ASSEMBLY SYSTEM FOR A SMART TANK FOR A BIO-PHARMA PROCESS

Abstract

The present invention relates to an assembly system for assembling a modular smart tank, a method for assembling a modular smart tank, a mobile storage means and an assembly bag. The assembly system comprises at least one mobile storage means for storing components of at least one smart tank, an assembly room, wherein the assembly room is adapted to provide clean room conditions and wherein the assembly room is configured to allow assembly of at least one smart tank within the assembly room from the components stored in the mobile storage means, and a manipulator, being adapted to automatically assemble the smart tank within the assembly room.

Claims

1. An assembly system (5000, 6000, 8000) for assembling a modular smart tank (1) for a bio-pharma process under clean room conditions, the system comprising: at least one mobile storage means (5300, 6300) for storing components of at least one smart tank (1), an assembly room (6200, 8200), wherein the assembly room is adapted to provide clean room conditions and wherein the assembly room is configured to allow assembly of at least one smart tank within the assembly room from the components stored in the mobile storage means, and a manipulator (5100, 8100), being adapted to automatically assemble the smart tank within the assembly room.

2. The system (5000, 6000, 8000) of claim 1, wherein the mobile storage means (7300) includes a sealable opening (7350) that is configured for allowing removal of components of the at least one smart tank from the mobile storage means, and wherein the assembly room (7200) comprises at least one corresponding sealable opening (7250) that is configured for receiving components from a mobile storage means, wherein the sealable opening of the mobile storage means and the corresponding sealable opening of the assembly room are configured to open jointly, when the assembly room is sealingly coupled to the mobile storage means, wherein optionally the sealable opening (7350) of the mobile storage means (7300) is covered by at least one cover element (7352, 7354), wherein the corresponding sealable opening (7250) of the assembly room (7200) is covered by at least one corresponding cover element (7252, 7254), and wherein the at least one cover element and the at least one corresponding cover element are configured to couple with each other to open jointly wherein further optionally the system further comprises a sealing frame (7600), the sealing frame being configured to frame the sealable opening of the mobile storage means and/or the corresponding sealable opening of the assembly room.

3. The system (5000, 6000, 8000) of claim 2, further comprising a UV-light source (7700), the UV-light source being preferably associated with the sealable opening of the mobile storage means and/or the corresponding sealable opening of the assembly room.

4. The system (5000, 6000, 8000) of claim 1, wherein the at least one manipulator (5100, 8100) is adapted to remove components from the mobile storage means and to assemble a smart tank within the assembly room from the removed components to form an assembled smart tank, wherein optionally the manipulator is further adapted to assemble at least one of the following, a filter, a valve and/or a sensor, to the assembled smart tank.

5. The system (5000, 6000, 8000) of claim 1, wherein the system includes components of at least one modular smart tank (1), the components include 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 can be assembled to form a reservoir (500) of the smart tank for receiving at least one biochemical medium, wherein at least one of the top plate element, the at least one sidewall element and/or the bottom plate element comprises at least one channel (20), for guiding the at least one biochemical medium and/or an operating medium.

6. The system (5000, 6000, 8000) of claim 1, further comprising at least one mobile delivery means (5900, 8900), such as an automated guided vehicle, the mobile delivery means being adapted to transport the at least one mobile storage means (5300) to the assembly room, and wherein optionally the at least one mobile delivery means is adapted to transport mobile storage means to the assembly room in a predefined order.

7. The system (5000, 6000, 8000) of claim 1, wherein the assembly room is an assembly bag, comprising flexible wall elements, the assembly bag being optionally a sterile bag, that is further optionally a single-use bag.

8. The system (5000, 6000, 8000) of claim 1, wherein the manipulator is provided outside the assembly room, and wherein optionally the manipulator is at least partially covered by a manipulator bag, further optionally the manipulator bag being integrally formed with the assembly bag.

9. The system (5000, 6000, 8000) of claim 1, wherein the mobile storage means (5300, 6300) comprises a tracking means, that allows geographical and/or local tracking of the mobile storage means, and/or, wherein the mobile storage means (5300, 6300) is adapted to allow sterilization of smart tank components being stored within the mobile storage means, wherein the mobile storage means (5300, 6300) optionally includes a transport bag, that is preferably a sterile bag, the transport bag houses the smart tank components being stored within the mobile storage means, wherein optionally the transport bag is an assembly bag (8200).

