Method and apparatus for decontaminating a controlled environment by means of a decontaminant

Abstract

The invention relates to a method for decontaminating (4') a controlled environment (1) by means of a stabilizer-free decontaminant (4), wherein the decontaminant (4) is produced in a direct vicinity (9) of the controlled environment (1) and / or immediately after being produced is fed into the controlled environment (1), in particular via an interface (3) designed in the form of an ultrasonic nozzle (15).

Description

[0001] PC 25 1434 C 1 / 29 1 . September 2025

[0002] Method and apparatus for decontaminating a controlled environment with a decontamination agent

[0003] The invention relates to a method for decontaminating a controlled environment with a decontamination agent, and to a controlled environment with an interface through which a decontamination agent can be introduced into the controlled environment. In particular, the invention relates to a method and a device for decontaminating an insulator with hydrogen peroxide in the field of pharmaceutical applications.

[0004] background

[0005] Decontamination in isolators is a critical process in various industries, particularly in pharmaceutical and biotechnology production, where sterile conditions are of paramount importance. Isolators are systems that provide a controlled environment and are used to protect products, processes, and / or personnel from contamination. Decontamination of these isolators ensures that germs, bacteria, viruses, and / or other contaminants, especially microbiological ones, are effectively eliminated before sterile, aseptic, and / or contamination-sensitive processes begin. Their use is primarily in the aseptic "fill finish" area, but also in the development of advanced therapy medicinal products (ATMPs) and cell and gene therapies, as well as in applications involving toxic substances.

[0006] Hydrogen peroxide (H₂O₂) is a commonly used decontamination agent in these applications. It is used because it is a strong oxidizing agent that effectively kills microorganisms by destroying their cell walls and PC 25 1434 C 2 / 29 1 September 2025

[0007] DNA is destroyed. The use of H2O2 has the advantage that it decomposes into water and oxygen after application and therefore leaves no harmful residues, or can be efficiently and controllably broken down using suitable catalysts.

[0008] Current practice for the decontamination of insulators uses hydrogen peroxide (H₂O₂) in various concentrations, preferably 35% or nearly 50%, which is commercially available. To ensure stability during storage and transport, this H₂O₂ is mixed with stabilizers.

[0009] Decontamination is typically achieved by evaporating or injecting H2O2 into the insulator. The resulting H2O2 vapor and / or H2O2 aerosol reaches all corners and surfaces of the insulator, ensuring an even distribution of the disinfectant and thus reaching even hard-to-access areas.

[0010] However, there are challenges associated with using H₂O₂ for decontamination. The stabilizers added to the H₂O₂ to extend its shelf life can lead to deposits and / or contamination in the pumping and piping system, as well as in the controlled environment, such as the isolator. These contaminants can impair pump efficiency and / or increase maintenance requirements. Furthermore, transporting H₂O₂ through long tubing systems can be problematic, as it can lead to bubble formation and partial decomposition of the H₂O₂, reducing the effectiveness of the decontamination.

[0011] Overall, decontamination in I-isolates is a highly specialized process requiring careful planning and maintenance to ensure the sterility and safety of the production environment. PC 25 1434 C 3 / 29 1 September 2025

[0012] The present invention is therefore based on the objective of making the decontamination of controlled environments more user-friendly.

[0013] Summary of the invention

[0014] The solution to this problem in the method of the type mentioned at the outset consists in particular in the fact that the method for decontaminating a controlled environment, in particular an insulator, with a decontamination agent, in particular hydrogen peroxide, comprises that the decontamination agent is stabilizer-free and is introduced into the controlled environment.

[0015] This aspect of the invention describes a method for decontaminating a controlled or protected environment, such as an isolator, a workbench, a glove box, a containment system, or a cleanroom. A decontamination agent is introduced into the controlled or protected environment. The decontamination agent is preferably hydrogen peroxide. The decontamination agent, or the hydrogen peroxide, is characterized by being free of stabilizers. Its use is intended primarily in aseptic "fill finish" applications, but also in the development of advanced therapy medicinal products (ATMPs) and cell and gene therapies, as well as in applications involving toxic substances.

[0016] A stabilizer is understood to be a substance added to a chemical compound, in this case the decontamination agent, especially H₂O₂, to increase its stability and prevent undesired chemical reactions such as decomposition, oxidation, and / or polymerization (PC 25 1434 C 4 / 29, September 1, 2025). Stabilizers function by reducing the reactivity of the compound to external influences such as light, heat, and / or catalysts.

