Multi-directional tilt mechanism and method of operation thereof

Abstract

The invention relates to a tilting mechanism. The tilting mechanism comprises a base, a tilting table, four hinges and a lifting component. Each hinge is positioned adjacent a corner of the base and a corner of the tilt table. Each hinge includes a sphere and a receiver, where the sphere or receiver is secured to the base frame or the table frame, and the other of the sphere or receiver is secured to the other of the base frame or the table frame. Each hinge includes a locking member that selectively secures a ball within a respective receiver. The lifting member is fixed to the center of the base frame and the center of the stage frame. The lifting member is configured to urge the tilt table away from the base such that selective engagement allows the tilt table to tilt in at least four directions relative to the base.

Description

Technical Field

[0001] The present disclosure relates to fluid handling and, more particularly, to a multi-directional tilt mechanism for filling and draining containers. Background Art

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

[0003] In some applications, containers (e.g., Celsius® FFT containers from Sartorius AG) are loaded into a fill and drain station (FDS) that is used to fill and drain the containers. In the FDS, the containers are held in a horizontal orientation. In the horizontal orientation, not all of the biopharmaceutical composition can be drained from the container. In addition, once the container is drained, the piping from the container to the fill and drain station may contain additional biopharmaceutical composition. In addition, in the horizontal orientation, it may be difficult to purge air from the piping leading to the container and / or the container itself before filling the container.

[0004] It has been found that tilting the container during filling and / or discharging can allow the biopharmaceutical composition to be more completely filled into or discharged from the container. FIG. 1 shows that the currently available tilting mechanism 910 can be capable of tilting in two directions (e.g., left and right). The tilting mechanism 910 includes a base 915 supporting a tilting platform 920 and a linear actuator 930. The linear actuator 930 is operably connected to the tilting platform 920 through 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 premature failure. In addition, the tilting mechanism 910 is limited to tilting the platform 920 to the right or left. In addition, the components of the tilting mechanism 910, particularly the linear actuator 930, may be costly. In some applications, the tilting mechanism 910 with the FDS fixed thereto may have a certain height that prevents the tilting mechanism 910 and the FDS from traveling through traditional doorways. Summary of the invention

[0005] The present disclosure generally relates to a tilting mechanism that can tilt the weighing station / platform of an FDS in multiple directions. The disclosed tilting mechanism can have a simplified structure compared to previous solutions (e.g., tilting mechanism 910). In addition, the disclosed tilting mechanism can have a reduced cost relative to tilting mechanism 910. In some embodiments, the tilting mechanism can allow the FDS to tilt in four directions, such as forward, backward, a first or right direction, and a second or left direction. In certain embodiments, the tilting mechanism can allow tilting in eight directions, including directions between each of the forward, backward, first side direction, and second side direction. The disclosed tilting mechanism can have a reduced height compared to the tilting mechanism of the prior art (e.g., tilting mechanism 910), so that the disclosed tilting mechanism can be suitable for passing through a standard doorway when the FDS is supported on the disclosed tilting mechanism.

[0006] In use, the disclosed tilting mechanism can be used to activate a fill line with a biopharmaceutical composition before filling a container, or can be used to discharge a container filled with a biopharmaceutical composition. Activating air from the fill line prevents 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 ranging from 5 degrees to 45 degrees. The disclosed tilting mechanism can allow the tilting table to be pushed away from the fixed base to tilt in multiple directions by operating a single lifting element based on the state of the multiple hinges selectively fixing the tilting table to the fixed base during filling and discharging.

[0007] In an embodiment of the present disclosure, the tilt mechanism includes a base, a tilt table, four multi-dimensional hinges and a lifting member. The base includes a rectangular base frame, and the tilt table includes a rectangular table frame. The hinges are positioned so that one hinge is adjacent to each corner of the base frame and each corner of the table frame. Each frame includes a sphere and a receiver, wherein the sphere or the receiver is fixed to the base frame or the table frame, and the other of the sphere or the receiver is fixed to the other of the base frame or the table frame. Each hinge includes a locking member so that the hinge has a captured state and a released state, in which the locking member fixes the sphere in the corresponding receiver and in which the locking member allows the sphere to enter and exit the corresponding receiver. The lifting member is fixed at the center of the base frame and the center of the table frame. The lifting member is configured to push the table frame away from the base frame so that the selective engagement of the hinge allows the table frame to tilt in at least four directions relative to the base frame.

[0008] In various embodiments, the tilting table can be configured to support a weighing platform configured to determine the amount of fluid disposed in one or more containers located on the weighing platform. The lifting member can be a lifting bag that expands in response to receiving a fluid in the lifting bag. The lifting bag can be an air bag that expands in response to receiving a gas in the air bag. The lifting bag can be in fluid communication with a pump. The pump can provide fluid to expand the bag.

[0009] In some embodiments, the tilt table can have a neutral point when the lifting member is in a non-extended position with each ball disposed in a respective one of the receivers.

[0010] In some embodiments, the tilt table may have a first tilt position in which the first hinge and the fourth hinge of the four hinges are in a captured state and the second hinge and the third hinge of the four hinges are in a released state, so that the tilt table is tilted around a first tilt axis defined by the first hinge and the fourth hinge in response to the extension of the lifting member. In the first tilt position, the tilt table can rotate around the first tilt axis at an angle in the range of 5 degrees to 45 degrees. The tilt table may have a second tilt position in which 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, so that the tilt table is tilted around a second tilt axis defined by the second hinge and the third hinge in response to the extension of the lifting member. The tilt table may have a third tilt position in which 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, so that the tilt table is tilted around a third tilt axis defined by the first hinge and the second hinge in response to the extension of the lifting member.