10. The system (5000, 6000, 8000) of claim 1, wherein the manipulator (5100, 8100) is adapted to disassemble smart tanks and optionally to remove assembled smart tanks from the clean room bag, and wherein the system optionally, further comprises at least one recycling means, adapted for receiving disassembled components of a smart tank and preferably for shredding said components, wherein the recycling means maybe adapted to sealingly couple to the assembly room, the recycling means optionally comprises at least one sealable opening that is configured for receiving disassembled components from the assembly room, wherein the sealable opening of the recycling means and the corresponding sealable opening of the assembly room are configured to open jointly, when the assembly room is sealingly coupled to the recycling means, and wherein the sealable opening of the recycling means is further optionally covered by at least one cover element, wherein the at least one cover element of the recycling means and the at least one corresponding cover element of the assembly room are configured to couple with each other to open jointly.

11. A method (10000) for assembling a modular smart tank for a bio-pharma process, the method comprising the following steps: providing (10100) at least one mobile storage means that stores components of at least one smart tank, providing (10200) an assembly room that is adapted to provide clean room conditions for assembling the modular smart tank, wherein the assembly room may be an assembly bag, providing (10300) a manipulator, and automatically assembling (10400) the smart tank within the assembly room from the components stored in the mobile storage means, using the manipulator, the method (10000) optionally, further comprising providing a clean room bag, coupling said clean room bag with the assembly room, interconnecting an assembled smart tank with a further assembled smart tank, and moving the interconnected smart tanks from the assembly room to the clean room bag.

12. A mobile storage means (5300, 6300) for being used in a system according to claim 1, the mobile storage means (5300, 6300, 7300) being adapted for storing components of at least one smart tank, further, the mobile storage means being adapted to sealingly couple to the assembly room (7200) of the system, the mobile storage means including: at least one sealable opening (7350) that is configured for allowing removal of components of the at least one smart tank from the mobile storage means, wherein the sealable opening (7350) of the mobile storage means is configured to open jointly with a corresponding sealable opening (7250) of an assembly room (7200) of the system, when the assembly room is sealingly coupled to the mobile storage means, the sealable opening (7350) of the mobile storage means being optionally covered by at least one cover element (7352, 7354), the at least one cover element of the sealable opening of the mobile storage means being configured to couple with a corresponding cover element (7252, 7254) of the corresponding sealable opening of the assembly room so that the sealable opening of the mobile storage means and the corresponding sealable opening of the assembly room open jointly.

13. The mobile storage means (5300, 6300) according to claim 12, wherein the mobile storage means (5300, 6300) comprises a tracking means, that allows geographical and/or local tracking of the mobile storage means, and/or, wherein the mobile storage means (5300, 6300) is adapted to allow sterilization of smart tank components being stored within the mobile mobile storage means (5300, 6300) optionally includes a transport bag, that is preferably a sterile bag, the transport bag houses the smart tank components being stored within the mobile storage means, wherein optionally the transport bag is an assembly bag (8200).

14. An assembly bag (6200, 7200, 8200), for an assembly system, the assembly bag is adapted to provide clean room conditions for assembling at least one smart tank from components stored in a mobile storage means, the assembly bag (7200) comprises at least one corresponding sealable opening (7250) that is configured for receiving components from a mobile storage means, wherein the corresponding sealable opening of the assembly bag is configured to open jointly with a sealable opening (7350) of a mobile storage means, when the assembly bag is sealingly coupled to the mobile storage means, the corresponding sealable opening (7250) of the assembly bag being optionally covered by at least one corresponding cover element (7252, 7254), the at least one corresponding cover element of the corresponding sealable opening of the assembly bag being configured to couple with a cover element of the sealable opening of the mobile storage means so that the sealable opening of the mobile storage means and the corresponding sealable opening of the assembly room open jointly.

