Humidity Control Device

Abstract

Humidity control devices, systems, and methods are provided for controlling humidity within a closed container. The humidity control device may include a cap configured to attach to the container; a first tubular member passing through the cap forming a first portion of the first tubular member and a second portion of the first tubular member, the first portion including a proximal end extending away from the cap, the second portion including an inlet portion configured to receive a fluid, the first portion being within the container and the second portion being outside the container when the cap is attached to the container; and the proximal end of the first tubular member including an outlet portion for delivering a fluid to an interior space of the container.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 217,445, filed July 1, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to humidity control devices and systems, and more particularly to humidity control devices and systems for pharmaceutical manufacturing processes. [Background technology]

[0003] The efficiency of a manufacturing process depends heavily on the ability of materials throughout the process to transfer from one unit to another. For example, manufacturing processes involving microparticles or nanoparticles can face flow challenges caused by moisture in the ambient air. Greater humidity (i.e., due to an increased amount of moisture in the ambient air) can cause the particles to absorb some of the moisture and to stick to equipment or to each other. Thus, high humidity or uncontrolled humidity can cause poor flow, which can lead to clogging, equipment malfunctions, inconsistent product quality, etc. Summary of the Invention [Means for solving the problem]

[0004] Provided herein are humidity control devices and systems for use in manufacturing processes. Also included are methods for controlling humidity in closed containers of manufacturing processes. The described humidity control devices, systems, and methods can increase the flowability of microparticles and nanoparticles, which can minimize the amount of downtime, equipment malfunctions, and inconsistent quality caused by material clogging, sticking, and poor flowability. In some embodiments, the provided humidity control devices can be used in pharmaceutical manufacturing processes (such as those involving roller compaction, tablet compression, and / or encapsulation).

[0005] Specifically, in roller compaction processes, poor flowability due to uncontrolled humidity can cause variable ribbon integrity, which can lead to different particle size distributions of the granules, which can affect downstream flow, dissolution of the final product, lubrication efficiency of the final blend, and changes in porosity / solid fraction of the granules.

[0006] In tablet compression processes, poor flowability can cause inconsistent weights, which can lead to unacceptable content uniformity or potency values ​​that are out of specification. It can also affect tablet hardness, friability, and the ability to apply an aqueous film coat as the next step in most processes.

[0007] Additionally, poor flowability can adversely affect the capsule filling process by causing inconsistent weights, which can lead to unacceptable content uniformity and / or potency values ​​that are out of specification.

[0008] Thus, the humidity control devices, systems, and methods provided herein can help achieve and maintain a desired humidity during a manufacturing process. The humidity control devices provided herein can also aerate and improve the flowability of materials in a manufacturing process. By achieving and maintaining a predetermined humidity level, materials in a manufacturing process may be able to flow more effectively downstream. Increased material flowability can help minimize clogging and malfunction of processing equipment, and can also minimize inconsistent uniformity.

[0009] Additionally, some manufacturing processes use hygroscopic materials. Hygroscopic materials absorb or adsorb water from the surrounding environment. Therefore, the optimal processing conditions for hygroscopic materials generally include low humidity. However, conventional systems for properly handling hygroscopic materials require special air handling units with high performance dehumidification systems. These systems are costly and time consuming to retrofit into existing facilities.

[0010] In some embodiments, the humidity control devices, systems, and methods are configured for use with manufacturing processes that use microparticles or nanoparticles. In some embodiments, the humidity control devices provided are configured for use with pharmaceutical manufacturing processes. In particular, the devices and systems described herein can be used with dry pharmaceutical manufacturing processes (e.g., roller compaction or direct blending) to achieve higher drug loadings than would otherwise be possible. For example, drug loadings of 40% or more by weight can be achieved with the humidity control devices and systems according to some embodiments.

[0011] In some embodiments, the humidity control device described can be configured to mount to a container, such as, for example, a hopper or bin. In some embodiments, the humidity control device can be configured to mount to two or more different containers (e.g., hoppers, bins) that are different sizes. The humidity control device can be mounted to the container at a top surface of the container. In some embodiments, the humidity control device can be mounted at a side surface or a bottom surface of the container. The humidity control device according to some embodiments can be fluidly coupled to a fluid supply. For example, the fluid supply can supply compressed air to the humidity control device. In some embodiments, the fluid supply is regulated by a flow meter.

[0012] The humidity control devices described herein include multiple outlets. When attached to the container, the multiple outlets are positioned within the container. In some embodiments, the outlets are submerged in the material. In some embodiments, the outlets are positioned within a void or open space of the container above an upper surface of the material. In some embodiments, the humidity control device includes one or more tubular members passing from the exterior of the container to the interior of the container. In some embodiments, the humidity control device includes multiple branches, the multiple branches extending from a portion of the one or more tubular members that is positioned within the container when the bottle lid is coupled to the bottle / container. Each branch includes one or more outlets at a proximal end. In some embodiments, each tubular member includes one or more outlets at a distal end of the portion of the tubular member that is positioned within the container when the bottle lid is coupled to the bottle / container. Fluid from the fluid supply passes from the humidity control device through the outlets to the interior of the container. In some embodiments, each outlet includes a nozzle.

[0013] The humidity control devices provided herein can additionally include an air vent. The air vent can include a filter. In some embodiments, the humidity control device can include a pressure relief valve.

[0014] In some embodiments, the depth to which the outlet extends into the container is adjustable. For example, the desired depth can depend on the size of the container, the amount of material in the container (and whether it is desired for the outlet to be submerged below the surface of the material or above the surface of the material), etc.