[0011] In certain embodiments, the locking member can be a fork that can slide linearly into and out of the receiver to transition the hinge between the captured state and the 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 pushes the fork into or out of the receiver.

[0012] In another embodiment of the present disclosure, a filling and discharging 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 discharged. The valve tower is configured to distribute fluid to each container in the at least one container. The tilting mechanism can be any tilting mechanism described in detail herein. The tilting mechanism supports the platform on its tilting platform.

[0013] In another embodiment of the present disclosure, a multi-dimensional hinge includes a sphere, a receiver, and a locking member. The receiver is configured to selectively receive the sphere. The locking member can be linearly translated between a capture position and a release position, in which the sphere is fixed in the receiver and in which the sphere is allowed to enter and exit the receiver. When the sphere is fixed in the receiver, the receiver can move in at least two degrees of freedom relative to the sphere. The locking member can be a fork-shaped member with two prongs, which can be linearly translated into and out of the corresponding receiver to fix the sphere in the corresponding receiver. The hinge may include a biasing member, which is configured to push the locking member toward the capture position or the release position.

[0014] In another embodiment of the present disclosure, a tilting mechanism includes a base, a tilting table, and a lifting member. The base has a base frame, and the tilting table has a table frame. The lifting member is fixed at the center of the base frame and the center of the table frame. The lifting member is configured to push the tilting table away from the base table so that the tilting table can be tilted in at least four directions relative to the base.

[0015] In various embodiments, the lifting member is an extendable bag disposed between the base frame and the table frame. The tilt mechanism may include a multi-dimensional hinge disposed at each corner of the base frame and each corner of the table frame. Each multi-dimensional hinge has a ball and a receiver, the ball being fixed to one of the base frame or the table frame, and the receiver being fixed to the other of the base frame and the table frame. The receiver may be configured to selectively fix a corresponding ball within the receiver.

[0016] In another embodiment of the present disclosure, a method for operating a tilt mechanism for filling or draining a fluid container supported on the tilt mechanism includes: tilting a table frame supporting the container in a first direction by placing a first hinge and a second hinge in a captured state and placing a third hinge and a fourth hinge in a released state and actuating a lifting mechanism to push the table frame away from a base frame. The method also includes: tilting the table frame in a second direction opposite to the first direction by placing the first hinge and the second hinge in a released state and placing the third hinge and the fourth hinge in a captured state and actuating the lifting mechanism to push the table frame away from the base frame.

[0017] In various embodiments, the method may include tilting the table frame in a third direction different from the first direction and the second direction by placing the first hinge and the third hinge in a captured state and placing the second hinge and the fourth hinge in a released state and actuating a lifting mechanism to push the table frame away from the base frame.

[0018] In some embodiments, actuating the lifting mechanism includes providing fluid into a lifting bag so that the lifting bag expands to push the table frame away from the base frame. Tilting the table frame in a first direction may include rotating the table frame about a first axis defined by a first hinge and a second hinge. Tilting the table frame in a second direction may include rotating the table frame about a second axis defined by a third hinge and a fourth hinge.

[0019] In some embodiments, placing one of the first hinge, the second hinge, the third hinge, or the fourth hinge in a captured state includes actuating a locking mechanism to secure the ball within the receiver so that the hinge can rotate about the ball in two degrees of freedom. Actuating the locking mechanism may include translating a fork into the receiver so that two prongs of the fork are disposed around a neck of the ball to prevent the ball from being withdrawn from the receiver.

[0020] In certain embodiments, placing one of the first hinge, the second hinge, the third hinge, or the fourth hinge in a released state includes actuating a locking mechanism to allow the ball to exit the receiver. Actuating the locking mechanism to allow the ball to exit the receiver may include translating a fork so that the prongs of the fork are substantially disposed outside the receiver to enable the ball to be withdrawn from the receiver.

[0021] Further, to the extent consistent, any of the embodiments or aspects described herein may be used in combination with any or all of the other embodiments or aspects described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Various aspects of the present disclosure are described hereinafter with reference to the accompanying drawings, which are incorporated into and constitute a part of this specification, in which:

[0023] FIG1 is a perspective view of a tilt mechanism of the prior art;

[0024] Figure 2 is a schematic diagram of a filling system provided according to an embodiment of the present disclosure;

[0025] Figure 3A is a schematic diagram of an exhaust system in a neutral position according to an embodiment of the present disclosure;

[0026] Figure 3B yes Figure 3A A schematic diagram of the discharge system of the invention in a tilted position;

[0027] Figure 4 is a top perspective view of a tilt mechanism provided according to an embodiment of the present disclosure, the tilt mechanism comprising a fixed base and a tilt table in a neutral position;

[0028] Figure 5 yes Figure 4A bottom-up stereogram of a tilt table;

[0029] Figure 6 yes Figure 4 A top perspective view of a fixed base;

[0030] Figure 7 yes Figure 4 A three-dimensional view of a multi-dimensional hinge of a tilt mechanism in a released state;

[0031] Figure 8 yes Figure 4 A three-dimensional view of a multi-dimensional hinge of a tilt mechanism in a captured state;

