TRACK AND TRACE PACKAGING PROCESS

Description

[0001] The invention relates to a track and trace packaging method for packaging goods with one or more process steps, wherein a number of products in a batch are fed into one or more traceable packaging units, in particular of different sizes.

[0002] The invention also relates to a system consisting of a packaging system, one or more mobile devices and a control unit for the packaging system, as well as a mobile device for use in the track and trace packaging process.

[0003] Furthermore, the invention relates to a computer program and a computer program product with program code means.

[0004] Various methods for tracing objects and track and trace procedures are known from the prior art. These methods aim to make it possible to determine at any time when, where, and by whom a product or commodity was obtained, manufactured, processed, stored, transported, consumed, or disposed of. Such control procedures play a crucial role, for example, in the pharmaceutical industry, particularly in the area of ​​pharmaceutical manufacturing. In this sector, they are primarily intended to ensure protection against counterfeiting and control over the distribution of the product.

[0005] Counterfeit consumer goods, particularly in the pharmaceutical and medical sectors, can pose a significant economic risk to manufacturers of genuine products and a health hazard to end consumers. Counterfeit prevention measures, which aim, among other things, to prevent counterfeit consumer goods from entering the official distribution chain, also necessitate dispensing controls in the pharmaceutical and medical consumer goods sector, especially in the area of ​​controlled substances, to prevent misuse. Therefore, the goal is not only to prevent consumer goods from being illicitly introduced into the distribution chain, but also to prevent them from being illicitly withdrawn from it.

[0006] In the packaging process for solid dosage forms, particularly tablets, pills, capsules, or similar products, the packaging is marked with a code or ID for traceability purposes. This typically begins with the blister pack. The folding carton, then the shipping carton, and finally the aggregated pallet are all marked with the corresponding codes. Between packaging units, especially those of different sizes, aggregation occurs, meaning a parent-child relationship is established. At each step of the packaging process, the codes are scanned, entered into a database, and verified.

[0007] Often, scanning, printing, and affixing labels with the corresponding markings or codes is done manually. This means that one employee scans individual folding boxes, another creates bundles of folding boxes, and yet another feeds the boxes to the shipping cartons. This process is time-consuming and requires a significant number of personnel.

[0008] Well-known track and trace systems are based on industrial solutions with interprocess communication (IPC), camera systems, and conventional software technology. These systems require additional hardware and have delivery times of several months.

[0009] DE 20 2012 102 237 U1 relates to a control device for marking, in particular for the pharmaceutical industry in the field of pharmaceutical manufacturing, with a detection and processing device for recording the marking.

[0010] Furthermore, reference is made to EP 2 747 003 A1, which discloses a method and a system for storing and retrieving packaging relationships.

[0011] US 2014 / 0330685 A1 concerns the tracking and management of tangible assets and, in particular, the tracking of tangible assets using a harmonizing code that is directly linked to a tangible asset or to a tracking unit attached to the tangible asset.

[0012] US 2011 / 0106681 A1 concerns a method and a system for managing entities using wireless devices.

[0013] The present invention is based on the objective of creating a track and trace packaging method of the type mentioned at the outset, which avoids the disadvantages of the prior art, is in particular flexible and can also be used in areas with low automation.

[0014] This problem is solved according to the invention by a track and trace packaging method with the features mentioned in claim 1.

[0015] According to the invention, a track and trace packaging method for packaging goods with one or more process steps is proposed, wherein a number of products in a batch are fed into one or more traceable packaging units, in particular of different sizes, which are marked for tracking purposes with a marking that is read during at least one process step or between process steps and stored and / or verified in a database, wherein: A batch workflow or batch process is created on a control unit, with at least one process step for processing the batch, and users can log on to or off the batch or batch workflow using a mobile device that is communicatively connected to the control unit and / or at least one other mobile device, and can partially or completely take over the processing of the at least one process step, wherein at least one process step is wholly or partially supported by a packaging system, and wherein mobile devices logged on to the batch workflow are directly communicatively connected to each other and synchronize with each other in real time.

