DOSING APPARATUS FOR PHARMACEUTICAL PURPOSES AND METHOD FOR OPERATING A DOSING APPARATUS

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation patent application of international application number PCT/EP2024/059637, filed on Apr. 9, 2024, and claims the benefit of priority of German application number 10 2023 109 926.4, filed on Apr. 19, 2023, the contents of both applications being incorporated herein by reference in their entireties and for all purposes.

FIELD

The present disclosure relates to a dosing apparatus for pharmaceutical purposes, which can be used with a facility for processing a product, in particular a filling machine for filling containers with a pharmaceutical product, wherein the dosing apparatus is arranged external to the facility.

The present disclosure also relates to a method for operating a dosing apparatus of the type described above.

BACKGROUND

In a filling machine for filling the containers, a pharmaceutical substance is filled into pharmaceutical containers, which may be, for example, vials, syringes, carpules or ampules. The containers may be freestanding or non-freestanding. In the present example, the pharmaceutical product is in particular a fluid, specifically a liquid.

It is known that a dosing apparatus is used with the filling machine, with the product being provided outside a chamber of the filling machine. A fluid conduit is fed through a defined connection device (for example an A/B port or an RTP, rapid transfer port) and filled into the containers in a dosed manner in the filling machine. For example, a conveyor unit of the dosing apparatus is used to dose the product. It is known, for example, to use hose pumps (peristaltic pumps), by which the liquid product can be conveyed in a dosed manner through a hose-like fluid conduit. In this connection, it is known to use single-use equipment for the hose conduit, the product containers and the filling needles.

In practice, it proves to be a challenge to comply with hygiene requirements. Usually, the interior of the filling machine is operated with a high cleanliness class (for example GMP Type A), whereas the dosing apparatus is located in an environment with a lower cleanliness class, for example GMP Type C.

An object underlying the present disclosure is to provide a dosing apparatus for pharmaceutical purposes and a method for operating such a dosing apparatus, the apparatus and method being suitable for versatile use, in particular with regard to compliance with hygiene requirements.

SUMMARY

In a first aspect of the present disclosure, a dosing apparatus for pharmaceutical purposes is provided. The apparatus comprises a closed container, which has a wall and an interior enclosed by the wall. The apparatus comprises at least one connection device for connecting the dosing apparatus to a pharmaceutical facility for processing an in particular liquid pharmaceutical product, wherein he at least one connection device is integrated in the wall and comprises at least one closure element for selectively closing an opening. The apparatus comprises a chassis for moving the dosing apparatus on a set-down surface, and at least one dosing tool in the interior. The at least one dosing tool has a fluid conduit for guiding the product and a dosing unit for dosing and/or conveying the product through the fluid conduit. The fluid conduit is moveable out of the interior when the at least one closure element is open.

In a second aspect of the present disclosure a method for operating a dosing apparatus in accordance with the first aspect is provided. The method comprises:

• • providing the container;
  • connecting the container to a chamber, in which at least one dosing tool is accommodated;
  • transferring the at least one dosing tool into the interior of the container and uncoupling the dosing apparatus from the chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary and the following description may be better understood in conjunction with the drawing figures, of which:

FIG. 1 shows a schematic perspective view of the dosing apparatus in accordance with the present disclosure in a preferred embodiment when used on a facility for processing a pharmaceutical product;

FIG. 2 shows the dosing apparatus in a cut-open partial view;

FIG. 3 shows a cut-open plan view of the dosing apparatus;

FIG. 4 shows a view corresponding to FIG. 2 in the case of an alternative use of the dosing apparatus;

FIG. 5 shows the dosing apparatus in a view corresponding to FIG. 2 in the case of an alternative use;

FIG. 6 shows the dosing apparatus in a view corresponding to FIG. 2 in the case of an alternative use;

FIG. 7 shows a perspective view of one embodiment of a holding part for a filling needle and a fluid conduit of the dosing apparatus in accordance with the present disclosure;

FIG. 8 shows a view of another preferred embodiment of a holding part for a filling needle and a fluid conduit of the dosing apparatus in accordance with the present disclosure;

FIG. 9 shows a schematic view of variants of an equipping process for equipping the dosing apparatus in accordance with the present disclosure;

FIG. 10 shows a further step in equipping the dosing apparatus; and

FIG. 11 shows a further step in equipping the dosing apparatus.

DETAILED DESCRIPTION

Although the present disclosure is illustrated and described herein with reference to specific embodiments, the present disclosure is not intended to be limited to the details shown. Rather, various modifications may be made in the details within the scope and range of equivalents and without departing from the present disclosure.

