CONTAINER UNIT, DEVICE FOR MANAGING CONTAINER, AND METHOD FOR MANAGING CONTAINER - Patent application

Abstract

A receptacle unit 201 for handling receptacles 102 comprises a support surface 202 on which a plurality of seats 204 are arranged. Each of said sets 204 is adapted to accommodate a receptacle 102, each receptacle 102 comprising a receptacle data storage medium 104 adapted to store a unique identifier of the receptacle 102. The receptacle unit 201 comprises at least one receptacle unit data storage medium 300 adapted to store data of the receptacles 102 accommodated in the seats 204, said data comprising the unique identifier of each receptacle 102 and the position of each receptacle 102 in the seats 204. A nest locator 208 is provided on a surface of the receptacle unit 201. The nest locator 208 is adapted to be a reference for mapping the position of the receptacle 102 in the seats 204.

Description

[Technical field]

[0001] The present invention relates to a container unit, an apparatus for managing containers and a method for managing containers. In particular, the present invention relates to a container unit adapted to accommodate primary containers for pharmaceutical or veterinary use, as well as an apparatus and a method for managing primary containers for pharmaceutical or veterinary use. [Background technology]

[0002] As is known, primary containers for pharmaceutical or veterinary applications are moved in bulk or collected together, with the containers collected and sterile, ready-to-use, for this purpose the primary containers are placed in secondary containers, where they are separated from each other and placed next to each other.

[0003] In this description and in the appended claims, the term "primary container" is intended to denote containers made of glass or polymers, such as, but not limited to, vials and cartridges with or without closure systems, and syringes with or without needle shields, needle safety devices, or luer lock caps.

[0004] Although specific reference is made in this discussion to containers for pharmaceutical and veterinary applications, the principles of the invention may be applied to other fields as well, as will be apparent to those skilled in the art. Furthermore, the present invention is not related to any particular type, size, or shape of glass container.

[0005] It is known to assemble the primary containers into a so-called nest and tub configuration, where the primary containers are placed within a nest and the nest is placed inside a tub.

[0006] This configuration is particularly adapted for handling the primary containers through the various operations they undergo, such as processing steps (filling, capping, manual or automated inspection operations), or for performing various synthesis, cleaning, sterilization, inspection operations, etc.

[0007] In these types of operations it is important to ensure full traceability of the origins of each container.

[0008] Serialization schemes, i.e. applying a machine or human readable code to a primary container to give it a unique identity, similar to a fingerprint, are known in the prior art.

[0009] By way of illustration, the readable code indicia of the containers may be marked on the containers by a printing unit capable of printing specific indicia on each container.

[0010] Besides serialization concepts, it is known in the packaging sector to apply aggregation concepts, which are used to create "parent-child" relationships between various packaging levels in order to simplify the management of processes in the supply chain.

[0011] As an example, a pallet may have a unique identifier, two shippers (children), and each shipper may have two tabs (children of the shipper). Thus, in this example, the collection of unique identifiers includes seven unique identifiers at three "parent-child" levels.

[0012] In this way, it is possible to provide all levels of parent-child identity by scanning one of the readable codes.

[0013] Although widely used and appreciated, prior art systems are not without their drawbacks.

[0014] First, the systems used by the prior art are unable to overcome problems associated with the orientation of the nest within the tub. In effect, the nest may house multiple containers in a particular location. Thus, an automated system must determine the location of each container's machine-readable code in order to map the location and orientation of each container.

[0015] Furthermore, readability of the machine readable code on each container is not straightforward given the expected orientation of the containers within the nest. Summary of the Invention [Problem to be solved by the invention]

[0016] SUMMARY OF THE PRESENT EMBODIMENT It is therefore an object of the present invention to overcome at least some of the drawbacks and limitations cited with respect to the prior art.

[0017] A first object of the present invention is to simplify the readability of machine-readable codes on containers, particularly in filling machines.

[0018] The second challenge is to overcome the mechanical nest orientation problem mentioned above.

[0019] Another challenge is to improve the ability to send product and supplier data to filling machines / lines to enhance product traceability. [Means for solving the problem]

[0020] The object is at least partly achieved by a receptacle unit according to claim 1, by an apparatus for managing receptacles according to claim 12 and by methods for managing receptacles according to claims 18 and 21.

