Tanks for biopharmaceutical processes

Abstract

The present invention relates to a reservoir element (200) for a tank 1 of a biopharmaceutical process line. The reservoir element (200) comprises a body element (210) and at least one shell element (220, 222). The body element (210) has a first end (212) and a second end (214) opposite the first end, each of the first end and the second end comprising an orifice, where the body element tapers from the first end to the second end, where an internal volume is defined between the first end and the second end. The body element and / or the at least one shell element comprises at least one groove (216, 217), where the at least one shell element (220, 222) is fixedly attached to the body element (210), and the body element and the at least one shell element form at least one channel across the groove. The at least one channel is adapted to conduct at least one biochemical medium and / or a working medium.

Description

[Technical field]

[0001] The present invention relates to a tank system including a reservoir element for the tank, a tank assembly, a tank, a cleanroom bag and a method for assembling the tank. The tank and / or the tank system can be used in biopharmaceutical processes. Furthermore, it can be adapted for example for the production and / or development of biopharmaceuticals and / or the development and / or testing of commercial production processes thereof.

[0002] Background technology Biopharmaceuticals, e.g. drugs for cancer therapy, gene therapy and / or cell therapy, are currently manufactured in so-called biopharmaceutical process lines.

[0003] Known biopharmaceutical process lines are, for example, stainless steel tanks interconnected by pipes or the like. These known biopharmaceutical process lines are difficult to maintain and clean. Therefore, so-called disposable biopharmaceutical process lines have been developed, which are replaced after use. Here, disposable containers, such as bags, serve as reservoirs for the extract and / or product of the biopharmaceutical process line. Said bags are usually supported in rigid containers, such as stainless steel vessels, and interconnected by hoses. These known rigid containers are bulky and require a lot of storage space when not in use, leading to increased storage and transportation costs.

[0004] Setting up a traditional disposable biopharmaceutical process line requires complex manual assembly, which increases costs. For example, multiple bags, filters, sensors, valves, etc. need to be connected through various hoses. The complex assembly carries a significant risk of biopharmaceutical process line malfunction due to improper or incorrect assembly.

[0005] Furthermore, disposable biopharmaceutical process lines are prone to damage as the (hose-based) connections and / or bags of the disposable containers tend to leak during uptime. In case of leakage or malfunction, the extract and / or product of the entire biopharmaceutical process line may be damaged or even destroyed. Thus, significant economic risks exist for biopharmaceutical process line operators.

[0006] Furthermore, known disposable biopharmaceutical process lines usually contain different materials that come into contact with the extracts and / or products, increasing the risk of their contamination. This contamination can be caused by extracts, especially leachables, that are originally contained in the various materials of the biopharmaceutical process line. Furthermore, cell growth and / or other biochemical process steps can be distorted. In particular, when pumps are used to transport fluids containing extracts and / or products through the biopharmaceutical process line, there is a risk of particle generation due to wear.

[0007] Due to the complex construction of single-use biopharmaceutical process lines, automating the assembly and operation of biopharmaceutical process lines is very difficult and expensive, therefore, biopharmaceutical process lines, especially small-scale ones, are often operated manually.

[0008] Furthermore, all components of a single-use biopharmaceutical process line are typically discarded after use, as they are often not cleanable or recyclable.

[0009] In view of the above, it is an object of the present invention to provide a reservoir element for a tank, a tank and a tank system that can be used in a biopharmaceutical process line, as well as a tank assembly and a method for assembling a tank that overcomes the above-mentioned drawbacks. Furthermore, the cost and time required for the development and production of biopharmaceuticals is reduced, thereby shortening the time to market. In particular, the tank and / or tank system should be adapted to be operated automatically. Furthermore, the tank and / or tank system should be adapted to be assembled automatically.

[0010] Summary of the Invention This object is achieved by the reservoir element, the tank, the tank assembly, the tank system, the clean room bag and the method for assembling the tank according to the independent claims. Further embodiments are described in the dependent claims and in the following description. The parts of the description which are not included in the claims are provided for a better understanding of the claimed invention.

[0011] In particular, this object is achieved by a reservoir element for a tank of a biopharmaceutical process line, the reservoir element including a body element and at least one shell element. The body element has a first end and a second end opposite the first end, each of the first end and the second end including an orifice, where the body element tapers from the first end toward the second end. Further, an interior volume is defined between the first end and the second end.

[0012] The body element and / or the at least one shell element include at least one groove, where the at least one shell element is fixedly attached to the body element and the body element and the at least one shell define at least one channel across the groove, the at least one channel adapted to conduct at least one biochemical medium and / or working medium.

[0013] The body element can be manufactured by injection molding, injection blow molding, extrusion blow molding, or thermoforming. Thus, the side walls of the internal volume are integrally formed, thereby increasing the airtightness of the reservoir element, in particular the tank containing said reservoir element. Furthermore, the injection molded or thermoformed elements can be manufactured cost-efficiently and with high quality. Thus, the costs of the tank and / or tank system for the biopharmaceutical process line can be reduced compared to conventional biopharmaceutical process lines.

[0014] The at least one shell element can be fixedly attached to a single sidewall or multiple sidewalls of the body element. For example, the shell element can be formed to cover all sidewalls of the body element when attached. In another embodiment, the shell element can be formed to cover only one or a portion (at least two) of the sidewalls of the body element when attached. The shell element can be attached to the inside or outside of the body element.

[0015] In particular, the at least one shell element can be welded to the body element, preferably by ultrasonic welding, or other suitable welding techniques (laser welding, transparent-to-transparent welding, friction welding). In a further embodiment, the at least one shell element is glued to the body element. For example, reactive or non-reactive adhesives, such as hot melt adhesives, can be used. Additionally or alternatively, the shell element can be attached to the body element using mechanical fasteners, such as screws, bolts, rivets, etc. A sealing member may further be provided to seal the body element and the shell element. The sealing member may be a sealing gasket or a liquid seal.

[0016] The body element and the shell element are preferably formed from a plastic material, preferably the same plastic material, for example, the body element and the shell element may be formed from COC (cyclic olefin copolymer), COP (cyclic olefin polymer), PP (polypropylene), PC (polycarbonate), PET (polyethylene terephthalate), etc.

[0017] The grooves included in the at least one body element and / or the at least one shell element may have any suitable cross-section (e.g., semicircular, triangular, rectangular, etc.). In particular, a first groove may be formed in the body element and a corresponding second groove may be formed in the shell element. Thus, when the shell element is attached to the body element, a channel is formed by the first and second grooves. For example, a channel having a circular cross-section may be formed by a semicircular first groove and a corresponding semicircular second groove.

[0018] The use of grooves to form channels allows for the creation of complex channel shapes that cannot be created by one-piece injection molding, for example, a heating or cooling channel can include several curvatures in the sidewall of the reservoir element.

[0019] The at least one channel may be selected from a group of different channel types including channel types such as an inlet channel, an outlet channel, a bypass channel, a heating or cooling channel, a sampling channel, etc.

[0020] The inlet channel serves to direct the biochemical medium and / or working medium into the internal volume (i.e., the reservoir of the assembled tank). The inlet channel may include or be coupled to a sparger. The outlet channel serves to remove the biochemical medium and / or working medium from the internal volume (i.e., the reservoir of the assembled tank). When connected to a further (second) tank, the outlet channel of the first tank can be connected to the inlet channel of the second tank to transfer the medium from the reservoir of the first tank to the reservoir of the second tank.

[0021] Furthermore, a channel may be provided for example to transfer the retentate from the filter or membrane back to the interior volume of the respective tank. This channel may be a separate retentate channel or said channel may be integrally formed with the outlet channel. To transfer the retentate back, the working fluid may be passed through the filter or membrane in a direction opposite to the working direction, which is the direction in which the media flows during filtration. During filtration, the permeate passes through the membrane / filter and the retentate is retained by the membrane / filter.

[0022] Further channels may be provided for transferring the permeate and / or filtrate back to the internal volume of the respective tank and / or reservoir of another tank. To transfer the permeate and / or filtrate, a positive pressure may be applied to the permeate or filtrate side of the filter, respectively. This can be achieved by directing a working medium, such as pressurized (sterile) air, to the permeate or filtrate side, respectively. The working medium can push the permeate towards the permeate channel and return the permeate / filtrate into the reservoir of the assembled tank and / or to another tank. The direction of flow can be controlled by opening and closing the respective valves associated with the respective channels.

[0023] Further channels that may be provided functioning for recirculating a medium in the assembled tank (recirculation channel); for wetting or flushing components of the assembled tank, in particular at least one filter (wetting channel, flushing fluid channel); for removing product (product channel); for providing medium (feed channel); for removing / recirculating permeate / filtrate (permeate or filtrate channel); for removing waste (waste channel); for cell harvesting (cell bleed channel); for feeding, removing and / or transferring cells (cell channel); for pressurizing at least a part of the assembled tank (pressure channel) and / or for loading different solutions into the assembled tank, in particular into cartridges for chromatography, i.e. washing, cleaning, elution (washing channel, washing channel, elution channel).

[0024] The bypass channel serves to direct the biochemical medium and / or the working medium, where the bypass channel is not connected to the internal volume of the reservoir element (respectively to the reservoir of the assembled tank). Thus, the medium can bypass the assembled tank without communicating with the reservoir of the assembled tank. For example, if three tanks are connected such that the first tank and the third tank sandwich the second tank, the fluid may be directed from the reservoir of the first tank to the reservoir of the third tank without passing through the reservoir of the second tank. In this case, the bypass channel may be provided in the reservoir element of the second tank. Optionally, the bypass channel may be adapted to be fluidically separated or connected from the internal volume of the assembled tank or the respective reservoir. This can be achieved, for example, by a valve. Depending on the position of the valve (open / closed), the bypass channel may or may not communicate with the internal volume / reservoir of the tank. Thus, in the process line, the flow of the medium can be controlled by whether it bypasses the reservoir of the tank or not.

[0025] For example, a bypass channel can be used to provide a biochemical medium, such as a buffer solution, used in various tanks of a biopharmaceutical process line in a large storage tank. The biochemical medium can then be transferred from the storage tank to all tanks that require the medium (e.g., buffer solution). If a tank does not require the medium, the medium can bypass the reservoir of the tank. Furthermore, the supply of the medium (e.g., amount and time) can be controlled by providing a valve in the bypass channel. Furthermore, the bypass channel can function to transfer a biochemical medium, such as a cell culture, from a first tank (e.g., a seed tank) to at least two subsequent tanks that can function as further bioreactors. Thus, a biochemical medium can be directed from a single tank to multiple subsequent tanks.

[0026] The heating or cooling channel serves to guide a conditioned heating or cooling medium and to condition the assembled tank. Depending on the degree of heating / cooling, the medium received in the tank may evaporate or condense. Furthermore, the reservoir element may comprise at least one longitudinal rib. The at least one longitudinal rib may protrude into the interior volume. The heating or cooling channel may be at least partially received in the at least one longitudinal rib. Thus, the efficiency of heating or cooling may be increased.

[0027] The sampling channels serve to take samples of the biochemical and / or working media from the reservoirs of the assembled tanks, so that extracts, products, intermediate products or process lines can be removed and analyzed.

[0028] In particular, the reservoir element may comprise a number of channels formed by respective grooves formed in the body element and / or in the at least one shell element. These channels may be adapted to conduct different biochemical and / or working media when the reservoir elements are assembled in the tank and the tank is in use. By providing respective reservoir elements, the functionality of the assembled tank can be adapted to the specific needs of the respective process line.

[0029] In particular, the assembled tank may be a multifunctional tank comprising several channels of different channel types and / or of the same channel type. At least one channel can be opened or closed, for example using a valve, a closure, etc. Thus, depending on the required function, one or several channels can be closed. These closed channels are not used. At least one other channel or several other channels can be opened and used, thereby defining the function of the multifunctional tank.

[0030] At least one of the multiple chancels may be in communication with the internal volume (i.e., a portion of the reservoir of the assembled tank) and / or may bypass the internal volume. Furthermore, the reservoir element may include an additional channel formed in a tube, e.g., a rigid tube, that can be inserted into the internal volume through an opening in the body element and / or the plate element. The tube may be sealingly received in the respective opening. The additional channel may be configured to direct at least one biochemical medium and / or working medium from outside the assembled tank into the reservoir of the tank.

[0031] The channels may have an equivalent diameter in the range of 0.1 to 3 inches (0.25 to 7.6 cm), preferably in the range of 0.2 to 2 inches (0.5 to 5.1 cm), more preferably in the range of 0.3 to 1.5 inches (0.75 to 3.8 cm), even more preferably in the range of 0.5 to 1 inch (1.2 to 2.5 cm), and most preferably about 0.75 inches (1.9 cm). Furthermore, different channels may have different diameters and / or the diameter of the channels may vary. Thus, for example, nozzles may be provided. The equivalent diameter of a channel having a non-circular cross section is equal to the diameter of a channel having a circular cross section, where both channels (non-circular and circular) have the same cross-sectional area. Thus, for a channel of circular cross section, the diameter and the equivalent diameter will be the same.

[0032] Furthermore, the body element may have a polygonal cross-section in a plane parallel to the first end, where at least one shell element may be plate-like. The polygonal cross-section may provide substantially flat side walls, which facilitate attachment of the shell element to the respective side walls of the body element. Alternatively, the shell element may have a polygonal cross-section. In yet another alternative, the shell element may be formed such that when attached it covers only a portion of the body element, for example at least two side walls.

[0033] The internal volume and the first orifice are configured such that the reservoir element is adapted to at least partially receive a further reservoir element. As a result, multiple reservoir elements can be stacked on top of each other. Thus, the reservoir element requires little storage space and can be easily transported and stored. Thus, costs can be further reduced.

[0034] Additionally, the reservoir element may include a plate element sealingly attached to the first end or the second end of the body element and covering a respective orifice, and the plate element may include at least one channel, where the at least one channel communicates with the channel formed by the body element and the at least one shell element.