The present disclosure relates to a dosing apparatus for pharmaceutical purposes. The apparatus comprises:

• • a closed container, which has a wall and an interior enclosed by the wall, and
  • at least one connection device for connecting the dosing apparatus to a pharmaceutical facility for processing an in particular liquid pharmaceutical product, wherein the at least one connection device is integrated in the wall and comprises at least one closure element for selectively closing an opening,
  • a chassis for moving the dosing apparatus on a set-down surface, and
  • at least one dosing tool in the interior. The at least one dosing tool has a fluid conduit for guiding the product and a dosing unit for dosing and/or conveying the product through the fluid conduit. The fluid conduit is guidable out of the interior when the at least one closure element is open.

The dosing apparatus in accordance with the present disclosure has a closed container with an interior, and a chassis for moving the dosing apparatus on a set-down surface. This makes it possible to equip the dosing apparatus for the intended use with the facility for processing the product, in particular the filling machine. The equipping of the dosing apparatus can take place separately from the facility, after which the dosing apparatus is moved to the facility and the fluid conduit is guided out of the interior of the container and into the facility via the opened at least one closure element of the connection device. Alternatively, equipping may also take place directly at the site of use of the dosing apparatus on the facility. At least one dosing tool, which comprises the fluid conduit and a dosing unit, is provided in the interior. The dosing unit makes it possible to dose and/or convey the provided product in a targeted manner and thus introduce it into the facility through the fluid conduit.

As an alternative or in addition to the at least one connection device, via which the fluid conduit can be guided out of the interior, the dosing apparatus may comprise at least one connector device, preferably in a standardized and/or sterile configuration. By way of example, the fluid conduit in the interior is connected to the connector device, and an external fluid conduit of the facility can be connected to the connector device externally. The connector device omits the need to open the container when the dosing apparatus is connected to the facility.

By virtue of the above configuration, the dosing apparatus can be pre-configured for the intended use. By way of example, a pre-sterilized or decontaminated dosing tool can be introduced into the previously sterilized or decontaminated interior in order to satisfy necessary hygiene requirements.

As an alternative or in addition, it is preferably conceivable that a non-sterile or non-decontaminated dosing tool is introduced into the non-sterilized or non-decontaminated interior and then a sterilization or decontamination of the interior, including the dosing tool accommodated therein, is carried out.

The equipping and in particular the introduction of the dosing tool into the interior may, for example, take place in various ways. For example, a stationary chamber is operated, onto which the movable dosing apparatus is docked and in which the dosing tool is accommodated. The latter may be sterile or decontaminated, or alternatively may be non-sterile or non-decontaminated. After undocking, the dosing apparatus can be moved to the facility and used.

As an alternative or in addition, it may be provided, for example, that a movable chamber, in which the dosing tool is located, is transported to the location of the dosing apparatus and docked onto the latter. After the equipping process, the movable chamber is removed and the dosing apparatus can be used on the facility.

It is particularly advantageous if the dosing apparatus is configured in such a way that an existing dosing tool can be operated with the dosing apparatus. Accordingly, the dosing apparatus is preferably adaptable to different dosing systems, wherein, for example, different dosing units, fluid conduits or other known types of dosing tool can selectively be used. In the present case, a dosing tool can in particular be regarded as an object that can be used to dose the product in the intended use of the dosing apparatus, wherein the dosing tool may in particular have contact with the product.

Multiple use of dosing tools is preferably possible.

The at least one connection device may be configured in various ways. For example, it is conceivable to use a standardized port, in particular an A port or a B port. For example, an RTP (rapid transfer port) is used for docking onto the facility. Overall, connection devices of any type, which specifically enable aseptic connection of the facility to the dosing apparatus, are conceivable. The connection device may be single-walled, with one closure element, or multi-walled, for example double-walled with two closure elements.

With regard to compliance with hygiene requirements, it is advantageous if the container is or forms an isolating device, in particular with a defined atmosphere in the interior.

For example, the container may have a RABS property (RABS, restricted access barrier system).

The container is preferably liquid-tight and/or gas-tight when the at least one connection device is closed.

In particular, the above properties enable the use of the dosing apparatus for processing highly active and/or toxic substances.

Advantageously, the level of cleanliness in the interior can be set in accordance with a specification, for example GMP Type A, B or C.

In order to provide and/or comply with the necessary hygiene requirements, it is advantageous if the dosing apparatus is decontaminatable and/or sterilizable in its entirety or in part, but at least in the interior, including objects accommodated therein and especially a dosing tool accommodated therein.

By way of example, the dosing apparatus has, in the interior, a decontamination device and/or a sterilization device. For example, sterilization may take place using steam, and decontamination may take place using H₂O₂.

