Method for reducing germ density, and corresponding device

Abstract

The invention relates to a method for reducing germ density in the useful space of a device, comprising heating the useful space to a process temperature such that a relative humidity in the useful space is below an upper moisture limit; controlling the relative humidity in the useful space to a first target value for a first duration, wherein a humidification system introduces an active ingredient; deactivating the control of the relative humidity; and reducing the active ingredient in the useful space for a reduction duration. The invention also relates to a corresponding device and to a corresponding system.

Description

[0001] W0151EP-THL

[0002] Methods for reducing germ density and corresponding equipment

[0003] The present invention relates to the field of reducing the germ load in usable areas of equipment, e.g. laboratory, air conditioning and heating equipment, and in particular the sterilization of the usable areas.

[0004] The operating chambers of equipment, particularly laboratory, climate control, and heating equipment, must be as sterile as possible for certain uses, such as cell culture and cell therapy applications. Similarly, some items, such as certain surgical instruments or, more generally, certain medical devices, require one-time or regular sterilization. Therefore, a method for reducing microbial density and, preferably, sterilizing the operating chamber of such equipment is essential to reduce or advantageously eliminate contamination by bacteria, viruses, mold, or other unwanted organisms in the operating chamber and / or the items contained therein.

[0005] A well-known and commonly used method is reducing the germ count by increasing the temperature. However, this can have several disadvantages. Firstly, it can be a lengthy and energy-intensive process; secondly, there are materials that cannot be exposed to such high temperatures without being damaged.

[0006] As an alternative, sterilization methods using a sterilizing agent are known. Due to its chemical properties, hydrogen peroxide (H2O2) is particularly suitable for this purpose. However, hydrogen peroxide is highly corrosive and cytotoxic; therefore, care must be taken when handling this sterilizing agent to prevent its release and avoid harm to users and the environment.

[0007] For example, hydrogen peroxide sterilization chambers are known for medical devices, where highly concentrated hydrogen peroxide is used, e.g., in a vacuum or plasma, and subsequently rendered harmless. However, these are purely sterilization chambers and not laboratory, climate control, or heating devices such as incubators. Additionally, these sterilization chambers typically have a small volume.

[0008] Mobile generators are also available, which can be used, for example, to decontamination rooms, insulators, or surfaces and typically vaporize or nebulize hydrogen peroxide. However, these generators generally do not have controlled processes and are therefore not suitable for changing environmental conditions. Furthermore, such generators are designed for the decontamination of entire laboratory spaces and are associated with high costs.

[0009] Additionally, sterilization devices for installation in corresponding laboratory, air conditioning, or heating equipment are known. For example, US Patent 2022 / 0243166 discloses an atomizing device that atomizes a hydrogen peroxide solution using a membrane. However, this can leave residues hazardous to the user in the work area, and the device must be installed and removed.

[0010] The Baker ReCChver™ incubator offers the option of using its internal nebulizer to decontaminate the incubator's interior. To do this, the user first warms a hydrogen peroxide solution and then manually fills it into the nebulizer's reservoir. The incubator's temperature is then raised to 45°C before the nebulizer runs for approximately 20 minutes. Afterward, a UV light is switched on for about 130 minutes to decompose any suspended hydrogen peroxide. The user then manually empties and cleans the reservoir. This procedure is disadvantageous because the user must manually fill, empty, and dispose of the hydrogen peroxide solution, as well as clean the reservoir. This poses a risk of direct contact with the hydrogen peroxide solution. Furthermore, the nebulization of the hydrogen peroxide solution is not regulated, but only controlled by the duration of the nebulization.

[0011] Against this background, it is an object of the present invention to overcome or at least reduce the shortcomings and disadvantages of the prior art. In general, it can be an object of the present invention to provide a device with an integrated capability for reducing the germ density and preferably sterilizing the usable space.

[0012] The problem is solved by the subject matter of the independent patent claims. Advantageous embodiments of the invention are described by the dependent patent claims, the following description, and the figures.