15. The assembly bag (6200, 7200, 8200), according to claim 14, wherein the assembly bag optionally 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, and/or wherein the assembly bag is initially stored in a frame assembly (9100), the frame assembly comprising air-permeable wall elements (9110, 9120), and wherein the assembly bag comprises an air inlet port that serves for pressurizing the stored assembly bag for leakage testing.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0136] In the following, the accompanying figures, that schematically show embodiments of the invention are described. Here,

[0137] FIG. 1 schematically shows a smart tank assembly in a disassembled state;

[0138] FIG. 2 schematically shows a smart tank in an assembled state;

[0139] FIG. 3A schematically shows a smart tank system;

[0140] FIG. 3B schematically shows a further smart tank system;

[0141] FIG. 4 schematically shows smart tanks, having different volumes;

[0142] FIG. 5 schematically shows an assembly system;

[0143] FIG. 6 schematically shows an assembly system, comprising a clean room bag;

[0144] FIG. 7A schematically shows a sealable opening being coupled to a corresponding sealable opening in an open state;

[0145] FIG. 7B schematically shows a sealable opening being coupled to a corresponding sealable opening in a closed state;

[0146] FIG. 7C schematically shows a sealing frame;

[0147] FIG. 8A schematically shows a system, comprising a transport bag;

[0148] FIG. 8B schematically shows the system of FIG. 8A;

[0149] FIG. 9 schematically shows an assembly bag in an initial state;

[0150] FIG. 10 schematically shows a flow diagram of a method;

[0151] FIG. 11 schematically shows an adapter, and

[0152] FIG. 12 schematically shows a smart tank system wherein a further adapter is connected to three smart tanks

DETAILED DESCRIPTION OF THE FIGURES

[0153] In particular, FIG. 1 schematically shows a smart tank assembly 1′ in a disassembled state. The smart tank assembly 1′ is adapted to be assembled to a smart tank 1 (as e.g. shown in FIG. 2) using the system for assembling a smart tank. The smart tank assembly 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 assembly 1′ of FIG. 1 comprises three sidewall elements 200, 210, 220.

[0154] The top plate element 100, the sidewall elements 200, 210, 220 and the bottom plate element 300 can be assembled, using a manipulator of the system, to form a reservoir 500 for receiving at least one biochemical and/or operating medium. The manipulator of the system (cf. e.g. FIG. 5) may be adapted to assemble any other component of the smart tank, such as a valve, a filter, a sensor and/or the like.

[0155] 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 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.

[0156] The smart tank assembly 1′ 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.

[0157] 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.

[0158] FIG. 2 shows a smart tank 1 in an assembled state. This smart tank can e.g. be achieved by an assembly system (cf. FIG. 5) or a method for assembling a smart tank (cf. FIG. 12). This smart tank may server for storing and/or transporting a biochemical medium. 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.

[0159] 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.

[0160] 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.

[0161] Further, the top plate element, the at least one sidewall element and/or the bottom plate element may comprise at least one longitudinal rib. The at least one longitudinal rib may protrude into the reservoir. The heating or cooling channel may be at least partially received within the at least one longitudinal rib. Thus, the efficiency of heating or cooling may be increased.

[0162] The smart tank may comprise a heating or cooling finger that may be inserted into the smart tank through the top plate element, the at least one sidewall element, and/or the bottom plate element. The heating or cooling finger serves for guiding a tempered heating or cooling medium, for tempering the smart tank, wherein the heating or cooling medium guided by the heating or cooling finger is separated from the contents of the reservoir. Depending on the degree of heating/cooling, the medium received in the smart tank may evaporate or condensate. The heating or cooling finger may be assembled to the smart tank by means of the manipulator. Further, the heating or cooling finger may be stored in the mobile storage means. Particularly, the heating or cooling finger may be stored in the mobile storage means that stores the components of at least one smart tank.

[0163] In the smart tank shown in FIG. 2, 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.

[0164] 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.

[0165] 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.

[0166] 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.

[0167] 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 element of a smart tank may be identically structured. Thus, the number of different elements required for setting up a smart tank is reduced.

[0168] FIG. 3A schematically shows a smart tank system that comprises multiple smart tanks 1, 2, 3. The smart tanks are directly interconnected with each other. The interconnection of the smart tank may be performed, using the manipulator of the system for assembling a smart tank (cf. e.g. FIG. 5). For example, the manipulator may assemble a first smart tank and guide the same in a clean room bag (not shown). After having assembled the first smart tank, a further, second smart tank is assembled. The second smart tank is then interconnected with the previously assembled first smart tank. The first and second smart tank can then be guided further into the clean room bag. Repeating this, an entire process line can be assembled and guided into the clean room bag bay the manipulator.

[0169] 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 Soc. 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.

[0170] FIG. 3B 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 manipulator (not shown). The 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 fluid connection may be controlled by a valve. 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. Alternatively, medium can be transferred by providing a positive pressure to the smaller smart tank and/or by providing a negative pressure to the larger smart tank.

