Device and method for producing medicaments
The integrated drug production device addresses the complexity of existing machines by eliminating intermediate connections, enhancing efficiency and quality through inline detection and management, ensuring rapid defect identification and correction.
Patent Information
- Application Number
- PCT/EP2025/064905
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-06-21
- Filing Date
- 2025-05-28
- Publication Date
- 2025-12-26
AI Technical Summary
Existing drug production machines require numerous interface connections between components for containment, leading to complexity and inefficiency.
A drug production device with an integrated enclosure containing a production unit, inline mass detection, and metal detection units, allowing for individualized processing and elimination of intermediate connections, thereby simplifying containment and reducing complexity.
The solution enhances production efficiency by eliminating the need for intermediate connections, saving space, reducing complexity, and enabling rapid identification and correction of defects, thus improving production quality and maintaining high throughput.
Smart Images

Figure EP2025064905_26122025_PF_FP_ABST
Abstract
Description
[0001] DEVICE AND METHOD FOR PRODUCING MEDICINES
[0002] technical field
[0003] The present invention relates to a device and a method for producing medicines consisting of pharmaceutical tablets.
[0004] Previous art
[0005] Drug production machines exist, but their various component parts are connected in a modular fashion. The drawback of these machines is that they require numerous interface connections between the parts to ensure containment both inside and along the machine.
[0006] There is a need for a device whose containment is achieved in a simpler way.
[0007] Description of the invention
[0008] To this end, the invention proposes a drug production device consisting of pharmaceutical tablets, the device comprising an enclosure having an outlet for the drugs, a drug production unit, the production unit being located inside the enclosure, an inline mass detection unit, for detecting the mass of drugs produced by the production unit, the mass detection unit being arranged inside the enclosure, between the production unit and the outlet and the production unit is capable of discharging the drugs individually to the mass detection unit.
[0009] In one variant, the device further includes a management unit configured to correlate drug characteristic data with drug production position data within the production unit. In another variant, the device includes a sorting unit configured to sort the drugs, with the sorting unit controlled by the management unit based on the correlated data.
[0010] According to one variant, the sorting unit is arranged at the exit of the enclosure.
[0011] According to one variant, the sorting unit is capable of sorting by compressed air.
[0012] According to one variant, the device also includes a unit for detecting metals present in medicines, the metal detection unit being arranged inside the enclosure.
[0013] According to one variant, the device further includes drug discharge mechanisms outside the production unit, the discharge mechanisms being capable of inducing a speed of passage of the drugs through the metal detection unit.
[0014] According to one variant, the mass detection unit is arranged between the metal detection unit and the exit of the enclosure.
[0015] According to one variant, the online mass detection unit is a 3D microwave resonance sensor.
[0016] According to one variant, the device also includes a compressed air injector, capable of injecting a flow of compressed air for the delivery of medicines through the mass detection unit.
[0017] According to one variant, the device further includes a drug conveying ramp, the ramp being inclined and extending externally to the enclosure from the exit.
[0018] According to one variant, the drug production unit is a tablet press, preferably a rotary tablet press, preferably a continuous rotary tablet press.
[0019] The invention also relates to a method for producing medicinal products consisting of pharmaceutical tablets, the method comprising: the production of the medicinal products by a production unit located inside an enclosure, the enclosure having an outlet for the medicinal products,
[0020] The detection by an online mass detection unit of the mass of drugs produced by the production unit, the mass detection unit being arranged inside the enclosure, between the production unit and the exit, the drugs being unloaded individually from the production unit to the mass detection unit.
[0021] According to one variant, the process further includes sending data from the production and mass detection units to a management unit, the data being drug characteristic data and drug production position data in the production unit, the correlation by the management unit of the characteristic data with the position data.
[0022] According to one variant, the process further includes sending drug sorting instructions based on correlated data to a drug sorting unit.
[0023] According to one variant, the process further includes the detection by a metal detection unit of the presence of metals in the medicinal products produced by the production unit, the metal detection unit being arranged inside the enclosure, between the mass detection unit and the exit of the enclosure.