[0013] According to a first aspect, the invention relates to a method for reducing a germ density in the usable space of a device, comprising heating the usable space to a process temperature such that the relative humidity in the usable space is below an upper humidity limit; controlling the relative humidity in the usable space to a first target value for a first duration, wherein a humidification system introduces an active ingredient; deactivating the control of the relative humidity; and breaking down the active ingredient in the usable space for a breakdown period.

[0014] This means that the relative humidity in the usable space is regulated to an initial target value for an initial duration, while a humidification system introduces an active ingredient, for example by evaporation or nebulization (especially atomization).

[0015] An active ingredient is introduced into the workspace. This active ingredient can reduce the microbial density. For example, the active ingredient could be hydrogen peroxide (H₂O₂). During the introduction of the active ingredient, the relative humidity in the workspace is initially regulated to a target value. The active ingredient then degrades within the workspace for a specified period. This process achieves a suitable reduction in microbial density, thus, for example, achieving effective sterilization. In particular, the invention allows for a suitable reduction in microbial density to be achieved with relatively few equipment modifications: Specifically, a humidification system is used for introducing the active ingredient—a system that is already present in many devices (e.g., in incubators).In particular, embodiments according to the invention make it possible to achieve a reduction in germ density at relatively low temperatures (for example, 55 °C or lower). This can be advantageous for various reasons: it can shorten the duration of the process, the energy required can be relatively low, and there are lower demands on the materials than would be the case at higher temperatures (for example, 180 °C).

[0016] In embodiments of the invention, the method may further include: inserting an active ingredient container containing an active ingredient liquid, and inserting a waste container for receiving waste liquids.

[0017] In embodiments of the invention, the method may further include: introducing a dismantling unit into the usable space of the device.

[0018] In embodiments of the invention, it may be provided that the dismantling unit is introduced into the usable space before heating.

[0019] In embodiments of the invention, it may be provided that the insertion of the dismantling unit into the usable space includes the electrical connection of the dismantling unit to the device.

[0020] In embodiments of the invention, it may be provided that the degradation unit is designed to decompose the active ingredient.

[0021] In embodiments of the invention, it may be provided that heating the usable space to the process temperature includes increasing the process temperature until the relative humidity at the process temperature is below the upper humidity limit.

[0022] In embodiments of the invention, it may be provided that heating the usable space to the process temperature includes heating the usable space to an initial value for the process temperature, wherein the initial value is provided by the user.

[0023] In embodiments of the invention, it may be provided that the initial value is at least 37°C.

[0024] In embodiments of the invention, it may be provided that the relative humidity in the usable space is determined during and / or after heating to the initial value and compared with the upper humidity limit. In embodiments of the invention, it may be provided that, if the relative humidity does not fall below the upper humidity limit, the process temperature is increased until the relative humidity falls below the upper humidity limit.

[0025] In embodiments of the invention, it may be provided that the process temperature is increased in stages until the upper humidity limit is undershot.

[0026] In embodiments of the invention, it may be provided that increasing the process temperature includes determining the process temperature based on a current relative humidity and temperature using the vapor pressure curve.

[0027] In embodiments of the invention, it can be provided that the process temperature is greater than or equal to the initial value and is selected such that the relative humidity at the process temperature falls below the upper humidity limit.

[0028] In embodiments of the invention, it can be provided that the process temperature is at least 37°C.

[0029] In embodiments of the invention, it can be provided that the process temperature is a maximum of 75°C, preferably a maximum of 65°C, and more preferably a maximum of 55°C.

[0030] In embodiments of the invention, it may be provided that the relative humidity is not regulated during heating.

[0031] In embodiments of the invention, it can be provided that the upper humidity limit is in the range of 45% to 75% relative humidity, preferably in the range of 45% to 60% relative humidity, and more preferably in the range of 45% to 55% relative humidity.

[0032] In embodiments of the invention, it can be provided that the process temperature is kept constant after heating at least until the active ingredient is broken down in the usable space.

[0033] In embodiments of the invention, the method may further include: increasing the relative humidity in the usable space to a value above a lower humidity limit.

