System and method for equipping an installation, and installation
An automated setup device with spacers and tool-free connections addresses sterility and efficiency issues in aseptic plant setup, ensuring compliance with EU Annex 1 by minimizing manual handling and air contamination.
Patent Information
- Application Number
- PCT/EP2025/065828
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-06-07
- Filing Date
- 2025-06-06
- Publication Date
- 2025-12-11
AI Technical Summary
Existing systems for setting up aseptic and filling plants face challenges in maintaining sterility and efficiency due to manual handling and the need for tool-assisted connections, which can introduce contaminants and violate sterility requirements.
An automated setup device with a spacer and motion apparatus is used to place tool units at workstations, utilizing tool-free connections and spacers made of sterilizable materials to maintain sterility, and magnetic elements to minimize air contamination and tolerate manufacturing inaccuracies.
The system ensures sterility compliance with EU Annex 1 requirements by minimizing manual handling and air contamination, enabling fully or semi-automated setup of aseptic plants while maintaining precise and repeatable tool unit placement.
Smart Images

Figure EP2025065828_11122025_PF_FP_ABST
Abstract
Description
[0001] System and procedure for setting up a plant as well as plant
[0002] SCOPE OF APPLICATION AND STATE OF THE ART
[0003] The invention relates to a system and a method for setting up a system, as well as a system. The invention relates in particular to a system and a method for setting up an aseptic system and / or a filling system, as well as an aseptic system and / or a filling system.
[0004] For the purposes of this application, aseptic facilities are defined as facilities with at least one workstation located in a sterile environment. This sterile environment can be, for example, a cleanroom created within an isolator. An isolator is typically defined as a decontaminated unit that allows its interior to be isolated from the external environment. In other configurations, the sterile environment may be the interior of a closed or open restricted access barrier system (RABS). Isolators and RABS are used particularly in the manufacture, processing, and handling of pharmaceutical products, biopharmaceutical products, biological products, highly potent products, and / or other highly sensitive products.Isolators and other partition systems that create a sterile environment, such as closed or open barrier systems with limited intervention, are generally referred to as partition systems in the context of the application.
[0005] TASK AND SOLUTION
[0006] It is an object of the invention to create an improved system and an improved method for setting up a plant using an automated setup device, as well as a plant with such a system.
[0007] According to a first aspect, a system for equipping a plant with a workstation, in particular an aseptic plant and / or a filling plant, in particular an aseptic plant, is created.The system comprises a tool unit, wherein the tool unit is configured for use in the workstation during the operation of the plant; an automated setup device, wherein the automated setup device is configured to place the tool unit at the workstation, in particular to place it fully automatically or semi-automatically, and wherein the automated setup device comprises at least a first motion apparatus; and a spacer made of a sterilizable, in particular autoclavable, material, wherein the spacer is configured for an arrangement between the tool unit and the first motion apparatus, and wherein a first end of the spacer is configured for a connection with the tool unit and a second end of the spacer is configured for a connection with the first motion apparatus.
[0008] The terms "a," "one," etc., are used in connection with the application solely as indefinite articles and not as numerical elements. In particular, one embodiment provides for several spacers, which can be used cumulatively or alternatively depending on the application. The terms "first" and "second" also serve only for differentiation and do not indicate any order. Furthermore, the use of "first" does not require the presence of a second and / or further element. Specifically, in some embodiments, the assembly comprises exactly one, namely the first, movement mechanism. In other embodiments, the assembly comprises several movement mechanisms.
[0009] In connection with the application, components and / or materials suitable for withstanding treatment without damage, in which the components and / or materials are freed from living microorganisms and viruses with a process reliability required depending on the application, are referred to as "sterilizable". Components and / or materials treatable in an autoclave, i.e., components and / or materials that are particularly suitable for withstanding pressure, humidity and / or temperature in an autoclave without damage, are referred to as "autoclavable".
[0010] In the context of this application, an "automated setup device" is defined as a device by means of which the setup of the system, at least with the tool unit, can be carried out semi- or fully automatically. The automated setup device comprises at least one motion apparatus. In the context of this application, a motion apparatus is defined as a single-axis or multi-axis system, in particular a two- to six-axis system, especially a six-axis system, for moving the tool unit between at least two positions. Depending on its configuration, a multi-axis system is designed, in particular, as a serial mechanism, as parallel kinematics, or as a hybrid mechanism.
[0011] The tool unit is moved into a workstation by means of the automated setup device. In one embodiment, the tool unit is moved into a setup position at the workstation by means of the automated setup device, wherein the tool unit is transferred from the setup position to a working position at the workstation, in particular automatically.
[0012] Particularly for the handling (manufacturing, processing and / or manipulation) of pharmaceutical and / or biopharmaceutical products, stringent sterility requirements are placed on the products. Requirements for a cleanroom in the pharmaceutical industry are specified, among other things, in Annex 1 of the EU GMP Guide concerning the manufacture of sterile medicinal products (EU Annex 1).
[0013] Depending on its design, an automated setup device may be at least partially or not at all autoclavable, or only partially so.
[0014] The spacer makes it possible to move defined areas of the tool unit, in particular areas which, after a setup during operation of the system, are located above products and / or above product-contacting surfaces, at least temporarily to a greater distance from the automated setup device and / or from components and / or areas of the automated setup device that are not or only conditionally autoclavable, in particular to meet the requirements of EU Annex 1.
[0015] In one embodiment, the first end of the spacer is configured for a tool-free connection with the tool unit and / or the second end of the spacer is configured for a tool-free connection with the first motion apparatus.
[0016] In the context of this application, a "tool-free connection" refers to a connection that can be closed and released without tools, particularly by means of relative movement between the connecting partners. Depending on the design, this relative movement occurs against a holding force and / or along a defined path to establish and / or release the connection. Tool-free connections are also referred to as self-forming fasteners.
[0017] The design of the connection as a tool-free connection allows, in particular, the connection of the spacer to the first movement device and / or to the tool unit to be engaged and / or disengaged by a suitable movement of the automated setup device, thus minimizing, and in particular eliminating, manual tasks during setup involving gloved operation. In one embodiment, it is provided that the first end of the spacer and the tool unit and / or the second end of the spacer and the first movement device comprise complementary connecting elements for a connection that is particularly tool-free.
