Device for connecting two silicone tube sections as part of a pharmaceutical media transfer method, monitoring system, method for monitoring a connection of two silicone tube sections, and software product

Abstract

The invention relates to a device (22) for connecting two silicone tube sections (1, 2) as part of a pharmaceutical media transfer method, comprising an overmolding mold (13) for overmolding two adjacent end-face regions (1a, 2a) of the two silicone tube sections (1, 2) with flowable silicone as the overmolding medium (15) in an overmolding cavity (14), comprising a metering device (17) for supplying the overmolding medium (15) into the overmolding chamber (14) from a media source (34) in a metered manner during the overmolding process, a monitoring device (35) for at least one parameter of the device (22), at least one monitoring sensor (36) for monitoring the at least one parameter of the device (22), a control unit (20) which is connected to the monitoring sensor (36) so as to transmit signals, and a data storage device (37) which is connected to the control unit (20) so as to transmit signals, wherein the monitoring device (35) is additionally designed to monitor at least one process parameter of at least one of the connection steps of "positioning", "overmolding", and "curing". The invention additionally relates to a monitoring system, to a method for monitoring a connection of two silicone tube sections, and to a software product.

Description

[0001] Device for connecting two silicone hose sections in a pharmaceutical media transfer process, monitoring system, method for monitoring a connection of two silicone hose sections and software product

[0002] The invention relates to a device for connecting two silicone tube sections within the framework of a pharmaceutical media transfer process. Furthermore, the invention relates to a monitoring system comprising such a device, a method for monitoring the connection of two silicone tube sections using such a device, and a software product for executing a program sequence according to such a method.

[0003] The connection of hose sections in connection with pharmaceutical or biomedical media transfer processes is known in the prior art in connection with hose materials embodied as thermoplastic elastomers. Such processes are known from EP 2 637 839 B1, EP 1 056 970 B1, and WO 2021 / 118780 A1, as well as from EP 3 060 292 B1 and EP 3 603 735 A1. EP 2 999 513 B1 discloses a device for a method for producing a sterile connection of hoses. US 2009 / 0 243 284 A1 discloses a fluid transfer assembly and methods used therefor. DE 10 2019 202 513 A1 discloses a device for forming or injecting plastic elements onto surfaces of a semifinished product.

[0004] It is an object of the present invention to further develop a connecting device of the type mentioned in the introduction in such a way that a process-reliable and reproducible connection of the two silicone hose sections is ensured.

[0005] This object is achieved according to the invention by a connecting device having the features specified in claim 1, by a monitoring system having the features specified in claim 17 and by a monitoring method having the features specified in claim 18. According to the invention, it was recognized that a connection result of a connecting device depends on a large number of process parameters of the various connection steps, which can include, for example, correct positioning of the mutually facing, adjacent end face regions of the two silicone hose sections to be connected, if appropriate, correct displacement of medium present in the silicone hose sections, correct cutting of the silicone hose sections, correct overmolding, correct curing and, if appropriate, correct sterilization of the resulting silicone hose with the connection.Parameter monitoring, in particular monitoring of the parameters listed above, can be carried out using at least one monitoring sensor. The monitoring sensor can measure, for example, the tensile strength of the produced hose connection, the temperature of injection-molded components, the pressure of injection-molded components, the geometry of injection-molded components, the flow behavior of an overmolding medium within a dosing device and / or within the overmolding cavity, the fill level of an overmolding medium during dosing, and the ozone content in the vicinity of components of the connecting device. Injection-molded components are, on the one hand, components of the overmolding medium, and, on the other hand, the silicone hose sections to be connected.The control unit, which is connected to the monitoring sensor, can send corresponding control signals to components of the connection device based on the measured parameters, allowing, for example, process adjustments to be made. Process adjustment here could mean, for example, that the amount of overmolding medium can be measured and automatically adjusted if, for example, the monitoring device determines that more overmolding medium is needed.

[0006] A data store can, for example, contain comparison parameters required for monitoring and / or serve documentation purposes. The data store can, for example, contain the target data that can be queried in the individual process steps and compared with the actual values.

[0007] With the help of a monitoring device, the connection process can be monitored and the expected process result can be predicted. When connecting the silicone hose sections, hose sections can be separated and then reconnected, particularly with other pairs of hose sections.

[0008] According to the invention, the monitoring device is designed to monitor at least one process parameter of at least one of the connection steps “positioning”, “overmolding”, “curing”.

[0009] Within the scope of this invention, process parameters such as the relative position of the silicone tube sections to one another and / or the volume of the medium not displaced or remaining in the silicone tube sections and / or the cutting angle during or after cutting the silicone tube sections can be monitored. Furthermore, the flow rate of the overmolding medium and / or injection pressures and / or overmolding pressures and / or exposure times during curing and / or cycle times can be monitored as process parameters.

[0010] For example, the monitoring device can be used to monitor the positioning of the silicone hose sections. It can be monitored to determine whether the relative position of the adjacent silicone hose sections deviates from one another. If a deviation is detected, the percentage by which the silicone hose sections are offset from one another compared to their outer diameters can be determined. If the deviation is within a specified tolerance range, the "positioning" process step can be considered successful. The tolerance range can be, for example, 1 percent.

[0011] Furthermore, the monitoring device can be used, for example, to monitor the displacement of the medium. Using a camera that films the area of ​​the silicone hose sections in which the displacement is taking place or has taken place, residues of non-displaced medium in the silicone hose sections can be detected. Using the size and / or dimensions of the silicone hose sections, the monitoring device can calculate a maximum volume of non-displaced medium that may remain in the silicone hose sections. Based on the camera recording, the monitoring device can estimate how much of the medium to be displaced, for example in milliliters, remains in the silicone hose sections. If the monitoring device determines that the volume of the residues of the non-displaced medium is greater than the maximum permitted volume, the displacement can be assessed as unsuccessful.In this case, the device can, for example, issue an error message that the position and dimensional accuracy of the displacement mechanism should or must be checked and, if necessary, serviced.