[0035] The plate element may be sealingly attached to the first or second end of the body element, for example, by welding, preferably ultrasonic welding, or other suitable welding techniques (e.g., laser welding, clear-to-clear welding, friction welding). In a further embodiment, the at least one shell element is glued to the body element. For example, a reactive or non-reactive adhesive, such as a hot melt adhesive, may be used. Additionally or alternatively, the plate element may be attached to the body element using mechanical fasteners, such as screws, bolts, rivets, etc. A sealing member may be further provided to seal the body element and the plate element. The sealing member may be a sealing gasket or a liquid seal. The plate element may be an integrally formed part or may be formed from multiple layers. For example, the plate element may have a two-layer structure, in which the first layer and / or the second layer include at least one groove. In which the first layer is fixedly attached to the second layer, and the first and second layers sandwich the groove and form at least one channel. The at least one channel is adapted to conduct at least one biochemical medium and / or working medium. Additionally, the channel may be in fluid communication with a channel formed between the body element and the at least one shell element.

[0036] The reservoir element may also include at least one insert adapted to at least partially cover an undercut of the internal volume. The insert may be integrally formed with the body element and / or the plate element or may be a separate part. The insert allows to cover the undercut of the internal volume. As a result, dead spaces in the internal volume can be prevented or at least reduced. Furthermore, the insert can increase the mechanical stability of the reservoir element.

[0037] In an alternative embodiment, the reservoir element may be formed using 3D printing techniques. For example, the body element and at least one shell element may be integrally formed. In this embodiment, the grooves / channels may be integrally formed in the wall of the reservoir element. Additionally, the plate element and / or the insert may be formed using 3D printing techniques. Thus, the entire reservoir element may be integrally formed.

[0038] The first end and / or the second end of the reservoir element may include a sealing surface for sealingly connecting the reservoir element to another reservoir element. In particular, the sealing surface may include at least one sealing member for providing a sealed connection between adjacent reservoir elements. The sealing member may be circumferentially disposed around the orifice of the first end and / or the second end. The sealing member may be compressed when the reservoir elements are assembled to form a reservoir of the tank.

[0039] Furthermore, the reservoir element, in particular the plate element, may include at least one port, where at least one port is associated with each channel, where the port is selected from a group of port types including the following port types: Fluid inlet port Gas inlet port Fluid outlet port Heating and cooling ports Gas outlet port * Cell bleed port Cell transfer port ○ Medium supply port Media removal port Element interconnection ports * Tank interconnection port

[0040] The inlet port (fluid or gas) serves to provide the biochemical medium and / or the working medium to the internal volume. In the assembled state, the internal volume may form part of a reservoir of the tank of the biopharmaceutical process line. The heating / cooling port serves to supply a temperature-regulated heating / cooling fluid to the heating / cooling channel. The outlet port (fluid or gas) serves to remove the biochemical medium and / or the working medium from the internal volume of the tank or the respective reservoir. The media supply port allows for supplying the medium (biochemical medium and / or working medium) to the internal volume / tank. The media removal port allows for removing the medium (or a part thereof) from the internal volume / tank. The media removal port may serve for example to transfer the retentate from the filter or membrane back to the internal volume / tank. The tank interconnection port serves to fluidly couple the channels of the reservoir element of the first tank to the corresponding channels of the reservoir element of the second tank when the first tank is connected to the second tank. This is done for example by using a connector device, as explained in more detail below. The tanks may be connected side-by-side (first tank adjacent to second tank) or the first tank may be above the second tank. The tank interconnection ports may function as media supply and / or media removal ports. The cell bleed port functions to remove cells from the interior volume / reservoir of the tank. The cells may be discarded or transferred to additional tanks or other devices for further processing.

[0041] At least one port may be associated with a valve that can be controlled, preferably by a handling manipulator (or a number of handling manipulators). Thus, the flow of medium from and to the tank can be controlled by opening and closing the valve. In particular, the valve may be a flow control valve that allows the flow to be adjusted in stages.

[0042] For example, a channel may be associated with a tank interconnection port and a fluid outlet port. Said channel may thus function to transfer a medium, such as a fluid, from an internal volume / reservoir of a tank to another tank. If a valve is attached to the tank interconnection port, the flow of the transferred medium may be controlled. Alternatively or additionally, the flow may be controlled by controlling the pressure (positive and / or negative) in the associated tank.

[0043] At least one port may comprise a protruding shroud at least partially surrounding the associated channel. The shroud may be concentrically arranged around a channel end of the associated channel. Furthermore, at least one port may comprise a recess at least partially surrounding the associated channel. The recess may be concentrically arranged around a channel end of the associated channel. The port may be adapted to be coupled to a hose or pipe element to fluidly connect the reservoir element and / or the tank with further surrounding objects. For example, a tank with the reservoir element may be integrated into a conventional biopharmaceutical process line. To connect the channels / tanks, the port may comprise a snap-fit ​​connection member adapted to engage with a corresponding snap-fit ​​connection member. This snap-fit ​​connection may provide a releasable and firm connection.

[0044] Furthermore, a port (e.g., a tank interconnection port or an element interconnection port) may be adapted to engage with a corresponding port (e.g., a corresponding tank interconnection port or an element interconnection port), where the port and the corresponding port are formed to provide a positive lock. For example, a reservoir element may comprise a port on a first side and a corresponding port on a second side, where the first side and the second side may be opposing outer surfaces of the reservoir element. A tank including said reservoir element may be coupled to a further tank using the port and the corresponding port, where the respective channels may be fluidly connected when coupling the tanks. Thus, a medium may be transferred from a first tank to a second tank without the use of intermediate conduit elements such as pipes or hoses. Thereby, a tank system of, for example, a biopharmaceutical process line may be easily assembled and less prone to assembly errors.

[0045] Furthermore, a first reservoir element of the tank can comprise a port and a second reservoir element of the tank can comprise a corresponding port, whereby the reservoir elements can be joined to form a reservoir of the tank. Thereby, the respective channels of the reservoir elements can be fluidly connected when assembling the tank. Thus, a medium can be guided through the channels formed in at least two reservoir elements of the tank. Thereby, the assembly of the tank is made easier and less prone to assembly errors.

[0046] The port may include a sealing member (e.g., a flexible sealing member such as a rubber seal, a silicone seal, a Teflon seal, etc.). The sealing member may be a radial and / or an axial seal. For example, the sealing member may be provided on the shroud and / or within a recess of the port. The sealing member may be provided as a sealing gasket allowing for sealing multiple ports of the reservoir element. Additionally, the sealing member may be port specific and adapted to seal only a single port.

[0047] A reservoir element may also include multiple tank interconnect ports to provide an interconnect interface that allows the tank to be easily coupled to another tank. Additionally, each reservoir element of a tank may include multiple element interconnect ports to provide an interconnect interface that allows different reservoir elements of the tank to be easily coupled to assemble the tank.

[0048] Furthermore, said at least one port associated with each channel may comprise a sterile quick connector, which allows the tanks to be connected to each other in a sterile manner in different environments. For example, the tanks may be delivered in a sterile state and connected using a sterile quick connector when they are assembled, for example, at the customer's site of use.

[0049] Furthermore, the reservoir element, in particular the plate element, may comprise at least one filter, where at least one port may be covered by at least one filter, where the filter may be selected from a group of filter types comprising the following filter types: Pre-filter Sterile filter * Bacteria filter Virus filter Mycoplasma filter Ultrafiltration filter Diafiltration filter Cell filter Cell harvest filter Fluid filters Bioburden filter Air filters, and Gas filters

[0050] The filter may be provided within the internal volume of the reservoir element. Thus, when assembled to the tank, the filter may be provided within the reservoir of the tank. Each tank may thus function as a filtration unit for filtering the medium received in the reservoir of the tank. The air filter may be a syringe filter. The filter may be a liquid filter. The liquid filter may function as a buffer for flushing.

[0051] Furthermore, the filter may be integrated into the reservoir element, in particular into the shell or plate element of the respective reservoir element, for example, the reservoir element (e.g. the top plate element or the side wall element of the tank) may be integrally formed with the filter housing.

[0052] Furthermore, at least one port of the reservoir element may be covered by a filter. Providing a port covered by a filter allows for retaining some of the medium in the assembled tanks and / or preventing other parts of the medium from entering the tanks. If the inlet port is covered by a filter, only filtrate can enter the internal volume of the reservoir element of the respective tank. If the outlet port is covered, only filtrate can leave the internal volume of the reservoir element of the respective tank. For example, the gas inlet port may be covered by a sterile filter. Thus, sterile pressurized air can be directed into the internal volume of the reservoir element of the respective tank. Thus, for example, the medium contained in the reservoir of the tank can be blown out of the reservoir for transfer to another tank.

[0053] Furthermore, the filter covering at least one port may be heated and / or cooled. Thus, the medium entering or leaving the reservoir element (respective tank) can be thermostated to a desired temperature. Furthermore, a heated filter allows high-temperature filtration, whereas a cooled filter allows low-temperature filtration. A heated filter can prevent undesired condensation.

[0054] Furthermore, the reservoir element, in particular the plate element, may comprise at least one valve. The at least one valve is associated with at least one channel. There, the valve may be a flow control valve, a cut-off valve, a pressure relief valve or a non-return valve, etc. Furthermore, the reservoir element may comprise several valves of the same type and / or of different types. In particular, a valve may be provided at the junction of at least two channels formed in the reservoir element. Thus, depending on the position of the valve, the medium can be directed to different channels and / or ports. Thus, the fluid flow rate can be controlled.

[0055] The flow control valve allows to control the amount of medium flowing through the channel per unit time (e.g. flow rate in liters / second). The flow control valve may be configured to dynamically control the flow rate and thus to control the biochemical process in the tank including said reservoir element. The cut-off valve allows to open and close the channel. The bypass channel may be provided with a cut-off valve. Thus, the bypass channel may be fluidically isolated from the internal volume of the tank or the respective reservoir (valve closed) or in communication with the internal volume / reservoir of the tank (valve open). Furthermore, the cut-off valve allows to close the channels not used in the tank and to open the channels used, depending on the function of the tank.

[0056] A non-return valve may be provided in the channel to prevent the medium removed from the internal volume / tank from flowing back into the internal volume / tank. Thus, for example, contamination of the internal volume / tank can be prevented. Furthermore, the non-return valve can prevent the medium that has entered the internal volume / tank from flowing back. Thus, the tank can be pressurized (for example, by pressurized air) and the medium contained in the reservoir of the tank can be directed in a desired direction, for example for filtration purposes. By using a pressurized tank, the medium can be directed without the use of a pump. Thus, contamination of the medium and the generation of particles (for example due to wear) can be effectively reduced or even prevented. Furthermore, the cost of the tank and / or tank system of the biopharmaceutical process line is reduced, since (expensive) pumps such as disposable pumps and pump heads are not required. Furthermore, avoiding pumps makes the tank easier to clean, maintain and / or sterilize.

[0057] The at least one valve can have any suitable configuration. For example, the at least one valve can be a ball valve, a butterfly valve, a diaphragm valve, a gate valve, a needle valve, a pinch valve, etc.

[0058] At least one valve may be configured for manual and / or automatic actuation. For example, the valve may be configured for mechanical, pneumatic, hydraulic, magnetic, electrical, etc. Furthermore, at least one valve may be configured for actuation from outside the tank by an actuation device. In particular, the valve may be a mechanical valve configured for actuation from outside the tank by an actuation device. The actuation means may be an actuation rod connecting the valve closure member in contact with the medium to the outside of the tank. The actuation rod may be supported and sealed in at least one reservoir element forming the tank. Furthermore, the actuation rod may include several sections, where each section of the actuation rod is supported in a respective reservoir element. In case of assembling the tank from several reservoir elements, the sections of the actuation rod may be coupled such that the valve in a first reservoir element can be actuated by first actuating the actuation rod of another (e.g. second) reservoir element.

[0059] To open or close the valve, the actuating means can be rotated or axially displaced depending on the type of valve involved. Furthermore, the actuating device may comprise a magnet (permanent magnet or electromagnet) adapted to open or close the valve. The magnet allows actuation of the respective magnetic valve from outside the tank. The provision of a magnetic actuating device facilitates sealing of the valve, since the valve closure member and the actuating device can be separated from each other, for example by a continuous wall section.

[0060] In certain embodiments, the valve is initially closed and can be opened by displacing the valve body axially. This can be done, for example, using an actuation rod or magnetic forces. In the initial closed state, the valve can be preloaded by a spring member or a magnetic member. Thus, when unactuated, the valve can be in a closed state. Only when it is manipulated (e.g., manually or via a handling manipulator) does the valve open.

[0061] Furthermore, the valve may comprise a switching mechanism corresponding to that of a ballpoint pen. The valve can therefore be opened or closed by axially displacing an actuator of the valve. This allows specific photometry to be performed. Furthermore, stable switching states can be established. The axial displacement can be achieved by a handling manipulator. In particular, the valve with said switching mechanism can be actuated via a cleanroom bag, as described herein.

[0062] The actuator may be adapted to couple with an actuation mechanism that may be part of a handling manipulator that allows for automated control of the actuator, the tank and / or the tank system.

[0063] In particular, when using mechanical and / or magnetic valves, it is possible to avoid the integration of electric valve components into the tank, thus facilitating and improving the recycling of the tank.

[0064] The valves, valve bodies and / or actuators may be initially integrated into the respective reservoir elements of the tank or may be adapted to be integrated into the respective reservoir elements of the tank after or during assembly of the tank. This facilitates assembly of the tanks and / or tank systems of the biopharmaceutical process line. This means that, as in conventional biopharmaceutical process lines, the valves are typically provided as separate (disposable) components that must be manually connected to other parts of the process line, such as bags.

[0065] Furthermore, the inner surface of the internal volume and / or at least one channel can be coated. Furthermore, at least the valve, port and / or filter components of the reservoir element that may come into contact with the biochemical and / or working medium can be coated. The coating may be a silicon dioxide coating, a glass-based coating, etc. The coating reduces the number of different contact materials that come into contact with the biochemical and / or working medium. Thus, the risk of contamination of the biochemical and / or working medium and / or the risk of distortion of cell growth and / or other biochemical process steps can be reduced.

[0066] Furthermore, the coating can form a gas barrier and / or provide an inert inner surface of the internal volume and / or at least one channel. The coating can be heat resistant so that the reservoir element and the respective tank can be heated and / or cooled. Furthermore, the reservoir element forming the tank can be formed of the same (partially coated) material, which can facilitate recycling of the reservoir element. The coating can be applied during or after the manufacture of the reservoir element, i.e., for example during injection molding and / or thermoforming.

