Method and apparatus for configuring a manufacturing process of a rotary press
Patent Information
- Application Number
- DE102023109039
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2023-04-11
- Publication Date
- 2025-03-20
- Estimated Expiration
- 2043-04-11
Smart Images

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Abstract
Description
[0001] The invention relates to a method for configuring a manufacturing process of a rotary press, wherein the rotary press comprises a rotor that can be driven in rotation by means of a rotary drive, wherein the rotor has upper and lower punch guides, wherein upper press punches of the rotor are guided in the upper punch guide and lower press punches of the rotor are guided in the lower punch guide, and wherein the rotor has a die plate with cavities arranged between the punch guides, wherein the rotary press further comprises a filling device by means of which powder material is filled into the cavities of the die plate, and wherein the rotary press further comprises a pressure device that cooperates with the upper and lower press punches during operation to compress the powder material in the cavities of the die plate into tablets.
[0002] The invention further relates to a device for configuring a manufacturing process of a rotary press, wherein the rotary press comprises a rotor that can be driven in rotation by means of a rotary drive, wherein the rotor has upper and lower punch guides, wherein upper press punches of the rotor are guided in the upper punch guide and lower press punches of the rotor are guided in the lower punch guide, and wherein the rotor has a die plate arranged between the punch guides with cavities, wherein the rotary press further comprises a filling device by which powder material is filled into the cavities of the die plate, and wherein the rotary press further comprises a pressure device that cooperates with the upper and lower press punches during operation to compress the powder material in the cavities of the die plate into tablets,
[0003] Rotary presses typically feature a multitude of upper and lower compression punches, each paired with a cavity in a die table. During operation of the rotary press, the upper and lower compression punches rotate together with the die table, with their axial movement controlled by control cams and guided by upper and lower punch guides. As it rotates, the die table passes through various devices on the rotary press, namely a filling device, in which powder material to be compressed is filled into the cavities of the die table, and a pressure device, in which the upper and lower compression punches are pressed into the cavities, usually by upper and lower pressure rollers, to compress the powder material into tablets.Following the compression device, the upper press rams are moved upwards out of the cavities, and the tablets produced in the cavities are pushed onto the upper side of the die plate by the lower press rams. The tablets are then stripped from the die plate, for example by a stripper, into an exit of the rotary press, from where they are fed for further processing.
[0004] The quality of the produced tablets, especially tablet hardness, tablet density, etc., depends both on the machine hardware, i.e., the components mounted in the rotary press, and on process parameters during the tabletting process, such as the rotational speed of the rotor or a filling wheel of a filling device. The powder characteristics of the powder material to be compressed in the rotary press, such as its density or particle size distribution, also influence the properties of the produced tablets. Overall, tablet quality is therefore influenced by numerous factors that also interact with each other.Changing a single influencing factor, for example a different powder material or a powder material composed differently of an active pharmaceutical ingredient (API) and one or more excipients, requires the adjustment of further parameters to maintain the desired tablet quality.
[0005] Until now, determining the optimal parameters for a tableting process has been based on personal expertise. In particular, an experienced operator sets the correct combination of different rotary press parameters for a tableting process based on the results of a series of tests.
[0006] However, personal expertise does not produce reliably reproducible and consistent results. Rather, the success of the process depends on the individual operator. Furthermore, the optimization process is time-consuming and material-intensive, especially when changing individual parameters. Since time constraints usually prevent all possible parameter combinations from being tested using statistical design of experiments, it is often impossible to guarantee that the optimal setup for the respective process can be identified within the available timeframe and thus that the optimal tablet quality can be achieved.
[0007] WO 2021 / 058516 A1 describes a device and method for monitoring a tabletting machine during operation using a measuring device attached to a press ram. The measuring device is energy-autonomous, operating independently of the tabletting machine's power supply.
[0008] WO 2021 / 105277 A1 describes a computer-implemented method for designing a shaped body based on target criteria.
[0009] From KR 10 2018 0121347 A a hydraulic metal powder press is known with a numerical control program arranged on an automatic control system.
