SYSTEM FOR AUTOMATICALLY OPERATING A SMART TANK

Abstract

The present invention relates to smart tank for a bio-pharma process line, a smart tank assembly, a method for assembling a smart tank and a system comprising multiple smart tanks. The smart tank comprises a top plate element, at least one sidewall element, and a bottom plate element, wherein the top plate element, the at least one sidewall element and the bottom plate element are arranged to form a reservoir for receiving at least one biochemical medium. The smart tank comprises further at least one channel, for guiding the at least one biochemical medium and/or an operating medium.

Claims

1. A system for automatically operating a smart tank (1, 2) in a bio-pharma process line, the system comprising: at least one smart tank (1, 2), wherein the smart tank comprises an access plate element (100) that forms a wall portion of a reservoir (500) of the smart tank (1, 2) that is adapted to receive at least one biochemical medium, wherein the access plate element is configured to provide access to the smart tank, and at least one handling manipulator (13000), wherein the handling manipulator (13000) comprises a manipulator head (13100, 14100, 16100, 17100), wherein the handling manipulator is arranged movably with respect to the at least one smart tank so as to access and to control at least one smart tank via the access plate element, wherein the handling manipulator is adapted to provide an operating medium to the smart tank and/or to remove operating medium from the respective smart tank, so as to transfer the biochemical medium to and/or out of the smart tank, and/or wherein the handling manipulator head comprises a driving means (17500) for driving an operating means of the smart tank.

2. The system of claim 1, wherein the at least one smart tank (1, 2) is a modular smart tank that is assembled from a top plate element (100), at least one sidewall element (200), and a bottom plate element (300), wherein the top plate element, the at least one sidewall element and the bottom plate element are arranged to form a reservoir of the smart tank, and 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, wherein the smart tank optionally further comprises at least one channel (20), for guiding the at least one biochemical medium and/or an operating medium, wherein the at least one channel extends within at least one of the top plate element, the at least one sidewall element and/or the bottom plate element.

3. The system of claim 1, wherein the at least one smart tank comprises at least one of the following components: a port (30), a filter (40), a valve (50), a sensor (1000) and/or an operating means, and wherein at least one of these components is accessible with the handling manipulator via the access plate element.

4. The system of claim 1, further comprising a clean room bag (8000, 9000) that comprises at least one foil portion (8500), wherein the clean room bag is configured to receive at least one smart tank (9011, 9013) and to provide a clean room environment for the at least one smart tank when the at least one smart tank is received in the clean room bag, wherein the at least one smart tank is accessible with the handling manipulator via the access plate element, from the outside of the clean room bag, the system optionally further comprising at least one adaptor plate element (600), wherein the adaptor plate element is associated with at least one smart tank and can be installed on the at least one smart tank, so that one of the at least one foil portions (8500) of the clean room bag is sandwiched between the access plate element (100) of the smart tank and the adaptor plate element (600), wherein the adaptor plate element (600) is configured to define at least one access point (630) to provide access to the smart tank from the outside of the clean room bag, via the access plate element, wherein further optionally the adaptor plate element (600) is configured to cover a filter (40) and/or a port (50) of the smart tank at least partially, and wherein the foil portion (8500) is provided removably and/or pierceably in an area of the filter and/or port of the smart tank to provide access to the smart tank and/or, wherein the adaptor plate element (600) is configured to support an actuating means (52) of a valve (50) and/or an operating means of the smart tank, and wherein the foil portion is provided removably and/or pierceably in an area of the actuating means of a valve and/or an operating means of the smart tank to provide access to the smart tank.

5. The system of claim 4, wherein the manipulator head (13100, 14100, 16100, 17100) is adapted to couple with the access plate element and/or the adaptor plate element, and wherein the driving means (17500) serves for driving an operating means of the smart tank via an access point of the adaptor plate, and wherein the manipulator head optionally comprises at least one of the following: a cover element (14300, 16300, 17300CI) adapted to cover the adaptor plate at least partially, so that at least one access point of the adaptor plate is covered; a UV-radiation means (14350, 16350), the UV radiation means being adapted to irradiate at least one access point of the adaptor plate and/or the access plate element; a pump head (14360, 16360), for providing a negative pressure in an area of a covered access point of the adaptor plate, a fluid line (17400a to 17400h), for supplying and/or removing fluid from the smart tank via an access point of the adaptor plate, a gas line (17400a to 17400h), for supplying and/or removing gas from the smart tank, via an access point of the adaptor plate, a valve actuating means (17800a to 17800c), for actuating a valve of the smart tank via an access point of the adaptor plate, a sensor for measuring operating conditions of the smart tank, such as a pressure sensor, and/or a spectrography means (17900).

6. The system of claim 1, wherein the handling manipulator (13000) is adapted to weld the foil portion (8500) with the adaptor plate (600) and/or the access plate (100).

7. The system of claim 1, further comprising a sampling means (18000), the sampling means is adapted to be coupled to a sampling channel (24) of the smart tank (2) for sampling from the smart tank, wherein optionally the sample is transferred to the sampling means by a positive pressure applied in the smart tank, the sampling means may comprise at least one syringe, wherein optionally the handling manipulator (13000) is adapted to move and/or actuate the sampling means (18000), wherein even further optionally the system further comprises a sampling means magazine (18500), for receiving multiple sampling means, and wherein the sampling means magazine is adapted to output a filled sampling means after sampling, wherein the sampling means magazine optionally outputs the filled sampling means to an air lock of the clean room bag (8000, 9000) and/or a cooled storing device.

8. A clean room bag (8000, 9000), for being used in a system for automatically operating a smart tank, the clean room bag (8000, 9000) being configured to receive at least one smart tank (9011, 9013) and to provide a clean room environment for the at least one smart tank when the at least one smart tank is received in the clean room bag, wherein the clean room bag comprises at least one foil portion (8550), that is adapted to be sandwiched between an access plate element (100) of the smart tank and an adaptor plate element (800), so as to define at least one access point to provide access to the smart tank from the outside of the clean room bag, via the access plate element.

9. The clean room bag (8000, 9000) of claim 8, wherein the clean room bag is adapted to sealingly couple to an assembly room that servers for assembling at least one smart tank, wherein the clean room bag is further configured to receive the at least one assembled smart tank from the assembly room, and/or wherein the clean room bag is a sterile bag, that is optionally a single-use bag.

10. The clean room bag (8000, 9000) of claim 8, wherein the clean room bag (8000, 9000) comprises a multi-ply outer shell, wherein a first ply of the shell is the outermost ply, and wherein a second ply of the shell is the innermost ply, and wherein the space surrounded by the second ply of the shell is pressurized with a pressure being lower than a pressure provided between the first and the second ply of the shell, wherein a colored gas may be provided between the first and the second ply of the shell.

11. The clean room bag (8000, 9000) of claim 8, wherein the clean room bag includes a sealable opening (8200) that is configured for receiving assembled smart tanks, wherein the sealable opening of the clean room bag is configured to open jointly with a corresponding sealable opening of an assembly room, when the clean room bag is sealingly coupled to the assembly room, wherein optionally the sealable opening (8200) of the clean room bag is covered by at least one cover element (8210), and wherein the at least one cover element is adapted to couple with a corresponding cover element of a corresponding sealable opening of an assembly room that is covered by the at least one corresponding cover element, to open jointly with the corresponding cover element, and wherein further optionally, the clean room bag (8000, 9000) comprises a sealing frame (8300, 9310, 9320, 9330), the sealing frame being configured to frame the sealable opening of the clean room bag, wherein the sealing frame may further comprise a UV-light source, the UV-light source is associated with the sealable opening of the clean room bag.

12. The clean room bag (8000, 9000) of claim 8, wherein the clean room bag comprises at least one rail (9015, 9025, 9035, 9045) for guiding at least one received assembled smart tank within the clean room bag.

13. The clean room bag (19500) of claim 8, wherein the clean room bag is initially stored in a frame assembly (19100), the frame assembly comprising air-permeable wall elements (19110, 19120, 19130, 19140, 19150), and wherein the clean room bag comprises an air inlet port that serves for pressurizing the stored clean room bag for leakage testing.

14. A handling manipulator (13000) for automatically operating a smart tank (1, 2) in a bio-pharma process line in a system according to claim 1, the handling manipulator is adapted to be movably with respect to at least one smart tank so as to access and to control at least one smart tank via an access plate element, wherein the handling manipulator (13000) may optionally comprise a manipulator head, wherein the manipulator head is adapted to couple with the access plate element and/or the adaptor plate element, wherein the handling manipulator is adapted to providing an operating medium to the smart tank and/or to removing operating medium from the respective smart tank, so as to transfer the biochemical medium to and/or out of the smart tank, and/or wherein the manipulator head comprises a driving means (17500) for driving an operating means of the smart tank via an access point of the adaptor plate.

