Controlled environment with a transport device, use of clamping means, use of at least one sealing element, use of a transport unit

Abstract

In a controlled environment (1), the invention proposes sealing adjacent drive modules (5) of a transport device (4) of the controlled environment (1) relative to one another in a sealing region (12) such that particles and / or contaminants, in particular microbiological contaminants, do not enter the controlled environment (1) from the outside, each drive module (5) being configured to levitate (6) at least one transport unit (7), in particular a mover (8), and a coupling side (9) of the drive module (5) being very largely covered by a sealing element (10) (Fig. 1).

Description

[0001] Controlled environment with a transport device, use of clamping devices, use of at least one sealing element, use of a transport unit

[0002] The invention relates to a controlled environment, in particular a containment or isolator, with a transport device comprising at least two drive modules in an arrangement, wherein each drive module is configured to magnetically levitate at least one transport unit.

[0003] The invention further relates to the use of clamping devices for force-fit and / or form-fit connection of the drive modules, in particular wherein the sealing area is compressed.

[0004] The invention further relates to the use of at least one sealing element in a sealing area.

[0005] The invention ultimately relates to a use of a transport unit.

[0006] Controlled environments with a transport device on which a transport unit can be moved are known in practice. Furthermore, levitable transport units are known in practice and are used, for example, to move and / or hold a payload in a magnetically controlled manner by means of a coil field and / or a permanent magnetic arrangement, which may be arranged in a drive surface.

[0007] The invention is based on the objective of reducing the risk of contamination of the controlled environment by particles and / or impurities, in particular microbiological impurities, which can enter the controlled environment from the outside through gaps between adjacent drive modules, and of protecting a coil field and / or a permanent magnetic arrangement of the drive surface from influences from the controlled environment, such as decontamination agents (for example hydrogen peroxide (H2O2)) and / or cleaning agents.

[0008] To solve the aforementioned problem, the features of claim 1 are provided according to the invention. In particular, to solve the aforementioned problem in a controlled environment of the type described above, it is proposed according to the invention that each drive module is covered with a sealing element on one coupling side and that adjacent drive modules seal against each other in a sealing area.

[0009] A transport device can be understood as any component of the controlled environment that causes and / or contributes to the levitation and / or movement of the transport unit, for example, a mover. A drive surface is therefore also considered part of the transport device. The drive surface is characterized by its coupling side, through which a magnetic interaction or coupling between the transport unit and the transport device can be effected via a levitation generator.

[0010] The concept of levitation can be characterized, for example, by the fact that the transport unit, equipped with at least one permanent magnet or electromagnet, or otherwise magnetically active, floats in a controlled magnetic field generated by the levitation generator of the transport device and / or is moved by controlled changes in the magnetic field. In particular, any smallest individually operable unit for generating levitation can be understood as a drive module. Thus, the levitation generator consists of at least one drive module or several drive modules of the transport device. The levitation generator, and thus, for example, the at least one drive module, can be designed, for example, with means for generating a coil field and / or with a permanent magnet arrangement.

[0011] The sealing element can in turn be formed by a separating layer, in particular a magnetically neutral one, which, as further described and claimed, is at least partially placed and / or applied to at least one drive module. Magnetically neutral within the meaning of the invention can mean that the materials used can reduce or prevent any disturbance or impairment of the magnetic coupling between the transport device, in particular the coupling side, and the transport unit, especially such that the control of the levitation is not disturbed to the point of levitation termination. Thus, an undisturbed magnetic coupling via the coupling side can be realized particularly advantageously.

[0012] Furthermore, the sealing element can form a separation between the drive modules and the controlled environment, which advantageously reduces the risk of contamination by particles and / or impurities, especially microbiological impurities.

[0013] The sealing zone, in which the at least two adjacent drive modules seal against each other, advantageously also prevents particles and / or contaminants, especially microbiological contaminants, from entering an intermediate area between the adjacent drive modules. Even if particles and / or contaminants do enter this intermediate area, the sealing zone prevents them from entering the interior of the controlled environment, particularly the containment or the isolator.

[0014] A controlled environment can be characterized, for example, as a confined space in which defined environmental conditions, particularly with regard to air purity and / or surface cleanliness, can be created and / or maintained, for instance, by controlling air exchange with the outside world of the controlled environment. Control of air exchange can be achieved, for example, by completely preventing air exchange during normal operation (e.g., except for closed air circulation) or by consistently specifying a direction of air exchange (into or out of the controlled environment). Examples of controlled environments include isolators, restricted access barrier systems (especially of open or closed type), containments, and gloveboxes.

[0015] Within the controlled environment, particularly the containment or isolator, various processes for handling a wide range of products, such as pharmaceuticals, can take place, thereby reducing the risk of contamination of at least one product by particles and / or impurities from outside the controlled environment. Such pharmaceutical products may, for example, each contain a pharmaceutical container for a pharmaceutical preparation. Examples of such pharmaceutical containers include at least vials, syringes, cartridges, and other refillable pharmaceutical containers.

[0016] The term "sealing" can thus be understood, for example, as a fluidic seal, so that no fluids, such as gas, especially air, which contains particles and / or impurities, can pass from the intermediate area of ​​the adjacent drive modules through the sealing area into the controlled environment.

[0017] A further advantage in reducing contamination can be achieved by having the sealing element cover the drive modules and thus also the sealing area, thereby achieving double sealing. Even if contaminants, for example from outside the controlled environment, manage to penetrate the sealing area, the sealing element prevents them from entering the interior of the controlled environment.

[0018] In a further advantageous embodiment, it can be provided that the sealing area has at least one sealing element.