[0171] FIG. 4 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. 4, 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.

[0172] 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.

[0173] 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.

[0174] 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, preferably by the manipulator. 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 is facilitated.

[0175] FIG. 5 schematically shows an assembly system 5000 for assembling a modular smart tank for a bio-pharma process under clean room conditions. The system 5000 comprises at least one mobile storage means 5310, 5320, 5330, 5340 for storing components of at least one smart tank and an assembly room (5200). The assembly room 5200 is adapted to provide clean room conditions is configured to allow assembly of at least one smart tank within the assembly room from the components stored in the mobile storage means 5310, 5320, 5330, 5340. The system also comprises a manipulator 5100 that is adapted to automatically assemble the smart tank within the assembly room 5200. The manipulator 5100 may be provided with in the assembly room to assemble the smart tank(s) within the assembly room. Further, the manipulator 5100 may be separated from the clean room environment by a flexible membrane 5250 (e.g. a glove). Further, the assembly room may be adapted to sealingly couple to at least one mobile storage means 5310, 5320, 5330, 5340, preferably by sealable opening 5315. The sealable opening may be covered by cover elements 5312, 5314.

[0176] Further the system may comprise at least one mobile delivery means 5900, such as an automated guided vehicle. The mobile delivery means 5900 may be adapted to transport the at least one mobile storage means 5310, 5320, 5330, 5340 to the assembly room, preferably in a predefined order.

[0177] FIG. 6 schematically shows an assembly system 6000. The manipulator not shown, as it is provided inside the assembly room 6200, which may be an assembly bag. The assembly room 6200 provides clean room conditions for assembling smart tanks, from components being stored in mobile storage means 6310, 6320, 6330, 6340, 6350, 6360, 6370, 6380. The assembly room 6200 comprises at least three sealable openings 6210, 6250 for sealingly couple to at least one mobile storage means 6310 and 6250 and to a clean room bag 6500. The clean room bag serves for receiving assembled smart tanks from the assembly room 6200.

[0178] FIGS. 7A and 7B schematically shows a sealable opening being coupled to a corresponding sealable opening. FIG. 7A shows an open state, wherein FIG. 7B shows a closed state. The sealable opening 7350 may be part of a mobile storage means 7300, of a clean room bag or of a recycling means. The corresponding sealable opening is part of an assembly room 7200, preferably of an assembly bag. In the following the opening/closing is described with respect to an assembly room being sealingly coupled to a mobile storage means. The described principle can be likewise transferred to the sealable opening of a clean room bag and/or of a recycling means.

[0179] The sealable opening 7350 is configured for allowing removal of components of the at least one smart tank from the mobile storage means 7300. The assembly room 7200 comprises at least one corresponding sealable opening 7250 that is configured for receiving components from a mobile storage means 7300. The sealable opening 7350 of the mobile storage means 7300 and the corresponding sealable opening 7250 of the assembly room 7200 are configured to open jointly, when the assembly room 7200 is sealingly coupled to the mobile storage means 7300.

[0180] Further, the sealable opening 7350 of the mobile storage means 7300 may be covered by at least one cover element 7352, 7354, such as a door leaf of a sliding door. The corresponding sealable opening 7250 of the assembly room 7200 may be covered by at least one corresponding cover element 7252, 7254. The at least one cover element 7352, 7354 and the at least one corresponding cover element 7252, 7254 are configured to couple with each other to open jointly. The coupling can e.g. be achieved magnetically or by positive locking.

[0181] Further, a sealing frame 7600 may be provided. Here, sealing frame 7600 is integrally formed with the mobile storage means 7300. The sealing frame 7600 is configured to frame the sealable opening 7350 of the mobile storage means 7300 and the corresponding sealable opening 7250 of the assembly room 7200. When the openings 7350 and 7250 are closed, the space within the sealing frame 7600 may be evacuated. Further the space may be sterilized using UV-light source 7700. The UV-light source 7700 is associated with the sealable opening 7350 of the mobile storage means 7300. The cover element(s) 7352, 7354 may be connected with the mobile storage means 7300 via a flexible portion 7322, 7344, such as a sealing foil portion. The flexible portion 7322, 7344 may be connected to the cover element 7352, 7354 on a first side and to the mobile storage means 7300 on a second side. Likewise, a flexible portion may be connected to the corresponding cover element of on a first side and to the assembly room on a second side. Thus, the sealable opening 7350 can be opened/closed without providing a gap between the cover element 7352, 7354 and the mobile storage means 7300 and/or the corresponding cover element and the assembly room, respectively.

