Device for connecting two silicone tube sections as part of a pharmaceutical media transfer process

Abstract

The invention relates to a device (22) for connecting two silicone tube sections as part of a pharmaceutical media transfer process, comprising an overmoulding mould for overmoulding two end face regions of the tube sections in an overmoulding space with flowable silicone as the overmoulding medium. A metering mechanism (17) is used for the metered addition of the overmoulding medium from a medium source (31, 32) into the overmoulding space during overmoulding. The metering mechanism (17) has at least one metering device (33) with the respective overmoulding medium source (31, 32) of a metering unit and a supply channel (16, 16a) for supplying the overmoulding medium (15) to be metered from the metering unit to the overmoulding space. The metering mechanism (17) is designed such that it dispenses a controlled metering volume of the overmoulding medium for overmoulding in a range between 0.1 cm3 and 10 cm3 during a metering duration in a range between 0.5 s and 10 s. The result is a connection device that ensures reliable and reproducible connection of the two silicone tube sections.

Description

[0001] Device for connecting two silicone hose sections in a pharmaceutical media transfer process

[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 method for connecting 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 at the outset 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 connection device or a connection system having the features specified in claim 1.

[0006] According to the invention, it was recognized that a dosage volume in the range between 0.1 cm 3 and 10 cm 3On the one hand, it is large enough to ensure reliable overmolding of the adjacent end faces of the silicone hose sections to be connected, but on the other hand, it is advantageously small to ensure low consumption of the overmolding medium per connection and also to ensure that the overmolding medium is not undesirably lost beyond the overmolding cavity. The dosing time ensures a rapid overmolding process during the connection. A reliable and reproducible connection with a particularly short process time can then be guaranteed.

[0007] The cured overmolding medium has a Shore A hardness between 20 and 70, especially between 30 and 70. The viscosity of the overmolding medium can be in the range between 10 6 mPa s and 1 .1 * 10 7mPa s. The overmolding media source can be designed as a storage container, in particular as a cartridge. The filling volume of the storage container can be in the range between 100 ml and 10 l and can in particular be in the range between 500 ml and 700 ml. The dosing device can have a programmable logic controller (PLC). The dosing device can be designed with stainless steel components, in particular in the area of ​​the components that come into contact with the overmolding media. In the area of ​​these components that come into contact with the overmolding media, the dosing device can be designed with hardened components, in particular for abrasion protection. The dosing device can have vacuum degassing to avoid unwanted gas bubbles in a feed volume between the media source and the overmolding cavity. The dosing device can have a dynamic and / or a static mixer for the overmolding medium.The dosing device may have a transfer pump for the overmolding medium.

[0008] A device for connecting two silicone hose sections within the framework of a pharmaceutical media transfer process according to claim 1 further comprises a set of overmolding molds, in particular for receiving different outer diameters of silicone hose sections, and a control unit which is designed such that, based on the silicone hose sections to be connected, a suitable overmolding mold can be selected from the set of overmolding molds, and a volume of the overmolding cavity and, via this, the metering volume of the overmolding medium for the connection process can be calculated.

[0009] The two silicone hose sections can be positioned with the end face areas facing each other in the selected overmolding mold, in particular by means of a positioning device, so that the facing end face areas abut against each other.

[0010] The metering device allows the calculated metered volume of the overmolding medium to be fed into the overmolding cavity in a controlled manner. A design of the metering device according to claim 2 enables the metering of even highly viscous overmolding media. The metering device can include a metering pump. The metering pump can be designed as an eccentric screw pump or a gear pump.

[0011] A dosing device according to claim 3 enables the addition of a two-component overmolding medium, which hardens after the two components have been combined. Alternatively or additionally, such a dosing device can also enable the addition of an additive and / or a dye. A dosing device with multiple overmolding medium sources, designed as storage containers, can also enable switching between the two dosing devices, particularly when the storage container of one of the dosing devices has been emptied. The emptied storage container can then be replaced during operation of the dosing device using the other storage container. Undesirable interruptions in the operation of the connecting device are then avoided.

[0012] Dosing ratios according to claim 4 have proven to be particularly suitable.

[0013] According to claim 5, the calculated dosing volume of the overmolding medium from the two overmolding medium sources can be fed into the overmolding cavity in a controlled manner in the appropriate dosing ratio.

[0014] According to claim 6, the device according to the invention further comprises a set of cutting units, in particular knives, blades or interchangeable knives / blades, wherein each cutting unit is designed to cut through a silicone tube to produce a sterile end face region of a silicone supply tube section of a silicone supply tube and / or to cut through a silicone tube to produce a sterile end face region of a silicone discharge tube section of a silicone discharge tube.

[0015] According to claim 7, the cutting unit (11) is designed such that the cutting of the silicone supply tube section and the silicone discharge tube section takes place at a cutting temperature of 0°C to 80°C, in particular from 0°C to 70°C, from 0°C to 60°C, from 0°C to 50°C, from 0°C to 40°C, or from 0°C to 30°C. According to claim 8, the device according to the invention further comprises a UV source for sterilization irradiation. The control unit is further designed such that, after cutting through the silicone tube(s), the UV source for the sterilization irradiation irradiates the two end face areas with an irradiation duration in the range between 5 s and 1 min, in particular between 10 s and 50 s or between 15 s and 45 s, and with a sterilization irradiation wavelength in the UV-C range, in particular in a wavelength range between 200 nm and 280 nm or in a range between 240 nm and 260 nm.

