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    • 专利摘要:
    Device and method for identifying pharmaceutical containers comprising at least one marking means of at least one identification code on each of the containers characterized in that the device comprises at least one inkjet system configured to print the identification code on at least one surface of the moving container with at least one ink that exhibits visible fluorescence when irradiated with ultraviolet (UV) radiation whose drying time is 1 to 3 seconds. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2736041A1
    申请号:ES201830632
    申请日:2018-06-22
    公开日:2019-12-23
    发明作者:Encina Javier Lopez-Belmonte；Gil José Cristobal；Urtiaga Cristina Casado
    申请人:Rovi Contract Manufacturing SL；
    IPC主号:
    专利说明:

    [0001]
    [0002] Device and procedure for identifying pharmaceutical containers
    [0003]
    [0004] Technical Field of the Invention
    [0005]
    [0006] The present invention pertains to the technical field of labeling processes for pharmaceutical containers, more particularly small-sized pharmaceutical containers such as syringes, cartridges or vials. The present invention relates to an identification device thereof, as well as to a method for carrying out said identification, which allows signaling and marking of said containers with an invisible ink, thus avoiding errors in identification, serialization. and traceability of them.
    [0007]
    [0008] Background of the Invention
    [0009]
    [0010] At present, the pharmaceutical industry has problems in identifying the existing drugs in the market. This generates two fundamental problems, the first of which is the possibility of errors during production and packaging when identifying the contents of the package for different reasons such as presenting an active ingredient or excipient different from that indicated on its packaging , be of different batch and / or expiration, have different concentration, etc. The second problem is that counterfeit medicines can be found in the market. Both problems require an identification system that allows the products to be traced and serialized individually to avoid alterations in the safety and suitability of medicines and other pharmaceutical products; which would result in an impact on Public Health and the rational use of medicines.
    [0011]
    [0012] To tackle the first problem, that is, the possibility of errors occurring during the production process itself when identifying the content of a medicine; It is necessary to achieve a system that allows a marking on the body of the container that carries it that does not interfere with the contents, in order to ensure the suitability and quality standard of the medicine. In addition, it is important that this method or system be carried out during the process of production or filling of the containers, so that an invisible marking and identification system is ensured that It can be carried out at any stage of the production process, even for containers destined for clinical trials that do not carry a label.
    [0013]
    [0014] In this sense, it is necessary to take into account that the production of medicines that go in containers of small dimensions has a series of packaging and conditioning stages associated, from the elaboration and formulation of the product they contain, to their distribution in the market. Some of these stages are, without limitation, the following:
    [0015]
    [0016] - Formulation
    [0017] - Filling, packing and capping of containers
    [0018] - Inspection of filled or empty containers
    [0019] - Terminal sterilization in autoclave
    [0020] - Stem placement and container labeling
    [0021] - Setting of safety device or back-stop (optional)
    [0022] - Emblistado
    [0023] - Boxing and marking of variable data and / or serialization
    [0024] - Embedded, etc.
    [0025]
    [0026] In addition, some products require refrigerated storage between these stages.
    [0027]
    [0028] Each of these stages is usually performed on different equipment that is usually separated from each other, so it is necessary to transport the containers (usually syringes or cartridges), usually in trays, after each of the stages to move them to the room in which the following takes place, being possible that they remain stored for a period of time, because depending on the availability of the product filling or packaging lines, it may not be that the entire process is carried out continuously.
    [0029]
    [0030] Although the trays in which they are stored must be properly identified, really until they are labeled, the pharmaceutical containers do not have any identification that determines the lot to which they belong and / or their packaging code, and as a consequence, no information about the product They contain inside. This means that there is a possibility of cases of cross contamination.
    [0031] For this reason, it is necessary to find a device and a method of marking that can be used both on the body of the containers (both glass and other materials such as cyclopolyolefin or other plastic materials) to, in this way, have the Properly identified containers from the start of the packaging or filling stage to the next stage of the filling and conditioning process.
    [0032]
    [0033] With respect to the second problem described, that is, that there is the possibility of finding counterfeit medicines on the market, counterfeit medicine is understood as any drug whose presentation is false with respect to its identity, including the packaging, labeling, name, composition or concentration with respect to any of its components, including excipients, and the dosage of said components, with respect to their origin, including manufacturer, country of manufacture, country of origin and holder of the marketing authorization, and also regarding its history, including records and documents related to the distribution channels used.
    [0034]
    [0035] It is necessary to review, that during the last years there has been an alarming increase in medicines detected worldwide that are falsified in terms of their identity, their history or their origin. These medications generally contain low-quality or counterfeit components, or that may even be toxic to health, or they do not contain them or contain components, including active ingredients, in which the content or dosage is not correct. Therefore, the existence of counterfeit drugs in the market poses a threat to patient safety.
    [0036]
    [0037] To act against counterfeit medicines, various measures such as serialization or marking and traceability have been carried out. Serialization is known as the adhesion of unique product identification codes in the unit package of all pharmacy materials. On the other hand, traceability is the most efficient tool to control drug transactions in real time, verify their origin, record the history of locations and transfers throughout the entire distribution chain. But currently this serialization and traceability is done either on the label or the pharmaceutical case (that is, on paper or cardboard), and not directly on the body of the containers, such as syringes or cartridges that contain the active ingredient, excipient or medication, these may be plastic or glass and of various sizes.
    [0038] This initiative is currently becoming very important thanks to the European Directive n ° 2016/161, through which the European Union has put in place certain mechanisms to combat counterfeit medicines and the threat they pose to Public Health, being mandatory as of 2019 for the pharmaceutical sector.
    [0039]
    [0040] Therefore, a serialization and traceability of the drug in the container's own body is necessary, allowing its individual identification during all stages of the production procedure (from the time it is packed until it reaches the patient) being able to ensure a correct identification of the same, allowing immediate error detection.
    [0041]
    [0042] Of the systems described in the state of the art, today there are different types of technology on the market for marking and identifying containers. Mainly, they highlight the printing of ink on labels and in cases and the direct marking on the container itself but by means of a laser system that generates a wear of different depth on the surface of the containers.
    [0043]
    [0044] The label printing systems and cases currently used are inkjet printing systems and indirect thermal transfer printing systems (which applies heat to the printheads and transfers the material to be printed to the support by direct contact (label or case) or direct thermal transfer printing, in which a direct contact of the head with the support that obscures it by heat is required.
    [0045]
    [0046] Since for its application in container identification it is necessary that the technology allows marking directly on the body of the same individually -even before the labeling stage-, direct thermal and thermal transfer printers are discarded for the present invention , since they require a support, such as a label, where to mark and that this is the one that adheres to a syringe or cartridge.
    [0047]
    [0048] On the other hand, if a laser type marking is used, which allows direct marking on the container, an engraving of different depth is generated on the body of the container that produces micro cracks in it, which weakens the surface of the container until such point that, depending on its material, may compromise its resistance and integrity. This causes a high rejection of containers filled in a production process such as that described in the present invention, because on the one hand Containers are friable (for example, glass syringes), on the other hand, they fill at high speed which causes shocks between them and finally they are of small dimensions which causes the marking in question to represent a large part of the specific surface of the container, which implies a high breaking point of the same (for example, it is not the same to mark a bottle of wine with a 5x5 mm data code as a syringe).