[0182] FIG. 7C schematically shows a sealing frame 7600′. The sealing frame 7600′ is a separate frame and is configured to frame the sealable opening 7350 of the mobile storage means 7300 and/or the corresponding sealable opening 7250 of the assembly room 7200. The sealing frame 7600′ may comprise a UV-light source 7700. The UV-light source may be adapted to destroy contaminants on the outer surface of the sealable openings prior to and/or during opening the sealable openings. Thus, the framed space may be sterilized. The sealing frame 7600′ may further comprise a port that allows evacuating a space between the sealing frame and the closed sealable openings of the mobile storage means and/or the assembly room prior to opening the sealable openings. Thus, the risk of contamination can be further reduced. The sealing frame may frame the sealable opening 7350 of the mobile storage means 7300 and/or the corresponding sealable opening 7250 of the assembly room 7200 sealingly, after the at least one cover element 7352, 7354 and the at least one corresponding cover element 7252, 7254 are coupled.

[0183] Further, the sealing frame may comprise a flexible frame portion. This allows to sealingly frame the sealable opening 7350 of the mobile storage means 7300 and/or the corresponding sealable opening 7250 of the assembly room 7200 prior to coupling the at least one cover element 7352, 7354 and the at least one corresponding cover element 7252, 7254. Accordingly, the sealing frame 7600′ may be able to UV irradiate outer surfaces of the at least one cover element 7352, 7354 and the at least one corresponding cover element 7252, 7254 and/or to remove particles and contaminants by evacuating, prior to coupling the coupling the at least one cover element 7352, 7354 and the at least one corresponding cover element 7252, 7254. Likewise, the integrally formed frame that is described with respect to FIGS. 7A and 7B may comprise a respective flexible frame portion. FIG. 8A and FIG. 8B show an assembly system 8000 for assembling a modular smart tank for a bio-pharma process under clean room conditions. The system 8000 comprises at least one mobile storage means (not shown) for storing components of at least one smart tank and an assembly bag 8200. The assembly bag 8200 is adapted to provide clean room conditions and is configured to allow assembly of at least one smart tank within the assembly bag from the components stored in the mobile storage means. The mobile storage means includes a transport bag, that may be a sterile bag. The transport bag houses the smart tank components being stored within the mobile storage means, wherein in the system shown in FIGS. 8A and 8B, the transport bag is the assembly bag 8200. The transport bag provides a secondary packaging for the components stored in the mobile storage means. Alternatively, the transport bag may be the mobile storage means.

[0184] The system also comprises a manipulator 8100 that is adapted to automatically assemble the smart tank 1 within the assembly bag. The manipulator 8100 is provided outside the assembly bag 8200, wherein the manipulator 8100 is at least partially covered by a manipulator bag that is integrally formed with the assembly bag 8200. For assembling the smart tank 1, the transport bag is removed from a mobile storage means and put over the manipulator 8100, using a mobile delivery means 8900. The transport bag includes components (smart tank assembly 1′) for at least one smart tank that can be assembled using the manipulator 8100. During assembly, the mobile delivery means 8900 may hold the transport/assembly bag, as shown in FIG. 8A

[0185] FIG. 9 shows an assembly bag 9200 in an initial state, being stored in a frame assembly 9000. The frame assembly 9100 comprise air-permeable wall elements 9110, 9120, 9130, 9140, 9150. The air-permeable wall elements 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. The assembly bag comprises an air inlet port (not shown) that serves for pressurizing the stored assembly bag 9200 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 assembly bag can be pressurized while being stored in the frame assembly 9000 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 assembly bag 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.

[0186] FIG. 10 shows a flow diagram of a method 10000 for assembling a modular smart tank for a bio-pharma process. The method 10000 comprises the following steps: Providing 10100 at least one mobile storage means that stores components of at least one smart tank. Providing 10200 an assembly room that is adapted to provide clean room conditions for assembling the modular smart tank, wherein the assembly room may be an assembly bag. Providing 10300 a manipulator. Automatically assembling 10400 the smart tank within the assembly room from the components stored in the mobile storage means, using the manipulator.

[0187] FIG. 11 schematically shows an adapter 3000 which may interconnect at least two smart tanks (as e.g. shown in FIG. 12). 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. The adapter 3000 may be assembled to the smart tank(s) using the manipulator.

