Method and device for connecting two tube sections and tube assembly connected using the method

Abstract

In order to connect two tube sections (1, 2), the facing end side regions (1a, 2a) of the tube sections (1, 2) to be connected and a cover sleeve (12b), which axially covers the facing end side regions (1a, 2a), are first positioned in an overmoulding mould. The facing end side regions (1a, 2a) and the cover sleeve (12b) are overmoulded in the overmoulding mould by filling an overmoulding space of the overmoulding mould with a flowable overmoulding medium (15), which is then cured. In order to close a tube section at at least one tube end, one end side of the tube end is positioned relative to a cover element, which covers the end side of the tube end, in an overmoulding mould. The tube end and the cover element are overmoulded in the overmoulding mould with an overmoulding medium, which is then cured. This results is a connection method that can be carried out safely, reproducibly and in an automated manner at reasonable cost.

Description

[0001] Method and device for connecting two hose sections and hose assembly connected by the method

[0002] The invention relates to a method and a device for connecting two silicone hose sections. Furthermore, the invention relates to a hose assembly connected using such a connection 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. EP 2 715 205 B1 discloses a connector for the fluid-tight connection of at least two fluid-carrying components.EP 2 990 183 B1 discloses a method for producing a fluid-tight connection between at least two fluid-carrying silicone hose components.

[0004] It is an object of the present invention to further develop a method for connecting two hose sections in such a way that it can be carried out safely, reproducibly and automatically with reasonable effort.

[0005] This object is achieved according to the invention by a connection method having the features specified in claim 1.

[0006] According to the invention, it was recognized that overmolding adjacent end regions of the hose sections to be connected with a flowable overmolding medium, which is subsequently cured, enables a secure connection solution. If appropriately sterilized hose sections are connected, a biocompatible and secure fluid connection results between the annexed hose sections. The cover sleeve ensures that a secure and, in particular, tight connection of the two hose sections occurs even if the end regions are not optimally complementary to one another and, in particular, even if the space between the facing end regions is irregularly extended in the circumferential direction. The cover sleeve can generally be used to compensate for dimensional tolerances of the two hose sections to be connected.In particular, the cover sleeve can prevent the overmolding medium from undesirably penetrating into a lumen of the hose sections before curing.

[0007] The flowable overmolding medium can be a flowable silicone. The flowable silicone can be liquid silicone rubber (LSR). It can be an LSR material with a hardness range between Shore A20 and Shore A70.

[0008] The flowability of the overmolding medium is such that the overmolding cavity is sufficiently filled. The viscosity of the flowable overmolding medium can be adapted to a typical cavity size or cavity design of the overmolding cavity.

[0009] The flowable overmolding medium can be cured using UV light irradiation, particularly in the UV-A wavelength range between 315 nm and 400 nm, and especially in the range between 315 nm and 380 nm. In principle, the flowable overmolding medium 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.

[0010] The hose sections can be made of a plastic material. The hose sections can, in particular, be made of silicone or a thermoplastic.

[0011] The cover sleeve can be made of a plastic material, such as a thermoplastic material. Alternatively, the cover sleeve can also be made of silicone. Alternatively, the cover sleeve can be made of metal. The hose sections can be made of the same material as the cover sleeve. Alternatively, the material of the cover sleeve can be different from that of the hose sections.

[0012] The cover sleeve can have a base body in the form of an outer sleeve, the inner diameter of which is larger than the outer diameter of the hose sections. The cover sleeve can then be designed so that it does not come into contact with the product, which increases the material selection for the cover sleeve. Alternatively, the cover sleeve can also be designed as an inner sleeve, in which case the base body of the cover sleeve has an outer diameter that is smaller than the inner diameter of the hose sections.

[0013] The facing end areas of the hose sections do not have to be adjacent to each other along the entire circumference of the hose. However, this is preferred.

[0014] A dimensioning of the overmolding mold according to claim 2 provides a secure connection of the two hose sections.

