Device for setting up a system to carry out process steps

Abstract

Device for setting up a system (1) for carrying out process steps on objects, in particular on containers, for example on pharmaceutical containers, at least partially under cleanroom conditions, The installation (1) comprises a machine setup, in particular the machine setup is, for example, a process station (2, 3) for carrying out a process step, a transport system (5) for transporting objects to or from a process station and / or a feeding system (4) for feeding packaging materials interacting with the objects to a process station (2, 3), and a cleanroom setup with a housing (6), wherein the cleanroom condition can be created in a cleanroom area of ​​the housing (6), wherein the machine equipment is arranged in the cleanroom area of ​​the housing (6), wherein the machine setup comprises at least one machine element (7) which is coupled in a production position (10) with at least one further element of the machine setup, wherein in particular an assembly section (70) of the machine element (7) in the production position (10) contacts a counter section of the at least one further element and / or the cleanroom setup, The device (8) comprises a casing (80) designed to accommodate the machine element (7), wherein at least one section, in particular at least process-relevant sections of the machine element (7), are separated from an environment by the casing (80) in a closed state of the casing (80). wherein, prior to a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example a decontamination, the machine element (7) contained in the housing (80) can be introduced into the cleanroom area in a closed state of the housing (80), and wherein, after the cleaning process of the cleanroom area, in particular after the germ- and / or residue-reducing cleaning process, for example after decontamination, the covering (80) in the cleanroom area can be opened without impairing the cleanroom condition.

Description

SCOPE OF APPLICATION AND STATE OF THE ART

[0001] The invention relates to a device for setting up a system for carrying out process steps on objects, in particular a system for carrying out process steps on objects at least partially under cleanroom conditions. The invention further relates to a system for carrying out process steps.

[0002] Process steps here refer to any form of handling, processing and / or manipulation of an object, for example a container, and / or its contents, including but not limited to filling, closing, labeling of objects designed as containers, as well as treatments without material change to the object and / or its contents, such as weighing and / or other recording of the object's condition and / or its contents, in particular optical inspection.

[0003] For the manufacture and / or processing, in particular the filling, of pharmaceutical products, biopharmaceutical products, biological products, highly potent products and / or other highly sensitive products, facilities are known to have a comprehensive cleanroom setup.

[0004] A cleanroom setup comprises an enclosure, wherein a cleanroom area of ​​the enclosure is separated from the environment, and a cleanroom condition is created within this cleanroom area. In particular, the cleanroom setup includes a barrier device, especially an isolator and / or a restricted access barrier system (RABS). The barrier device protects a cleanroom condition within a room by separating it from the environment. An isolator is defined as a decontaminated unit that allows its interior to be isolated from an external environment. Both closed and open isolators are known. In closed isolators, material transfer to and from the isolator occurs exclusively via auxiliary devices such as alpha-beta port systems and not via pass-throughs to the environment.Closed isolators remain fluid-tight throughout operation. Open isolators have pass-throughs that are open during operation, particularly permanently open pass-throughs for continuous material transfer. These pass-throughs are designed to prevent the ingress of external contaminants into the isolator, for example, through appropriate pressure conditions and / or airlocks. In some configurations, the cleanroom condition is created within a cleanroom area of ​​a housing designed as a RABS (Remotely Absorbed Boiling System). Such systems have a cleanroom area separated from the environment by the housing, but not necessarily fluid-tight. Depending on the ventilation, a distinction is made between open and closed RABS systems.

[0005] The required cleanroom conditions are defined by the application, in particular by the product being handled and / or the intended use of the handled object. Specifically, cleanroom conditions require at least a certain degree of sterility. Regulations defining cleanroom conditions include, for example, DIN EN ISO 14644-1 and / or VDI 2083 and / or "The Rules Governing Medicinal Products in the European Union, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use" (EU GMP Guide), Annex 1 (currently: Volume 4 dated August 22, 2022) and the regulations referenced therein. The cleanroom conditions required, at least in part, for handling objects in the system disclosed herein are, in particular, classes A, B, C, and D according to EU GMP, Annex 1, especially classes A, B, and C.In particular, the required cleanroom condition for filling and sealing the containers is class A. TASK AND SOLUTION

[0006] The objects of the invention are to create an improved device for the aseptic setup of a system for carrying out process steps on objects under cleanroom conditions and an improved system.

[0007] According to a first aspect, a device for setting up a system for carrying out process steps on objects, in particular on containers, for example on pharmaceutical containers, is created at least partially under cleanroom conditions.

[0008] The system comprises a cleanroom setup with an enclosure, whereby the cleanroom conditions can be created in a cleanroom area of ​​the enclosure.

[0009] The system comprises a machine facility, the machine facility being arranged in the cleanroom area of ​​the housing.

[0010] The terms "a", "an", "a", etc. are used in connection with the application only as indefinite articles and not as counters. If a feature is described in the singular, the description shall apply analogously to the feature in the plural, unless explicitly stated otherwise. In particular, the system, in its various configurations, comprises more than one machine component arranged in the cleanroom area of ​​the housing.

[0011] The machine setup and / or one or more of the machine setups is / are, for example, a process station for carrying out a process step. The process station is, for example, an unpacking station and / or a filling station and / or a sealing station and / or an inspection station and / or a sorting station.

[0012] The unpacking station is designed for unpacking, in particular to unpack the objects from an object packaging material, for example to unpack from an outer packaging and / or to remove the objects from a microscope slide.

[0013] The filling station is configured for filling, in particular for filling objects designed as containers with a product, especially a pharmaceutical product. For example, the filling station includes a filling path for a product, especially a liquid, wherein the filling path includes, in particular, filling needles and, for example, hoses. For example, the filling station includes a dosing unit for dosing a product to be filled, which may be, for example, a liquid and / or a powder. In some configurations, the filling station includes a feeding unit for the product to be filled, for example, the feeding unit includes a pump and / or a vibrating drive.

[0014] The sealing station is configured for sealing, in particular for sealing objects designed as containers, especially filled objects. For example, a sealing station is configured for inserting a stopper. For example, a sealing station is configured for crimping a closure element. The inspection station is configured for inspection. For example, an inspection station is configured to check the process and / or the result of a completed process step. For example, an inspection station is configured to check an item, in particular an object and / or packaging material, especially for sufficient quality and / or for damage and / or contamination. In some configurations, an inspection station is a weighing station.In various configurations, the control station includes a recording device, in particular a sensor, for example a scale and / or a camera.

[0015] The machine setup and / or one or more of the machine setups is / are, for example, a transport system for transporting objects. For example, the transport system includes a transport device for transporting objects to and / or through and / or away from a process station and / or for feeding objects and / or for removing objects, for example, for removing objects on which all required process steps have been carried out and / or as rejects and / or as sample trains. In some embodiments, a transport device of the transport system is configured for transferring objects, for example, for transferring objects from one transport device to another. The transport system, in particular a transport device of the transport system, is configured in some embodiments to transport objects individually and / or as a group, for example, in a carrier that holds the objects.The transport system, in particular a transport device of the transport system, comprises, in various configurations, guide rails, conveyor belts, racks, or other elements that contact the objects during transport. The transport system is, in various configurations, a linear motor transport system or a planar motor transport system comprising a runner for transporting individual objects and / or groups of objects.

[0016] The machine setup and / or one or more of the machine setups is / are, for example, a feeding system for supplying objects, for example, to a process station and / or to a transport device of the transport system. In particular, the supplied objects are packaging materials that interact with the objects, for example, closure elements. The feeding system is configured to store, feed, and / or sort the objects, especially the packaging materials, for example, by singulating them and / or arranging them in a defined orientation. For example, the feeding system includes a sorting hopper and / or a sorting rail for singulating, sorting, and / or feeding the objects, especially the packaging materials, wherein elements of the feeding system contact the objects, especially the packaging materials.

[0017] In certain configurations, the machine equipment and / or one or more of the machine equipment is / are a cleanroom device for creating and / or maintaining cleanroom conditions in the cleanroom area, for example, a flow device, in particular an air supply. For example, the machine equipment and / or one or more of the machine equipment is / are a cleaning device, in certain configurations a cleaning device for carrying out a cleaning process that reduces germs and / or residues.

[0018] In various configurations, a machine setup, for example a process station and / or a transport device of the transport system and / or a feeding system and / or a cleanroom facility, includes a manipulator. For example, the manipulator is designed to assist in carrying out at least one process step in a process operation and / or in troubleshooting the system and / or in transport and / or feeding.

[0019] In its various configurations, a machine unit, for example a process station and / or a transport device of the transport system and / or a feeding system and / or a cleanroom facility, comprises a unit for creating a defined atmosphere. In particular, the defined atmosphere is a protective atmosphere. For example, the protective atmosphere is an atmosphere comprising a protective gas, in particular an inert gas, and / or an atmosphere under negative pressure, for example a vacuum. In particular, a filling station comprises a unit for creating a defined atmosphere, for example, for creating a protective atmosphere in a container before filling, in particular so-called pre-gassing, and / or for filling under a protective atmosphere. In particular, a sealing station, for example a stopper insertion station, comprises a unit for creating a defined atmosphere, in particular for sealing under a protective atmosphere.

[0020] The machine assembly is located within the cleanroom area of ​​the housing. In some configurations, the machine assembly is located entirely within the cleanroom area of ​​the housing. In other configurations, the machine assembly includes elements located outside the cleanroom area of ​​the housing.

[0021] The machine assembly comprises at least one machine element that is coupled to at least one other element of the machine assembly in a production position. In certain embodiments, a mounting section of the machine element contacts a corresponding section of the at least one other element in the production position. Specifically, the production position is located within the cleanroom area of ​​the housing.

[0022] A production position is defined as a position, particularly a fixed one, in which the machine element is arranged in a production facility of the plant.

[0023] The term "setup" refers above and / or below to a process in which the machine equipment is fitted with at least the machine element, for example a format part.

[0024] The device for setting up the system comprises a casing designed to accommodate the machine element, wherein at least one section, in particular at least process-relevant sections, of the machine element are separated from the environment by the casing in a closed state.

[0025] The term "process-relevant sections" of the machine element refers above and below to sections for which a high degree of purity, in particular a high degree of sterility, is required. For example, process-relevant sections include product-contacting sections and / or sections that contact objects and / or packaging materials interacting with the objects, and / or sections in a primary air supply to product-contacting and / or object-contacting and / or packaging material-contacting sections, and / or sections for which a high degree of purity, in particular a high degree of sterility, is required for other reasons.

[0026] For the purposes of the above and below, "germ-free" means, in particular, the removal of at least active germs and, for example, inactive germs. Specifically, a germ-free treatment includes the inactivation of germs. For example, a germ-free treatment includes the removal of germs, in particular the removal of at least active and, for example, inactive germs.

[0027] For example, a process for disinfection includes autoclaving and / or steam sterilization. For example, a process for disinfection includes irradiation, in particular irradiation with ultraviolet radiation (UV radiation), for example UV-C radiation, and / or with gamma rays.

[0028] In specific formulations, the high level of purity, in particular the high level of sterility, is defined in relevant regulations, and a process to achieve the high level of purity, in particular a process for sterility, is carried out in a manner and / or to a degree in accordance with relevant regulations, whereby, for example, the relevant regulations are "The Rules Governing Medicinal Products in the European Union, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use" (EU GMP Guide) and its annexes, in particular Annexes 1 and 2 (currently: Volume 4 of 22 August 2022) and / or the "Guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products", published in Part IV of Eudralex Volume 4 (in force from 22 May 2018) and / or the regulations mentioned therein.

[0029] The device is designed such that, prior to a cleaning process of the cleanroom area, in particular a germ-reducing cleaning process, for example decontamination, the machine element contained in the enclosure, in particular a germ-free one, can be introduced into the cleanroom area in a closed state of the enclosure, and after the cleaning process of the cleanroom area, in particular after the germ-reducing cleaning process, for example after decontamination, the enclosure can be opened, in particular to remove the machine element from the enclosure in the cleanroom area and / or to expose the machine element for production operations without impairing the cleanroom conditions.

[0030] The cleaning process of the cleanroom area is carried out in a manner and / or to a degree in accordance with relevant regulations, for example, in accordance with the "The Rules Governing Medicinal Products in the European Union, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use" (EC-GMP Guide) and its annexes, in particular Annex 1 and 2 (currently: Volume 4 of 22 August 2022) and / or the "Guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products", published in Part IV of Eudralex Volume 4 (in force from 22 May 2018) and / or the regulations mentioned therein.

[0031] A germ- and / or residue-reducing cleaning process, in particular decontamination, is carried out in embodiments using a germ- and / or residue-removing agent, especially a sterilizing agent. In particular, germ- and / or residue removal includes nebulization of a hydrogen peroxide solution, also referred to as vaporized hydrogen peroxide. In embodiments, germ- and / or residue removal includes wet cleaning, in particular using a high-pressure steam jet, also referred to as a wash-down. In embodiments, cleaning, in particular residue removal, includes treatment using water, in particular with subsequent germ-removal. In embodiments, cleaning, in particular residue removal, includes treatment using a sterile, in particular fluid, germ- and / or residue-removing agent, which, for example, includes an alcohol and / or a sterile solution.

[0032] In some configurations, the cleanroom area is not separated from the surrounding environment when the machine element is inserted into the enclosure. For the cleaning process, the cleanroom area is separated from the surrounding environment in some configurations, so that cleanroom conditions can be created within the cleanroom area.

[0033] The device is designed such that when the casing is opened and, for example, the machine element is exposed and / or removed from the casing after the cleaning process, the cleanroom conditions achieved, in particular, through the cleaning process, are not impaired. The cleanroom conditions are considered "not impaired" within the meaning of the disclosure if the cleanroom conditions are maintained in accordance with the relevant regulations.

[0034] The device allows for the easy transfer of a machine element, particularly a sterile one, into the cleanroom area of ​​the housing and, in certain configurations, at least partial setup of the machine before the housing is closed and isolated from the environment. By encasing the machine element, a degree of sterileness can be ensured to meet relevant regulations.

[0035] In particular, the machine element contained within the enclosure can be introduced into the cleanroom area through an access opening in the housing when the enclosure is closed. In some embodiments, the access opening is a large-area opening and / or an opening that can be closed with a door. Specifically, the open access opening creates a direct connection between the cleanroom area and the surrounding environment of the cleanroom structure's housing. In particular, the cleanroom conditions cannot be maintained within the cleanroom area when the access opening is open. Specifically, the cleanroom conditions within the cleanroom area are compromised when the access opening is open.

[0036] In certain embodiments, the enclosure can be opened non-destructively and, in particular, resealed. For example, the non-destructively openable enclosure can be reused multiple times. Specifically, in certain embodiments, the non-destructively openable and, in particular, resealable enclosure can also be used to move the machine element from the cleanroom area to an environment outside the housing. To move the machine element from the cleanroom area, it is placed inside the enclosure and / or the enclosure is placed around the machine element, and, for example, the enclosure is closed.

[0037] In various configurations, a mechanism, actuator and / or manipulator is provided to open and / or close the casing at least semi-automatically and, for example, fully automatically.

[0038] In this design, the covering is opened in such a way that the covering is at least partially destroyed.

[0039] In certain embodiments, the enclosure is designed such that a machine element enclosed within the enclosure can be subjected to a sterilization process while the enclosure is closed. In particular, the enclosure is designed such that when a machine element enclosed within the enclosure is subjected to a sterilization process while the enclosure is closed, sections of the machine element that are separated from the environment by the enclosure are also subjected to the sterilization process, and thus, in particular, the separated sections are also sterilized.

[0040] In certain embodiments, the enclosure has at least a section of a radiolucent material, so that radiation for germicidal purposes can pass through the enclosure to sections of the machine element that are separated from the environment when the enclosure is closed, thus allowing the sections separated from the environment to be subjected to a germicidal process.

[0041] In certain embodiments, the casing is designed such that a medium for sterilizing the machine element enclosed within it, particularly the sections separated from the environment by the casing, can be supplied through it, especially for steam sterilization and / or autoclaving of the machine element enclosed within the casing. In particular, the casing comprises a semi-permeable material, at least in sections. Specifically, the semi-permeable material is selected such that it is permeable to a sterilization medium for the machine element enclosed within the casing, but impermeable to microbiological substances, especially germs. For example, the casing has a wall that, in a closed state, separates the enclosed interior space from the environment, at least in sections.In certain embodiments, the wall has an opening that can be closed by an insert, and the insert is made of the semi-permeable material. Specifically, the insert serves as a closure for the opening and includes a sterile filter. In some embodiments, at least a section of the wall is made of the semi-permeable material.

[0042] In some configurations, a treatment facility for germ elimination is provided, wherein the treatment facility is designed to carry out a process for germ elimination, for example by irradiation and / or autoclaving and / or steam sterilization.

[0043] In certain embodiments, the casing is designed such that it can be inserted, along with an incorporated machine element, into the interior of a chamber of a treatment device for germ elimination, wherein the chamber of the treatment device is designed to carry out a process for germ elimination.

[0044] For example, the casing has a nozzle, wherein in particular at least one nozzle is designed for at least one function, in particular for several functions, of the functions described above and / or below in connection with a nozzle.

[0045] In some embodiments, the casing has a nozzle through which, when the casing is closed, a disinfection medium can be introduced into the separated interior of the casing, particularly for steam sterilization and / or autoclaving of the sections of the machine element separated by the casing. In other embodiments, the casing has at least two nozzles through which, when the casing is closed, a disinfection medium can be introduced into and / or removed from the separated interior of the casing. In other embodiments, several casings can be connected in such a way that their separated interiors are connected to the disinfection medium via a fluid pathway and are simultaneously isolated from the surrounding environment.This enables the disinfection medium to be guided through separate interior spaces of several casings to disinfect sections of the respective machine elements enclosed by the casings. Specifically, the disinfection medium is provided by a disinfection treatment unit. This treatment unit comprises a supply unit, which is designed to provide the medium and, for example, has a connection for the nozzle of a casing. In some embodiments, this treatment unit does not include a separate chamber for carrying out the disinfection process.

[0046] In its various configurations, the system comprises the treatment unit for germ reduction, for example, a treatment unit with a chamber and / or, in particular, a treatment unit that provides the medium for germ reduction. For example, but not necessarily, the treatment unit of the system, which in particular has a chamber, has at least one feature and / or combination of features that is described below in connection with a system with a treatment unit of a further aspect.

[0047] In its design, the treatment facility for germ elimination is a separate and external treatment facility from the plant.

[0048] The encapsulation is designed such that, in a closed state, the sections of the machine element enclosed by the encapsulation that are separated from the environment, and in particular those that are sterile, are protected from contamination, especially by germs. In particular, the encapsulation is impermeable to microbiological substances, especially germs, in certain configurations.