[0188] Further, the depicted adapter 3000 comprises a fluidic module 3030. In the embodiment depicted in FIG. 11, 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.

[0189] Further, the at least one fluidic module 3030 may be replaceable. 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. The at least one fluidic module may be replaced by means of the manipulator.

[0190] Moreover, as illustrated in FIG. 11, 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. 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.

[0191] The adapter 3000 shown in FIG. 11 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. The adapter units may be assembled by means of the manipulator. Further, the adapter units may be stored in the mobile storage means. Particularly, the adapter units may be stored in the mobile storage means that stores the components of at least one smart tank.

[0192] 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.

[0193] FIG. 12 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. 12, the two fluidic modules 3020a, 3020b are filters, each comprising a capsules 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. In FIG. 12, 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.

[0194] Moreover, assembly, operation, fluidic connection and/or disassembly of the adapter with at least one smart tank may be performed by means of the 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 by means of the manipulator.

Further Embodiments

[0195] Embodiment 1. An assembly system 5000, 6000, 8000 for assembling a modular smart tank 1 for a bio-pharma process under clean room conditions, the system comprising: [0196] at least one mobile storage means 5300, 6300 for storing components of at least one smart tank 1, [0197] an assembly room 6200, 8200, wherein the assembly room is adapted to provide clean room conditions and wherein the assembly room is configured to allow assembly of at least one smart tank within the assembly room from the components stored in the mobile storage means, and [0198] a manipulator 5100, 8100, being adapted to automatically assemble the smart tank within the assembly room.

[0199] Embodiment 2. The system 5000, 6000, 8000 of embodiment 1, wherein the assembly room is adapted to sealingly couple to at least one mobile storage means.

[0200] Embodiment 3. The system 5000, 6000, 8000 of any preceding embodiment, wherein the mobile storage means 7300 includes a sealable opening 7350 that is configured for allowing removal of components of the at least one smart tank from the mobile storage means, and wherein [0201] the assembly room 7200 comprises at least one corresponding sealable opening 7250 that is configured for receiving components from a mobile storage means, wherein [0202] the sealable opening of the mobile storage means and the corresponding sealable opening of the assembly room are configured to open jointly, when the assembly room is sealingly coupled to the mobile storage means.

[0203] Embodiment 4. The system 5000, 6000, 8000 of embodiment 3, wherein the sealable opening 7350 of the mobile storage means 7300 is covered by at least one cover element 7352, 7354, wherein [0204] the corresponding sealable opening 7250 of the assembly room 7200 is covered by at least one corresponding cover element 7252, 7254, and wherein [0205] the at least one cover element and the at least one corresponding cover element are configured to couple with each other to open jointly.

[0206] Embodiment 5. The system 5000, 6000, 8000 of any one of embodiments 3 or 4, further comprising a sealing frame 7600, the sealing frame being configured to frame the sealable opening of the mobile storage means and/or the corresponding sealable opening of the assembly room.

[0207] Embodiment 6. The system 5000, 6000, 8000 of any one of embodiments 3 to 5, further comprising a UV-light source 7700, the UV-light source being preferably associated with the sealable opening of the mobile storage means and/or the corresponding sealable opening of the assembly room.

[0208] Embodiment 7. The system 5000, 6000, 8000 of any preceding embodiment, wherein the at least one manipulator 5100, 8100 is adapted to remove components from the mobile storage means and to assemble a smart tank within the assembly room from the removed components to form an assembled smart tank, wherein optionally the manipulator is further adapted to assemble at least one of the following, a filter, a valve and/or a sensor, to the assembled smart tank.

[0209] Embodiment 8. The system 5000, 6000, 8000 of any preceding embodiment, wherein the system includes components of at least one modular smart tank 1, the components include [0210] a top plate element 100, at least one sidewall element 200, and a bottom plate element 300, wherein [0211] the top plate element, the at least one sidewall element and the bottom plate element can be assembled to form a reservoir 500 of the smart tank for receiving at least one biochemical medium, wherein at least one of the top plate element, the at least one sidewall element and/or the bottom plate element comprises at least one channel 20, for guiding the at least one biochemical medium and/or an operating medium.

[0212] Embodiment 9. The system 5000, 6000, 8000 of any one of embodiment 8, wherein the assembled smart tank comprises at least one connector means for interconnecting the assembled smart tank with a further smart tank, wherein the connector means may provide a fluidical connection, and wherein the at least one manipulator is adapted to interconnect an assembled smart tank with at least one further assembled smart tank.