[0024] According to one variant, the characteristics of the drugs include the presence of metals in the drugs and / or, when the process is according to the preceding claim, the mass of the drugs.
[0025] According to one variant, the process further includes, based on correlated data, determining that a position within the production unit is defective.
[0026] The use, in this document, of the verb "comprendre" (to understand), its variants, and its conjugations, cannot in any way exclude the presence of elements other than those mentioned. The use, in this document, of the indefinite article "un" (a), "une" (an), or the definite article "le" (the), "la" (the), or "l'" (it) to introduce an element does not exclude the presence of multiple such elements.
[0027] The terms "first," "second," "third," etc., are used in this document solely to differentiate between various elements, without implying any order among them. All preferred embodiments and all advantages of the production device according to the invention are applicable mutatis mutandis to the production process, program, and program support, and vice versa. The various embodiments may be considered individually or in combination.
[0028] Brief description of the figures
[0029] Other features and advantages of the present invention will become apparent upon reading the detailed description that follows, for understanding of which reference should be made to the attached figure which shows:
[0030] - Figure 1, a schematic view of a drug production device.
[0031] The drawing in the figure is not to scale. Similar features are generally denoted by similar reference numerals in figures. Within the scope of this document, identical or analogous features may bear the same reference numerals. Furthermore, the presence of reference numerals or letters in drawings shall not be considered limiting, even when such numerals or letters are specified in the claims.
[0032] Detailed description of embodiments of the invention
[0033] The invention relates to a drug production device for pharmaceutical tablets. The device comprises an enclosure with an outlet for the produced medication. The device also includes a drug production unit, located inside the enclosure, and an inline mass detection unit for detecting the mass of medication produced by the production unit. The mass detection unit is arranged inside the enclosure, between the production unit and the drug outlet, and the production unit is capable of individually discharging medication to the mass detection unit. Thus, the detection unit is in the same enclosure as the production unit. The production unit and the mass detection unit are therefore connected to each other without any confined interface within the device during the transfer of medication from one unit to the other.This simplifies containment within the device. Furthermore, within the enclosure, the mass detection unit can individually characterize drugs downstream of the production unit, thereby improving production.
[0034] Figure 1 illustrates a drug production device 10. This device is used in the pharmaceutical industry, which imposes very high quality requirements. Drugs are particulate substances. They consist of pharmaceutical tablets. The device 10 includes an enclosure 12. The enclosure is a rigid casing protecting the various units of the device 10 described below. Such an enclosure creates a closed environment except for controlled inlets and outlets of material flow. The enclosure 12 is dust-tight and prevents the escape of any materials used in drug production. There is no air exchange between the inside and outside of the enclosure. The enclosure 12 can also ensure containment, even high containment, of the drug production within it. As shown in Figure 1, the enclosure 12 includes an inlet 13 and an outlet 14 for materials.The enclosure defines an internal environment isolated from the outside. Inlet 13 allows the introduction of materials used in the manufacture of medicines into the enclosure as indicated by arrow 17, and outlet 14 allows the extraction of these materials, namely the medicines, from the enclosure. At outlet 14, device 10 includes an interface to ensure a contained connection with any equipment located downstream in the direction of production, after outlet 14 of the enclosure.
[0035] Device 10 also includes a drug production unit 16. The production unit 16 is capable of discharging (or transferring) the drugs individually. The production unit 16 consists of a tablet press. A tablet press is a machine in which a volume of powder (possibly containing an active ingredient) is dispensed into cavities. The cavities may be supported by a rotor. The powder is then compressed in the cavities, possibly between upper and lower punches, before the tablet is discharged from the cavities. The tablets are discharged from the production unit 16 by discharge devices. As an example of a discharge device, a scraper directs the tablet towards a discharge chute. The drugs in tablet form are discharged individually, successively, one after the other.As an example, production unit 16 could be a rotary tablet press or a rotary disc tablet press.