[0019] The sealing element can, for example, completely or partially seal an intermediate area between the adjacent drive modules, such as the one already mentioned. However, it is particularly advantageous to seal the area facing the interior of the controlled environment. In addition to the already described advantages of reducing the risk of contamination in the controlled environment, the wide range of different sealing elements allows for various sealing solutions for the adjacent drive modules within the sealing area.

[0020] For example, it can be provided that the sealing element contacts at least one drive module, preferably the two drive modules, so that the sealing area can be closed. Furthermore, it can be provided, for example, that the sealing element contacts at least one sealing element and / or at least one sealing element and one drive module.

[0021] In a further advantageous embodiment of the invention, it can be provided that the sealing area is made of or with an H2O2-resistant material.

[0022] Hydrogen peroxide (H₂O₂) is an important component of the controlled environment described herein, as the controlled environment, in particular the containment or isolator, is decontaminated by means of hydrogen peroxide before or before a process to be carried out within the controlled environment via a decontamination cycle. For this purpose, the controlled environment is flushed with hydrogen peroxide, which ensures that all particles and / or contaminants, especially microbiological contaminants, within the controlled environment can be biologically deactivated.Since the sealing area is also decontaminated with hydrogen peroxide before or during a process to be carried out within the controlled environment, it is important that the sealing area is made of, or at least contains, an H2O2-resistant material to ensure that the material does not suffer any damage during the decontamination cycle. Advantageously, this can ensure a long service life for the sealing area material over a large number of cycles.

[0023] Decontamination cycles ensure consistently good sealing of the adjacent drive modules in the sealing area.

[0024] Alternatively or additionally, it may be provided that the sealing element is made of or with an H2O2-resistant material.

[0025] Since the sealing element must also be decontaminated before or during a process to be carried out within the controlled environment via a decontamination cycle to prevent impurities, especially microbiological impurities, from contaminating the product to be processed, it is particularly advantageous if the sealing element is resistant to the decontamination agent used, in this case also hydrogen peroxide. This also advantageously results in a long service life for the sealing element.

[0026] A wide variety of products can be used for cleaning and decontamination of the controlled environment, and combinations are also possible. For example, insulators are often treated in several steps with different cleaning and / or decontamination agents. Hydrogen peroxide (H₂O₂), isopropanol, ethylene oxide, and other agents are used, for example.

[0027] The sealing element and / or the sealing area can, for example, be made of or comprise stainless steel and / or glass. Alternatively or additionally, the sealing element and / or the sealing area can be made of a plastic, such as rubber, and / or a composite material. It can be used as a rigid or flexible, in particular film-like, layer.

[0028] In general, it may also be provided that the sealing area and / or the sealing element is made or designed from a material that is resistant to various other decontamination agents.

[0029] In a further advantageous embodiment, it can be provided that the sealing element consists of a non-outgassing material, in particular a non-H2O2-outgassing material.

[0030] The term "non-outgassing" can be understood to mean that the pore size of the material is selected such that, for example, either no gas, particularly hydrogen peroxide, can be absorbed at all, or if a gas, particularly hydrogen peroxide, is absorbed by the material, it is not released back into the environment. Thus, it is advantageously possible to prevent the release of any gas, particularly hydrogen peroxide, absorbed by the material during a process carried out within the controlled environment. The release of gases, particularly hydrogen peroxide, from the material during processing of the product, particularly a pharmaceutical product, can lead to contamination and should therefore be prevented.

[0031] Alternatively or additionally, the sealing area can be made of a non-outgassing material, in particular a non-H2O2-outgassing material. This allows the advantages already described to be achieved when the sealing element is made of a non-outgassing material, in particular a non-H2O2-outgassing material.

[0032] For example, it may be provided that the sealing element and the sealing area are made of the same material.

[0033] In a further advantageous embodiment of the invention, it can be provided that the sealing area is formed integrally on the sealing element.

[0034] The sealing area can, for example, include the sealing element already mentioned and claimed, which is integrally connected to the sealing element. This can be achieved, for example, by bonding the sealing element to the sealing element. For instance, the sealing element can be glued or welded to the sealing element. Furthermore, it can be provided, for example, that the sealing area can be sealed by two integrally connected sealing elements. Alternatively or additionally, it can be provided that the sealing element and the material of the sealing area form a composite material.

[0035] This can be particularly advantageous, for example, in ensuring that there is no separate transition area between the sealing area and the sealing element through which contamination could occur.

[0036] In a further advantageous embodiment of the invention, the sealing area can be configured to connect at least two sealing elements, preferably in a mesh-like manner. A mesh-like connection can be characterized, for example, by the sealing area having at least one hole into which, for example, a drive module can be inserted. A human-like shape for the seal can be created, in particular, by using silicone for sealing.

[0037] For example, the sealing area may include a sealing element, such as the one already mentioned, which is connected on one side to the first sealing element (which covers, for example, a first of the two drive modules) and on the other side to the second sealing element (which covers, in particular, a second of the two drive modules), preferably by positive locking and / or force locking. This allows for a particularly advantageous direct transition between the sealing area and the sealing element, thus improving the sealing of the sealing area.

[0038] Furthermore, it may be provided, for example, that the two sealing elements are connected to each other across the sealing area without a sealing element, such as the one already mentioned, for example by a form-fit and / or force-fit connection. This is particularly advantageous because it eliminates the need for an additional sealing element in the sealing area.

[0039] Preferably, the sealing area connects at least four or a plurality of sealing elements together.