15. The handling manipulator according to claim 14, wherein the manipulator head comprises at least one of the following: a cover element (14300, 16300, 17300d) adapted to cover the adaptor plate at least partially, so that at least one access point of the adaptor plate is covered; a UV-radiation means (14350, 16350), the UV radiation means being adapted to irradiate at least one access point of the adaptor plate and/or the access plate element; a pump head (14360, 16360), for providing a negative pressure in an area of a covered access point of the adaptor plate, a fluid line (17400a to 17400h), for supplying and/or removing fluid from the smart tank via an access point of the adaptor plate, a gas line (17400a to 17400h), for supplying and/or removing gas from the smart tank, via an access point of the adaptor plate, a valve actuating means (17800a to 17800c), for actuating a valve of the smart tank via an access point of the adaptor plate, a sensor for measuring operating conditions of the smart tank, such as a pressure sensor, and/or a spectrography means (17900), wherein the manipulator head may be an interchangeable manipulator head.

16. A method (20000) for automatically operating at least one smart tank in a bio pharma process line, the method comprising: providing (20100) a system according to claim 1, receiving (20200) sensor signals from at least one sensor of the at least one smart tank; controlling (20300) at least one handling manipulator based on the received sensor signals operating (20400) the at least one smart tank according to a predetermined control scheme, using the handling manipulator.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0162] In the following, the accompanying figures, that schematically show embodiments of the invention are described. Here,

[0163] FIG. 1 schematically shows an exploded view of a smart tank;

[0164] FIG. 2A schematically shows a smart tank in an assembled state;

[0165] FIG. 2B schematically shows a further smart tank in an assembled state;

[0166] FIG. 3 schematically shows a valve comprising an actuating rod;

[0167] FIG. 4A schematically shows a top plate element, comprising a valve;

[0168] FIG. 4B schematically shows a further top plate element;

[0169] FIG. 5 schematically shows a smart tank system;

[0170] FIG. 6 schematically shows a further smart tank system;

[0171] FIG. 7 schematically shows smart tanks, having different volumes;

[0172] FIG. 8 schematically shows a clean room bag;

[0173] FIG. 9 schematically shows further clean room bag(s);

[0174] FIG. 10A schematically shows inlet openings of a clean room bag;

[0175] FIG. 10B schematically shows a sealable opening in an open state;

[0176] FIG. 10C schematically shows a sealable opening in a closed state;

[0177] FIG. 11A schematically shows an adaptor plate element prior to assembly;

[0178] FIG. 11B schematically shows an assembled adaptor plate element;

[0179] FIGS. 12A to C schematically show assembling steps of an adaptor plate element;

[0180] FIG. 13 schematically shows a handling manipulator;

[0181] FIG. 14A schematically shows a handling manipulator operating a smart tank;

[0182] FIG. 14B schematically shows a handling manipulator operating a smart tank;

[0183] FIG. 15 schematically shows a handling manipulator operating a smart tank;

[0184] FIG. 16 schematically shows a perspective view of a manipulator head;

[0185] FIG. 17A schematically shows a perspective view of a manipulator head;

[0186] FIG. 17B schematically shows a bottom view of the manipulator head;

[0187] FIG. 18A schematically shows a sampling means;

[0188] FIG. 18B schematically shows an operating principle of a sampling means and a sampling means magazine;

[0189] FIG. 19 schematically shows a clean room bag in an initial state;

[0190] FIG. 20 schematically shows a flow diagram of a method;

[0191] FIG. 21 schematically shows an adapter, and

[0192] FIG. 22 schematically shows a smart tank system wherein a further adapter is connected to three smart tanks

DETAILED DESCRIPTION OF THE FIGURES

[0193] In particular, FIG. 1 schematically shows an exploded view of a smart tank 1. The smart single elements of the smart tank can be assembled to a smart tank 1 (as e.g. shown in FIGS. 2A, 2B). The assembly may be automated or manually. The smart tank 1 comprises a top plate element 100, at least one sidewall element 200, 210, 220, and a bottom plate element 300. As depicted, the smart tank of FIG. 1 comprises three sidewall elements 200, 210, 220.

[0194] The top plate element 100, the sidewall elements 200, 210, 220 and the bottom plate element 300 can be assembled to form a reservoir 500 for receiving at least one biochemical and/or operating medium. The channel may be associated with a valve that allows to open/close the channel. The valve may also be a flow control valve, that allows to control the flow through the channel. The channel may further comprise a port, such as an inlet and/or outlet port.

[0195] At least one of the top plate element 100, the sidewall elements 200, 210, 220 and the bottom plate element 300 comprises at least one channel, for guiding the at least one biochemical medium and/or an operating medium. The at least one channel may be associated with a valve, wherein the valve allows opening and/or closing the channel. Further, the valve may be a flow control valve that allows to control or set a desired flow rate through the channel.

[0196] The smart tank may comprise at least one sealing member 1020 for providing a sealed connection between the elements (top plate element 100, sidewall elements 200, 210, 220 and bottom plate element 300). The sealing member 1020 may be arranged circumferentially at each sidewall element 200, 210, 220, top plate element 100 and/or bottom plate element 300. When the elements are assembled to form the reservoir 500, the sealing member 1020 may be compressed, so as to provide a retaining force that acts on assembly-connecting means 70 and corresponding assembly-connecting means 72. Thereby, a self-retaining engagement may be provided.

[0197] Each of the elements (top plate element 100, sidewall elements 200, 210, 220 and bottom plate element 300) may be adapted to be provided with a sensor 1010 and/or a sensor module 1000. A sensor module 1000 may comprise multiple sensors, such as at least one of a pH sensor, a temperature sensor, a dissolved oxygen sensor, a biomass sensor, a foam sensor, a pressure sensor, a flow sensor, an O.sub.2 sensor, a N.sub.2 sensor, a CO.sub.2 sensor, and spectroscopy means, such as RAMAN, NIR and/or UV spectroscopy means. The sensor module may be connectable to the respective top plate element 100, sidewall element 200, 210, 220 and/or bottom plate element 300. The sensor module 1000 may be provided with a power source such as a rechargeable battery, that allows to operate the sensor module 1000 autonomously. Further, the sensor module 1000 may comprise a data interface, particularly a wireless data interface for transferring the measured sensor data to a respective control or storing unit.

[0198] FIG. 2A shows a smart tank 1 in an assembled state. This smart tank may serve for storing and/or transporting a biochemical medium or may be a bio reactor in a bio-pharma process line. This smart tank can be operated by a handling robot, as will be described in greater detail below. The shown smart tank comprises a top plate element 100, multiple sidewall elements 200, 210, and a bottom plate element 300. The top plate element, the sidewall elements and the bottom plate element are arranged to form a reservoir for receiving at least one biochemical medium.

[0199] The smart tank 1 comprises further channels 20, 21, 22, 23 for guiding the at least one biochemical medium and/or an operating medium. The channels extend within at least one of the top plate element 100, the sidewall elements 200, 210 and/or the bottom plate element 300.

[0200] For example channel 21 extends in the sidewall element 200 and the top plate element 100. Other channels may be provided that extend in the at least one sidewall element and at least one of the top plate element and the bottom plate element. Each of the channels may be at least one of the following channel types: An inlet channel, for guiding a biochemical medium and/or an operating medium to the reservoir of the smart tank. An outlet channel, for removing a biochemical medium and/or an operating medium from the reservoir of the smart tank. A retentate channel, for transferring a retentate back into the smart tank or out of the smart tank. A bypass-channel, for guiding a biochemical medium and/or an operating medium, wherein the bypass-channel is not connected to the reservoir of the smart tank. Alternatively, the bypass-channel can be adapted to be fluidically separated from the reservoir of the smart tank, e.g. by means of a valve. A heating or cooling channel for guiding a tempered heating or cooling medium. A sampling channel, for taking a sample of biochemical medium and/or of operating medium from the reservoir of the smart tank. Particularly, the smart tank may comprise multiple channels of different channel-types and/or the same channel type.

[0201] In the smart tank shown in FIG. 2A, channel 20 serves as outlet channel, particularly for removing waste. Channel 22 can be either an inlet or an outlet channel. This channel 22 enters the reservoir at a bottom side of the smart tank (i.e. near the bottom plate element). Channel 22′ can also be either an inlet or an outlet channel. This channel 22 enters the reservoir at a top side of the smart tank (i.e. near the top plate element). Channel 21 is a bypass-channel, that allows guiding a biochemical medium and/or an operating medium, via the smart tank, without entering the reservoir of the smart tank. Channels 28, 28′ and 28″ are not connected to the reservoir and may serve as cooling and/or heating channels.