[0010] Based on the explained prior art, the invention is therefore based on the object of providing a method and a device of the type mentioned at the outset, with which the manufacturing process of the rotary press can be optimally configured for the respective desired tabletting process in a reliable, simple and reliably reproducible manner, even with changing parameters.
[0011] The invention solves the problem by the independent claims 1 and 16. Advantageous embodiments can be found in the dependent claims, the description and the figures.
[0012] For a method of the type mentioned above, the invention solves the problem by the following steps: • Several groups of parameter data are stored in a database, comprising in a first group component parameter data on components assembled in the rotary press, in a second group process parameter data on process parameters during operation of the rotary press, in a third group powder parameter data on powder properties of the powder material to be pressed in the rotary press, and in a fourth group tablet parameter data on tablet properties of the tablets to be produced in the rotary press, • the parameter data of the different groups stored in the database are correlated with each other in such a way that for given parameter data from at least two of the four groups, parameter data of the other four groups can be determined, • To configure the manufacturing process of the rotary press, parameter data of the other four groups are defined for given parameter data from at least two of the four groups according to the correlation of the parameter data stored in the database.
[0013] For a device of the type mentioned at the outset, the invention achieves the object by providing a configuration device comprising a database in which several groups of parameter data are stored, comprising, in a first group, component parameter data relating to components mounted in the rotary press, in a second group, process parameter data relating to process parameters during operation of the rotary press, in a third group, powder parameter data relating to powder properties of the powder material to be pressed in the rotary press, and in a fourth group, tablet parameter data relating to tablet properties of the tablets to be produced in the rotary press, wherein the parameter data of the various groups stored in the database are correlated with one another in such a way that, for predetermined parameter data from at least two of the four groups, parameter data of the further four groups can be determined,and that the configuration device is designed to determine component parameter data and / or process parameter data for configuring the manufacturing process of the rotary press to predetermined powder parameter data and / or predetermined tablet parameter data according to the correlation of the parameter data stored in the database.
[0014] The basic structure of the rotary press, as used in the method according to the invention or as the subject of the present invention, was explained at the beginning.In order to enable a reproducible configuration of the rotary press for an optimal tabletting process, the invention proposes grouping parameter data relevant to the tabletting process, namely the component parameter data characterizing the hardware components mounted in the rotary press, the process parameter data characterizing the process parameters during operation of the rotary press, the powder parameter data characterizing the powder properties of the powder material pressed in the rotary press, and the tablet parameter data characterizing the tablet properties of the tablets produced in the rotary press, into one group each, so that at least four groups of parameter data relevant to the tabletting process in the rotary press are formed.These at least four groups of parameter data are stored in a database so that they are reproducible and available at any time.
[0015] The parameter data of the four groups stored in the database are further correlated with one another in such a way that, given parameter data from at least two of the four groups, for example, given powder parameter data and tablet parameter data, the parameter data of the other four groups, for example, the component parameter data and the process parameter data, can be determined. Of course, based on the correlation, parameter data of the other four groups can also be determined for given parameter data from three of the four groups. To configure the manufacturing process, parameter data of the other four groups are determined for given parameter data from at least two of the four groups based on the correlation of the parameter data stored in the database.For example, to configure the manufacturing process in the rotary press, component parameter data and / or process parameter data can be defined based on the correlation of the parameter data stored in the database with predefined powder parameter data and / or with predefined tablet parameter data. In particular, the component parameter data and process parameter data resulting from the correlation stored in the database can be determined for predefined tablet parameter data, in particular target tablet parameter data predefined for a desired tablet quality, taking into account predefined powder parameter data that are fixed for the respective powder material to be pressed.The process parameter data are generally adjustable and can be selected accordingly so that the desired tablet quality, particularly with the desired tablet parameter data, is achieved during operation of the rotary press for the specified powder material and its powder parameter data. The component parameter data can also be adjusted within certain limits. For example, the filling wheels of the filling device or other components can be flexibly selected.