    [0049]
    [0050] It is necessary, therefore, to obtain a device that allows a label on the body of the container individually that can be adapted to any production process and at any stage of filling of pharmaceutical containers and that does not compromise its resistance and integrity .
    [0051]
    [0052] As an example of the prior art, the following reference documents ES25311415, WO2017 / 048499 A1, US9662920 B2, US5837042 A and US9378445 B2 can be mentioned, in which marking processes are described.
    [0053]
    [0054] Reference document ES25311415 defines a method for marking a transparent container with a transparent wall, comprising the steps consisting of applying at least one ink stain on an outer surface of said transparent wall, heating said transparent wall and recording a data matrix. in the ink stain of said transparent wall. This document already explains the importance of, on the one hand, determining exactly where a container comes from, what it contains and its intended use and, on the other hand, that this information cannot be falsified. They therefore propose the need for marking of containers as syringes, to protect against copying or imitation, for the authentication of the original containers and the substance they may contain, for the traceability of the containers and the substance and, for identification of the container both in the distribution chains and in the particular use. To solve this problem, in this document it is decided to initially apply an amount of ink that is the one that is etched with the laser and then the remaining ink is removed. This implies weakness of the containers due to the laser marking procedure and costs due to excess ink consumption. In addition, all the necessary steps for marking, having to first apply the ink and then remove it, generate a very slow marking that affects the production of syringes.
    [0055]
    [0056] Reference document WO2017 / 048499 A1 discloses an ink composition used in an inkjet thermal printer, but does not determine any process or method Printing through it. In this case, it is not allowed to mark directly on the body of the same individually before the labeling stage, so the thermal transfer printers are discarded since they require a support, such as a label, where to mark and Let it be the one that adheres to the container.
    [0057]
    [0058] Reference document US9662920 B2 refers to an ink composition for printing a security code on flat surfaces such as labels, cases or envelopes. The ink defined herein for printing comprises an organic solvent in a percentage between 60% and 90% by weight of the total ink, an ink dissolving agent and two or more different luminescent inks, in which each luminescent ink has a different luminescence emission profile, an invisible one that absorbs ultraviolet light and a visible one. In this case, the pharmaceutical container is not directly marked or marked on a curved surface.
    [0059]
    [0060] Reference document US5837042 A discloses an inkjet ink composition with a fluorescent dye for printing on white or light colored objects, specifically for checks, passports, tickets, certified documents, etc., which have nothing to do with the containers of the present invention nor with the material that forms them.
    [0061]
    [0062] Finally, reference document US9378445 B2 refers to a method to ensure the authenticity of glass or plastic containers such as syringes, to check the authenticity of the drugs they contain. In this case, a 3D code is used that is marked on the surface of the container, and is carried out by means of a laser, which implies a method of reading the specific code for this type of marking. As already indicated, the laser printing technique generates microcracks in most of the materials with which the container or syringe is made, changes in the density or index of refraction and small bubbles or gaps in the glass. These microcracks, bubbles or changes in the body of the syringe, affect the integrity of the syringe, and make the marking is not fully readable, so it is not an appropriate printing method.
    [0063]
    [0064] It is therefore necessary to find a marking device and a method or procedure for marking syringes that is suitable to allow proper traceability thereof and appropriate to withstand the conditions to which they are exposed, and in particular that is appropriate for be able to be applied on the usual material with which it They make pharmaceutical containers, that is, glass or plastic materials such as polyolefins, without jeopardizing the integrity of the syringes and that is fast so as not to affect the productivity of the marking process or the filling process, and that exceeds the disadvantages of the systems described in the state of the art.
    [0065]
    [0066] Description of the invention
    [0067]
    [0068] The inventors of the present invention have identified that a solution to this problem would be a label with a code made on pharmaceutical containers directly using ultra-fast drying inkjet techniques in which the resulting labeling is invisible to the human eye, such as ink marking that is only visible in the ultraviolet (UV) or infrared (IR) frequency of the spectrum, or alternatively that exhibits visible fluorescence when illuminated by UV light, in which the incidence of a UV light beam produces a visible fluorescence induced by the effect of UV radiation. When the UV light beam is absorbed by the material, the electrons are temporarily placed in a higher state of energy, and later that energy is released by returning the electrons to their normal state. It is this radiant energy released, or fluorescence, that can be seen in the visible spectrum depending on the irradiated material. In this way, the code marked on the body of the same is invisible except in specific conditions, making it difficult to falsify them.
    [0069]
    [0070] The system developed by the inventors of the present invention allows the marking of moving containers, integrating seamlessly into production lines, with the highest quality and reliability. Therefore, the inventors have developed a pharmaceutical container identification device comprising at least one marking means of at least one identification code on each of the containers that is characterized in that the device comprises at least one inkjet system configured to print the identification code on at least one surface of the moving container with at least one ink that exhibits visible fluorescence when irradiated with ultraviolet (UV) radiation whose drying time is 1 to 3 seconds, preferably 1 to 2 seconds.
    [0071]
    [0072] This system preferably refers to an autonomous identification unit, which allows marking with a code individually and automatically, in pharmaceutical containers of small dimensions in motion, with inks invisible to the human eye that have the characteristic of being resistant to heat and being quick drying.
    [0073] For the purpose of the present invention, code is understood as any two-dimensional industrial coding system that allows the generation of a large volume of information in a very small format, with high reading reliability thanks to its redundant information systems and correction of errors (readable with up to 20% -30% damaged) of datamatrix type, or 2D data coding. The code is formed by black and white cells that form a square or rectangular figure. Each of these cells represents a bit of information. The information can be encoded as raw text or data (raw data in English). For the purpose of the invention, the identification code is selected from the group consisting of a two-dimensional code, a QR code, a BIDI code, a datamatrix code or an alphanumeric code, alone or in any combination thereof.
    [0074]
    [0075] For the purpose of the present invention, small pharmaceutical containers or containers are understood as those selected from the group consisting of syringes, vials, capsules, ampoules, single dose devices, inhalers, bottles, cartridges or bags with liquid substances, in the form of a gel, semi-solid or solid selected from the group consisting of powder, lyophilized, granules, pellets, nanoparticles or microparticles, whether sterile or not. These containers can be both glass and other materials, such as polymers, elastanes, gums, polyolefins or other plastic materials.
    [0076]
    [0077] To achieve this objective, the system and the marking procedure must use inks that are only visible in those parts of the light spectrum that are outside the visible spectrum by the human eye, such as the ultraviolet spectrum (UV inks) or infrared , or that they show visible fluorescence when a UV light beam (fluorescent inks) is applied.
    [0078]
    [0079] In this regard, it is necessary to take into account that the visible portion of the UV spectrum radiates between 400 and 700 nm, and is the only radiation in the spectrum capable of being seen by the human eye. Consequently, this strip of the spectrum must be avoided. On the other hand, the invisible portion to the human eye of the UV spectrum radiates from 10 to 400 nm and is divided into four regions, the long wave between 320 and 400 nm, medium wave between 280 and 320 nm, short wave, between 180 and 280 nm and finally the vacuum, between 10 and 180 nm. Accordingly, in the present invention UV ink should emit in the range of 10 to 400 nm, more preferably in the range of 320 to 400 nm, and even more preferably about 365 nm.