For sterilization and/or decontamination via an external sterilization device and/or decontamination device, at least one connection element or transfer element may be present on the wall in order to introduce a medium into the interior. This eliminates the need for an internal sterilization device and/or decontamination device. The at least one connection element allows the connection of a fluid conduit, and the transfer element allows, for example, the passage of a fluid conduit. As an alternative or in addition, the connection element may be formed for docking a unit for decontaminating or sterilizing material that is to be introduced, for example an autoclave, an H₂O₂ lock or a UV lock.

A fluid conduit and a dosing unit are accommodated as a dosing tool in the interior, wherein more than one fluid conduit and/or more than one dosing unit may be provided.

The at least one dosing tool may further comprise at least one product container for accommodating the product, to which a fluid conduit is connected. The product container may in particular be a bag.

Advantageously, the dosing apparatus comprises, in the interior, a holding element for arranging and in particular suspending the product container in a defined manner.

The product container and in particular the bag may be a product bag or a batch bag.

The at least one dosing tool may comprise a filter element, in particular a sterile filter, connected into the fluid conduit.

By way of example, the fluid conduit is connected to an outlet of the product container, with the filter being connected into the fluid conduit.

Overall, the equipping of the dosing apparatus may depend on, and preferably can be adapted to, the user-specific and product-specific requirements.

The dosing apparatus may comprise a further fluid conduit as a dosing tool, wherein a feedthrough device for feeding the further fluid conduit into the interior from outside is arranged in the wall and the further fluid conduit is connected to an inlet of the product container. Such a configuration is used, for example, when using two product containers. By way of example, a batch bag is present outside the container, from which the product is transferred through the further fluid conduit into the interior and into a product bag accommodated therein, from which the product is conveyed through the fluid conduit by means of the dosing unit.

The feedthrough device is preferably sterile. It may be, for example, an aseptic liquid transfer port (SART port or AT port).

The filter element may be connected into the further fluid conduit in the interior or into the further fluid conduit outside the container.

If, for example, just one fluid conduit is used, the dosing apparatus may comprise a feedthrough device in the wall for feeding the fluid conduit into the interior from outside, wherein the feedthrough device may be formed as described above. Such a configuration is used, for example, when using just one product container. By way of example, the product bag, to which the fluid conduit is connected, is arranged outside the container.

It is clear from what has been stated above that the dosing apparatus may comprise, outside the interior, a product container for accommodating the product, to which the further fluid conduit or the fluid conduit is connected.

The dosing apparatus may comprise, for example outside the interior, a holding element for arranging and in particular suspending the product container in a defined manner. The holding element is preferably arranged on and secured to the container and can be moved together with the latter.

The at least one connection device and the feedthrough device may be arranged, for example, on opposite sides of the container.

The dosing apparatus may preferably comprise, in the interior, a receptacle for detachably mounting the dosing unit. When equipping the dosing apparatus, for example, a suitable dosing unit can be introduced and mounted on the receptacle.

Preferably, a connection element for providing electrical power to the dosing unit is arranged outside the interior. As an alternative or in addition, the dosing apparatus may comprise a power supply device.

Preferably, a connection element for a control and/or signal line is arranged outside the interior in order to control the operation of the dosing unit. An optional control device of the dosing apparatus is advantageously arranged outside the interior.

Advantageously, at least one adapter element is provided for detachably mounting different types of dosing unit on the receptacle. This enables a versatile configuration with regard to user-specific and product-specific requirements and enables corresponding adaptation of the dosing apparatus.

By way of example, a peristaltic pump, a rotary piston pump, a time-pressure dosing unit and/or a multi-dosing aggregate may be provided as the dosing unit.

It may be advantageous if the interior is divided into a first zone and a second zone by means of a separating element, for example a partition wall, wherein the first zone has a higher level of cleanliness than the second zone. Separate zones may be provided, for example, in order to process products that have a particular property, such as toxic products.

It may be provided, for example, that the fluid conduit, in its entirety or in part, and a filling needle connected to the fluid conduit are arranged in the first zone, and/or that a product container for accommodating the product is arranged in the second zone. The dosing unit may be arranged, for example, in the first zone or in the second zone.

In one embodiment of the present disclosure, at least one glove port for a user may be provided on the container.

The wall is advantageously configured transparent at least in portions, in order to enable a user to see into the container.

In one preferred embodiment of the present disclosure, the at least one dosing tool may comprise at least one filling needle, which is connected to the fluid conduit and is arranged in the interior. When the at least one connection device is open, the filling needle can be introduced into the facility and used to fill the containers.

It may be provided that the dosing apparatus comprises, in the interior, a holding part for arranging and in particular suspending the filling needle in a defined manner.