[0202] Channels 21, 22 and 22′ meet each other at a channel junction 25. This channel junction is provided with at least one (in the embodiment shown with two) valves 50′, 50″. These valves 50′, 50″ are actuatable from the outside of the smart tank, by means of an actuating means 52′, 52″. The actuating means 52′, 52″ are provided in form of actuation rods. Channel 20 is associated with a respective valve 50 which can be actuated from the outside of the smart tank, by means of actuating means 52. Each of the actuating rods 52′, 52″/actuating means 52 can be actuated by the handling manipulator.

[0203] Further, the smart tank 1 comprises ports 30, 32. The ports are each associated with respective channel(s). The ports may be chosen from a group of port-types, comprising the following port-types: a fluid inlet port, a gas inlet port, a fluid outlet port, a gas outlet port, a cell blead port, a medium supply port, a medium remove port, an element-interconnecting port, and a tank-interconnecting port.

[0204] For example, port 32 is associated via valves 52′, 52″ with channels 21, 22 and 22′. Accordingly, this port 32 may serve as fluid inlet port, gas inlet port, fluid outlet port, gas outlet port, medium supply port, medium remove port, or tank-interconnecting port. Chanel 20, which serves as outlet channel is associated with an outlet port (not shown) on a bottom side of the bottom plate element 300. Thus, medium can be transferred to and/or out of the smart tank via the ports, e.g. by using a handling manipulator.

[0205] Particularly, all sides of the smart tank (or at least some of the sides) may provide the same port interface. I.e. ports are arranged at the same position. Thus, a smart tank can be easily interconnected to a further smart tank. Further, all side wall elements of a smart tank may be identically structured. Thus, the number of different elements required for setting up a smart tank is reduced.

[0206] FIG. 2B schematically shows a further smart tank that can be operated by a handling manipulator. This smart tank may serve for transporting and storing a biochemical medium. The smart tank comprises a stirring means 90. The smart tank shown in FIG. 2B corresponds to the smart tank described with respect to FIG. 2A, wherein two sidewall elements are not depicted, to allow a view inside the reservoir 500 of the smart tank. The inner surface 510 of the reservoir may be coated e.g. by a glass coating.

[0207] The stirring means 90 comprises at least one stirring member 91, wherein the stirring member comprises multiple stirring blades. Further, the stirring means comprises an actuating rod 92. Said actuating rod 92 is supported and sealed in the top plate element 100 of the smart tank. The actuating rod is engageable with a drive mechanism (not shown), such as an electric drive mechanism, provided on the outside of the smart tank. The drive mechanism may be part of a handling manipulator (not shown) that allows automated control of the smart tank and/or a smart tank system.

[0208] FIG. 3 schematically shows a valve 50 comprising an actuating rod 52. The valve 50 is associated with a channel 20. The valve 50 is coupled to an actuating rod 52, which has at its end a coupling portion 52a. The actuating rod 52 is supported in the top plate element 100 and/or the adaptor plate element 60o and can be easily installed. Preferably, the actuating rod 52 can be slided into the sidewall element/top plate element. The handling manipulator, particularly the handling manipulator head, may comprise a valve actuating means (not shown) to couple with the coupling portion 52a of actuating rod 52. By actuating (rotating) the valve actuating means, the handling manipulator can control the valve 50. The valve 50 may comprise a sealing member, that allows to seal the valve 50 and the channel 20, so that medium cannot flow along the actuating rod 52. The sealing member may be integrally formed (e.g. using 2K-injection moulding) and/or may be assembled. Further, the sealing member may be associated with the smart tank (e.g. the side wall element) and/or with the actuating rod 52.

[0209] FIG. 4A schematically shows a top plate element 100 that comprises a valve 50 for opening/closing channel 20. The valve 50 is a mechanical valve that is configured to be actuatable from the outside of the smart tank, by means of an actuating means 52. The actuating means 52 is provided in form of an actuation rod that can be actuated from the outside of the smart tank, e.g. by a handling manipulator (not shown). For opening/closing the channel, the actuating means 52 can be rotated or axially displaced, depending on the type of associated valve. The actuating means may be supported in an adaptor plate element 600 that can be installed on top of the top plate. The adaptor plate element may cover a filter 40 and/or a port 30 at least partially. Thus, operating and/or biochemical medium can be guided to the smart tank via the filter 40. The operating and/or biochemical medium may be provided by the handling manipulator. Further, the handling manipulator may be adapted to remove operating and/or biochemical medium from the smart tank via port 30 and optionally filter 40.

[0210] FIG. 4B schematically shows a further top plate element 100 that comprises multiple filters 40, 41, 42 that cover associated ports 30, 31, 32. Further, a pressure sensor 1010 may be provided. The filter covered port 30 and the pressure sensor 1010 allow for integrity testing the smart tank (including all channels and tank interconnections) and single filters. Further, an inlet 179 may be provided that allows to insert a spectrography means 17900 of a handling manipulator into the smart tank.

[0211] FIG. 5 schematically shows a smart tank system that comprises multiple smart tanks 1, 2, 3. The smart tanks are directly interconnected with each other. At least one of the one or more channels 21a of the first smart tank 1 is fluidically connected to a respective channel 21b of the second smart tank 2 which can be connected to a respective channel 21c of the third smart tank. Depending on the position of the valves 50a, 50b and/or 50c, which can be operated using a handling manipulator, medium can be e.g. transferred from the first smart tank to the second smart tank or the third smart tank. When transferring medium to the third smart tank medium can either be guided through the reservoir of the second smart tank or medium can bypass the reservoir of the second smart tank. Thus, a bio-pharma process of a bio-pharma process line that includes the smart tank system can controlled by operating the valves.

[0212] FIG. 6 schematically shows a further smart tank system. The smart tank system comprises two smart tanks, a larger smart tank 1 and a smaller small tank 4. The smaller smart tank 4 is provided on top of the larger smart tank 1. The smaller smart tank 4 can be provided on top of the larger smart tank 1 by using the handling manipulator (not shown). The handling manipulator may comprise a gripping device that is adapted to grip the smaller smart tank and to put it on top of the larger smart tank 1. Both smart tanks may be fluidically connected, via a channel or port (not shown). The channel or port may comprise a sterile filter, allowing to transfer medium from the smaller smart tank to the larger smart tank without contaminating the larger smart tank. The sterile filter may be provided in the top plate element of the larger smart tank 1. The fluid connection may be controlled by a valve that is preferably operable by at least one handling manipulator. The smaller smart tank may serve to provide an operating medium and/or a biochemical medium to the larger smart tank. As the smaller smart tank 4 is installed on top of the larger smart tank 1, it is possible to transfer medium from the smaller smart tank to the larger smart tank by using gravitation. The medium may be gaseous, fluidic and/or solid (e.g. in form of a powder, crystals, granulate, and/or the like). For transferring a solid medium into the larger smart tank 1, a vibrating means may be provided (e.g. at the handling manipulator) that allows to control a dose of solid medium, supplied to the larger smart tank. Further, in particular for transferring fluidic and/or solid medium pressure (positive or negative) may be applied to the smaller and/or larger smart tank.

[0213] Further, the smaller smart tank may be provided outside the clean room bag, wherein the larger smart tank may be provided within the clean room bag. In other words, a foil portion of the clean room bag may be sandwiched between the smaller smart tank 4 and the larger smart tank 1. The foil portion may be pierced/removed, as described above, using the handling manipulator. Further, the foil portion may be welded to the top plate of the smart tank 1, an adaptor plate element and/or to the smaller smart tank 4.

[0214] FIG. 7 schematically shows smart tanks 1, 2, 3, having different volumes. To provide different volumes, it is possible to provide different kinds of sidewall elements. Thus, different volumes can be provided, using the same top plate element and bottom plate elements. Further, different volumes can be provided by stacking multiple sidewall elements 202, 202′; 203, 203′, 203″. As shown in FIG. 7, smart tank 1 comprises sidewall elements 200 that are all arranged in the same level of the smart tank 1. This smart tank has the following stack of elements: bottom plate element 300/side wall element 200/top plate element 100.

[0215] Smart tanks 2 and 3 comprises multiple sidewall elements 202, 202′; 203, 203′, 203″, wherein the groups of side wall elements are arranged in different levels of the smart tank. Smart tank 2 has the following element stack: bottom plate element 302/side wall element 202′/sidewall element 202/top plate element 102 and smart tank 3 has the following element stack: bottom plate element 303/side wall element 203″/side wall element 203′/sidewall element 203/top plate element 103.

[0216] As described above, channel portions extending in the respective sidewall elements are interconnected with corresponding channel portions in the neighboring element (sidewall element, bottom plate element or top plate element). Likewise, actuating means for actuating a valve and/or for driving a stirring means and/or the like that are provided in the sidewall element(s) may be coupled to corresponding actuating means of a neighboring element. Thus, a valve or the like provided e.g. in sidewall element 202′ or 203″ can be actuated from the top side of the smart tank using the handling manipulator.