    [0080] In addition, advantageously the inks usable in the systems and methods of the present invention may also have one or more of the following desirable technical characteristics that can provide additional advantages:
    [0081]
    [0082] - Have fast drying to prevent the ink from becoming illegible by rubbing during the transport of the containers through the line, taking into account that the operating speed can reach up to 200 units / min. Ideally, the ink drying time is about 1 to 3 seconds, preferably 1 to 2 seconds.
    [0083]
    [0084] - Display sufficient adhesion on containers that are at a temperature from 15 ° C, that is, those that require refrigerated storage, to room temperature.
    [0085]
    [0086] - Also exhibit resistance to high temperatures, especially for those products that require terminal sterilization, that is, they undergo a process of radiating or autoclaving at a temperature exceeding 120 ° C for at least 20 min.
    [0087]
    [0088] - Do not interfere with container filling procedures under sterile production conditions.
    [0089]
    [0090] These advantages allow the use of the device object of the present invention, without limitation, to:
    [0091] a) identify pharmaceutical containers and / or their content unequivocally between various stations of a production process before labeling,
    [0092] b) to trace the product, for example, in manufacturing to third parties,
    [0093] c) to serialize products and prevent and / or detect fraud, possible contamination, an error in a batch, or any other contingency and
    [0094] d) to identify drugs and placebos in a clinical trial that employ masking techniques that seek to prevent the expectations of the patient, the doctor / researcher or the evaluator himself from influencing the observed result (see, single blind, double blind or triple blind) blind).
    [0095]
    [0096] Detailed description of the invention
    [0097] Consequently, in a first aspect the invention is directed to a pharmaceutical container identification device comprising at least one marking means of at least one identification code on each of the containers characterized in that the device comprises at least one system of inkjet configured to print the identification code on at least one surface of the container with at least one ink that exhibits visible fluorescence when irradiated with ultraviolet (UV) radiation.
    [0098]
    [0099] In a second aspect, the invention is directed to a method of identifying pharmaceutical containers comprising at least one means of marking at least one identification code on each of the containers, comprising the step of printing the identification code by an inkjet system on at least one surface of the container with at least one ink that exhibits visible fluorescence when irradiated with ultraviolet (UV) radiation.
    [0100]
    [0101] Preferably, the drying time is 1 to 3 seconds, more preferably 1 to 2 seconds.
    [0102]
    [0103] Also preferably, the printing stage is performed on the syringe (s) when they are in motion. The term "on the move" means the movement of the syringes within a manufacturing or assembly line, and consequently can range from a very slow movement, several millimeters per minute, to very fast movements, up to 500 meters per minute, more preferably up to 300 meters per minute.
    [0104]
    [0105] In preferable embodiments of the invention, the fluorescent ink produces a visible luminescent radiation when an excitation radiation with a wavelength between 320 and 400 nm of the UV is applied, and more preferably around 365 nm.
    [0106]
    [0107] In a preferred embodiment, the ink comprises at least one luminescent dye, at least one organic solvent and at least one binder resin. Preferably, the luminescent dye is a sulfonamide, more preferably a toluenesulfonamide, and even more preferably N-ethyl-o (op) -toluenesulfonamide. This luminescent component may be accompanied by any organic solvent compatible with its nature. In preferred embodiments, the solvent is selected from the group consisting of methanol, ethanol, propanol, ketone, ethyl ketone, methyl ethyl ketone, isopropyl acetate, butanone, 2-pyrrolidone, alone or in any combination thereof.
    [0108]
    [0109] Optionally, the ink may further comprise at least one solubilizing agent selected from cyclic ketones, heterocyclic amides, cyclic alcohols and furans.
    [0110]
    [0111] According to a preferred embodiment, the at least one identification code is selected from the group consisting of at least one two-dimensional code, QR code, BIDI code, datamatrix code or alphanumeric code. More preferably, the at least one identification code is a datamatrix code. The datamatrix codes are generally squares or rectangles of 2-4 mm2 composed of individual cells in which each represents a bit of information. The information is encoded in a two-dimensional data matrix that allows a large amount of information to be contained, and the data can be encoded as text or raw data, and can include data such as the identity of the manufacturer, the details of the component marked (including the active ingredient (s) incorporated in the container) and its serial number. The code is read by means of a camera or sensor that is capable of capturing the visible luminescent radiation radiated by the identification code, and then proceeds to read it depending on the type of code in question (two-dimensional, QR , BIDI, datamatrix, etc.) and thus determine its content, which is a numerical or alphanumeric code identifying the pharmaceutical container. To improve the visibility and readability of the code, the reading is preferably carried out by placing a dark or optimally black background behind the pharmaceutical container, so that the camera reads the illuminated identification code on a dark background. In this way visibility is optimized, and therefore the reading of the code, thus avoiding reading errors. This reading can be done either with the container in a stationary state, or in motion in the marking line itself. Optionally, a cleaning stage of the surface of the container can be introduced prior to said reading, aimed at improving the readability of the code reading.
    [0112]
    [0113] In preferred embodiments, the method and the system of identification of pharmaceutical containers can be applied to different mechanical systems of handling and transport of these in the filling lines of the pharmaceutical container with its active ingredient (s) or excipients and its corresponding seal. The following describes some of these mechanical systems to which the identification procedure and system described in this document can be applied:
    [0114] In a preferred embodiment, the pharmaceutical container identification device comprises a station formed by means for holding and moving the containers, constituted by at least one horizontal turning platform that has turning means relative to a vertical central axis, and has its peripheral zone adjusting means of a container body respectively.
    [0115]
    [0116] Said station also comprises, associated to each turning platform, marking means of at least one identification code as explained above on each of the containers and verification means in at least some of them, suitable for Detect the identification code printed on them. Said station verification means comprise a container rejection station with at least one collection container. In accordance with one embodiment, this pharmaceutical container identification device comprises ink sealing means of the identification code to the container body.
    [0117]
    [0118] According to another possible embodiment, the means for holding and moving the station are able to keep the containers in a substantially vertical position at least in a part of the path. In this case and in an optional embodiment, the means for holding and moving the station further comprise a device for turning the containers at an angle of 180 °.
    [0119]
    [0120] According to one embodiment, the horizontal turning platform comprises means for rotating the containers with respect to their longitudinal axis. These turning means are formed by a motorized band disposed inferiorly to the turning platform which, in one embodiment, transmits the turning movement directly to the containers by means of an adjustment to the lower part thereof, while in another embodiment indirectly transmits them, by means of the movement of rollers in contact with the containers.
    [0121]
    [0122] According to one embodiment, the means for adjusting the body of the container in the peripheral area of the turning platform are formed by compartments suitable for coupling at least the collar of a container in each of them.
    [0123]
    [0124] According to another embodiment, the signaling means of the station comprise at least one UV or fluorescent inkjet printhead associated with each turning platform.
