Controlled environment with a device, pharmaceutical installation, and method for monitoring microbiological contaminations in a controlled environment

Abstract

The object underlying the invention is to continuously monitor microbiological contaminations within a controlled environment (2) in an area (4) delimited from the controlled environment (2) without interrupting a process taking place within the controlled environment (2).

Description

[0001] PC 26 0262 C March 18, 2026

[0002] Controlled environment with a device, pharmaceutical plant and method for monitoring microbiological contamination in a controlled environment

[0003] The invention relates to a controlled environment with a device for monitoring microbiological contamination in a controlled environment, preferably in an isolator, with at least one area delimited from the controlled environment, wherein a fluid flow from the controlled environment can be directed, wherein the fluid flow passes through a disposal medium arranged in the delimited area.

[0004] The invention further relates to a controlled environment with a device for monitoring microbiological contamination in a controlled environment, preferably an isolator, with at least one area separated from the controlled environment, wherein a fluid flow from the controlled environment can be directed.

[0005] The invention further relates to a controlled environment with a device for monitoring microbiological contamination in a controlled environment, preferably an isolator, with at least one area delimited from the controlled environment, wherein a fluid flow from the controlled environment can be directed, wherein the fluid flow passes through a disposal medium in a delimited and / or decontaminable area.

[0006] The invention further relates to a method for monitoring microbiological contamination in a controlled environment, preferably an isolator, wherein a fluid flow, in particular an air flow, is discharged from the controlled environment, wherein the fluid flow discharged from the controlled environment is collected in a device controlled by the PC 26 0262 C 2 / 74 18 March 2026

[0007] A landfill material passes through a delimited and / or decontaminated area in the surrounding environment.

[0008] The invention further relates to a method for monitoring microbiological contamination in a controlled environment, preferably an isolator, wherein a fluid stream, in particular an air stream, is discharged from the controlled environment, wherein the fluid stream discharged from the controlled environment passes through a disposal agent that is arranged in a demarcated and / or decontaminable area.

[0009] The invention further relates to a method for monitoring microbiological contamination in a controlled environment, preferably an isolator, wherein a fluid stream, in particular an air stream, is discharged from the controlled environment, wherein the fluid stream discharged from the controlled environment passes through a depositing medium (for example, exposed via a presentation medium) which is arranged in a delimited area.

[0010] The invention further relates to a method for monitoring microbiological contamination in a controlled environment, preferably an isolator, wherein a fluid stream, in particular an air stream, is discharged from the controlled environment, wherein the fluid stream discharged from the controlled environment passes through a disposal medium (for example, exposed via a presentation medium) which is arranged in a demarcated and / or decontaminable area.

[0011] The invention further relates to the use of an encapsulated unit for transporting a depositing agent and / or a nutrient medium to a position of use in which the depositing agent is exposed in a fluid stream. PC 26 0262 C 3 / 74 18 March 2026

[0012] Finally, the invention relates to the use of a port door for handling, in particular for transporting, an object that is arranged in an encapsulated unit that can be coupled to the port.

[0013] Finally, the invention relates to a method for monitoring microbiological contamination in a controlled environment, preferably an isolator, wherein a fluid stream, in particular an air stream, is discharged from the controlled environment, wherein the fluid stream discharged from the controlled environment passes through a disposal agent that is arranged in a demarcated and / or decontaminable area.

[0014] The invention is based on the objective of simplifying the monitoring of a controlled environment for microbiological contamination.

[0015] Devices and methods for monitoring microbiological contamination in a controlled environment are known from practice; for example, a nutrient medium is introduced directly into the controlled environment, such as an isolator.

[0016] To solve the aforementioned problem, the features of claim 1 are provided according to the invention. In particular, to solve the aforementioned problem in a controlled environment with a device of the type described above, it is proposed according to the invention that contacting means for contacting the depositing agent with a nutrient medium are provided in the delimited area.

[0017] Thus, the invention makes it possible to detect microbiological contaminants early and continuously within a PC 26 0262 C 4 / 74 18 March 2026

[0018] to detect and monitor controlled environments without the monitoring itself posing a contamination risk to the controlled bypass. This significantly simplifies monitoring.

[0019] A controlled environment can be characterized, for example, as a confined space in which defined environmental conditions, particularly with regard to air purity and / or surface cleanliness, can be created and / or maintained, for instance, by controlling air exchange with the outside world. Air exchange control can be achieved, for example, by completely preventing air exchange during normal operation (e.g., except for closed-loop air circulation) and / or by consistently specifying a direction of air exchange (into or out of the controlled environment). Examples of controlled environments include isolators, restricted access barrier systems (particularly open or closed types), containments, gloveboxes, and / or cleanrooms in general.Within the controlled environment, particularly the containment or isolator, various processes for handling a wide range of products, such as pharmaceutical products, can take place, thereby reducing the risk of contamination of at least one product by particles and / or microbiological impurities from outside and / or to the outside of the controlled environment. Such pharmaceutical products may, for example, each contain a pharmaceutical container for a pharmaceutical preparation. A list of examples of such pharmaceutical containers includes at least vials, syringes, cartridges (cylindrical ampoules), and other refillable pharmaceutical containers, as well as all other refillable pharmaceutical containers. (PC 26 0262 C 5 / 74 18 March 2026)

[0020] which requires aseptic handling.

[0021] Another characteristic of a controlled environment can be the ability to introduce purified air. This can be ensured by filters, especially HEPA filters (High Efficiency Particulate Air filters), which, for example, form the upper boundary of a controlled environment as large as possible within isolators.

[0022] A demarcated area can be understood, for example, as an area that is distinguishable from the controlled environment and / or the outside world, in particular by being lockable and / or spatially separable. The demarcated area can also fulfill the previously described requirements of a controlled environment and thus, for example, constitute another controlled or at least controllable environment.

[0023] The fluid flow can, for example, be an air flow that is preferably actively drawn from the controlled environment, for example by means of a pump, and directed to the demarcated area.

[0024] Another characteristic of a controlled environment can be the ability to control the airflow. This makes it more difficult for contaminants to accumulate unintentionally.

[0025] The depositing material can be, for example, a permeable filter element, such as one made of gelatin, or a plate, such as one made of gelatin.

[0026] The disposal agent can, for example, consist of a material that dissolves on a nutrient medium. This allows for residue-free or virtually residue-free transfer of deposited contaminants, particularly from an internal PC 26 0262 C 6 / 74 18 March 2026

[0027] of the depositing agent, onto the nutrient medium upon contact. For example, the gelatin dissolves and / or decomposes almost completely, especially partially, upon contact with a particularly moist agar-agar plate, so that colonies of microbiological contaminants become visible.

[0028] For example, the partial dissolution of the gelatin on the agar-agar plate can also occur during incubation, depending on temperature and humidity. This makes the gelatin particularly advantageous as it becomes soft and transparent, thus facilitating the growth and evaluation of colonies of microbiological contaminants. Evaluation can be performed, for example, by identification and / or CFU (colony forming units) counting.

[0029] A suitable gelatin filter is also advantageously biodegradable and soluble at temperatures above approximately 30 °C. For incubation (transfer of impurities to the nutrient medium), the filter is placed directly onto the agar, usually TSA (Tryptic Soy Agar). As already mentioned, the filter is not completely absorbed or dissolved, but it is significantly liquefied, allowing microorganisms and microbiological contaminants to continue growing on the agar.

[0030] The structure of the gelatin filters is thus initially preserved, which is highly advantageous, but it softens over time and partially dissolves, although it does not completely transfer into the agar-agar. Therefore, germs can be collected from the air and subsequently used as a carrier medium for cultivation.

[0031] The landfill material can, for example, be sugar-free and / or protein-based. Thus, the landfill material cannot be PC 26 0262 C 7 / 74 18 March 2026

[0032] It should be suitable for immediate incubation. However, it is advantageous that the depositing agent does not dry out or only dries out very slowly, which makes longer-term use difficult with culture media.

[0033] In general, a deposition agent within the meaning of the invention can be understood as a preferably thin-walled element arranged in the flow path of the fluid stream, which allows microbiological contaminants to be captured and / or absorbed. A deposition agent designed as a gelatin plate has the outstanding advantage that microbiological contaminants can adhere to it as soon as they come into contact with the gelatin. A significant advantage of gelatin plates is that, as already described, they dissolve almost completely in the culture medium, and ideally, all or nearly all of the microbiological contaminants adhering to the gelatin plate can then be transferred to the culture medium.

[0034] The nutrient medium can be, for example, jelly-like, solid, especially as agar, or liquid, especially as broth, and serves to detect and / or prove microbiological growth.

[0035] Agar-agar is a gelling agent derived from red algae. It forms a solid, jelly-like substance that serves as a carrier medium for nutrients. Microorganisms, especially microbiological contaminants, do not grow directly on the agar itself, but rather on the nutrients dissolved within it (e.g., tryptic soybeans, blood, etc.).

[0036] Agar melts at approximately 85°C and solidifies at approximately 40 to 45°C, which offers a significant advantage: it can be heated and cooled without changing shape. PC 26 0262 C 8 / 74 18 March 2026

[0037] Agar liquefies again at incubation temperatures (>30°C). Furthermore, agar offers the advantage of a stable surface on which colonies can grow separately, which is important for counting and identifying microorganisms. However, agar itself does not serve as a nutrient source for microorganisms; therefore, without the addition of nutrients such as peptone, glucose, blood, etc., no microbial growth occurs.

[0038] The nutrient medium and the depositing agent can, for example, be part of an encapsulated unit that can be connected to the enclosed environment via a port, wherein the depositing agent and the nutrient medium are initially spatially separated from each other by at least one interface within the encapsulated unit, for example, a removable closure covering the nutrient medium, such as a nutrient medium closure. The encapsulated unit can, for example, be formed from two separable units that can, in turn, be coupled together.A first unit can, for example, consist of a base body with a placeholder for the second unit containing the nutrient medium, a lid. The depositing material, through which the fluid flows, can be placed at the bottom of the base body, which in turn is supported by a base or contact point of the base body that is at least partially permeable to the fluid. The unit containing the nutrient medium can be the lid, into which a spring element, a nutrient medium holder, and the nutrient medium itself can be inserted. The lid can be coupled to the nutrient medium closure by force-fit and / or form-fit, for example, using a bayonet fitting. This seals the nutrient medium and pre-tensions the spring element. Furthermore, the base body can be connected to the lid by force-fit and / or form-fit, for example, via a bayonet fitting. PC 26 0262 C 9 / 74 18 March 2026.

[0039] The closure consists of a base and a lid, forming a sealed unit. When the base, at whose base the depositing material can be placed and supported, is coupled to the lid of the second unit, thus forming the sealed unit, the depositing material and the nutrient medium are spatially separated from each other by the lid's closure, which covers the nutrient medium, as previously mentioned. To expose the depositing material to the fluid flow, the lid is first placed in a separate area within the enclosed space. This can be done using a handling device, which is described in more detail below.

[0040] Once the fluid flow has passed through the depositional medium, the lid of the encapsulated unit, which covers the nutrient medium, can be removed. This allows the nutrient medium carrier, along with the nutrient medium, to be moved by the spring return force of the pre-tensioned spring element. As soon as the base body, at whose contact point the depositional medium is placed, is in the same plane of movement as the lid, contact between the nutrient medium and the depositional medium is established. The spring-mounted nutrient medium and the base of the depositional medium form the contact points.