[0018] In certain embodiments, it is specifically provided that the connecting elements of the first end of the spacer and the tool unit, on the one hand, and the second end of the spacer and the first motion assembly, on the other, differ. The connecting elements differ particularly with regard to the relative movement of the components for forming and / or releasing the connection and / or with regard to the direction of force exerted by the formed connections. This ensures, in particular, that when forming and / or releasing the connection of the spacer with the tool unit (or with the first motion assembly), any existing connection between the spacer and the first motion assembly (or with the tool unit) is maintained.
[0019] The complementary connecting elements can be selected appropriately in terms of their design and / or number, depending on the application. In further training, it is specifically stipulated that the complementary connecting elements are designed for at least one of the following:
[0020] - for a connection that is formed and / or released by means of rotation, in particular connecting elements for a bayonet fitting, and / or
[0021] - for a connection that is entered and / or released by means of linear movement, in particular connecting elements for a snap-fit connection, and / or
[0022] - for magnetic attachment.
[0023] In particular, connecting elements for movement by means of linear movements and a magnetic attachment at a connection point of the spacer with the movement apparatus and / or the tool unit are combined.
[0024] In various embodiments, the complementary connecting elements comprise at least first complementary connecting elements that, in the connected state, define a relative position of the components against linear displacement, and second complementary connecting elements that, in the connected state, define a relative orientation of the components against rotation. In particular, multiple complementary connecting elements, each configured for a different degree of freedom, are advantageous for automated connection formation, as this allows the connection to be formed step by step, with tolerance inaccuracies in the single degree of freedom potentially affecting the connection at each step.
[0025] In particular, at least a partially magnetic fastening is advantageous because it is less susceptible to tolerance inaccuracies and / or because it can support movement to establish the connection.
[0026] In a further development, it is provided that a distance between the first end and the second end of the spacer is sufficiently long so that, during handling of the tool unit by means of the first motion apparatus, wherein the tool unit is connected to the motion apparatus by means of the spacer, air which touches the first motion apparatus does not enter defined areas of the tool unit, in particular not defined areas which are located above products and / or product-contacting surfaces during operation of the system.
[0027] A sufficient length can be determined, particularly through simulation, depending on the application. This sufficient length depends on various factors, including, but not limited to, the airflow velocity, the design of the spacer, and / or the travel distance of the motion device.
[0028] In various embodiments, distances between the first end and the second end of at least approximately 6 cm and / or up to approximately 15 cm have proven suitable, particularly to achieve sufficient length and / or to ensure ease of handling. However, the invention is not limited to these distances, and in some applications, the distance between the first end may be less than 6 cm or more than 15 cm may be necessary.
[0029] In certain embodiments, a distance measured along a longitudinal axis of the spacer between the first end and the second end is greater than a (particularly maximum or average) extent of the spacer perpendicular to the longitudinal axis.
[0030] In one embodiment, the spacer has a wall section arranged transversely, and in particular perpendicularly, to a longitudinal axis of the spacer. In particular, in certain embodiments, the wall section (in the connected state) can reduce the flow of air from the movement apparatus to the tool unit.
[0031] In one embodiment, the first end of the spacer has a wall section arranged transversely, and in particular perpendicularly, to a longitudinal axis of the spacer. In certain embodiments, the connecting elements (for connection to the tool unit) are arranged on the wall section.
[0032] In one embodiment, the first motion apparatus is configured to pick up the tool unit in a first staging position using the spacer connected to it, move it from the first staging position to a first delivery position, and place it at the first delivery position. Alternatively or additionally, the first motion apparatus is designed as a two- to six-axis system. The first motion apparatus allows, in particular, fully automated handling of the tool unit up to its placement in the first delivery position. In some embodiments, the staging position is located at a transfer gate.
[0033] The first delivery position is provided for in configurations at the workstation.
[0034] In another embodiment, the setup device further comprises a second motion apparatus, wherein the second motion apparatus is configured to receive the tool unit in a second staging position, move it from the second staging position to a second delivery position, and place it at the second delivery position. In particular, the second staging position is identical to the first delivery position. In some embodiments, the second delivery position is located at the workstation. In these embodiments, the second delivery position is identical to the working position. In other embodiments, the second delivery position is a setup position, wherein the tool unit can be moved from the setup position to a working position by means of a further motion apparatus, in particular a motion apparatus of the workstation, such as a setup arm and / or a filling arm of a workstation designed as a filling station.The second movement apparatus is, in particular, a parallel kinematic system which allows for very precise, repeatable movement of the tool unit manually or by means of a drive element.
[0035] In another embodiment, the second delivery position is the same as the first provisioning position. According to a second aspect, a system for setting up a plant with a workstation, in particular an aseptic plant and / or a filling plant, is created, the system comprising an automated setup device or a system according to the first aspect, wherein the system includes a provisioning device with at least one provisioning holder for at least one element to be picked up by means of the setup device, in particular for a tool unit and / or a spacer, wherein in particular the at least one provisioning holder is configured for the floating provision of the at least one element to be picked up by means of the setup device.
[0036] The floating mounting allows for tolerance-compensating movement of the element to be picked up during handling by the setup device. This ensures a secure connection, particularly indirectly or directly, to the automated setup device within a defined mounting area, especially when the element to be picked up has tolerances, for example, manufacturing tolerances.
[0037] In particular, the floating provision ensures that the element to be picked up by the setup device is provided with clearance in at least one degree of freedom, especially linear and / or rotational. In certain embodiments, the clearance is at least twice, and in particular three times, the permissible tolerance, especially the manufacturing tolerance and / or the positional tolerance. In other embodiments, the clearance is at most ten times, for example, at most five times, the permissible tolerance, especially the manufacturing tolerance and / or the positional tolerance. The manufacturing tolerance is, in particular, ±0.2 mm in certain embodiments.
[0038] A system according to the second aspect can be implemented both on its own and in combination with a system according to the first aspect and / or with defined features of the system of the first aspect, for example with optional features, in particular with regard to the setup device and / or with regard to the tool unit and / or with regard to the spacer.