[0040] For example, if more than two adjacent drive modules are formed, all further drive modules can advantageously also be sealed against each other in the sealing area. In a further advantageous embodiment, the invention can provide that adjacent sealing elements are separated from each other.

[0041] The term "separate" in this context can mean, for example, that two adjacent sealing elements do not directly contact each other. This allows, for instance, the sealing elements to be replaced separately if necessary. It may be the case, for example, that the sealing elements are located adjacent to, or adjacent to, the sealing element of the sealing area already described and subject to the relevant regulations.

[0042] For example, it can be provided that the sealing elements do not touch the sealing area, which in turn allows the sealing element or elements to be replaced independently of the sealing elements.

[0043] Furthermore, it can be provided that the two sealing elements, as already described and / or claimed, are connected to each other via the sealing area. Thus, a hermetically and / or fully surface-sealed and / or gap-free sealing separation surface can be formed.

[0044] Alternatively or additionally, the sealing area can be formed integrally with the sealing elements. This allows for the realization of the advantages already described. A gas-tight transition from the sealing area to each sealing element can thus be easily achieved. In a further advantageous embodiment of the invention, the sealing area can define a seal between the controlled environment and the outside.

[0045] “Outwards” can, for example, mean that the sealing area seals off an area outside the controlled environment from an area inside the controlled environment.

[0046] The area outside the controlled environment, particularly the containment or isolator, may be characterized, for example, by an air quality that differs from that within the controlled environment. The area within the controlled environment may, for example, be a highly clean, sterile, and / or decontaminated environment.

[0047] This is particularly advantageous because it prevents particles and / or contaminants, especially microbiological contaminants, from entering the controlled environment from outside and vice versa. This also increases process reliability.

[0048] In a further advantageous embodiment of the invention, it can be provided that at least one drive module of the arrangement forms a tight connection to a boundary wall of the controlled environment.

[0049] The boundary wall can, for example, define a tight boundary between the outside and inside of the controlled environment. The boundary wall can be arranged horizontally, vertically, and / or at an angle. Because the drive module of the arrangement forms a tight connection to the boundary wall of the controlled environment, a particularly space-saving version of the transport device can be realized.

[0050] For example, it may be provided that the boundary wall is formed from the or a, for example, the already mentioned, in particular magnetically neutral separating layer, which in turn may be part of the sealing element, or that it contacts the separating layer itself.

[0051] If the sealing area includes, for example, the sealing element already described and claimed, it can be provided, for example, that the sealing element contacts the at least one drive module and the boundary wall. Furthermore, it can be provided, for example, that the sealing element contacts at least one sealing element, the drive module, and the boundary wall.

[0052] The drive surface can generally be arranged horizontally, vertically, and / or at an angle. The sealing and / or gasketing areas attached above and / or to it, for example the sealing elements, can be arranged accordingly.

[0053] In a further advantageous embodiment, the invention can provide that the sealing element covers the coupling side of at least one drive module at least 60%, preferably completely.

[0054] This makes it particularly advantageous to achieve the highest possible coverage of the drive module.

[0055] In a further advantageous embodiment of the invention, the sealing element can be designed as a flat or linear element. For example, if the sealing element is designed as a flat element, a large part of the drive module can be covered with just one element. This can be achieved particularly simply and efficiently, for example, by a film that is applied and / or laid onto the drive module in a force-fit and / or form-fit manner. The sealing element can also be designed as a flat element extending around an edge.

[0056] If the sealing element is linear, this can mean that its longitudinal extent is less than its transverse extent. This can be particularly advantageous in achieving lower material consumption, for example, by applying and / or placing one or more linear sealing elements side by side on the drive module. This also allows for the creation of more complex shapes, such as crosses, and / or the sealing of remaining gaps.

[0057] Alternatively or additionally, it can be provided that the sealing area is designed as a flat or linear surface.

[0058] A planar sealing zone can be understood, for example, as a sealing element, particularly one already mentioned and claimed, that seals the area or an intermediate region of the adjacent drive modules. It is particularly advantageous for the sealing zone to be defined over a larger area, thereby reducing the risk of contamination. A planar sealing zone can be characterized, for example, by the fact that its extent in one dimension is significantly smaller (e.g., by at least an order of magnitude smaller) than its extent in the two remaining dimensions.

[0059] A linear sealing zone can be understood to mean that only the area of ​​the adjacent drive modules is sealed by a linear element, for example, by the sealing element already mentioned and claimed, where a linear intermediate zone is formed between the adjacent drive modules and where the risk of contamination by the penetration of particles and / or contaminants from the outside is greatest. A linear sealing zone can be characterized, for example, by the fact that an extent in one dimension is significantly larger (for example, by at least one order of magnitude larger) than an extent in the two remaining dimensions. A linear sealing zone can advantageously be achieved by applying / sealing with silicone.

[0060] In a further advantageous embodiment of the invention, it can be provided that the sealing area is formed as a closed circumferential feature along an edge of the sealing element.

[0061] For example, the sealing area may include a sealing element, in particular the aforementioned and claimed sealing element, and the sealing area (e.g., the sealing element) may be formed as a closed, continuous seal along each edge of the sealing element. This allows for direct sealing immediately following the sealing element, which is particularly advantageous. Furthermore, the sealing area may encompass the entire drive module, except at the point where the drive module is covered by the sealing element. If the sealing area preferably includes a sealing element, such as the aforementioned one, it may also be provided that the sealing element is initially formed at each edge of the sealing element and, in addition, encloses the entire drive module not covered by the sealing element, in order to further reduce the risk of contamination.