[0016] According to claim 9, the device according to the invention further comprises a UV source for curing irradiation. The control unit is further configured such that, after the overmolding medium has been supplied into the overmolding cavity, the UV source for curing irradiation irradiates the overmolding medium with an irradiation duration in the range between 10 s and 120 s, in particular between 60 s and 120 s, and with a crosslinking wavelength in the UV-A range, in particular in a wavelength range between 315 nm and 400 nm.

[0017] According to claim 10, the device according to the invention further comprises a reading unit, in particular designed as a code reader or QR code reader, for specifying a knife within the knife set andZor for specifying an overmolding mold within the overmolding mold set andZor for specifying the hoses for the hose sections to be connected andZor for specifying the overmolding medium.

[0018] The knives within the knife set andZor the overmolding mold within the overmolding mold set andZor the hoses for the hose sections to be connected andZor the dosing device, in particular theZthe overmolding medium reservoir of the dosing device, each have default data, in particular in the form of machine-readable codes or QR codes.

[0019] According to claim 11, the device according to the invention is designed to be mobile and movable, and is suitable for laboratory or clinical use, for a clean room, or a pre-production environment. The device has, in particular, several casters mounted on a frame of the device. The dosing device can be arranged below and separately from the connection device. The device according to the invention is an isolated solution / a self-sufficient solution. The total weight of the device according to the invention can be between 20 and 100 kg. The footprint of the device according to the invention is typically less than 1 m 2 In particular, a base area of ​​40 by 60 cm is possible. The total height of the device according to the invention can be, for example, 1.00 m to 1.20 m.

[0020] A flushing device according to claim 12 prevents clogging of the at least one supply channel. A flushing device for flushing the overmolding mold of the connecting device can also be provided.

[0021] A fill level sensor according to claim 13 can be ensured by measuring a piston stroke of a dosing piston of the dosing unit. Using such a fill level sensor, it is also possible to measure mixing ratios in a dosing device with multiple dosing devices.

[0022] At least one pressure sensor according to claim 14 enables the measurement of a feed pressure, which can be used in particular for quality control and also for monitoring the need for maintenance of the dosing device.

[0023] A volume flow sensor according to claim 15 and a bubble detection sensor according to claim 16 have corresponding advantages.

[0024] A leak testing device according to claim 17 makes it possible to test the established connection for leaks. The leak testing device can have a compressed gas source that is in signal communication with a pressure sensor of the leak testing device.

[0025] The advantages of a connection method according to claim 18 correspond to those already explained above with reference to the connection device.

[0026] The advantages and embodiments stated above with reference to the device according to the invention also apply, in terms of method, to the connection method according to claim 18. No dependent method claims have been directed to this method to date. However, the applicant expressly reserves the right to establish dependent method claims at a later stage of the process that correspond to the dependent device claims 2 to 17 in terms of method.

[0027] A speed-proportional material discharge during overmolding and especially during dosing leads to a desired process-reliable connection.

[0028] The advantages of a software product according to claim 19 correspond to those already explained above, in particular with reference to the connection method.

[0029] The following can be used as input variables for the program flow:

[0030] Information on the combination of the silicone hose sections to be connected, for example inner / outer diameters and wall thicknesses of the silicone hose sections, data on the respective silicone hose material and, if applicable, pretreatment of the silicone hose material.

[0031] The type of overmolding mold currently used during the connection process, specifically the type of overmolding cavity used during the overmolding process. From this, the program can calculate the volume of the overmolding cavity and, using this information, calculate a shot quantity setting, i.e., the amount of overmolding medium to be added per connection process. This results in the overmolding medium being metered accordingly as needed.

[0032] The type of overmolding medium used. Depending on this, the program can control the curing technique, which, for example, can comply with any specified curing time when using a multi-component curing overmolding medium. The program can also control a UV light source for UV-curable overmolding medium. Entering the type of overmolding medium used can also influence the program control of additive or color addition via the dosing device.

[0033] A dosing ratio when using multiple dosing devices. This can be specified programmatically by appropriately controlling the dosing devices of the dosing devices. Input variables related to the hose can, for example, be contained in a machine-readable code assigned to the hose. Input variables related to the overmolding medium can, for example, be contained in a machine-readable code assigned to the overmolding medium source, in particular the storage container. The program sequence can be influenced via teach-in processes or machine learning processes. Process parameters from previously completed connection sequences, for example a cycle duration of a dosing step or a temporal parameter progression of injection pressure, volume flow, and fill level values, can be used here.

[0034] The flowable silicone can be liquid silicone rubber (LSR) or high-temperature curing silicone (HTV). It can be a silicone material with a hardness range of between Shore A20 and Shore A70.

[0035] The flowability of the silicone is such that the overmolding cavity is sufficiently filled. The viscosity of the flowable silicone can be adapted to a typical cavity size or cavity design of the overmolding cavity.

