A rotary tablet press comprising a turret and a filling device and a method for producing a tablet outside of specification

Abstract

Disclosed is a rotary tablet press (1) comprising a turret (2). The turret comprises a die element (20) comprising one or more bores (200), a plurality of punches comprising at least one bottom punch (22) and at least one top punch (24), a bottom punch guide (26) supporting the at least one bottom punch, and a top punch guide (28) supporting the at least one top punch. The rotary tablet press further comprises 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 plurality of punches supported by the bottom and top punch guides are configured to, during operation of the rotary tablet press, produce 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. Further disclosed is a method.

Description

[0001] Title of Invention

[0002] A rotary tablet press comprising a turret and a filling device and a method.

[0003] Technical Field

[0004] 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 one or more bores of the die element. The present invention further relates to a method for producing a tablet outside of specification.

[0005] Background Art

[0006] In tablet manufacturing, tablets are generally formed from a material, such as a powder or granulate, which is compressed into tablets by a tablet press. In rotary tablet presses, the material is commonly filled into a bore and subsequently compressed by punches, which apply a pressure to compress the material into a tablet during rotation of the turret of the rotary tablet press. Traditionally, in tablet presses, a pre-compression, e.g. by pre-compression rollers or cams moving the punches, is applied to the material by the punches after the material has been filled into the bore but prior to the compression by the punches that compresses the material into the tablet. Such compression is typically caused by compression rollers or cams moving the punches to compress the material into the tablet.

[0007] 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.

[0008] To ensure that the tablets exiting the tablet press are within the set tolerances, 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. Typically, the tablets are sorted accordingly, so that tablets outside of tolerances are sorted separately from the tablets within tolerances.

[0009] When setting up a tablet press to manufacture a given type tablet, it generally remains desirable to perform a “reject test”, i.e. verify whether a tablet outside of tolerances is detected and sorted accordingly.

[0010] Traditionally, such 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. For instance, such 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.

[0011] An alternative reject test is disclosed in document US2015 / 0375268A1 in which a test programme software can be activated. When activated, a compression force signal, representing a compressive force of a punch, is impinged with an offset that triggers a rejection and corresponding rejection of the tablet produced by the punch. This, however, provides the drawback that, while it can be determined that a tablet has been rejected and sorted accordingly, it cannot subsequently be determined if this tablet was manufactured by the specific punch, whose compressive-force signal was impinged with the offset, since rejected tablet is most likely a tablet within tolerances. Correspondingly, the reject test in US2015 / 0375268A1 relies on a “false negative”.

[0012] Thus, there remains a need for a tablet press allowing for a flexible and verifiable reject test.

[0013] Summary of the Invention

[0014] An object of the present invention is to provide a rotary tablet press overcoming at least some of the above-mentioned drawbacks.

[0015] This and further objects are achieved by a rotary tablet press according a first aspect of the invention comprising 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, wherein the plurality of punches supported by the bottom and top punch guides are configured to, during operation of the rotary tablet press, produce 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, characterised in that the rotary tablet press further comprises an alteration device 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 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 during operation of the rotary tablet press.

[0016] By 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. In particular, it has been realised that by the alteration device being configured to allow for tablets with specifications within and outside of the predetermined ranges to be manufactured by the plurality of punches, depending on the state of the alteration device, punch replacements to alternative punches specifically configured to produce only tablets with specifications outside of the predetermined ranges may be avoided. Notably where 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.

[0017] Furthermore, by 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. Correspondingly, 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.

[0018] Throughout the present specification, the term 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. Correspondingly, 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).

[0019] Where the present specification refers to mass and / or dimensions of the tablet(s), it will be appreciated that a tablet hardness may equally or alternatively be referred to. Generally, a tablet hardness depends on the mass and outer dimensions of tablet.

[0020] 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”.

[0021] It will be appreciated that terms such as “first” and “second” throughout this disclosure are merely nomenclature and do not specify any interrelation between the two, unless where so stated. In particular, it will be appreciated that the presence of a “second tablet” does not require or infer the presence of a “first tablet”.