[0016] The invention proposes a flexible track and trace packaging system or process with flexible process stations and the personnel involved in production that can be changed during the production process. It can also serve production areas with limited automation where personnel primarily perform manual packaging. Users can download and install their track and trace packaging system themselves, for example, via a digital distribution platform for application software, onto their mobile devices. Inexpensive, commercially available devices (mobile devices, smartphones, and printing systems) can be used. Direct implementation without long process lead times is possible. Process reliability can be ensured through intelligent measures and appropriate management of production personnel. A batch to be produced can be created and released by a supervisor on a server.Employees can log into the batch using their mobile device and independently take over individual process steps, especially depending on their qualifications.

[0017] In this context, mobile devices are defined as portable communication devices that can be used for voice and data communication regardless of location, such as mobile phones, smartphones, netbooks, notebooks, or tablets. These are usually also equipped with a camera.

[0018] The products to be packaged can be, in particular, solid dosage forms, such as tablets, pills, capsules, or the like. These are packaged in traceable packaging units, especially of varying sizes, which are marked with a label, code, or ID. For solid dosage forms, this begins with the blister pack, then the folding carton, followed by the shipping carton, and finally the aggregated pallet. Aggregation can occur between the different packaging units, meaning a parent-child relationship is established. Labeling can be achieved by applying a label or an RFID tag or RFID chip containing an ID. Both 1D marking methods (e.g., barcode or serial number) and 2D marking methods (e.g., QR code or Data Matrix code) can be used.When using a passive RFID chip, it is applied to or embedded in objects, whereby the ID stored in the chip can be read by a radio wave pulse from a suitable, active reader.

[0019] The control unit can be implemented as a microprocessor. Instead of a microprocessor, any other device can be used to implement the control unit and / or control device, for example, one or more arrangements of discrete electrical components on a printed circuit board, a programmable logic controller (PLC), an application-specific integrated circuit (ASIC), or another programmable circuit, such as a feed-programmable gate array (FPGA), a programmable logic assembly (PLA), and / or a standard computer. Furthermore, the control unit can also be implemented as a server, line controller, SCADA (supervisory control and data acquisition system, i.e., a computer system for monitoring and controlling technical processes), or mobile device.

[0020] In this context, "batch" refers to a lot, i.e., a production or manufacturing lot, a batch, or a lot. This can be a quantity or number of products that are produced, manufactured, or packaged under identical conditions.

[0021] At least one process step, which is primarily controlled by the control unit, is wholly or partially supported by a packaging system.

[0022] This means that the flexible track and trace packaging process is at least partially automated in conjunction with a packaging system.

[0023] It is advantageous to use the mobile device or its camera to read the marking of at least one packaging unit.

[0024] The hardware of mobile devices can thus be easily used to scan the codes on the packaging units. Most mobile devices nowadays already have built-in camera systems, which is why inexpensive, commercially available mobile devices can be used. Likewise, standard printing systems can be used to create the labels with the identification codes.

[0025] Multiple users can process the same step in parallel. This further increases the flexibility of the method according to the invention, as several users can work on the same process step if necessary. For example, a user whose process step has already been completed can provide support in later steps. The workers participating in production can be changed during production.

[0026] Logging in or out of the batch or batch workflow can be done via the control unit, via at least one other mobile device, or via a cloud system.

[0027] Mobile devices registered with the batch or batch workflow synchronize with each other in real time, particularly with regard to batch data. One mobile device, or all connected mobile devices, can act as the data master. This enables master-to-master synchronization of mobile devices within the track and trace system in production. As a result, the packaging process can be designed with great flexibility.

[0028] Advantageously, the mobile device can receive the data from the preceding process step in the subsequent process step, allowing processing to continue, particularly without interruption.

[0029] The batch process or batch workflow can be started via a mobile device.

[0030] User authentication can be performed via a cloud system, a connection to a local domain, or through local user management on the mobile device.

[0031] Users can be assigned to groups, whereby the groups can be used to determine which process steps a particular user is allowed to process, for example based on their qualifications.

[0032] Employees logging into a batch with their mobile devices can independently take over individual process steps depending on their qualifications, which are determined by their group membership. These groups can be defined, for example, via the cloud system or the local domain.

[0033] Any mobile device can take on the role of master and, if necessary, take over the batch and invite or add other people.