[0015] In some embodiments, a humidity control device is provided, the device comprising: a cap configured to attach to a container; a first tubular member passing through the cap forming a first portion of the first tubular member and a second portion of the first tubular member, the first portion including a proximal end extending away from the cap, the second portion including an inlet portion configured to receive a fluid, the first portion being within the container and the second portion being outside the container when the cap is attached to the container; and the proximal end of the first tubular member including an outlet portion for delivering fluid to an interior space of the container.

[0016] In some embodiments of the device, the first tubular member is centrally positioned relative to the cap.

[0017] In some embodiments of the device, the device includes a second tubular member passing through the cap forming a first portion of the second tubular member and a second portion of the second tubular member, the first portion including a proximal end extending away from the cap, the second portion including an inlet portion configured to receive a fluid, when the cap is attached to the container, the first portion is within the container and the second portion is outside the container, and the proximal end of the second tubular member includes an outlet portion for delivering fluid to an interior space of the container.

[0018] In some embodiments of the device, each outlet includes one or more nozzles.

[0019] In some embodiments of the device, the device includes an air vent in the cap.

[0020] In some embodiments of the device, the air vent comprises a filter.

[0021] In some embodiments of the device, the device includes a pressure relief valve in the cap.

[0022] In some embodiments of the device, the fluid comprises compressed air.

[0023] In some embodiments of the device, the device is configured to achieve a relative humidity within the container of 20% or less.

[0024] In some embodiments, a humidity control system is provided, the system including: a container; a humidity control device; a cap configured to attach to the container; a first tubular member passing through the cap forming a first portion of the first tubular member and a second portion of the first tubular member, the first portion including a proximal end extending away from the cap, the second portion including an inlet portion configured to receive a fluid, the first portion being within the container and the second portion being outside the container when the cap is attached to the container; and a fluid supply, the fluid supply fluidly connected to the second portion of the tubular member of the humidity control device and configured to deliver fluid to the humidity control device; the proximal end of the first tubular member including an outlet portion for delivering fluid to an interior space of the container.

[0025] In some embodiments, a humidity control device is provided, the device including: a cap configured to attach to a container; a central tubular member passing through the cap forming a first portion of the central tubular member and a second portion of the central tubular member, the first portion including a proximal end extending away from the cap, and the second portion including an inlet portion configured to receive a fluid, wherein when the cap is attached to the container, the first portion is within the container and the second portion is outside the container; and a plurality of branches extending from the proximal end of the first portion of the central tubular member, each branch including a distal end at the central tubular member and a proximal end extending away from the central tubular member, each proximal end including an outlet portion for delivering a fluid to an interior space of the container.

[0026] In some embodiments of the device, the multiple prongs include four, five, or six prongs.

[0027] In some embodiments of the device, each outlet includes one or more nozzles.

[0028] In some embodiments of the device, the device includes an air vent in the cap.

[0029] In some embodiments of the device, the air vent comprises a filter.

[0030] In some embodiments of the device, the device includes a pressure relief valve in the cap.

[0031] In some embodiments of the device, each branch of the multiple branches extends away from the central tubular member in a direction perpendicular to the direction in which the central tubular member passes through the cap.

[0032] In some embodiments of the device, each branch of the multiple branches extends away from the central tubular member and away from the cap in a direction that is at an angle between 0 degrees and 90 degrees relative to the direction in which the central tubular member passes through the cap.

[0033] In some embodiments of the device, each branch of the multiple branches extends away from the central tubular member and away from the cap in a direction that is at an angle of between 30 degrees and 60 degrees relative to the direction in which the central tubular member passes through the cap.

[0034] In some embodiments of the device, the multiple branches are equally spaced around the proximal end of the central tubular member.

[0035] In some embodiments of the device, the multiple branches are not equally spaced around the proximal end of the central tubular member.

[0036] In some embodiments of the device, the fluid comprises compressed air.

[0037] In some embodiments of the device, the device is configured to achieve a relative humidity within the container of 20% or less.

[0038] In some embodiments, a humidity control system is provided, the system including: a container; a humidity control device; a cap configured to attach to the container; a central tubular member passing through the cap forming a first portion of the central tubular member and a second portion of the central tubular member, the first portion being within the container and including a proximal end extending away from the cap, and the second portion being outside the container and including an inlet portion configured to receive a fluid; and a plurality of branches extending from the proximal end of the first portion of the central tubular member, each branch including a distal end at the central tubular member and a proximal end extending away from the central tubular member, each proximal end including an outlet portion for delivering a fluid to an interior space of the container; and the humidity control system includes a fluid supply, the fluid supply fluidly connected to the second portion of the central tubular member of the humidity control device and configured to deliver a fluid to the humidity control device.

[0039] In some embodiments of the system, the system includes a hygrometer configured to measure the humidity of the fluid exiting the container.

[0040] In some embodiments of the system, the system includes a controller configured to control fluid flow from the fluid supply to the humidity control device based on humidity measurements received from the hygrometer.

[0041] In some embodiments of the system, the system includes an adjustment mechanism configured to allow the central tubular member to slide through the cap to adjust the lengths of the first and second portions of the central tubular member, and the adjustment mechanism configured to lock the central tubular member in place once a desired position is achieved.

[0042] In some embodiments of the system, the multiple prongs include four, five, or six prongs.

[0043] In some embodiments of the system, each outlet includes one or more nozzles.

[0044] In some embodiments of the system, the system includes an air vent in the cap.

[0045] In some embodiments of the system, the air vent includes a filter.

[0046] In some embodiments of the system, the system includes a pressure relief valve in the cap.

[0047] In some embodiments of the system, each branch of the multiple branches extends away from the central tubular member in a direction perpendicular to the direction in which the central tubular member passes through the cap.

