Method, system, automated dispensing device and computer program product for determining suitability of pharmaceutical packaging

Abstract

The present invention relates to a method, a system (50), said automated dispensing device (1) and a computer program product for determining the suitability of a plurality of pharmaceutical packagings (P1, P2, ..., Pn) for containing individual pharmaceuticals (M) to be dispensed and packaged by an automated dispensing device (1), the method comprising the steps of: - for each pharmaceutical packaging of the plurality of pharmaceutical packagings, associating with each pharmaceutical packaging (P1, P2, ..., Pn) one or more process values ​​(V1-Vn) indicative of a manufacturing process of the automated dispensing device (1) that affects the respective pharmaceutical packaging or at least one of the individual pharmaceuticals contained in the respective pharmaceutical packaging; - identifying anomalies in the one or more process values ​​(V1-Vn); and - recommending at least one pharmaceutical packaging of the plurality of pharmaceutical packagings for further suitability testing based on the identified anomalies in the one or more process values ​​associated with the at least one pharmaceutical packaging.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to methods, systems, automated dispensing devices and computer program products for determining the suitability of pharmaceutical packaging, particularly pouches. [Background technology]

[0002] U.S. Patent Application Publication No. 2014 / 0366489 A1 discloses a device for automatically dispensing solid medical substances. The device includes a number of dispenser units, also known as "canisters," distributed in a radial grid around a rotational axis. Each dispenser unit holds a quantity of solid substance specific to that dispenser unit. Thus, together, the dispenser units are capable of dispensing a variety of solid substances.

[0003] The device further comprises a collection frame rotatable about an axis of rotation below the array of dispenser positions, the collection frame comprising a series of collection trays for collecting solid material dispensed from any of the dispenser units at the array of dispenser positions.

[0004] The device further includes a packaging unit located in a fixed position below the collection frame for packaging the solid material received from the collection trays in foil that is sealed to form individually sealed pockets, also known as "pouches." The collection frame is rotated about an axis of rotation such that each collection tray advances along each feeder unit in the array of feeder positions before reaching the packaging unit.

[0005] The dispensing device disclosed in US Patent Application Publication No. 2014 / 0366489 A1 is configured to continuously produce pouches at high speed as part of a string of pouches that remain interconnected as they exit the dispensing device, with each completed pouch being the result of many different steps in the dispensing device, including but not limited to filling a feeder unit, separating the individual medications in the feeder unit, dispensing the individual medications one by one from the feeder unit, collecting the dispensed individual medications from the feeder unit, rotating a collection frame with a collection tray to the correct feeder position, printing relevant information on the foil, sealing and punching the foil to form the pouch, and sending the string of pouches from the dispensing device.

[0006] Outside the dispensing device, the array of pouches is wound onto a collection reel. At another inspection station, the array of pouches is unwound again and each pouch is automatically visually inspected by a camera for package conformance and pouch contents. If a pouch is found to be non-compliant, a human operator is alerted and the non-compliant pouch is manually inspected. Pouches that pass visual inspection by camera are processed without further human operator intervention and sent directly to the patient.

[0007] Visual inspection by camera is not perfect and may miss small or partial defects, such as leak seals, resulting in a pouch marked as compliant that is actually non-compliant and may reach the patient. Summary of the Invention [Problem to be solved by the invention]

[0008] It is an object of the present invention to provide a method, system, automated dispensing device and / or computer program product for determining suitability of pharmaceutical packaging, which allows for improved suitability determination. [Means for solving the problem]

[0009] According to a first aspect, the present invention provides a method for determining the suitability of a plurality of medication packages for containing individual medications to be dispensed and packaged by an automated dispensing device, comprising: - for each medication package of the plurality of medication packages, associating with the respective medication package one or more process values ​​indicative of a manufacturing process for the automated dispensing device that affects the respective medication package or at least one of the individual medications contained in said respective medication package; - identifying an anomaly in one or more process values; - recommending at least one medication package of the plurality of medication packages for further conformance testing based on the identified anomaly in one or more process values ​​associated with the at least one medication package; The present invention provides a method comprising:

[0010] Anomalies in one or more process values ​​may be indicative of problems during the manufacturing process of the automated dispensing device, which may result in defects of individual drugs and / or drug packages. Some of these defects may be very small or hidden from plain view and therefore difficult to detect during automated visual inspection downstream of the dispensing device. Therefore, by identifying such anomalies, the drug package may be recommended for further conformance testing or flagged, even if the automated visual inspection does not find any non-conformance. In this way, defects may be detected more reliably and / or various defects may be found, thereby improving the determination of (non-)conformance.

[0011] In one embodiment, the automated dispensing device includes one or more sensors for providing feedback regarding the manufacturing process, and the one or more process values ​​are indicative of feedback signals generated by the one or more sensors, which may be fed forward to be used in determining (in)conformity.

[0012] In another embodiment, further compatibility testing is performed by a human operator who can use the recommendations to selectively test only those medication packaging flagged for further compatibility testing.