[0039] In particular, the staging device, especially the staging holder, defines a staging position for a motion assembly of the setup device, specifically the first staging position of the first motion assembly or, for example, the second staging position of the second motion assembly. In one embodiment, the at least one staging holder is mounted to a base body of the staging device in a floating manner with respect to at least one degree of freedom (in particular, a linear degree of freedom and / or a rotational degree of freedom). Specifically, the at least one staging holder is mounted to the base body of the staging device in a floating manner in at least one xy-plane (in particular, linear and / or rotational). In particular, the xy-plane is a plane that is at least substantially parallel to a substrate and / or a horizontal plane.
[0040] In one embodiment, the at least one staging holder is mounted by means of an elastic retaining element and / or magnetically, in particular mounted on the base body of the staging device. The elastic retaining element and / or the magnetic mounting each allow movement of the staging holder at least within one staging area. The magnetic mounting, in particular, allows movement of the staging holder for tolerance compensation without restoring forces acting on the staging holder that would force it back into an initial position.
[0041] Alternatively or additionally, in one embodiment, the at least one mounting holder has a recess for receiving the at least one element to be picked up by the setup device, wherein, in particular, the recess is configured for the floating reception of the at least one element to be picked up by the setup device. The floating reception also allows movement of the element to be picked up for tolerance compensation during connection, in particular direct or indirect, with the automated setup device.
[0042] In particular, the at least one element to be received by means of the assembly device is arranged in the recess with clearance, especially with clearance as explained above. Specifically, clearance is provided in one arrangement direction when arranging the element in the recess, wherein the arrangement direction is transverse, in particular perpendicular to a removal direction in which the element can be removed from the recess.
[0043] In one embodiment, the staging device comprises a carriage, wherein the system in particular includes a partition system, especially an isolator, and a transfer lock, and the carriage is configured for at least partial transport of the at least one element to be picked up by the staging device through the transfer lock. Depending on the application, the carriage is configured for manual, semi-automated, or fully automated transport of the element to be picked up. In particular, embodiments provide that the carriage is moved from the transfer lock into the sterile area defined by the partition system by means of a drive element. In embodiments, the drive element is accessible from an area outside the sterile area defined by the partition system.In other configurations, it is provided that the sled is transferred from the transfer lock to the sterile area using the automated setup device.
[0044] The system is suitable for use with various tool units, particularly those that, in their working position, have direct or indirect product contact. Indirect product contact occurs specifically with tool units that can impair the product-relevant primary air supply, especially with tool units that, during system operation, are located upstream of a primary packaging material for the product and / or surfaces contacting the product. Product contact also occurs specifically with tool units that touch primary packaging materials for the product and / or the product itself. Primary packaging materials include, in particular, containers to be filled with the product and / or closures for these containers.
[0045] In some configurations, the tool unit is, for example, a tool unit for a dispensing station where containers (especially those to be filled) are removed from a container. In other configurations, the tool unit is, for example, a tool unit for a closing station, in particular a tool unit for a plug-setting station, a closure station, a flanging station, or the like. In still other configurations, the tool unit is, for example, a format part for setting up and / or retooling the system. Depending on the application, the system can be used with only one or with several different tool units, whereby, for use with different tool units, the tool units have, in particular, uniform connecting elements for a connection to the spacer, especially without tools.
[0046] In a further development, the tool unit is designed as a filling unit comprising several, in particular four to 16, filling needles, and a filling needle holder. Setting up a filling station with a filling unit comprising several filling needles is automated using the setup device, whereby, in particular, the spacer prevents air that comes into contact with non-autoclavable areas of the setup device from reaching the filling needles.
[0047] According to a third aspect, a system for setting up a plant with a workstation, in particular an aseptic plant and / or a filling plant, is created. In embodiments of the system of the third aspect, the system comprises a tool unit, wherein the tool unit is configured for use in the workstation during operation of the plant, and an automated setup device, wherein the automated setup device is configured to place the tool unit at the workstation, in particular to place it fully or semi-automatically, and wherein the automated setup device comprises at least a first motion apparatus, wherein at least one hose, i.e., in particular exactly one hose or several hoses, is arranged on the tool unit.
[0048] In one variant of the system of the third aspect, the system comprises a tool unit, wherein the tool unit is configured for use in the workstation during the operation of the plant, and an automated setup device, wherein the automated setup device is configured to place the tool unit at the workstation, in particular to place it fully or semi-automatically, and wherein the automated setup device comprises at least a first motion apparatus, wherein at least one hose is arranged on the tool unit and wherein the at least one hose is provided with at least one magnetic element.
[0049] In configurations with multiple hoses, at least some, for example all, of the multiple hoses are each provided with at least one magnetic element.
[0050] In some embodiments, a hose is provided with several magnetic elements, for example with magnetic elements arranged opposite each other.
[0051] In particular, a magnetic element is designed to interact with a magnet. Specifically, a magnetic element is at least partially made of a magnetic and / or magnetizable material.
[0052] In certain embodiments, at least one magnetic element, and in particular several magnetic elements, are arranged on the hose, for example, attached, wherein the several magnetic elements are arranged at intervals from each other on the hose. In certain embodiments, an element of the hose is also designed as a magnetic element. For example, a sheath of the hose is designed as a magnetic element.
[0053] In a variant of the system of the third aspect, the system comprises a tool unit, wherein the tool unit is configured for use in the workstation during the operation of the plant, and an automated setup device, wherein the automated setup device is configured to place the tool unit at the workstation, in particular to place it fully or semi-automatically, and wherein the automated setup device comprises at least a first motion apparatus, wherein several hoses are arranged on the tool unit, wherein the system comprises at least one composite element which holds at least some, in particular all, of the several arranged hoses in a composite, wherein the composite element comprises several recesses on one circumference of the same for receiving the hoses held in a composite.
[0054] In one variant of the system of the third aspect, the system comprises a tool unit, wherein the tool unit is configured for use in the workstation during the operation of the plant, and an automated setup device, wherein the automated setup device is configured to place the tool unit at the workstation, in particular to place it fully or semi-automatically, and wherein the automated setup device comprises at least a first motion apparatus, wherein several hoses are arranged on the tool unit, wherein the system comprises at least one composite element which holds at least some, in particular all, of the several arranged hoses in a composite, wherein the composite element is designed at least partially from a magnetic and / or magnetizable material.
[0055] In particular, for example during the setup of the system, especially the setup of a workstation, especially the setup of the filling station, the magnetic element and / or the particularly magnetic and / or magnetizable composite element can interact with a counter element made of a magnetic and / or magnetizable material for fixation.
