Dosing device for medical purposes and method for operating dosing device

Abstract

The invention relates to a dosing device (100) for medical purposes, comprising a closed reservoir (104) having a wall (126) and an inner space (128) surrounded by the wall, at least one attachment mechanism (136, 142) for attaching the dosing device (100) to a medical device (102) for treating, in particular, a liquid medical product, wherein at least one attachment mechanism (136, 142) is integrated into the wall portion (126) and comprises at least one closure element (138, 144) for selectively closing the opening (139, 145), a travel base frame (108) for advancing the dosing device (100) on the seating surface (110), and at least one dosing tool (166) in the interior space (128), the invention relates to a dosing tool for conveying and / or dosing a product, comprising a fluid line (168, 182) for guiding the product and a dosing unit (156) for conveying and / or dosing the product through the fluid line (168, 182), wherein the fluid line (168, 182) can be led out of the interior (128) when at least one closure element (138, 144) is open. The invention further relates to a method for operating the dosing device (100).

Description

Technical Field

[0001] The present invention relates to a dispensing device for pharmaceutical purposes, which can be used with equipment for processing products, particularly with a filling machine for filling containers with pharmaceutical products, wherein the dispensing device is arranged outside the equipment.

[0002] Furthermore, the present invention relates to a method for operating a quantitative dispensing device of the type described above. Background Technology

[0003] In a filling machine used for filling containers, pharmaceutical substances are filled into pharmaceutical containers, which can be, for example, vials (tubular bottles), syringes, cartridges, or ampoules. The containers can be stably upright or unstable upright. In the current example, the pharmaceutical product is particularly a fluid, especially a liquid.

[0004] It is known that metering devices are used with filling machines, in which product outside the cavity is supplied to the filling machine. Fluid lines are supplied through defined attachment mechanisms (e.g., A / B ports or RTP, quick transfer ports) and filled into containers in a metering manner within the filling machine. For example, the delivery unit of the metering device is used to meter the product. For example, the use of a hose pump (peristaltic pump) is known, which can deliver liquid product in a metering manner through a hose-shaped fluid line. In this context, it is known to use disposable equipment (single-use devices) for hose lines, product containers, and filling needles.

[0005] In practice, meeting hygiene requirements has proven challenging. Typically, the interior of the filling machine operates at a high cleanliness level (e.g., GMP Type A), while the dispensing unit is located in a lower cleanliness level environment, such as GMP Type C. Summary of the Invention

[0006] The object of the present invention is to provide a quantitative dispensing device for pharmaceutical purposes and a method for operating such a quantitative dispensing device or method, which can be used in many aspects, especially with regard to compliance with hygiene requirements.

[0007] This objective is achieved by a dispensing device for pharmaceutical purposes according to the invention, comprising a closed reservoir having a wall and an interior space surrounded by the wall, at least one attachment mechanism for attaching the dispensing device to a pharmaceutical device for handling, in particular, liquid pharmaceutical products, wherein at least one attachment mechanism is integrated into the wall and includes at least one closure element for selectively closing an opening, a travel frame for allowing the dispensing device to travel on a mounting surface, and at least one dispensing tool in the interior space having a fluid line for guiding the product and a dispensing unit for delivering and / or dispensing the product through the fluid line, wherein the fluid line can be drawn out from the interior space when at least one closure element is open.

[0008] The dispensing device according to the invention comprises a closed reservoir with an internal space and a traveling frame for moving the dispensing device on a mounting surface. This allows the dispensing device to be prepared in advance for a predetermined purpose, together with equipment for processing products, particularly a filling machine. The dispensing device can be equipped separately from the equipment, whereby the dispensing device moves toward the equipment, and a fluid line is guided from the internal space of the reservoir through at least one open closing element of the attachment mechanism into the equipment. Alternatively, the dispensing device can be equipped directly at the location where it is used within the equipment. At least one dispensing tool is provided within the internal space, comprising a fluid line and a dispensing unit. The dispensing unit allows the supplied product to be dispensed and / or conveyed in a targeted manner, thereby being brought into the equipment through the fluid line.

[0009] Alternative to or supplementing at least one attachment mechanism, through which fluid lines can be led out from the internal space, the dispensing device may preferably include at least one connecting mechanism in a standardized and / or sterilized design. For example, fluid lines in the internal space are attached to the connecting mechanism, and fluid lines outside the device can be attached to the connecting mechanism on the outside. Due to this connecting mechanism, the opening of the reservoir can be eliminated when the dispensing device is attached to the device.

[0010] The above design allows for the pre-configuration of the dispensing device for specific applications. For example, pre-sterilized or purified dispensing tools can be brought into a previously sterilized or purified interior space to meet necessary hygiene requirements.

[0011] Alternatively or supplementally, it may be preferable to bring unsterilized or unpurified dispensing tools into an unsterilized or unpurified interior space, and then sterilize or purify the interior space together with the dispensing tools contained therein.

[0012] The preparation, and especially the bringing of the dispensing device, into the interior space can be done in different ways. For example, a stationary cavity is operated, a movable dispensing device is attached to the stationary cavity, and the dispensing device is received in the stationary cavity. It may be sterilized or purified, or in other cases, unsterilized or unpurified. After detachment, the dispensing device can be moved toward the equipment and used.

[0013] Alternatively or supplementally, it may be specified that the movable cavity in which the dispensing tool is located is transported to and docked with the dispensing device. After assembly, the movable cavity is removed, and the dispensing device can be used at the equipment.