[0049] In certain embodiments, the enclosure includes a seal, in particular a seal for a sealed separation. For example, a seal of the enclosure seals between two elements of the enclosure. For example, a seal of the enclosure seals between an element of the enclosure and a section of the enclosed machine element. In particular, the enclosure is designed such that, in a closed state, the interior of the enclosure, separated from its surroundings, and / or the sections of the enclosed machine element separated from the surroundings by the enclosure are sealed from the surroundings. For example, the sealing separation is provided at least in areas between elements of the enclosure and / or between an element of the enclosure and the enclosed machine element.In particular, the seal in the sealed partition and / or the seal provided by the gasket is designed to be fluid-tight and / or sterile-tight and / or to seal against overpressure in the interior relative to the environment. For example, at least the fluid-tight and / or overpressure-tight partition is provided up to the area of ​​the semi-permeable material, whereby, for example, a sterile seal is also provided in the area of ​​the semi-permeable material.In embodiments, the covering comprises a sealing closure, in particular adjustable, for the area of ​​the semi-permeable material, wherein the area of ​​the semi-permeable material is sealed by the sealing closure in a sealing position of the sealing closure, in particular fluid-sealing and / or sterile sealing and / or sealing against overpressure in the interior relative to the environment, and the semi-permeable material is exposed in an open position of the sealing closure to allow the medium to enter for germ elimination.

[0050] In particular, the sealed separation and / or the sealing by the gasket, the separation of the interior of the enclosure and / or the separation of the separated sections of the received machine element, especially the sealing separation, can be tested and, for example, quantified by an integrity test.

[0051] For example, the enclosure includes a nozzle to which a pressure device can be connected. In particular, the connected pressure device can be used to create overpressure inside the enclosure when it is closed, thus allowing, for example, testing of the enclosure and its closed state, especially for integrity.

[0052] In particular, the sealing provided by the gasket and / or the sealed separation offers particularly reliable protection against contamination, especially against contamination that would impair the germ-free condition of the interior and / or the separated sections of the received machine element.

[0053] In certain embodiments, the sealing element of the casing is designed such that it seals along a sealing line in a sealing position. In particular, the sealing position is the closed state of the casing. For example, the size of a sealing sector in which two parts of the seal contact each other for sealing purposes in the sealed position and / or in the closed state is smaller compared to a surface seal, and in particular, the size of the sealing sector is minimized in the case of a line seal. Specifically, the sealing sections of the two parts of the seal that contact each other for sealing purposes in the sealed position and / or in the closed state do not contact each other when the casing is open, and in particular, these sealing sections are exposed when the casing is open.

[0054] In certain embodiments, a seal of the casing comprises at least a section of a soft sealing material. For example, the soft sealing material has good sealing properties. For example, the soft sealing material is an elastically deformable, yet dimensionally stable material. For example, the soft sealing material is a particularly elastic plastic and / or an elastomer and / or silicone and / or rubber. For example, a sealing element is made of a hard sealing material, for example, steel, particularly stainless steel.

[0055] In certain embodiments, the seal of the casing includes, at least in sections, a tapered sealing element. In particular, the tapered sealing element can be used to create a sealing line. In some embodiments, the tapered sealing element is dimensionally stable and / or made of a hard sealing material. In other embodiments, the tapered sealing element forms a sealing lip, in particular, where the sealing element is made of a soft sealing material.In some embodiments, the sealing element of the casing comprises a first sealing element and a second sealing element. The first sealing element has a pointed cross-section along a sealing line to be formed, and the second sealing element forms a mating surface along a sealing line to be formed. In a sealing position, the pointed portion of the first sealing element and the mating surface of the second sealing element are pressed together to form a sealing line. In some embodiments, the first sealing element is made of a soft sealing material along the sealing line to be formed, and the second sealing element is made of a hard sealing material along the sealing line to be formed.In some embodiments, the first sealing part along the sealing line to be formed is made of a hard sealing material, and the second sealing part along the sealing line to be formed is made of a soft sealing material.

[0056] In certain embodiments, the setup device incorporates an exposure actuator. This exposure actuator is specifically designed to at least temporarily move the enclosure at least partially out of the closed state, in particular to open it, such that contact sections of the enclosure are non-contacting in the opened state, while the contact sections in the closed state make contact with another section, in particular a section of the enclosure and / or a section of the machine element contained within the enclosure.

[0057] In particular, the contact sections are sections of a so-called "ring of concern," whereby the ring of concern is usually inaccessible for sterilization during a sterilization process. Specifically, the contact sections are exposed by the exposure actuator by moving them out of the closed state, thus making them accessible for sterilization during a sterilization process.

[0058] In particular, the exposure actuator enables the contact sections to be accessed and sterilized during a sterilization process. In certain configurations, this reduces, for example, the risk that the sterilized state of the machine element sections separated from the environment by the encapsulation could be compromised by the contact sections when the encapsulation is subsequently opened.

[0059] In particular, the exposure actuator is designed to at least partially remove the enclosure in the treatment facility from its closed state in order to carry out a process for germ removal, especially inside the chamber of the treatment facility.

[0060] In certain embodiments, the exposure actuator is designed such that, through the action of the germ-free process, the coating is at least partially opened from its closed state. In particular, after the action of the process, for example, with a time delay after its completion, the exposure actuator at least enables and, in particular, causes the coating to return to its closed state. For example, the exposure actuator includes a temperature-sensitive section whose length depends on the temperature. For example, the temperature-sensitive section expands with increasing temperature, at least within a certain temperature range.In certain embodiments, the sterilization process involves a temperature change from an initial temperature to a modified temperature. In particular, during autoclaving and / or steam sterilization, the temperature is increased, and this temperature change alters the length of the temperature-sensitive section. This change in length causes the casing to at least partially open. After the sterilization process, the temperature returns to the initial temperature, and the temperature-sensitive section changes its length accordingly. This, for example, at least allows the casing to be returned to the closed state. The corresponding change in length of the temperature-sensitive section, for example, causes the casing to close again.

[0061] In some designs, the exposure actuator includes a drive for at least partially removing the casing from the closed state.

[0062] In its design, the enclosure includes the exposure actuator.

[0063] In its design, the exposure actuator is separate from the casing.

[0064] For example, the treatment device for carrying out a germ-free process includes the exposure actuator. In some configurations, the exposure actuator is located inside the chamber of the treatment device for carrying out a germ-free process.

[0065] Alternatively or additionally, in certain embodiments, the enclosure includes a shield for contact sections, wherein the contact sections, in the closed state, contact another section, in particular a section of the enclosure and / or a section of the machine element enclosed within the enclosure. In particular, the shield is designed to protect contact sections from sections of the machine element enclosed within the enclosure, especially process-relevant sections, when the enclosure is open. In certain embodiments, this can at least reduce the risk that, after a sterilization process for the sections of the machine element separated from the environment by the enclosure, the sterilized state of these sections could be compromised by the contact sections when the enclosure is subsequently opened.

[0066] In its various configurations, the casing includes an indication device for indicating the condition of the casing. In particular, the indication device includes an indicator.

[0067] In some embodiments, an indicator of the indication device is arranged in the interior of the enclosure, which is separated from its surroundings, when the enclosure is closed. For example, the indicator in the interior is visible from outside the enclosure, for instance, through a viewing window in the enclosure. In other embodiments, an indicator of the indication device is arranged on an outer surface of the enclosure, wherein, particularly when the enclosure is closed, this indicator is located outside the interior of the enclosure, which is separated from its surroundings.

[0068] In certain configurations, the indicator device, in particular the indicator, is designed to indicate whether the casing has undergone a cleaning process, especially a process for germ reduction and / or elimination. Specifically, the indicator device, for example the indicator, is designed to indicate a germ-free state in the interior and / or an impairment of the germ-free state in the interior. For example, the indicator device can be used to monitor whether the germ-free state in the interior is maintained and / or impaired.

[0069] In various embodiments, the casing, in particular the indicator device, comprises a sensor, in particular a temperature sensor and / or a pressure sensor and / or a humidity sensor and / or a sterility sensor and / or a saturation sensor. For example, a sterility sensor and / or saturation sensor is suitable for a Bowie-Dick test. For example, a sterility sensor comprises a chemical and / or biological and / or enzyme marker. In particular, the sensor is at least part of an indicator of the indicator device, and for example, the sensor is an indicator. In particular, a sensor is configured to detect a parameter. In various embodiments, a sensor is configured to detect the parameter during a cleaning process, in particular during a process for germ reduction and / or elimination. For example, a sensor is configured to detect the parameter qualitatively and / or quantitatively.For example, the parameter could be temperature and / or pressure and / or humidity. For instance, the process of an autoclave could be at least partially detected in this way. In some configurations, a sensor is designed to detect a state and / or a change of state.

[0070] In certain embodiments, a sensor is configured to detect when a parameter threshold is exceeded. For example, threshold detection can indicate sufficient cleaning during a cleaning process, particularly when a sufficiently high temperature, pressure, and / or humidity has been reached during autoclaving. A threshold detection can also be used to detect a change of state.

[0071] In some embodiments, a sensor is configured to detect the temporal evolution of a parameter. In others, detecting this temporal evolution allows for monitoring the proper progress of a cleaning process. Similarly, detecting the temporal evolution of the parameter can monitor whether a state is maintained. For example, it can be monitored whether the interior of the casing and / or sections separated from the environment by the casing remain in the cleaned, and in particular germ-reduced and / or germ-free, state after a cleaning process, especially a process for germ reduction and / or elimination.

[0072] In certain embodiments, an overpressure relative to the ambient pressure is generated, at least temporarily, in the interior of the enclosure, which is separated from the environment. For example, a gas, particularly a protective gas, is introduced into the interior of the enclosure, which is separated from the environment, specifically to generate the overpressure. The overpressure is generated and / or the gas is introduced, particularly after a cleaning process, especially a process for germ reduction and / or elimination.In particular, the gas, especially the protective gas, is introduced in accordance with the cleanliness requirements of the cleaned sections of the machine element, in particular in a germ-reduced and / or germ-free state, wherein, for example, the gas is provided in accordance with the cleanliness requirements and / or the gas is introduced through a cleaning unit, for example a filter, and the cleaning unit cleans the gas in accordance with the cleanliness requirements, in particular in a germ-reduced and / or germ-free state. In certain embodiments, the overpressure relative to ambient pressure is at least 100 mbar, for example at least 500 mbar. For example, the gas, especially the protective gas, is a gas mixture. For example, the gas, especially the protective gas, comprises at least one component of nitrogen and / or process air, for example air from an autoclave and / or air from a flow device and / or air from an air supply.

[0073] For example, by monitoring the overpressure in the interior and / or the composition of the gas in the interior, the condition of the enclosure, in particular its interior and / or its separation from the environment, and / or the condition of the sections of the machine element separated from the environment by the enclosure, can be monitored at least indirectly. If, for example, the overpressure remains at least substantially unchanged and / or the composition of the gas remains at least substantially unchanged, this indicates, in certain embodiments, that the separation, in particular the sealing separation, by the enclosure is intact and / or that the separated sections are still in a clean state, in particular a germ-reduced and / or germ-free state.In particular, the parameter detected by the sensor is a pressure inside the enclosure and / or a parameter of the gas composition, for example a concentration of a component of the gas.

[0074] In certain configurations, the indication device, for example at least its sensor, can be subjected to a process for germ elimination, in particular autoclavable.

[0075] In various configurations, the indicator device, for example its sensor, includes a power supply, for example a battery.

[0076] In certain embodiments, the indicator device, for example its sensor, is readable, in particular by machine and / or wirelessly. Specifically, the device is designed for setting up the indicator device, for example the sensor, and is also designed for transmitting the read data to other components.

[0077] For example, such a setup can be performed with machine elements for which the read data indicates a correct status. For example, such a setup with a machine element can be aborted if the read data indicates a faulty status of that machine element. For example, wireless reading is advantageous for the transportability of the casing. For example, wireless reading is performed via a wireless network and / or a point-to-point connection. For example, wireless reading is performed using radio technology, in particular Bluetooth.

[0078] In certain embodiments, the enclosure includes a readable storage element. For example, the indicator device includes the storage element. Specifically, the storage element is readable by machine and / or wirelessly and / or as described above in connection with the indicator device. In particular, a minimum date is stored on the storage element, whereby the machine element enclosed by the enclosure is in proper working order at least until this minimum date. In certain embodiments, data acquired by the indicator device and / or the sensor and / or evaluated data are stored on the storage element. In certain embodiments, the minimum date and / or stored data are read out during system setup to enable proper setup.

[0079] In certain embodiments, the enclosure includes a locking device that secures the enclosure in the closed state, for example, in a sealing position. Specifically, the locking device has a locking position and a release position, wherein in the locking position the enclosure is secured in the closed state, and in the release position the enclosure can be moved from the closed state and, in particular, opened. For example, in the case of an enclosure that is in a closed state and contains a machine element, this reduces and minimizes the risk of unintentional opening of the enclosure, particularly when the enclosure is moved to the system, especially to the housing, and / or when the enclosure is brought into the cleanroom area.For example, the safety device is set up as a transport safety device.

[0080] For example, the locking device comprises at least two locking parts. In particular, moving the locking device from the locked position to the released position requires an action, especially a force and / or a relative movement of two locking parts, in a release direction, wherein the release direction is perpendicular to an opening direction. Opening the enclosure requires a force and / or a relative movement of two parts of the enclosure in the opening direction. For example, opening the enclosure is not possible when an action is applied in the release direction. In some embodiments, opening the enclosure is blocked when an action is applied in the release direction.In various embodiments, the locking device comprises at least two interlocking locking parts that interlock in the locking position, wherein, for example, one of the interlocking locking parts engages in an undercut of another locking part and / or interlocking locking parts latch together and / or interlocking locking parts wedge together and / or interlocking locking parts are lockable.

[0081] In particular, overpressure is maintained inside the enclosure, at least when the locking device is in the locked position. In some embodiments, overpressure is also maintained inside the enclosure when the locking device is in the unlocked position. In other embodiments, overpressure cannot be maintained inside the enclosure when the locking device is in the unlocked position. For example, the locking device is then moved from the locked position to the unlocked position by a primary air supply.

[0082] In certain embodiments, the enclosure includes a holding device that keeps the enclosure in the closed state, for example, in a sealing position. For instance, this reduces the risk of unintentional displacement of elements within an enclosure that is in a closed state and contains a machine element, which could cause the enclosure to open.

[0083] For example, the holding device is configured such that it can be released by a relative movement of two elements of the enclosure and / or by the application of a force in a release direction, in particular exactly one release direction, wherein the release direction corresponds in particular to the opening direction, and opening the enclosure requires the application of a force and / or a relative movement of two parts of the enclosure in the opening direction. In some embodiments, the release direction is a linear direction, so that releasing the device as a relative movement requires a translation and / or the application of a force in a linear direction. In other embodiments, the release direction is a rotational direction, so that releasing the device as a relative movement requires a rotational movement and / or the application of a torque.

[0084] For example, the holding device increases, or in particular merely increases, the force required to open the covering. For example, the holding device does not block the opening of the covering. For example, the holding device forms a positive-locking connection, wherein in particular a positive lock is formed transversely to the release direction and / or opening direction, and the positive lock can be released in the release direction and / or opening direction. In embodiments, the holding device comprises at least two holding parts, wherein the two holding parts are positively locked to each other. For example, the holding device forms at least one contact point, in particular at least three contact points, wherein the contact of at least one holding part against a contact point prevents relative movement of at least two elements of the covering in at least one direction.In some embodiments, the holding device is a magnetic holding device, whereby holding is achieved by at least one magnet. For example, a magnetic force from the magnet acts in the opening direction of the casing, particularly to increase the force required to open the casing.

[0085] In some configurations, the enclosure features a locking device and a holding device. For example, the enclosure can be transported to the system and / or into the cleanroom in the closed state and secured by the locking device, in particular positioned in a setup position, and then the locking device can be moved to the release position, with the enclosure still held in the closed state by the holding device.

[0086] In particular, the covering can be held in the closed state by the holding device during a cleaning process for cleaning the cleanroom area, and after the cleaning process the covering can be opened, in particular easily opened by action in the opening direction, which corresponds, for example, to the release direction of the holding device.

[0087] In some configurations, the enclosure completely encloses the machine element, so that all sections of the machine element are contained within the closed enclosure.

[0088] In certain embodiments, the enclosure has a passage opening, which is particularly sealed, whereby a section of the machine element enclosed by the enclosure is exposed outside the enclosure. For example, in some embodiments, an assembly section is exposed, at least partially, outside the enclosure. In the production position, this assembly section contacts, for example, a counterpart section of at least one other element and / or the cleanroom structure. In some embodiments, the section exposed outside the enclosure is accessible during a cleaning process of the cleanroom area and can be cleaned during this process, particularly for microbial reduction.

[0089] In certain embodiments, the through-hole has a cross-section that is free of corners. For example, the cross-section is oval. In particular, the cross-section is circular. Specifically, a cylindrical section of the machine element is arranged in the through-hole, with one base area of ​​the cylindrical section corresponding to the cross-section of the through-hole. This design allows for a reliable seal of the through-hole, in order to prevent, in particular, the ingress of microbiological substances through the through-hole.

[0090] In some embodiments, the device comprises a cover element arranged within the casing, which at least partially covers the machine element. In some embodiments, the cover element prevents airflows that have previously flowed over other components, particularly those not subject to a defined cleaning process (also referred to as "second air"), from reaching the process-relevant sections of the machine element. In some embodiments, the cover element is designed such that an area of ​​the machine element covered by the cover element can be subjected to a sterilization process.

[0091] In certain embodiments, the cover element is at least partially made of a semi-permeable material, allowing a disinfection medium to be introduced through the cover element, particularly for steam sterilization and / or autoclaving of the machine element. For example, the cover element is made of a polyethylene nonwoven fabric, such as Tyvek®. The machine element can be enclosed within the cover element, with at least process-relevant sections of the machine element being located within the cover, and subjected to a disinfection process, with the cover element resting on areas of the machine element.

[0092] For example, after the enclosure containing the machine element has been placed in the cleanroom area and after the cleaning process for cleaning the cleanroom area, the enclosure is opened and the machine element, in which a section is still covered by the cover element and thus still at least partially protected, is positioned in the production position and then the cover element is removed from the covered section of the machine element.

[0093] In some embodiments, the machine element can be removed from the casing when the casing is open.

[0094] In particular, the machine element can be accessed opposite to the direction of airflow to the system. For example, air is supplied to the system from a ceiling area of ​​the housing. For example, air is supplied to the system as a laminar flow from a ceiling area of ​​the housing, particularly in at least a substantially vertical direction.

[0095] In certain embodiments, locally purified air can be supplied to the area of ​​the enclosure, wherein the purified air is purified air in accordance with the relevant regulations, for example, so-called "first air" according to the EC GMP Guide. In particular, purified air can be locally supplied to the enclosure when the enclosure is opened. Specifically, purified air can be locally supplied to the setup position and / or the production position. In certain embodiments, air can be locally extracted from the enclosure, particularly when the enclosure is opened, and / or from the machine element, particularly the machine element positioned in the setup position and / or the machine element positioned in the production position, and / or during movement of the machine element from the setup position to the production position. For example, a cleanliness requirement, particularly a cleanliness requirement for process-relevant sections, can thus be better met, particularly through air supply and / or air extraction.

