Method and apparatus for setting up a rotary press manufacturing process
The database-based correlation of parameter data in rotary presses optimizes tableting processes, ensuring consistent tablet quality by predicting optimal settings without reliance on personal expertise.
Patent Information
- Application Number
- JP2024039394
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2023-04-11
- Filing Date
- 2024-03-13
- Publication Date
- 2025-10-24
- Estimated Expiration
- 2044-03-13
AI Technical Summary
Existing rotary press manufacturing processes rely heavily on personal expertise for setting up optimal tableting parameters, leading to inconsistent and time-consuming optimization, making it difficult to achieve safe, reproducible, and consistent tablet quality.
A method and apparatus that utilize a database to store and correlate parameter data groups related to components, process, powder, and tablet characteristics, allowing for the determination of optimal settings based on correlations and reducing the need for manual testing.
Enables reliable, reproducible, and efficient setup of rotary press processes to produce high-quality tablets by predicting optimal parameter combinations, reducing time and material waste.
Smart Images

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Abstract
Description
[Technical Field]
[0001] The present invention relates to a method for setting up a manufacturing process for a rotary press, in which the rotary press comprises a rotor rotatable by a rotary drive device, the rotor having an upper punch guide and a lower punch guide, an upper press punch of the rotor being guided by the upper punch guide and a lower press punch being guided by the lower punch guide, the rotor having a die plate with cavities arranged between the punch guides, the rotary press also comprising a filling device for filling a powder raw material into the cavities of the die plate, and a pressing device for pressing the powder raw material in the cavities of the die plate to form tablets by interacting with the upper press punch and the lower press punch during operation.
[0002] The present invention also relates to an apparatus for setting up a manufacturing process for a rotary press, in which the rotary press comprises a rotor rotatable by a rotary drive device, the rotor having an upper punch guide and a lower punch guide, the upper press punch of the rotor being guided by the upper punch guide, the lower press punch of the rotor being guided by the lower punch guide, the rotor comprising a die plate having cavities disposed between the punch guides, the rotary press comprising a filling device for filling a powdered raw material into the cavities of the die plate, and the rotary press also comprising a pressing device for pressing the powdered raw material in the cavities of the die plate to form tablets by interaction between the upper press punch and the lower press punch during operation. [Background technology]
[0003] Rotary presses typically have multiple upper and lower press punches, each paired with one cavity in the die plate. During operation, the upper and lower press punches rotate together with the die plate, their axial movement controlled by a control cam and guided by upper and lower punch guides. During rotation, the die plate passes through various devices in the rotary press, including a filling device that fills the cavity with powdered material to be pressed, and a pressing device that uses upper and lower press rollers to push the upper and lower press punches into the cavity to form tablets. After passing through the pressing device, the upper press punch is guided above the cavity, and the tablets produced in the cavity are pushed onto the upper surface of the die plate by a lower press punch. The tablets are then scraped off the die plate, for example, by a scraping element, to the output of the rotary press, where they are further processed.
[0004] The quality of the produced tablets, specifically their hardness and density, depends on both process parameters, such as the rotation speed of the rotor or wheel of the filling device during the tableting process, as well as the hardware components, i.e., the components mounted on the rotary press. The powder characteristics of the powder material pressed in the rotary press, such as the powder material's density or particle size distribution, also affect the properties of the produced tablets. Therefore, tablet quality is determined by a variety of factors that interact with each other. Changing individual influencing factors, such as a different powder material or a powder material composed of an active pharmaceutical ingredient (API) and one or more excipients, requires the adaptation of more parameters to maintain the corresponding desired tablet quality.
[0005] Traditionally, finding the optimum parameters for each tableting process is based on personal expertise, especially the combination of different parameters for the rotary press in the tableting process, which are correctly set by an experienced operator using a series of test results.