[0041] Particularly advantageous is the prevention of contamination of the controlled environment during contact or monitoring by establishing contact between the depositing material and the nutrient medium within a defined area, and thus outside the controlled environment. The nutrient medium is therefore not directly traversed by the fluid flow; rather, passive contact between the fluid flow and the nutrient medium occurs via the depositing material within the defined area. Thus, a PC 26 0262 C 10 / 74 18 March 2026

[0042] The process occurring within the controlled environment cannot be interrupted. Furthermore, due to the contacting means, contact can be established very advantageously without external intervention.

[0043] In a further advantageous embodiment, it can be provided that the contacting means can be actuated from outside the demarcated area.

[0044] A particularly advantageous aspect is that the contacting means do not require any intervention in the defined area. For example, it can be provided that the contacting means are operated manually and / or automatically controlled.

[0045] In particular, the contacting devices can be driven from outside the demarcated area.

[0046] For example, the contacting means can be driven by a motor. Advantageously, the motor for driving the contacting means is located outside the enclosed area to prevent contamination of the enclosed area by the motor.

[0047] Alternatively or additionally, the features of the dependent claim, which relates to a controlled environment with a device, are provided according to the invention to solve the aforementioned problem. In particular, to solve the aforementioned problem in a controlled environment with a device of the type described at the outset, it is proposed according to the invention that guiding means are designed for a defined and / or guided contact of the depositing agent with the nutrient medium or a nutrient medium. PC 26 0262 C 11 / 74 18 March 2026

[0048] The features defined in the claim may be features that have already been described and / or claimed.

[0049] The guiding means can, for example, guide the contacting means.

[0050] A particularly advantageous aspect is achieving controllable and / or guided contact between the depositing material and the nutrient medium. For example, this allows for relative movement between the depositing material and the nutrient medium, thus enabling contact with the nutrient medium, which may be spring-mounted. If, for instance, a gelatin disc is used as the depositing material, the guided and / or defined contact ensures that it is completely absorbed by the nutrient medium, such as agar.

[0051] For example, the device can have a movable housing section that can be moved translationally, for example up and down. It can be provided, for example, that the movable housing section at least partially surrounds the encapsulated unit already described, in particular the base body of the encapsulated unit, which in turn advantageously enables the defined and / or guided contact of the depositing agent with the nutrient medium as claimed above. Furthermore, it can be provided that the base body can be coupled to the movable housing section via the port by means of a force-fit and / or form-fit connection, for example by means of a bayonet fitting.

[0052] Furthermore, it may be provided, for example, that the lid of the encapsulated unit has a coupling element which is connected to PC 26 0262 C 12 / 74 18 March 2026

[0053] A counter-coupling element interacts with a movable handling device in a force-fit and / or form-fit manner. It can be provided that the counter-coupling element can also be moved in such a way that the lid, together with the nutrient medium and closure, is advantageously detached from the base body and positioned in or in a separate area within the delimited area, whereby, after removal of the lid, the depositing medium in the base body is exposed. Furthermore, this exposes or opens a feed section upstream of the port for supplying the fluid flow, which was previously closed by the handling device. The feed section can define a suction point for the fluid flow from the controlled environment. Furthermore, the feed section can be coupled to a fluid inlet line that carries the fluid flow from the controlled environment and thus defines the suction point for the fluid flow.It may be stipulated that a pipe length of less than or equal to one meter is determined between the suction point for the fluid flow and the depositing material.

[0054] For example, it may also be provided that the guiding device performs rotary movements.

[0055] The handling device can, for example, be moved such that the base body, which is preferably coupled to the lid of the encapsulated unit by means of a bayonet fitting, can be released. The base body can also be coupled to the movable housing section via the port by means of a force-fit and / or form-fit connection, for example, also by means of a bayonet fitting. As soon as the lid has been picked up by the counter-coupling element of the handling device and moved into the separate area, the movable housing section can be moved, as described in more detail below, such that the PC 26 0262 C 13 / 74 18 March 2026

[0056] The depositing medium placed in the base body rests closely against the feed section and completely fills a fluid flow path, for example, by selecting a fluid flow path perpendicular to the longitudinal orientation of the depositing medium. After the fluid flow has passed through the depositing medium, the base body can be moved away from the feed section, and the lid, without the closure covering the nutrient medium, can be moved by the movable handling device back to its original position, thus aligning it with the depositing medium in a common plane and / or axis. Subsequently, the housing section, which is movable via guide elements, can be moved, in particular driven, towards the lid with the nutrient medium exposed, thereby enabling contact between the nutrient medium and the depositing medium via the contacting means and guide elements already described.

[0057] Defined contact can be understood as the ability to achieve sufficient and definable pressing force between the depositing material and the nutrient medium via the guiding means. Guided contact can be understood as the prevention of the depositing material and / or the nutrient medium being oriented differently relative to each other during contact.

[0058] For example, it may be provided that the movement sequences of the guidance devices are capable of being driven, regulated and / or controlled.

[0059] In a further advantageous embodiment of the invention, the guide means can form a linear guide. A linear guide can facilitate contact between two planar objects without introducing bending stress that could cause the materials to break. PC 26 0262 C 14 / 74 March 18, 2026

[0060] For example, it can be provided that the elements connected to the guide elements, such as contact elements, can perform upward, downward, and / or lateral movements to establish contact between the depositing material and the nutrient medium. Furthermore, it can also be provided that rotary movements can be performed via the guide elements. This allows for a particularly advantageous range of movements. In addition to a linear guide, the guide elements can also consist of other guides that enable movements in all degrees of freedom.

[0061] In general, the guidance means and / or the contact means of robots can be formed.

[0062] In a further advantageous embodiment, it can be provided that the nutrient medium is spring-supported.

[0063] For example, the nutrient medium can be supported within the lid by the previously described spring element. Particularly advantageously, when the lid's closure covering the nutrient medium is removed, especially in the manner already described, the spring restoring force can move the nutrient medium so that it extends over an axial end of the lid, thus facilitating and / or improving contact with the depositing material via the contacting means and guides, preferably driven by a motor.

[0064] In a further advantageous embodiment of the invention, a particle counter can be installed upstream of the disposal agent. PC 26 0262 C 15 / 74 18 March 2026

[0065] The particle counter can, for example, be used to record the number of particles of contaminants.

[0066] For example, it may be provided that the particle counter is arranged in the controlled environment and / or in the demarcated area on a fluid line and / or the or a feed section.

[0067] A particular advantage is that monitoring for microbiological contamination can thus be supplemented by functionally different methods to provide quantitative information, such as the number and / or size of the microbiological contaminants. Furthermore, the particle counter can be used to more precisely pinpoint the time of microbiological contamination, which in turn allows batches processed within the controlled environment to be sorted out early.

[0068] The advantage of such a combination is that it allows for a faster reaction time to interrupt the process carried out within the controlled environment.

[0069] Another advantage is that the particle counter can determine the number of possible contaminants, while the nutrient medium can be used to detect the type of contamination.

[0070] Alternatively or additionally, to solve the aforementioned problem, the features of the dependent claim, which relates to a controlled environment with a device, are provided according to the invention. In particular, to solve the aforementioned problem in a controlled environment with a device of the type described at the outset, it is thus proposed according to the invention that the decontaminated and / or confined PC 26 0262 C 16 / 74 18 March 2026

[0071] The area has a port to which a base body of an encapsulated unit can be docked, and the encapsulated unit has a lid removable via the port and receives a nutrient medium, and the base body in the operating position guides a section of the fluid flow, and the section of the fluid flow is guided through the port to the disposal medium.

[0072] The features defined in the claim may be features that have already been described and / or claimed.

[0073] The encapsulated unit can be the encapsulated unit already described and / or claimed. A particular advantage of the encapsulated unit is that it can also be used during toxic processes (and thus also during toxic fluid flows that are discharged) without risking toxic contamination of the outside environment when the encapsulated unit is disconnected.

[0074] The operating position of the base body of the encapsulated unit can be understood as the position in which the fluid flow is directed via the port to the depositing medium.

[0075] The decontaminable area can correspond to the already described and / or claimed delimited environment. Furthermore, the decontaminable area can be part of the controlled environment or constitute the controlled environment. The decontaminable area is also the area of ​​the device that is decontaminated before being monitored for microbiological contamination, preferably using hydrogen peroxide.

[0076] This makes it particularly advantageous to ensure, prior to monitoring for microbiological contamination, that the controlled environment and / or the decontaminable PC 26 0262 C 17 / 74 18 March 2026

[0077] The area must be free of microbiological contamination before monitoring takes place.

[0078] Furthermore, it is advantageous that the cover can be removed via the port itself, for example using the handling device already described, so that no additional intervention from outside the decontaminated and / or demarcated area is necessary. Monitoring for microbiological contamination can thus be carried out continuously during a process taking place within the controlled environment without having to stop it and without risking microbiological contamination entering the controlled environment itself as a result of the monitoring.

[0079] In a further advantageous embodiment of the invention, it can be provided that the lid and / or the base body has a coupling element that can be coupled to a counter-coupling element of the port.

[0080] For example, it may be provided that the lid and / or the base body of the encapsulated unit is docked to or coupled with the port by means of a bayonet fitting, which particularly advantageously enables quick coupling and / or decoupling of the encapsulated unit to the port.

[0081] A further advantageous embodiment of the invention may provide that the encapsulated unit forms a fluid-permeable attachment point and / or presentation means for the depositing material.

[0082] The fluid-permeable installation point and / or the presentation equipment could, for example, be the already PC 26 0262 C 18 / 74 18 March 2026

[0083] The described substrate is for contacting means.

[0084] This allows the depositing material to be precisely received by the base body of the encapsulated unit, which is particularly advantageous. Due to the fluid permeability, the fluid flow, after passing through the depositing material, can pass the injection point and be advantageously discharged from the encapsulated unit. Below the depositing material and the fluid-permeable injection point, a subfloor formed by the base body of the encapsulated unit, through which the fluid flow can be directed to a fluid outlet, can be provided. This constitutes the fluid flow section.

[0085] In a further advantageous embodiment of the invention, the base body can be designed to permanently hold the depositing material. This can be achieved, for example, by a form-fit, force-fit, and / or material-fit connection.

[0086] A captive fastening or mounting can be characterized, for example, by the fact that uncontrolled, automatic detachment is prevented, at least up to a predefined stress. This does not preclude the possibility of intentional detachment.

[0087] For example, it may be provided that the fluid-permeable installation point and / or the presentation means has circumferentially formed hooks that at least partially encircle the deposited material.

[0088] This allows for particularly advantageous locking, positioning, and / or fixing of the depositing material. PC 26 0262 C 19 / 74 March 18, 2026

[0089] In a further advantageous embodiment, the invention can provide that the lid irretrievably receives the nutrient medium.

[0090] This can be achieved, for example, by means of a nutrient medium carrier, which advantageously allows the nutrient medium to be locked, positioned and / or fixed in the lid.

[0091] In a further advantageous embodiment of the invention, it can be provided that the encapsulated unit has a non-return valve in the section of the fluid flow.

[0092] Particularly advantageous is the fact that the fluid flow supplied to the landfill material via the port, after passing through the landfill material and the fluid-permeable installation point, can be directed to the fluid outlet with the non-return valve, thereby preventing backflow of the fluid, in particular backflow of the fluid flow from the base body back into the controlled environment.