[0096] In some embodiments, a mechanism and / or an actuator is provided with which the opening of the casing and at least partial removal of the machine element from the casing are carried out in one process.

[0097] In certain embodiments, the enclosure comprises at least one dimensionally stable section. In some embodiments, this section interacts with the machine element to separate it from its surroundings, in particular to isolate at least one section, for example, process-relevant sections of the machine element, from the environment.

[0098] In certain embodiments, the enclosure comprises at least two sections that are coupled to each other, particularly dimensionally stable, at least when closed. In certain embodiments, the sections are separable for opening the enclosure, particularly for removing and / or exposing the machine element, and in particular, separable without damage. In certain embodiments, the sections are movable relative to each other for opening the enclosure, and in particular, without damage.

[0099] In certain embodiments, the sections or some sections can be separated by a linear relative movement in a separation direction when the casing is in its intended orientation for use. In these embodiments, the separation direction runs, in particular, transversely to a horizontal plane and, for example, at least substantially in a vertical direction. For example, the sections can be separated by raising and / or lowering a section transversely to a horizontal plane, for example, in a vertical direction.

[0100] In various embodiments, the covering comprises two or more sections which can be separated by a linear relative movement in a separation direction that is at least essentially horizontal.

[0101] In some embodiments, the sections or some sections can be pivoted relative to each other to open the casing. For example, the sections or some sections are coupled to each other via a pivot joint, such as a hinge, whereby at least one section can be pivoted about an axis to open the casing.

[0102] In certain designs, the sections touch each other along a dividing line when closed.

[0103] The dividing line lies in a plane in various configurations. For example, in some configurations, the dividing line lies in a plane perpendicular to a linear dividing direction. In others, the dividing line lies in a plane transverse to a linear dividing direction. In some configurations, the dividing line comprises sections that lie in two or more planes offset perpendicular to a linear dividing direction. The sections arranged in offset planes are connected in some configurations by sections parallel to the dividing direction and / or by inclined sections. In some configurations, the dividing line comprises at least one section that lies in a plane perpendicular to a linear dividing direction and at least one section that lies in a plane parallel to a linear dividing direction.

[0104] For example, in certain designs the dividing line lies at least partially in a plane of the pivot joint, in particular the hinge.

[0105] For example, the components comprise a plate-shaped base element and a hood-shaped lid element placed on the base element when closed. In embodiments, the components comprise a tub-shaped base element and a plate-shaped lid element placed on the base element when closed. In embodiments, the components comprise a tub-shaped base element and a hood-shaped lid element placed on the base element when closed. For example, the components comprise a plate-shaped base element and two lid elements that can pivot relative to the base element. For example, the components comprise a plate-shaped lid element and two base elements that can pivot relative to the lid element.

[0106] In certain configurations, at least one section, in particular the base element, has at least one opening.

[0107] In some designs, a dividing line runs through the area of ​​at least one opening.

[0108] In some designs, the sections are coupled by a band that can be cut and / or removed to separate the sections.

[0109] In some embodiments, at least one section has a window covered with a semi-permeable material. In others, the window is covered by an insert comprising the semi-permeable material, wherein, for example, the insert is adjustable at least between a covering position and a position exposing the window. In some embodiments, the semi-permeable material is permanently fixed to the section, covering the window, and in particular, the semi-permeable material cannot be removed from the window without damage. In particular, a sterile filter comprises the semi-permeable material that covers the window.The sterile filter is specifically designed such that a medium for sterilizing the machine element enclosed within the housing can be supplied through the sterile filter to the interior of the housing in a closed state, for example, for sterilization in an autoclave, while preventing the ingress of microbiological substances, especially germs, into the interior of the housing in a closed state. In some embodiments, a closure element is provided, whereby the window can be closed after sterilization has been carried out.

[0110] The enclosure comprises, in particular, a dimensionally stable base element and / or a dimensionally stable ceiling element, wherein the base element and / or the ceiling element is / are arranged at an inclination relative to a horizontal plane, at least during the cleaning process. This inclined arrangement allows cleaning fluid supplied during the cleaning process to drain away. Specifically, the inclined arrangement allows cleaning fluid supplied during a so-called wash-down for residue removal to drain away. In some embodiments, the base element is trough-shaped, with an outlet for the cleaning fluid. In some embodiments, the outlet is covered by an element of the enclosure when the enclosure is closed.

[0111] In certain embodiments, the enclosure comprises a particularly flexible element that forms a wall, and the wall formed by the element, in a closed state of the enclosure, at least partially separates the enclosed interior space from the surroundings. In particular, the particularly flexible element is connected to at least one other element of the enclosure in a way that holds it together in both the closed and open states, such that the connected elements are only movable to a limited extent relative to each other and are, for example, held in defined relative positions.In certain embodiments, the particularly flexible element is adjustable relative to at least one other element, for example, at least partially displaceable, in order to open the casing, wherein, for example, the particularly flexible element can be rolled up to open the casing. For example, the particularly flexible element is made of a semi-permeable material that is impermeable to microbiological substances and permeable to media for sterilization. For example, the particularly flexible element is a sheet of metal.

[0112] The enclosure comprises, in various embodiments, a dimensionally stable, receptacle-forming section with an access opening, for example, a trough-shaped base element, and a cover element, particularly a flexible one, that closes the access opening when closed. In some embodiments, the cover element is designed to be moved from a closed state, in which it covers the access opening, to a release state, in which the access opening is exposed for removal of the machine element. In some embodiments, the receptacle-forming section is designed such that the machine element to be received is completely enclosed by the section. In some embodiments, the receptacle-forming section has a passage opening, particularly a sealed one, whereby a portion of the machine element enclosed by the section is exposed outside the section via the passage opening.The cover element is designed to be returned from the released state to the closed state, for example, to receive a machine element for removal from the housing. In some embodiments, the cover element is dimensionally stable. In others, the cover element is dimensionally flexible. For example, the dimensionally flexible cover element can be rolled up to open the casing. In some embodiments, the dimensionally flexible cover element is made of a semi-permeable material that is impermeable to microbiological substances and permeable to disinfection media. In other embodiments, the dimensionally stable cover element and / or the dimensionally flexible cover element is made of a material impermeable to microbiological substances and disinfection media, for example, a sheet metal plate.

[0113] In some embodiments, the casing includes a flexible covering. In other embodiments, the flexible covering is made of a semi-permeable material that is impermeable to microbiological substances but permeable to disinfection media. In other embodiments, the flexible covering is made of a nonwoven polyethylene fabric, such as Tyvek®. In other embodiments, the flexible covering is made of a material that is impermeable to both microbiological substances and disinfection media, and may include, for example, a window with an insert, such as a sterile filter.

[0114] The flexible coating is inexpensive to manufacture. After opening the encapsulation, the coating can be removed from the cleanroom area, for example via an airlock or an alpha-beta port system.

[0115] In some embodiments, the casing comprises a dimensionally stable section coupled to the machine element. In some embodiments, this dimensionally stable section is designed as a base element. In others, the dimensionally flexible covering is bonded to the dimensionally stable section, for example, by gluing and / or welding. In some embodiments, the casing is cut to allow removal of the machine element.

[0116] In embodiments, the covering comprises a clamping ring with which at least a part of the covering is clamped to the machine element and / or to a dimensionally stable part of the covering coupled to the machine element, at least in one state, in particular at least in the closed state.

[0117] In some embodiments, the covering has a clamping ring with which the covering is clamped to the machine element and / or to a dimensionally stable section of the casing coupled to the machine element, at least in one state, in particular at least in the closed state. To remove the machine element, the casing is cut in some embodiments. In others, the clamping ring is released for removal, for example, by stretching and / or opening it.

[0118] The device for setting up the packaging is designed to hold the elements and / or parts of the casing in their respective defined positions in an open state of the casing, particularly after the casing has been opened in the cleanroom area.

[0119] The setup device includes, in some embodiments, a retaining device, in particular a clamping element. The retaining device is provided, in particular, at the setup position. The retaining device is designed to hold an element of the casing, in particular the flexible covering, in a position for the removal of the machine element, in particular semi- or fully automated removal. In some embodiments, the machine element can be removed by moving it relative to the retained element of the casing.

[0120] In various embodiments, the enclosure comprises at least one first element which, in a closed state of the enclosure, contacts a first counter-element, in particular a second element of the enclosure and / or the machine element, in a first closed position to close the enclosure. In some embodiments, the first element is adjustable relative to the first counter-element from the first closed position to a second closed position, wherein in the second closed position the first element contacts a second counter-element at a contact surface which, in the first closed position, is exposed in an interior of the enclosure, particularly in a closed state of the enclosure, for the purpose of sterilization. In particular, the second counter-element is the first counter-element. In some embodiments, the second counter-element and the first counter-element are distinct elements.A movement from the first closed position to the second closed position can be effected, in particular before and / or during a cleaning process of the cleanroom area, so that surfaces of the counter element concealed in the first closed position can be exposed and subjected to sterilization during the cleaning process. When the casing is opened, the contact surface is exposed, which was previously sterilized by the machine element. In some embodiments, the movement of the first element from the first closed position to the second closed position is effected by a manipulator. In some embodiments, an actuating device with a bimetallic strip is provided. In particular, in some embodiments, the actuating device is part of the first element and / or functionally connected to it.

[0121] For example, in certain embodiments, the enclosure comprises a flexible covering and a dimensionally stable section coupled to the machine element, wherein in a first closing position the covering contacts the section to close the enclosure, and wherein the covering is adjustable relative to the dimensionally stable section from the first closing position to a second closing position, wherein in the second closing position the covering touches the dimensionally stable section at a contact surface which in the first closing position is exposed in an interior of the enclosure for germ removal, in particular for germ removal in a closed state of the enclosure.

[0122] In certain embodiments, the device is designed such that, before and / or after opening the casing, at least a section of the casing and / or a section of the machine element and / or a section of the further element of the machine assembly to which the machine element is coupled in the production position, which is not accessible during the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example, decontamination, and / or is not provided germ-free in the closed casing, is not exposed. In particular, the system is configured so that some, in particular a large proportion, for example, all sections of the machine assembly that are not accessible during the cleaning process of the cleanroom area and / or are not provided germ-free in the closed casing, are not exposed before and / or during and / or after opening the casing.In particular, the system is designed so that some, especially a large part, for example all sections of the housing and / or the cleanroom structure that are located in the cleanroom area and that are not accessible during the cleaning process of the cleanroom area, and / or are not provided germ-free in the closed enclosure, are not exposed before and / or during and / or after the enclosure is opened.

[0123] Any germs present in this section cannot enter the cleanroom area when the packaging is opened.

[0124] The casing is designed in such a way that when the machine element is exposed from the casing, for example when the machine element is removed from the casing and / or when the machine element is exposed for production operation and / or when the machine element is arranged in the production position for production operation, at least a part of the casing remains on the machine element and / or in a setup position.

[0125] In some embodiments, an element of the enclosure has a base surface designed such that, in a top view, the machine element is completely projected onto the base surface.

[0126] In particular, this element is a dimensionally stable component, especially a base element, for example a trough-shaped base element and / or a base plate, and / or a part of the enclosure that remains attached to the machine element or in a setup position.

[0127] In some embodiments, the enclosure is designed to accommodate multiple machine elements. These multiple machine elements comprise at least two different machine elements, which can be attached to the same machine or to different machine installations. In other embodiments, the multiple machine elements comprise at least two identical machine elements, which can be attached to the same machine or to different machine installations. For example, in a production plant, the identical machine elements can be positioned sequentially at a production station, with one machine element being replaceable by a second machine element when worn.

[0128] In certain embodiments, the device, particularly in the case of exactly one enclosure that accommodates several machine elements, comprises a positioning device arranged within the enclosure. The positioning device enables the positioning of the accommodated machine element, and in particular the positioning of each of the multiple machine elements, in a defined position, especially for semi- or fully automated removal, for example with a manipulator.

[0129] In some embodiments, the machine element enclosed by the housing can be positioned in a setup position within the cleanroom area when the housing is closed. In some embodiments, the setup position is located at the machine installation. In other embodiments, the setup position is spatially separated from the machine installation.

[0130] In particular, the machine element enclosed by the housing can be positioned in the setup position in such a way that a section of the machine element exposed outside the housing, which is exposed in the production position and / or is exposed, for example, during a transfer of the machine element from the setup position to the production position, is accessible for cleaning during the cleaning process of the cleanroom area, in particular during the germ- and / or residue-reducing cleaning process, for example, during decontamination of the cleanroom area.

[0131] In certain embodiments, the machine element enclosed by the housing can be positioned in the setup position such that a section of the machine element exposed outside the housing is at least partially accessible for cleaning during the cleanroom cleaning process, particularly during germ- and / or residue-reducing cleaning processes, such as decontamination. For example, the exposed section could be an assembly section, specifically an assembly section that, in the product position, contacts a counterpart section of at least one other element of the machine setup and / or the cleanroom structure.

[0132] In some embodiments, moving the machine element from the setup position to the production position and / or towards the production position causes the casing to open. For example, moving the machine element pulls off a covering element of the casing to open the casing. Alternatively, moving the machine element can apply an actuating force to a translationally adjustable and / or pivotable element of the casing.

[0133] In certain embodiments, a movement of the machine element from the setup position to the production position and / or in the direction of the production position is coupled with an adjustment movement of an element of the enclosure to open the enclosure. For example, a movement of the machine element from the setup position to the production position and / or in the direction of the production position, and an opening of the enclosure, is effected by one, and in particular exactly one, adjusting mechanism. In certain embodiments, the machine element can be moved back to the setup position by an adjustment movement in the opposite direction.

[0134] In this embodiment, a transfer device is provided to move the machine element from the setup position to the production position after or during the opening of the casing, particularly semi- or fully automatically. In various embodiments, the transfer device includes a mechanism and / or an actuator for semi- or fully automated movement.

[0135] In some embodiments, the machine element is movable for movement from the setup position to the production position, in particular linearly displaceable and / or rotatable, within the cleanroom area. For example, in some embodiments, the machine element is mounted on the transfer device and can be moved to the production position with the transfer device. In other embodiments, the machine element remains on the transfer device in the production position. In other embodiments, the machine element can be decoupled from the transfer device in the production position.

[0136] In certain embodiments, the setup position is identical to the production position in at least one degree of freedom, for example, one translational degree of freedom and / or one rotational degree of freedom. For example, in certain embodiments, the setup position is identical to the production position in two translational degrees of freedom and / or in two rotational degrees of freedom, where, for example, the two translational degrees of freedom are at least approximately degrees of freedom in a horizontal plane and / or, for example, the rotational planes of the two rotational degrees of freedom lie at least approximately in a horizontal plane.For example, the machine element can be attached to a bearing point in the cleanroom area, in particular on the machine equipment, with at least one degree of freedom, for example with exactly one degree of freedom or with two degrees of freedom, and the machine element attached to the bearing point can be adjusted between the setup position and the production position, in particular rotatably and / or linearly adjustable, in particular height-adjustable.

[0137] In some configurations, a process drive of the system is also designed to at least partially move a machine element being set up during setup, whereby the process drive is intended and configured to drive a movement within a process operation of the system. For example, the process drive moves the machine element being set up, at least partially, from the setup position to the production position. In particular, the process drive moves the machine element being set up, especially in the production position, for adjustment of the machine element, for example, to compensate for tolerances and / or inaccuracies during setup. For example, the process drive is a drive for a transport device and / or a feeding system and / or a process station. For example, the process drive is a vibratory drive and / or a linear drive.

[0138] In various embodiments, the system includes a storage module. In these embodiments, a target production position for at least one machine element being set up can be stored and, in particular, saved in the storage module. Specifically, a target production position for at least some machine elements being set up can be stored and, in particular, saved in the storage module. The system also includes a recognition unit for recognizing a machine element being set up. A machine element being set up includes a recognition marker for automated recognition by the recognition unit. In some embodiments, the recognition marker is an optically and / or radio-frequency readable marker, such as a barcode and / or an RFID chip.In certain configurations, the system is designed such that the recognition unit, particularly automatically, identifies the machine element to be added, for example, using the recognition marker. The recognition unit then communicates the identified machine element to a controller, which in turn activates a drive, such as the process drive, to move the identified machine element to its target production position stored in the memory module. This enables, in particular, the at least semi-automated movement and positioning of machine elements of different formats into their respective format-dependent target production positions.For example, this makes it possible to provide a specific target production position for specific machine elements of different and / or the same format, in particular to store them in the storage module, and to move and position them at least semi-automatically into the respective specific target production position, whereby in particular a respective specific target production position can also take into account tolerance-related inaccuracies in the specific machine element.

[0139] In certain embodiments, an element of the encapsulation can also be a machine element; in particular, a machine setup can be equipped with an element of the encapsulation. Specifically, a surface of the element facing the interior of the encapsulation is sterile if the interior of the encapsulation has undergone a sterile process. For example, the inner surface of the element can thus also form a process-relevant section. In certain embodiments, an element of the encapsulation can be an element of a feeding system, for example, an element for feeding and / or sorting a fed item, in particular a fed packaging material. For example, an element of the encapsulation can be an element of a process station. For example, an element of the encapsulation can be an element of the transport system, for example, a transport device of the transport system.

[0140] In certain embodiments, at least one element, for example at least some elements of the encapsulation, can be positioned in a fixed location after the encapsulation has been introduced into the cleanroom area, for example in the setup position and / or in the production position and / or in a storage position, wherein in particular the storage position is a position different from the setup position and from the production position.

[0141] In certain configurations, at least one element, for example at least some elements of the encapsulation, is positioned in a movable manner after the encapsulation has been introduced into the cleanroom area.

[0142] In some embodiments, at least one element of the casing is removed after the casing of a position, in particular the opening position and / or the setup position and / or the production position, has been opened.

[0143] In some configurations, the system includes a collection point, for example in the cleanroom area, where elements of packaging that are no longer needed, especially after the respective packaging has been opened, are taken to the collection point.

[0144] In certain configurations, the system is designed to remove no-longer-needed components of enclosures, particularly after the respective enclosure has been opened, from the cleanroom area, for example, through an airlock and / or a port and / or using the system's transport system. Specifically, the no-longer-needed components of enclosures are moved to an environment surrounding the cleanroom structure, such as an environment surrounding the system. For example, the transport system for moving the objects, in particular at least one transport device of the transport system, and / or an element of the enclosure, is designed such that the element of the enclosure can be moved out of the cleanroom area using the transport system, in particular with the at least one transport device, and in particular to an environment surrounding the cleanroom structure, such as an environment surrounding the system.

[0145] In various embodiments, the device comprises a manipulator, wherein the manipulator is designed to open the enclosure and / or to expose the machine element in the enclosure and / or to remove the machine element from the enclosure and / or to move the machine element into the production position and / or to couple the machine element in the production position with at least one further element of the machine equipment, in particular after a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example a decontamination, of the cleanroom area.