[0015] In the further development of the method according to the invention according to claim 3, the hose sections to be connected are a silicone supply hose section of a silicone supply hose and a silicone discharge hose section of a silicone discharge hose.

[0016] The silicone supply tube section can be cut through with a cutting unit to create a sterile end face area, and the silicone discharge tube section can be cut through with a cutting unit to create a sterile end face area.

[0017] According to claim 4, the cutting of the silicone supply hose section (6) and the silicone discharge hose section (7) can take 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.

[0018] According to claim 5, after cutting through the silicone tube(s), the two end face regions are irradiated by a UV source for sterilization irradiation 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.

[0019] According to claim 5, during curing of the overmolding medium, the overmolding medium is irradiated by a UV source for curing irradiation 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.

[0020] According to claim 7, by means of a reading unit, in particular designed as a code reader or QR code reader, default data, in particular in the form of machine-readable codes or QR codes of a cutting unit, in particular within a set of cutting units and / or an overmolding mold within an overmolding mold set and / or the hoses for the hose sections to be connected and / or the cover sleeve, are read.

[0021] The advantages of a hose assembly according to claim 8 correspond to those already explained above with reference to the connection method.

[0022] In the further development of the hose assembly according to the invention according to claim 9, the cover sleeve provides a direct connection between the two hose sections facing each other. The cover sleeve has a cylindrical outer shape. The cover sleeve is designed, in particular, without a lateral port, particularly one opening into the cylindrical casing of the cover sleeve.

[0023] An internally circumferential projection according to claim 10 can compensate for irregularities in the adjacent, mutually facing end regions. Furthermore, such a projection makes it more difficult for the overmolding medium to undesirably penetrate the lumen of the tube sections.

[0024] In a hose assembly according to claim 11, the inner circumferential projection of the cover sleeve has a width that essentially corresponds to the wall thickness of the cylindrical wall of the cover sleeve or is less than this. The inner circumferential projection of the cover sleeve can have a width that essentially corresponds to the wall thickness of the two hose sections or is less than this.

[0025] The cover sleeve can have the shape of a horizontal H when viewed in a radial section.

[0026] In a hose assembly according to claim 12, the inner circumferential projection has end faces on which sealing elements are arranged.

[0027] The sealing elements are firmly connected to the end faces of the inner circumferential projection, in particular by adhesive bonding.

[0028] The hose sections can rest against the sealing elements with their end faces, in the manner of a press fit, and / or be glued to them.

[0029] The sealing elements can be designed as an O-ring, sealing bead, or half O-ring.

[0030] A hose assembly according to claim 13 is the result of a flexibly implemented connection method. Hose sections of the same diameter are not necessarily required to establish a secure connection. This increases the flexibility of the connection method and also of the correspondingly manufactured hose assembly.

[0031] A cover sleeve according to claim 14 is well adapted to a difference in diameter of the hose sections, which improves the security of the connection.

[0032] The advantages of a projection according to claim 15 correspond to those already explained above. Furthermore, the inner diameter design of the projection ensures that no undesirable flow resistance exists in the connection area.

[0033] Silicone tube sections according to claim 16 can be designed to be biocompatible.

[0034] A silicone hose section within the meaning of the present application is a hose section made of a material that consists predominantly of silicone. A silicone cover sleeve according to claim 17 has corresponding advantages, which were explained above in connection with the silicone hose sections.

[0035] The invention also relates to a device for connecting two hose sections, having the following features: two hose sections to be connected; a cover sleeve; a positioning device; an overmolding mold; a feed device for a flowable overmolding medium; and a UV source for curing irradiation; wherein the hose sections to be connected and the cover sleeve can be positioned in the overmolding mold by means of the positioning device such that the end face regions of the two hose sections to be connected face each other and that the cover sleeve axially covers the facing end face regions; wherein the feed device is designed such that the mutually facing end face regions and the cover sleeve can be overmolding with the flowable overmolding medium in the overmolding mold and an overmolding cavity of the overmolding mold can be filled;and wherein the UV source for the curing irradiation is designed such that the overmolding medium can be irradiated 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.;

[0036] The advantages of the connecting device according to claim 18 correspond to those already explained above with reference to the connecting method.