[0032] Fig. 9 yes Figure 4 A top perspective view of a tilt mechanism, wherein the tilt table is tilted in a first direction;

[0033] Fig.10 yes Figure 4 A top perspective view of a tilt mechanism, wherein the tilt table is tilted in a second direction;

[0034] Fig.11 yes Figure 4 A top perspective view of a tilting mechanism, wherein the tilting table is tilted in a third direction;

[0035] Fig.12 yes Figure 4 A top perspective view of a tilting mechanism, wherein the tilting stage is tilted in a fourth direction;

[0036] Fig.13 is a flow chart of a method for filling a container according to an embodiment of the present disclosure; and

[0037] Fig.14 is a flow chart of a method for draining a container according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0038] The present disclosure will now be described more fully below with reference to the accompanying drawings with reference to exemplary embodiments of the present disclosure, in which the same reference numerals indicate the same or corresponding elements in each of the several views. These exemplary embodiments are described so that the present disclosure is thorough and complete, and the scope of the present disclosure will be fully conveyed to those skilled in the art. Features from one embodiment or aspect may be combined with features from any other embodiment or aspect in any appropriate combination. For example, any individual or collective feature of an aspect or embodiment of a method may be applied to an aspect or embodiment of a device, product or component, and vice versa. The present disclosure may be implemented in many different forms and should not be interpreted as being limited to the embodiments set forth herein; rather, these embodiments are provided so that the present disclosure meets applicable legal requirements. As used in the specification and the appended claims, the singular forms "one", "an", "the", etc. include plural references unless the context clearly dictates otherwise. In addition, although quantitative measurements, values, geometric relationships, etc. may be referenced herein, unless otherwise specified, any one or more (if not all of these) thereof may be absolute or approximate to take into account acceptable variations that may be caused, such as due to manufacturing or engineering tolerances, etc. Furthermore, the term "biopharmaceutical composition" as used herein refers to a product derived from biotechnology, culture environments, cell cultures, buffer solutions, artificial nutrient solutions, blood products and derivatives of blood products, pharmaceutical products or more generally products intended for use in the medical field, including but not limited to monoclonal antibodies (mAbs), therapeutic proteins, viruses, lipid nanoparticles, vaccines, viral banks, exosomes, cell banks and cell therapy products.

[0039] Reference now Figure 2 , a schematic diagram of a filling system 800 according to an embodiment of the present disclosure is provided. The filling system 800 includes a supply vessel 810, a supply pump 820, and a fill and drain station (FDS) 830. The supply vessel 810 includes a biopharmaceutical composition to be dispensed into one or more containers fixed in the FDS 830. The supply vessel 810 is in fluid communication with the FDS 830 via conduits 812, 822 that run through the supply pump 820. The filling system 800 can include a sterilizing filter, a buffer supply, and a buffer waste.

[0040] The FDS 830 includes a platform 840 that receives a tray or structure including one or more containers 850 to be filled or discharged. The platform 840 can be a weighing platform for measuring the weight of the biopharmaceutical composition in the container 850. The platform 840 can be a tray with multiple containers 850 supported above a base. As shown, the tray is a European-sized tray that supports four 75-liter containers 850 for filling a total of 300 liters of biopharmaceutical compositions into the container 850 and / or discharging from the container 850. In use, the tray can be loaded and / or unloaded onto the platform with machinery such as a forklift. In some embodiments, the tray can have the capacity to support ten containers 850, each container having a volume of 12, 6, 4 or 2 liters. The tray can have the ability to support a number of containers between one and ten, each container having a volume from 2L to 75L. In some embodiments, the tray can have a capacity greater than 300L and / or support more than ten containers.

[0041] The FDS 830 includes at least one distribution column or valve tower 832 on one side of the FDS 830 that receives the biopharmaceutical composition from the pump 820. In certain embodiments, such as when a large container 850 is used, the FDS 830 uses a single valve tower 832. In some embodiments, the FDS 830 can include valve towers 832 on each side of the FDS 830. Each valve tower 832 can include a valve 834 for each container 850 on the platform 840 to place the container 850 in fluid communication with the pump 820 via a conduit 836. When each valve tower 832 is used, for example, when a small container 850 is supported on the platform 840, the valve 834 of the first valve tower 832 can place the first container 850 in fluid communication with the pump 820, and another valve 834 of the second valve tower 832 can place the second container 850 in fluid communication with the pump 820. As shown, the valve 834 for the respective container 850 can be positioned slightly above the respective container 850 so that fluid flow into the container 850 can be assisted by gravity. In some embodiments, the platform 840 can be tilted to position the respective valve 834 above the respective container 850 to help enable the fill conduit 836, for example, to help gas flow out of the fill tube to the bubble trap or air purge bag 838. In embodiments with valve towers 832 on each side of the FDS 830, the platform 840 can be tilted in a first direction to enable the fill tube 836 by placing the valve 834 of the first valve tower 832 above the respective container 850, and can be tilted in a second direction to enable the fill tube 836 by placing the valve 834 of the second valve tower 832 above the respective container 850.

[0042] The valve tower 832 may include an air purge bag 838. The air purge bag is configured to receive gas from the FDS 830 and / or the fill tube 836. The gas may flow from the pipes 812, 822 connecting the supply vessel 810 with the FDS 830 and / or may flow from the fill tube 836. In some embodiments, the fill tube 836 is connected to the valve 834 with an inclined T-shaped connector so that the fill tube 836 has an angle less than 90 degrees on the lower side of the T-shaped connector and an angle greater than 90 degrees on the upper side of the T-shaped connector. In some embodiments, the inclined T-shaped connector is inclined within a range of 10 degrees to 45 degrees (e.g., 15 degrees). The inclined T-shaped connector may help allow gas to flow toward the air purge bag 838.

