A powder injection device, method, and system for injecting powder
The powder injection device addresses contamination and exposure risks in traditional spiking methods by providing precise and controlled powder addition, enhancing the accuracy of RTD and MTD analysis in continuous tablet production.
Patent Information
- Application Number
- PCT/EP2025/065952
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-06-07
- Filing Date
- 2025-06-06
- Publication Date
- 2025-12-11
AI Technical Summary
Traditional spiking methods for continuous tablet production involve manual addition of tracers, which pose risks of contamination and exposure to harmful substances, lack control over timing and rate of addition, and reduce the accuracy of Residence Time Distribution (RTD) and Mass Time Distribution (MTD) analysis.
A powder injection device with a cavity for storing a pre-defined amount of powder, connected to a powder unit, that uses actuators to control the fluid connection and sealing of the inlet, allowing precise and controlled addition of powder without contamination or exposure, and includes multiple cavities for continuous use.
The device ensures precise and controlled addition of powder, reducing contamination risks and enhancing the accuracy of RTD and MTD analysis by maintaining a contained system and minimizing exposure to aerosols.
Smart Images

Figure EP2025065952_11122025_PF_FP_ABST
Abstract
Description
[0001] Title of Invention
[0002] A powder injection device, method, and system for injecting powder.
[0003] Technical Field
[0004] The present invention relates to the field of continuous production processes, especially to the field of continuous production of tablets, pellets, and capsules. The present invention relates to a powder injection device for adding a pre-defined amount of powder into a powder unit, a method of adding an amount of powder to a powder unit, and a system for adding powder to a powder unit of a tablet press.
[0005] Background Art
[0006] In the continuous production of tablets, spiking is a technique used to assess the quality of the production process. The technique involves adding a known quantity of a tracer into the continuous manufacturing process, referred to as "spiking" the system.
[0007] The technique aids in process dynamic characterization by monitoring the tracer, it can be ensured that the flow of material through the entire system is operating as designed. Additionally, spiking allows for Residence Time Distribution (RTD) and Mass Time Distribution (MTD) analysis, which is fundamental to understanding how long the material stays in the system. The RTD gives insights into the flow dynamics and potential hold-up times within the process.
[0008] The spiking is often done by a person adding a known amount of tracer into the continuous process by hand, for example by pouring the content of a measuring container into a processing part of a pharmaceutical processing system, such as a blender or a manifold of a blender. In order to pour in the desired content of the measuring container, access generally needs to be provided to the processing part, leading to a risk of breaking containment of the processing system. Consequently, there is a risk that a person performing spiking is exposed to potentially potent or harmful substances as the process is running, allowing for, for instance, powder to be processed, such as an active pharmaceutical ingredient to escape through a spiking opening. Additionally, traditional spiking risks contaminating the production process with extraneous materials, such as skin cells, dust or other impurities, due to breach of contamination and as a consequence, compromise the output pharmaceutical product quality.
[0009] An additional drawback of the traditional spiking methods manual introduction of tracer is the lack of control over the timing of addition, as well as the rate of tracer addition to the process, thus introducing an uncertainty when using the spiking in RTD or MTD analysis, reducing the accuracy of these.
[0010] Thus, it remains desirable to provide a spiking method allowing for an increased reliability of the analyses as well as robust spiking method, allowing for a reduced risk for contamination of operators and manufactured pharmaceutical product.
[0011] Summary of the Invention
[0012] An object of the present invention is to address the above-mentioned drawbacks, this is achieved in a first aspect by a powder injection device, the powder injection device being connectable to an inlet of a powder unit. Alternatively, the powder injection device is connectable to the powder unit. It is appreciated that the powder unit may be a blender, such as a linear blender, a feeder, manifold, or the like.
[0013] The powder injection device comprises a cavity for storing a pre-defined amount of powder. The pre-defined amount of powder may be pre-defined as it is measured by mass and / or volume before it is inserted in the cavity. Furthermore, the cavity may be delimited by walls. Those walls may be formed by a drum, alternatively the cavity may be delimited by a container. The drum or container may be enclosed by an enclosure with an opening having the same shape as the inlet of the powder unit keeping the cavities closed in the disconnected state.
[0014] The powder injection device further comprises an actuator configured to, in a connected state of the powder injection device to the inlet of the powder unit, change the powder injection device from a first state, in which the cavity is fluidly disconnected from the inlet of the powder unit, into a second state, in which the cavity is fluidly connected to the inlet of the powder unit so as to allow, in the second state, the pre-defined amount of powder from the cavity to enter the powder unit. An open side of the cavity may be aligned with the inlet of the powder unit in the second state, while in the first state the open side of the cavity may be not aligned with the inlet and instead faces a plate of the powder injection device.
