Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B30—PRESSES
  • B30B—PRESSES IN GENERAL
  • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
  • B30B11/02—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space
  • B30B11/08—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space co-operating with moulds carried by a turntable
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B30—PRESSES
  • B30B—PRESSES IN GENERAL
  • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
  • B30B11/005—Control arrangements
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B30—PRESSES
  • B30B—PRESSES IN GENERAL
  • B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
  • B30B15/30—Feeding material to presses
  • B30B15/302—Feeding material in particulate or plastic state to moulding presses

Definitions

• the present invention relates to a rotary tablet press comprising a turret, a turret, comprising a die element comprising one or more bores, a plurality of punches comprising at least one bottom punch and at least one top punch, a bottom punch guide supporting the at least one bottom punch, and a top punch guide supporting the at least one top punch, at least one filling device associated with the turret, said filling device comprising a feeder configured to, during operation of the rotary tablet press, arrange powder in the at least one bore of the die element.
• the present invention further relates to a method for producing a tablet outside of specification.
• tablets are generally formed from a material, such as a powder or granulate, which is compressed into tablets by a tablet press.
• a material such as a powder or granulate
• punches which apply a pressure to compress the material into a tablet during rotation of the turret of the rotary tablet press.
• a pre-compression e.g. by pre-compression rollers or cams moving the punches
• Such compression is typically caused by compression rollers or cams moving the punches to compress the material into the tablet.
• the tablets When manufacturing tablets, it is generally desirable to manufacture the tablets to have a certain mass and certain dimensions, depending on the specific tablet to be manufactured. Generally, a tolerance applies so that manufactured tablets with a mass within a certain, predefined mass range and with dimensions within a certain, predefined dimension range are considered acceptable. In order to manufacture such tablets, the rotary tablet press is often set up to cause such tablets to be produced.
• a system is commonly used to determine whether the tablets are within the tolerances, i.e. whether mass and dimensions are within the respective acceptable ranges, or outside of tolerances, i.e. mass and/or dimensions outside of a respective acceptable range.
• the tablets are sorted accordingly, so that tablets outside of tolerances are sorted separately from the tablets within tolerances.
• reject tests are often performed by replacing a punch of the turret with a special punch, which causes a tablet outside of tolerances to be produced.
• a special punch may have a different length so that more or less material is filled in the bore or another compression force is applied when producing the tablet, in turn resulting in a mass and/or dimensions outside of tolerances.
• the special punch should then be extracted and replaced to manufacture the desired tablets after the test has been performed. While generally reliable, this process may be time-consuming as the tablet press must be stopped from operation during exchange of the punches. Furthermore, in case of a system requiring a high degree of containment, the containment may need to be breached to exchange the punches, in turn requiring time-consuming safety procedures.
• An object of the present invention is to provide a rotary tablet press overcoming at least some of the above-mentioned drawbacks.
• the alteration device being configured to cause a tablet, i.e. one or more tablets, with outer dimensions and/or a mass outside of the respective predetermined range(s) by the plurality of punches during operation of the rotary tablet press, a reject test may be performed based on this manufactured tablet.
• a tablet i.e. one or more tablets
• punch replacements to alternative punches specifically configured to produce only tablets with specifications outside of the predetermined ranges may be avoided.
• the tablets or the material, which is compressed into tablets require containment, alleviating the need for this punch replacement may allow for a reject test without breaking this containment.
• the alteration device being configured, in the second state, to cause the tablet with outer dimensions outside of the predetermined dimension range and/or with a mass outside the predetermined mass range to be produced by the plurality of punches during operation of the rotary tablet press while maintaining the adjustment of the adjustable dosing device, no need for re-adjustment of any adjustable dosing device of the tablet press may be necessary.
• the alteration may be brought into the first state after the production of the tablet with specifications outside of the predetermined range(s) and subsequently manufacture tablets with specifications within the predetermined ranges without requiring re-adjustment and/or without stopping the operation of the tablet press.
• in-specification or in-spec tablet(s) may be used to refer to tablet(s) with a mass inside the predetermined mass range and outer dimensions within the predetermined dimension range.
• tablet(s) with outer dimensions outside of the predetermined dimension range and/or with a mass outside the predetermined mass range are in the present specification denoted out-of-specification or out-of-spec tablet(s).
• a tablet hardness may equally or alternatively be referred to.
• a tablet hardness depends on the mass and outer dimensions of tablet.
• the tablet having outer dimensions within a predetermined dimension range and having a mass within a predetermined mass range may be denoted a "first tablet” and the tablet with outer dimensions outside of the predetermined dimension range and/or with a mass outside the predetermined mass range may throughout the present disclosure be denoted a "second tablet”.
• the predetermined dimension range may be a dimension range, in which the tablet(s) may be considered acceptable and/or may be a desired or intended dimension range for the tablet(s).
• the predetermined dimension range may be an acceptable dimension range, a desired dimension range, an intended dimension range, or the like.
• the predetermined dimension range may be a tolerance dimension range for the tablet(s) to be produced, for instance so that tablets within the predetermined dimension range are considered within manufacturing tolerances.
• the predetermined dimension range may comprise nominal or desired outer dimensions for the tablet(s) and a tolerance.
• the predetermined dimension range may be determined based on the tablet(s) to be produced and/or characteristics thereof, such as a type of tablet(s), a product composition(s) including active pharmaceutical ingredient(s), a product specification, or the like.
• the predetermined dimension range may be a predetermined size range, or the like.
• the predetermined dimension range may comprise a dimension range for one or more outer dimensions.
• the predetermined dimension range may comprise a predetermined dimension range for one or more dimensions, such as a height, a width, and a length of the tablet(s).
• the predetermined dimension range may be or comprise a desired or predetermined height or thickness of a tablet and a tolerance.
• the tolerance may be up to ⁇ 2.0 mm, such as up to ⁇ 1.5 mm, such as up to ⁇ 1.0 mm, such as up to ⁇ 0.8 mm, such as up to ⁇ 0.6 mm, such as up to ⁇ 0.5 mm, such as up to ⁇ 0.4 mm, such as up to ⁇ 0.3 mm, such as up to ⁇ 0.2 mm, such as up to ⁇ 0.15 mm, such as up to ⁇ 0.1 mm.