[0013] In a further embodiment, the method comprises: - displaying further compatibility testing recommendations to a human operator; - waiting for feedback from a human operator regarding further compatibility testing; Further includes:

[0014] Human operators assigned to inspection duties typically have greater experience and dexterity in identifying defects that are difficult to detect automatically and can reliably determine the suitability of flagged pharmaceutical packaging.

[0015] In a further embodiment, the method comprises: - Steps to display the reason for the recommendation along with the recommendation wherein the reason includes one or more elements of a group of information including the identified anomaly, a possible root cause associated with the anomaly, and an examination area containing the anomaly.

[0016] The reason for the recommendation may provide more context to enable a human operator to more confidently determine the suitability of the flagged medication packaging. The reason may indicate, for example, the anomaly identified, the type of anomaly, the type of defect that may result from such anomaly, and / or areas of interest such as information printed on the medication packaging or closure.

[0017] In an alternative embodiment of the method, the further compatibility checks are at least partially automated, thus reducing the amount of human work involved in the further compatibility checks.

[0018] In another embodiment, the method comprises: - performing an automated compatibility check on each medication package before recommending further compatibility testing; The results of the automated compatibility check may be used to further assist a human operator in determining the compatibility of the flagged medication packaging.

[0019] In a further embodiment, the method comprises: - recommending at least one medication packaging for a further compatibility test of a first type if the result of the automatic compatibility check is that at least one respective medication packaging is compatible; - recommending at least one medication packaging for a further compliance test of a second type if the result of the automatic compliance check is that at least one respective medication packaging is not compliant; Further includes:

[0020] An identified anomaly in a process value does not necessarily cause a defect in the pharmaceutical packaging that is large enough or severe enough to warrant discarding each pharmaceutical package. Thus, if an anomaly is identified, the automatic compatibility check may still not detect the defect, and many of the pharmaceutical packages may be deemed compliant despite the identified anomaly. However, if the automatic compatibility check confirms a non-conformity that may be due to the identified anomaly, it is highly likely that each pharmaceutical package is actually non-compliant and requires appropriate correction, repair, or should be discarded altogether. The above distinction between types of further compatibility tests can be used to select the type of further compatibility test that is most appropriate for the likelihood that each pharmaceutical package is actually non-compliant. In particular, it can prevent time from being wasted on one type of further compatibility test, while the other type of further compatibility test is more suitable for processing the most likely result.

[0021] Instead, the method is - determining whether there is a relationship between the identified anomaly in one or more process values ​​and the results of the automated conformance check; - recommending at least one medication packaging for further compatibility testing of a first type if it is determined that there is no relationship between the identified anomaly in the one or more process values ​​and the results of the automated compatibility check; - recommending at least one medication packaging for further conformance testing of a second type if it is determined that there is a relationship between the identified anomaly in the one or more process values ​​and the results of the automated conformance check; Further includes:

[0022] This embodiment has the same technical advantages as the above-mentioned embodiment, but allows for a more accurate discrimination when the identified anomalies and the results of the automatic compatibility check are concerned, for example, if an anomaly is detected in a process value of the sealing process corresponding to a seal non-conformity during the automatic compatibility check, since the pharmaceutical packaging is only recommended for a second type of further compatibility check.

[0023] In a further embodiment, the method comprises: - providing an inspection station for conformance inspection and a correction station for conformance inspection and correction; wherein the first type of further conformance check is performed at the inspection station and the second type of further conformance check is performed at the correction station.

[0024] The inspection station may be conveniently located alongside or adjacent to the dispensing device to allow for rapid further conformance testing with minimal impact on further handling and / or processing of the medication packages. In contrast, the correction station may be in a separate or dedicated location with more tools for more thorough testing and possible correction or repair. Medication packages being inspected at the correction station may be separated from medication packages found to be conforming and transported from the inspection station to the correction station.

[0025] In a further embodiment, the plurality of medication packages is delivered from and collected outside of the automated dispensing device, and the automated compatibility check is performed outside of the automated dispensing device before or during collection of the plurality of medication packages. Thus, one or more process values ​​from the manufacturing process within the automated dispensing device may be combined with the results of the automated compatibility check outside of the automated dispensing device.

[0026] In another embodiment, the method comprises: - automatically flagging one or more of the plurality of medication packages for regeneration. If each medication package is determined to be non-compliant, the inspection step can be skipped, and in fact the dispensing device may already be instructed to begin reconditioning each medication package.

[0027] Preferably, the method further includes skipping at least a portion of the manufacturing process for one or more pharmaceutical packages flagged for remanufacturing. For example, if a printing error is detected upstream of filling and / or sealing, the filling or sealing step may be skipped. Thus, each pharmaceutical package arrives at the inspection station empty and / or unsealed. In this way, the amount of waste resulting from incorrectly filled pharmaceutical packages can be reduced.