[0093] The fluid outlet can be connected to a fluid outlet line, in particular a suction line, which directs the fluid flow, for example to the outside world.

[0094] In a further advantageous embodiment of the invention, it can be provided that the decontaminated area is the controlled environment, a part of the controlled environment, or an area delimited from the controlled environment.

[0095] In particular, the controlled environment is decontaminated before monitoring for microbiological contamination. The fluid stream containing the decontamination agent is discharged from the controlled environment in a similar manner and returned to the controlled environment. PC 26 0262 C 20 / 74 18 March 2026

[0096] a demarcated area is maintained, which then forms the decontaminated area. Furthermore, it may be provided, for example, that the controlled environment contains a separate decontamination system. It may also be provided that the decontaminated area itself is part of or forms part of the controlled environment, thereby advantageously enabling various monitoring options for microbiological contamination.

[0097] Particularly advantageous is the ability to also decontaminate the demarcated area to ensure that microbiological contaminants are not already present in the demarcated and / or decontaminable area or controlled environment prior to monitoring.

[0098] It can be designed so that the lid holds the nutrient medium and the base body the depositing agent. This is particularly advantageous because all the materials necessary for detecting microbiological contamination can be stored in the same encapsulated unit and yet moved independently.

[0099] Furthermore, the previously described advantages of the depositing material and / or the nutrient medium result.

[0100] In a further advantageous embodiment of the invention, it can be provided that the delimited area or the decontaminated area has a movable housing section.

[0101] The movable housing section can be the movable housing section already described and / or claimed, over which the base body can advantageously be moved. Furthermore, the PC 26 0262 C 21 / 74 18 March 2026

[0102] The port receiving the base body can be part of the movable housing section. For example, the port is formed by a recess in the movable housing section that is adapted to the base body.

[0103] In particular, the movable housing section allows the fluid flow section to be connected to the upstream feed section and / or the nutrient medium to be brought into contact with the disposal medium.

[0104] This allows for highly advantageous, fully autonomous monitoring for microbiological contamination. Connecting the fluid flow section to the upstream feed section can mean that the base body, including the depositing agent, is connected to the feed section upstream of the port, in particular the port, in the manner already described, in order to present the depositing agent perpendicular to the fluid flow direction. This can be achieved, for example, via previously described and / or claimed guiding means. Furthermore, contact between the nutrient medium and the depositing agent can also be facilitated via previously described and / or claimed guiding means and / or contacting means, as already described, thereby realizing previously described features.

[0105] In a further advantageous embodiment of the invention, it can be provided that the movable housing section of the delimited area is connected to a flexible seal.

[0106] It may be provided that the movable housing section is movably connected to the flexible seal, whereby movement of the flexible seal is enabled by a force-fit and / or form-fit coupling with the PC 26 0262 C 22 / 74 18 March 2026

[0107] The movable housing section can be initiated. The flexible seal can advantageously define a maximum and a minimum translational movement range for the movable housing section.

[0108] The flexible seal is advantageously designed outside of the flow path of the fluid flow.

[0109] Due to the flexible seal, the demarcated and / or decontaminated area can be advantageously separated from the outside world, which in turn prevents microbiological contaminants from penetrating the demarcated and / or decontaminated area from the outside.

[0110] Alternatively or additionally, the features of the dependent claim, which relates to a method, are provided according to the invention to solve the aforementioned problem. In particular, it is thus proposed according to the invention that, in a method of the type described at the outset, the delimited area is decontaminated to solve the aforementioned problem.

[0111] A particularly advantageous aspect is that the demarcated area can be decontaminated independently of the controlled environment. For example, if an ongoing process within the controlled environment is planned to last longer than the monitoring for microbiological contamination of a single landfill material allows (a landfill material can be used for approximately eight hours before it dries out and / or becomes unusable), a new landfill material can be introduced into the demarcated area and decontaminated beforehand without interrupting the process within the controlled environment. A particular advantage is therefore that PC 26 0262 C 23 / 74 18 March 2026

[0112] the encapsulated unit can be replaced without interrupting a process within the controlled environment for carrying out decontamination.

[0113] Alternatively or additionally, the features of the dependent claim, which relates to a method, are provided according to the invention to solve the aforementioned problem. In particular, it is thus proposed according to the invention to solve the aforementioned problem in a method of the type described at the outset that the depositing agent, after exposure in the fluid stream, is brought into contact with a nutrient medium in the delimited area.

[0114] The features defined in this claim may be features that have already been described and / or claimed.

[0115] It is particularly advantageous that the nutrient medium itself does not need to be actively brought into contact with the fluid flow. This, in turn, reduces the risk of contamination because no interface adjacent to the controlled environment needs to be opened for the introduction and / or removal of the nutrient medium to check for microbiological contamination, thus preventing external contaminants from entering the controlled environment. Furthermore, contact between the depositing material and the nutrient medium does not occur within the controlled environment itself, allowing for the monitoring of microbiological contamination without interrupting any process taking place within the controlled environment.

[0116] In a further advantageous embodiment of the invention, it can be provided that the disposal agent during the PC 26 0262 C 24 / 74 18 March 2026

[0117] Exposure is arranged outside the controlled environment.

[0118] As already described, the depositing material can be passed outside the controlled environment in the demarcated area of ​​the fluid flow, resulting in the advantages already described.

[0119] In a further advantageous embodiment, it can be provided that the nutrient medium and / or the depositing medium are moved at least partially along a contacting direction for the purpose of contacting.

[0120] This can be particularly advantageous as it enables improved contact between the nutrient medium and the depositing material. For example, the nutrient medium and / or the depositing material can be spring-mounted, and other techniques for extending the depositing material and / or the nutrient medium, such as by rotating and / or pushing, can also be incorporated.

[0121] Alternatively or additionally, the features of the dependent claim, which relates to a method, are provided according to the invention to solve the aforementioned problem. In particular, it is thus proposed according to the invention to solve the aforementioned problem in a method of the type described at the outset that the deposition agent, after exposure in the fluid stream, is brought into contact with the nutrient medium in a defined and / or decontaminated area, in particular in a guided manner.

[0122] The features defined in the claim may be features that have already been described and / or claimed.

[0123] It can therefore be achieved particularly advantageously that the PC 26 0262 C 25 / 74 18 March 2026

[0124] Contact between the depositing material and the nutrient medium is carried out in a controlled manner, so that it can be ensured that the contact is sufficient to transfer microbiological contaminants from the depositing material to the nutrient medium.

[0125] For example, it may be provided that contacting means and / or guiding means already described and / or claimed are used for contacting in the manner already described.

[0126] In a further advantageous embodiment, the demarcated area can be arranged outside the controlled environment. This allows for a structural separation of the demarcated area from the controlled environment.

[0127] In a further advantageous embodiment, the demarcated area can be accessed independently of the controlled environment. This allows for the decoupling of the demarcated area from the controlled environment.

[0128] In a further advantageous embodiment, the demarcated area can be accessed from outside the controlled environment. This allows for the replacement of consumables without disruption or with minimal disruption to the controlled environment.

[0129] In a further advantageous embodiment, the delimited area can be fluidically connected to the controlled environment via a feedthrough in a wall that delimits the controlled environment. Thus, an intervention in the controlled environment is avoided. PC 26 0262 C 26 / 74 18 March 2026

[0130] especially when the demarcated area is processed.

[0131] In an alternative embodiment, an encapsulated unit, such as the one already mentioned, which preferably contains the landfill material in a tightly sealed manner, can be designed as an impactor. This allows the use of conventional landfilling methods.

[0132] Alternatively or additionally, it can be provided that an encapsulated unit, such as the one already mentioned, which preferably contains the landfill material in a tightly sealed manner, is designed to allow the landfill material to flow through it. An advantage of this is that drying out of the landfill material is avoided.

[0133] Preferably, an upper shell of the base body is designed to allow the connection of a conventional disposable impactor.

[0134] In a preferred application, the invention provides a pharmaceutical plant comprising a controlled environment and a device, particularly as described above and / or claimed below. Thus, the invention enables pharmaceutical processes to be monitored continuously, regularly, or at short intervals with minimal intervention in the controlled environment.

[0135] Alternatively or additionally, the features of the dependent claim, which relates to a method, are provided according to the invention to solve the aforementioned problem. In particular, it is thus proposed according to the invention to solve the aforementioned problem in a method of the type described at the outset that the disposal agent is applied to the PC 26 0262 C 27 / 74 18 March 2026 before exposure in the fluid stream in the or an encapsulated unit.

[0136] or is docked to a demarcated and / or decontaminated area and that the encapsulated unit guides a section of the fluid flow during exposure.

[0137] The features defined in the claim may be features that have already been described and / or claimed.

[0138] The docking of the encapsulated unit, i.e. the lid together with the base body, can be carried out particularly advantageously in the manner already described, in particular via a bayonet connection between the base body and the port, whereby at the same time the lid is also coupled to the handling device via a bayonet connection.

[0139] Before the fluid flow is directed to the disposal material, the lid is simultaneously decoupled from the base body and, as already described, positioned in a separate area of ​​the demarcated and / or decontaminated environment, so that the fluid flow path or a feed section is exposed and the section of the fluid flow is directed through the base body.

[0140] In a further advantageous embodiment, it can be provided that at least parts of the encapsulated unit, in particular the base body, are made from components already available on the market, preferably as parts of the “BioCapt” from PMS (Particle Measuring Systems) and / or as a lower shell, as described below.

[0141] A particularly advantageous feature is the ability to quickly attach and detach the encapsulated unit. For example, after contact between the depositing material and the nutrient medium, the entire encapsulated unit can be easily detached and a new encapsulated unit attached. It may also be possible, for example, to ensure that PC 26 0262 C 28 / 74 18 March 2026

[0142] Several encapsulated units can be docked to the decontaminated and / or demarcated area, for example via several ports, in order to perform parallel monitoring for microbiological contamination.

[0143] In a further advantageous embodiment of the invention, it can be provided that after docking the encapsulated unit or a unit receiving the depositing material, a feed section for the fluid flow is connected to the encapsulated unit.

[0144] The feed section may be the feed section already described and / or claimed.

[0145] The encapsulated unit that receives the depositing material can be the basic body already described and / or claimed.

[0146] For example, the connection of the base body to the feed section can be achieved by means of a movable housing section. This allows the fluid flow to be directed to the disposal material via the feed section, which is particularly advantageous.

[0147] In a further advantageous embodiment of the invention, it can be provided that the fluid flow is passed through a particle counter to detect a particle number and / or particle size, in particular wherein the same fluid flow is subsequently directed to the disposal medium.

[0148] The particle counter can be the particle counter already described and / or claimed, for example. As already described, it can thus advantageously be achieved that the PC 26 0262 C 29 / 74 18 March 2026

[0149] Monitoring for microbiological contamination using functionally different methods can be supplemented with quantitative information, such as the number and / or size of the microbiological contaminants. Furthermore, the particle counter can be used, for example, to more precisely pinpoint the time of contamination.

[0150] Alternatively or additionally, in particular a partial volume of the fluid flow is diverted, especially wherein the diverted fluid flow is transferred to the particle counter.

[0151] Parallel monitoring for microbiological contamination can therefore be particularly advantageous. For example, the particle counter can also be used advantageously even when no encapsulated unit is docked, such as when contact is taking place between the depositing material and the nutrient medium and the feed section is closed.

[0152] Alternatively or additionally, it may be provided that the branch or diversion takes place outside the controlled environment.