• the predetermined dimension range may be h d ⁇ t d , where h d is a desired height or thickness of the tablet and t d is an absolute value of the depth or thickness tolerance.
• the predetermined mass range may be a mass range, in which the tablet(s) may be considered acceptable and/or may be a desired or intended mass range for the tablet(s).
• the predetermined mass range may be an acceptable mass range, a desired mass range, an intended mass range, or the like.
• the predetermined mass range may be a tolerance mass range for the tablet(s) to be produced, for instance so that tablets within the predetermined mass range are considered within manufacturing tolerances.
• the predetermined mass range may comprise a nominal or desired mass for the tablet(s) and a tolerance.
• the predetermined mass range may be determined based on the tablet(s) to be produced and/or characteristics thereof, such as a type of tablet(s), a product composition(s) including active pharmaceutical ingredient(s), a product specification, or the like.
• the predetermined mass range may alternatively be denoted a predetermined weight range.
• the predetermined mass range be a desired or predetermined mass of a tablet and a tolerance.
• the tolerance may be a percentage of the desired or predetermined mass of the tablet.
• the tolerance may be up to ⁇ 15 %, such as up to ⁇ 12 %, such as up to ⁇ 10 %, such as up to ⁇ 8 %, such as up to 7 %, such as up to 5 %, such as up to 3 %, such as up to 2 % of the desired or predetermined mass of the tablet.
• the tolerance may be selected based on the tablet to be produced.
• the predetermined dimension range may be m d ⁇ t m , where m d is a desired mass the tablet and t m is an absolute value of the mass tolerance.
• the alteration device may alternatively be denoted “a device” or may be denoted a “tablet alteration device”.
• a turret In rotary tablet presses, a turret generally refers to a portion of a compression section of the tablet press, namely the portion of the tablet press comprising a number of the rotating parts of the rotary tablet press, including the die element.
• the turret may itself be movable, such as rotatable, liftable, removable, or replaceable, into and out of an operational position, so that it is in the operational position during operation of the rotary tablet press and can be moved out of the operational position afterwards for, for instance, cleaning or maintenance.
• the alteration device may be configured to, in the first state thereof cause a tablet having outer dimensions within the predetermined dimension range and having a mass within the predetermined mass range to be produced from the powder arranged in the one or more bores, such as a respective bore, by the plurality of punches, e.g. by compressing the powder into the in-spec tablet, during operation of the tablet press.
• the alteration device may be configured to, in the second state thereof, cause a tablet with outer dimensions outside of the predetermined dimension range and/or with a mass outside the predetermined mass range to be produced from the powder arranged in the one or more bores, such as a respective bore, by the plurality of punches, e.g. by compressing the powder into the in-spec tablet, during operation of the rotary tablet press.
• the rotary tablet press further comprises an adjustable dosing device adjusted to cause a predetermined amount of powder to be filled into the one or more bores of the die element by the filling device.
• the plurality of punches supported by the bottom and top punch guides may be configured to, during operation of the rotary tablet press, produce a tablet by compressing the of predetermined amount of powder in each of the one or more bores into a tablet having outer dimensions within a predetermined dimension range and having a mass within a predetermined mass range.
• the plurality of punches may be configured to alternatively or additionally be configured to, during operation of the tablet press, produce one tablet at a time or a plurality of tablets simultaneously or substantially simultaneously.
• the alteration device may alternatively or additionally be configured to, in a second state of the alteration device, cause a tablet with outer dimensions outside of the predetermined dimension range and/or with a mass outside the predetermined mass range to be produced by the plurality of punches during operation of the rotary tablet press while maintaining the adjustment of the adjustable dosing device.
• the alteration device may switch between the first and second states while the dosing device maintains configured and adjusted to arrange the same predetermined amount of powder in the bore(s). While the dosing device may be adjusted during operation of the tablet press, it will be appreciated that the present alteration device may be configured to allow a such adjustment, similar to traditional dosing devices, regardless of the alteration device or any state of the alteration device.
• the die element may comprise any number of bores.
• the number of punches correspond to the number of bores, for instance so that one top punch and one bottom punch is provided for each bore.
• the die element may comprise a plurality of bores.
• the plurality of punches may comprise a plurality of bottom punches comprising one bottom punch per bore of the plurality of bores
• the plurality of top punches may comprise a plurality of top punches comprising one top punch per bore of the plurality of bores.
• the die element may be a single-piece die element, such as substantially one piece of material comprising the one or more bores.
• the die element may comprise and/or consist of a plurality of segments, wherein the bore(s) are provided by the plurality of segments.
• the die element may alternatively or additionally be or comprise a die table, a die plate, or a die disc.
• the one or more bore(s) may be dies or die bores.
• the bottom punch(es) may be arranged, such that at least a portion of the bottom punch(es), such as at least a portion of each bottom punch, is located substantially below or below the die element in an axial direction of the turret.
• the top punches may be arranged such that at least a portion of the top punch(es), such as at least a portion of each top punch, is located substantially above or above the die element in the axial direction.
• An axial direction of the turret may be a direction substantially parallel to or parallel to an axis of rotation of the die element during operation of the rotary tablet press.
• the axial direction may be substantially orthogonal to or orthogonal to a radial direction and tangential direction of the turret, such as a radial direction and a tangential direction of the die element.
• the axial direction may be substantially parallel to or parallel to a vertical direction.
• the bore(s) of the die element may be bore(s) arranged as openings in the axial direction of the turret.
• the tablets may be manufactured by the compression rollers causing a corresponding top punch and bottom punch to be pressed towards each other, such as in the axial direction, during operation of the rotary tablet press to compress the powder in the bore(s), such as during rotation of the die element.
• the feeder may be configured to arrange powder in the bore(s), for instance by arranging powder on the die element to let the powder enter the bore(s) by means of gravity.
• the feeder may be arranged above the die element, for instance when seen in the axial direction of the die element.
• the feeder may be arranged on a same side of the die element, i.e. facing the same surface of the die element, as the top punch(es) and/or the top punch guide.
• the feeder is arranged to arrange powder in a subset of the one or more bores at the same time, for instance by arranging powder onto a portion or section of the die element.
• the at least one feeding device may alternatively or additionally comprise a scraper, wall, barrier, or the like, for scraping powder into the bore(s).
• a such scraper, wall, barrier, or the like may thus, in combination with the feeder ensure complete filling of the bore(s).