[0043] refer to Figure 3A and Figure 3B , a schematic diagram of an exhaust system 801 is provided according to an embodiment of the present disclosure. The elements of the exhaust system 801 may be similar to the filling system 800 and are represented by the same reference numerals, and for the sake of brevity, only the differences are described in detail herein. The exhaust system 801 includes a FDS 830, a container 850, a pump 820, and a product container 870.

[0044] In the discharge configuration, the FDS 830 includes a valve tower 832 having a valve 834. The valve 834 is placed in fluid communication with a corresponding container 850 via a conduit 836. The valve 834 for the corresponding container 850 can be positioned slightly below the corresponding container 850 so that the flow of fluid from the container 850 can be assisted by gravity. The valve tower 832 can include a purge bag 838 to capture gas from the valve tower 832, the conduit 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 valve 834 of the first valve tower 832 below the corresponding container 850, and tilted in a second direction to position the valve 834 of the second valve tower 832 below the corresponding container 850, as shown in FIG. Figure 3B shown.

[0045] The pump 820 is in fluid communication with the FDS 830 and the product vessel 870 via a conduit 822. The conduit 822 may include a sample container that allows for sampling of the biopharmaceutical composition to be periodically dispensed during the discharge operation. The pump 820 may pump the biopharmaceutical composition from the container 850 to the product vessel 870.

[0046] In some embodiments, product container 870 can be replaced with a dispensing system including multiple product containers 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 Publications No. 2021 / 0024338, No. 2021 / 0188615, and No. 2021 / 0395071, the entire contents of each of which are incorporated herein by reference.

[0047] refer to Figures 4 to 6 According to the present disclosure, a tilting mechanism 100 is provided. The tilting mechanism 100 can support the entire FDS 830 or the platform 840 of the FDS 830. The tilting mechanism 100 includes a fixed base 110 and a tilting table 140. In some embodiments, the fixed base 110 can support the valve tower 832 of the FDS 830, and the tilting table 140 can support the platform 840 of the FDS 830. In some embodiments, the fixed base 110 is supported by one or more legs, and the one or more legs include sensors to determine the weight supported by the legs, so that the fixed base 110 is a weighing platform. For example, the fixed base 110 can

[0048] The fixed base 110 includes a base frame 112 that can be fixed in place or can include wheels or rollers 114 that allow the base frame 112 to move. One or more of the wheels or rollers 114 can include a locking mechanism that allows the base frame 112 to be fixed in place during a filling or discharging operation. The fixed base 110 includes a sphere 116 located at each corner of the fixed base 110 and extending upward toward the tilting table 140. The fixed base 110 can include one or more cross members 118 extending between the sides of the fixed base 110. One of the cross members 118 can be substantially disposed at the center of the fixed base 110. The fixed base 110 can include a channel 119 formed by vertical side walls extending perpendicular to the cross members 118, wherein the sphere 116 is disposed within the channel 119.

[0049] 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 tilt table 140. The lifting element 122 is fixed to the fixed base 110 and the tilt table 140 so that the lifting element 122 can expand in a generally vertical direction regardless of the orientation of the tilt table 140 relative to the fixed base 110. The lifting element 122 and / or the attachment point of the lifting element 122 is configured to hinge at different angles so that as the lifting element 122 extends to push the tilt table 140 away from the fixed base 110, the tilt table 140 tilts in multiple directions based on the state of the multi-dimensional hinge 170 of the tilt mechanism 100.

[0050] As shown, the lifting element 122 is a lifting bag. The lifting element 122 can be an air bag or a hydraulic bag that expands in response to the increased pressure of the fluid in the lifting element 122. The lifting element 122 can be connected to a supply source of compressed air. For example, the lifting element 122 can be connected to a facility compressed air pipeline to receive compressed air to expand the lifting element 122, so that the lifting element 122 expands to push the center of the tilting table 140 away from the fixed base 110. The lifting element 122 may include a release valve 128 for releasing air from the lifting element 122 into the environment. Since the air provided to the lifting element 122 is facility compressed air, releasing air from the lifting element 122 may not damage the clean indoor environment.

[0051] In some embodiments, the fixed base 110 includes a pump 126 to provide fluid to the lifting element 122 so that the lifting element 122 expands to push the center of the tilt table 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 release valve 128 for releasing air into the environment. In some 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 an embodiment, the pump 126 can draw fluid from the expansion tank 124 to pressurize the lifting element 122, and the release valve 128 releases the fluid back to the expansion tank 124. The closed system can allow the lifting system 120 to operate in a clean room environment without harming the environment due to the release of fluid from the lifting element 122.