[0067] The reservoir element may further comprise at least one assembly connecting device and / or at least one corresponding assembly connecting device, where the assembly connecting device and the corresponding assembly connecting device are configured to engage with each other to secure the assembly of at least two adjacent reservoir elements, where the assembly connecting device and the corresponding assembly connecting device engage, and the assembly connecting devices may be configured to automatically engage with the corresponding connecting device, for example, using an assembly manipulator.

[0068] For example, the assembly connection device may be a threaded member integrated into the reservoir element. The threaded member may have an internal or external thread and may be formed integrally with the reservoir element. Optionally or additionally, the threaded member may be an inlay, such as a metal inlay, that is held securely in the reservoir element. The inlay may be, for example, overmolded or glued to the reservoir element. The corresponding assembly connection device may be a trough opening that may be aligned with the threaded member having an internal thread. Thus, the reservoir element may be connected and engaged by threading a screw into the threaded member through the through opening. Furthermore, the corresponding assembly connection device may be a trough opening that receives a threaded member having an external thread. Thus, the reservoir element may be connected and engaged by threading a nut or the like into the threaded member, whereby the reservoir element is engaged.

[0069] Furthermore, the assembly connecting device may be a protrusion, such as a bolt. The protrusion may be integrally formed with the reservoir element or may be an inlay. The inlay may be, for example, overmolded or glued to the reservoir element. The corresponding assembly connecting device may be a corresponding recess. The recess may be integrally formed with the reservoir element or may be an inlay, such as a sleeve. The inlay may be, for example, overmolded or glued to the reservoir element. During assembly, the assembly connecting device engages with the corresponding assembly connecting device and provides a positive lock. The engagement of the assembly connecting device with the corresponding assembly connecting device may be a self-retaining engagement. The self-retaining engagement may be achieved by a retention force provided by a flexible member that may be provided between the reservoir elements to be engaged (e.g., an upper plate element and a sidewall element, two sidewall elements, and / or a lower plate element and a sidewall element). Upon assembly, the flexible member is compressed, thereby providing a retention force. In particular, the flexible member may be a sealing member that seals the reservoir formed by the reservoir element.

[0070] Furthermore, the assembly connecting device may include a latching member, such as a hook, where the corresponding assembly connecting device may include a recess formed for engaging said hook. This object is further achieved by a tank assembly adapted to be assembled to a tank, where the tank assembly comprises at least two reservoir elements as described above. Furthermore, the tank assembly may include two reservoir elements having a plate element sealingly attached to the first end or the second end of the body element, and at least one, preferably at least two further reservoir elements not having such a plate element.

[0071] The first end of each reservoir element of the tank assembly may have the same size and shape, and the second end of each reservoir element of the tank assembly may have the same size and shape. It should be understood that when the body element of the reservoir element tapers from the first end to the second end, the first end and the second end have different sizes and / or shapes.

[0072] In particular, the reservoir elements may have different heights (distance between the first and second ends). Thus, when combining reservoir elements of different heights, tanks of different volumes can be assembled. Furthermore, by assembling multiple reservoir elements, different volumes can be achieved.

[0073] The tank assembly is adapted to be assembled into a tank as described below and includes the reservoir element described above, so that all of the advantages described with respect to the tank and reservoir element can be achieved by the tank assembly, at least when assembled. Furthermore, the tank assembly allows for transportation and storage of the disassembled tank with little space requirements.

[0074] This object is further achieved by a tank for a biopharmaceutical process line, the tank comprising a top plate element, optionally at least one sidewall element, and a bottom plate element, the optional at least one sidewall element being a reservoir element without a plate element, and the top plate element and the bottom plate element being reservoir elements with a plate element sealingly attached to a first or second end of the respective body element.

[0075] The top plate element, the optional at least one sidewall element, and the bottom plate element are arranged to form a reservoir for receiving at least one biochemical medium. The tank further comprises at least one channel for conducting the at least one biochemical medium and / or the working medium, wherein the at least one channel extends inside the at least one top plate element, the at least one sidewall element, and / or the bottom plate element. A length of the at least one channel is greater than a thickness of the respective top plate element, the sidewall element, and / or the bottom plate element.

[0076] In general, all channels and / or reservoirs of the tank may be configured to be automatically emptied, i.e., medium that enters a channel and / or reservoir may be allowed to flow out of the respective channel and / or reservoir by gravity.

[0077] The assembled tank can comprise one reservoir or multiple (at least two) reservoirs formed by a top plate element, at least one sidewall element, and a bottom plate element. In case of multiple reservoirs, the reservoirs can be arranged in series or parallel with each other. A medium flowing through reservoirs in series flows through a single reservoir one after the other. A medium flowing through reservoirs in parallel flows through a single reservoir in parallel. A combination of series and parallel arrangement of reservoirs is also possible.

[0078] The tank (and accordingly the reservoir element) is adapted for use in biopharmaceutical process lines, for the manufacture and / or development of biopharmaceuticals, and / or for the development and / or testing of commercial manufacturing processes for these commodities. Additionally, the tank may be used in other manufacturing lines and may be adapted to be operated automatically and / or manually.

[0079] The biochemical medium and / or the manipulation medium can be any extract or product of the process line, such as a sample-containing medium, a cell-containing medium, a drug-containing medium, a buffer medium, an acid, a base, etc. The medium can include at least one of the following: small molecule API, an antibody, a drug conjugate, RNA or fragments thereof, a rec protein, a viral vaccine, a bacterial / microbial process, a virus-like particle, a viral vector, an ADC, DNA, etc. Additionally, the actuating medium may include a heating or cooling fluid, pressurized air or gas, etc. For example, if pressurized air is used as the actuating medium, the actuating medium can function to drive the biochemical medium through the channel and / or into (or out of) the reservoir of the tank.

[0080] The biochemical medium and / or the working medium may be provided in liquid and / or gas form, as well as in the form of a solution and / or emulsion and / or suspension.

[0081] In particular, a working medium such as pressurized air can be used to transfer the biochemical medium to and / or from the tank. The tank is thus actuable via the working medium. When transferring the biochemical medium from the tank, a positive pressure can be applied to the first tank by applying the working medium to the tank. The biochemical medium is thus pushed out of the tank, for example towards the second tank and / or towards the filter. To transfer the biochemical medium to the tank, a negative pressure can be established, for example by removing (actuating) the medium from the tank. When pressurized air is used as the working medium, preferably sterile pressurized air is used. Sterile pressurized air can be obtained by directing the pressurized air through a respective sterile filter before entering the tank. The working medium such as pressurized air can be supplied to or removed from the tank by a respective gas inlet and / or outlet port.

[0082] The terms top plate element, sidewall element, and bottom plate element do not specify the orientation of the tank during assembly and use. Rather, the assembled tank can be used in any orientation. Typically, the bottom plate element acts as a base and can optionally be provided on a stand to adjust the height of the tank during use / operation. For example, the tank can be oriented standing up (i.e., top plate element on top), lying down (i.e., sidewall element on top), or upside down (bottom plate element on top).

[0083] Furthermore, the top plate element serves to support the tank and may be adapted to be supported in a support rail, as will be explained in more detail below. In this case, the tank is in a suspended configuration and the bottom plate element may not be in contact with the ground. In addition, a support member may be provided that supports the tank on the bottom plate element in addition to the suspension support of the top plate element. Said support member may be adapted to be height adjustable, for example by a linear drive, such as a magnetic drive, an electric drive, a pneumatic drive and / or a hydraulic drive. The support member may include a weighing member that allows the supported tank to be weighed. The weight of the respective tank may be used to control the process line.

[0084] Providing reservoir elements, such as a top plate element, optionally at least one side wall element and a bottom plate element, assembled to the tank and arranged to form in particular a reservoir for receiving at least one biochemical medium, facilitates cleaning and maintenance of the tank after use. Thus, each reservoir element or at least parts of the reservoir elements can be reused and / or recycled separately. Furthermore, the tank (each reservoir-forming element) can be easily cleaned and sterilized before use.

[0085] The at least one channel extends into at least one of the top plate element, the at least one sidewall element, and the bottom plate element. Different channels may be provided in different reservoir elements or in the same reservoir element, such that each reservoir element (top plate element, optionally at least one sidewall element and / or bottom plate element) may comprise at least one channel (or multiple channels).

[0086] Optionally, the transfer of the medium to and / or from the reservoir of the tank may be achieved exclusively by at least one channel or a plurality of channels extending in the top plate element, at least one sidewall element, and / or the bottom plate element. Thus, the surfaces of the at least one channel and the reservoir in contact with the medium may be of the same material. Thus, the risk of contamination of the extract and / or product (i.e., biochemical medium and / or working medium) of the biopharmaceutical process line by unfavorable combinations of different materials can be reduced, and cell growth and / or other biochemical process steps are not distorted.

[0087] By using channels to transfer media, high consistency between lots of a product line can be achieved. This is because, for example, in the case of traditional fluid connections using hoses (e.g., as traditional disposable lines), variability in different contact materials occurs from lot to lot. This leads to undesirable and unexpected contamination of the transferred fluid. By using channels in the tank elements to transfer media, the number of different contact materials can be minimized, which allows for higher consistency between lots of a product line.

[0088] At least one channel may extend into at least one of the sidewall element, the top plate element, and the bottom plate element. In another example, at least one channel may extend into the top plate element and into at least one of the sidewall element. At least one additional channel may extend into at least one of the sidewall element, the top plate element, and / or the bottom plate element.

[0089] Via at least one channel (or, respectively, an additional channel), the biochemical medium can be removed from the lower part of the tank (e.g., via a first end of the channel provided in the bottom plate element or in a side wall element adjacent to the bottom plate element) or be led to the upper part of the tank (e.g., via a second end of the channel provided in the top plate element or in a side wall element adjacent to the top plate element) for transfer to another tank, for example. Correspondingly, the biochemical medium can be removed from the upper part of the tank (e.g., via a first end of the channel provided in the top plate element or in a side wall element adjacent to the top plate element) or be led to the lower part of the tank (e.g., via a second end of the channel provided in the bottom plate element or in a side wall element adjacent to the bottom plate element) for transfer to another tank, for example. Furthermore, a working medium, such as a heating medium or a cooling medium, can be led inside at least one side wall element and at least one of the top and bottom plate elements to provide a suitable cooling / heating of the assembled tank. The heating or cooling medium may be guided into the top plate element, the at least one side wall element and / or the bottom plate element without contacting the reservoir, so that the heating or cooling medium and the biochemical medium are separated from each other.

[0090] In general, the tank serves as a reservoir for the extract or product of the process line, such as a biochemical medium and / or a working medium. The received medium can thus be stored and / or transported. Furthermore, the tank may be configured to mix different media received in the reservoir of the tank. Furthermore, the tank may serve as a bioreactor and support a biologically active environment. For example, chemical processes involving organisms or biochemically active substances derived from such organisms can be carried out in said tank. Furthermore, the tank may be designed to grow cells or tissues in cell culture. The tank can be used as a batch bioreactor, fed-batch bioreactor, enrichment fed-batch bioreactor, or continuous bioreactor, and / or perfusion bioreactor. Additionally or optionally, the tank can serve as a filtration unit for filtering the medium received in the reservoir of the tank. In this case, the filter may be provided in or on the top plate element, at least one sidewall element, and / or the bottom plate element. Furthermore, the tank can serve to prepare a biochemical medium, such as a buffer medium, and / or to carry out preparative chromatography. Additionally, the tank may be equipped with cross-flow cassettes and / or hollow fiber modules for virus filtration, cell harvesting and / or ultrafiltration or diafiltration.

[0091] The reservoir of the tank may have a volume of at least about 10 ml, at least about 15 ml, at least about 20 ml, at least about 50 ml, at least about 100 ml, at least about 200 ml, at least about 250 ml, at least about 500 ml, at least about 1 liter, at least about 2 liters, at least about 5 liters, at least about 10 liters, at least about 20 liters, at least about 50 liters, at least about 100 liters, at least about 200 liters, at least about 500 liters, at least about 1000 liters, at least about 2000 liters, at least about 3000 liters, at least about 4000 liters, or at least about 5000 liters. Thus, the biopharmaceutical process line can be expanded. For example, a tank with a smaller volume is used during development. A larger tank is used during subsequent production. Furthermore, tanks of different volumes can be combined in the tank system of the biopharmaceutical process line.

[0092] Tanks of different volumes can be achieved by assembling reservoir elements with different heights (distance between the first and second ends) and / or by assembling multiple reservoir elements. If all first ends of each reservoir element of the tank assembly have the same size and shape, and the second ends of each reservoir element of the tank assembly have specifically the same size and shape, any combination of reservoir elements can be used to assemble tanks with different volumes. Thus, based on a small number of different reservoir elements, a large number of different tanks can be assembled.

[0093] In an embodiment, tanks with different volumes can be provided and used as reservoir elements substantially identical to the top and bottom plate elements, reservoir elements of different height dimensions or sidewall elements of multiple reservoir elements.

[0094] For example, the reservoir element may have a width in the range of 80 mm to 1500 mm, preferably in the range of 200 mm to 1200 mm, even more preferably in the range of 300 mm to 1000 mm, and most preferably in the range of 450 mm to 600 mm. Furthermore, the reservoir element may have a height in the range of 150 mm to 2000 mm, preferably in the range of 200 mm to 1300 mm, even more preferably in the range of 500 mm to 1000 mm, and most preferably in the range of 450 mm to 650 mm.

[0095] The tank may have height, depth, and width dimensions, where the ratio of height:depth:width may be about 2:1:1. It should be noted that this ratio is preferred when the tank is used as a bioreactor. Other dimensions may be selected depending on the desired function of the tank.

[0096] The tank may include heating or cooling fingers that may be inserted into the tank through the top plate element, at least one sidewall element, and / or the bottom plate element. The heating or cooling fingers function to direct a conditioned heating or cooling medium to condition the tank, where the heating or cooling medium directed by the heating or cooling fingers is separated from the contents of the reservoir. Depending on the degree of heating / cooling, the medium received in the tank may evaporate or condense.

[0097] Additionally, the tank may comprise at least one port that may be provided in at least one of the reservoir elements, where the at least one port may be associated with a respective channel. The port may be selected from a group of port types including the following port types: fluid inlet port, gas inlet port, fluid outlet port, gas outlet port, cell bleed port, tank interconnect port, element interconnect port, media supply port, media removal port, etc., as described above with respect to the reservoir elements.