[0034] In embodiments of the invention, it may be provided that the increase of the relative humidity in the usable space to a value above a lower humidity limit is carried out before the relative humidity is regulated to a first target value for a first duration. In embodiments of the invention, it may be provided that the increase of the relative humidity in the usable space to a value above a lower humidity limit is carried out after the usable space has been heated to the process temperature.

[0035] In embodiments of the invention, it may be provided that the increase of the relative humidity in the usable space to a value above a lower humidity limit includes the evaporation of water.

[0036] In embodiments of the invention, it may be provided that the lower humidity limit is in the range of 30% to 40% relative humidity.

[0037] In embodiments of the invention, it may be provided that the increase of the relative humidity in the usable space to a value above a lower humidity limit is carried out before the relative humidity in the usable space is regulated to a first target value.

[0038] In embodiments of the invention, it may be provided that the first target value is a first amount above the humidity at the beginning of the control of the relative humidity to a first target value.

[0039] In embodiments of the invention, it can be provided that the first amount is in the range of 10%-40% relative humidity, more preferably in the range of 15%-30% relative humidity, and even more preferably in the range of 15%-25% relative humidity.

[0040] In embodiments of the invention, it can be provided that the first duration is in the range of 5 min to 120 min, preferably in the range of 30 min to 90 min, more preferably in the range of 40 to 70 min.

[0041] In embodiments of the invention, it may be provided that the introduction of the active ingredient comprises the evaporation or nebulization of an active ingredient liquid in the humidifier of the humidification system.

[0042] In embodiments of the invention, it may be provided that the active ingredient liquid is supplied in an active ingredient container and / or at an active ingredient connection of the device.

[0043] In embodiments of the invention, it may be provided that the active ingredient liquid is an active ingredient solution.

[0044] In embodiments of the invention, it may be provided that the active ingredient is a sterilizing agent.

[0045] In embodiments of the invention, the active ingredient may be hydrogen peroxide (H2O2). In embodiments of the invention, the method may further comprise: after the first duration has elapsed, determining the current relative humidity in the usable space and controlling the relative humidity to a second target value for a second duration, wherein the humidification system introduces an active ingredient liquid.

[0046] In embodiments of the invention, it may be provided that the second target value is a second amount above the current relative humidity.

[0047] In embodiments of the invention, it can be provided that the second amount is in the range of 10%-40% relative humidity, more preferably in the range of 15%-30% relative humidity, and even more preferably in the range of 15%-25% relative humidity.

[0048] In embodiments of the invention, it can be provided that the second duration is in the range of 5 min to 120 min, preferably in the range of 30 min to 90 min, more preferably in the range of 40 to 70 min.

[0049] In embodiments of the invention, it may be provided that the steps of deactivating the control, breaking down the active ingredient and rinsing only take place after the first and / or second duration has elapsed.

[0050] In embodiments of the invention, it may be provided that the control of the relative humidity in the usable space to a first target value and / or a second target value includes the active distribution of the air in the usable space of the device.

[0051] In embodiments of the invention, the method may include diluting the active ingredient liquid before evaporation or nebulization.

[0052] In embodiments of the invention, it may be provided that the degradation of the active ingredient in the usable space includes the activation of the neutralization unit.

[0053] In embodiments of the invention, it may be provided that the degradation of the active ingredient includes a decomposition of the active ingredient.

[0054] In embodiments of the invention, it may be provided that the degradation time is selected such that a residual concentration of the gaseous active ingredient in the usable space does not pose a danger to a user.

[0055] In embodiments of the invention, it can be provided that the degradation time is in a range of 10 min to 600 min, preferably in a range of 20 min to 400 min, and more preferably in a range of 30 min to 240 min.

[0056] In embodiments of the invention, the method may further comprise: flushing at least a portion of the supply lines to a humidifier of the humidification system. In embodiments of the invention, the flushing may be bidirectional.

[0057] In embodiments of the invention, it may be provided that the rinsing includes emptying liquid lines into a waste container.

[0058] In embodiments of the invention, it may be provided that the rinsing includes filling the emptied liquid lines with fresh water.