• the feeder may comprise a distribution device for transporting and/or distributing powder to and from a bore filling area, i.e. a section of the turret, in which one or more of the at least one bore(s) are filled.
• a such distribution device may be or may comprise rotating paddle wheels.
• the feeding device may alternatively or additionally comprise a feeder adjustment device configured to adjust a position of the feeder relative to the die element.
• the feeder adjustment device may be configured to adjust a position of the feeder in an axial direction of the turret.
• the alteration device may be configured to, in a second state of the alteration device, cause a tablet with outer dimensions outside of the predetermined dimension range and/or with a mass outside the predetermined mass range to be produced by the plurality of punches during operation of the of the rotary tablet press while maintaining an adjustment of feeder, such as maintaining an adjustment of the feeder adjustment device.
• filling may herein be referred to the arrangement of powder in the bore(s).
• filling device in the respective bore(s) of the one or more bore(s).
• a bottom punch may be arranged to have a section which extends into a bore of the die element, such as partly into the bore of the die element.
• the adjustable dosing device may be configured to cause the predetermined amount of powder to be filled into each of the one or more bores of the die element by the filling device.
• the adjustable dosing device may, in some embodiments, comprise a dosing cam.
• the dosing cam may be a part of the bottom punch guide.
• the adjustable dosing device and/or a dosing cam thereof may be arranged below the die element when seen in an axial direction of the turret and/or may be arranged on the same side of the die element, such as facing the same surface of the die element, as the bottom punch(es) and/or the bottom punch guide.
• the adjustable dosing device such as a dosing cam thereof, may be configured to cause the predetermined amount of powder to be filled into the bore(s) by setting a position of the bottom punch in the axial direction during filling by the at least one filling device.
• the bottom punch(es) has a section, which extends, such as extends partly, into the bore(s)
• an adjustment of the position in the axial direction of the of punch(es) during filling may cause a change of volume of the respective bore, thereby causing a change of volume and correspondingly mass of powder filled in each bore.
• the adjustable dosing device such as a dosing cam thereof, may be adjustable and/or adjusted during operation of the tablet press to ensure that the predetermined amount of powder is filled into each bore.
• the adjustable dosing device such as a dosing cam thereof, may be adjusted during operation to account for wear and tear of the plurality of punches or to cope with potential changes of product density occurring over time during the operation of the tablet press.
• the adjustable dosing device such as a dosing cam thereof, may be adjustable and/or adjusted during operation to maintain a desired tablet mass.
• the adjustable dosing device such as a dosing cam thereof, may be pre-set or pre-adjusted, e.g. prior to operation of the tablet press, to cause the predetermined amount of powder to be filled in the one or more bores, such as each of the one or more bore(s).
• the adjustable dosing device and/or a dosing cam thereof may be pre-set or pre-adjusted to set a predetermined position of the bottom punch(es), such as of each of the bottom punches, during filling of the bore(s), such as of each of the bores.
• the predetermined amount of powder may correspond to a predetermined mass of powder and/or predetermined volume of the powder.
• the predetermined amount of powder may be a desired amount of powder or an acceptable amount of powder, for instance so that a compression of the predetermined amount of powder by the punches result in a desired tablet, i.e. in an in-spec tablet.
• the predetermined amount of powder may be based on the specific type of tablet to produced.
• the alteration device may comprise an actuating device, such as an actuator, configured to change the alteration device from the first state to the second state.
• the actuator may, for instance, be a linear actuator, an electric motor, a pneumatic actuator, a hydraulic actuator, or the like.
• the alteration device may be in the first state as a default state.
• the alteration device may alternative or additionally be configured to, during operation of the tablet press, be in the second state for less than a certain threshold time period, such as for less than the time of a 360° rotation of the die element, less than the time of a 270° rotation of the die element, less than the time of a 180° rotation of the die element, or less than a 90° rotation of the die element, such as less than 45°, such as less than 15°, less than 10°, or less than 5° before changing to the first state.
• the alteration device may be configured to be in the second state for less than 2 seconds, such as less than 1 second, such as less than 800 milliseconds, less than 600 milliseconds, less than 400 milliseconds, less than 300 milliseconds, less than 200 milliseconds, less than 100 milliseconds, less than 50 milliseconds, less than 30 milliseconds, less than 20 milliseconds or less than 10 milliseconds.
• 2 seconds such as less than 1 second, such as less than 800 milliseconds, less than 600 milliseconds, less than 400 milliseconds, less than 300 milliseconds, less than 200 milliseconds, less than 100 milliseconds, less than 50 milliseconds, less than 30 milliseconds, less than 20 milliseconds or less than 10 milliseconds.
• the alteration device may be configured to be change into the second state only for the duration necessary to cause a single tablet to be produced by the plurality of punches before changing back to the first state.
• the alteration device may be configured to be in the second state for a time duration causing a mass of powder filled in a single bore to be altered before the alteration device changes back into the first state.
• the alteration device may be configured to cause an out-of-spec tablet to be produced in a subset of the bores, during one rotation of the die element, e.g. by switching between the first and second states of the alteration device.
• the first state of the alteration device may alternatively or additionally be a deactivated state or an inactive state of the alteration device.
• the second state of the alteration device may alternatively or additionally be an activated state or an active state of the alteration device.
• the alteration device may be changed into the second state in response to the rotary tablet press performing a reject test.
• the rotary tablet press may perform a reject test in response to the alteration device changing into the second state.
• the alteration device may be controllable by a control unit.
• the control unit may be configured to control the actuation device to change between the first and the second state of the alteration device.
• the alteration device and the control unit may be operably connected.
• the control unit may be operably connected to a user interface and/or may be configured to cause the actuation device to change to the second state and then back to the first state based on a user input. Alternatively or additionally, the control unit may be configured to cause the actuation device to change to the second the state and then back to the first state at predetermined time intervals during operation of the rotary tablet press so as to perform a reject test at certain time intervals.
• a such control unit may comprise a processing unit, such as a central processing unit (CPU), a microcontroller unit (MCU), a field-programmable gate array (FPGA), any combination thereof, or the like.
• the control unit may additionally comprise a memory, such as a Random Access Memory (RAM), a Read Only Memory (ROM), a non-volatile storage medium, a Conductive Metal-Oxide-Semiconductor (CMOS) memory, a flash memory, any combination thereof, or the like.