    [0125] On the other hand, in one embodiment, the verification means act continuously on all pharmaceutical containers and are formed by at least one continuous UV code reader or at least one UV illumination chamber, suitable for composing a global image to from multiple captures.
    [0126]
    [0127] In another embodiment, the verification means act in a timely manner on a certain number of containers and are formed by a manual scanner with UV illumination.
    [0128]
    [0129] According to another embodiment, the securing and displacement means comprise two or more horizontal turning platforms and, the marking device comprises, at the entrance to the station, a means of distributing the containers consecutively to each of the platforms.
    [0130]
    [0131] According to a preferred embodiment, the at least one identification code is a datamatrix code or an alphanumeric code.
    [0132]
    [0133] In preferred embodiments, this method comprises a first phase of introducing a container in an upright position through a first conveyor belt at a station.
    [0134]
    [0135] A second phase of securing said container then takes place in the adjustment means of a horizontal turning platform of the means for holding and moving the containers of said station.
    [0136]
    [0137] A third phase in which there is a rotation of the container to a second printing position of the at least one identification code.
    [0138]
    [0139] Next, a fifth phase consisting of the signaling of the containers with at least one identification code by means of the signaling means of the station.
    [0140]
    [0141] And, a sixth phase of rotation of the container to an exit position thereof, of the station.
    [0142] In a possible further embodiment, the signaling phase of the containers with at least one identification code comprises a finishing stage formed by sealing the ink to the container body. By means of these sealing means, with which the ink is fixed to the body of the container by means of varnish, lacquer, etc., it is possible, in those cases in which the container must undergo an autoclave terminal sterilization process, avoid possible damages that the ink could suffer due to the material of the container.
    [0143]
    [0144] According to a preferred embodiment, after the signaling phase with at least one identification code, the method comprises an additional phase of verification of the identification code.
    [0145]
    [0146] In this case and in one embodiment, the process comprises a phase prior to the additional phase of verification of the identification code, consisting of the rotation of the container from the second position to a third position, in which said additional phase is carried out. check.
    [0147]
    [0148] In this case and according to one embodiment, prior to the signaling phase of the containers with at least one identification code, they comprise a first turning of them at an angle of 180 °.
    [0149]
    [0150] Said additional verification phase takes place for each of the containers that are introduced into the station, in the case where the verification means act continuously and, in a timely manner, in the case where the verification means act as punctual form.
    [0151]
    [0152] On the other hand, in one embodiment, in the event that after verification of the code, it is suitable, the container rotates to an exit position that is aligned with a second conveyor belt leaving the station.
    [0153]
    [0154] Likewise, in the case where the containers have been subjected to a first 180 ° turn, the procedure comprises a second turn of these at an angle of 180 ° to the initial position, after verification and prior to the rotation of the container to the starting position.
    [0155] Likewise, in a preferred embodiment, in the event that after verification of the code, it is incorrect, the container rotates to an exit position that is aligned with the collection containers of the rejection station and the container is ejected by pneumatic or mechanical means to one of said collection containers.
    [0156]
    [0157] According to one embodiment, when the clamping and displacement means comprise two or more turning platforms, after entering the container in the station and prior to clamping it in the adjustment means, it comprises an intermediate distribution phase of these containers consecutively to each of the turning platforms, by means of distribution means.
    [0158]
    [0159] According to a preferred embodiment, in the case where the identification code is suitable, it is possible to carry out a new inspection stage, either within the internal production line of a company, or outside of it, in a later moment during distribution.
    [0160]
    [0161] Thus, after moving the container to the inspection stage, the procedure comprises a series of phases that are as follows:
    [0162]
    [0163] First, a first phase of introducing the container in an upright position through a third transport belt, in an additional station.
    [0164]
    [0165] Then, a second phase of holding the container takes place by means of adjusting the means for holding and moving said additional station.
    [0166]
    [0167] The third phase is the rotation of the container to a second position in which the inspection of the identification code and rotation of the container is performed by means of rotation on itself.
    [0168]
    [0169] In this case, the inspection at the additional station is carried out on 100% of the containers to avoid cases of cross contamination.
    [0170]
    [0171] Next, the procedure presents two possibilities for the fourth phase, the first is that the result of the inspection is that the identification code is suitable, in which In case the container rotates to an exit position, aligned with a fourth transport belt for its movement outside the additional station.
    [0172]
    [0173] The second possibility is that the result of the inspection is that the code is incorrect in which case the container rotates to an exit position, aligned with the collection containers of the rejection station and the expulsion of the container by pneumatic means or mechanics to one of said collection containers.
    [0174]
    [0175] With the pharmaceutical container identification device and the procedure proposed here, a significant improvement in the state of the art is obtained.
    [0176]
    [0177] This is thus achieved by a device for identifying pharmaceutical containers by means of which it is possible to signal small containers and any material, whether glass or plastic material, in the body itself and where this device integrates all necessary parts in a compact device, that is, it integrates the signaling means and the verification means in a modular equipment that is easily attachable at any point of the production line, so it can be installed at that point of the line in the that a need for verification arises, depending on the peculiarities of different production lines existing in the market.
    [0178]
    [0179] Thus, it is possible to locate it after the packaging and capping stage of the containers, so that a correct identification of both the container and the contents is ensured, during the entire remaining production process avoiding errors in the identification of the containers and subsequently on its release to the market, thus preventing possible falsifications of medicines in the distribution stage, as well as possible identification errors.
    [0180]
    [0181] In addition, in the event that an identification device installed at one point of the line presents some operational problem, being completely modular, it is possible to remove it from the line, so that production can continue to operate independently of this device, until be repaired
    [0182]
    [0183] The identification device is configured as a compact device sufficiently robust to give the necessary stability to the containers during their movement. This identification device is capable of signaling any material, in curved surfaces, more quickly, an increase in effectiveness, and reducing the risk of breakage in handling and ensuring the aseptic process environment.
    [0184]
    [0185] In addition, it is preferably a fully automated process, in which the staff has no contact with the containers, thus being hygienic and predictable because it does not depend on the human factor.
    [0186]
    [0187] The signaling is done with an ink visible only in the UV spectrum, so it is invisible to the human eye. It has good adhesion to refrigerated containers, at temperatures around 15 ° and up to room temperature and, very fast drying, which allows high operating speeds.
    [0188]
    [0189] It is therefore a very effective device and identification procedure, valid both internally at the production level and at the time of distribution, which manage to obtain control of the traceability of pharmaceutical containers, providing safety and reliability to medicines, allowing on the one hand a greater internal control of pharmaceutical companies by facilitating the identification of their product from the moment it is packaged, avoiding possible errors or confusions in them and on the other hand, avoiding forgeries as well as possible medication identification errors , since it is also possible to verify the post-production code, in the distribution or sales centers. Preferably, the procedure is characterized in that it is carried out under sterile conditions.
    [0190]
    [0191] The device of the present invention and the method for carrying it out are preferably configured for syringes, generally for glass or plastic syringes for pharmaceutical use. Preferably for sterile injectables.