[0022] 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). Correspondingly, the predetermined dimension range may be an acceptable dimension range, a desired dimension range, an intended dimension range, or the like. Alternatively or additionally, 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. In some examples, the predetermined dimension range may comprise nominal or desired outer dimensions for the tablet(s) and a tolerance.

[0023] In some embodiments, 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.

[0024] Alternatively or additionally, the predetermined dimension range may be a predetermined size range, or the like.

[0025] The predetermined dimension range may comprise a dimension range for one or more outer dimensions. For instance, 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).

[0026] The predetermined dimension range may be or comprise a desired or predetermined height or thickness of a tablet and a tolerance. For instance, in some examples 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. In mathematical terms, the predetermined dimension range may be hd + td, where hd is a desired height or thickness of the tablet and td is an absolute value of the depth or thickness tolerance.

[0027] 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). Correspondingly, the predetermined mass range may be an acceptable mass range, a desired mass range, an intended mass range, or the like. Alternatively or additionally, 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. In some examples, the predetermined mass range may comprise a nominal or desired mass for the tablet(s) and a tolerance.

[0028] In some embodiments, 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.

[0029] For instance, in some examples, the predetermined mass range be a desired or predetermined mass of a tablet and a tolerance. In some examples, the tolerance may be a percentage of the desired or predetermined mass of the tablet. For instance, 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. In some embodiments, the tolerance may be selected based on the tablet to be produced. In mathematical terms, the predetermined dimension range may be md+ tm, where md is a desired mass the tablet and tm is an absolute value of the mass tolerance.

[0030] The alteration device may alternatively be denoted “a device” or may be denoted a “tablet alteration device”.

[0031] 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. In some embodiments, 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.

[0032] 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.

[0033] In some embodiments, 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.

[0034] Alternatively or additionally, 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.

[0035] 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.

[0036] 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.

[0037] By “maintaining an adjustment of the dosing device” may be understood that 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.

[0038] The alteration device may be configured to switch between the first and the second state during operation of the tablet press, such as during an operation and / or during rotation of the die element, of the tablet press. In some examples, the rotary tablet press, such as the alteration device thereof, is configured to, during an operation of the tablet press, 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 by the alteration device being in the first state and, during the operation of the tablet press, 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 by the alteration device being in the second state. During the operation may refer to during rotation, such as during a continuous rotation, of the die element.

[0039] In some embodiments, the plurality of punches supported by the bottom and top punch guides are arranged and configured to, during an operation of the rotary tablet press, produce 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, at least when the alteration device is in the first state. The alteration device may be 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 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 during the operation of the rotary tablet press.

[0040] By during an operation may herein be understood during rotation of the rotary tablet press, such as of the die element thereof, i.e. without stopping or halting the die element.

[0041] In some embodiments, the alteration device may be configured to alter the amount of a powder in one or more bore(s) prior to compression, precompression or both of the powder by the plurality of punches so that a first amount of powder is present in the die prior to and / or at the time of compression, pre-com pression or both of the powder by the plurality of punches when the alteration device is the first state and a second amount of powder is present in the die prior and / or at the time of to compression, precompression or both of the powder by the plurality of punches when the alteration device is in the second state. In some examples, the alteration device is configured to alter the amount of the powder in the one or more bore(s) prior to any compression of the powder by the punches.

[0042] In some embodiments, the alteration device, in the first state of the alteration device, is configured to cause a first amount of the powder to be present in at least one of the one or more bores prior to and / or at the time of a compression by the plurality of punches of the first amount of powder of the at least one of the one or more bores, wherein the alteration device, in the second state of the alteration device, is configured cause a second amount of the powder to be present in at least one of the one or more bores prior to and / or at the time of the compression by the plurality of punches of the second amount of powder of the at least one of the one or more bores.

[0043] It will be appreciated that any first amount of the powder is different from any second amount of the powder and that such first and second amounts of powder are non-zero amounts. The first and second amounts of powder may, alternatively or additionally, be denoted first and second masses of powder and / or first and second volumes of powder.

