Multi-directional tilting mechanism and method for operating a multi-directional tilting mechanism

Abstract

The tilting mechanism comprises a base, a tilting deck, four hinges, and a lifting member. Each hinge is positioned adjacent to a corner of the base and the tilting deck. Each hinge includes a socket and a receiver, with one of the socket or the receiver fixed to the base frame or the deck frame, and the other fixed to the other of the base or the tilting deck. Each hinge includes a locking member that selectively fixes the socket within its respective receiver. The lifting member is fixed to the center of the base frame and the center of the deck frame. The lifting member is configured to move the tilting deck away from the base such that the tilting deck can tilt relative to the base in at least four directions by selective engagement.

Description

Technical Field

[0001] The present disclosure relates to fluid handling, and more specifically, to a multi-directional tilting mechanism for filling and draining containers.

Background Art

[0002] During the manufacture, storage, and distribution of biopharmaceutical compositions, containers are filled with and emptied of the biopharmaceutical composition in a liquid state. For example, the biopharmaceutical composition is pumped from a production vessel into one or more storage containers. In the filled state, the storage containers can be frozen, stored, and / or shipped to another facility. Before use, the biopharmaceutical composition in the storage container is thawed and / or emptied from the storage container.

[0003] In some applications, containers, such as Celsiust (registered) FFT containers from Sartorius AG, are loaded into a filling and discharge station (FDS) used for filling and draining the containers. In the FDS, the containers are held horizontally. Horizontally, not all of the biopharmaceutical composition can be drained from the container. In addition, with the container drained, the piping from the container to the filling and discharge station may contain additional biopharmaceutical composition. In addition, horizontally, it may be difficult to purge air from the piping leading to the container and / or the container itself before filling the container.

Summary of the Invention

Problems to be Solved by the Invention

[0004] It has been found that tilting the container during filling and / or discharging can enable more complete filling of the biopharmaceutical composition into the container or discharging from the container. As shown in FIG. 1, the currently available tilting mechanism 910 may be tiltable in two directions, for example, to the left and right. The tilting mechanism 910 includes a base 915 that supports a tilting platform 920 and a linear actuator 930. The linear actuator 930 is operably coupled to the tilting platform 920 by a linkage 940 to actuate the tilting platform 920 to the right or left. During testing, it has been found that the tilting mechanism 910 is complex and prone to early failure. In addition to this, the tilting mechanism 910 is limited to tilting the platform 920 to the right or left. Further, the components of the tilting mechanism 910, particularly the linear actuator 930, may be prohibitively expensive. In some applications, the tilting mechanism 910 with the FDS fixed thereto may have a height that prevents the tilting mechanism 910 and the FDS from passing through conventional entrances and exits.

Means for Solving the Problem

[0005] The present disclosure generally relates to a tilting mechanism that can tilt the metering station / platform of the FDS in multiple directions. The disclosed tilting mechanism can have a simplified configuration compared to previous solutions, such as the tilting mechanism 910. In addition to this, the disclosed tilting mechanism can have a reduced cost compared to the tilting mechanism 910. In some embodiments, the tilting mechanism can enable tilting of the FDS in four directions, for example, forward, backward, the first or right side direction, and the second or left side direction. In a particular embodiment, the tilting mechanism can enable an eight-direction tilt including directions between each of forward, backward, the first side direction, and the second side direction. The disclosed tilting mechanism can have a reduced height compared to prior art tilting mechanisms, such as the tilting mechanism 910, such that the disclosed tilting mechanism with the FDS supported thereon can fit through standard entrances and exits.

[0006] In use, the disclosed tilting mechanism can be used to prime the filling line with the biopharmaceutical composition before filling the container, or to drain the container filled with the biopharmaceutical composition. Priming the air from the filling line can prevent air from entering the container so that the entire container is filled with the biopharmaceutical composition. In some embodiments, it may be beneficial to tilt the container at an angle in the range of 5 degrees to 45 degrees. The disclosed tilting mechanism can enable tilting in multiple directions during filling and draining by actuating a single lifting element to move the tilting deck away from the fixed base based on the state of a plurality of hinges that selectively fix the tilting deck to the fixed base.

[0007] In an embodiment of the present disclosure, the tilting mechanism includes a base, a tilting deck, four multi-dimensional hinges, and a lifting member. The base includes a rectangular base frame, and the tilting deck includes a rectangular deck frame. The hinges are positioned such that one hinge is adjacent to each corner of the base frame and the deck frame. Each frame includes a globe and a receiver, where the globe or the receiver is fixed to the base frame or the deck frame, and the other of the globe or the receiver is fixed to the other of the base frame or the deck frame. Each hinge includes a locking member, and the hinge is adapted to have a captured state in which the locking member fixes the globe within each respective receiver and a released state in which the locking member allows the globe to enter and exit each respective receiver. The lifting member is fixed to the center of the base frame and the center of the deck frame. The lifting member is configured to move the deck frame away from the base frame such that the deck frame can tilt relative to the base frame in at least four directions by selective engagement of the hinges.

[0008] In an embodiment, the tilt deck can be configured to support a weighing platform configured to determine the amount of fluid disposed within one or more containers disposed on the weighing platform. The lifting member can be a lifting bag that expands in response to receiving fluid therein. The lifting bag can be an airbag that expands in response to receiving gas therein. The lifting bag can be in fluid communication with a pump. The pump can supply fluid to inflate the bag.

[0009] In some embodiments, the tilt deck can have a neutral point when the lifting member is in a non-expanded position where each glove is disposed in one of the respective receivers.