[0056] In particular, a hose equipped with at least one magnetic element and / or a composite of hoses with at least one, in particular, magnetic and / or magnetizable composite element is designed to be brought into at least one more compact state. In the more compact state, at least two different parts of the hose and / or the composite interact, in particular attractively and / or magnetically. This interaction is achieved, in particular, by magnetic elements and / or composite elements. Specifically, the interaction limits the extension of the hose and / or the composite. For example, the interaction limits the relative positions of individual parts of the hose and / or the composite to each other.
[0057] In certain embodiments, the more compact state is advantageous when dismantling a workstation, particularly the filling station, and / or the entire system. In other embodiments, the more compact state is advantageous for moving the hose and / or the assembly into and / or out of a port.
[0058] In various embodiments, a composite element comprises at least one magnetic element. For example, a composite element is designed as a magnetic element. For example, a magnetic element is designed as a composite element.
[0059] The magnetic element and / or the composite element is made in particular of a sterilizable material, and further elements in particular of an autoclavable material.
[0060] A system according to the third aspect can be implemented both on its own and in combination with a system according to the first aspect, the second aspect, and / or with defined (especially optional) features of the system of the first aspect and / or the second aspect. In particular, features of the systems can be combined to obtain further embodiments.
[0061] In certain embodiments, the tool unit is designed as a filling unit. The filling unit comprises at least one filling needle, in particular exactly one filling needle or several, in particular four to 16, filling needles, and a filling needle holder for the at least one filling needle. In certain embodiments, the filling needle holder is designed to hold the exactly one filling needle or the several filling needles. In certain embodiments, the at least one hose is fluid-carrying and connected to the at least one filling needle. In certain embodiments, the multiple hoses are fluid-carrying and connected to the multiple filling needles.
[0062] In some embodiments, the recesses are evenly distributed around the circumference of the composite element and / or arranged symmetrically around a central point of the composite element. In particular, this arrangement allows a twist applied to the hoses to force them into a parallel alignment. The design of the composite element can be selected to suit the specific application. In one embodiment, the composite element is plate-shaped, especially with a circular base. With this circular base, protruding corners and edges that could damage the hoses are reliably avoided.
[0063] In particular, certain embodiments of the system provide for at least one guide element to be arranged in the installation, especially a stationary one. The guide element is designed to interact with the at least one magnetic element and / or with the composite element in order to hold at least one section of the at least one hose and / or at least one section of the composite in an installation space, especially on the guide element, either temporarily or permanently, and in particular by means of a frictional connection. This frictional connection is achieved in particular by means of magnetic force.
[0064] According to a fourth aspect, an aseptic plant with a workstation, in particular an aseptic filling plant with a workstation designed as a filling station, is created, comprising a partition system, in particular an isolator and a system for setting up the plant.
[0065] In particular, the workstation is located in the sterile environment of the partition system.
[0066] According to a fifth aspect, a method for setting up a system with a workstation, in particular an aseptic system and / or an aseptic filling system, is created by means of an automated setup device comprising a first motion apparatus, wherein the automated setup device is operated to place a tool unit at the workstation, in particular fully or semi-automatically, and wherein a spacer made of a sterilizable, in particular autoclavable, material is accommodated between the tool unit and the first motion apparatus, wherein a first end of the spacer is configured for a connection, in particular without tools, with the tool unit and the second end of the spacer is configured for a connection, in particular without tools, with the first motion apparatus.
[0067] In one embodiment, the first motion apparatus is operated to connect the spacer to the motion apparatus without tools. For this purpose, the first motion apparatus is operated, in particular, with a defined movement pattern. In embodiments, the spacer and the motion apparatus, especially a coupling end of a motion apparatus designed as a robot arm, have complementary connecting elements for connection by means of rotation, wherein, in particular, the first motion apparatus is operated to rotate the coupling end so that the spacer is connected to the motion apparatus.
[0068] Alternatively or additionally, in certain embodiments, the first motion device is operated to pick up the tool unit in a first staging position by means of the spacer connected to the motion device, to move the tool unit from the first staging position to a first delivery position, and to place the tool unit at the first delivery position. In certain embodiments, the spacer and the tool unit have complementary connecting elements for connection by means of linear movements. The first motion device is operated, in particular, to move the connected spacer along a path with one or more sections, especially those angled relative to each other, so that the spacer is connected to the tool unit.
[0069] In some embodiments, the first motion device is operated to connect the spacer to the first motion device before the tool unit is picked up. In other embodiments, the first motion device is operated to release the connection between the tool unit and the spacer after the tool unit has been placed in the first dispensing position. In other embodiments, the spacer is placed in the first dispensing position along with the tool unit. The spacer is then separated from the tool unit either manually or by means of another motion device. In some embodiments, this separation occurs specifically in the first dispensing position. In other embodiments, separation occurs after the tool unit has been moved from the dispensing position to another position.
[0070] In one embodiment, the setup device further comprises a second motion apparatus, which is operated to receive the tool unit in a second staging position, move it from the second staging position to a second discharge position, and place it at the second discharge position, wherein, in particular, the second staging position is identical to the first discharge position. In certain embodiments, the second discharge position is a setup position in a workstation. In particular, the second motion apparatus is a parallel kinematic system that allows for very precise, repeatable movement of the tool unit, either manually or by means of a drive element.
[0071] In another aspect, an alternative or supplementary method is provided for at least partially setting up and / or at least partially dismantling a system, in particular for at least partially setting up and / or at least partially dismantling a workstation, in particular a filling station, wherein at least one point of a hose and / or at least one point of a combination of hoses with magnetic interaction is at least partially positioned in the method.
[0072] In various embodiments of the method, at least one point of a hose and / or at least one point of a group of hoses with magnetic interaction is at least partially positioned and, for example, fixed in place on a counter element and / or in a defined area of the system.
[0073] In embodiments of the method, at least one point of a hose and / or at least one point of a composite of hoses is positioned at least partially at another point of the hose and / or another point of the composite, in particular to bring the hose and / or the composite into a more compact state.
[0074] In embodiments of the method, a magnetic element and / or a magnetic and / or magnetizable composite element with at least one feature and / or at least one combination of features of the features described above and below is used for the magnetic interaction.