[0044] The first amount of powder may be selected to cause an in-spec tablet to be produced, e.g. within the predetermined mass range, and the second amount of powder may be selected to cause an out-of-spec tablet to be produced, e.g. outside of predetermined mass range. The second amount of powder may be less than 98 %, such as less than 97 %, such as less than 96 %, such as less than 95 %, such as less than 93 %, such as less than 90 %, such as less than 85 %, such as less than 80 %, first amount of powder, e.g. by weight or by volume. Additionally, the second amount of powder may be at least 25 %, such as at least 35 %, such as at least 45 %, such as at least 55 %, such as at least 65 %, such as at least 75 % of the first amount of powder, e.g. by weight or by volume. In some embodiments, the second amount of powder may be between 25-98 %, such as 35-97%, such as 45-96%, such as 55-95%, such as 65-95%, such as 75-95% of the first amount of powder by weight or volume.

[0045] Alternatively, the second amount of powder may be at least 102 %, such as at least 103 %, such as at least 104 %, such as at least 105 %, such as at least 107 %, such as at least 110 %, such as at least 115 %, such as at least 120 %, such as at least 125 % of the first amount of powder, e.g. by weight of volume. Additionally, the second amount of powder may be less than 175 %, such as less than 165 %, such as less than 155 %, such as less than 145 %, such as less than 135 %, such as less than 125 % of the first amount of powder, e.g. by weight of volume. In some embodiments, the second amount of powder may be between 102-175 %, such as 103 - 165 %, such as 104 - 155 %, such as 105 - 145 %, such as 105 - 135 %, such as 105 - 125 % of the first amount of powder by weight or volume.

[0046] As an example, the predetermined mass range may be a nominal mass ± 3 %. The second amount of powder may correspondingly be selected to result in a tablet having a mass more than 3 % higher or lower than the nominal mass. For instance, the second amount of powder may, in a such instance, be, e.g., 105 % - 125 % or 75 - 95 % of the first amount of powder by weight, i.e. weigh between 105 % - 125 % or 75 - 95 %, respectively, of the first amount of powder. Where the predetermined mass range is different, the relation between the first and second amounts of powder may be altered accordingly to ensure an out-of-spec tablet.

[0047] In some embodiments, the alteration device is configured to transition from the first to the second state during a rotation, such as a continuous rotation, of the die element. Correspondingly, the alteration device may be configured to transition from the second to the first state during the same rotation or a rotation, such as a continuous rotation, of the die element.

[0048] The die element may comprise any number of bores. In some embodiments, 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. Correspondingly, 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, and the plurality of top punches may comprise a plurality of top punches comprising one top punch per bore of the plurality of bores.

[0049] The die element may be a single-piece die element, such as substantially one piece of material comprising the one or more bores. Alternatively, 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.

[0050] The one or more bore(s) may be dies or die bores.

[0051] 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. Correspondingly, 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.

[0052] 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. In some embodiments, the axial direction may be substantially parallel to or parallel to a vertical direction.

[0053] The bore(s) of the die element may be bore(s) arranged as openings in the axial direction of the turret.

[0054] 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.

[0055] 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. Correspondingly, the feeder may be arranged above the die element, for instance when seen in the axial direction of the die element. Alternatively or additionally 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. In some embodiments, 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. Thus, by the rotation of the die element, the bores, e.g. where a plurality of bores are provided, may be filled sequentially. 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).

[0056] Alternatively or additionally, 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.

[0057] 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.

[0058] 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.

[0059] By filling may herein be referred to the arrangement of powder in the bore(s). Correspondingly, it will be appreciated that the term filling used throughout this disclosure relates to the arrangement of powder by the filling device in the respective bore(s) of the one or more bore(s).

[0060] 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.

[0061] Where the tablet press comprises an adjustable dosing device, 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.

[0062] The adjustable dosing device may, in some embodiments, comprise a dosing cam. The dosing cam may be a part of the bottom punch guide. Alternatively or additionally, 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.

[0063] Where the tablet press comprises an adjustable dosing device, 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. Where 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.