[0037] The advantages and embodiments stated above with reference to the connection method according to the invention also apply, in terms of the device, to the connection device according to claim 18. No dependent device claims have been directed to this to date. However, the applicant expressly reserves the right to establish dependent device claims at a later stage of the process that correspond to the dependent method claims 2 to 7 in terms of the device.

[0038] According to claim 19, the device is designed to be mobile and movable and is suitable for laboratory or clinical use, or for a clean room or pre-series environment.

[0039] The device may have several rollers mounted on a frame of the device.

[0040] 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.

[0041] The methods described above can represent parts of a pharmaceutical media transfer process for supplying a pharmaceutical medium from a source reservoir to a target reservoir and accordingly improve the operational and handling safety of such a media transfer process.

[0042] 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.

[0043] The pharmaceutical media transfer process can also include a sterilization step for the end areas of the tube sections created during cutting. Such 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. A connecting device can be used to carry out the processes described above. A positioning device can be used that is already known for positioning in connection with the connection of TPE tube components.

[0044] 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.

[0045] In particular, a robust and tear-resistant connection can be created, which at the same time ensures safe media or fluid passage.

[0046] The flowable overmolding medium can be a 1K or a 2K material.

[0047] Embodiments of the invention are explained in more detail below with reference to the drawing. Figure 1 shows a flow diagram of a method for connecting two hose sections and a device for carrying out the method;

[0048] Fig. 2 shows an axial section through a hose assembly which is manufactured by means of the connection method and has two hose sections and a cover sleeve which axially covers the end face regions of the hose sections;

[0049] Figure 3 shows, in a representation similar to Figure 2, a further embodiment of a hose assembly with two hose sections and a cover sleeve arranged in the transition region of the end face regions, wherein the two hose sections have different diameters;

[0050] Figure 4 shows, in a representation similar to Figures 2 and 3, a further embodiment of a hose assembly which is manufactured using a variant of the connection method for closing a hose section, wherein the hose assembly has a hose section and a cover element covering the end face thereof; and

[0051] Figure 5 shows an axial section of an alternative hose assembly which is manufactured by means of the connection method and has two hose sections and a cover sleeve which axially covers the facing end face regions of the hose sections.

[0052] 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 another pharmaceutical process.

[0053] The method for connecting the two silicone hose sections 1, 2 is described below with reference to Figures 1 to 3. A variant of the connection method for closing one of the hose sections 1, 2 is also described in addition with reference to Figure 4.

[0054] 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.

[0055] 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.

[0056] The pharmaceutical filling process is as follows:

[0057] 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.

[0058] 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.

[0059] 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 face region 1a of the silicone supply tube section. In the same way, in a further cutting step 12, which is also illustrated in Fig. 1, left center, a silicone discharge tube section of the silicone discharge tube 7 is cut through with the cutting unit 11 to create a sterile end face region 2a of the silicone discharge tube section. The cutting unit 11 can be a replaceable blade. 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.

[0060] The two cutting steps 10, 12 for cutting the hoses 6, 7 can be performed simultaneously using the same cutting unit 11. For this purpose, the two hoses 6, 7 can be arranged parallel to each other.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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 the end face regions 1a, 2a facing each other such that the facing end face regions 1a, 2a abut one another. This occurs in a positioning step 12a. Regarding the positioning of the hose sections 1, 2 relative to each other, the positioning device 11a is basically already known from the prior art. The positioning device 11a is schematically indicated in the center left of Figure 1.

[0065] Typically, the overmolding mold 13 consists of two separate overmolding mold parts. Typically, the inner height of the overmolding mold 13, viewed in the radial direction of the silicone tube sections, is 1.5 to 4 times the outer diameter of the tube sections. Likewise, the inner width of the overmolding mold is 1.5 to 4 times the outer diameter of the silicone tube sections.