[0213] Embodiment 10. The system 5000, 6000, 8000 of any preceding embodiment, further comprising at least one mobile delivery means 5900, 8900, such as an automated guided vehicle, the mobile delivery means being adapted to transport the at least one mobile storage means 5300 to the assembly room, and wherein optionally the at least one mobile delivery means is adapted to transport mobile storage means to the assembly room in a predefined order.

[0214] Embodiment 11. The system 5000, 6000, 8000 of any preceding embodiment, wherein the assembly room is an assembly bag, comprising flexible wall elements, the assembly bag being optionally a sterile bag, that is further optionally a single-use bag.

[0215] Embodiment 12. The system 5000, 6000, 8000 of any preceding embodiment, wherein the manipulator is provided within the assembly room, and wherein the manipulator is optionally at least partially covered by a manipulator bag.

[0216] Embodiment 13. The system 5000, 6000, 8000 of any one of embodiments 1 to 12, wherein the manipulator is provided outside the assembly room, and wherein optionally the manipulator is at least partially covered by a manipulator bag, further optionally the manipulator bag being integrally formed with the assembly bag.

[0217] Embodiment 14. The system 5000, 6000, 8000 of any preceding embodiment, the system further comprising at least one clean room bag 6500, wherein the clean room bag is configured to receive at least one assembled smart tank 1 from the assembly room 6200, and optionally, the clean room bag is configured to receive multiple interconnected smart tanks from the assembly bag, wherein the at least one clean room bag is adapted to sealingly couple to the assembly room.

[0218] Embodiment 15. The system 5000, 6000, 8000 of embodiment 14, wherein the clean room bag 6500 is a sterile bag and optionally a single-use bag.

[0219] Embodiment 16. The system 5000, 6000, 8000 of any one of embodiments 11 to 15, wherein the assembly bag 6200 and/or the clean room bag 6500 is held by a support structure, and/or wherein the assembly bag and/or the clean room bag can be inflated.

[0220] Embodiment 17. The system 5000, 6000, 8000 of any one of embodiments 14 to 16, further comprising an adaptor plate element, the adaptor plate element is adapted to be arranged outside the clean room bag and to be coupled to an assembled smart tank, to cover a port of the smart tank and/or a filter at least partially, so as to give access to the smart tank from the outside of the clean room bag.

[0221] Embodiment 18. The system 5000, 6000, 8000 of any one of embodiments 14 to 17, wherein the clean room bag 6500 comprises at least one rail for guiding the at least one received assembled smart tank within the clean room bag.

[0222] Embodiment 19. The system 5000, 6000, 8000 of any preceding embodiment, wherein the mobile storage means 5300, 6300 comprises a tracking means, that allows geographical and/or local tracking of the mobile storage means.

[0223] Embodiment 20. The system 5000, 6000, 8000 of any preceding embodiment, wherein the mobile storage means 5300, 6300 is adapted to allow sterilization of smart tank components being stored within the mobile storage means.

[0224] Embodiment 21. The system 5000, 6000, 8000 of any preceding embodiment, wherein the mobile storage means 5300, 6300 is adapted to maintain the sterilized state of smart tank components being stored within the mobile storage means.

[0225] Embodiment 22. The system 5000, 6000, 8000 of any preceding embodiment, wherein the mobile storage means 5300, 6300 includes [0226] a sterile indicator, the sterile indicator being adapted to indicate whether the components stored in the mobile storage means were sterilized within the mobile storage means, and/or the mobile storage means including [0227] a port for receiving sterilized air allowing to perform sterile leakage testing of the mobile storage means.

[0228] Embodiment 23. The system 5000, 6000, 8000 of any preceding embodiment, wherein the mobile storage means 5300, 6300 includes [0229] a transport bag, that is preferably a sterile bag, the transport bag houses the smart tank components being stored within the mobile storage means, wherein optionally the transport bag is an assembly bag 8200.

[0230] Embodiment 24. The system 5000, 6000, 8000 of any preceding embodiment, wherein the mobile storage means 5300, 6300 includes at least one locking element, that is adapted to lock the mobile storage means during sterilization and/or transportation.

[0231] Embodiment 25. The system 5000, 6000, 8000 of any preceding embodiment, wherein the manipulator 5100, 8100 is adapted to disassemble smart tanks and optionally to remove assembled smart tanks from the clean room bag.