[0021] Further features and advantages of the present invention will become more apparent from the following description of preferred but non-exclusive examples of a method and device for managing containers according to the invention, shown as non-limiting examples in the accompanying drawings, in which: [Brief description of the drawings]

[0022] [Figure 1] 1 is a schematic diagram of a container, nest, and tub according to one embodiment of the present invention. [Diagram 2] 1 is a schematic diagram of an apparatus according to one embodiment of the present invention; [Diagram 3] FIG. 13 is a schematic diagram of a nested tab configuration according to an alternative embodiment of the present invention. [Figure 4] FIG. 13 is a schematic diagram of a nested tab configuration according to an alternative embodiment of the present invention. [Diagram 5] FIG. 2 is a schematic diagram of a tab according to one embodiment of the present invention. [Figure 6] FIG. 2 is a schematic diagram of a tab according to one embodiment of the present invention. [Figure 7] FIG. 13 is a schematic diagram of a nested tab configuration according to an alternative embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Elements or parts of elements that the embodiments described below have in common are designated by the same reference numerals.

[0024] FIG. 1 shows a container unit 201 for handling containers 102 according to the invention.

[0025] The receptacle unit 201 comprises a support surface 202 on which a number of seats 204 are arranged, each of the seats 204 adapted to receive a receptacle 102 .

[0026] Each container 102 includes a container data storage medium 104 adapted to store a unique identifier for the container 102 .

[0027] The container unit 201 comprises at least one container unit data storage medium 300 adapted to store data of the containers 102 accommodated in the seat 204, said data including a unique identifier of each container 102 and the position of each container 102 within the seat 204.

[0028] According to one possible embodiment, the at least one receptacle unit data storage medium 300 may be provided on the bottom wall 212 of the receptacle unit 201. As can be seen in Figures 5 and 6, the at least one receptacle unit data storage medium 300 may preferably be provided on the bottom wall 212 in a central position with respect to the periphery of the bottom wall 212.

[0029] At least one receptacle unit data storage medium 300 is adapted to allow data to be read from and written to.

[0030] In particular, the at least one receptacle unit data storage medium 300 can be a two-dimensional bar code, an electronic chip or a storage device. Preferably, the at least one receptacle unit data storage medium 300 can be an RFID or NFC type chip. Furthermore, the receptacle unit data storage medium 300 can be any information storage medium that allows modification of its information content.

[0031] According to one possible embodiment, the receptacle unit 201 may comprise at least one receptacle (102). The receptacle data storage medium 104 may be adapted to store data comprising a unique identifier of the receptacle 102 and the position of each receptacle 102 within the seat 204.

[0032] The standard for unique identity may be based on agreed standards, published guidance documents, international standards, or regulatory requirements.

[0033] According to one possible embodiment, the unique identifier may be delivered, for example, by the computerized control system 304, a data storage medium, or may be received or uploaded from an external system (not shown).

[0034] According to one possible embodiment, the container data storage medium 104 can be, for example, a two-dimensional bar code, in particular a QR code.

[0035] The container data storage medium 104 may be applied to each container 102 via a marking process, such as a laser, inkjet, or other related marking process capable of providing a variable data string and a two-dimensional barcode image. According to an alternative embodiment, the container data storage medium 104 may also be added to the container 102 via a third party component, such as an electronic or semiconductor based data storage medium, that is associated with the container 102 during the manufacturing process.

[0036] As mentioned above, the container 102 may be manufactured from glass, plastic, rubber, be a multi-material assembly, or be formed from other suitable materials, and may include the container data storage medium 104 as a component or part of the assembly.

[0037] Advantageously, the container data storage medium 104 may be adapted to be machine-readable using a camera system, electronic reader (RFID or NFC), or other reading device that may be required to ensure automatic readability within the production environment.

[0038] The unique identity stored in the container data storage medium 104 may be stored in the computer control system 304 as a digital data string, an electronic file, along with any specific data to create parent-child relationships between different aggregation levels.

