Transport container, loading system, production system, and associated methods

Abstract

The present invention relates to a transport container (10) for introducing and / or discharging objects, in particular in a sterile manner, into or from a production cell, in particular a pharmaceutical or cosmetic production cell, wherein the transport container has one or more receptacles, and wherein a carrier element for carrying at least one of the objects can be arranged in each receptacle. The invention also relates to a loading system, to a production system, and to associated methods.

Description

Transport container, loading system, production system and associated processes

[0001] The present invention relates to a transport container for the, in particular sterile, introduction and / or removal of objects into and from a production cell, in particular a pharmaceutical or cosmetic cell. The present invention further relates to a loading system. The present invention further relates to a production system. The present invention further relates to a method for introducing objects into a production cell, in particular a pharmaceutical or cosmetic cell, using a transport container. The present invention further relates to a method for removing objects from a production cell, in particular a pharmaceutical or cosmetic cell, using a transport container. The present invention further relates to a method for filling and closing containers in a production cell, in particular a pharmaceutical or cosmetic cell.Furthermore, the present invention relates to a method for loading a transport container.

[0002] Both transport containers for objects and pharmaceutical or cosmetic production cells are generally known in the prior art. However, there are still... Room for improvement, especially regarding structural design, simplicity and efficiency.

[0003] Against this background, it is an object of the present invention to provide an improved transport container, an improved production system and correspondingly improved processes, which are improved in particular with regard to structural design, simplicity and efficiency.

[0004] According to a first aspect of the present invention, a transport container is provided for the, in particular sterile, introduction and / or removal of objects into or from a, in particular pharmaceutical or cosmetic, production cell, wherein the transport container has one or more receptacles, wherein a support element for carrying at least one of the objects can be arranged in each receptacle.

[0005] The transport container preferably has one or more support elements for carrying the objects, in particular wherein each support element can be arranged in one or more receptacles. The transport container can, in particular, contain the objects. The objects can be arranged in nests.

[0006] The transport container can have an interior. The transport container can have an opening. The opening provides access to the interior. The transport container can have a housing. The housing encloses the interior. The transport container can have a cover element for sealing the opening, particularly tightly. When the cover element seals the opening, the interior is isolated from the external environment. The opening can be part of a port system through which the transport container can be connected, for example, to a production cell. During or after connection, the cover element can be removed, preferably automatically, to open the transport container. Connecting and opening the transport container can, in particular, occur simultaneously. The transport container can have one or more ports, particularly on the housing, for sterilizing the interior.The transport container can. have a coupling section or interface for coupling with a transport system and / or a holding device and / or a loading unit.

[0007] The transport container has one or more receptacles, in particular a plurality of receptacles. A support element for carrying at least one of the objects can be arranged in each receptacle. The receptacles are arranged in the interior of the transport container, in particular vertically stacked one above the other. The receptacles serve to receive support elements. Each receptacle can be designed so that a support element can be placed or inserted into it. In particular, a support element can be inserted or inserted into the receptacle or removed or pulled out of the receptacle.

[0008] The receptacles are formed by first and second receptacle sections. The first and second receptacle sections are arranged on opposite sides of the interior. The first and second receptacle sections are arranged vertically, one above the other. Thus, the first and second receptacle sections are horizontally spaced apart. Each first and second receptacle section forms a receptacle. The receptacle sections can be designed as grooves that open towards the interior.

[0009] The one or more support elements serve to carry the objects. The objects can be containers (e.g., vials, syringes, ampoules), closure elements (e.g., stoppers, caps), format parts, monitoring components (e.g., Petri dishes), filling needles, and / or single-lellse filling paths.

[0010] Each support element can have first and second retaining sections. The first retaining sections and the second retaining sections are arranged on opposite sides of the support plate. The retaining sections can be engaged with the receiving sections to position and hold the support element in a receiving space. In particular, a first retaining section of a support element can engage with a first receiving section of a receiving space, and a second retaining section of the support element can engage with A second receiving section of the receiver is engaged. The holding sections can be designed as projections that can be shaped to fit the grooves.

[0011] Each support element can have a plate as its basic body. The plate shape is particularly suitable for supporting objects such as containers, closures, format parts, Petri dishes, filling needles, and single-cell filling paths. The plates can have recesses for the objects and / or retaining elements (such as clips) to hold the objects in place.