[0052] Special reference Figure 5, the tilting table 140 includes a table frame 142, which includes cross supports 144 and channel members 146, the channel members extending between the cross supports 144 and perpendicular to the cross supports, so that the table frame 142 is substantially rectangular in shape. The tilting table 140 can be slightly larger than the fixed base 110, so that the tilting table 140 is assembled above the fixed base 110. In some embodiments, the tilting table 140 can be smaller than the fixed base 110, so that the tilting table 140 is disposed within the fixed base 110. In embodiments where the tilting table 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 tilting table 140 can support the tilting platform 840 of the FDS. Two of the cross supports 144a, 144c can be located adjacent to the ends of the table frame 142, wherein each cross support 144 covers two of the spheres 116 of the fixed base 110. The central cross support 144b of the cross support 144 may be positioned at the central position of the table frame 142 to cover the central point of the table frame 142. The central cross support 144b may be fixed to the top end portion of the lifting element 122. The channel member 146 may extend vertically relative to the cross support 144 to define a first channel 147a and a second channel 147b adjacent to the side of the table frame 142. The channel member 146 may act as a stopper to limit the downward movement of the tilt table 140 relative to the fixed base 110.

[0053] Tilt table 140 includes a receiver 150 at each corner of table frame 142. Each receiver 150 is positioned to receive a corresponding one of balls 116. In some embodiments, receiver 150 is positioned within first channel 147a or second channel 147b of table frame 142. Each receiver 150 is sized to receive one of balls 116 therein and selectively capture and release a corresponding one of balls 116.

[0054] Continue to refer to Figure 7 and Figure 8 , receiver 150 defines a chamber 152 and a locking member or fork 154. Chamber 152 is sized and dimensioned to receive a corresponding one of balls 116 therein. Locking fork 154 has a first or released state ( Figure 7 ) and the second or captured state ( Figure 8). In the released state, the fork 154 is substantially disposed outside of the chamber 152 such that the ball 116 is free to enter and exit the chamber 152. In the released position, the tip 155 of the fork 154 may be partially disposed in the chamber 152, but in a position that does not interfere with the movement of the ball 116 into or out of the chamber 152. In the captured state, the fork 154 is inserted into the chamber 152 such that the prongs 156 of the fork 154 are disposed about the neck 117 of the ball 116 disposed within the chamber 152 such that the ball 116 is secured within the chamber 152. The chamber 152 may include a bushing or bearing surface that is shaped to complement the shape of the ball 116 such that the chamber 152 may pivot about the ball 116 to form a multi-dimensional hinge 170, thereby allowing the tilt stage 140 to be selectively moved relative to the fixed base 110, as described below. When the ball 116 is secured within the chamber 152, the receiver 150 can move relative to the ball in at least two degrees of freedom.

[0055] The fork 154 may include a handle 158 extending from a bridge 159 that is interconnected with the fork 156. The receiver 150 may include a stop 151 that is abutted by the bridge 159 in the release position to prevent the fork 154 from retracting further beyond the release state. The handle 158 may be actuated by an actuator 160. The actuator 160 may be actuated by a variety of actuators, including but not limited to linear actuators, solenoids, hydraulic actuators, electromagnetic actuators, and pneumatic actuators. In some embodiments, the actuator 160 operates in a similar manner or by a similar medium as the lifting member or element 122, so that the medium is shared between the lifting element 122 and the actuator 160. For example, the lifting element 122 may be an air bag, and the actuator 160 may receive air from the same pump or facility air supply source to move the fork 154 between the capture state and the release state. In some embodiments, the actuator can be a double-acting pneumatic cylinder so that the fork 154 moves toward the captured state in response to air entering through the first valve, and the fork 154 moves toward the released state in response to air entering through the second valve. The double-acting pneumatic cylinder allows the fork 154 to stay in the previous state until input is provided. In certain embodiments, the fork 154 includes a biasing member 157 around the handle 158, which biases the fork 154 toward the captured state or the released state. For example, the biasing member 157 can be a spring that biases the fork 154 toward the captured state or biases the fork toward the released state. In such an embodiment, the actuator 160 overcomes the bias of the biasing member 157 and moves the fork 154 so that the fork 154 moves toward the captured state or the released state.

[0056] As shown herein, each multidimensional hinge 170 is formed with a single receiver and a single sphere. In some embodiments, each multidimensional hinge 170 is a hinge assembly comprising one or more single-dimensional hinges. For example, a single multidimensional hinge can be formed by two single-degree-of-freedom hinges, each single-degree-of-freedom hinge having a captured state and a released state.

[0057] Reference now Figure 9-12 , the lifting element 122 and the hinge 170 operate in a manner according to an embodiment of the present disclosure to move the tilting table 140 in a Figure 5 from its natural or flat position to a left-leaning position ( Fig. 9 ), tilted to the right ( Fig.10 ), forward tilt position ( Fig.11 ) and the rearward tilt position ( Fig.12 ) between the two. For example, Fig. 9 As shown, hinges 170a and 170d are in a captured state and hinges 170b and 170c are in a released state, so that when the lifting element 122 is actuated toward the extended position, the tilt table 140 pivots about a first tilt axis that passes through hinges 170a and 170d to move toward the left tilt position. Fig.10 As shown, hinges 170b and 170c are in a captured state and hinges 170a and 170d are in a released state, so that when the lifting element 122 is actuated toward the extended position, the tilt table 140 pivots about a second tilt axis that passes through hinges 170b and 170c to move toward the right tilt position. Fig.11 As shown, hinges 170c and 170d are in a captured state and hinges 170b and 170c are in a released state, so that when the lifting element 122 is actuated toward the extended position, the tilt table 140 pivots about a fourth tilt axis that passes through hinges 170c and 170d to move toward the rearward tilt position. Fig.12 As shown, hinges 170a and 170b are in a captured state and hinges 170c and 170d are in a released state so that when the lifting element 122 is actuated toward the extended position, the tilt table 140 pivots about a third tilt axis that passes through hinges 170a and 170b to move toward the forward tilt position.