[0015] Furthermore, the powder injection device comprises a control device operably connected to the actuator and configured to operate the actuator to change the powder injection device from the first to the second state, and wherein the powder injection device is configured to, when in the connected state, unseal the inlet of the powder unit at least prior to the powder injection device entering the second state, and wherein the powder injection device is further configured to seal the inlet of the powder unit prior to entering a disconnected state, in which the powder injection device is disconnected from the powder unit, such as the inlet of the powder unit. The actuator may be connected to a baseplate via a rail. Thereby, the actuator may be moved to disengage a coupling to allow for eased disconnecting.
[0016] Thereby the device advantageously allows to inject a pre-defined amount of powder into a powder unit and observe a production parameter, such as residence time, during an ongoing production without contaminating the production with unwanted contaminants or expose personnel to aerosols and / or airborne particles of the production process. Additionally or alternatively, the point in time at which the injection takes place may be controllable with high precision, or at least the point in time at which the injection takes place may be recorded with high precision. Consequently, subsequent analyses may have a higher precision.
[0017] A cavity may be a cavity of a container. The powder injection device may, thus, comprise one or more cavities for storing a predetermined or pre-defined amount of powder. Alternatively or additionally, the first cavity may equally be denoted a first container. Similarly a second cavity, a third cavity, any further cavity, a plug cavity may equally be denoted a second container, a third container, a further container, a plug container, or the like. Correspondingly, any cavity denoted in here may be a cavity of a corresponding container. The powder may be a spiking material, such as an active pharmaceutical ingredient or the like, a dye, or other common materials used for spiking.
[0018] By a connected state of the powder injection device to the inlet of the powder unit may herein be understood that the powder injection device in the connected state is in a position to inject the powder into the powder unit by operations of the powder injection device, such as operations only by the powder injection device. In the connected state, the powder injection device may be connected to and / or fixed to the powder unit.
[0019] Correspondingly, by a disconnected state of the powder injection device to the inlet of the powder unit may herein be understood that the powder injection device in the disconnected state is prevented from injecting the powder into the powder unit by operations of the powder injection device, such as solely by operations of the powder injection device. In the disconnected state, the powder injection device may be disconnected from and / or physically removed from the powder unit.
[0020] The powder unit may be a powder processing unit, such as any one of a blender, a feeder, a manifold, or the like. The powder unit may be a powder unit of a pharmaceutical processing device, such as a tablet press.
[0021] By fluidly connected may herein be understood that at least powder, such as the powder of the cavity, may enter through the connection.
[0022] The control device may be any control device. The control unit may be configured to control any actuator. The control device may comprise a processing unit and a memory comprising instructions causing the processing unit to perform the functions, i.e. operate the actuator to change the powder injection device from the first to the second state. The processing unit may be and / or comprise any processing unit, such as one or more of a central processing unit (CPU), a microcontroller unit (MCU), a field-programmable gate array (FPGA), a programmable logic controller (PLC), or the like. Correspondingly, the memory may be and / or comprise any type of memory, such as random-access memory (RAM), read-only memory (ROM), or the like.
[0023] The actuator may be any actuator, such as a linear actuator, an electrical motor, such as an Alternating Current (AC) motor, a Direct Current (DC) motor, a stepper motor, or the like. The actuator may alternatively or additionally comprise gearing, chains, belts or the like to cause the actuation between the respective states.
[0024] By sealing the inlet may herein be understood to prevent a fluid connection between the inlet of the powder unit and the surroundings of the powder unit. The sealing may be provided by the powder injection device reestablishing a seal, such as re-establishing a lip seal, closing a valve or the like, prior to or upon entering the disconnected state. Alternatively or additionally, the sealing may be provided by inserting a plug to cover and / or seal the inlet, e.g. so as to prevent a fluid connection between the powder unit and its surroundings.
[0025] Correspondingly, by unsealing the outlet may herein be understood to establish a fluid connection between the inlet of the powder unit and the surroundings of the powder unit. When in the connected state, the powder injection device may be configured and / or arranged to establish a fluid connection between the powder unit and at least a portion of the powder injection device. The unsealing may be provided by the powder injection device breaking a seal, such as opening / breaking a lip seal, closing a valve or the like, upon entering the connected state. Alternatively or additionally, the unsealing may be provided by removing a plug to uncover and / or unseal the inlet, e.g. so as to allow a fluid connection between the powder unit and its surroundings, i.e. the powder unit in the connected state.