    [0192]
    [0193] Brief description of the drawings
    [0194]
    [0195] In order to help a better understanding of the features of the invention, according to a preferred example of practical implementation thereof, an integral part of said description is provided, a series of drawings where, for illustrative and non-limiting purposes, represented the following:
    [0196] Figure 1 shows a perspective view of the station, for a preferred embodiment of the invention.
    [0197]
    [0198] Figure 2.- Shows a perspective view of the additional station, for a preferred embodiment of the invention.
    [0199]
    [0200] Figure 3.- Shows a block diagram of the method of identification of pharmaceutical containers, by means of a marking device with that described, for a preferred embodiment of the invention.
    [0201]
    [0202] Detailed description of a preferred embodiment of the invention
    [0203]
    [0204] In view of the figures provided, it can be seen how in a preferred embodiment of the invention, the syringe marking device, which is proposed herein, comprises a station (1) formed by means for securing and moving the syringes, signaling means of at least one identification code on each of the syringes and, verification means in at least some of the syringes, capable of detecting the identification code printed therein.
    [0205]
    [0206] In this preferred embodiment of the invention, the marking device is located between the syringe packing and capping stage and the inspection stage, so that perfect traceability of the production process thereof can be obtained. On the other hand, the at least one identification code is a datamatrix code which, being a two-dimensional code allows to include a large volume of information in a very small format and the information is included redundantly, has a high reading reliability. Thus, due to the existing space limitations for marking smaller syringes and the high speed at which they are processed, the datamatrix code has advantages over the alphanumeric code.
    [0207]
    [0208] In the station (1), the means for holding and moving the syringes are able to keep them in a substantially vertical position during the entire journey. On the other hand, in other embodiments, the means for holding and moving the station can also comprise a syringe turning device at an angle of 180 °.
    [0209]
    [0210] As shown in Figure 1, said fastening and displacement means are constituted by a horizontal turning platform (3) which has turning means with respect to to a vertical central axis and has in its peripheral area adjustment means of a syringe body respectively.
    [0211]
    [0212] Likewise, in other embodiments, in case of a higher line speed, two or more turning platforms are used, in which case, each of them would have associated signaling means and verification means respectively.
    [0213]
    [0214] In this preferred embodiment of the invention, the identification code is invisible and said signaling means comprise a print head (5) by UV inkjet associated with said turning platform (3). The marking device further comprises sealing means (not shown in the Figures) of the ink to the syringe body as explained above.
    [0215]
    [0216] Likewise, in this preferred embodiment of the invention, the verification means act continuously on 100% of the syringes, and are formed by three UV illumination chambers (6), capable of composing a global image from of multiple captures.
    [0217]
    [0218] When performing a 100% verification of the syringes, it is allowed to know in real time if the print head (5) is working properly, being able to stop the marking device in case of consecutive failures, to solve the problem .
    [0219]
    [0220] In this preferred embodiment of the invention, given the speed of the line, the clamping and moving means have a single turning platform (3).
    [0221]
    [0222] On the other hand, the means of verification of the station (1), comprise a rejection station with at least one collection container (7) of the syringes, for those in which the identification code is incorrect or defective.
    [0223]
    [0224] In this preferred embodiment of the invention, the horizontal turning platform comprises means of rotation of the syringes with respect to the longitudinal axis thereof formed by a motorized band disposed inferior to the rotation platform (3) that transmits the movement of rotation directly to the syringes by means of an adjustment to the inferior part of the same ones.
    [0225] In other embodiments, these turning means of the syringes may be formed by a motorized band disposed inferiorly to the turning platform that transmits the turning movement indirectly thereto, by means of the movement of rollers in contact with the syringes These rollers at the same time provide stability to the syringes.
    [0226]
    [0227] In this preferred embodiment of the invention, the adjustment means of a syringe body in the peripheral area of the turning platform (3) are formed by compartments (4) suitable for coupling at least the collar of a syringe in each one of them. These holding compartments (4) can hold the syringe by the collar or by a larger area thereof.
    [0228]
    [0229] In this preferred embodiment of the invention, the UV ink is visibly luminescent by excitation light in the ranges between 320 and 400 nm of the UV. Also, this UV ink comprises at least one organic solvent, at least one binder resin, at least one luminescent dye and, at least one solubilizing agent selected from cyclic ketones, heterocyclic amides, cyclic alcohols and furans.
    [0230]
    [0231] In order to reach this solution, a previous study has been carried out in which the following premises were taken as fundamental premises:
    [0232]
    [0233] - The syringes arrive at the marking device in an upright position, held by the collar, and must be delivered by the marking device to the next equipment in the same position.
    [0234] - The syringes arrive without minimum separation between them.
    [0235] - The syringes are marked on the body and can be of different sizes and material. - It is necessary to have collection containers (7) in which the syringes that the inspection device determines are not suitable are collected, either because the information included in the datamatrix code does not match, due to printing error or due to error in the inspection.
    [0236] - This collection container (7) must be arranged so that it is not possible to manipulate and / or withdraw syringes prior to their expulsion, as it would cause errors in rejection. In addition, it must be in such a way that the syringes are not damaged when they fall, since those that are rejected incorrectly (false rejection) or by bad impression, must be reprocessed.
    [0237] - The speed at which the syringes should be processed depends on the line.
    [0238] Taking this information into account, different alternatives for transport were studied in the previous study, in order to develop optimal and appropriate fastening and displacement means:
    [0239]
    [0240] Test 1. Transport in horizontal position
    [0241]
    [0242] In this case, the syringes, which are initially in a vertical position and without separation between them, are passed through a system of transport belts with 90 ° rotation that also establishes a minimum separation between them.
    [0243]
    [0244] In a horizontal position, printing and verification are carried out, in the case of the exit of the packing and capping stage, and only the inspection in the case of inspection prior to the labeling stage. After inspection, syringes that are not considered suitable are rejected pneumatically, while the suitable ones pass into a group of 90 ° turning tapes to be placed back in an upright position.
    [0245]
    [0246] This solution provides the syringe with sufficient stability for printing and initial verification at the exit of the packaging machines. However, in pre-entry inspection of the labeller, where the mark can be anywhere on the syringe body (360 °), it is necessary to rotate them, since only a part of it is visible, which increases the complexity when the syringes are in a horizontal position. For this reason, this solution has been ruled out.
    [0247]
    [0248] Test 2. Transport in an upright position using a belt system.
    [0249]
    [0250] In this case, the syringes enter the marking device through an endless screw, or similar equipment, which establishes a minimum separation between them. Inside the device, they are transported in an upright position, held by the collar by a system of sidebands. They are marked laterally and verified in the case of the exit of the packing and capping stage, or are only inspected in the case of the inspection prior to the entry of the labeling stage.
    [0251]
    [0252] After inspection, syringes that are not considered suitable are rejected pneumatically, while the accepted ones pass to a longitudinal conveyor belt that carries them by the collar to the next equipment.
    [0253] Holding the syringes only by the collar makes them not stable enough, especially during printing at the exit of the packing and capping stage. In addition, the transport by means of longitudinal bands makes it necessary to use at least four chambers in the inspection prior to the labeling stage to ensure the visibility of the mark that may be on any part of the syringe body. They must be in opposite positions to perform the inspection properly, which causes the lighting of some to affect the others. For these reasons, this option is discarded.