• the memory may store thereon instructions which, when executed by the processing unit, causes the processing unit to cause the actuation device to change between the first and second states.
• the tablet press according to the first aspect comprises at least one sensor arrangement configured to estimate a mass and outer dimensions of a tablet.
• the reject test may equally verify the functionality and configuration of the at least one sensor arrangement, as it may be verified that the out-of-spec tablet is detected by the sensor arrangement.
• the at least one sensor arrangement may be configured to obtain a measurement value indicative of a displacement of one or more compression rollers of the rotary tablet press, at least during the compression of the powder in the bore(s).
• the compression roller(s) may be configured to, during operation, cause the punches to move towards each other to compress the powder in the bore(s) of the die element.
• the compression roller(s) may be suspended and/or connected to a piston.
• the sensor arrangement(s) may be provided with and/or obtain information about the suspension and/or piston, such as spring stiffness or equivalents, damping, mass, or the like.
• the sensor arrangement may be configured to determine, based on the measurement value indicative of the displacement of the roller(s) and information about the suspension and/or piston of the compression roller(s), a value indicative of the tablet mass and/or tablet dimension.
• the at least one sensor arrangement may be configured to obtain a measurement value indicative of a compression force applied by one or more compression rollers and/or indicative of a roller displacement of one or more compression rollers, which compression rollers cause the punches to move towards each other to compress the powder in the bore(s) of the die element, during the compression of the powder in the bore(s).
• the sensor arrangement(s) may determine if an excess or too low amount of powder is present in the bore(s), thereby providing an estimate of whether at least the mass and/or outer dimensions of the tablet(s) is within the predetermined mass and/or outer dimension ranges, respectively.
• the rotary tablet press further comprises a tablet ejection device configured to,
• the sorting by the tablet ejection device may equally be tested during the reject test, in turn allowing for a more reliable reject test.
• such tablet ejection devices generally rely on a time delay and/or on a travelled rotational angle by the die element from an out-of-spec tablet is determined until a tablet is sorted to the second exit.
• the time delay need to be configured based on the products, the rotational speed of the rotating parts of the turret, or the like. Accordingly, by determining if a tablet is indeed diverted to the second exit in response to sensor arrangement(s) determining that the tablet is an out-of-spec tablet, an improved reject test may be provided.
• the reject test may be further verified, allowing for a robust reject test.
• the rotary tablet press further comprises a tablet ejection device configured to, in response to the sensor arrangement determining that a mass of a produced tablet is within the predetermined mass range and/or that the outer dimensions of the produced tablet is within the predetermined dimension range, divert the produced tablet to a first exit of the tablet press, and otherwise divert the produced tablet to a second exit of the tablet press.
• a verification device may be connected to the press, such as to the second exit.
• the verification device may be configured to determine any one or more of a mass, a dimension, such as a height or thickness, and a hardness of the tablet. Thereby, an automated evaluation of these parameters may be provided for.
• a verification device may alternatively or additionally be configured to determine a trajectory of the rejected tablet, such as optically determine a trajectory of the tablet, for instance so as to confirm or verify that an out-of-spec tablet has been rejected.
• the verification device may comprise a camera.
• the sorting device may comprise and/or be connected to a tablet chute.
• the alteration device is configured to cause a tablet a mass outside the predetermined mass range to be produced by the plurality of punches by causing a reduced mass or an increased mass of powder in at least one of the one or more bores.
• the produced tablet will correspondingly have a reduced or increased mass, respectively.
• the alteration device is configured to cause a reduced mass or an increased mass of powder in the a bore, such as a subset of the one or more bores and/or selectively in the one or more bores.
• the alteration device may be configured to cause a reduced or increased mass of powder selectively in some or a subset of the plurality of bores.
• the alteration device may be configured to cause a reduced mass or an increased mass of powder in the respective bore(s) simultaneously and/or subsequent to the filling device arranging powder in the respective bore(s) of the at least one bore.
• the alteration device may be configured to cause the reduced mass or the increased mass of powder in the respective bore(s) prior to a pre-compression, a compression, and/or any compression of the powder by the punches.
• the alteration device may be configured to cause the reduced or increased mass of powder in at least one of the one or more bores in the second state of the alteration device, such as exclusively in the second state of the alteration device.
• the alteration device is configured to, in the first state of the alteration device, cause a predetermined amount of powder, optionally the predetermined amount of powder arranged in the bore(s) by a dosing device, which may correspond to a predetermined mass of powder, in each of the one or more bore and, in the second state of the alteration device, cause a reduced or increased mass of powder in at least one of the one more bores, such as in a subset of the one or more bores.
• the reduced mass of powder may be or correspond to a mass outside of the predetermined mass range.
• the increased mass of powder may be or correspond to a mass outside of the predetermined mass range.
• the increased or reduced mass of powder may correspondingly refer to an increased or reduced volume of powder in the bore(s).
• the alteration device may be configured to cause the reduced or increased mass of powder in the bore(s) by altering a flow of powder from the feeding device into the bore(s), when the alteration device is in the second state.
• the alteration device may, in its second state, be configured to alter the flow of powder relative to when in its first state.
• the alteration of the flow may comprise limiting or increasing the flow, such as the flow speed.
• the alteration device may be configured to, in its second state, alter the flow of powder from the feeding device into the bore(s) by, e.g., partially covering a respective opening of the bore(s), applying a vibration to any one or more of a punch, such as a bottom punch, arranged partially in the bore, at least a part of the die element, and at least a part of the feeding device, and/or by causing a temporary densification of powder inside the feeder, at least relative to when in the first state.
• a punch such as a bottom punch
• the alteration device is configured to remove an amount of powder in at least one bore, in which powder has been arranged by the feeder, of the one or more bores.
• the alteration device may be configured to remove the amount of powder simultaneous with or subsequent to filling of the bore and prior to pre-compression or compression of the powder in the bore(s) by the punches.
• the removed amount of powder may result in the mass of the remaining amount of powder in the bore(s) to be outside of the predetermined mass range.
• the removed amount of powder may result in the volume of the remaining powder in the bore(s) to result in a tablet with outer dimensions outside the predetermined dimension range when compressed into a respective tablet by the punches.