[0012] Furthermore, the monitoring device can be used to monitor the cutting process step, for example. After the cutting process, it can be checked whether the cut was made at the correct angle to the inner lumen of the respective silicone tube section, for example, 90° to the inner lumen. The monitoring device can determine whether there are any deviations from the upper and / or lower cutting edge.

[0013] Furthermore, the monitoring device can be used to monitor the overmolding process. For example, the monitoring device can determine whether the correct amount of overmolding medium is being used based on the flow rate and the known volume of the dispensing device. For example, depending on the dispensing device, a volume with tolerances can be defined in the monitoring device, which can be used to characterize the dispensing device as "full." Once the overmolding process is complete, the monitoring device can then determine how much overmolding medium has been dispensed based on the flow rate. Depending on the dimensions of the overmolding cavity and / or the silicone hose sections, a different amount of overmolding medium may be required.The monitoring device can determine the dispensed quantity of overmolding medium and evaluate the overmolding process as successful if the dispensed quantity of overmolding material is greater than or equal to a target specification.

[0014] The monitoring device can monitor individual process steps or several steps simultaneously.

[0015] Embodiments of the monitoring sensor according to claims 7 or 9 have proven particularly useful for monitoring corresponding process parameters. Using an optical and / or fiber-optic sensor, it is possible to measure, in particular, the tensile strength of the produced hose connection and / or the pressure of components of the overmolding mold, in particular the pressure within the overmolding cavity. An imaging sensor can be used, in particular, for follow-up inspection. According to one embodiment, the monitoring sensor is designed to monitor the tensile strength of the produced hose connection and / or the pressure of components of the overmolding mold, in particular the pressure within the overmolding cavity.

[0016] According to a particular embodiment, the monitoring sensor is a fiber optic sensor and is designed to monitor a tensile strength of the produced hose connection and / or a pressure measurement of components of the overmolding mold, in particular a pressure measurement within the overmolding cavity.

[0017] In particular, an optical fiber of the monitoring sensor can be subjected to bending and / or tensile loading. The optical fiber can include a fiber Bragg grating for determining tensile forces within the fiber.

[0018] According to one embodiment, the monitoring sensor is designed to monitor dimensions of the silicone hose sections used, in particular wall thicknesses and / or inner diameters and / or outer diameters.

[0019] A documentation unit according to claim 11 can fulfill process documentation requirements that must be met, in particular, due to corresponding obligations in the pharmaceutical media transfer process. The documentation unit can, for example, include or be an OPC UA interface for recording process parameters such as injection and / or overmolding pressures, cycle times, exposure times, or other test values.

[0020] The documentation unit can be part of the control unit. Alternatively, the documentation unit can also be a standalone module of the monitoring system.

[0021] An interface according to claim 12 can enable remote monitoring of the connecting device via the external device. A CMI module, for example, can fulfill remote monitoring via remote devices.

[0022] Network interfaces according to claim 12 enable correspondingly flexible data communication. A Kl module according to claim 13 makes it possible, after initial training, to draw appropriately trained conclusions from the sensor data of the at least one monitoring sensor acquired during a process sequence. These conclusions can be used, in particular, for the maintenance and servicing of the connecting device. The Kl module can be used, in particular, to propose solutions to problems identified by the Kl module within the process sequence.

[0023] The Kl module can be designed to learn from previous hose connections and / or process steps and automatically make suggestions, for example to use more overmolding medium because the required quantity in the previous overmoldings was higher than the target specification or was at the limit of the tolerance.

[0024] In particular, the AI ​​module can be trained based on previous process steps and / or process results. For example, the AI ​​module can be trained using multiple camera recordings or images of faulty and / or faulty connections.

[0025] The Kl module also enables condition assessments of wear components involved in the process, such as tools, UV lamps, etc. The determined values, such as injection and / or overmolding pressures, exposure times, and the mechanical strength of the hose connection, subsequently allow for a real-time assessment of process stability and potential maintenance requirements.

[0026] According to one embodiment, the monitoring sensor is designed to image the manufactured silicone hose after curing, wherein the Kl module is used to perform Kl-based image recognition of the overmolding result.

[0027] According to a particular embodiment, the monitoring sensor is designed as an imaging sensor, in particular as a camera, and the monitoring device comprises the Kl module. The monitoring sensor is designed to image the produced silicone tube after curing, and the Kl module is used to perform Kl-based image recognition of the overmolding result. According to one embodiment, the control unit is designed to evaluate each connection process.

[0028] In particular, the control unit can be designed to compare actual measured values ​​measured via the at least one monitoring sensor with specified target values ​​and then to adjust and / or correct corresponding process parameters if the actual and target values ​​differ from each other by more than a specified tolerance value.

[0029] The control unit can evaluate the connection by comparing predefined target values ​​with actual values. If the target values ​​and actual values ​​match within a specified tolerance range, the connection process can be evaluated as successful.

[0030] According to one embodiment, the device comprises at least one UV lamp. A UV lamp can be used to cure the overmolding medium after overmolding and / or to sterilize the manufactured, connected silicone tube. The required intensity of the curing and / or sterilization light to be generated by the UV lamp can be measured by the at least one monitoring sensor of the monitoring device. At least one useful wavelength or multiple useful wavelengths of the UV lamp can also be monitored by the at least one monitoring sensor. At least one monitoring sensor can then, in particular, have a dispersive component.

[0031] According to one embodiment, the at least one monitoring sensor comprises one monitoring sensor, two, three, four, five, six, seven, eight, nine, ten or more monitoring sensors.

[0032] According to one embodiment, the at least one monitoring sensor comprises an optical sensor and / or a fiber optic sensor and / or an imaging sensor and / or a camera, in particular for industrial image processing (machine vision), and / or a tensile strength sensor and / or a pressure sensor and / or a temperature sensor and / or a flowability sensor for the overmolding medium and / or a fill level sensor for the overmolding medium and / or an environmental monitoring sensor, in particular for recording actual data in comparison to target data, for example to characterize and / or monitor the quality of the environment, and / or a flow measurement sensor and / or a laser-based position and measurement sensor, in particular for recording the position and / or external shape of the silicone hose sections.