[0064] Alternatively or additionally, 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. In particular, the adjustable dosing device, such as a dosing cam thereof, may be adjustable and / or adjusted during operation to maintain a desired tablet mass.

[0065] In some embodiments, 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.

[0066] 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. Alternatively or additionally, the predetermined amount of powder may be based on the specific type of tablet to produced.

[0067] In some embodiments, 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.

[0068] In some embodiments, 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.

[0069] Alternatively or additionally, 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.

[0070] In some embodiments, 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. For instance, 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.

[0071] Where the die element comprises a plurality of bores, 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.

[0072] 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.

[0073] The alteration device may be changed into the second state in response to the rotary tablet press performing a reject test. Alternatively or additionally, the rotary tablet press may perform a reject test in response to the alteration device changing into the second state.

[0074] In some embodiments, 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.

[0075] 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.

[0076] 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-Sem iconductor (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.

[0077] In some embodiments, 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.

[0078] Thereby, 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.

[0079] 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.

[0080] Alternatively or additionally, 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).

[0081] By determining the compression force and / or of a roller displacement, 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.

[0082] An example of an exemplary sensor arrangement is provided in the applicant’s patent EP2021168, “Method for controlling a tablet press and such a press” as set out, for instance, in the Summary section thereof. In some embodiments, 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, 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, divert the produced tablet to a second exit of the tablet press.

[0083] Thereby, the sorting by the tablet ejection device may equally be tested during the reject test, in turn allowing for a more reliable reject test. In particular, 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.

[0084] Moreover, by diverting the out-of-spec tablet to the second exit, it may be verified afterwards that the sorted tablet is indeed out-of-spec, i.e. by measuring, such as manually measuring, the outer dimensions and / or the mass of the tablet. Thereby, the reject test may be further verified, allowing for a robust reject test.

[0085] In some embodiments, 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.

[0086] Alternatively or additionally, 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.

[0087] 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. In some embodiments, the verification device may comprise a camera.

[0088] The sorting device may comprise and / or be connected to a tablet chute.

[0089] In some embodiments, 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.

[0090] Thereby, when the powder is compressed into tablet(s) by the punches, the produced tablet will correspondingly have a reduced or increased mass, respectively.

[0091] In some embodiments, 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. In particular, where the die element comprises a plurality of 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.

[0092] 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.

[0093] 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.

[0094] In some embodiments, 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.

[0095] 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.

[0096] It will be appreciated that the increased or reduced mass of powder may correspondingly refer to an increased or reduced volume of powder in the bore(s).

[0097] Where the alteration device is configured to cause a reduced mass in at least one of the one or more bores, the alteration device may be configured to remove part or a portion, i.e. some but not all, of the powder from the respective bore(s) subsequent to and / or during filling of the respective bore(s). The amount or mass of powder in the at least one of the one or more bores may be a non-zero amount or mass. The alteration device may be configured to cause the reduced mass of the powder prior to compression, precompression or both of the powder.

[0098] The tablet may be a single-layer tablet, i.e. consisting of one type of powder, or a multi-layer tablet having a plurality of layers, each layer consisting of different powders filled and compressed one by one. Where the tablet is a multi-layer tablet, the alteration device may be configured to cause a reduced mass and / or volume of a powder of one or more of the layers, such as each layer, prior to the compression, pre-compression or both of the powder of the layer(s), e.g. by removing part or a portion, i.e. some but not all, of the respective powder from the respective bore(s) subsequent to and / or during filling of the respective bore(s). The part of portion of the powder of the layer(s) may be removed after filling and compression of a powder of another layer of the multi-layer tablet.

[0099] In some embodiments, 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.

[0100] In some embodiments, 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.

[0101] Thereby a reduced mass of powder may be provided in the at least one bore while allowing for the feeding device and, where an adjustable dosing device is present also the dosing cam, to continue operation. Correspondingly, no alteration may be needed for the adjustable dosing device or the feeding device when performing a reject test, in turn allowing for a simple and efficient reject test.

[0102] The alteration device may be configured to remove the amount of powder simultaneous with or subsequent to filling of the bore and prior to precompression or compression of the powder in the bore(s) by the punches.