[0146] In the preceding and / or following terms, a manipulator is defined as a fully or partially automated single-axis or multi-axis system, in particular a two- to six-axis system, especially a four-axis or six-axis system. In certain embodiments, the manipulator is configured for at least translational movement along at least one axis. Alternatively or additionally, in certain embodiments, the manipulator is configured for at least rotational movement along at least one axis. Depending on the specific embodiment, a multi-axis system is configured as a serial mechanism, a parallel kinematic system, or a hybrid mechanism. In certain embodiments, the manipulator is configured as a serial mechanism, in particular as an articulated robot arm, for example with four or six axes, and further, in particular, as a SCARA robot.

[0147] In some embodiments, the manipulator of the device is a manipulator of the plant, wherein the manipulator is designed to assist in the execution of at least one process step in a process operation and / or in troubleshooting the plant.

[0148] In various configurations, the same end effector of the manipulator can be used for its task in setting up the system and in its task in carrying out at least one process step in a process operation and / or in troubleshooting the system.

[0149] If at least partial manual setup is intended, a handle is provided on at least one element of the casing in certain designs, particularly for good ergonomics during manual setup.

[0150] According to a second aspect, a facility for carrying out process steps on objects, especially containers, for example pharmaceutical containers, is provided for at least partially under cleanroom conditions.

[0151] The system comprises a machine setup and a cleanroom structure with a housing, whereby the cleanroom conditions can be created in a cleanroom area of ​​the housing.

[0152] The machine assembly is located within the cleanroom area of ​​the housing. The machine assembly comprises at least one machine element that, in a production position, is coupled to at least one other element of the machine assembly. In certain embodiments, the machine element has an assembly section that, in the production position, contacts a corresponding section of the at least one other element and / or the housing.

[0153] The system comprises a device for setting up the system, including a casing, wherein the machine element can be received in the casing, and the machine element received in the casing, in particular received in a germ-free state, can be introduced into the cleanroom area in a closed state of the casing before a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example a decontamination.

[0154] In various embodiments, the machine element is part of a process station, wherein the machine element is particularly attachable and removable from other parts of the process station, wherein the process station is in particular an unpacking station and / or a filling station and / or a sealing station and / or a control station and / or a sorting station.

[0155] In some embodiments, the machine element is part of a transport device, wherein the machine element is particularly attachable and removable from other parts of the transport device, wherein in particular the transport device is designed for transporting the objects, especially containers, separately and / or in a carrier.

[0156] In embodiments, the machine element is part of a feeding system for feeding packaging materials interacting with the objects to a process station, wherein the machine element is particularly attachable and removable from other parts of the feeding system, wherein in particular the feeding system comprises at least a transport device and / or a storage unit and / or a feeding station, in particular a sorting station.

[0157] According to another aspect, a system for carrying out process steps on objects, particularly containers, for example pharmaceutical containers, is created at least partially under cleanroom conditions. The system comprises a cleanroom structure with an enclosure, wherein the cleanroom conditions can be created in a cleanroom area of ​​the enclosure, and the system includes a treatment unit for sterilization, wherein the treatment unit specifically includes a chamber for carrying out the sterilization process. In particular, the treatment unit is designed for steam sterilization as a sterilization process and / or includes an autoclave.

[0158] In its various configurations, the facility includes several treatment facilities.

[0159] In its various configurations, the system with the treatment facility does not include a device for preparing the equipment that includes a covering.

[0160] In some configurations of a system, features and / or combinations of features, which are described in connection with different aspects, are combined, for example, optional features and / or combinations of features.

[0161] In its various configurations, the plant comprises a machine setup, in particular a machine setup as described above and / or below.

[0162] In certain configurations, the system, in particular the cleanroom structure and / or the treatment facility, is designed such that an object which has been subjected to a process for germ elimination by the treatment facility can be moved from the treatment facility, in particular its chamber, to the cleanroom area of ​​the housing of the cleanroom structure without passing through a less clean environment, wherein the less clean environment does not meet any or at most a lesser cleanroom condition than the treatment facility, in particular its chamber, and / or the cleanroom area.

[0163] Foreword and hereinafter, the less clean environment is such an environment, in particular the environment of the treatment equipment and / or the housing, which does not meet a cleanroom condition or at most a lesser cleanroom condition than the treatment equipment, in particular its chamber, and / or the cleanroom area.

[0164] In some configurations, the treatment facility is located close to the housing of the cleanroom structure.

[0165] In certain embodiments, the treatment device and the cleanroom housing are arranged in contact with each other. For example, an outer surface of the treatment device contacts an outer surface of the housing. For example, the treatment device and the cleanroom housing, arranged in contact with each other, comprise a common wall section, wherein, in particular, one side of the common wall section faces the treatment device and one side of the common wall section faces the cleanroom housing. In particular, the common wall section is a wall section of the treatment device and / or the housing. For example, one side of the common wall section delimits the chamber of the treatment device. For example, one side of the common wall section delimits the cleanroom area of ​​the housing.

[0166] In some embodiments, the treatment device and the cleanroom housing are arranged at a distance from each other. For example, a space is provided between an outer surface of the treatment device and an outer surface of the housing, with these outer surfaces facing each other. In particular, the distance between the treatment device and the housing is smaller than the dimensions of the treatment device and / or the housing, so that in some embodiments, the treatment device is still spatially close to the cleanroom housing despite the distance.

[0167] In various embodiments, the system comprises a passage unit configured to connect the treatment unit and the housing in such a way that an object, which, for example, has undergone a sterilization process by the treatment unit, can be moved between the treatment unit, in particular its chamber, and the cleanroom area of ​​the cleanroom structure's housing through a passage in the passage unit. This movement includes, in particular, moving the object from the treatment unit into the cleanroom area and / or from the cleanroom area back to the treatment unit, in particular into its chamber. Specifically, the passage unit is configured such that an object can be moved between the treatment unit, in particular its chamber, and the cleanroom area of ​​the cleanroom structure's housing through the passage without passing through a less clean environment.

[0168] In particular, the system, especially the cleanroom setup and / or the treatment unit and / or the throughput unit, is designed so that when an object is moved between the treatment unit, especially its chamber, and the cleanroom area of ​​the cleanroom setup's housing, the cleanroom condition of the cleanroom area is not impaired, and / or that when an object that has been subjected to a process for germ elimination by the treatment unit is moved from the treatment unit, especially its chamber, into the cleanroom area of ​​the housing, the germ-free state of the object is not impaired.

[0169] In particular, the transit unit is arranged in a stationary position, specifically between the treatment facility and the cleanroom area.

[0170] In particular, the through-flow unit is integrally joined with the treatment device and / or with the housing of the cleanroom structure, wherein in particular the integrally joined through-flow unit is mounted to the treatment device and / or to the housing and / or is part of the treatment device and / or the housing.

[0171] In certain embodiments, the through-passage unit, which is integrally joined, forms an openable and closable through-passage opening. In the open state, the treatment device, in particular the interior of the treatment device's chamber, and the cleanroom area, in particular directly, are connected to each other through the through-passage opening for the transport of the object. In the closed state, the treatment device, in particular at least the interior of the treatment device's chamber, and the cleanroom area are separated from each other. The through-passage unit forming a through-passage opening is particularly well-suited for a treatment device and a cleanroom housing that are arranged in contact with each other.

[0172] In various embodiments, the through-passage unit, for example, which is integrally joined, includes a bridging piece, wherein the bridging piece at least partially forms the passage. In particular, the bridging piece is designed to bridge a gap between the treatment unit and the housing. Specifically, the bridging piece is designed such that when an object is moved between the treatment unit, especially its chamber, and the cleanroom area of ​​the housing of the cleanroom structure, the cleanroom conditions of the cleanroom area are not compromised, and / or that when an object that has undergone a sterilization process by the treatment unit is moved from the treatment unit, especially its chamber, into the cleanroom area of ​​the housing, the sterilized state of the object is not compromised.In particular, one end of the bridging piece is connected to the treatment device, and another end of the bridging piece is connected to the housing of the cleanroom setup. The bridging piece has an interior, which is separated from the environment. In particular, at least when the connecting unit is at least partially open, the interior of the bridging piece is connected, for example, directly, to the treatment device, especially to the interior of its chamber, for transporting the object. In particular, at least when the connecting unit is at least partially open, the interior of the bridging piece is connected, for example, directly, to the cleanroom area for transporting the object.In certain embodiments, when the connecting unit is open, the processing device, in particular the interior of its chamber, and the cleanroom area are continuously connected through the interior of the bridging piece for the purpose of transporting the object. Specifically, when the connecting unit is at least partially detached, the processing device, in particular the interior of its chamber, and the cleanroom area are separated from each other.

[0173] In its various configurations, the treatment device has an inlet from an environment for introducing an object into the treatment device, in particular into its chamber. Specifically, the inlet comprises an openable and closable inlet opening, wherein, in an open state, the treatment device, in particular the interior of the chamber of the treatment device, is connected to an environment through the inlet opening for introducing the object, and in a closed state, the treatment device, in particular at least the interior of the chamber of the treatment device, is separated from the environment.

[0174] In some configurations, an object that is to be subjected to a process of germ elimination can and / or is supplied via the connection unit of the treatment facility.

[0175] In another aspect, a method for equipping a system to carry out process steps on objects, especially containers, for example pharmaceutical containers, is revealed, at least partially under cleanroom conditions.

[0176] The system to be equipped comprises a machine setup and a cleanroom structure with a housing, whereby the cleanroom conditions can be created in a cleanroom area of ​​the housing.

[0177] In certain configurations, the machine setup is, for example, a process station for carrying out a process step.

[0178] In its various configurations, the machine equipment is a transport system for moving objects to or away from a process station.

[0179] In its various configurations, the machine equipment is a feeding system for supplying packaging materials that interact with the objects to a process station.

[0180] In certain embodiments, the machine setup comprises at least one machine element that is coupled to at least one other element of the machine setup in a production position. For example, the machine element is coupled in the production position such that a mounting section of the machine element contacts a corresponding section of the at least one other element and / or the housing.

[0181] In various embodiments, the method comprises at least the following steps: introducing the machine element into the cleanroom area of ​​the housing prior to a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example, decontamination, wherein the machine element is received by an enclosure in a closed state of the enclosure, such that at least one section, in particular at least process-relevant, especially germ-free, sections of the machine element are separated from the environment by the enclosure; performing a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example, decontamination;and opening the casing after the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example decontamination, of the cleanroom area, without impairing the cleanroom condition, in particular to expose the machine element and / or to remove the machine element from the casing.

[0182] In certain embodiments, it is provided that, before the machine element is inserted into the cleanroom area of ​​the housing, the machine element enclosed within the housing is subjected to a sterilization process, in particular in an autoclave and / or steam sterilization, while the housing is closed. For this purpose, the housing is, in certain embodiments, at least partially semi-permeable.

[0183] In some embodiments, it is provided that the casing with the incorporated machine element is transported from a treatment facility for germ removal to the housing of the cleanroom setup, packed in a packaging material, wherein in particular the casing with the incorporated machine element is transported in the packaging material through an environment, especially a less clean environment.

[0184] For example, the packaging material is at least partially made of a semi-permeable material and / or a nonwoven fabric made of polyethylene, such as Tyvek®. For example, the packaging material includes a bag. In particular, the casing containing the machine element is at least partially and, for example, completely encased in the packaging material. In particular, the casing containing the machine element is encased in the packaging material before the sterilization process is carried out. For example, the casing containing the machine element is encased in the packaging material after the sterilization process has been carried out. For example, the casing containing the machine element is unpacked from the packaging material before the housing.For example, the housing containing the machine element is unpacked from the packaging material in the cleanroom area of ​​the enclosure. In some embodiments, the machine element is held in the housing in such a way that a section of the machine element, in particular the assembly section, is exposed outside the housing, at least partially.

[0185] In certain embodiments, the machine element enclosed within the housing is positioned in a setup position within the cleanroom area such that the section exposed outside the housing, for example, the assembly section, is at least partially accessible for cleaning during the cleanroom cleaning process, particularly during germ- and / or residue-reducing cleaning processes, such as decontamination. The exposed sections are thus subjected to a cleaning process along with the cleanroom area.

[0186] In certain embodiments, it is provided that before, during, and / or after opening the casing, a section of the casing and / or a section of the machine element and / or a section of the further element of the machine assembly, to which the machine element is coupled in the production position, which is not accessible during the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example, decontamination, and / or is not provided germ-free in the closed casing, is not exposed. In particular, the system is configured so that some, in particular a large proportion, for example, all sections of the machine assembly that are not accessible during the cleaning process of the cleanroom area and / or are not provided germ-free in the closed casing are not exposed before, during, and / or after opening the casing.In particular, the system is designed so that some, especially a large part, for example all sections of the housing and / or cleanroom structure that are located in the cleanroom area and that are not accessible during the cleaning process of the cleanroom area, and / or are not provided germ-free in the closed enclosure, are not exposed before and / or during and / or after the enclosure is opened.

[0187] Sections of the machine element and / or sections of the machine equipment that are inaccessible for germ removal, either before or after entering the cleanroom area, remain covered.

[0188] In certain embodiments, it is provided that when the casing is opened and / or when the machine element is removed from the casing, the machine element is at least partially covered by a cover element, wherein in particular the cover element is removed after, during or before coupling the machine element in the production position with the at least one other element of the machine equipment.

[0189] In some embodiments, the casing comprises a dimensionally stable, receptacle-forming section with an access opening, for example a trough-shaped base element, and a lid element, particularly a flexible one, which closes the access opening when closed. The lid element is removed to open the casing. In some embodiments, the lid element is rolled up to open the casing.

[0190] In some embodiments, the casing comprises a flexible covering. In other embodiments, the covering is bonded to another element of the casing, in particular to a dimensionally stable section of the casing. In some embodiments, the covering has a clamping ring with which it is clamped to the machine element and / or to a dimensionally stable section of the casing coupled to the machine element. To open the casing, the flexible covering is cut in some embodiments. In other embodiments, the flexible covering is pulled off by stretching the clamping ring.

[0191] In some embodiments, an element of the casing, in particular the flexible covering, is secured by a retaining device, especially comprising a clamping element, before the casing is opened. In some embodiments, the element is secured manually. For example, the element is fixed at the setup position. In other embodiments, the retaining device holds the element of the casing, in particular the flexible covering, in a position during removal and / or exposure of the machine element, particularly during semi- or fully automated processes. This, in particular, causes the retained covering to tighten. In other embodiments, this applies an actuating force to a dimensionally stable section, which is arranged to pivot, for opening the casing.

[0192] In various embodiments, the enclosure comprises at least one first element which, in a protective state of the enclosure, contacts a counter element, in particular a second element of the enclosure and / or the machine element, in a first closed position to close the enclosure. In some embodiments, the first element is moved relative to the counter element from the first closed position to a second closed position, wherein in the second closed position the first element contacts the counter element at a contact surface which, in the first closed position, is exposed within an interior of the enclosure for sterilization. When sterilizing the machine element enclosed by the enclosure, particularly before introducing the machine element into a cleanroom area, for example in an autoclave, the contact surface can be subjected to sterilization.The first element is moved from its first closed position to a second closed position, particularly relative to the opposing element, before the cleaning process of the cleanroom area, especially the germ- and / or residue-reducing cleaning process, such as decontamination. An area that was covered in the first position is thus cleaned during the cleaning process, and in particular, disinfected.

[0193] In some embodiments, the machine element, which is enclosed by the housing in a closed state, is positioned in a setup position. In other embodiments, the machine element is positioned in the setup position so that the section exposed outside the housing, in particular an assembly section, is at least partially accessible for sterilization.

[0194] In certain embodiments, the machine element is moved, particularly semi- and / or fully automatically, from the setup position to the production position and / or towards the production position, especially after the cleaning process of the cleanroom area, particularly after the germ- and / or residue-reducing cleaning process, for example, after decontamination. In certain embodiments, the movement of the machine element from the setup position to the production position and / or towards the production position causes the casing to open. For example, a movement of the machine element peels off a covering element of the casing to open the casing. For example, a movement of the machine element applies an actuating force to a translationally adjustable and / or pivotable element of the casing.In some embodiments, the movement of the machine element from the setup position to the production position and / or in the direction of the production position is coupled with an adjustment movement of an element of the enclosure to open the enclosure.

[0195] In certain embodiments, the setup position is identical to the production position in at least one degree of freedom. In these embodiments, the machine element is mounted at a bearing point in the cleanroom area, particularly on the machine assembly, with at least one degree of freedom, for example, with exactly one degree of freedom or with two degrees of freedom, and the machine element mounted at the bearing point is adjusted between the setup position and the production position, in particular rotated, for example about a horizontal axis, and / or adjusted linearly, in particular vertically.

[0196] In certain configurations, the setup position is the same as the production position with respect to the rotational and / or translational degrees of freedom.

[0197] In certain configurations, the opening of the casing and / or the exposure of the machine element within the casing and / or the removal of the machine element from the casing and / or the movement of the machine element into the production position and / or the coupling of the machine element in the production position with at least one other element of the machine setup is carried out semi- or fully automatically using a manipulator. In particular, this movement is carried out semi- or fully automatically after cleaning and / or decontamination of the cleanroom area.

[0198] In certain embodiments, the machine element is removed from the casing while the casing is open. Specifically, the machine element is removed in the opposite direction to the airflow direction of the system. This prevents sections of the casing from entering the primary air supply to the machine element.

[0199] In its various configurations, the cleanroom structure includes an airlock. Specifically, the airlock comprises an airlock chamber, a lockable and openable airlock access, and a lockable and openable airlock passage. When the airlock access is open, the interior of the airlock chamber is connected to the environment surrounding the cleanroom structure, allowing the movement of objects between the environment and the interior of the airlock chamber. When the airlock access is closed, the interior of the chamber is separated from the environment. When the airlock passage is open, the interior of the airlock chamber is connected to the cleanroom area within the cleanroom structure's housing, allowing the movement of objects between the interior of the airlock chamber and the cleanroom area. When the airlock passage is closed, the cleanroom area is separated from the interior of the chamber. Movement includes, in particular, the insertion and / or removal of objects.In various configurations, the airlock chamber includes a treatment unit for cleaning an object located inside the chamber, in particular for germ-reducing and / or germ-free and / or residue-free cleaning of the object. For example, the airlock makes it possible to introduce objects, such as machine elements, from the environment into the cleanroom area without compromising the cleanroom conditions. For example, an object, particularly a machine element, is introduced in a casing. The casing, along with the object it contains, is then cleaned and subsequently introduced into the cleanroom area without compromising the cleanroom conditions.In particular, the airlock allows for the introduction of an object. In certain configurations, an object, especially a machine element, is introduced into the interior of the airlock chamber without its casing, cleaned there, and then introduced into the cleanroom area without compromising the cleanroom conditions. Specifically, the airlock allows for the introduction of an object, especially a machine element, into the cleanroom area of ​​a production facility within the plant.

[0200] In a further aspect, a method for operating a plant is disclosed, wherein the plant is designed to carry out process steps on objects, in particular on containers, for example pharmaceutical containers, at least partially under cleanroom conditions, wherein the plant comprises a cleanroom structure with an enclosure, wherein the cleanroom conditions can be created in a cleanroom area of ​​the enclosure, and wherein the plant comprises a treatment unit for carrying out a process for sterilization, wherein in particular the treatment unit comprises a chamber for carrying out the process for sterilization. In particular, the treatment unit is designed for steam sterilization as a process for sterilization and / or the treatment unit comprises an autoclave.