[0062] In a further advantageous embodiment of the invention, the sealing area can be configured to contact at least one boundary wall, for example the one already mentioned, and / or a connection to a process station. This allows a complete wall of a controlled environment to be designed as a drive surface and / or enables a sealable access to the process station via the connection.

[0063] The boundary wall can, for example, be formed by the boundary wall already described. This makes it particularly advantageous to achieve a stable seal not only between the adjacent drive modules, but also against the boundary wall.

[0064] In a further advantageous embodiment of the invention, it can be provided that the sealing area surrounds the arrangement of drive modules all around and seals against the or a boundary wall.

[0065] As already introduced in the preamble of claim 1, an arrangement of drive modules can, for example, be understood as the entirety of at least two drive modules. If the sealing area encloses the arrangement and thus one or more drive modules and also seals against the boundary wall, for example the boundary wall already described, it can advantageously be achieved that all further gaps of the drive module, which are not directly facing the interior of the controlled environment but can nevertheless be contaminated, are sealable. It can be provided that the arrangement of drive modules, or at least one drive module, is sealed from below in addition to a lateral seal.The term "lateral" can be understood to mean that the drive modules seal against each other on one narrow side in the sealing area and / or that at least one drive module has the sealing element on its narrow side, which forms the tight connection to the boundary wall. The term "bottom" can be understood to mean that the sealing element is formed on a side of at least one drive module facing away from the coupling side. It is particularly advantageous that the drive modules, or at least one drive module, can be mounted on an opening in the controlled environment in order to route any electrical connections from the controlled environment without increasing the risk of decontamination.

[0066] In a further advantageous embodiment of the invention, it can be provided that the sealing area contacts at least one sealing element.

[0067] For example, the sealing area may be provided with a sealing element, such as the sealing element already described and claimed, which in turn is in contact with at least one sealing element. This can particularly advantageously achieve a seamless transition between the sealing element and the sealing area, or sealing element.

[0068] For example, the sealing element can be connected to the sealing element by force and / or form-fitting. This allows for particularly effective seals. In a further advantageous embodiment of the invention, the sealing element can be permanently connected to the drive module.

[0069] The term "non-removable" can be understood, for example, to mean that the sealing element cannot be removed from the drive module without causing damage. This prevents the sealing element from accidentally or uncontrollably coming loose. Furthermore, it ensures that the sealing element, once correctly applied to the drive module, will not slip or become wavy.

[0070] However, it can also be advantageous if the sealing element is detachably connected to the drive module, as this allows the sealing element to be replaced.

[0071] Alternatively or additionally, it can be provided that the sealing element is materially connected to the drive module.

[0072] For example, the sealing element may be formed by a film, such as the one already mentioned, which is bonded to the drive module. This could mean, for instance, that the sealing element, such as the film, is glued onto the drive module. Other bonding methods are also possible.

[0073] In a further advantageous embodiment of the invention, the sealing element can be designed to be flexible. "Flexible" can be understood to mean that the sealing element advantageously adapts to a substrate, for example, the drive module, or is adaptable to it, for example, by being stretchable. This can again be achieved by the film already described. This also allows, for example, the sealing element to be removed from the drive module without damage.

[0074] In a further advantageous embodiment of the invention, it can be provided that the sealing element is guided around an edge of the drive module or around all edges bordering the coupling side.

[0075] The edge of the drive module, or any edge bordering the coupling side, forms a critical interface for particles and / or contaminants, particularly microbiological contaminants, which can enter the controlled environment via these areas. Therefore, it is particularly advantageous for the sealing element to extend around at least one edge of the drive module or around all edges bordering the coupling side, as this provides additional sealing capability. For example, it is also possible for two sealing elements to extend around the edges of two drive modules and for these sealing elements to contact each other in the sealing area. Furthermore, it is possible for two sealing elements to extend around the edges of two drive modules and for these to be connected in the sealing area to the sealing element or a sealing element, for example, the sealing element already described.This allows for a high degree of sealing between the adjacent drive modules. In a further advantageous embodiment of the invention, the sealing element can be rigid.

[0076] Rigidity can mean, for example, that the sealing element is flexible and thus ductile to a certain extent, but also plastically deformable. It can also be designed, for instance, that the sealing element material is rigid and is placed and / or applied to the drive module in such a way that the latter can expand without stress under thermal load. However, it is advantageous if the sealing element is thermally stable across various temperature levels that may prevail during the process in the controlled environment, so that thermal expansion does not occur in the first place and the sealing element can therefore be fixed to at least one drive module.

[0077] This can be achieved, for example, by using a stainless steel, plastic, and / or glass layer and / or a film and / or a composite material. This is particularly advantageous in preventing the sealing element from slipping and / or wrinkling, which in turn creates gaps that can be critical for contamination.

[0078] A described thermal stability can also apply to the sealing area.

[0079] In a further advantageous embodiment of the invention, it can be provided that the sealing element projects beyond the drive module, at least along one side.

[0080] For example, the sealing element can be designed to extend beyond the drive module and into the sealing area. This allows gaps between the drive modules to be bridged.

[0081] For example, it may be designed so that two sealing elements protrude beyond the respective drive module and contact each other in the sealing area. The degree of protrusion can vary and may, for example, be the thickness of the sealing area or a multiple thereof.

[0082] Furthermore, it may be provided, for example, that two sealing elements project beyond the respective drive module and thereby form a transition to the sealing area. In this case, one or more sealing elements may be formed in the sealing area, which advantageously contacts the sealing element(s) to seal the adjacent drive modules.

[0083] This advantageously allows for various sealing options for the adjacent drive modules in the sealing area.

[0084] In a further advantageous embodiment of the invention, it can be provided that the two drive modules are not positioned further apart than necessary to allow the transport unit operated on them to levitate and / or move seamlessly.