[0103] 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. Alternatively or additionally, 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.

[0104] In some embodiments, 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.

[0105] Thereby, 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.

[0106] 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.

[0107] Alternatively or additionally, 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.

[0108] 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). In some embodiments, 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.

[0109] In some embodiments, the nozzle may be dimensioned, arranged and / or selected based on a desired quantity of powder to be removed from the bore(s). Alternatively or additionally, 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.

[0110] 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.

[0111] Alternatively or additionally, 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.

[0112] The nozzle may be any type of nozzle and / or opening(s), which allows a fluid flow through the nozzle.

[0113] Alternatively or additionally, 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.

[0114] In some embodiments, the fluid may be provided by the alteration device with an excess pressure relative to the air pressure in the turret.

[0115] The fluid may be a gas, such as atmospheric air, nitrogen, oxygen, or the like.

[0116] In some embodiments, 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.

[0117] 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.

[0118] In some embodiments, the alteration device comprises an adjustment device configured to adjust a position of one or more of the plurality of punches.

[0119] By adjusting 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.

[0120] 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. Alternatively or additionally, 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.

[0121] Alternatively or additionally, 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. Alternatively or additionally, 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.

[0122] 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-com pression or compression, and / or during pre-compression or compression.

[0123] Where the turret comprises a plurality of bottom punches, 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.

[0124] Alternatively or additionally, where the turret comprises a plurality of top punches, 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.

[0125] In some embodiments, 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.

[0126] Thereby, in particular where the bottom punch(es) comprises a portion extending into a part of the respective bore(s), 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.

[0127] In some embodiments, the turret defines an axial direction, a radial direction, and a tangential direction, and wherein 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.

[0128] The axial, radial, and tangential directions may be orthogonal or substantially orthogonal to each other.

[0129] 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.

[0130] In some embodiments, 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.

[0131] 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.

[0132] 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.

[0133] Alternatively or additionally, 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. For instance, in case of a pneumatic 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.

[0134] Alternatively or additionally, 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.

[0135] 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. Where the adjustment device comprises an actuator, the actuator may physically move the interface portion of the adjustment device.

[0136] 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.

[0137] In one example, 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. In this example, 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.

[0138] In another example, 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. In this example, 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.

[0139] In another example, 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). In this example, 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. relative to when the alteration device is in the first state, in the axial direction when the adjustment device is in a third 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, 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.

[0140] Thereby, 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.

[0141] In some examples, 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.

[0142] 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.

[0143] In some embodiments, 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.

[0144] In some embodiments, 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.

[0145] In some embodiments, 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.

[0146] 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.

[0147] 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.

[0148] 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.

[0149] In some embodiments, the rotary tablet press comprises an enclosure surrounding the turret in its operational position in a compression section of the rotary tablet press.

[0150] 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.

[0151] 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.

[0152] The enclosure may provide a contained volume within the enclosure, i.e. the volume may be a contained volume.

[0153] By the term “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. Correspondingly, 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. By “contained volume” may herein be understood that the volume is to have a containment capability of dust containment of up to 10 pg per m3. Correspondingly the contained volume may be a volume, which when in the installed is configured to have a dust containment of up to 10 pg per m3.

[0154] Correspondingly, when performing a reject test, containment need not be broken to perform the reject test, in turn allowing for a safe and efficient reject test.

[0155] Where 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. Alternatively, the top and / or bottom punch guides, and optionally the top and bottom punches, may be arranged within the volume of the enclosure.

[0156] In some embodiments, the rotary tablet press comprises a marking device for marking a tablet with outer dimensions outside of the predetermined dimension range and / or with a mass outside the predetermined mass range.

[0157] Thereby, an easy visual identification of an out-of-spec tablet may be provided.

[0158] The marking device may be configured to mark the tablet by marking the tablet subsequent to compression and / or pre-compression by the plurality of punches and / or by marking the powder to be compressed and / or precompressed by the plurality of punches prior to compression thereof by the plurality of punches. The marking device may alternatively or additionally be configured to mark the tablet by colouring the tablet and / or the powder. In some embodiments, the marking device is configured to colour the powder during or subsequent to filling of the powder into the die.