[0026] In some embodiments, the powder injection device may be a contained system, at least during operation of the powder injection device and / or in the connected state of the powder injection device. Alternatively or additionally, the powder injection device may, at least during operation of the powder injection device and / or in the connected state of the powder injection device, form part of a contained system, for instance so that the powder unit or a pharmaceutical processing system, of which the powder unit is part, with the powder injection device in the connected state to the powder unit form a contained system. The contained system may be contained to the same level as the pharmaceutical processing system.
[0027] By the term "contained system" is herein to be understood that a system is to fulfil certain requirements to containment, i.e. that the system when functioning is at least dust tight. Equally, any part denoted herein as "contained" may be configured so that the part, at least during use, fulfils certain requirements to containment, i.e. that the system when functioning is at least dust tight. Correspondingly, a contained system may be a system which when functioning is configured to prevent that extensive amounts, such as detectable amounts and / or amounts over a certain threshold, of pharmaceutical components are emitted from the contained system into the surroundings, such as into a room in which it is arranged. By "contained" may herein be understood that a respective system and / or part is to have a containment capability of dust containment of up to 1 pg per m3. Correspondingly, a contained system or part may be a system or part, which when functioning is configured to have a dust containment of up to 1 pg per m3.
[0028] In some embodiments, the transition from the first to the second state may comprise a physical movement of at least part of the powder injection device. Alternatively or additionally, the actuator may be configured to change the powder injection device from the first to the second state by physically moving the cavity. For instance, the actuator may be configured to change the powder injection device from the first to the second state by physically moving the cavity, such as at least an opening of the cavity, from being misaligned with the inlet in the first state to be aligned with the inlet in the second state.
[0029] In some embodiments, the actuator may further be configured to change the powder injection device from the second state to the first state. Correspondingly, the control device may be configured to operate the actuator to change the powder injection device from the second to the first state. The transition from the second state to the first state may be corresponding to the transition from the first to the second state as described above.
[0030] The powder injection device may be suitable for or configured to adding a pre-defined amount of powder into a powder unit.
[0031] In some embodiments of the powder injection device, the cavity is a first cavity and the powder injection device comprises a second cavity for storing a second pre-defined amount of powder and the actuator is configured to, in the connected state of the powder injection device, change the powder injection device from the second state, into a third state, in which the second cavity is fluidly connected to the inlet of the powder unit so as to allow, in the third state, the second pre-defined amount of powder from the second cavity to enter the powder unit. It is appreciated that the second cavity may be delimited by walls that are formed by the same drum that is forming the first cavity. Thus, the powder injection device allows to inject a second pre-dosed amount of powder into a powder unit without having to reload the powder injection device after injecting the first pre-defined amount of powder. Thereby multiple spikings may be performed, while the powder injection device is mounted.
[0032] The second cavity may be identical or similar to the first cavity. For instance, the second cavity may have the substantially same or same volume as the first cavity, may have the substantially same or same shape as the first cavity, and / or may be configured to store the substantially same or same amount of powder as the first cavity.
[0033] The first cavity may be configured to store a first pre-defined amount of powder. The first and second pre-defined amounts of powder may be identical or different.
[0034] The control device may be further configured to operate the actuator to change the powder injection device from the second state to the third state.
[0035] In some embodiments, the actuator may further be configured to change the powder injection device from the first state to the third state and / or from the third state to any one of the second or first state. Correspondingly, the control device may be configured to operate the actuator to change the powder injection device from the first to the third state and / or from the third to the second or first state.
[0036] It is appreciated that the powder injection device may comprise further cavities, such as a third cavity, or such as a third cavity and a fourth cavity, or such as a third cavity, fourth cavity, and fifth cavity, and so on. Each such cavity may be configured to or suitable for storing a respective pre-defined amount of powder, which may be identical to each other or different. Each of these further cavities may be formed by walls in a drum of the powder injection device. Additionally, this would enable extended use of the powder injection device before refilling becomes necessary.
[0037] It will be appreciated that by addition of such further cavities, the actuator may be further configured to change into and from further states, in which a respective one of the cavities are fluidly connected to the inlet of the powder unit. Correspondingly, the control device may be configured to operate the actuator to changing into such further states.
[0038] In any one of the first, second, or any further potential states, only one cavity may be fluidly connected to the inlet. Any remaining cavity may be fluidly disconnected from the inlet.
[0039] Any cavity denoted herein may be a cavity of a respective container, cartridge or the like. Such container, cartridge or the like may comprise an opening for allowing for the fluid connection between the respective cavity and the inlet when the powder injection device is in the corresponding state.