• the alteration device comprises a nozzle configured to apply a fluid, such as a pressurised gas, to the at least one bore during or subsequent to the filling of the at least one bore by the feeder.
• a fluid such as a pressurised gas
• a fluid pulse generated by the nozzle may allow for an easily controllable and fast-acting removal of powder from the bore(s) so as to cause a tablet with a reduced mass to be produced.
• the nozzle may be operably connected to the at least one of the one or more bores and/or to a part of the filling device, such as a scraper thereof.
• the nozzle may be co-arranged and/or integrated with a scraper of the feeding device.
• the nozzle may be arranged to apply a fluid into and/or above or at an opening of the at least one bore during or subsequent to the filling of the at least one bore.
• the nozzle may be configured to remove an amount of powder from the bore(s), so as to remove the mass of powder in the bore(s).
• the mass of powder removed from the bore may depend on a fluid pressure of the fluid applied through the nozzle, a duration of the applied pressure, such as the duration during which the alteration device is in the second state, and/or the dimensions and/or orientation of the nozzle.
• the nozzle may be dimensioned, arranged and/or selected based on a desired quantity of powder to be removed from the bore(s).
• a fluid pressure of the fluid applied through the nozzle, and/or a duration of the applied pressure, such as the duration during which the alteration device is in the second state may be pre-defined prior to operation of the tablet press and/or may be adjustable, e.g. during operation of the tablet press and/or in response to a desire to remove more or less material from the bore(s) when the alteration device is in the second state.
• the alteration device is configured to apply the fluid during or subsequent to the filling of the at least one bore but prior to compression and/or pre-compression of the powder in the at least one bore
• the alteration device may further comprise an actuator for causing a fluid pulse to be applied through the nozzle to the bore(s).
• the actuator may be a pneumatic actuator configured to cause a fluid pressure and/or increase a pressure in the fluid.
• the actuator may be a linear actuator, a pneumatic actuator, a hydraulic actuator or the like.
• the actuator may alternatively or additionally comprise a piston and/or be configured to be actuated electrically.
• the alteration device may comprise a fluid valve, such as a fast-acting fluid valve, to provide the fluid or a fluid pulse to the at least one bore.
• a fluid valve such as a fast-acting fluid valve
• the nozzle may be any type of nozzle and/or opening(s), which allows a fluid flow through the nozzle.
• the alteration device may comprise a valve function to prevent powder from flowing into the alteration device, such as into a potential actuator of the alteration device.
• the valve function may be any type of valve, such as a one-way valve, a ball valve, a check valve, or the like.
• the fluid may be provided by the alteration device with an excess pressure relative to the air pressure in the turret.
• the fluid may be a gas, such as atmospheric air, nitrogen, oxygen, or the like.
• the alteration device may be configured to be arranged above the die element when seen along the axial radiation and/or on a same side of the die element as the top punch, top punch guide, and/or the feeder, i.e. facing the same surface of the die element as the top punch, top punch guide, and/or the feeder.
• the alteration device may comprise a housing.
• the housing may surround at least a portion of the alteration device, such as a valve, part of the nozzle, and/or part of the actuator.
• the alteration device may alternative or additionally comprise a mounting portion to allow or facilitate mounting the alteration device to at least a portion of the turret and/or to a housing or frame of the tablet press, e.g. a press housing or press frame, for instance so as to fasten and maintain a position of the alteration device relative to the die element during operation of the rotary tablet press.
• the alteration device comprises an adjustment device configured to adjust a position of one or more of the plurality of punches.
• an amount of powder in the bore may be altered and/or a compression force applied by the punches to the powder during compression thereof may be altered, which may, again, allow for an out-of-spec tablet to be produced.
• the adjustment device may be configured to adjust the position of the one or more of the plurality of punches in the second state of the alteration device, such as exclusively or only when the alteration device is in the second state.
• the adjustment device may be configured to support the punch(es) when the alteration device is in the second state, such as exclusively or only when the alteration device is in the second state.
• the adjustment device may be configured to provide substantially no adjustment or change of position of the punch(es) when the alteration device is in the first state.
• the adjustment device may be configured to let the respective punch(es), such as each of the punch(es), be supported by the respective bottom and top punch guides when the alteration device is in the second state.
• the adjustment device may be configured to adjust a position of the bottom punch(es) and/or of the top punch(es).
• the adjustment device may be configured to adjust a position of the bottom and/or top punch(es) during filling, subsequent to filling but before pre-compression or compression, and/or during pre-compression or compression.
• the adjustment device may be configured to adjust a position of a subset of the bottom punches, such as of one of the bottom punches, at each point in time.
• the adjustment device may be configured to adjust a position of a subset of the top punches, such as of one of the top punches, at each point in time.
• the adjustment device is configured to adjust a position of a respective bottom punch of the at least one bottom punch relative to the bottom punch guide, at least during or subsequent to the arrangement of powder in a respective bore of the die element corresponding to the respective bottom punch.
• the volume of the bore(s) and, thus, the mass of the powder in the bore(s) may be altered, in turn resulting in an out-of-spec tablet to be produced while maintaining operation of the feeding device and, where a dosing device is provided, the dosing device.
• the turret defines an axial direction, a radial direction, and a tangential direction
• the adjustment device is configured to adjust a position of the one or more of the plurality of punches in the axial direction or in a direction substantially parallel to the axial direction.
• the axial, radial, and tangential directions may be orthogonal or substantially orthogonal to each other.
• the adjustment device may be configured to adjust the position of the punch(es) at a specific rotational position of the die element, e.g. so that a position of one or more punches may be adjusted at a given angular position/given angular positions of the rotation of the die element and/or the turret.
• the adjustment device is configured to adjust the position of the one or more of the plurality of punches by an interaction with the one or more of the plurality of punches.
• the interaction may be or comprise a mechanical interaction, a magnetic interaction, such as an electromagnetic interaction, a pneumatic interaction, and/or a hydraulic actuator.
• the adjustment device may comprise an actuator.
• the actuator may be configured to cause a physical movement of the punch(es), e.g. in the axial direction, such as upwards or towards the die element and/or the top punch(es), when the alteration device is in the second state.
• the actuator may be deactivated in the first state of the alteration device and activated in the second state of the alteration device.
• the actuator may be a linear actuator, a DC motor, or the like.