[0039] According to the present invention, the receptacle unit 201 includes a nest locator 208 provided on a surface thereof, the nest locator 208 being adapted to be a reference for mapping the location of the receptacle 102 within the seat 204. The nest locator 208 may be a machine readable code.

[0040] According to one possible embodiment, the nest locator may be a two-dimensional barcode and / or a textual component, so that it is machine and / or human readable.

[0041] The container unit 201 is a support element 200 comprising a support surface 202 on which a number of seats 204 are arranged; a tray 206 adapted to be associated with said support element 200 for handling said support element 200 and the containers 102; It may comprise:

[0042] According to one possible embodiment, the tray 206 may include a side wall 210 and a bottom wall 212 .

[0043] The receptacle unit data storage medium 300 may be provided on said support element 200 or on said tray 206 .

[0044] The container unit data storage medium 300 should be placed in a position that enhances readability while at the same time not affecting the operation or sterility of any machine using the device according to the invention. Similarly, the location of the container unit data storage medium 300 may be dictated by various stakeholders while still allowing compliance with process requirements.

[0045] The receptacle unit data storage medium 300 may be used as a method to facilitate the transfer of data between various machines.

[0046] According to one possible embodiment, the container unit data storage medium 300 may be adapted to read and write data sets in a defined manner. By way of example, the container unit data storage medium may be adapted to store data regarding the manufacturer, production date, batch number, supplier code, production time, location of the unique identifier, number of objects, line number, nest locator, type of object, object dimensions, unique identifier code of the container.

[0047] According to one possible embodiment, the support element 200 may comprise a nest locator 208 .

[0048] As mentioned above, the container 102 may be made of glass or a polymer. Additionally, the container 102 may be a vial or cartridge with or without a closure system, or a syringe with or without a needle shield, needle safety device, or luer lock cap.

[0049] FIG. 2 shows an embodiment of a device for managing containers 102 according to the present invention. The device 100 comprises: a container unit 201; - a reading device 302 adapted to read the data stored on the container unit data storage medium 300; - a computerized control device 304 operatively connected to the reading device 302 and adapted to receive the data of the container unit data storage medium 300 from the reading device 302; Equipped with.

[0050] According to one possible embodiment, the nest locator 208 may be adapted to be used as a zero point by the computerized control device 304 using a matrix method in which the seats 204 are divided into rows and columns, the nest locator 208 is adapted to define a first row and a first column, and each seat 204 is defined by a column number and a row number.

[0051] This is the preferred method since many of the machines using the ready to use configuration process nests in rows, and the work required for each unique identifier / container is completed by the machine / process before indexing to the next row.

[0052] According to an alternative embodiment, the computerized controller 304 is adapted to determine the positions of the seats 204 by counting the seats 204 from one side to the other along a row starting with the seat 204 closest to the nest locator 208, and when a row is finished, the sequence continues with the next row.

[0053] Referring to the example of FIG. 3, the location of the containers may be defined as a unique location number when counting from the location of the nest locator 208 located in the upper left corner of the nest. In this case, the locations are considered sequentially moving from left to right along a first row. When the row ends, the sequence continues in the second row in the same manner - moving from left to right. This method defines each location as a unique number.

[0054] According to one possible embodiment, the nest locator 208 may comprise a two-dimensional barcode, but the nest locator 208 may also be located within the image by its color, shape, or different visual marks.

[0055] According to an alternative embodiment, the nest locator 208 may include two-dimensional bar code and text components. In this manner, the nest locator may be both machine and human readable as a fail-safe to prevent errors and facilitate human intervention when needed, or to indicate the correct "zero position" when more than one "nest locator" may be printed on the nest. Indeed, in some manufacturing lines, the nest may be rotated during the process.

[0056] According to one possible embodiment, the tray may be equipped with a second nest locator 214 adapted to be used as an end point.

[0057] The apparatus 100 may comprise a first camera reader 306 operatively connected to a computerized control device 304 adapted to read a nest locator 208 provided on said container unit 201 in order to map the location of the container 102.

[0058] According to one possible embodiment, the apparatus may include a second camera reader 306 operably connected to the computerized control device 304 adapted to read the unique identifier of the container 102 .