[0033] According to one embodiment, the monitoring device further comprises devices for testing, measuring or monitoring protective measures such as according to DIN EN IEC 61557-1 (VDE 0413-1), 2022-12.

[0034] The advantages of a monitoring system according to claim 17 correspond to those already explained above with reference to the connecting device. The monitoring platform of the monitoring system can be used to centrally monitor, for example, a plurality of corresponding devices. The monitoring platform can be cloud-based and / or server-based.

[0035] The monitoring system can communicate with the respective devices, in particular the connecting device, using a corresponding network with associated interfaces. A Kl module can also be part of the monitoring platform, which can communicate with the Kl module of the monitoring device, if present. The functions of the Kl module correspond to those already explained above in connection with the Kl module of the monitoring device. In principle, the central Kl module can also replace the Kl modules of the monitoring devices of the respective devices that are then no longer required. The monitoring system can be used for process monitoring and also for process forecasting.

[0036] The advantages of a monitoring method according to claim 18 correspond to those already explained above with reference to the connecting device and the monitoring system. All feature explanations relating to the connecting device can also be applied to the method, and vice versa.

[0037] This applies accordingly to the method according to claim 19.

[0038] According to one embodiment of the invention, the monitoring device can be used to check the correct fit of the ends of the silicone hose sections by measuring the axis. Further process parameters can include the target filling times of the overmolding mold for the different hose dimensions and / or the irradiation time and intensity of the curing radiation (UV-A) and / or the sterilization radiation (UV-C).

[0039] According to one embodiment, the monitoring device can be used to qualitatively test the hose connection by tensile tests after curing.

[0040] A software product according to claim 20 can be specifically adapted to a respective process flow of the connection method and also of the entire monitoring process. The software product can contain software components that were obtained through previously performed training steps of AI modules and / or utilize correspondingly obtained information.

[0041] Embodiments of the invention are explained in more detail below with reference to the drawings, in which:

[0042] Fig. 1 is a flow diagram of a method for connecting two silicone hose sections and a device for carrying out the method; and

[0043] Fig. 2 again schematically shows the device for carrying out the connection method including components of a monitoring device for monitoring at least one parameter of the device and a monitoring system which includes the connection device and a monitoring platform.

[0044] A method for connecting two silicone hose sections 1, 2 is used in a pharmaceutical media transfer process, in particular in a pharmaceutical filling process for supplying a pharmaceutical medium from a source reservoir 3 to a target reservoir 4. In principle, the connection method can also be used in other pharmaceutical, biological, medical, or other scientific or industrial processes, in particular in the manufacturing process. The silicone hose sections 1, 2 are hose sections made of a material that consists predominantly, i.e., more than 50 percent by weight, of silicone.This silicone material of the silicone hose sections 1, 2 can also consist of more than 60 weight percent, more than 70 weight percent, more than 75 weight percent, more than 80 weight percent, more than 85 weight percent, more than 90 weight percent, more than 95 weight percent, or even more than 98 weight percent silicone.

[0045] The output reservoir 3 is in media connection with the silicone hose section 1 and the target reservoir 4 is in media connection with the silicone hose section 2, for example in fluid connection, in particular for guiding a liquid medium.

[0046] The pharmaceutical filling process is as follows:

[0047] First, a pharmaceutical medium 5 is provided in the outlet reservoir 3, including a silicone supply tube 6 connected to the outlet reservoir 3. The silicone tube section 1 is part of the silicone supply tube 6. Furthermore, the target reservoir 4 is provided, including a silicone discharge tube 7 connected to the target reservoir. The silicone tube section 2 is part of the silicone discharge tube 7.

[0048] The pharmaceutical medium 5 is now displaced in a silicone feed tube section of the silicone feed tube 6, particularly toward the outlet reservoir 3, as indicated in the top left of Figure 1, where the pharmaceutical medium 5 is displaced from a right half of the illustrated section of the silicone feed tube 6 by means of a displacement mechanism 8. Figure 1 thus shows a displacement step 9 of the filling process in the top left.

[0049] In a cutting step 10 (cf. Fig. 1 left center) of the filling process, the silicone supply tube section of the silicone supply tube 6 is then cut through with a cutting unit 11 to create a sterile end face region 1a of the silicone supply tube section. In the same way, in a further cutting step 12, which is also illustrated in Fig. 1 left center, a silicone discharge tube section of the silicone discharge tube 7 is cut through with the cutting unit 11 to create a sterile end face region 2a of the silicone discharge tube section. The cutting unit 11 can be an exchangeable knife. The two cutting steps 10, 12 for cutting the tubes 6, 7 can take place simultaneously with the same cutting unit 11. For this purpose, the two tubes 6, 7 can be arranged parallel to one another.

[0050] The two hose sections, on the one hand the silicone supply hose section and on the other hand the silicone discharge hose section, represent the two silicone hose sections 1, 2 to be connected after the cutting steps 10, 12.

[0051] The silicone supply hose section 6 and the silicone discharge hose section 7 are cut with the cutting unit 11 at a cutting temperature that is less than 80°C. This temperature can be less than 70°C, less than 60°C, less than 50°C, less than 40°C, or less than 30°C. Cutting steps 10 and 12 each involve a cold cut, which is purely mechanical, i.e., does not involve the exposure of the silicone material of the silicone hose sections to heat.

[0052] Sterilization of the two end face areas 1a, 2a can be carried out as part of the filling process by means of UV sterilization lighting of these end face areas 1a, 2a.