[0217] As shown, the height dimension of the first smart tank 1 is smaller than a height dimension of the second smart tank 2 and the third smart tank 3. To provide the top plate elements 100, 102 and 103 on substantially the same height, a height compensation means 1100, 1102 can be provided. Said height compensation means 1100, 1102 is adapted to be coupled to the smart tank 1, 2 and allows to install the top plate element 100 of the first smart tank 1, the top plate element 102 of the second smart tank 2 and in substantially the same height as the top plate element 103 of the third smart tank 3. Thus, interconnection of the smart tanks as well as automated operation of the smart tanks is facilitated.

[0218] FIG. 8 schematically shows a clean room bag 8000 that is configured to receive at least one smart tank (cf. FIG. 9) and to provide a clean room environment or even a sterile environment for the at least one smart tank when the at least one smart tank is received in the clean room bag 8000. The clean room bag 8000 comprises at least one foil portion, that is adapted to be sandwiched between an access plate element of the smart tank and an adaptor plate element, so as to define at least one access point to provide access to the smart tank from the outside of the clean room bag, via the access plate element (cf. FIGS. 11A, 11B and FIGS. 12A to 12C). The clean room bag 8000 can sealingly couple to an assembly room (not shown) that servers for assembling at least one smart tank, wherein the clean room bag is configured to receive the at least one assembled smart tank from the assembly room.

[0219] The clean room bag 8000, 9000 is held by a support structure 8100, 9100. The support structure may be connected or integrally formed with the guide rails of the handling manipulator. The support structure 8100, 9100 may be provided in form of multiple U-shaped frames. However, other support structures can be used. The support structure may be modular, hence, the support structure can be adapted to the spatial requirements of the smart tank system. The support structure 8100, 9100 may be formed integrally with the clean room bag 8000, 9000, or may be a separate support structure that can be coupled with the clean room bag, e.g. by click connection(s). The support structure 8100, 9100 is used to span the clean room bag and thus to open up the operating space.

[0220] For receiving smart tanks, the clean room bag 8000 includes at least one sealable opening 8200. The sealable opening 8200 of the clean room bag is configured to open jointly with a corresponding sealable opening of an assembly room (not shown), when the clean room bag is sealingly coupled to the assembly room. Particularly, the sealable opening 8200 of the clean room bag 8000 may be a sliding door and/or may be covered by at least one cover element 8210. The at least one cover element 8210 may be adapted to couple with a corresponding cover element of a corresponding sealable opening of an assembly room (not shown) that is covered by the at least one corresponding cover element, to open jointly with the corresponding cover element. The cover element 8210 may comprise a magnetic means for coupling with a corresponding cover element. Additionally, or alternatively, the coupling may be achieved by form fit or any other coupling means.

[0221] Further a sealing frame 8300 may be provided. The sealing frame 8300 may be configured to frame the at least one sealable opening 8200 of the clean room bag 8000, wherein the sealing frame 8300 may further comprise a UV-light source (not shown), that is associated with the sealable opening 8200 of the clean room bag 8000. Alternatively, or additionally, the sealable frame can be evacuated. Thus, contaminants on the outside of the sealable opening 8200 can be removed and/or destroyed prior to opening the sealable opening 8200.

[0222] FIG. 9 schematically shows a further clean room bag 9000. The clean room bag 9000 is adapted to receive smart tanks 9011, 9013 in multiple rows 9010, 9020, 9030, 9040. Here, four rows 9010, 9020, 9030, 9040 of smart tanks are shown. However, the clean room bag 9000 may be adapted to receive at least one row of smart tanks, preferably at least two rows of smart tanks, even more preferably at least three rows of smart tanks, even more preferably at least four rows of smart tanks, even more preferably at least five rows of smart tanks, and most preferably at least eight rows of smart tanks. The smart tanks of a row may be interconnected and/or the smart tanks of different rows may be interconnected so that a bio-chemical medium and/or operating medium may be transferred from a smart tank to another smart tank within a row and/or from a smart tank to another smart tank of different rows. For example, a first row 9020 may include tanks of a bio-pharma process line that outputs the product to be manufactured. A second row 9010 and/or third row 9030 may provide additives or further educts for producing the product (e.g. operating medium, such as a buffer solution). Further, the rows of smart tanks may be interconnected in a way that different products can be manufactured starting from a single educt.

[0223] The clean room bag 8000, 9000 may comprise at least one rail 9015, 9025, 9035, 9045 for guiding at least one received assembled smart tank within the clean room bag (cf. also FIG. 10A). Each of the rails 9015, 9025, 9035, 9045 may be associated with a row of smart tanks.

[0224] The clean room bag, at least one of the received smart tanks and/or the system may further comprise at least one height compensation means 9012, 9014, that may be coupled to a smart tank 9011, 9012, and to adjust the height of the smart tank 9011, 9012, so that an access plate element of the smart tank 9011, 9012 is installed at substantially the same height of a further smart tank 9011, 9012 received within the clean room bag 8000, 9000. Thus, automated operation of the smart tanks can be facilitated.

[0225] FIG. 10A schematically shows sealable openings of the clean room bag 9000. For receiving smart tanks, the clean room bag 9000 includes three sealable openings, each of the openings being associated with a sealable frame 9310, 9320, 9330. Alternatively, to providing a clean room bag for receiving multiple rows of smart tanks, multiple clean room bags can be provided, wherein each of the clean room bags may receive at least one row of smart tanks. The rows of smart tanks of different clean room bags may be interconnected, so that bio-chemical and/or operating medium can be transferred from one row to another row. The interconnection of the smart tanks, e.g. of different rows, may be achieved by at least one hose-based connection. The hose-based connection may be installed outside the smart tank, wherein a respective hose is coupled via respective access plate elements and/or adaptor plate elements with the respective smart tanks. The hose-based connection may be established, using the handling manipulator, i.e. automatically.

[0226] Generally, the handling manipulator may comprise a hose connection means, that is adapted to provide a hose and/or to connect a hose to the respective access plate element and/or adaptor plate element, sealingly. The hose connection may be achieved using a quick connector. Preferably, the hose may be welded to the respective access plate element and/or adaptor plate element. Further, the hose connection means may be covered by a cover element that may be provided with a UV-radiation means and or a pump head.

[0227] If different clean room bags are used, each clean room bag may provide the same or a different clean room class. Preferably, all clean room bags provide a sterile environment. Alternatively, in case of different clean room classes, for example, the actual product line may be provided in a sterile clean room bag, wherein operating media containing tanks (such as buffer solution tanks) may be provided in a clean room bag having a lower clean room class.

[0228] FIGS. 10B and 10C schematically shows a sealable opening being coupled to a corresponding sealable opening. FIG. 10B shows an open state, wherein FIG. 10C shows a closed state. The sealable opening 9200 may be part of a clean room bag. The corresponding sealable opening 9350 is part of an assembly room 9300, preferably of an assembly bag. In the following the opening/closing is described.

[0229] The sealable opening 9200 allows receiving/removing smart tanks. An assembly room 9300 comprises at least one corresponding sealable opening 9350 that is configured for transferring smart tanks from the assembly room to the clean room bag. The sealable opening 9350 of the assembly room 9300 and the corresponding sealable opening 9200 of the clean room bag 9000 are configured to open jointly, when the assembly room 9300 is sealingly coupled to the clean room bag 9000.

[0230] Further, the sealable opening 9350 of the assembly room 9300 may be covered by at least one cover element 9352, 9354, such as a door leaf of a sliding door. The corresponding sealable opening 9200 of the clean room bag 9000 may be covered by at least one corresponding cover element 9252, 9254. The at least one cover element 9352, 7354 and the at least one corresponding cover element 9252, 9254 are configured to couple with each other to open jointly. The coupling can e.g. be achieved magnetically or by positive locking.

[0231] FIGS. 11A and 11B schematically show an adaptor plate element 600, wherein FIG. 11A shows the adaptor plate element 600 prior to assembly and FIG. 11B shows an assembled adaptor plate element 600. The adaptor plate element 600 may be associated with at least one smart tank (not shown). Particularly the adaptor plate element may be associated with a single smart tank or with multiple smart tanks. The adaptor plate element 600 can be installed on the at least one smart tank, so that one of the at least one foil portions 8500 of the clean room bag is sandwiched between the access plate element 100 (e.g. a top plate element) of the smart tank and the adaptor plate element 600.