[0085] This allows for a particularly advantageous reduction in the number of drive modules, saving space and enabling a more compact design of the entire controlled environment.

[0086] For example, it may be stipulated that the distance between the two adjacent drive modules must be precisely defined to ensure seamless levitation and / or traversability of the transport unit at the transition between the two drive modules. This advantageously ensures that the transport unit can pass through both drive modules without any loss of levitation and / or traversability properties. The term "seamless" can be understood to mean that the transport unit maintains its levitation and / or traversability properties while passing between the two adjacent drive modules.

[0087] In a further advantageous embodiment of the invention, it can be provided that at least one process station is arranged in the controlled environment.

[0088] For example, it may be provided that sealing elements and / or sealing areas that can be closed tightly together represent or create at least a partial boundary between the controlled environment and an external environment.

[0089] This makes it particularly advantageous for the transport unit to approach and / or interact with the process station, which in turn allows, for example, pharmaceutical products to be processed and / or manufactured within the controlled environment.

[0090] Alternatively or additionally, it may be provided that at least one section of the process station, in particular at least one filling needle, is arranged higher than at least one of the drive modules.

[0091] The term "higher" can be understood, for example, to mean that the section of the process station, in particular the at least one filling needle, is positioned higher than a, in particular laminar, airflow of filtered air within the controlled environment. The airflow ensures that particles and / or impurities are guided in a predetermined direction to prevent contamination of the pharmaceutical product. This can be particularly advantageous for implementing the "First Air" principle, as it ensures that, after passing through a filter, the air is not interrupted or comes into contact with other components, such as the section of the process station, especially the filling needle, but only with an exposed product, for example, the exposed pharmaceutical product, and / or the surfaces touching this product.This advantageously prevents particles and / or impurities from the higher section of the process station, for example the filling needle, from being transferred to the pharmaceutical product by the airflow.

[0092] "Higher" can therefore be understood, for example, in relation to the airflow in the sense of upstream and / or in relation to the Earth's gravitational field. For example, the section may be located above one of the propulsion modules.

[0093] In an advantageous embodiment of the invention, it can be provided that the transport device, which has the at least two drive modules in an arrangement, is positioned at least partially raised above the floor of the controlled environment.

[0094] Particularly advantageous, this can result, for example, in improved airflow within the controlled environment. It also allows for a reduction in the volume of the controlled environment and / or better utilization of that volume, thereby reducing the duration of one or more decontamination cycles and / or optimizing the entire decontamination cycle.

[0095] Alternatively or additionally, the features of the dependent claim, which is directed towards a specific use, are provided according to the invention to solve the aforementioned problem. In particular, the use of clamping devices for force-fit and / or form-fit connection of at least two drive modules in a controlled environment, preferably containments or isolators, and especially in a controlled environment already described and claimed, is proposed to solve the aforementioned problem, particularly wherein the sealing area is compressed. This allows the drive modules to be easily brought into a defined position. It is also thus easily possible to compress the sealing area after an arrangement of the drive modules in order to achieve a tight seal.

[0096] The clamping devices can be particularly advantageous in minimizing a sealing area, such as the one already described and stressed. The sealing area is the area that absolutely must be sealed to minimize the risk of contamination of the interior of the controlled environment. The clamping devices can, for example, be formed by a boundary wall of the controlled environment, over which the drive modules can be fixed. Alternatively, the clamping device can be an adjustable frame over which at least two drive modules can be clamped together by force and / or form locking.

[0097] The clamping means can furthermore, in particular, cause a sealing element, for example the sealing element already described, to be compressed and thus pressed in the sealing area. Alternatively or additionally, the features of the dependent claim 11, which is directed towards a specific use, are provided according to the invention to solve the aforementioned problem. In particular, the invention proposes the use of a sealing element in a sealing area to seal adjacent drive modules of a controlled environment, for example the one already mentioned, against each other. Thus, a structurally simple variant is described for applying a drive force to transport units inside the controlled environment without compromising the external seal of the controlled environment.

[0098] The described features and / or components may be features and / or components that have already been described.

[0099] This allows for the particularly advantageous benefits already described.

[0100] Alternatively or additionally, the features of dependent claim 12, which is directed towards a specific use, are provided according to the invention to solve the aforementioned problem. In particular, the invention proposes the use of a transport unit for levitating over a sealing element and / or a sealing area, optionally adjacent thereto, covering a drive module of a controlled environment, for example, the one already mentioned, in order to solve the aforementioned problem. In the sealing area, adjacent drive modules of a transport device of the controlled environment seal against each other. Thus, a practically interference-free or at least controlled transition of the transport units from one drive module to an adjacent drive module is feasible, particularly despite the measures for sealing the controlled environment to the outside.

[0101] The described features and / or components may be features and / or components that have already been described, thereby enabling the realization of previously described advantages.

[0102] The invention will now be described in more detail with reference to exemplary embodiments, but is not limited to these embodiments. Further exemplary embodiments result from combining the features of one or more claims with each other and / or with one or more features of the exemplary embodiment.

[0103] It shows, in each case in a highly simplified, schematic illustration,

[0104] Fig. 1 a two-dimensional, schematic representation

[0105] (Side view in section) of four drive modules with sealing elements of a controlled environment, a boundary wall, a transport unit and a sealing area,

[0106] Fig. 2 shows a two-dimensional, schematic representation of three adjacent drive modules in a controlled environment with these covering sealing elements and a sealing area adjacent to the sealing elements and contacting the installation elements.