[0010] In certain embodiments, the tilt deck can have a first tilt position where a first hinge and a fourth hinge of four hinges are in a captured state and a second hinge and a third hinge of the four hinges are in a released state, whereby the tilt deck is tilted about a first tilt axis defined through the first hinge and the fourth hinge in response to expansion of the lifting member. In the first tilt position, the tilt deck can be rotated about the first tilt axis at an angle in the range of 5 degrees to 45 degrees. The tilt deck can have a second tilt position where the first hinge and the fourth hinge are in a released state and the second hinge and the third hinge are in a captured state, whereby the tilt deck is tilted about a second tilt axis defined through the second hinge and the third hinge in response to expansion of the lifting member. The tilt deck can have a third tilt position where the first hinge and the second hinge are in a captured state and the third hinge and the fourth hinge are in a released state, whereby the tilt deck is tilted about a third tilt axis defined through the first hinge and the second hinge in response to expansion of the lifting member.

[0011] In certain embodiments, the locking member can be a fork that is linearly slidable to enter and exit the receiver to move the hinge between a captured state and a released state. The fork can be linearly actuated by a linear actuator, a solenoid, or a pneumatic actuator. The hinge can include a biasing member that biases the fork to enter and exit the receiver.

[0012] In another embodiment of the present disclosure, the filling and draining system includes a platform, a valve tower, and a tilting mechanism. The platform is configured to support at least one container to be filled or drained. The valve tower is configured to distribute fluid to each of the at least one container. The tilting mechanism can be any of the tilting mechanisms detailed herein. The tilting mechanism supports the platform on its tilting deck.

[0013] In another embodiment of the present disclosure, the multi-dimensional hinge includes a glove, a receiver, and a locking member. The receiver is configured to selectively receive the glove. The locking member is linearly translatable between a mounting position where the glove is fixed within the receiver and a release position that allows the glove to enter and exit the receiver. The receiver is movable relative to the glove with at least two degrees of freedom when the glove is fixed within the receiver. The locking member can be a fork having two tongs that are linearly translatable to enter and exit the respective receivers to fix the glove within the respective receivers. The hinge can include a biasing member configured to bias the locking member toward a captured position or a released position.

[0014] In another embodiment of the present disclosure, the tilting mechanism includes a base, a tilting deck, and a lifting member. The base has a base frame, and the tilting deck has a deck frame. The lifting member is fixed to the center of the base frame and the center of the deck frame. The lifting member is configured to move the tilting deck away from the base deck such that the tilting deck is tiltable relative to the base in at least four directions.

[0015] In an embodiment, the lifting member is an expandable bag disposed between the base frame and the deck frame. The tilting mechanism can include multi-dimensional hinges disposed at each corner of the base frame and the deck frame. Each multi-dimensional hinge has a glove fixed to one of the base frame or the deck frame and a receiver fixed to the other of the base frame and the deck frame. The receiver can be configured to selectively secure each glove therein.

[0016] In another embodiment of the present disclosure, a method of operating a tilting mechanism to fill or drain a fluid container supported on the tilting mechanism includes tilting a deck frame supporting the container in a first direction by placing a first hinge and a second hinge in a captured state and a third hinge and a fourth hinge in a released state and operating a lifting mechanism to move the deck frame away from the base frame. The method also includes tilting the deck frame in a second direction opposite the first direction by placing the first hinge and the second hinge in a released state and the third hinge and the fourth hinge in a captured state and operating the lifting mechanism to move the deck frame away from the base frame.

[0017] In an embodiment, the method can include tilting the deck frame in a third direction different from the first and second directions by placing the first hinge and the third hinge in a captured state and the second hinge and the fourth hinge in a released state and operating the lifting mechanism to move the deck frame away from the base frame.

[0018] In some embodiments, the step of operating the lifting mechanism includes supplying fluid into the lifting bag such that the lifting bag expands to move the deck frame away from the base frame. The step of tilting the deck frame in the first direction can include rotating the deck frame about a first axis defined through the first hinge and the second hinge. The step of tilting the deck frame in the second direction can include rotating the deck frame about a second axis defined through the third hinge and the fourth hinge.

[0019] In certain embodiments, placing one of the first, second, third, or fourth hinges in a captured state includes operating a locking mechanism to secure the glove within the receiver such that the hinge is rotatable about the glove with two degrees of freedom. The step of operating the locking mechanism can include translating the fork into the receiver such that the two tines of the fork are disposed about the neck of the glove to prevent the glove from being pulled out of the receiver.

[0020] In certain embodiments, placing one of the first, second, third, or fourth hinges in a released state includes operating the locking mechanism to enable the glove to exit the receiver. The step of operating the locking mechanism to enable the glove to exit the receiver can include translating the fork such that the tines of the fork are disposed substantially outside of the receiver to enable the glove to slip out of the receiver.

[0021] Furthermore, to the extent not inconsistent, any of the embodiments or aspects described herein can be used in combination with any or all of the other embodiments or aspects described herein.

[0022] Various aspects of the present disclosure are described below with reference to the drawings incorporated herein and forming a part hereof.