[0059] According to one possible embodiment, the receptacle data storage medium 104 of each receptacle 102 may include an RFID chip. In this case, the second camera reader 306 operatively connected to the computerized control device may be replaced or supplemented by a device capable of reading and / or writing the RFID chip. Regardless of the type of reader used for reading and possibly reading / writing the information carried by the receptacle data storage medium 104, at least one reader may be used to locate and / or identify both the nest locator and the receptacle data storage medium 104.

[0060] The configuration of the equipment depends on the product type, packaging, and required production specifications. In particular, the equipment can be integrated within the container production line or designed as a separate product management station running parallel to the production line.

[0061] When equipment is designed as a separate product management station, product is moved from one line to another once the associated process step is complete.

[0062] The apparatus of the present invention is adapted to manage higher level aggregations as part of a process such as from container unit 201 to shipper, shipper to pallet, etc., to meet a wide range of customer or industry specifications. The higher level aggregation uses the same methods of creating electronic associations between higher level packages using data storage media.

[0063] By way of illustration, a shipper may be provided with a particular unique identifier that may be associated with an associated tray, nest locator, and container unit data storage medium of the container's unique identifier.

[0064] The apparatus according to the present invention may operate as a stand-alone unit or may be integrated with an automated production process, such as a container manufacturing line, etc. In this regard, the computerized controlled system 304 of the apparatus may be a stand-alone system or may be integrated as software within the main computerized control system of the manufacturing line.

[0065] Specifically, the main computerized control system of a manufacturing line can be adapted to continue to operate in conjunction with a process control system, during which embedded software systems and algorithms designed specifically for the process manage and regulate the process, and share data in both directions across various levels and parts of the facility.

[0066] During the manufacturing process, data may be added to the container data storage medium and / or to the container unit data storage medium associated with the tray, which may be adapted to be stored in the computerized control system of the device or in the main computerized control system of the manufacturing line. By way of example, this data may be batch number, identity, unique identifier, location, status changes, and collection relationships.

[0067] According to one possible embodiment, the receptacle data storage medium 104 and the receptacle unit data storage medium 300 may be associated with a memory on a controlled system, for example a computerized system, which is not adapted to physically store all the necessary data, but is able to make use of said data. In this particular case, the receptacle data storage medium 104 and the receptacle unit data storage medium 300 may be optical codes, for example bar codes or QR codes.

[0068] According to one possible embodiment, data may be generated, uploaded, and stored in an enterprise-level system 308 designed to be an overall data management and control system. The enterprise-level system may be designed to allow data sharing with other computer systems. Data sharing may be done via a variety of file formats, which may include, but are not limited to, XML, JSON, EPICS messaging, etc.

[0069] The enterprise-level system 308 may be configured in a manner that facilitates compliance with any relevant international standards and obligations that may be required by external authorities, which may include access control and other security features to ensure data integrity and security.

[0070] The status, readability, image, unique identifier, or any other relevant parameters may be updated in the enterprise-level system 308 and stored for later use.

[0071] Any state changes at any point in the process can be added to the existing data being managed or stored so that the entire history of the product can be viewed during its life. This data can be uploaded or transferred to an external computer system.

[0072] Further functionality can be added to the enterprise-level system 308 to enable external messaging, alerts and notifications, reporting, and tracking and tracing of shipments.

[0073] As described above, the device may be adapted to create electronic relationships between components, nests, tubs, shippers, or higher aggregation levels within a bulk container manufacturing process, or a ready-to-use process that delivers pre-sterilized product to an aseptic processing machine, line, or system.

[0074] In case of bulk packaging, the device may be adapted to create specific electronic relationships between the unique identifiers of the containers and the various levels of the packaging hierarchy, such as container 102 to container unit 201, container unit 201 to shipper, shipper to pallet, etc. Access to the aggregate structure may be provided, for example, via URL access, system integration, and data exchange or data storage media.

[0075] A possible method for managing the containers with the device according to the invention will now be described.

[0076] The method, in its basic form, comprises: a) providing the apparatus 100 with a receptacle unit 201; b) scanning the receptacle data storage medium 104 of each receptacle 102 contained within the receptacle unit 201; c) writing data of the scanned container 102 to a container unit data storage medium 300; Including, Prior to step b), the apparatus aligns the nest locator to ensure correct orientation of the nest within the apparatus.