[0017] In the case of hydrogen peroxide, stabilizers prevent decomposition by binding catalysts (such as metal ions) or by protecting against external influences such as light.

[0018] Typical stabilizers for hydrogen peroxide are: (i) phosphoric acid or its salts (e.g., sodium phosphate): These bind metal ions that could act as catalysts, (ii) sodium stannate: This also stabilizes hydrogen peroxide by binding catalysts, (iii) chelating agents such as ethylenediaminetetraacetic acid (EDTA): These specifically bind metal ions that promote decomposition, (iv) sodium silicate: This can contribute to stabilization by forming a barrier against decomposition.

[0019] In the present invention, the decontamination agent is in particular free of these and similar, or similarly acting, stabilizers.

[0020] Advantageous aspects of this method according to the invention include the fact that the stabilizer-free decontamination agent leaves no residues in the decontamination agent supply system to the controlled environment and / or in the controlled environment, particularly the isolator. This minimizes the effort required for cleaning steps and simplifies the decontamination process. Furthermore, it increases the service life of the equipment. The reproducibility of the decontamination process is also improved. For example, the composition and concentration of the stabilizers are often unknown to the user, which can negatively impact the reproducibility of the decontamination process (PC 25 1434 C 5 / 29, September 1, 2025). Safety during operation of the equipment and during upstream and / or downstream processes, particularly in the area of ​​supply chain management, is also improved.

[0021] Preferably, in the present invention, the decontamination agent is generated in an immediate vicinity of the controlled environment.

[0022] As described above, stabilizers serve to prevent the decomposition of the decontamination agent, in particular the H₂O₂, and to ensure its stability during storage and / or use. In the present invention, the decontamination agent is introduced into the controlled environment to be decontaminated precisely free of these stabilizers. "Sterilizer-free" also means that the H₂O₂ can be at least almost completely freed of the stabilizers shortly before being introduced into the controlled environment.

[0023] Preferably, the decontamination agent is produced or manufactured in the immediate vicinity of the controlled environment. This has the advantage that storage periods and / or transport routes can be kept short, thus preventing and / or significantly reducing degradation or deterioration of the decontamination agent between production and use.

[0024] Preferably, the immediate environment defines an area in which the decontamination agent can be transported and / or introduced into the controlled environment without degradation. This not only reduces transport and storage costs but also lowers the safety risk, as large quantities of the substance do not need to be transported and / or stored over long distances. In other words, the immediate environment is the area (PC 25 1434 C 6 / 29, September 1, 2025) in which degradation of the decontamination agent is prevented, either temporally or spatially. For example, in this area, transport routes and / or storage periods for the decontamination agent are designed in such a way as to prevent degradation.

[0025] A time limit can be, in particular, a few hours, e.g., 6, 12, 16 hours, a few days, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 14 days, or less than 30 days.

[0026] The immediate vicinity may refer in particular to the same room, the same or neighboring building, the same city, the same region in which the controlled space is located, or also to a radius of less than 15km, 25km, 50km, 100km or 200km.

[0027] In one implementation, the decontamination agent is to be produced electrochemically. An advantage of electrochemical production of the decontamination agent, particularly hydrogen peroxide, is the environmental friendliness of this process. Unlike conventional methods, such as the anthraquinone process, electrochemical production does not generate any harmful byproducts. The reaction requires only water, oxygen, and electricity, making the process significantly cleaner and more sustainable.

[0028] Furthermore, electrochemical production is energy-efficient. The process can be carried out under mild conditions, such as room temperature and ambient pressure, which significantly reduces energy consumption compared to other production methods.

[0029] Another advantage lies in the flexibility and

[0030] Scalability of the method. It can be easily adapted, PC 25 1434 C 7 / 29 1 September 2025, to produce both small quantities for special applications and industrial quantities, as required.

[0031] Finally, the reduced generation of by-products leads to a final product of higher purity, which is particularly important in the pharmaceutical industry, where high quality requirements exist.

[0032] However, the present invention is not limited to electrochemical processes; H2O2 can also be obtained and used by any other process known to those skilled in the art.

[0033] In another embodiment, the decontamination agent is adjusted to a desired concentration after production, preferably to a concentrated concentration.