[0048] In some embodiments of the system, each branch of the multiple branches extends away from the central tubular member and away from the cap in a direction that is at an angle between 0 degrees and 90 degrees relative to the direction in which the central tubular member passes through the cap.

[0049] In some embodiments of the system, each branch of the multiple branches extends away from the central tubular member and away from the cap in a direction that is at an angle between 30 degrees and 60 degrees relative to the direction in which the central tubular member passes through the cap.

[0050] In some embodiments of the system, the multiple branches are equally spaced around the proximal end of the central tubular member.

[0051] In some embodiments of the system, the multiple branches are not equally spaced around the proximal end of the central tubular member.

[0052] In some embodiments of the system, the fluid includes compressed air.

[0053] In some embodiments of the system, the device is configured to achieve a relative humidity in the container of 20% or less.

[0054] In some embodiments, a method for controlling humidity in a container is provided, the method including the steps of receiving a fluid from a fluid supply; passing the fluid through a humidity control device, the humidity control device being attached to the container such that the humidity control device passes through a wall of the container, the humidity control device being fluidly connected to the fluid supply; and diffusing the fluid into an interior space of the container to achieve a humidity level of 20% relative humidity or less within the container.

[0055] In some embodiments, any one or more of the features, characteristics, or elements discussed above with respect to any of the embodiments may be incorporated into any of the other embodiments described above or elsewhere herein. [Brief description of the drawings]

[0056] [Figure 1] FIG. 1 illustrates a humidity control device attached to a container according to some embodiments. [Diagram 2] FIG. 1 illustrates a humidity control device according to some embodiments. [Diagram 3] FIG. 1 illustrates an image of a humidity control device according to some embodiments. [Figure 4] FIG. 1 illustrates an image of a humidity control system including a humidity control device attached to a container, according to some embodiments. [Diagram 5] 1 illustrates a method for controlling humidity inside a container according to some embodiments. [Figure 6] FIG. 1 illustrates a humidity control device attached to a bin lid, according to some embodiments. [Figure 7] FIG. 1 illustrates a humidity control device attached to a bin lid, according to some embodiments. [Figure 8A] FIG. 13 is a close-up view of multiple branches extending from a central tubular member, according to some embodiments. [Figure 8B] FIG. 13 is a close-up view of multiple branches extending from a central tubular member, according to some embodiments. [Figure 9] FIG. 13 is a close-up view of multiple outlets according to some embodiments. [Figure 10] 13A-13C illustrate dispense time data for various humidity control device configurations, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0057] Described herein is a humidity control device for use in a manufacturing process. The humidity control device can improve the flowability of various materials (e.g., materials including microparticles, nanoparticles, etc.) by controlling the humidity of the environment surrounding the material. The humidity control device and system according to some embodiments can also aerate the material in a container to improve the flowability of the material. Aeration promotes the flow of particles due to the air gaps required for the particles to rearrange in such a manner and to move by gravity.

[0058] Conventional humidity control systems require rooms or facilities equipped with special air handlers, which are very expensive, to achieve the low humidity levels of <20% relative humidity required in many manufacturing processes. For example, some compounds (e.g., hygroscopic compounds) can only be successfully handled at such low humidity levels without compromising the stability and / or efficacy of the compound.

[0059] Thus, humidity control devices and systems according to embodiments described herein can achieve desired process conditions (e.g., humidity levels) necessary for optimal material flow and handling at a lower cost, with less materials, and with less labor than would otherwise be required to fit out an entire process room or facility.

[0060] In some embodiments, the humidity control devices described herein can be configured to attach to containers (e.g., bins, hoppers) used during the manufacturing process, more specifically, to bin / container lids or caps. Containers that may be suitable for use with the humidity control devices provided herein can include containers used for blending, storage, and / or transfer to downstream processing. Additionally, the humidity control devices and systems described are configured to be used with conventional containers. Although there are certain containers / bins that include ports for air jets, these bins are expensive and often must be custom-made. Thus, the humidity devices can be used with conventional containers that do not need to be specially ordered or manufactured, thus minimizing the costs associated with controlling humidity to improve the flowability of materials. Furthermore, because the humidity control devices can be used with conventional containers, the devices are versatile and portable, which allows them to be easily switched from one container to another and from one processing line to another.

[0061] The humidity control device can improve the flowability of the material by diffusing a fluid (e.g., gas) in the processing environment. The fluid can be used to achieve and maintain a predetermined humidity. The controlled humidity and aeration of the material provided by the humidity control device can improve the material flowability and minimize the occurrence of equipment clogging or malfunction. The improved flowability can also improve the content uniformity of the final product. Furthermore, controlling the humidity of the processing environment can be particularly useful for certain materials, such as, for example, hygroscopic materials. Hygroscopic materials attract water from the surrounding environment through absorption or adsorption. When this occurs, the physical properties (e.g., volume, viscosity) of the hygroscopic material change, which can adversely affect its flowability. In particular, when the hygroscopic material absorbs or adsorbs moisture from the surrounding environment, the cohesive properties of the hygroscopic material increase, which reduces the flowability of the material.

[0062] In some embodiments, the humidity control device can be used in pharmaceutical manufacturing processes, food manufacturing processes, dietary supplement processing, and any other processes involving the transfer of powdered or granular materials. Furthermore, the humidity control devices provided herein can be used in dry processes, wet processes, and / or oxygen-sensitive processes or other processes that require a controlled atmosphere. For example, dry pharmaceutical manufacturing processes (e.g., roller compaction or direct blending) can achieve higher drug loadings using humidity control devices / systems according to some embodiments than would otherwise be possible. For example, drug loadings of up to 90% or more by weight can be achieved with humidity control devices and systems according to some embodiments.