[0028] Additionally or alternatively, the method comprises: - recommending the removal without inspection of one or more medication packages flagged for reclamation; In this way, valuable time can be saved by not having to inspect medication packaging that is certainly non-compliant.

[0029] In another embodiment, the plurality of medication packages form a queue. The order of the medication packages in the queue corresponds to the order in which the medication packages were formed. Thus, an identified anomaly can be linked to a specific medication package that can be tracked to its position in the queue based on the order in which the queue was formed. The queue can be wound onto a collection reel, such as a collection reel on a spooler, so that long continuous queues can be collected and stored for immediate or later inspection.

[0030] In another embodiment, the multiple medication package is a pouch. The pouch is formed by dispensing individual medications into folds of a folded foil and sealing the foil around the individual medications to form individual sealed pockets. Defects can occur at various steps in forming these pockets, particularly during sealing. Such defects can be reflected by anomalies in one or more process values.

[0031] In another embodiment, the manufacturing process includes one or more processes from the group including storing individual medications, preparing individual medications for dispensing, dispensing individual medications, packaging individual medications into multiple packages, and delivering said multiple packages from an automated dispensing device, any one of which processes may directly or indirectly cause defects in the individual medications and / or medication packages.

[0032] In further embodiments, the dispensing process includes one or more of the following sub-processes: separation of individual medications before dispensing, dispensing of the individual medications, intermediate collection of dispensed individual medications, and delivery of the collected dispensed individual medications.

[0033] In further embodiments, the packaging process includes one or more of the following sub-processes: providing packaging material used to form the drug package, printing relevant information on the packaging material or drug package, sealing the drug package, providing perforations and / or tear notches in or between the drug package, and delivering the drug package from an automated dispensing device.

[0034] In another embodiment, the one or more process values ​​indicate one or more causes of non-conformity from a group including hardware problems, software problems, incorrect storage of individual medications, incorrect filling of individual medications before dispensing, over-dispensing, under-dispensing, failure to dispense, dispensing of incorrect individual medications, dispensing of damaged individual medications, incorrect collection of dispensed individual medications, failure to seal, partial seal, leaking seal, incorrect perforation, incorrect tear notch, printing error, poor print quality, incorrectly printed information, incorrect handling of packaging material, incorrect packaging material, damaged packaging material, and errors during delivery of the medication package.

[0035] According to a second aspect, the present invention provides a system for determining the suitability of a plurality of medicament packagings for containing individual medicaments to be dispensed and packaged by an automated dispensing device, the system comprising a control unit configured to perform the steps of the method according to any one of the embodiments according to the first aspect of the invention.

[0036] The above-described system performs the steps of the method according to the first aspect and therefore has the same technical advantages that will not be repeated below.

[0037] In a further embodiment, the system further comprises a human machine interface operatively connected to the control unit, the control unit configured to cause the human machine interface to display recommendations for further compatibility tests.

[0038] According to a third aspect, the present invention provides an automated dispensing device comprising a system according to any one of the embodiments according to the second aspect of the invention.

[0039] Through the system, the automated dispensing device performs the steps of the method according to the first aspect and therefore has the same technical advantages that are not repeated below.

[0040] In a further embodiment, the automated dispensing device further includes one or more sensors for providing feedback regarding the manufacturing process, the control unit being operably connected to the one or more sensors for receiving feedback signals generated by the one or more sensors, and the one or more process values ​​being indicative of the feedback signals generated by the one or more sensors.

[0041] According to a fourth aspect, the present invention provides a computer program product comprising a non-transitory computer readable medium carrying instructions which, when executed by a processor, cause a system according to any one of the embodiments according to the second aspect of the invention to perform the steps of the method according to any one of the embodiments according to the first aspect of the invention, and thus has the same technical advantages not repeated below.

[0042] The various aspects and features described and illustrated in this specification may be applied individually whenever possible. These individual aspects, particularly those described in the accompanying dependent claims, may be the subject of divisional patent applications.

[0043] The invention will now be described on the basis of exemplary embodiments shown in the accompanying schematic drawings. [Brief explanation of the drawings]

[0044] [Figure 1] 1 shows a front view of an automated dispensing device and system for determining the suitability of a plurality of medication packages for containing individual medications to be dispensed and packaged by the automated dispensing device. [Figure 2] 2 shows a flow chart of a method for determining compatibility of a plurality of pharmaceutical packagings using the system according to FIG. 1; [Figure 3] An alternative method for determining compatibility of multiple pharmaceutical packages using a system according to FIG. 1 is shown. [Figure 4] An alternative method of flagging one or more medication packages for reconditioning using a system according to FIG. 1 is shown. DETAILED DESCRIPTION OF THE INVENTION

[0045] 1 shows an automatic or automated dispensing device 1 and a system 50 for dispensing and filling individual medications M according to an exemplary embodiment of the present invention that determines the suitability of multiple medication packages P1, P2, ..., Pn that are intended to contain individual medications M to be dispensed and packaged by the automated dispensing device 1. The system 50 may be part of the dispensing device 1 or may share components with the dispensing device 1.