[0034] The effectiveness and safety of the decontamination agent can depend on its concentration. If the concentration is too low, H₂O₂ may not achieve the desired effect. For example, the effectiveness of the decontamination agent may be reduced if its concentration is too low. Conversely, an excessively high concentration of decontamination agents can pose safety risks.

[0035] It is therefore advantageous to adjust the decontamination agent to a desired concentration after production in order to ensure the effectiveness and safety of the application.

[0036] As a further, potentially independent aspect, the solution to the aforementioned problem in the aforementioned method consists, alternatively or additionally, in particular, in producing only the quantity of decontamination agent required for the decontamination process of the controlled environment. PC 25 1434 C 8 / 29 1 September 2025

[0037] The required quantity includes losses or production uncertainties or safety margins for the decontamination process, or can be understood as the quantity required to carry out several decontamination processes.

[0038] It is advantageous to produce only the required amount of H2O2 in order to maximize efficiency, minimize costs and risks, and reduce environmental impact.

[0039] First, the decontamination agent, especially H₂O₂, can decompose, particularly under the influence of light, heat, surface contact, contact with air, contact with other media, or impurities. If more H₂O₂ is produced than needed, there is a risk that it will lose effectiveness before use, leading to waste. Producing precisely the required amount minimizes this risk and ensures that the H₂O₂ can be used at its full concentration and effectiveness.

[0040] Secondly, producing only the required quantity reduces storage and / or transport costs.

[0041] Decontamination agents may require special storage conditions, as they can be dangerous in higher concentrations and pressure build-up due to decomposition can lead to explosions. Producing only the required quantity reduces the need to safely store and / or transport larger quantities, thus lowering both costs and safety risks. This is especially true since handling H₂O₂ by personnel is either unnecessary or only required for a short period.

[0042] Furthermore, demand-driven production minimizes environmental impact. Less excess material is generated that needs to be disposed of or treated, as per PC 25 1434 C 9 / 29 1 September 2025.

[0043] Environmental impact is reduced. Furthermore, avoiding overproduction saves resources such as energy and raw materials.

[0044] As a further potentially independent aspect, the solution to the aforementioned problem in the method of the type mentioned above consists alternatively or additionally in particular in the fact that the decontamination agent is generated in or an immediate vicinity of the controlled environment and is preferably converted from a liquid form to a gaseous form by means of ultrasound and is introduced into the controlled environment, in particular via an ultrasonic nozzle.

[0045] The use of ultrasound, particularly ultrasonic nozzles or other ultrasound-protected evaporation elements or components, offers several advantages, including the ability to atomize liquids extremely finely, enabling uniform and precise distribution and preventing condensation. They offer precise control of droplet size and spray rate, resulting in material savings and increased efficiency. Furthermore, they are more energy-efficient, requiring less pressure, and versatile, capable of handling a wide range of liquids without clogging.

[0046] In one implementation form, the decontamination agent is injected into the controlled environment and / or evaporated during introduction.

[0047] Spraying and / or evaporating the decontamination agent ensures an even distribution of the liquid, resulting in homogeneous coatings or room humidity distribution. PC 25 1434 C 10 / 29 1 September 2025

[0048] Fine atomization during spraying accelerates evaporation, which is advantageous for fast processes. Furthermore, spraying allows for precise dosing of the liquid and reduces material waste, saving costs and being more environmentally friendly. In chemical processes, it can also improve reaction rate by promoting a more uniform distribution of reactants.

[0049] Evaporating the decontamination agent is technologically simpler and requires no special equipment, which can reduce costs. Material losses due to droplet formation are avoided, as no atomization occurs, which is particularly advantageous with expensive or sensitive liquids. Finally, it allows for precise control of the evaporation rate while simultaneously preventing unnecessary droplet formation.

[0050] The decontamination agent is typically introduced via an interface. The H₂O₂ can also be added to the air by another method known to those skilled in the art. Through the use of fans, pressurized introduction, or by natural dynamics and gravity, the decontamination agent reaches all surfaces of the controlled environment.

[0051] In an alternative implementation form, the decontamination agent is distributed, particularly homogeneously, within the controlled environment after introduction.

[0052] One advantage of a particularly homogeneous distribution of the decontamination agent is that it preferably acts uniformly across the entire surface within the controlled environment and / or can be transported to it (PC 25 1434 C 11 / 29 1 September 2025). This ensures complete coverage and effective decontamination or disinfection, as all areas of the surface are treated uniformly. Uniform distribution prevents material waste and residues and contributes to safety by ensuring that all contaminants are removed. Homogeneous distribution can be achieved, for example, by means of a fan and / or compressed air.