[0063] The humidity control system may include a fluid supply in fluid communication with the humidity control device. The flow of fluid from the fluid supply to the humidity control device may be controlled by a flow meter. The fluid enters the humidity control device through a conduit extending from the fluid supply to the humidity control device and exits through a plurality of outlets. When installed in a container of a manufacturing process, the outlets of the humidity control device are positioned within the closed container. The outlets may each include a nozzle through which the fluid exits the device and enters a processing environment (e.g., an interior space of the container).

[0064] The humidity control system may additionally include an air vent (which may optionally include a filter), a pressure relief valve, and / or an adjustment mechanism that may adjust the depth to which the outlet portion extends into the container.

[0065] In some embodiments, the humidity control device of the humidity control system includes one or more tubular members that extend from the exterior of the container to the interior of the container when the humidity control device is attached to the container. In cases where the humidity control device is attached to the top surface of the container, the one or more tubular members can extend vertically. In some embodiments, the portion of the one or more tubular members that is positioned within the container when the device is attached to the container can include multiple branches. In some embodiments, the multiple branches extend radially from a central body portion. The branches each include a distal end and a proximal end on the one or more tubular members. The proximal end of each branch includes an outlet port through which fluid exits the device and enters the interior of the container.

[0066] Referring now to the drawings, wherein like parts are marked throughout this specification and the drawings with the same reference numerals, respectively. The drawing figures are not necessarily to scale and in certain figures parts may be exaggerated for purposes of clarity.

[0067] 1 illustrates a humidity control device 102 attached to a container 104, according to some embodiments. As shown, the humidity control device 102 includes a tubular member 106, a number of branches 108, and a number of outlets 110.

[0068] The container 104 can be any closed chamber used during the manufacturing process. For example, the container 104 can be a bin, a hopper, a big bag, a drum, a tablet press, an encapsulation machine, a high shear granulator, a low shear granulator, a collette gral, etc. In some embodiments, the humidity control device 102 is configured to attach to the container 104 at a top location as shown in the figure. In some embodiments, the humidity control device 102 can be configured to attach to the container 104 at a side or bottom of the container 104. In some embodiments, the humidity control device 102 can be centrally attached to the container 104. In some embodiments, the humidity control device can be attached to the container 104 offset from the central location.

[0069] The container 104 can be used in a manufacturing process for a pharmaceutical compound. In some embodiments, the container 104 is configured to hold materials for a pharmaceutical compound. The materials can include excipients and / or active pharmaceutical ingredients (APIs). In some embodiments, the materials can include microparticles, nanoparticles, and the like. In some embodiments, the materials can include a higher drug loading than could otherwise be achieved by using the disclosed humidity control device. For example, the materials can include 10-90% API by weight. In some embodiments, the materials can include 90, 80, 70, 60, 50, 40, 30, or 20% API or less by weight. In some embodiments, the materials can include 10, 20, 30, 40, or 50% API or more by weight.

[0070] The humidity control device 102 includes a tubular member 106 that extends from the exterior of the container 104 through the walls of the container 104 to the interior of the container 104. In some embodiments, the tubular member 106 is configured to slide into and out of the container 104 to adjust the depth to which the humidity control device 102 extends into the container 104. In some embodiments, when the humidity control device 102 is attached to the top of the container 104, the tubular member 106 can extend vertically into the container 104. The tubular member 106 can include a straight shaft, as shown in FIG. 1, or the tubular member 106 can include one or more bends to form multiple straight sections (e.g., as shown in FIG. 3). In some embodiments, the tubular member 106 passes through a cap, which is attached to the container 104 at the geometric center of the cap. In some embodiments, the tubular member 106 passes through the cap at a location that is not the geometric center of the cap. In some embodiments, the tubular member 106 includes one or more bends inside the container 104 (when the humidity control device 102 is attached to the container 104). In some embodiments, the tubular member 106 includes one or more bends outside the container 104 (when the humidity control device 102 is attached to the container 104).

[0071] The portion of the tubular member 106 that is positioned within the container 104 (when the humidity control device 102 is attached to the container 104) can include multiple branches 108 extending radially from the tubular member 106. Each branch 108 includes a distal end (of the tubular member 106) and a proximal end. In some embodiments, each branch extends radially from the tubular member 106 in a direction perpendicular to the direction in which the tubular member 106 passes through the cap. In some embodiments, each branch extends from the tubular member 106 at an angle such that the proximal end of each branch points away from the entry point of the tubular member 106 (i.e., the point where the tubular member 106 passes through the wall of the container 104).

[0072] In some embodiments, each proximal end includes an outlet 110 through which fluid exits the humidity control device 102 and enters the interior environment of the container 104. In some embodiments, each outlet 110 includes a nozzle. In some embodiments, each outlet 110 includes two or more nozzles. In some embodiments, each outlet 110 and / or branch 108 includes two or more nozzles that can direct fluid in different directions from the device 102. In some embodiments, each outlet 110 includes a hole through which fluid can exit the device 102. In some embodiments, each branch 108 includes multiple holes through which fluid can exit the device 102.

[0073] In some embodiments, the humidity control device 102 may not include a branch. For example, the tubular member 106 may include an outlet 110 at an end of the tubular member 106 that is positioned within the container 104 when the humidity control device is attached to the container 104.