[0058] Although not explicitly shown, the lifting element 122 and the hinge 170 can be operated to tilt the tilt table 140 to a position between a left tilt position, a right tilt position, a forward tilt position, and a rearward tilt position. For example, the hinge 170a can be in a captured state, wherein the hinges 170b, 170c, 170d are in a released state, so that when the lifting element 122 is extended, the tilt table 140 tilts to the left front tilt position.

[0059] As described above, ball 116 is secured to fixed base 110 and receiver 150 is secured to tilt table 140 ; ​​however, in some embodiments, one or more balls 116 may be secured to tilt table 140 , and one or more receivers 150 may be secured to fixed base 110 .

[0060] The tilt angles of the tilting platform 140 from the left tilting position, the right tilting position, the forward tilting position, and the rearward tilting position are controlled by the distance that the lifting element 122 is extended toward the extended position. The amount or degree of tilt in the corresponding direction can be selected from a plurality of preset degrees, such as 5, 10, 15, 20, 25, 30, 35, 40, and 45 degrees, or can be variable. In some embodiments, the tilting mechanism 100 includes a controller 102 ( Figure 6 ) and one or more sensors 104, 106, 108 to determine the state of the hinge 170 and the lifting element 122, and the angle of the tilt table 140. The controller 102 can move the tilt table 140 in response to user input, or can move the tilt table 140 based on preprogrammed operations (e.g., enable and fill, enable and drain). For example, the sensor 104 ( Figure 5 ) can be configured to determine the state of each of the hinges 170, the sensor 106 ( Figure 6 ) can determine the extension or lift of the lifting element 122, and the sensor 108 ( Figure 5 ) can determine the direction and / or tilt angle of the tilt stage 140.

[0061] In some embodiments, the tilt mechanism 100 may include one or more safety sensors to prevent the weighing station from over-tilting and / or tipping over. The safety sensors may prevent people from being caught and / or pressed by the tilting of the tilting platform 140. The safety sensors may detect that a person enters a dangerous area around the weighing station before or during the tilting. When one of the safety sensors is activated, the tilting may be prevented from starting or the tilting may be stopped. The safety sensors may include one or more laser safety scanners configured to detect that a person enters a tilted or dangerous area before or during the tilting of the tilting platform 140. In some embodiments, the safety sensors may include, but are not limited to, light curtains, pressure-sensitive mats, laser radars, or ultrasonic sensors. In certain embodiments, the tilt mechanism 100 may include a fence system around the tilt mechanism 100 to prevent people or objects from entering a dangerous or tilted area during the tilting. The fence system may include an interlocked gate that prevents or stops the tilting of the tilting platform 140 when it is opened.

[0062] In some embodiments, the controller 102 can detect the state of each hinge 170 before tilting to prevent the lifting element 122 from extending when one or more of the hinges 170 are not in place. The controller 102 can monitor the tilt angle of the tilt table 140 and prevent the tilt table 140 from tilting beyond a preset maximum tilt angle, such as 15, 20, 25, 30, 45, 40 or 45 degrees. The tilt mechanism 100 can include a mechanical stop for limiting the tilt to prevent the tilt table 140 from lifting beyond the mechanical limit.

[0063] Reference now Fig.13 According to the embodiments of the present disclosure, Figure 2 Filling system 800 and Figures 4 to 12 The tilt mechanism of the present invention describes a method of filling a container, and the method is generally referred to as method 300. To begin the filling operation, a filling scheme is selected (step 305). The filling scheme can be selected by interacting with the controller 102. With the filling scheme selected, a supply vessel 810 including a biopharmaceutical composition is placed in fluid communication with the FDS 830 having conduits 812, 822 (step 310). The conduits 812, 822 may include one or more filters, which are activated once the supply vessel 810 is placed in fluid communication with the FDS 830.

[0064] The containers 850 are loaded onto the platform 840 of the FDS 830 (step 320). The containers 850 may be loaded onto the platform 840 as part of a bulk transport. The bulk transport may be a Euro-sized pallet that includes between one and ten containers 850. With the containers 850 loaded onto the platform, the fill tubes 836 are connected between the respective valves 834 and the respective containers 850 (step 330).

[0065] When all containers 850 are connected to the corresponding valve 834 through the corresponding filling tube 836, the filling tube 836 is enabled to purge air from the filling tube 836 (step 340). The filling tube 836 is enabled by tilting the platform 840 so that the valve 834 is positioned above the corresponding container 850 and opening the valve 834 so that the gas in the filling tube 836 is replaced by the biopharmaceutical composition (step 345). The container 850 may include a closure, such as a clamp or a pinch valve, to close the container 850 until the corresponding filling tube 836 is enabled. It may take thirty seconds to five minutes to enable the container, such as one minute and forty-five seconds. In some embodiments, the filling tubes 836 may be enabled simultaneously or may be enabled sequentially.

[0066] In an embodiment, the platform 840 may need to be tilted in a first direction to enable the fill tube 836 of the first valve tower 832 and in a second direction to enable 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 enable all of the fill tubes 836. For example, a 75L Celsius® FFT container has fill and drain ports disposed on the left side of the container, such that the tilting stage 140 is tilted to the right or clockwise to enable the container and the fill tube 836. In contrast, the 12L, 6L, 4L, and 2L Celsius® FFT containers have fill and drain ports at the front of the container, such that the tilting stage 140 is tilted rearward to enable the container and the fill tube 836. In an embodiment where two valve towers 832 are used with fill and discharge ports for containers located on each side of the platform 840, the tilt table 140 can be tilted to the right to enable the containers and fill tube 836 on the left valve tower 832, and then the tilt table 140 can be tilted to the left to enable the containers and fill tube 836 on the right valve tower 832.