[0014] Advantageously, the dispensing device is designed to allow existing dispensing tools to operate in conjunction with it. Accordingly, the dispensing device can preferably be adapted to different dispensing systems, wherein various types of dispensing units, fluid lines, or different types of known dispensing tools can be selectively used. Currently, objects that can be used to dispense products quantitatively in the intended use of the dispensing device can be particularly considered as dispensing tools, wherein the dispensing tools can particularly have a product contact portion.

[0015] Preferably, there is a possibility of using the quantitative distribution tool multiple times.

[0016] At least one attachment mechanism can be designed in different ways. For example, standardized ports, particularly Port A or Port B, can be considered. For instance, an RTP (Rapid Transfer Port) is used for docking with the device. In general, any type of attachment mechanism can be considered, particularly one that enables aseptic connection between the device and the dispensing apparatus. The attachment mechanism can be single-walled with one sealing element; or multi-walled, such as double-walled, with two sealing elements.

[0017] Regarding compliance with hygiene requirements, it is advantageous for storage containers to be or form isolation mechanisms, especially those with a defined atmosphere within the interior space.

[0018] For example, the reservoir can have RABS characteristics (RABS, Restricted Access Barrier System).

[0019] With at least one attachment mechanism closed, the reservoir is preferably liquid-tight and / or gas-tight.

[0020] The aforementioned characteristics particularly allow the use of the dispensing device for handling highly active and / or toxic substances.

[0021] Beneficially, the cleanliness level of the interior space can be adjusted according to regulations, such as GMP Type A, Type B, or Type C.

[0022] In order to provide and / or comply with necessary hygiene requirements, it is beneficial that the dispensing device can be completely or partially, but at least in its interior space, along with the objects contained therein and, in particular, the dispensing tools contained therein.

[0023] For example, the dispensing device has a purification and / or sterilization mechanism in its internal space. For example, sterilization can be performed by steam, and purification can be performed by H2O2.

[0024] For disinfection and / or purification via external disinfection and / or purification mechanisms, at least one attachment element or transfer element may be present at the wall to bring the medium into the interior space. This eliminates the need for internal disinfection and / or purification mechanisms. At least one attachment element allows for the attachment of fluid lines, and the transfer element, for example, allows for the feedthrough of fluid lines. Alternatively or additionally, the attachment element may be configured to dock with a unit for purifying or disinfecting the material to be brought in, such as an autoclave, H2O2 gate, or UV gate.

[0025] As a dispensing tool, fluid lines and dispensing units are housed within an internal space, where more than one fluid line and / or more than one dispensing unit can be installed.

[0026] At least one dispensing tool may also include at least one container for receiving the product, to which a fluid line is attached. The container may, in particular, be a bag.

[0027] Advantageously, the dispensing device includes a defined arrangement of containers and, in particular, a holding element for suspension within its internal space.

[0028] Containers, especially bags, can be product bags or accessory bags.

[0029] At least one dispensing tool may include a filter element, particularly a sterilizing filter, connected to a fluid line.

[0030] For example, a fluid line is attached to the outlet of a container, with a filter connected to the fluid line.

[0031] In general, the layout of the dispensing device can be determined based on user-specific and product-specific requirements and is preferably adapted accordingly.

[0032] The dispensing device may include other fluid lines as dispensing tools, wherein a feed-through mechanism is arranged in the wall for the other fluid lines to enter the interior space from the outside, and the other fluid lines are attached to the container inlet. This type of implementation is adopted, for example, when using two containers. For example, an accessory bag exists outside the storage container, from which the product is transferred via other fluid lines to a product bag contained therein in the interior space, and from the product bag, the product is conveyed via fluid lines using the dispensing unit.

[0033] The feedthrough mechanism is preferably implemented as sterile. In this case, it can be, for example, a sterile liquid transfer port (SART or AT port).

[0034] The filter element can be connected to other fluid lines inside the internal space or outside the reservoir.

[0035] When using, for example, a single fluid line, the dispensing device may include a feedthrough mechanism in the wall for feeding the fluid line from the outside to the inside space, wherein the feedthrough mechanism may be constructed as described above. This type of arrangement is used, for example, with a single container. For example, a product bag is arranged outside the reservoir to which the fluid line is attached.

[0036] As can be seen from the above, the dispensing device may include a container for receiving the product outside the internal space, with other fluid lines or conduits attached to the container.

[0037] The dispensing device may include, for example, a defined arrangement for the container and, in particular, a suspension retaining element outside the internal space. The retaining element is preferably arranged and secured at the reservoir and can travel with it.

[0038] At least one attachment mechanism and feedthrough mechanism may be arranged, for example, on opposite sides of the reservoir.

[0039] The dispensing device may preferably include a receiving portion within its internal space for detachably assembling a dispensing unit. When equipping the dispensing device, for example, a suitable dispensing unit can be brought in and assembled into the receiving portion.

[0040] Preferably, attachment elements for providing electrical power to the metering unit are arranged outside the internal space. Alternatively or supplementarily, the metering device may include an energy supply mechanism.

[0041] Attachment elements for control and / or signal lines are preferably arranged within the internal space to control and / or regulate the operation of the dispensing unit. Optional control mechanisms for the dispensing device are advantageously located outside the internal space.

[0042] Advantageously, at least one adapter element is provided for detachably assembling various types of dispensing units at the receiving part. This enables versatile designs to meet user-specific and product-specific requirements, as well as related adaptations to the dispensing device.

[0043] The dispensing unit may include, for example, a peristaltic pump, a rotary piston pump, a time-pressure dispensing unit, and / or a multiple dispensing kit.

[0044] Beneficially, the interior space can be divided into a first zone and a second zone using partitions, such as partition walls, where the first zone has a higher cleanliness level than the second zone. For example, a separate zone can be set up for handling products with special properties, such as toxic products.