[0232] The adaptor plate element 600 defines at least one access point 630 to provide access to the smart tank from the outside of the clean room bag, via the access plate element 100. Accordingly, the smart tank can be provided in a clean room or sterile environment (e.g. within a clean room bag, cf. FIGS. 8, 9, 10) and at the same time can be accessed from the outside of the clean room bag. Thus, a handling manipulator and other control or operating devices can be provided outside of the clean room bag.

[0233] The adaptor plate element 600 may cover a filter (not shown) and/or a port 30 of the smart tank at least partially. Thus, medium (bio-chemical and/or operating medium) can be transferred to and/or removed from the smart tank from the outside of the clean room bag.

[0234] The foil portion 8500 of the clean room bag, that is sandwiched between the access plate element 100 of the smart tank and the adaptor plate element 600, may be provided removably and/or pierceable in an area of the filter and/or port 30 of the smart tank. In FIG. 11B, the foil portion 8500 is pierceable. Thus, for accessing the smart tank from the outside of the clean room bag, a handling manipulator may pierce the foil portion 8500 covering port 30 for supplying/removing medium to/from the smart tank.

[0235] For accessing a smart tank from the outside of a clean room bag, the handling manipulator may carry out the following steps:

[0236] Step 1: Install an adaptor plate element 600 on the at least one smart tank, so that one of the at least one foil portions 8500 of the clean room bag is sandwiched between the access plate element 100 of the smart tank and the adaptor plate element 600. Optionally, remove a cover element, such as a cap, from a through hole (access point) of the adaptor plate element.

[0237] Step 2: Perforate the at least one foil portion 8500 of the clean room bag with a perforating means, such as a knife, needle, laser and/or the like. The perforation may be carried out in a way, that a foil portion is separated from the clean room bag.

[0238] Step 3: Optionally, gripping the separated foil portion 8500 using a gripping means, such as a vacuum gripper of the handling manipulator.

[0239] Step 4: Optionally, welding the remaining foil portion 8500 with the adaptor plate element 600 and/or the top plate element 100, preferably by using the handling manipulator.

[0240] Step 5: Optionally, placing a connector means, such as a quick connector means on the adaptor plate in an area of the removed/perforated foil portion.

[0241] For facilitating access to the smart tank, a connector element may be provided. The connector element 650, such as a fluidical quick connector, may be inserted into the access point 300, preferably by the handling manipulator (cf. FIGS. 14, 15).

[0242] FIGS. 12A to C schematically show assembling steps of an adaptor plate element 600. Particularly, an access plate element, which may be a top plate element 100 of a smart tank, is shown. The top plate element supports an actuating means 52, comprising an actuating rod 52 of a valve (not shown). Said valve is coupled to the actuating rod 52, which has at its end a coupling portion 52a. The actuating rod 52 is supported in the top plate element 100 and/or the adaptor plate element 600. A handling manipulator, particularly a handling manipulator head, may comprise a valve actuating means (not shown) to couple with the coupling portion 52a of actuating rod 52. By actuating (rotating) the valve actuating means 52, the handling manipulator can control the valve 50.

[0243] A foil portion 8500 of a clean room bag may be provided removably and/or pierceable in an area of the actuating means 52. Alternatively, the foil portion 8500 may be dimensioned so that operating the actuating means is possible, without removing/piercing the foil portion 8500.

[0244] The adaptor plate element 600 may comprise an access point 630 in form of a through hole. The adaptor plate element 600 may be installed on top of the access plate element 100 so that at least the coupling portion 52a of the actuating rod 52 extends out of the through hole of the adaptor plate element 600. The foil portion 8500 may cover the coupling portion 52a and thus, the smart tank can be provided entirely in a clean room/sterile environment and can be operated from the outside of the clean room bag. Optionally, the foil portion 8500 may be welded with the adaptor plate element 600 and/or the access plate element 100 in a welding zone 8510. Accordingly, the handling manipulator may comprise a foil welding device. Welding the foil portion 8500 to the adaptor plate element 600 and/or the access plate element 100 allows to provide a tightly sealed connection and thus prevents entry of contaminants. The welding device of the handling manipulator may be any suitable plastics welding device, such as hot plate welding, electro fusion welding, high frequency welding, laser transmission welding, circular welding, rotary friction welding, ultrasonic welding, vibration welding, hot gas welding, and/or the like. Particularly, the welding device may be adapted to weld different materials with each other.

[0245] FIG. 13 schematically shows a handling manipulator 13000, at least partially. The handling manipulator 13000 is arranged movably with respect to the at least one smart tank so as to access and to control at least one smart via the access plate element 100. The handling manipulator 13000 and in particular a handling manipulator head 13100 is configured to couple with the access plate of the smart tank to control and/or operate the smart tank.

[0246] The handling manipulator 13000 may be arranged movably in all directions. Preferably, the at least one manipulator is provided on a guide rail(s) 13200 that allows movement of the manipulator 13000 in a horizontal and/or vertical plane. Here, only one guide rail 13200 is shown, however further guide rails may be provided. The manipulator may further be arranged movable in a direction perpendicular to a plane defined by the guide rails 13200. For example, the at least one manipulator may be a portal robot that comprises a first guide rail 13200 that allows moving the manipulator in a x-direction and a second guide rail (not shown) that allows moving the manipulator in a y-direction, wherein the x-direction is perpendicular to the y-direction. Additionally, or alternatively, the manipulator may comprise a third guide rail (also not shown) that allows moving the manipulator in a z-direction, wherein the z-direction is perpendicular to the x-direction and the y-direction.

[0247] The handling manipulator 13000 (respectively the manipulator head 13100) may be moved towards a smart tank for operating the same. The handling manipulator (respectively manipulator head) may couple to a coupling portion 52a of an actuating rod 52 for opening/closing an associated valve. Thereby, the smart tank and/or the smart tank system can be operated and controlled.

[0248] FIG. 14A schematically shows a handling manipulator 14000 and in particular a manipulator head 14100 in a cut view, operating a smart tank 1. FIG. 14B shows the manipulator head 14100 in cut view, cut in a different plane. The smart tank 1 may comprise a channel 20 that ends at a port 30, which may be covered by a filter. Further, a quick connector 650 may be provided. The smart tank 1 is associated with an adaptor plate element 600 that defines an access point (here at port 30). Further, the smart tank may comprise at least one valve 50 that is associated with channel 20. The valve 50 may open channel 20 to be in communication with channel 22. The valve may be coupled to an actuating rod 52, so as to be controllable by the handling manipulator 14000.

[0249] All channels of a smart tank, at least one channel of the smart tank and/or the reservoir(s) of the smart tank may be designed to be self-emptying. Thus, e.g. product and or cleaning fluid, such as sodium hydroxide solution can be entirely removed from the smart tank.

[0250] The handling manipulator 14000 and in particular the manipulator head 14100 of the handling manipulator 14000 is adapted to couple with the access plate element (not shown) and/or the adaptor plate element 600. The manipulator head 14100 comprises a cover element 14300 adapted to cover the adaptor plate 600 at least partially, so that at least one access point (here port 30) of the adaptor plate 600 is covered. Covering the access point reduces the risk of contamination. The cover element 14300 may comprise a sealing lip 14320 that allows to sealingly couple the cover element 14300 with the adaptor plate element 600.

[0251] Further, a UV-radiation means 14350 may be provided, preferably within the cover element 14300. The UV radiation means 14350 is adapted to irradiate at least one access point (here port 30) of the adaptor plate 600 and/or the access plate element. Using UV radiation, potential contaminants can be destroyed.

[0252] Still further a pump head or a venturi nozzle 14360 can be provided. The venturi nozzle 14360 allows to provide a negative pressure in an area of a covered access point of the adaptor plate. Thus, the covered space covered by the cover element 14300 can be evacuated and/or potential contaminants may be removed.

[0253] The at least one handling manipulator 14000 and in particular the manipulator head 14100 of the handling manipulator 14000 is adapted to provide an operating medium to the smart tank and/or to remove operating medium from the respective smart tank, so as to transfer the biochemical medium to and/or out of the smart tank. For example, at least one fluid and/or gas line 14400 may be provided, for supplying and/or removing fluid or gas from the smart tank via an access point of the adaptor plate. The fluid may be an operating fluid and/or a bio-chemical fluid. In particular, the fluid may be a buffer solution and/or an acid or a base for adjusting the pH value within the smart tank. The gas may be an operating gas, such as pressurized air. Thus, the smart tank can be pressurized for controlling the flow of bio-chemical medium stored in the tank. Further, O.sub.2, N.sub.2, and/or CO.sub.2 may be supplied via a gas line. The gases may be supplied vie a common gas line or vie separate gas lines. Still further, a sensor (not shown) for measuring operating conditions of the smart tank 1, such as a pressure sensor, may be provided. This allows e.g. for integrity or leakage testing.