[0153] It is particularly advantageous for the particle counter to be located outside the controlled environment, thereby reducing the risk of contamination within the controlled environment.

[0154] Alternatively or additionally, the features of the dependent claim, which relates to a method, are provided according to the invention to solve the aforementioned problem. In particular, it is thus proposed according to the invention, to solve the aforementioned problem in a method of the type described at the outset, that the demarcated area is decontaminated before the deposition material is exposed. PC 26 0262 C 30 / 74 18 March 2026

[0155] This is particularly advantageous because it prevents the need to decontaminate the demarcated area independently of the controlled environment, as already described.

[0156] Alternatively or additionally, the features of the dependent claim, which relates to a method, are provided according to the invention to solve the aforementioned problem. In particular, it is thus proposed according to the invention to solve the aforementioned problem in a method of the type described at the outset that, for exposing the disposal agent, the base body of the encapsulated unit or a base body receiving the disposal agent is coupled to the port of the delimited and / or decontaminated area via a coupling movement, in particular a rotary movement.

[0157] The features defined in the claim may be features that have already been described and / or claimed.

[0158] The connection between the base body and the port, and the connection between the base body and the cover, can each be formed, for example, by a bayonet fitting. A coupling between the encapsulated unit and the port can thus be achieved particularly advantageously using an RTP (Rapid Transfer Port) system.

[0159] In a further advantageous embodiment, it can be provided that the same coupling movement, in particular a rotary movement, releases a connection between the base body and the or a cover of the encapsulated unit.

[0160] A coupling of the base body with the port and, in particular, a simultaneous PC 26 0262 C 31 / 74 18 March 2026 can therefore be particularly advantageous.

[0161] The connection between the base body and the lid can be released with a single movement.

[0162] Alternatively or additionally, the features of the dependent claim, which relates to a method, are provided according to the invention to solve the aforementioned problem. In particular, it is thus proposed according to the invention to solve the aforementioned problem in a method of the type described at the outset that, for exposing the disposal agent, the base body of the encapsulated unit is coupled to the port (15) of the delimited and / or decontaminated area via a coupling movement, in particular a rotary movement, wherein a force-locking and / or form-locking connection is established between a door of the port and the lid of the encapsulated unit by the same coupling movement, in particular a rotary movement.

[0163] For example, the coupling movement can be the coupling movement described and / or claimed above. This allows, with great advantage, the base body to be coupled to the port and the cover to the port's door, and the cover to be decoupled from the base body, all by means of a single coupling movement.

[0164] The door can be formed, for example, by the handling device or one of the handling devices already described.

[0165] Thus, a combination of these aspects allows for the creation of an alpha and a beta port of an RTP (Rapid Transfer Port) system. This is extremely advantageous, as no decontamination process of the controlled PC 26 0262 C 32 / 74 18 March 2026 is required between the exchange of the encapsulated units.

[0166] This must be done in the surrounding area, the demarcated and / or decontaminated area, as potentially contaminated surfaces are mutually covered, thus minimizing the risk of contamination.

[0167] Alternatively or additionally, the features of the dependent claim, which is directed towards a specific use, are provided according to the invention to solve the aforementioned problem. In particular, it is thus proposed according to the invention to solve the aforementioned problem when using the type described at the outset, that a previously claimed method is carried out and / or that the base body or a base body is docked externally to the or a delimited and / or decontaminated area.

[0168] The features defined in the claim may be features that have already been described and / or claimed.

[0169] The encapsulated unit is particularly advantageous because it forms an interchangeable and / or reusable unit that can be easily coupled to the demarcated and / or decontaminated area for monitoring microbiological contamination, for example in the manner already described and / or claimed.

[0170] In a further advantageous embodiment, it can be provided that the lid or cover of the encapsulated unit is removed after docking via the port or a port, preferably inwards.

[0171] This allows for the particularly advantageous exposure of the landfill material or material covering the lid. "Inwards" can mean that the lid is removed from within the demarcated and / or decontaminated area. PC 26 0262 C 33 / 74 18 March 2026

[0172] In a further advantageous embodiment of the invention, it can be provided that, during docking, a fluid outlet of the base body is connected to a fluid outlet line, in particular a suction line.

[0173] This can be made particularly advantageous by the coupling movement already described and / or claimed.

[0174] This makes it particularly advantageous that no further step is required to couple the fluid outlet to the fluid outlet line.

[0175] Alternatively or additionally, the features of the dependent claim, which is directed towards a specific use, are provided according to the invention to solve the aforementioned problem. In particular, the invention thus provides for the use of a port door for handling, especially for transporting, an object that is arranged in an encapsulated unit that can be coupled to the port.

[0176] The defined features may be features already described and / or claimed. It is particularly advantageous that the object, in particular the nutrient medium and / or the depositing agent, can be moved via the door, which preferably opens or closes an access point, in particular the port, to the delimited and / or decontaminated area. For example, the door may be pivotable and accommodate the lid in the manner already described, thereby exposing the depositing agent in the base body of the encapsulated unit. Furthermore, the door may perform linear movement to move the lid out of a fluid flow path and release the port, and vice versa. PC 26 0262 C 34 / 74 March 18, 2026

[0177] In a further advantageous embodiment of the invention, it can be provided that the door is a handling device.

[0178] This allows the previously described advantages of the handling device to be achieved particularly advantageously.

[0179] The invention further describes the use of a lid of an encapsulated unit for handling, and in particular transporting, an object, especially a nutrient medium and / or a disposal medium, which is arranged in the encapsulated unit, preferably connectable to a port of a controlled environment. For this purpose, it can be advantageous if the object is permanently attached to the lid. An advantage of this use is that gripping the object, which always carries the risk of damage, is avoided.

[0180] According to the invention, a base body of an encapsulated unit is further used for handling, in particular for providing, an object, especially a nutrient medium and / or a depositing agent, which is arranged in the encapsulated unit, preferably connectable to a port of a controlled environment. For this purpose, it can be advantageous if the object is captive and attached to the base body. An advantage of this use is that grasping or otherwise handling the object, which always carries the risk of damage, is avoided, since the object can be provided directly in its operating position.

[0181] The invention will now be described in more detail with reference to exemplary embodiments, but is not limited to these embodiments. Further exemplary embodiments result from combining the features of one or more claims. PC 26 0262 C 35 / 74 18 March 2026

[0182] among themselves and / or with one or more features of the embodiment.

[0183] It shows, in a highly simplified representation,

[0184] Fig. 1 shows a three-dimensional sectional view of a device for monitoring microbiological contamination in a controlled environment.

[0185] Fig. 2 shows a three-dimensional representation of an encapsulated unit with lid and base body,

[0186] Fig. 3 shows a three-dimensional sectional view of the encapsulated unit according to Fig. 2, wherein a nutrient medium is encapsulated in the lid,

[0187] Fig. 4 shows a three-dimensional sectional view of an encapsulated unit, with a closure of the lid covering the nutrient medium removed.

[0188] Fig. 5 shows a three-dimensional representation of the encapsulated unit, with the lid and base body separated from each other.

[0189] Fig. 6 shows a three-dimensional sectional view of the encapsulated unit according to Fig. 5, wherein the nutrient medium is encapsulated in the lid.

[0190] Fig. 7 shows a three-dimensional sectional view of the encapsulated unit according to Fig. 6, with the closure covering the nutrient medium removed.

[0191] Fig. 8 shows a three-dimensional sectional view of the encapsulated unit after contact between nutrient medium and depositing agent, PC 26 0262 C 36 / 74 18 March 2026

[0192] Fig. 9 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in a first process step.

[0193] Fig. 10 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in a second process step.

[0194] Fig. 11 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in a third process step.

[0195] Fig. 12 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in a fourth process step,

[0196] Fig. 13 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in a fifth process step.

[0197] Fig. 14 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in a sixth process step.

[0198] Fig. 15 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in a seventh process step.

[0199] Fig. 16 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in an eighth process step.

[0200] Fig. 17 a three-dimensional sectional view of the device for monitoring for microbiological PC 26 0262 C 37 / 74 18 March 2026

[0201] Contaminants in a ninth process step,

[0202] Fig. 18 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in a tenth process step,

[0203] Fig. 19 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in an eleventh process step.

[0204] Fig. 20 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in a twelfth process step.

[0205] Fig. 21 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in a thirteenth process step.

[0206] Fig. 22 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in a fourteenth process step.

[0207] Fig. 23 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in a fifteenth process step.

[0208] Fig. 24 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in a sixteenth process step,

[0209] Fig. 25 a three-dimensional sectional view of PC 26 0262 C 38 / 74 18 March 2026

[0210] Device for monitoring for microbiological contamination in a seventeenth process step,

[0211] Fig. 26 shows a three-dimensional sectional view of the device for monitoring for microbiological contamination in an eighteenth process step.

[0212] Fig. 27 shows a two-dimensional representation of a controlled environment, wherein the device for monitoring for microbiological contamination is arranged at the controlled environment.

[0213] Fig. 28 shows a two-dimensional representation of a controlled environment, wherein the device for monitoring for microbiological contamination is designed to be separate from the controlled environment.

[0214] Fig. 29 shows a two-dimensional representation of a controlled environment in which the device for monitoring for microbiological contamination is arranged.

[0215] Fig. 30 shows a two-dimensional representation of another device according to the invention for monitoring microbiological contamination,

[0216] Fig. 31 is a three-dimensional representation of an encapsulated unit according to the invention with a rotary knob; Fig. 32 is a block diagram illustrating process steps of a possible method for monitoring microbiological contamination in a controlled environment; PC 26 0262 C 39 / 74 18 March 2026

[0217] Fig. 33 is a block diagram illustrating the process steps of a possible method for monitoring microbiological contamination in a controlled environment.

[0218] Fig. 34 is a block diagram illustrating the process steps of a possible method for monitoring microbiological contamination in a controlled environment.

[0219] Fig. 35 is a block diagram illustrating the process steps of a possible method for monitoring microbiological contamination in a controlled environment.

[0220] Fig. 36 is a block diagram illustrating the process steps of a possible method for monitoring microbiological contamination in a controlled environment.

[0221] Fig. 37 is a block diagram illustrating the process steps of a possible method for monitoring microbiological contamination in a controlled environment.

[0222] Fig. 38 is a block diagram illustrating the process steps of a possible method for monitoring microbiological contamination in a controlled environment.

[0223] Fig. 39 is a block diagram illustrating the process steps of a possible method for monitoring microbiological contamination in a controlled environment, PC 26 0262 C 40 / 74 18 March 2026

[0224] Fig. 40 is a block diagram illustrating the process steps of a possible method for monitoring microbiological contamination in a controlled environment.

[0225] Fig. 41 shows a further embodiment, an encapsulated unit for alternative use on the device according to Fig. 1.

[0226] Fig. 42 shows the lid of the encapsulated unit according to Fig. 41,

[0227] Fig. 43 shows the upper shell of the base body of the encapsulated unit according to Fig. 42.

[0228] Fig. 44 shows the lower shell of the base body of the encapsulated unit according to Fig. 43.

[0229] Fig. 45 shows an axial section to Fig. 41,

[0230] Fig. 46 shows an axial section to Fig. 43 and

[0231] Fig. 47 shows an axial section to Fig. 44.

[0232] Figure 1 shows a device, designated as a whole by 1, for monitoring microbiological contamination in a controlled environment 2.