[0201] In its various configurations, the plant comprises a machine setup, in particular a machine setup as described above and / or below.

[0202] In its various forms, the procedure for operating the plant includes at least the following steps: - Feeding an item, in particular a machine part and / or an object and / or a packaging material and / or a consumable, to the treatment device; feeding includes in particular placing the item into the chamber, - Carrying out the process for germ elimination, in particular steam sterilization and / or autoclaving of the object, - Transferring the item from the treatment device, in particular from its chamber, into the cleanroom area of ​​the housing without passing through a less clean environment, wherein the less clean environment does not meet any or at most a lower cleanroom condition than the treatment device, in particular its chamber, and / or the cleanroom area.

[0203] In particular, the cleanroom conditions of the cleanroom area are not compromised when the item is moved from the treatment unit, especially from its chamber, into the cleanroom area of ​​the cleanroom structure's housing. Specifically, the sterile state of the item is not compromised when an item that has undergone a sterilization process in the treatment unit is moved from the treatment unit, especially from its chamber, into the cleanroom area of ​​the housing.

[0204] In some configurations, the object is introduced into the treatment facility of the plant without any covering and, in particular, is placed in the chamber of this treatment facility.

[0205] In some configurations of a procedure, features and / or combinations of features, which are described in connection with different aspects, are combined, for example, optional features and / or combinations of features.

[0206] In some configurations, the object is moved from the treatment facility, in particular from its chamber, to the cleanroom area before and / or during a process operation of the plant.

[0207] In some configurations, the fitting of a machine setup with machine parts to be disinfected is carried out at least partially via the treatment device of the system, in particular before and / or during a process operation of the system, for example without encapsulation, and / or at least partially with encapsulation, in particular before a process operation of the system.

[0208] In some configurations, the object or objects are individually introduced to the treatment facility of the plant and, in particular, individually placed into the chamber of this treatment facility.

[0209] In various configurations, several objects are arranged together in a carrier, fed to the treatment facility of the plant, and in particular, placed together in the carrier into the chamber of this treatment facility.

[0210] In particular, the method comprises process steps that correspond to features of the configurations of the plant and / or the device. Specifically, the plant and / or the device is designed to implement configurations of the method. To avoid repetition, reference is made to the respective descriptions in full.

[0211] The terms "first", "second", etc. are used above and / or below solely for differentiation purposes and do not indicate any order or total number.

[0212] In particular, two directions within the meaning of this disclosure are perpendicular to each other if the angle between these directions is at least 20 degrees, in particular at least 45 degrees, and / or if these two directions are at least mostly, in particular at least approximately, perpendicular to each other.

[0213] In particular, a feature is at least largely realized in an entity within the meaning of this disclosure if the feature is realized in at least 65%, and in particular in at least 80% of the entity, and / or if the feature is realized at least approximately in the entity.

[0214] In particular, a feature is realized at least approximately in an entity within the meaning of this disclosure if the feature is realized in at least 90% of the entity and / or if the feature is realized with technically irrelevant deviations and / or technically caused deviations. BRIEF DESCRIPTION OF THE DRAWINGS

[0215] 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: Fig. 1 schematically a section of a plant for carrying out process steps under cleanroom conditions with a housing in an open state of the housing; Fig. 2 schematically the section according to Fig. 1 in a closed state of the housing; Fig. 3 a flowchart of a procedure for setting up a system for carrying out process steps under cleanroom conditions; Fig. 4 schematically an embodiment of a device for setting up a plant comprising a covering with a dimensionally stable section and a positioning device in various process steps; Fig. 5 schematically an embodiment of a device for setting up a plant comprising a covering with two dimensionally stable parts, in particular a trough-shaped bottom element and a lid element, in various process steps; Fig. 6 schematically an embodiment of a device for setting up a plant similar to Fig. 5 in different process steps; Fig. 7 schematically an embodiment of a device for setting up a plant comprising a covering with two dimensionally stable parts, in particular a plate-shaped base element and a hood-shaped cover element in various process steps; Fig. 8 schematically a detail of a plant with a device for equipping the plant with a machine element, wherein the machine element is movably mounted at a bearing point; Fig. 9 schematically a detail of a plant with a device for equipping the plant with two machine elements, wherein the machine elements are movably mounted at respective bearing points; Fig. 10 schematically a detail of a plant with a device for equipping the plant with a machine element, wherein the device comprises an enclosure with a trough-shaped, dimensionally stable bottom element and a dimensionally flexible top element in various process steps; and Fig. 11 schematically a detail of a plant with a device for setting up the plant similarly Fig. 10 in different process steps. Fig. 12 schematically an embodiment of a device for setting up a plant comprising a covering with two dimensionally stable parts, in particular two shell elements, in various process steps; Fig. 13 schematically an embodiment of a device for setting up a plant comprising a covering with a dimensionally stable section and a coating in various process steps; Fig. 14 schematically an embodiment of a device for setting up a plant similar Fig. 13 in different process steps; Fig. 15 schematically an embodiment of a device for setting up a plant comprising a covering with a dimensionally stable section and a coating and a retention device for retaining the coating in various process steps; Fig. 16 schematically an embodiment of a device for setting up a plant similar Fig. 15 in different process steps; Fig. 17 schematically a detail of a plant with a device for equipping the plant with a machine element, wherein the device comprises a covering with a dimensionally stable part designed as a base element and a coating; Fig. 18 schematically a detail of a plant with a device arranged at a setup position for setting up the plant with a machine element, wherein the device comprises a covering with a coating; Fig. 19 schematically a detail of a plant with a device for setting up the plant comprising a covering with three dimensionally stable parts, in particular a base element and two cover elements pivotably attached thereto before and after opening the covering; and Fig. 20 schematically depicts a facility with a treatment center. DETAILED DESCRIPTION OF THE EXECUTION EXAMPLES

[0216] Uniform reference symbols are used in the following figures for identical or similar components and / or entities.

[0217] Fig. 1 and Fig. Figure 2 schematically shows a system 1 for carrying out process steps on objects not shown in the figures, in particular on containers, for example on pharmaceutical containers.

[0218] Plant 1 is specifically designed for filling and sealing containers. For example, the plant comprises a first process station 2, designed as a filling station for filling containers, and a second process station 3, designed as a closing station for closing the filled containers. The closing station is arranged downstream of the filling station in a transport direction indicated by an arrow. Further process stations, such as a control station and / or a sorting station for the objects, and / or alternative process stations are provided in various configurations.

[0219] The depicted system 1 comprises a transport system 5 for transporting the objects, in particular for transporting the objects to and / or away from the process stations 2, 3.

[0220] The depicted system 1 further includes a feeding system 4 for feeding objects. For example, the feeding system is designed to feed packaging materials that interact with the objects to a process station, for example, to feed closure elements (not shown) to the second process station 3, which is designed as a closing station.

[0221] The feeding system 4 comprises, for example, a storage unit 40, and / or a feeding station, in particular a sorting station 42, and / or a transport device 44. In some embodiments, the sorting station 42 is also part of the transport device 44, wherein the sorting of the packaging materials takes place at least partially during transport in a transport direction schematically represented by an arrow.

[0222] The process station 2, 3, the transport system 5 and the feeding system 4 and / or other or further facilities of the plant 1 are referred to together or each individually as machine equipment.

[0223] The system 1 is designed in particular for carrying out process steps on objects, at least partially, under cleanroom conditions. System 1 comprises a cleanroom setup with an enclosure 6, in which the cleanroom conditions can be created within a cleanroom area of ​​the enclosure 6. The required cleanroom conditions are defined by the application, in particular by a product being handled and / or manufactured, and / or the intended use of the handled object.

[0224] Fig. Figure 1 shows the housing 6 in an open state, wherein a cleanroom area of ​​the housing 6 is accessible from the surrounding environment through an access opening 60. For a production operation, the access opening 60 is closed, and the cleanroom conditions are established within the cleanroom area. In particular, a cleaning process of the cleanroom area, especially a germ-reducing cleaning process, such as decontamination, is carried out in a closed state to create the required cleanroom conditions.

[0225] The housing 6 includes, in various configurations, at least one, for example as in Fig. 1 and Fig. Figure 2 shows several glove openings 61, wherein, in the closed state, particularly after the cleaning process of the cleanroom area, access to the cleanroom area is possible via the glove openings 61. For the insertion of parts, such as objects, media and / or machine elements, into the closed housing 6, embodiments such as those shown Fig. 1 and Fig. Figure 2 shows a feed port 62. The feed port 62 is configured as a gate and / or as an alpha-beta port system. In some configurations, a packaging material feed port 63 is provided to feed packaging materials to the feed system 4. The packaging material feed port 63 is configured as a gate and / or as an alpha-beta port system.

[0226] At least one of the machine components, for example one of the process stations 2, 3, the transport system 5, the feeding system 4 and / or another component of the system 1, must be equipped with at least one machine element 7, for example a format part, for process operation. The loading process is also referred to as setting up the system 1.

[0227] Annex 1 includes a device 8 for setting up Annex 1.

[0228] The device 8 comprises a casing 80 which is configured to enclose the machine element 7 in a closed state as schematically shown in Fig. 1 shown, wherein at least one section of the machine element 7, in particular at least process-relevant sections of the machine element 7, is to be included in a Fig. 1. The closed state of the enclosure 80 is schematically represented, and the enclosure is separated from its surroundings. As schematically shown in Fig. As shown in Figure 1, several machine elements 7 are enclosed in a common covering 80 in various configurations.

[0229] As schematically in Fig. As shown in Figure 1, before closing the access opening 60 and before a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example decontamination, the exact machine element 7 contained in the housing 80 or as schematically shown in Figure 1 is positioned. Fig. Figure 1 shows the several machine elements 7 included in the enclosure 80 can be introduced into the cleanroom area in a closed state of the enclosure 80.

[0230] The machine elements 7 are contained in the casing in a sterile state. The casing 80 is designed such that, in a closed state, the sections of the machine elements 7 contained within the casing 80, which are separated from the environment and are sterile, are protected from contamination, particularly by germs. In particular, the casing is impermeable to microbiological substances, especially germs, in certain embodiments.

[0231] After the casing 80 containing the machine element 7 has been inserted, the access opening 60 can be closed.

[0232] After closing the access opening 60, a cleaning process of the cleanroom area can be carried out, in particular a germ- and / or residue-reducing cleaning process, for example decontamination.

[0233] As schematically in Fig. As shown in Figure 2, after the cleaning process of the cleanroom area, in particular after the germ- and / or residue-reducing cleaning process, for example after decontamination, the enclosure 80 can be opened in order to remove the machine element 7 from the enclosure 80 in the cleanroom area and / or to expose the machine element 7 in the cleanroom area and / or to move the machine element 7 into a production position in the cleanroom area and / or to couple the machine element 7 in the production position in the cleanroom area with another element of a machine device.

[0234] In some configurations, opening the casing 80, exposing the machine element 7 in the cleanroom area, removing the machine element 7, moving the machine element 7 into a production position and / or coupling the machine element 7 with another element of the machine equipment is carried out manually, for example via a glove opening 61.

[0235] In various embodiments, the device 8 comprises a schematically described Fig. 1 and Fig. 2 Manipulator 81 shown. The manipulator 81 is designed in configurations to open the enclosure 80 and / or to expose the machine element 7 in the cleanroom area with respect to the enclosure 80 and / or to remove the machine element 7 from the enclosure 80 and / or to move the machine element 7 into the production position and / or to couple the machine element 7 in the production position with at least one other element of the machine equipment.

[0236] In embodiments, the manipulator 81 of the device 8 is a manipulator of the system 1, wherein the manipulator 81 is designed to at least participate in the execution of at least one process step in a process operation of the system and / or in troubleshooting on the system.

[0237] In certain embodiments, the enclosure 80 is dimensioned such that, after closing the access opening 60, a machine element 7 contained in the enclosure 80 can be moved into the housing 6 via the supply port 62.

[0238] Fig. Figure 3 schematically shows a flowchart of a procedure for setting up a system to carry out process steps under cleanroom conditions, for example, a system according to the Fig. 1 and Fig. 2.

[0239] The procedure includes a step 100 of introducing a component in a casing 80 (see Fig. 1 and Fig. 2) recorded machine element 7 (see Fig. 1 and Fig. 2) into a cleanroom area of ​​housing 6 (see Fig. 1 and Fig. 2) In particular, introduction into the cleanroom area occurs in a non-germ-reduced state of the cleanroom area, for example through an open access opening 60 (see Fig. 1 and Fig. 2) The machine element 7 is received in the casing 80, in particular in a germ-free state, wherein at least the sections of the machine element 7 separated from the environment by the casing 80 are protected from contamination by the casing 80 in the closed state of the casing 80.

[0240] The procedure comprises step 101 of closing the housing 6 to separate the cleanroom area of ​​the housing 6 from the environment and performing a cleaning process of the cleanroom area, in particular a germ-reducing cleaning process, for example decontamination.

[0241] The process includes a step 102 for opening the casing 80. In some embodiments, the casing 80 is opened directly at a production position. For example, in some embodiments, the machine element 7 with the casing 80 is placed in the housing 6 and attached to the production position with the casing 80. During the cleaning process according to step 101, the machine element 7 is in the production position with the casing 80 in a closed state. In some embodiments, the casing 80 is opened directly at the production position.

[0242] In some embodiments, the machine element 7, together with the casing 80, is placed in the housing 6 and positioned with the casing 80 in a setup position. During the cleaning process according to step 101, the machine element 7, with the casing 80 in a closed state, is in the setup position. In some embodiments, the casing 80 is also opened at the setup position.

[0243] In embodiments, the process further comprises a step 103, wherein the machine element 7 exposed when opening the casing 80 is moved from the setup position to a production position or is moved to a production position without moving, for example by pivoting.

[0244] The Fig. Figures 4 to 19 schematically show configurations of devices 8 for equipping a plant 1, for example a plant 1 according to the Fig. 1 and Fig. 2. In particular, the Fig. 4 to 19 configurations of devices 8 in various process steps. Identical reference numerals are used for identical or similar components.

[0245] Fig. Figure 4 schematically shows an embodiment of a device 8 for setting up a system comprising a casing 80 in various process steps (a) to (i). The in Fig. The enclosure 80 shown in Figure 4 comprises two elements. The first element is, in the embodiment shown in Figure 4, Fig. 4. The first element is designed as a dimensionally stable section 801 forming a receptacle with an access opening 8010. The second element is designed as a cover element 802 that closes the access opening 8010 when the casing 80 is closed. In some embodiments, the cover element 802 is dimensionally stable. In others, the cover element 802 is flexible. The receptacle section 801 is designed as shown in the following embodiments: Fig. Figure 4 shows the dimensioned such that several machine elements 7 can be accommodated. In some embodiments, a positioning device 82 is provided, whereby the positioning device 82 allows the several machine elements 7 to be positioned in defined positions within the first section 801. For example, the positioning device 82 is as shown in Fig. Figure 4 is designed as a shelf insert to divide the interior of the section 801 forming the mounting into several compartments. The machine elements 7 can be placed in the compartments. For example, exactly one machine element 7 can be placed in each compartment.

[0246] The access opening 8010 is designed according to Fig. 4. The access opening is provided on a side surface, in particular on a side surface of the section 801 that is at least substantially vertical. In some embodiments, the access opening extends over the entire side surface to allow maximum access. In some embodiments, the first section 801 has surface sections on the side surface of the access opening 8010 that define the access opening 8010.

[0247] The in Fig. The device 8 shown in Figure 4 comprises several cover elements 83, wherein one cover element 83, in particular exactly one cover element 83, is arranged on a machine element 7 to cover it.

[0248] In a Fig. In the open state of the enclosure 80 shown in Figure 4(a), the machine elements 7 can be inserted into the enclosure 80. For example, the machine elements 7 are inserted in such a way that the enclosure 80 completely encloses them in a closed state.

[0249] Fig. Figure 4(b) shows the enclosure 80 undergoing a treatment for the sterilization of the machine elements 7 contained within the enclosure 80. The enclosure 80 is designed such that a machine element 7 contained within the enclosure 80 can be subjected to a sterilization process in a closed state of the enclosure 80.

[0250] In some embodiments, the cover element 802 is made of a semi-permeable material, so that a medium for disinfecting the machine element 7 enclosed by the casing 80 can be supplied via the cover element 802. In some embodiments, an element of the casing, for example as in Fig. Figure 4 shows the dimensionally stable section 801 forming a receptacle with a window 84 containing an insert, for example made of a semi-permeable material, in particular a sterile filter 85. The insert, in particular the sterile filter 85, is designed such that a medium for germ elimination, as indicated by arrows in Fig. 4 (b) shown, can be supplied to an interior of the enclosure 80 for germ removal.

[0251] Treatment for germ elimination takes place, for example, in a treatment facility 9, in particular in an autoclave.

[0252] The casing 80 is designed in such a way as to prevent the entry of microbiological substances into the interior, in particular the entry of germs. In particular, the insert, for example the sterile filter 85, is also designed in such a way as to prevent the entry of microbiological substances into the interior, in particular the entry of germs.

[0253] As schematically in Fig. As shown in Figure 4 (c), the enclosure 80 with the incorporated machine elements 7 can be placed in a closed state of the enclosure 80 into a cleanroom area of ​​a housing 6 of a plant 1 (see Figure 4 (c)). Fig. 1 and Fig. 2) be moved. In particular, the enclosure 80 can be moved into the cleanroom area via an open access opening 60 in a non-sterile state. The sterile state of the interior of the enclosure 80 is thereby maintained.

[0254] As schematically in Fig. As shown in Figures 4 (d) and (e), after the enclosure 80 has been moved into the cleanroom area of ​​the housing 6, the housing 6 can be closed and a cleaning process, in particular a germ- and / or residue-reducing cleaning process, for example decontamination, can be carried out in the cleanroom area.

[0255] As schematically in Fig. As shown in Figures 4(f) and (g), after the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example decontamination, the enclosure 80 can be opened and a machine element 7 can be moved to a production position 10. As shown schematically in Fig. Figure 4(g) shows that in embodiments, the machine element 7 is transferred with the cover element 83, the cover element 83 being arranged, in particular, above the machine element 7. The cover element 83 protects at least process-relevant sections of the machine element 7 from contamination during the transfer. As shown in Fig. As shown in Figure 4 (h), the cover element 83 can then be removed and the machine element 7 is ready for a production plant as in Fig. 4 (i) is shown ready.

[0256] In some embodiments, machine element 7 is an element that needs to be replaced in a production plant after a certain process runtime, for example, due to contact with packaging materials. In some embodiments, a machine element 7 removed from the casing 80 can be replaced by another machine element 7 stored within the casing 80.

