Closure device for closing a pharmaceutical container

Abstract

The invention relates to a closure device for closing a pharmaceutical container, having a closure tool for engaging a closure element to a pharmaceutical container (68), having a fluid unit for applying at least one gaseous fluid to the container, having at least one filter (64, 66), wherein the closure device (10) has a tool receptacle (14) and a tool unit (18), wherein the tool unit (18) is designed as a module which can be repeatedly detached from or connected to the tool receptacle (14) by means of a coupling device (16) and which comprises the closure tool (42), the fluid unit (90) and at least one filter (66, 68).

Description

Technical Field

[0001] The present invention relates to a sealing device for sealing a pharmaceutical container, having a sealing tool for engaging a sealing element to the pharmaceutical container, and a fluid unit for applying at least one gaseous fluid to the container, wherein the fluid unit has at least one filter. Background Technology

[0002] The aforementioned types of sealing devices are particularly used for sealing syringes, cartridges, and vials. If these containers are filled with highly reactive filling materials, there is a risk that the filling material will react with oxygen. To avoid this, a protective gas is applied to the partially filled container so that after the sealing element has been engaged or placed on the container, as little oxygen as possible remains in the container (i.e., above the filling level of the filling material). To prevent foreign matter from being introduced into the container along with the protective gas, the protective gas is passed through an appropriate filter.

[0003] It is also known that a negative pressure can be applied to the space above the filling position of the filling material inside the container to simplify the introduction of protective gas. If the filling material is a toxic and reactive substance, it is known that, in the case of using negative pressure gas or partial vacuum, a filter is used near the container to prevent toxic gases from escaping from the container to external areas, such as the area of ​​the negative pressure supply device.

[0004] To prevent the introduction of bacteria into the container during the sealing process under the aforementioned conditions, it is necessary to first sterilize the fluid lines of the fluid unit and at least one filter outside the sealing station. The sterilized components are then placed in the cleanroom area of ​​the sealing station, where they are assembled using gloves. This process must be repeated each time a new filling material is switched, especially if toxic filling materials have been previously handled.

[0005] Removing, disinfecting, and installing numerous components (fluid lines, filters) with gloves is both time-consuming and error-prone. Furthermore, from an occupational safety perspective, the procedures described above in existing technologies are not optimal. Summary of the Invention

[0006] Therefore, the present invention addresses the problem of providing a closed device that enables simplified operation.

[0007] This problem is solved by a closed device according to this application.

[0008] In the closure device according to the invention, a tool unit designed as a module is provided. This module allows simultaneous manipulation of the closure tool, fluid unit, and filter. The module can be specifically connected to or detached from the tool receiving device along with the aforementioned components via a coupling device. In other words, the assembly and disassembly processes are correspondingly limited to connecting the tool unit to the tool receiving device via the coupling device and removing the tool unit from the tool receiving device. The tool unit removed from the tool receiving device can be manipulated outside the closure station, particularly for cleaning, wherein, in this state of removal of the module from the tool receiving device, individual components within the module, such as at least one filter, can be removed.

[0009] The tool receiving device can also be purified, particularly by simply passing a purifying agent (e.g., hydrogen peroxide) through it. Since the components of the tool unit have already been sterilized, since the tool unit carries at least one filter, and since, in the coupled state of the tool unit and the tool receiving device, this filter prevents bacteria from entering the fluid in the area downstream of the at least one filter, further sterilization is not required.

[0010] In a preferred embodiment, the coupling device has a coupling element and a coupling element receiving device that interact in a form-fitting manner while coupled to each other. One component, such as the coupling element, is associated with the tool receiving device, while the other component, such as the coupling element receiving device, is associated with the tool unit. An inverted arrangement is also possible. The form-fitting nature of the components of the coupling device allows for simple and precise connection of the tool unit to the tool receiving device, thus enabling the tool unit to move accordingly through easily transmitted automatic movements of the tool receiving device.

[0011] Further preferably, the tool receiving device includes an actuation mechanism for switching the coupling device between a locked state and a released state, wherein the module is connected to the tool receiving device in the locked state and the module can be released from the tool receiving device in the released state. This allows actuation of the coupling device to be transferred to the area of ​​the tool receiving device, thereby simplifying the structure of the tool unit.