[0036] A silicone hose section within the meaning of the present application is a hose section made of a material that consists predominantly of silicone. The adjacent end faces of the silicone hose sections do not have to be adjacent to one another over the entire circumference of the hose. However, this is preferred.

[0037] The flowable silicone is cured using UV light irradiation, particularly in the UV-A wavelength range between 315 nm and 400 nm, especially in the range between 315 nm and 380 nm. In principle, the flowable silicone can also be cured using UV light irradiation by irradiation with a different UV wavelength in the range between 100 nm and 315 nm, particularly in the range between 280 nm and 315 nm (UV-B). A broadband UV light source can be used, in which the UV wavelength range actually used is then filtered out. The advantages of the connection method according to the invention are particularly well realized through the use of a pharmaceutical media transfer process.Such media transfer can take place throughout the entire production chain of a pharmaceutical manufacturing process, for example, during the manufacturing process from a batch preparation to a final filling process. The media transfer process can be used in pharmaceutical development steps, from laboratory development through intermediate scale-up steps to mass production. An example of a pharmaceutical media transfer process is a pharmaceutical filling process, in particular the addition of a buffer solution for pH regulation in the target reservoir. The target reservoir can be a sterile container, a process reactor, or even a bag.

[0038] The pharmaceutical media transfer process may also include a sterilization step for the end areas of the tubing sections created during cutting. This sterilization of the end areas can again be achieved using UV light irradiation. A UV-C wavelength in the wavelength range between 100 nm and 280 nm, particularly in the range between 100 nm and 200 nm or between 200 nm and 280 nm, can be used.

[0039] As a positioning device of the connecting device for carrying out the positioning step of the connecting method, a device can be used which is already known for positioning in connection with the connection of TPE hose components.

[0040] The connection device can be designed to be mobile. Such a mobile design is particularly suitable for laboratory or clinical use. This mobile design can also be advantageously used in a clean room or pre-production environment. The connection device can be designed to be mobile. The device carrying out the connection process can, in particular, be designed to be mobile. For this purpose, the device can have a plurality of casters mounted on a frame of the device. In the mobile design, the device can also have a drive, for example, via at least one electric motor. The connection device can have a self-sufficient power supply, i.e., can be designed so that it does not depend on external power connections. The connection device can be designed for battery operation.The connecting device can have a set of cutting units, for example, knives. The connecting device can have a set of interchangeable overmolding molds. The connecting device can have a reading unit for specifying a knife within the knife set and / or for specifying an overmolding mold within the overmolding mold set. This specification can be tailored to the hose sections to be connected. For the corresponding specification, the hoses for the hose sections to be connected can have specification data, which can be coded, for example, in the form of a QR code. The reading unit can then be designed as a QR code reader.

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

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

[0043] Fig. 2 again shows in perspective an embodiment of the device for carrying out the connection method with a dosing device for the dosed addition of an overmolding medium for a connection step of the method;

[0044] Fig. 3 also schematically shows a leak testing device of the connection device.

[0045] A method for connecting two silicone hose sections 1, 2 is used in a pharmaceutical media transfer process, in particular in a pharmaceutical discharge 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.

[0046] The silicone hose sections 1, 2 are hose sections made of a material that predominantly consists of silicone, i.e., more than 50 percent by weight. This silicone material of the silicone hose sections 1, 2 can also consist of more than 60 percent by weight, more than 70 percent by weight, more than 75 percent by weight, more than 80 percent by weight, more than 85 percent by weight, more than 90 percent by weight, more than 95 percent by weight, or even more than 98 percent by weight. The output reservoir 3 is in media communication with the silicone hose section 1, and the target reservoir 4 is in media communication with the silicone hose section 2, for example, in fluid communication, in particular for conducting a liquid medium.

[0047] The pharmaceutical filling process is as follows:

[0048] First, a pharmaceutical medium 5 is provided in the output reservoir 3, including a silicone supply tube 6 connected to the output 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.

[0049] 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.

[0050] In a cutting step 10 (see 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 region 1a of the silicone supply tube section. Similarly, in a further cutting step 12, 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 region 2a of the silicone discharge tube section. The cutting unit 11 can be a replaceable blade.

[0051] This cutting step 10 allows existing tubes to be shortened to the optimal length and individually reconnected, thereby meeting the requirements for a sterile connection, as is typical in pharmaceutical applications. The two cutting steps 10, 12 for cutting the tubes 6, 7 can be performed simultaneously using the same cutting unit 11. For this purpose, the two tubes 6, 7 can be arranged parallel to each other.

[0052] 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.

[0053] Cutting through the silicone supply hose section 6 and the silicone discharge hose section 7 is performed with the cutting unit 11 at a cutting temperature of 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.

[0054] Sterilization of the two end face areas 1a, 2a can be carried out as part of the filling process using UV sterilization lighting of these end face areas 1a, 2a.

[0055] After the cutting steps 10, 12, the two silicone hose sections 1, 2 are positioned relative to each other in an overmolding mold 13 with their end face regions 1a, 2a facing each other such that the facing end face regions 1a, 2a abut one another. A positioning device, which is fundamentally 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.

[0056] Typically, the overmolding mold 13 consists of two separate overmolding mold parts.