Brief Description of the Drawings

[0023]

Figure 1

Figure 2

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Figure 3B

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DETAILED DESCRIPTION OF THE INVENTION

[0024] The present disclosure will be described in more detail below with reference to the drawings in which like reference numerals refer to the same or corresponding elements in each of several figures, by way of example embodiments. These example embodiments are described such that the present disclosure will be thorough and complete and will fully convey the scope of the present disclosure to those skilled in the art. Features from one embodiment or aspect can be combined with features from any other embodiment or aspect in any suitable combination. For example, any individual or collective features of a method aspect or embodiment can be applied to an apparatus, product, or component aspect or embodiment, and vice versa. The present disclosure can be embodied in many different forms and should not be construed as limited to the embodiments recited herein; rather, these embodiments are provided so that this disclosure will meet the applicable legal requirements. When used in this specification and the appended claims, singular forms such as "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. In addition, although quantitative measures, values, or geometric relationships etc. may be referred to herein, unless otherwise specified, all or any one or more of these can be absolute values or approximations to account for possible variations such as those due to manufacturing tolerances or engineering tolerances etc. Further, as used herein, the term "biopharmaceutical composition" refers to a product derived from a product intended for use in the medical field including, without any limitation, biotechnology, culture environments, cell cultures, buffer solutions, artificial nutrient solutions, blood products and derivatives of blood products, pharmaceuticals, or more generally, monoclonal antibodies (mAbs), therapeutic proteins, viruses, lipid nanoparticles, vaccines, virus banks, exosomes, cell banks, and cell therapy products.

[0025] Referring now to FIG. 2, a schematic diagram of a filling system 800 is provided in accordance with an embodiment of the present disclosure. The filling system 800 includes a supply vessel 810, a supply pump 820, and a filling and draining station (FDS) 830. The supply vessel 810 contains a biopharmaceutical composition that is to be dispensed into one or more containers secured at the FDS 830. The supply vessel 810 is in fluid communication with the FDS 830 through pipes 812, 822 that pass through the supply pump 820. The filling system 800 can include a sterilizing filter, a buffer supply, and a buffer waste.

[0026] The FDS 830 includes a platform 840 that receives a pallet or structure containing one or more containers 850 to be filled or drained. The platform 840 can be a weighing platform that measures the weight of the biopharmaceutical composition within the container 850. The platform 840 can be a pallet with a plurality of containers 850 supported above a base. As shown, the pallet is a Euro-sized pallet that supports four 75-liter containers 850 for a total of 300 liters of biopharmaceutical composition to be filled into and / or drained from the containers 850. In use, the pallet can be loaded onto and / or unloaded from the platform with a machine such as a forklift. In some embodiments, the pallet can have a capacity to support ten containers 850 each having a volume of 12, 6, 4, or 2 liters. Each of the pallets can have a capacity to support from 1 to 10 containers having a volume from 2L to 75L. In some embodiments, the pallet can support a capacity greater than 300L and / or more than 10 containers.

[0027] The FDS830 includes at least one distribution column or valve tower 832 on one side of the FDS830 that receives the biopharmaceutical composition from the pump 820. In certain embodiments, a single valve tower 832 is used for the FDS830 when, for example, large containers 850 are employed. In some embodiments, the FDS830 can include valve towers 832 on each side of the FDS830. Each valve tower 832 can include valves 834 for each container 850 on the platform 840 to fluidly connect the container 850 to the pump 820 through piping 836. When each valve tower 832 is used, for example, when small containers 850 are supported on the platform 840, the valves 834 of the first valve tower 832 can fluidly connect the first container 850 to the pump 820, and the other valves 834 of the second valve tower 832 can fluidly connect the second container 850 to the pump 820. As shown, the valves 834 for each container 850 can be positioned slightly above each respective container 850 so as to assist the flow of fluid into the container 850 by gravity. In some embodiments, the platform 840 can be tilted so as to position each valve 834 above each respective container 850 to assist, for example, in priming the fill tube 836 or to assist when gas flows out of the tube towards, for example, a bubble trap or air purge bag 838. In embodiments having valve towers 832 on each side of the FDS830, the platform 840 can be tilted in a first direction to prime the fill tube 836 by positioning the valves 834 of the first valve tower 832 above each respective container 850 and tilted in a second direction to prime the fill tube 836 by positioning the valves 834 of the second valve tower 832 above each respective container 850.

[0028] The valve tower 832 can include an air purge bag 838 configured to receive gas from the FDS 830 and / or the filling tube 836. The gas can flow from the pipes 812, 822 connecting the supply appliance 810 and the FDS 830, and / or from the filling tube 836. In some embodiments, the filling tube 836 is connected by a valve 834 having an inclined T-connection such that the filling tube 836 has an angle of less than 90 degrees below the connection and an angle greater than 90 degrees above the connection. In some embodiments, the inclined T-connection is inclined in the range of 10 degrees to 45 degrees, for example, 15 degrees. The inclined T-connection can assist the gas to flow towards the air purge bag 838.

[0029] Referring to FIGS. 3A and 3B, a schematic diagram of an exhaust system 801 according to an embodiment of the present disclosure is shown. The elements of the exhaust system 801 can be similar to those of the filling system 800 and can be represented by the same labels, and only the differences will be detailed herein for simplicity. The exhaust system 801 includes an FDS 830, a container 850, a pump 820, and a product appliance 870.

[0030] In the exhaust configuration, the FDS 830 includes a valve tower 832 having valves 834. The valves 834 are in fluid communication with the respective containers 850 through pipes 836. The valves 834 for the respective containers 850 can be positioned slightly below the respective containers 850 so as to assist the flow of fluid from the containers 850 by gravity. The valve tower 832 can include a purge bag 838 that captures gas from the valve tower 832, the pipe 837, and / or the container 850. Similar to the filling process detailed above, the platform 840 can be tilted in a first direction to position the valves 834 of the first valve tower 832 below the respective containers 850 and in a second direction to position the valves 834 of the second valve tower 832 below the respective containers 850, as shown in FIG. 3B.