[0066] During positioning step 12a, a cover sleeve 12b (see Figure 2) is additionally positioned relative to the two mutually facing end regions 1a, 2a of the hose sections 1, 2. This is done in such a way that the cover sleeve 12b axially covers the two mutually facing end regions 1a, 2a.

[0067] The cover sleeve 12b is made of silicone. The material parameters of the cover sleeve 12b can correspond to those explained above in connection with hose sections 1 and 2.

[0068] Figure 2 shows, among other things, the relative position achieved after the positioning step 12a between the cover sleeve 12b and the two hose sections 1, 2.

[0069] The cover sleeve 12b has an inner circumferential projection 12c. This projection 12c lies axially between the two end face regions 1a, 2a when the cover sleeve 12b is positioned relative to the two hose sections 1, 2. An inner diameter of the inner circumferential projection 12c, i.e. an inner diameter of the cover sleeve 12b in the region of the circumferential projection 12c, is as large as a common inner diameter of the hose sections 1, 2. In the embodiment according to Figure 2, the two hose sections 1, 2 have the same inner and outer diameters. A sleeve base body 12d of the cover sleeve 12b has an inner diameter that is larger than the outer diameter of the two hose sections 1, 2.

[0070] The overmolding mold 13 is dimensioned, particularly axially but also radially, in such a way that it completely covers the cover sleeve 12b.

[0071] Now, the adjacent end face regions 1a, 2a and the cover sleeve 12b are overmolded in the relative position according to Figure 2 in the overmolding mold 13 by filling an overmolding cavity 14 of the overmolding mold 13 with flowable silicone 15. The cover sleeve 12b lies completely within the overmolding cavity 14. The flowable silicone can be a two-component (2K) material with components A and B, which are fed into the overmolding cavity 14 via separate feed / dosage channels with dosing units 16, 17. Alternatively, the flowable silicone can also be a one-component (1K) material. If the flowable silicone 15 is a one-component material, this one component contains a base polymer, a catalyst, and a crosslinker.If the flowable silicone 15 is a two-component material, one of the two components may contain a base polymer and a crosslinker and the other component may contain a catalyst.

[0072] The dosing units 16, 17 represent a supply device for the flowable silicone 15 as overmolding material.

[0073] A flowable, UV-curing silicone material in the form of flowable silicone 15 is used as an overmolding material in the pharmaceutical filling process, in particular in the connection process.

[0074] Figure 1 shows, bottom left, an overmolding step 18 of the connection process after the preceding positioning step, which is not shown in detail.

[0075] 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.

[0076] Curing irradiation and sterilization irradiation can be carried out in the same process step during the pharmaceutical filling process.

[0077] 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. The irradiation time for sterilization 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. The 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.

[0078] 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.

[0079] 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.

[0080] The crosslinking / curing irradiation does not overlap with the sterilization irradiation period. Sterilization irradiation usually occurs during the bonding process before the crosslinking / curing irradiation.

[0081] 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.

[0082] The result of the connection process is a hose assembly 21a, which is shown with section-wise hose sections 1, 2 in Figure 2.

[0083] Figure 1 (center) shows a connection device 22 for carrying out the pharmaceutical filling process, and in particular for carrying out the connection process. This connection process can be controlled or regulated via the control / regulation unit 20. For this purpose, the control / regulation unit 20 is in signal communication with the components of the connection device 22.

[0084] The connecting device 22 includes the replaceable blade 11, the positioning device or a positioning robot 11a, 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 therefore be matched to the hose sections 1, 2 to be connected.

[0085] The connecting device 22 can have a set of overmolding molds 13, in particular for accommodating different outer diameters of silicone hose sections in the manner of the silicone hose sections 1, 2. This set of overmolding molds 13 can correspond to a set of associated cover sleeves 12b, which can also be held by the connecting device 22.

[0086] 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 three and twelve overmolding mold sizes, which are particularly matched to pharmaceutical standard sizes of the outer diameters of the silicone tube sections 1, 2 and corresponding dimensions of the associated cover sleeves 12b.