[0254] Further, a syringe 14200 may be provided. The syringe may be operated to remove medium from a smart tank (e.g. for sampling) and/or for providing medium to a smart tank. Further, the syringe 14200 may comprise a venting valve 14250 that may be provided with an air filter. The syringe 14200 may be coupled removably with the handling manipulator. Thus, after being used (e.g. filled), the syringe may be stored in a sampling storage means, such as a refrigerator and/or the syringe may be transferred to an analyzing means for analyzing the sample.

[0255] FIG. 15 schematically shows a handling manipulator 15000 and in particular a manipulator head 15100 in a cut view, operating a smart tank 1. A valve actuating means 15152, for actuating an actuating rod 52 of a valve of the smart tank 1 via an access point of the adaptor plate 600 is provided. The valve actuating means 15152 may be part of a drive mechanism and may be adapted to couple to an actuating means 52 of a valve of the smart tank 1, via a coupling portion 52a. Thus, the associated valve (not shown) can be controlled (e.g. opened/closed), using the handling manipulator 15000. Further, a driving means (not shown) for driving an operating means of the smart tank via an access point of the adaptor plate may also be provided. The operating means may be a stirring means. Thus, e.g. the stirring of the smart tank can be controlled, using the handling manipulator 15000.

[0256] Still further, at least one fluid and/or gas line 15400 may be provided, for supplying and/or removing fluid or gas from the smart tank via an access point of the adaptor plate.

[0257] FIG. 16 schematically shows a perspective view of a further manipulator head 16100. The manipulator head 16100 comprises a cover element 16300 adapted to cover an adaptor plate 600 at least partially, so that at least one access point (not shown) of the adaptor plate 600 is covered. The manipulator head 16100 comprises multiple UV-radiation means 16350. The UV radiation means 16350 are adapted to irradiate at least one access point of the adaptor plate 600 and/or an access plate element.

[0258] Still a venturi nozzle 16360 is provided. The venturi nozzle 16360 allows to provide a negative pressure in an area of a covered access point of the adaptor plate. Thus, the covered space covered by the cover element 16300 can be evacuated and/or potential contaminants may be removed. Further, a fluid and/or gas line 16400 is provided, for supplying and/or removing fluid or gas from the smart tank via an access point of the adaptor plate.

[0259] FIG. 17A schematically shows a perspective view of a manipulator head 17100. FIG. 17B shows a bottom view of the manipulator head 17100. The manipulator head 17100 comprises multiple fluid and/or gas line 17400a to 17400h, wherein each of the fluid and/or gas lines may be associated with a separate cover element 17300d. Further the manipulator head 17100 may comprise multiple valve actuating means 17800a, 17800b, 17800c, for actuating a valve 50 of the smart tank 1. Further, a driving means 17500 for driving an operating means, such as a stirring means of the smart tank is provided. Still further, at least one sensor (not shown) for measuring operating conditions of the smart tank 1, such as a pressure sensor, may be provided. Further, a spectrography means 17900 is provided. The spectrography means may be movable in z-direction to be inserted into the smart tank.

[0260] The handling manipulator may comprise at least one interchangeable manipulator head. A first interchangeable manipulator head may provide different functionality than a second interchangeable manipulator head. Different functionality may be provided by providing the respective manipulator head with different combinations of the above-mentioned means that may be part of a manipulator head. Particularly, a manipulator head, such as manipulator head 17100, may comprise a base element 17700 that is adapted to hold and support at least one or multiple of a cover element, a UV-radiation means, a pump head, a syringe, a fluid line, a gas line, a valve actuating means, a driving means, a sensor and/or a spectrography means.

[0261] FIG. 18A schematically shows a sampling means 18000 and FIG. 18B schematically shows an operating principle of a sampling means 18000 and a sampling means magazine 18500. The system and/or the handling manipulator (particularly the manipulator head) may comprise a sampling means 18000. The sampling means is adapted to be coupled to a sampling channel 24 of the smart tank 2 for sampling from the smart tank 2. The sampling means 18000 may be cylinder, a cartridge and/or a syringe 18100. The sample may be transferred to the sampling means 18000 by applying a positive pressure to the smart tank 2 and/or by applying a negative pressure within the sampling means 18000. In case of a syringe, negative pressure can be applied by retracting a plunger 18110. This may be done manually or automatically, e.g. by the handling manipulator. Prior to sampling an optional valve 50′ that is associated with the sampling channel 24 may be opened, preferably by the handling manipulator. e.g. by operating actuating rod 52′.

[0262] The sampling means may be adapted to be guided along multiple interconnected smart tanks 1, 2. For example, a guide rail 18200 may be provided that guides the sampling means 18000 and/or a magazine of sampling means 18500 (cf. FIG. 18B). The guide rail 18200 may be integrally formed in sidewall elements of the smart tanks. Further, the sampling means may be guided by the handling manipulator. The sampling means may be adapted to be coupled to a sampling channel of any one of the interconnected smart tanks for sampling from the respective smart tank. Thus, samples can be taken from different smart tanks.

[0263] Particularly, the handling manipulator may be adapted to move and/or actuate the sampling means. Optionally, the sampling means 18000 may be arranged to be outputted e.g. to an air lock of a clean room bag, after being filled. The sampling means 18000 may be held in a support structure 18550, which may be part of a sampling magazine 18500. The support structure may be coupled, preferably hinged, to an actuating means, such as an actuating rod 18552. The actuating rod can be actuated in z-direction, e.g. by a handling manipulator. Further, the actuating means 18552 may comprise a coupling portion 18552a that is preferably magnetic. Thus, a handling manipulator can couple to the actuating means, e.g. by an electro-magnet, and actuate the actuating means for outputting the sampling means as shown in FIG. 18B.

[0264] FIG. 18B shows a sampling means 18000a being held by a support structure 18550. The support structure may be coupled, preferably hinged, to an actuating means, such as an actuating rod 18552. The actuating rod can be actuated in z-direction, e.g. by a handling manipulator. When being actuated (pulled) in z-direction, the support structure is tilted, and sampling means 18000a is outputted. The sampling magazine 18550 comprises multiple further sampling means 18000b to 18000f. By retracting locking element 18560, a further sampling means 18000b is released and can be held and supported by support structure 18550 for further sampling.

[0265] The sampling means allows to take a sample under clean room/sterile environment and to transfer the sample/filled sampling means to the outside of a clean room bag.

[0266] FIG. 19 shows a clean room bag 19500 in an initial state, being stored in a frame assembly 19100. The frame assembly 19100 comprise air-permeable wall elements 19110, 19120, 19130, 19140, 19150. The clean room bag 19500 comprises an air inlet port (not shown) that serves for pressurizing the stored clean room bag 19500 for leakage testing. Thus, the clean room bag 19500 can be pressurized while being stored in the frame assembly 19100 and the change of pressure over time can be measured. As the frame assembly comprises air-permeable wall elements 19110, 19120, 19130, 19140, 19150, air that leaves the stored clean room bag 19500 can also leave the frame assembly 19100 and thus, leakages can be detected. In case the change of pressure exceeds a predefined threshold, the clean room bag 19500 can be discarded as it is not as air-tight as required. The air-permeable wall elements 19110, 19120, 19130, 19140, 19150 may be provided in form of wall elements with through holes, such as punctured sheets and/or in form of wall elements that are covered with an air-permeable means, such as an open-pored foam, a fabric, a non-woven, and/or the like.

[0267] The clean room bag 19500 may comprise an air inlet port (not shown) that serves for pressurizing the stored clean room bag 19500 for leakage testing. The air inlet port may be covered with at filter, such as a sterile filter, that allows pressurizing the assembly bag in a sterile fashion. Thus, the clean room bag 19500 can be pressurized while being stored in the frame assembly 19100 and the change of pressure over time can be measured. Particularly, leakages can be detected by comparing the measured change of pressure over time with a predefined threshold. In case the change of pressure over time exceeds the threshold, there is leakage and the clean room bag 19500 cannot be used. As the frame assembly comprises air-permeable wall elements 9110, 9120, 9130, 9140, 9150, air that leaves the stored assembly bag 9200 can also leave the frame assembly 9100 and thus, leakages can be detected.

[0268] FIG. 20 schematically shows a flow diagram of a method 20000 for automatically operating at least one smart tank in a bio-pharma process line. The method 20000 comprises the step of providing 20100 a system for automatically operating at least one smart tank in a bio-pharma process line, as described above. Further, the method 20000 comprises receiving 20200 sensor signals from at least one sensor of the at least one smart tank, controlling 20300 at least one handling manipulator based on the received sensor signals and operating 20400 the at least one smart tank according to a predetermined control scheme, using the handling manipulator.

[0269] FIG. 21 schematically shows an adapter 3000 which may interconnect at least two smart tanks (as e.g. shown in FIG. 22). The adapter 3000 comprises at least one channel 3001 guiding the at least one of a biochemical medium and/or an operating medium. The at least one channel 3001 may be further configured as described above with reference to the smart tank.