[0053] In an alternative embodiment, it is provided that the decontamination agent ( 4 ) becomes stabilizer-free in the controlled environment, in particular freed from stabilizers, or that the decontamination agent becomes stabilizer-free before being introduced into the controlled environment, in particular freed from stabilizers.

[0054] In other words, the decontamination agent may initially contain stabilizers, which are removed before the decontamination agent is distributed in the controlled environment. This removal can occur before the decontamination agent is introduced into, for example, the isolator. Alternatively, the stabilizers can be removed during a processing step of the decontamination agent in the controlled environment. Removing the stabilizers from the decontamination agent, or separating the decontamination agent from the stabilizers, can be achieved through chemical and / or physical processes. For example, this processing step may also include concentrating or reducing the concentration of the decontamination agent.

[0055] This allows the use of a previously stabilized decontamination agent, while retaining the advantages described above of using a stabilizer-free decontamination agent for the decontamination of controlled PC 25 1434 C 12 / 29 1 September 2025

[0056] The environment will be preserved, as only stabilizer-free decontamination agent will continue to be used for decontamination.

[0057] In another implementation, the decontamination agent is temporarily stored without stabilizers before being introduced into the controlled environment. This allows the decontamination agent to be collected and / or processed, for example, concentrated, after production. This can compensate for a low throughput of the unit(s) producing the decontamination agent. The temporary storage can, for example, be provided by the unit supplying the decontamination agent.

[0058] As a further potentially independent aspect, the solution to the aforementioned problem consists in a controlled environment, in particular an isolator, with at least one interface through which a decontamination agent, in particular hydrogen peroxide, can be introduced into the controlled environment and is particularly suitable for carrying out a process as described above, wherein the interface can be connected to a unit generating the decontamination agent and / or a unit providing the decontamination agent without stabilizers.

[0059] This aspect of the invention describes a controlled or protected environment, such as an isolator, a workbench, a glovebox, a containment system, and / or a cleanroom. This controlled environment includes at least one interface through which a decontamination agent can be introduced into the controlled space within the controlled environment. The number of interfaces depends on the configuration of the controlled environment. PC 25 1434 C 13 / 29 1 September 2025

[0060] The environment, for example, after the isolator has been installed, is defined. The at least one interface can include nozzles or spray heads that distribute the decontamination agent as evenly as possible. Furthermore, the interface is designed such that a unit can be connected that provides and / or generates the decontamination agent. This unit can, for example, include storage containers for the decontamination agent and / or a generation unit, in particular electrochemical reaction cells, that produce the decontamination agent. This allows the decontamination agent to be introduced into the controlled environment immediately after generation, without the need for separate transport. Furthermore, the decontamination agent can be introduced after generation without contact with the (uncontrolled) environment, which significantly reduces the risk of contamination of the decontamination agent through transfer, transport, and / or storage.This also increases the reproducibility of the decontamination process within the controlled environment.

[0061] In one embodiment, the interface is designed to transfer the decontamination agent, preferably by means of ultrasound, from a liquid form into a gaseous form and to introduce it into the controlled environment, in particular via an ultrasonic nozzle.

[0062] As described above, the use of ultrasound, particularly ultrasonic nozzles, enables extremely fine atomization of the decontamination agent, allowing for uniform and precise distribution. They offer accurate control of droplet size and spray rate, resulting in material savings and increased efficiency. Furthermore, they are more energy-efficient, requiring less pressure (PC 25 1434 C 14 / 29 1 September 2025), and versatile, as they can handle a wide range of decontamination agents without clogging.

[0063] In one implementation, the controlled environment additionally includes an intermediate storage unit in which the decontamination agent, particularly after its generation, can be temporarily stored without stabilizers. This allows the decontamination agent to be collected and / or processed, for example, concentrated, after generation. The intermediate storage unit can be, for example, the unit supplying the decontamination agent. In particular, the concentration or reduction of the decontamination agent can take place in the intermediate storage unit. The intermediate storage unit can be part of the supply unit or located decentrally in the immediate vicinity of the controlled environment. The controlled environment, especially the isolator, can be centrally supplied by an intermediate storage unit, or each interface can be assigned its own intermediate storage unit.