[0233] In the illustrated embodiment, the controlled environment 2 is an isolator 3 as part of a pharmaceutical plant (not shown), at the outer boundary of which the device 1 is arranged, as also shown, for example, in Figure 27. In other embodiments, the device 1 can also be arranged remotely from the controlled environment or form part of the PC 26 0262 C 41 / 74 18 March 2026

[0234] form a controlled environment.

[0235] The device 1 according to Figure 1 has a region 4, separated from the controlled environment 2, with a feed section 28 for a fluid flow 5, here an air flow 5', which can be discharged from the controlled environment 2 via a suction point 57. In the illustrated embodiment, the separated region 4 corresponds to a decontaminable region 14. The separated region 4r can be decontaminated independently of or together with the controlled environment 2.

[0236] In other embodiments, the decontaminated area is part of the controlled environment, and the demarcation is no longer necessary.

[0237] The decontaminable area 14 in Figure 1, or the demarcated area 4, has a port 15 to which a base body 17 of an encapsulated unit 16 can be docked. The demarcated area 4 is thus accessible from outside the controlled environment 2 and independently of it. Furthermore, the encapsulated unit 16 has a lid 18 that can be removed via the port 15 and which can be picked up by a movable door 50, here a handling device 25, via the port 18.

[0238] The base body 17 accommodates an object 51, here a depositing medium 6 passing through the fluid flow 5, while the lid 18 accommodates another object 51, here a spring-mounted and / or supported nutrient medium 9.

[0239] In a service position 19, the base body 17 guides a section 20 of the fluid flow 5, wherein the section 20 of the fluid flow 5, as shown and described in more detail in the embodiment according to Fig. 16, is PC 26 0262 C 42 / 74 18 March 2026

[0240] Port 15 has been led to the disposal medium 6.

[0241] It can therefore be said that the fluid flow 5 in the operating position of the base body 17 passes through the decontaminationable and / or demarcated area 4, 14 and the disposal material 6.

[0242] Port 15 is furthermore part of a movable housing section 27 of the delimited area 4, wherein the movable housing section 27 can be driven, for example, by a motor (not shown) from outside the delimited area 4 and guided by guide means 10, as specified in more detail below. The movable housing section 27 is in turn rigidly connected to a flexible seal 29, which defines and / or limits a translational movement range of the movable housing section 27.

[0243] The movable housing section 27 surrounds the base body 17 of the encapsulated unit 16 at least partially.

[0244] The encapsulated unit 16, here the base body 17, further forms a fluid-permeable insertion point 23 for the landfill material 6. The encapsulated unit 16, also the base body 17 in the illustrated embodiment, furthermore has a fluid outlet 31 with a

[0245] Return shut-off valve 24. It can be said that the encapsulated unit 16 in section 20 of fluid flow 5 has a return shut-off valve 24.

[0246] Figure 2 shows the encapsulated unit 16, with the cover 18 coupled to the base body 17. Components and functional units that are functionally and / or structurally similar or identical to the preceding embodiment are designated with the same reference numerals and are not further distinguished. PC 26 0262 C 43 / 74 18 March 2026

[0247] once described separately.

[0248] As can also be seen in Figure 5, in which the cover 18 is detached from the base body 17, the cover 18 has coupling elements 21, here projections 32, on an outer circumference 34 extending radially inwards. These projections interact with counter-coupling elements 22, here recesses 33, in particular longitudinal and transverse slots, on the base body 17, whereby the base body 17 and the cover 18 can be coupled and uncoupled by a rotational movement. This enables a bayonet fitting.

[0249] Furthermore, Figure 2 shows that the base body 17 also has projections 32 on an outer circumference 35, which, as shown in Fig. 9, can interact with counter-coupling elements 22, here recesses 33, at the port 15 of the movable housing section 27, thereby also enabling a bayonet closure between port 15 and the encapsulated unit 16.

[0250] Furthermore, it can be seen in Figures 2 and 5 that the cover 18 has further coupling elements 21 on a further outer circumferential section 34 ' which can interact with counter-coupling elements 22 on the handling device 25 in such a way that a bayonet closure is also formed.

[0251] It can therefore be said that the depositing agent 6 is docked to the decontaminated and / or demarcated area 4, 14 in the encapsulated unit 16 before exposure in the fluid stream (Figure 16).

[0252] Furthermore, the fluid outlet 31 with return shut-off valve 24 is visible on the outer circumference 35 of the base body 17. The fluid outlet 31 of the encapsulated unit 16 can be described in more detail in Figure 1. PC 26 0262 C 44 / 74 18 March 2026

[0253] The fluid outlet line 36 shown in Figure 1 is connected to a suction line 36' in order to convey the fluid flow 5. The depositing agent 6, here the gelatin sheet 6', is also captive and attached to the base body 17 by hooks 59 on the outer circumference of the attachment point 23.

[0254] Figures 3 and 6 show the encapsulated unit 16 according to Figures 2 and 5 in a sectional view. The depositing agent 6 is located in the base body 17, with the nutrient medium 9 arranged in the lid 18 and sealed by a closure 26, here a nutrient medium closure 26', of the lid 18. The nutrient medium 9 is captive in the lid 18 by a nutrient medium carrier 37, which is supported in the lid 18 by a spring element 12. As long as the nutrient medium closure 26' closes the lid 18, the spring element 12, together with the nutrient medium carrier 37 and the nutrient medium 9, is pre-tensioned. A presentation means 48, which also includes the fluid-permeable application point 23, forms a base on which the depositing agent 6 is presented.

[0255] Figure 3 shows the encapsulated unit 16 in its entirety in a sectional view, in which the lid 18 and the base body 17 are coupled to each other in the manner already described. The encapsulated unit 16 shown in Figure 3 could be docked to port 15 as shown, and a procedure for monitoring for microbiological contamination could be started. In Figure 6, the base body 17 and the lid 18 are separated. Analogous to Figure 3, it can be seen that the lid 18, together with the nutrient medium carrier 37 and the nutrient medium 9, is pre-tensioned by the spring element 12 and closed by the nutrient medium closure 26'. The nutrient medium 9 and the receptacle 6 are connected when the base body 17 and lid 18 are coupled. PC 26 0262 C 45 / 74 March 18, 2026

[0256] are spatially separated from each other by the nutrient medium closure 26 '.

[0257] Figure 6 illustrates in greater detail that the base body 17 provides the fluid-permeable attachment point 23 for the depositing material 6 and on which the depositing material 6 is placed.

[0258] Figures 4 and 7, unlike Figures 3 and 6, show that the nutrient medium closure 26' is located away from the lid 18, causing a spring return force 38 of the spring element 12 to extend the nutrient medium carrier 37, along with the nutrient medium 9, from the lid 18. In another embodiment, for example, as shown in Figure 31, the nutrient medium carrier 37, along with the nutrient medium 9, can be rotatably extended from the lid 18 via a rotary knob 52. This can be done manually or automatically. In further embodiments, not shown in detail, the depositing medium 6 is extended alternatively or additionally. For example, it could be provided that the depositing medium 6 and / or the nutrient medium 9 can be extended and retracted via a ballpoint pen mechanism.

[0259] If the lid 18 is then coupled to the base body 17 in the manner already described, contact 8 can be established in the contact direction 49 between the depositing material 6 arranged in the base body 17 (which ideally has previously been passed through by the fluid flow 5) and the nutrient medium 9, which is spring-mounted here. It can therefore be said that the nutrient medium 9 and / or the depositing material 6 is / are movably mounted, in this case spring-mounted, for contact 8.

[0260] Furthermore, it can be said that the nutrient medium 9 for contacting 8 at least partially along a PC 26 0262 C 46 / 74 18 March 2026

[0261] The contact direction 49 is moved.

[0262] For example, an agar 9' can serve as the nutrient medium 9, wherein the depositing agent 6 can be a gelatin disc 6' which is absorbed by the agar 9' during contact 8. The gelatin disc 6' particularly advantageously dissolves after contact 8 with the agar 9'.

[0263] Figure 8 shows that after contact 8 with the nutrient medium 9, the depositing agent 6 is no longer located in the base body 17, but is absorbed by the nutrient medium 9, with the lid 17 then being resealed by the nutrient medium closure 26'. Figure 8 also clearly shows the fluid-permeable contact point 23, onto which the depositing agent 6, here the gelatin disc 6', is placed before contact 8 with the nutrient medium 9.

[0264] Figures 9 to 26 describe a method for monitoring microbiological contamination in controlled environment 2.

[0265] Figure 9 shows the delimited area 4 already presented in Figure 1. Components and functional units that are functionally and / or structurally similar or identical to the preceding embodiment are designated with the same reference numerals and are not described separately again.

[0266] At port 15 of the movable housing section 27, a decontamination base body 38 is first coupled in the manner already described, prior to monitoring for microbiological contamination. The decontamination base body 39 corresponds in its design to the base body 17 of the encapsulated unit 16. (See PC 26 0262 C 47 / 74, March 18, 2026)

[0267] First, a decontamination process 40 of the demarcated area 4 is carried out. It can therefore be said that the demarcated area 4 is decontaminated and that the demarcated area 4 is decontaminated before the exposure of the landfill material 6.

[0268] For this purpose, the movable housing section 27, which is coupled to the flexible seal 29, is fully extended so that the decontamination base body 39 is spaced apart from the feed section 28. The handling device 25 is positioned in the delimited area 4 such that a fluid flow path 41 from the feed section 28 to the decontamination base body 39 is opened and not blocked by it. A decontamination agent 42, here hydrogen peroxide 43, is introduced into the controlled environment 2, whereby the fluid flow 5 containing the decontamination agent 42 is discharged from the controlled environment 2 and introduced into the delimited area 4 via the feed section 28.The fluid stream containing the decontamination agent 42 thus decontaminates all elements arranged within the delimited area 4, such as the handling device 25, a rail 44 guiding the handling device 25 along which the handling device 25 can be moved, the feed section 28, and a separate area 45, which is specified in more detail below. The fluid stream 5 containing the decontamination agent 42 is guided out of the delimited area 4 via the decontamination base body 39, which guides the section 20 of the fluid stream 5, through a fluid outlet 31 with the return shut-off valve 24, and a fluid outlet line 36 connected to the fluid outlet 31. The demarcated area 4 then forms the decontaminated area 14. Subsequently, the fluid flow 5 is stopped, and the decontamination process 40 is completed. PC 26 0262 C 48 / 74 March 18, 2026.

[0269] Before the decontamination base 39 is removed, the handling device 25 is moved along the rail 44 such that it is positioned between the decontamination base 39 and the feed section 28, as shown in Figure 10. The movable housing section 27 is then moved such that an outer boundary 46 of the delimited area 4 is on the same plane as the movable housing section 27. The movable housing section 27 is in a central position. The handling device 25 can then be coupled to the port 15, in particular by means of a bayonet fitting, as shown in Figure 11. The delimited area 4 is thus closed by the handling device 25.

[0270] Subsequently, the decontamination base body 39, as shown in Figure 12, can be removed without risk of contamination of the demarcated area 4.

[0271] The base body 17 of the encapsulated unit 16, which is coupled to the lid 18, can then be docked from the outside to the port 15 of the demarcated and / or decontaminated area 4, 14, as shown in Figure 13, in the manner already described. Furthermore, the lid 18 is picked up by the handling device 25 via the port 15. The encapsulated unit 16 coupled to the port 15 corresponds to the encapsulated unit shown in Figures 2 and 3. The handling device 25 separates the feed section 28 from the encapsulated unit 16.