[0159] The marking device may be activated in response to the alteration device being in or changing into the second state. Alternatively or additionally, the marking device may be integrated with or into the alteration device. As an example, where 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, the marking device may be integrated thereinto, and the fluid may be or may comprise a colouring element, such as paint. Thereby, when the nozzle applies the fluid to remove the powder from the at least one bore, a colour may be added to the powder to easily perform a visual identification of the out-of-spec tablet. The visual identification may be carried out by an operator or by a visual sensor, such as a camera, optionally connected or connectable to the rotary tablet press.

[0160] The marking device may alternatively be configured to mark the out- of-spec tablet by introducing a detectable component into the tablet. The detectable component may be detectable by a sensor, optionally connected to the tablet press.

[0161] In one example, the detectable component may be a colouring element. In another example, the detectable component may be a component, which alters an impedance, such as a capacitance, of the out-ot-spec tablet. Thereby, the out-of-spec tablet may be detectable by a sensor, such as a capacitive sensor, optionally connected or connectable to the rotary tablet press. In another example, the detectable component may be a magnetic material allowing for a magnetic sensor to detect the out-of-spec tablet.

[0162] A second aspect of the present invention relates to a method for producing a tablet outside of specification, the method comprising: providing a tablet press according to the first aspect; producing, 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; 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 by changing the state of the alteration device from the first to the second state. The method may provide identical or similar advantages to the rotary tablet press according to the first aspect of the invention. The rotary tablet press of the method according to the second aspect of the invention may comprise any feature and / or provide any advantage described with respect to the rotary tablet press according to the first aspect of the invention. Embodiments of the rotary tablet press of the method may be the same as described with respect to the rotary tablet press according to the first aspect of the invention .

[0163] In particular, by allowing for a production of an in-spec and an out-of- spec tablet by the rotary tablet press, an easy and reliable reject test may be performed.

[0164] 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.

[0165] 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.

[0166] In some embodiments, the step of producing the in-spec tablet may comprise setting the alteration device in the first state.

[0167] In some embodiments, 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. In particular, 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.

[0168] For instance, the steps of producing the in-spec and the out-of-spec tablet may be performed during a rotation, such as a same or continuous rotation, of the die element. Alternatively or additionally, the steps of producing the in-spec and the out-of-spec tablet may be performed subsequent to a setup and / or adjustment of the tablet press, such as an adjustment or setup of the plurality of punches. The steps of producing the in-spec and the out-of-spec tablet may be performed while maintaining the setup and / or adjustment of the tablet press. Alternatively or additionally, the method may comprise readjusting the tablet press subsequent to the steps of producing the in-spec and the out-of-spec tablets.

[0169] In some embodiments 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: arranging, by the filling device, powder in at least one bore of the die element; simultaneous with or subsequent to the arranging of powder in the at least one bore, altering, by the alteration device, a mass of powder arranged in the at least one bore; subsequent to altering the mass of powder, compressing the powder in the at least one bore into a tablet.

[0170] Altering may refer to reducing or increasing the mass of powder in the at least one bore. Where the mass of powder in the at least one bore is reduced, a part or portion of the powder, i.e. some but not all of the powder, in the at least one bore may be removed to achieve a reduced, non-zero, mass of powder.

[0171] In some embodiments, 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.

[0172] Where the rotary tablet press comprises a sensor arrangement(s) and a tablet ejection device, 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.

[0173] Presently preferred embodiments and further advantages will be apparent from the subsequent detailed description and drawings. A person skilled in the art will appreciate that any one or more of the above aspects of this disclosure and embodiments thereof may be combined with any one or more of the other aspects of the disclosure and embodiments.