[0053] After the cutting steps 10, 12, the two silicone hose sections 1, 2 are positioned relative to one another in an overmolding mold 13 with the end face regions 1a, 2a facing one another such that the facing end face regions 1a, 2a abut one another. A positioning device which is basically already known from the prior art can be used to position the silicone hose sections 1, 2 to be connected. Such a positioning device is schematically indicated in Figure 1, center left at 11a. During the positioning step, a cover sleeve (not shown) can also be positioned relative to the two mutually facing end face regions 1a, 2a of the silicone hose sections 1, 2 to be connected. This is done such that the cover sleeve axially covers the two mutually facing end face regions 1a, 2a.

[0054] The adjacent end face regions 1a, 2a are then overmolded in the overmolding mold 13 by filling an overmolding cavity 14 of the overmolding mold 13 with flowable silicone 15 as the overmolding medium. The overmolding medium 15 can be a two-component (2K) material with components A and B, which are fed into the overmolding cavity 14 via separate feed and metering channels with metering units 16, 16a.

[0055] Alternatively, the overmolding medium 15 can also be a one-component (IK) material. If the overmolding medium 15 is a one-component material, this one component contains a base polymer, a catalyst, and a crosslinker. If the overmolding medium 15 is a two-component material, one of the two components can contain a base polymer and a crosslinker, and the other component can contain a catalyst.

[0056] The cured overmolding medium 15 has a Shore A hardness between 30 and 70. Depending on the overmolding medium 15, the Shore hardness measurement can be carried out according to DIN 53505 (silicone) or according to DIN ISO 7619 (TPE).

[0057] The viscosity of the overmolding medium 15 can be in the range between 10® and 1.1 * 10 7 mPa s.

[0058] A flowable, UV-curing silicone material in the form of flowable silicone 15 can be used as an overmolding material or medium in the pharmaceutical filling process, particularly in the connection process. Liquid silicone rubber (LSR) or high-temperature curing (HTV) silicone, for example, can be used as the overmolding medium 15.

[0059] The dosing units 16, 16a represent a supply device for the flowable silicone 15 as overmolding material and are components of a dosing device 17 for the metered addition of the overmolding medium 15 from a media source into the overmolding cavity 14 during overmolding.

[0060] Figure 1 shows, bottom left, an overmolding step 18 of the connection process after the preceding positioning step, which is not shown in detail.

[0061] After overmolding 18, the flowable silicone is cured by irradiating the flowable silicone 15 with a UV lamp 19 at a UV curing wavelength. The UV curing wavelength can differ from the UV sterilization wavelength. The cured silicone material resulting from the flowable silicone 15 can have a hardness in the range of Shore A 40 to Shore A 60.

[0062] Curing irradiation and sterilization irradiation can be carried out in the same process step during the pharmaceutical filling process.

[0063] The irradiation time for curing or crosslinking the flowable silicone 15 is in the range between 10 s and 120 s, for example, between 60 s and 120 s. The crosslinking wavelength is in the UV-A range, i.e., in a wavelength range between 315 nm and 400 nm.

[0064] During sterilization, the irradiation duration is in the range between 5 s and 1 min, for example between 10 s and 50 s or between 15 s and 45 s. A sterilization irradiation wavelength is in the UV-C range, i.e. in a wavelength range between 200 nm and 280 nm, for example in a range between 240 nm and 260 nm.

[0065] Two different UV sources can be used for cross-linking irradiation on the one hand and for sterilization irradiation on the other. Alternatively, it is possible to work with a single UV source, in which the respective irradiation wavelengths for cross-linking / curing and sterilization are then specified via appropriate filters.

[0066] The cross-linking irradiation time can be longer than the sterilization irradiation time. Alternatively, the sterilization irradiation time can be longer than the cross-linking irradiation time. Both irradiation times can also be the same.

[0067] The crosslinking / curing irradiation does not overlap with the sterilization irradiation period. Sterilization irradiation usually occurs during the bonding process before the crosslinking / curing irradiation.

[0068] The sterilization or curing irradiation is carried out via a control unit 20. This irradiation can be temperature-controlled and / or time-controlled or temperature-controlled and / or time-controlled. A corresponding curing step 21 is shown in the top right of Figure 1. The center of Figure 1 shows a connecting device 22 for carrying out the pharmaceutical filling process and in particular for carrying out the connecting process. The dosing device 17 is part of the connecting device 22.

[0069] The connecting device 22 includes the replaceable blade 11 and the overmolding mold 13. The connecting device 22 can have a magazine with several replaceable blades 11 or interchangeable blades, which can be used selectively and, in particular, automatically. For example, ten to one hundred cutting operations can be performed with one blade. The connecting device 22 can have a set of blades 11. The respective overmolding mold 13 can thus be tailored to the hose sections 1, 2 to be connected.

[0070] The connecting device 22 can have a set of overmolding molds 13, in particular for receiving different outer diameters of silicone hose sections in the manner of the silicone hose sections 1, 2.

[0071] The overmolding mold 13 can be designed as an interchangeable overmolding mold. The connecting device 22 can have a mold magazine containing a plurality of such overmolding molds, in particular with several selectable overmolding cavity sizes. Switching between the interchangeable overmolding molds can be automated. For example, 500 to 100,000, in particular 10,000 to 25,000 overmolding processes can be performed per overmolding mold. The connecting device 22 can store between 3 and 12 overmolding mold sizes, which are particularly matched to pharmaceutical standard sizes of the outer diameters of the silicone tube sections 1, 2.

[0072] The overmolding mold 13 can be accommodated in a mold receptacle of the connecting device 22, which has a contour complementary to the contour of the accommodated overmolding mold. This can ensure, on the one hand, that the overmolding mold is secured against rotation in the mold receptacle and, on the other hand, that the overmolding mold is correctly oriented and positioned in the mold receptacle.

[0073] A signal connection can be established between the overmolding mold 13 and the mold holder, ensuring that the correct overmolding mold is used for a current connection task. This can be achieved, for example, by a plurality of contact pins on the mold holder, between which corresponding conductive connections are established via the overmolding mold 13 when correctly selected.

[0074] The overmolding mold 13 can be made of a polymer material, for example PMMA.

[0075] An operating time and a number of usage cycles of the respective indirect knife 11 can be specified and documented in the control unit 20, which also serves to control the knife 11.