[0046] The individual medications M can be individual solid medications, pharmaceuticals or solid items, articles or substances for medical use, such as pills, tablets, capsules, etc. The medications are "individual" in the sense that the medications can be dispensed singly, individually, separately or in dosage units.

[0047] The dispensing device 1 comprises a housing 10 defining a supply portion 2, a collection portion 3 and a packaging portion 4. Furthermore, the dispensing device 1 comprises a control unit 8 and a memory 9, e.g. a control portion 11, which holds a database, for controlling and monitoring the manufacturing process of the dispensing device 1.

[0048] The supply portion 2 may contain a plurality of supply units 20 held in a circular array of supply positions similar to that disclosed in U.S. Patent Application Publication No. 2014 / 0366489 A1, the contents of which are incorporated herein by reference. Each supply unit 20 includes a container 21 for holding ingredients of an individual drug M, a dispensing mechanism 22 for separating the individual drugs M, and an outlet 23 for dispensing the separated individual drugs M one by one.

[0049] The collection portion 3 includes collection trays 30 held in a circular array, again similar to that of US Patent Application Publication No. 2014 / 0366489 A1, for containing the individual medications M dispensed by the dispenser units 2. The array of collection trays 30 is rotatable such that each collection tray 30 moves along all the dispenser positions.

[0050] The packaging section 4 is configured to contain the individual medications M collected in the collection section 3 and to fill or package the individual medications M into medication packages P1-Pn. In this exemplary embodiment, the medication packages P1-Pn are individual sealed pockets or pouches formed from a continuous packaging material, in particular a foil F. More specifically, the packaging section 4 includes a foil supply reel 41 that supplies the foil F, a printer unit 42 having a printer head 44 that prints relevant information, such as patient information or medical information, on the foil F, and a sealing unit 43 having one or more sealing members 45, 46 that seal the foil F around the individual medications M. Typically, the foil F is pre-folded so that the individual medications M can be contained in the folds. Thereafter, one or more sealing members 45, 46 seal the other three sides of the medication packages P1-Pn.

[0051] In this example, the collection section 3 is placed below or vertically below the supply section 2 and the packaging section 4 is placed below or vertically below the collection section 3. The individual medicaments M fall from one section 2, 3, 4 to the other under the influence of gravity.

[0052] Furthermore, the dispensing device 1 is provided with a number of sensors 51-59 for monitoring the manufacturing process at the dispensing device 1. The manufacturing process includes one or more processes from a group including, but not limited to, storing the individual drugs M, preparing the individual drugs M for dispensing, dispensing the individual drugs M, packaging the individual drugs M into a number of packages P1-Pn and delivering said number of packages P1-Pn from the dispensing device 1.

[0053] More specifically, the dispensing process may include one or more of the following sub-processes: separation of individual drugs M before dispensing, dispensing of individual drugs M, intermediate collection of dispensed individual drugs M, and delivery of collected dispensed individual drugs M.

[0054] Similarly, the packaging process may include one or more of the following sub-processes: providing packaging material F used to form the drug packages P1-Pn, printing relevant information on the packaging material F or the drug packages P1-Pn, sealing the drug packages P1-Pn, providing perforations and / or tear notches in or between the drug packages P1-Pn and delivering the drug packages P1-Pn from the dispensing device 1.

[0055] In each of these processes, errors, failures or anomalies may occur that are outside of the "normal" operation of the dispensing device 1. Each of these processes may result in defects in the individual medications M and / or medication packages P1-Pn (e.g., incorrect amount or type of individual medication M, damaged individual medication M, partial seals, leaking seals, incorrect perforations, incorrect tear notches, printing errors, poor print quality and / or incorrectly printed information). Depending on the compliance requirements, these defects may be reason to modify medication packages P1-Pn that are found to be non-compliant or reason to discard such non-compliant medication packages P1-Pn.

[0056] In this example, the multiple sensors 51-59 include a first sensor 51 that monitors the separation of individual drugs M in the dispensing mechanism 22 of the supply unit 20, a second sensor 52 that monitors the dispensing of individual drugs M, in particular to detect "over-dispensing" when two or more individual drugs M are dispensed simultaneously from the same supply unit 20, or to detect "under-dispensing" when an individual drug M is not dispensed from the supply unit 20 when the dispensing mechanism 22 is operated, a fourth sensor 54 that monitors the overall condition (e.g., storage condition) in the dispensing device 1, a fifth sensor 55 that monitors the supply of packaging material, a sixth sensor 56 that monitors the operation of the printer unit 42, seventh sensors 57 and eighth sensors 58 that monitor the operation of the packaging unit 43, in particular the operation of one or more sealing members 45, 46, and a ninth sensor 59 that monitors the delivery of drug packages P1-Pn from the dispensing device 1.