[0087] 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 ensure, on the one hand, that the overmolding mold is secured against rotation in the mold receptacle and, on the other hand, that the overmolding mold is correctly oriented and positioned in the mold receptacle.

[0088] A signal connection can be established between the overmolding mold 13 and the mold holder, ensuring that the correct overmolding mold 13 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, if correctly selected, corresponding conductive connections are established via the overmolding mold 13. The overmolding mold 13 can be made of a polymer material, for example, PMMA.

[0089] An operating time and a number of usage cycles of the respective replaceable knife 11 can be specified and documented in the control unit 20, which also serves to control the knife 11.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] The connection device 22 can be designed to be mobile. The connection device 22 can be configured for battery operation 24 and Z or for mains operation 25.

[0095] 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 and / or on the cover sleeve 12b, 32, which code can in turn be embodied as a QR code.

[0096] 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, i.e. the hose assembly 21a, is used for media supply in a pharmaceutical filling process.

[0097] Figure 3 shows a further embodiment of a hose assembly 31 that can be manufactured using the connection method explained above in connection with Figures 1 and 2. Components and functions that correspond to those already explained above with reference to Figures 1 and 2 have the same reference numerals and will not be discussed in detail again.

[0098] The hose sections 1, 2 of the hose assembly 31 have different diameters. An inner diameter of hose section 1 is larger than an inner diameter of hose section 2. Accordingly, an outer diameter of hose section 1 is also larger than an outer diameter of hose section 2.

[0099] A cover sleeve 32 of the hose assembly 31, which otherwise corresponds in its function to the cover sleeve 12b of the embodiment according to Figure 2, has a radial step 33, the radial extent of which corresponds to a difference in diameter between the two hose sections 1, 2. In the embodiment according to Figure 3, an inner diameter of the cover sleeve 32 is as large as the outer diameter of the hose section 2 with the smaller outer diameter. Alternatively, as indicated by dashed lines at 34 in Figure 3, the cover sleeve 32 can also have a projection in the axial region of the radial step 33, the inner diameter of which is as large as the smaller inner diameter of the two hose sections 1, 2, i.e. as large as the inner diameter of the hose section 2.

[0100] A further manufacturing method which can be carried out using the connecting device 22 is described below, particularly in connection with Figure 4. In this method, a hose section is closed at at least one hose end, which is illustrated in Figure 4 using the hose section 1. In this further manufacturing method, the end face 1a of a hose end 1b of the hose section 1 is positioned relative to a cover element 35 in a positioning step which basically corresponds to the positioning step 12a of the connecting method explained above. In this positioning step, the end face 1a of the hose end 1b and the cover element 35 are positioned in a correspondingly designed overmolding mold 13 of the connecting device 22.

[0101] The cover element 35 can again be made of silicone, corresponding to what was stated above for the cover element 12b or 32.

[0102] In a subsequent overmolding step, which corresponds to overmolding step 18 of the connection process, the hose end 1b of the hose section 1a and the cover element 35 are overmolded in the overmolding mold 13 by filling the corresponding overmolding cavity 14 of the overmolding mold 13 with the flowable overmolding medium 15. In a subsequent curing step, which corresponds to curing step 21 of the connection process, the overmolding medium 15 is then cured.

[0103] The result of this closure process is a hose assembly according to Figure 4. In this embodiment, the cover element 35 is designed as a cover cap which has a collar section 35a which receives the hose end 1b, i.e. has an inner diameter which is larger than an outer diameter of the hose end 1b.

[0104] Alternatively, the cover element 35 can also be designed as a cover plug, which is inserted in the manner of a plug or cork into a lumen of the hose end 1b during the positioning step 12a.

[0105] Figure 5 shows an alternative embodiment of the hose assembly from Figure 2.

[0106] The hose sections 1, 2 with their end face areas 1a, 2a, the cover sleeve 12b, the overmolding mold 13 and the overmolding cavity 14 of the overmolding mold 13, which is overmolded and filled with flowable silicone 15, correspond to the corresponding elements from Figure 2. Identical elements are identified by the same reference numerals and will not be explained again here.