[0057] Typically, the internal height of the overmolding mold 13, viewed in the radial direction of the silicone tube sections, is 1.5 to 4 times the external diameter of the tube sections. Likewise, the internal width of the overmolding mold is 1.5 to 4 times the external diameter of the silicone tube sections. 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.

[0058] The overmolding medium 15 can be a two-component (2K) material with components A and B, which are fed to the overmolding cavity 14 via separate feed / dosage channels with dosing units 16, 16a (see also Fig. 2). 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.

[0059] 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).

[0060] The viscosity of the uncured overmolding medium 15 can be in the range between 10 6 and 1 ,1 * 10 7 mPa s.

[0061] A flowable, UV-curing silicone material in the form of flowable silicone 15 can be used as an overmolding material in the pharmaceutical filling process, particularly in the connection process. Liquid silicone rubber (LSR) or high-temperature curing (HTV) silicone can be used as the overmolding medium 15.

[0062] 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 (see Fig. 2) for the metered addition of the overmolding medium 15 from a media source into the overmolding cavity 14 during overmolding. The associated supply channels of the dosing device 17 of the dosing units 16 / 16a are shown in the drawing. The dosing device 17 will be explained in more detail below.

[0063] Figure 1 shows, at the bottom left, an overmolding step 18 of the connection process following the preceding positioning step (not shown in detail). 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.

[0064] Curing irradiation and sterilization irradiation can be carried out in the same process step during the pharmaceutical filling process.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] The crosslinking / curing irradiation does not overlap with the sterilization irradiation time. Sterilization irradiation typically occurs during the connection process before the crosslinking / curing irradiation. The sterilization or curing irradiation is temperature- and / or time-controlled or regulated by a control unit 20. A corresponding curing step 21 is shown in Figure 1, top right.

[0070] Figure 1 (center) shows a connection device 22 for carrying out the pharmaceutical filling process, and in particular for carrying out the connection process. The dosing device 17 is part of the connection device 22.

[0071] 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 matched to the hose sections 1, 2 to be connected.

[0072] 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.

[0073] 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.

[0074] The overmolding mold 13 can be accommodated in a mold receptacle of the connecting device 22, which has a contour that is complementary to the contour of the accommodated overmolding mold. This can, on the one hand, ensure that the overmolding mold is secured against rotation in the mold receptacle and, on the other hand, ensure that the overmolding mold is correctly oriented and positioned in the mold receptacle. A signal connection can be established between the overmolding mold 13 and the mold receptacle, which ensures that the correct overmolding mold is used for a current connection task. This can be achieved, for example, by a plurality of contact pins in the mold receptacle, between which corresponding conductive connections are established via the overmolding mold 13 when correctly selected.

[0075] The overmolding mold 13 can be made of a polymer material, for example PMMA.

[0076] 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.

[0077] The control unit 20 also serves 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] The connecting device 22 provides a self-explanatory user interface via the display and operating units 23 and 29. The display and operating units 23 and 29 of the connecting device 22 and the dosing device 17, respectively, can also be operated via a pedal and / or a remote control.

[0082] The connection device 22 can be designed to be mobile. The connection device 22 can be configured for battery operation 24 and / or mains operation 25.

[0083] 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.

[0084] 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.

[0085] Fig. 2 shows the dosing device 17 as an assembly housed in the connecting device 22. The dosing device 17 can be designed to be replaceable.

[0086] Main components of the dosing device 17, in particular components that come into contact with the product or overmolding medium, e.g., feed channels of the dosing units 16 / 16a, can be designed as stainless steel components.

[0087] The dosing device 17 can have its own display / operating unit 29, as indicated in Fig. 2. Alternatively, a display / operating unit for the dosing device 17 can be integrated into the display / operating unit 23 of the connecting device 22. The display / operating unit of the dosing device 17 can be used to specify a program, in particular a dosing step sequence, when carrying out the connecting process. Within a corresponding dosing program preselection, it is possible to query which overmolding mold 13 is to be used in the subsequent connecting process and which pair of silicone hose sections 1, 2 are to be connected. In particular, data on diameters and hose wall thicknesses, hose materials and, if applicable, pretreatments of the silicone hose sections 1, 2 can be queried.

[0088] The dosing device 17 can have its own control / regulation unit 30. In an alternative embodiment of the connecting device, the dosing device 17 can also be controlled via the control / regulation unit 20 of the connecting device 22.

[0089] If a separate display / operating unit 29 is present, this can be in signal connection with the display / operating unit 23 of the connecting device 22.

[0090] If a separate control / regulation unit 30 is used, this can be in signal connection with the control / regulation unit 20 of the connecting device 22.

[0091] The control unit 20 andZor 30 can be designed as a programmable logic controller.

[0092] The two control / regulation units 20, 30 of the connecting device 22, on the one hand, and the dosing device 17, on the other, are signal-connected to each other via appropriate interfaces. These components can also be signal-connected to external devices via appropriate interfaces.

[0093] An interface connection can be established, in particular, via an OPC UA interface. OPC UA (Open Platform Communications Unified Architecture) is a collection of standards for communication and data exchange in the industrial automation environment. OPC UA can be used to describe the transport of machine-to-machine data, specifically a data protocol and data format, as well as interfaces and data semantics.