• the actuator may be a hydraulic or pneumatic actuator, for instance configured to cause a position adjustment of the punch(es) upon activation and/or deactivation of the actuator.
• the adjustment device may be configured to adjust the position of the punch(es) by means of one or more air pulse(s) by the pneumatic actuator, in turn allowing for a fast-acting adjustment of the position of the punch(es).
• a pneumatic actuator may be any actuator configured to apply a gas or air pressure to the punch, such as a punch head, to adjust its position.
• the actuator may be a magnetic or electromagnetic actuator, optionally configured to adjust the position of the punch(es) by means of a magnetic force.
• the adjustment device may alternatively or additionally comprise an interface portion.
• the interface portion may be configured to physically move the punch(es) to adjust the position of the punch(es) and/or may be configured to support and/or be in contact with the punch(es) when the alteration device is in the second state, such as exclusively or only when the alteration device is in the second state, or when in the first state, such as exclusively or only when the alteration device is in the first state.
• the adjustment device comprises an actuator
• the actuator may physically move the interface portion of the adjustment device.
• the interface portion may comprise an interface surface configured to be in contact with the punch(es) when the alteration device is in the second state, such as exclusively or only when the alteration device is in the second state.
• the interface surface may be angled or slated in the rotational direction of the die element, for instance so as to guide the punch when the alteration device is in the second state.
• the interface surface may be angled or slated at an angle different from 0° and 90° relative to the axial direction and/or relative to the rotational direction.
• the adjustment device may, e.g. by an actuator and/or interface portion thereof, be configured to move the bottom punch(es) upwards, e.g. relative to when the alteration device is in the first state, in the axial direction when the adjustment device is in the second state, in turn reducing a volume of the bore(s) and thereby an amount and mass of powder filled in the respective bore(s).
• the adjustment device may, correspondingly, offset the bottom punch(es) upwards in the axial direction when in the second state as compared to when in the first state.
• an interface portion of the adjustment device may be configured to support the punches when the alteration device is in the second state, such as when in the second state exclusively or only.
• the adjustment device may, e.g. by an actuator and/or interface portion thereof, be configured to move the bottom punch(es) downwards, e.g. relative to when the alteration device is in the first state, in the axial direction when the adjustment device is in the second state, in turn increasing a volume of the bore(s) and thereby an amount and mass of powder filled in the respective bore(s).
• the adjustment device may, correspondingly, in this embodiment offset the bottom punch(es) downwards in the axial direction when in the second state as compared to when in the first state.
• an interface portion of the adjustment device may be configured to support the punches when the alteration device is in the first state, such as when in the first state exclusively or only.
• the adjustment device may, e.g. by an actuator and/or interface portion thereof, be configured to move the bottom punch(es) downwards, e.g. relative to when the alteration device is in the first state, in the axial direction when the alteration device is in the second state, in turn increasing a volume of the bore(s) and thereby an amount and mass of powder filled in the respective bore(s).
• the adjustment device may, e.g. by an actuator and/or interface portion thereof, be further configured to move the bottom punch(es) upwards, e.g.
• the adjustment device may, correspondingly, in this embodiment offset the bottom punch(es) downwards in the axial direction when in the second state as compared to when in the first state and upwards in the axial direction when in the third state as compared to when in the first state.
• the adjustment device may be configured to change between the second state and the first state and between the first state and the third state, and/or between the second state and the third state.
• a more versatile reject test may be performed, since both a tablet with excess mass and/or dimensions, i.e. having a mass and/or dimensions above the respective predetermined mass and/or dimensions threshold, respectively, and a tablet with insufficient mass and/or dimensions, i.e. having a mass and/or dimensions below the respective predetermined mass and/or dimensions threshold, respectively, may be produced by means of the alteration device.
• the rotary tablet press further comprises a control unit configured to control the alteration device to cause a tablet with outer dimensions outside of the predetermined dimension range and/or with a mass outside the predetermined mass range to be produced by the plurality of punches.
• the control unit may be the control unit configured to control the actuation device to change between the first and the second state of the alteration device as described in the preceding.
• the bottom punch guide supports the at least one bottom punch so that a respective punch head of the at least one bottom punch contacts the bottom punch guide, wherein the alteration device comprises a replacement bottom punch head to replace a punch head of a respective bottom punch of the at least one bottom punch.
• the top punch guide supports the at least one top punch so that a respective punch head of the at least one top punch contacts the top punch guide wherein the alteration device comprises a replacement top punch head to replace a punch head of a respective top punch of the at least one top punch.
• a length of the respective at least one top punch, upon replacement of the punch head of the respective top punch by the replacement top punch head of the alteration device, is altered.
• a length of the respective at least one bottom punch and/or the respective at least one top punch may be altered upon replacement of the punch head of the respective bottom punch by the replacement bottom punch head of the alteration device.
• the length of the punch(es) is thus the total length of punch and the punch head, so that the length of the punch when replacing the punch head by the replacement punch head is the altered length including replacement punch head.
• the bottom and/or top punch(es) may, potentially each, be configured to be disassembled into a punch head and a remaining portion of the punch.
• the remaining portion of the punch may comprise a section configured to be in contact with the powder so as to compress this during operation of the rotary tablet press.
• the punch head may be configured to be attached to the remaining portion of the punch by a thread in the punch head and a corresponding thread in the remaining portion of the punch and/or by press-fit, magnetism, or the like.
• the rotary tablet press comprises an enclosure surrounding the turret in its operational position in a compression section of the rotary tablet press.
• the enclosure may surround the alteration device and/or a portion thereof, such as a nozzle, an actuator, an interface portion, a housing, a valve, and/or a mounting portion thereof.
• the enclosure may enclose a volume, in which the die element and filling device are arranged. At least a portion of each of the plurality of punches may be arranged within the volume. The alteration device and/or a portion thereof may further be arranged in the volume.
• the enclosure may provide a contained volume within the enclosure, i.e. the volume may be a contained volume.
• a contained volume is herein to be understood that the volume is to fulfil certain requirements to containment, i.e. that the volume, of the enclosure , is at least dust tight.
• a contained volume may be a volume, which is configured to prevent that extensive amounts, such as detectable amounts and/or amounts over a certain threshold, of an input composition, which the turret of the rotary tablet press is processing, are emitted from the contained volume into the surroundings, such as into a room in which it is arranged or into an enclosure surrounding at least a part of the turret.