[0098] The tank may include at least one filter, which may be provided in at least one of the reservoir elements, where the at least one filter may be selected from a group of filter types including the following filter types: pre-filter, sterile filter, bacterial filter, viral filter, mycoplasma filter, ultrafiltration filter, diafiltration filter, cell filter, cell harvest filter, liquid filter, air filter, gas filter, etc., as described above with respect to the reservoir elements.

[0099] The tank may comprise at least one valve. The valve may be provided in at least one of the reservoir elements. The at least one valve may be associated with at least one channel. The at least one valve may be a flow control valve, a cut-off valve, a pressure relief valve, a non-return valve, etc. Furthermore, the tank may comprise multiple valves of the same type and / or different types. In particular, a valve may be provided at the junction of at least two channel portions. Thus, depending on the position of the valve, the medium may be directed to different channels and / or tanks, as described above with respect to the reservoir elements.

[0100] The tank may further comprise an adapter plate element, where the adapter plate element is attached to the top plate element. The adapter plate element may be configured to at least partially cover a filter and / or a port of the tank. In certain embodiments, the top plate element of the tank and the associated adapter plate element may form a filter housing. Additionally, the adapter plate element may be configured to support an actuator of the valve.

[0101] The adapter plate element and the top plate element can sandwich a barrier element, where the barrier element is part of a cleanroom. The cleanroom can be, for example, a cleanroom bag or tent. In this case, the adapter plate element can be located outside the cleanroom and the top plate elements of the assembled tanks can be located inside the cleanroom.

[0102] Furthermore, the adapter plate element may provide access to at least one port of the tank, to at least one filter of the tank, and / or to at least one actuator of a valve of the tank. When the barrier element is sandwiched between the adapter plate element and the top plate element, the top plate element, as well as at least one sidewall element and the bottom plate element of the tank, can be maintained in a clean room, where access to the tank is possible from outside the clean room via the access provided by the adapter plate element. Thus, biochemical and / or actuating media can be supplied to and / or removed from the tank from outside the clean room. Furthermore, at least one valve can be actuated and controlled from outside the clean room.

[0103] The tank may further comprise at least one connector device for interconnecting the tank (first tank) with another (second) tank. The connector device may be included in at least one of the reservoir elements forming the tank. The connector device allows for a quick set-up of a tank system comprising several tanks, since the tanks can be interconnected by said connector device. Thus, the assembly of a biopharmaceutical process line is facilitated and / or accelerated. In addition, the risk of malfunctions or leaks due to improper assembly can be reduced. In particular, the connector device can be adapted for automated interconnection. As a result, the tank system of the biopharmaceutical process line can be automated, thereby further reducing the risk of improper assembly.

[0104] The connector arrangement may be a threaded connector arrangement, such as a screw and respective nut and / or a belt or strap, which interconnects the first and second tanks.

[0105] The connector arrangement may be a latch connector arrangement, where the tank comprises a first latch connector arrangement for directly interconnecting the tank with a further tank comprising a corresponding latch connector arrangement. The first latch connector arrangement may be a latch arm including a latch protrusion. The latch protrusion may be adapted to latch with a corresponding latch connector arrangement, which may be formed as a latch recess.

[0106] The tank, in particular the respective reservoir element of the tank, may alternatively or additionally comprise a second latching connector arrangement adapted to latch with the interlatching connector arrangement. This interlatching connector arrangement is adapted to latch with a second latching connector arrangement of a further tank. As a result, the tank may be directly interconnected with said further tank via the interlatching connector arrangement. The second latching connector arrangement may for example comprise a protrusion, such as a knob, adapted to latch with an interlatching connector arrangement having a corresponding recess to provide a positive lock. The interlatching connector arrangement may be a flexible interlatching connector arrangement which, when latched with the second latching connector arrangement of the tank, is tensioned, thereby pressing the first tank against the second tank.

[0107] The connector device can provide a fluid connection between a first tank and a second tank. For example, the connector device can be designed and shaped such that when latched, the tank interconnect ports of the first and second tanks engage with each other and the respective channels are aligned (sealed) and in fluid communication. Thus, assembly of the tank system of a biopharmaceutical process line can be facilitated and accelerated.

[0108] The connector device, in particular the latching connector device, may be provided on the top plate element, at least one side wall element and / or the bottom plate element. Furthermore, the connector device may be provided in a recess in the top plate element, at least one side wall element and / or the bottom plate element to prevent the connector device from being damaged during transport and / or storage.

[0109] In particular, the connector device may be configured to be actuated automatically and / or without tools. The connector device may provide a permanent interconnection of the tanks or a separable interconnection.

[0110] At least one connector device of the tank may be configured as a bottom drain. The bottom drain may provide a fluid connection between the first tank and the second tank and may be provided in the lower half of the first tank, in particular in the bottom plate element. The bottom drain may be configured such that the first tank is emptied automatically and / or by application of pressure.

[0111] Any of the reservoir elements and / or tank may be sterilizable by autoclave, ETO gas, x-ray and / or gamma irradiation before, during, or after assembly. The tank can be assembled from the reservoir elements (top plate element, optional at least one sidewall element, and / or bottom plate element), making sterilization easy. If the tank needs to be sterilized after it is assembled, ports can be used to allow ETO gas or steam to enter or exit the tank. In general, any of the reservoir elements and / or tank may be sterilizable by any gas that allows for sterilization.

[0112] Furthermore, the tank may comprise an assembly strengthening device for strengthening the assembly of the reservoir elements (e.g., the top plate element, at least one sidewall element, and / or the bottom plate element) of the tank. The assembly strengthening device may include a threaded device, such as a threaded rod, a strap and / or a belt. For example, at least two reservoir elements may comprise a through opening for receiving a threaded rod. The reservoir elements may then be assembled by using at least one threaded member, such as a nut that threadably engages with the threaded rod. Furthermore, at least one strap or belt may be wrapped around the tank to strengthen the assembly of the reservoir elements. Furthermore, the assembly strengthening device may improve the airtightness of the tank. Thus, leakage may be prevented and the assembly of the tank may be facilitated.

[0113] Furthermore, the tanks may be mounted on an external frame that acts as a stiffening device. The external frame may be configured to apply forces to the assembled tanks, for example by means of at least one hydraulic plate, to stiffen the assembly of the tanks. Furthermore, the external frame may be part of a guide rail system of a handling manipulator that allows for automatic control of the tanks and / or the tank system.

[0114] The tank can include multiple sidewall elements, where a top plate element, a sidewall element, and a bottom plate element are arranged to form a reservoir, which can reduce the packaging size of the disassembled tank (i.e., the tank assembly).

[0115] Typically the tank may be configured to withstand (without leakage) an internal pressure of at least 2 bar, or at least 4 bar, or at least 10 bar. The normal operating pressure of the tank / tank system may be in the range of 0.1-1 bar, preferably in the range of 0.2-0.6 bar, even more preferably in the range of 0.25-0.5 bar. In particular the operating pressure may be less than 0.5 bar, preferably less than 0.3 bar.

[0116] Depending on the cross section of the reservoir element of the tank, the reservoir of the tank may have a substantially rectangular, hexagonal or octagonal cross section when viewed from the top plate element side. In the case of a rectangular cross section, the tank can be directly interconnected with up to four adjacent tanks. In the case of a hexagonal cross section, the tank can be directly interconnected with up to six adjacent tanks. And in the case of an octagonal cross section, the tank can be directly interconnected with up to eight adjacent tanks. In a tank system, tanks of the same and / or different configurations, such as different cross sections, can be combined. Thus, process lines, such as biopharmaceutical process lines, can be installed in a very small installation space. This can reduce costs, such as clean room costs.

[0117] The tank may further comprise at least one pumping device. The pumping device may be separated from the reservoir and / or the at least one channel by a flexible membrane to prevent direct contact between the at least one biochemical medium and the pumping device. The pumping device may be included in the reservoir element.

[0118] The tank may further comprise at least one stirring device, where the stirring device may be drivable from outside the tank. For example, the stirring device may be driven by a magnetic actuator. Using a magnetic actuator allows the stirring device to be driven from outside the tank, for example because the magnetic actuator can be separated from the actual stirring device by a continuous wall section, facilitating sealing. The stirring device may be included in a reservoir element, in particular in a bottom plate element. Furthermore, the stirring device may comprise an actuating rod. Said actuating rod may be supported and sealed in a reservoir element of the tank. The actuating rod may engage with a drive mechanism, such as an electric or magnetic drive mechanism, provided outside the tank. Preferably, the actuating rod protrudes from the top plate element. The drive mechanism may be part of a handling manipulator, allowing automatic control of the tank and / or the tank system.

[0119] The stirrer may be supported in the tank by an actuation rod. Furthermore, the stirrer may be suspended in the tank, for example by a magnetic bearing. To drive the stirrer, a handling manipulator can be magnetically coupled to said suspended stirredr from outside the tank and drive the stirrer from outside the tank.

[0120] Furthermore, the handling manipulator may be mechanically and / or in any other suitable manner coupled to said stirring device from outside the tank and capable of driving the stirring device from outside the tank.

[0121] Furthermore, at least one handling manipulator can be provided above or below the tank for driving the stirring device.

[0122] The agitation device may comprise at least one agitation member, where the agitation member comprises a plurality of agitation blades. The agitation blades may be provided in various forms, such as Rushton agitation blades, pitched blades, gentle marine blades, etc. Furthermore, the agitation device may comprise a plurality of agitation members, for example, provided in different levels of the tank. Furthermore, the agitation device may include an integrated sparger.

[0123] The stirring device may be operable in a pulse mode, which generates waves and allows cleaning the filter from the reservoir side. Furthermore, a further stirring member may be provided adapted to rotate in close proximity to the filter in order to clean the filter. Depending on the type of filter, the reservoir side may be the permeate side or the retentate side of the filter.

[0124] As an example, the stirring device can comprise at least two stirring members, where each stirring member comprises a plurality of stirring blades. A first stirring member of the at least two stirring members can be arranged on the bottom plate element and a second stirring member of the at least two stirring members can be arranged on the top plate element. Furthermore, the handling manipulator can be magnetically, mechanically and / or in other suitable manner coupled to the at least two stirring members from outside the tank and drive the stirring device from outside the tank. For example, the stirring members can be jointly or individually driven by magnetic actuators and / or superconductors of the handling manipulator.

[0125] The tank may further comprise at least one mixing device, such as a fluid deflector, which may be integrally formed with any of the reservoir elements. Additionally, the mixing device may be a separate means provided within the reservoir of the tank. At least one mixing device may be associated with an inlet port of the tank / respective reservoir element.

[0126] The tank may further comprise at least one device for avoiding foaming of the at least one biochemical medium and / or working medium. The at least one device for avoiding foaming may reduce the velocity, the drop height and / or the flow characteristics of the at least one biochemical medium and / or working medium. The at least one device for avoiding foaming may be a fluid deflection plate and / or a channel (e.g., a rigid tube) as described above. In the case of a channel, the opening of the channel may be directed to either the side wall element, the top plate element and / or the bottom plate element. As a result, the biochemical medium and / or working medium is deflected when entering the reservoir. The at least one device for avoiding foaming may be integrally formed with one of the reservoir elements. Furthermore, the at least one device for avoiding foaming may be a separate device provided in the reservoir of the tank. The at least one device for avoiding foaming may be associated with the inlet port of the tank.

[0127] The tank may further comprise at least one cell harvesting device. The cell harvesting device may comprise a filter and / or a filter cartridge that can be coupled or integrated into a reservoir element, in particular a bottom plate element of the tank. The cell harvesting device may comprise a media removal port (also called cell bleed port) for removing the medium or a part of the medium (such as cells) contained in the reservoir of the tank. The media removal port may also be provided in the bottom plate element and / or in at least one side wall element. In particular, the media removal port may be provided anywhere on the reservoir side of the filter of the cell harvesting device for removing the retentate, such as cells, and / or on the opposite side for removing the filtrate (permeate). Furthermore, the cell harvesting device may comprise a (working) media supply port that allows rinsing the filter of the cell harvesting device.

[0128] Further, the tank may be associated with at least one magnet, where the at least one magnet may be used for cell selection, cell activation, transduction and / or proliferation. The at least one magnet may be positioned directly on the top plate element, the at least one sidewall element, and / or the bottom plate element. The at least one manipulator may be adapted to position and / or remove the at least one magnet.

[0129] The working medium supply port can be provided on the permeate or filtrate side of the filter, respectively. Thus, when a positive pressure (gaseous or fluid) is applied to the permeate / filtrate side of the filter, for example, the feed or retained portion of the retentate can be diverted back to the tank, out the media removal port, and / or out the waste port via the (working) media supply port. Additionally, a negative pressure can be applied to the retentate side of the filter to divert the retentate back to the tank and / or out the media removal port.

[0130] Applying positive pressure to the permeate / filtrate side of the filter (preferably by providing a pressurized working medium) and / or applying negative pressure to the retentate / upstream side of the filter can flush the filter, thus potentially blowing out a blocked filter, e.g., a cell filter.

[0131] In addition, a positive pressure (gaseous or fluidic) is applied to the permeate or filtrate side, respectively, of the filter. For example, the permeate / filtrate can be forced into the permeate or respective filtrate channel via the (active) media supply port. Thus, the permeate / filtrate can be returned to the reservoir and / or further tank. Preferably, the positive pressure is applied by providing sterile pressurized air to the permeate or filtrate side, respectively.

[0132] The tank may further comprise at least one cartridge for chromatography so that preparative chromatography can be performed. Additionally, the tank may comprise at least one resin device, membrane absorber, etc. The tank may further comprise at least one cross-flow cassette so that cross-flow or tangential flow filtration can be performed within the tank.

[0133] The tank may further comprise at least one hollow fiber device for cell harvesting, diafiltration, microfiltration, ultrafiltration, etc. The hollow fiber device may be provided in a cartridge that may be integrated in the reservoir of the tank or may be located outside the reservoir of the tank. For example, the hollow fiber device may be coupled to at least one of the reservoir elements of the tank using a respective port. Furthermore, the tank may comprise a plurality of hollow fiber devices. In particular, the tank may be used to increase the cell concentration of a cell-containing solution, for example by filtering the solvent. This allows the cultured cells to be harvested.