[0075] In embodiments, a combination of an aspect with an optional feature, which has been explained in more detail in connection with another aspect, is provided. In embodiments of the system, it is configured to carry out at least one process step described above and / or below, for example, optionally, and for example, a combination of at least two process steps described above and / or below, for example, optionally. In embodiments of the process, this is carried out with a system, wherein the system has at least one feature and / or at least one combination of features of the features described above and / or below in connection with a system, for example, optionally. BRIEF DESCRIPTION OF THE DRAWINGS
[0076] Further advantages and aspects of the invention will become apparent from the claims and from the description of exemplary embodiments of the invention, which are explained below with reference to the figures. These figures show:
[0077] Fig. 1 shows an embodiment of a plant with a system for setting up the plant;
[0078] Fig. 2 shows a provisioning device of the system for setting up the plant according to Fig. 1;
[0079] Fig. 3 shows a spacer of the system for setting up the plant according to Fig. 1;
[0080] Fig. 4 shows a detail of the system according to Fig. 1 with the system for setting up the system in a first state;
[0081] Fig. 5 shows a detail of the plant with the system for setting up the plant according to Fig. 1 in a second state;
[0082] Fig. 6 shows a detail of the plant with the system for setting up the plant according to Fig. 1 in a third state;
[0083] Fig. 7 shows a detail of the plant with the system for setting up the plant according to Fig. 1 in a fourth state; and
[0084] Fig. 8 shows a connecting element for a system for setting up a plant.
[0085] DETAILED DESCRIPTION OF THE EXECUTION EXAMPLES
[0086] Fig. 1 schematically shows an embodiment of a system 2 for setting up a plant 1 with a workstation 10 shown only schematically in Fig. 1. Fig. 2 shows a provisioning device 6 of the system 2 and Fig. 3 shows a spacer 5 of the system 2 according to Fig. 1.
[0087] The illustrated system 1 is designed as an aseptic filling system, with the workstation 10, designed as a filling station, being arranged in a sterile environment. In various embodiments, system 1 includes further workstations not shown in Fig. 1. The sterile environment is separated from the external environment by means of a schematically depicted partition system 11, in particular an isolator. A transfer lock 12 is provided for introducing elements into the sterile environment after decontamination of the sterile environment. Air, in particular filtered air in some embodiments, is supplied to the sterile environment by means of a ventilation device (not shown), particularly from above.
[0088] The system 2 shown in Fig. 1 for setting up the plant 1, in particular for setting up the plant 1 after decontamination of the sterile environment, comprises a tool unit 3, an automated setup device 4, the spacer 5 shown separately in Fig. 3, and the provisioning device 6 shown in detail in Fig. 2. In other embodiments, the system 2 comprises individual components of the following described in detail, either separately or in combination with other components.
[0089] The system 1 is shown schematically in Fig. 1, with various elements, in particular the tool unit 3 and the spacer 5, depicted multiple times in different positions to illustrate their movement in the sterile environment during setup of the system 1. In a real-world implementation, these elements may be present only once or multiple times, depending on the application.
[0090] The illustrated setup 4 comprises a first motion apparatus 41 and a second motion apparatus 42. The first motion apparatus 41 is designed as a serial multi-axis system, in particular as a serial six-axis system, also referred to as a robot arm or industrial robot. The second motion apparatus 42 is designed as a parallel kinematic system. However, the invention is not limited to either of these configurations.
[0091] During setup of the system 1, the tool unit 3 is placed at the workstation 10 by means of the setup device 4. In the illustrated embodiment, the system 2 places the tool unit 3 at the workstation 10 in a setup position. The system 1 includes a further motion apparatus, in particular a motion apparatus 13 shown schematically, by means of which the tool unit 3 is moved from a setup position to a working position at the workstation. In other embodiments, the motion apparatus 13 is part of the system 2 for setting up the system 1. In still other embodiments, the tool unit 3 is moved into the working position at the workstation 10 by means of the second motion apparatus 42. The spacer 5, shown in detail in Fig. 3, is configured for an arrangement between the tool unit 3 and the first motion apparatus 41. As best seen in Fig.As can be seen in Figure 3, the spacer 5 has a first end 51 configured for connection with the tool unit 3 (see Fig. 1) and a second end 52 configured for connection with the first motion apparatus 41 (see Fig. 1).
[0092] In the illustrated embodiment, the first end 51 of the spacer 5 and the tool unit 3 comprise complementary connecting elements for a tool-free connection. In the illustrated embodiment, the connecting elements at the first end 51 comprise a locking pin 53, a magnet 54, and a locking element 55. In the illustrated embodiment, the first end 51 of the spacer has a wall section 50 arranged transversely, in particular perpendicularly to a longitudinal axis of the spacer 5, wherein the connecting elements 53, 54, 55 are arranged on the wall section 50.
[0093] As best seen in Fig. 2, the complementary connecting elements of the tool unit 3 in the illustrated embodiment comprise a figure-eight-shaped receptacle 30 with a first hole of larger diameter and a second hole of smaller diameter. The detent pin 53 of the spacer 5 can be inserted into the first hole by moving it axially and into the second hole by moving it transversely to the axial direction of the detent pin 53, where it can be engaged by a detent projection. For secure guidance of the detent pin, lateral guide walls are provided between the first and second holes in certain embodiments, with the distance between the guide walls decreasing in the direction of the second hole. The detent pin 53 and the figure-eight-shaped receptacle form a snap-fit connection by means of which linear degrees of freedom are blocked.Rotation of the tool unit 3 relative to the spacer 5 is blocked by means of the locking element 55 of the spacer 5 and a complementary locking element 31 of the tool unit 3. The locking elements 55 and 31 are designed, in particular, as a spring-loaded pin and associated opening. In the illustrated embodiment, relative movement of the spacer 5 and the tool unit 3 for locking is assisted by a magnetic force applied via the magnet 54. The magnetic force also secures the snap-fit connection. The connection between the spacer 5 and the tool unit 3 is released, in particular, by a relative movement of the components against the magnetic force, so that the locking pin 53 moves into the first hole of the figure-eight-shaped receptacle 30. During this relative movement, the locking elements 31 and 55 also disengage.In the illustrated embodiment, the second end 52 of the spacer 5 and the motion apparatus 41 comprise complementary connecting elements for a tool-free connection. In this embodiment, the connecting elements at the second end 52 include a slot 56 for a bayonet fitting with a complementary connecting element, designed as a button 44, at a coupling end 401 of the first motion apparatus 41 (see Fig. 4). The coupling end 401, also referred to as the end effector, is in particular the last element of the first motion apparatus 41, which is designed as a serial multi-axis system.