[0016] The invention is therefore based on the finding that parameter data of one or two groups can be determined from a specific combination of parameter data of the other groups in such a way that the predetermined or desired result of the manufacturing process in the rotary press is achieved, in particular the desired tablet parameter data, and thus the predetermined tablet quality.
[0017] It can usually be assumed that the powder material and its powder parameter data are fixed for a given manufacturing process. The tablet parameter data are also defined as target values to achieve the desired tablet quality. The process parameter data and the component parameter data are adjustable. These can be defined in the database using the correlation method proposed in the invention to ensure the desired tablet quality is achieved for the respective powder material.
[0018] Whenever we refer to predefined, determined, or predicted parameter data of a group, this includes the possibility of all or only some of the parameter data stored in the respective group. In particular, component parameter data and, if applicable, process parameter data can be partially fixed and partially adjustable. The correlation of the parameter data of the groups can also include all or only some of the parameter data of the group(s). Naturally, the more parameter data from the respective group is included in the correlation, the more meaningful the correlation becomes.
[0019] By storing the groups of parameter data in a database and correlating the data in the database according to the invention, the configuration result for the respective manufacturing process is easy to achieve and reliably reproducible. Once the parameter data has been stored and correlated in the database, no more complex test series are required to find the optimal configuration. Finding the optimal configuration for the respective manufacturing process, for example, during process development and the subsequent setup process of the rotary press, is independent of personal expertise and can therefore be carried out safely, reliably and reproducibly.
[0020] The data output of the parameter data determined or specified according to the invention, for example, the process parameter data, can be made available to an operator via a display device, for example, a dashboard. The display device can be stationary on or near the rotary press. However, it can also be embodied on a PC, a tablet, or a smartphone. It is also conceivable for the parameter data determined during the configuration of the manufacturing process, for example, the process parameter data, to be set automatically, in particular by the configuration device of the rotary press according to the invention.According to the invention, with the help of database correlation, an ideal machine configuration, in particular the component parameter data and the process parameter data, can be predicted for the respective manufacturing process based on, for example, predetermined powder parameter data and predetermined tablet parameter data. The powder parameter data in particular are of crucial importance for the success of the tabletting process and have so far been difficult to take into account in a reliably reproducible manner in existing processes or rotary presses. As explained, the configuration of the manufacturing process can take place upstream of the actual manufacturing process in a rotary press. The results of the configuration can then be used accordingly in the subsequent manufacturing process. However, it is also possible for the configuration according to the invention to take place directly on the rotary press for the manufacturing process, i.e., to include the specific machine configuration.
[0021] Overall, the invention improves the quality of tablets, which can be, for example, solid oral dosage forms (OSDs), and saves time and money. A reliably reproducible and documentable prediction for improving the tableting process, thus making it more efficient, is possible. In particular, a process prediction for the "best" tablet, i.e., the tablet that meets all required characteristics while exhibiting the least variability between tablets within a batch, is possible. Furthermore, standardization of the work process is achieved.
[0022] As already explained, one embodiment makes it possible for given parameter data from at least two of the four groups to predict the parameter data of the remaining four groups based on the correlation of the parameter data stored in the database. Using appropriate algorithms, as explained in more detail below, it is particularly possible to predict the parameter data even for parameter combinations that have not yet been experimentally investigated in test series. This further simplifies the configuration of a rotary press, particularly for parameter combinations that have not yet been investigated.
[0023] The component parameter data can include, for example, the type of press ram, die table, filling device, and / or pressure device mounted in the rotary press. This includes, for example, the number, diameter, length, punch head and / or punch tip geometry of the mounted press rams. This also includes, for example, whether the die table is a single piece or constructed from ring segments and / or the number and / or geometry of the cavities of the die table, as well as, for example, whether the cavities are designed directly as bores in the die table or in die inserts inserted into the die table. This also includes, for example, the type of filling device, for example, the geometry of a filling chamber of the filling device and / or the presence of one or more rotatingly driven filling wheels, as well as the geometry(s) of the filling wheel(s).Furthermore, this includes, for example, the number and type of printing device, in particular the type of upper and lower pressure rollers and / or the presence of pre- and main printing devices. The presence of multiple filling and / or printing devices for the production of multi-layer tablets is also included in the component parameter data, for example. Of course, the component parameter data can also include other components of the rotary press, for example, upper and / or lower control cams for the press rams, in particular filling cams, as well as an ejector device and its components and seals or sealing segments.