[0057] It will be apparent to one skilled in the art that more or different selections of sensors 51 - 59 may be used to monitor related processes, sub-processes or operations related to the manufacturing process of the dispensing device 1 .

[0058] The plurality of sensors 51-59 are configured to generate signals (particularly feedback signals) indicative of process values ​​V1-Vn monitored by the sensors 51-59. The process values ​​V1-Vn are indicative of process parameters in which an error, failure, and / or abnormality may occur. In particular, the process values ​​V1-Vn may relate to process parameters (e.g., interruption of a light screen or light beam, pressure, force, current, state, etc.). The process values ​​V1-Vn may be analog or digital. A control unit 8 is electronically, functionally, and / or operatively connected to the plurality of sensors 51-59 for receiving the signals and for processing and / or analyzing the process values ​​V1-Vn that can be derived from the signals. The process values ​​V1-Vn are stored in a memory 9 together with the pharmaceutical packagings P1-Pn and / or the pharmaceutical M filled in the pharmaceutical packagings P1-Pn manufactured using the process values ​​V1-Vn.

[0059] As shown in FIG. 1 , the packaging portion 4 further includes a delivery opening 47 in the housing 10 for delivering the medication packages P1-Pn from the dispensing device 1. In this example, the medication packages P1-Pn are delivered from the dispensing device 1 in a continuous row. Outside the dispensing device 1, a spooler 6 is provided with a collection reel 60 that collects the medication packages P1-Pn over several turns of the row. A camera 61 may be provided at or near the spooler 6 to perform an automated or automatic compatibility check. In this example, the camera 61 is a visual camera that takes a scan or image of each medication package P1-Pn. In this example, a control unit 8 is electronically, functionally, and / or operably connected to the camera 61 for receiving the scans or images and processing and / or analyzing the scans or images for compatibility.

[0060] As shown in FIG. 1 , an inspection station A1 is provided at or near the spooler 6 for human or manual inspection (e.g., inspection by a human operator (e.g., a pharmacist)) of the pharmaceutical packaging P1-Pn. Additionally, a correction station A2 may be provided that can also be used for inspection by a human operator but is further equipped for correcting or repairing pharmaceutical packaging P1-Pn that is found to be non-conforming. The correction station A2 may include, for example, a workbench and tools for more detailed inspection, refilling, and / or repackaging. When the correction station A2 is provided, the inspection station A1 is typically not used for correcting or repairing the pharmaceutical packaging P1-Pn. Instead, cameras, sensors, and / or manipulators may be provided at the correction station A2 to at least partially automate the more detailed inspection, correction, and / or repair of the pharmaceutical packaging P1-Pn.

[0061] The system 50 further includes one or more human-machine interfaces 71, 72 (e.g., screens or displays) that present information to a human operator at each station A1, A2. The one or more human-machine interfaces 71, 72 are electronically, functionally and / or operatively connected to the control unit 8.

[0062] The control unit 8, memory 9, sensors 51-59, camera 61 and / or one or more human-machine interfaces 71, 72 may be shared by both the dispensing device 1 and the system 50 for determining the suitability of the plurality of medication packagings P1-Pn. Alternatively, one or more of the components described above (or other additional components) may be provided as part of the system 50, separate from the dispensing device 1.

[0063] FIG. 2 illustrates steps in a method for determining the compatibility of a plurality of pharmaceutical packagings P1-Pn using the system 50 described above.

[0064] When starting the method (step S0), the dispensing device 1 is controlled or allowed to carry out a production process (step S1). During the production process, the control unit 8 receives signals from the sensors 51 to 59 in Figure 1 indicating process values ​​V1 to Vn (step S2).

[0065] The control unit 8 is arranged, programmed or configured to associate the process values ​​V1-Vn with the medication packages P1-Pn that were generated with said process values ​​V1-Vn (step S3). In other words, it links all process values ​​V1-Vn to each medication package P1 that represent the state of the dispensing device 1 during the dispensing, packaging or any other process or sub-process of the manufacturing process that ultimately results in the individual medication M being packaged in each medication package P1 for delivery. The process values ​​may be linked, for example, to the serial number of each medication package P1, a patient number, a batch number or a prescription number associated with each medication package P1. The process values ​​V1-Vn may be stored in a memory 9 (e.g. a database structure) that is cross-referenced to information relating to the medication packages P1-Pn.

[0066] The control unit 8 is further arranged, programmed, or configured to retrieve the process values ​​V1-Vn for each one of the pharmaceutical packagings P1-Pn (P1 in this example), analyze the process values ​​V1-Vn, and identify any anomalies in the process values ​​V1-Vn for each pharmaceutical packaging P1 (step S4). This analysis may include a comparison between the received process values ​​V1-Vn for each one of the pharmaceutical packagings P1-Pn and expected process values ​​pre-stored in memory to determine deviations from expected values ​​and identify these deviations as anomalies. In some cases, the expected values ​​may be dynamic based on the most recent set of values ​​received and / or compared to other recent values, and anomalies may be identified as anything outside of an acceptable deviation (e.g., 10% of the average). The control unit 8 then determines whether one or more anomalies are identified from the analysis of each pharmaceutical packaging P1 (step S5).