[0006] However, safe, reproducible, and consistent results are not achieved through personal expertise. Rather, the success of a process depends on the individual operator. Furthermore, optimizing a process is time- and material-intensive, especially when varying individual parameters. Because time constraints do not allow for the use of statistical test plans to always test all possible parameter combinations, the optimal settings for each process cannot be reliably identified within the tests performed within the available timeframe, and optimal tablet quality cannot be guaranteed. Summary of the Invention [Problem to be solved by the invention]
[0007] Proceeding from the prior art described above, the present invention is based on the problem of providing a method and an apparatus of the aforementioned type, by which the production process of a rotary press can be optimally set for each desired tableting process in a reliable, simple and safe reproducible way, even when parameters change. [Means for solving the problem]
[0008] The invention achieves this object by means of independent claims 1 and 16. Advantageous embodiments are disclosed in the dependent claims, the description and the drawings.
[0009] With respect to the method of the type described above, the present invention provides storing a plurality of parameter data groups in a database, wherein a first group includes part parameter data related to parts mounted on the rotary press, a second group includes process parameter data related to process parameters during operation of the rotary press, a third group includes powder parameter data related to powder characteristics of powder raw materials to be pressed by the rotary press, and a fourth group includes tablet parameter data related to tablet characteristics of tablets to be produced by the rotary press; - correlating the parameter data of the different groups stored in the database with each other, so that for specified parameter data from at least two of the four groups, parameter data of the other groups of the four groups can be determined; and defining parameter data of other groups of the four groups with respect to parameter data specified from at least two groups of the four groups according to correlations of parameter data stored in the database to set the manufacturing process of the rotary press.
[0010] The present invention achieves the above-described object by providing a setting device including a database in which multiple parameter data groups are stored. Among the multiple groups, a first group includes part parameter data related to parts mounted on a rotary press, a second group includes process parameter data related to process parameters during operation of the rotary press, a third group includes powder parameter data related to powder characteristics of powder raw materials pressed in the rotary press, and a fourth group includes tablet parameter data related to tablet characteristics of tablets produced in the rotary press. The parameter data of the different groups stored in the database are correlated with each other so that the parameter data of the other groups of the four groups can be determined for specified parameter data from at least two of the four groups. The setting device for setting the manufacturing process of the rotary press is designed so that the part parameter data and / or the process parameter data are defined for specified powder parameter data and / or specified tablet parameter data according to the correlation of the parameter data stored in the database.
[0011] The basic design of the rotary press, which is the basis for the method or device according to the invention, is as described above. To reproducibly configure the rotary press for an optimal tableting process, it is proposed in accordance with the invention to classify parameter data related to the tableting process. The parameter data related to the tableting process, i.e., component parameter data characterizing the hardware parts attached to the rotary press, process parameter data characterizing the process parameter data of the rotary press during operation, powder parameter data characterizing the properties of the powder pressed in the rotary press, and tablet parameter data characterizing the tablet properties of the tablets produced in the rotary press, are each divided into one group, forming at least four groups of parameter data related to the tableting process in the rotary press. These at least four groups of parameter data are stored in a database so that they can be reproducibly and searchably accessed at any time.
[0012] The four groups of parameter data stored in the database are also correlated with each other. Taking into account designated parameter data from at least two of the four groups, e.g., designated powder parameter data and tablet parameter data, parameter data from the other four groups, e.g., component parameter data and process parameter data, can be determined. Of course, one parameter data can also be determined from designated parameter data from three of the four groups based on the correlation. To set up a manufacturing process, other parameter data can be defined from designated parameter data from at least two of the four groups based on the parameter correlations stored in the database. For example, to set up a manufacturing process for a rotary press, component parameter data and / or process parameter data can be defined based on the correlations of parameter data stored in the database with predefined powder parameter data and / or tablet parameter data. In particular, the component parameter data and process parameter data resulting from the correlations stored in the database are determined by designated tablet parameter data for the desired tablet quality, and further take into account the designated powder parameter data, with the component parameter data and process parameter data being determined by the powder raw material to be pressed. The process parameter data is generally adjustable and can be selected to correspond to the specified powder raw material with the powder parameter data of the rotary press in operation so as to obtain the desired tablet quality with the desired tablet parameter data. Furthermore, the component parameter data can also be adjusted within a certain range. For example, the filling wheel and other setting components of the filling device can be flexibly selected.