[0024] The process parameter data can include, for example, the rotational speed of the rotor, the rotational speed of at least one filling wheel of the filling device, and / or the pressing force of the pressure device. If filling devices have filling wheels, these are often driven in rotation to improve powder availability. The rotational speed of the filling wheels influences the filling of the cavities of the die table with powder material. The pressing force is the force exerted by the interaction of the pressure device, in particular the upper and lower pressure rollers, with the upper and lower press punches when compressing the powder material. It also has a decisive influence on the tabletting result.
[0025] As already mentioned, the invention is further based on the finding that the powder parameter data, in particular the selection of the powder parameter data taken into account and the powder characterization methods, are crucial for the meaningful use of the database for predicting tabletting results. Only if the parameters crucial for the tabletting process are correctly recorded can the fundamental data basis for a suitable prediction or configuration of the rotary press manufacturing process be provided. With regard to the powder parameter data, which are particularly relevant in this regard, the analytical methods for recording the powder properties as a whole should be predictive of, among other things, the flow properties, compressibility, compactibility, tabletability, and the tendency of the powder to stick.The selection of measurement methods for powder parameters must also be suitable for a meaningful comparison of different powders. In pharmaceutical quality control, a separate method is usually developed for each powder material, unless it is a so-called conventional method. During method development for the respective powder parameter, the settings of the variable variables are selected so that the relevant properties of the respective powder material are reliably recorded. It should be noted that the powder material to be pressed is generally a fixed input variable in the rotary press manufacturing process. Therefore, for the configuration of the production process, it is essential to know and understand the powder-technological properties of the starting product relevant to the respective process.The challenge in the method development for the database according to the invention is to find a method for recording powder parameter data that is suitable for as many powder materials as possible in order to ensure comparability of the powder materials on the one hand and to be predictive of the behavior of the powder material during tabletting on the other.
[0026] Based on these findings, the powder parameter data can include the powder volume, powder density, particle size distribution, moisture content, and / or loss on drying of the powder material. The powder volume and powder density, in particular the bulk and tapped volume, as well as the equally important bulk and tapped densities, including derived parameters such as the Hausner factor and Carr index, as well as the angle of repose, serve to characterize the flowability of the powder material, which is important for the tabletting process. The (residual) moisture or loss on drying is also important for flow behavior and can be measured, for example, using an infrared or halogen balance. This parameter data is also important for the tabletability and mechanical strength of the resulting tablet.The particle size distribution is predictive of the flow behavior as well as the compressibility and compactibility of the powder material. For example, when determining the particle size distribution using laser diffraction, a suitable dispersion pressure must be determined that is capable of optimally atomizing the powder material in order to deliver meaningful results for the intended purpose. For example, the complete particle size distribution can be measured.
[0027] Another powder parameter identified by the present inventors as relevant is the water activity of the powder material. Similar to drying loss, water activity influences the flow behavior and tabletability of the powder material. While drying loss measures the total water contained in the powder material, water activity only measures the proportion of available water in the powder material compared to the water content at complete saturation. The inventors have recognized that water activity is better suited to predicting the tabletting properties of the powder material than drying loss. A further advantage of water activity is that essentially all powder materials are suitable for determining this parameter under the same conditions. In contrast, not all powder materials are suitable for a meaningful determination of drying loss.An example is effervescent powder.
[0028] According to the inventors' findings, the aforementioned powder parameter data achieve a suitable balance between data quality, in particular sufficient acquisition of the powder parameter data for the correlation or configuration according to the invention on the one hand, and practicability, in particular the measurement duration and the associated effort, on the other hand.