    [0254]
    [0255] Test 3. Transport in an upright position using a turning platform.
    [0256]
    [0257] The syringes, transported vertically held by the collar, are introduced in a turning platform, so that a minimum distance between them is established. This system rotates, making the syringes, without turning on themselves, go through four positions:
    [0258]
    [0259] - Position 1: printing is carried out in the case of the equipment arranged after the packing and capping stage. The equipment intended for the pre-labeling action does not have the printing option.
    [0260] - Position 2: verification or inspection is carried out, according to one or the other equipment.
    [0261] - Position 3: Accepted syringes are delivered to a longitudinal conveyor belt that goes to the next equipment.
    [0262] - Position 4: the rejected syringes are pneumatically ejected to a drawer.
    [0263]
    [0264] As in the previous case, the holding of the syringes only by the collar makes them not stable enough, especially during printing at the exit of the packaging and capping stage. In addition, before the labeling stage, since the mark can be anywhere on the body of the syringes and since they do not rotate on themselves, it is necessary to integrate a vision system composed of at least four facing chambers, with the possibility that the lighting of some affects the others. For these reasons, this option is discarded.
    [0265]
    [0266] Test 4. Transport in an upright position using a platform with syringe rotation.
    [0267] This solution is similar to the previous one, with the difference that the syringes, in addition to being held by the collar on the turning platform (3), have clamping means at the bottom that rotates them on themselves (motorized belt ).
    [0268]
    [0269] In this way, the stability of the syringes during transport is increased and the problem of the interference of the illumination of the cameras used in the inspection is eliminated.
    [0270]
    [0271] Therefore, this is the most preferred alternative.
    [0272]
    [0273] In this report a syringe marking procedure is also presented, by means of a marking device as defined.
    [0274]
    [0275] As shown in Figure 3, this procedure comprises a first phase of introduction (11) of a syringe in an upright position through a first conveyor belt (8) in a station (1).
    [0276]
    [0277] Next, the second phase consists in the clamping (12) of said syringe in the adjustment means of a horizontal turning platform (3) of the clamping and displacement means of the syringes of said station (1). In this preferred embodiment of the invention, the syringe adjustment means are formed by a compartment (4) in the peripheral area of the turning platform (3), as can be seen in Figure 1.
    [0278]
    [0279] Thus, in this second clamping phase (12) of the syringe, the coupling (13) of the syringe collar in said compartment (4) is performed, as well as the clamping of the lower part thereof by means of a motorized band ( not shown in the Figures) which generates a turning movement of the syringe with respect to the longitudinal axis thereof. Said compartment (4) is in a first entry position (P1).
    [0280]
    [0281] The turning platform (3) is different for each syringe format, and has defined holding compartments (4), so that it establishes a minimum separation between syringes.
    [0282]
    [0283] Next, the fourth phase takes place in which there is a rotation (14) of said holding compartment (4) to a second printing position (P2) of at least one invisible identification code in this embodiment, which in this case it is Preferably it is a datamatrix code. In this preferred embodiment of the invention, the equipment has a double-blind system, that is, two different people will enter the information that the datamatrix code to print should contain, to ensure that this information is entered correctly.
    [0284]
    [0285] As shown in Figure 3, the fifth phase consists of the signaling (15) of the syringes with said identification code, a datamatrix code, by means of the signaling means of the station.
    [0286]
    [0287] In this preferred embodiment of the invention, the signaling phase (15) of the syringes with at least one invisible identification code, comprises a finishing step formed by the sealing (21) of the ink to the syringe body.
    [0288]
    [0289] Also, in this preferred embodiment of the invention, after the signaling phase (15) of the syringes with an invisible identification code, the method comprises an additional verification phase (17) of the invisible identification code. It also includes a phase prior to said additional verification phase (17) of the identification code, consisting of the rotation (16) of the syringe from the second position (P2) to a third position (P3), in which carries out said additional verification phase (17).
    [0290]
    [0291] In other embodiments it is possible that the additional verification phase (17) is carried out in the same second position (P2) in which the signaling phase (15) of the syringes is carried out, so that there is no rotation of the syringes to no third position (P3), for the completion of the additional verification phase (17).
    [0292]
    [0293] Since in this embodiment the verification means act continuously, this second additional verification phase (17) takes place for each and every one of the syringes.
    [0294]
    [0295] In this preferred embodiment of the invention, the syringes are kept vertical throughout the entire process, but in other embodiments it is possible that prior to the signaling phase (15) of the syringes with at least one identification code , make a first turn of the syringes at an angle of 180 °. In this case, it is subsequently necessary to carry out a second turning of the syringes at an angle of 180 ° to its initial position, after verification (17) and prior to the rotation (18) of the syringe to the starting position (PS1).
    [0296] Finally, once the identification code has been printed on the body of the syringe, and the verification (17) thereof has been carried out by means of verification, the sixth phase in which the rotation of the compartment (4) takes place clamping to an outlet position of the syringes, of the station (1).
    [0297]
    [0298] In the event that after said additional verification phase (17), the code is suitable (19), the syringe holder compartment (4) rotates (18) to an exit position (PS1) that is aligned with a second conveyor belt (9) for leaving the station.
    [0299]
    [0300] On the other hand, in the case where the code is incorrect (20), the syringe holder compartment (4) rotates (22) to an exit position (PS2) that is aligned with the collection containers (7 ) and the syringe is ejected (23) by pneumatic or mechanical means to one of said collection containers (7).
    [0301]
    [0302] In this preferred embodiment of the invention, in the case where the identification code is suitable (19), the existence of a new inspection stage is proposed, which in this case is carried out within the internal production line of a company, because the syringes in this case in the passage from one equipment to another are stored in a tray, so it is considered necessary a new verification of them. In other cases, this inspection stage can be carried out outside the production of syringes, that is, in the process of distribution, transport, sale ...
    [0303]
    [0304] Thus, a new verification of the invisible identification code of the syringes is performed, to avoid possible errors, so that an additional module consisting of a station equal to the previous one is installed in which only the syringe inspection is performed and in In this case, no signaling is performed. This new inspection can also be carried out as already indicated, outside the company, by the final customer, the carrier, the person in charge of the distribution.
    [0305]
    [0306] Thus, after moving the syringe to the inspection stage, the procedure comprises a series of phases that are as follows:
    [0307]
    [0308] First, a first phase of introduction (24) of the syringe in an upright position through a third transport belt (10.1), in an additional station (2).
    [0309] Next, a second clamping phase (25) of the syringe takes place in the means for adjusting the clamping and displacement means of the syringes of said additional station (2). Since in this embodiment the adjustment means are formed by holding compartments (4) in the peripheral area of the turning platform, in said second stage the coupling (26) of the syringe collar is made in said compartment ( 4) of subjection and the subjection of the inferior part of the same by means of a motorized band (not represented in the Figures). By means of this motorized band, a turning movement of the syringe is generated relative to the longitudinal axis thereof. Said compartment (4) is in a first entry position (P1).