[0067] If no abnormality is identified, the process is repeated for the next one of the medication packages P2-Pn, as indicated by arrow "N."

[0068] If one or more anomalies are identified based on the analysis and comparison, for example as indicated by an exclamation mark "!" in the database table for the process value V2 and the medication package P1, information about each medication package P1 (e.g., serial number, patient number, batch number or prescription number) is sent to one of the human machine interfaces 71, 72 (step S6) along with a recommendation R1 for further compatibility testing for the medication package P1, which is then caused to display said recommendation R1. Information indicating the anomaly "!" and / or the process value V2 may be accompanied by information to provide a context or reason C for the recommendation R1.

[0069] 3 illustrates an alternative step (step S106) following the step of determining whether one or more anomalies are identified for each pharmaceutical packaging P1 (step S5). In the alternative step (step S106), scans or images from the camera 61 in the spooler 6 are processed to perform an automatic compatibility check for each pharmaceutical packaging P1, and / or results D of the automatic compatibility check based on the scans or images are received for each pharmaceutical packaging P1. The control unit is arranged, programmed, or configured to determine whether the results of the automatic compatibility check indicate that each pharmaceutical packaging is compatible, or to determine whether there is a relationship between the identified anomaly in one or more process values ​​and the result of the automatic compatibility check (step S107). For example, the relationship may be determined based on a rule set or artificial intelligence that indicates possible relationships between the process values ​​V1-Vn and possible results of the automatic compatibility check. The rule set may indicate, for example, that there is a relationship if the identified anomaly arises from a process value V1 to Vn associated with the sealing of each pharmaceutical packaging P1 and the result D of the automatic compatibility check is that the sealing of each pharmaceutical packaging P1 is incompatible.

[0070] If the answer is "yes," as indicated by arrow "Y," a recommendation R1 is sent or issued (step S108) to one or more human-machine interfaces 71, 72 for further conformance checks of a first type performed at inspection station A1 of Figure 1. If the answer is "no," as indicated by arrow "N," a different recommendation R2 is sent or issued (step S109) to one or more human-machine interfaces 71, 72 for further conformance checks of a second type performed at modification station A2 of Figure 1.

[0071] The recommendation R2 for the second type of further conformity inspection may be sent to the human-machine interface 71 at the inspection station A1 and / or directly to the human-machine interface 72 at the correction station A2. If the recommendation R2 for the second type of further conformity inspection is sent to the human-machine interface 71 at the inspection station A1, the human operator at the inspection station A1 does not need to inspect each drug package P1. Instead, the human operator may separate or remove each drug package P1 from the remaining drug packages P2-Pn after transferring each drug package P1 to the correction station A2 for the second type of further conformity inspection. Therefore, time is not wasted inspecting each drug package P1 at the inspection station A1.

[0072] It should be noted that the separation and / or removal of each pharmaceutical packaging P1 from the remaining pharmaceutical packagings P2-Pn can alternatively be automated, for example using a suitably configured manipulator (eg, a robot).

[0073] Figure 4 shows that if an anomaly is detected early in the process, for example by the printer unit 42 (step S206), the control unit 8 can be arranged, programmed or configured to automatically flag each drug packaging P1 for regeneration (step S207) and control the dispensing device 1 to skip any further steps in the manufacturing process for each drug packaging P1 (step S208).

[0074] For example, if the patient information is not printed in the correct place on the foil, the control unit 8 may already decide to discard each pharmaceutical package P1 and to abort the next step of filling and / or sealing each pharmaceutical package P1. Thus, each pharmaceutical package P1 arrives at the inspection station A1 empty and / or unsealed. In this way, the amount of waste as a result of incorrectly filled pharmaceutical packages can be reduced.

[0075] The determination of whether each pharmaceutical packaging P1 needs to be regenerated can be made independently of a human operator, for example using a rules engine or artificial intelligence.

[0076] The control unit 8 may alert a human operator via the human-machine interface 71 at inspection station A1 to physically remove the defective pharmaceutical packaging P1 from the queue (step S209), or a robot may be provided to further automate the removal process.

[0077] A computer program product (e.g., software) may be loaded into the control unit 8, which holds instructions that, when executed by a processor (part of the control unit 8), cause the system 50 to perform the above-described steps S1-S6, S106-S109 of the method. The computer program product may be stored on or may include a non-transitory computer-readable medium (e.g., memory 9) or an internal memory of the control unit 8.