[0040] In some embodiments of the powder injection device, the actuator is configured to change the powder injection device from at least the second to the third state by a rotational motion of the first and second cavities.
[0041] Thereby the first and second cavity can be put into the second and third state while maintaining a compact form of the powder injection device.
[0042] This may similarly apply where further cavities and / or further containers are provided.
[0043] In some embodiments of the powder injection device, the actuator is a first actuator and the powder injection device comprises a second actuator configured to apply a force to the pre-defined amount of powder towards the inlet of the powder unit.
[0044] The time of the powder injection may be greatly reduced while the certainty of the injection is increased.
[0045] In some embodiments of the powder injection device, the second actuator comprises a piston for pushing a pre-defined amount of powder out of the powder injection device. Thereby the injection of powder is performed with even greater certainty as the piston affects the pre-defined amount of powder uniformly. The second actuator may be a linear actuator configured to expel the pre-defined amount of powder out of the powder injection device.
[0046] The piston may be for pushing the pre-defined amount of powder out of the cavity. The piston may be arranged to and / or configured to push out the powder from the cavity in the second state. Where multiple cavities are provided, the piston may be arranged to and / or configured to push out the powder from the cavity into the powder unit when the powder injection device is in the respective state, in which the respective cavity is fluidly connected to the inlet, i.e., the second state for the first cavity, the third state for the second cavity, etc.
[0047] In some embodiments of the powder injection device the second actuator is configured to push the pre-defined amount of powder out of the powder injection device in less than 5.0 seconds, such as less than 2.0 seconds, such as less than 1.5 seconds, such as less than 1.2 seconds, such as less than 1.0 seconds, such as less than 0.8 seconds, such as less than 0.6 seconds, such as less than 0.5 seconds, such as less than 0.2, such as less than 0.1 seconds, such as less than 0.05 seconds. Alternatively or additionally the second actuator is configured to push the pre-defined amount of powder out of the powder injection device with a delivery rate of more than 100 g / s, such as more than 200 g / s, such as more than 500 g / s.
[0048] The powder injection device provides thereby an increased level of precision.
[0049] In some embodiments of the powder injection device, the powder injection device further comprises a plug cavity, the plug cavity being configured to receive a plug in the connected state, and wherein the powder injection device comprises an actuator configured to, in the connected state of the powder injection device, extract a plug from the inlet of the powder unit into the plug cavity and to insert the plug from the plug cavity into the inlet of the powder unit prior to switching from the connected state to the disconnected state. The plug cavity may be similar in shape as the cavity and should there be at least two cavities, similar to those cavities, alternatively the plug cavity may be differently shaped, for example if the cavities are cylindrical the diameter of the plug cavity may be larger than the diameter of the other cavities. In the case that the inlet of the powder unit may be round the diameter of the plug cavity may be the same diameter as the one of the inlet. The plug cavity may be formed by the drum.
[0050] The powder injection device thus is able to unseal the opening by removing the plug and storing it in a clean and controlled cavity, thereby being able to reuse the plug, and avoid exchange of material from the powder unit to the environment and vice versa.
[0051] The actuator may be the second actuator or may be a further actuator, such as a third actuator, a sealing actuator, or the like.
[0052] In some embodiments of the powder injection device, in the first state, the first cavity is not aligned with the inlet of the powder unit and in the second state the first cavity is aligned with the inlet of the powder unit.
[0053] Consequently the injection process is reliable as accidental injection is avoided.
[0054] In some embodiments of the powder injection device, a volume of the cavity configured to store pre-defined amount of powder of the cavity is less than 1 liter and more than 1 milliliter, such as less than 0.5 liter and more than 5 milliliter.
[0055] In some embodiments of the powder injection device, the powder unit is a blender or a manifold.
[0056] In some embodiments of the powder injection device, the powder injection device further comprises a control device configured to control the actuator, and when the second actuator is present, the control device is furthermore configured to store at least a value indicating time information of, when at least the actuator is activated. Additionally the control device may control a gripper actuation for grabbing and releasing pistons located in the cavities and the plug.
[0057] Thereby the point in time at which the powder injection device injected powder is known with great precision. Alternatively, the control device is furthermore configured to store at least a value indicating time information of, when at least the second actuator is activated.
[0058] Another aspect relates to a method of adding a pre-defined amount of powder in a powder unit, the method comprising the steps of: a) filling a cavity of a powder injection device with a pre-defined amount of the powder, b) connecting the powder injection device to a powder unit, c) unsealing an inlet of the powder unit, d) changing the powder injection device from a first state, in which the cavity is fluidly disconnected from the inlet of the powder unit, into a second state, in which the cavity is fluidly connected to the inlet of the powder unit so as to allow, in the second state, the pre-defined amount of powder from the cavity to enter the powder unit, e) sealing the inlet of the powder unit, and f) disconnecting the powder injection device from the powder unit, wherein step c) is performed subsequent to step b) and wherein step f) is performed subsequent to step e).