[0074] In some embodiments, the humidity control device 102 can include two, three, four, five, six, seven, eight, nine, or ten branches 108. Each branch 108 of the multiple branches 108 can extend from the tubular member 106 such that the multiple branches 108 are equally spaced around the tubular member 106. In some embodiments, each branch 108 of the multiple branches 108 may not be equally spaced around the tubular member 106. In some embodiments, each branch 108 can include a single straight member. A branch 108 having a single straight member can extend from the tubular member 106 perpendicularly (with respect to the direction in which the tubular member 106 passes through the cap) or at an angle (e.g., extend at an angle and away from the tubular member 106). In some embodiments, each branch 108 can include one or more bends or two or more straight members. For example, FIG. 1 shows branches 108 each having a bend. Stated another way, each branch 108 in FIG. 1 includes two straight members. In some embodiments, one straight member can extend perpendicular to the tubular member 106 and one straight member can extend parallel to the tubular member 106. In some embodiments, one straight member can extend perpendicular to the tubular member 106 and one straight member can extend at an angle between 0 degrees and 90 degrees relative to the direction in which the tubular member 106 passes through the cap. In some embodiments, two straight members can extend at an angle between 0 degrees and 90 degrees relative to the tubular member 106. In some embodiments, one straight member can extend parallel to the direction in which the tubular member 106 passes through the cap.In some embodiments, one or more straight members of the branches 108 may extend away from the tubular member 106 at an angle between 30 degrees and 60 degrees relative to the tubular member 106. Specifically, one or more straight members of the branches 108 may extend away from the tubular member 106 at an angle relative to the direction in which the tubular member 106 passes through the wall of the container 104. The configuration of the branches 108 may be important to achieve an efficient humidity control mechanism and may depend on the type and particle size of the material, the size and shape of the container, and / or the depth to which the tubular member 106 extends into the pin.

[0075] In some embodiments, the humidity control device may not include a branch extending from the tubular member 106. In some embodiments, the humidity control device may include multiple tubular members with or without multiple branches extending from each of the multiple tubular members.

[0076] For example, in some embodiments, the humidity control device can include one or more tubular members that pass through the bottle lid or cap, such as those depicted in FIG. 6 and / or FIG. 7. For example, instead of the central tubular member 106 of FIG. 1 that includes multiple branches extending (e.g., radially) from a central body portion, the humidity control device can include a single tubular member that passes through the bottle lid or cap, such as a central tubular member that does not include multiple extending branches. In this embodiment, the portion of the tubular member that is below the surface of the bottle lid or cap or is within the bottle when the lid / cap is attached to the bottle. In some embodiments, instead of the central tubular member of FIG. 1 that includes multiple branches extending (e.g., radially) from a central body portion, the humidity control device can include multiple tubular members that pass through the bottle lid or cap. In some embodiments, the multiple tubular members can pass through the bottle lid / cap such that a single tube is not centrally positioned relative to the bottle lid. In some embodiments, the tubular members can be symmetrically positioned relative to the bottle lid. In some embodiments, one or more of the plurality of tubular members may have multiple branches extending (e.g., radially) from a bottom portion of the tube. In some embodiments, the tubular member may not include any extending branches. In some embodiments, the nozzle or hole is in a portion of the tubular member that is below the surface of the bottle lid or cap, or is within the bottle when the lid / cap is attached to the bottle. In some embodiments, the humidity device may include 2-10, 2-8, 2-6, or 3-5 tubular members. In some embodiments, the humidity control device may include 10, 9, 8, 7, 6, 5, 4, or 3 or less tubular members. In some embodiments, the humidity control device may include 2, 3, 4, 5, 6, 7, 8, or 9 or more tubular members.

[0077] 2 illustrates a humidity control system 200 according to some embodiments. As shown, the humidity control system 200 includes a humidity control device 202 that includes a tubular member 206, a cap 207, a number of branches 208, an outlet 210, a pressure relief valve 222, an air vent 224, a filter 226, and an adjustment mechanism 220. The humidity control system 200 also includes a fluid supply 212, a flow meter 216, a conduit 214, and a coupling mechanism 218.

[0078] The humidity control device 202 may include any of the features described above with respect to the humidity control device 102 of FIG. 1. The humidity control device 202 may include a tubular member 206 passing through a cap 207. In some embodiments, the cap 207 may act as a lid for a container in which the humidity control device is attached. When attached to a container, the tubular member 206 passes through an opening in the wall of the container to form an interior portion of the tubular member 206 (i.e., 206b) and an exterior portion of the tubular member 206 (i.e., 206a). In some embodiments, the tubular member 206 may include a single straight shaft. In some embodiments, the tubular member 206 includes one or more bends to form multiple straight sections. In some embodiments, the tubular member 206 may pass through the cap 207 at the geometric center of the cap 207. In some embodiments, the tubular member 206 passes through the cap 207 at a location that is offset from the geometric center of the cap 207.

[0079] The length of the inner portion 206b and the length of the outer portion 206a can be adjusted using the adjustment mechanism 220. For example, the depth to which the tubular member 206 extends into the container can depend on the particular manufacturing process, the type of material, the amount of material, whether the outlet portion 210 is submerged in the material or positioned above the material in the container, etc. In some embodiments, the adjustment mechanism 220 can include a nut, a clamp, or the like.

[0080] The interior portion 206b of the tubular member 206 includes a distal end located at the cap 207 (where the tubular member 206 passes through the wall of the container) and a proximal portion located furthest from the entry point (i.e., the point where the tubular member 206 enters the container). In some embodiments, a plurality of branches 208 extend from a location near the proximal end. Each branch includes a distal end and a proximal end in the tubular member 206. Each proximal end of each branch 208 includes an outlet port through which fluid passes from the humidity control device 202 to the interior space of the container in which the device is attached. In some embodiments, all branches 208 of the plurality of branches 208 are of the same size and shape. In some embodiments, the plurality of branches 208 can include two or more different sizes and / or shapes. In some embodiments, the proximal end of the interior portion 206b of the tubular member 206 also includes an outlet port. For example, as shown in FIG. 2, outlets are located at both the proximal-most end of inner portion 206b and at the proximal end of each branch 208 that extends from a location near the proximal end of inner portion 206b.