[0107] Fig. 3 shows a two-dimensional, schematic representation of three adjacent, vertically arranged drive modules of a controlled environment with these covering sealing elements and a sealing area, wherein the sealing elements are separated from each other.

[0108] Fig. 4 shows a two-dimensional, schematic representation of three adjacent drive modules in a controlled environment with these covering, linear sealing elements and planar sealing area.

[0109] Fig. 5 shows a two-dimensional, schematic representation of three adjacent drive modules in a controlled environment with these covering sealing elements, wherein the sealing elements extend beyond the drive modules and are connected to the sealing area.

[0110] Fig. 6 shows a two-dimensional, schematic representation of two adjacent drive modules in a controlled environment with these covering sealing elements and a sealing area, wherein each sealing element is guided around an edge of the respective drive module and is formed in a closed circumferential manner with the sealing area.

[0111] Fig. 7 shows a two-dimensional, schematic representation of two adjacent drive modules in a controlled environment with sealing elements covering them, each sealing element being guided around an edge of the respective drive module and contacting each other in the sealing area. Fig. 8 shows a two-dimensional, schematic side view of two sealing elements contacting each other in the sealing area.

[0112] Fig. 9 shows a two-dimensional, schematic top view of a controlled environment with eight drive modules, process stations and a transport unit that can be moved and levitated on the drive modules.

[0113] Fig. 10 is a two-dimensional, schematic representation.

[0114] (Side view in section) of three drive modules with sealing element, wherein the drive modules are raised above a floor of the controlled environment.

[0115] Fig. 1 shows a controlled environment, designated as a whole by 1, here an isolator 2 or a containment 3, with a transport device 4 in a side view in cross-section. The transport device 4 has four drive modules 5 in an arrangement 5', each drive module 5 being configured for magnetic levitation 6 of at least one of the transport units 7 shown, here a mover 8.

[0116] The mover 8 is located within the controlled environment 1 and is levitated and moved without contact by a coupling side 9 of the drive modules 5. Furthermore, each drive module 5 is completely, or at least 60%, covered on the coupling side 9 by a sealing element 10, here a magnetically neutral separating layer 11, which is designed as a flexible film 10'. A first side 27 of the sealing element 10 faces the controlled environment and a second side 28 of the sealing element 10 faces the coupling side 9. Adjacent drive modules 5 are also connected in a

[0117] Sealing area 12 is sealed against each other.

[0118] In the illustrated embodiment, each sealing area 12 has a sealing element 13, resulting in a total of five sealing areas 12 and five sealing elements 13. Each sealing area 12, here each sealing element 13, and each sealing element 10, here four sealing elements 10, are made of a material 14, here of or with an H2O2-resistant material 14'. Furthermore, the material 14 of the sealing area 12, here the material 14 of the sealing element 13, and the material 14 of the sealing element 10 consist of a non-outgassing material 14'', here a non-H2O2-outgassing material 14''''.

[0119] In Fig. 1 it can also be seen that two sealing elements 10 are connected to each other over each sealing area 12, here over each sealing element 13.

[0120] It is also possible that the sealing area 12 connects at least four or a multitude of sealing elements 10 in a mesh-like manner, as shown in more detail in Fig. 9.

[0121] It can also be said that the sealing area 12 contacts at least one sealing element 10.

[0122] Furthermore, it can be seen that each sealing area 12, here each sealing element 13, defines a seal 17 between the controlled environment 1 and an external environment 15 of the controlled environment 1. This prevents particles and / or contaminants from entering an internal environment 16 of the controlled environment from the external environment 15. It can therefore be said that the sealing area 12 defines a seal 17 between the controlled environment 1 and the outside.

[0123] Fig. 1 further illustrates that each outer drive module 5 of the arrangement 5' forms a tight connection 18 to a boundary wall 19 of the controlled environment 1 and that each outer sealing area 12, here each outer sealing element 13, contacts the boundary wall 19 and thus seals the tight connection 18.

[0124] In the illustrated embodiment, each sealing element 10 is planar and each sealing area 12, here each sealing element 13, is linear, so that linear gaps 20 between the adjacent drive modules 5 can be sealed in a material-saving, cost-saving and efficient manner.

[0125] In the illustrated embodiment, the sealing elements 10, here the films 10', are bonded to the respective drive module 5. This is achieved by gluing each sealing element 10 to the respective drive module 5. However, it is also possible that one or more sealing elements 10 are permanently or detachably bonded to the respective drive module 5. Furthermore, the sealing element 10 may also be designed as a rigid component.

[0126] Each sealing element 10 of each drive module 5 is further guided around the respective edge 21 of the drive module 5. This also results in the outer sealing elements 10 being guided around all edges 21 bounding the coupling side 9. Furthermore, as shown, the respective adjacent drive modules 5 are positioned no further apart than that the transport unit 7 operated on them can be levitated and moved seamlessly from one drive module 5 to the next within the controlled environment 1.

[0127] Fig. 2, in contrast to the previous embodiment, shows only three drive modules 5 in an arrangement 5 ' .

[0128] Components and functional units that are functionally and / or structurally similar or identical to the preceding example are designated with the same reference symbols and are not described separately again.

[0129] Here too, each sealing area 12 has a sealing element 13.

[0130] In contrast to the preceding embodiment, three sealing elements 10 are connected to each other via two sealing elements 13, with each sealing element 10 again covering the coupling side 9 of the respective drive modules 5. It can be said that each sealing element 13, and thus each sealing area 12, contacts two drive modules 5 and two sealing elements 10. Furthermore, each sealing area 12 can contact the boundary wall 19, which is not shown here.