[0045] For example, it can be specified that the fluid line is arranged wholly or partially in the first zone and the filling needle attached to the fluid line is arranged in the first zone and / or the container for receiving the product is arranged in the second zone. The dispensing unit can be arranged, for example, in the first zone or the second zone.

[0046] In an embodiment of the present invention, at least one glove insertion part for the user can be provided at the storage container.

[0047] The walls are advantageously designed to be transparent, at least in sections, so that users can see the interior of the storage unit.

[0048] In a preferred embodiment of the invention, at least one dispensing tool may include at least one filling needle attached to a fluid line, the filling needle being arranged within an internal space. With at least one attachment mechanism open, the filling needle can be brought into the device and used to fill a container.

[0049] It can be specified that the dispensing device includes a defined arrangement for the filling needle and, in particular, a suspension holding component within its internal space.

[0050] The retaining component may be arranged, for example, at at least one closure element that can be pivotally rotated out from the internal space when at least one attachment mechanism is opened. This allows, for example, a filling needle to be transported into the internal space of the device when the closure element is open, so that it can be grasped there in a more convenient manner, for example by a robotic device and / or by a hand.

[0051] The retaining member is preferably configured to be variable in size or length, wherein it can be transitioned from a storage posture to a use posture, wherein the filling needle can be guided in a spaced-apart manner from the reservoir with at least one closure element open. This improves the handling of the filling needle during insertion or when it is being inserted into the internal space of the device. The retaining member can be, for example, telescopic, pull-out, flip-up, or similar. An actuator for the retaining member can be provided. A scissor pull or scissor grid can be used, at which the filling needle is held.

[0052] The dispensing device may include additional attachment mechanisms integrated into the wall, having at least one other closure element, wherein the attachment mechanisms are arranged, for example, on opposite sides of the reservoir. These additional attachment mechanisms can be designed in various ways. For example, A / B ports, RTP, or the like may be considered. Advantageously, the additional attachment mechanisms allow for a sterile connection to the reservoir.

[0053] Other attachment mechanisms, such as those that allow the dispensing device to be attached to a stationary cavity, may be considered. Alternatively or supplementarily, a portable cavity may be used, which is guided toward the dispensing device and from which the dispensing tool is removed.

[0054] The metering device may include a gas supply mechanism comprising a container for gas within an internal space, a gas line attached to the container, and a preferably nozzle-shaped outlet element at the gas line, wherein the gas line can be led out of the internal space with at least one sealing element open. This allows for pre-supply, filling, and / or post-supply during product loading, for example. This eliminates the need for a separate gas supply path.

[0055] In a preferred embodiment, the dispensing device may include an air conditioning mechanism for adjusting the temperature and / or humidity in the interior space.

[0056] Alternatively or supplementally, the dispensing device may include a ventilation mechanism for providing a preferably defined airflow within the interior space. For example, a laminar flow (LF) may be provided. The ventilation mechanism may be arranged within the interior space or outside the exterior space, wherein airflow is generated through openings in the walls. The ventilation mechanism may be designed as an overpressure mechanism or a negative pressure mechanism.

[0057] A dispensing device may include a weighing element arranged in an internal space, the signal of which can preferably be used for dispensing the product. For example, a holding element for a container is provided with a weighing element. The weighing element can be used to confirm the weight of the contents of the container or changes in the contents, and thereby infer and / or control the dispensing.

[0058] The dispensing device can be manually guided by the user, for example.

[0059] It can be stipulated that the driving base has a driving drive.

[0060] In an advantageous embodiment of the invention, the dispensing device is designed to be self-propelled and self-steering, and capable of moving independently on the mounting surface without user assistance. Accordingly, the dispensing device can be designed as robotic.

[0061] As described above, the present invention also relates to a method.

[0062] The method for operating a quantitative dispensing device of the above type according to the present invention includes:

[0063] - Provides storage space;

[0064] - The reservoir is attached to the cavity, which contains at least one dispensing tool;

[0065] - Transfer at least one dispensing tool into the internal space of the reservoir and disconnect the dispensing device from the cavity.

[0066] The advantages already described in conjunction with the explanation of the quantitative dispensing device according to the invention can also be achieved by implementing this method. Reference is made to the foregoing statements in this regard.

[0067] Advantageous embodiments of the method are derived from advantageous implementations of the quantitative dispensing apparatus according to the invention. Refer to the foregoing statements.

[0068] The cavity may be stationary, with the dispensing device moving toward and attached to the cavity. Alternatively, a movable cavity may be provided, which is guided toward and attached to the dispensing device.

[0069] This method may include, for example, other method steps:

[0070] - Attach the storage container to medical equipment used for processing products;

[0071] - Remove at least one fluid line and transfer it to the equipment;

[0072] - Operate the quantitative distribution unit to supply products. Attached Figure Description

[0073] The following description of preferred embodiments of the present invention is provided to illustrate the invention in more detail with reference to the accompanying drawings. In the drawings:

[0074] Figure 1A schematic perspective view of the quantitative dispensing device according to the invention being used in an apparatus for processing pharmaceutical products is shown with reference to a preferred embodiment.

