DE102023205431A1 - Device for connecting two silicone hose sections in a pharmaceutical media transfer process - Google Patents

Abstract

A device (22) for connecting two silicone hose sections as part of a pharmaceutical media transfer process has an overmolding mold for overmolding two end face areas of the hose sections in an overmolding cavity with flowable silicone as overmolding medium. A metering device (17) is used for the metered addition of the overmolding medium from a media source (31, 32) into the overmolding cavity during overmolding. The metering device (17) has at least one metering device (33) with the respective overmolding media source (31, 32) of a metering unit and a feed channel (16, 16a) for feeding the overmolding medium (15) to be metered from the metering unit to the overmolding cavity. The dosing device (17) is designed in such a way that it dispenses a controlled dosing volume of the overmolding medium for overmolding in the range between 0.1 cm3 and 10 cm3 during a dosing time in the range between 0.5 s and 10 s. The result is a connection device that ensures a reliable and reproducible connection of the two silicone hose sections.

Description

The invention relates to a device for connecting two silicone hose sections in the context of a pharmaceutical media transfer process. The invention also relates to a method for connecting two silicone hose sections by means of such a device and a software product for carrying out a program sequence according to such a method.

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 that are designed as thermoplastic elastomers. Such processes are known from EP 2 637 839 B1 , the EP 1 056 970 B1 and the WO 2021/118780 A1 as well as from the EP 3 060 292 B1 and the EP 3 603 735 A1 . The EP 2 999 513 B1 discloses a device for a method for producing a sterile connection of tubes. The US 2009/0 243 284 A1 discloses a fluid transfer assembly and methods used therefor. The DE 10 2019 202 513 A1 discloses a device for forming or injecting plastic elements onto surfaces of a semi-finished product.

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

This object is achieved according to the invention by a connection device or a connection system with the feature specified in claim 1.

According to the invention, it was recognized that a dosing volume in the range between 0.1 cm ³ and 10 cm ³ is on the one hand large enough to ensure reliable overmolding of the adjacent end face areas of the silicone hose sections to be connected, but on the other hand is advantageously small in order 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 that the overmolding process is carried out quickly during connection. A reliable and reproducible connection with a particularly short process time can then be ensured.

The hardened overmolding medium has a Shore A hardness of between 20 and 70, in particular between 30 and 70. The viscosity of the overmolding medium can be in the range between 10 ⁶ mPa s and 1.1 * 10 ⁷ mPa s. The overmolding medium 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 1 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 medium. In the area of these components that come into contact with the overmolding medium, the dosing device can be designed with hardened components, in particular for abrasion protection. The dosing device can have a 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 can have a transfer pump for the overmolding medium.

A design of the dosing device according to claim 2 enables the addition of highly viscous overmolding media. The dosing device can have a dosing pump. The dosing pump can be designed as an eccentric screw pump or as a gear pump.

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 several overmolding medium sources, which are designed as storage containers, can also enable a change between the two dosing devices, in particular when the storage container of one of the dosing devices has been emptied. The emptied storage container can then be changed during operation of the dosing device using the other storage container. Undesirable interruptions in the operation of the connection device are then avoided.

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

A flushing device according to claim 5 prevents the at least one feed channel from becoming blocked. A flushing device for flushing the overmolding mold of the connecting device can also be provided.

A level sensor according to claim 6 can be ensured by measuring a piston stroke of a dosing piston of the dosing unit. With the help of such a level sensor, a measurement of mixing ratios can also be made possible in an embodiment of the dosing device with several dosing devices.

At least one pressure sensor according to claim 7 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.

A volume flow sensor according to claim 8 and a bubble detection sensor according to claim 9 have corresponding advantages.

A leak testing device according to claim 10 makes it possible to check the connection produced for leaks. The leak testing device can have a compressed gas source that is in signal connection with a pressure sensor of the leak testing device.

The advantages of a connection method according to claim 11 correspond to those already explained above with reference to the connection device.

A speed-proportional material discharge during overmolding according to claim 12 and in particular during dosing leads to a desired process-reliable connection.

The advantages of a software product according to claim 13 correspond to those already explained above, in particular with reference to the connection method.