[0059] Thereby the method advantageously injects a pre-defined amount of powder into a powder unit and allows to observe a production parameter, such as residence time, during an ongoing production without contaminating the production with unwanted contaminants, and reduce the risk of exposing personnel to potent active ingredients. Additionally or alternatively, the point in time at which the injection takes place may be controllable with high precision.
[0060] The method according to the second aspect may provide the same or identical advantages and benefits described in relation to the powder injection device according to the first aspect. It will be appreciated that any embodiment disclosed in relation to the powder injection device according to the first aspect may equally apply to the method according to the second aspect of the invention.
[0061] The method steps may occur in the order a), b), c), d), e), f).
[0062] In some embodiments, the method may be a method of operating a powder injection device according to the first aspect of the invention. The method may comprise a step of providing a such device. Changing the state of the powder injection device may be performed by a control device and an actuator.
[0063] In some embodiments of the method, the cavity is a first cavity and wherein step a) further comprises filing a second cavity of the powder injection device with a second pre-defined amount of powder, and wherein the method further comprises: g) subsequent to step d) and prior to steps e) and f), changing the powder injection device into a third state in which the second cavity is fluidly connected to the inlet of the powder unit so as to allow, in the third state, the second pre-defined amount of powder from the second cavity to enter the powder unit, wherein, in the first and second states, the second cavity is fluidly disconnected from the inlet of the powder unit.
[0064] Thus the method allows to inject a second pre-dosed amount of powder into a powder unit without having to reload the powder injection device after injecting a first pre-defined amount of powder. It is appreciated that the method may comprise filling further cavities, such as a third cavity, or such as a third cavity and a fourth cavity, or such as a third cavity, fourth cavity, and fifth cavity.
[0065] Where further cavities are provided, such as third, fourth cavities, etc., for containing powder, steps corresponding to steps d) and g) may be performed for each cavity, i.e. changing the powder injection device into third, fourth states, etc.
[0066] In some embodiments, steps d) and, where step g) is present, may comprise pushing, optionally by a second actuator and / or a piston thereof, the pre-defined amount of powder out of the powder injection device, such as out of the respective first and / or second cavities. Step d) and, where step g) is present also step g), may further comprise pushing, optionally by a second actuator and / or a piston thereof, the respective pre-defined amount of powder out of the powder injection device, such as the respective cavity, in less than 5.0 seconds, such as less than 2.0 seconds, such as less than 1.5 seconds, such as less than 1.2 seconds, such as less than 1.0 seconds, such as less than 0.8 seconds, such as less than 0.6 seconds, such as less than 0.5 seconds, such as less than 0.2, such as less than 0.1 seconds, such as less than 0.05 seconds
[0067] In some embodiments of the method, step c) comprises removing a plug from the inlet and storing this in a plug cavity of the powder injection device, and wherein step e) comprises inserting the plug from the plug cavity into the inlet.
[0068] The powder injection device thus is able to unseal the opening by removing the plug and storing it in a clean and controlled cavity, thereby being able to reuse the plug.
[0069] In some embodiments of the method, the method comprises the step of pushing, by an actuator of the powder injection device, the pre-defined amount of powder towards the inlet of the powder unit.
[0070] The time of the powder injection may be greatly reduced while the certainty of the injection is increased.
[0071] A third aspect relates to a system for adding powder to a powder unit of a tablet press, the system comprising a powder injection device according to any one of the previously described embodiments relating to a device and a tablet press, comprising a powder unit.
[0072] Thereby the device advantageously allows to inject a pre-defined amount of powder into a tablet production process and observe a production parameter, such as residence time, during an ongoing production without contaminating the production with unwanted contaminants. Additionally or alternatively, the point in time at which the injection takes place may be controllable with high precision.
[0073] The system according to the third aspect of the present invention may provide the same or identical advantages and benefits described in relation to the powder injection device according to the first aspect and / or to the method according to the second aspect. It will be appreciated that any embodiment disclosed in relation to the powder injection device according to the first aspect and / or to the method according to the second aspect of the invention may equally apply to the system according to the third aspect of the present invention.
[0074] In some embodiments of the system, the powder unit may be a blender and the powder injection device may be connected to an inlet of the blender. A blender may generally refer to any type of blender units for blending or mixing one or more powders. It will be appreciated that such blender units are commonly known in the art.