The holding part may for example be arranged on the at least one closure element, which for example is pivotable out of the interior when the at least one connection device is opened. For example, this enables the filling needle to be moved into the interior of the facility when the closure element is opened, so that it can be grasped there more easily, for example by a robotic apparatus and/or by hand.

The holding part may preferably be size-adjustable or length-adjustable, wherein it is transferable from a storage position to a use position, in which the filling needle is movable so as to be at a distance from the container when the at least one closure element is open. This improves the handling of the filling needle when introducing it or for introducing it into the interior of the facility. For example, the holding part may be telescopic, extendable, foldable or the like. A drive for the holding part may be provided. It is conceivable to use a scissors-type extension arm, on which the filling needle is held.

The dosing apparatus may comprise a further connection device integrated in the wall and having at least one further closure element, wherein the connection devices are arranged, for example, on opposite sides of the container. The further connection device may be configured in various ways. For example, it is conceivable to use an A/B port, an RTP or the like.

Advantageously, an aseptic connection to the container is possible via the further connection device.

For example, the further connection device enables the dosing apparatus to be connected to a stationary chamber. As an alternative or in addition, it is conceivable to use a portable chamber, which is brought to the dosing apparatus and from which the dosing tool is retrieved.

The dosing apparatus may comprise a gassing device, which comprises, in the interior, a gas container for gas, a gas conduit connected thereto, and preferably a nozzle-like outlet element thereon, wherein the gas conduit is guidable out of the interior when the at least one closure element is open. By way of example, this enables a pre-gassing, filling gassing and/or post-gassing when filling the product. There is therefore no need for a separate gassing path.

In a preferred embodiment, the dosing apparatus may comprise a climate control device for adjusting a temperature and/or a humidity content in the interior.

As an alternative or in addition, the dosing apparatus may comprise a ventilation device for providing a preferably defined air flow in the interior. By way of example, a laminar air flow (LF, laminar flow) is provided. The ventilation device may be arranged in the interior or outside the interior, with the air flowing through an opening in the wall. The ventilation device may be configured as a positive pressure device or as a negative pressure device.

The dosing apparatus may comprise a weighing element, which is arranged in the interior and the signal from which can preferably be used to dose the product. By way of example, the holding element for the product container is provided with a weighing element. By means of the weighing element, the contents of the product container or a change in the contents can be ascertained via the weight and thus the dosage can be deduced and/or controlled.

The dosing apparatus may, for example, be manually guided by a user.

It may be provided that the chassis has a traction drive.

In one advantageous embodiment of the present disclosure, it is provided that the dosing apparatus is configured self-driving and self-steering and can move over the set-down surface independently, without any intervention by a user. Accordingly, the dosing apparatus may be configured robotic.

As mentioned in the introduction, the present disclosure further relates to a method.

A method in accordance with the present disclosure for operating a dosing apparatus of the type described above comprises:

• • providing the container;
  • connecting the container to a chamber, in which at least one dosing tool is accommodated;
  • transferring the at least one dosing tool into the interior of the container and uncoupling the dosing apparatus from the chamber.

The advantages already achieved in connection with the explanation of the dosing apparatus in accordance with the present disclosure can also be achieved by carrying out the method. In this regard, reference is made to what has been stated above.

Advantageous embodiments of the method follow from advantageous embodiments of the dosing apparatus in accordance with the present disclosure. Reference is made to what has been stated above.

The chamber may be stationary, with the dosing apparatus being moved to the chamber and connected thereto. Alternatively, a movable chamber may be provided, which is brought to the dosing apparatus and is connected thereto.

The method may, for example, comprise the further method steps:

• • connecting the container to a pharmaceutical facility for processing the product;
  • retrieving the at least one fluid conduit and transferring it into the facility;
  • operating the dosing unit to supply the product.

The drawing shows an advantageous embodiment of the dosing apparatus in accordance with the present disclosure, designated overall by reference numeral 100, with which the method in accordance with the present disclosure can be carried out in accordance with one preferred embodiment.

The dosing apparatus 100 is suitable for a variety of uses and is used with a facility 102 for processing a pharmaceutical product. In the present case, the product is a liquid, which can be provided and in particular can be introduced in a dosed manner into the facility 102 by means of the dosing apparatus 100. In the facility 102, pharmaceutical containers, for example vials, syringes, carpules or ampules, are filled with the product. The facility 102 comprises a wall 103.

The dosing apparatus 100 can be adapted in a variety of ways to meet user-specific and product-specific requirements, depending on the product to be processed. It is particularly advantageous that different types of hygiene requirements can be met. Preferably, different levels of cleanliness can be achieved, for example GMP Type A, B or C.

It is preferably possible to form the dosing apparatus with the container as an isolating device, with a defined atmosphere in the interior. The container may have a RABS property and in particular may be liquid-tight and/or gas-tight when closed.