[0012] More preferably, the module includes at least one fluid connection structure, the tool receiving device includes at least one fluid supply device, and the at least one fluid connection structure and the fluid supply device are fluidly connected to each other when the module and the tool receiving device are interconnected. In other words, by coupling the tool unit to the tool receiving device, the fluid unit of the tool unit and the fluid supply device are simultaneously connected without the need for a separate engagement operation.

[0013] Preferably, the tool receiving device includes an actuator for actuating the closing tool. This has the advantage that the tool unit does not need its own actuation device to actuate the closing tool; therefore, no control or power supply is required for the tool unit. This simplifies the tool unit design and makes cleaning easier.

[0014] According to the present invention, the fluid unit is designed to apply at least two different gaseous fluids to the container. This means that the tool unit has at least two fluid connection structures, which are supplied with at least two different gaseous fluids via the fluid supply device of the tool receiving device.

[0015] According to the invention, the module further includes at least two filters, each of which interacts with one of different gaseous fluids. These at least two filters can also be manipulated together with the module, that is, they can be removed from the enclosed device together with the tool unit when it is detached from the tool receiving device, and can be sterilized elsewhere, with the filters removable if necessary.

[0016] Preferably, the gaseous fluid is used in combination as a negative pressure gas and a protective gas. The negative pressure gas refers to a vacuum or partial vacuum. The protective gas is an inert gas, such as nitrogen.

[0017] Preferably, the tool receiving device is held on the robotic arm. This allows the tool receiving device to be manipulated (in a positioning sense), and the tool unit can also be manipulated when coupled to the tool receiving device, and therefore, in particular, the closure tool can also be manipulated. Such a robotic arm defines an internal space in which components of the fluid supply device, i.e., in particular fluid lines, and possibly valves or other devices, are arranged. Therefore, the exposed closure equipment surfaces in the area of ​​the closure station adjacent to the drug container to be closed can be limited to the outer surfaces of the robotic arm, the tool receiving device, and the tool unit. This greatly simplifies the cleaning of the components of the closure station or closure equipment.

[0018] Furthermore, preferably, the enclosed device has a control mechanism for manipulating the module. This control mechanism is independent of the aforementioned robotic arm and allows the tool unit to be positioned relative to the tool receiving device. For example, this control mechanism could be a second robotic arm. Attached Figure Description

[0019] Other features and advantages of the present invention are the subject of the following description and illustrations of preferred exemplary embodiments.

[0020] In the attached diagram:

[0021] Figure 1 A schematic diagram of one embodiment of the enclosure device is shown;

[0022] Figure 2 It shows according to Figure 1 A perspective view of the tool receiving device and tool unit of the enclosed equipment in a mutually coupled state;

[0023] Figure 3 It shows the relationship with Figure 2 A view showing the tool receiving device and tool unit in a decoupled state, corresponding to the other two.

[0024] Figure 4 A perspective view of the tool unit is shown;

[0025] Figure 5 A cross-sectional view of the tool unit along the first section is shown; and

[0026] Figure 6 A cross-sectional view of the tool unit along a second section that is offset at a certain angle from the first section is shown. Detailed Implementation

[0027] A sealing device for sealing pharmaceutical containers is generally indicated by reference numeral 10 in the figure. The sealing device 10 is arranged within the sealing station area of ​​a filling facility, particularly within a cleanroom. The sealing device 10 has... Figure 1 The robotic arm 12 is schematically shown, which holds the tool receiving device 14. The tool receiving device 14 can be repeatedly detached and connected to the tool unit 18 via a coupling device 16.

[0028] The robotic arm 12 has an internal space 20 in which fluid lines 22, 24 for different gaseous fluids are arranged. Fluid line 22 is used to conduct vacuum. Specifically, fluid line 22 can be connected to vacuum pump 26 using a first switching valve 28. A second switching valve 30 is used to introduce a protective gas, particularly nitrogen, into fluid line 24, or to prevent such introduction. Components 20 to 30 together form a fluid supply device 32, which extends to the area of ​​tool receiving device 14 facing coupling device 16. There, tool receiving device 14 has various supply connection structures 34 and 36, which can be coupled to corresponding fluid connection structures 38 and 40 of tool unit 18, respectively.