[0076] The control unit 20 also serves, in conjunction with a monitoring device described below, to document the operation of the respective UV lamp, both for curing and sterilization. Each connection process can be evaluated in the control unit 20.

[0077] In particular, a radiation intensity, an irradiation duration and a temperature, in particular of the flowable silicone 15 during the curing process or of the end face areas 1a, 2a during the sterilization process, can be specified and documented.

[0078] After connection, the pharmaceutical medium is filled from the source reservoir 3 via the now connected silicone tubing sections 1, 2 to the target reservoir 4. The pharmaceutical medium is, for example, a buffer solution for pH regulation.

[0079] The connection device 22 can be designed to be mobile. The connection device 22 has a display / operating unit 23, which can be designed as a touchscreen and is in signal communication with the control / regulation unit 20.

[0080] The connection device 22 provides a self-explanatory user interface via the display and operating units 23.

[0081] The display / control unit 23 of the connecting device 22 can also be operated via a pedal and / or a remote control. The connecting device 22 can be designed to be mobile. The connecting device 22 can be configured for battery operation 24 and / or mains operation 25.

[0082] The connecting device 22 can have a reading unit 26 for specifying the respective blade 11 and / or for specifying the respective overmolding mold 13, which is schematically illustrated in Figures 1, center left and 1, bottom left, respectively. The reading unit 26 can read a code on the respective blade 11 and / or on the respective overmolding mold 13, for example, a QR code. Alternatively or additionally, the reading unit 26 can read a corresponding code on at least one of the silicone hose sections 1, 2, which in turn can be embodied as a QR code.

[0083] A fully connected silicone hose 27 with the two connected, sterile end face areas 1a, 2a of the silicone hose sections 1, 2, which are connected to each other via an overmolding 28, is used for media supply in a pharmaceutical filling process.

[0084] Fig. 2 shows, in an even more schematic representation compared to Fig. 1, the connecting device 22 as part of a monitoring system 31, which, in addition to the connecting device 22 and possibly other devices to be monitored, includes a monitoring platform 32 that is signal-connected to the connecting device 22 via a network 33, indicated as a cloud in Fig. 2. The network 33 can be a cellular network or a LAN network. A WLAN connection between the monitoring platform 32 and the connecting device 22 via the network 33 is also possible, for example.

[0085] Components and functions that have already been explained above in connection with Fig. 1 have the same reference numbers and are not discussed again in detail in the description of Fig. 2.

[0086] In addition to the dosing device 17, Fig. 2 also shows a media source 34 for the overmolding medium 15, which is in fluid communication with the dosing device 17. Depending on the design of the connecting device 22, several such media sources can also be provided, so that the dosing device 17 can, for example, provide the overmolding medium 15 in the form of the two-component material already mentioned above.

[0087] The connecting device 22 also includes a monitoring device 35 for monitoring at least one parameter of the connecting device 22. The monitoring device 35 is in signal connection with the dosing device 17, the overmolding mold 13 and the UV lamp 19, which is not shown in detail in Fig. 2. Part of this signal connection can be a data bus of the connecting device 22.

[0088] The monitoring device 35 includes at least one monitoring sensor 36 for monitoring at least one parameter of the connecting device 22.

[0089] The monitoring sensor 36 can be embodied as an optical sensor, particularly as a fiber optic sensor. Such a fiber optic sensor can be used to measure tensile or tension forces, to measure axial strain, and also to measure strength, whereby the respective optical fiber can be subjected to bending / tensile loading. The optical fiber can include a fiber Bragg grating, which can be used to determine tensile forces within the fiber.

[0090] The use of a corresponding fiber Bragg grating (FBG) in the determination of forces in a basal textile-reinforced composite material is known, for example, from J. Jonckheere, F. Narbonneau, L. D'Angelo, J. Witt, B. Paquet, and D. Kinet, “FBG-based smart textiles for continuous monitoring of respiratory movements for healthcare applications,” in IEEE Int. Conf. E-Health Networking Applications and Services, 277-282 (Academic, 2010), from LQ Tang, XM Tao, WC Du, HY Tam, "Reliability of Fiber Bragg Grating Sensors in Textile Composites," in J. Composite Interfaces, Vol. 5 No. 5, pp. 421-435, 1998, and from https: / / www.researchgate.net / profile / Stefan-Kaeseberg / publication /

[0091] 283214424_Sensortextilien_fuer_Monitoring_und_Verstärkeung_von_Bauteilen / links / 56325df608ae911fcd490dd8 / Sensortextilien-fuer-Monitoring-und-

[0092] Reinforcement of components.pdf.

[0093] An optical monitoring sensor 36, particularly embodied as an optical fiber, can be introduced into the overmolding mold 13 for monitoring the overmolding cavity 14 through an opening covered by an optically transmissive window, for example, a sapphire window. This can be used to measure the internal pressure in the overmolding cavity 14.

[0094] Alternatively or additionally, the monitoring sensor 36 can be designed as an imaging sensor.

[0095] An optical sensor can be used to measure a thickness of the overmolding 28.

[0096] With the monitoring sensor 36, bubble detection within a flow of the overmolding medium 15 can be carried out, in particular by optical means.

[0097] The monitoring device 35 also includes the control unit 20, which is in signal communication with the monitoring sensor 36. In addition to controlling the monitoring device 35, the control device 20 can also, as explained above, serve to control, in particular, the dosing device 17 and the UV lamp 19. In an alternative embodiment of the connecting device 22, these tasks can also be performed by an additional control unit.

[0098] The monitoring device 35 also includes a data storage unit 37, which is in signal communication with the control unit 20. The data storage unit 37 serves to store sensor and documentation data. Further information regarding the operation of the connection device 22 can also be stored in the data storage unit 37.