[0064] In another embodiment, the interface is connected via a line to the unit generating the decontamination agent and / or to the unit supplying the decontamination agent without stabilizers. This allows the decontamination agent to be transported directly into the controlled environment, free of contaminants and without contact with the atmosphere or surroundings. Chemically resistant lines and hose connections are used for transporting decontamination agents such as hydrogen peroxide. For example, suitable lines include PTFE hoses, silicone hoses, FEP and PVDF hoses, or stainless steel pipes, particularly high-alloy stainless steel pipes. PC 25 1434 C 15 / 29 1 September 2025

[0065] The pipe can also be chemically resistant.

[0066] Connecting elements, such as fittings and seals made of PTFE, are included to ensure secure connections.

[0067] For example, the pipe may be designed to be geometrically higher than the interface. This facilitates pumping or suctioning out the decontamination agent after the controlled environment has been decontaminated.

[0068] Another potentially independent aspect of the invention lies in the use of a controlled environment as described above for carrying out a process as described above.

[0069] The advantages are as described above.

[0070] The invention will now be described in more detail with reference to exemplary embodiments, but is not limited to these embodiments. Further exemplary embodiments result from combining the features of one or more claims with each other and / or with one or more features of the exemplary embodiment.

[0071] It shows, in a highly simplified representation,

[0072] Fig. 1 shows a schematic, two-dimensional representation of a controlled environment with a filter unit and an interface connected via a line to a unit generating a decontamination agent and a unit concentrating the decontamination agent, the decontamination agent being introduced into the controlled environment via the interface. PC 25 1434 C 16 / 29 1 September 2025

[0073] Fig. 2 shows a schematic, two-dimensional representation of a controlled environment according to Fig. 1, wherein the decontamination agent generated by the unit is conveyed by means of a pump via the line to the interface and introduced into the controlled environment via the interface.

[0074] Fig. 3 shows a schematic, two-dimensional representation of a controlled environment according to Fig. 2, into which decontamination agent is introduced, wherein the decontamination agent is obtained from a unit that freely provides the decontamination agent stabilizer.

[0075] Fig. 4 shows a schematic, two-dimensional representation of a controlled environment with an object to be processed after decontamination and filter units formed therein, wherein the decontamination agent is generated in the immediate vicinity of the controlled environment by a unit and introduced into the controlled environment via an interface.

[0076] Fig. 5 shows a schematic, two-dimensional representation of a controlled environment into which decontamination agent generated in the immediate vicinity of the controlled environment according to Fig. 4 is introduced, wherein the decontamination agent is drawn in and distributed by a fan unit within the controlled environment.

[0077] Fig. 6 shows a schematic, two-dimensional representation of a controlled environment into which decontamination agent generated in the immediate vicinity of the controlled environment is introduced by evaporation and PC 25 1434 C 17 / 29 1 September 2025 according to Fig. 5 is drawn in by the fan unit and distributed within the controlled environment.

[0078] Fig. 1 shows a controlled environment, designated as a whole by 1, here an insulator 2. The controlled environment 1 has at least one interface 3 through which a decontamination agent 4, in this exemplary embodiment hydrogen peroxide (H₂O₂) 5, can be introduced into the controlled environment 1 for decontamination 4'. The decontamination 4' of the controlled environment 1 reduces the microbial load, so that a subsequent process can be carried out within the controlled environment 1 under suitable conditions, or a controlled room can be opened. In particular, microbiological contaminants and / or toxic and / or active substances are inactivated.

[0079] The controlled environment 1 includes, in particular for the process taking place after decontamination, a filter unit 18, which can also play a role during the decontamination 4' of the controlled environment 1, in particular for the distribution of the decontamination agent 4 within the controlled environment 1 (see in particular the description of the figures for Figs. 5 and 6).

[0080] In the embodiment shown in Fig. 1, interface 3 is connected via a line 6 to a unit 7 that generates the decontamination agent 4. The unit 7 that generates the decontamination agent 4 comprises an electrochemical cell 8, through which the decontamination agent 4 is generated electrochemically in the immediate vicinity 9 of the controlled environment 1, thus eliminating the need for stabilizers in the decontamination agent 4. A further highly advantageous aspect of the stabilizer-free decontamination agent 4, as described in PC 25 1434 C 18 / 29, September 1, 2025, is that even if it decomposes, no residues are formed that could, for example, contaminate the controlled environment.