[0081] The branches 208 can take different forms. In some embodiments, the branches 208 can include a single straight section. In some embodiments, the branches 208 can include two or more straight sections (e.g., having one or more bends). For example, as shown in FIG. 2, each of the four branches 208 includes a single bend or two straight sections. In some embodiments, one straight section of the branches 208 can extend perpendicular to the direction in which the tubular member 206 extends through the cap 207. In some embodiments, two or more straight sections of the branches 208 can extend at an angle between 0 degrees and 90 degrees, or between 30 degrees and 60 degrees, to the direction in which the tubular member 206 extends through the cap 207. In some embodiments, one or more straight sections extend in a direction away from the cap 207. Each outlet can include a nozzle or spray head.

[0082] The humidity control device 202 also includes a pressure relief valve 222, an air vent 224, and a filter 226. The pressure relief valve 222 is configured to release any pressure buildup in the closed container. The air vent 224 is configured to allow air to exit the closed container. The filter 226 can include a filter sock and work in conjunction with the air vent 224. The filter 226 can allow air to pass (and exit the closed container) while filtering out materials (e.g., microparticles, nanoparticles) so that the materials remain in the closed container. In some embodiments, the pressure relief valve 222 and the air vent 224 are both located at a location above the cap 207. The pressure relief valve 222 can act as a safety mechanism, for example, if the filter 226 becomes clogged with materials. When this occurs, the pressure relief valve 222 is configured to open and relieve any pressure buildup in the container. The humidity inside the container can be monitored by using a hygrometer to measure the humidity of the air exiting the system through air vent 224.

[0083] To control the humidity in the container, the humidity control system 200 can include a fluid supply 212. Specifically, the humidity control device 202 can be fluidly coupled to the fluid supply 212. For example, the fluid supply 212 can provide compressed air. Other suitable gases or fluids can include nitrogen, argon, or any other inert gas. The fluid supply 212 can be fluidly coupled to the humidity control device 202 via a conduit 214. The conduit 214 can be coupled to the tubular member 206 of the humidity control device 202 at a coupling mechanism 218. In some embodiments, the coupling mechanism 218 can be a quick connect coupling.

[0084] The flow meter 216 can be used to control the flow of fluid from the fluid supply 212 to the humidity control device 202. The flow meter 216 can be configured to measure and control the flow of fluid passing from the fluid supply 212 through the conduit 214 to the humidity control device 202. For example, the flow meter 216 could be capable of controlling the pressure of the fluid flowing to the humidity control device from 1-20 standard cubic feet per minute.

[0085] In some embodiments, the humidity control system 200 includes a controller. The controller can be designed to control the fluid supplied to the container 204 such that a predetermined humidity level is achieved and maintained. In some embodiments, the controller is configured to receive input from a user, such as, for example, a desired or predetermined humidity level. Based on this input, the controller is configured to control the flow of fluid from the fluid supply 212 delivered to the humidity control device 202 via the conduit 214. As explained above, the hygrometer can measure the humidity of the air exiting the container 204 via the air vent 224. This measurement can be transmitted to the controller, which can adjust the flow of fluid accordingly (e.g., via the flow meter 216). In some embodiments, the controller is configured to continuously monitor the humidity and control the incoming fluid flow accordingly.

[0086] In some embodiments, the humidity control system 200 is manually operated.

[0087] In some embodiments, a single humidity control device / system can be used with multiple different container sizes. Thus, humidity control devices and systems can be versatile and portable because they can be used with a variety of different containers, processing lines, different materials, etc.

[0088] The humidity control device can be easily cleaned, allow for versatility (e.g., for use in different bottles and / or with different materials), and minimize cross-contamination. Additionally, the device can include features that allow for thorough cleaning, such as, for example, visible threads and sanitary flanges. It can be made from sanitary materials, such as, for example, stainless steel and / or aluminum.

[0089] Humidity control devices can also be different sizes to accommodate a variety of container sizes. For example, one size is custom designed to fit 10L and 15L bins. Another size can be used with 50L and 100L bins, and another size may be suitable for use with 200L, 300L, 400L, and 600L bins. In some embodiments, humidity control devices can be configured to accommodate containers up to 1400L or larger.

[0090] Figure 3 shows an image of a humidity control device 300 according to some embodiments. As shown, the tubular member of the humidity control device of Figure 3 includes at least two bends below the cap and passes through the cap at a location that is offset from the geometric center. Figure 4 shows an image of a humidity control system 400 including a humidity control device attached to a container according to some embodiments.

[0091] How to Control Humidity Using a Humidity Control Device Humidity control devices and humidity control systems can be used to control humidity in closed spaces, aerate materials in containers, and improve material flowability. For example, the devices and systems provided herein can be used to control humidity in containers (e.g., bins, hoppers, big bags) used in manufacturing processes. In some embodiments, the devices and systems can be used to control humidity in containers used in pharmaceutical manufacturing processes. Controlling humidity can improve material flowability in the process, which can minimize processing challenges (e.g., clogging, malfunctions) and improve product quality.

[0092] The humidity device is attached to the container to control the humidity of the closed space and to improve the flowability of the material in the closed space. When attached to the container, the fluid inlet is located outside the container and the fluid outlet is located inside the container. The humidity control device can form an airtight seal with the container. Fluid enters the humidity control device from a fluid supply, which is fluidly connected to the fluid inlet of the humidity control device. The fluid passes through the humidity control device and is discharged through the fluid outlet of the humidity control device. Thus, the humidity control device diffuses the fluid into the closed space (i.e., the container) and aerates the material (including, for example, microparticles, nanoparticles). The humidity control device can also control the humidity as needed. In some embodiments, the humidity control device can control the humidity of the closed space to 1-75%, 5-50%, 5-30%, 5-20%, or 5-10%. In some embodiments, the humidity control device can control the humidity of the enclosed space to 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, or 5% or less. In some embodiments, the humidity control device can control the humidity to 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, or 70% or more. Conventional humidity control methods require modification or retrofitting of processing facilities. However, the humidity control device described herein can be used to control the humidity of a single container without the need to modify processing facilities. This can save significant time and costs.