[0094] The control unit of the dosing device 17 can calculate the volume of the overmolding cavity 14 from the input data. This allows a shot quantity adjustment for the respective dosing step, i.e., the amount of overmolding medium 15 to be supplied per dosing step.

[0095] The display / operating unit of the dosing device 17 also allows for querying which type of overmolding medium 15 is being used, from which data on the withstand technology, additives, and, if applicable, color addition can be derived. When using multiple dosing units 16 and 16a of the dosing device 17, a dosing ratio can also be specified via the display / operating unit of the dosing device 17 or adjusted via the control / regulating unit 30 of the dosing device 17.

[0096] An additive dosage can, for example, be in the range between 0.1% and 10% of a quantity of the basic overmolding medium 15.

[0097] Hose-related input variables can be contained in a machine-readable code that is assigned to the hose or, if applicable, printed on it. This code can then be read via the reading unit 26 or a reading unit assigned to the dosing device 17 to specify the corresponding dosing target values.

[0098] Input variables related to the overmolding medium can also be entered or read via the control unit of the dosing device 17 or the connection device 22. These overmolding medium input variables can, for example, be contained in a machine-readable code assigned to the medium source.

[0099] The dosing device 17 has two cartridges 31, 32 as media sources for the overmolding medium 15. These cartridges 31, 32 are emptied in a controlled manner during the dosing steps of the connection process, as is known, for example, from DE 20 2017 106 256 U1, DE 10 2012 109 341 A1, and the references cited therein.

[0100] A filling volume of the cartridges 31, 32 is in the range between 100 ml and 10 l. The cartridges 31, 32 can in particular have a filling volume in the range of 500 ml to 700 ml.

[0101] Each of the dosing units 16Z16a of the dosing device 17 is assigned a dosing device 33. One of the dosing devices 33 is schematically indicated in Fig. 2. The dosing device 33 is in signal communication with the control unit of the dosing device 17 and serves for the metered addition of a desired amount of the overmolding medium 15 from the respective cartridge 31, 32 via the respective feed channel 16 / 16a to the overmolding cavity 14.

[0102] The dosing device 17 is designed such that it dispenses a controlled dosing volume of the overmolding medium 15 for overmolding in the range between 0.1 g and 10 g.

[0103] The dosing device 17 is designed such that it dispenses the overmolding medium 15 for overmolding in a controlled manner via the feed channels 16 / 16a during a dosing time of a dosing step in the range between 0.5 s and 10 s.

[0104] For the cartridges 31, 32, vacuum degassing can be provided in the dosing device 17. The dosing device 17 can have a dynamic or static mixer for mixing the overmolding medium 15. Such a mixer can be electrically driven. Part of the mixer can be a dynamic mixing head. Such a dynamic mixing head can be electrically driven. Such a mixing head can be used in particular for applications with a high flow rate of the overmolding medium through the feed channels 16 / 16a.

[0105] Part of the respective dosing unit, which is assigned to the feed channels 16 / 16a, can be a transfer pump or an accumulator of the dosing device 17, via which the overmolding medium 15 can be conveyed directly from the cartridges 31, 32.

[0106] The dosing device 17 is designed to provide an overmolding pressure in the range between 10 bar and 150 bar in the feed channels 16 / 16a. For this purpose, the dosing devices 33 have a dosing pump, which can be designed as an eccentric screw pump or a gear pump, as a dosing unit for feeding the feed channels 16 / 16a.

[0107] Using the two dosing units with the feed channels 16 / 16a, components A and B of the two-component overmolding medium 15 can be fed into the overmolding cavity 14, with such a two-component overmolding medium 15 curing after the two components are combined. Alternatively or additionally, a base overmolding medium 15 can be added via the first feed channel 16 via the dosing device 17 with the two dosing units assigned to the feed channels 16 / 16a, and an additive and / or color can be added via the second feed channel 16a. Furthermore, it is possible to feed the overmolding medium 15 for a dosing step exclusively via one of the two feed channels 16 or 16a until the associated cartridge 31 or 32 is empty.After emptying one cartridge 31 or 32, a change can then be made between the two dosing units assigned to the feed channels 16 / 16a, whereby the empty cartridge 31 or 32 can then be exchanged for a full cartridge. This enables uninterrupted operation of the dosing device 17 and in particular of the connecting device 22. In principle, it is also possible to design the dosing device 17 with exactly one dosing unit and one associated feed channel, for example, the feed channel 16.

[0108] If two feed channels 16 / 16a are provided, the two dosing units of the feed channels 16 / 16a can be designed for adding the overmolding medium 15 or for adding components A and B or the basic overmolding medium 15 and at least one additive and / or dye in a dosing ratio alternating between 10:1 and 1:10. This dosing ratio can, for example, be in the range between 3:1 and 1:3 and, for example, in the range between 2:1 and 1:2, between 1.5:1 and 1:1.5 or even in the range of 1:1.

[0109] The dosing device 33 can ensure that the storage containers 31, 32 are emptied of residual quantities down to a residual quantity of less than 1% of the medium stored in the storage container 31, 32.

[0110] The dosing device 33 can be pneumatically driven. Another drive mechanism for the dosing device 33 is also possible.