[0081] Furthermore, a component 10 is formed, here downstream of the unit 7 that generates the decontamination agent 4, via which the decontamination agent 4 can be adjusted to a desired concentration, here concentrated. Dilution of the decontamination agent is also conceivable.

[0082] In an embodiment not shown here, an intermediate storage unit could be connected downstream of the generating unit 7, in which the decontamination agent 4 is stored before being introduced into the controlled environment 1. This is particularly relevant if the generating unit 7 cannot immediately provide the required quantity of decontamination agent 4.

[0083] The decontamination agent 4, generated via the electrochemical cell 8 as shown in Figure 1, is concentrated in this embodiment, then transported via the line 6 to the interface 3 and introduced into the controlled environment 1 via this interface, here injected, and, at least in this embodiment, distributed within the controlled environment 1 by means of an injection pressure, for example, by means of compressed air. As shown in another embodiment (e.g., Figures 4, 5, and 6), such a component 10 can also be omitted.

[0084] It can therefore be said that a method for decontaminating 4 ' the controlled environment 1 , here the insulator 2 , with the decontamination agent 4 , here by means of hydrogen peroxide (H2O2 ) 5 , can be carried out, wherein the decontamination agent 4 , at least at the time of PC 25 1434 C 19 / 29 1 September 2025

[0085] Entry into the controlled environment, is stabilizer-free and is introduced into controlled environment 1.

[0086] It should be noted that the unit 7 generating the decontamination agent 4 is not limited to an electrochemical cell 8 and alternatively or additionally other units 7 generating decontamination agent 4 known from the prior art are conceivable.

[0087] In the illustrated embodiment, the unit 7 generating the decontamination agent 4 (with or without the component 10 for adjusting the concentration of the decontamination agent 4) also forms a unit 11 providing the decontamination agent 4 without stabilizers, since the decontamination agent 4 generated by the unit 9 in the immediate vicinity of the controlled environment 1 is not only generated but also provided and immediately introduced into the controlled environment 1, thus eliminating the need for stabilizers within the decontamination agent 4. The immediate vicinity 9 defines an area in which the decontamination agent 4 can be transported without degradation and / or introduced into the controlled environment 1.

[0088] Because the unit 7 generating the decontamination agent 4 is connected to the component 10, via which the concentration of the decontamination agent 4 can in turn be adjusted, it can thus be said that the decontamination agent 4 is adjusted to a desired concentration, here concentrated, after generation 12.

[0089] Furthermore, by using the described controlled environment 1, for example, a method for decontaminating 4' the controlled environment 1 can be implemented (PC 25 1434 C 20 / 29, September 1, 2025), wherein the decontamination agent 4 is generated in the immediate vicinity 9 of the controlled environment 1, for example in the manner already described, and is converted from a liquid form 13 into a gaseous form 14, for example by means of ultrasound, and is introduced into the controlled environment 1. This is particularly advantageous if the interface 3 through which the decontamination agent 4 is introduced is designed as an ultrasonic nozzle 15, since ultrasonic nozzles 15 enable extremely fine atomization of the decontamination agent 4.

[0090] Furthermore, since the production of the decontamination agent 4 takes place in the immediate vicinity 9 of the controlled environment, the decontamination agent 4 can be introduced into the controlled environment 1 without stabilizers, thereby preventing clogging of the ultrasonic nozzle 15 by stabilizers of the decontamination agent 4.

[0091] It may also be provided that, for example via the unit 7 generating the decontamination agent 4, only the amount of decontamination agent 4 actually required for the decontamination process, in particular the decontamination, of the controlled environment 1 is produced.

[0092] Fig. 2 shows, in contrast to the preceding embodiment, a further variant for decontaminating 4' the controlled environment 1. Components and functional units that are functionally and / or structurally similar or identical to those in the preceding embodiment are designated with the same reference numerals and are not described separately again.

[0093] To ensure that the area in the immediate vicinity of 9 of the controlled environment

[0094] To introduce the decontamination agent 4 generated in 1 into the controlled environment 1, it is transported via a pump 16 from PC 25 1434 C 21 / 29 1 September 2025 from the unit 7 generating the decontamination agent 4 and the downstream component 10 for adjusting the concentration through line 6 to interface 3. The decontamination agent 4 is then introduced into the controlled environment via interface 3, for example by injection or spraying. It is also possible for the decontamination agent 4 to vaporize and for this vapor to then be directed into the controlled environment 1.