[0107] In contrast to the embodiment of Figure 2, sealing elements 38 are now arranged on the end faces of the inner circumferential projection 12c, which are directed toward the end face regions 1a, 2a of the hose sections 1, 2. These sealing elements 38 are firmly connected to the end faces of the inner circumferential projection 12c, for example, by adhesive bonding.

[0108] The sealing elements 38 fill a space between the end faces of the inner circumferential projection 12c and the end face regions 1a, 2a of the hose sections 1, 2 in the axial direction, and thus ensure a dead-space-free connection of the end face regions 1a, 2a of the hose sections 1, 2 and the cover sleeve 12b, in particular in the connection region located radially inward from the cylindrical sleeve wall between the cover sleeve 12b and the end face regions 1a, 2b of the hose sections 1, 2.

[0109] In the present exemplary, non-limiting embodiment, a first O-ring or sealing bead, for example in the form of a half O-ring, whose flat rear side rests against the left end face of the inner circumferential projection 12c, is arranged on the end face of the inner circumferential projection 12c in Figure 5, i.e., directed toward the end face region 1a of the hose section 1. This O-ring, sealing bead, or half O-ring can be connected to the left end face of the inner circumferential projection 12c, in particular, glued thereto.

[0110] Analogously, a second O-ring or sealing bead, for example in the form of a half O-ring, whose flat rear side rests against the right end face of the inner circumferential projection 12c, is arranged on the end face of the inner circumferential projection 12c on the right in Figure 5, i.e., facing the end face region 2a of the hose section 2. This O-ring, sealing bead, or half O-ring can be connected to the right end face of the inner circumferential projection 12c, in particular, glued thereto.

[0111] These sealing elements 38 can be made of silicone. Viewed in the radial direction, the sealing elements 38 can fill the annular area corresponding to the wall area of ​​the adjacent hose sections 1, 2. The hose sections 1, 2 can rest against the sealing elements 38 with their end face areas 1a, 2a, in the manner of a press fit, or can be additionally glued to them.

[0112] Otherwise, the advantages of the hose assembly shown in Figure 5 correspond to the advantages explained with reference to Figure 2.

Claims

Patent claims 1. Method for connecting two hose sections (1, 2) with the following steps: Positioning (12a) -- mutually facing end face areas (1a, 2a) of the hose sections (1, 2) to be connected and -- a cover sleeve (12b; 32) which axially covers the facing end face regions (1a, 2a), in an overmolding mold (13), Overmolding (18) the mutually facing end face regions (1a, 2a) and the cover sleeve (12b; 32) in the overmolding mold (13) by filling an overmolding cavity (14) of the overmolding mold (13) with a flowable overmolding medium (15); Curing of the overmolding medium (15).

2. Method according to claim 1, characterized in that the overmolding mold (13) is dimensioned such that it completely covers the cover sleeve (12b, 32) axially.

3. Method according to one of the preceding claims, wherein the hose sections (1, 2) to be connected are a silicone supply hose section (6) of a silicone supply hose and a silicone discharge hose section (7) of a silicone discharge hose; and / or wherein the silicone supply hose section (6) is cut through with a cutting unit (11) to create a sterile end-side region (1a) and the silicone discharge hose section (7) is cut through to create a sterile end-side region (2a).

4. The method according to claim 3, wherein 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.

5. Method according to one of the preceding claims, wherein after cutting through the silicone tube / silicone tubes, the two end face regions (1a, 2a) are irradiated by a UV source for sterilization irradiation 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.

6. Method according to one of the preceding claims, wherein during curing of the overmolding medium (15), the overmolding medium (15) is irradiated by a UV source for curing irradiation 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.

7. Method according to one of the preceding claims, Reading, by means of a reading unit, in particular designed as a code reader or QR code reader, of predefined data, in particular in the form of machine-readable codes or QR codes of a cutting unit (11), in particular within a set of cutting units (11) and / or an overmolding mold within an overmolding mold set (13) and / or the hoses for the hose sections (1, 2) to be connected and / or the cover sleeve (12b; 32).