[0094] The spacer 5 serves to ensure that, in particular before, after, and / or during movement of the tool unit 3 by means of the automated setup device 4 and / or parts thereof, and especially before, after, and / or during movement of the tool unit 3 by means of the first motion device 41, air touching the first motion device 41 does not enter defined areas of the tool unit 3. Specifically, the spacer 5 serves to prevent air touching the first motion device 41 from reaching areas of the tool unit 3 that, during operation of the system 1, are located above products and / or product-contacting surfaces. With suitable process control, this ensures, in particular, that the requirements of EU Annex 1 are met during fully or partially automated setup of the system 1 using the automated setup device 4.
[0095] For this purpose, a distance A between the first end 51 and the second end 52 can be suitably chosen depending on the application, so that air touching the first motion apparatus 41 does not enter defined areas of the tool unit 3, in particular that no air touching the first motion apparatus 41 reaches the tool unit 3 connected to the first end 51.
[0096] As shown in Fig. 1, the spacer 5 and the tool unit 3 can be introduced into the sterile area via the transfer lock 12. In the illustrated embodiment, the spacer 5 and the tool unit 3 are provided by the staging device 6 for transfer by the automated setup device 4.
[0097] As shown in detail in Fig. 2, the staging device 6 in the illustrated embodiment comprises a base body 60 and two staging holders 61, 62 mounted on the base body 60. In the illustrated embodiment, the base body 60 is essentially L-shaped with a base 601 and a rear wall 602. However, this design is merely exemplary, and in other embodiments the staging device 6 has a different design. In some embodiments, the rear wall 602 can serve to separate one side of the staging device 6, which faces the automated setup device (see Fig. 1), from the other side.
[0098] In the illustrated embodiment, the two supply holders 61, 62 are mounted on the base surface 601, which lies in an xy-plane of the system 1 (see Fig. 1) during use. The supply holders 61, 62 are each mounted on the base surface 601 in a floating manner, as schematically indicated by arrows in Fig. 2. In particular, this floating mounting is achieved by means of magnetic and / or magnetizable areas 611, 621 provided on the supply holders 61, 62, which are shown schematically in Fig. 2 and interact with the base body 60, especially its base surface 601. However, the invention is not limited to this configuration.
[0099] The two illustrated mounting holders 61, 62 each have a recess 612, 622 for receiving the spacer 5 or the tool unit 3, respectively. The recesses 612, 622 are configured to allow the spacer 5 or the tool unit 3 to float. For this purpose, the spacer 5 and / or the tool unit 3 are mounted in the respective recess 612, 622, in configurations that include some play.
[0100] An exemplary embodiment of a method for setting up the system 1 is described below with reference to Figures 4 to 7.
[0101] The spacer 5 and the tool unit 3 are first introduced into the sterile environment via the transfer lock 12 using the staging device 6. For this purpose, the staging device 6 comprises, in various embodiments, a carriage with a guide rail 63, along which the base body 60 of the staging device 6 is inserted into the sterile environment manually, semi-automatically, or fully automatically.
[0102] In a next step, the spacer 5 is connected to the motion device 41. In the illustrated embodiment, this connection is preferably semi- or fully automated, with the first motion device 41 being operated to connect the spacer 5 to the motion device 41 without tools. The motion device 41 is moved, in particular, such that the coupling end 401 of the motion device 41 is inserted into the second end 52 of the spacer 5. The knob 44 on the coupling end 401 of the motion device 41 is inserted into the slot 56, and a rotation of the coupling end 401 of the motion device 41 relative to the spacer 5 creates a secure connection.For tolerance compensation in a connection of the spacer 5 with the movement apparatus 41, the spacer 5 is mounted as described above, in particular floating configurations in the supply holder 61 and / or the supply holder 61 is mounted floating on the base body 60.
[0103] Fig. 5 shows a detail of the system 2 after the spacer 5 has been connected to the motion apparatus 41.
[0104] The tool unit 3 is then picked up and connected to the motion apparatus 41 by means of the spacer 5.
[0105] For this purpose, the first motion apparatus is operated in particular to receive the tool unit 3 in a first provision position on the provision holder 62 by means of the spacer 5 connected to the motion apparatus 41. As described above, the spacer 5 and the tool unit 3 have, in particular, complementary connecting elements for a tool-free connection by means of relative movement of the components.
[0106] After the tool unit 3 has been picked up, the first motion apparatus 41 is operated to move the tool unit 3 from the first staging position to a first delivery position and to place it at the first delivery position.
[0107] Fig. 6 shows a detail of the system 2 after a movement of the tool unit 3 into the first delivery position, whereby the first motion apparatus 41 is not shown for better clarity.
[0108] As shown in Fig. 6, the tool unit 3 is connected to the second motion apparatus 42 in the first delivery position 3.
[0109] After the tool unit 3 has moved into the first dispensing position 3, the spacer 5 can be separated from the tool unit 3. In particular, this separation is achieved by means of the first movement device 41, which is operated to move the spacer 5 relative to the tool unit 3 against the magnetic force of the magnet 54 (see Fig. 3) and to release the connection between the tool unit 3 and the spacer 5.
[0110] Fig. 7 shows a detail of system 2 after separation of the connection between the tool unit 3 and the spacer 5.
[0111] In the illustrated embodiment, the setup device 4 further comprises, as already mentioned, the second motion apparatus 42. In the illustrated embodiment, the second motion apparatus 42 is operated after a separation of the connection between the tool unit 3 and the spacer 5 in order to move the tool unit 3 from the first delivery position to a second delivery position at the workstation 10 (see Fig. 1).
[0112] The system 2 shown in Figs. 1 to 7 allows for fully automated setup of the system 1 with different tool units 3.