[0272] Subsequently, the movable housing section 27, as shown in Figures 14 and 15, is fully extended again, thereby releasing the cover 18 coupled to the handling device 25 from the port 15 and the base body 17 and moving it along the rail 44 in such a way that the handling device 25 together with the cover 18 is no longer PC 26 0262 C 49 / 74 18 March 2026

[0273] The depositing agent 6, here the gelatin disc 6', located on the fluid-permeable attachment point 23, is not positioned between the base body 17 and the feed section 28, but rather in the separate area 45. This exposes the depositing agent 6 within the base body 17. The base body 17 is in the operating position 19.

[0274] It can therefore be said that, to expose the depositing agent 6, the base body 17 of the encapsulated unit 16, which receives the depositing agent 6, is coupled to the port 15 of the demarcated and / or decontaminated area 14 via a coupling movement, here a rotary movement, whereby the same coupling movement, here rotary movement, releases a connection between the base body 17 and the lid 18 of the encapsulated unit 16, and that simultaneously a connection is established by the same coupling movement between the door 50, here the handling device 25, of the port 15 and the lid 18 of the encapsulated unit. It can also be said that the lid 18 of the encapsulated unit 16 is removed inwards via the port 15 after docking.

[0275] When the encapsulated unit 16 is docked, the fluid outlet 31 of the base body 17 is connected to the fluid outlet line 36, here suction line 36' (Figure 15).

[0276] The movable housing section 27 is then fully retracted, as shown in Figure 16, with the flexible seal 29 defining and limiting the retracted position of the housing section 27. This allows the base body 17 to be connected to the feed section 28. The gelatin disc 6' and the fluid-permeable contact point 23 completely fill an opening cross-section 47 of the feed section 28, so that it fills the entire fluid flow path 41. PC 26 0262 C 50 / 74 March 18, 2026

[0277] It can be said that after docking the encapsulated unit 16 which receives the depositing material 6, the feed section 28 for the fluid flow 5 is connected to the encapsulated unit 16, here the base body 17.

[0278] The fluid flow 5, here the air flow 5', is drawn off from the controlled environment 2 and passes through the feed section 28 to the gelatin plate 6', allowing the discharged section 20 of the fluid flow 5 to pass over the gelatin plate 6', which is positioned on the fluid-permeable attachment point 23. The section 20 of the fluid flow 5, having passed over the gelatin plate 6' and the attachment point 23, is directed to the fluid outlet 31, which is fluidically sealed to the fluid outlet line 36, and can thus be discharged from the enclosed area 4. Backflow of the fluid flow 5 is prevented by the return shut-off valve 24 of the fluid outlet 31.

[0279] It can therefore be said that the base body 17, in its operating position 19, guides a section 20 of the fluid flow 5 and that the section 20 of the fluid flow 5 is guided through port 15 to the depositing agent 6. Furthermore, it can be said that during exposure in the fluid flow 5, the depositing agent 6 is located outside the controlled environment 2, namely, in the delimited area 4 in the illustrated embodiment.

[0280] In one embodiment not shown in detail, a particle counter 13 is connected upstream of the landfill material 6. The fluid flow 5 can be directed through the particle counter 13 to determine the number and / or size of particles, and then the fluid flow 5 is directed to the landfill material 6. Alternatively or additionally, in another embodiment not shown in detail, a partial volume of the PC 26 0262 C 51 / 74 18 March 2026

[0281] Fluid flow 5 is diverted and transferred to the particle counter 13.

[0282] After the fluid flow 5 has passed through the depositing medium 6, the movable housing section 27, as shown in Figure 17, is fully extended again, allowing the nutrient medium closure 26' to be removed from the lid 18 via the handling device 25 in the separate area 45 of the delimited area 4 and placed there. The lid 18 remains connected to the handling device 25. After the nutrient medium closure 26' has been removed, the nutrient medium 9, carried by the nutrient medium carrier 37, is moved by the spring return force 38 of the spring element 12 in the manner already described. Once the nutrient medium closure 26' has been removed, the lid 18 assumes the state shown and described in Figure 7.

[0283] The lid 18 is then placed again between the feed section 28 and the base body 17, containing the depositing material 6 previously flowed through by the fluid flow 5, using the movable handling device 25. This process step is shown in Figure 18.

[0284] The movable housing section 27 is then moved to the central position, as shown in Figure 19, causing the gelatin platelet 6', which has been passed through by the fluid flow 5, to contact the spring-mounted nutrient medium 9. Through this contact 8, the gelatin platelet 6' is picked up by the nutrient medium 9, in this case the agar 9'.

[0285] The spring-mounted nutrient medium 9 and the base body 17, which is movable via the movable housing section 27, form contacting means 7 for contacting the depositing medium 6 with the nutrient medium 9. Since the movable housing section 27 can be actuated from outside the delimited area 4, PC 26 0262 C 52 / 74 18 March 2026

[0286] It should be stated that the contacting means 7 can be driven from outside the delimited area 4. Furthermore, the movable housing section 27 is guided by the guide means 10, here a linear guide 11, so that guided and / or defined contact 8 of the depositing material 6 with the nutrient medium 9 is enabled. It can also be provided that rotational movements can be carried out via the guide means 10.

[0287] In general, it can be said that the movable housing section 27 allows the nutrient medium 9 to be brought into contact with the deposition agent 6. Furthermore, it can be said that after exposure in the fluid stream 5, the deposition agent 6 is brought into contact with the nutrient medium 9 in a defined and controlled manner within the delimited and decontaminated area 4, 14.

[0288] After contacting 8 and picking up the gelatin disc 6' from the agar 9', the movable housing section, as shown in Figure 20, is fully extended again, with the handling device 25 still connected to the lid 18 containing the nutrient medium 9 and the material from it.

[0289] The lid 18 is coupled to the deposited material 6. The lid 18 is then moved, as shown in Figure 21, via the rail 44 by the handling device 25 in the direction of the separate area 45 in which the nutrient medium closure 26' is positioned.

[0290] Subsequently, as shown in Figure 22, the movable housing section 27 is fully retracted, thereby sealing the nutrient medium 9 and the depositing agent 6 absorbed by it with the nutrient medium closure 26 '.

[0291] According to Figures 23 to 25, the movable housing section 27 is first fully extended and the closed cover 18 is again closed via the handling device PC 26 0262 C 53 / 74 18 March 2026

[0292] 25 to port 15 with the base body 17. The movable housing section 27 is then moved to the middle position, whereby the cover 18 can be received by the base body 17 or connected to / docked to it in the manner already described.

[0293] Finally, the entire encapsulated unit 16 can be removed from port 15 for evaluation of microbiological contamination from the demarcated area 4 (Figure 26) and, for example, transferred to an incubator for analysis. The coupling and decoupling of the encapsulated unit 16 to or from port 15 is effected via an RTP (Rapid Transfer Port) system, which eliminates the need for decontamination between changes of the encapsulated unit 16, as potentially contaminated surfaces are mutually covered, thus minimizing the risk of contamination.

[0294] Subsequently, the enclosed environment 4 can be decontaminated in the manner already described by means of decontamination process 40 and another encapsulated unit 16 can be docked.

[0295] If the fluid stream 5 discharged from the controlled environment 2, here insulator 3, contains microbiological contaminants, this can be demonstrated by cultivating microorganisms on the nutrient medium 9 which absorbed the depositing agent 6.

[0296] In general, for monitoring for microbiological contamination, it can be said that a door 50 of a port 15, here the handling device 25, is used for handling, here for transporting, an object 51 that is arranged in an encapsulated unit 16 that can be coupled to the port 15. PC 26 0262 C 54 / 74 18 March 2026

[0297] becomes.

[0298] Figure 27 shows a pharmaceutical plant 61, in particular a controlled environment 2 designed as an isolator 3, wherein the device 1 for monitoring for microbiological contamination is arranged at the controlled environment 2. The fluid flow 15 is directed from the extraction point 57 to the supply section 28 via a fluid inlet line 56, which is guided through a penetration 63 through a wall 62 (here a floor, but also, for example, a side wall or a ceiling). Thus, the controlled environment 2 and the confined area 4 are fluidically connected via the penetration 63 in the wall 61. The confined area 4 is accessible independently of the controlled environment 2 and is arranged outside (e.g., spatially separated and / or spaced apart from) the controlled environment 2. The confined area 4 is accessible from outside the controlled environment 2. The fluid inlet line 56 is no longer than one meter.

[0299] Figure 28 shows another pharmaceutical plant 61 with another controlled environment 2 designed as an isolator 3, wherein the device 1 for monitoring for microbiological contamination is designed as a unit separated from the controlled environment 2, in contrast to the previous embodiment.

[0300] It can be said that the decontaminable area 14 of the device 1 is an area 4 separated from the controlled environment.

[0301] Figure 29 shows another pharmaceutical plant 61 with a further controlled environment 2 designed as an isolator 3, wherein the device 1 is for monitoring for microbiological contamination within the controlled PC 26 0262 C 55 / 74 18 March 2026

[0302] Environment 2 is configured without fluid inlet line 56. It can be said that the decontaminable area 14 of the device 1 is part of the controlled environment 2.

[0303] Figure 30 shows a further method and a further device 1 for monitoring microbiological contamination in a controlled environment 2, here an isolator 3. The fluid flow 15 is discharged from the controlled environment 2 through a feedthrough 63 in the wall 62 via the fluid inlet line 56 and the feed section 28. The fluid inlet line 56 is equipped with a ball valve 53 to prevent backflow of the fluid flow 15 from the demarcated and decontaminable area 4, 14 into the controlled environment 2. In contrast to the previously presented embodiments, the nutrient medium 9, here the agar 9', and the depositing agent 6, here gelatin sheets 6', are not arranged within a common encapsulated unit 16. Rather, the depositing agent 6 is positioned on a depositing carrier 58 and covered by a cover 60.Before the fluid stream 15 is discharged from the controlled environment 2, the entire decontaminated and delimited area 4, 14 is decontaminated. For this purpose, the decontamination agent 42, in this case hydrogen peroxide 43, is introduced into the delimited and decontaminated area 4, 14 via a nozzle 54. Subsequently, the cover 60 covering the deposition material 6 can be picked up and removed by a pivoting handling device 50 by means of a pivoting movement 55, thereby exposing the deposition material 6. Now the fluid stream 15 can be discharged from the controlled environment 2 and fed to the deposition material 6. As soon as the fluid flow 15 is stopped, the pivotally mounted nutrient medium carrier 37, which receives the nutrient medium 9, here the agar 9 ', can move in the direction of the PC 26 0262 C 56 / 74 18 March 2026.

[0304] The depositing medium 6 is pivoted, allowing contact 8 (not shown here) to be established between the depositing medium 6 and the nutrient medium 9. Subsequently, both units, i.e., the depositing medium 6 and the nutrient medium 9 containing it, can be positioned in front of a door 50 separating the delimited and decontaminated area 4, 14 from an outside environment 30 by means of a further pivoting movement 55 of the nutrient medium carrier 37, and removed from the delimited and decontaminated area 4, 14 by opening the door 50. In the illustrated embodiment, the depositing carrier 58 is formed on the base body 17, with the door 50 not forming the handling device 25 according to the preceding embodiments.