8. Hose assembly (21a; 31) with two hose sections (1, 2) facing each other at the end and a cover sleeve (12b; 32) which axially covers mutually facing end regions (1a, 2a) of the hose sections (1, 2), wherein the hose sections (1, 2) are connected to each other by means of the connection method according to one of the preceding claims.

9. Hose assembly according to claim 8, characterized in that the cover sleeve (12b; 32) provides a direct connection between the two hose sections (1, 2) facing each other; and / or the cover sleeve (12b; 32) has a cylindrical outer shape; and / or the cover sleeve (12b; 32) is designed without a lateral port, in particular opening into the cylindrical casing of the cover sleeve (12b; 32).

10. Hose assembly according to claim 8 or 9, characterized in that the cover sleeve (12b; 32) has an inner circumferential projection (12c; 34) which, when the cover sleeve (12b; 32) is positioned relative to the two hose sections (1, 2), lies axially between the two end face regions (1a, 2a).

11. Hose assembly according to claim 10, characterized in that the inner circumferential projection (12c) of the cover sleeve (12b) has a width which substantially corresponds to the wall thickness of the cylindrical wall of the cover sleeve (12b) or is less than this; and / or the inner circumferential projection (12c) of the cover sleeve (12b) has a width which substantially corresponds to the wall thickness of the two hose sections (1, 2) or is less than this; and / or wherein the cover sleeve (12b), seen in a radial section, has the shape of a horizontal H.

12. Hose assembly according to claim 10 or 11, characterized in that the inner circumferential projection (12) has end faces on which sealing elements (38) are arranged; and / or the sealing elements (38) are firmly connected to the end faces of the inner circumferential projection (12c), in particular by adhesive bonding; and / or the hose sections (1, 2) bear with their end face regions (1a, 2a) against the sealing elements (38), in the manner of a press fit, or / or are adhesively bonded thereto; and / or the sealing elements (38) are each designed as an O-ring, sealing bead, or half an O-ring.

13. Hose assembly according to one of claims 8 to 12, characterized in that the two hose sections (1, 2) have a different diameter.

14. Hose assembly according to claim 13, characterized in that the cover sleeve (32) has a radial step (33) whose radial extent corresponds to a difference in diameter of the two hose sections (1, 2).

15. Hose assembly according to one of claims 8 to 14, characterized in that an inner diameter of the cover sleeve (12b; 32) in the region of the circumferential projection (12c; 34) is at least as large as a common Inner diameter of the hose sections (1, 2) or like a smaller inner diameter of one of the two hose sections (2).

16. Hose assembly according to one of claims 8 to 15, characterized in that both hose sections (1, 2) are silicone hose sections.

17. Hose assembly according to one of claims 8 to 16, characterized in that the cover sleeve (12b; 32) is made of silicone.

18. A device for connecting two hose sections (1, 2), comprising: two hose sections (1, 2) to be connected; a cover sleeve (12b; 32); a positioning device (11a); an overmolding mold (13); a supply device for a flowable overmolding medium (15); and a UV source for curing irradiation; wherein the hose sections (1, 2) to be connected and the cover sleeve (12b; 32) can be positioned in the overmolding mold (13) by means of the positioning device (11a) such that the end face regions (1a, 2a) of the two hose sections (1, 2) to be connected face each other and that the cover sleeve (12b; 32) axially covers the facing end face regions (1a, 2a); wherein the feed device is designed such that the mutually facing end face regions (1a, 2a) and the cover sleeve (12b;32) in the overmolding mold (13) can be overmolded with the flowable overmolding medium (15) and an overmolding cavity (14) of the overmolding mold (13) can be filled; and wherein the UV source for the curing irradiation is designed such that the overmolding medium (15) can be irradiated 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.

19. The device according to claim 18, wherein the device (22) is mobile and movable and is suitable for laboratory or clinical use, or for a clean room or pre-production environment; wherein the device in particular comprises a plurality of casters mounted on a frame of the device.

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