[0036] The production device 10 also includes an inline mass detection unit 19. The mass detection unit 19 is capable of determining the mass of the medicinal products produced by the production unit 16. During medicinal product production, the mass of the medicinal products must fall within certain ranges of mass values (to meet pharmacy requirements). For example, in the tablet press, it is possible (although undesirable) for the volume of powder dispensed into the cavities and intended to be compressed by the punches to vary outside the required ranges.
[0037] The mass detection unit 19 is arranged inside the enclosure 12 (i.e., within the enclosure). The mass detection unit 19 is located in the same enclosure as the production unit 16. This allows for the characterization (or qualification) of the medications within the enclosure 12 itself. Each medication is processed individually, successively, and sequentially, one after the other, within the enclosure. In other words, the individualized unloading of medications from the production unit 16 is used to characterize the medications individually. This avoids having the medications in bulk before characterization, which would require reorganizing them individually before they passed through the mass detection unit 19. The device results in a production time saving.The device also makes it possible to avoid a loss of production linked to the disposal of a volume of medicines in the event of the detection of a defect in a medicine from a volume of bulk medicines.
[0038] Furthermore, the two units 16 and 19 are arranged within the same containment space. This eliminates the need for an interface allowing a confined connection between the detection unit 19 and the rest of the device. Device 10 makes it possible to do without such an interface, thus reducing the size and complexity of the device. The mass detection unit 19 is arranged between the production unit 16 and the outlet 14 of the enclosure 12. The mass detection unit 19 is arranged downstream of the production unit 16, or in other words, after the production unit, within the enclosure 12 – in the direction of drug production illustrated by arrow 15.
[0039] The mass detection unit 19 can be arranged directly downstream of the production unit 16 (i.e., without an intermediary), or in other words, directly or immediately after the production unit, within the enclosure 12 – in the direction of drug production. The mass detection unit 19 is connected to the production unit 16. The mass detection unit 19 is directly connected to the production unit 16. The unloading devices of the production unit 16 discharge the drugs into the mass detection unit 19 to perform immediate and individualized mass detection – within the same enclosure 12. Downstream (or after) mass detection, the drugs are conveyed towards the exit 14 of the enclosure.This arrangement also saves floor space (or reduces the footprint) because there is no ramp for conveying medications to the mass detection unit 19, nor is there an interface for a confined connection between units 16 and 19. This arrangement also saves vertical space because the metal detection unit is not placed after sorting the medications conveyed by gravity.
[0040] The device 10 may also include a metal detection unit 18. The metal detection unit 18 detects metals present in the medicinal products produced by the production unit 16. During medicinal product production, metal particles may end up in the medicinal products. These metal particles may originate from the production unit 16. For example, in the tablet press, it is possible (although undesirable) for metal particles from the punches to end up in the tablets. Thus, the metal detection unit 18 makes it possible to detect the presence of metals in the medicinal products. The metal detection unit 18 is arranged inside the enclosure 12 (i.e., within the enclosure). The metal detection unit 18 is arranged in the same enclosure as the production unit 16. This makes it possible to characterize (or qualify) the medicinal products within the enclosure 12 itself.Each medication is processed individually, successively, and sequentially, one after the other, within the facility. In other words, the individual unloading of medications from production unit 16 is used to characterize them individually. This avoids having the medications in bulk before characterization and eliminates the need to reorganize them individually before they pass through the metal detection unit 18. This system saves production time. It also prevents production losses due to the exclusion of a batch of medication from production if a defect is detected in a medication from a batch of bulk medication.
[0041] Furthermore, the two units 16 and 18 are arranged within the same containment space. This eliminates the need for an interface allowing a confined connection between the detection unit 18 and the rest of the device. Device 10 makes it possible to do without such an interface, thus reducing the size and complexity of the device. The metal detection unit 18 is arranged between the production unit 16 and the outlet 14 of the enclosure 12. The metal detection unit 18 is arranged downstream of the production unit 16, or in other words, after the production unit, within the enclosure 12 – in the direction of drug production illustrated by arrow 15.