[0134] A reservoir element, such as at least one sidewall element or bottom plate element, may be integrally formed with the above-mentioned filters, cell harvesting devices, chromatography cartridges, crossflow cassettes, resin devices, hollow fiber devices, and / or other fluid storage or directing components.

[0135] In particular, any of the above-mentioned filters, cell harvesting devices, chromatography cartridges, cross-flow cassettes, resin devices, hollow fiber devices, and / or other fluid storage or directing components may include a capsule, where the capsule houses the respective filter, device, cassette, and / or component. Furthermore, the capsule and at least one sidewall element and / or bottom plate element may be integrally formed, where at least one channel of the reservoir may extend into the capsule (i.e., at least one sidewall element and / or bottom plate element). Alternatively, the capsule may be connected to at least one reservoir element, where this connection may be permanent or reversible.

[0136] The tank may further comprise at least one rupture disc, which may be provided in the reservoir element. The rupture disc may be made of different materials, such as stainless steel, graphite, silicon, plastic, etc. The rupture disc may be arranged, for example, to block an outlet port or a medium removal port of the tank. If the pressure in the reservoir exceeds a predefined threshold (e.g. due to a clogged filter, etc.), the rupture disc ruptures and the medium is led out of the reservoir through the respective port without damaging the tank. Additionally or alternatively, a pressure relief valve may be provided, which can release excess pressure from the reservoir of the tank.

[0137] The tank may further comprise at least one bag, where the bag may line an inner wall of a reservoir formed by the reservoir element, such that the reservoir of the tank may be easily prepared to receive further fluid, for example by replacing the bag.

[0138] The tank may be connectable to at least one sensor, or to a sensor module comprising a plurality of sensors, where the at least one sensor and the sensor of the sensor module are selected from the group of pH sensors, temperature sensors, dissolved oxygen sensors, biomass sensors, foam sensors, pressure sensors, flow sensors, O2 sensors, N2 sensors, CO2 sensors, etc. Furthermore, the at least one sensor may be a spectroscopic device, such as a RAMAN, NIR and / or UV spectroscopic device. Furthermore, the sensor or sensor module may be connected to the tank, in particular to a reservoir element of the tank. Furthermore, the sensor or sensor module may be a disposable sensor / sensor module. Furthermore, the flow sensor may be an ultrasonic sensor, optionally placed in at least one channel of the tank. Furthermore, the sensor or sensor module may be washable and optionally sterilizable.

[0139] To measure the pressure in the tank and / or its channels, the channels may include a flexible membrane. This membrane may be associated with a pressure sensor adapted to the pressure in the tank and / or channel. Furthermore, the pressure in the tank and / or channel may be measured using a hydrophobic filter, such as a vent filter, attached to the top plate element. This filter may be separated from the reservoir of the tank by a valve. When the pressure is to be measured, the valve may be opened.

[0140] Being able to measure the pressure in the tank and / or its channels allows leak testing of the tank and / or non-destructive integrity testing of filters provided in the tank. Before the test, the tank is pressurized, for example by adding pressurized air. The pressure drop can then be measured and compared with a respective predefined pressure value. Leaks can thus be detected. If the measured pressure drop exceeds the predefined pressure value, the test fails.

[0141] To test the integrity of the filters, all input and output channels of the tank must be closed, for example using the respective valves. Closing the valves is preferably performed by a handling manipulator, i.e. automatically. Furthermore, the filters must be wetted before testing. Wetting the filters can be achieved by opening a wetting channel associated with the filter to be tested. The wetting channel can direct a buffer solution to the filter, wetting it. The tank can then be pressurized, in particular the permeate side (filtrate side) and / or the retentate side (upstream side) of the filter, and the pressure drop over time can be measured. To pressurize, positive and / or negative pressure can be applied, such that a differential pressure is applied across the filter. The measured pressure drop can be compared to a predefined threshold to determine whether the integrity test passes. This integrity test can be performed for each filter in the tank. The integrity can then be tested, for example using a pressure hold test, a pressure drop test, and / or a forward flow test.

[0142] To test the integrity, you can follow these steps: a) The filter to be tested is moistened with a wetting fluid, for example by applying a buffer solution. The buffer solution can be applied, preferably by using a handling manipulator, i.e. automatically, through a cartridge or tank containing the buffer solution. To moisten the filter, a channel fluidically connecting the cartridge or tank containing the buffer solution and the tank containing the filter to be tested is opened, for example by opening the respective valves and / or by connecting the cartridge or tank containing the buffer solution to the tank containing the filter to be tested. The actuation of the valves and the connection of the cartridge containing the buffer solution can be performed by a handling manipulator.

[0143] Furthermore, it is also possible to monitor whether the wetting is complete. For example, the completion of the wetting step can be detected by detecting the permeate and / or filtrate that has passed through the filter under test. This can be done by weighing, by providing a fluid sensor, such as a capacitive sensor. Additionally or alternatively, the wetting fluid and the respective pressure can be provided at a predefined time that ensures proper wetting of the filter. Excess wetting fluid can be removed via a waste channel or the like, for example being directed to a waste tank. Furthermore, if necessary, back pressure can be applied via a valve to improve the wetting of the filter.

[0144] b) After wetting is complete, for example, the permeate side (filtrate side) and / or retentate side (upstream side) of the filter are pressurized, preferably by applying sterile pressurized air. Prior to pressurization, all valves allowing the pressurized air to exit the pressurized side of the filter must be closed, preferably by the respective handling manipulator.

[0145] When testing a membrane filter, the upstream side of the filter is usually pressurized. A channel may be opened on the filtrate side of the filter. For example, the waste channel is opened, preferably by actuating the respective valve. This allows the pressurized air that has passed through the filter to be removed from the filtrate side.

[0146] When testing the cross-flow cassette and / or hollow fiber module, pressure can be applied to the retentate side, preferably via the retentate outlet channel of the tank. The retentate outlet channel can be openable and closable by an associated valve. The feed channel of the cross-flow cassette and / or hollow fiber module can be closed for the integrity test. Also, the permeate channel of the cross-flow cassette and / or hollow fiber module can be opened for the integrity test. A channel can be opened on the permeate side of the filter. For example, one permeate channel is connected to a waste channel, preferably by activating the respective valve. This allows the pressurized air that has passed through the filter to be removed from the permeate side.

[0147] c) After or during pressurization, the pressure drop over time can be measured and compared to a predefined threshold. Preferably, the measurement begins after a predefined stabilization time. If the pressure drop exceeds the threshold, the test fails.

[0148] After testing, the pressurized air can be removed from the tank through the outlet port.

[0149] In traditional bag-based process lines, integrity testing is very difficult because the applied pressure causes the bags and / or hose connections to expand; therefore, the test results are distorted. Therefore, expensive helium leak testing is required for traditional bag-based process lines. Furthermore, helium leak testing is complex and typically cannot be performed on the interconnected bags of traditional bag-based process lines, or even on the entire biopharmaceutical process line. In particular, the bag interconnections cannot be tested. Therefore, the ability to use integrity testing on easily assembled process lines and / or easily assembled tanks significantly reduces the risk of leaks. Furthermore, the cost of operating the process line is also reduced.

[0150] At least one reservoir element of the tank (top plate element, optionally at least one side wall element and / or bottom plate element) may comprise a sensor module connection part allowing to connect a sensor or a sensor module comprising a plurality of sensors to the tank. The sensor and / or sensor module may comprise a wired or wireless data transfer unit for transferring the achieved sensor data to a control unit. Furthermore, the sensor and / or sensor module may comprise a rechargeable battery and / or a power supply interface for supplying power to the sensor and / or sensor module. The power supply interface may be wired or wireless, such as an inductive or capacitive power supply interface. Furthermore, the sensor and / or sensor module may be configured to be multi-purpose. In particular, the sensor and / or sensor module may be sterilizable.

[0151] The sensors and / or sensor modules may be connected to the respective handling manipulator. The connection may be wired or wireless. Thereby, data may be transferred between the sensors and / or sensor modules and the handling manipulator. Furthermore, said connection may allow the sensors to be powered by the handling manipulator.

[0152] The reservoir elements and tanks may be free of electrical or electronic components, but may also have connections to them (e.g. sensors or sensor modules), and therefore can be easily recycled.

[0153] Furthermore, this object is achieved by a tank system comprising a plurality of tanks as described above. When the second tank is arranged adjacent to the first tank, the first tank of the tank system is interconnectable with the second tank by at least one connector device. Furthermore, when the first tank is interconnected with the second tank, at least one or more channels of the first tank are fluidly connected to respective channels of the second tank. Thus, process lines, such as biopharmaceutical process lines, can be easily set up and automated. In particular, the number of hose- or pipe-based fluid connections can be significantly reduced compared to conventional process lines.

[0154] In particular, if the second tank is located directly adjacent to the first tank, the first tank of the tank system may be directly interconnectable with the second tank by at least one connector device. Alternatively, or in addition, a hose-based fluid connection may be used.

[0155] To facilitate the connection, the top plate elements, in particular the plate elements, of the first and second tanks can protrude laterally above the side wall elements. Thus, the connection of the tanks is facilitated, since the side wall elements do not interfere with the connection. Furthermore, the bottom plate elements can protrude laterally above the side wall elements. Thus, the tanks may additionally be connected via the bottom plate elements.

[0156] Furthermore, the height dimension of the first tank may be smaller than the height dimension of the second tank. To compensate for the height difference, the tank system may comprise a support rail, where the support rail is adapted to support at least two tanks. When the tanks are supported on the support rail, the support rail may engage with the top plate elements of the respective tanks (here, for example, the first and second tanks) such that the top plate elements of the tanks with different height dimensions are arranged at the same level. Additionally or alternatively, the support rail may engage with the side wall elements of the respective tanks such that (additional) support of the tanks is provided. The support rail may include at least one metering member capable of weighing the supported tanks individually. The weight of the respective tanks may then be used to control the process line formed by the tanks.

[0157] It should be understood that the support rails may also be utilized for tanks of the same height dimensions. In particular, the support rails may be at least partially contained within a cleanroom bag.

[0158] Thus, all top plate elements of the tank system can be located at substantially the same height. This allows the respective adapter plate elements to be mounted on top of the plate elements, where the adapter plate elements are also located at substantially the same height. Thus, the tank ports, the tank filters, and / or the actuators of the tank valves can be accessed and actuated at substantially the same height, thereby facilitating automated actuation and operation of the tank system. Furthermore, when the adapter plate elements and the top plate elements sandwich a barrier element that is part of the cleanroom, the cleanroom can have a substantially flat top surface and does not need to have a complex shape.

[0159] Furthermore, at least one adapter plate may be configured to be attached to a plurality of upper elements of different tanks, thereby enhancing the interconnection of said tanks.

[0160] Furthermore, the volume of the first tank may be smaller than the volume of the second tank, and the first tank may be configured to be installed above the second tank. The first and second tanks may be fluidly connected, where the fluid connection (channel) may be controlled by a valve. The first tank may function to provide a working medium and / or a biochemical medium to the second tank. Since the first tank is installed above the second tank, gravity may be utilized to transfer fluids from the first tank to the second tank. Thus, the use of a pump may be avoided.

[0161] Furthermore, the medium can be transferred from the first tank to the second tank by pressurizing at least one tank. If the medium needs to be transferred from the first tank to the second tank, a positive pressure can be applied to the first tank and / or a negative pressure can be applied to the second tank. Thus, the medium is pushed from the first tank towards the second tank. If a filter is provided between the first tank and the second tank (e.g. in the interconnecting channel and / or in the upper plate element of the second tank, if the first tank is installed above the second tank), the filtration can be controlled by controlling the pressure level in the first tank and / or in the second tank. The positive pressure can be established by providing a (working) medium, such as pressurized air, to the tanks. The negative pressure can be established by removing (working) the medium from the respective tank. If pressurized air is used as the working medium, preferably sterile pressurized air is used. Sterile pressurized air can be obtained by directing the pressurized air through the respective sterile filter before entering the tanks.

[0162] Furthermore, the tank system may comprise a connecting plate element. Said connecting plate element may include at least one channel and may be adapted to interconnect tanks that are not provided directly adjacent to each other. The use of the connecting plate element facilitates the interconnection of spaced apart tanks, which may for example sandwich one or more further tanks. Furthermore, the connecting plate element may be configured to multiplex or demultiplex the flow of media. For example, the connecting plate element may include a channel junction or a channel manifold. Thus, a medium received from a first tank may be supplied to several other tanks (multiplexing). Furthermore, different media may be mixed in the connecting plate element and supplied together to a single tank (demultiplexing). Furthermore, the connecting plate element may be integrally formed with either the top plate element, the at least one sidewall element, and / or the bottom plate element.

[0163] The top plate element, the bottom plate element, and / or the connecting plate element may also be utilized as a stand-alone product. By way of example, the top plate element and / or the bottom plate element may function as a filter unit with at least one filter as described throughout this disclosure. By way of further example, the top plate element and / or the bottom plate element may function as a fluid flow control unit with at least one valve as described throughout this disclosure.

[0164] Furthermore, the tank system may comprise an adapter, which may be adapted to interconnect the first tank and the second tank, optionally the adapter being adapted to interconnect the first tank and the second tank by means of at least one connector device.

[0165] The adapter may include at least one channel and at least one fluid module, and when the adapter interconnects a first tank and a second tank, the at least one channel of the adapter may be fluidly connected to a respective channel of the first tank and a respective channel of the second tank.

[0166] The at least one fluidic module may function to filter, mix, separate and / or activate the media stream (biochemical media and / or working media). The at least one fluidic module may be at least one of the following: a cross-flow cassette, a cross-flow hollow fiber module, a hollow fiber filter, a resin capsule, a filter capsule, and / or a magnetic tube. It is understood that an adapter may include multiple fluidic modules of the same type and / or different types.

[0167] Furthermore, the at least one fluid module may be exchangeable. Thus, maintenance can be facilitated. In particular, the at least one fluid module may be exchangeable with a fluid module of another type. Thus, the function of the adapter can be adapted with little effort. Furthermore, the at least one fluid module may be exchangeable with a fluid module of the same type. Thus, for example, a worn filter can be easily replaced.