[0077] According to one possible embodiment shown in Fig. 4, the nest locator 208 may be used as a zero point in a pick operation using a matrix method in which the seats are divided into rows and columns, where the nest locator 208 is adapted to define a first row and a first column, in this method each seat is defined by a column number and a row number.

[0078] According to an alternative embodiment, the positions of the seats 204 are determined by counting the seats 204 from one side to the other along a row, starting with the seat 204 closest to the nest locator 208, and when a row is completed, the sequence continues with the next row.

[0079] According to one possible embodiment, after step c), the support element 200 is provided inside a tray 206, and the support element 200 and the tray 206 can be sealed together.

[0080] Further, the method comprises: - removing each container (102) from its seat before scanning the container data storage medium; - a step to write batch data to the tab, - placing the sealed tubs in a sterile bag; and - Putting the sealed unit into the shipper It may include other steps such as:

[0081] The advantages that can be obtained with the present invention are clear.

[0082] First, the apparatus and method of the present invention can simplify the readability of unique identifiers on containers passing through a filling machine.

[0083] Furthermore, by defining a zero point on the nest, it is possible to overcome problems with mechanical nest orientation.

[0084] Similarly, product and supplier data can be sent to the filling line to enhance product traceability.

[0085] Additionally, the aggregation process creates an electronic relationship between the nest, each individual UID / container, its location within the nest, and any production data associated with the manufacturing process.

[0086] The nest and tub assembly process can be part of a ready-to-use manufacturing process that requires the process steps to be performed in a specified class of clean room. All components associated with the system are maintained within a specific set environmental condition temperature that follows internal norms or standards such as the International Standards Organization (ISO). This can be as a complete unit or as separate components within a manufacturing line.

[0087] Those skilled in the art may make numerous modifications and variations to the above-described structures for the purpose of meeting fortuitous and specific needs, all of which fall within the scope of the present invention as defined by the following claims.

Claims

1. A container unit (201) for handling a container (102), comprising: a support surface (202) on which a plurality of seats (204) are arranged, each of said seats (204) adapted to receive a container (102), each container (102) comprising a container data storage medium (104) adapted to store a unique identifier of said container (102); at least one receptacle unit data storage medium (300) adapted to store data of the receptacles (102) accommodated in said seat (204), said data comprising said unique identifier of each receptacle (102) and the position of each receptacle (102) in said seat (204); Equipped with A container unit (201), characterized in that it comprises a nest locator (208) provided on a surface of the container unit (201) and adapted to serve as a reference for mapping the position of the container (102) in the seat (204).

2. 2. Receptacle unit (201) according to claim 1, characterized in that said at least one receptacle unit data storage medium (300) is provided on a bottom wall (212) of said receptacle unit (201).

3. 2. Receptacle unit (201) according to claim 1, characterized in that said at least one receptacle unit data storage medium (300) is adapted to have data written to and read from it.

4. 4. Receptacle unit (201) according to claim 3, characterized in that said at least one receptacle unit data storage medium (300) is an electronic chip or a memory device.

5. 5. Receptacle unit (201) according to claim 4, characterized in that said at least one receptacle unit data storage medium (300) is a chip of RFID or NFC type.

6. 2. A container unit (201) as described in claim 1, characterized in that it comprises at least one container (102), and the container data storage medium (104) is adapted to store data including the unique identifier of the container (102) and the position of each container (102) within the seat (204).

7. 2. The container unit (201) of claim 1, wherein the nest locator (208) adapted to be the reference for mapping the position of the container (102) in the seat (204) is a machine-readable code.

8. 2. The receptacle unit (201) according to claim 1, characterized in that said nest locator is a two-dimensional barcode and / or a textual element, so as to be machine and / or human readable.

9. a support element (200) comprising said support surface (202) on which said seats (201) are arranged, a tray (206) adapted to be associated with said support element (200) for handling said support element (200) and said containers (102); Equipped with 2. The receptacle unit (201) according to claim 1, characterized in that the receptacle unit data storage medium (300) is provided on the tray (206).