[0131] Furthermore, the sealing elements 10 are not guided around an edge 21 of the drive modules 5, but rather close approximately with the edges 21.

[0132] Depending on how the respective sealing elements 10 are connected to the respective sealing areas 12 with the sealing elements 13, for example materially bonded, it can also be said that each sealing area with the sealing element 13 is formed integrally on the sealing element 10.

[0133] Fig. 3, in contrast to the embodiment shown in Fig. 2, shows a vertical arrangement of the drive modules 5 of the transport device 4, in which adjacent sealing elements 10 do not contact each other. It can therefore be said that adjacent sealing elements 10 are separated from each other.

[0134] In this embodiment as well, each sealing area 12 has a sealing element 13. The sealing area 12 with the sealing element 13 is formed in an intermediate area 22 between each pair of drive modules 5 and seals the adjacent drive modules 5 there. Furthermore, in this embodiment, the sealing area 12 with the sealing element 13 completely surrounds the individual drive modules 5 and thus also seals against the boundary wall 19, which is not shown in detail here. It can therefore be said that the sealing area 12 completely surrounds the arrangement 5' of drive modules 5 and seals against the boundary wall 19. In the illustrated embodiment, the sealing elements 13 are located centrally in the intermediate space 22; however, it is also conceivable that they are placed on the plane of the sealing elements 10 and are flush with them. The sealing elements 13 can therefore also be offset from a center of the space 22.

[0135] Fig. 4 shows, in contrast to the preceding exemplary embodiments, that the sealing element 10 is no longer planar but linear. Furthermore, the sealing area 12 with the sealing element 13 is not planar but planar.

[0136] Fig. 5 shows, in contrast to Figure 2 in particular, that each sealing element 10 projects beyond the respective drive module 5 along one side, here along each coupling side 9, in such a way that each sealing element 10 contacts the sealing element 13 in the sealing area 12.

[0137] Fig. 6 shows two adjacent drive modules 5 according to Fig. 1. The sealing element 10 is, as in Fig. 1, formed as a flat surface extending around the edge 21 of each drive module 5.

[0138] In contrast to the preceding embodiment, Fig. 7 shows two adjacent drive modules 5, each of which is again covered on the coupling side 9 by the sealing element 10. Unlike the embodiment according to Fig. 6, the sealing area 12 does not have an additional sealing element 13 that differentiates it from the sealing element 10. Instead, the two sealing elements 10 are connected to each other, for example by welding, bonding, and / or pressing, such that the sealing area 12 of the adjacent drive modules 5 is formed by the sealing element 10 itself. It can therefore also be said here that the sealing area 12 is formed integrally with the sealing element 10.

[0139] Fig. 8 shows a schematic representation of two rigid sealing elements 10 contacting each other in the sealing area 12, corresponding to the embodiment shown in Fig. 7, wherein the sealing elements 10 have recesses 23 in the sealing area 12. By using clamping devices (not shown in detail here) to force-fit and / or form-fit the at least two drive modules 5 (not shown in detail here) by applying a clamping force 24, the two sealing elements 10 are also pressed together in such a way that the sealing area 12 with the recesses 23 is compressed. The sealing element 13 can also be inserted into the recesses 23, for example.

[0140] Fig. 9 shows a top view of the controlled environment 1, in particular the controlled environment according to the embodiment shown in Fig. 1. Since this is a top view of the controlled environment 1, in addition to the four adjacent drive modules 5 already described in Fig. 1, four further drive modules 5 are also visible, which are arranged behind the drive modules 5 already described and are therefore not visible in Fig. 1. The controlled environment 1 thus comprises eight adjacent drive modules 5 in this embodiment. The coupling side 9 of the drive modules 5 is also shown in the top view. Furthermore, three movers 8 are visible, which are levitated and moved on the coupling side 9 of the drive modules 5. The movers 8 move to at least one process station 25.

[0141] In the illustrated embodiment, it is also clearly visible that each sealing area 12 has a sealing element 13, here a mesh-like sealing element 13'. The sealing area 12 with the sealing element 13 is also formed as a closed circumferential element along an edge 26 of a sealing element 10 that covers each coupling side 9. It can further be said that the sealing area 12 circumferentially encloses the arrangement 5' of drive modules 5 and seals against the boundary wall 19. It can also be said that the sealing area 12 connects a plurality of sealing elements 10 to each other in a mesh-like manner. The sealing area 12 as a whole is thus formed in a mesh-like manner.

[0142] Fig. 10 shows a further embodiment of a controlled environment 1 according to the invention, here an isolator 2 or containment 3. Three drive modules 5 are formed in an arrangement 5' of the transport device 4. The drive modules 5 are configured to drive two transport units 7, here two movers 8, magnetically levitating via the respective coupling side 9. In addition, each drive module 5 is covered on the coupling side 9, as also in the embodiment according to Fig. 1, with a sealing element 10, here a magnetic neutral separating layer 11, which is designed in particular as a flexible film 10'.

[0143] In contrast to the embodiment shown in Fig. 1, the illustrated embodiment has four sealing areas 12 and four sealing elements 13. The two outermost sealing areas 12 with the sealing elements of the left and right drive modules 5 contact the boundary wall 19 and thus seal the tight connection 18.