[0257] In some embodiments, the enclosing 80 remains at least partially inside the housing 6. In particular, in some embodiments, at least the section 801 of the enclosing 80, which contacts and / or is placed on surfaces within the cleanroom area, remains stationary inside the housing 6. Surfaces within the cleanroom area that are covered by the section 801 during the cleaning process of the cleanroom area, especially the germ- and / or residue-reducing cleaning process, for example, decontamination, thus remain covered during production operations.

[0258] Fig. Figure 5 schematically shows an embodiment of a device 8 for setting up a system comprising a casing 80 in various process steps (a) to (i). The in Fig. The enclosure 80 shown in Figure 5 comprises two elements. The first element is, in the embodiment shown in Figure 5, Fig. 5 is designed as a dimensionally stable section 801 forming a receptacle with an access opening 8010. In particular, the section 801 is designed as a trough-shaped base element with an access opening 8010 accessible from above. In embodiments, the access opening extends over the entire top surface of the section 801.

[0259] The second element is designed as a cover element 802 that closes the access opening 8010 when the casing 80 is closed. In some embodiments, the cover element 802 is a dimensionally stable cover element. In others, the cover element 802 is a dimensionally flexible cover element. The receiving section 801 is, in embodiments as shown in Fig. Figure 4 shows the component dimensioned such that exactly one machine element 7 can be accommodated in the section 801. In some embodiments, the component 801 forming the accommodating element is dimensioned such that several machine elements 7 can be accommodated in the component 801. In some embodiments, the interior of the component 801 is subdivided by a positioning device.

[0260] The in Fig. Device 8 as shown in Figure 5 comprises a cover element 83, wherein the cover element 83 is arranged on the machine element 7 to cover it.

[0261] The casing 80, in particular the section 801 designed as a trough-shaped base element, has two sealed through-openings 87. A portion of the machine element 7 enclosed by the casing 80 extends through the casing 80, and at least one section of the enclosed machine element 7 is exposed outside the casing 80. In particular, an assembly section 70 of the machine element 7 is exposed. In particular, in embodiments such as those shown in Fig. 5 shown in a closed state of the enclosure 80, at least one assembly section 70, for example two or more assembly sections 70, are exposed, which is / are in a Fig. 5 (i) the production facility shown in a production position contacts / contacts a counterpart section of another element of the machine setup and / or cleanroom setup.

[0262] In a Fig. In the open state of the enclosure 80 shown in Figure 5(a), the machine element 7 can be inserted into the enclosure 80. For example, the machine element 7 is inserted such that the assembly sections 70 are exposed outside the enclosure 80 when the enclosure is closed. Process-relevant sections of the machine element 7 are separated from the environment by the enclosure 80 when the enclosure 80 is closed.

[0263] The cover element 802 contacts the section 801 along a dividing line visualized by a dashed line. In some embodiments, the cover element 802 contacts the section 801 along a horizontal dividing line. In some embodiments, the dividing line has steps, ledges, and / or sloping sections.

[0264] Fig. Figure 5(b) shows the enclosure 80 undergoing a treatment for the sterilization of the machine element 7 contained in the enclosure 80. The enclosure 80 is designed such that at least the sections of the machine element 7 arranged in an interior of the enclosure 80 when the enclosure 80 is closed can be subjected to a sterilization process.

[0265] In some embodiments, the cover element 802 is made of a semi-permeable material, allowing a medium for disinfection of the machine element 7 enclosed by the casing 80 to be supplied via the cover element 802. In some embodiments, the cover element 802 is a dimensionally stable section. In some embodiments, a section of the casing, for example as in Fig. Figure 5 shows the section 802, designed as a cover element 802, with a window 84 containing an insert, for example made of a semi-permeable material, in particular a sterile filter 85. The insert, in particular the sterile filter 85, is designed such that a medium for germ elimination, as indicated by arrows in Fig. 5 (b) shows that the interior of the casing 80 can be supplied with a sterile agent. The insert, in particular the sterile filter 85, is designed in such a way that the entry of microbiological substances via the insert, in particular the entry of germs, is prevented.

[0266] Treatment for germ elimination is carried out, for example, in a treatment unit 9, in particular in an autoclave. The sections exposed outside the casing 80, especially the assembly section 70, are also disinfected. However, the sections are not protected from contamination after removal from the treatment unit 9.

[0267] The casing 80 is designed in such a way that the entry of microbiological substances into the interior space, which is separated from the environment by the casing 80 when closed, is prevented, in particular the entry of germs.

[0268] As schematically in Fig. As shown in Figure 5 (c), the enclosure 80 with the incorporated machine elements 7 can be placed in a closed state of the enclosure 80 into a cleanroom area of ​​a housing 6 of a plant 1 (see Figure 5 (c)). Fig. 1 and Fig. 2) be moved. In particular, the enclosure 80 can be moved into the cleanroom area via an open access opening 60 in a non-sterile state. The sterile state of the interior of the enclosure 80 is thereby maintained.

[0269] As schematically in Fig. As shown in Figures 5 (d) and (e), after the enclosure 80 has been moved into the cleanroom area of ​​the housing 6, the housing 6 can be closed and a cleaning process, in particular a germ- and / or residue-reducing cleaning process, for example decontamination, can be carried out in the cleanroom area.

[0270] As schematically in Fig. As shown in Figure 5(d), the machine element 7 arranged in the casing 80 is moved into a setup position 11 in embodiments with the casing 80. As shown in Fig. As shown in Figure 5 (d), the setup position 11 is selected in particular such that sections, especially assembly sections 70, which are arranged outside the enclosure 80 in a closed state, are exposed.

[0271] As schematically in Fig. As shown in 5 (e), the exposed sections, in particular the assembly sections 70, are also disinfected during the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example decontamination.

[0272] As schematically in Fig. As shown in Figures 5 (f) and (g), after the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example decontamination, the enclosure can be opened and a machine element 7 can be moved to a production position 10. As shown schematically in Fig. Figure 5 (g) shows that in some embodiments, the machine element 7 is repositioned after the cover element 83 is removed. In some embodiments, the cover element 83 is removed after the machine element 7 is repositioned into production position 10.

[0273] As schematically in Fig. As shown in Figures 5 (h) and (i), in embodiments the covering 80 remains at least partially inside the housing 6. In particular, in embodiments at least the section 801 of the covering 80 remains stationary inside the housing 6, so that areas within the cleanroom area which are covered by the section 801 during the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example decontamination, remain covered during production operation.

[0274] Fig. Figure 6 schematically shows an embodiment of a device 8 for setting up a plant similar to Fig. 5 in different process steps (a) to (i). As schematically shown in Fig. 6 (d) is shown in the design according to Fig. 6. The machine element 7, arranged in the casing 80, is also moved with the casing 80 into a setup position 11. As in Fig. As shown in 6 (d), the setup position 11 differs from the design according to Fig. 5 is selected such that sections, in particular assembly sections 70, which are arranged outside the casing 80 in a closed state of the casing 80, are not exposed. In certain configurations, the sections are sterilized before, during, or after being moved into the setup position 11.

[0275] Fig. Figure 7 schematically shows an embodiment of a device 8 for setting up a system comprising a covering 80 with two dimensionally stable parts, in particular a plate-shaped base element 804 and a hood-shaped cover element 805 in various process steps (a) to (h).

[0276] The in Fig. The depicted covering 80 is available in configurations as shown in 7. Fig. 7 is shown dimensioned such that exactly one machine element 7 can be accommodated.

[0277] The element of the covering 80, designed as a plate-shaped base element 804, has in its design according to Fig. 7 a base surface, so that in a top view the machine element 7 is completely projected onto the base surface.

[0278] The in Fig. The device 8 shown in Figure 7 comprises a cover element 83, wherein the cover element 83 is arranged on the machine element 7 to cover it.

[0279] The casing 80, in particular the section designed as a plate-shaped base element 804, has two sealed through-openings 87. A portion of the machine element 7 enclosed by the casing 80 extends through the casing, and at least one section of the enclosed machine element 7 is exposed outside the casing 80. In particular, an assembly section 70 of the machine element 7 is exposed. In particular, in embodiments such as in Fig. 7 shown in a closed state of the enclosure 80, at least one assembly section 70, for example two or more assembly sections 70, is free, which(s) are in a Fig. 7 (h) depicted production plant in a production position 10 contact a counterpart section of another element of the machine setup and / or cleanroom setup.

[0280] In a Fig. In the open state of the enclosure 80 shown in Figure 7(a), the machine element 7 can be inserted into the enclosure 80. For example, the machine element 7 is inserted such that the assembly sections 70 located outside an interior space of the enclosure 80 are exposed when the enclosure 80 is closed. Process-relevant sections of the machine element 7 are separated from the environment by the enclosure 80 when the enclosure 80 is closed.

[0281] The hood-shaped cover element 805 contacts the plate-shaped base element 804 along a dividing line visualized by a dashed line. In some embodiments, the cover element 805 contacts the base element 804 along a horizontal dividing line.

[0282] Fig. Figure 7(b) shows the enclosure 80 undergoing a treatment for the sterilization of the machine elements 7 contained in the enclosure 80. The enclosure 80 is designed such that at least the sections of the machine element 7 arranged in a closed state within an interior of the enclosure 80 can be subjected to a sterilization process.

[0283] In certain embodiments, the cover element 805 is a dimensionally stable component. In one embodiment, a section of the casing 80, for example as in Fig. Figure 7 shows the section designed as a cover element 805 with a window 84 containing an insert, in particular a sterile filter 85. The insert, in particular the sterile filter 85, is designed such that a medium for germ elimination, as indicated by arrows in Fig. Figure 7(b) shows that the insert, in particular the sterile filter 85, is designed to retain microbiological substances, especially germs.

[0284] Treatment for germ elimination is carried out, for example, in a treatment unit 9, in particular in an autoclave. The sections exposed outside the casing 80, especially the assembly section 70, are also disinfected. However, the sections are not protected from contamination after removal from the treatment unit 9.

[0285] The casing 80 is designed in such a way that the entry of microbiological substances into the interior space, which is separated from the environment by the casing 80 when closed, is prevented, in particular the entry of germs.

[0286] As schematically in Fig. As shown in Figure 7 (c), the enclosure 80 with the incorporated machine elements 7 can be placed in a closed state of the enclosure 80 into a cleanroom area of ​​a housing 6 of a plant 1 (see Figure 7 (c)). Fig. 1 and Fig. 2) be moved. In particular, the enclosure 80 can be moved into the cleanroom area via an open access opening 60 in a non-sterile state. The sterile state of the interior of the enclosure 80 is thereby maintained.

[0287] As schematically in Fig. As shown in Figures 7 (d) and (e), after the enclosure 80 has been moved into the cleanroom area of ​​the housing 6, the housing 6 can be closed and a cleaning process, in particular a germ- and / or residue-reducing cleaning process, for example decontamination, can be carried out in the cleanroom area.

[0288] As schematically in Fig. As shown in Figure 7(d), the machine element 7 arranged in the casing 80 is moved into a production position 10 in embodiments with the casing 80. As shown in Fig. As shown in Figure 7(d), the production position 10 is selected such that sections, in particular assembly sections 70, which are arranged outside the covering 80 when the covering 80 is closed, are not exposed but touch opposing surfaces. The assembly sections 70 are concealed by the opposing surface.

[0289] As schematically in Fig. 7 (e) A cleaning process of the cleanroom area takes place, in particular a germ- and / or residue-reducing cleaning process, for example decontamination, while the machine element 7 is already arranged in the production position. The enclosure 80 is in a closed state.

[0290] As schematically in Fig. As shown in Figures 7 (f) and (g), after the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example decontamination, the covering 80 can be opened and a cover element 83 removed.

[0291] As schematically in Fig. As shown in Figures 7 (f) to (h), in some embodiments the covering 80 remains at least partially attached to the machine element 7. In particular, in some embodiments the section 801 of the covering 80 designed as a base plate 804 remains attached to the machine element 7.

[0292] The machine element 7 remains in production position 10, with the mounting surfaces 70 of the machine element 7 continuing to contact the mating surfaces even during production. The mating surfaces that the machine element 7 contacts with the mounting sections 70 during the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example decontamination, and which are thus covered, remain covered during production.

[0293] Fig. Figure 8 schematically shows a detail of a system 1 with a housing 6 and a device 8 for setting up the system 1, in particular for equipping a machine unit of the system 1 with a machine element 7. The in Fig. Device 8 shown is similar to device 8 according to Fig. 7. The device 8 comprises an enclosure 80. The machine element 7 can be received by the enclosure 80, wherein at least process-relevant sections of the machine element 7 are separated from the environment by the enclosure 80 when it is closed. In particular, the enclosure 80 has openings, with sections, especially mounting sections 70, lying freely outside the enclosure 80. The machine element 7 can be attached to the enclosure 80 at a bearing point in the cleanroom area of ​​the housing 6. In particular, it is attached such that the mounting sections 70 contact mating sections of another element 71 of a machine assembly (not shown in detail). After the machine element 7 has been attached to the bearing point, a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example, decontamination, can be carried out.After the cleanroom area has been cleaned, the enclosure can be opened. In some embodiments, the machine element 7 is arranged in a setup position for the cleaning process. After the cleaning process, and before, during, or after opening the enclosure, the machine element can be moved from the setup position to a production position at its bearing point. In some embodiments, the machine element 7 is rotatable at its bearing point, for example, as shown schematically in [Figure 1]. Fig. Figure 8 shows the movement around a horizontal axis. In some embodiments, the machine element 7 is alternatively or additionally linearly adjustable at the bearing point, in particular as schematically shown in Figure 8. Fig. Figure 8 shows a height-adjustable device. In various embodiments, the machine element 7 is moved at the bearing point from the setup position 11 to the production position 10 in such a way that sections of the machine element 7 which are not protected from contamination in a closed state of the enclosure 80, and which are covered during the cleaning process, for example, assembly sections 70, and / or external sections of the enclosure 80 which are covered during the cleaning process, and / or opposing sections of the further element 71 which are covered during the cleaning process, remain covered when the machine element 7 is moved at the bearing point from the setup position 11 to the production position 10.

[0294] Fig. Figure 9 schematically shows a detail of a system 1 with a housing 6 and a device 8 for setting up the system 1, in particular for equipping a machine unit of the system 1 with two machine elements 7, in a top view in two states. The in Fig. Device 8 shown in Figure 9 is similar to device 8 according to Figure 9. Fig. 8. The two machine elements 7 can each be attached to a respective bearing point in the cleanroom area of ​​the housing 6 with a covering 80. In particular, they are attached such that in Fig. 9 concealed mounting sections 70 of the machine elements 7 contact opposing sections of another element 71 of a machine device not shown in detail. The machine elements 7 are attached, for example, in a Fig. 9 (a) setup position 11. After the machine elements 7 have been attached to the bearing point, a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example decontamination, can be carried out. After the cleaning process of the cleanroom area, the enclosure 80 can be opened. At least one machine element 7, for example both machine elements 7, is / are arranged in the setup position for the cleaning process. After the cleaning process and before, during or after opening the enclosure, the machine element 7 or the machine elements 7 can be moved from the setup position 11 to a position shown in Figure 9 (a). Fig. 9 (b) Production position 10 shown is moved. In particular, the movement is such that non-sterile sections remain covered.

[0295] Fig. Figure 10 schematically shows a detail of a system 1 with a housing 6 and a device 8 for setting up the system 1, in particular for equipping a machine unit of the system 1 with a machine element 7 in three process steps. The in Fig. Device 8 shown in Figure 10 is similar to device 8 according to Figure 10. Fig. 8. The machine element 7 can be mounted in an enclosure 80 at a bearing point in the cleanroom area of ​​the housing 6. In some embodiments, the enclosure 80 comprises a dimensionally stable section 801 designed as a base element, in particular as a trough-shaped base element. In other embodiments, the enclosure 80 comprises a dimensionally flexible cover element 806. The cover element 806 is removable for opening the enclosure 80. In some embodiments, the cover element 806 can be rolled up for opening, for example, onto a winding reel 86. In other embodiments, the cover element 806 can be pulled off the winding reel 86 to reseal the enclosure 80. In other embodiments, the cover element 806 is cut to open the enclosure 80.

[0296] The machine element 7 is attached to the bearing point in such a way that mounting sections 70 of the machine element 7 contact opposing sections of another element 71 of a machine device not shown in detail. The machine element 7 is attached, for example, in a Fig. The setup position 11 shown in Figure 10(a) is used. After attaching the machine element 7 to the bearing point, a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example decontamination, can be carried out. The machine element 7 is arranged in setup position 11 for the cleaning process.

[0297] After the cleaning process of the cleanroom area, the encapsulation 80 can be removed as shown schematically in Fig. 10 (b) shown. After the cleaning process and before, during or after opening the casing 80, the machine element 7 can be moved from the setup position to a position at the bearing point. Fig. The production position 10 shown in Figure 10(c) is adjusted. In particular, the machine element 7 is moved such that it is drawn from the system 1 in the opposite direction to the flow direction of an air supply. For example, the air supply to the system is at least substantially vertical from above. In embodiments, the machine element 7 is positioned as shown in Figure 10(c). Fig. 10 (c) shown, raised in a vertical direction.

[0298] In the Fig. In the embodiment shown in Figure 10, the section designed as a base element is arranged at an angle to a horizontal plane. This allows a cleaning medium, particularly a cleaning fluid, to flow out during a cleaning process in the cleanroom area, especially a residue-reducing cleaning process such as a wash-down, when the enclosure is open. For this purpose, the section 801, designed as a trough-shaped base element, has an outlet in some configurations. The outlet is, for example, closed when the enclosure is closed and / or designed in such a way as to prevent contaminants from entering an interior space defined by the enclosure 80 in its closed state via the outlet.

[0299] Fig. Figure 11 schematically shows a detail of a system 1 with a housing 6 and a device 8 for setting up the system 1, in particular for equipping a machine unit of the system 1 with a machine element 7 in three process steps. The in Fig. The device 8 shown in Figure 11 is similar to the device 8 according to Figure 11. Fig. 10. The covering 80 comprises, in various embodiments, a dimensionally stable section 801 designed as a base element, in particular as a trough-shaped base element, and a dimensionally flexible cover element 806. The cover element 806 can, for example, be wound onto a winding roll 86.

[0300] The machine element 7 can be attached in a covering 80 at a bearing point in the cleanroom area of ​​the housing 6.

[0301] The machine element 7 is attached to the bearing point in such a way that mounting sections 70 of the machine element 7 contact opposing sections of another element 71 of a machine device (not shown in detail). Furthermore, a section 75 of the casing 80 contacts an actuating element 76. The machine element 7 is attached, for example, in a Fig. The production position is shown in Figures 11(a) to 11(c). After the machine element 7 is attached to the bearing point, a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example decontamination, can be carried out. The machine element 7 is arranged in the housing 80 for the cleaning process.