[0305] Thus, the invention uses the knowledge that the lid 18 of the encapsulated unit 16 can be used for handling, in particular for transporting, the object 51, i.e., the nutrient medium 9 and the disposal agent 6, which is arranged in the encapsulated unit 16 that can be connected to the port 15 of the controlled environment 2 or also of the demarcated area 4 or of the decontaminated area 14.

[0306] Furthermore, the invention proposes the use of the base body 17 of the encapsulated unit 16 for handling, in particular for providing (here, for example, for filtration or disposal), the object 51, in particular the nutrient medium 9 and / or the disposal agent 6, which is arranged in the encapsulated unit 16, which can preferably be coupled to a port 15 of the controlled environment 2 or also of the demarcated area 4 or of the decontaminable area 14.

[0307] Fig. 32 shows a possible, but not limiting, sequence of process steps A to F for carrying out PC 26 0262 C 57 / 74 18 March 2026

[0308] The inventive method for monitoring microbiological contamination in a controlled environment 2 with the inventive device 1 is shown in a block diagram. Components and functional units that are functionally and / or structurally similar or identical to the preceding embodiments are designated with the same reference numerals and are not described separately again.

[0309] In a first process step A, preparation for decontamination A' takes place. In the illustrated embodiment, the delimited area 4 is first prepared for the decontamination process 40. Next, in process step B, decontamination B' of the delimited area 4 takes place. Once decontamination B' of the delimited area 4 has been completed, in process step C, the encapsulated unit 16 can dock C' to the port 15 of the delimited area 4 in the manner already described. After docking C', in the next process step D, the depositing agent 6, here the previously described gelatin sheet 6', is exposed D' to the fluid stream 5 or the air stream 5'. In the next process step E, contact and transfer E' of the depositing agent 6 to the nutrient medium 9, for example, the agar 9', takes place.Finally, in process step F, the entire encapsulated unit 16 is removed in the manner already described.

[0310] Fig. 33 shows another way of carrying out the process according to Fig. 32, wherein, in contrast to Fig. 32, after the removal F' of the encapsulated unit 16, another encapsulated unit 16 is docked according to process step C and the process steps D to F already described are carried out. PC 26 0262 C 58 / 74 18 March 2026

[0311] Fig. 34 shows another possibility for carrying out the method according to Fig. 32, wherein, in contrast to Fig. 32, after the removal F ' of the encapsulated unit 16 and before the docking C ' of another encapsulated unit 16, a renewed decontamination B ' of the demarcated area 4 takes place.

[0312] The previously described process steps C to F can then be carried out.

[0313] Fig. 35 shows another way of carrying out the process according to Fig. 32, wherein, in contrast to Fig. 32, an additional process step G takes place between process steps B and C. Here, after decontamination B', the demarcated area 4 is prepared for receiving the encapsulated unit 16 (step G').

[0314] The next steps in the process are C to F.

[0315] Fig. 36 shows another way of carrying out the process according to Fig. 35, wherein, in contrast to Fig. 35, after the removal F', another encapsulated unit 16 is docked to port 15 of the delimited area according to process step C. Subsequently, process steps D to F can be carried out.

[0316] Fig. 37 shows another possibility for carrying out the procedure according to Fig. 35, wherein, in contrast to Fig. 35, after the removal F ' a further decontamination B ' takes place before the further process steps G to F are subsequently carried out.

[0317] Figures 38 to 40 illustrate possible variations of the method according to Figures 32 to 37 in more detail. The method for monitoring microbiological contamination according to Figure 38 is carried out as follows (see Figures 9 to 26): PC 26 0262 C 59 / 74 March 18, 2026

[0318] First, process step A is carried out, in which, as already described, the preparation for decontamination A' of the demarcated area 4 for decontamination B' of process step B is performed. After decontamination B', preparation for receiving G' of the encapsulated unit 16 of the demarcated area 4 takes place.

[0319] Subsequently, the encapsulated unit 16 docks C' to port 15 of the delimited area 4. Then, in process step H, the lid 18 is detached and removed from the base body 17 of the encapsulated unit 16, thereby exposing the depositing agent 6, for example, the gelatin disc 6', and allowing its exposure D' to the fluid stream 5, here air stream 5', which is drawn from the controlled environment 2. Subsequently, in process step I, the closure I', here the nutrient medium closure 26', is detached and removed from the lid 18, thereby exposing the nutrient medium 9, here the agar 9', as already described, so that in process step E, the depositing agent 6 can be contacted and transferred E' to the nutrient medium 9. In process step J, the closure J ' is then placed on the lid 18.In process step K, the lid K ' is placed on the base body 17 of the encapsulated unit 16, so that the encapsulated unit 16 can be removed in process step F in the manner already described.

[0320] In contrast to the preceding embodiment according to Fig. 38, the method according to Fig. 39 differs in that, after the removal F' of the encapsulated unit 16, process step C, the docking C' of another encapsulated unit 16, and then the execution of the process steps preceding process step C take place. PC 26 0262 C 60 / 74 March 18, 2026

[0321] In contrast to the preceding embodiment according to Fig. 38, the method according to Fig. 40 differs in that, after the removal F' of the encapsulated unit 16, process step B of decontamination B' is carried out. Subsequently, the further preceding process steps according to Fig. 38 can be carried out with another encapsulated unit 16.

[0322] Figures 41 to 47 show another example of an encapsulated unit 16, which can be used on the device according to Figure 1 in the manner described, instead of the encapsulated unit according to Figure 2. The corresponding interfaces to port 15 and the handling device 25 are identical, thus ensuring interchangeability. Therefore, the preceding statements apply accordingly. In principle, the illustrated embodiment can also be used separately.

[0323] The embodiment shown in Figs. 41 to 47 differs from the preceding embodiments in that it is designed in the manner of an impactor.

[0324] The basic body 17 has at least two parts: Firstly, a lower shell 66 in which a nutrient medium carrier 37 is formed, although the nutrient medium is not shown here.

[0325] Secondly, the base body 17 has an upper shell 67 in which impactor openings 64 (here, by way of example, star-shaped slits) are formed in an impactor plate 65. The nutrient medium carrier 37 covers the impactor openings 64 on the downstream side, but leaves an annular gap 70 in a manner known per se, which forms a labyrinth to force the deposition of microorganisms on the nutrient medium. The inserted nutrient medium thus forms a PC 26 0262 C 61 / 74 18 March 2026

[0326] Landfill materials, especially of the type described.

[0327] A seal 69 is inserted between the lower shell 66 and the upper shell 67, which - together with the lower shell 66 and the upper shell 67 - shields an inserted nutrient medium from the outside.

[0328] The encapsulated unit 16 can be docked to port 15 in the manner already described. The handling device can now pick up the cover 18 and remove it from the base body 17.

[0329] Subsequently, the feed section 28 can be attached to the base body 17 to supply the airflow from the controlled environment 2 to the nutrient medium presented in the nutrient medium carrier 37.

[0330] A suction port 68 can be used alternatively or additionally to the suction port on the non-return valve 24 to generate sufficient suction.

[0331] Once loading is complete, the encapsulated unit can be closed again by inserting the lid 18 into the base body 17.

[0332] To remove the nutrient medium, the lower shell 66 can be separated from the upper shell 67.

[0333] / Reference list PC 26 0262 C 62 / 74 March 18, 2026

[0334] Reference symbol list

[0335] 1 Device

[0336] 2 controlled environment

[0337] 3 Insulator

[0338] 4 delimited area

[0339] 5 Fluid flow

[0340] 5' airflow

[0341] 6 landfill materials

[0342] 6 ' Gelatin discs

[0343] 7 Contacting means

[0344] 8 Contacting

[0345] 9. Nutrient medium

[0346] 9' Agar

[0347] 10 Management tools

[0348] 11 Linear guide

[0349] 12 spring element

[0350] 13 particle counters

[0351] 14 decontaminable areas

[0352] 15 ports

[0353] 16 encapsulated units

[0354] 17 basic shapes

[0355] 18 lids

[0356] 19 Operating position

[0357] Section 20

[0358] 21 coupling element

[0359] 22 Negative feedback element

[0360] 23 mooring point

[0361] 24 Non-return valve

[0362] 25 Handling device

[0363] 26 Closure

[0364] 26 ' nutrient medium closure

[0365] 27 Housing section

[0366] 28 Feed section

[0367] 29 flexible seal PC 26 0262 C 63 / 74 March 18, 2026

[0368] 30 Outside world

[0369] 31 Fluid outlet

[0370] 32 lead

[0371] 33 recess

[0372] 34 Outer circumference of lid

[0373] 34' Outer circumferential section

[0374] 35 Outer circumference Base body

[0375] 36 Fluid outlet line

[0376] 36 ' Suction line

[0377] 37 nutrient medium carriers

[0378] 38 Spring return force

[0379] 39 Decontamination base body 40 Decontamination process

[0380] 41 Fluid flow path

[0381] 42 decontamination agents

[0382] 43 Hydrogen peroxide

[0383] 44 rail

[0384] 45 separate area

[0385] 46 outer boundary

[0386] 47 Opening cross-section

[0387] 48 presentation tools

[0388] 49 Contact direction

[0389] 50 Door

[0390] 51 objects

[0391] 52 Rotary knob

[0392] 53 ball valve

[0393] 54 nozzle

[0394] 55 Swivel movement

[0395] 56 Fluid inlet line

[0396] 57 Suction point

[0397] 58 landfill carriers

[0398] 59 hooks

[0399] 60 Coverage

[0400] 61 Pharmaceutical Plant PC 26 0262 C 64 / 74 March 18, 2026

[0401] 63 Implementation

[0402] 64 Impactor opening

[0403] 65 Impactor plate

[0404] 66 Lower shell

[0405] 67 Upper shell

[0406] 68 Suction port

[0407] 69 Seal

[0408] 70 annular gap

[0409] A process step

[0410] A' Preparation for decontamination

[0411] B Procedure step

[0412] B ' Decontamination

[0413] C Process step

[0414] C ' Docking

[0415] D Process step

[0416] D' exposure

[0417] E Process step

[0418] E ' contacting and transmission

[0419] F Process step

[0420] F ' withdrawal

[0421] G Process step

[0422] G ' Preparation for admission

[0423] H Process step

[0424] H ' Loosening and removing a lid I Process step

[0425] I ' Loosening and removing a closure J Procedure step

[0426] J ' Putting on a closure

[0427] K Process step

[0428] K ' Putting on a lid

[0429] / Claims

Claims

PC 26 0262 C 65 / 74 March 18, 2026 Claims 1. Controlled environment (2) with a device (1) for monitoring microbiological contamination in the controlled environment (2), preferably an isolator (3), with at least one area (4) delimited from the controlled environment (2), wherein a fluid flow (5) can be directed out of the controlled environment (2), wherein the fluid flow (5) passes through a depositing agent (6) arranged in the delimited area (4), characterized in that contacting means (7) for contacting (8) the depositing agent (6) with a nutrient medium (9) are provided in the delimited area (4).

2. Controlled environment ( 2 ) with a device ( 1 ) according to claim 1, characterized in that the contacting means ( 7 ) can be actuated, in particular driven, from outside the delimited area ( 4 ).

3. Controlled environment (2) with a device (1) for monitoring microbiological contamination, in particular according to the preamble of claim 1 or according to one of the preceding claims, in the controlled environment (2), preferably an insulator (3), wherein the fluid flow (5) from the controlled environment (2) can be guided over the depositing medium (6), characterized in that guiding means (10) are designed for a defined and / or guided contact (8) of the depositing medium (6) with the nutrient medium (9).