[0031] Pump 820 is in fluid communication with FDS 830 and product implement 870 via piping 822. The piping 822 can include a sample container that enables sampling of the biopharmaceutical composition that is periodically dispensed during the discharge operation. The pump 820 can pump the biopharmaceutical composition from container 850 to product implement 870.

[0032] In some embodiments, the product implement 870 can be replaced with a dispensing system that includes a plurality of product implements or containers connected to one or more dispensing hubs. Non-limiting examples of dispensing systems are described in U.S. Patent No. 11,319,201 and U.S. Patent Application Publication Nos. 2021 / 0024338, 2021 / 0188615, and 2021 / 0395071, the entire contents of each of these patents and documents being hereby incorporated by reference.

[0033] Referring to FIGS. 4 to 6, an inclination mechanism 100 according to the present disclosure is provided. The inclination mechanism 100 can support the entire FDS 830 or the platform 840 of the FDS 830. The inclination mechanism 100 includes a fixed base 110 and an inclined deck 140. In some embodiments, the fixed base 110 can support the valve tower 832 of the FDS 830, and the inclined deck 140 can support the platform 840 of the FDS 830. In some embodiments, the fixed base 110 is supported by one or more legs including sensors, and the legs determine the weight supported such that the fixed base 110 is a weighing platform. For example, the fixed base 110 can.

[0034] The fixed base 110 includes a base frame 112, which can be fixed in a stationary position or can include wheels or rollers 114 that enable the base frame 112 to move. One or more of the wheels or rollers 114 can include a locking mechanism that enables the base frame 112 to be fixed in a stationary position during filling or discharging operations. The fixed base 110 includes globes 116 that extend upward at each corner of the fixed base 110 and toward the inclined deck 140. The fixed base 110 can include one or more cross members 118 that extend between the sides of the fixed base 110. One of the cross members 118 can be disposed substantially at the center of the fixed base 110. The fixed base 110 can include a channel 119 formed by vertical side walls, and the vertical side walls extend perpendicular to the cross member 118 in which the globe 116 is disposed within the channel 119.

[0035] The fixed base 110 also includes a lifting system 120 having a lifting element 122 disposed at or near the center of the fixed base 110. The lifting element 122 is configured to provide a lifting force in the middle of the inclined deck 140. The lifting element 122 is fixed to the fixed base 110 and the inclined deck 140 such that the lifting element 122 can expand in a substantially vertical direction regardless of the direction of the inclined deck 140 relative to the fixed base 110. The lifting element 122 and / or the attachment points of the lifting element 122 are configured to articulate at different angles such that when the lifting element 122 expands to move the inclined deck 140 away from the fixed base 110, the inclined deck 140 tilts in various directions based on the state of the multidimensional hinge 170 of the tilting mechanism 100.

[0036] As shown in the figure, the lifting element 122 is a lifting bag. The lifting element 122 can be an airbag or a hydraulic bag that expands in response to an increase in the pressure of the fluid within the lifting element 122. The lifting element 122 can be connected to a source of compressed air. For example, the lifting element 122 can be connected to a facility compressed air line to receive compressed air that inflates the lifting element 122 so that the lifting element 122 expands to move the center of the inclined deck 140 away from the fixed base 110. The lifting element 122 can include a discharge valve 128 that releases air from within the lifting element 122 to the environment. Since the air supplied to the lifting element 122 is facility compressed air, there is no risk of damaging the cleanroom environment even if the air is released from within the lifting element 122.

[0037] In certain embodiments, the fixed base 110 includes a pump 126 that supplies fluid to the lifting element 122 such that the lifting element 122 expands to move the center of the inclined deck 140 away from the fixed base 110. In some embodiments, the pump 126 can draw air from the environment, and the lifting element 122 can include a discharge valve 128 that releases air to the environment. In certain embodiments, the lifting system 120 is a closed system that includes the lifting element 122, a reservoir or expansion tank 124, and the pump 126. In such embodiments, the pump 126 can draw fluid from the expansion tank 124 to pressurize the lifting element 122, and the discharge valve 128 returns the fluid to the expansion tank 124. The closed system can enable the lifting system 120 to operate within a cleanroom environment without damaging the environment from the release of fluid from the lifting element 122.

[0038] Referring particularly to FIG. 5, the inclined deck 140 includes a deck frame 142 which includes cross-supports 144 and channel members 146 which extend between and perpendicular to the cross-supports 144 such that the shape of the deck frame 142 is substantially rectangular. The inclined deck 140 can be made slightly larger than the fixed base 110 such that the inclined deck 140 fits above the fixed base 110. In some embodiments, the inclined deck 140 can be made smaller than the fixed base 110 such that the inclined deck 140 is disposed within the fixed base 110. In embodiments where the inclined deck 140 is smaller than the fixed base 110, the fixed base 110 can support a stationary portion of the FDS, such as a valve tower, and the inclined deck 140 can support an inclined platform 840 of the FDS. Two of the cross-supports 144a, c can be positioned adjacent to the ends of the deck frame 142 such that each cross-support 144 covers two of the globes 116 of the fixed base 110. The central cross-support 144b of the cross-supports 144 can be positioned at the center of the deck frame 142 above the center point of the deck frame 142. The central cross-support 144b can be fixed to the upper end of the lifting element 122. The channel members 146 extend perpendicularly from the cross-supports 144 to define a first channel 147a and a second channel 147b adjacent to the sides of the deck frame 142. The channel members 146 can act as a stop to limit downward movement of the inclined deck 140 relative to the fixed base 110.