• - Informationen zur Kombination der zu konnektierenden Silikon-Schlauchabschnitte, zum Beispiel Innen-/ Außendurchmesser sowie Wandstärken der Silikon-Schlauchabschnitte, Daten zum jeweiligen Silikon-Schlauchmaterial sowie gegebenenfalls zu Vorbehandlungen des Silikon-Schlauchmaterials.
• - Der beim Konnektieren aktuell verwendete Typ der Umspritzform, insbesondere der Typ des Umspritzhohlraums, der beim Umspritzen zum Einsatz kommt. Hieraus kann das Programm ein Volumen des Umspritzhohlraums berechnen und hierüber eine Schussmengeneinstellung, also eine Menge des zuzuführenden Umspritzmediums pro Konnektierungsvorgang berechnen. Eine entsprechend bedarfsgerechte Zudosierung des Umspritzmediums ist die Folge.
• - Der Typ des zum Einsatz kommenden Umspritzmediums. Abhängig hiervon kann das Programm die Aushärtetechnik steuern, die beispielsweise bei Verwendung eines Mehrkomponenten-Aushärte-Umspritzmediums jeder Vorgabe einer entsprechenden Aushärtezeit bestehen kann. Auch die Ansteuerung einer UV-Lichtquelle bei UVaushärtbarem Umspritzmedium kann dann durch das Programm erfolgen. Die Eingabe des Typs des einzusetzenden Umspritzmediums kann auch die Programmsteuerung einer Additiv- oder Farbzugabe über die Dosiervorrichtung beeinflussen.
• - Ein Dosierverhältnis beim Einsatz mehrerer Dosiereinrichtungen. Dies kann über entsprechende Ansteuerung der Dosiereinrichtungen der Dosiervorrichtungen programmgesteuert vorgegeben werden.

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

• - 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, pre-treatments of the silicone hose material.
• - The type of overmolding mold currently used for connection, in particular the type of overmolding cavity used for overmolding. From this, the program can calculate a volume of the overmolding cavity and use this to calculate a shot quantity setting, i.e. an amount of overmolding medium to be added per connection process. The result is a corresponding metering of the overmolding medium as required.
• - The type of overmolding medium used. Depending on this, the program can control the curing technology, which, for example, can comply with any specification of a corresponding curing time when using a multi-component curing overmolding medium. The program can also then control a UV light source for UV-curable overmolding medium. Entering the type of overmolding medium to be used can also influence the program control of an additive or color addition via the dosing device.
• - A dosing ratio when using multiple dosing devices. This can be programmed by controlling the dosing devices of the dosing equipment accordingly.

Input variables that are hose-related can, for example, be contained in a machine-readable code that is assigned to the hose. Input variables that are related to the overmolding medium can, for example, be contained in a machine-readable code that is 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 of connection sequences that have already taken place, for example a cycle duration of a dosing step or a temporal parameter progression of injection pressure, volume flow, fill level values, can be used.

The flowable silicone can be liquid silicone rubber (LSR) or high-temperature-curing silicone (HTV). It can be a silicone material type in the hardness range between Shore A20 and Shore A70.

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.

A silicone hose section in the sense of the present application is a hose section made of a material that consists predominantly of silicone. The adjacent end face areas of the silicone hose sections do not have to lie against one another over the entire circumference of the hose. However, this is preferred.

The curing of the flowable silicone is carried out by means of UV light irradiation, especially in the UV-A wavelength range between 315nm and 400nm, especially in the range between between 315nm and 380nm. In principle, curing of the flowable silicone using UV light irradiation can also be achieved by irradiating it with a different UV wavelength in the range between 100nm and 315nm, particularly in the range between 280nm and 315nm (UV-B). A light source that emits broadband UV light can be used, in which the UV wavelength range that is actually used is then filtered out.

By using the connection method according to the invention in a pharmaceutical media transfer method, its advantages are particularly effective. Such a media transfer can take place in an entire production chain of a pharmaceutical manufacturing process, for example as part of the manufacturing process from a batch approach to a final filling process. The media transfer method can be used in the context of pharmaceutical development steps from laboratory development to scale-up intermediate steps to mass production. An example of the pharmaceutical media transfer method is a pharmaceutical filling method, in particular the supply of a buffer solution for pH regulation in the target reservoir. A sterile container, a process reactor or even a bag can be used as the target reservoir.