[0093] FIG. 5 illustrates a method 500 for controlling humidity and therefore improving the flowability of a material in a container, according to some embodiments.

[0094] In step 502, fluid is received from a fluid supply (e.g., fluid supply 212 of FIG. 2). In step 504, the fluid is passed through a humidity control device (e.g., humidity control device 102 of FIG. 1, humidity control device 202 of FIG. 2). The humidity control device is attached to the container such that the humidity control device passes through the wall of the container and is fluidly connected to the fluid supply. In step 506, fluid is diffused from the humidity control device into the interior space of the container. This can achieve a relative humidity in the container of 20% or less.

[0095] (Example) The present disclosure is further illustrated by the following non-limiting examples.

[0096] Example 1 One example of a humidity control device and system can be in the configuration shown in Figure 2. As described below, this configuration was used to develop three different sizes of humidity control devices for use with different size containers.

[0097] The tubular member 206 is ¼ inch stainless steel pipe. The branches 108 are also made from ¼ inch stainless steel pipe. The four branches were configured in an “X” or “T” pattern as shown in FIG. 2. At the top, the coupling mechanism 218 is a quick connect coupling to accept the air inlet. The adjustment mechanism 220 is a lock nut. The air vent 224 is a 2 inch ferrule and the filter 226 is a 1 micron filter sock. The cap 207 is a tri-clover cap that can fit over a container lid. The outlet 210 is a full cone spray nozzle and the fluid provided by the fluid supply 212 is compressed air.

[0098] The respective dimensions for each of the three different size humidity control devices are as follows: Each consists of an 8" tri-clover cap that fits over the bin lid. The "X" pattern air nozzles are approximately 180mm apart and angled 45° downwards. The fifth nozzle points straight down. The total height of the adjustable pipe and air nozzles is approximately 150mm for the 10L and 15L bins, 300mm for the 50L and 100L bins, and 600mm for the 200L and 300L bins.

[0099] Example 2 Four different configurations of humidity control devices were tested with talc to determine the effect of each configuration on the delivery time of the talc. Specifically, the delivery time measures the total amount of time for the talc to exit the bottle. Each test included the same size bottle and the same amount of talc (the bottle was 80% filled with talc). In addition to a control (no humidity device), the four configurations tested included one tubular member, four tubular members, a tubular member with multiple branches above the talc product (i.e., antler design), and a tubular member with multiple branches within the talc product (i.e., antler design).

[0100] A first configuration, one tubular member configuration, is shown in Figure 6. As shown, a single tubular member 636 or central body portion is passed through a bottle lid or cap 607. The lid 607 includes an inner lid 630 and an outer lid 632. The inner lid 630 includes five compression fittings 634 and the outer lid 632 includes four compression fittings 634. Each compression fitting 634 can be used to insert a tubular member or can be uncapped. The tubular member / central body portion 636 includes multiple holes in the lower portion of the tubular member (i.e., the portion that is inserted into the bottle).

[0101] A second configuration, a four tubular member configuration, is shown in FIG. 7. As shown, four tubular members 736 are passed through an inner lid 732. (Lid 707, like lid 607, includes an inner lid 732 and an outer lid 734, each of which also includes a number of compression fittings 732.) Inner lid 730 includes five compression fittings 734 and outer lid 732 includes four compression fittings 734. Each compression fitting 734 can be used to insert a tubular member or can be uncapped. Each of the tubular members 736 includes a number of holes in the lower portion of the tubular member (i.e., the portion that is inserted into the bottle).

[0102] Both the third and fourth configurations, the antler configuration, are depicted in Figures 8A and 8B. As shown, the antler configuration includes a central tubular member 806 that includes multiple branches 808 that extend from the tubular member at a downward angle. Each of the branches 808 includes multiple inwardly facing holes.

[0103] FIG. 9 shows a close-up view of the holes 940 in each of the tubular members 636, 736 and / or branches 808.

[0104] Figure 10 shows the dispense times for each of the four configurations and the control. Note that the "antlers above product configuration" indicates that the prongs 808 shown in Figures 8A and 8B were positioned in the bottle such that they were above the talc level, and the "antlers in product" indicates that the prongs 808 shown in Figures 8A and 8B were positioned in the bottle such that they were below the talc level (i.e., inserted into the talc).

[0105] In this example, talc was used because it has relatively poor flow properties. As shown in the graph of FIG. 10, the shorter the dispense time, the better the performance of the humidity control device / configuration. Thus, the configurations of one tubular member, four tubular members, and antlers in the product were the most effective.

[0106] The foregoing description describes example systems, methods, techniques, parameters, etc. However, it should be recognized that such description is not intended as a limitation on the scope of the present disclosure, but instead is provided as a description of example embodiments.