[0039] The inclined deck 140 includes a receiver 150 at each corner of the deck frame 142. Each receiver 150 is positioned to receive one of each of the globes 116. In some embodiments, the receiver 150 is positioned in the first channel 147a or the second channel 147b of the deck frame 142. Each receiver 150 has a size such that it receives one of the globes 116 therein and selectively captures and releases each of the globes 116.

[0040] Continuing to refer to FIGS. 7 and 8, receiver 150 defines chamber 152 and locking member or fork 154. Chamber 152 is sized and dimensioned to receive therein each one of gloves 116. Locking fork 154 has a first or released state (FIG. 7) and a second or captured state (FIG. 8). In the released state, fork 154 is disposed substantially outside chamber 152 such that glove 116 can freely enter and exit chamber 152. In the released position, tip 155 of fork 154 can be partially disposed within chamber 152 but is positioned such that it does not interfere with the movement of glove 116 into or out of chamber 152. In the captured state, fork 154 is inserted into chamber 152 such that tongs 156 of fork 154 are disposed around neck 117 of glove 116 disposed within chamber 152 so that glove 116 is fixed within chamber 152. Chamber 152 can include a backing or bearing surface shaped to complement the shape of glove 116 such that chamber 152 can pivotally rotate around glove 116 to form a multi-dimensional hinge 170 that allows for selective movement of tilt deck 140 relative to fixed base 110, as detailed below. When glove 116 is fixed within chamber 152, receiver 150 is movable relative to the glove in at least two degrees of freedom.

[0041] The fork 154 can include a shank 158 extending from a bridge 159 that interconnects the tongs 156. The receiver 150 can include a stop 151 against which the bridge 159 abuts in the released position to prevent further retraction of the fork 154 beyond the released state. The shank 158 can be actuated by an actuator 160. The actuator 160 can be actuated by various actuators including, but not limited to, linear actuators, solenoids, hydraulic actuators, electromagnetic actuators, pneumatic actuators. In some embodiments, the actuator 160 operates in a manner similar to or by a similar medium as the lifting member or element 122, such that the medium is shared between the lifting element 122 and the actuator 160. For example, the lifting element 122 can be an airbag, and the actuator 160 can receive air from the same pump or facility air supply to move the fork 154 between the captured state and the released state. In some embodiments, the actuator can be a double-acting pneumatic cylinder such that the fork 154 is moved towards the captured state in response to air entering through a first valve and towards the released state in response to air entering through a second valve. The double-acting pneumatic cylinder can allow the fork 154 to remain in the previous state until an input is provided. In certain embodiments, the fork 154 includes a biasing member 157 around the shank 158 that biases the fork 154 towards the captured or released state. For example, the biasing member 157 can be a spring that biases the fork 154 towards the captured state or a spring that biases the fork towards the released state. In such embodiments, the actuator 160 moves the fork 154 against the bias of the biasing member 157 to move the fork 154 towards the captured or released state.

[0042] As shown herein, each multi - dimensional hinge 170 is formed of a single receiver and a single glove. In some embodiments, each multi - dimensional hinge 170 is a hinge assembly that includes one or more single - dimensional hinges. For example, one multi - dimensional hinge can be composed of two one - degree - of - freedom hinges, and each one - degree - of - freedom hinge has a captured state and a released state.

[0043] Referring now to FIGS. 9 - 12, the lift element 122 and the hinge 170 are actuated in a manner according to an embodiment of the present disclosure to move the tilt deck 140 between the natural or flat position of FIG. 5 to a left - tilt position (FIG. 9), a right - tilt position (FIG. 10), a forward - tilt position (FIG. 11), and a rear - tilt position (FIG. 12). For example, as shown in FIG. 9, hinges 170a and 170d are in the captured state, and hinges 170b and 170c are in the released state such that when the lift element 122 is actuated toward the extended position, the tilt deck 140 pivots about a first tilt axis passing through hinges 170a and 170d to move toward the left - tilt position. As shown in FIG. 10, hinges 170b and 170c are in the captured state, and hinges 170a and 170d are in the released state such that when the lift element 122 is actuated toward the extended position, the tilt deck 140 pivots about a second tilt axis passing through hinges 170b and 170c to move toward the right - tilt position. As shown in FIG. 11, hinges 170c and 170d are in the captured state, and hinges 170b and 170c are in the released state such that when the lift element 122 is actuated toward the extended position, the tilt deck 140 pivots about a fourth tilt axis passing through hinges 170c and 170d to move toward the rear - tilt position. As shown in FIG. 12, hinges 170a and 170b are in the captured state, and hinges 170c and 170d are in the released state such that when the lift element 122 is biased toward the extended position, the tilt deck 140 pivots about a third tilt axis passing through hinges 170a and 170b to move toward the forward - tilt position.

[0044] Although not explicitly shown, the lifting element 122 and the hinge 170 can be actuated to tilt the tilt deck 140 with respect to positions between a left tilt position, a right tilt position, a front tilt position, and a rear tilt position. For example, the hinge 170a can be in a captured state, and the hinges 170b, c, d can be in a released state, and when the lifting element 122 is extended, the tilt deck 140 is adapted to be tilted to a left front tilt position.

[0045] As described above, the glove 116 is fixed to the fixed base 110, and the receiver 150 is fixed to the tilt deck 140. However, in some embodiments, one or more of the gloves 116 can be fixed to the tilt deck 140, and one or more of the receivers 150 can be fixed to the fixed base 110.