The pharmaceutical media transfer process can also include a sterilization step for the front areas of the tube sections created during cutting. Such sterilization of the front areas can again be carried out by means of 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.

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.

The connection device can be designed to be mobile. Such a mobile design is particularly suitable for use in the laboratory or clinic. This mobile design can also be used advantageously in a clean room or in a pre-production environment. The connection device can be designed to be mobile. The device that carries out the connection process can in particular be designed to be mobile. For this purpose, the device can have several rollers that are 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 an independent energy supply, i.e. can be designed so that it does not depend on external mains connections. The connection device can be designed for battery operation. The connection device can have a set of cutting units, for example knives. The connection device can have a set of interchangeable overmolding molds. The connection 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 that can be coded, for example in the form of a QR code. The reading unit can then be designed as a QR code reader.

• 1 ein Ablaufschema eines Verfahrens zur Konnektierung zweier Silikon-Schlauchabschnitte sowie eine Vorrichtung zur Durchführung des Verfahrens;
• 2 wiederum perspektivisch eine Ausführung der Vorrichtung zur Durchführung des Konnektierungsverfahrens mit einer Dosiervorrichtung zur dosierten Zugabe eines Umspritzmediums für einen Konnektierungsschritt des Verfahrens;
• 3 ebenfalls schematisch eine Dichtigkeits-Prüfeinrichtung der Konnektierungs-Vorrichtung.

Embodiments of the invention are explained in more detail below with reference to the drawing, in which:

• 1 a flow chart of a method for connecting two silicone hose sections and a device for carrying out the method;
• 2 again 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;
• 3 also schematically a leak testing device of the connection device.

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 starting reservoir 3 to a target reservoir 4. In principle, the connection method can also be used in another pharmaceutical, biological, medical technology or other scientific or industrial process.

The silicone hose sections 1, 2 are hose sections made of a material that consists predominantly 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, i.e. 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 more than 98 percent by weight silicone.

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.

• Zunächst wird ein pharmazeutisches Medium 5 im Ausgangsreservoir 3 einschließlich eines mit dem Ausgangsreservoir 3 in Medienverbindung stehenden Silikon-Zuführschlauchs 6 bereitgestellt. Der Silikon-Schlauchabschnitt 1 ist Teil des Silikon-Zuführschlauchs 6. Zudem wird das Zielreservoir 4 einschließlich eines mit diesem in Medienverbindung stehenden Silikon-Abführschlauchs 7 bereitgestellt. Der Silikon-Schlauchabschnitt 2 ist Teil des Silikon-Abführschlauchs 7.

The pharmaceutical filling process works as follows:

• First, a pharmaceutical medium 5 is provided in the output reservoir 3 including a silicone supply tube 6 that is in media connection with the output reservoir 3. The silicone tube section 1 is part of the silicone supply tube 6. In addition, the target reservoir 4 is provided including a silicone discharge tube 7 that is in media connection with it. The silicone tube section 2 is part of the silicone discharge tube 7.

Now the pharmaceutical medium 5 is displaced in a silicone feed tube section of the silicone feed tube 6, in particular towards the outlet reservoir 3, which in the 1 is indicated at the top left, 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. 1 shows a displacement step 9 of the filling process at the top left.

In a cutting step 10 (cf. 1 In the first step (left middle) of the filling process, the silicone feed tube section of the silicone feed tube 6 is then cut through with a cutting unit 11 to produce a sterile front side area 1a of the silicone feed tube section. In the same way, in a further cutting step 12, which is also in the 1 As illustrated in the middle left, a silicone discharge tube section of the silicone discharge tube 7 is cut through with the cutting unit 11 to produce a sterile front side area 2a of the silicone discharge tube section. The cutting unit 11 can be a replaceable knife.

The two cutting steps 10, 12 for cutting through the hoses 6, 7 can be carried out simultaneously with the same cutting unit 11. For this purpose, the two hoses 6, 7 can be arranged parallel to one another.

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

The silicone supply hose section 6 and the silicone discharge hose section 7 are cut using the cutting unit 11 at a cutting temperature that is less than 80°C. This temperature can be less than 70°C, can be less than 60°C, can be less than 50°C, can be less than 40°C, can be less than 30°C. The cutting steps 10, 12 are each a cold cut that is carried out purely mechanically, i.e. not under the influence of heat on the silicone material of the silicone hose sections.