[0270] Further, the depicted adapter 3000 comprises a fluidic module 3030. In the embodiment depicted in FIG. 21, the fluidic module 3030 is a hollow fiber filter. In further embodiments the adapter 3000 can comprise at least one (i.e. also multiple) fluidic module(s) 3030. The at least one fluidic module 3030 may be at least one of the following: a crossflow cassette, a crossflow hollow fiber module, a hollow fiber filter, a resin capsule, a filter capsule, and/or a magnetic tube. It is to be understood, that the adapter may include multiple fluidic modules of the same type and/or of different types. Further, it is to be understood, that the at least one channel 3001 may be at least partially arranged in the at least one fluidic module 3030, in particular in a capsule of the fluidic module.

[0271] Further, the at least one fluidic module 3030 may be replaceable, optionally by means of the at least one handling manipulator. Thus, maintenance may be facilitated. Particularly, the at least one fluidic module 3030 may be replaceable by another type of fluidic module 3030. Thus, the functionality of the adapter 3000 may be adapted with reduced effort. Further, the at least one fluidic module may be replaceable by the same type of fluidic module. Thus, e.g. a consumed filter can be easily replaced.

[0272] Moreover, as illustrated in FIG. 21, the adapter 3000 comprises a port 3002, a filter 3003, a valve 3004 and a sensor 3005. In further embodiments, the adapter may comprise at least one (i.e. also multiple) of the following: a port 3002, a filter 3003, a valve 3004, a sensor 3005, and/or any other kind of operating means. Said operating means (port 3002, filter 3003, valve 3004 and sensor 3005) may be further configured as already described with reference to the smart tank. Further, said operating means may be operated by means of the handling operator. Moreover, said port 3002 may be adapted to be connectable to at least one corresponding port of at least one smart tank and/or another adapter. Further, the adapter may be adapted to allow a horizontal and/or vertical arrangement of the adapter relative to a horizontal base surface. Particularly, the at least one port 3002 may be adapted to allow a vertical arrangement of the adapter relative to a horizontal base surface. Particularly, at least two ports may be configured to allow a connection of the top plate element of a first smart tank to the bottom plate element of a second smart tank by means of the adapter.

[0273] The adapter 3000 shown in FIG. 21 comprises three adapter units, a first side adapter unit 3010a, a second side adapter unit 3010b and a middle adapter unit 3020. The middle adapter unit 3020 is arranged between the first and second side adapter units 3010a, 3010b. Said adapter units may be connected by means of click connections. Thus, the adapter units may be separate adapter units and interconnectable to form the adapter. Further, the at least two adapter units (or all adapter units) forming the adapter may be integrally formed. In further embodiments, the number of side adapter units and/or middle adapter units may be different. For example, the length of the adapter and/or the number of fluidic modules may be adjustable by choosing the number of side and/or middle adapter units.

[0274] The adapter 3000 may have a telescopic functionality and/or may be provided in different sizes. Preferably, the telescopic functionality is provided by the middle adapter unit 3020. This may be beneficial to adapt the distance between the side adapter units 3010. Thus, the adapter may be adapted to fluidic modules 3030 with different lengths. Thus, the flexibility of the adapter 3000 may be increased.

[0275] FIG. 22 schematically shows an adapter 3000 which is connected to three smart tanks 1, 2, 3. The adapter 3000 comprises two fluidic modules 3020a, 3020b. In the embodiment depicted in FIG. 22, the two fluidic modules 3020a, 3020b are filters, each comprising a capsule. The connection of the smart tanks 1, 2, 3 to the fluidic modules 3020a, 3020b is achieved by means of the adapter 3000, particularly via at least one of the first side adapter unit, the second side adapter unit and/or the middle adapter unit.

[0276] In FIG. 22, the adapter is attached to the top plate elements 100a, 100b, 100c of the smart tanks 1, 2, 3. In further embodiments, the adapter 3000 may be attached to the top plate element, the at least one sidewall element and/or the bottom plate element of a respective smart tank.

[0277] Further, the at least one adapter may allow an integrity test as already described with respect to the smart tank, above. Moreover, assembly, operation, fluidic connection and/or disassembly of the adapter with the at least one smart tank may be performed manually and/or with the aid of the at least one handling manipulator. It is to be understood that assembly, operation, fluidic connection and/or disassembly of the at least one smart tank with at least one further smart tank may be performed manually and/or with the aid of a respective handling manipulator. Operating the adapter is performed analogous to the handling of the smart tank. Hence, any port, filter, valve, sensor and/or any other operating means of the adapter may be accessible with the handling manipulator so as to operate the adapter.

Further Embodiments

[0278] Embodiment 1. A system for automatically operating a smart tank 1, 2 in a bio-pharma process line, the system comprising:

[0279] at least one smart tank 1, 2, wherein the smart tank comprises an access plate element 100 that forms a wall portion of a reservoir 500 of the smart tank 1, 2 that is adapted to receive at least one biochemical medium, wherein the access plate element is configured to provide access to the smart tank, and

[0280] at least one handling manipulator 13000, wherein the handling manipulator is arranged movably with respect to the at least one smart tank so as to access and to control at least one smart via the access plate element.

[0281] Embodiment 2. The system of embodiment 1, wherein the at least one smart tank 1, 2 is a modular smart tank that is assembled from a top plate element 100, at least one sidewall element 200, and a bottom plate element 300, wherein

[0282] the top plate element, the at least one sidewall element and the bottom plate element are arranged to form a reservoir of the smart tank, and 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, wherein

[0283] the smart tank optionally further comprises

[0284] at least one channel 20, for guiding the at least one biochemical medium and/or an operating medium, wherein the at least one channel extends within at least one of the top plate element, the at least one sidewall element and/or the bottom plate element.

[0285] Embodiment 3. The system of any one of the preceding embodiments, wherein the at least one smart tank comprises at least one of the following components: [0286] a port 30, a filter 40, a valve 50, a sensor 1000 and/or an operating means, and wherein at least one of these components is accessible with the handling manipulator via the access plate element.

[0287] Embodiment 4. The system of any one of the preceding embodiments, the system further comprising [0288] a clean room bag 8000, 9000 that comprises at least one foil portion 8500, wherein the clean room bag is configured to receive at least one smart tank 9011, 9013 and to provide a clean room environment for the at least one smart tank when the at least one smart tank is received in the clean room bag, wherein the at least one smart tank is accessible with the handling manipulator via the access plate element, from the outside of the clean room bag.

[0289] Embodiment 5. The system of embodiment 4, the system further comprising [0290] at least one adaptor plate element 600, wherein the adaptor plate element is associated with at least one smart tank and can be installed on the at least one smart tank, so that one of the at least one foil portions 8500 of the clean room bag is sandwiched between the access plate element 100 of the smart tank and the adaptor plate element 600, wherein [0291] the adaptor plate element 600 is configured to define at least one access point 630 to provide access to the smart tank from the outside of the clean room bag, via the access plate element.

[0292] Embodiment 6. The system of any one of embodiments 4 or 5, wherein the adaptor plate element 600 is configured to cover a filter 40 and/or a port 50 of the smart tank at least partially, and wherein the foil portion 8500 is provided removably and/or pierceably in an area of the filter and/or port of the smart tank to provide access to the smart tank.

[0293] Embodiment 7. The system of any one of embodiments 4 to 6, wherein the adaptor plate element 600 is configured to support an actuating means 52 of a valve 50 and/or an operating means of the smart tank, and wherein the foil portion is provided removably and/or pierceably in an area of the actuating means of a valve and/or an operating means of the smart tank to provide access to the smart tank.

[0294] Embodiment 8. The system of the preceding embodiment, wherein the handling manipulator comprises a manipulator head 13100, 14100, 16100, 17100, wherein the manipulator head is adapted to couple with the access plate element and/or the adaptor plate element, and wherein the manipulator head comprises at least one of the following:

[0295] a cover element 14300, 16300, 17300d adapted to cover the adaptor plate at least partially, so that at least one access point of the adaptor plate is covered;

[0296] a UV-radiation means 14350, 16350, the UV radiation means being adapted to irradiate at least one access point of the adaptor plate and/or the access plate element;

[0297] a pump head 14360, 16360, for providing a negative pressure in an area of a covered access point of the adaptor plate,

[0298] a fluid line 17400a to 17400h, for supplying and/or removing fluid from the smart tank via an access point of the adaptor plate,

[0299] a gas line 17400a to 17400h, for supplying and/or removing gas from the smart tank, via an access point of the adaptor plate,

[0300] a valve actuating means 17800a to 17800c, for actuating a valve of the smart tank via an access point of the adaptor plate,

[0301] a driving means 17500 for driving an operating means of the smart tank via an access point of the adaptor plate,

[0302] a sensor for measuring operating conditions of the smart tank, such as a pressure sensor, and/or

[0303] a spectrography means 17900.