[0067] Once the fill tube 836 is activated, 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 so that the amount of the biopharmaceutical composition can be determined by the weight of the platform 840. The tilt table 140 can be returned to a neutral position after activation and during filling. During activation and / or filling, the pump 820 can be activated to flow the biopharmaceutical composition from the supply vessel 810 to the container 850.

[0068] Container 850 can be filled in a tilted or neutral position. When container 850 is filled in a neutral position, container 850 can be tilted at the end of the filling process to allow the biopharmaceutical composition to clear from fill tube 836 and enter container 850.

[0069] With container 850 filled and fill tube 836 cleared, container 850 is sealed (step 360) and the bulk carrier including container 850 is removed from platform 840 (step 370).

[0070] It has been found that activating the container and the fill tube 836 prior to filling can reduce or eliminate the gas within the container 850. For example, in some experiments, the amount of air within each container can be reduced by 100 mL. Reducing the air in the container can increase the life of the biopharmaceutical composition stored in the container. The increase in the life of the biopharmaceutical composition may be the result of reduced interaction between the biopharmaceutical composition and the remaining air in the container.

[0071] Reference now Fig.14 According to an embodiment of the present disclosure, referring to the exhaust system 801 and Figures 4 to 12 The tilting mechanism of the present invention describes a method of discharging a container, and the method is generally referred to as method 400. To begin the discharging operation, a discharging scheme is selected (step 405). A container 850 including a biopharmaceutical composition to be discharged is loaded onto the platform 840 (step 410). The container 850 can be loaded onto the platform as part of a bulk transport device. A product vessel 870 for receiving the biopharmaceutical composition is placed in fluid communication with the FDS 830 using a pipe 822 (step 420). With the product vessel 870 placed in fluid communication with the FDS 830, one or more of the container valves 834 are opened to allow the biopharmaceutical composition to flow from the container 850 to the product vessel 870 (step 420). The pump 820 can be activated to allow the biopharmaceutical composition to flow from the container 850 to the product vessel 870. During the discharging, the tilting mechanism 100 can be in a neutral position or can be tilted, as described in detail below. When one or more of the containers 850 are drained or substantially drained, the containers 850 are tilted to clean the containers 850 and the drain tubes 837 connected to the containers 850 (step 430). Tilt the containers 850 and drain tubes 837 to allow the containers 850 and drain tubes 837 to drain substantially completely.

[0072] During discharge, it may be necessary to tilt the platform 840 in more than one direction to clean the container 850 and the drain tube 837. For example, a 75L Celsius® FFT container has fill and drain ports disposed on the left side of the container, such that the tilt table 140 is tilted left or counterclockwise to drain the container 850 and the drain tube 837. In contrast, the 12L, 6L, 4L, and 2L Celsius® FFT containers have fill and drain ports at the front of the container, such that the tilt table 140 is tilted forward to drain the container and the drain tube 837. In embodiments where two valve towers 832 are used with fill and drain ports for the containers located on each side of the platform 840, the tilt table 140 can be tilted to the left to clean the container 850 and the drain tube 837 on the left valve tower 832, and then the tilt table 140 can be tilted to the right to clean the container and the drain tube 837 on the right valve tower 832. In some configurations, a limited amount of the biopharmaceutical composition can be discharged from the container 850 without tilting during the discharge process. Thus, tilting the container 850 can allow for substantially complete draining of the container 850. Tilting the container 850 and drain tube 837 can allow for additional biopharmaceutical composition to be extracted from the container 850.

[0073] In some embodiments, the steps of the filling method 300 and / or the draining 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, the controller 102 can monitor the amount of biopharmaceutical composition filled into or drained from the container 850 and switch between containers 850 during the filling or draining operation. In some embodiments, the controller 102 can operate valves or clamps of the container 850 during the filling and / or draining operation. In certain embodiments, the controller 102 can operate valves of a sampling tube during the filling and / or draining operation to sample the biopharmaceutical composition at different times during the respective operation.

[0074] Although several embodiments of the present disclosure have been shown in the accompanying drawings, it is not intended to limit the present disclosure thereto, as it is intended that the scope of the present disclosure be as broad as the art will allow and the specification is read similarly. Any combination of the above embodiments is also foreseeable and within the scope of the appended claims. Therefore, the above description should not be interpreted as limiting, but merely as an illustration of a particular embodiment. Other modifications within the scope of the appended claims will occur to those skilled in the art.

Claims

1. A tilting mechanism, comprising: A base having a rectangular base frame; A tilting table having a rectangular table frame; four multi-dimensional hinges, one hinge being positioned adjacent each corner of the base frame and each corner of the table frame, each hinge comprising a ball and a receiver, wherein the ball or the receiver is secured to the base frame or the table frame and the other of the ball or the receiver is secured to the other of the base frame or the table frame, each hinge further comprising a locking member such that each hinge has a captured state in which the locking member secures the ball within the corresponding receiver and a released state in which the locking member allows the ball to enter and exit the corresponding receiver; and A lifting member is fixed at the center of the base frame and the center of the table frame, the lifting member being configured to push the table frame away from the base frame so that selective engagement allows the table frame to tilt in at least four directions relative to the base frame.