[0174] Brief Description of Drawings

[0175] In the following description embodiments of the invention will be described with reference to the drawings, in which

[0176] FIG. 1 shows a perspective view of an embodiment of a turret of a rotary tablet press;

[0177] FIG. 2 shows a perspective view of an embodiment of a turret of a rotary tablet press;

[0178] FIG. 3 shows a perspective view of an embodiment of an alteration device of a rotary tablet press according to the present invention;

[0179] FIG. 4A shows a cross-sectional view of the embodiment of the alteration device shown in FIG. 3 in a first state of the alteration device;

[0180] FIG. 4B shows a cross-sectional view of the embodiment of the alteration device shown in FIG. 3 in a second state of the alteration device;

[0181] FIG. 5A shows a cross-sectional view of a section of the turret with the embodiment of the alteration device shown in FIG. 3 in a first state of the alteration device;

[0182] FIG. 5B shows a cross-sectional view of a section of the turret with the embodiment of the alteration device shown in FIG. 3 in a second state of the alteration device;

[0183] FIG. 6A shows a perspective view of another embodiment of an alteration device of a rotary tablet press according to the present invention;

[0184] FIG. 6B shows another perspective view of the embodiment of an alteration device of a rotary tablet press according to the present invention shown in FIG. 6A;

[0185] FIG. 7 shows a cross-sectional view of a section of the turret with the embodiment of the alteration device shown in FIGs. 6A and 6B in a first state of the alteration device; and

[0186] FIG. 8 shows a flow chart of a method according to the present invention.

[0187] Similar reference numerals are used for similar elements across the various embodiments and figures described herein.

[0188] Detailed Description

[0189] The present invention will now be described in more detail hereinafter with reference to the accompanying drawings, in which an embodiment 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.

[0190] FIG. 1 shows a perspective view of an embodiment of a turret 2 of a rotary tablet press 1 according to the present invention.

[0191] 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.

[0192] In FIG. 1 only a section of the bottom punch guide 26 is shown for illustrative purposes. 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.

[0193] 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.

[0194] 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 .

[0195] 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.

[0196] FIG. 2 shows a perspective view of an embodiment of a turret 2 of a rotary tablet press 1 according to the present invention.

[0197] The turret 2 defines an axial direction z, a radial direction r, and a tangential direction 9.

[0198] 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.

[0199] 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.

[0200] In the tablet press 1 shown in FIGs. 1 and 2, 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. As shown in FIG. 2, 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. In other embodiments, 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.

[0201] In the tablet press 1 shown in Fig. 2, 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. As shown in Fig. 2, 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. In other embodiments, 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.

[0202] FIG. 3 shows a perspective view of an embodiment of the alteration device 5. Similarly, 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. Similarly, 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. As shown in FIGs. 3-5B, the alteration device 5 is housed at least partly in the bottom punch guide 26.

[0203] 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.

[0204] 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.

[0205] 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 9 but may in other embodiments be angled more or less, such as between 2° and 65°, such as between 5° and 45°.

[0206] As shown in FIGs. 4B and 5B, 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. Thereby, 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. Thus, 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.

[0207] When the alteration device 5 is in the first state, as shown in FIGs. 4A and 5A, 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.

[0208] While the 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.

[0209] 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.

[0210] When seen from above the axial direction z, FIG. 6A shows a top perspective view, i.e. a view from above in the axial direction, and FIG. 6B shows a bottom perspective view of the alteration device 6 in a mounted condition of the alteration device 6. As also illustrated in FIG. 7, the major surfaces visible in FIG. 6B are intended to face the die element in its mounted condition.

[0211] 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 precompression of the powder in the bore 200a.

[0212] Thereby, an amount of powder is removed from the bore 200a that a tablet with a reduced mass and / or reduced dimensions is produced by the bottom punch 22a and a corresponding top punch during compression.

[0213] 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. While the 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.

[0214] The fluid is a gas, such as atmospheric air, nitrogen, oxygen, or the like.

[0215] 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.

[0216] 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 .

[0217] While the 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.

[0218] FIG. 8 shows a flow chart of a method 7 according to the present invention.

[0219] 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 .

[0220] 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.

[0221] Although some embodiments have been described and shown in detail, it will be appreciated that 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 utilised and that structural and functional modifications may be made within the scope of the appended claims without departing from the scope of the present invention.