[0042] The metal detection unit 18 can be arranged directly (i.e., without an intermediary) downstream of the production unit 16, or in other words, directly or immediately after the production unit, within the enclosure 12 – in the direction of drug production. The metal detection unit 18 is connected to the production unit 16. The metal detection unit 18 is directly connected to the production unit 16. The unloading devices of the production unit 16 discharge the drugs into the metal detection unit 18 for immediate and individualized metal detection – within the same enclosure 12. Downstream (or after) metal detection, the drugs are conveyed towards the outlet 14 of the enclosure. The metal detection unit 18 can be directly connected on either side to the production unit 16 and to the outlet 14.Device 10 also saves floor space (or reduces floor footprint) because there is no ramp for conveying medicines to the metal detection unit 18, nor is there an interface for a confined connection between units 16 and 18. Such an arrangement also saves height, because the metal detection unit is not placed after sorting the medicines conveyed by gravity.
[0043] In particular, by arranging the metal detection unit 18 inside the enclosure 12, the metal detection unit 18 is integrated with the production unit 16 and the mass detection unit 19 within the enclosure. The advantages mentioned elsewhere are enhanced. Individualized drug unloading from the production unit 16 is used to characterize the drugs individually by the metal detection unit 18 and the mass detection unit 19. The three units 16, 19, and 18 are arranged in the same containment space. This eliminates the need for interfaces that would allow for a confined connection between the three units 16, 18, and 19. The device 10 makes it possible to do without such interfaces, thus reducing the size and complexity of the device.
[0044] The mass detection unit 19 can be arranged downstream of the production unit 16 and upstream of the metal detection unit 18. Preferably, the metal detection unit 18 is interposed between the production unit 16 and the mass detection unit 19. The mass detection unit 19 is arranged downstream of the metal detection unit 18. In other words, the mass detection unit 19 is arranged between the metal detection unit 18 and the outlet 14 of the enclosure 12. The mass detection unit 19 is arranged downstream of the metal detection unit 18, or in other words after the metal detection unit, within the enclosure 12 – in the direction of drug production. The mass detection unit 19 is arranged directly downstream of the metal detection unit 18 (i.e.without intermediary), or in other words, directly or immediately after the metal detection unit 18, within enclosure 12 – in the direction of drug production. The mass detection unit 19 is connected to the metal detection unit 18. The mass detection unit 19 is directly connected to the metal detection unit 18 (i.e., without intermediary). The drugs pass individually from the metal detection unit 18 to the mass detection unit 19 for mass detection immediately after metal detection – within the same enclosure 12. Downstream (or after) mass detection, the drugs are conveyed towards the exit 14 of the enclosure.
[0045] The medications are discharged (or expelled, or ejected) from production unit 16. Downstream within the facility, the medications pass through mass detection unit 19 and, if applicable, metal detection unit 18. Within the facility, all medications produced by production unit 16 pass through detection unit(s) 19 and 18. All medications produced by production unit 16 are checked by detection unit(s) 19 and 18. Detection unit(s) 19 and 18 are configured before any medication sorting (according to pharmacy requirements and / or based on sampling). This allows for mass checks and, potentially, the detection of metals in all medications.In addition, and preferably, all drugs produced by production unit 16 pass through detection unit(s) 19, 18 individually, successively, sequentially, one after the other (and without a step of drugs grouped in bulk).
[0046] The mass detection unit 19 may include a three-dimensional (or 3D) microwave resonance sensor for detecting the mass of medications. The unit may further include an inlet port and an outlet port. Medications are introduced into the unit through the inlet port. A passage space for medications through the unit is provided between the inlet and outlet ports. The sensor detects the mass of all medications passing through this passage space. The sensor detects the mass of all medications passing individually, successively, sequentially, one after the other through the passage space.
[0047] The metal detection unit 18 may include a sensor for detecting metals present in medications. The unit may further include an inlet port and an outlet port. Medications are introduced into the unit through the inlet port. A passage space for medications to pass through the unit is provided between the inlet and outlet ports. The sensor detects metals in all medications passing through this passage space. The sensor detects metals in all medications passing individually, successively, sequentially, one after the other through the passage space.