4. Controlled environment (2) with a device (1) according to one of the preceding claims, characterized in that the guide means (10) form a linear guide (11). PC 26 0262 C 66 / 74 March 18, 2026 5. Controlled environment ( 2 ) with a device ( 1 ) according to one of the preceding claims, characterized in that the nutrient medium ( 9 ) and / or the depositing medium ( 6 ) for contacting ( 8 ) is / are movably mounted, in particular springily.

6. Controlled environment ( 2 ) with a device ( 1 ) according to one of the preceding claims, characterized in that a particle counter ( 13 ) is connected upstream of the disposal medium ( 6 ).

7. Controlled environment (2) with a device (1) for monitoring microbiological contamination, in particular according to the preamble of claim 1 or 3 or according to one of the preceding claims, in the controlled environment (2), preferably the or an isolator (3), wherein the or a fluid stream (5) can be drawn from the controlled environment (2), wherein the fluid stream (5) passes through a depositing agent (6) in a delimited and / or decontaminable area (4, 14), characterized in that the delimited and / or decontaminable area (4, 14) has a port (15) to which a base body (17) of an encapsulated unit (16) can be docked.and that the encapsulated unit (16) has a lid (18) that can be removed via the port (15) and contains a nutrient medium (9), and that the base body (17) in the operating position (19) carries a section (20) of the fluid flow (5), and that the section (20) of the fluid flow (5) is led through the port (15) to the depositing medium (6).

8. Controlled environment ( 2 ) with a device ( 1 ) according to one of the preceding claims, characterized in that the cover ( 18 ) and / or the base body ( 17 ) has a coupling element ( 21 ) which can be coupled to a negative feedback element ( 22 ) of the port ( 15 ).

9. Controlled environment ( 2 ) with a device ( 1 ) according to PC 26 0262 C 67 / 74 18 March 2026 one of the preceding claims, characterized in that the encapsulated unit ( 16 ) forms a fluid-permeable placement point ( 23 ) and / or a presentation means ( 48 ) for the depositing agent ( 6 ).

10. Controlled environment ( 2 ) with a device ( 1 ) according to one of the preceding claims, characterized in that the base body ( 17 ) receives the depositing medium ( 6 ) in a captive manner.

11. Controlled environment ( 2 ) with a device ( 1 ) according to one of the preceding claims, characterized in that the lid ( 18 ) receives the nutrient medium ( 9 ) in a captive manner.

12. Controlled environment ( 2 ) with a device ( 1 ) according to one of the preceding claims, characterized in that the encapsulated unit ( 16 ) has a non-return valve ( 24 ) in the section ( 20 ) of the fluid flow ( 5 ).

13. Controlled environment ( 2 ) with a device ( 1 ) according to one of the preceding claims, characterized in that the decontaminated area ( 14 ) is the controlled environment ( 2 ), a part of the controlled environment ( 2 ) or an area ( 4 ) delimited from the controlled environment ( 2 ).

14. Controlled environment (2) with a device (1) according to one of the preceding claims, characterized in that the delimited area (4) or the decontaminable area (14) has a movable housing section (27), in particular wherein the movable housing section (27) allows the section (20) of the fluid flow (5) to be connected to an upstream feed section (28) and / or the nutrient medium (9) to be brought into contact with the disposal medium (6). PC 26 0262 C 68 / 74 March 18, 2026 15. Controlled environment ( 2 ) with a device ( 1 ) according to one of the preceding claims, characterized in that the movable housing section ( 27 ) of the delimited or decontaminated area ( 4, 14 ) is connected to a flexible seal ( 29 ).

16. Controlled environment (2) with a device (1), in particular according to the preamble of one of the preceding claims or according to one of the preceding claims, for monitoring microbiological contamination in the controlled environment (2), preferably an isolator (3), with at least one area (4) delimited from the controlled environment (2), wherein a fluid flow (5) can be drawn from the controlled environment (2), wherein the fluid flow (5) passes through a disposal medium (6) arranged in the delimited area (4) and in particular exposed via a presentation medium (48), characterized in that the delimited area (4) is decontaminated.

17. Controlled environment ( 2 ) with a device ( 1 ) according to one of the preceding claims, characterized in that the delimited area ( 4 ) is arranged outside the controlled environment ( 2 ) and / or is accessible independently of and / or from outside the controlled environment ( 2 ) and / or is fluidically connected to the controlled environment ( 2 ) via a feedthrough ( 63 ) in a wall ( 62) delimiting the controlled environment ( 2 ).

18. Controlled environment (2) with a device (1) according to one of the preceding claims, characterized in that the or an encapsulated unit (16), which preferably tightly contains the landfill material (6), is designed as an impactor and / or for a flow through the landfill material (6). PC 26 0262 C 69 / 74 18 March 2026 19. Pharmaceutical plant ( 61 ) comprising a controlled environment (2 ) and a device ( 1 ) according to any of the preceding claims.

20. Method for monitoring microbiological contamination in a controlled environment (2), preferably an isolator (3), wherein a fluid stream (5), in particular an air stream (5'), is discharged from the controlled environment (2), wherein the fluid stream (5) discharged from the controlled environment (2) passes through a depositing agent (6) in an area (4, 14) that is delimited from the controlled environment (2) and / or decontaminable, characterized in that the depositing agent (6) is brought into contact with a nutrient medium (9) after exposure in the fluid stream (5) in the delimited and / or decontaminable area (4, 14).

21. Method according to the preceding claim, characterized in that the disposal agent ( 6 ) is arranged outside the controlled environment (2 ) during exposure in the fluid stream (5 ).

22. Method according to one of the preceding claims, characterized in that the nutrient medium ( 9) and / or the depositing medium ( 6) are moved at least partially along a contacting direction (49) for contacting ( 8).

23. Method according to the preamble of claim 17 or according to one of the preceding claims, characterized in that the depositing agent (6) is brought into contact with the nutrient medium (9) in a defined and / or decontaminable area (4, 14) after exposure in the fluid stream (5), in particular by guided action. PC 26 0262 C 70 / 74 18 March 2026 24. Method, in particular according to one of the preceding claims, for monitoring microbiological contamination in the or a controlled environment (2), preferably an isolator (3), wherein the or a fluid stream (5), in particular an air stream (5'), is discharged from the controlled environment (2), wherein the fluid stream (5) discharged from the controlled environment (2) passes a depositing agent (6) which is arranged in a delimited and / or decontaminable area (4, 14), characterized in that the depositing agent (6) is docked to the decontaminable and / or delimited area (4, 14) in the or an encapsulated unit (16) prior to exposure in the fluid stream (5) and that the encapsulated unit (16) carries a section (20) of the fluid stream (5) during exposure.

25. Method according to one of the preceding claims, characterized in that after docking the encapsulated unit (16) receiving the depositing agent (6), a feed section (28) for the fluid flow (5) is connected to the encapsulated unit (16).

26. Method according to one of the preceding claims, characterized in that the fluid flow (5) is passed through a particle counter (13) to detect a particle count and / or particle size, in particular wherein the same fluid flow (5) is subsequently directed to the disposal medium (6) and / or wherein a partial volume of the fluid flow (5) is diverted, in particular wherein the diverted fluid flow (5) is transferred to the particle counter (13) and / or wherein the diversion or a diversion takes place outside the controlled environment (2).

27. Method, in particular according to one of the preceding claims, for monitoring microbiological contamination in or a controlled environment PC 26 0262 C 71 / 74 18 March 2026 (2 ), preferably an insulator (3), wherein the fluid stream (5), in particular an air stream (5 ' ), is discharged from the controlled environment (2 ), wherein the fluid stream (5) discharged from the controlled environment (2 ) passes a depositing agent (6) exposed in particular via a presentation means, which is arranged in a delimited area (4 ), characterized in that the delimited area (4 ) is decontaminated before the depositing agent (6) is exposed.

28. Method, in particular according to one of the preceding claims, for monitoring microbiological contamination in the or a controlled environment (2), preferably an isolator (3), wherein the or a fluid stream (5), in particular an air stream (5'), is discharged from the controlled environment (2), wherein the fluid stream (5) discharged from the controlled environment (2) passes through a depositing agent (6) which is arranged in a delimited and / or decontaminable area (4, 14), characterized in that, for the purpose of exposing the depositing agent (6), the or a base body (17) of the or an encapsulated unit (16) receiving the depositing agent (6) is coupled to the or a port (15) of the delimited and / or decontaminable area (4, 14) via a coupling movement, in particular a rotary movement.

29. Method according to the preceding claim, characterized in that a connection between the base body ( 17 ) and the or a cover ( 18 ) of the encapsulated unit ( 16) is released by the same coupling movement, in particular rotational movement.

30. Method, in particular according to one of the preceding claims, for monitoring microbiological contamination in or a controlled environment PC 26 0262 C 72 / 74 18 March 2026 (2), preferably an insulator (3), wherein the fluid flow (5), in particular an air flow (5'), is discharged from the controlled environment (2), wherein the fluid flow (5) discharged from the controlled environment (2) passes through a disposal medium (6) which is arranged in a delimited and / or decontaminable area (4, 14), characterized in that, for the purpose of exposing the disposal medium (6), the base body (17) of the encapsulated unit (16) is coupled to the port (15) of the delimited and / or decontaminable area (4, 14) via a coupling movement, in particular a rotary movement, wherein the same coupling movement, in particular a rotary movement, creates a force-fit and / or form-fit connection between a door (50) of the port (15) and the or a lid ( 18 ) of the encapsulated unit ( 16 ).

31. Method according to any of the preceding claims directed to a method using a device ( 1 ) or a controlled environment ( 2 ) with a device ( 1 ) according to any of claims 1 to 16.

32. Use of an encapsulated unit (16) for transporting a disposal agent (6) and / or a nutrient medium (9) to a position of use (19) in which the disposal agent (6) is exposed in a fluid stream (15), characterized in that a method according to one of the preceding claims directed to a method is carried out and / or that the or a base body (17) (16) is docked from the outside to the or a delimited and / or decontaminated area (4, 14).

33. Use according to the preceding claim, characterized in that the or a lid (18) of the encapsulated unit (16) is, after docking via the or PC 26 0262 C 73 / 74 18 March 2026 a port ( 15 ), preferably inwards, is extracted.

34. Use according to one of the preceding claims, characterized in that during docking a fluid outlet ( 31 ) of the base body ( 17 ) is connected to a fluid outlet line ( 36 ), in particular a suction line ( 36 ' ), in particular without intermediate pieces and / or directly.

35. Use of a door ( 50 ) of a port ( 15 ) for handling, in particular for transporting, an object (51), in particular a nutrient medium (9) and / or a disposal medium (6), which is arranged in an encapsulated unit (16) that can be coupled to the port (15).

36. Use according to the preceding claim, characterized in that the door ( 50 ) is a handling device ( 25 ).

37. Use of a lid ( 18 ) of an encapsulated unit ( 16 ) for handling, in particular for transporting, an object (51), in particular a nutrient medium (9) and / or a disposal medium (6), which is arranged in the encapsulated unit (16) which is preferably connectable to a port (15) of a controlled environment (2).

38. Use of a base body ( 17 ) of an encapsulated unit ( 16 ) for handling, in particular for providing, an object (51), in particular a nutrient medium (9) and / or a disposal medium (6), which is arranged in the encapsulated unit (16) which is preferably connectable to a port (15) of a controlled environment (2).

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