[0013] The present invention is based on the insight that by determining one or two groups of parameter data from a specified combination of the other groups of parameter data, specified or respectively desired results, particularly desired tablet parameter data and tablet quality, can be achieved in a manufacturing process on a rotary press. Typically, it is assumed that the powder raw material with powder parameter data is defined by a specified manufacturing process. The tablet parameter data is similarly defined as target values for achieving the desired tablet quality. Process parameter data and part parameter data are also set. By means of the database correlation according to the present invention, these can be defined so that the desired tablet quality is achieved for each powder raw material.
[0014] To the extent that specified, determined, or predicted parameter data for a group is referred to in this embodiment, this includes the possibility of all or only a portion of the parameter data stored in each group. In particular, the part parameter data, and (although not necessarily) the process parameter data, may be partially defined and partially adjustable. Also, the correlation of parameter data between groups may include all or only a portion of the group's parameter data. Of course, the correlation will be better the more parameter data from each group is included in the correlation.
[0015] According to the present invention, by storing groups of parameter data in a database and correlating the data in the database, settings can be easily achieved and reliably reproduced for each manufacturing process. Once the parameter data is stored and correlated in the database, there is no need to perform a series of tests to find each optimal setting. For example, when dealing with process development or subsequent setting processes for rotary presses, finding the optimal setting for each manufacturing process is independent of personal expertise and can therefore be done in a safe, reliably repeatable manner.
[0016] The data output of the parameter data determined or respectively specified according to the present invention, e.g., process parameter data, can be viewed by the operator on a display device, such as a dashboard. The display device can be arranged on or near the rotary press and can also be formed on a PC, tablet, or smartphone. It is also conceivable that parameter data defined during the setup of a production process, such as process parameter data, can be automatically set according to the present invention, particularly by a setting device for a rotary press. Using database correlation according to the present invention, ideal machine settings, particularly component parameter data and process parameter data, for each production process can be predicted based on, for example, specified tablet parameter data. Powder parameter data, in particular, is crucial for the success of the tableting process, and it is almost impossible to reliably reproducibly consider this in conventional production processes or with each rotary press. As explained above, in a rotary press, the production process can be set up before the actual production process. The setting results can be used for subsequent production processes. However, the setup according to the present invention for a production process, i.e., the actual machine setup, can also be performed directly on the rotary press.
[0017] Overall, the present invention achieves improved quality of tablets, e.g., oral solid dosage forms (OSD), and time and cost savings. It is possible to predict a reliable, reproducible, and documentable process to improve the tableting process to a more efficient process, especially to produce "best" tablets, i.e., tablets that meet all the required characteristics, such as minimal tablet-to-tablet variability within a batch. Furthermore, standardization of the work process is achieved.
[0018] As already explained, according to one embodiment, it is possible to predict other parameter data from parameter data designated from at least two of the four groups corresponding to the correlations of parameter data stored in the database. As will be explained in more detail below, by using the corresponding algorithm, it is possible to predict parameter data, especially for parameter combinations that have not yet been experimentally investigated in tests. This further simplifies the setup of the rotary press, especially for parameter combinations that have not yet been investigated.
[0019] The part parameter data may include, for example, the type of press punch, die plate, filling device, and / or pressing device attached to the rotary press. The part parameter data may include, for example, the number, diameter, length, and shape of the punch head and / or punch tip of the attached press punches. Furthermore, the part parameter data may include, for example, whether the die plate is composed of a single piece or ring segments, and / or the number and / or shape of the cavities in the die plate, as well as, for example, whether the cavities are designed directly as holes in the die plate or in die inserts inserted into the die plate. The part parameter data may also include, for example, the type of filling device, such as the shape of the filling chamber of the filling device and / or the presence of one or more rotating filling wheels, as well as the shape of the filling wheels. Furthermore, the part parameter data may include, for example, the number and type of pressing devices, particularly the presence of upper and lower pressing rollers and / or pre-pressing and main pressing devices. Multiple filling devices and / or pressing devices for producing multi-layer tablets may also be included in the part parameter data. Of course, the part parameter data may also include other parts of the rotary press, such as the upper and / or lower control cams of the press punch, in particular the filling cam, as well as the dispenser and its parts and / or sealing seals or respective sealing parts.