[0099] Parameters of the connecting device 22 that can be measured with the at least one monitoring sensor 36 are a tensile strength of a hose connection created in the silicone hose 27 between the silicone hose sections 1 and 2 via the overmolding 28, a temperature of injection components of the connecting device, in particular of components of the metering device 17 and the overmolding mold 13 that carry the overmolding medium 15, a pressure of injection components, in particular of components of the metering device 17 and / or the overmolding mold 13 that carry the overmolding medium 15, a geometry of injection components, in particular of the overmolding mold 13, a flow behavior of the overmolding medium within the metering device 17 and / or within the overmolding cavity 14 of the overmolding mold 13, a fill level measurement of the media source 34 or of components, for example a metering piston, of the metering device 17,an ozone content of the ambient air around the overmolding mold 13, within the connecting device 22, or also around the connecting device 22, as well as parameters of the UV lamp 19, for example, a temperature of the UV lamp 19, a UV emission wavelength, or a useful illumination intensity for curing and / or sterilization. The respective monitoring sensor 36 is designed to detect the corresponding parameter or a plurality of these corresponding parameters. The at least one monitoring sensor 36 can thus be designed as a tensile strength sensor, e.g., fiber-optic, a temperature sensor, a pressure sensor, a length measuring sensor, an area measuring sensor, a volume measuring sensor, a flow sensor, e.g., an anemometer, a fill level sensor, a chemical sensor, an intensity sensor, and / or a spectrometric sensor. In particular, the following can be monitored:Whether appropriate wavelengths in the UV-A and / or UV-C range are available for curing and sterilization. This can ensure, in particular, a sufficient degree of curing or sterilization. The service life of the UV lamp 19 can also be monitored in this way.

[0100] The monitoring sensor 36 may be an IoT compatible sensor component.

[0101] The monitoring device 35 further includes a documentation unit 38. The documentation unit 38 is signal-connected to the monitoring sensor 36, the control unit 20, and the data storage device 37. The documentation unit 38 serves to store documentation data, which includes, in particular, sensor data from the monitoring sensor 36. The documentation unit 38 can be part of the control unit 20 or, as illustrated in Fig. 2, a standalone module of the monitoring device 35.

[0102] The monitoring device 35 further has an interface 39 for data communication with an external device. A data connection 40 for this data communication is indicated in Fig. 2 by a dashed line between the interface 39 and the network 33. Remote monitoring of the connecting device 22 can be carried out via the interface 39. The network 33 can be an IoT (Internet of Things) network and / or a cloud network. An IoT network is known, for example, from WO 2020 / 229496 A1.

[0103] The monitoring device 35 can further comprise an artificial intelligence (AI) module 41, for example in the form of a neural network. Such an AI module can be used to initially train the individual steps of the connection method described above on the basis of the sensor data acquired by the at least one monitoring sensor 36 and, if applicable, further data provided by the control unit 20, the data storage device 27, and the documentation unit 38. With the aid of the AI ​​module 41, in particular, AI-based image recognition of an overmolding result can be performed, provided that at least one imaging sensor is used as the monitoring sensor 36, which images the produced silicone tube 27 after the curing step 21 has been completed.Intermediate steps of the connection process, for example, the result of the displacement step 9, the result of at least one of the cutting steps 10, 12, and the result of the overmolding step 18, can also be recorded by at least one appropriately positioned imaging monitoring sensor 35 and evaluated using the Kl module 41. The algorithm of the Kl module can continue to learn through each evaluation application in the sense of a self-learning system and thus be further optimized.

[0104] The monitoring device 35 can, in particular, output corresponding messages via the display / operating unit 23 when maintenance or repair of corresponding components of the connecting device is required. After completing a corresponding training phase, the Kl module can then submit suggestions for solutions to problems identified by evaluating corresponding sensor data from the monitoring sensors 36 in the Kl module 41 via the display / operating unit 23.

[0105] The monitoring platform 32 comprises an external control unit 42, which may have a data memory and a documentation unit, the functions of which correspond to those described above in connection with these components of the monitoring device 35.

[0106] Part of the monitoring platform 32 is a central AI module 43, whose function essentially corresponds to that of the AI ​​module 41 of the monitoring device 35 of the connecting device 22. Information from various devices monitored via the monitoring platform 32 and connected to it via the network 33 can converge in the central AI module 43. In this way, operating situations of all devices monitored via the monitoring platform 32 can be used to train the operating sequence of the respective devices. The central AI module 43 exchanges information with the decentralized AI modules 41 of the respective monitoring devices 35 of the devices according to the connecting device 22.

[0107] The monitoring platform 32 can be used to monitor the process and predict the process of the connection process that can be carried out via the connection device 22.

[0108] The monitoring platform 32 may be an IoT platform.

[0109] When monitoring the connection of the silicone hose sections 1, 2 with the connection device 22 or with the monitoring system 31, the connection method is carried out with the positioning step, the cutting steps, the overmolding step, and the curing step, as already explained above. At least one of the process parameters of the connection method is monitored by the monitoring device 35 during the execution of at least one of these connection steps. The result of the monitoring is documented via the documentation unit 38. In addition, this result is transmitted to the monitoring platform 32 via the network 33, provided that the monitoring is at least partly carried out centrally via the monitoring platform 32.

[0110] Monitoring can be carried out during individual dosing steps of the dosing device 17 in order to monitor a progress, in particular of a flow of the overmolding medium 15 along a dosing path between the media source 34 and the overmolding cavity 14.

[0111] Through appropriate geometry measurement and analysis of 3D data, specific corrections to tool components of the overmolding mold 13 can be performed. This allows for full-surface shape and dimensional analyses. In particular, a three-dimensional flow analysis can be performed.

[0112] With the aid of at least one monitoring sensor 36, the dimensions of the silicone hose sections 1, 2 used, in particular wall thicknesses, inner diameters, and / or outer diameters, can be monitored. This can be done for process control. If the expected dimensions required to carry out a process specified via the display / operating unit 23 do not match the measured ones, the further process flow can be interrupted and a corresponding warning can be output via the display / operating unit 23.