[0078] The above description is included to illustrate the operation of the preferred embodiment and is not intended to limit the scope of the invention. From the above description, many variations will be apparent to those skilled in the art that are still encompassed by the scope of the invention. [Explanation of symbols]

[0079] 1. Dispensing Device 10. Housing 11 Control section 2 Supply part 20 Supply Unit 21 Container 22 Dispensing mechanism 23 Exit 3 Collection section 30 Collection Tray 4 Packaging part 41 Foil supply reel 42 Printer unit 43 Packaging Unit 44 Printer head 45 First sealing member 46 Second sealing member 47 Delivery opening 50 systems 51~59 Sensors 6 Spooler 60 Collecting Reels 61 Camera 71 First Human-Machine Interface 72 Second Human-Machine Interface 8. Control Unit 9. Memory A1 Inspection Station A2 Correction Station C reason D Automatic compatibility check results F foil M drug P1~Pn Medicine packaging R1 Recommendation of further conformance testing of the first type R2 Recommendation of further conformance testing of the second type S0 method S1 Step S1: "Execute the manufacturing process" S2 Step S2: "Receive process value" S3 Step S3: "Associate process values ​​with drug packaging" S4 Step S4: "Identify abnormalities in the process values ​​for each medicine package." S5 Step S5: "Have one or more anomalies been identified?" S6 Step S6: "Issue recommendations for further compliance testing for each drug package" S106 Step S106: "Receive the results of the automatic compatibility check for each medicine package." S107 Step S107: "Do the results of the automatic compatibility check indicate that each medication package is compatible / Is there a relationship between the identified anomaly in one or more process values ​​and the result of the automatic compatibility check?" S108 Step S108: "Issue a recommendation for a further suitability test of the first type for each drug package performed at the testing station." S109 Step S109: "Issue a recommendation for a second type of further conformity test for each drug package performed at the correction station." S206 Step S206: "Is each medication package definitely incompatible?" S207 Step S207: "Automatically flag one or more medication packages for regeneration" Step S208: "Skip at least a portion of the manufacturing process for one or more pharmaceutical packages flagged for reconditioning." S209 Step S209: "Issue a recommendation to remove without inspection one or more medication packages flagged for reclamation." V1~Vn process values ! Abnormal

Claims

1. 1. A method for determining the suitability of a plurality of medicament packagings (P1, P2, ..., Pn) for containing individual medicaments (M) to be dispensed and packaged by an automated dispensing device (1), comprising: - for each pharmaceutical package (P1-Pn) of said plurality of pharmaceutical packages (P1-Pn), associating (S3) with said respective pharmaceutical package (P1) one or more process values ​​(V1-Vn) indicative of a manufacturing process (S1) of said automated dispensing device (1) that affects said respective pharmaceutical package (P1) or at least one of said individual pharmaceuticals (M) contained in said respective pharmaceutical package (P1); a step (S4) of identifying an anomaly (!) in said one or more process values ​​(V1 to Vn); - recommending (S6, S108, S109) at least one pharmaceutical packaging (P1) of said plurality of pharmaceutical packagings (P1-Pn) for further conformity testing based on the identified anomaly (!) of said one or more process values ​​(V1-Vn) associated with said at least one pharmaceutical packaging (P1); A method comprising:

2. 2. The method of claim 1, wherein the automated dispensing device (1) comprises one or more sensors (51-59) for providing feedback regarding the manufacturing process (S1), and the one or more process values ​​(V1-Vn) are indicative of feedback signals generated by the one or more sensors (51-59).

3. The method of claim 1 or 2, wherein the further compatibility check is performed by a human operator.

4. - displaying further compatibility check recommendations (R1, R2) to said human operator; - waiting for feedback from said human operator regarding said further compatibility check; The method of claim 3 further comprising:

5. - displaying said recommendation (R1, R2) together with the reason (C) for said recommendation (R1, R2); 5. The method of claim 4, further comprising: wherein the reason (C) comprises one or more elements of a group of information including the identified anomaly (!), a possible root cause associated with the anomaly (!), and an inspection area containing the anomaly (!).

6. The method according to claim 1 or 2, wherein the further compatibility check is at least partly automated.

7. - performing an automatic compatibility check (S106) on each pharmaceutical packaging (P1) before recommending further compatibility checks (S108, S109); The method of any one of claims 1 to 6, further comprising:

8. - if the result of the automatic compatibility check (S106) is that the at least one respective pharmaceutical packaging (P1) is compatible, a step (S108) of recommending the at least one pharmaceutical packaging (P1) for a further compatibility check of a first type; - if the result of the automatic compatibility check (S106) is that the at least one respective pharmaceutical packaging (P1) is not compatible, recommending (S109) the at least one pharmaceutical packaging (P1) for a further compatibility check of a second type; The method of claim 7 further comprising:

9. a step (S107) of determining whether there is a correlation between the identified anomalies (!) of the one or more process values ​​(V1 to Vn) and the result of the automatic compatibility check (S106); - recommending (S108) said at least one pharmaceutical packaging (P1) for said further conformity check of a first type if it is determined (S107) that there is no correlation between said identified anomaly (!) of said one or more process values ​​(V1 to Vn) and said result of said automatic conformity check (S106); recommending (S109) the at least one pharmaceutical packaging for a further compatibility check of a second type if it is determined (S107) that there is a correlation between the identified anomaly (!) of the one or more process values ​​(V1 to Vn) and the result of the automatic compatibility check (S106); The method of claim 7 further comprising:

10. - providing an inspection station (A1) for conformity inspection and a correction station (A2) for conformity inspection and correction; 10. The method according to claim 8 or 9, further comprising: a) performing a further conformance check of a first type in the inspection station (A1) and a further conformance check of a second type in the correction station (A2).