[0168] Furthermore, the adapters may be adapted to interconnect tanks that are not located directly adjacent to one another. The adapters facilitate the interconnection of spaced apart tanks, which may, for example, sandwich one or more further tanks. Furthermore, the adapters may be configured to multiplex or demultiplex the flow of media, similar to the connecting plate elements.

[0169] The system may further comprise at least one cleanroom bag. Furthermore, some objects are achieved by said cleanroom bag. The cleanroom bag is configured to receive at least one tank. Also, when the at least one tank is received in the cleanroom bag, it provides a cleanroom environment for the at least one tank. The cleanroom bag comprises at least one foil portion adapted to be sandwiched between an access plate element of the tank, for example a top plate element of the tank and an adapter plate element, in order to define at least one access point via the access plate element to provide access to the tank from outside the cleanroom bag. Furthermore, the at least one tank may be accessible from outside the cleanroom bag with a handling manipulator via the access plate element.

[0170] Cleanroom bags can be installed in almost any environment, e.g. in a conventional factory hall. Thus, expensive and time-consuming planning and construction of pharmaceutical process line plants can be avoided. Thus, biopharmaceutical process lines can be set up very quickly. Moreover, there is no need to install expensive conventional cleanrooms, since the cleanroom bags themselves provide at least the cleanroom conditions. Moreover, in the case of disposable cleanroom bags, expensive and time-consuming cleaning and testing can be avoided.

[0171] The cleanroom bag is preferably a flexible bag that does not require much storage space when not in use. The cleanroom bag can be pre-sterilized and then inflated / expanded when in use, thus providing a sterile or at least cleanroom environment.

[0172] The cleanroom bag provides at least cleanroom conditions. The cleanroom bag can provide at least ISO 8 (ISO 14644-1 and ISO 14698) conditions. Depending on the environment required, cleanroom conditions up to ISO 1 are also possible. More preferably, the cleanroom bag provides a sterile environment for operating the tank. The cleanroom bag can be sterilizable, for example, by ETO, gamma sterilization, X-ray sterilization, or autoclave sterilization.

[0173] The system may further comprise at least one adapter plate element, where the adapter plate element is associated with at least one tank. In particular, the adapter plate element may be associated with a single tank or with a plurality of tanks. The adapter plate element may be attached to the at least one tank such that one of the at least one foil portion of the cleanroom bag is sandwiched between the access plate element of the tank and the adapter plate element. The access plate element may be a top plate element, at least one side wall element, or a bottom plate element. Particularly preferably, the top plate element is an access plate element.

[0174] Additionally, the adapter plate element is configured to define at least one access point for providing access to the tank from outside the cleanroom bag through the access plate element.

[0175] Thus, the tank can be placed in a clean room or sterile environment while at the same time allowing access to the tank from outside the clean room bag. Thus, handling manipulators and other control or actuation devices can be provided outside the clean room bag. Thus, the size of the clean room bag can be minimized.

[0176] The adapter plate element may be configured to at least partially cover the filter and / or the port of the tank. Thus, media (biochemical and / or working media) can be transferred to and / or removed from the tank from outside the cleanroom bag. The foil part of the cleanroom bag sandwiched between the access plate element of the tank and the adapter plate element may be provided to be removable and / or pierceable in the area of ​​the filter and / or the port of the tank. Thus, access to the tank can be provided from outside the cleanroom bag.

[0177] To access the tank from outside the cleanroom bag, the handling manipulator can perform the following steps:

[0178] Step 1: Attach an adapter plate element to at least one tank such that one of the at least one foil portion of the cleanroom bag is sandwiched between the access plate element of the tank and the adapter plate element. Optionally, remove a cover element, such as a cap, from a through hole (access point) of the adapter plate element.

[0179] Step 2: Perforating at least one foil portion of the cleanroom bag with a perforating device such as a knife, needle, laser, etc. The perforation can be performed in a manner that separates the foil portion from the cleanroom bag.

[0180] Step 3: Optionally, a gripping device, such as a vacuum gripper of a handling manipulator, is used to grip the separated foil portion.

[0181] Step 4: Optionally, weld the remaining foil portion with the adapter plate element and / or the top plate element, preferably using a handling manipulator.

[0182] Step 5: Optionally, a connector device, such as a quick connector device, is placed on the adapter plate in the area of ​​the removed / perforated foil portion. The adapter plate element may be configured to support valve actuators and / or tank operating devices (such as stirrer devices), whereby the foil portion may be provided removably and / or pierceably in the area of ​​the valve actuators and / or tank operating devices to provide access to the tank. As mentioned above, access can be provided using handling manipulators. Thus, operating devices such as valves and stirrers can be operated from outside the cleanroom bag.

[0183] Furthermore, the cleanroom bag may be adapted to be sealedly coupled to an assembly room serving to assemble at least one tank, where the cleanroom bag may be further configured to receive at least one assembled tank from the assembly room. The assembly room may also provide a cleanroom and / or sterile environment for assembling the tank. Thus, a risk of contamination of the tank during assembly is reduced.

[0184] The cleanroom bag may be a sterile bag or, optionally, a disposable bag. The cleanroom bag may be initially sterile or may be sterilizable on-site at the biopharmaceutical manufacturer. Providing a disposable bag further reduces the risk of contamination of the tank. Additionally, cleaning of the cleanroom bag after use is not required.

[0185] The cleanroom bag may be held by a support structure. The support structure may be a rigid support structure such as a frame. Alternatively, the support structure may be inflatable. It is also possible for the cleanroom bag itself to be inflatable. Thus, a mobile, free-standing cleanroom may be provided.

[0186] The cleanroom bag may comprise a multi-layer outer shell, where a first layer of the shell is the outermost layer, and where a second layer of the shell is the innermost layer. The space enclosed by the second layer of the shell may be pressurized at a pressure lower than that provided between the first and second layers of the shell. A colored gas may be provided between the first and second layers of the shell. Thus, if the second layer of the shell leaks, the colored gas will enter the space enclosed by the second layer, which can be detected and indicates the ingress of a contaminant into the sterile and / or cleanroom environment.

[0187] The cleanroom bag may include a sealable opening configured to receive the assembled tank. When the cleanroom bag is sealingly coupled to the assembly room, therein a sealable opening of the cleanroom bag may be configured to open together with a corresponding sealable opening of the assembly room. Furthermore, the sealable opening may be used to remove the tank from the cleanroom bag. The cleanroom bag may include multiple sealable openings. Thus, it becomes easier to transfer the assembled tank from the assembly room to the cleanroom bag or to remove it from the cleanroom bag.

[0188] As mentioned above, if the cleanroom bag is sealingly coupled to the assembly room, the sterilization of the assembly room can serve to sterilize the outside of the sealable opening of the cleanroom bag, thus facilitating aseptic transfer to the cleanroom bag.

[0189] The sealable opening of the cleanroom bag may be covered by at least one cover element. The corresponding sealable opening of the assembly room may be covered by at least one corresponding cover element. The at least one cover element and the at least one corresponding cover element are configured to mate with each other and open together.

[0190] For example, the sealable opening and the corresponding sealable opening may be provided as sliding doors. At least one cover element / corresponding cover element may be a door of the respective sliding door. The coupling of the cover element and the corresponding cover element may be achieved, for example, by a magnetic device, a positive locking device, or other coupling or locking device. Preferably, magnets (permanent magnets) are distributed at least on the edge portion of the cover element / corresponding cover element. This allows the coupling of the cover element with the corresponding cover element in a defined manner. Thus, the non-sterile outer surfaces of the cover element / corresponding cover element cover each other after coupling. Thus, the risk of contamination of the assembled tank when transferred from the assembly room to the clean room bag through the sealable opening can be further reduced.

[0191] The cover element / corresponding cover element is movable relative to the cleanroom bag and / or the assembly room. The cover element / corresponding cover element and the cleanroom bag / assembly room may be sealed, for example, by at least one brush seal, lip seal, etc. Even more preferably, the cover element / corresponding cover element may be connected to the cleanroom bag or the assembly room via a flexible part, such as a sealing foil part. The flexible part may be connected to the cover element on a first side and to the cleanroom bag on a second side. Similarly, the flexible part may be connected to the corresponding cover element on a first side and to the assembly room on a second side. Thus, the sealable opening can be opened and closed without a gap between the cover element and the cleanroom bag and / or between the corresponding cover element and the assembly room. Thus, the contamination risk can be further reduced.

[0192] The cleanroom bag may further comprise or be associated with a sealing frame. The sealing frame may be configured to surround a sealable opening of the assembly room. Thus, when the opening is opened, an additional seal is provided to seal the opening from the environment. Thus, the risk of contamination may be further reduced. The sealing frame may be a separate frame or may be provided in the assembly room.

[0193] The system may further comprise a UV light source. The UV light source may be associated with the sealable opening of the assembly room. Thus, possible contaminants on the outer surface of the sealable opening can be removed / destroyed before and / or during the opening of the sealable opening. At least one UV light source may be provided in the seal frame. Preferably, the UV light source is configured to illuminate the sealable opening from different directions. Thus, the contaminants can be effectively removed / destroyed.

[0194] The seal frame may further comprise a port allowing for evacuating the space between the seal frame and the closed sealable opening of the assembly room before opening the sealable opening, thus effectively removing particles and / or contaminants and further reducing the risk of contamination.

[0195] The cleanroom bag may comprise at least one rail for guiding the received at least one assembled tank into the cleanroom bag. Thus, positioning of the assembled tank in the cleanroom bag is facilitated. For example, a first tank may be placed on the rail. A second tank may be interconnected with the first tank and placed on the rail. Thereby, the first tank may be further guided into the cleanroom bag. By repeating this, the entire process line may be assembled and guided into the cleanroom bag.

[0196] The rail may be a support rail for guiding the received at least one assembled tank into the cleanroom bag. The support rail is adapted to support at least two tanks. When the tanks are supported on the support rail, the support rail may engage with the top plate element and / or the side wall element of the respective tank such that the top plate elements of the tanks with different height dimensions are arranged at the same level. In this case, the tanks are in a hanging configuration and the bottom plate element may not be in contact with the ground. In addition, a support member may be provided to support the tank with the bottom plate element in addition to the hanging support of the top plate element.

[0197] The support rail may be formed from multiple support rail sections such that the cleanroom bag is foldable. In particular, the support rail sections may be made from a plastic material and may be injection molded. In certain embodiments, the foil portions and the support rail sections are fixedly attached (e.g., welded or glued) to one another or even integrally formed. To increase the load-bearing capacity of the support rail sections, the sections may include metal inserts.

[0198] Additionally, the support rail sections may be configured to receive corresponding support rails of a frame that may be part of the handling manipulator. The frame may include a rigid corresponding support rail, such as a metal support rail. The support rail sections may be formed to fit the corresponding support rails of the frame. Additionally, the support rail sections may include a latching device that engages the support rail sections with the corresponding support rails of the frame, preferably by a snap fit.

[0199] Furthermore, to improve the guidance of the support rail, the top plate element, the side wall element and / or the tank within the support rail, the support rail sections may each comprise a support wheel or a support roller. The support roller / wheel may be included in a roller member connectable to the respective top plate element and / or the side wall element of the tank. The support roller / wheel is then guided within the support rail to support and guide the tank in a suspended configuration.

[0200] The support rail / support rail section may include at least one weighing member capable of weighing the supported tanks individually. The weight of each tank can then be used to control the process line formed by the tanks.

[0201] This object is also achieved by a method for assembling a tank, comprising the steps of: providing a top plate element, optionally providing at least one sidewall element, providing a bottom plate element, and assembling the top plate element and the bottom plate element and the optional at least one sidewall element to form a reservoir for receiving at least one biochemical medium.

[0202] The assembly can be fully automated. Moreover, the assembly is preferably performed in a clean room or even in a sterile environment. The further parts of the tank mentioned above can also be assembled. [Brief description of the drawings]

[0203] In the following there is described the accompanying drawings which show, in a simplified manner, embodiments of the invention, in which: [Figure 1A] 1 shows a schematic exploded view of a reservoir element. [Figure 1B] 13 shows a schematic exploded view of a further reservoir element; [Diagram 2] 1 shows a schematic representation of a reservoir element. [Diagram 3] 1 shows a schematic representation of a reservoir element. [Figure 4]1 shows diagrammatically a reservoir element which can be used as a bottom plate element of a tank. [Diagram 5] 1 shows diagrammatically a reservoir element which can be used as a top plate element of a tank. [Figure 6] 1 shows a schematic of the assembled tank. [Figure 7] Figures A-C illustrate schematics of assembled tanks with different volumes. [Figure 8] 1 shows a schematic representation of a tank system. [Figure 9] 1 shows a schematic enlarged view of a reservoir element. [Figure 10] 13A-13C show schematic enlarged views of further reservoir elements; [Figure 10A] 1 shows a cutaway view of the valve attached to the top plate element. [Figure 10B] 1 shows an exploded view of the valve. [Figure 11] 2 illustrates a further aspect of the tank system diagrammatically; [Figure 12] 1 shows a schematic diagram of a clean room bag. [Figure 13] 1 shows a schematic diagram of a cleanroom bag; [Figure 14] 1 shows a schematic flow diagram of a method for assembling a tank.

[0204] Detailed Description of the Drawings 1A and 1B show schematic exploded views of different reservoir elements 200, 200a of a tank 1 (see FIG. 6) of a biopharmaceutical process line. The reservoir element 200 includes a body element 210 and a plurality of shell elements 220, 222 (see FIG. 1A). The reservoir element 200a includes a body element 210a and a single shell element 220a (see FIG. 1B). The body element has a first end 212, 212a and a second end 214, 214a opposite the first end, each of the first end and the second end including an orifice, where the body element 210, 210a tapers from the first end 212, 212a toward the second end 214, 214a. Wherein an internal volume is defined between the first end and the second end.

[0205] The body elements 210, 210a shown in Figures 1A and 1B have a polygonal cross-section (rectangle) in a plane parallel to the first ends 212, 212a. Thus, the body elements form four substantially flat sidewall portions. In Figure 1A, each shell element 220, 222 is similarly plate-like. Alternatively, the shell element 220b may also have a polygonal cross-section, as shown in Figure 1B. In yet another alternative, the shell elements may be formed to cover only a portion of the body elements 210, 210a when attached, for example at least two sidewall elements.