Sterilization of the two front side areas 1a, 2a can be carried out during the filling process by means of UV sterilization lighting of these front side areas 1a, 2a.

After the cutting steps 10, 12, the two silicone hose sections 1, 2 are positioned with the end face areas 1a, 2a facing each other in an overmolding mold 13 in such a way that the facing end face areas 1a, 2a rest against each other. 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 described in the 1 schematically indicated in the middle left at 11a.

Now, the adjacent end face areas 1a, 2a are overmolded in the overmolding mold 13 by filling an overmolding cavity 14 of the overmolding mold 13 with flowable silicone 15 as overmolding medium.

The overmolding medium 15 can be a two-component (2K) material with components A and B, which are fed via separate feed dosing channels with dosing units 16, 16a (see also 2 ) are fed to the overmolding cavity 14. Alternatively, the overmolding medium 15 can also be a one-component (1K) 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.

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

A viscosity of the uncured overmolding medium 15 can be in the range between 10 ⁶ and 1.1 * 10 ⁷ mPa s.

A flowable, UV-curing silicone material in the form of the flowable silicone 15 can be used as an overmolding material in the pharmaceutical filling process, in particular in the connection process.

Liquid silicone rubber (LSR) or high-temperature curing (HTV) silicone can be used as the overmolding medium 15.

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 (cf. 2 ) for the metered addition of the overmolding medium 15 from a media source into the overmolding cavity 14 during overmolding. The associated feed channels of the dosing device 17 of the dosing units 16/16a are shown in the drawing. The dosing device 17 is explained in more detail below.

The 1 shows at the bottom left an overmolding step 18 of the connection process after the preceding positioning step, which is not shown in detail.

After the overmolding 18, the flowable silicone is cured by irradiating the flowable silicone 15 with a UV curing wavelength using a UV lamp 19. 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 Shore A 40 to Shore A 60.

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

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

When sterilizing, the irradiation time 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.

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 common UV source, where the respective irradiation wavelengths for cross-linking/curing and sterilization are then specified via appropriate filters.

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 length.

The cross-linking/curing irradiation does not overlap with the sterilization irradiation period. Sterilization irradiation usually takes place during the connection process before the cross-linking/curing irradiation.

The sterilization or curing irradiation is carried out by a control unit 20 in a temperature and/or time-controlled or regulated manner. A corresponding curing step 21 is provided in the 1 shown top right.

1 The middle 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.

The connecting device 22 includes the exchangeable knife 11 and the overmolding mold 13. The connecting device 22 can have a magazine with several exchangeable knives 11 or interchangeable blades, which can be used selectively and in particular automatically. For example, ten to one hundred cutting processes can be carried out with one blade. The connecting device 22 can have a set of knives 11. The respective overmolding mold 13 can therefore be matched to the hose sections 1, 2 to be connected.

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.

The overmolding mold 13 can be designed as an interchangeable overmolding mold. The connecting device 22 can have a mold magazine in which a plurality of such overmolding molds, in particular also with several selectable sizes of the overmolding cavity, can be stored. A change between the interchangeable overmolding molds can be carried out automatically. For example, 500 to 100,000, in particular 10,000 to 25,000 overmolding processes can be carried out per overmolding mold. The connecting device 22 can store between 3 and 12 overmolding mold sizes, which are particularly matched to standard pharmaceutical sizes of the outer diameters of the silicone hose sections 1, 2.

The overmolding mold 13 can be accommodated in a mold holder of the connecting device 22, which has a contour that is complementary to the contour of the overmolding mold accommodated. This can ensure that the overmolding mold is secured against rotation in the mold holder and that the overmolding mold is correctly oriented or positioned in the mold holder.

A signal connection can be set up between the overmolding mold 13 and the mold holder, 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 on the mold holder, between which corresponding conductive connections are established via the overmolding mold 13 if correctly selected.

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

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

The control/regulation unit 20 also serves to document the operation of the respective UV lamp, on the one hand for curing and on the other hand for sterilization. Each connection process can be evaluated in the control/regulation unit 20.

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 front side areas 1a, 2a during the sterilization process, can be specified and documented.