[0111] A metered quantity supplied to the overmolding cavity 14 via the metering device 33, also referred to as a shot, can be specified in a variably controlled manner. Alternatively or additionally, it is possible to specify a number of shots in a variably controlled manner and adapted to a total volume to be metered. In particular, a design is possible in which a single shot precisely specifies a defined metered volume, whereby only an adjusted number of shots is specified via the control system, adapted to the total volume to be added. The metering device 33 can have a vent, particularly in the region of a highest partial volume of a total metered volume of the metering device 33.

[0112] A dosing piston of the dosing device 33 can be sealed by an additional barrier fluid.

[0113] The dosing device 17 has a flushing device 34 for flushing the at least one feed channel 16, 16a. The flushing device 34 can also be designed to flush the overmolding mold 13. In general, all components of the dosing device 17 that come into contact with the overmolding medium 15 can be flushed with the flushing device 34. The flushing device 34 is in signal communication with the control / regulation unit 30 of the dosing device 17 or the control / regulation unit 20 of the connecting device 22.

[0114] The dosing device 17 has at least one fill level sensor 35 for measuring a fill level of the overmolding medium 15 in the respective storage container, i.e., in the respective cartridge 31, 32. Such a fill level sensor 35 is schematically indicated in Fig. 2 in the area of ​​the cartridge 32. The fill level sensor 35 can be implemented by a measuring unit for measuring a piston stroke of a dosing piston of the respective dosing unit of the dosing device 33 in the storage container of the dosing device 17. If both storage containers 31, 32 are equipped with respective fill level sensors 35, the dosing device 17 can measure an addition mixing ratio of media via the two feed channels 16 / 16a.

[0115] The dosing device 17 further has pressure sensors 36 in the dosing path of the overmolding medium 15 between the storage containers 31 and 32, each of which represents an overmolding medium source, and the overmolding cavity 14. Such a pressure sensor 36 is indicated schematically in Fig. 2. Several such pressure sensors 36 can be arranged in the dosing path of the respective overmolding medium 15 between the storage container 31, 32 and the overmolding cavity 14 in order to measure a pressure drop of the overmolding medium 15 or of further media supplied via the supply channels 16 / 16a along the media supply path between the storage containers 31, 32 and the overmolding cavity 14. The dosing device 17 further has at least one volume flow sensor 37 in the dosing path of the overmolding medium or other dosed media components between the respective storage container 31, 32 and the overmolding cavity 14.Such a volume flow sensor 37 serves to determine a flow rate of the medium metered via the feed channels 16 / 16a between the storage containers 31, 32 and the overmolding cavity 14. Such a volume flow sensor is indicated schematically at 37 in Fig. 2. Several such volume flow sensors 37 can also be provided along the metering path between the storage containers 31, 32 and the overmolding cavity 14. This can be used to determine the dependence of the flow rate of the medium along these metering paths. This flow rate dependence can be compared with a target value curve, from which conclusions can be drawn about any undesirable metering path constrictions, which in turn require the use of the flushing device 34.

[0116] The dosing device 17 further has at least one bubble detection sensor 37a in the dosing path of the overmolding medium 15 or other media to be dosed between the storage containers 31, 32 and the overmolding cavity 14.

[0117] The dosing device 17 further has at least one leak testing device 38 in the dosing path of the overmolding medium 15 or other media to be dosed between the storage containers 31, 32 and the overmolding cavity 14. Such a leak testing device 38 is explained in more detail below with reference to Fig. 3. Fig. 3 schematically shows the dosing device 17 on the right, which is in media communication with the overmolding mold 13 of the connecting device 22 shown on the left in Fig. 3 via the dosing units with the feed channels 16 / 16a. The respective media, in particular the overmolding medium 15, are dosed into the overmolding cavity 14, which is indicated schematically in Fig. 3.

[0118] During the leak test using the leak testing device 38, after a connection step of the two silicone hose sections 1, 2, a connected inner lumen of the two hose sections 1, 2 is pressurized with a test gas, for example, nitrogen, via a pressure source 39. A throttle 40, which is schematically indicated in Fig. 3, can be used to close a connection lumen of the two hose sections 1, 2 in the area of ​​the end faces 1a, 2a, and a corresponding pressure increase is measured using a pressure sensor 41 of the leak testing device 38 and compared with a target value. When a specified value is reached, the connection lumen has passed the leak test using the leak testing device 38.

[0119] The leak testing device 38 is in signal connection with the control unit 30 of the dosing device 17 and / or with the control unit 20 of the connecting device 22.

[0120] The sensors 35 to 37, 37a are in signal connection with the control / regulation unit 30 of the dosing device 17 and / or with the control / regulation unit 20 of the connecting device 22.

[0121] The program sequence for metering the overmolding medium 15 into the overmolding cavity 14, on the one hand, and the entire connection process, on the other hand, can be software-controlled using a software product. The input variables already explained and listed above, "combination of the silicone hose sections to be connected," "type of overmolding mold," "type of overmolding medium," and, when using multiple feed channels 16 / 16a for metering into the overmolding cavity, a metering ratio, are taken into account. This can be done by reading correspondingly coded information on the hose sections 1, 2 used, as well as the overmolding mold 13 used, and the cartridges 31, 32.