[0206] The body element and / or at least one shell element includes at least one groove 216, 217, 218, where the grooves 216, 217, 218 are included in the body element. The groove 217 extends from the first end to the second end, where the groove 216 extends from the first end 212 to a port 230 of the reservoir element. The port 230 can be a fluid inlet port. The groove 218 starts at the first end 212 and ends at the first end 212, but includes some curvature. In FIG. 2, the shell elements 220, 222 are fixedly attached (e.g., welded or glued) to the body element 210, such that the body element 210 and the shell elements 220, 222 sandwich the respective grooves 216, 217 to form channels. These channels are adapted to conduct at least one biochemical medium and / or working medium. For example, the channel formed by groove 216 may be used to direct a biochemical fluid into the interior volume of the reservoir element (via port 230), the channel formed by groove 217 is adapted to transfer a fluid from a first end to a second end, and the channel formed by curved groove 218 may be used as a heating / cooling channel.

[0207] Furthermore, the first end 212 of the reservoir element 200 includes a sealing surface 213 for sealingly connecting the reservoir element 200 to a further reservoir element, as shown by way of example in FIG.

[0208] 3 shows diagrammatically two reservoir elements 200, 200' stacked on top of one another. In particular, the internal volume and the first orifice of said reservoir elements 200, 200' are configured such that the reservoir element 200 is adapted to at least partially receive a further reservoir element 200'. As a result, multiple reservoir elements can be stacked on top of one another. Thus, storage space can be minimized.

[0209] 4 shows a schematic representation of a reservoir element 300 that can be used as a bottom plate element for a tank. The reservoir element 300 includes a tapered body element 310 and a number of shell elements 320, 322 fixedly attached to the body element.

[0210] Furthermore, the reservoir element 300 includes a plate element 330 sealingly attached to the first end 312 of the body element 320 so as to cover the respective orifices. Said plate element 330 may include multiple layers and in particular may include at least one channel (not shown), where the at least one channel may communicate with the channel formed by the body element 310 and the at least one shell element 320, 322. The reservoir element 300 further includes an insert 340 at least partially covering the undercut of the internal volume. Thus, the formation of dead volumes is prevented. Furthermore, the reservoir element includes an actuator 352 that may be used to open and close a valve (not shown). Said valve may be a magnetic valve.

[0211] FIG. 5 shows a schematic representation of a reservoir element 100 that can be used as an upper plate element of a tank. Furthermore, the reservoir element 100 comprises a plate element 130 sealingly attached to the first end 112 of the body element 120 so as to cover the respective orifices. Said plate element 130 can comprise multiple layers and in particular can comprise at least one channel (not shown), where the at least one channel can communicate with the channel formed by the body element 110 and the at least one shell element 120, 122. The reservoir element 100 further comprises an insert 140 that at least partially covers the undercut of the internal volume. Thus, the formation of dead volumes is prevented. Furthermore, the reservoir element 100 comprises an actuator 152 that can be used to open and close a valve (not shown). Said valve can be a magnetic valve.

[0212] The reservoir elements 100, 200, 200', 300 can form a tank assembly adapted to be assembled into a tank 1 as shown in FIG. 6. The first end 112, 212, 312 of each reservoir element has in particular the same size and shape. Similarly, the second end 114, 214, 314 of each reservoir element has in particular the same size and shape. It should be understood that as the body elements 110, 210, 310 of the respective reservoir elements 100, 200, 300 taper from the first end towards the second end, the size and / or shape of the first and second ends differ. Providing the first ends 112, 212, 312 having in particular the same size and shape and providing the second ends 114, 214, 314 having in particular the same size and shape makes it possible to assemble the respective reservoir elements of tanks having different volumes (see, for example, FIG. 7).

[0213] In Figure 6 an assembled tank 1 for a biopharmaceutical process line is shown. The tank comprises a top plate element 100, two side wall elements 200, 200' and a bottom plate element 300. The side wall elements are the side wall elements 200, 200' described with respect to Figures 1 to 3. The bottom and top plate elements may have substantially the same configuration and may be the reservoir elements shown in Figures 4 and 5, respectively.

[0214] The top plate element 100, the side wall elements 200, 200' and the bottom plate element 300 are arranged to form at least one reservoir 500 for receiving at least one biochemical medium. As the reservoir elements include at least one channel, the tank also comprises at least one channel (not shown) for conducting at least one biochemical medium and / or working medium, where the at least one channel extends inside at least one top plate element, at least one side wall element and / or the bottom plate element. The at least one channel of each of the reservoir elements 100, 200, 200', 300 can be connected to form a joint channel of the tank.

[0215] To form the tank, the second end 114 of the reservoir element 100 is sealingly joined to the second end 214 of the reservoir element 100. Similarly, the first ends 112, 112' of the reservoir elements 200, 200' are sealingly joined and the second end 214' of the reservoir element 200' is sealingly joined to the second end 314 of the reservoir element 300.

[0216] Each of the reservoir elements 100, 200, 300 may include at least one assembly connection device 160, 260, 260' and a corresponding assembly connection device 262, 262', 362. The assembly connection device may include a latching member, such as a hook, where the corresponding assembly connection device may include a recess formed for engaging with said hook. Upon engagement, a sealed connection between adjacent reservoir elements may be achieved.

[0217] In an alternative embodiment (not shown), the assembly connection device may be a threaded member integrated into the reservoir element. The threaded member may have an internal thread (e.g., a nut) or an external thread (e.g., a threaded shaft or screw) and may be formed integrally with the reservoir element. Optionally or additionally, the threaded member may be an inlay, such as a metal inlay, that is held securely within the reservoir element. The inlay may, for example, be overmolded or glued to the reservoir element. The corresponding assembly connection device may be a trough opening that may be aligned with the threaded member having an internal thread. Thus, the reservoir element may be connected and engaged by threading a screw through the through opening into the threaded member. Additionally, the corresponding assembly connection device may be a trough opening that receives the threaded member having an external thread. Thus, the reservoir element may be connected and engaged by threading a nut or the like onto the threaded member, whereby the reservoir element is engaged.

[0218] In particular, each of the first and second ends may be associated with an assembly connecting device and a corresponding assembly connecting device, such that different reservoir elements may be optionally coupled.

[0219] Furthermore, the actuators 152 and 352 of the top plate element 100 and the bottom plate element 300 may be interconnected by the actuators 252, 252' of the sidewall elements 200, 200', respectively. Thus, for example, actuation of a valve provided on the bottom plate element (not shown) is possible by actuating the actuator 152 of the top plate element 100.

[0220] Each element (top plate element 100, side wall elements 200, 200', and bottom plate element 300) may be adapted to comprise a sensor and / or a sensor module. The sensor module may comprise a number of sensors. For example, at least one pH sensor, a temperature sensor, a dissolved oxygen sensor, a biomass sensor, a foam sensor, a pressure sensor, a flow sensor, an O2 sensor, an N2 sensor, a CO2 sensor, and a spectroscopic device, such as a RAMAN, NIR and / or UV spectroscopic device. The sensor module may be connectable to the respective top plate element 100, side wall element 200, 200', and / or bottom plate element 300. The sensor module may be provided with a power source, such as a rechargeable battery, that allows the sensor module to operate autonomously. Furthermore, the sensor module may comprise a data interface, in particular a wireless data interface, for transferring the measured sensor data to the respective control unit or storage unit.

[0221] Furthermore, the tank, in particular the top plate element 100, can comprise at least one filter. The filter can be provided in the interior volume of the reservoir element 100. Furthermore, the filter may be integrated into the plate element 130 of the reservoir element 100. Furthermore, an adapter plate element can be configured to at least partially cover the filter and / or the port of the tank. In a particular embodiment, the top plate element of said tank and the associated adapter plate element can form a filter housing.

[0222] As shown in Figures 7A-7C, the reservoir elements are suitable for forming tanks of different volumes. In Figure 7A, a tank is assembled that includes a top plate element 100, four side wall elements 200, 200', 200'', 200''' and a bottom plate element 300. The side wall elements are the reservoir elements 200, 200', 200'', 200''' described with reference to Figures 1-3. The bottom plate element and the top plate element may have substantially the same configuration and may be the reservoir elements shown in Figures 4 and 5, respectively. Thus, the tank in Figure 7A can be assembled from the same elements as the tank shown in Figure 6, with approximately double the volume.

[0223] Figure 7B shows a further tank similar to the tank shown in Figure 7A. In this configuration, side wall element 200 is replaced by side wall element 200a. This side wall element 200a has a lower height dimension than side wall element 200, but the first and second ends have in particular the same shape and size as the first and second ends of side wall element 200. This allows for the interchangeability of side wall elements 200, 200a.

[0224] Figure 7C shows a configuration without side wall elements: the tank is formed only from the top plate element 100 and the bottom plate element 300. Thus, a very small volume can be achieved.

[0225] Fig. 8 shows diagrammatically a tank system comprising two tanks 1, 2. Both tanks are configured as described with respect to Fig. 6. The first tank 1 is interconnected with the second tank 2 by at least one connector device (not shown). When the first tank 1 is interconnected with the second tank 2, at least one or more channels of the first tank 1 are fluidly connected to respective channels of the second tank 2. Thus, a medium can be transferred from the first tank to the second tank or vice versa.

[0226] The top plate elements 100a, 100b, in particular the plate elements 130a, 130b, of the first and second tanks 1, 2 can project laterally above the side wall elements 200a, 200'a; 200b, 200'b. Thus, the connection of the tanks 1, 2 is facilitated, since the side wall elements do not interfere with the connection. Furthermore, the bottom plate elements 300a, 300b can project laterally above the side wall elements 200a, 200'a; 200b, 200'b. Thus, the tanks may additionally be connected via the bottom plate elements.

[0227] Figures 9 and 10 show diagrammatically an enlarged view of a reservoir element, which may be the bottom plate element 300. In particular, a plate element such as the plate element 330 of the reservoir element 300 is shown (see Figure 9). Figure 10 shows a different configuration of the plate element 330'. The plate element 330; 330' comprises an agitator 90, where the agitator may be drivable from outside the tank. The agitator comprises an actuation rod 92, which may comprise a gearing (not shown). The gearing allows to provide an angle (here 90 degrees) between the drive part 92a of the actuation rod 92 and the output part 92b of the actuation rod 92. The actuation rod 92 may be coupled to a drive mechanism 80, such as an electric drive mechanism, provided outside the tank. The drive mechanism may be part of a handling manipulator (not shown) allowing automatic control of the tank and / or the tank system. This coupling may be achieved by a magnetic coupling 89. Thus, when the drive mechanism 80 rotates, the magnetic coupling 89 transmits the rotation to the drive part 92a. This rotation is transmitted via output portion 92b to agitator 90. Output portion 92b and agitator 90 may be magnetically coupled (see FIG. 10, magnetic coupling 98) or mechanically coupled as shown in FIG.

[0228] Furthermore, the plate element 330 may include a channel 336 associated with two ports 337, 338. The port 337 may be a fluid inlet or outlet port for feeding a biochemical medium to / from the internal volume of the reservoir element. The port 338 is associated with a valve 339, which may be a solenoid valve. Preferably, the magnetic valve can be opened or closed by the driving mechanism 80, inducing the magnetic coupling. In a particular embodiment, the driving mechanism 80 can move the magnetic coupling of the actuation rod 92 and the magnetic valve 39. Thus, the driving mechanism 80 can be used to actuate the valve 339 and the stirring device 90. The magnetic coupling allows, for example, the tank to be provided inside the cleanroom bag. The handling manipulator and the driving device 80 are provided outside the cleanroom bag.

[0229] In an alternative embodiment, the drive mechanism may be located below the bottom plate element 300. Thus, no gearing is required.

[0230] The magnetic valve 39 may be a needle valve. The valve may be initially closed and can be opened by displacing the valve body axially. This can be achieved, for example, by applying a magnetic force. In the initial closed state, the valve may be preloaded by a spring member or a magnetic member. Thus, when not actuated, the valve may be in a closed state. Only when it is manipulated (for example, manually or via a handling manipulator) does the valve open.

[0231] FIG. 10A shows a detail of the top plate element 100, where a valve 50 is attached to the top plate element 100. The valve 50 comprises a switching mechanism corresponding to that of a ballpoint pen. The valve 50 can therefore be opened and closed by axially displacing an actuator 51 of the valve 50. In this embodiment, the actuator 51 is a valve actuation body 51. In FIG. 10A, the valve 50 is in an open state, allowing a fluid flow rate 60 through a passage 55. The illustrated top plate element 100 comprises three plate elements with seals between them, where the valve 50 extends inside all three plate elements. The valve 50 is sealed to the top plate element by a seal 52.

[0232] FIG. 10B shows the valve 50 of FIG. 10A in an exploded view. The valve 50 comprises said valve actuation body 51, a valve housing 53, a switching element 54, a fluid control element 56, and a spring 57. The valve actuation body 51, the switching element 54, and the fluid control element 56 are axially displaceably arranged in the valve housing 53. Thereby, the switching element 54 is configured to rotate relative to the valve housing 53 when displaced axially. In particular, the switching element 54 is configured to engage with an inclined surface 58 in the valve housing 53. The fluid control element 56 comprises a seal 59 configured to seal the fluid control element 56 relative to the valve housing 53. Furthermore, the fluid control element 56 is adapted to open and close the passage 55 to control the fluid flow rate 60. The spring 57 may be arranged elsewhere and / or may be a polymer spring. In another particularly preferred embodiment, the spring 57 is arranged such that fluid contact with the spring 57 is avoided.

[0233] Fig. 11 shows a further aspect of a tank system, which comprises a number of tanks, where in the view of Fig. 11 only tank 1 is shown. Said first tank 1 may be interconnected with a second tank (not shown). The tank may be a tank as shown in Fig. 6.

[0234] The tank 1 comprises an access plate element, here a top plate element 100, which is part of the assembled tank 1. The access plate element 100 is configured to provide access to the tank 1. Furthermore, to improve the guidance of the tank in the support rails, the top plate element, the side wall elements and / or the support rail sections may comprise support wheels or support rollers, respectively.

[0235] The support rollers / wheels may be included in roller members connectable to the respective top plate element and / or side wall element of the tank. The support rollers / wheels are then guided in the support rails to support and guide the tank in the suspended configuration.