After connection has been made, the pharmaceutical medium is filled from the starting reservoir 3 via the now connected silicone hose sections 1, 2 to the target reservoir 4. The pharmaceutical medium is, for example, a buffer solution for pH regulation.

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 connection with the control/regulation unit 20.

The connection device 22 provides a self-explanatory user interface via the display/operating units 23, 29.

The display/operating units 23 and 29 of the connection device 22 and the dosing device 17 can also be operated via a pedal and/or a remote control.

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

The connecting device 22 can have a reading unit 26 for specifying the respective knife 11 and/or for specifying the respective overmolding mold 13, which is shown in the 1 left middle and 1 bottom left are each shown schematically. 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 designed as a QR code.

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 one another via an overmolding 28, is used for media supply in a pharmaceutical filling process.

2 shows the dosing device 17 as an assembly housed in the connecting device 22. The dosing device 17 can be designed to be exchangeable.

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.

The dosing device 17 can have its own display/operating unit 29, as shown in the 2 indicated. Alternatively, a display/operating unit for the dosing device 17 can be integrated into the display/operating unit 23 of the connection 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 connection process. Within a corresponding dosing program preselection, it is possible to query which overmolding mold 13 is used in the following connection process and which pairing 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 here.

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

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.

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

The control/regulation unit 20 and/or 30 can be designed as a programmable logic controller.

The two control/regulation units 20, 30 of the connection device 22 on the one hand and the dosing device 17 on the other hand are in signal connection with each other via corresponding interfaces. These components can also be in signal connection with external devices via corresponding interfaces.

An interface connection can be made 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 field of industrial automation. OPC UA can be used to describe the transport of machine-to-machine data, in particular a data protocol and a data format, as well as interfaces and the semantics of data.

The control/regulation unit of the dosing device 17 can be used to calculate a volume of the overmolding cavity 14 from the input data. This can be used to set a shot quantity for the respective dosing step, i.e. a quantity of the overmolding medium 15 to be supplied per dosing step.

The display/operating unit of the dosing device 17 also makes it possible to query which type of overmolding medium 15 is being used, from which data on the withstand technology, additives and, if necessary, the addition of color can be derived. When using several 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 set via the control/regulating unit 30 of the dosing device 17.

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

Input variables that are related to the hose 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 out via the reading unit 26 or a reading unit assigned to the dosing device 17 in order to specify corresponding dosing target values.

Input variables that are related to the overmolding medium can also be entered or read via the control/regulation 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 that is assigned to the media source.

The dosing device 17 has two cartridges 31, 32 as overmolding medium storage containers 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 can be seen, for example, from the DE 20 2017 106 256 U1 , the DE 10 2012 109 341 A1 and the references given therein.

A filling volume of the cartridges 31, 32 is in the range between 100 ml and 10 1. The cartridges 31, 32 can in particular have a filling volume in the range of 500 ml to 700 ml.

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

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.

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 duration of a dosing step in the range between 0.5 s and 10 s.

Vacuum degassing can be provided for the cartridges 31, 32 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.

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.

The dosing device 17 is designed such that it provides 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 as a dosing unit for feeding the feed channels 16/16a, which can be designed as an eccentric screw pump or as a gear pump.

With the help of the two dosing units with the feed channels 16/16a, the components A and B of the two-component overmolding medium 15 can be fed to the overmolding cavity 14, whereby such a two-component overmolding medium 15 hardens after the two components have been combined. Alternatively or additionally, a basic overmolding medium 15 can be added via the first feed channel 16 and an additive and/or color can be added via the second feed channel 16a via the dosing device 17 with the two dosing units assigned to the feed channels 16/16a. It is also possible to feed the overmolding medium 15 for a dosing step exclusively via one of the two feed channels 16 or 16a until the assigned 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. In this way, uninterrupted operation of the dosing device 17 and in particular of the connecting device 22 is possible. In principle, it is also possible to design the dosing device 17 with exactly one dosing unit and one assigned feed channel, for example the feed channel 16.

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 the 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 be, for example, 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.

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.

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

A dosing quantity that is fed to the overmolding cavity 14 via the dosing device 33 and is 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 dosed. In particular, a design is possible in which a single shot specifies a precisely defined dosing volume, with the control system only specifying an adapted number of shots, adapted to the total volume to be added.