[0304] Embodiment 9. The system of the preceding embodiment, wherein the handling manipulator 13000 comprises at least one interchangeable manipulator head 13100, 14100, 16100, 17100, and wherein a first interchangeable manipulator head may provide different functionality than a second interchangeable manipulator head.

[0305] Embodiment 10. The system of any one of the preceding embodiments, wherein the handling manipulator 13000 is adapted to weld the foil portion 8500 with the adaptor plate 600 and/or the access plate 100.

[0306] Embodiment 11. The system of any one of the preceding embodiments, wherein the handling manipulator 13000 is adapted to weld and/or seal a hose portion of the smart tank.

[0307] Embodiment 12. The system of any one of the preceding embodiments, further comprising a sampling means 18000, the sampling means is adapted to be coupled to a sampling channel 24 of the smart tank 2 for sampling from the smart tank, wherein optionally the sample is transferred to the sampling means by a positive pressure applied in the smart tank, the sampling means may comprise at least one syringe.

[0308] Embodiment 13. The system of the preceding embodiment, wherein the sampling means 18000 is adapted to be guided along multiple interconnected smart tanks, and wherein the sampling means is adapted to be coupled to a sampling channel of any one of the interconnected smart tanks for sampling from the respective smart tank.

[0309] Embodiment 14. The system of the any one of embodiments 12 or 13, wherein the handling manipulator 13000 is adapted to move and/or actuate the sampling means 18000.

[0310] Embodiment 15. The system of any one of embodiments 12 to 14, wherein the system further comprises a sampling means magazine 18500, for receiving multiple sampling means, and wherein the sampling means magazine is adapted to output a filled sampling means after sampling, wherein

[0311] the sampling means magazine optionally outputs the filled sampling means to an air lock of the clean room bag 8000, 9000 and/or a cooled storing device.

[0312] Embodiment 16. The system of the preceding embodiment, wherein the smart tanks have different height dimensions, the system further comprising at least one height compensation means 9012, 9014, that is adapted to be coupled to at least one of the multiple smart tanks 9011, 9013, so that the access plate elements of the multiple smart tanks can be installed at substantially the same height, wherein the height compensation means optionally is provided within a bottom plate element of the smart tank.

[0313] Embodiment 17. The system of any one of the preceding embodiments, further comprising a control unit, the control unit is adapted to receive sensor signals from at least one sensors 1000 of the at least one smart tank and to control the at least one handling manipulator based on the received sensor signals to control the at least smart tank according to a predetermined control scheme.

[0314] Embodiment 18. A clean room bag 8000, 9000, for being used in system according to any one of the previous system embodiments,

[0315] the clean room bag 8000, 9000 being configured to receive at least one smart tank 9011, 9013 and to provide a clean room environment for the at least one smart tank when the at least one smart tank is received in the clean room bag, wherein

[0316] the clean room bag comprises at least one foil portion 8550, that is adapted to be sandwiched between an access plate element 100 of the smart tank and an adaptor plate element 800, so as to define at least one access point to provide access to the smart tank from the outside of the clean room bag, via the access plate element.

[0317] Embodiment 19. The clean room bag 8000, 9000 of embodiment 18, wherein the clean room bag is adapted to sealingly couple to an assembly room that servers for assembling at least one smart tank, wherein the clean room bag is further configured to receive the at least one assembled smart tank from the assembly room.

[0318] Embodiment 20. The clean room bag 8000, 9000 of any one of embodiments 18 or 19, wherein the clean room bag is a sterile bag, that is optionally a single-use bag.

[0319] Embodiment 21. The clean room bag 8000, 9000 of any one of embodiments 18 to 20, wherein the clean room bag is held by a support structure 8100, 9100, and/or wherein the clean room bag is inflatable.

[0320] Embodiment 22. The clean room bag 8000, 9000 of any one of embodiments 18 to 21, wherein the clean room bag 8000, 9000 comprises a multi-ply outer shell, wherein a first ply of the shell is the outermost ply, and wherein a second ply of the shell is the innermost ply, and wherein the space surrounded by the second ply of the shell is pressurized with a pressure being lower than a pressure provided between the first and the second ply of the shell, wherein a colored gas may be provided between the first and the second ply of the shell.

[0321] Embodiment 23. The clean room bag 8000, 9000 of any one of embodiments 18 to 22, wherein the clean room bag includes an sealable opening 8200 that is configured for receiving assembled smart tanks, wherein the sealable opening of the clean room bag is configured to open jointly with a corresponding sealable opening of an assembly room, when the clean room bag is sealingly coupled to the assembly room.

[0322] Embodiment 24. The clean room bag 8000, 9000 of embodiment 23, wherein the sealable opening 8200 of the clean room bag is covered by at least one cover element 8210, and wherein the at least one cover element is adapted to couple with a corresponding cover element of a corresponding sealable opening of an assembly room that is covered by the at least one corresponding cover element, to open jointly with the corresponding cover element.

[0323] Embodiment 25. The clean room bag 8000, 9000 of any one of embodiments 23 or 24, further comprising a sealing frame 8300, 9310, 9320, 9330, the sealing frame being configured to frame the sealable opening of the clean room bag, wherein the sealing frame may further comprise a UV-light source, the UV-light source is associated with the sealable opening of the clean room bag.

[0324] Embodiment 26. The clean room bag 8000, 9000 of any one of embodiments 18 to 25, wherein the clean room bag comprises at least one rail 9015, 9025, 9035, 9045 for guiding at least one received assembled smart tank within the clean room bag.

[0325] Embodiment 27. The clean room bag 8000, 9000 of any one of embodiments 18 to 26, wherein the clean room bag 8000, 9000 further comprises at least one height compensation means, that is adapted to be coupled to a received smart tank, and to adjust the height of the smart tank, so that an access plate element of the smart tank is installed at substantially the same height of a further smart tank received within the clean room bag.

[0326] Embodiment 28. The clean room bag 19500 of any one of embodiments 18 to 27, wherein the clean room bag is initially stored in a frame assembly 19100, the frame assembly comprising air-permeable wall elements 19110, 19120, 19130, 19140, 19150, and wherein the clean room bag comprises an air inlet port that serves for pressurizing the stored clean room bag for leakage testing.

[0327] Embodiment 30. A handling manipulator 13000 for automatically operating a smart tank 1, 2 in a bio-pharma process line in a system according to any one of embodiments 1 to 17,

[0328] the handling manipulator is adapted to be movably with respect to at least one smart tank so as to access and to control at least one smart via an access plate element.

[0329] Embodiment 31. The handling manipulator 13000 of embodiment 30, further comprising a manipulator head, wherein the manipulator head is adapted to couple with the access plate element and/or the adaptor plate element, and wherein the manipulator head comprises at least one of the following:

[0330] a cover element 14300, 16300, 17300d adapted to cover the adaptor plate at least partially, so that at least one access point of the adaptor plate is covered;

[0331] a UV-radiation means 14350, 16350, the UV radiation means being adapted to irradiate at least one access point of the adaptor plate and/or the access plate element;

[0332] a pump head 14360, 16360, for providing a negative pressure in an area of a covered access point of the adaptor plate,

[0333] a fluid line 17400a to 17400h, for supplying and/or removing fluid from the smart tank via an access point of the adaptor plate,

[0334] a gas line 17400a to 17400h, for supplying and/or removing gas from the smart tank, via an access point of the adaptor plate,

[0335] a valve actuating means 17800a to 17800c, for actuating a valve of the smart tank via an access point of the adaptor plate,

[0336] a driving means 17500 for driving an operating means of the smart tank via an access point of the adaptor plate,

[0337] a sensor for measuring operating conditions of the smart tank, such as a pressure sensor, and/or

[0338] a spectrography means 17900, wherein

[0339] the manipulator head may be an interchangeable manipulator head.

[0340] Embodiment 32. The handling manipulator 13000 of any one of embodiments 39 to 31, wherein the handling manipulator is adapted to weld the foil portion with the adaptor plate and/or the access plate and/or wherein the handling manipulator is adapted to weld and/or seal a hose portion of the smart tank.

[0341] Embodiment 33. A method 20000 for automatically operating at least one smart tank in a bio-pharma process line, the method comprising:

[0342] providing 20100 a system according to any one of embodiment 1 to 17,

[0343] receiving 20200 sensor signals from at least one sensor of the at least one smart tank;

[0344] controlling 20300 at least one handling manipulator based on the received sensor signals

[0345] operating 20400 the at least one smart tank according to a predetermined control scheme, using the handling manipulator.