[0232] Embodiment 26. The system 5000, 6000, 8000 of any preceding embodiment, further comprising at least one recycling means, adapted for receiving disassembled components of a smart tank and preferably for shredding said components, wherein the recycling means may be adapted to sealingly couple to the assembly room, the recycling means optionally comprises [0233] at least one sealable opening that is configured for receiving disassembled components from the assembly room, wherein [0234] the sealable opening of the recycling means and the corresponding sealable opening of the assembly room are configured to open jointly, when the assembly room is sealingly coupled to the recycling means, and wherein the [0235] sealable opening of the recycling means is further optionally covered by at least one cover element, wherein [0236] the at least one cover element of the recycling means and the at least one corresponding cover element of the assembly room are configured to couple with each other to open jointly.

[0237] Embodiment 27. A method 10000 for assembling a modular smart tank for a bio-pharma process, the method comprising the following steps: [0238] providing 10100 at least one mobile storage means that stores components of at least one smart tank, [0239] providing 10200 an assembly room that is adapted to provide clean room conditions for assembling the modular smart tank, wherein the assembly room may be an assembly bag, [0240] providing 10300 a manipulator, and [0241] automatically assembling 10400 the smart tank within the assembly room from the components stored in the mobile storage means, using the manipulator.

[0242] Embodiment 28. The method 10000 of embodiment 27, further comprising [0243] providing a clean room bag, [0244] coupling said clean room bag with the assembly room, interconnecting an assembled smart tank with a further assembled smart tank, and [0245] moving the interconnected smart tanks from the assembly room to the clean room bag.

[0246] Embodiment 29. A mobile storage means 5300, 6300 for being used in a system according to any one of embodiments 1 to 26, the mobile storage means 5300, 6300, 7300 being adapted for storing components of at least one smart tank, further, the mobile storage means being adapted to sealingly couple to the assembly room 7200 of the system, the mobile storage means including: [0247] at least one sealable opening 7350 that is configured for allowing removal of components of the at least one smart tank from the mobile storage means, wherein the sealable opening 7350 of the mobile storage means is configured to open jointly with a corresponding sealable opening 7250 of an assembly room 7200 of the system, when the assembly room is sealingly coupled to the mobile storage means, [0248] the sealable opening 7350 of the mobile storage means being optionally covered by at least one cover element 7352, 7354, the at least one cover element of the sealable opening of the mobile storage means being configured to couple with a corresponding cover element 7252, 7254 of the corresponding sealable opening of the assembly room so that the sealable opening of the mobile storage means and the corresponding sealable opening of the assembly room open jointly.

[0249] Embodiment 30. The mobile storage means 5300, 6300 according to embodiment 30, being adapted as specified in any one of embodiments 19 to 24.

[0250] Embodiment 31. An assembly bag 6200, 7200, 8200, for being used in a system according to any one of embodiments 11 to 26, the assembly bag is adapted to provide clean room conditions for assembling at least one smart tank from components stored in a mobile storage means, [0251] the assembly bag 7200 comprises at least one corresponding sealable opening 7250 that is configured for receiving components from a mobile storage means, wherein the corresponding sealable opening of the assembly bag is configured to open jointly with a sealable opening 7350 of a mobile storage means, when the assembly bag is sealingly coupled to the mobile storage means, [0252] the corresponding sealable opening 7250 of the assembly bag being optionally covered by at least one corresponding cover element 7252, 7254, the at least one corresponding cover element of the corresponding sealable opening of the assembly bag being configured to couple with a cover element of the sealable opening of the mobile storage means so that the sealable opening of the mobile storage means and the corresponding sealable opening of the assembly room open jointly.

[0253] Embodiment 32. The assembly bag 6200, 7200, 8200, according to embodiment 31, being adapted as specified in any one of embodiments 11 or 16.

[0254] Embodiment 33. The assembly bag 6200, 7200, 8200 of any one of embodiments 31 or 32, wherein the assembly bag 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.

[0255] Embodiment 34. The assembly bag 6200, 7200, 8200 of any one of embodiments 31 to 33, wherein the assembly bag is initially stored in a frame assembly 9100, the frame assembly comprising air-permeable wall elements 9110, 9120, and wherein the assembly bag comprises an air inlet port that serves for pressurizing the stored assembly bag for leakage testing.