[0020] The process parameter data includes, for example, the rotation speed of the rotor, the rotation speed of at least one filling wheel of the filling device, and / or the pressing force of the pressing device. To the extent that the filling device has a filling wheel, the filling wheel is often driven to rotate in order to improve powder utilization. The rotation speed of the filling wheel affects the filling of the powder raw material into the die plate cavity. The pressing force is the pressing force exerted by the interaction of the pressing device, particularly the upper and lower pressing rollers, with the upper and lower pressing punches when pressing the powder raw material. Furthermore, the process parameter data has a decisive influence on the tableting results.
[0021] As already mentioned, the present invention is also based on the insight that the powder parameter data, particularly the selection of the powder parameter data to be considered, as well as the powder characterization method, are crucial for meaningful use of the database in predicting tableting results. A basic database for properly predicting or configuring a manufacturing process for a rotary press only exists if the parameter values important to the tableting process are correctly recorded. Regarding particularly relevant powder parameter data in this regard, analytical methods for recording powder properties should be generally predictable, particularly with respect to powder flowability, compressibility, compatibility, tabletability, and cohesion. The selection of a measurement method for powder parameters is also suitable for meaningfully comparing different powders. In pharmaceutical quality control, unless otherwise specified, individual method development is usually performed for each powder raw material. Within the method development for each powder parameter, the variable amounts of the powder raw material are set so that the relevant properties of each powder raw material are recorded with comparable reliability. It should be noted that, as a rule, the input amounts of the pressed powder raw materials generally do not change during the manufacturing process in a rotary press. Therefore, knowing and understanding the powder technical properties of the starting materials relevant to each process is essential for configuring the manufacturing process. The challenge in developing the database method according to the present invention is to find a way to record powder parameter data suitable for as many powder raw materials as possible in order to, on the one hand, ensure the compatibility of multiple powder raw materials and, on the other hand, predict the behavior of the powder raw materials during tableting.
[0022] Based on these findings, powder parameter data can include powder volume, powder density, particle size distribution, moisture content, and / or loss on drying of powder raw materials. Powder volume (e.g., bulk volume and tapped volume) and, more particularly, powder density (e.g., bulk density and tapped density), along with derivatives such as the Hausner factor and Carr index, and angle of repose, characterize the flowability of powder raw materials, which is important for the tableting process. Residual moisture and loss on drying are important for flow behavior and can be measured, for example, using infrared or halogen scales. These parameter data are also important for the tabletability and mechanical strength of the resulting tablets. Particle size distribution predicts the flow behavior as well as the compressibility and compatibility of powder raw materials. For example, when determining particle size distribution using laser diffraction, it is necessary to determine the appropriate dispersion pressure that will optimally atomize the powder raw materials to obtain meaningful results. For example, the complete particle size distribution can be measured.
[0023] The powder parameter that the inventors have found relevant is, more specifically, the water activity of the powder raw material. Similar to loss on drying, water activity affects the flow behavior and tabletability of the powder raw material. While loss on drying measures the total moisture content of the powder raw material, water activity only measures the proportion of available moisture in the powder raw material compared to the moisture content at full saturation. The inventors have recognized that water activity is better suited to predicting the tableting properties of powder raw materials than loss on drying. Another advantage of water activity is that it is well suited to measuring powder parameters under the same conditions for all powder raw materials. In contrast, loss on drying does not allow for significant measurement of powder parameters for all powder raw materials. Effervescent powders are a good example.