[0012] Each support element (as a basic body) can also have a frame. The frame can serve to hold nests in which the objects can be arranged. The frame shape is particularly suitable for supporting objects such as containers, closures, or filling needles.

[0013] The transport container and / or the objects can have a marking, such as a printed barcode. This enables tracking and identification of the containers and objects. An RFID chip can also be used to mark the transport container.

[0014] The transport container (especially its housing or interior) can have a height of 400mm, a width of 400mm and a length of 400mm.

[0015] The transport container may also have one or more of the following features: Transport container for the sterile insertion and removal of various objects (sealed) [based on FOIIP (Front Opening Unified Pod) from wafer production] The container is reusable (multi-use) unlike, for example, the tubs used by syringe manufacturers ("waste reduction" when syringe manufacturers deliver the nests directly in the transport containers). Objects: Containers (vials, syringes, ampoules), closures (stoppers, caps), Format components, Petri dishes, filling needles, Singlellse filling path as with robocell, ... The objects are pre-sorted in nests, trays, drawers, etc. Multiple trays in one transport container at different insertion heights All containers and associated closures in 1 transport container The container opening is part of a transfer port system (similar to an alpha-beta port). Option to supply gas via the wall -> Decontamination / sterilization using, for example, hot steam, H2O2, ethylene oxide (EtO) with interface for (overhead) transport system, handling / transport Transport containers and objects are coded for traceability and assignment.

[0016] According to a second aspect of the present invention, a loading system is provided, wherein the loading system comprises a loading unit for loading at least one transport container, in particular according to the first aspect, with objects.

[0017] The loading unit serves to load the transport container with objects. For example, the loading unit can be designed to load one or more support elements, particularly outside the transport container, with the objects. To load a support element, the loading unit can arrange the objects in or on the support element. The loading unit can furthermore be designed to arrange the loaded support elements in corresponding receptacles of the respective transport container, in particular by inserting or sliding them in. Alternatively, one or more support elements can already be arranged in receptacles within the transport container, with the loading unit being designed to load the support elements directly in the transport container. For handling the objects and / or the support elements, The loading unit shall have one or more handling devices, in particular handling robots.

[0018] Preferably, the objects can be provided in nests. Nested objects are typically containers or closure elements. The loading unit can be designed to arrange the nests in or on the support elements.

[0019] The loading system may also include an unpacking device (also called a "de-bagger") for unpacking the objects. For example, containers and / or closure elements may be provided as objects in transport tubs (also called "tubs"), particularly in nests within transport tubs, which may be outer packaging. The unpacking device may be designed to remove the outer packaging of the respective transport tub. The loading system may also include a sterilization device (also called "tub sterilizer") for sterilizing the unpacked transport tub. The loading system may also include an opening device (also called "de-id / de-lining") for opening the transport tub. The transport tub may be sealed with a film. The opening device may be designed to remove this film. Furthermore, a fleece may be arranged on the nest within the transport tub.The opening device may be designed to remove this fleece, particularly after the foil has been removed.

[0020] The loading system can include a decontamination device for decontaminating or The device must be capable of sterilizing the interior of the transport container. In particular, the decontamination device can be connected to the transport container's ports to decontaminate or sterilize the container while it is closed, for example, using hot steam, hydrogen peroxide (H₂O₂), or ethylene oxide (E₂O₂). For instance, the appropriate gas can be introduced into the interior via the ports.

[0021] According to a third aspect of the present invention, a production system is provided, wherein the production system includes at least one, in particular pharmaceutical, or cosmetic, production cell and at least one transport container according to the first aspect.

[0022] The production system can have the loading system according to the second aspect.

[0023] The production system comprises one or more production cells, in particular a plurality of production cells. Each production cell may have a barrier system, in particular an isolator or a barrier system with restricted access (a so-called "RABS"), in particular to provide a sterile or aseptic environment in the respective production cell.

[0024] The production system includes one or more transport containers, in particular a plurality of transport containers. Each transport container can be coupled to a respective production cell, in particular to introduce objects into and / or remove them from the production cell. Coupling can be automated or manual. Coupling can be achieved via a port system. In particular, each production cell can have one or more port systems. When coupled, the interior of the transport container is connected to the sterile or aseptic environment of the corresponding production cell via the container opening.