[0113] In the control unit 20, actual measured values ​​measured via the at least one monitoring sensor 36 can be compared with specified target values ​​and corresponding process parameters can then be adjusted if the actual and target values ​​differ from each other by more than a specified tolerance value.

[0114] The monitoring device 35 and the monitoring system 31 can be used to make a quality prediction and also a prediction of upcoming maintenance or repair.

[0115] The documentation unit 38 can be used to document, in particular, the number of units produced and the cycle times required for this.

[0116] Data transfer can be achieved using OPC-UA (Open Platform Communication Unified Architecture). This is a collection of standards for communication and data exchange in the field of industrial automation. OPC-UA describes the transport of machine-to-machine data, interfaces, and a data or data protocol structure.

[0117] To execute a program sequence according to the monitoring method explained above, and in particular according to the connection method explained above, which may be refined through monitoring, software is used that is processed by the control units 20 and 42, respectively. This software includes software components that are influenced by the control modules 41 and 43, respectively. This description also covers the following aspects:

[0118] 1. Device (22) for connecting two silicone hose sections (1, 2) within the framework of a pharmaceutical media transfer process, comprising an overmolding mold (13) for overmolding two adjacent end face regions (1a, 2a) of the two silicone hose sections (1, 2) in an overmolding cavity (14) with flowable silicone as overmolding medium (15), comprising a metering device (17) for the metered addition of the overmolding medium (15) from a media source (34) into the overmolding cavity (14) during overmolding, comprising a monitoring device (35) for at least one parameter of the device (22), comprising at least one monitoring sensor (36) for monitoring the at least one parameter of the device (22), comprising a control unit (20) which is in signal connection with the monitoring sensor (36), comprising a data memory (37) which is connected to the control unit (20) is in signal connection.

[0119] 2. Device according to aspect 1, characterized in that the monitoring sensor (36) is designed as an optical sensor.

[0120] 3. Device according to aspect 2, characterized in that the monitoring sensor (36) is designed as a fiber optic sensor.

[0121] 4. Device according to aspect 2 or 3, characterized in that the monitoring sensor (36) is designed as an imaging sensor.

[0122] 5. Device according to one of aspects 1 to 4, characterized in that the monitoring device (35) has a documentation unit (38) which is in signal connection with the monitoring sensor (36) for storing documentation data, which includes sensor data of the monitoring sensor (36).

[0123] 6. Device according to one of aspects 1 to 5, characterized in that the monitoring device (35) has an interface (39) for data communication with an external device (42). 7. Device according to aspect 6, characterized in that the interface (39) is part of an IoT network.

[0124] 8. Device according to aspect 6 or 7, characterized in that the interface (39) is part of a cloud network.

[0125] 9. Device according to one of aspects 1 to 8, characterized in that the monitoring device has a Kl module (41).

[0126] 10. Device according to one of aspects 1 to 9, characterized by at least one UV lamp (19).

[0127] 11. Monitoring system with a device (22) according to one of aspects 1 to 10, with a monitoring platform (32) which is in signal connection with the device (22).

[0128] 12. Method for monitoring a connection of two silicone hose sections (1, 2) with a connecting device (22) according to one of aspects 1 to 10 and / or with a monitoring system according to aspect 11, comprising the following steps:

[0129] Positioning mutually facing end face regions (1a, 2a) of the silicone hose sections (1, 2) to be connected in the overmolding mold (13) of the connecting device (22) such that the facing end face regions (1a, 2a) lie against one another,

[0130] Overmolding the adjacent end face areas (1a, 2a) in the overmolding mold (13) by filling the overmolding cavity (14) of the overmolding mold (13) with the overmolding medium (15) by means of the dosing device (17) of the connecting device (22),

[0131] Curing (21) of the overmolding medium (15), wherein at least one process parameter of at least one of the connection steps “positioning”, “overmolding”, “curing” is monitored by means of the monitoring device (35) and / or by means of the monitoring platform (32).

[0132] 13. Method according to aspect 12, characterized in that a monitoring result of the monitoring device (35) and / or the monitoring platform (32) is documented. 14. Software product for executing a program sequence according to a method according to one of aspects 12 or 13.

Claims

Patent claims 1. Device (22) for connecting two silicone hose sections (1, 2) within the framework of a pharmaceutical media transfer process, comprising an overmolding mold (13) for overmolding two adjacent end face regions (1a, 2a) of the two silicone hose sections (1, 2) in an overmolding cavity (14) with flowable silicone as overmolding medium (15), comprising a metering device (17) for the metered addition of the overmolding medium (15) from a media source (34) into the overmolding cavity (14) during overmolding, comprising a monitoring device (35) for at least one parameter of the device (22), comprising at least one monitoring sensor (36) for monitoring the at least one parameter of the device (22), comprising a control unit (20) which is in signal connection with the monitoring sensor (36), comprising a data memory (37) which is connected to the control unit (20) is in signal connection, wherein the monitoring device (35) is further designed toto monitor at least one process parameter of at least one of the connection steps “positioning”, “overmolding”, “curing”.

2. Device according to claim 1, wherein the monitoring device is designed to monitor at least one of the following process parameters: a relative position of the silicone hose sections to each other, and / or a volume of the medium not displaced or remaining in the silicone hose sections after displacing the medium, and / or a cutting angle during or after cutting the silicone hose sections, and / or a flow rate of the overmolding medium, and / or Injection pressures and / or overmolding pressures of the overmolding medium, and / or Exposure times during curing, and / or Cycle times.

3. Device according to one of the preceding claims, wherein the monitoring device is designed to detect the positioning of the silicone hose to monitor cuts by monitoring whether the relative position of the silicone hose sections placed next to one another deviates from one another; wherein, if a deviation is detected by the monitoring device, the monitoring device determines by what percentage the silicone hose sections are offset from one another in comparison to their outer diameters; wherein, if the deviation is within a predetermined tolerance range, the "positioning" process step is assessed by the monitoring device as successful, the tolerance range in this case being, for example, 1 percent.