    [0310]
    [0311] As shown in Figure 3, the third phase is the rotation (27) of said holding compartment (4) to a second position (P2) in which the inspection (28) of the invisible identification code and rotation of the syringe by means of rotation on itself.
    [0312]
    [0313] In this case, the inspection (28) in the second station (2) is the one that is carried out before the syringes enter the labeling stage and in this case, it is necessary to verify that 100% of the syringes that are to be labeled belong to the lot and corresponding packaging code, to avoid cases of cross contamination.
    [0314]
    [0315] As the syringes rotate on themselves thanks to the turning movement generated by the motorized band, it is possible to use both continuous datamatrix code readers and cameras capable of composing a global image from multiple captures, with UV illumination in both cases. The use of one type or another is determined by the speed at which the information must be processed. In this preferred embodiment of the invention it has been decided to use three cameras (6) that take pictures of the syringe in motion, both translation and rotation, and compose the overall image, in which is the mark that must be verified .
    [0316]
    [0317] In this preferred embodiment of the invention, at this point the procedure presents two possibilities for the fourth phase, the first is that the result of the inspection is that the identification code is suitable (29.1) and the second, that the The result of the inspection is that the code is incorrect (29.2).
    [0318]
    [0319] As shown in Figure 3, when the result of the inspection is that the code is suitable (29.1), the holding compartment (4) rotates (30) to an exit position (PS1), aligned with a fourth transport belt (10.2) for movement to a next stage of the production process and the syringe (31) is moved in a vertical position to said fourth transport tape (10.2).
    [0320]
    [0321] On the other hand, when the result of the inspection is that the code is incorrect (29.2), the syringe holder compartment (4) rotates (32) to an exit position (PS2), aligned with the collection containers ( 7) from the rejection station and ejection (23) of the syringe is produced by pneumatic or mechanical means to one of said collection containers (7).
    [0322]
    [0323] The described embodiment constitutes only an example of the present invention, therefore, the specific details, terms and phrases used herein are not to be considered as limiting, but are only to be understood as a basis for the claims and as a representative basis that provides an understandable description as well as sufficient information to the person skilled in the art to apply the present invention.
    [0324]
    [0325] With the syringe marking device and the marking procedure by means of the same presented here, significant improvements are achieved with respect to the state of the art.
    [0326]
    [0327] A marking device is achieved with which the medicine is identified from the packaging until it reaches the patient, thus offering a safety of the same, by achieving a control of the traceability of the syringes both internally in the same line of production as at the level of their distribution.
    [0328]
    [0329] With this marking device it is possible to print an identification code on the body of the container, be it glass or plastic and is of any size, this code being also invisible, so it will not affect the appearance of the syringe or other markings you may submit.
    [0330]
    [0331] In addition, it is achieved that the marking device is integrated in a compact and modular station, which integrates the signaling and verification means, being robust enough to provide the necessary stability to the syringes during their movement.
    [0332] This, in addition to providing greater security to the process, allows greater speed, which results in greater productivity.
    [0333]
    [0334] In addition, being a modular station, it can be implemented in the place of the line that requires it, depending on the particular problem of each line or even, outside the production line, in the distribution centers or in the sales centers , which allows to obtain a correct and safe traceability of these syringes.
    [0335]
    [0336] The code on the other hand is invisible and can only be observed in the UV spectrum, making possible counterfeits difficult.
    [0337]
    [0338] It is a simple and very effective marking device and procedure in the signaling and traceability of syringes, in which the human factor does not intervene, reducing the possible failures due in this regard.
    权利要求:
    Claims (45)
    [1]
    1) Pharmaceutical container identification device comprising at least one marking means of at least one identification code on at least one container, characterized in that the marking means comprises at least one inkjet system configured to print the code of identification on at least one surface of the container with at least one ink that exhibits visible fluorescence when irradiated with ultraviolet (UV) radiation.
    [2]
    2) Device according to claim 1, wherein the ink exhibits visible fluorescence when irradiated with wavelength UV radiation in the range between 320 and 400 nm.
    [3]
    3) Device according to claims 1 or 2, wherein the ink exhibits visible fluorescence when irradiated with UV radiation of a wavelength of 365 nm.
    [4]
    4) Device according to any one of claims 1 to 3 that is configured to print the identification code on the at least one moving container.
    [5]
    5) Device according to any of the preceding claims, wherein the ink comprises at least one luminescent dye and at least one organic solvent.
    [6]
    6) Device according to claim 5, wherein the luminescent dye of the ink is a sulfonamide.
    [7]
    7) Device according to claim 6, wherein the luminescent dye of the ink is a toluenesulfonamide.
    [8]
    8) Device according to claim 7, wherein the luminescent dye is N-ethyl-o (or p) -toluenesulfonamide.
    [9]
    9) Device according to any one of the preceding claims 5 to 8, wherein the organic solvent is selected from the group consisting of methanol, ethanol, propanol, ketone, ethyl ketone, methyl ethyl ketone, isopropyl acetate, butanone, 2-pyrrolidone , alone or in any combination between them.
    [10]
    10) Device according to any of the preceding claims, wherein the ink further comprises at least one solubilizing agent selected from the group consisting of cyclic ketones, heterocyclic amides, cyclic alcohols and furans, alone or in any combination thereof.
    [11]
    11) Device according to any of the preceding claims, wherein the ink has a drying time on the surface of the container of 1 to 3 seconds.
    [12]
    12) Device according to any of the preceding claims, wherein the identification code is selected from the group consisting of a two-dimensional code, a QR code, a BIDI code, a datamatrix code or an alphanumeric code, alone or in any combination between them.
    [13]
    13) Device according to claim 12, wherein the at least one identification code is a datamatrix code.
    [14]
    14) Device according to claim 13, wherein the datamatrix code has a square or rectangular shape and a surface area of 2 to 4 mm2.
    [15]
    15) Device according to any of the preceding claims, further comprising sealing means of the ink to the body of the container.
    [16]
    16) Device according to any one of the preceding claims, wherein the container is a syringe.
    [17]
    17) Device according to any one of the preceding claims, wherein the container is a glass or plastic syringe for pharmaceutical use.
    [18]
    18) Device according to any of the preceding claims, further comprising a station formed by means for holding and moving the containers comprising at least one horizontal turning platform (3) having turning means with respect to a central axis vertical, and also presents, in its peripheral zone, adjustment means of a container body respectively, further comprising, associated with each turning platform (3), verification means in at least some of them, suitable for reading The identification code.
    [19]
    19) Device according to claim 18, further comprising a container rejection station with at least one collection container (7).
    [20]
    20) Device according to claims 18 or 19, wherein the means for holding and moving the station (1) are configured to keep the containers in a substantially vertical position at least in a part of the path.
    [21]
    21) Device according to any of claims 18 to 20, wherein the means for holding and moving the station (1) further comprise a device for turning the containers at an angle of 180 °.
    [22]
    22) Device according to any of claims 18 to 21, wherein the horizontal turning platform (3) comprises means for rotating the containers with respect to the longitudinal axis thereof, formed by a motorized band arranged in a lower way to the turning platform (3), which transmits the turning movement directly to the containers by means of an adjustment to the lower part thereof or that indirectly transmits them, by means of the movement of rollers in contact with them.