[0029] In addition to the powder parameter data or measurement methods mentioned above, additional powder parameter data or measurement methods may be useful. Examples include: - Other methods for flow characterization such as “flow through an orifice”, - Determination of the true density of the powders by means of helium pycnometry; this may provide even more precise information on compressibility and compactibility, - Determination of flow behaviour using a ring shear cell or powder rheometry; this may provide even more precise information on flowability, - Particle size determination using imaging techniques such as scanning electron microscopy or dynamic image analysis; in addition to the particle size, information on particle shape would also be collected, which can be predictive of flow properties, compressibility and compactibility, as well as tabletability, - Powder compaction analyses; while the other methods mentioned describe compressibility, compactibility, and tabletability rather indirectly, there are also ways to collect this data directly. Such data could also be included in the database, or (similar to particle size distribution) certain characteristic quantities could be recorded and used together with any derived quantities for analytical purposes. In this way, further information regarding compressibility and compactibility, as well as tabletability and stickiness, could be obtained.
[0030] The tablet parameter data may include, for example, the tablet hardness, the tablet density and / or the tablet size of the tablets to be produced or produced in the rotary press, as already explained.
[0031] According to a particularly practical embodiment, the parameter data stored in the database can be determined experimentally, including the correlation of the parameter data, as part of a series of tests.
[0032] For example, the correlation of the parameter data can be determined experimentally by measuring the resulting tablet parameter data for combinations of component parameter data, process parameter data, and powder parameter data that have been changed during the test series. Through test and / or production runs, different combinations of parameter data from the different groups can be set, and the resulting tablet parameter data, for example, for a specific powder material, can be determined. The parameter data determined during the test series are stored in the database with the powder parameter data correlated accordingly.
[0033] In principle, the powder parameter data and / or the tablet parameter data can be determined both outside the manufacturing process of the rotary press and within the manufacturing process of the rotary press, or outside the rotary press and within the rotary press. For example, determination can be carried out outside the manufacturing process of the rotary press or outside the rotary press in a laboratory separate from the rotary press. Recording during the manufacturing process can be in-line, online, or at-line. When parameter data is recorded during the manufacturing process or in the rotary press, for example, tablet parameter data is measured in a measuring system connected to the rotary press, which reports the corresponding measurement results of the powder parameter data back, for example to the configuration device, which stores them accordingly in the database.Powder parameter data can, for example, be determined in a laboratory separate from the rotary press and also stored in the database, especially automatically. However, measurements of powder parameter data during the production process in the rotary press are also conceivable.
[0034] The correlation of the parameter data stored in the database can be achieved using an algorithm stored in an evaluation device. With the evaluation device or the algorithm stored therein, as explained above, a correlation of parameter data combinations of the various groups that have not yet been experimentally recorded can also be achieved, in particular with algorithms as explained in more detail below. Automatic configuration of the rotary press for the respective manufacturing process is also possible, in particular with the configuration device. The evaluation device can be part of the rotary press, for example, integrated into the machine control system, or implemented separately, for example on a PC, a tablet, or a smartphone. The evaluation device can also be integrated into the configuration device.The database can be integrated into the configuration device or the evaluation device or can be designed separately from them.
[0035] The algorithm can comprise a machine learning algorithm. In particular, a self-learning algorithm can be stored in the evaluation device, which (continuously) adapts or optimizes the correlation of the parameter data stored in the database based on training data and / or empirical data from the operation of the rotary press. The machine learning algorithm can comprise, for example, neural networks.
[0036] According to a further embodiment, the correlation of the parameter data stored in the database can be carried out using multivariate data analysis. Multivariate data analyses allow multiple parameters—in this case, the parameter data of different groups—to be examined simultaneously and evaluated for their correlation. Multivariate data analysis can be used, in particular, to distinguish between information relevant to the correlation of the parameter data and information irrelevant to it.