[0075] Figure 2 A partial view of the dispensing device is shown in a cutaway manner;

[0076] Figure 3 A top view of the dispensing device is shown in a cutaway manner;

[0077] Figure 4 To correspond to Figure 2 The diagram shows a view of the dispensing device in alternative use;

[0078] Figure 5 To correspond to Figure 2 The diagram shows a view of the dispensing device in use with alternatives;

[0079] Figure 6 To correspond to Figure 2 The method illustrates the quantitative dispensing device in the use of alternatives;

[0080] Figure 7 A perspective view is shown of an embodiment of a filling needle and a fluid line holding member for a metering device according to the present invention;

[0081] Figure 8 A view is shown of another preferred embodiment of the filling needle and fluid line holding component for the metering device according to the invention;

[0082] Figure 9 A schematic diagram of a variation of the preparation process for equipping the quantitative dispensing device according to the present invention is shown;

[0083] Figure 10 Further steps are shown when equipping the dispensing device; and

[0084] Figure 11 Further steps are shown when equipping the metering device. Detailed Implementation

[0085] The accompanying drawings show an advantageous embodiment of the quantitative dispensing device according to the invention, indicated by reference numeral 100, which allows the method according to the invention to be implemented according to a preferred embodiment.

[0086] The dispensing device 100 can be used in many ways and is used in conjunction with a device 102 for processing pharmaceutical products. The product is currently a liquid, which can be provided by means of the dispensing device 100 and, in particular, brought into the device 102 in a dispensing manner. In the device 102, pharmaceutical containers are filled with the product, such as vials (tubular bottles), syringes, cartridges, or ampoules. The device 102 includes a wall 103.

[0087] The dispensing device 100 can be adapted in various ways to meet specific user and product requirements, depending on the product to be processed. This is particularly advantageous because it can satisfy various types of hygiene requirements. Preferably, different cleanliness levels, such as GMP Type A, Type B, or Type C, can be achieved.

[0088] Preferably, the dispensing device is constructed with a reservoir as an isolation mechanism, providing a confined atmosphere within the internal space. The reservoir may have RABS properties and, in a closed state, be particularly liquid-tight and / or gas-tight.

[0089] Overall, the dispensing device 100 forms a closed, sealed containment that is movable, in the present case, able to travel on the mounting surface 110 and move toward and away from the device 102.

[0090] Figures 1 to 3 A dispensing device 100 in the case of an exemplary apparatus is shown and explained below.

[0091] The dispensing device 100 includes a reservoir 104. The reservoir 104 is currently arranged on a lower structure 106, for example, in the form of a frame. A travel frame 108 for traveling on a mounting surface 110 is arranged at the lower structure 106. Currently, the travel frame 108 includes undriven rollers 112. In the current example, the dispensing device 100 can be manually traveled on the mounting surface 110 by a user 114.

[0092] Alternative or supplementary locations may be considered, such as a driving base 108 having a driving drive 116.

[0093] Alternatively or supplementally, the dispensing device 100 may be designed to be self-driving and self-steering, and to move autonomously on the mounting surface 110 in a robotic manner.

[0094] For example, to control and / or regulate the operation of the dispensing device 100 during autonomous operation, a control mechanism 118 is provided, which is advantageously arranged outside the storage container 104.

[0095] For example, the control mechanism 118 is housed in the housing 120 held at the lower structure 106.

[0096] For example, the energy supply mechanism 122 may be received in the housing 120. Alternatively or additionally, attachment elements 124 for attaching external energy supply mechanisms may be arranged outside the storage unit 104, for example at the lower structure 106 or at the housing 120.

[0097] In the current embodiment, the storage unit 104 is configured as square, but is not limited thereto. In this case, the storage unit 104 includes a wall 126 surrounding the interior space 128. The wall 126 may be completely or partially transparent, allowing the user 114 to see the interior space 128.

[0098] It may be specified that the storage container 104 includes removable walls or removable sections of walls (e.g., as a removable or flip-up cover) to open the storage container and access the interior space 128.

[0099] The dispensing device 100 may include at least one glove insertion portion 130 at the reservoir 104, through which the user 114 can access the interior space 128 in a sterile manner. Currently, two glove insertion portions 130 are provided, by way of example. The wall portion 126 is advantageously transparent in the wall that receives the glove insertion portions 130.

[0100] The dispensing device 100 can be attached to the device 102 and, in particular, can be aseptically connected. For this purpose, an attachment mechanism 132 is provided at the device 102, which has an inwardly opening closure element 134.

[0101] The dispensing device 100 is positioned at device 102 such that attachment mechanism 136 integrated into wall portion 126 covers attachment mechanism 132 with closure element 138. Closure element 138 can be opened to release opening 139 in wall portion 126, which in this case is preferably pivotable into internal space 140 of device 102. In this way, internal space 128 can communicate with internal space 140.

[0102] The attachments 132 and 136 are preferably standardized, for example, designed as A / B ports or RTP ports.

[0103] The dispensing device 100 may include additional attachment mechanisms 142 integrated into the wall portion 126. This type of attachment mechanism 142 is currently shown in the drawings, wherein attachment mechanisms 136, 142 are arranged on opposite sides of the wall portion 126. This can prove advantageous, for example, for the manipulation of the dispensing device 100 in order to comply with a defined operating procedure. In this case, it can be stipulated that the dispensing tool is brought into the interior space 128 from one side via attachment mechanism 142 and brought out on the opposite side via attachment mechanism 136.

[0104] The attachment mechanism 142 itself also includes a closing element 144. When the closing element 144 is opened, the opening 145 in the wall portion 126 is released.

[0105] The attachment 142 is preferably implemented in a standardized manner, for example, as an A / B port or as an RTP port.

[0106] In the current embodiment, the dispensing device 100 includes a feedthrough mechanism 147 integrated into the wall portion 126. Fluid lines can be guided from the outside to the inside of the interior space 128 in a sterile manner through the feedthrough mechanism 147. For example, the feedthrough mechanism 147 is constructed in a standardized manner, such as being configured as a sterile liquid transfer port (SART or AT port).