[0029] The structure of the tool receiving device 14, the coupling device 16, and the tool unit 18 will be referred to below. Figures 2 to 4 To explain. Here, Figure 2 The diagram shows the tool unit 18 connected to the tool receiving device 14. The tool unit 18 is used by means of... Figure 5 and 6 The sealing tool 42 shown in the figure is used for sealing. Figure 2 , 3 The medicine container 68 is shown in 5 and 6.

[0030] The coupling device 16 includes a coupling element 46 (see reference). Figure 3 ), its in Figure 2 When the coupling device 16 shown is in the locked state, it is connected to the coupling element receiving device 48 of the tool unit 18 (see reference). Figure 4 They cooperate with each other. The coupling element 46 can be formed, for example, into a plug head, which cooperates with the coupling element receiving device 48, which is in the form of a groove.

[0031] The coupling element 46 is preferably arranged on the tool receiving device 14 and can be actuated by means of the actuating device 50, which is only schematically shown. When the coupling element 46 is actuated, it moves relative to the tool receiving device 14 and relative to the coupling element receiving device 48, such that the coupling device is in a locked state (see reference). Figure 2 ) or released state (refer to Figure 3 ).

[0032] The tool receiving device 14 also includes a receiving device bushing 52, such as Figure 3 As shown by the dashed line, it serves as the pin 54 for receiving the tool unit 18. The connection between components 52 and 54 supports the form-fit connection between the tool unit 18 and the tool receiving device 14, as explained above, achieved by means of the coupling device 16.

[0033] The tool receiving device 14 also includes an actuator 56, in Figure 3 The dashed line indicates that it can move along the actuator axis 58, thereby actuating the actuation surface 60 of the closing tool 42 (see reference). Figure 4 , 5 and 6).

[0034] The following reference Figure 4 , 5 Sections 6 further describe the structure of tool unit 18.

[0035] Tool unit 18 is designed as a module with housing 62. Housing 62 is used to arrange and position the following components. In particular, housing 62 includes components already referenced... Figure 1 The fluid connection structures 38 and 40 and the sealing tool 42 are mentioned. Furthermore, a corresponding filter 64 (see reference) is provided downstream of the fluid connection structures 38 and 40, relative to the fluid supply device 32. Figure 5 ) and 66 (refer to) Figure 6 ).

[0036] The first filter 64 is designed as a sterile filter. Filter 64 prevents any toxic gases from entering the area of ​​the fluid supply device 32 or the external area of ​​the sealing device 10 from the interior of the pharmaceutical container 68 to be sealed. Filter 64 is therefore associated with negative pressure gas or vacuum or partial vacuum of the fluid supply device 32.

[0037] The second filter 66 is associated with a protective gas (e.g., nitrogen). Filter 66 prevents foreign matter from being introduced from the fluid supply device 32 into the container 68.

[0038] The first filter 64 is assigned to the fluid path leading to the annular collection chamber 72 via the first branch pipe 70 (see reference). Figure 5 For the protective gas supplied to the second filter 66, a corresponding second branch line 74 is provided, which also leads to the collection chamber 72 (see reference). Figure 6 ).

[0039] The collection chamber 72 extends annularly around the obstruction plunger 44 of the sealing tool 42. The obstruction plunger 44 is loaded by force via a compression spring 76, holding the obstruction plunger 44 in a basic position closer to the tool receiving device 14, thus... Figure 5 and Figure 6 Compared to the actuation state shown, the actuation surface 60 (corresponding to) Figure 4 The actuator 56 is positioned further away from the container 68 to be closed. In this actuated state, the actuator 56 presses against the actuation surface 60, causing the actuation plug plunger 44 to press the closing element 78 (e.g., a plug) into the open end region of the container 68.

[0040] Container 68 is provided, for example, in the form of a syringe, cartridge, or vial. Container 68 is preferably held on a retainer (not shown) so that the initial open portion of the container is facing upward relative to gravity.