[0048] The production device 10 may further include a management unit 20. The management unit 20 is configured to correlate drug characteristic data with drug production position data within the production unit 16. Based on the position of the drugs in the production process, the management unit 20 identifies defective drugs and the origin of their characteristics. This enables precise drug production management and supports decision-making regarding production interventions. In particular, if the drug characteristic data indicates that drugs have a defect or do not conform to a requirement, the management unit 20 traces the problem back to its origin based on the drugs' position in the production process.
[0049] The control unit 20 may be located within the production unit 16, as shown in Figure 1 as an example, but could also be located elsewhere (within or outside the facility). The control unit 20 is, for example, a computer module, a computer, or a programmable data processing system known to those skilled in the art. In this case, the steps of the process described below, particularly the data management, analysis, and / or correlation steps, are preferably implemented by computer (in the generic sense of the term). The characteristic data are, for example, the presence of metals in medications and / or the mass of the medications. This data is provided to the control unit 20 by units 19 and 18, as appropriate. According to Figure 1, unit 18 and / or unit 19 can be connected to the control unit 20 by a connection 22, 23 (wired or otherwise), respectively.Position data is provided to the management unit 20 by the production unit 16 - via a wired or other link, not shown in Figure 1.
[0050] With units 16, 19, and 18 (as applicable) arranged in the same enclosure, one after the other, and medications passing individually and successively under detection, without any intermediate bulk storage area, the management unit is able to correlate the characteristics of the medications with their position in the production line. Management unit 20 is capable of assigning a characteristic (such as the presence of metals or mass) and a position in the production line to a medication. Management unit 20 is also capable of determining whether the characteristic meets the production requirements (presence or absence of metals, mass value within or outside the required ranges). Furthermore, management unit 20 is capable of determining whether a medication is defective. Management unit 20 is capable of determining which position within production unit 16 is defective.The fact that the medications are in a line (because they come off the tablet press one after the other) allows for correlation and tracing back from a position on the line to the problematic or defective production position. Data correlation makes it possible to isolate the defective medication(s) and quickly decide on the necessary production maintenance—any intervention on the production unit 10 is immediately targeted. For example, the management unit 20 can determine, based on the defective position, which punch on the tablet press is faulty. Maintenance of the production unit 10 is simpler and more efficient—and the production rate is maintained. Furthermore, by targeting defective medications, the number of medications excluded from production is reduced. The production unit 10 can also include a sorting unit 24.Sorting unit 24 is configured to sort medications. Control unit 20 can control sorting unit 24 based on received data. Sorting can be performed according to medication characteristics, mass, and / or the presence of metals (regardless of the medication's position in the production line). Control unit 20 can also control sorting unit 24 based on received and correlated data. Based on medication characteristics data correlated with the medication's production position data in production unit 16, control unit 20 can send control signals to sorting unit 24 to remove medications from a main conveyor line. Thus, not only are medications sorted according to defects and / or non-conformity to specific requirements, but the origin of the defect and / or non-conformity is also identified.Furthermore, the sorting of medications can be ordered by the management unit 20 according to other criteria. For example, according to a sampling criterion, followed by analysis of the collected samples. The sorting of medications by the sorting unit 24 is schematically represented in Figure 1 by the arrows 26 – the number of three arrows 26 in Figure 1 is given as an example.
[0051] Sorting unit 24 sorts medications at outlet 14 of enclosure 12. For example, medications are sorted at outlet 14 according to their conformity (arrow 27), non-conformity (arrow 28), and / or according to a sampling method (arrow 29). Sorting unit 24 can be arranged downstream of units 16, 19, and 18, if necessary, within the enclosure. Sorting unit 24 is downstream of the last detection unit 19, 18 arranged in enclosure 12, in the direction of medication production. In a configuration with both detection units 19 and 18, medications are sorted only after double detection on individual medications. Sorting is performed if at least one of the detections leads to a conclusion of defect or non-conformity. The advantage is that a single sorting is carried out after the drugs have passed under detection, which reduces the sorting equipment to be put in place in such a production device.A single 24-unit sorting system can be implemented. This system saves space both on the ground and vertically; multiple sorting stations would require multiple ramps for raising and lowering medications as needed for sorting.