[0222] 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.

[0223] It should be emphasised 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.

[0224] List of reference numerals

[0225] 1 rotary tablet press

[0226] 2 turret

[0227] 20 die element

[0228] 200 bores

[0229] 200a bore

[0230] 22 bottom punches

[0231] 22a bottom punch

[0232] 24 top punches

[0233] 26 bottom punch guide

[0234] 260 adjustable dosing device

[0235] 3 enclosure

[0236] 4 feeder

[0237] 5 alteration device

[0238] 50 adjustment device

[0239] 52 actuator

[0240] 54 interface portion

[0241] 540 interface surface

[0242] 6 alteration device

[0243] 60 actuator

[0244] 62 housing

[0245] 64 openings

[0246] 66 mounting portion

[0247] 7 method

[0248] 70 method step

[0249] 71 method step

[0250] 72 method step

Claims

43CLAIMS1 . A rotary tablet press comprising 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 one or more bores of the die element, wherein the plurality of punches supported by the bottom and top punch guides are configured to, during operation of the rotary tablet press, produce 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, characterised in that the rotary tablet press further comprises an alteration device 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 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 during operation of the rotary tablet press.

2. The rotary tablet press according to claim 1 , wherein the alteration device, in the first state of the alteration device, is configured to cause a first amount of the powder to be present in at least one of the one or more bores prior to a compression by the plurality of punches of the first amount of powder of the at least one of the one or more bores, wherein the alteration device, in44 the second state of the alteration device, is configured cause a second amount of the powder to be present in at least one of the one or more bores prior to the compression by the plurality of punches of the second amount of powder of the at least one of the one or more bores.

3. The rotary tablet press according to claim 1 , wherein the alteration device is configured to transition from the first to the second state during a rotation, such as a continuous rotation, of the die element.

4. The tablet press according to any one of the preceding claims further comprising at least one sensor arrangement configured to estimate a mass and outer dimensions of a tablet.

5. The tablet press according to claim 4 further comprising 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, 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, divert the produced tablet to a second exit of the tablet press.

6. The tablet press according to any one of the preceding claims, wherein 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.

7. The tablet press according to claim 6, wherein the alteration device is configured to remove an amount of powder in at least one bore, in which45 powder has been arranged by the feeder, of the one or more bores.

8. The tablet press according to claim 6 or 7, wherein 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.

9. The tablet press according to any one of the preceding claims, wherein the alteration device comprises an adjustment device configured to adjust a position of one or more of the plurality of punches.

10. The tablet press according to claim 9, wherein 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.11 . The tablet press according to claim 9 or 10, wherein the turret (2) defines an axial direction (z), a radial direction (r), and a tangential direction (9), and wherein the adjustment device is configured to adjust a position of the one or more of the plurality of punches in the axial direction (z) or in a direction substantially parallel to the axial direction (z).

12. The tablet press according to any one of claims 9-11 , wherein the adjustment device is configured to adjust the position of the one or more of the plurality of punches by an interaction, such as with the one or more of the plurality of punches.

13. The tablet press according to any one of the preceding claims further comprising 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 beproduced by the plurality of punches.

14. The tablet press according to any one of the preceding claims, wherein the rotary tablet press comprises an enclosure surrounding the turret in its operational position in a compression section of the rotary tablet press.

15. The rotary tablet press according to any one of the preceding claims, wherein the rotary tablet press further comprises a marking device for marking a tablet with outer dimensions outside of the predetermined dimension range and / or with a mass outside the predetermined mass range.

16. A method for producing a tablet outside of specification, the method comprising: providing a tablet press according to any one of the preceding claims; producing, 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; 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 by changing the state of the alteration device from the first to the second state.

17. The method according to claim 16, wherein 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: arranging, by the filling device, powder in at least one bore of the die element; simultaneous with or subsequent to the arranging of powder in the at least one bore, altering, by the alteration device, a mass of powder arranged in the at least one bore; subsequent to altering the mass of powder, compressing the powderin the at least one bore into a tablet.

18. The method according to claim 16 or 17, wherein 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.

Images