[0107] A dispensing tool for quantitatively dispensing products, especially liquid products, can be housed in an internal space 128. It may be specified that at least one dispensing unit and at least one fluid line are included. The dispensing tool, particularly within the internal space 128, may include, for example, at least one dispensing unit, at least one fluid line, at least one container for the product, at least one filter element, and at least one filling needle attached to the fluid line. Various types of equipment for the dispensing apparatus 100 are discussed below.

[0108] However, other alternative mechanisms for the dispensing device are first shown as examples.

[0109] Disinfection mechanism 148, purification mechanism 150, ventilation mechanism 152 and air conditioning mechanism 154 can be set.

[0110] Mechanisms 148, 150, 152 and 154 may be arranged wholly or partially in the interior space 128, or wholly or partially outside the storage unit 104. Figure 3 Mechanisms 148, 150, 152, and 154 are shown exemplary in the interior space 128. When arranged outside the storage unit 104, at least one attachment element or the like may be provided in the wall portion 126 to act on the interior space 128 in a desired manner.

[0111] The disinfection unit 148 and the purification unit 150 are capable of disinfecting or purifying the interior space 128 and the materials arranged therein, especially the dispensing tools. For example, steam or H2O2 can be used for disinfection or purification.

[0112] A defined flow, such as laminar flow, can be generated in the interior space 128 via the ventilation mechanism 152.

[0113] For example, the temperature and / or humidity in the interior space 128 can be adjusted via the air conditioning unit 154.

[0114] Mechanisms 148, 150, 152 and 154 are preferably connected to control mechanism 118 for controlling and / or regulating operation.

[0115] Such as especially by Figures 1 to 3 It is understood that a dispensing unit 156, currently designed as a peristaltic pump 158, is arranged in the internal space 128. To drive the dispensing unit 156, a drive unit 160 may be arranged in or guided into the internal space 128, with a design preferably suited to pharmaceuticals. The drive unit 160 is powered, for example, by means of an energy supply mechanism 122 or from the outside via an attachment element 124.

[0116] Advantageously, the drive unit 160 forms a receiving portion 162, and various types of dispensing units 156 can be detachably mounted at this receiving portion depending on the application of the dispensing device 100. For example, a corresponding adapter element 164 is provided to adapt to the corresponding dispensing unit 156.

[0117] The dispensing unit 156 is currently a dispensing tool 166 for dispensing and / or conveying liquid products.

[0118] As another dispensing tool 166, a fluid line 168 is currently provided in the internal space 128, which is specifically designed as a flexible hose and inserted into the peristaltic pump 158.

[0119] As another dispensing tool 166, a filling needle 170 is currently provided attached to the fluid line 168. The product can be filled into the container via the filling needle 170.

[0120] As another dispensing tool 166, a container 172 in the form of a bag 174 is currently provided. A fluid line 168 is attached to the outlet of the bag 174, guided through a peristaltic pump 158, and has a filling needle 170 at one end.

[0121] For the defined arrangement of the filling needle 170 in the internal space 128, the dispensing device 100 includes a retaining member 176. For example, the filling needle 170 is held at the retaining member 176 by force engagement and / or form engagement.

[0122] Advantageously, the retaining member 176 is secured at the closing element 138. When the closing element 138 is opened, the retaining member 176, which has the filling needle 170 held there, is thus moved into the internal space 128 of the device 102 and can be gripped more easily.

[0123] The retaining element 178 for the defined arrangement of the bag 174 is preferably arranged in the interior space 128. Currently, the retaining element 178 is secured to the wall portion 126, and the bag 174 is suspended at the retaining element 178.

[0124] For example, a weighing element 180, configured as a balance, can be provided at the holding element 178. This allows for the detection of changes in the mass of the bag 174, thereby controlling and / or regulating the quantitative dispensing process. The weighing element 180 can be coupled to a control mechanism 118.

[0125] As another dispensing tool 166, the dispensing device 100 in the present example includes an additional fluid line 182, which is designed as a flexible hose. The fluid line 182 is attached to the inlet of the bag 174, wherein the fluid line is guided from the outside into the interior space 128 via a feed mechanism 147.

[0126] A filter element 184, which is connected to the fluid line 182 as another metering tool 166, is in particular a sterilizing filter. The filter element 184 is currently arranged in the internal space 128.

[0127] Other fluid lines 182 are attached to the outlet of another container 186, which is currently designed as a bag 188.

[0128] For the defined arrangement of the bag 188, the dispensing device 100 includes a retaining element 190. In the current example, the bag 188 can be suspended at the retaining element 190. The retaining element 190 is preferably secured at the reservoir 104.

[0129] In the current exemplary configuration of the dispensing device, bag 188 serves as an accessory for storing the product. The product enters the bag 174, which serves as the product bag, via fluid line 182. From the bag, the product reaches the filling needle 170 via fluid line 168 and can be filled into a container.

[0130] In application, the dispensing device 100 is positioned at the device 102. Attachment mechanisms 132 and 136 overlap to mate with the dispensing device 100. With the closure elements 134 and 138 open, a fluid line 168 with a filling needle 170 can be introduced into the internal space 128. This... Figure 2 The filling needle 170 is shown in dashed lines. It can be held, for example, by a robotic device or by a user.

[0131] Figures 4 to 6 Different types of equipment for the dispensing device 100 are shown, such as those that can be used, for example, when processing different products or in situations requiring different types of user requests. Only those relative to [specific product type] are illustrated. Figures 1 to 3 The difference in equipment.

[0132] According to Figure 4 In the equipment variant, the filter element 184 is also connected to the fluid line 182, but is arranged outside the reservoir 104.