[0052] According to Figure 1, the sorting unit 24 can be connected to the management unit 20 by a connection 25 (wired or otherwise).
[0053] The 24-unit sorting unit is capable of operating compressed air sorting. The advantage lies in the speed with which sorting is performed, particularly to keep pace with pharmaceutical production rates. The sorting unit can be a pneumatic sorting unit. The 24-unit sorting unit can be comprised of modules, each with compressed air supply valves. The intensity of the compressed air jet supplied by each module varies depending on the combination of valves activated. The sorting unit can also include nozzles emitting one or more air jets from the modules, depending on the number of modules activated. The nozzles have aligned outlet orifices. The nozzles direct one or more air jets towards the medications to be sorted, according to the medications' characteristics.
[0054] The individual delivery of medications within enclosure 12, as indicated by arrows 15, can be achieved in various ways. A velocity generated by the production unit 16 (or more specifically by the unloading mechanisms) during the unloading of production unit 16 enables the individual delivery of medications. A velocity generated by a compressed air injector, capable of injecting a flow of compressed air, also enables the individual delivery of medications. To pass through the detection unit 18 (if applicable), located downstream of production unit 16, the velocity generated by the unloading mechanisms of production unit 16 allows the medications to pass through the detection unit. The medications can be delivered through the metal detection unit 18 via a conduit (for example, a blowpipe-type conduit) to isolate the medications and increase the throughput.In order to pass through mass detection unit 19, a compressed air injector is desired. Thus, for example, in a configuration where the metal detection unit 18 is (directly) downstream of the production unit 16 and where the mass detection unit 19 is (directly) downstream of the metal detection unit 18 and connected (directly) to the sorting unit 24, a velocity induced by the unloading devices of the production unit 16 is preferred to allow the drugs to pass through the metal detection unit 18 and then a velocity induced by the compressed air injector to pass through the mass detection unit 19. The drugs reaching the outlet 14 of the enclosure with a high velocity (induced by the injector), for example between 2m / s and 20m / s, the sorting unit 24, capable of sorting the drugs by compressed air, makes it possible to maintain the rate and velocity of the drugs at this stage of production.
[0055] The production unit 10 may further include a drug conveying ramp, the ramp being inclined and extending externally from the outlet to the enclosure. This allows the drugs to be conveyed by gravity to other production stations.
[0056] Device 10 also allows for the acquisition of other drug characteristics. The device may include units of measurement. For example, the device may include a unit of measurement for drug moisture content and / or a unit of measurement for the drug's chemical content (e.g., by NIR spectroscopy). Using the moisture content, chemical content, and mass of the drug, it is possible to extrapolate to obtain the drug's hardness, dissolution profile, or friability.
[0057] The invention also relates to a method for producing medicinal products. The medicinal products consist of pharmaceutical tablets. Advantageously, the method can be implemented using the production device 10 described above. Reference is made hereafter to device 10 – but not in a limiting manner.
[0058] The process may include the production of the medication by the production unit 16 located inside the enclosure 12, the enclosure having the outlet 14 for the medication. The process may then include the mass detection by the mass detection unit 19 of the medication produced by the production unit, the mass detection unit being arranged inside the enclosure, and the medication being discharged individually from the production unit 16 to the mass detection unit 19. The mass detection unit is arranged inside the enclosure, between the production unit and the outlet. Both medication production and mass detection are carried out within the same enclosure and independently. Production is performed without a confined connection interface between the production unit and the mass detection unit. The production process is carried out under simpler containment conditions.The drugs are individually processed at the exit of production unit 16, which allows them to be individually characterized by any unit downstream of production unit 16, within the enclosure.