[0095] In contrast to the embodiment shown in Fig. 2, Fig. 3 does not show a unit 7 generating the decontamination agent 4, but only a unit 11 providing the decontamination agent 4 without stabilizers. In the illustrated embodiment, the interface 3 is therefore not connected to the unit 7 generating the decontamination agent 4, but to the unit 11 providing the decontamination agent 4 without stabilizers, here in the form of a bottle 17, into which the decontamination agent 4, previously generated in the immediate vicinity 9 of the controlled environment 1, was filled and from which it can be obtained.

[0096] The concentration of the decontamination agent 4, which is filled into bottle 17 without stabilizers, can already be adjusted accordingly. Alternatively, a corresponding component 10 for adjusting the concentration of the decontamination agent is connected downstream of the unit 11 that provides the decontamination agent 4 without stabilizers, as shown in the preceding exemplary embodiments.

[0097] The stabilizer-free decontamination agent 4 can also be introduced into the controlled environment 1, here the insulator 2, in this exemplary embodiment in the manner already described. PC 25 1434 C 22 / 29 1 September 2025

[0098] Fig. 4 shows, at least schematically, an extended configuration of the controlled environment 1 with a fan unit 19, which is positioned upstream of the filter unit 18 already shown. As further specified in the description of Figs. 5 and 6, a fluid flow 20 (not shown in Fig. 4) can be generated via the fan unit 19, which can then be filtered via another filter unit 18' and returned to the fan unit 19. Furthermore, one or more internal components 21 are formed within the controlled environment 1, which can be used during the decontamination process and / or in a process following decontamination 4', for example, to fill, process, move, analyze, or process a pharmaceutical and / or biotechnological product.For example, the installation 21 can be a machine that processes and / or handles a container, for example, filling it with a pharmaceutical product. Alternatively, installation 21 can also be, for example, a filling machine, process station, or measuring device. During the decontamination 4' of the controlled environment 1, which is carried out in the manner already described, the fan unit 19 is inactive. In an alternative embodiment, the fan unit 19 can also be active.

[0099] A further distinguishing feature in the embodiment shown in Fig. 4 is that the unit 7 generating the decontamination agent 4 is not followed by a component 10 for adjusting the concentration of the decontamination agent 4. However, in an embodiment not shown, an adjusting component 10 can be used to adjust the concentration. PC 25 1434 C 23 / 29 1 September 2025

[0100] Fig. 5 shows a further embodiment according to the invention of a controlled environment 1, here also an insulator 2, through which a previously described method, in particular the method for decontamination 4 ' of the controlled environment 1 with a stabilizer-free decontamination agent 4, which is introduced into the controlled environment 1, can be carried out.

[0101] In contrast to the embodiment shown in Fig. 4, the fan unit 19 is activated during the decontamination 4' of the controlled environment 1, thereby generating the fluid flow 20 introduced in the description of Fig. 4. The decontamination agent 4 is first generated by the unit 7 and transported by the pump 16 via the line 6 to the interface 3, through which the decontamination agent 4 is introduced into the controlled environment 1 in the manner already described.

[0102] The interface 3 is further configured on the controlled environment 1 such that the introduced, in particular injected, decontamination agent 4 can then be drawn in by the activated fan unit 19 23 and distributed within the controlled environment 1 by the fluid flow 20 after passing through the filter unit 18 downstream of the fan unit 19. Furthermore, in the illustrated embodiment, the fluid flow 20 is returned laterally in the intermediate wall / intermediate disk without further filtration.

[0103] Figure 6 differs from the embodiment shown in Figure 5, in particular in that the decontamination agent 4 is not injected via interface 3, but rather introduced into the controlled environment 1 by vaporization via an evaporation unit 22, which can be part of interface 3. It can thus be said that the decontamination agent 4 is vaporized during introduction. The vaporized decontamination agent 4 is then drawn in by the fan unit 19, which is also activated in this embodiment, passed through the filter unit 18, and distributed within the controlled environment 1 by the fluid flow 20.

[0104] The invention thus proposes a method for decontaminating 4 ' a controlled environment 1 with a stabilizer-free decontamination agent 4, wherein the decontamination agent 4 is generated in an immediate environment 9 of the controlled environment 1 and is immediately introduced into the controlled environment 1, in particular via an interface 3 designed as an ultrasonic nozzle 15.