Overall, the dosing apparatus 100 forms in particular a closed containment, which is movable, in the present case movable on the set-down surface 110, and can be moved toward the facility 102 and away from the latter.

FIG. 1 to 3 show the dosing apparatus 100 equipped in an exemplary manner and will be explained below.

The dosing apparatus 100 comprises a container 104. The container 104 is arranged on a substructure 106, which in the present case, for example, is in the form of a frame. A chassis 108 for moving on a set-down surface 110 is arranged on the substructure 106. In the present case, the chassis 108 comprises casters 112, which are not driven. In the present example, the dosing apparatus 100 can be moved manually on the set-down surface 110 by a user 114.

As an alternative or in addition, it is conceivable that the chassis 108 has a traction drivel 16.

As an alternative or in addition, it is conceivable that the dosing apparatus 100 is configured self-driving and self-steering and can be moved autonomously on the set-down surface 110 in a robotic manner.

To control the operation of the dosing apparatus 100, for example during autonomous operation, a control device 118 is provided, which is advantageously arranged outside the container 104.

By way of example, the control device 118 is accommodated in a housing 120, which is held on the substructure 106.

For example, a power supply device 122 may be accommodated in the housing 120. As an alternative or in addition, a connection element 124 for connecting an external power supply device may be arranged outside the container 104, for example on the substructure 106 or on the housing 120.

In the present embodiment, the container 104 is formed as a cuboid, although this is not limiting. The container 104 comprises a wall 126, which encloses an interior 128. The wall 126 may be transparent in its entirety or in part, in order to enable the user 114 to see into the interior 128.

It may be provided that the container 104 comprises a removable wall or a removable portion of a wall (for example in the manner of a removable or hinged cover), in order to open the container and reach into the interior 128.

The dosing apparatus 100 may comprise at least one glove port 130 on the container 104, via which the user 114 can reach into the interior 128 in a sterile manner. In the present case, two glove ports 130 are provided by way of example. The wall 126 is advantageously transparent in the wall that accommodates the glove ports 130.

The dosing apparatus 100 can be connected to the facility 102, and in particular can be aseptically connected thereto. For this purpose, a connection device 132 having an inwardly opening closure element 134 is provided on the facility 102.

The dosing apparatus 100 is positioned on the facility 102 in such a way that a connection device 136 integrated in the wall 126 and having a closure element 138 is brought into alignment with the connection device 132. The closure element 138 can be opened in order to expose an opening 139 in the wall 126, wherein the closure element can preferably be pivoted into the interior 140 of the facility 102. In this way, the interior 128 can communicate with the interior 140.

The connection devices 132, 136 are preferably configured of standardized configuration, for example in the form of A/B ports or RTP ports.

The dosing apparatus 100 may comprise a further connection device 142, which is integrated in the wall 126. Such a connection device 142 is shown in the drawing, wherein the connection devices 136, 142 are arranged on the wall 126 on opposite sides. This may prove advantageous, for example, for handling the dosing apparatus 100 to comply with a defined work process. In this case, it may be provided that dosing tools are introduced into the interior 128 from one side via the connection device 142 and are removed at the opposite side via the connection device 136.

The connection device 142 for its part also comprises a closure element 144. When the closure element 144 is open, an opening 145 in the wall 126 is exposed.

The connection device 142 is preferably of standardized configuration, for example in the form of an A/B port or an RTP port.

In the present embodiment, the dosing apparatus 100 comprises a feedthrough device 147, which is integrated in the wall 126. Through the feedthrough device 147, a fluid conduit can be guided from outside into the interior 128 in a sterile manner. By way of example, the feedthrough device 147 is of standardized configuration, for example in the form of an aseptic liquid transfer port (SART port or AT port).

Dosing tools for dosing the in particular liquid product can be accommodated in the interior 128. It is provided that in any case one dosing unit and at least one fluid conduit are accommodated. For example, the dosing tools may comprise the following, in particular in the interior 128: at least one dosing unit, at least one fluid conduit, at least one product container for the product, at least one filter element, at least one filling needle connected to the fluid conduit. Different ways of equipping the dosing apparatus 100 will be discussed below.

First, however, further devices of the dosing apparatus will be explained by way of example, these being optional.

A sterilization device 148, a decontamination device 150, a ventilation device 152 and a climate control device 154 may be provided.

The devices 148, 150, 152 and 154 may be arranged entirely or in part in the interior 128 or entirely or in part outside the container 104. By way of example, FIG. 3 shows the devices 148, 150, 152 and 154 in the interior 128. When arranged outside the container 104, at least one connection element or the like may be provided in the wall 126 in order to supply the interior 128 in the desired manner.