[0059] In embodiments of the invention, it may be provided that the rinsing again includes emptying the liquid lines into the waste container.

[0060] In embodiments of the invention, it may be provided that emptying and / or filling is carried out by means of a bidirectional pump.

[0061] In embodiments of the invention, the method may further include: locking a door to the usable space of the device, wherein the locking is carried out before the usable space is heated to a process temperature.

[0062] In embodiments of the invention, the method may further include: performing an automatic check of the device, wherein the check is performed before heating the usable space to a process temperature and the heating of the usable space to a process temperature is only carried out if the check is successful.

[0063] In embodiments of the invention, it may be provided that performing the automatic check includes:

[0064] - Checking a temperature control system,

[0065] - Checking a humidity system,

[0066] - Checking a ventilation system, and / or

[0067] - Checking the amount of water in a storage container.

[0068] In embodiments of the invention, it may be provided that performing the automatic check includes: - Checking the status of the dismantling unit.

[0069] In embodiments of the invention, it may be provided that the humidification system includes a liquid sensor, wherein performing the automatic check includes: - Checking the status of the liquid sensor.

[0070] In embodiments of the invention, it can be provided that an alarm system is active at least during the first period of time, which monitors at least one function of the device.

[0071] Overall, various safety mechanisms can be implemented. The door can be locked. Furthermore, the process can only be started if there are no faults in the temperature, humidity, and ventilation systems and the water reservoir is filled with a sufficient quantity of water. Additionally, it can be checked whether the degradation unit (which can also be called the neutralization unit) is connected. If a sensor is used to detect the water column (for example, in a tube before the evaporator), its functionality can also be tested. During the introduction of the active ingredient (which can also be called fumigation), the same alarm system used in a potential incubation operation can be continuously active. It can have various functions, such as...: Failure of sensors, fan, heating systems, water supply monitoring, and / or exceeding of setpoint values ​​of the controllers.

[0072] In embodiments of the invention, it may be provided that the device is a laboratory device.

[0073] In embodiments of the invention, the device may be an air conditioning or heating device.

[0074] In embodiments of the invention, the device may be an incubator, for example a CCh incubator and / or a reach-in incubator.

[0075] According to another aspect, the invention relates to a device. The device comprises: a usable space; an active humidification system designed to increase the relative humidity in the usable space; a humidity sensor for measuring the relative humidity in the usable space; a temperature control system designed to increase the temperature in the usable space; a temperature sensor for measuring the temperature in the usable space; wherein the humidification system comprises at least one active ingredient connection designed for connection to an active ingredient container containing a liquid containing an active ingredient; and wherein the device is designed to introduce the active ingredient into the usable space via the humidification system.

[0076] In embodiments of the invention, it may be provided that the humidification system further comprises at least one waste port designed for connection to a waste container, wherein the device is designed to rinse at least part of the humidification system and to direct any waste liquid accumulating therein to the waste port.

[0077] In embodiments of the invention, the humidification system may include a humidifier designed to evaporate and / or atomize liquids.

[0078] In embodiments of the invention, the humidifier may be an evaporator and / or a nebulizer. In embodiments of the invention, the humidification system may include a water connection designed for connection to a water reservoir that provides fresh water.

[0079] In embodiments of the invention, the humidification system may include a pump.

[0080] In embodiments of the invention, the pump may be a bidirectional pump.

[0081] It goes without saying that a bidirectional pump can pump in both directions.

[0082] In embodiments of the invention, it may be provided that the pump is designed to convey liquids from the active ingredient connection to the humidifier.

[0083] In embodiments of the invention, it may be provided that the pump is designed to pump liquids from the water connection to the humidifier.

[0084] In embodiments of the invention, the humidification system may include a valve matrix designed to enable fluidic connections between different ports.

[0085] In embodiments of the invention, the valve matrix may be further designed to adjust the flow rate for at least one fluidic connection.

[0086] In embodiments of the invention, it may be provided that the valve matrix is ​​arranged between the pump and the active ingredient connection.