[0034] Claim 9 specifies a system consisting of a packaging system, one or more mobile devices and a control unit for the packaging system, wherein the control unit is communicatively connected to the packaging system, communicatively connectable to the at least one mobile device and is configured to control at least one process step of a track and trace packaging process according to the invention running on a process module of the packaging system, and wherein a batch or batch workflow with the at least one process step for processing a batch can be created on the control unit.

[0035] Claim 10 relates to a mobile terminal for use in a track and trace packaging method according to the invention, which is communicable with the control unit or at least one other mobile terminal, and which is configured to log a user on or off the batch or the batch workflow.

[0036] The mobile device is also configured to synchronize itself or batch-related data with at least one other communication-connected mobile device in real time.

[0037] Claim 11 specifies a computer program with program code means for logging a user on or off to a batch or batch workflow in a track and trace packaging method according to the invention and / or for performing a synchronization of batch-related data with other communication-connected mobile devices in real time when the program is executed on a mobile device.

[0038] Claim 12 relates to a corresponding computer program product comprising program code means stored on a computer-readable data carrier.

[0039] Advantageous embodiments and further developments of the invention are set out in the dependent claims.

[0040] The following is a basic description of an embodiment of the invention with reference to the drawing.

[0041] They show: Fig. 1 is a first illustration to clarify a track and trace packaging method according to the invention; and Fig. 2 is a second illustration to clarify the track and trace packaging method according to the invention.

[0042] In the figures, functionally identical elements are provided with the same reference symbols.

[0043] The track and trace packaging method according to the invention is a cost-effective solution that can also be used in simple and less automated markets or sectors. The method can be operated using a conventional tablet as a mobile device. The mobile device can be set up, for example, via a digital sales platform for application software. Registration may be required for this. Pay-by-use techniques can also be used.

[0044] Figure 1This is intended to illustrate the process of a track and trace packaging method according to the invention for packaging end products (not shown in detail) with several process steps S1, S2, S3, S4, and S5. A number of products (not shown in detail), for example, tablets, which are contained in blister packs, are fed as a batch to one or more traceable packaging units, in particular of different sizes. These packaging units are marked with a unique identifier 1 for tracking purposes. This identifier is read or scanned during at least one process step S1-S5 and stored and / or verified in a database (not shown in detail). The identifier 1 can be a code or an ID. On a control unit configured as a server 2, a batch workflow with at least one process step S2-S5 for processing the batch can be created in step S1.In other embodiments not shown, the control unit could also be a cloud system, a line controller, a SCADA system, or a mobile device. In addition to one or more mobile devices configured as tablets 3, printers 4 and 5 are included. Figure 1The devices 2, 3, 4, and 5 can be wirelessly connected to each other, for example via Bluetooth, WLAN, or similar technologies. In this exemplary embodiment, the packaging units are designed as a folding box 6 and a carton 7. Tablets in blister packs, for example, can be placed in the folding boxes 6. In other exemplary embodiments not shown, the packaging units can, of course, be other products or goods. Users can log in to and out of the batch or batch workflow using a mobile device, in particular a tablet 3, which is connected to the control unit (designed as a server 2) and / or at least one other mobile device or tablet 3, and can partially or completely take over the processing of at least one process step S2-S5.

[0045] In a further embodiment not shown, at least one process step S2 - S5, which is controlled in particular by the control unit, can be carried out wholly or partially supported by a packaging insert not shown.

[0046] As from Figure 1 As further shown, after logging into the server 2 or the batch, the user can print corresponding labels 8 with the identifier 1 for the folding cartons 6 on the tablet 3 in process step S2 using the printer 4. The tablets 3 or the server 2 can be connected to a cloud system 9 to transmit data about the produced or packaged products, for example, to a government agency or similar entity. This may be necessary, particularly in the case of pharmaceutical products. A connection can be established, for example, via a VPN tunnel.

[0047] In process step S3, a user logged into the batch or batch workflow can now apply the labels generated in process step S2 to the folding cartons 6, which may contain the blister packs with the tablets. Using tablet 3, the folding cartons 6 can then be verified via their identification mark 1.

[0048] In step S4, the folding cartons 6 of the batch are combined and packed layer by layer into a carton 7. Here too, a user logged into the batch can use the tablet 3 to verify the folding cartons 6 arranged in individual layers in the carton 7.