[0113] As can best be seen in Figures 6 and 7, the illustrated tool unit 3 is in particular a filling unit comprising a holder 34 and several filling needles 35. The illustrated filling unit further includes a hose holder 36. The hose holder 36 is configured to clamp hoses connected to the filling needles 35 (not shown in the figures). The spacer 5 ensures, in particular, that no air touching the first movement apparatus reaches the filling needles 35.
[0114] Fig. 8 shows a composite element 7 for use in a system for setting up a plant, in particular, but not limited to, use in a system 2 as shown in Figs. 1 to 7, for setting up an aseptic filling plant with a tool unit 3 designed as a filling unit, wherein, in particular, a hose (not shown in the figures) is connected to each filling needle 35. However, the composite element 7 is not limited to use in a system 2 as shown in Figs. 1 to 7, but can be used when moving any tool unit, on which several hoses (not shown in the figures) are arranged, by means of an automated setup device, in particular an automated setup device comprising one or more movement devices. The automated setup device is, in particular, one embodiment of a setup device 3 shown in Figs. 1 to 7.The connecting element 7 is used in other embodiments during setup by means of an alternative setup device. The hoses (not shown) are moved with the tool unit, in particular but not limited to a tool unit 3 as shown in FIGS. 1 to 7, by means of the setup device, wherein the connecting element 7 holds at least some, in particular all, of the several hoses in a composite.
[0115] The illustrated composite element 7 has several recesses 70 around its circumference for this purpose, each designed to clamp a hose (not shown). The illustrated recesses 70 have an opening with a reduced diameter for this purpose.
[0116] The composite element 7 is made of a sterilizable, in particular autoclavable, material for use in a system for setting up an aseptic filling plant and / or for use in an aseptic filling plant and can be introduced into a sterile environment with the tool unit 3, in particular the filling unit.
[0117] The composite element 7 shown is plate-shaped, i.e. it has a low height compared to its base area.
[0118] In the illustrated embodiment, the composite element 7 has a circular plan, with the recesses 70 being evenly distributed around the circumference of the composite element and arranged symmetrically to a center point 71 of the composite element 7. Each of these configurations, both individually and in combination, is advantageous for imparting a twist that forces the inserted tubes (not shown) into a parallel alignment.
[0119] The composite element 7 is designed in embodiments made of a magnetic and / or magnetizable material and is therefore suitable for interacting with defined areas of a system, for example, but not limited to, a system 1 according to Figures 1 to 7, such that attractive forces act between the composite element 7 and these areas. These attractive forces cause the composite element 7, and thus the hoses held together by it, to be permanently or temporarily fixed in a position during setup. This allows the movement of multiple highly flexible hoses to be restricted to a specific range of motion. At the same time, crushing forces or similar stresses on the hoses are prevented or at least reduced.In one embodiment, at least one hose of a tool unit is provided with at least one magnetic element, wherein the magnetic element is in particular at least partially made of a magnetic and / or magnetizable material.
[0120] For example, a hose is designed by means of at least one magnetic element to interact with defined areas, in particular magnetic and / or magnetizable areas, of a system, for example, but not limited to, a system 1 according to Figures 1 to 7, such that attractive forces act between the at least one magnetic element and these areas. These attractive forces enable the magnetic element and the at least one hose to be permanently or temporarily fixed in a position during setup. For example, movement of the hose can be restricted to a movement corridor.
[0121] For example, a hose is designed by means of several magnetic elements and / or at least one magnetic element extending over at least a significant section of the hose, such that individual points of the hose interact, in particular by attractive forces, limiting their relative position and, for example, fixing them in place. For example, the hose equipped with at least one magnetic element is designed to be compacted, for example, at least partially coiled or tangled. For example, the more compact shape of the hose is advantageous when dismantling a workstation, in particular the filling station, and / or when moving the hose through a port.
[0122] The examples shown and / or described are merely illustrative and numerous variations are conceivable.
Claims
Patent claims 1. System for equipping a plant (1) with a workstation, in particular an aseptic plant and / or a filling plant, the system (2) comprising: - a tool unit (3), wherein the tool unit (3) is configured for use in the workstation during the operation of the plant (1), and - an automated setup device (4), wherein the automated setup device (4) is configured to place the tool unit (3) at the workstation, and wherein the automated setup device (4) comprises at least a first motion apparatus (41), characterized in that the system (2) further comprises a spacer (5) made of a sterilizable, in particular autoclavable, material, wherein the spacer (5) is configured for an arrangement between the tool unit (3) and the first motion apparatus (41), and wherein a first end (51) of the spacer (5) is configured for a connection with the tool unit (3) and a second end (52) of the spacer (5) is configured for a connection with the first motion apparatus (41).
2. System according to claim 1, characterized in that the first end (51) of the spacer (5) is configured for a tool-free connection with the tool unit (3) and / or the second end (52) of the spacer (5) is configured for a tool-free connection with the first motion apparatus (51).
3. System according to claim 1 or 2, characterized in that the first end (51) of the spacer (5) and the tool unit (3) and / or the second end (52) of the spacer (5) and the first movement apparatus (41) comprise complementary connecting elements for a connection, in particular without tools, wherein in particular the connecting elements of the first end (51) of the spacer (5) and the tool unit (3) on the one hand and of the second end (52) of the spacer (5) and the first movement apparatus (41) on the other hand differ.
4. System according to claim 3, characterized in that the complementary connecting elements are designed for at least one of the following: for a connection that is entered and / or released by means of rotation, in particular connecting elements for a bayonet fitting, and / or for a connection that is entered and / or released by means of linear movement, in particular connecting elements for a snap-in fastening connection, and / or for a magnetic fastening.
5. System according to one of claims 1 to 4, characterized in that a distance between the first end (51) and the second end (52) of the spacer (5) is sufficiently long so that during handling of the tool unit (3) by means of the first motion apparatus (41), wherein the tool unit (3) is connected to the motion apparatus (41) by means of the spacer (5), air which touches the first motion apparatus (41) does not enter defined areas of the tool unit (3), in particular not defined areas which are arranged above products and / or product-contacting surfaces during operation of the system (1).
6. System according to one of claims 1 to 5, characterized in that the first end (51) of the spacer (5) has a wall piece (50) arranged transversely, in particular perpendicularly to a longitudinal axis of the spacer (5).