[0059] The production process may further include the transmission of data from the units to the management unit 20. This data consists of drug characteristics and production position data for the drugs within the production unit. Subsequently, the process may include the correlation of the characteristic data with the position data by the management unit 20. The process (like device 10) enables production management using drug characteristic data and production position data. Furthermore, the process (like device 10) allows for the management of data, and in particular correlated data, as a production parameter. A data integration strategy can be implemented, thereby improving production.
[0060] The process can also include sending drug sorting instructions based on characteristic data, position data, and correlated data to the drug sorting unit 24. This allows for precise production management. Furthermore, the metal detection unit 18 can detect the presence of metals in the drugs produced by the production unit. The metal detection unit 18 can be arranged within the enclosure, between the production unit and the mass detection unit. The drug characteristics include the presence of metals and / or the drug mass.
[0061] The process can also implement the determination of whether a position within production unit 16 is defective. This step is preferably carried out by the management unit based on the aforementioned correlated data. Thus, thanks to the individual processing of medications, immediately upon leaving production unit 16, defective medications can be easily identified, and depending on the defective position, which production component is defective—such as a tablet press punch—allowing for rapid intervention on the identified defective component.
[0062] Preferably, the method also includes a step of transmitting information about this defective position (by the control unit) to a user. This step can be done, for example, via a screen or interface of the device 10, or by sending a message to the user's mobile electronic device (such as a smartphone).
[0063] Information transmission can be achieved through an audible and / or visual alarm. For example, a light signal (such as a lamp) can illuminate at the identified faulty location, making it easy to locate that location.
[0064] The management unit can also send the production unit a production instruction related to the defective position. In this case, the production unit is configured to produce medications taking such an instruction into account, so that the defective position is no longer used for medication production.
[0065] Individual processing of all produced medications allows for more precise production control—unlike production processes and equipment where medications pass through bulk drug storage stations. The invention enables the organization of individual medication processing within the facility and allows for immediate action as soon as a defect or non-conformity is identified by the detection unit(s)—all within a single, confined space. Identified defective medications can be immediately isolated to prevent rendering a volume of produced medication unusable. Production can be corrected quickly, as the data integration and correlation strategy allows for the identification of defective production components (and thus improves production quality).The implementation of control loops within the management unit 20 enables the real-time detection of manufacturing defects (such as variations in mass and / or the presence of metals). This allows for rapid corrective actions. The invention enables quality control to be implemented across all medications, rather than through sampling. This allows for faster detection of quality deviations. The management unit 20 can be configured and programmed to operate the production process. A computer program is also proposed, comprising instructions which, when executed by a computer (or a programmable unit such as the management unit 20), lead the computer to implement steps in the production process, such as data reception, data processing, data analysis, data correlation, and the sending of medication sorting instructions.A computer-readable data carrier (or a programmable unit such as the management unit 20) is also offered, on which the computer program is recorded.
[0066] The invention differs from any intermittently operating production machine, which uses a different technology, particularly (but not exclusively) capsule production machines. These machines employ rotating elements such as drums, intermittent rotary transfers, etc., which are suitable for filling capsule shells (or capsules, vials, etc., which have a certain rigidity) and are intermittent by nature. The production unit 16 is continuous, operating continuously. The production unit 16 is a tablet press (or continuous tablet press, rotary tablet press, or continuous rotary tablet press), comprising continuously rotating components (such as dies). Powders are poured into the continuously rotating dies (for example, into continuously rotating turrets). The tablets formed after compression can be handled without special precautions.Within the framework of unit 16 in the form of a tablet press (or continuous tablet press or rotary tablet press or continuous rotary tablet press), it is therefore incompatible to insert an element operating intermittently, such as an intermittent drum (taking into account, in particular, the rates).
[0067] The mass detection unit 19 operates inline, enabling continuous mass detection and keeping pace with the (high) production rates of the (continuous) production unit 16. In the context of this invention, the inline mass detection unit 19 is also compact, unlike prior art designs for similar production rates.