[0037] According to a particularly practical embodiment, multivariate data analysis can include principal component analysis. Principal component analysis (PCA) can be used to identify the data relevant to the current research question—here, the correlation of the parameter data of the different groups—and to separate it from information irrelevant to the current research question in a particularly reliable manner. Thus, within the framework of principal component analysis, at least one principal component can be identified for the parameter data of each group that exhibits the greatest variance with respect to the correlation of the parameter data of the different groups. The principal component(s) with the greatest variance contain(s) the most information regarding the correlation of the parameter data and are therefore particularly relevant to the current research question.By reducing the parameter data to at least one principal component per group, for example to two or three principal components per group, a reliable correlation of the parameter data can be achieved while significantly simplifying the amount of data and thus the evaluation.
[0038] Multivariate data analysis may also include a multivariate regression procedure, such as a Partial Least Square Regression (PLS / PLSR) procedure, in order to create models for the correlation of the parameter data of the different groups.
[0039] The configuration device of the device according to the invention can be designed to carry out the method according to the invention. The method according to the invention can be carried out accordingly using a device according to the invention.
[0040] The invention also relates to a rotary press comprising a device according to the invention.
[0041] An embodiment of the invention is explained in more detail below with reference to the figures. They show schematically: Fig. 1 a rotary press in a developed view of the rotor, Fig. 2 an illustration of the influence of different parameter data on the tablet parameter data, Fig. 3 an illustration of the provision of data for the database used according to the invention, and Fig. 4 an illustration of the relationship between the parameter data of the different groups and the prediction of parameter data based on them.
[0042] Unless otherwise stated, the same reference symbols in the figures refer to the same objects.
[0043] The Fig. The rotary press shown in Figure 1 is a rotary press for tablet production in which powdered material is compressed into tablets. The rotary press comprises a rotor driven in rotation by a rotary drive and having a die plate 10 having a plurality of cavities 12. The cavities 12 can be formed, for example, by bores in the die plate 10. The rotor further comprises a plurality of upper press punches 14 and lower press punches 16 that rotate synchronously with the die plate 10. The upper press punches 14 are axially guided in an upper punch guide 18, and the lower press punches 16 are axially guided in a lower punch guide 20. The axial movement of the upper press punches 14 and lower press punches 16 during the rotation of the rotor is controlled by upper control cam elements 22 and lower control cam elements 24.The rotary press further comprises a filling device 26, which has a filling reservoir 28 and a filling chamber 30, which are connected via a filling pipe 32. In this way, in the present example, powder material flows from the filling reservoir 28 via the filling pipe 32 into the filling chamber 30 by gravity, and from there, via a filling opening provided on the underside of the filling chamber 30, into the cavities 12 of the die plate 10 by gravity.
[0044] The rotary press also comprises a pressure device 34. The pressure device 34 comprises a pre-pressure device with an upper pre-pressure roller 36 and a lower pre-pressure roller 38, as well as a main pressure device with an upper main pressure roller 40 and a lower main pressure roller 42. In addition, the rotary press comprises an ejection device 44 and a stripping device 46 with a stripping element that feeds the tablets 48 produced in the rotary press to a discharge device 50 for removal from the rotary press. The stripping device 46 can, for example, comprise a preferably sickle-shaped stripping element that, in the region of the ejection device 44, strips tablets 48, which have been conveyed onto the upper side of the die plate 10 by the lower press rams 16, from the die plate 10 and feeds them to the discharge device 50.
[0045] The rotary press also comprises an evaluation device 52 for controlling the operation of the rotary press and for carrying out the method according to the invention, as explained in more detail below. The evaluation device 52, together with the database configured in the evaluation device 52 or separately from the evaluation device 52, accordingly forms a device according to the invention.
[0046] In Fig. Figure 2 shows schematically how parameter data, here powder parameter data, component parameter data and process parameter data of the rotary press influence the tablet parameter data, i.e. the tablet quality of the tablets produced in the rotary press. Fig. 3 shows a database 54 contained in the evaluation device 52, in which the groups of parameter data according to the invention are stored. Fig. 3 shows several clients 56, 58 and 60, which form data sources for storing the corresponding parameter data in the database 54, as indicated by the arrow in Fig. 3. The clients 56, 58, 60 can, for example, be measuring devices in a laboratory and / or in or on the rotary press, which transmit corresponding measurement data for parameter data, for example powder parameter data or tablet parameter data, to the evaluation device 52, which stores these data according to the respective groups in the database 54 formed in the evaluation device 52 or separately from the evaluation device 52 and correlates them as explained above.