[0024] According to the inventors' findings, the powder parameter data described above achieves an appropriate balance between the quality of the data, in terms of whether the powder parameter data can be sufficiently detected from the correlation, and the feasibility, such as the measurement period and effort required for the measurement.
[0025] In addition to the powder parameter data or respective measurement methods described above, other powder parameter data or measurement methods are useful, Other methods for characteristic flow such as orifice jets Determination of the true density of powders by He pycnometry; this gives much more accurate information regarding compressibility and compactibility. Flowability measurement by ring shear or powder flow method Particle size measurement using imaging techniques such as scanning electron microscopy and dynamic image analysis: In addition to measuring particle size, information about particle shape is also gathered. Powder compression analysis; compressibility, compactibility, and tabletability data are described somewhat indirectly in the other cited methods, but these data can also be collected directly. Such data can also be included in a database, and specified characteristic quantities (as well as particle size distribution) can be recorded and used for analytical purposes, along with any derived quantities. In this way, information on compressibility, compatibility, tabletability, cohesion, etc. can be obtained.
[0026] The tablet parameter data may, as already explained, include, for example, tablet hardness, tablet density and / or tablet size of the tablets produced or, respectively, of the tablets produced in the rotary press.
[0027] According to a particularly practical embodiment, the parameter data stored in the database can be experimentally determined as part of a series of tests, including parameter data correlations, if necessary. For example, parameter data correlations can be experimentally determined by measuring the results of tablet parameter data with combinations of part parameter data, process parameter data, and powder parameter data that are varied within the test. Thus, various combinations of parameter data for different groups are established through tests and / or production runs, resulting in tablet parameter data for, for example, a powder raw material. The parameter data determined within the test are stored in the database together with the powder parameter data, with the corresponding correlations.
[0028] In principle, powder parameter data and / or tablet parameter data can be determined both outside and inside the production process in the rotary press, or both outside and inside the rotary press, respectively. For example, the parameter data can be determined outside the production process in the rotary press, or outside the rotary press, respectively, at a production location separate from the rotary press. Recording of the production process can be performed inline, online, or at-line. When recording parameter data within the production process or within the respective rotary press, for example, tablet parameter data is measured using a measuring system connected to the rotary press. The measuring system reports the corresponding measurement results of the powder parameter data to, for example, a setting device, which then stores the measurement results in a database accordingly. For example, the powder parameter data can be determined at a production location separate from the rotary press and automatically stored in a database. However, in principle, it is also conceivable to measure powder parameter data during the production process in the rotary press.
[0029] The parameter data stored in the database can be correlated by an algorithm stored in the evaluation device. As explained at the beginning, the evaluation device or the algorithms stored therein can also, in principle, correlate various groups of parameter data that have not yet been experimentally recorded with the algorithms described in detail below. Automatic configuration of the rotary press for the respective production process is also possible simultaneously with the setting device. The evaluation device can be part of the rotary press, integrated into the machine control, or located separately from the rotary press, e.g., on a PC, tablet, or smartphone. The evaluation device can also be integrated into the setting device. The database can be integrated into the setting device or evaluation device, or it can be separate.
[0030] The algorithm can be a machine learning algorithm. In particular, a self-learning algorithm can be stored in the evaluation device, which (continuously) adapts or, respectively, optimizes the correlations of the parameter data stored in the database based on training data and / or empirical data of the rotary press during operation. Machine learning algorithms include, for example, neural networks.
[0031] According to another embodiment, the parameter data stored in the database can be correlated using multivariate data analysis, which allows multiple parameters (in this case, parameter data from different groups) to be analyzed simultaneously and evaluated for correlations between them, allowing information specifically related to the correlation of parameter data to be separated from information unrelated to this.