The sterilization device 148 and the decontamination device 150 respectively enable, for example, a sterilization and a decontamination of the interior 128 and of the material arranged therein, in particular the dosing tools. For example, steam and H₂O₂, respectively, can be used for the sterilization and the decontamination.

A defined flow, for example a laminar flow, can be generated in the interior 128 by way of the ventilation device 152.

For example, the temperature and/or a degree of humidity in the interior 128 can be adjusted by way of the climate control device 154.

To control operation, the devices 148, 150, 152 and 154 are preferably connected to the control device 118.

As can be seen from FIG. 1 to 3 in particular, a dosing unit 156, which in the present case is configured as a peristaltic pump 158, is arranged in the interior 128. In order to drive the dosing unit 156, a drive unit 160, preferably configured in a manner suitable for the pharmaceutical sector, may be arranged in the interior 128 or may be introduced into the latter. By way of example, the drive unit 160 is supplied with electrical power by means of the power supply device 122 or from outside via the connection element 124.

Advantageously, the drive unit 160 forms a receptacle 162, on which different types of dosing units 156 can be detachably mounted, depending on the use of the dosing apparatus 100. By way of example, a corresponding adapter element 164 is provided in order to adapt the corresponding dosing unit 156.

In the present case, the dosing unit 156 is a dosing tool 166 which is used for dosing and/or conveying the liquid product.

In the present case, a fluid conduit 168 is provided as a further dosing tool 166 in the interior 128, which fluid conduit is in particular configured as a hose conduit and is inserted into the peristaltic pump 158.

In the present case, a filling needle 170 connected to the fluid conduit 168 is provided as a further dosing tool 166. The product can be filled into the containers via the filling needle 170.

In the present case, a product container 172 in the form of a bag 174 is provided as a further dosing tool 166. The fluid conduit 168 is connected to an outlet of the bag 174, is guided through the peristaltic pump 158, and has the filling needle 170 at the end.

The dosing apparatus 100 comprises a holding part 176 for arranging the filling needle 170 in the interior 128 in a defined manner. By way of example, the filling needle 170 is held on the holding part 176 by force-locking and/or positive-locking.

It may be advantageous if the holding part 176 is secured to the closure element 138. When the closure element 138 is opened, the holding part 176 with the filling needle 170 held thereon will thus be moved into the interior 128 of the facility 102 and therefore can be grasped more easily.

Preferably, a holding element 178 for arranging the bag 174 in a defined manner is arranged in the interior 128. In the present case, the holding element 178 is secured to the wall 126, and the bag 174 is suspended from the holding element 178.

For example, a weighing element 180 may be provided on the holding element 178, which weighing element 180 is formed as a beam balance. In particular, any change in weight of the bag 174 can thus be ascertained, and thereby the dosing process can be controlled. The weighing element 180 may be coupled to the control device 118.

In the present example, the dosing apparatus 100 comprises a further fluid conduit 182 as a further dosing tool 166, said further fluid conduit being configured as a hose conduit. The fluid conduit 182 is connected to an inlet of the bag 174, wherein it is guided from the outside into the interior 128 through the feedthrough device 147.

As a further dosing tool 166, a filter element 184, which in particular is a sterile filter, is connected into the fluid conduit 182. In the present case, the filter element 184 is arranged in the interior 128.

The further fluid conduit 182 is connected to the outlet of a further product container 186, which in the present case is configured as a bag 188.

The dosing apparatus 100 comprises a holding element 190 for arranging the bag 188 in a defined manner. In the present example, the bag 188 can be suspended from the holding element 190. The holding element 190 is preferably secured to the container 104.

With the dosing apparatus equipped as in the present example, the bag 188 serves as a product storage batch. The product passes through the fluid conduit 182 into the bag 174, which serves as a product bag. From the bag, the product passes through the fluid conduit 168 to the filling needle 170 and can be filled into the product containers.

During use, the dosing apparatus 100 is positioned at the facility 102. The connection devices 132, 136 are brought into alignment in order to dock the dosing apparatus 100. When the closure elements 134, 138 are open, the fluid conduit 168 with the filling needle 170 can be introduced into the interior 128. This is shown in dashed line in FIG. 2. The filling needle 170 can be grasped, for example, by a robotic apparatus or by a user.

FIG. 4 to 6 show different ways of equipping the dosing apparatus 100, as can be used, for example, when processing a different product or in the case of different user requirements. Only the differences compared to the way of equipping shown in FIG. 1 to 3 will be explained.

In the equipping variant shown in FIG. 4, the filter element 184 is likewise connected into the fluid conduit 182, but is arranged outside the container 104.