[0047] In Fig. 4, the correlation of the parameter data of the four groups stored in the database 54 is represented by arrows. For example, based on the correlation of the parameter data of the various groups in the database 54, it is possible to predict the parameter data of group 4 for given parameter data of groups 1, 2, and 3, as shown in Fig. 4 and as explained above. Based on the correlation according to the invention, it is also possible to predict the parameter data of groups 3 and 4 for given parameter data, for example, of groups 1 and 2. The correlation can be determined experimentally through appropriate test series and / or by appropriate algorithms, for example, machine learning algorithms, even for combinations of parameter data not experimentally recorded.
[0048] Based on the correlated parameter data stored in the database 54, the parameter data of the further groups can be defined for predefined parameter data from at least two groups by means of a configuration device 52, which can also be formed, for example, by the evaluation device 52. For example, the defined parameter data of group 3 can be component parameter data, and the parameter data of group 4 can be process parameter data of the rotary press, both of which can be adjusted within certain limits depending on the respective process. List of reference symbols 10 die plate 12 cavities 14 upper press rams 16 lower press punches 18 upper punch guide 20 lower punch guide 22 upper control cam elements 24 lower control cam elements 26 Filling device 28 Filling reservoir 30 filling chamber 32 filling tube 34 Printing device 36 upper pre-print roll 38 lower pre-print roll 40 upper pressure roller 42 lower pressure roller 44 Ejection device 46 Stripping device 48 tablets 50 Drainage device 52 Evaluation device / configuration device 54 Database 56 clients 58 Client 60 clients
Claims
[1] Method for configuring a manufacturing process of a rotary press, wherein the rotary press comprises a rotor which can be driven in rotation by means of a rotary drive, wherein the rotor has upper and lower punch guides (18, 20), wherein upper press punches (14) of the rotor are guided in the upper punch guide (18) and lower press punches (16) of the rotor are guided in the lower punch guide (20), and wherein the rotor has a die plate (10) arranged between the punch guides (18, 20) and having cavities (12), wherein the rotary press further comprises a filling device (26) by which powder material is filled into the cavities (12) of the die plate (10), and wherein the rotary press further comprises a pressure device (34) which, in operation, cooperates with the upper and lower press punches (14, 16) to compress the powder material in the cavities (12) of the die plate (10) into tablets (48) cooperates,the method being characterized by the following steps: • several groups of parameter data are stored in a database (54), comprising in a first group component parameter data on components mounted in the rotary press, in a second group process parameter data on process parameters during operation of the rotary press, in a third group powder parameter data on powder properties of the powder material to be pressed in the rotary press, and in a fourth group tablet parameter data on tablet properties of the tablets (48) to be produced in the rotary press, • parameter data of the different groups stored in the database (54) are correlated with each other in such a way that parameter data of the other of the four groups can be determined for given parameter data from at least two groups, • To configure the manufacturing process of the rotary press, parameter data of the other four groups are defined for given parameter data from at least two of the four groups according to the correlation of the parameter data stored in the database (54). [2] Method according to claim 1, characterized by in that, in order to configure the manufacturing process of the rotary press, component parameter data and / or process parameter data are determined for predetermined powder parameter data and / or predetermined tablet parameter data in accordance with the correlation of the parameter data stored in the database (54). [3] Method according to one of the preceding claims, characterized by that for given parameter data from at least two of the four groups, parameter data of the other of the four groups are predicted according to the correlation of the parameter data stored in the database (54). [4] Method according to one of the preceding claims, characterized by that the component parameter data comprise the press rams, die plate (10), filling device (26), in particular at least one filling wheel of the filling device (26), pressure device (34), control cams, in particular filling cams, and / or seals mounted in the rotary press. [5] Method according to one of the preceding claims, characterized by that the process parameter data include the rotational speed of the rotor, the rotational speed of at least one filling wheel of the filling device (26) and / or the