• the contained volume may herein be understood that the volume is to have a containment capability of dust containment of up to 10 ⁇ g per m3.
• the contained volume may be a volume, which when in the installed is configured to have a dust containment of up to 10 ⁇ g per m3.
• the alteration device comprises one or more punch heads to replace a punch head of a top and/or bottom punch
• the punch heads of the punches may be arranged outside of the volume of the enclosure.
• the top and/or bottom punch guides, and optionally the top and bottom punches, may be arranged within the volume of the enclosure.
• a second aspect of the present invention relates to a method for producing a tablet outside of specification, the method comprising:
• an easy and reliable reject test may be performed.
• the method may alternatively be considered a "method” or "a method for producing a tablet”. Alternatively or additionally, the method may be a method of performing a rejection test.
• the step of producing the tablet having outer dimensions within a predetermined dimension range and having a mass within a predetermined mass range may occur prior to and/or after the step of producing the tablet with outer dimensions outside of the predetermined dimension range.
• the step of producing the in-spec tablet may comprise setting the alteration device in the first state.
• the step of producing the in-spec tablet and the step of producing the out-of-spec tablet may be provided during an operation, such as during a same operation, of the tablet press.
• the method may comprise a step of initiating an operation, such as normal operation, of the rotary tablet press and subsequent to initiating the operation producing the in-spec tablet and the step of producing the out-of-spec tablet.
• the method may comprise stopping the operation of the tablet press subsequent to the steps of producing the in-spec and the out-of-spec tablets.
• the step of producing, the tablet with outer dimensions outside of the predetermined dimension range and/or with a mass outside the predetermined mass range comprises:
• Altering may refer to reducing or increasing the mass of powder in the at least one bore.
• the method further comprises, determining, subsequent to the step of producing, by the tablet press, a tablet with outer dimensions outside of the predetermined dimension range and/or with a mass outside the predetermined mass range, that the tablet with outer dimensions outside of the predetermined dimension range and/or with a mass outside the predetermined mass range is identified and/or sorted as an out-of-spec tablet.
• the step of determining may comprise determining, by the sensor arrangement(s), that the tablet has outer dimensions outside of the predetermined dimension range and/or has a mass outside the predetermined mass range and, in response to the sensor arrangement determining that a mass of a produced tablet is outside the predetermined mass range and/or that the outer dimensions of the produced tablet is outside the predetermined dimension range, determine that the product is diverted to a second exit of the tablet press.
• FIG. 1 shows a perspective view of an embodiment of a turret 2 of a rotary tablet press 1 according to the present invention.
• the rotary tablet press 1 comprises an enclosure 3 enclosing a die element 20 and a feeder 4 of a feeding device of the rotary tablet press.
• the feeding device is associated with the turret 2.
• the feeder is configured to, during operation of the rotary tablet press 1, arrange powder in the at least one bore 200 of the die element 20.
• the die element 20 comprises a plurality of bores 200.
• the turret 2 further comprises a plurality of bottom punches 22 and a plurality of top punches 24.
• the turret moreover comprises a bottom punch guide 26 supporting the plurality of bottom punches 22.
• the rotary tablet press further comprises an alteration device (not shown in FIG. 1 ) as well as a top punch guide 28 supporting the top punches 24.
• the plurality of punches 22, 24 are supported by the bottom 26 and top punch guides 28 and are configured to, during operation of the rotary tablet press 1, produce a tablet by compressing the powder in each of the bores 200 into a tablet having outer dimensions within a predetermined dimension range and having a mass within a predetermined mass range.
• the alteration device is configured to, in a first state of the alteration device, cause a tablet having outer dimensions within the predetermined dimension range and having a mass within the predetermined mass range to be produced by the plurality of punches 22, 24 and, in a second state of the alteration device, cause a tablet with outer dimensions outside of the predetermined dimension range and/or with a mass outside the predetermined mass range to be produced by the plurality of punches 22, 24 during operation of the of the rotary tablet press 1.
• the enclosure 3 encloses a volume, in which the feeder 4, the die element 20 and a portion of each of the top punches 24 and a portion of each of the bottom punches 22 are arranged.
• FIG. 2 shows a perspective view of an embodiment of a turret 2 of a rotary tablet press 1 according to the present invention.
• the turret 2 defines an axial direction z, a radial direction r, and a tangential direction ⁇ .
• the turret 2 further comprises bottom punch guide 26.
• the bottom punch guide 26 comprises an adjustable dosing device 260.
• the adjustable dosing device 260 is configured to be adjusted to cause a predetermined amount of powder to be filled into the bores 200, in particular each bore, of the die element 20 by the filling device, e.g. by the feeder 40.
• the turret 2 moreover comprises an alteration device 5.
• the alteration device 5 is configured to, in a first state of the alteration device 5, cause a tablet having outer dimensions within the predetermined dimension range and having a mass within the predetermined mass range to be produced by the plurality of punches 22, 24 and, in a second state of the alteration device, cause a tablet with outer dimensions outside of the predetermined dimension range and/or with a mass outside the predetermined mass range to be produced by the plurality of punches 22, 24 during operation of the of the rotary tablet press 1 while maintaining the adjustment of the adjustable dosing device 260.
• the adjustable dosing device 260 is formed as part of the bottom punch guide 26.
• the adjustable dosing device 260 is, thus, arranged on the same side of the die element 20 as the bottom punch guide 26, i.e. facing the same surface of the die element 20.
• the adjustable dosing device 260 is arranged on the same side of the die element 20 as the bottom punch guide 26 when seen in the axial direction z, specifically below the die element 20 when seen in the axial direction z.
• the adjustable dosing device 260 may not be part of the bottom punch guide 26 but may, instead, be separate from the bottom punch guide 26 and/or may be arranged on an opposite side of the die element 20, such as above the die element 20 when seen in the axial direction z.
• the alteration device 5 is integrated with the bottom punch guide 26.
• the alteration device 5 is, thus, arranged on the same side of the die element 20 as the bottom punch guide 26, i.e. facing the same surface of the die element 20.
• the alteration device 5 is arranged on the same side of the die element 20 as the bottom punch guide 26 when seen in the axial direction z, specifically below the die element 20 when seen in the axial direction z.