The dosing device 33 can have a vent, in particular in the region of a highest partial volume of a total dosing volume of the dosing device 33.

A dosing piston of the dosing device 33 can be sealed by an additional sealing fluid.

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 connection with the control/regulation unit 30 of the dosing device 17 or the control/regulation unit 20 of the connection device 22.

The dosing device 17 has at least one level sensor 35 for measuring a level of the overmolding medium 15 in the respective storage container, i.e. in the respective cartridge 31, 32. Such a level sensor 35 is in the 2 in the area of the cartridge 32 is indicated schematically. The fill level sensor 35 can be designed as 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 designed 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.

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 in the 2 indicated schematically. Several such pressure sensors 36 can be arranged in the metering 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 in via the feed channels 16/16a between the storage containers 31, 32 and the overmolding cavity 14. Such a volume flow sensor is shown at 37 in the 2 indicated schematically. 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 dependency of the flow rate of the medium along these metering paths. This flow rate dependency can be compared with a target value curve, from which conclusions can be drawn about any undesirable constrictions in the metering path, which in turn make it necessary to use the flushing device 34.

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.

The dosing device 17 further has at least one leak test 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 test device 38 is described below with reference to the 3 explained in more detail. The 3 shows schematically on the right the dosing device 17, which is connected via the dosing units with the feed channels 16/16a with the 3 The respective media, in particular the overmolding medium 15, are metered into the overmolding cavity 14, which is in the 3 is indicated schematically.

During the leak test using the leak test 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. Via a throttle 40, which is in the 3 As is indicated schematically, a connection lumen of the two hose sections 1, 2 can be closed in the area of the front side areas 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 target value is reached, the connection lumen has passed the leak test using the leak testing device 38.

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

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

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 carried out under software control 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 several feed channels 16/16a for metering into the overmolding cavity, a metering ratio are taken into account. This can be done by reading out the corresponding coded information on the hose sections 1, 2 used as well as the overmolding mold 13 used and the cartridges 31, 32.

Part of the program sequence can be a teach-in or machine learning routine, in which process parameters are recorded, in particular via the sensors 35 to 37 and, if applicable, sensors of the leak test device 38, which are assigned to connection sequences that have already taken place with the input variables there. In particular, a cycle duration of a dosing 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 process that is currently being carried out.

When carrying out the connection process, in particular a cycle duration of a dosing step and/or a curing step or also of another process step can be measured.

In particular, volume flow control can be carried out.

The process parameters recorded during the connection process, in particular during the dosing and curing steps carried out, are stored in a protocol memory 42 of the control/regulation unit 20 of the connection device 22 (cf. 1 This makes it possible to provide a connection protocol with all relevant input variables and all relevant process parameters, which can be used to comply with quality assurance requirements.

This offers a user of the connection device 22 the possibility of recording process data of the connection method in a connection-specific manner. In particular, a complete chain of evidence of the materials used and the sequence of the connection method can be provided.

The dosing device 17 also has a maintenance indicator 43 (see 2 ), which is equipped with three status lights "red", "yellow" and "green" like a traffic light. These displays can be designed as LED lights. The operational readiness of the dosing device 17 can be read directly from the maintenance display 43. A "yellow light" status of the maintenance display 43 indicates that maintenance of the dosing device 17 is required in the near future, for example a necessary rinsing process, a necessary cartridge replacement or a necessary basic cleaning.