[0302] After the cleaning process of the cleanroom area, the encapsulation 80 can be removed as shown schematically in Fig. 11 (b) shown to be opened. After the cleaning process and before, during or after opening the casing 80, the casing 80 can be adjusted to expose the machine element 7. In particular, in embodiments such as in Fig. Figure 11 shows that the section 801, designed as a trough-shaped base element, is moved relative to the machine element 7, with the section 801 being moved in the direction of an airflow direction to the system 1. For example, air is supplied to the system in at least a substantially vertical direction from above. In embodiments, the section 801 is arranged as shown in Fig. 11 (c) shown, lowered in a vertical direction.

[0303] In embodiments, the section 801 is moved to expose the machine element 7 in such a way that external sections 75 of the covering 80, which are covered during the cleaning process, and / or opposing sections of the further element 71, which are covered during the cleaning process, remain uncovered during a movement of the section 801.

[0304] Fig. Figure 12 schematically shows an embodiment of a device 8 for setting up a system comprising a covering 80 with two dimensionally stable parts 807, in particular two shell elements, in various process steps (a) to (g) each in a top view and a side view.

[0305] The in Fig. The depicted covering 80 is available in configurations as shown in 12. Fig. Figure 7 is shown dimensioned such that exactly one machine element 7 can be accommodated. In embodiments, the enclosure 80 is dimensioned to accommodate more than one machine element 7.

[0306] The two dimensionally stable sections 807 are designed symmetrically with respect to a dividing line schematically represented by a dashed line. In some embodiments, the dividing line lies in a vertical plane.

[0307] The in Fig. The device 8 shown in Figure 12 comprises a cover element 83, wherein the cover element 83 is arranged on the machine element 7 to cover it.

[0308] The casing 80 has two sealed through-openings 87. In certain embodiments, the dividing line runs through the through-openings 87. A portion of the machine element 7 enclosed by the casing 80 extends through the casing 80, and at least one section of the enclosed machine element 7 is exposed outside the casing 80. In particular, a mounting section 70 of the machine element 7 is exposed. In particular, in embodiments such as in Fig. 12 shown in a closed state of the enclosure 80, at least one assembly section 70, for example two or more assembly sections 70, is free, which(s) are not in Fig. 12. In a production position 10, the production plant shown in 12 contacts a counterpart section of another element of the machine equipment and / or the cleanroom setup.

[0309] In a Fig. In the open state of the enclosure 80 shown in Figure 12(a), the machine element 7 can be inserted into the enclosure 80. For example, the machine element 7 is inserted such that the two shell elements are positioned towards the machine element 7 from two sides, with a portion of the machine element 7 being arranged in the opening 87 and a section, in particular the assembly section 70, lying freely outside an interior space of the enclosure 80 when the enclosure is closed. Process-relevant sections of the machine element 7 are separated from the environment by the enclosure 80 when the enclosure is closed.

[0310] Fig. Figure 12(b) shows the enclosure 80 undergoing a treatment for the sterilization of the machine elements 7 contained in the enclosure 80. The enclosure 80 is designed such that at least the sections of the machine element 7 arranged in a closed state within an interior of the enclosure 80 can be subjected to a sterilization process.

[0311] In some embodiments, a section 807 of the casing 80, for example as in Fig. Figure 12 shows both sections 807, a window 84 with an insert, for example made of a semi-permeable material, in particular a sterile filter 85. The insert, in particular the sterile filter 85, is designed such that a medium for germ elimination, as indicated by arrows in Fig. 12 (b) shown, can be supplied to an interior of the enclosure 80 for germ removal.

[0312] Treatment for germ elimination takes place, for example, in a treatment facility 9, in particular in an autoclave.

[0313] As schematically in Fig. As shown in Figure 12 (c), the enclosure 80 with the incorporated machine elements 7 can be placed in a closed state of the enclosure 80 into a cleanroom area of ​​a housing 6 of a plant 1 (see Figure 12 (c)). Fig. 1 and Fig. 2) be moved. In particular, the enclosure 80 can be moved into the cleanroom area via an open access opening 60 in a non-sterile state. The enclosure 80 is designed such that the entry of microbiological substances into the interior space, which is separated from the environment by the enclosure 80 when closed, is prevented, in particular the entry of germs. A sterile state of the interior space of the enclosure 80 is thereby maintained.

[0314] As schematically in Fig. As shown in Figures 12 (d) and (e), after the enclosure 80 has been moved into the cleanroom area of ​​the housing 6, the housing 6 can be closed and a cleaning process, in particular a germ- and / or residue-reducing cleaning process, for example decontamination, can be carried out in the cleanroom area.

[0315] As schematically in Fig. As shown in Figure 12(e), the machine element 7 arranged in the casing 80 is moved into a production position 10 in embodiments with the casing 80. As shown in Fig. As shown in Figure 12(e), the production position 10 is selected such that sections, in particular assembly sections 70, which are arranged outside the enclosure 80 when the enclosure is closed, are not exposed but touch opposing surfaces. The assembly sections 70 are concealed by the opposing surface.

[0316] As schematically in Fig. 12 (e) In embodiments, a cleaning process of the cleanroom area takes place, in particular a germ- and / or residue-reducing cleaning process, for example decontamination, while the machine element 7 is already arranged in the production position 1ß. The enclosure 80 is in a closed state.

[0317] As schematically in Fig. As shown in Figures 12 (f) and (g), after the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example decontamination, the covering 80 can be opened and a cover element 83 removed.

[0318] Fig. Figure 13 schematically shows an embodiment of a device 8 for setting up a system comprising a casing 80 with a dimensionally stable section 808 and a coating 809 in various process steps (a) to (g). The coating 809 has, in embodiments as schematically shown in Fig. Figure 12 shows a clamping ring 803. The covering 809 is, for example, attached to the section 808 by means of the clamping ring 803. In other embodiments, the covering 809 is connected to the section 808 in a different way, for example by a material bond, in particular by welding. In other embodiments, the covering 809 is attached to the mounting element 7 via the clamping ring 803.

[0319] The coating 809 is made of a semi-permeable material in certain embodiments, wherein the coating 809 is permeable to a medium for germ-free sterilization and impermeable to contaminants, especially microbiological substances. In certain embodiments, the coating has a window 84 with an insert, for example made of a semi-permeable material, in particular a sterile filter 85.

[0320] Section 808 has openings 87 such that at least one section, in particular an assembly section 70, lies outside an interior space defined by section 808 and the covering 809. Process-relevant sections of the machine element are arranged within the interior space defined by section 808 and the covering 809 in certain embodiments.

[0321] Fig. Figure 13(b) shows the enclosure 80 undergoing a treatment for the sterilization of the machine element 7 contained in the enclosure 80. The enclosure 80 is designed such that a machine element 7 contained in the enclosure 80 can be subjected to a sterilization process in a closed state of the enclosure 80.

[0322] The cover 809 and / or the insert, in particular the sterile filter 85, is designed such that a medium for germ elimination, as indicated by arrows in Fig. 13 (b) shown, can be supplied to an interior of the enclosure 80 for germ removal.

[0323] Treatment for germ elimination takes place, for example, in a treatment facility 9, in particular in an autoclave.

[0324] As schematically in Fig. As shown in Figure 13 (c), the enclosure 80 with the incorporated machine element 7 can be placed in a closed state of the enclosure 80 into a cleanroom area of ​​a housing 6 of a plant 1 (see Figure 13 (c)). Fig. 1 and Fig. 2) be moved. In particular, the enclosure 80 can be moved into the cleanroom area via an open access opening 60 in a non-sterile state. The sterile state of the interior of the enclosure 80 is thereby maintained.

[0325] As schematically in Fig. As shown in 13 (d), the machine element 7 with the casing can be moved, in particular, to a production position. In embodiments, contact is made as shown in Fig. Figure 13 shows assembly sections 70 of the machine element 7 in the production position counter surfaces.

[0326] As schematically in Fig. As shown in Figures 13 (d) and (e), after the enclosure 80 has been moved into the cleanroom area of ​​the housing 6, the housing 6 can be closed and a cleaning process, in particular a germ- and / or residue-reducing cleaning process, for example decontamination, can be carried out in the cleanroom area.

[0327] As schematically in Fig. As shown in Figures 13(f) and (g), after the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example decontamination, the casing 80 can be opened and the machine element 7 exposed. As shown schematically in Fig. As shown in Figure 13(f), in embodiments the coating 809 is cut to open the covering. As in Fig. As shown in Figures 13 (f) and (g), in particular in embodiments at a production plant, the section 808 and the clamping ring 803 with a remainder of the coating 809 remain on the machine element 7.

[0328] Fig. Figure 14 schematically shows an embodiment of a device 8 for setting up a plant similar to Fig. 13 in various process steps (a) to (g). The device 8 comprises a casing 80 with a dimensionally stable section 808 and a coating 809. In contrast to the design according to Fig. 13 is used for opening the covering of the cover 809 as in Fig. 14 (f) schematically shown removed by stretching the clamping ring 803. As in Fig. As shown in Figure 14 (g), in particular in embodiments at a production plant, the section 808 remains attached to the machine element 7.

[0329] Fig. Figure 15 schematically shows an embodiment of a device 8 for setting up a plant similar to Fig. 13 in various process steps (a) to (h). The device 8 comprises a casing 80 with a dimensionally stable section 808 and a coating 809. In contrast to the design according to Fig. In step 13, the machine element 7, with its covering, is moved into a setup position 11 for a cleaning process. A retaining device 88, comprising, for example, a clamping device, is provided at the setup position 11. To open the covering, the machine element 7 can be moved relative to the covering 809, which is held in position by the retaining device 88. For example, the machine element 7 is moved from the setup position 11 using a manipulator 81. The movement of the machine element 7 relative to the covering 809 stretches, in particular, so that the covering 809 is removed. The machine element 7 can then be removed as described in [reference missing]. Fig. 15 (g) shown in the production position. As shown in Fig. As shown in Figures 15 (g) and (h), in particular in embodiments at a production plant, the section 808 remains attached to the machine element 7.

[0330] Fig. Figure 16 schematically shows an embodiment of a device 8 for setting up a plant similarly Fig. 15 in various process steps (a) to (h). The device 8 comprises a casing 80 with a dimensionally stable section 808 and a coating 809. In contrast to the design according to Fig. In step 15, the machine element 7 with its casing is moved to a setup position 11 for a cleaning process and positioned on assembly aids 78 at setup position 11. Positioning at setup position 11 is carried out such that the assembly sections 70 are exposed. The assembly sections 70 can then be cleaned as shown schematically in the following diagram. Fig. 15 (e) is shown to be cleaned, in particular disinfected. At the setup position 11, the retaining device 88, comprising, for example, the clamping device, is further provided. To open the covering, the machine element 7 can be moved relative to the coating 809, which is held in position by the retaining device 88.

[0331] Fig. Figure 17 schematically shows a detail of a system 1 with a device 8 for equipping the system with a machine element 7. The in Fig. The device 8 shown in Figure 17 comprises a casing 80 with a dimensionally stable section 808 and a coating 809. The device 8 further comprises a manipulator 81. The manipulator 81 is configured to cut and remove the coating 809. The manipulator 81 is configured to remove the coating 809, for example, by stretching a clamping ring (see Figure 17). Fig. 15 or Fig. 16) to be removed. The casing is opened by the manipulator 81, for example, in a production position.

[0332] Fig. Figure 18 schematically shows a detail of a system 1 with a device 8 for equipping the system with a machine element 7. The in Fig. The device 8 shown in Figure 18 comprises a casing 80 with a dimensionally stable section 808 and a coating 809. The device 8 further comprises a manipulator 81. The manipulator 81 is configured to cut and remove the coating 809. The manipulator 81 is configured to cut the coating 809, for example, by stretching a clamping ring (see Figure 18). Fig. 15 or Fig. 16) to be removed. Unlike the design according to... Fig. 17 in a preparedness position.

[0333] The cover 809 contacts as in Fig. Figure 18 shows the section 808 for closing the casing, for example with a clamping ring 803 (see Figure 18). Fig. 15 and Fig. 16) In certain embodiments, the coating 809 contacts the machine element 7. The section 808 and the machine element 7 are collectively also referred to as the counter element. In certain embodiments, the coating 809 contacts the counter element in a first closed position. In certain embodiments, the coating 809 is arranged as shown schematically in Fig. 18, represented by an arrow, is adjusted relative to the counter element from the first closed position to a second closed position. In particular, the second closed position is selected such that the cover 809 touches the counter element at a contact surface which, in the first closed position, is exposed in an interior of the casing 80 for sterilization, for example, in a treatment unit 9. When sterilizing the machine element 7 enclosed by the casing 80, especially before introducing the machine element 7 into the cleanroom area, particularly in a treatment unit 9, for example, an autoclave, the contact surface can be subjected to sterilization.The cover 809 is moved from the first closed position to the second closed position relative to the counter element, particularly before the cleaning process of the cleanroom area, especially the germ- and / or residue-reducing cleaning process, for example, decontamination. An area covered in the first closed position is thus cleaned during the cleaning process, in particular disinfected. Subsequently, the cover 809 can be removed and the machine element 7 moved into a production position. In some embodiments, the movement from the first closed position to the second closed position is carried out by the manipulator 81. In other embodiments, the movement from the first closed position to the second closed position is carried out by a separate actuator, for example, an actuator comprising a bimetallic strip.

[0334] Fig. Figure 19 schematically shows a detail of a system 1 with a device 8 for setting up the system 1, comprising a casing 80 with three dimensionally stable sections, in particular a base element 804 and two cover elements 801 pivotably attached thereto, before and after opening the casing 80. The cover elements 801 are coupled to the base element 804 via pivot joints 89, for example, via hinges, in embodiments as shown. To open the casing 80, the cover elements 801 are made of a material in Fig. 19 (a) closed position shown in a Fig. The open position shown in 19 (b) is pivotable. In particular, the cover elements 801 are as schematically shown in Fig. 19 shown, can be moved from the closed position to the open position by a manipulator 81.

[0335] In Fig. Figure 20 schematically illustrates exemplary embodiments of a system 1, which includes a treatment unit 9 for germ elimination. The system 1 includes a connecting unit 91 for transferring an object between the treatment unit 9, in particular a chamber of the treatment unit, and a cleanroom area of ​​a housing 6 of a cleanroom structure of the system 1.

[0336] For example, the treatment device 9 includes an inlet opening 92 for supplying an object from an environment.

[0337] In one exemplary embodiment, for example in Fig. As shown in Figure 20 a), the treatment device 9 and the housing 6 are arranged in contact with each other. In this embodiment, the connecting unit 91 forms a through-opening.

[0338] In one exemplary embodiment, for example in Fig.As shown in Figure 20 b), the treatment device 9 and the housing 6 are arranged at a distance from each other. The connecting unit 91 in the exemplary embodiment comprises a bridging piece which bridges the distance and forms at least a partial passage.

[0339] The embodiments described above are merely examples, and numerous variations are conceivable. In particular, features, components, and / or entities described in connection with one embodiment can be combined with another embodiment to obtain further embodiments.