pressing force of the pressure device (34). [6] Method according to one of the preceding claims, characterized by that the powder parameter data includes the powder volume, powder density, particle size distribution, moisture content and / or loss on drying of the powder material. [7] Method according to one of the preceding claims, characterized bythat the powder parameter data includes the water activity of the powder material. [8] Method according to one of the preceding claims, characterized by that the tablet parameter data include the tablet hardness, the tablet density and / or the tablet size of the tablets (48) to be produced in the rotary press. [9] Method according to one of the preceding claims, characterized by that the parameter data stored in the database (54) are determined experimentally in the context of test series. [10] Method according to one of the preceding claims, characterized by that the powder parameter data and / or the tablet parameter data are determined outside the manufacturing process of the rotary press or within the manufacturing process of the rotary press. [11] Method according to one of the preceding claims, characterized bythat the correlation of the parameter data stored in the database (54) is carried out by means of an algorithm stored in an evaluation device (52). [12] Method according to claim 11, characterized by that the algorithm includes a machine learning algorithm. [13] Method according to one of claims 11 or 12, characterized by that the correlation of the parameter data stored in the database (54) is carried out by means of a multivariate data analysis. [14] Method according to claim 12, characterized by that multivariate data analysis includes principal component analysis. [15] Method according to one of claims 13 or 14, characterized by that multivariate data analysis includes a multivariate regression procedure. [16] Device for configuring a manufacturing process of a rotary press, wherein the rotary press comprises a rotor which can be driven in rotation by means of a rotary drive, wherein the rotor has upper and lower punch guides (18, 20), wherein upper press punches (14) of the rotor are guided in the upper punch guide (18) and lower press punches (16) of the rotor are guided in the lower punch guide (20), and wherein the rotor has a die plate (10) arranged between the punch guides (18, 20) with cavities (12), wherein the rotary press further comprises a filling device (26) by which powder material is filled into the cavities (12) of the die plate (10), and wherein the rotary press further comprises a pressure device (34) which, in operation, cooperates with the upper and lower press punches (14, 16) to compress the powder material in the cavities (12) of the die plate (10) into tablets (48) cooperates, characterized bythat a configuration device (52) is provided, comprising a database (54) in which several groups of parameter data are stored, comprising in a first group component parameter data on components mounted in the rotary press, in a second group process parameter data on process parameters during operation of the rotary press, in a third group powder parameter data on powder properties of the powder material to be pressed in the rotary press, and in a fourth group tablet parameter data on tablet properties of the tablets (48) to be produced in the rotary press, wherein parameter data of the various groups stored in the database (54) are correlated with one another such that parameter data of the further four groups can be determined for predetermined parameter data from at least two of the four groups, and that the configuration device (52) is designed,to configure the manufacturing process of the rotary press to predetermined parameter data from at least two of the four groups according to the correlation of the parameter data stored in the database (54), to determine parameter data of the other of the four groups. [17] Device according to claim 16, characterized by that the configuration device (52) is designed to carry out the method according to one of claims 1 to 15. [18] Rotary press, comprising a rotor that can be driven in rotation by means of a rotary drive, wherein the rotor has upper and lower punch guides (18, 20), wherein upper press punches (14) of the rotor are guided in the upper punch guide (18) and lower press punches (16) of the rotor are guided in the lower punch guide (20), and wherein the rotor has a die plate (10) arranged between the punch guides (18, 20) with cavities (12), wherein the rotary press further comprises a filling device (26) by which powder material is filled into the cavities (12) of the die plate (10), and wherein the rotary press further comprises a pressure device (34) that cooperates during operation with the upper and lower press punches (14, 16) to compress the powder material in the cavities (12) of the die plate (10) into tablets (48), further comprising a device according to one of the claims 16 or 17.
Citation Information
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