[0144] Each mover 8 carries a pharmaceutical container 34, which can be moved by the mover 8 within the controlled environment 1 and transferred to the process station 25, which here comprises a robot arm 33 with gripping elements 35. The gripping elements 35 enable the containers 34 to be picked up, so that they can be transferred, for example, via the robot arm 33, which is particularly swiveling, to another process station 35. It can also be provided that the gripping elements 35 can be used to remove and / or pick up closure elements 36, which close the pharmaceutical container 34, so that the container 34 can be processed and, for example, filled with a pharmaceutical product using a filling needle as described above (but not shown).The transport device 4 with the drive modules 5 is raised above, or positioned higher than, a floor 30 of the controlled environment 1. A lower part of the robot arm 33 is installed on the floor 30.

[0145] Also shown is an airflow 31. The airflow 31 is introduced into the controlled environment 1 via filter units 32 and flows laterally out of the controlled environment 1 along a flow direction 37 via further filter units 32'. In the illustrated embodiment, the filter units 32', through which the airflow 31 is discharged, are not higher than, or on the same plane as, the transport device 4.The invention thus proposes, in a controlled environment 1, to seal adjacent drive modules 5 of a transport device 4 of the controlled environment 1 against each other in a sealing area 12, so that particles and / or contaminants, in particular microbiological contaminants, do not enter the controlled environment 1 from the outside, wherein each drive module 5 is configured for levitation 6 of at least one transport unit 7, in particular mover 8, and a coupling side 9 of the drive module 5 is largely covered by a sealing element 10.

[0146] / Reference numeral list Reference numeral list Controlled environment

[0147] I solator

[0148] Containment

[0149] Transport device

[0150] Drive module arrangement

[0151] Levitation

[0152] Transport unit

[0153] mover

[0154] Coupling side

[0155] Vers lege lungs element

[0156] film

[0157] Separating layer

[0158] Sealing area

[0159] Sealing element mesh-like sealing element

[0160] material

[0161] H2O2-resistant material, non-outgassing material, non-H2O2-outgassing material, external environment, internal environment

[0162] Sealing tight connection

[0163] boundary wall

[0164] Split

[0165] edge

[0166] Intermediate area

[0167] recess

[0168] Tension

[0169] Process station

[0170] margin first page second page

[0171] mesh

[0172] Floor

[0173] airflow

[0174] Filter unit

[0175] Filter unit

[0176] robot arm

[0177] container

[0178] Greif f element e

[0179] Locking element

[0180] Flow direction / Requirements

Claims

Claims 1. Controlled environment (1), in particular containment (3) or isolator (2), with a transport device (4) comprising at least two drive modules (5) in an arrangement (5'), wherein each drive module (5) is configured to magnetically levitate (6) at least one transport unit (7), characterized in that each drive module (5) is covered on a coupling side (9) with a sealing element (10) and that adjacent drive modules (5) seal against each other in a sealing area (12).

2. Controlled environment (1) according to claim 1, characterized in that the sealing area (12) has at least one sealing element (13) and / or that the sealing area (12) and / or the sealing element (10) is made of or with an H2O2-resistant material (14').

3. Controlled environment (1) according to one of the preceding claims, characterized in that the sealing area (12) is formed integrally on the sealing element (10) and / or that the sealing area (12) connects at least two sealing elements (10), preferably at least four or a plurality of sealing elements (10), preferably in a mesh-like manner.

4. Controlled environment (1) according to one of the preceding claims, characterized in that adjacent sealing elements (10) are separated from each other and / or that the sealing area (12) defines a seal (17) of the controlled environment (1) to the outside.

5. Controlled environment (1) according to one of the preceding Claims, characterized in that at least one drive module (5) of the arrangement (5') forms a tight connection (18) to a boundary wall (19) of the controlled environment (1) and / or that the sealing element (10) covers the coupling side (9) of the drive module (5) at least 60%, preferably completely.

6. Controlled environment (1) according to one of the preceding claims, characterized in that the sealing element (10) and / or the sealing area (12) is formed in a planar or linear form and / or that the sealing area (12) is formed in a closed circumferential form along an edge (26) of the sealing element (10).

7. Controlled environment (1) according to one of the preceding claims, characterized in that the sealing area (12) surrounds the arrangement (5') of drive modules (5) and seals against the or a boundary wall (19) and / or that the sealing area (12) contacts at least one sealing element (10).

8. Controlled environment (1) according to one of the preceding claims, characterized in that the sealing element (12) is inseparably and / or materially bonded to the drive module (5) and / or that the sealing element (10) is flexible.

9. Controlled environment (1) according to one of the preceding claims, characterized in that the sealing element (10) is guided around an edge (21) of the drive module (5) or around all edges (21) bounding the coupling side (9) and / or that the sealing element (10) is rigid.

10. Controlled environment (1) according to one of the preceding claims, characterized in that the two drive modules (5) are not designed to be further apart from each other than that the transport unit (7) operated thereon can be levitated and / or moved without transition.

11. Controlled environment (1) according to one of the preceding claims, characterized in that at least one process station (25) is arranged in the controlled environment (1) and / or that at least one section of the process station (25), in particular at least one filling needle, is arranged higher than at least one of the drive modules (5).

12. Use of clamping devices for force-fit and / or form-fit connection of at least two adjacent drive modules (5) of a controlled environment (1), preferably containments (3) or isolators (2), in particular according to one of the preceding claims, in particular wherein the sealing area (12) is compressed.

13. Use of at least one sealing element (13) in a sealing area (12) for sealing adjacent levitating drive modules (5) of a controlled environment (1), in particular according to one of the preceding claims, against each other.

14. Use of a transport unit (7) for levitating over a drive module (5) of a controlled environment (1), in particular a controlled environment (1) according to one of the preceding claims, covering sealing element (10) and / or a preferably adjacent sealing area (12) , wherein in the sealing area (12) adjacent drive modules (5) of a transport device (4) seal against each other the controlled environment (1).

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