7. System according to one of claims 1 to 6, characterized in that the first motion apparatus (41) is configured to receive the tool unit (3) in a first provision position by means of the spacer (5) connected to the first motion apparatus (41), to move it from the first provision position to a first delivery position, and to place it at the first delivery position, and / or that the first motion apparatus (41) is designed as a two- to six-axis system.
8. System according to one of claims 1 to 7, characterized in that the setup device (4) further comprises a second movement apparatus (42), wherein the second movement apparatus (42) is configured to receive the tool unit (3) in a second provision position, to move it from the second provision position to a second delivery position, and to place it at the second delivery position, wherein in particular the second provision position is the same as the first delivery position.
9. System for setting up a system (1) with a workstation, in particular an aseptic system and / or filling system, the system (2) comprising an automated setup device (4), or system (2) according to one of claims 1 to 8, characterized in that the system (2) comprises a provisioning device (6) with at least one provisioning holder (61, 62) for at least one element to be picked up by means of the setup device (5), in particular for a tool unit (3) and / or a spacer (5), wherein the at least one provisioning holder (61, 62) is configured for floating provision of the at least one element to be picked up by means of the setup device (4).
10. System according to claim 9, characterized in that the at least one provision holder (61 , 62) is mounted floating on a base body (60) of the provision device (6) with respect to at least one degree of freedom, in particular at least in an xy-plane.
11. System according to claim 9 or 10, characterized in that the at least one provision holder (61 , 62) is mounted by means of an elastic retaining element and / or magnetically, in particular on the base body (60) of the provision device (6).
12. System according to claim 9, 10 or 11, characterized in that the at least one provision holder (61, 62) has a recess (612, 622) for receiving the at least one element to be received by means of the setup device, wherein in particular the recess (612, 622) is configured for floating reception of the at least one element to be received by means of the setup device.
13. System according to one of claims 9 to 12, characterized in that the provisioning device (6) comprises a slide, wherein in particular the system (1) comprises a partition system, in particular an isolator, and a transfer lock (12) and the slide is configured for at least partial transport of the at least one element to be picked up by means of the setup device through the transfer lock (12).
14. System according to one of claims 1 to 13, characterized in that the tool unit (3) is designed as a filling unit comprising several, in particular four to 16, filling needles (35), and a filling needle holder (34) holding the filling needles (35).
15. System according to the preamble of claim 1 or according to one of the preceding claims, characterized in that at least one hose is arranged on the tool unit (3) and wherein the at least one hose is provided with at least one magnetic element.
16. System according to the preamble of claim 1 or according to one of the preceding claims, characterized in that several hoses are arranged on the tool unit (3), wherein the system comprises at least one connecting element (7) which holds at least some, in particular all, of the several arranged hoses in a composite, wherein the connecting element (7) comprises several recesses (70) on its circumference for receiving the hoses held in a composite.
17. System according to the preamble of claim 1 or according to one of the preceding claims, characterized in that several hoses are arranged on the tool unit (3), wherein the system comprises at least one composite element (7) which holds at least some, in particular all, of the several arranged hoses in a composite, wherein the composite element (7) is designed at least partially from a magnetic and / or magnetizable material.
18. System according to claim 15, 16 or 17 characterized in that the tool unit (3) is designed as a filling unit comprising at least one filling needle, in particular several, in particular four to 16 filling needles (35), and a filling needle holder (34) holding the filling needle or the several filling needles (35), wherein the at least one hose is fluid-carrying connected to the at least one filling needle (35), in particular wherein the several hoses are fluid-carrying connected to the several filling needles (35).
19. System according to one of claims 15 to 18, characterized in that the recesses (70) are evenly distributed over a circumference of the composite element (7) and / or arranged symmetrically to a center point (71) of the composite element (7).
20. System according to one of claims 15 to 19, characterized in that the composite element (7) is plate-shaped, in particular with a circular plan.
21. System according to one of claims 15 to 20, characterized in that the system (2) comprises at least one guide element to be arranged in the system (1), in particular to be arranged in a stationary manner, which interacts with the at least one magnetic element and / or the at least one composite element (7) in order to hold at least one section of the at least one hose and / or at least one section of the composite in an arrangement space area, in particular on the guide element, temporarily or permanently, in particular to hold it in a force-fit manner.
22. Aseptic system with a workstation, in particular an aseptic filling system, comprising a partition system, in particular an isolator, and a system according to any one of claims 1 to 21.
23. Method for setting up a system (1) with a workstation (10), in particular an aseptic system and / or a filling system, by means of an automated setup device (4) comprising a first motion apparatus (41), wherein the automated setup device (4) is operated to place a tool unit (3) at the workstation (10), characterized in that a spacer (5) made of a sterilizable, in particular autoclavable, material is received between the tool unit (3) and the first motion apparatus (41), wherein a first end (51) of the spacer (5) is configured for a connection, in particular without tools, with the tool unit (3) and the second end (52) of the spacer (5) is configured for a connection, in particular without tools, with the first motion apparatus (41).
24. Method according to claim 23, characterized in that the first movement apparatus (41) is operated to connect the spacer (5) to the movement apparatus (41) without tools.
25. Method according to one of the preceding method claims, characterized in that the first motion apparatus (41) is operated to receive the tool unit (3) in a first provision position by means of the spacer (5) connected to the motion apparatus (41), to move it from the first provision position to a first delivery position, and to place it at the first delivery position.
26. Method according to one of the preceding method claims, characterized in that the first movement apparatus (41) is operated to connect the spacer (5) to the first movement apparatus (41) before the tool unit (3) is received, and in particular to release the connection between the tool unit and the spacer after the tool unit has been placed in the first delivery position.
27. Method according to one of the preceding method claims, characterized in that the setup device further comprises a second movement apparatus, wherein the second movement apparatus is operated to receive the tool unit in a second provision position, to move it from the second provision position to a second delivery position, and to place it at the second delivery position, wherein in particular the second provision position is the same as the first delivery position.
Citation Information
Patent Citations
Device for processing medical containers and fastening device for such a device
CN116601396A
Device for joining a tool to a robot arm
EP0325913B1
Coating installation with sprayhead changing station
EP1245296B1
Machine for filling and packaging bottles, cartridges, syringes and the like
US20210292014A1
Method for transferring at least one filling needle of a number of filling needles into an aseptic isolator
US20220379500A1