[0046] The tilt angle of the tilt deck 140 to the left, right, front, and rear tilt positions is controlled by the distance by which the lifting element 122 extends toward the extended position. The amount or degree of tilt in each direction can be selected from several preset degrees, such as 5 degrees, 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, 40 degrees, 45 degrees, or can be variable. In some embodiments, the tilt mechanism 100 includes a controller 102 (FIG. 6), and one or more sensors 104, 106, 108 that determine the angular states of the hinge 170, the lifting element 122, and the tilt deck 140. The controller 102 can move the tilt deck 140 in response to user input, or can move the tilt deck 140 based on pre-programmed operations, such as priming and filling, priming and discharging. For example, the sensor 104 (FIG. 5) can be configured to determine the state of each hinge 170, the sensor 106 (FIG. 6) can determine the amount of extension or lift of the lifting element 122, and the sensor 108 (FIG. 5) can determine the direction and / or tilt angle of the tilt deck 140.

[0047] In some embodiments, the tilting mechanism 100 can include one or more safety sensors that prevent excessive tilting and / or tipping of the metering station. The safety sensors can prevent people from being pinched and / or crushed by the tilting of the tilting deck 140. The safety sensors can sense when a person enters a danger zone around the metering station before or during tilting. When one of the safety sensors is activated, tilting can be prevented from starting or can be stopped. The safety sensors can include one or more laser safety scanners configured to detect when a person enters a tilting zone or a danger zone before or during the tilting of the tilting deck 140. In some embodiments, the safety sensors can include, but are not limited to, light curtains, pressure-sensitive mats, lidars, ultrasonic sensors. In certain embodiments, the tilting mechanism 100 can include a fence system around the tilting mechanism 100 that prevents people or objects from entering a danger zone or a tilting zone during tilting. The fence system can include an interlocking gate that prevents or stops the tilting of the tilting deck 140 when opened.

[0048] In some embodiments, the controller 102 can detect the state of each hinge 170 before tilting to prevent the extension of the lifting element 122 if one or more of the hinges 170 are out of position. The controller 102 can monitor the tilt angle of the tilting deck 140 and prevent the tilting deck 140 from tilting beyond a preset maximum tilt angle, for example, 15 degrees, 20 degrees, 25 degrees, 30 degrees, 40 degrees, or 45 degrees. The tilting mechanism 100 can include a mechanical stop that limits the tilt to prevent the tilting deck 140 from lifting beyond its mechanical limits.

[0049] Referring now to FIG. 13, a method of filling a container according to an embodiment of the present disclosure is shown, generally referred to as method 300, with reference to the filling system 800 of FIG. 2 and the tilting mechanism of FIGS. 4-12. To initiate the filling operation, a filling recipe is selected (step 305). The filling recipe can be selected by interacting with the controller 102. With the filling recipe selected, a supply vessel 810 containing a biopharmaceutical composition is placed in fluid communication with the FDS 830 using pipes 812, 822 (step 310). Pipes 812, 822 can include one or more filters that are primed when the supply vessel 810 is placed in fluid communication with the FDS 830.

[0050] The container 850 is loaded onto the platform 840 of the FDS 830 (step 320). The container 850 can be loaded onto the platform 840 as part of a bulk shipper. The bulk shipper can be a euro-sized pallet containing from 1 to 10 containers 850. With the container 850 loaded onto the platform, a filling tube 836 is connected between each valve 834 and each container 850 (step 330).

[0051] With all the containers 850 connected to their respective valves 834 by their respective filling tubes 836, the filling tubes 836 are primed to purge air from the filling tubes 836 (step 340). The filling tubes 836 are primed by tilting the platform 840 so that the valves 834 are positioned above their respective containers 850, and the valves 834 are opened so that the gas in the filling tubes 836 is replaced with the biopharmaceutical composition (step 345). The container 850 can include a closure, such as a clamp or pinch valve, to close the container 850 until its respective filling tube 836 is primed. Priming of the container can take from 30 seconds to 5 minutes, for example, 1 minute and 45 seconds. In some embodiments, the filling tubes 836 can be primed simultaneously or sequentially.

[0052] In an embodiment, the platform 840 may need to be tilted in a first direction to prime the fill tube 836 of the first valve tower 832 and tilted in a second direction to prime the fill tube 836 of the second valve tower 832. In certain embodiments, the platform 840 may need to be tilted in more than two directions to prime all of the fill tubes 836. For example, a 75L Celsius (registered) FFT container has fill and drain ports located on the left side of the container such that the tilt deck 140 is tilted to the right or clockwise to prime the container and the fill tube 836. In contrast, 12L, 6L, 4L, and 2L Celsius (registered) FFT containers have fill and drain ports on the front of the container such that the tilt deck 140 is tilted backward to prime the container and the fill tube 836. In an embodiment, when both valve towers 832 are used with ports to fill and drain containers on each side of the platform 840, the tilt deck 140 can be tilted rightward to prime the containers and fill tubes 836 on the left valve tower 832, and then the tilt deck 140 can be tilted leftward to prime the containers and fill tubes 836 on the right valve tower 832.

[0053] With the fill tube 836 primed, the container 850 is placed in fluid communication with the valve 834 so that the container 850 is filled (step 350). The containers 850 can be filled simultaneously or sequentially. The amount of the biopharmaceutical composition can be measured by the weight of the platform 840. As described above, the platform 840 can be a weighing platform such that the amount of the biopharmaceutical composition can be determined by the weight of the platform 840. The tilt deck 140 can be returned to a neutral position after priming and during filling. During priming and / or filling, the pump 820 can be operated to flow the biopharmaceutical composition from the supply device 810 to the container 850.