[0105] / Reference list

[0106] PC 25 1434 C 25 / 29 1 . September 2025

[0107] Reference symbol list

[0108] 1 controlled environment

[0109] 2 I solator

[0110] 3 Interface

[0111] 4 decontamination agents

[0112] 4 ' Decontamination

[0113] 5 Hydrogen peroxide (H2O2)

[0114] 6 Line

[0115] 7 generating unit

[0116] 8 electrochemical cell

[0117] 9 immediate surroundings

[0118] 10 components

[0119] 11 providing unit

[0120] 12 Production

[0121] 13 liquid form

[0122] 14 gaseous form

[0123] 15 ultrasonic nozzles

[0124] 16 pump

[0125] 17 bottles

[0126] 18 filter units

[0127] 18 ' Filter unit

[0128] 19 fan unit

[0129] 20 Fluid flow

[0130] 21 Installation

[0131] 22 Evaporation unit

[0132] 23 Intake

[0133] 24 buffers

[0134] / Claims

Claims

PC 25 1434 C 26 / 29 September 1, 2025 Claims 1. Method for decontaminating (4') a controlled environment (1) , in particular an isolator (2) , with a decontamination agent (4) , in particular hydrogen peroxide (5) , characterized in that the decontamination agent (4) is stabilizer-free and is introduced into the controlled environment (1).

2. Method according to claim 1, characterized in that the decontamination agent (4) is generated in an immediate environment (9) of the controlled environment (1).

3. Method according to claim 2, characterized in that the immediate environment (9) defines an area in which the decontamination agent (4) is transported without decomposition and / or introduced into the controlled environment (1).

4. Method according to one of the preceding claims, characterized in that the decontamination agent (4) is produced electrochemically.

5. Method according to one of claims 2 to 4, characterized in that the decontamination agent (4) is adjusted to a desired concentration after production, preferably concentrated.

6. Method according to the preamble of claim 1 or according to one of the preceding claims, characterized in that only an amount of the decontamination agent (4) required for the decontamination process (4') of the controlled environment (1) is produced.

7. Method according to the preamble of claim 1 or according to one of the preceding claims, characterized in that the decontamination agent (4) is placed in or in an immediate vicinity (9) of the controlled environment (1) PC 25 1434 C 27 / 29 1 September 2025 is produced and is preferably converted from a liquid form (13) into a gaseous form (14) by means of ultrasound and is introduced into the controlled environment (1) , in particular via an ultrasonic nozzle (15) .

8. Method according to one of the preceding claims, characterized in that the decontamination agent (4) is injected into the controlled environment (1) and / or evaporated during introduction.

9. Method according to one of the preceding claims, characterized in that the decontamination agent (4) is distributed, in particular homogeneously, after being introduced within the controlled environment (1).

10. Method according to one of the preceding claims, characterized in that the decontamination agent (4) becomes stabilizer-free in the controlled environment (1), in particular freed from stabilizers, or that the decontamination agent (4) becomes stabilizer-free before being introduced into the controlled environment (1), in particular freed from stabilizers.

11. Method according to one of the preceding claims, characterized in that the decontamination agent (4) is temporarily stored without stabilizers before being introduced into the controlled environment (1).

12. Controlled environment (1), in particular an isolator (2), with at least one interface (3) through which a decontamination agent (4), in particular hydrogen peroxide (5), can be introduced into the controlled environment (1), in particular for carrying out a method according to one of claims 1 to 11, characterized in that the interface (3) is equipped with a decontamination agent (4) PC 25 1434 C 28 / 29 1 September 2025 generating unit (7) and / or a unit (11) providing the decontamination agent (4) without stabilizers.

13. Controlled environment (1) according to claim 12, further comprising an intermediate storage (24) in which the decontamination agent (4) can be temporarily stored without stabilizers, in particular after its production.

14. Controlled environment (1) according to one of the preceding claims 12 - 13, characterized in that the at least one interface (3) is designed to transfer the decontamination agent (4) preferably by means of ultrasound from a liquid form (13) into a gaseous form (14) and to introduce it into the controlled environment (1), in particular via an ultrasonic nozzle (15).

15. Controlled environment (1) according to one of the preceding claims 12 - 14, characterized in that the at least one interface (3) is connected via at least one line (6) to the unit (7) generating the decontamination agent (4) and / or to the unit (11) providing the decontamination agent (4) without stabilizers.

16. Use of a controlled environment (1) according to any one of claims 10-15 for carrying out a method according to any one of claims 1 to 11. / Summary

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