In the equipping variant shown in FIG. 5, the bag 174 in the interior 128 is omitted. Instead, only the external bag 188 is present as a product bag. Only the fluid conduit 168 is used, which is guided from an outlet of the bag 188 through the feedthrough device 147, and into which the filter element 184 is connected.

In the equipping variant shown in FIG. 6, the external bag 188 is omitted. The fluid conduit 182 is omitted. The fluid conduit 168, into which the filter element 184 is connected, is connected to the outlet of the bag 174, as in the variant shown in FIG. 1 to 3.

FIG. 7 shows an embodiment of the holding part 176 which is configured length-adjustable. A view from the side of the facility 102 is shown, in which the filling needle 170 has already been introduced into the interior 128.

The holding part 176 is configured to be unfolded, and to this end comprises three segments 192, 193, 194 in the present example. The segments 192, 193 are pivotably connected to each other at a joint 195. Correspondingly, the segments 193 and 194 are pivotably connected to each other at a further joint 196.

In the present case, the filling needle 170 is held on the segment 194, and the fluid conduit 168 is guided along the holding part 176.

FIG. 7 shows the unfolded position of the holding part 176. For as long as the holding part 176 is arranged in the closed container 104, the holding part 176 is folded together (not shown). To unfold the holding part 176 or fold it together, the segments 192 to 194 can be pivoted relative to each other.

The dosing apparatus 100 may comprise a gassing device 198, which is preferably arranged in the interior 128 and can be controlled, for example, by the control device 118 (FIG. 3). The gassing device 198 may be configured for pre-gassing, intermediate gassing and/or post-gassing of the container to be filled.

The gassing device 198 may comprise, for example, a gas container 200 for gas, a gas conduit 202, and at least one outlet element 204 in the form of a nozzle.

FIG. 7 schematically shows an outlet element 204. The outlet element 204 is held on the segment 194.

Two outlet elements 204 are shown in the embodiment of the holding part 176 shown in FIG. 8.

In the variant shown in FIG. 8, the outlet elements 204 as well as the filling needle 170 are held on a holding member 206 of the holding part 176. In the present case, the holding member 206 is secured to the end of an extension member 208, which in this example comprises a scissors-type extension arm 210. In FIG. 8, the scissors-type extension arm 210 is shown in the extended position, in which it projects into the interior 128 of the facility 102.

In the retracted position (not shown in the drawing), the scissors-type extension arm 210 is arranged in a receptacle 212 inside the opening 139, so that the holding member 206 is also positioned inside the container 104 when the closure element 138 is closed.

FIG. 9 to 11 schematically show an equipping process for equipping the dosing apparatus 100 in accordance with the task to be performed. The equipping variant shown here by way of example is the one shown in FIG. 5 and already explained.

To equip the dosing apparatus 100, different types of chamber 214, 216, 218 can be connected to the container 104, in particular to the connection device 142. For a preferably aseptic connection, the chambers 214, 216, 218 advantageously comprise a connection device which can be aseptically coupled to the connection device 142.

In the present case, the chambers 214, 216, 218 differ in that the corresponding content with dosing tools 166 is different. It is assumed here that the dosing unit 156, for example the peristaltic pump 158, is already located in the interior 128 of the container 104.

The chamber 214 used in the assumed example, the contents of which are or have been introduced into the container 104 in FIGS. 10 and 11, contains the fluid conduit 168 with the filling needle 170 and the filter element 184. After docking (FIG. 10), these dosing tools 166 are introduced into the interior 128 and then the chamber 214 is uncoupled. The fluid conduit 168 is guided through the feedthrough device 147 and is connected to the bag 188 (FIG. 11).

For one equipping variant that is not explained below, the chamber 216 may for example be used, in which, in addition to the aforementioned dosing tools 166, the dosing unit 156 is introduced as a further dosing tool into the interior 128.

In one equipping variant that is also not explained further, the bag 174 is additionally introduced into the interior 128 via the chamber 218. In this example, the fluid conduit 168 remains in the interior 128, for example.

FIG. 9 to 11 show the chambers 214 to 218 in movable form, which are moved toward the dosing apparatus 100. The chambers 214 to 218 are configured to be movable, are connected to the dosing apparatus 100, and are subsequently removed again therefrom.

In the view shown, the dosing apparatus 100 is already positioned in the desired position on the facility 102, but the closure elements 134, 138 are not yet open. It will be understood that the dosing apparatus 100 can be positioned at a distance from the facility 102 during the equipping processes.

As an alternative or in addition to the movable chambers 214 to 218, it is conceivable that the dosing apparatus 100 is moved on the set-down surface 110 to a stationary chamber 220, in which the dosing tools 166 are accommodated and which is shown schematically in FIG. 9.

Depending on the use scenario, it may be provided that the dosing tools 166 to be introduced are already sterilized or decontaminated, or that the sterilization or decontamination only takes place in the interior 128.