[0025] Each production cell can have one or more handling devices, in particular handling robots, to handle the objects that are introduced into or removed from the production cell by means of each transport container. In particular, each handling device can be configured to remove objects and / or nests and / or carrier elements from a transport container, especially to introduce objects into or remove them from the production cell.

[0026] Each production cell can have one or more processing stations. The production cell can contain the same or different processing stations. For example, a production cell can have a filling station and / or a sealing station. In the filling station, for example, containers with a The containers are filled with pharmaceutical or cosmetic products. The dosing pumps and / or storage containers for the pharmaceutical or cosmetic product can be located outside the production cell. At the capping station, the filled containers can be sealed with a closure element. The capping station can be, for example, a stopper insertion station for placing a stopper onto the container and / or a crimping station for applying a crimp cap to a container.

[0027] For example, a production cell can be used to fill containers with a pharmaceutical or cosmetic product and then seal them with a closure element. The containers can be introduced into the production cell using a first transport container. The closures can be introduced into the production cell using a second transport container. The filled containers can then be removed from the production cell using a third transport container.

[0028] Preferably, format components, such as a single-lellse filling path (e.g., with hose and filling needles), can be introduced into the production cell by means of a transport container prior to the filling process. The transport container can have a sealed hose feedthrough for the filling path hose or a special hose coupling to route the hose to the outside (e.g., to the metering pump and / or storage container).

[0029] Furthermore, monitoring components, such as Petri dishes with nutrient media, can be introduced into the production cell before the filling process using a transport container and removed from the production cell after the filling process.

[0030] The production system may include a transport system. The transport system may be configured to automatically transport each transport container to and / or from a specific production cell. The transport system may include one or more transport units (vehicles or sleds) for transporting the transport containers. The transport units may be configured to... The purpose is to transport the transport containers. In particular, the transport containers can be coupled to the transport units. For this purpose, the transport units can have a coupling section to which the coupling section of the transport container can be coupled. The transport units can, for example, be designed as autonomous vehicles. Alternatively, the transport units can also be movable along a transport track, such as an overhead rail system.

[0031] The transport system can, in particular, transport each transport container from the loading unit of the loading system to the corresponding production cell. Specifically, the transport system can distribute the transport containers to a network of several production cells.

[0032] Each production cell can process, for example, 100 containers per minute.

[0033] The production system may also have one or more of the following characteristics: Small production cell with isolator insulator one or more handling devices one or more port systems for transport containers Filling station (dosing pumps are outside the cell) Locking station Flanging station Transport system

[0034] Furthermore, the production system may also exhibit one or more of the following characteristics: Loading unit (isolator) Loading unit for nests with upstream de-excavator, tub sterilization, delide / delining (required as long as the containers are still conventionally supplied in tubs by the manufacturer) A loaded transport container can also come directly from a supplier / manufacturer. Distribution of transport containers to a network of several production cells (goal: replacing a large production plant with smaller units; but overall similar footprint and output performance) Different containers also mean processing in different production cells. Among other things, avoiding the need to change format parts, reducing cleaning times, ... Distribution via (overhead) transport system and docking at production cell Docking can be done manually or automatically. The transport system can also be an AMR. Ability to (automatically) assemble the pre-assembled containers for a batch and provide them to the production plant -> the entire rest (feeding, docking, setup, filling process, ...) is fully automated.

[0035] According to a fourth aspect of the present invention, a method for introducing objects into a production cell, in particular a pharmaceutical or cosmetic cell, by means of a transport container, in particular according to the first aspect, is provided, wherein the method comprises the following step: Removing the objects from the transport container using a handling device of the production cell.

[0036] In particular, the nests and / or the support elements can also be removed from the transport container during the removal step.

[0037] Before the removal step, the transport container can be coupled to the production cell. Specifically, the removal step occurs when the transport container is coupled to the production cell. The coupling and opening of the transport container can be automated. After the removal step, the transport container can be disconnected from the production cell.

[0038] According to a fifth aspect of the present invention, a method for removing objects from a production cell, in particular a pharmaceutical or cosmetic cell, by means of a transport container, in particular according to the first aspect, is provided, wherein the method comprises the following steps: Insertion, in particular resetting, of the objects into the transport container using a handling device of the production cell;

[0039] In particular, the nests and / or the support elements can also be inserted into the transport container during the insertion step.