[0032] According to a particularly practical embodiment, the multivariate data analysis can include principal component analysis. Principal component analysis (PCA) allows for the identification of correlations between data relevant to the problem at hand, in this case, between different groups of parameter data, and for separating them from information not relevant to the problem at hand in a particularly reliable manner. Within the framework of principal component analysis, at least one principal component can be identified by the parameter data of each group that has the greatest variance associated with the correlations between the parameter data of the different groups. The principal component with the greatest variance contains the most information about the parameter data and is therefore most relevant to the problem at hand. Reducing the parameter data to at least one principal component per group, for example, two or three, can significantly simplify the amount of data and evaluation, while still producing reliable correlations between the parameter data.
[0033] Multivariate data analysis can also be performed using multivariate regression methods, such as partial least squares regression (PLS / PLSR), to allow for the creation of models that correlate the parameter data of different groups.
[0034] The setting device according to the invention can be designed to carry out the method according to the invention. Likewise, the setting device and its database containing the correlation of parameter data can be designed according to the method according to the invention. The method according to the invention can be carried out correspondingly using the device according to the invention.
[0035] The invention also relates to a rotary press comprising an apparatus according to the following method.
[0036] Exemplary embodiments of the invention are explained in more detail below with reference to the drawings, which are shown diagrammatically. [Brief explanation of the drawings]
[0037] [Figure 1] 1 shows a rotary press according to the present invention with the rotor depicted flat. [Figure 2] FIG. 1 shows a schematic diagram of the effect of various parameter data on tablet parameter data. [Figure 3] 1 is a schematic diagram of a data provision for a database used in accordance with the present invention; [Figure 4] 1 shows a relationship diagram between parameter data of different groups and prediction of parameter data based thereon. DETAILED DESCRIPTION OF THE INVENTION
[0038] Unless otherwise specified, like reference numbers refer to like objects in the figures.
[0039] The rotary press shown in FIG. 1 is a tablet-producing rotary press that compresses powdered raw materials to produce tablets. The rotary press includes a rotor that is driven by a rotary drive and includes a die plate 10 having multiple cavities 12. The cavities 12 can be formed, for example, by holes in the die plate 10. The rotor further includes multiple upper and lower press punches 14 and 16 that rotate synchronously with the die plate 10. The upper and lower press punches 14 and 16 are axially guided by an upper punch guide 18 and a lower punch guide 20, respectively. The axial movements of the upper and lower press punches 14 and 16 during rotor rotation are controlled by an upper control cam 22 and a lower control cam 24. The rotary press further includes a filling device 26, which includes a filler storage section 28 and a filling chamber 30 connected via a filling pipe 32. In this manner, in this embodiment, the powder raw material reaches the filling chamber 30 by gravity from the filling material storage section 28 through the filling pipe 32, and from there reaches the cavity 12 of the die plate 10 through the filling port provided in the filling chamber 30.
[0040] The rotary press further includes a press device 34. The press device 34 includes a pre-press device having an upper pre-press roller 36 and a lower pre-press roller 38, and a main press device having an upper main press roller 40 and a lower main press roller 42. The rotary press further includes a discharger 44 and a collector 46 having an element that collects tablets 48 produced by the rotary press and directs them to a discharger 50 for discharging them from the rotary press. The collector 46 preferably includes a crescent-shaped collector portion, for example, that scrapes tablets 48 transported to the top of the die plate 10 by the lower press punch 16 in the discharger 44 from the die plate 10 and supplies them to the discharger 50.
[0041] The rotary press also has an evaluation control device 52 for controlling the operation of the rotary press and for carrying out the method according to the invention, as will be explained in more detail below. Together with a database formed in the evaluation control device 52 or separately from the evaluation control device 52, the evaluation control device 52 accordingly forms a device according to the invention.
[0042] FIG. 2 shows a schematic diagram of how parameter data (in this case, powder parameter data, component parameter data, and process parameter data of the rotary press) affect tablet parameter data, i.e., the quality of tablets produced by the rotary press. FIG. 3 shows a database 54 included in the evaluation control device 52, in which parameter data groups according to the present invention are stored. In FIG. 3, arrows indicate a number of clients 56, 58, 60 that form data sources for storing the corresponding parameter data in the database 54. The clients 56, 58, 60 can, for example, measure the production site and / or equipment in or on the rotary press, and provide the evaluation control device 52 with measurement data corresponding to the parameter data, such as powder parameter data or tablet parameter data. The evaluation control device 52 stores the measurement data corresponding to the respective groups in the database 54 formed within the evaluation control device 52, or correlates the measurement data separately from the evaluation control device 52, as described above.