11. The method according to any one of claims 6 to 9, wherein the plurality of pharmaceutical packagings (P1 to Pn) are sent from and collected outside the automated dispensing device (1), and the automatic compatibility check (S106) is performed outside the automated dispensing device (1) before or during collection of the plurality of pharmaceutical packagings (P1 to Pn).

12. - automatically flagging one or more pharmaceutical packagings (P1-Pn) of said plurality of pharmaceutical packagings (P1-Pn) for regeneration (S207); The method of any one of claims 1 to 11, further comprising:

13. 13. The method of claim 12, further comprising the step (S208) of skipping at least a portion of the manufacturing process (S1) for the one or more pharmaceutical packagings (P1-Pn) that are flagged for reconditioning.

14. - recommending (S209) the removal without inspection of said one or more pharmaceutical packagings (P1-Pn) flagged for reclamation; 14. The method of claim 12 or 13, further comprising:

15. The method according to any one of claims 1 to 14, wherein the plurality of pharmaceutical packagings (P1 to Pn) form a row.

16. The method according to any one of claims 1 to 15, wherein the plurality of pharmaceutical packages (P1 to Pn) are pouches.

17. 17. The method according to any one of claims 1 to 16, wherein the manufacturing process (S1) comprises one or more processes from the group comprising storing individual medications (M), preparing the individual medications (M) for dispensing, dispensing the individual medications (M), packaging the individual medications (M) into the plurality of packages (P1-Pn) and delivering the plurality of packages (P1-Pn) from the automated dispensing device (1).

18. 18. The method of claim 17, wherein the dispensing process includes one or more of the following sub-processes: separation of the individual medications (M) before dispensing, dispensing of the individual medications (M), intermediate collection of the dispensed individual medications (M), and delivery of the collected dispensed individual medications (M).

19. 19. The method according to claim 17 or 18, wherein the packaging process comprises one or more of the following sub-processes: providing packaging material (F) used to form the pharmaceutical packages (P1-Pn), printing relevant information on the packaging material (F) or the pharmaceutical packages (P1-Pn), sealing the pharmaceutical packages (P1-Pn), providing perforations and / or tear notches in or between the pharmaceutical packages (P1-Pn) and delivering the pharmaceutical packages (P1-Pn) from the automated dispensing device (1).

20. 20. The method of any one of claims 1 to 19, wherein the one or more process values ​​(V1 to Vn) indicate one or more causes of non-conformity from the group comprising: a hardware problem, a software problem, incorrect storage of the individual medication (M), incorrect filling of the individual medication (M) before dispensing, over-dispensing, under-dispensing, a dispensing failure, dispensing of an incorrect individual medication (M), dispensing of a damaged individual medication (M), incorrect collection of dispensed individual medication (M), a sealing failure, a partial seal, a leaking seal, an incorrect perforation, an incorrect tear notch, an incorrect printing, poor print quality, incorrectly printed information, incorrect handling of packaging material (F), incorrect packaging material (F), damaged packaging material (F), and an error during delivery of the medication packages (P1 to Pn).

21. A system (50) for determining the suitability of a plurality of drug packagings (P1-Pn) for containing individual drugs (M) to be dispensed and packaged by an automated dispensing device (1), the system (50) comprising a control unit (8) configured to perform the steps of the method according to any one of claims 1 to 16.

22. 22. The system (50) of claim 21, further comprising a human-machine interface (71, 72) operatively connected to the control unit (8), wherein the control unit (50) is configured to cause the human-machine interface (71, 72) to display the recommendation (R1, R2) for further compatibility testing.

23. An automated dispensing device (1) comprising a system (50) according to claim 21 or 22.

24. 24. The automated dispensing device (1) of claim 23, further comprising one or more sensors (51-59) for providing feedback regarding the manufacturing process (S1), wherein the control unit (8) is operatively connected to the one or more sensors (51-59) for receiving feedback signals generated by the one or more sensors (51-59), and the one or more process values ​​(V1-Vn) are indicative of the feedback signals generated by the one or more sensors (51-59).

25. A computer program product comprising a non-transitory computer-readable medium (9) carrying instructions which, when executed by a processor (8), cause a system (50) according to claim 21 or 22 to perform the steps (S1 to S6, S106 to S109) of the method according to any one of claims 1 to 20.

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