[0107] Although the description herein uses the terms first, second, etc. to describe various elements, these elements should not be limited by such terms, these terms are only used to distinguish one element from another. [Explanation of symbols]

[0108] 102 Humidity Control Device 104 Container 106 Tubular member 108 Branch 110 Exit section 200 Humidity Control System 202 Humidity Control Device 206 Tubular members 206a: outer portion of tubular member 206 206b Inner portion of tubular member 206 207 Cap 208 Branch 210 Exit section 212 Fluid supply section 214 Conduit 216 Flow meter 218 Coupling Mechanism 220 Regulatory Mechanism 222 Pressure Relief Valve 224 Air Vent 226 Filters 300 Humidity Control Device 400 Humidity Control System 607 Lids, Caps 630 Inner lid 632 Outer lid 634 Compression Fitting 636 Single tubular member 707 Lid 730 Inner lid 732 Inner lid 734 Compression Fitting 736 4 tubular members 806 Central tubular member 808 Branch 940 Hole

Claims

1. A humidity control device, wherein the humidity control device comprises: a cap configured to be attached to a container; a first tubular member that passes through the cap and forms a first portion of the first tubular member and a second portion of the first tubular member, the first portion including a proximal end extending away from the cap, the second portion including an inlet configured to receive fluid, wherein when the cap is attached to the container, the first portion is inside the container and the second portion is outside the container, and the first tubular member; comprising a humidity control device, wherein the proximal end of the first tubular member includes an outlet for delivering the fluid into the internal space of the container.

2. The device according to claim 1, wherein the first tubular member is centered with respect to the cap.

3. The device includes a second tubular member that passes through the cap and forms a first portion of the second tubular member and a second portion of the second tubular member, the first portion including a proximal end extending away from the cap, the second portion including an inlet configured to receive fluid, wherein when the cap is attached to the container, the first portion is inside the container and the second portion is outside the container, a humidity control device, wherein the proximal end of the second tubular member includes an outlet for delivering the fluid into the internal space of the container.

4. The device according to any one of claims 1 to 3, wherein the device is configured to achieve a relative humidity in the container of 20% or less.

5. A humidity control system, wherein the humidity control system comprises: a container; a humidity control device; comprising wherein the humidity control device comprises: a cap configured to be attached to the container; A first tubular member, the first tubular member passing through the cap and forming a first portion of the first tubular member and a second portion of the first tubular member, the first portion including a proximal end extending away from the cap, the second portion including an inlet portion configured to receive fluid, wherein when the cap is attached to the container, the first portion is within the container and the second portion is outside the container, the first tubular member; A fluid supply unit, the fluid supply unit being fluidly connected to the second portion of the tubular member of the humidity control device and configured to deliver fluid to the humidity control device, the fluid supply unit; comprising; The humidity control system, wherein the proximal end of the first tubular member includes an outlet for delivering the fluid into the internal space of the container.

6. A humidity control device, the humidity control device a cap configured to be attached to a container; A central tubular member, the central tubular member passing through the cap and forming a first portion of the central tubular member and a second portion of the central tubular member, the first portion including a proximal end extending away from the cap, the second portion including an inlet portion configured to receive fluid, wherein when the cap is attached to the container, the first portion is within the container and the second portion is outside the container, the central tubular member; A plurality of branch portions extending from the proximal end of the first portion of the central tubular member, each branch portion including a distal end in the central tubular member and a proximal end extending away from the central tubular member, the proximal end of each branch portion including an outlet for delivering the fluid into the internal space of the container, the plurality of branch portions; A humidity control device comprising.

7. The device according to claim 6, wherein each branch portion of the plurality of branch portions extends away from the central tubular member in a direction perpendicular to the direction in which the central tubular member passes through the cap.

8. Each branch portion of the plurality of branch portions extends away from the central tube-shaped member and away from the cap in a direction at an angle between 0 degrees and 90 degrees with respect to the direction in which the central tube-shaped member passes through the cap. The device according to claim 6 or 7.

9. Each branch portion of the plurality of branch portions extends away from the central tube-shaped member and away from the cap in a direction at an angle between 30 degrees and 60 degrees with respect to the direction in which the central tube-shaped member passes through the cap. The device according to any one of claims 6 to 8.

10. A humidity control system, wherein the humidity control system A container; A humidity control device; Including The humidity control device A cap configured to be attached to the container; A central tube-shaped member, the central tube-shaped member passes through the cap, and forms a first portion of the central tube-shaped member and a second portion of the central tube-shaped member. The first portion is inside the container and includes a proximal end portion extending away from the cap. The second portion is outside the container and includes an inlet portion configured to receive fluid. A central tube-shaped member; A plurality of branch portions extending from the proximal end portion of the first portion of the central tube-shaped member, each branch portion includes a distal end portion in the central tube-shaped member and a proximal end portion extending away from the central tube-shaped member. The proximal end portion of each branch portion includes an outlet portion for delivering the fluid to the internal space of the container. A plurality of branch portions; Including Also, the humidity control system A fluid supply unit, the fluid supply unit is fluidly connected to the second portion of the central tube-shaped member of the humidity control device and is configured to deliver fluid to the humidity control device. A fluid supply unit A humidity control system including.

11. The system according to claim 10, wherein the system includes a hygrometer configured to measure the humidity of the fluid exiting the container.

12. The system according to claim 11, comprising a controller configured to control the fluid flowing from the fluid supply unit to the humidity control device based on a humidity measurement value received from the hygrometer.

13. The system according to any one of claims 10 to 12, comprising an adjustment mechanism configured to enable the central tube-shaped member to slide through the cap in order to adjust the lengths of the first and second portions of the central tube-shaped member, and the adjustment mechanism is configured to lock the central tube-shaped member in place when a desired position is achieved.

14. A method for controlling the humidity of a container, the method comprising: receiving a fluid from a fluid supply unit; passing the fluid through a humidity control device, wherein the humidity control device is attached to the container such that the humidity control device passes through the wall of the container, and the humidity control device is fluidly connected to the fluid supply unit; diffusing the fluid into the internal space of the container so as to achieve a humidity of 20% relative humidity or less inside the container; and including.

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