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

• - eine aktuelle Zyklusdauer: die Zyklusdauer setzt sich aus einer Dosierdauer, einer Nachfüllzeit, einer Verdrängerkammer der Dosiereinrichtung 33 sowie einer Wartezeit bis zum nächsten Dosierschritt zusammen;
• - eine aktuelle Hubhöhe: die während des Dosierschritts vom Dosierkolben durchgeführte Hubhöhe;
• - eine Nachfüllzeit von Verdrängerkammern der Dosiereinheiten, die den Kanälen 16, 16a zugeordnet sind: nach Ausschieben beim Dosierschritt fährt der Dosierkolben der Dosiereinheit wieder in eine Endposition zurück, Stößel von den zugeordneten Verdrängerkammern werden durch nachfließendes Umspritzmedium in Richtung eines Hubzylinders gedrückt. Eine Zeitdauer, bis der Stößel wieder am Hubzylinder anliegt und die ein Maß für die Nachfüllzeit der Verdrängerkammern ist, wird gemessen und angezeigt;
• - Position Hubzylinder: aktuell gemessene Position des Hubzylinders beziehungsweise Dosierkolbens;
• - Materialdruck des jeweiligen Mediums, gemessen mit dem mindestens einen Drucksensor 41;
• - Ist-Dosiermenge im aktuellen Dosierschritt;
• - Mischverhältnis der Dosiereinheiten 16 und 16a;
• - Vergleich zwischen Soll- und Ist-Werten von Kolbenbewegungsdaten, Zykluszeiten, Zykluszahlen sowie Anzahl der verwendeten Kartuschen;
• - Ist-Volumenstrom, gemessen über den mindestens einen Volumenstromsensor 37;
• - Ist-Flussrate, gemessen anhand des mindestens einen Volumenstromsensors 37;
• - gegebenenfalls detektierte Blasen, detektiert über den Blasendetektions-Sensor 37a.

The following process parameters can be taken into account when carrying out the procedure:

• - a current cycle duration: the cycle duration consists of a dosing duration, a refilling 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 that are 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, tappets from the assigned displacement chambers are pressed in the direction of a lifting cylinder by the inflowing overmold medium. A time period until the tappet rests against the lifting cylinder again and which is a measure of the refill time of the displacement chambers is measured and displayed;
• - Position of lifting cylinder: currently measured position of the lifting cylinder or dosing piston;
• - Material pressure of the respective medium, measured with at least one pressure sensor 41;
• - Actual dosing quantity in the current dosing step;
• - Mixing ratio of dosing units 16 and 16a;
• - Comparison between target and actual values of piston movement data, cycle times, cycle numbers and number of cartridges used;
• - Actual volume flow, measured via at least one volume flow sensor 37;
• - Actual flow rate, measured by at least one volume flow sensor 37;
• - possibly detected bubbles, detected via the bubble detection sensor 37a.

QUOTES INCLUDED IN THE DESCRIPTION

This list of documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions.

Cited patent literature

• EP 2 637 839 B1 [0002]
• EP 1 056 970 B1 [0002]
• WO 2021/118780 A1 [0002]
• EP 3 060 292 B1 [0002]
• EP 3 603 735 A1 [0002]
• EP 2 999 513 B1 [0002]
• US 2009/0 243 284 A1 [0002]
• DE 10 2019 202 513 A1 [0002]
• DE 20 2017 106 256 U1 [0087]
• DE 10 2012 109 341 A1 [0087]

Claims (13)

Device (22) for connecting two silicone hose sections (1, 2) in the context of a pharmaceutical media transfer process, - with an overmolding mold (13) for overmolding two adjacent end face areas (1a, 2a) of the two silicone hose sections (1, 2) in an overmolding cavity (14) with flowable silicone as overmolding medium (15), - with a metering 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 metering device (17) has at least one metering device (33), with the overmolding media source (31) and a metering unit with a feed channel (16) for feeding the overmolding medium (15) to be metered from the metering unit to the overmolding cavity (14), - wherein 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 cm ³ and 10 cm ³ , - that it dispenses the overmolding medium (15) for overmolding in a controlled manner during a dosing time in the range between 0.5 s and 10 s. 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. 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 media 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). 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. Device according to one of the Claims 1 until 4 , characterized in that the dosing device (17) has a flushing device (34) for flushing the at least one feed channel (16, 16a). Device according to one of the Claims 1 until 5 , 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). Device according to one of the Claims 1 until 6 , 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 media source and the overmolding cavity (14). Device according to one of the Claims 1 until 7 , 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 media source (31, 32) and the overmolding cavity (14). Device according to one of the Claims 1 until 8 , 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). Device according to one of the Claims 1 until 9 , 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 media source (31, 32) and the overmolding cavity (14). Method for connecting two silicone hose sections (1, 2) with a connecting device (22) according to one of the Claims 1 until 10 with the following steps: - positioning mutually facing end face regions (1a, 2a) of the silicone hose sections (1, 2) to be connected in an 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 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). procedure according to claim 11 , characterized in that during overmolding a material discharge proportional to the speed takes place. Software product for executing a program sequence according to a method according to one of the Claims 11 or 12 .

Images