[0054] Container 850 can be filled in an inclined position or a neutral position. When container 850 is filled in the neutral position, container 850 can be tilted at the end of the filling process to purge the biopharmaceutical composition from filling tube 836 and into container 850.

[0055] With container 850 filled and filling tube 836 purged, container 850 is sealed (step 360) and the bulk shipper containing container 850 is removed from platform 840 (step 370).

[0056] It has been found that by priming the container and filling tube 836 prior to filling, the gas within container 850 can be reduced or eliminated. For example, in some experiments, the air volume within each container can be reduced by 100 mL. By reducing the air within the container, the lifespan of the biopharmaceutical composition stored within the container can be increased. The extension of the lifespan of the biopharmaceutical composition can result from a reduction in the interaction between the biopharmaceutical composition and the residual air within the container.

[0057] Referring now to FIG. 14 and to the discharge system 801 of FIG. 3 and the tilting mechanism of FIGS. 4-12, a method of draining a container according to an embodiment of the present disclosure is described and is generally referred to as method 400. To initiate the discharge operation, a discharge recipe is selected (step 405). A container 850 containing the biopharmaceutical composition to be discharged is loaded onto a platform 840 (step 410). The container 850 can be loaded onto the platform as part of a bulk shipper. A product receptacle 870 for receiving the biopharmaceutical composition is placed in fluid communication with the FDS 830 using a pipe 822 (step 420). With the product receptacle 870 in fluid communication with the FDS 830, one or more container valves 834 are opened to allow the biopharmaceutical composition to flow from the container 850 to the product receptacle 870 (step 420). The pump 820 can be operated to flow the biopharmaceutical composition from the container 850 to the product receptacle 870. During discharge, the tilting mechanism 100 can be in a neutral position or can be tilted as detailed below. When one or more of the containers 850 are drained or substantially drained, the container 850 is tilted to purge the container 850 and the discharge tube 837 connected to the container 850 (step 430). By tilting the container 850 and the discharge tube 837, it is possible to substantially completely drain the container 850 and the discharge tube 837.

[0058] During discharge, it may be necessary to tilt the platform 840 in multiple directions to purge the container 850 and the discharge tube 837. For example, a 75L Celsius (registered) FFT container has a fill and drain port located on the left side of the container such that the tilt deck 140 is tilted to the left or counterclockwise to drain the container 850 and the discharge tube 837. In contrast, 12L, 6L, 4L, and 2L Celsius (registered) FFT containers have fill and drain ports on the front of the container such that the tilt deck 140 is tilted forward to drain the container and the discharge tube 837. In embodiments, when both valve towers 832 are used with ports to fill and drain containers on each side of the platform 840, the tilt deck 140 can be tilted to the left to purge the container 850 and the discharge tube 837 on the left valve tower 832, and then the tilt deck 140 can be tilted to the right to purge the container and the discharge tube 837 on the right valve tower 832. In some configurations, a limited amount of biopharmaceutical composition can be discharged from the container 850 without tilting during the discharge process. Thus, tilting the container 850 can enable substantially complete draining of the container 850. By tilting the container 850 and the discharge tube 837, additional biopharmaceutical composition can be extracted from the container 850.

[0059] In some embodiments, the steps of the filling method 300 and / or the discharging method 400 can be automated such that the controller 102 controls the pump 820, the valve 834, and / or the tilting mechanism 100. In addition to this, the controller 102 can monitor the amount of biopharmaceutical composition filled into or discharged from the container 850 and can switch between containers 850 during a filling or discharging operation. In some embodiments, the controller 102 can operate the valves or clamps of the container 850 during a filling and / or discharging operation. In certain embodiments, the controller 102 can operate the valve of the sampling tube during a filling and / or discharging operation to sample the biopharmaceutical composition at different times during each operation.

[0060] Although some embodiments of the present disclosure are shown in the drawings, the present disclosure is not intended to be limited thereto, but is intended to have as broad a scope as permitted by the art, and is also intended to be read in the same manner as this specification. Any combination of the above-described embodiments is also envisioned and is within the scope of the appended claims. Accordingly, the above description should not be construed as limiting, but rather should be construed merely as illustrative of particular embodiments. Those skilled in the art will envision other modifications within the scope of the claims appended hereto.

Claims

1. A base having a rectangular base frame, An inclined deck having a rectangular deck frame, Four multi-dimensional hinges, each having one hinge positioned adjacent to each corner of the base frame and the deck frame, each hinge including a glove and a receiver, the glove or the receiver being fixed to the base frame or the deck frame, the other of the glove or the receiver being fixed to the other of the base frame or the deck frame, each hinge further including a locking member, each hinge having a captured state in which the locking member fixes the glove within the respective receiver and a released state in which the locking member allows the glove to enter and exit the respective receiver, the four multi-dimensional hinges; A lifting member fixed to the center of the base frame and the center of the deck frame, configured to move the deck frame away from the base frame so that the deck frame can be tilted in at least four directions relative to the base frame by selective engagement, the lifting member; An inclined mechanism comprising.

2. The inclined deck is configured to support a weighing platform, the weighing platform being configured to determine the amount of fluid disposed within one or more containers disposed on the weighing platform, the inclined mechanism according to claim 1.

3. The lifting member is a lifting bag that expands in response to receiving fluid into the lifting member, the inclined mechanism according to claim 1.

4. The lifting bag is an airbag that expands in response to receiving gas into the lifting bag, the inclined mechanism according to claim 3.