[0040] Before the insertion step, the transport container can be coupled to the production cell. Specifically, the insertion step occurs when the transport container is coupled to the production cell. The coupling and opening of the The transport container can be automated, in particular. After insertion, the transport container can be decoupled from the production cell again.

[0041] According to a sixth aspect of the present invention, a method for filling and closing containers in a production cell, in particular a pharmaceutical or cosmetic one, is provided, wherein the method comprises the following steps: Introducing the closure elements into the production cell using a first transport container; Introducing the containers into the production cell using the first transport container or a second transport container; Filling the containers with a pharmaceutical or cosmetic product; Sealing the filled containers with the sealing elements; Discharge of the filled and sealed containers from the production cell using the first transport container, or using the second transport container, or using a third transport container.

[0042] During the insertion step of the closure elements, one or more handling devices within the production cell can remove the closure elements from the first transport container and / or process them. Specifically, the closure elements can be transferred to the closure station by means of one or more handling devices.

[0043] During the container insertion step, one or more handling devices within the production cell can remove the containers from the first or second transport container and / or process them. Specifically, the containers can be transferred to the filling station using one or more handling devices.

[0044] In the filling step, the containers can be filled with the pharmaceutical or cosmetic product at the filling station of the production cell. One or more handling devices can then transfer the filled containers from the filling station to the capping station. In the capping step, the filled containers can be sealed with the capping elements at the capping station.

[0045] In the discharge step, one or more handling devices of the production cell can transfer the filled and sealed containers from the sealing station to the first, second, or third transport container and insert them into this transport container.

[0046] In particular, the containers can be processed in nested form within the production cell. In this case, the nest containing the containers is removed and then transferred to the filling station and on to the sealing station, and then placed into the first, second, or third transport container.

[0047] The process may further include the following step, particularly after the removal of the filled and sealed containers: Transfer of the transport container to one or more subsequent processing stations (e.g. freeze-drying plant, inspection machine, etc.), in particular where the transfer is carried out using the transport system of the production system.

[0048] The procedure may further include the following step, particularly before the insertion of the closure elements and the containers: Introduction of monitoring components (e.g. Petri dishes) into the production cell using a fourth transport container, in particular wherein the removal and installation of the monitoring components are carried out via handling devices of the production cell.

[0049] The process may further include the following step, particularly after the removal of the filled and sealed containers: Ejection of the monitoring components from the production cell using the fourth or fifth transport container.

[0050] The procedure may also include the following step, particularly before the introduction of the monitoring components: Introducing format parts, such as a single-cell filling path (e.g., with hose and filling needles), into the production cell by means of a sixth transport container, in particular wherein the removal and installation of the format parts are carried out via handling devices of the production cell.

[0051] Each of the transport containers (i.e., the first through sixth) can be designed according to the first aspect. The steps for inserting the various objects, in particular the containers, closure elements, format parts, and / or monitoring components, can be carried out using the procedure described in the fourth aspect. The steps for removing the various objects, in particular the filled and sealed containers, and / or the monitoring components, can be carried out using the procedure described in the fifth aspect.

[0052] According to a seventh aspect of the present invention, a method for loading a transport container, in particular according to the first aspect, with objects is provided, wherein the method comprises the following steps: Arranging at least one object on or in at least one support element; and Arranging, in particular inserting or sliding, the carrier element into each receptacle of the transport container.

[0053] The placement of at least one object on or in a support element can occur before or after the placement of the support element in one or more recesses of the transport container. Multiple objects can be placed on or in the support element. In particular, a nest of objects, such as containers or closures, can be placed on or in the support element. Multiple support plates can also be placed in separate recesses of the transport container.

[0054] The procedure may further include the following step, particularly after the two ordering steps: Closing the transport container, in particular by closing the container opening with the cover element.

[0055] The process may further include the following step, particularly after the two sealing steps: Sterilize the transport container, in particular using the decontamination device.

[0056] The procedures described in aspects four through seven can be carried out, in particular, in the production system described in aspect three. The procedure described in aspect seven can also be carried out using the loading system described in aspect two.