[0133] According to Figure 5 In the modified equipment, the bag 174 in the internal space 128 is eliminated. Instead, only the external bag 188 is provided as the product bag. Only the fluid line 168 is used, which is guided from the outlet of the bag 188 through the feed mechanism 147 and the filter element 184 is connected to the fluid line.

[0134] According to Figure 6 In the modified equipment design, the external bag 188 is eliminated. The fluid line 182 is eliminated. The filter element 184 is connected to the fluid line 168 as per [the original design]. Figures 1 to 3 In the variant, it is attached to the outlet of bag 174 as in the example.

[0135] Figure 7 An embodiment of the retaining member 176 designed in a variable length manner is shown. A view taken from the side of the device 102 is shown, in which the filling needle 170 has been introduced into the internal space 128.

[0136] The retaining component 176 is designed to be flip-out and, in the current example, includes three sections 192, 193, and 194. Sections 192 and 193 are pivotally connected to each other at hinge 195. Correspondingly, sections 193 and 194 are pivotally connected to each other at other hinges 196.

[0137] The filling needle 170 is currently held at section 194, and the fluid line 168 is guided along the retaining member 176.

[0138] Figure 7The holding member 176 is shown in an extended position. The holding member 176 is folded (not shown) as long as it is arranged within the closed storage container 104. Sections 192 to 194 can pivot relative to each other to unfold or fold the holding member 176.

[0139] The metering device 100 may include a gas supply mechanism 198, which is preferably arranged in the internal space 128 and can be triggered, for example, by a control mechanism 118. Figure 3 The gas supply mechanism 198 can be designed to pre-supply, intermediate-supply, and / or post-supply gas to the container to be filled.

[0140] The gas supply mechanism 198 may include, for example, a gas container 200, a gas line 202, and at least one nozzle-shaped outlet element 204.

[0141] Figure 7 The outlet element 204 is schematically shown. The outlet element 204 is held at section 194.

[0142] According to Figure 8 The embodiment of the retaining member 176 shows two outlet elements 204.

[0143] According to Figure 8 In a variant, the outlet element 204 and the filling needle 170 are held at the retaining member 206 of the retaining member 176. The retaining member 206 is currently secured at the end side to the pull-out member 208, which in this example includes a scissor pull 210. The scissor pull 210 in Figure 8 It is shown in the pulled-out position, in which it protrudes into the internal space 128 of the device 102.

[0144] In the pulled-in posture (not shown in the accompanying drawings), the scissor puller 210 is arranged in the receiving portion 212 within the opening 139, such that in the case of the closed closing element 138, the retaining member 206 is also positioned within the reservoir 104.

[0145] Figures 9 to 11 The preparation process for equipping the quantitative dispensing device 100 according to the task to be performed is illustrated schematically. In this case, an exemplary illustration is shown... Figure 5 The equipment variants shown and explained in the document.

[0146] For equipping the dispensing device 100, various types of cavities 214, 216, 218 can be attached to the reservoir 104, particularly the attachment mechanism 142. Cavities 214, 216, 218 include attachment mechanisms that are beneficial for (preferably) aseptic connection, which can be aseptically connected to the attachment mechanism 142.

[0147] In the current case, the cavities 214, 216, and 218 differ in the contents of the corresponding dispensing tool 166. In this case, it is assumed that the dispensing unit 156, such as the peristaltic pump 158, is already located in the internal space 128 of the reservoir 104.

[0148] In the hypothetical example used and its contents are Figure 10 and Figure 11 The cavity 214, which has been or is being introduced into the reservoir 104, contains a fluid line 168 with a filling needle 170 and a filter element 184. (In docking...) Figure 10 Afterwards, these dispensing tools 166 are brought into the internal space 128, and then the cavity 214 is disconnected. The fluid line 168 is guided through the feed mechanism 147 and connected to the bag 188. Figure 11 ).

[0149] For equipment variants not explained below, cavity 216 may be used, in which the metering unit 156 is brought into the internal space 128 as a metering tool in addition to the metering tool 166 mentioned above.

[0150] In another equipment variant, which is also not elaborated further, the bag 174 is additionally brought into the internal space 128 via the cavity 218. In this example, the fluid line 168 is, for example, retained in the internal space 128.

[0151] Figures 9 to 11 Cavities 214 to 218 are shown in a movable form, which move toward the metering device 100. Cavities 214 to 218 are designed to be movable, attached to the metering device 100, and subsequently removed from the metering device 100.

[0152] In the illustration, the dispensing device 100 is positioned at the target location on the equipment 102, however, the closing elements 134, 138 have not yet been opened. It should be understood that during the assembly process, the dispensing device 100 may be positioned spaced apart from the equipment 102.

[0153] Alternatively or supplementing the movable cavities 214 to 218, the dispensing device 100 may move on the mounting surface 110 of the stationary cavity 220, in which the dispensing tool 166 is received and Figure 9 It is shown schematically in the diagram.

[0154] Depending on the application, it may be stipulated that the quantitative dispensing tool 166 to be brought in has been disinfected or purified, or that it is disinfected or purified in the internal space 128.

[0155] For example, the following steps can be considered when the dispensing device 100 is in operation:

[0156] - A pre-sterilized (single-use) dispensing tool 166 is provided in the previously sterilized or purified cavities 214 to 220 via RTP or different types of attachment mechanisms. It is installed by the user 114 through the glove intervention 130, the reservoir 104 is closed and docked, the device 102 is connected, the attachment mechanisms 132, 136 are opened, one or more filling needles 170 are introduced and loading begins.

[0157] - Take the unsterilized dispensing tool 166 into the unsterilized or unpurified storage container 104, install the dispensing tool 166, close the storage container 104 and sterilize or purify the internal space 128 with the contents, connect to the device 102, open the attachment mechanisms 132, 136, take in (one or more) filling needles 170 and begin loading.