5. The lifting bag is in fluid communication with a pump that supplies fluid to expand the lifting bag, the inclined mechanism according to claim 3.

6. The inclined deck has a neutral position when the lifting member is in a non-expanded position in which each glove is disposed in its respective receiver, the inclined mechanism according to claim 1.

7. The inclined deck has a first inclined position, and at the first inclined position, a first hinge and a fourth hinge among the four hinges are in a captured state, and a second hinge and a third hinge among the four hinges are in a released state, so that the inclined deck is tilted around a first inclined axis defined through the first hinge and the fourth hinge in response to the expansion of the lifting member. The inclined mechanism according to claim 1.

8. At the first inclined position, the inclined deck rotates around the first inclined axis at an angle in the range of 5 degrees to 45 degrees. The inclined mechanism according to claim 7.

9. The inclined deck has a second inclined position, and at the second inclined position, the first hinge and the fourth hinge are in the released state, and the second hinge and the third hinge are in the captured state, so that the inclined deck is tilted around a second inclined axis defined through the second hinge and the third hinge in response to the expansion of the lifting member. The inclined mechanism according to claim 7.

10. The inclined deck has a third inclined position, and at the third inclined position, the first hinge and the second hinge are in the captured state, and the third hinge and the fourth hinge are in the released state, so that the inclined deck is tilted around a third inclined axis defined through the first hinge and the second hinge in response to the expansion of the lifting member. The inclined mechanism according to claim 9.

11. The locking member is a fork that linearly slides in and out of each receiver to shift the hinge between the captured state and the released state. The inclined mechanism according to claim 1.

12. The fork is linearly actuated by a linear actuator, a solenoid, or a pneumatic actuator. The inclined mechanism according to claim 11.

13. The hinge includes a biasing member that biases the fork to slide in and out of the receiver. The inclined mechanism according to claim 11.

14. A platform configured to support at least one container to be filled or drained; A valve tower configured to distribute fluid to each of the at least one container; The tilting mechanism according to claim 1, comprising the tilting mechanism that supports the platform on the tilting deck of the tilting mechanism, A filling and discharging system comprising.

15. A glove, A receiver configured to selectively receive the glove, A locking member linearly translatable between a capture position where the glove is fixed within the receiver and a release position where the glove can enter and exit the receiver, the receiver being movable relative to the glove with at least two degrees of freedom when the glove is fixed within the receiver, the locking member; A multi-dimensional hinge comprising.

16. The hinge according to claim 15, wherein the locking member is a fork having two tongs linearly translatable to enter and exit the receiver to fix the glove within the receiver.

17. The hinge according to claim 15, further comprising a biasing member configured to bias the locking member toward the capture position or the release position.

18. A base having a base frame, A tilting deck having a deck frame, A lifting member fixed to the center of the base frame and the center of the deck frame and configured to move the tilting deck away from the base frame so that the tilting deck can be tilted in at least four directions relative to the base, A tilting mechanism comprising.

19. The tilting mechanism according to claim 18, wherein the lifting member is an expandable bag disposed between the base frame and the deck frame.

20. Further comprising multi-dimensional hinges disposed at each corner of the base frame and the deck frame, Each multi-dimensional hinge is selectively engageable such that the deck frame can tilt relative to the base frame with at least two degrees of freedom, The tilting mechanism according to claim 18.

21. The tilting mechanism according to claim 20, wherein the multi-dimensional hinge includes a glove fixed to one of the base frame or the deck frame and a receiver fixed to the other of the base frame and the deck frame, the receiver being configured to selectively fix each glove therein.

22. A method of operating the tilting mechanism for filling or draining a fluid container supported on a tilting mechanism, placing the first hinge and the second hinge in a captured state and the third hinge and the fourth hinge in a released state, and operating a lifting mechanism to move the deck frame away from the base frame, thereby tilting the deck frame supporting the container in a first direction; placing the first hinge and the second hinge in a released state and the third hinge and the fourth hinge in a captured state, and operating the lifting mechanism to move the deck frame away from the base frame, thereby tilting the deck frame in a second direction opposite to the first direction; A method comprising.

23. placing the first hinge and the third hinge in a captured state and the second hinge and the fourth hinge in a released state, and operating the lifting mechanism to move the deck frame away from the base frame, thereby further comprising tilting the deck frame in a third direction different from the first direction and the second direction, the method according to claim 22.

24. Operating the lifting mechanism includes supplying fluid into the lifting bag such that the lifting bag expands to move the deck frame away from the base frame, the method according to claim 22.

25. The step of tilting the deck frame in the first direction includes the step of rotating the deck frame about a first axis defined through the first hinge and the second hinge, The step of tilting the deck frame in the second direction includes the step of rotating the deck frame about a second axis defined through the third hinge and the fourth hinge, The method according to claim 22.

26. Placing one of the first, second, third, or fourth hinges in the captured state includes operating a locking mechanism to fix the glove within the receiver such that the hinge is rotatable about the glove with two degrees of freedom, the method according to claim 22.

27. The step of operating the locking mechanism to fix the glove includes the step of translating the fork into the receiver such that the two tongs of the fork are disposed around the neck of the glove to prevent the glove from slipping out of the receiver, the method according to claim 26.

28. Placing one of the first, second, third, or fourth hinges in the released state includes the step of operating a locking mechanism to enable the glove to exit the receiver, the method according to claim 22.

29. The step of operating the locking mechanism to enable the glove to exit the receiver includes the step of translating the fork such that the tongs of the fork are disposed substantially outside the receiver, enabling the glove to slip out of the receiver, the method according to claim 28.

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