[0236] The system may further comprise at least one handling manipulator 13000, 13100, 13200. For example, a first handling manipulator 13000 may be arranged above the tank 1, a second handling manipulator 13100 may be arranged below the tank 1 and a third handling manipulator 13200 may be arranged next to the tank 1. The handling manipulators are arranged movably relative to the tank 1, for example to access and control the at least one tank via the access plate element 100. In particular, the handling manipulator may comprise a guide rail 12000, which allows the handling manipulator to move in at least one axial direction. In a particular embodiment, the handling manipulator comprises a gantry robot.

[0237] In particular, the handling manipulators 13000, 13100, 13200 may be adapted to provide a working medium to the tank 1 and / or remove a working medium from the respective tank in order to transfer a biochemical medium to and / or from the tank.

[0238] The handling manipulators 13000, 13100, 13200 may be equipped with drives (not shown) that can be coupled to actuators of the tank for driving pumps, agitators, etc. and / or for opening and closing valves.

[0239] Furthermore, the handling manipulators 13000, 13100, 13200 may be configured to supply / hold the biochemical medium and / or the actuating medium in the tank. In particular, the biochemical medium can be transferred to and / or from the tank using an actuating medium, such as pressurized air. The tank is thus actuable via the actuating medium. When transferring the biochemical medium from the tank, a positive pressure can be applied to the first tank 1 (e.g., by the handling manipulators 13000, 13100, 13200) by applying the actuating medium to the tank. Thus, the biochemical medium is pushed out of the tank 1, e.g., towards the second tank 2 and / or the filter.

[0240] To transfer the biochemical medium to the tank, a negative pressure can be established, for example by removing or actuating the medium from the tank, in particular by the handling manipulators 13000, 13100, 13200. If pressurized air is used as actuation medium, preferably sterile pressurized air is used. Sterile pressurized air can be obtained by directing the pressurized air through a respective sterile filter before entering the tank.

[0241] An actuation medium, such as pressurized air, can be supplied to or removed from tank 1 by respective gas inlet and / or outlet ports using handling manipulators 13000, 13100, 13200. Application of medium to and / or removal of medium from the tank can be performed, for example, by pressure control, volume control, and / or mass control.

[0242] Furthermore, at least one handling manipulator, such as the handling manipulator 13200, may include a weighing member that allows weighing the tanks of the tank system. The weight of each tank can then be used to control the process line formed by the tanks.

[0243] The system may further include at least one cleanroom bag 8000 (shown in dashed lines in FIG. 11). The cleanroom bag 8000 comprises at least one foil portion 8500. The cleanroom bag is configured to receive at least one tank 1 and provides a cleanroom environment 8000 to the at least one tank 1 when the at least one tank 1 is received in the cleanroom bag. The at least one tank 1 is accessible from outside the cleanroom bag 8000 using handling manipulators 13000, 13100, 13200.

[0244] Additionally, the system includes at least one adapter plate element 600. The adapter plate element 600 can be associated with and attached to at least one tank 1 such that one of the at least one foil portion 8500 of the cleanroom bag 8000 is sandwiched between the access plate element 100 of the tank 1 and the adapter plate element 600.

[0245] The adapter plate element 600 is configured to define at least one access point (not shown) for providing access to the tank from outside the cleanroom bag 8000 via the access plate element 100. For example, the adapter plate element 600 is configured to at least partially cover a filter and / or a port of the tank 1.

[0246] The foil portion 8500 is removably and / or pierceably provided in the area of ​​the tank's filters and / or ports to provide access to the tank 1. The adapter plate element 600 may further be configured to support a valve actuator 152 (not shown).

[0247] As best shown in Fig. 12, the cleanroom bag 8000 comprises at least one support rail 8015 for guiding at least one received assembled tank within the cleanroom bag 8000. The support rail 8015 is adapted to support at least two tanks. When supported on the support rail 8015, the support rail 8015 engages with the top plate elements 100 of the respective tanks 1 such that the top plate elements 100 of the tanks with different height dimensions are positioned at the same level.

[0248] Furthermore, as shown in FIG. 13, the support rail 8015 may be formed from a number of support rail sections 8015a, 8015b, 8015c. These sections may be separated by foil portions so that the cleanroom bag 8000 is foldable. In particular, the support rail sections 8015a, 8015b, 8015c may be made from a plastic material and may be injection molded. In certain embodiments, the foil portion 8500 and the support rail sections 8015a, 8015b, 8015c are fixedly attached (e.g., welded or glued) to each other or even integrally formed. To increase the load-bearing capacity of the support rail sections 8015a, 8015b, 8015c, they may include metal inserts.

[0249] Additionally, the support rail sections 8015a, 8015b, 8015c may be configured to receive a corresponding support rail of a frame 7000, which may be part of a handling manipulator. The frame 7000 may include a rigid corresponding support rail 7015, such as a metal support rail. The support rail sections 8015a, 8015b, 8015c may be formed to fit the corresponding support rail 7015 of the frame 7000. Additionally, the support rail sections 8015a, 8015b, 8015c may include latching devices 8020a, 8020b that engage the support rail sections 8015a, 8015b, 8015c with the corresponding support rail 7015 of the frame 7000, preferably by a snap fit.

[0250] The support rail may include weighing members that allow the supported tanks to be individually weighed The weight of each tank can then be used to control the process line formed by the tanks.

[0251] As shown in FIG. 11, the support rails 8015 further support the tank 1 in a suspended configuration, where the bottom plate element 300 is not in contact with the ground. In addition, in addition to the suspended support of the top plate element 100, a support member 8300 can be provided that supports the tank 1 on the bottom plate element 300. Said support member can be adapted to be height adjustable, for example by a linear drive, such as a magnetic drive, an electric drive, a pneumatic drive and / or a hydraulic drive. The support member may include a weighing member that allows weighing the supported tank. The weight of the respective tank can be used to control the process line.

[0252] The cleanroom bag 8000 may further include a sealable opening (not shown) configured to receive the assembled tank, where the sealable opening of the cleanroom bag is configured to open together with a corresponding sealable opening of the assembly room when the cleanroom bag is sealingly coupled to the assembly room 9000. Furthermore, the sealable opening can be used to remove the tank from the cleanroom bag. The cleanroom bag may include multiple sealable openings. Thus, it becomes easier to transfer the assembled tank from the assembly room to the cleanroom bag or to remove it from the cleanroom bag.

[0253] 14 is a schematic flow diagram of a method 2000 for assembling a tank. The method includes the steps of: providing a top plate element 2100; optionally providing at least one sidewall element 2200; providing a bottom plate element 2300; and assembling the top and bottom plate elements, and optionally at least one sidewall element 2400, to form a reservoir for receiving at least one biochemical medium.

Claims

1. A reservoir element (200) for a tank (1) of a biopharmaceutical process line, the reservoir element (200) comprising: A body element (210); At least one shell element (220, 222), The body element (210) has a first end (212) and a second end (214) opposite the first end, each of the first end and the second end including an orifice, where the body element tapers from the first end to the second end; An interior volume is defined between the first end and the second end; wherein the body element and / or at least one shell element includes at least one groove (216, 217); wherein at least one shell element (220, 222) is fixedly attached to the body element (210), the body element and the at least one shell having a groove therebetween to form at least one channel; The at least one channel is adapted to conduct at least one biochemical medium and / or working medium.

2. The reservoir element (200) of claim 1, The body element has a polygonal cross-section in a plane parallel to the first end (212), where at least one shell element (220, 222) may be plate-like.

3. A reservoir element (200) according to claim 1 or 2, The interior volume and the first orifice are configured such that the reservoir element (200) is adapted to at least partially receive a further reservoir element (200'), such that multiple reservoir elements can be stacked on top of each other.

4. A reservoir element (100; 300) according to any one of claims 1 to 3, Further comprising a plate element (130; 330), a plate element (130, 330) sealingly attached to either the first end (112; 312) or the second end (114; 314) of the body element and covering a respective orifice; wherein the plate element can include at least one channel; Therein, the at least one channel communicates with the channel formed by the body element and the at least one shell element.

5. A reservoir element (100; 300) according to any one of claims 1 to 4, It further comprises an insert (140; 340) adapted to at least partially cover the undercut of the interior volume.

6. A reservoir element (100; 200; 300) according to any one of claims 1 to 5, The first end and / or the second end of the reservoir element (100; 200; 300) comprises a sealing surface (215) for sealingly connecting the reservoir element to another reservoir element.

7. A reservoir element (100; 200; 300) according to any one of claims 1 to 6, The reservoir element (100; 200; 300), in particular the plate element, comprises at least one of the following: At least one port (230; 337, 338). Therein, at least one port is associated with each channel (336), where the ports are selected from a group of port types including the following port types: Fluid inlet port Gas inlet port Fluid outlet port Heating / cooling port Gas outlet port * Cell bleed port Cell transfer port ○ Medium supply port Media removal port Element interconnection ports * Tank interconnection port At least one filter, where at least one port (230) may be covered by at least one filter, where the filter may be selected from a group of filter types including the following filter types: Pre-filter Sterile filter * Bacteria filter Virus filter Mycoplasma filter Ultrafiltration filter Diafiltration filter Cell filter Cell harvest filter Fluid filters Bioburden filter Air filters, and Gas filters Therein a filter covering at least one port may be heated and / or cooled. - At least one valve (339). At least one valve is associated with the at least one channel (336), where the valve may be a flow control valve, a cut-off valve, a pressure relief valve, or a check valve, where the valve, which may be a mechanical or magnetic valve, is configured to be actuated from outside the tank by an actuator (152).

8. A reservoir element (100; 200; 300) according to any one of claims 1 to 7, At least one assembly connection device (160, 260, 260') and / or at least one corresponding assembly connection device (262, 262', 362), where The assembly connecting device (160, 260, 260') and the corresponding assembly connecting device (262, 262', 362) are configured to engage with each other to secure the assembly of at least two adjacent reservoir elements, where the assembly connecting device (262, 262', 362) and the corresponding assembly connecting device (262, 262', 362) engage.

9. A tank assembly adapted to be assembled to a tank (1), wherein the tank assembly comprises: Comprising at least two reservoir elements (100; 300) according to any one of claims 4 to 8, Therein the tank assembly in particular comprises two reservoir elements (100; 300) according to any one of claims 4 to 8 and at least two further reservoir elements (200) according to any one of claims 1 to 8, Therein the first end of each reservoir element has in particular the same size and shape, and the second end of each reservoir element has in particular the same size and shape.

10. A tank (1) for a biopharmaceutical process line, the tank comprising: having a top plate element (100), optionally at least one sidewall element (200, 200', 200'', 200''), and a bottom plate element (300); wherein at least one side wall element is a reservoir element as defined in any one of claims 1 to 3 or 5 to 8, wherein the upper plate element (100) and the lower plate element (300) are reservoir elements as defined in any one of claims 4 to 8, wherein the top plate element, optionally at least one sidewall element, and the bottom plate element are arranged to form at least one reservoir (500) for receiving at least one biochemical medium; There, the tank (1) is further The plate comprises at least one channel for conducting at least one biochemical medium and / or working medium, where the at least one channel extends inside at least one top plate element, at least one sidewall element and / or at least one bottom plate element, where the length of the at least one channel is greater than the thickness of the respective top plate element, sidewall element and / or bottom plate element.

11. A tank system comprising a plurality of tanks (1, 2) according to claim 10, wherein the first tank (1) is interconnectable with the second tank (2) by at least one connector device when the second tank (2) is placed directly adjacent to the first tank (1), Wherein, when a first tank (1) is interconnected with a second tank (2), at least one or more channels of the first tank are fluidly connected to a respective channel of the second tank (2).

12. 12. The tank system according to claim 11, Further comprising a support rail (7015, 8015), The support rail is adapted to support at least two tanks (1, 2), When the tanks are supported on the support rails, the support rails engage with the top plate elements (100) and / or side wall elements (200) of the respective tanks such that the top plate elements of tanks of different height dimensions are positioned at the same level.

13. 13. The tank system according to claim 11 or 12, Further comprising a cleanroom bag (8000) comprising at least one foil portion (8500), The cleanroom bag is configured to receive at least one tank (1, 2), providing a cleanroom environment for the at least one tank when the at least one tank is received in a cleanroom bag; wherein the at least one tank is accessible from outside the cleanroom bag using a handling manipulator; The system is also optionally At least one adapter plate element (600), an adapter plate element is associated with and attachable to the at least one tank such that one of the at least one foil portion (8500) of the cleanroom bag is sandwiched between the access plate element (100) of the tank and the adapter plate element (600); wherein at least one of the top plate element, the at least one sidewall element, and the bottom plate element is an access plate element; The adapter plate element (600) is configured to define at least one access point for providing access to the tank from outside the cleanroom bag through the access plate element, where further optionally The adapter plate element (600) is configured to at least partially cover a filter and / or a port of the tank, where the foil portion (8500) is provided in a removable and / or pierceable manner in the area of ​​the filter and / or the port of the tank to provide access to the tank, and where the adapter plate element (600) is configured to support an actuator and / or a control device of a valve of the tank, where the foil portion is provided in a removable and / or pierceable manner in the area of ​​the valve actuator and / or the control device of the tank to provide access to the tank.

14. A cleanroom bag (8000) for use in the system according to any one of claims 11 to 13, comprising: The cleanroom bag (8000) is configured to receive at least one tank (1, 2) and provides a cleanroom environment to the at least one tank when the at least one tank is received in the cleanroom bag; wherein the cleanroom bag comprises at least one foil portion (8500) adapted to be sandwiched between an access plate element (100) of the tank and an adapter plate element (600) to define at least one access point via the access plate element to provide access to the tank from outside the cleanroom bag, the cleanroom bag further comprising at least one support rail (8015) for guiding the received at least one assembled tank into the cleanroom bag, the support rail is adapted to support at least two tanks, and the support rail can engage with the top plate elements (100) and / or the side wall elements (200) of the respective tanks such that the top plate elements of the tanks having different height dimensions are arranged at the same level when the tanks are supported on the support rail, Therein, the support rail may be formed from multiple support rail sections (8015a, 8015b, 8015c) such that the cleanroom bag is foldable.

15. A method (2000) for assembling a tank (1) according to claim 10, comprising the following steps: providing a top plate element (2100); Optionally, providing at least one sidewall element (2200); providing a bottom plate element (2300); The top plate element, the bottom plate element, and optionally at least one sidewall element are assembled (2400) to form a reservoir for receiving at least one biochemical medium.

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