[0075] A fourth aspect relates to a system comprising: a blender comprising an inlet, and a powder injection device according to the first aspect, wherein the powder injection device is connected to the inlet of the blender.
[0076] The further aspect may provide similar or identical advantages to the powder injection device according to the first aspect, the method according to the second aspect, and / or the system according to the third aspect. In particular, the system according to the fourth aspect allows for a reliable and secure addition of a predetermined amount of powder into the blender, e.g., during operation of the blender.
[0077] In some embodiments, the powder injection device may be connected to the inlet of the blender via a manifold of the blender.
[0078] It will be appreciated that any embodiment described with respect to the powder injection device according to the first aspect may equally apply to the powder injection device of the system of the fourth aspect.
[0079] The different aspects of the present invention can be implemented in different ways including a powder injection device, a method of adding an amount of powder in a powder unit, a system comprising a powder injection device and a tablet press, and a system comprising a blender and a powder injection device as described above and in the following, each yielding one or more of the benefits and advantages described in connection with at least one of the aspects described above, and each having one or more preferred embodiments corresponding to the preferred embodiments described in connection with at least one of the aspects described above and / or disclosed in the dependent claims. Furthermore, it will be appreciated that embodiments described in connection with one of the aspects described herein may equally be applied to the other aspects. Brief Description of Drawings
[0080] In the following description embodiments of the invention will be described with reference to the drawings, in which
[0081] FIG. 1 is a cross-sectional view of a powder injection device.
[0082] FIG. 2 is a flowchart showing the steps performed in a method.
[0083] FIG. 3 is a perspective view of a system comprising a powder injection device and a powder unit.
[0084] FIG. 4 is a perspective view of a powder injection device.
[0085] Detailed description
[0086] The present invention will now be described in more detail hereinafter with reference to the accompanying drawings, in which embodiments of the invention is shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided for thoroughness and completeness.
[0087] Starting with FIG. 1, a powder injection device 20 is shown the powder injection device 20 comprises a first cavity 22 configured to be filled with a predefined amount of powder. A cavity may be a cavity of a container or a drum 2. The powder injection device may, thus, comprise one or more containers and / or cavities. Alternatively or additionally, the first cavity 22 may equally be denoted a first container. Similarly a second cavity, a third cavity, any further cavity, or a plug cavity may equally be denoted a second container, a third container, a further container, a plug container, or the like.
[0088] The first cavity 22 is aligned with an inlet 3 of a powder unit so as to allow pre-loaded powder to be injected into the powder unit. On top of the first cavity 22 there is a piston 30 configured to be pushed down towards the inlet 3 of the powder unit by a second actuator 24, the second actuator 24 may be a linear actuator. The second actuator comprises a gripper actuation 25 for grabbing and releasing a plug 29 or a piston 30. The plug 29 is configured to be stored inside the plug cavity 31 while the powder injection device is in a connected state. Furthermore, the device comprises a first actuator 26 configured to rotate a drum 2 forming the first cavity and potentially additional cavities. Alternatively, or additionally, the cavity / cavities may be configured to store up to a predetermined mass of powder, such as up to 200 grams, such as between 5 and 150 grams. Correspondingly, the pre-defined amount of powder may be up to 200 grams, such as between 5 and 150 grams. Alternatively or additionally, the cavity / cavities may be configured to store a mass of powder corresponding to a predetermined percentage, such as between 2 % and 15 %, such as between 5 % and 10 %, of a residence mass of a blender of a pharmaceutical processing system. Alternatively or additionally the cavities may be configured to hold powder with a bulk density of 0.1 to 1.4 grams per milliliter and a mass of up to 200 grams.
[0089] The cavities may be rotated by the first actuator 26 such that a bottom opening of one of the cavities align with the inlet of the powder unit.
[0090] The cartridge as shown in FIG. 1 is connected to a blender head 12 of the powder unit. The first actuator may be connected to a base plate 21 via a rail 27, allowing to decouple the first actuator 26 from a coupling 28 and consequently easing the removal of a part of the powder injection device delimiting the cavity or cavities, for example a drum 2. The powder unit comprises a filter 15 configured to allow air to move from the inside of the powder unit to the environment and vice versa while hindering the movement of particles.