2. The tilt mechanism according to claim 1, wherein: The tilt table is configured to support a weighing platform configured to determine an amount of fluid disposed within one or more containers located on the weighing platform.

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

4. The tilt mechanism according to claim 3, wherein: The lift bag is an air bag that expands in response to receiving gas in the air bag.

5. The tilt mechanism according to claim 3, wherein: The lift bag is in fluid communication with a pump that provides fluid to inflate the lift bag.

6. The tilt mechanism according to claim 1, wherein: The tilt table has a neutral position when the lifting member is in a non-extended position with each ball disposed in a respective one of the receptacles.

7. The tilt mechanism according to claim 1, wherein: The tilt table has a first tilt position in which a first hinge and a fourth hinge of the four hinges are in the captured state and a second hinge and a third hinge of the four hinges are in the released state, so that the tilt table tilts about a first tilt axis defined by the first hinge and the fourth hinge in response to extension of the lifting member.

8. The tilt mechanism according to claim 7, wherein: In the first tilt position, the tilt table is rotated about the first tilt axis at an angle in the range of 5 degrees to 45 degrees.

9. The tilt mechanism according to claim 7, wherein: The tilt table has a second tilt position in which 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 tilt table tilts about a second tilt axis defined by the second hinge and the third hinge in response to extension of the lifting member.

10. The tilt mechanism according to claim 9, wherein: The tilt table has a third tilt position in which 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 tilt table tilts about a third tilt axis defined by the first hinge and the second hinge in response to extension of the lifting member.

11. The tilt mechanism according to claim 1, wherein: The locking member is a fork that can slide linearly into and out of a corresponding receiver to transition the hinge between the captured state and the released state.

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

13. The tilt mechanism according to claim 11, wherein: The hinge includes a biasing member that urges the fork into or out of the receiver.

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

15. A multi-dimensional hinge, comprising: sphere; a receiver configured to selectively receive the ball; and A locking member capable of linearly translating between a capture position in which the ball is secured within the receptacle and a release position in which the ball is permitted to enter and exit the receptacle, the receptacle being capable of moving relative to the ball in at least two degrees of freedom while the ball is secured within the receptacle.

16. The hinge according to claim 15, wherein: The locking element is a fork-shaped member having two prongs that can be linearly moved into and out of the receiver to secure the ball within the receiver.

17. The hinge of claim 15, further comprising a biasing member configured to urge the locking member toward the captured position or the released position.

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

19. The tilt mechanism according to claim 18, wherein: The lifting member is an extendable bag disposed between the base frame and the table frame.

20. The tilt mechanism of claim 18, further comprising a multi-dimensional hinge, wherein the multi-dimensional hinge is disposed at each corner of the base frame and each corner of the table frame, each multi-dimensional hinge being selectively engageable to allow the table frame to tilt in at least two degrees of freedom relative to the base frame.

21. The tilt mechanism according to claim 21, wherein: The multi-dimensional hinge includes a ball and a receiver, wherein the ball is fixed to one of the base frame or the table frame, and the receiver is fixed to the other of the base frame and the table frame, and the receiver is configured to selectively fix a corresponding ball within the receiver.

22. A method of operating a tilt mechanism for filling or draining a fluid container supported on the tilt mechanism, the method comprising: tilting a table frame supporting a fluid container in a first direction by placing the first hinge and the second hinge in a captured state and placing the third hinge and the fourth hinge in a released state and actuating a lift mechanism to push the table frame away from the base frame; as well as The table frame is tilted in a second direction opposite to the first direction by placing the first hinge and the second hinge in a released state and placing the third hinge and the fourth hinge in a captured state and actuating a lifting mechanism to push the table frame away from the base frame.

23. The method of claim 22, further comprising tilting the table frame in a third direction different from the first direction and the second direction by placing the first hinge and the third hinge in a captured state and placing the second hinge and the fourth hinge in a released state and actuating a lifting mechanism to push the table frame away from a base frame.

24. The method according to claim 22, wherein: Actuating the lift mechanism includes providing fluid into a lift bag such that the lift bag expands to push the table frame away from the base frame.

25. The method according to claim 22, wherein: Tilting the table frame in the first direction includes rotating the table frame around a first axis defined by the first hinge and the second hinge, wherein tilting the table frame in the second direction includes rotating the table frame around a second axis defined by the third hinge and the fourth hinge.

26. The method of claim 22, wherein: Placing one of the first hinge, the second hinge, the third hinge, or the fourth hinge in the captured state includes actuating a locking mechanism to secure a ball within a receptacle such that the hinge can rotate about the ball in two degrees of freedom.

27. The method according to claim 26, wherein: Actuating the locking mechanism to secure the ball includes translating a fork into the receiver such that two prongs of the fork are disposed around a neck of the ball to prevent the ball from being withdrawn from the receiver.

28. The method of claim 22, wherein: Placing one of the first hinge, the second hinge, the third hinge, or the fourth hinge in the released state includes actuating a locking mechanism to allow a ball to exit a receiver.

29. The method according to claim 28, wherein: Actuating the locking mechanism to allow the ball to exit the receptacle includes translating a fork such that a prong of the fork is disposed substantially outside of the receptacle to enable the ball to be withdrawn from the receptacle.

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