    [23]
    23) Device according to any of claims 18 to 22, wherein the adjustment means of a body of the container in the peripheral area of the turning platform (3) are formed by compartments (4) suitable for coupling in inside of at least one container collar in each of them.
    [24]
    24) Device according to any of claims 18 to 23, wherein the marking means of the station (1) comprise at least one inkjet print head (5) associated with each turning platform (3) .
    [25]
    25) Device according to any of claims 18 to 24, wherein the verification means act continuously on all the containers and are formed by at least one continuous UV code reader and / or at least one camera ( 6) UV lighting, suitable for reading the identification code when irradiated with UV lighting on a dark background.
    [26]
    26) Device according to any of claims 18 to 25, wherein the verification means act in a timely manner on a certain number of containers and are formed by a manual scanner with UV illumination.
    [27]
    27) Device according to any of claims 18 to 26, wherein the clamping and displacement means comprise two or more horizontal turning platforms (3) and, the system comprises at the entrance to the station (1), about container distribution means consecutively to each of the platforms.
    [28]
    28) Device according to any of claims 18 to 27 characterized in that it is configured as an autonomous identification unit adaptable to different production stages for pharmaceutical containers.
    [29]
    29) Method of identifying pharmaceutical containers comprising at least one means of marking at least one identification code on at least one container, comprising the step of printing the identification code by means of an inkjet system on at least one surface of the container with at least one ink that exhibits visible fluorescence when irradiated with ultraviolet (UV) radiation.
    [30]
    30) A method according to claim 29, wherein the ink exhibits visible fluorescence when irradiated with ultraviolet radiation in the range between 320 and 400 nm.
    [31]
    31) A method according to claim 30, wherein the ink exhibits visible fluorescence when irradiated with ultraviolet radiation of a wavelength of 365 nm.
    [32]
    32) A method according to any one of claims 29 to 31, wherein the step of printing the identification code is performed on the at least one moving container.
    [33]
    33) A method according to any of claims 29 to 32, wherein the ink has a drying time on the surface of the container of 1 to 3 seconds.
    [34]
    34) A method according to any of claims 29 to 33, wherein the identification code is selected from the group consisting of a two-dimensional code, a QR code, a BIDI code, a datamatrix code or an alphanumeric code, alone or in any combination between them.
    [35]
    35) A method according to any of claims 29 to 34, comprising the steps of:
    a) introduction (11) of a container in an upright position through a first conveyor belt (8) in a station (1);
    b) securing (12) thereof in the adjustment means of a horizontal turning platform (3) of the means for holding and moving the containers of said station (1);
    c) rotation (14) of the container to a second printing position (P2) of at least one identification code;
    d) marking (15) of the containers with at least one identification code by means of the marking means of the station (1), and;
    e) rotation (16) of the container to an outlet position of the containers, of the station (1).
    [36]
    36) A method according to any of claims 29 to 35, further comprising a sealing step (21) of the ink of the identification code to the surface of the container.
    [37]
    37) Method according to any of claims 29 to 36, further comprising a verification phase (17) of the identification code after the marking phase (15), which consists of reading, on a dark background, the identification code by means of a UV code reader and / or a UV illumination chamber (6) while the code is emitting visible fluorescence when irradiated with UV radiation.
    [38]
    38) A method according to claim 37 wherein, prior to the verification phase (17) of the identification code, a step of cleaning the surface of the container is introduced to improve the readability of the code.
    [39]
    39) A method according to any of claims 29 to 38, further comprising a phase prior to the verification phase (17) of the identification code, consisting of the rotation (16) of the container from the second position (P2) to a third position (P3), in which said additional verification phase is carried out (17).
    [40]
    40) A method according to any one of claims 29 to 39 comprising a first turning of the containers at an angle of 180 ° prior to the marking phase (15) of the containers with at least one identification code.
    [41]
    41) A method according to any one of claims 29 to 40 in which, after verification (17) the code has proved suitable (19), the container rotates (18) to an exit position (PS1) that is aligned with a second conveyor belt (9) for leaving the station.
    [42]
    42) A method according to any one of claims 29 to 41 comprising a second turning of the containers at an angle of 180 ° to their initial position, after verification (17) and prior to the rotation (18) of the container to the position of output (PS1).
    [43]
    43) A method according to any one of claims 29 to 42 in which, after verification the code has proved incorrect (20), the container rotates (22) to an outlet position that is aligned with the collection containers (7 ) and the container is ejected (23) by pneumatic or mechanical means to one of said collection containers.
    [44]
    44) A method according to any of claims 29 to 43 in which, in another area of container production or after said production, it comprises the steps of:
    a) introduction (24) of the container in an upright position through a third transport belt (10.1), in an additional station (2);
    b) securing (12) thereof in the adjustment means of a horizontal turning platform (3) of the securing and displacement means of the containers of said additional station (2);
    c) rotation (27) of the container to a second position in which the inspection (28) of the identification code and rotation of the container is performed by means of rotation on itself;
    d) if after inspection (28) the code is suitable (29.1), the container rotates (30) to an exit position (PS1) that is aligned with a fourth transport belt (10.2) for its movement outside of the additional station (2);
    e) if after inspection (28) the code is incorrect, the container rotates (32) to an exit position (PS2) that is aligned with the collection containers (7) of the rejection station and the container is ejected (23) by pneumatic means to one of said collection containers (7).
    [45]
    45) Method according to any of claims 29 to 44 characterized in that it is carried out under sterile conditions.
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    同族专利:
    公开号 | 公开日
    WO2019243654A1|2019-12-26|
    ES2736041B2|2021-04-30|
    EP3812163A1|2021-04-28|
    US20210125014A1|2021-04-29|
    引用文献:
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    GB1177754A|1966-02-07|1970-01-14|Rejafix Ltd|Improvements in or relating to Machines for Printing on Cylindrical Surfaces|
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    法律状态:
    2019-12-23| BA2A| Patent application published|Ref document number: 2736041 Country of ref document: ES Kind code of ref document: A1 Effective date: 20191223 |
    2020-01-30| PC2A| Transfer of patent|Owner name: ROVI PHARMA INDUSTRIAL SERVICES S.A.U. Effective date: 20200130 |
    2020-02-03| PC2A| Transfer of patent|Owner name: FROSST IBERICA, S.A.U. Effective date: 20200128 |
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    优先权:
    申请号 | 申请日 | 专利标题
    ES201830632A|ES2736041B2|2018-06-22|2018-06-22|Pharmaceutical container identification device and procedure|ES201830632A| ES2736041B2|2018-06-22|2018-06-22|Pharmaceutical container identification device and procedure|
    PCT/ES2019/070435| WO2019243654A1|2018-06-22|2019-06-21|Device and procedure for the identification of pharmaceutical containers|
    EP19739321.8A| EP3812163A1|2018-06-22|2019-06-21|Device and procedure for the identification of pharmaceutical containers|
    US17/116,676| US20210125014A1|2018-06-22|2020-12-09|Device and procedure for the identification of pharmaceutical containers|
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