[0049] In process step S5, a label 10 with an identifier 11 for the carton 7 can be created after the carton 7 has been filled with the folding boxes 6 and the corresponding verification has been carried out using the printer 5. The label 10 is affixed to the carton 7, thus verifying it at the end of the track and trace packaging process. This can also be done using the tablet 3. In steps S3-S5, a Figure 1The camera of tablet 3 (not shown in detail) can be used to read or scan labels 8 and 10, or markings 1 and 11. A matrix scan can be used to read the layers of folding cartons 6. Aggregation takes place between the packaging units, i.e., between the folding carton 6 and the carton 7, establishing a parent-child relationship. Verification can be performed by the tablets 3 in conjunction with a database (not shown in detail), which is located, for example, on server 2.

[0050] To read the marking 1, 11 of the at least one packaging unit, in this case designed as a folding box 6 or carton 7, the mobile device, in particular the tablet 3, can be used.

[0051] Figure 2This is intended to illustrate the flexibility of a track and trace packaging process according to the invention. In step S10, for example, a supervisor in the office creates a new batch workflow with at least one process step for processing a batch.

[0052] The first user, John, has a Tablet 3.1, which he can use to start a batch workflow and perform implementation or assembly. In step S11, John starts the batch workflow. In step S12, John prepares some serialized cartons.

[0053] In Figure 2 Real-time connections are indicated by dashed lines.

[0054] In step S13, Adam joins the production line by logging into the batch workflow started by John using his Tablet 3.2 on John's Tablet 3.1. John confirms Adam's joining. Adam then takes over assembling the batch.

[0055] In step S14, Linda joins the local network with her Tablet 3.3 by establishing a real-time connection with Adam's Tablet 3.2, which then confirms Linda as an employee. Linda works in quality control and occasionally takes samples. She does this for several production lines.

[0056] For example, after packing one hundred boxes, John and Linda could switch positions, as both need a change after a certain period of time.

[0057] In steps S15 and S16, which can also run in parallel, Ahmed and Marissa join the team with their Tablet 3.4 and Smartphone 3.5, respectively. Ahmed is a floater in the group and can help out in case of bottlenecks at the individual stations. Marissa assembles the pallets for several production lines and usually ends the batch workflow with a notification from Cloud System 9.

[0058] Multiple users can edit the same process step in parallel.

[0059] Logging in or out of the batch workflow or the batch can be done via the control unit running as Server 2, via at least one mobile device running as Tablet 3, 3.1, 3.2, 3.3, 3.4 or Smartphone 3.5 or via the cloud system 9.

[0060] As from Figure 2 As can be seen, the mobile devices registered in the batch workflow synchronize with each other in real time.

[0061] A mobile device can be a data master. In principle, all communication-connected mobile devices can be data masters.

[0062] In step S17, Marissa ends the batch workflow.

[0063] The mobile device can receive the data from the preceding process step S2 to S4 in the subsequent process step S2 to S4, thus enabling processing to continue.

[0064] User authentication can be performed via the Cloud System 9, via a connection to a local domain, or through local user management on a mobile device.

[0065] Users can be assigned to groups, whereby the groups determine which process steps S2-S4 each user is allowed to process.

[0066] In further embodiments not shown, the server 2 can also be designed as a control unit for a packaging system, which is communicationally connected to the packaging system and can be communicationally connected to one or more mobile devices, which is configured to control at least one process step of the track and trace packaging process according to the invention running on a process module of the packaging system, wherein a batch workflow with at least one process step S2-S4 for processing a batch can be created on the control unit.

[0067] A mobile device used in the track and trace packaging method according to the invention can be communicatively connected to the control unit and / or to at least one other mobile device and can be configured to log a user in or out of the batch workflow.

[0068] Furthermore, the mobile device can be designed to exchange batch-related data via the communication link.

[0069] As from Figure 2 As can be seen, the mobile device can synchronize batch-related data in real time with at least one other communication-connected mobile device.

[0070] A computer program can be executed on the mobile devices using program code means to log a user on and / or off the batch workflow in the track and trace packaging method according to the invention and / or to perform synchronization with other communication-connected mobile devices, in particular of batch-related data, in real time.