• the alteration device 5 may not be integrated with the bottom punch guide 26 but may, instead, be separate from the bottom punch guide 26 and/or may be arranged on an opposite side of the die element 20, such as above the die element 20 when seen in the axial direction z.
• FIG. 3 shows a perspective view of an embodiment of the alteration device 5.
• FIGs. 4A and 5A show cross-sectional views of the alteration device 5 and a cross-sectional view of a section of the turret 2 with the alteration device 5, respectively, in a first state of the alteration device 5.
• FIGs. 4B and 5B show cross-sectional views of the alteration device 5 and a cross-sectional view of a section of the turret 2 with the alteration device 5, respectively, in a second state of the alteration device 5.
• the alteration device 5 is housed at least partly in the bottom punch guide 26.
• the alteration device 5 comprises an adjustment device 50 with an actuator 52.
• the actuator 52 is configured to cause a physical movement of a bottom punch 22a of the plurality of bottom punches 22, upwards in the axial direction z towards the die element 20 and the top punch, when the alteration device 5 is in the second state.
• the actuator 52 is deactivated in the first state of the alteration device 5 and activated in the second state of the alteration device 5.
• the alteration device 5 adjustment device 50 further comprises an interface portion 52.
• the interface portion 52 is configured to physically move the bottom punch 22a to adjust the position of the punch 22a.
• the interface portion 52 is configured to support and be in contact with the punch 22a when the alteration device 5 is in the second state as shown in FIGs. 5B .
• the actuator physically moves the interface portion 52 up and down in the axial direction z.
• the interface portion 54 comprises an interface surface 540 configured to be in contact with the punch 22a when the alteration device 5 is in the second state as shown in Fig. 5B .
• the interface surface 540 is angled in the rotational direction of the die element 20 so as to guide the punch 22a when the alteration device 5 is in the second state as shown in FIG. 5B .
• the interface surface may be angled approximately 10°-15° relative to the rotational direction ⁇ but may in other embodiments be angled more or less, such as between 2° and 65°, such as between 5° and 45°.
• the interface surface 540 protrudes from a supporting surface of the bottom punch guide 26 when the alteration device 5 is in the second state.
• the interface surface 540 supports the punch 22a and moves this upwards in the axial direction z so that a volume of the respective bore 200a is reduced somewhat as illustrated in FIG. 5 .
• a volume and thereby mass of powder filled in the bore 200a is reduced, in turn causing the bottom punch 22a and a corresponding top punch of the plurality of top punches 24 to produce an out-of-spec tablet.
• the interface surface 540 is arranged below the supporting surface of the bottom punch guide 26 so that the interface surface 540 is not in contact with the bottom punch 22a.
• alteration device 5 is illustrated in the embodiment shown in FIGs. 2-5B arranged and housed in the bottom punch guide 26, it will be appreciated that the alteration device 5 may alternatively be implemented in a bottom punch guide, such as bottom punch guide 26, which does not comprise an adjustable dosing device 260.
• FIG. 6A shows a perspective view of another embodiment of an alteration device 6 of a rotary tablet press.
• the alteration device may be part of the rotary tablet press 1.
• FIG. 6B shows another perspective view of the embodiment of the alteration device 6 and
• FIG. 7 shows a cross-sectional view of a section of the turret 2 with the alteration device 6 in a first state of the alteration device 6.
• FIG. 6A shows a top perspective view, i.e. a view from above in the axial direction
• FIG. 6B shows a bottom perspective view of the alteration device 6 in a mounted condition of the alteration device 6.
• the major surfaces visible in FIG. 6B are intended to face the die element in its mounted condition.
• the alteration device 6 comprises a nozzle in the form of three openings 64 operatively connected to the at least one 200a of the bores 200 and configured to apply a fluid, such as a pressurised gas, to the bore 200a during or subsequent to the filling of the bore 200a by the feeder 4.
• the alteration device 6 is configured to apply the fluid by the openings 64 during or subsequent to the filling of the bore 200a but prior to compression and/or pre-compression of the powder in the bore 200a.
• the alteration device 6 further comprises an actuator 60 for causing the fluid pulse to be applied through the openings 64 to the bore 200a.
• nozzle is illustrated as three openings in the embodiment of the alteration device 6 shown in FIGs. 6A, 6B , and 7 , it will be appreciated that any number of openings may be provided or other fluid connections allowing for a fluid flow.
• the fluid is a gas, such as atmospheric air, nitrogen, oxygen, or the like.
• the alteration device 6 is configured to be arranged above the die element 20 when seen along the axial radiation z and on a same side of the die element 20 as the top punches 24, top punch guide 28, and the feeder 4, i.e. facing the same surface of the die element 20 as the top punch 24, top punch guide 28, and the feeder 4.
• the alteration device 6 comprises a housing 62.
• the housing 62 surrounds a portion of the alteration device 6, in particular part of the openings 64.
• the alteration device 6 further comprises a mounting portion 66 to allow mounting of the alteration device 6 to at least a portion of the turret 2 so as to fasten and maintain a position of the alteration device 6 relative to the die element 20 during operation of the rotary tablet press 1.
• alteration device 6 is shown in an embodiment of a rotary tablet press 1 comprising a bottom punch guide 26 with an adjustable dosing device 260, it will be appreciated that the alteration device may alternatively be provided in an embodiment of a rotary tablet press without the adjustable dosing device 260 and/or where any adjustable dosing device is not integrated with or arranged as part of the bottom punch guide 26.
• FIG. 8 shows a flow chart of a method 7 according to the present invention.
• the method 7 is a method 7 for producing a tablet outside of specification.
• the method 7 comprises providing 70 a tablet press according to the first aspect, such as tablet press 1 or tablet press 1.
• the method 7 further comprises producing 71, by the tablet press, a tablet by compressing the powder in each of the one or more bores into a tablet having outer dimensions within a predetermined dimension range and having a mass within a predetermined mass range.
• the method 7 further comprises producing 72, by the tablet press, a tablet with outer dimensions outside of the predetermined dimension range and/or with a mass outside the predetermined mass range by changing the state of the alteration device from the first to the second state.

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  • 2024-08-12 EP EP24194184.8A patent/EP4696492A1/de active Pending
• 2025
  • 2025-08-11 WO PCT/EP2025/072968 patent/WO2026037766A1/en active Pending

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