[0057] Furthermore, the present disclosure also includes a process that exhibits one or more of the following features or process steps: (if necessary, loading the transport containers) Inserting format parts via transport container Removal and installation via handling equipment (optional) Incorporating monitoring components Removal and installation via handling equipment (optional) Insertion of closures Removal / processing via handling equipment Bringing in containers Removal / processing via handling equipment (processing either in the nest or prior removal from nest similar to robocell) Fill (+100%-IPK) Seal / Flang. Place back into transport container (the same or a different one). Resetting the monitoring components to the transport container (optional) If necessary, transfer the transport container to the subsequent freeze-drying system, inspection machine (these may be located in different rooms) The transport containers are opened automatically.

[0058] It is understood that the features mentioned above and those to be explained below can be used not only in the combinations specified, but also in other combinations or on their own, without leaving the scope of the present invention.

[0059] Exemplary embodiments of the invention are shown in the drawing and are explained in more detail in the following description. They show: Fig. 1 shows an isometric view of an embodiment of a transport container; Fig. 2 shows a view of a first example of a loaded transport container; Fig. 3 shows a view of a second example of a loaded transport container; Fig. 4 shows a view of the second example of the loaded transport container during extension; Fig. 5 shows a view of a third example of a loaded transport container; Fig. 6 shows a view of the third example of the loaded transport container during extension; Fig. 7 shows a view of a fourth example of a loaded transport container; Fig. 8 shows a view of a fifth example of a loaded transport container; Fig. 9 shows a view of the fifth example of the loaded transport container during extension; Fig. 10 shows a view of a sixth example of a loaded transport container; Fig. 11 shows a view of a seventh example of a loaded transport container; Fig. 12 shows a view of an eighth example of a loaded transport container; Fig. 13 shows a view of a ninth example of a loaded transport container; and Fig. 14 shows a schematic view of an embodiment of a production system; and Fig. 15 shows a schematic view of a production cell.

[0060] Fig. 1 shows an embodiment of a transport container in its entirety, designated by reference numeral 10. The transport container 10 has a housing 12 that encloses an interior space. The transport container 10 has a loading opening 14 and a cover element 16. The container opening 14 provides access to the interior space. The cover element serves to close the container opening 14, in particular to create a tight seal. The transport container has a coupling section 18 for connecting to a transport system and / or a holding device and / or a loading unit.

[0061] Figures 2 to 13 show various examples in which the transport container from Fig. 1 is loaded with different support elements and / or with different objects.

[0062] Figures 2 to 13 show that the transport container has multiple receptacles. These receptacles are arranged vertically, one above the other, within the interior of the transport container. The receptacles serve to hold support elements. They are formed by first and second receptacle sections, which are located on opposite sides of the interior.

[0063] The various support elements have first and second retaining sections. The first and second retaining sections are arranged on opposite sides of the support plate. The retaining sections can be engaged with the receiving sections to position and hold the support element in a receiving section.

[0064] In the example shown in Fig. 2, the transport container is loaded with syringes. Three support elements are arranged within the transport container. The support elements are positioned at different insertion heights. Each support element carries a nest in which the syringes are arranged. Each support element has a nest receptacle into which the nest is inserted. The support element has a frame that surrounds the nest receptacle. Specifically, the nests for syringes are placed in the frame. These frames are used for loading and unloading transport containers. They can also be used for centering on the machines.

[0065] In the example shown in Figures 3 and 4, the support element also has a frame that is open at the front. The syringe holders are inserted into the frame, and the frames remain in the transport containers. Centering is achieved via the holders. In Figure 3, the syringe holder is fully inserted into the frame, and in Figure 4, it is slightly pulled out.

[0066] The example shown in Figures 5 and 6 is essentially the same as the example shown in Figures 3 and 4. The support plate in this example has only two first and two second holding sections, which engage in adjacent first receiving sections on each side.

[0067] In the example shown in Fig. 7, a divider is inserted into a recess between the transport containers. Due to the arrangement of several nests stacked on top of each other in a transport container, particles could enter the open objects in the lower nests. This can be prevented by using dividers.

[0068] Figures 8 and 9 show a transport container with an integrated divider or cover. This is therefore a slide-in frame with a cover over the objects.

[0069] In the example shown in Fig. 10, two support elements with frames are inserted, each of which has a nest containing closure elements (e.g., Araymond caps) arranged on it. Thus, Araymond caps can also be fed into nests via frames.