[0043] 4, arrows represent correlations between the four groups of parameter data stored in database 54. For example, as shown schematically in FIG. 4 and described above, it is possible to predict parameter data for group 4 for given parameter data for groups 1, 2, and 3 based on correlations between parameter data for different groups in database 54. It is also possible to predict parameter data for groups 3 and 4, for example, from given parameter data for groups 1 and 2 based on correlations according to the present invention. Correlations, including combinations of parameter data that have not been experimentally determined, can be determined experimentally by a suitable test series and / or a suitable algorithm (e.g., a machine learning algorithm).
[0044] Based on the correlated parameter data stored in the database 54, parameter data of other groups are defined for designated parameter data from at least two groups, for example, using a setting device 52 formed from the evaluation device 52. For example, the defined parameter data of group 3 can be part parameter data, and the parameter data of group 4 can be process parameter data of a rotary press, and the parameter data of groups 3 and 4 can be set within certain limits according to their respective processes. [Explanation of symbols]
[0045] 10 Die Plate 12 cavities 14 Upper press punch 16 Lower press punch 18 Upper punch guide 20 Lower punch guide 22 Upper control cam element 24 Lower control cam element 26 Filling equipment 28 Filler storage section 30 Filling chamber 32 Filling tube 34 Press equipment 36 Upper spare press roller 38 Lower spare press roller 40 Upper press roller 42 Lower main press roller 44 Discharge machine 46 Raking machine 48 tablets 50 Ejector 52 Evaluation control device 54 databases 56 clients 58 clients 60 clients
Claims
1. 1. A method for setting up a manufacturing process for a rotary press, comprising: the rotary press includes a rotor that can be rotated by a rotary drive device; The rotor has upper and lower punch guides (18, 20); The upper press punch (14) of the rotor is guided by the upper punch guide (18), and the lower press punch (16) of the rotor is guided by the lower punch guide (20); The rotor has a die plate (10) with a cavity (12) disposed between the punch guides (18, 20), The rotary press also includes a filling device (26) for filling powder raw material into the cavity (12) of the die plate (10). The rotary press also includes a press device (34) that, during operation, interacts with the upper and lower press punches (14, 16) to press the powdered raw material within the cavity (12) of the die plate (10) to form tablets (48), The method comprises: storing a plurality of parameter data groups in a database (54), wherein a first group includes only part parameter data related to parts mounted on the rotary press, a second group includes only process parameter data related to process parameters during operation of the rotary press, a third group includes only powder parameter data related to powder characteristics of the powder raw material to be pressed in the rotary press, and a fourth group includes only tablet parameter data related to tablet characteristics of the tablets (48) to be produced in the rotary press; correlating the parameter data of the different groups stored in the database (54) with each other so that parameter data of at least two of the four groups can be used to predict parameter data of the other groups of the four groups; and setting parameter data of other groups of the four groups to parameter data designated from at least two groups according to the correlation of the parameter data stored in the database (54) to set the manufacturing process of the rotary press; 3. A method according to claim 1, wherein the manufacturing process is set up before the actual manufacturing process.
2. 2. The method of claim 1, wherein part parameter data and / or process parameter data are set to designated powder parameter data and / or designated tablet parameter data in accordance with the correlation of the parameter data stored in the database (54) to set the manufacturing process of the rotary press.
3. 3. The method according to claim 1, wherein for designated parameter data from at least two of the four groups corresponding to the correlation of the parameter data stored in the database (54), parameter data of the other groups of the four groups are predicted.
4. 3. The method according to claim 1, wherein the part parameter data includes the number, diameter, length, shape of the punch head and / or punch tip of the press punches mounted on the rotary press, the number and / or shape of the cavities in the die plate, the type of the filling device, in particular the shape of the filling chamber and / or the number of filling wheels of the filling device, and the shape of the filling wheels, and the number and type of pressing devices.