[0041] Container 68 is used to receive pharmaceutical filling material 80 having an upper filling position 82. A space 84 is provided between the filling position 82 and the boundary of the upper initial opening of container 68. The sealing element 78 is received on the plug plunger 44 before being inserted into the end region of the initial opening of container 68. However, the plug plunger 44 is initially still in its upper basic position (see reference). Figure 4 In this position, the actuating surface 60 is arranged higher, so the closing element 78 is initially still arranged outside the container 68.

[0042] The sealing element 78 is initially positioned at the height of the sealing connector 86, one end of which is connected to the tool unit 18, and the other end abuts against the end flange 88 of the container 68. The sealing connector 86 is hollow, and its dimensions allow the sealing element 78 to have a smaller diameter, enabling gaseous fluid to enter and exit the space 84 from the collection chamber 72 around the sealing element 78. In this state, a negative pressure can be applied to the space 84 by actuating the vacuum pump 26 and the first switching valve 28. Then, a protective gas can be introduced into the space 84 by actuating the second switching valve 30. This operation can be repeated until the oxygen in the space 84 is depleted as much as possible, and then the sealing element 78 is introduced into the container 68 by actuating the blocking plunger 44, thereby sealing the container 68. The sealing element 78 remains on the container 68.

[0043] Subsequently, the plug plunger can be engaged with another sealing element 78 and provide another partially filled container 68, repeating the above operation until a batch of filling material is filled and sealed.

[0044] The area of ​​tool unit 18 located downstream of filters 64 and 66 relative to fluid supply device 32, i.e., the area facing container 68, is collectively referred to as fluid unit 90. In particular, fluid unit 90 includes collection chamber 72 and fluid piping area, especially in the form of branched pipes 70, 74.

[0045] Especially from Figure 3 As can be seen, tool unit 18 can be operated as a whole as a module. This module includes the aforementioned fluid unit 90, filters 64 and 66, and a portion of the sealing tool 42 and coupling device 16. This unit, as... Figure 4 The device can be manipulated as a module, that is, as a whole, and can be connected to or removed from the tool receiving device 14 for sterilization in preparation for subsequent batches. For these engagement operations, further manipulation devices (not shown) can be used, such as in the form of a second robotic arm.

Claims

1. A closing apparatus (10) for closing a pharmaceutical container (68), the closing apparatus (10) having a closing tool (42) for engaging a closing element (78) to a pharmaceutical container (68), the closing apparatus (10) having a fluid unit (90) for applying at least one gaseous fluid to the container (68), wherein, The fluid unit (90) has at least one filter (64, 66), characterized in that the closure apparatus (10) has a tool receiving device (14) and a tool unit (18), wherein the tool unit (18) is designed as a module which can repeatedly be detached from or connected to the tool receiving device (14) by means of a coupling device (16) and which comprises a closure tool (42), a fluid unit (90) and the at least one filter (64, 66), wherein the fluid unit (90) is designed to apply at least two different gaseous fluids to a container (68), wherein the module comprises at least two filters (64, 66), each of which interacts with one of the different gaseous fluids, and at least one fluid connection (38, 40), the tool receiving device (14) comprises at least one fluid supply (32), and the at least one fluid connection (38, 40) and the fluid supply (32) are in fluid connection with one another in the state in which the module and the tool receiving device (14) are connected to one another.

2. The closure device (10) according to claim 1, characterized in that The coupling device (16) has a coupling component (46) and a coupling component clamping device (48) which interact in a form-fit manner in the coupled state.

3. Closing device (10) according to claim 1 or 2, characterized in that The tool receiving device (14) comprises an actuating device (50) for switching the coupling device (16) between a locked state in which the module is connected to the tool receiving device (14) and a released state in which the module can be released from the tool receiving device (14).

4. The closure device (10) according to claim 1 or 2, characterized in that The tool receiving device comprises an actuator (56) for actuating the closure tool (42).

5. The closure device (10) according to claim 1 or 2, characterized in that One of the gaseous fluids is a negative pressure gas and the other gaseous fluid is a protective gas.

6. The closure device (10) according to claim 1 or 2, characterized in that The tool receiving device (14) is held on a robot arm (12).

7. The closure device (10) according to claim 1 or 2, characterized in that The closure apparatus (10) has a handling device for handling the module. The tool receiving device (14) is held on a robot arm (12). The closure apparatus (10) has a handling device for handling the module.

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