[0122] Part of the program sequence can be a teach-in or machine learning routine, in which process parameters are recorded, particularly via sensors 35 to 37 and, if applicable, sensors of the leak test device 38, which are then assigned to previously completed connection sequences with the input variables there. In particular, a cycle duration of a dispensing step and / or a curing step can also be part of the corresponding process parameters. Based on these recorded process parameters, corresponding empirical values ​​of the process parameters can then be used within the program sequence for a connection procedure currently being performed.

[0123] When performing the connection process, the cycle duration of a dosing step and / or a curing step, or even another process step, can be measured. In particular, volume flow control can be implemented.

[0124] The process parameters recorded during the connection process, particularly during the dosing and curing steps, are stored in a log memory 42 of the control unit 20 of the connection device 22 (see Fig. 1). This makes it possible to provide a connection log with all relevant input variables and all relevant process parameters, which can be used to comply with quality assurance requirements.

[0125] This provides a user of the connection device 22 with the opportunity to record process data of the connection process on a connection-specific basis. In particular, a complete traceability chain of the materials used and the connection process sequence can be provided.

[0126] The dosing device 17 also has a maintenance indicator 43 (see Fig. 2), which is equipped with three status lights: "red," "yellow," and "green," similar to a traffic light. These indicators can be implemented as LEDs. The maintenance indicator 43 provides immediate indication of the operational readiness of the dosing device 17. A "yellow light" status of the maintenance indicator 43 indicates that maintenance of the dosing device 17 is imminent, for example, a necessary rinsing process, a necessary cartridge replacement, or a necessary thorough cleaning.

[0127] The maintenance indicator 43 can also be equipped with at least one acoustic signal generator.

[0128] The following process parameters can be taken into account when carrying out the method: a current cycle duration: the cycle duration consists of a dosing duration, a refill time, a displacement chamber of the dosing device 33, and a waiting time until the next dosing step; a current stroke height: the stroke height performed by the dosing piston during the dosing step; a refill time of displacement chambers of the dosing units assigned to channels 16, 16a: after being pushed out during the dosing step, the dosing piston of the dosing unit returns to an end position, and plungers from the assigned displacement chambers are pushed towards a lifting cylinder by the inflowing overmolding medium. The time until the plunger rests against the lifting cylinder again, which is a measure of the refill time of the displacement chambers, is measured and displayed.

[0129] Position of lifting cylinder: currently measured position of the lifting cylinder or dosing piston;

[0130] Material pressure of the respective medium, measured with at least one pressure sensor 41;

[0131] Actual dosing quantity in the current dosing step;

[0132] Mixing ratio of dosing units 16 and 16a;

[0133] Comparison between target and actual values ​​of piston movement data, cycle times, cycle numbers and number of cartridges used;

[0134] Actual volume flow, measured via at least one volume flow sensor 37;

[0135] Actual flow rate, measured by at least one volume flow sensor 37; any detected bubbles, detected by the bubble detection sensor 37a.

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 dosing device (17) for the metered addition of the overmolding medium (15) from a media source (31, 32) into the overmolding cavity (14) during overmolding, wherein the dosing device (17) has at least one dosing device (33), comprising the overmolding media source (31) and a dosing unit with a feed channel (16) for feeding the overmolding medium (15) to be dosed from the dosing unit to the overmolding cavity (14), wherein the dosing device (17) is designed such that it controls a dosing volume of the overmolding medium (15) for overmolding in the range between 0.1 cm3 and 10 cm 3dispenses the overmolding medium (15) for overmolding in a controlled manner during a dosing time in the range between 0.5 s and 10 s; further comprising a set of overmolding molds (13), in particular for accommodating different outer diameters of silicone hose sections (1, 2); further comprising a control / regulation unit (20) which is designed such that, based on the silicone hose sections (1, 2) to be connected, a suitable overmolding mold (13) can be selected from the set of overmolding molds (13), and a volume of the overmolding cavity (14) and, via this, the dosing volume of the overmolding medium (15) for the connection process can be calculated; wherein the two silicone hose sections (1, 2) with the end face regions (1a, 2a), in particular by means of a positioning device (11a), can be positioned facing one another in the selected overmolding mold (13) in such a way that the facing end face regions (1a, 2a) abut one another;and wherein the calculated dosing volume of the overmolding medium (15) can be fed into the overmolding cavity (14) in a controlled manner by the dosing device (17); 2. Device according to claim 1, characterized in that the dosing device (17) is designed such that it provides an overmolding pressure in the range between 10 bar and 150 bar.

3. Device according to claim 1 or 2, characterized in that the dosing device (17) has at least one further dosing device with a further overmolding medium source (32), a further dosing unit with a further feed channel (16a) for feeding the overmolding medium (15) to be dosed from the further dosing unit to the overmolding cavity (14).

4. Device according to claim 3, characterized in that the two dosing units for adding the overmolding medium (15) from the two overmolding medium sources (31, 32) are designed in a dosing ratio between 10:1 and 1:

10.