[0091] FIG. 2 is a flowchart of a method for adding a pre-dosed amount of powder to a powder unit. The first step 100 a) is to fill a cavity of a powder injection device with a pre-defined amount of the powder. The amount of powder may be weighed or measured by volume before it is placed inside the cavity. This step may be executed by a person in a protected environment. After the cavity is loaded it is connected 101 b) by manual installation in proximity to the powder unit. The cavity may be formed by a container and this container may be connected to the first actuator allowing to rotate the container that forms the cavity. The third step 102 c) is to unseal the inlet of the powder unit. This may be done by removing, by the second actuator 24, a plug 29 from the inlet of the powder unit and storing the plug 29 inside an additional cavity. Alternatively a controllable valve may be opened. After the inlet is unsealed the state of the powder injection device is changed 103 d) from a first state, in which the cavity is fluidly disconnected from the inlet of the powder unit, into a second state, in which the cavity is fluidly connected to the inlet of the powder unit so as to allow, in the second state, the pre-defined amount of powder from the cavity to enter the powder unit. The step may comprise changing, by an actuator of the powder injection device, the powder injection device from the first to the second state. Steps c) and d) may be performed simultaneously, or step d) might be performed subsequent to step c). For example the first actuator may rotate the container forming the cavity over the inlet and thus establish a fluid connection between the cavity and the powder handling device. This may cause the pre-determined amount of powder to fall into the powder unit. Thereafter the method comprises sealing 104 e) the inlet and removal 105 f) of at least parts of the powder injection device. For example, the container configured to form cavities may be removed such as for example, the drum 2. After which the container or drum may be loaded again with powder.
[0092] Step d) might be performed subsequent to step c). Alternatively or additionally, steps e) and f) may be performed simultaneously, or step f) might be performed subsequent to step e).
[0093] The powder injection device may be the powder injection device according to the first aspect.
[0094] FIG. 3 shows a system comprising a tablet press and a powder injection device as described before. Besides the powder injection device there are also powder feeders 13 connected to a blender head 12. In the shown system both the powder injection device and the powder feeders 13 are connected to a linear blender 11 which has a blender outlet 14 connectable to a tablet press (not shown), capsule machine (not shown), pellet extruder (not shown), or subsequent blender (not shown).
[0095] FIG. 4 shows in detail a powder injection device 20. Here, the first actuator 26 is movably connected via a rail 27 to allow for the drum 2 to be removed for loading from the powder unit. The second actuator 24 comprises a gripper actuation 25 configured to grab and release a piston or a plug. Although some embodiments have been described and shown in detail, the invention is not restricted to them, but may also be embodied in other ways within the scope of the subject matter defined in the following claims. In particular, it is to be understood that other embodiments may be utilized, and structural and functional modifications may be made without departing from the scope of the present invention.
[0096] In device claims enumerating several means, several of these means can be embodied by one and the same item of hardware. The mere fact that certain measures are recited in mutually different dependent claims or described in different embodiments does not indicate that a combination of these measures cannot be used to advantage.
[0097] It should be emphasized that the term "comprises / comprising" when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.
[0098] List of reference numerals
[0099] 2 drum
[0100] 3 inlet
[0101] 11 linear blender, powder handling device
[0102] 12 blender header
[0103] 13 powder feeder
[0104] 14 blender outlet
[0105] 15 filter
[0106] 20 powder injection device
[0107] 21 base plate
[0108] 22 cavity
[0109] 23 lid
[0110] 24 second actuator
[0111] 25 gripper actuation
[0112] 26 first actuator
[0113] 27 rail
[0114] 28 coupling
[0115] 29 plug
[0116] 30 piston
[0117] 31 plug cavity
[0118] 100 filing-step
[0119] 101 connecting-step
[0120] 102 unsealing-step
[0121] 103 state-changing-step
[0122] 104 sealing-step
[0123] 105 removal-step
Claims
1. Claims1. A powder injection device, wherein the powder injection device is connectable to an inlet of a powder unit, wherein the powder injection device comprises: a cavity for storing a pre-defined amount of powder, an actuator configured to, in a connected state of the powder injection device to the inlet of the powder unit, change the powder injection device from a first state, in which the cavity is fluidly disconnected from the inlet of the powder unit, into a second state, in which the cavity is fluidly connected to the inlet of the powder unit so as to allow, in the second state, the pre-defined amount of powder from the cavity to enter the powder unit, a control device operably connected to the actuator and configured to operate the actuator to change the powder injection device from the first to the second state, wherein the powder injection device is configured to, when in the connected state, unseal the inlet of the powder unit at least prior to the powder injection device entering the second state, and wherein the powder injection device is further configured to seal the inlet of the powder unit prior to entering a disconnected state, in which the powder injection device is disconnected from the inlet of the powder unit, and wherein the cavity is a first cavity and the powder injection device comprises a second cavity for storing a second pre-defined amount of powder and the actuator is configured to, in the connected state of the powder injection device, change the powder injection device from the second state, into a third state, in which the second cavity is fluidly connected to the inlet of the powder unit so as to allow, in the third state, the second pre-defined amount of powder from the second cavity to enter the powder unit.
