downwards nor in an exclusively horizontal direction, not even in sections. Therefore, no air pockets form inside the temperature control cavity wall 20 outside the collection chamber 23. At the same time, the flow guide elements 22 are arranged so flatly, i.e., essentially horizontally, that a sufficient horizontal distribution of the temperature control medium along the inner walls of the temperature control cavity wall 20 is achieved.

[0085] Figure 7 shows a side view of a second embodiment of a receptacle 10' for receiving a disposable bag without a single-leaf door 30 and without an outer wall. This receptacle 10' has, in the side view, essentially horizontally extending flow guide elements 21. These flow guide elements 21 are similar—except for their essentially horizontal arrangement—to the flow guide elements 22 described above.

[0086] Figure 7 thus shows an alternative design of the receiving container with essentially horizontal, non-bevelled flow guide elements 21 (without gradient).

[0087] Figure 8shows a perspective, schematic representation of the second receiving container 10' without a single-leaf door 30 and without an outer wall. Since both the bottom viewing window 12 and the door opening 36 for the single-leaf door 30 disrupt a spiral design of the flow guide elements 21 from bottom to top, the flow channel is essentially divided into two parts. The flow channel has the individual flow sections arranged essentially in a horizontal direction on both sides of the door opening 36. A first number of flow guide elements 21 defines a first, e.g. right-hand, flow channel from the temperature control medium inlet 27 to the collection chamber 23 and a second number of flow guide elements 21 defines a second, e.g. left-hand, flow channel from the temperature control medium inlet 27 to the collection chamber 23, where the temperature control medium flows out of the temperature control cavity wall 20 again.

[0088] In general, the flow guide elements 21 and / or 22 can define and / or delimit one or more flow channels inside the temperature control cavity wall 20. These flow channels can lead from a single temperature control medium inlet 27 to the same, single collection chamber 23. List of reference symbols

[0089] 1 Device 10 Receptacle 10' Receptacle 12 Bottom viewing window 13 Cable guide 14 Stirring device 15 Collecting tray 16 Container wall 18 Casters 19 Fixing feet 20 Temperature control cavity wall 21 Flow guide element 22 Flow guide element 23 Collection chamber 24 Vent outlet 25 Insulating cavity wall 26 Temperature control line 27 Temperature control medium inlet 28 Temperature control medium outlet 30 Single-leaf door 32 Door viewing window 33 Door shade 34 Door hinge 35 Door handle 36 Door opening 40 Fill level 41 Temperature control height 42 Biological medium 44 Disposable bag

Claims

1. System having a device (1) for receiving a disposable bag (44), comprising: - a receptacle (10) with a receptacle interior to receive the disposable bag (44), - a hollow temperature control wall (20) that at least partially surrounds the receptacle interior of the receptacle (10) and - a controller, by means of which the pressure of a temperature control medium arranged in the hollow temperature control wall (20) is controlled and / or adjusted to at most about 1 bar, wherein the temperature control medium for controlling the temperature of the receptacle interior is accommodated in the hollow temperature control wall (20) at a pressure of at most about 1 bar.

2. System according to claim 1, comprising a temperature control unit that controls the temperature of the receptacle interior by means of the temperature control medium arranged in the hollow temperature control wall (20) at the pressure of at most about 1 bar.

3. System according to claim 2, wherein the temperature control unit adjusts the temperature control medium in a closed temperature control loop in the hollow temperature control wall (20) to a predetermined maximum pressure of approximately 1 bar.

4. System according to any one of the preceding claims, wherein the temperature control medium for controlling the temperature of the receptacle interior is accommodated in the hollow temperature control wall (20) at a pressure of about 0.20 bar to about 0.45 bar.

5. System according to any one of the preceding claims, wherein at least one flow guide element (21; 22) is arranged in the hollow temperature control wall (20) for guiding the flow of the temperature control medium through the hollow temperature control wall (20).

6. System according to claim 5, wherein the at least one flow guide element (22) is inclined so that the temperature control medium flows through the hollow temperature control wall (20) with a continuous, vertical direction component.

7. System according to any one of the preceding claims, wherein a collecting chamber (23) with a ventilation outlet (24) and a temperature control medium outlet (28) separate therefrom is arranged on an upper end of the hollow temperature control wall (20).

8. System according to any one of the preceding claims, wherein the hollow temperature control wall (20) is designed in such a manner that it completely surrounds at least a lower third of the receptacle interior.

9. System according to any one of the preceding claims, wherein the hollow temperature control wall (20) is designed in such a manner that it controls the temperature of, and / or surrounds, the receptacle interior to above a predetermined fill level (40) in the receptacle (10).

10. System according to any one of the preceding claims, comprising a relief valve for adjusting and / or limiting the pressure of the temperature control medium in the hollow temperature control wall (20).

11. System according to any one of the preceding claims, comprising an electric heater that exchanges heat with the temperature control medium.

12. System according to any one of the preceding claims, wherein the temperature control medium can be conveyed through an external heat exchanger.

13. System according to any one of the preceding claims, wherein an insulation is at least partially formed on the side of the hollow temperature control wall (20) facing away from the receptacle interior, the insulation insulating the hollow temperature control wall (20) from the outside.

14. System according to claim 13, wherein the insulation is at least partially arranged in a hollow insulation wall (25) formed on the side of the hollow temperature control wall (20) facing away from the receptacle interior.

15. System according to any one of the preceding claims, wherein the receptacle (10) has an openable door (30), through which the disposable bag (44) can be inserted into the receptacle interior in a substantially horizontal plane.

16. System according to claim 15, wherein the receptacle (10) is substantially designed in the form of a cylinder arranged vertically, and the door (30) is constructed in the cylinder shell of the receptacle (10) over a cylindrical sector of about 80° to about 150°.

17. Method for receiving a disposable bag, having the steps: - receiving a disposable bag (44) in a receptacle interior of a receptacle (10) of a system according to any one of the preceding claims, - controlling the temperature of the disposable pouch (44) received in the receptacle interior, by means of a temperature control medium arranged in a hollow temperature control wall (20) that at least partially surrounds the receptacle interior of the receptacle (10), wherein the temperature control medium in the hollow temperature control wall (20) is at a pressure of at most about 1 bar.