5. Device according to claim 3 or 4, wherein the calculated dosing volume of the overmolding medium (15) from the two overmolding medium sources (31, 32) can be fed into the overmolding cavity (14) in a controlled manner in the appropriate dosing ratio.

6. Device according to one of the preceding claims, further comprising a set of cutting units (11), in particular knives, blades or interchangeable knives / blades, wherein each cutting unit (11) is designed to cut through a silicone tube to produce a sterile end face region (1a) of a silicone supply tube section (6) of a silicone supply tube (6) and / or to cut through a silicone tube to produce a sterile end face region (2a) of a silicone discharge tube section of a silicone discharge tube (7).

7. Device according to claim 6, wherein the cutting unit (11) is designed such that the cutting of the silicone supply hose section (6) and the silicone discharge hose section (7) takes place at a cutting temperature of 0°C to 80°C, in particular from 0°C to 70°C, from 0°C to 60°C, from 0°C to 50°C, from 0°C to 40°C, or from 0°C to 30°C.

8. Apparatus according to any one of the preceding claims, further comprising a UV source for sterilizing irradiation; wherein the control unit (20) is further designed such that, after the silicone tube(s) have been cut through, the UV source for the sterilization irradiation irradiates the two end face regions (1a, 2a) with an irradiation duration in the range between 5 s and 1 min, in particular between 10 s and 50 s or between 15 s and 45 s, and with a sterilization irradiation wavelength in the UV-C range, in particular in a wavelength range between 200 nm and 280 nm or in a range between 240 nm and 260 nm.

9. Device according to one of the preceding claims, further comprising a UV source for curing irradiation; wherein the control unit (20) is further designed such that, after the encapsulation medium (15) has been fed into the encapsulation cavity (14), the UV source for curing irradiates the encapsulation medium (15) with an irradiation duration in the range between 10 s and 120 s, in particular between 60 s and 120 s, and with a crosslinking wavelength in the UV-A range, in particular in a wavelength range between 315 nm and 400 nm.

10. Device according to one of the preceding claims, further comprising a reading unit, in particular designed as a code reader or QR code reader, for specifying a knife within the knife set (11) andZor for specifying an overmolding mold within the overmolding mold set (13) andZor for specifying the hoses for the hose sections (1, 2) to be connected andZor for specifying the overmolding medium (15); wherein the knives within the knife set (11) andZor the overmolding mold within the overmolding mold set (13) andZor the hoses for the hose sections (1, 2) to be connected andZor the dosing device (17), in particular the overmolding medium reservoirs (31, 32) of the dosing device (17), have specification data, in particular in the form of machine-readable codes or a QR code.

11. Device according to one of the preceding claims, wherein the device (22) is mobile and movable and is suitable for laboratory or clinical use, for a clean room or a pre-production environment; wherein the device in particular has a plurality of castors mounted on a frame of the device; andZor wherein the dosing device (17) is arranged below and separately from the connecting device (22).

12. Device according to one of the preceding claims, characterized in that the dosing device (17) has a flushing device (34) for flushing the at least one feed channel (16, 16a). 13 Device according to one of the preceding claims, characterized in that the dosing device (17) has at least one storage container (31, 32) as an overmolding medium source, wherein the dosing device (17) has at least one fill level sensor (35) for measuring a fill level of the overmolding medium (15) in the storage container (31, 32). 14 Device according to one of the preceding claims, characterized in that the dosing device (17) has at least one pressure sensor (36) in the dosing path of the overmolding medium (15) between the overmolding medium source and the overmolding cavity (14).

15. Device according to one of the preceding claims, characterized in that the dosing device (17) has at least one volume flow sensor (37) in the dosing path of the overmolding medium (15) between the overmolding medium source (31, 32) and the overmolding cavity (14).

16. Device according to one of the preceding claims, characterized in that the dosing device (17) has at least one bubble detection sensor (37a) in the dosing path of the overmolding medium (15) between the overmolding medium source (31, 32) and the overmolding cavity (14).

17. Device according to one of the preceding claims, characterized in that the dosing device (17) has at least one leak testing device (38) in the dosing path of the overmolding medium (15) between the overmolding medium source (31, 32) and the overmolding cavity (14).

18. Method for connecting two silicone hose sections (1, 2) with a connecting device (22) according to one of the preceding claims, comprising the following steps: Positioning mutually facing end face areas (1a, 2a) of the silicone hose sections (1, 2) to be connected in an overmolding mold (13) of the con- necting device (22) such that the facing end face regions (1a, 2a) lie against one another; Overmolding the adjacent end face regions (1a, 2a) in the overmolding mold (13) by filling an 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) the flowable silicone (15); Selecting, based on the silicone hose sections (1, 2) to be connected, a suitable overmolding mold (13) from the set of overmolding molds (13); Calculating a volume of the overmolding cavity (14) and, via this, the dosing volume of the overmolding medium (15) for the connection process; Positioning the two silicone hose sections (1, 2) with the mutually facing end regions (1a, 2a) in the selected overmolding mold (13) such that the facing end regions (1a, 2a) abut one another; and controlled feeding of the calculated dosing volume of the overmolding medium (15) into the overmolding cavity (14) by the dosing device (17).

19. A software product for executing a program sequence according to a method according to claim 18.

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