[0068] The invention relates to a device for the production of pharmaceutical tablets, the device comprising an enclosure having an outlet for pharmaceutical tablets, a pharmaceutical tablet production unit, the production unit being located inside the enclosure, an inline mass detection unit, for detecting the mass of pharmaceutical tablets produced by the production unit, the mass detection unit being arranged inside the enclosure, between the production unit and the outlet for the medicines.
[0069] It will be obvious to a person skilled in the art that the invention is not limited to the achievements and examples illustrated and / or described above, but that its scope is more broadly defined by the claims introduced below.
Claims
Demands 1. Device (10) for producing medicinal products consisting of pharmaceutical tablets, the device comprising - an enclosure (12) having an outlet (14) for medication, - a drug production unit (16), the production unit being located inside the enclosure (12), - an inline mass detection unit (19) for detecting the mass of drugs produced by the production unit, the mass detection unit being arranged inside the enclosure (12), between the production unit (16) and the outlet (14) and the production unit (16) is capable of unloading drugs individually to the mass detection unit (19).
2. Device 10) according to the preceding claim, further comprising a management unit (20) configured to correlate drug characteristic data with drug production position data in the production unit.
3. Device (10) according to the preceding claim, comprising a sorting unit (24) configured to sort drugs, the sorting unit being controlled by the management unit based on correlated data.
4. Device (10) according to the preceding claim, in which the sorting unit is arranged at the exit of the enclosure.
5. Device (10) according to one of the two preceding claims, wherein the sorting unit is capable of sorting by compressed air.
6. Device (10) according to any one of the preceding claims, further comprising a unit for detecting metals (18) present in the medicines, the metal detection unit being arranged inside the enclosure.
7. Device (10) according to the preceding claim, comprising drug discharge members out of the production unit (16), the discharge members being capable of inducing a speed of passage of the drugs through the metal detection unit (18).
8. Device (10) according to the preceding claim, in which the mass detection unit (19) is arranged between the metal detection unit (18) and the outlet (14) of the enclosure.
9. Device (10) according to any one of the preceding claims, wherein the online mass sensing unit is a 3D microwave resonance sensor.
10. Device (10) according to any one of the preceding claims, comprising a compressed air injector, capable of injecting a flow of compressed air for the delivery of drugs through the mass detection unit.
11. Device (10) according to any one of the preceding claims, further comprising a drug conveying ramp, the ramp being inclined and extending externally to the enclosure from the outlet.
12. Device (10) according to any one of the preceding claims, wherein the drug production unit (16) is a tablet press, preferably a rotary tablet press, preferably a continuous rotary tablet press.
13. A process for producing medicinal products consisting of pharmaceutical tablets, the process comprising: - the production of medicinal products by a production unit (16) located inside an enclosure (12), the enclosure having an outlet (14) for the medicinal products, - Detection by an online mass detection unit (19) of the mass of drugs produced by the production unit, the mass detection unit being arranged inside the enclosure, between the production unit and the outlet (14), the drugs being unloaded individually from the production unit (16) to the mass detection unit (19).
14. A method according to the preceding claim, further comprising - the sending of data by the production (16) and mass detection (19) units to a management unit (20), the data being drug characteristic data and drug production position data in the production unit, - the correlation by the management unit (20) of characteristic data with position data.
15. A method according to the preceding claim, further comprising - sending drug sorting instructions based on correlated data to a drug sorting unit.
16. A method according to any one of the preceding claims, further comprising - the detection by a metal detection unit (18) of the presence of metals in the medicinal products produced by the production unit, the metal detection unit being arranged inside the enclosure, between the mass detection unit and the exit of the enclosure.
17. A process according to any one of the four preceding claims, wherein the characteristics of the drugs include the presence of metals in the drugs and / or, where the process is according to the preceding claim, the mass of the drugs.
18. A method according to any one of the five preceding claims, further comprising, depending on the correlated data, - the determination that a position within the production unit is defective.
19. A method according to any one of the six preceding claims, further comprising the implementation of mass variation control loops.
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