2. The powder injection device according to claim 1, wherein the actuator is configured to change the powder injection device from at least the second to the third state by a rotational motion of the first and second cavities.
3. The powder injection device according to any one of the preceding claims, wherein the actuator is a first actuator and the powder injection device comprises a second actuator configured to apply a force to the pre-defined amount of powder towards the inlet of the powder unit.
4. The powder injection device according to the claim 3, wherein the second actuator comprises a piston for pushing a pre-defined amount of powder out of the powder injection device.
5. The powder injection device according to any one of claims 3 - 4, wherein the second actuator is configured to push the pre-defined amount of powder out of the powder injection device in less than 5.0 seconds, such as less than 2.0 seconds, such as less than 1.5 seconds, such as less than 1.2 seconds, such as less than 1.0 seconds, such as less than 0.8 seconds, such as less than 0.6 seconds, such as less than 0.5 seconds, such as less than 0.2, such as less than 0.1 seconds, such as less than 0.05 seconds.
6. The powder injection device according to any one of the preceding claims, wherein the powder injection device further comprises a plug cavity, the plug cavity being configured to receive a plug in the connected state, and wherein the powder injection device comprises an actuator configured to, in the connected state of the powder injection device, extract a plug from the inlet of the powder unit into the plug cavity and to insert the plug from the plug cavity into the inlet of the powder unit prior to switching from the connected state to the disconnected state.
7. A powder injection device according to any one of the preceding claims, wherein, in the first state, the first cavity is not aligned with the inlet of the powder unit and in the second state the first cavity is aligned with the inlet of the powder unit.
8. The powder injection device according to any one of the preceding claims, wherein a volume of the cavity configured to store pre-defined amount of powder of the cavity is less than 1 liter and more than 1 milliliter, such as less than 0.5 liter and more than 5 milliliter.
9. The powder injection device according to any one of the preceding claims, wherein the powder unit is a blender or a manifold.
10. A powder injection device according to any one of the previous claims, wherein the control device is configured to control the actuator, and when dependent on any one of claims 4 - 6 the second actuator, wherein the control unit is furthermore configured to store at least a value indicating time information of, when at least the actuator is activated.
11. A method of adding an amount of powder in a powder unit, the method comprising the steps of: a) filling a cavity of a powder injection device with a pre-defined amount of a powder, b) connecting the powder injection device to an inlet of a powder unit, c) unsealing the inlet of the powder unit, d) changing the powder injection device from a first state, in which the cavity is fluidly disconnected from the inlet of the powder unit, into a second state, in which the cavity is fluidly connected to the inlet of the powder unit so as to allow, in the second state, the pre-defined amount of powder from the cavity to enter the powder unit, e) sealing the inlet of the powder unit, and f) disconnecting the powder injection device from the powder unit, wherein step c) is performed subsequent to step b) and wherein step f) is performed subsequent to step e), and wherein the cavity is a first cavity and wherein step a) further comprisesfiling a second cavity of the powder injection device with a second pre-defined amount of powder, and wherein the method further comprises: g) subsequent to step d) and prior to steps e) and f), changing the powder injection device into a third state in which the second cavity is fluidly connected to the inlet of the powder unit so as to allow, in the third state, the second pre-defined amount of powder from the second cavity to enter the powder unit, wherein, in the first and second states, the second cavity is fluidly disconnected from the inlet of the powder unit.
12. The method according to claim 11, wherein step c) comprises removing a plug from the inlet and storing this in a plug cavity of the powder injection device, and wherein step e) comprises inserting the plug from the plug cavity into the inlet of the powder unit.
13. The method according to any one of claims 11 - 12, wherein the method comprises the step of pushing, by an actuator of the powder injection device, the predefined amount of powder towards the inlet of the powder unit.
14. A system for adding powder to a powder unit of a tablet press, capsule machine, or pellet extruder, the system comprising a powder injection device according to any one of claims 1 - 10 and a tablet press, comprising a powder unit.
15. The system according to claim 14, wherein the powder unit is a blender, and wherein the powder injection device is connected to an inlet of the blender.
Citation Information
Patent Citations
Powder pouring device
CN107792681A
Systems, methods and apparatuses for manufacturing dosage forms
US20030072799A1
Single piece device for storing, metering and mixing a powder with a diluent
US20110121017A1
Device for introducing a defined amount of a second powder into a process container
US20140311627A1