[0340] Disclosed process configurations include the following combinations of features: 1. Process design for setting up a system (1) for carrying out process steps on objects, in particular on containers, for example on pharmaceutical containers, at least partially under cleanroom conditions, the system (1) comprises a machine setup, in particular the machine setup is, for example, a process station (2, 3) for carrying out a process step, a transport system (5) for transporting objects to or from a process station (2, 3) and / or a feeding system (4) for feeding packaging materials interacting with the objects to a process station (2, 3), and a cleanroom setup with a housing (6), wherein the cleanroom condition can be created in a cleanroom area of ​​the housing (6), wherein the machine equipment is arranged in the cleanroom area of ​​the housing (6), wherein the machine setup comprises at least one machine element (7) which is coupled in a production position (10) with at least one further element of the machine setup, wherein in particular an assembly section (70) of the machine element (7) in the production position (10) contacts a counter section of the at least one further element and / or the housing (6), the method comprising at least the steps: Insertion (100) of the machine element (7) into the cleanroom area of ​​the housing (6) prior to a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example a decontamination, of the cleanroom area, wherein the machine element (7) is received by a covering (80) in a closed state of the covering (80), such that at least a section, in particular at least process-relevant sections, of the machine element (7) are separated from the environment by the covering (80), Performing (101) a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example a decontamination, of the cleanroom area, and Opening (102) of the enclosure (80) after the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example decontamination, of the cleanroom area, without impairing the cleanroom condition, in particular to expose the machine element (7) and / or to remove the machine element (7) from the enclosure (80). 2. Process design according to the preceding process design, wherein, prior to the insertion (100) of the machine element (7) into the cleanroom area of ​​the housing (6), the machine element (7) received by the enclosure (80) is subjected to a process for germ elimination in a closed state of the enclosure (80), in particular in an autoclave and / or steam sterilization. 3. Procedural design according to one of the preceding procedural designs, where the machine element (7) is received in the casing (80) in such a way that a section of the machine element (7), in particular the assembly section (70), is exposed at least partially outside the casing (80), particularly The machine element (7) enclosed by the casing (80) is positioned in a setup position (11) in the cleanroom area, so that the section exposed outside the casing (80) is at least partially available for cleaning during the cleaning process of the cleanroom area, in particular the germ and / or Residue-reducing cleaning process, for example decontamination, of the cleanroom area is accessible. 4. Procedural design according to one of the preceding procedural designs, where before and / or during and / or after opening (102) the casing (80) at least one section of the casing (80) and / or a section of the machine element (7) and / or a section of the further element of the machine equipment to which the machine element (7) is coupled in the production position (10), which is not accessible during the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example decontamination, and / or is not provided germ-free in the closed casing (80), is not exposed. 5. Procedural design according to one of the preceding procedural designs, where When opening (102) the casing (80) and / or removing the machine element (7) from the casing (80), the machine element (7) is at least partially covered by a cover element (83), wherein the cover element (83) is removed after, during or before coupling the machine element (7) in the production position (10) with the at least one other element of the machine device. 6. Procedural design according to one of the preceding procedural designs, where the covering (80) comprises at least two, in particular dimensionally stable, sections (801, 804, 805, 807, 808) coupled to each other at least in a closed state, wherein the sections (801, 804, 805, 807, 808) can be separated and / or moved relative to each other for the purpose of removing the machine element (7), in particular non-destructively, for example by moving linearly relative to each other and / or pivoting. wherein in particular the sections (801, 804, 805, 807, 808) are coupled by a band, wherein the band is cut and / or removed to separate the sections (801, 804, 805, 807, 808). 7. Procedural design according to one of the preceding procedural designs, where the covering (80) comprises a dimensionally stable, receiving-forming section (801, 804, 805, 807, 808) with an access opening (8010), for example a trough-shaped bottom element, and a cover element (802) that closes the access opening (8010) in the closed state, in particular a form-flexible, wherein the cover element (802) is removed to open the covering (80), in particular wherein the cover element (802) is rolled up to open the covering (80). 8. Procedural design according to one of the preceding procedural designs, where the covering (80) comprises a form-flexible coating (809), wherein in particular the coating (809) has a clamping ring with which the coating (809) is clamped to the machine element (7) and / or to a form-stable section (801-809) of the covering (80) coupled to the machine element (7), wherein in particular the form-flexible coating (809) is cut to open the covering (80) and / or the form-flexible coating (809) is pulled off by releasing the clamping ring. 9. Procedural design according to one of the preceding procedural designs, where an element of the covering (80), in particular the form-flexible cover (809), is fixed by a retaining device (88), in particular comprising a clamping element, before the covering (80) is opened, in particular fixed at the setup position (11), wherein the retaining device (88) holds the element (801-809) of the covering (80), in particular the form-flexible cover (809), in a position during a, in particular semi- or fully automated, removal and / or exposure of the machine element (7). 10. Procedural design according to one of the preceding procedural designs, where The enclosure (80) comprises at least one first element (801-809) which, in a protective state of the enclosure (80), contacts a counter element, in particular a second element (801-809) of the enclosure (80) and / or the machine element (7), in a first closed position for closing the enclosure (80), wherein the first element (801-809) is moved relative to the counter element from the first closed position to a second closed position, wherein in the second closed position the first element (801-809) touches the counter element at a contact surface which, in the first closed position, is exposed in an interior of the enclosure (80) for germ removal, wherein in particular the first element (801-809) is moved relative to the counter element from the first closed position to a second closed position before the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example decontamination. 11. Procedural design according to one of the preceding procedural designs, where the machine element (7) received by the enclosure (80) in a closed state of the enclosure (80) is placed in a setup position (11) in the cleanroom area, wherein in particular the machine element (7) received by the enclosure (80) is positioned in the setup position (11) so that the section exposed outside the enclosure (80), in particular an assembly section (70), is at least partially accessible for sterilization, and / or the machine element (7), in particular semi- and / or fully automated, is moved from the setup position (11) to the production position (10) and / or towards the production position (10), in particular after the cleaning process of the cleanroom area, wherein the movement of the machine element (7) from the setup position (11) to the production position (10) and / or towards the production position (10) causes the enclosure (80) to open, and / or wherein the movement of the machine element (7) from the setup position (11) to the production position (10) and / or towards the production position (10) is coupled with an adjustment movement of an element (801-809) of the enclosure (80) to open the enclosure (80). 12. Procedural design according to one of the preceding procedural designs, where the setup position (11) is equal to the production position (10) in at least one degree of freedom, wherein in particular the machine element (7) is attached at a bearing point in the cleanroom area, in particular on the machine equipment, with at least one degree of freedom, for example with exactly one degree of freedom or with two degrees of freedom, and the machine element (7) attached at the bearing point is adjusted between the setup position (11) and the production position (10), in particular rotated, for example about a horizontal axis, and / or linearly adjusted, in particular height-adjusted. 13. Procedural design according to one of the preceding procedural designs, where an opening (102) of the casing (80) and / or an exposure of the machine element (7) with respect to the casing (80) and / or a removal of the machine element (7) from the casing (80) and / or a moving (103) of the machine element (7) into the production position (10) and / or a coupling of the machine element (7) in the production position (10) with the at least one other element of the machine equipment is carried out semi- or fully automatically with a manipulator (81), in particular after a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example a decontamination. 14. Procedural design according to one of the preceding procedural designs, where the machine element (7) is removed from the casing (80) in an open state of the casing (80), in particular the machine element (7) is removed opposite to a flow direction of an air supply to the system (1). 15. Process design for operating a plant (1) for carrying out process steps on objects, in particular on containers, for example on pharmaceutical containers, at least partially under cleanroom conditions, the plant (1) comprises a cleanroom structure with a housing (6), wherein the cleanroom condition can be created in a cleanroom area of ​​the housing (6), the plant (1) comprises a treatment device for carrying out a process for germ elimination, wherein in particular the treatment device comprises a chamber for carrying out the process for germ elimination, in particular the treatment facility for steam sterilization is designed as a process for germ elimination and / or the treatment facility includes an autoclave, The installation (1) includes in particular a machine installation, in particular the machine installation is, for example, a process station (2, 3) for carrying out a process step, a transport system (5) for transporting objects to or from a process station (2, 3) and / or a feeding system (4) for feeding packaging materials interacting with the objects to a process station (2, 3), wherein the machine equipment is arranged in the cleanroom area of ​​the housing (6), wherein the machine equipment comprises at least one machine element (7) which is coupled in a production position (10) with at least one further element of the machine equipment, wherein in particular a mounting section (70) of the machine element (7) in the production position (10) contacts a counter section of the at least one further element and / or the housing (6), the procedure encompasses at least the following steps: Feeding an item, in particular a machine part and / or an object and / or a packaging material and / or a consumable, to the treatment device; feeding includes in particular placing the item into the chamber. Carrying out the process for germ elimination, in particular steam sterilization and / or autoclaving of the object, Moving the item from the treatment device, in particular from its chamber, into the cleanroom area of ​​the housing without passing through a less clean environment, wherein the less clean environment does not meet any or at most a lower cleanroom condition than the treatment device, in particular its chamber, and / or the cleanroom area. Reference symbol list 1 Annex 10 production positions 11 Equipment position 2, 3 Process station 4 Feeding system 40 storage units 42 sorting stations 44 Transport device 5 Transport system 6 cases 60 Access opening 61 glove procedures 62 Supply connection 63 Packaging material feed connection 7 Machine element 70 Assembly section 71 Element of the assembly device Section 75 (of the covering) 76 Actuator 78 assembly aids 8 Device 80 covering 801 Section 802 Cover element 803 Clamping ring 804 Section, plate-shaped floor element 805 Section, hood-shaped cover element 806 flexible lid element 807 Section, shell element 808 Section 809 coating 8010 Access opening 81 Manipulator 82 Positioning device 83 Cover element 84 windows 85 sterile filters 86 winding roll 87 Passage opening 88 Restraint system 89 joint 9 Treatment facility 91 Connection unit 92 Entrance opening 100 steps (insertion) 101 steps (Closing and Cleaning) Step 102 (Opening) Step 103 (Moving into production position) QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited non-patent literature

[0000] The Rules Governing Medicinal Products in the European Union, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EG-GMP Guide), Annex 1 (currently: Volume 4 from August 22, 2022

[0005] The Rules Governing Medicinal Products in the European Union, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use” (EG-GMP-Guide

[0028] Guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products“, veröffentlicht in Part IV von Eudralex Volume 4 (in Kraft ab 22. Mai 2018 [0028, 0030] The Rules Governing Medicinal Products in the European Union, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use“ (EG-GMP-Leitfaden)

[0030] 2 (zur Zeit: Volume 4 vom 22. August 2022

[0030]

Claims

[1] Device for setting up a system (1) for carrying out process steps on objects, in particular on containers, for example on pharmaceutical containers, at least partially under cleanroom conditions, The installation (1) comprises a machine setup, in particular the machine setup is, for example, a process station (2, 3) for carrying out a process step, a transport system (5) for transporting objects to or from a process station and / or a feeding system (4) for feeding packaging materials interacting with the objects to a process station (2, 3), and a cleanroom setup with a housing (6), wherein the cleanroom condition can be created in a cleanroom area of ​​the housing (6), wherein the machine equipment is arranged in the cleanroom area of ​​the housing (6), wherein the machine setup comprises at least one machine element (7) which is coupled in a production position (10) with at least one further element of the machine setup, wherein in particular an assembly section (70) of the machine element (7) in the production position (10) contacts a counter section of the at least one further element and / or the cleanroom setup, The device (8) comprises a casing (80) designed to accommodate the machine element (7), wherein at least one section, in particular at least process-relevant sections of the machine element (7), are separated from an environment by the casing (80) in a closed state of the casing (80). wherein, prior to a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example a decontamination, the machine element (7) contained in the housing (80) can be introduced into the cleanroom area in a closed state of the housing (80), and wherein, after the cleaning process of the cleanroom area, in particular after the germ- and / or residue-reducing cleaning process, for example after decontamination, the covering (80) in the cleanroom area can be opened without impairing the cleanroom condition. [2] Device according to claim 1, characterized by, that the covering (80) is designed such that a machine element (7) received by the covering (80) can be subjected to a process for germ elimination in a closed state of the covering (80), and / or that the covering (80) is designed such that a medium for germ elimination of the machine element (7) received by the covering (80) can be supplied via the covering (80), in particular for steam sterilization and / or autoclaving of the machine element (7). [3] Device according to claim 1 or 2, characterized by, that the covering (80) is designed such that, in a closed state, the sections of the machine element (7) enclosed by the covering (80) that are separated from the environment, in particular germ-free, are protected from contamination, in particular germs, and in particular the covering is designed such that, in a closed state of the covering, the separated interior of the covering and / or the sections of the enclosed machine element that are separated from the environment by the covering are sealed off from the environment. [4] Device according to any of the preceding claims, characterized by , that The device for setting up the equipment includes a release actuator, wherein in particular the exposure actuator is designed to at least temporarily move the covering (80) at least partially out of the closed state such that contact sections of the covering (80) are contactless in the opened state, wherein the contact sections in the closed state contact another section. [5] Device according to any of the preceding claims, characterized by , that the covering (80) includes an indication device for indicating a condition of the covering. [6] Device according to any of the preceding claims, characterized by , that the covering (80) has a passage opening (87), in particular a sealed one, wherein a section of the machine element (7) received by the covering (80) is exposed outside the covering (80), wherein in particular the assembly section (70) is exposed at least partially outside the covering (80), and / or wherein in particular the passage opening (87) has a circular cross-section and / or wherein in particular a cylindrical section of the machine element (7) is arranged in the passage opening (87). [7] Device according to any of the preceding claims, characterized by , that A cover element (83) is provided in the casing (80) and covers the machine element (7) at least partially, wherein in particular the cover element (83) is made at least partially of a semi-permeable material, so that a medium for sterilization can be supplied via the cover element (83), in particular for steam sterilization and / or autoclaving of the machine element (7), and / or the cover element (87) is designed such that an area of ​​the machine element (7) covered by the cover element (87) can be subjected to a process for germ elimination. [8] Device according to any of the preceding claims, characterized by , that the machine element (7) of the casing (80) can be removed in an open state of the casing (80), wherein in particular the machine element (7) can be removed opposite to a flow direction of an air supply to the system (1). [9] Device according to any of the preceding claims, characterized by , that the covering (80) comprises at least one dimensionally stable section (801, 804, 805, 807, 808) wherein in particular the enclosure (80) comprises at least two, at least in the closed state, coupled, in particular dimensionally stable, sections (801, 804, 805, 807, 808), wherein the sections (801, 804, 805, 807, 808) are separable and / or movable relative to each other, for example linearly movable and / or pivotable, for opening the enclosure (80), in particular for removing and / or exposing the machine element (7), in particular non-destructively. particularly the segments (801, 804, 805, 807, 808) touch each other along a dividing line in the closed state, and / or the sections (801, 804, 805, 807, 808) are coupled by a band that can be cut and / or removed to separate the sections (801, 804, 805, 807, 808), and / or at least one section (801, 804, 805, 807, 808) has a window (84) covered with a semi-permeable material. [10] Device according to any of the preceding claims, characterized by , that the enclosure (80) comprises a, in particular dimensionally stable, base element and / or a, in particular dimensionally stable, ceiling element (802), wherein in particular the base element and / or the lid element (802) is / are arranged inclined relative to a horizontal plane at least during a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example a wash-down. [11] Device according to any of the preceding claims, characterized by, that the covering (80) comprises a dimensionally stable, receiving-forming section (801, 804, 805, 807, 808) with an access opening (8010), for example a trough-shaped bottom element, and a cover element (802) that closes the access opening (8010) in the closed state, in particular being dimensionally flexible, wherein in particular the cover element (802) is rollable for opening the covering (80). [12] Device according to any of the preceding claims, characterized by that the covering (80) comprises a shape-flexible coating (809), wherein in particular the coating (809) has a clamping ring with which the coating (809) is clamped to the machine element (7) and / or to a shape-stable part of the covering (80) coupled to the machine element (7) at least in one state, in particular at least in the closed state. [13] Device according to any of the preceding claims, characterized by, that a retaining device (88), in particular comprising a clamping element, is provided, in particular at the setup position (11), wherein the retaining device (88) is designed to retain an element of the covering (80), in particular the form-flexible cover (809), in a position for a, in particular semi- or fully automated, removal of the machine element (7). [14] Device according to any of the preceding claims, characterized by, that the enclosure (80) comprises at least one first element (801-809) which, in a closed state of the enclosure (80), contacts a counter element, in particular a second element (801-809) of the enclosure (80) and / or the machine element (7), in a first closing position, for closing the enclosure (80), wherein the first element (801-809) is adjustable relative to the counter element from the first closing position to a second closing position, wherein in the second closing position the first element (801-809) touches the counter element at a contact surface which, in the first closing position, is exposed in an interior of the enclosure (80), in particular in a closed state of the enclosure (80), for germ removal. [15] Device according to any of the preceding claims, characterized by, that the device (8) is designed such that before and / or after opening the casing (80) at least one section of the casing (80) and / or a section of the machine element (7) and / or a section of the further element of the machine equipment to which the machine element (7) is coupled in the production position (10), in particular sections of the machine equipment which is not accessible during the cleaning process of the cleanroom area, in particular the germ- and / or residue-reducing cleaning process, for example decontamination, and / or is not provided germ-free in the closed casing (80), is not exposed. [16] Device according to any of the preceding claims, characterized by, that the covering (80) is designed such that when the machine element (7) is exposed with respect to the covering (80), at least a part of the covering (80) remains on the machine element (7) or in a setup position (11). [17] Device according to any of the preceding claims, characterized by , that an element of the enclosure (80) has a base surface, such that in a top view the machine element (7) is completely projected onto the base surface, wherein in particular this element is a dimensionally stable component (801, 804, 805, 807, 808), in particular a bottom element, for example a trough-shaped bottom element and / or a base plate, and / or a part of the casing (80) which remains attached to the machine element (7) or in a setup position (11). [18] Device according to any of the preceding claims, characterized bythat the enclosure (80) is designed to accommodate at least two machine elements (7), wherein in particular the device (8) comprises a positioning device (82) arranged in the enclosure (80). [19] Device according to any of the preceding claims, characterized by , that the machine element (7) received by the enclosure (80) can be positioned in a setup position (11) in the cleanroom area in a closed state of the enclosure (80), wherein in particular the machine element (7) received by the enclosure (80) can be positioned in the setup position (11) so that the section exposed outside the enclosure (8), in particular an assembly section (70), is at least partially accessible for cleaning during a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example a decontamination, of the cleanroom area, and / or by moving the machine element (7) from the setup position (11) to the production position (10) and / or in the direction of the production position (10) the covering (80) can be opened, and / or a movement of the machine element (7) from the setup position (11) to the production position (10) and / or in the direction of the production position (10) is coupled with an adjustment movement of an element of the enclosure (80) to open the enclosure (80). [20] Device according to the preceding claim, characterized by. that a transfer device is provided to move the machine element (7) from the setup position (11) to the production position (10) after or during the opening of the casing (80), in particular semi- or fully automatically, and / or the machine element (7) is mounted in the cleanroom area in a manner that allows movement from the setup position (11) to the production position (10), in particular in a linearly displaceable and / or rotatable manner. [21] Device according to one of the two preceding claims, characterized by, that the setup position (11) is equal to the production position (10) in at least one degree of freedom, wherein in particular the machine element (7) can be attached to a bearing point in the cleanroom area, in particular on the machine equipment, with at least one degree of freedom, for example with exactly one degree of freedom or with two degrees of freedom, and the machine element (7) attached to the bearing point is adjustable between the setup position (11) and the production position (10), in particular rotatable and / or linearly adjustable, in particular height-adjustable. [22] Device according to any of the preceding claims, characterized by, that a manipulator (81) is provided, wherein the manipulator (81) is configured to open the enclosure (80) and / or to expose the machine element (7) with respect to the enclosure (80) and / or to remove the machine element (7) from the enclosure (80) and / or to move the machine element (7) into the production position (10) and / or to couple the machine element (7) in the production position (10) with at least one other element of the machine equipment, in particular after a cleaning process of the cleanroom area, in particular a germ- and / or residue-reducing cleaning process, for example a decontamination, of the cleanroom area. [23] Plant (1) for carrying out process steps on objects, in particular on containers, for example on pharmaceutical containers, at least partially under cleanroom conditions, the system (1) comprises a machine setup and a cleanroom setup with a housing (6), wherein the cleanroom condition can be created in a cleanroom area of ​​the housing (6), wherein the machine equipment is arranged in the cleanroom area of ​​the housing (6), wherein the machine equipment comprises at least one machine element (7) which is coupled in a production position (10) with at least one further element of the machine equipment, wherein in particular a mounting section (70) of the machine element (7) in the production position (10) contacts a counter section of the at least one further element and / or the housing (6), wherein a device (8) for setting up the system according to one of the preceding claims is provided. [24] Plant according to the preceding claim, characterized by, that the machine element (7) is part of a process station (2, 3), wherein the machine element (7) is in particular attachable and removable from other parts of the process station (2, 3), wherein in particular the process station (2, 3) is an unpacking station and / or a filling station and / or a sealing station and / or a control station and / or a sorting station (42). [25] Plant according to one of the two preceding claims, characterized by that the machine element (7) is part of a transport device (44), wherein the machine element (7) is in particular attachable and removable from other parts of the transport device (44), wherein in particular the transport device (44) is designed for transporting the objects, in particular containers, separately and / or in a carrier. [26] Plant according to one of the preceding claims directed to a plant (1), characterized by, that the machine element (7) is part of a feeding system (4) for feeding packaging materials interacting with the objects to a process station (2, 3), wherein the machine element (7) is in particular attachable and removable from other parts of the feeding system (4), wherein in particular the feeding system (4) comprises at least a transport device (44) and / or a storage unit (40) and / or a feeding station, in particular a sorting station (42). [27] Plant (1) for carrying out process steps on objects, in particular on containers, for example on pharmaceutical containers, at least partially under cleanroom conditions, the system (1) comprises a cleanroom setup with a housing (6), wherein the cleanroom condition can be created in a cleanroom area of ​​the housing (6), in particular a system comprising a feature of one of the preceding claims directed to a system (1), characterized by , that the facility includes a treatment unit for germ elimination, in particular the treatment unit including a chamber for carrying out the process of germ elimination, in particular the treatment facility for steam sterilization is designed as a process for germ elimination and / or the treatment facility includes an autoclave. [28] Plant according to one of the preceding claims directed to a plant (1), characterized by, that the facility, in particular the cleanroom setup and / or the treatment equipment, is designed so that an object which has been subjected to a process for germ elimination by the treatment equipment can be moved from the treatment equipment, in particular its chamber, to the cleanroom area of ​​the housing of the cleanroom setup without passing through a less clean environment, wherein the less clean environment does not meet any or at most a less cleanroom condition than the treatment equipment, in particular its chamber, and / or the cleanroom area. [29] Plant according to any of the preceding claims directed to a plant (1), characterized bythat the system includes a through-pass unit which is designed to connect the treatment device and the housing in such a way that an object can be moved between the treatment device, in particular its chamber, and the cleanroom area of ​​the housing of the cleanroom structure through a passage of the through-pass unit, wherein in particular the through-pass unit is arranged in a stationary position.

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