For example, the following steps are conceivable during operation of the dosing apparatus 100:

• • provision of a pre-sterilized dosing tool (single-use) 166 via an RTP or another type of port in the previously sterilized or decontaminated chamber 214 to 220, installation thereof by the user 114 by way of the glove ports 130, closing and undocking of the container 104, connection to the facility 102, opening of the connection device 132, 136, introduction of the filling needle(s) 170, and start of filling;
  • introduction of a non-sterile dosing tool 166 into the non-sterilized or non-decontaminated container 104, installation of the dosing tool 166, closing of the container 104 and sterilization or decontamination of at least the interior 128 together with the contents, connection to the facility 102, opening of the connection device 132, 136, introduction of the filling needle(s) 170, and start of filling;
  • docking of the previously internally sterilized or decontaminated container 104 onto a sterile external chamber or equipping unit 214 to 220 via a connection device, installation of the external chamber or equipping unit 214 to 220 through glove ports 130, closing and undocking of the container 104, connection to the facility 102, opening of the connection device 132, 136, introduction of the filling needle(s) 170, and start of filling;
  • docking of the non-sterilized or decontaminated container 104 onto a non-sterile chamber or external equipping unit 214 to 220 via a connection device, joint sterilization or decontamination of the container 104 and of the chamber or equipping unit 214 to 220, installation of the dosing tool 166 through glove ports of the chamber or external equipping unit 214 to 220, closing and undocking of the connection device, connection to the facility 102, opening of the connection device 132, 136, introduction of the filling needle(s) 170, and start of filling;
  • docking of the non-sterilized or decontaminated container 104 onto a non-sterile chamber or external equipping unit 214 to 220 via a connection device, installation of the dosing tool 166, sterilization or decontamination of at least the interior 128 together with the contents, closing and undocking of the connection device, connection to the facility 102, opening of the connection device 132, 136, introduction of the filling needle(s) 170, and start of filling.

It proves to be advantageous that the container 104 can maintain its hygiene properties for a relatively long time. By way of example, the dosing apparatus 100 can be equipped and stored or temporarily parked for a sufficient length of time prior to use, with it only being moved to the facility 102 at a later point in time.

FIG. 3 shows, by way of a dashed line 222, a separating element 224 which is optionally present in the interior 128. The separating element 224 may be, for example, a partition wall 226 with at least one opening.

The interior 128 is divided by the separating element 224 into a first zone 228 and a second zone 230, wherein the first zone 228 has a higher cleanliness class than the second zone 230.

In the present example, the fluid conduit 168, the filling needle 170 and the dosing unit 156 are arranged in the first zone 228. The fluid conduit 168 is guided through the separating element 224 into the second zone 230, in which the bag 174 and the filter element 184 are arranged.

The interior 128 may have different levels of cleanliness, depending on requirements. For example, a GMP A level of cleanliness is conceivable for highly active and toxic substances. On the other side, a GMP B or GMP C level of cleanliness is conceivable, for example. It is advantageous that the corresponding level of cleanliness can be achieved as required in the dosing apparatus 100 depending on the intended use, as a result of which the dosing apparatus 100 proves to be particularly versatile.

LIST OF REFERENCE NUMERALS

• • 100 dosing apparatus
  • 102 facility
  • 103 wall
  • 104 container
  • 106 substructure
  • 108 chassis
  • 110 set-down surface
  • 112 caster
  • 114 user
  • 116 traction drive
  • 118 control device
  • 120 housing
  • 122 power supply device
  • 124 connection element
  • 126 wall
  • 128, 140 interior
  • 130 glove port
  • 132, 136, 142 connection device
  • 134, 138, 144 closure element
  • 139, 145 opening
  • 147 feedthrough device
  • 148 sterilization device
  • 150 decontamination device
  • 152 ventilation device
  • 154 climate control device
  • 156 dosing unit
  • 158 peristaltic pump
  • 160 drive unit
  • 162, 212 receptacle
  • 164 adapter element
  • 166 dosing tool
  • 168, 182 fluid conduit
  • 170 filling needle
  • 172 product container
  • 174, 188 bag
  • 176 holding part
  • 178, 190 holding element
  • 180 weighing element
  • 184 filter element
  • 186 product container
  • 192, 193, 194 segment
  • 195, 196 joint
  • 198 gassing device
  • 200 container
  • 202 gas conduit
  • 204 outlet element
  • 206 holding member
  • 208 extension member
  • 210 scissors-type extension arm
  • 214, 216, 218 chamber
  • 220 stationary chamber
  • 222 dashed line
  • 224 separating element
  • 226 partition wall
  • 228 first zone
  • 230 second zone