[0071] The control unit can be implemented as a microprocessor. Instead of a microprocessor, any other device can be used to implement the control unit and / or control device, for example, one or more arrangements of discrete electrical components on a printed circuit board, a programmable logic controller (PLC), an application-specific integrated circuit (ASCI), or another programmable circuit, such as a field-programmable gate array (FPGA), a programmable logic assembly (PLA), and / or a standard computer. Furthermore, the control unit can also be implemented as a server, line controller, SCADA system, or mobile device. Reference symbol list

[0072] 1 Labeling of folding carton 2 Server 3 Tablet 3.1 John's Tablet 3.2 Adam's Tablet 3.3 Linda's Tablet 3.4 Ahmed's Tablet 3.5 Marissa's Smartphone 4 Printer 5 Printer 6 Folding carton 7 Carton 8 Labels for folding cartons 9 Cloud system 10 Label for carton 11 Labeling of carton S1-S5 Process steps S10-S17 Steps

Claims

1. A track and trace packaging method for packaging goods comrpising one or more process steps (S1-S5), wherein a number of products is supplied as a batch to one or more trackable packaging units, in particular of different size, that, for tracking purposes, are provided with an identification (1, 11) that is read in during the at least one process step (S2-S5) and stored in a database and / or verified, wherein a control unit creates a batch workflow comprising the at least one process step (S2-S5) for working on the batch, wherein users can sign into or out of the batch or the batch workflow using a mobile terminal, which is communicatively connected to the control unit and / or to at least one other mobile terminal, and can undertake processing the at least one process step (S2-S5) partially or completely, and wherein at least one process step (S2-S5) is carried out completely or partially by a packaging plant in a supporting capacity, characterized in that mobile terminals signed into the batch workflow are communicatively connected to one another directly and synchronize one another in real time.

2. The track and trace packaging method according to claim 1, wherein the at least one process step (S2-S5) which is carried out completely or partially by the packaging plant in a supporting capacity is controlled by the control unit.

3. The track and trace packaging method according to claim 1 or 2, wherein the identification of the at least one packaging unit is read in using the mobile terminal.

4. The track and trace packaging method according to claim 1, 2 or 3, wherein multiple users can work on the same process step in parallel.

5. The track and trace packaging method according to one of claims 1 to 4, wherein signing into or out of the batch workflow is accomplished by way of the control unit, by way of the at least one other mobile terminal or by way of a cloud system (9).

6. The track and trace packaging method according to one of claims 1 to 5, wherein the mobile terminal receives the data from the preceding process step (S2-S4) in the next process step (S3-S5), as a result of which the work can be continued.

7. The track and trace packaging method according to one of claims 1 to 6, wherein user authentication is accomplished by way of a cloud system (9) or a connection to a local domain or by a local user management on the mobile terminal.

8. The track and trace packaging method according to one of claims 1 to 7, wherein the users are assigned to groups, the groups being used to stipulate which process steps (S1-S5) a respective user can work on.

9. A system consisting of a packaging plant, one or more mobile terminals and a control unit for the packaging plant, wherein the control unit is communicatively connected to the packaging plant, is communicatively connectable to the at least one mobile terminal and is configured to control at least one process step (S2-S5) of a track and trace packaging method according to one of claims 1 to 8 that is taking place on a process module of the packaging plant, and wherein a batch workflow comprising the at least one process step (S2-S5) for working on a batch is creatable in the control unit.

10. A mobile terminal for use in a track and trace packaging method according to one of claims 1 to 8, which mobile terminal is communicatively connectable to the control unit and / or at least one other mobile terminal, and which mobile terminal is configured to use the communication connection to interchange batch-related data, in particular to sign a user into or out of the batch workflow, and which mobile terminal is further configured to synchronize batch-related data with the at least one other communicatively connected mobile terminal in real time.

11. A computer program comprising program code means in order, during a track and trace packaging method according to one of claims 1 to 8, to sign a user into or out of a batch workflow and / or to carry out a synchronization of batch-related data with other communicatively connected mobile terminals in real time when the program is executed on a mobile terminal according to claim 10.

12. A computer program product comprising program code means that are stored on a computer-readable data carrier in order, during a track and trace packaging method according to one of claims 1 to 8, to sign a user into or out of a batch workflow and / or to carry out a synchronization of batch-related data with other communicatively connected mobile terminals in real time when the program is executed on a mobile terminal according to claim 10.