[0158] - The previously sterilized or purified reservoir 104 is connected to the sterilized external cavity or preparation unit 214 to 220 via the attachment mechanism. The reservoir 104 is installed, closed and connected to the device 102 through the glove intervention part 130 of the external cavity or preparation unit 214 to 220. The attachment mechanism 132, 136 is opened, one or more filling needles 170 are introduced and loading begins.

[0159] - Connect the unsterilized or unpurified reservoir 104 to the unsterilized cavity or external preparation unit 214 to 220 via the attachment mechanism, sterilize or purify the reservoir 104 and the cavity or preparation unit 214 to 220 together, install the dispensing tool 166 through the glove intervention part of the cavity or external preparation unit 214 to 220, close and detach the attachment mechanism, connect to the device 102, open the attachment mechanisms 132, 136, bring in (one or more) filling needles 170 and begin loading;

[0160] - Connect the unsterilized or unpurified storage container 104 to the unsterilized cavity or external preparation unit 214 to 220 via the attachment mechanism, install the dispensing tool 166, sterilize or purify at least the internal space 128 with the contents, close and detach the attachment mechanism, connect to the device 102, open the attachment mechanisms 132, 136, bring in (one or more) filling needles 170 and begin loading.

[0161] Advantageously, the storage container 104 can maintain its hygienic properties for a longer period of time. For example, the dispensing device 100 can be prepared and stored or temporarily stored for a sufficient period of time before use, whereby it is moved toward the device 102 at a later time.

[0162] Figure 3A partition element 224, optionally present in the interior space 128, is shown via dashed line 222. The partition element 224 may be, for example, a partition wall 226 having at least one opening.

[0163] The interior space 128 is divided into a first zone 228 and a second zone 230 by a partition element 224, wherein the first zone 228 has a higher cleanliness level than the second zone 230.

[0164] In the current example, fluid line 168, filling needle 170, and dispensing unit 156 are arranged in the first zone 228. Fluid line 168 is guided through separator element 224 into the second zone 230, in which bag 174 and filter element 184 are arranged.

[0165] The internal space 128 can have different cleanliness levels as required. For example, a GMP A cleanliness level for highly reactive and toxic substances can be considered. On the other hand, a GMP B or GMP C cleanliness level can also be considered. Advantageously, the corresponding cleanliness level can be achieved in the dispensing device 100 as needed in an application-related manner, thus demonstrating that the dispensing device 100 is particularly applicable to many aspects.

[0166] Explanation of reference numerals in the attached figures

[0167] 100 quantitative dispensing device

[0168] Equipment 102

[0169] 103 wall section

[0170] 104 storage units

[0171] 106 Substructure

[0172] 108 driving base

[0173] 110 resettlement area

[0174] 112 rolls

[0175] 114 users

[0176] 116 driving drive

[0177] 118 control mechanism

[0178] 120 housing

[0179] 122 Energy Supply Organizations

[0180] 124 Attachment Components

[0181] 126 wall section

[0182] 128, 140 interior space

[0183] 130 gloves interventional department

[0184] 132, 136, 142 Attachment Mechanisms

[0185] 134, 138, 144 closed elements

[0186] 139, 145 openings

[0187] 147 Feeder Mechanism

[0188] 148 Disinfection Agency

[0189] 150 purification units

[0190] 152 Ventilation System

[0191] 154 Air Conditioning Mechanism

[0192] 156 quantitative distribution units

[0193] 158 peristaltic pump

[0194] 160 drive unit

[0195] Reception Departments 162 and 212

[0196] 164 adapter components

[0197] 166 Quantitative Allocation Tool

[0198] 168 and 182 fluid pipelines

[0199] 170 filling needle

[0200] 172 containers

[0201] 174, 188 bags

[0202] 176 retaining components

[0203] 178, 190 holding elements

[0204] 180 weighing element

[0205] 184 filter element

[0206] 186 container

[0207] Sections 192, 193, and 194

[0208] 195, 196 Hinges

[0209] 198 Gas Supply Organization

[0210] 200 containers

[0211] 202 Gas Pipeline

[0212] 204 Export Components

[0213] 206 retaining member

[0214] 208 pull-out component

[0215] 210 scissor pull component

[0216] 214, 216, 218 cavities

[0217] 220 Immovable Cavity

[0218] 222 dashed line

[0219] 224 separator elements

[0220] 226 partition wall

[0221] 228 First District

[0222] 230 Second District

Claims

1. A quantitative dispensing device (100) for pharmaceutical purposes, comprising: A closed storage container (104) having a wall (126) and an interior space (128) surrounded by the wall. At least one attachment mechanism (136, 142) for attaching the dispensing device (100) to a medical device (102) for processing, in particular, liquid, pharmaceutical products, wherein at least one of the attachment mechanisms (136, 142) is integrated into the wall portion (126) and includes at least one closure element (138, 144) for selectively closing openings (139, 145). A travel frame (108) for enabling the metering device (100) to travel on a mounting surface (110). The internal space (128) contains at least one dispensing tool (166) having a fluid line (168, 182) for guiding the product and a dispensing unit (156) for delivering and / or dispensing the product in a manner passing through the fluid line (168, 182), wherein the fluid line (168, 182) is extendable from the internal space (128) when at least one closure element (138, 144) is open.

2. The quantitative dispensing device (100) according to claim 1. Its features are, At least one of the following applies: - The storage container (104) is or forms an isolation mechanism, especially having a defined atmosphere in the interior space (128); - The reservoir (104) has RABS characteristics; - The reservoir (104) is liquid-tight and / or gas-tight.