[0070] In the examples shown in Figures 11 and 12, a plate-shaped support element is inserted. Two Petri dishes are arranged on the support element. This allows Petri dishes to be fed in via the plates. In Figure 11, clips are provided for holding the Petri dishes. In Figure 12, recesses are provided in the plates for inserting the Petri dishes.

[0071] In the example shown in Fig. 13, the support element carries a filling set (in particular with filling needles and / or tubing).

[0072] Fig 14 shows an embodiment of a production system in its entirety, designated by the reference numeral 100.

[0073] Production system 100 comprises eight production cells (labeled "V" and "S" in the figure). In the five production cells V, vials are filled and sealed. In the three production cells S, syringes are filled and sealed. The production cells are arranged in a controlled environment with cleanroom class D. Two transport containers (labeled "P" in the figure) are connected to each production cell. Each production cell can be configured to operate in a controlled environment with a higher cleanroom class, for example, cleanroom class A.

[0074] Production system 100 includes a loading system. The loading system comprises a loading unit (labeled "Load" in the figure) for loading transport containers P with objects, in particular vials, syringes, and corresponding closure elements. The loading system also includes an unpacking device (labeled "De-Bag" in the figure), a sterilization device (labeled "STERILIZE" in the figure), and an opening device (labeled "De-lid / De-Iine" in the figure). The loading system is located in a controlled environment of cleanroom class D.

[0075] Production system 100 includes a transport system (represented in the figure as transport tracks) that transports the transport containers P. In particular, the transport system transports (especially distributes) the transport containers P from the loading unit to the respective production cells V and S. The transport system can also transport the transport containers P away from the production cells, especially to downstream processing stations.

[0076] The transport system can also supply empty transport containers P to the loading station so that they can then be loaded inside.

[0077] Figure 15 shows a production cell. In the production cell, containers are filled with a pharmaceutical or cosmetic product. The filled containers are then sealed with closure elements. Four transport containers are connected to the production cell. A first transport container, "Denesten," is used to insert the containers to be filled. A second transport container, "Reesten," is used to remove the filled and sealed containers. A third transport container, "Stopfen," is used to insert the closure elements. In this example, the closure elements are stoppers. A fourth transport container, "Füllen," is used to insert the filling kit, in particular the tubing and filling needles.

Claims

Patent claims 1. Transport container (10) for the, in particular sterile, introduction and / or removal of objects into or from a, in particular pharmaceutical or cosmetic, production cell, wherein the transport container has one or more receptacles, wherein a support element for carrying at least one of the objects can be arranged in each receptacle.

2. Transport container (10) according to claim 1, wherein the transport container has one or more support elements for carrying the objects, in particular wherein each support element can be arranged in one of the one or more receptacles.

3. Transport container (10) according to claim 1 or 2, wherein the transport container comprises the objects.

4. Loading system, wherein the loading system comprises a loading unit for loading at least one transport container, in particular according to one of claims 1 to 3, with objects.

5. Production system (100), wherein the production system comprises at least one, in particular pharmaceutical or cosmetic, production cell and at least one transport container according to any one of claims 1 to 3.

6. Production system (100) according to claim 5, wherein the production system comprises the loading system according to claim 4.

7. Method for introducing objects into a production cell, in particular a pharmaceutical or cosmetic cell, by means of a transport container, in particular according to one of claims 1 to 3, wherein the method comprises the following steps: Removing the objects from the transport container using a handling device of the production cell.

8. Method for removing objects from a production cell, in particular a pharmaceutical or cosmetic cell, by means of a transport container, in particular according to one of claims 1 to 3, wherein the method comprises the following steps: Insertion, in particular resetting, of the objects into the transport container using a handling device of the production cell.

9. A method for filling and closing containers in a production cell, in particular a pharmaceutical or cosmetic one, wherein the method comprises the following steps: Introducing the closure elements into the production cell using a first transport container; Introducing the containers into the production cell using the first transport container or a second transport container; Filling the containers with a pharmaceutical or cosmetic product; Sealing the filled containers with the sealing elements; Discharge of the filled and sealed containers from the production cell using the first transport container, or using the second transport container, or using a third transport container.

10. Method for loading a transport container, in particular according to one of claims 1 to 3, with objects, wherein the method comprises the following steps: Arranging at least one object on or in at least one support element; and Arranging at least one carrier element in each of the receptacles of the transport container.

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