10. - a container unit (201) according to claim 1, a reading device (302) adapted to read said data stored on said receptacle unit data storage medium (300); a computerized control system (304) operatively connected to said reading device (302) and adapted to receive said data of said receptacle unit data storage medium (300) from said reading device (302); A device (100) for managing a container (102), comprising:

11. 11. The apparatus (100) for managing containers (102) according to claim 10, characterized in that the nest locator (208) is adapted to be used as a zero point by the computerized control system (304) using a matrix method in which the seats (204) are divided into rows and columns, the nest locator (208) is adapted to define a first row and a first column, and each seat (204) is defined by a column number and a row number.

12. 11. The apparatus (100) for managing containers (102) according to claim 10, characterized in that the computerized control system (304) is adapted to determine the positions of the seats (204) by counting the seats (204) from one side of a row to the other side, starting with the seat (204) closest to the nest locator (208), and when the row is finished, the sequence continues with the next row.

13. 11. The apparatus (100) for managing containers (102) according to claim 10, characterized in that it comprises a first camera reader (306) operatively connected to the computerized control system (304) and adapted to identify the nest locator (208) provided on the container unit (201) in order to map the location of the container (102).

14. 11. The apparatus (100) for managing containers (102) according to claim 10, further comprising a second camera reader (306) operably connected to the computerized control system (304) and adapted to read the unique identifier of the container (102).

15. A container production line comprising the device for managing containers according to claim 10.

16. A method for managing a container (102) by means of a device for managing a container according to claim 10, comprising the steps of: a) providing said device (100) with a receptacle unit (201) comprising a support element (200) with said support surface (202); b) scanning the container data storage medium (104) of each container (102) contained in the container unit (201); c) writing data of the scanned container (102) to the container unit data storage medium (300); Including, A method for managing containers (102), wherein prior to step b), the apparatus aligns the nest locator (208) to ensure correct orientation of the support element (200) within the apparatus.

17. 17. The method for managing containers (102) of claim 16, wherein the nest locator (208) is used as a zero point in the removal operation using a matrix method in which the seats are divided into rows and columns, the nest locator (208) being adapted to define a first row and a first column, and each seat being defined by a column number and a row number.

18. 17. The method for managing containers (102) of claim 16, wherein the locations of the seats (204) are determined by counting the seats (204) from one side of a row to the other starting with the seat (204) closest to the nest locator (208), and when the row is finished, the sequence continues with the next row.

19. A method for managing containers (102) for pharmaceutical or veterinary use moved along a production line, each of said containers (102) having a container data storage medium (104) storing data for said container (102), said method comprising: a) providing a receptacle unit (201) arranged with a number of seats (204), each of said seats (204) housing a respective receptacle (102), said receptacle unit (201) having a receptacle unit data storage medium (300) adapted to store said data of said receptacles (102); b) scanning the receptacle data storage medium (104) of each receptacle (102) accommodated in the seat (204) of the receptacle unit (201); c) writing the data of the scanned receptacle data storage medium (104) to the receptacle unit data storage medium (300); d) modifying the data written in the receptacle unit data storage medium (300) when a state change occurs at any point in the manufacturing line; A method for managing a container (102), comprising:

20. 20. The method for managing containers (102) of claim 19, wherein the data stored in the container data storage medium (104) is changed if a state change occurs at any point in the manufacturing line.

21. 21. A method for managing containers (102) as described in claim 19 or 20, comprising the step of positioning the container unit (201) in a shipper having a shipper data storage medium, and wherein the data stored in the shipper data storage medium is changed when a state change occurs at any point in the production line.

22. 22. The method for managing containers (102) of claim 21, comprising positioning the shipper in a pallet having a pallet data storage medium, wherein if a state change occurs at any point in the manufacturing line, the data stored on the pallet data storage medium is changed.

23. 20. The method for managing containers (102) of claim 19, wherein the container unit data storage medium (300) is adapted to store data relating to the manufacturer, production date, batch number, supplier code, production time, line number, number and / or type and / or size of the container (102).

24. 20. The method for managing containers (102) of claim 19, wherein the data of the containers (102) comprises a unique identifier of the containers (102) and the position of each container (102) in the seat (204), and the container unit (201) comprises a nest locator (208) adapted to become the reference for mapping the position of the containers (102) in the seat (204).

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