3. The quantitative dispensing device (100) according to claim 1 or 2. Its features are, At least one of the quantitative dispensing tools (166) further includes at least one of the following: - A container (172) for receiving the product, the fluid lines (168, 182) are attached to the container, wherein the container (172) is in particular a bag (174, 188), and wherein the dispensing device (100) preferably includes a defined arrangement for the container (172) and, in particular, a suspension holding element (178, 190) in the internal space (128). - A filter element (184), particularly a sterilizing filter, is connected to the fluid lines (168, 182), wherein the fluid lines (168, 182) are preferably attached to the outlet of the container (172) and the filter is connected to the fluid lines (168, 182).

4. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, The metering device (100) includes other fluid lines (168, 182) as metering tools (166), wherein a feed mechanism (147) for the other fluid lines (168, 182) to enter the interior space (128) from the outside is arranged in the wall, and the other fluid lines (168, 182) are attached to the inlet of the container (172), wherein preferably the filter element (184) is connected to the other fluid lines (168, 182) in the interior space (128) or outside the reservoir (104).

5. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, The metering device (100) includes a feedthrough mechanism (147) in the wall portion (126) for feedthrough of the fluid lines (168, 182) from the outside to the internal space (128).

6. The quantitative dispensing device (100) according to claim 4 or 5. Its features are, The dispensing device (100) includes, outside the internal space (128), a container (172) for receiving the product, to which the other fluid lines (168, 182) or the fluid lines (168, 182) are attached, wherein the dispensing device (100) includes, particularly outside the internal space (128), retaining elements (178, 190) for a defined arrangement of the container (172), wherein the retaining elements (178, 190) are preferably arranged or secured at the reservoir (104).

7. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, At least one of the attachment mechanisms (136, 142) and the feedthrough mechanism (147) are arranged on opposite sides of the reservoir (104).

8. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, The dispensing device (100) includes a receiving portion (162, 212) in the internal space (128) for detachably assembling the dispensing unit (156), wherein preferably at least one adapter element (164) is provided for detachably assembling various types of dispensing units (156) at the receiving portion (162, 212).

9. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, The metering unit (156) is provided with a peristaltic pump (158), a rotary piston pump, a time-pressure metering unit and / or a multiple metering kit.

10. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, The interior space (128) is divided into a first zone (228) and a second zone (230) by means of a partition element (224), wherein the first zone (228) has a higher cleanliness level than the second zone (230), wherein the partition element (224) is in particular a partition wall (226).

11. The quantitative dispensing device (100) according to claim 10. Its features are, The fluid lines (168, 182) are arranged wholly or partially in the first zone (228) and the filling needles (170) attached to the fluid lines (168, 182) are arranged in the first zone (228), and / or the container (172) for receiving the product is arranged in the second zone (230).

12. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, At least one glove insertion part (130) for a user (114) is provided at the storage container (104).

13. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, At least one of the metering tools (166) includes at least one filling needle (170) attached to the fluid line (168, 182) and the filling needle is arranged in the internal space (128).

14. The quantitative dispensing device (100) according to claim 13. Its features are, At least one of the following applies: - The metering device (100) includes a defined arrangement for the filling needle (170) and, in particular, a suspension holding member (176) in the internal space (128). - The retaining member (176) is arranged at at least one of the closing elements (138, 144), which can be pivotally rotated out of the internal space (128) when at least one of the attachment mechanisms (136, 142) is opened.

15. The quantitative dispensing device (100) according to claim 13 or 14. Its features are, The retaining member (176) is configured to be dimensionally or length-variable and to be able to transition from a storage posture to a use posture, in which the filling needle (170) can be guided in a manner spaced apart from the reservoir (104) with at least one closing element (138, 144) open.

16. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, The dispensing device (100) includes additional attachment mechanisms (136, 142) integrated into the wall portion (126) having at least one other closure element (138, 144), wherein the attachment mechanisms (136, 142) are arranged, in particular, on opposite sides of the reservoir (104).

17. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, The metering device (100) includes a gas supply mechanism (198) in the internal space (128), which includes a container (172) for gas, a gas line (202) attached to the container, and a preferably nozzle-shaped outlet element (204) at the gas line, wherein the gas line (202) can be drawn out from the internal space (128) when at least one sealing element (138, 144) is open.

18. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, The dispensing device (100) is purifiable and / or sterilizable. And / or the metering device (100) has a purification mechanism (150) and / or a disinfection mechanism (148) in the interior space (128).

19. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, The quantitative dispensing device (100) includes an air conditioning mechanism (154) for adjusting the temperature and / or humidity in the interior space (128).

20. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, The metering device (100) includes a ventilation mechanism (152) for providing a preferably defined airflow in the interior space (128).

21. The quantitative dispensing device (100) according to any one of the preceding claims. Its features are, At least one of the following applies: - The dispensing device (100) is manually guided; - The driving base (108) has a driving drive (118). - The dispensing device (100) is designed to be self-driving and self-steering.

22. A method for operating a quantitative dispensing apparatus according to any one of the preceding claims, comprising: - Provide the storage device (104); - The reservoir (104) is attached to the cavity (214, 216, 218, 220), in which at least one dispensing tool (166) is received. - Transfer at least one of the dispensing tools (166) into the internal space (128) of the reservoir (104) and disconnect the dispensing device (100) from the cavity (214, 216, 218, 220).

23. The method according to claim 22, Including other methods and steps: - Attach the reservoir (104) to a device (102) for handling pharmaceutical products, especially liquid ones. - Remove at least one of the fluid lines (168, 182) and transfer it into the device (102); - Operate the quantitative dispensing unit (156) to supply the product.

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