5. 3. The method according to claim 1, wherein the process parameter data comprises the rotation speed of the rotor, the rotation speed of at least one filling wheel of the filling device (26), and / or the pressing force of the pressing device (34).
6. 3. The method according to claim 1, wherein the powder parameter data consists of powder volume, powder density, particle size distribution, moisture content, and / or loss on drying of the powder raw material.
7. 3. The method of claim 1, wherein the powder parameter data comprises the water activity of the powder ingredient.
8. 3. The method according to claim 1, wherein the tablet parameter data consists of tablet hardness, tablet density, and / or tablet size of the tablets (48) produced in the rotary press.
9. 3. The method according to claim 1, wherein the parameter data stored in the database (54) are predicted experimentally in a series of tests.
10. 3. The method according to claim 1, wherein the powder parameter data and / or the tablet parameter data are predicted outside the production process of the rotary press.
11. 3. The method according to claim 1, wherein the parameter data stored in the database (54) are correlated by an algorithm stored in an evaluation device (52).
12. The method of claim 11 , wherein the algorithm comprises a machine learning algorithm.
13. 12. The method of claim 11, wherein the parameter data stored in the database (54) is correlated by multivariate data analysis.
14. 14. The method of claim 13, wherein the multivariate data analysis comprises principal component analysis.
15. 14. The method of claim 13, wherein the multivariate data analysis comprises multivariate regression.
16. An apparatus for setting a manufacturing process for a rotary press, comprising: the rotary press includes a rotor that can be rotated by a rotary drive device; The rotor has upper and lower punch guides (18, 20); The upper press punch (14) of the rotor is guided by the upper punch guide (18), and the lower press punch (16) of the rotor is guided by the lower punch guide (20); The rotor has a die plate (10) having a cavity (12) disposed between the punch guides (18, 20); The rotary press also includes a filling device (26) for filling powder raw material into the cavity (12) of the die plate (10). The rotary press also includes a press device (34) that, during operation, interacts with the upper and lower press punches (14, 16) to press the powdered raw material within the cavity (12) of the die plate (10) to form tablets (48), A setting device (52) is provided, which includes a database (54) in which a plurality of groups of parameter data are stored; a first group including only part parameter data relating to parts mounted on the rotary press, a second group including only process parameter data relating to process parameters during operation of the rotary press, a third group including only powder parameter data relating to powder characteristics of the powder raw material pressed in the rotary press, and a fourth group including only tablet parameter data relating to tablet characteristics of the tablets (48) produced in the rotary press; the parameter data of the different groups stored in the database (54) are correlated with one another such that parameter data of at least two of the four groups can be used to predict parameter data of other groups of the four groups; In order to set the manufacturing process of the rotary press, the setting device (52) is designed to set parameter data of other groups of the four groups with respect to parameter data designated from at least two groups of the four groups according to the correlation of the parameter data stored in the database (54); The manufacturing process is set up prior to the actual manufacturing process.
17. 17. Apparatus according to claim 16, characterized in that the setting device (52) containing the database (54) is designed to implement according to the method according to any one of claims 1 or 2.
18. A rotary press having a rotor that can be rotated by a rotary drive device, The rotor comprises upper and lower punch guides (18, 20); The upper press punch (14) of the rotor is guided by the upper punch guide (18), and the lower press punch (16) of the rotor is guided by the lower punch guide (20); The rotor has a cavity (12) disposed between the punch guides (18, 20). a die plate (10) having The rotary press also includes a filling device (26) for filling powder raw material into the cavity (12) of the die plate (10). The rotary press also includes a press device (34) that, during operation, interacts with the upper and lower press punches (14, 16) to press the powdered raw material into tablets (48) within the cavity (12) of the die plate (10); 18. A rotary press, characterized in that the rotary press also comprises a device according to claim 16 or 17.
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