4. Device according to one of the preceding claims, wherein the monitoring device is designed to monitor the process step of "displacing" the medium, wherein residues of non-displaced medium in the silicone hose sections are detected by means of a camera that films an area of the silicone hose sections in which the displacement is taking place or has taken place; wherein the monitoring device is designed to calculate a maximum volume of non-displaced medium that may remain in the silicone hose sections based on the size and / or dimensions of the silicone hose sections; wherein the monitoring device is further designed to estimate, based on the camera recording, how much of the medium to be displaced, for example in milliliters, remains in the silicone hose sections.If the monitoring device detects that the volume of the remaining non-displaced medium is greater than the maximum permitted volume, the displacement is deemed unsuccessful; in this case, the device is particularly designed to issue an error message indicating that the position and dimensional accuracy of the displacement mechanism should or must be checked and, if necessary, serviced.

5. Device according to one of the preceding claims, wherein the monitoring device is designed to monitor the process step “cutting”, wherein after the cutting process it is checked whether the cut was made at the correct angle to the inner lumen of the respective silicone tube section, for example 90° to the inner lumen; wherein the monitoring device is further configured to determine whether there are deviations from the upper and / or lower cutting edge.

6. Device according to one of the preceding claims, wherein the monitoring device is designed to monitor the process step “overmolding”; wherein the monitoring device determines, based on the flow rate of the overmolding medium and the known volume of the dosing device, whether the correct amount of overmolding medium is being used; wherein, depending on the dosing device, a volume with tolerances is defined in the monitoring device, by which the dosing device can be characterized as “full”; wherein, when the overmolding takes place, the monitoring device is designed to determine, based on the flow rate of the overmolding medium, how much overmolding medium has been dispensed; wherein the monitoring device is designed to determine the dispensed amount of overmolding medium and to evaluate the overmolding process as successful if the dispensed amount of overmolding material is greater than or equal to a target specification.

7. Device according to one of the preceding claims, wherein the monitoring sensor (36) is designed as an optical sensor, wherein the monitoring sensor (36) is designed in particular as a fiber optic sensor.

8. Device according to one of the preceding claims, wherein the monitoring sensor (36) is designed to monitor a tensile strength of the produced hose connection and / or a pressure measurement of components of the overmolding mold (13), in particular a pressure measurement within the overmolding cavity (14), wherein in particular an optical fiber of the monitoring sensor is subjected to a bending and / or tensile load, wherein the optical fiber in particular includes a fiber Bragg grating for determining tensile forces within the fiber.

9. Device according to one of the preceding claims, wherein the monitoring sensor (36) is designed as: imaging sensor, camera, in particular for industrial image processing, tensile strength sensor, pressure sensor, temperature sensor, flowability sensor for the overmolding medium, fill level sensor for the overmolding medium, environmental monitoring sensor, in particular for recording actual data in comparison to target data, for example to determine the quality of the environment. to characterize and / or monitor the application, flow measuring sensor, or laser-based position and measurement sensor, in particular for detecting the position and / or external shape of the silicone hose sections.

10. Device according to one of the preceding claims, wherein the monitoring sensor (36) is designed to monitor dimensions of the silicone hose sections (1, 2) used, in particular wall thicknesses and / or inner diameters and / or outer diameters.

11. Device according to one of the preceding claims, wherein the monitoring device (35) has a documentation unit (38) which is in signal connection with the monitoring sensor (36) for storing documentation data, which includes sensor data of the monitoring sensor (36), wherein the documentation unit contains in particular target data which is queried in the individual process steps and compared with predetermined actual values.

12. Device according to one of the preceding claims, wherein the monitoring device (35) has an interface (39) for data communication with an external device (42), wherein the interface (39) is in particular part of an IoT network and / or cloud network.

13. Device according to one of the preceding claims, wherein the monitoring device comprises a KL module (41).

14. Device according to claim 13, wherein the monitoring sensor (36) is designed to image the produced silicone hose after curing has taken place, wherein a Kl-based image recognition of the overmolding result is carried out with the aid of the Kl module (41).

15. Device according to claim 13 or 14, wherein the Kl module is designed to learn from previous hose connections and / or process steps of the connection, wherein the Kl module is or is trained in particular on the basis of previous process steps and / or process results, wherein the Kl module is or is trained, for example, by means of several camera recordings or images of error-free and / or faulty connections.

16. Device according to one of the preceding claims, wherein the control unit (20) is designed to compare actual measured values measured via the at least one monitoring sensor (36) with specified target values and then adjust corresponding process parameters if the actual and target values deviate from one another by more than a specified tolerance value; and / or wherein the control unit in signal communication with the monitoring sensor is designed to issue corresponding control signals to components of the connecting device depending on the measured process parameters, so that a process adjustment takes place, wherein process adjustment includes, for example, that the amount of overmolding medium is measured and automatically corrected if the monitoring device determines that more overmolding medium is required.

17. A monitoring system comprising a device (22) according to any one of the preceding claims, comprising a monitoring platform (32) which is in signal communication with the device (22).

18. Method for monitoring a connection of two silicone hose sections (1, 2) with a connecting device (22) according to one of claims 1 to 16 and / or with a monitoring system according to claim 17 with the following steps: Positioning mutually facing end face regions (1a, 2a) of the silicone hose sections (1, 2) to be connected in the overmolding mold (13) of the connecting device (22) such that the facing end face regions (1a, 2a) lie against one another, Overmolding the adjacent end face areas (1a, 2a) in the overmolding mold (13) by filling the overmolding cavity (14) of the overmolding mold (13) with the overmolding medium (15) by means of the dosing device (17) of the connecting device (22), Curing (21) of the overmolding medium (15), wherein at least one process parameter of at least one of the connection steps "positioning", "overmolding", "curing" is monitored by means of the monitoring device (35) and / or by means of the monitoring platform (32).

19. The method according to claim 18, wherein a monitoring result of the monitoring device (35) and / or the monitoring platform (32) is documented.

20. A software product for executing a program sequence according to a method according to one of claims 18 or 19.

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