[0087] In embodiments of the invention, the valve matrix can be arranged between the pump and the water connection.

[0088] In embodiments of the invention, it can be provided that the valve matrix is ​​arranged between the pump and the waste port.

[0089] In embodiments of the invention, it may be provided that the valve matrix comprises at least 2 valves.

[0090] In embodiments of the invention, it may be provided that the device additionally includes an air distribution system designed to circulate the air in the usable space.

[0091] In embodiments of the invention, the air distribution system may include a fan. In embodiments of the invention, the device may further include a ventilation system designed to supply fresh air to the usable space.

[0092] In embodiments of the invention, it may be provided that the device is designed to carry out the described method.

[0093] In embodiments of the invention, it may be provided that the device includes a processing unit designed to control the device.

[0094] In embodiments of the invention, it may be provided that the processing unit is designed to carry out the described method.

[0095] In embodiments of the invention, it may be provided that the active ingredient liquid is an active ingredient solution.

[0096] In embodiments of the invention, it may be provided that the active ingredient is a sterilizing agent.

[0097] In embodiments of the invention, it may be provided that the active ingredient is hydrogen peroxide (H2O2).

[0098] In embodiments of the invention, it may be provided that the device is a laboratory device.

[0099] In embodiments of the invention, the device may be an air conditioning or heating device.

[0100] In embodiments of the invention, the device may be an incubator, for example a CCh incubator and / or a reach-in incubator.

[0101] In embodiments of the invention, the humidification system may further comprise a liquid sensor arranged between the humidifier and the pump.

[0102] In embodiments of the invention, it may be provided that the device is a device as described above.

[0103] According to another aspect, the invention relates to a system. The system comprises the described device and a degradation unit designed to degrade an active ingredient within the device's usable space.

[0104] In embodiments of the invention, the degradation unit may be designed to be placed in the usable space and electrically connected to the device. In embodiments of the invention, the degradation unit may include a UV lamp.

[0105] In embodiments of the invention, it may be provided that the degradation unit comprises a reaction partner and / or catalyst for the active ingredient.

[0106] In embodiments of the invention, the degradation unit may include a fan designed to direct air over the reaction partner and / or catalyst.

[0107] In general, embodiments of the invention are therefore directed towards a method, a device and a system for reducing germ density.

[0108] It is understandable that a standard device (for example, an incubator) with an active humidification system typically includes the following components: • Water reservoir or external water connection

[0109] • Steam generator

[0110] • Pipe or hose system for hydraulic connections

[0111] • Pump or valve for dosing the water

[0112] • Humidity sensor

[0113] • Air distribution in the usable space

[0114] • Heating(s) and

[0115] • Temperature sensor.

[0116] According to embodiments of the present invention, such a device or a corresponding system can be expanded with the existing components for other tasks. The system can be extended so that, in addition to the connected water tank, other tanks containing further liquid media can be connected. Valves allow selection of which tank the liquid is metered from to the evaporator. After evaporation from these other tanks, any residues in the hydraulic system can be flushed with water from the first tank. The first water tank remains connected to the system.

[0117] The residual fluids in the hydraulic system and the flushing fluid can be directed into a third container as waste fluid.

[0118] Embodiments of the invention therefore include the extension of the humidification system into a sterilization system for the interior.

[0119] The following tasks can be accomplished by the system according to the invention and the evaporation of appropriate sterilizing agents.

[0120] • Reduction of germ contamination in the usable space,

[0121] • Disinfection of the usable space, and / or

[0122] • Sterilization of the usable space. Additionally, a valve unit can be connected to mix a different sterilizing agent from various starting chemicals or to produce a dilution solution from a concentrate.

[0123] The following advantages can be achieved using embodiments according to the invention:

[0124] The same existing components that perform the standard humidification function can be used. Therefore, relatively few further modifications to the components are necessary.

[0125] An automated and controlled process can be implemented, and control can be achieved via the device (for example, the incubator).

[0126] The process can be monitored and automatic adjustment of the process to the environmental conditions at the installation site can be achieved (the sterilization temperature is adjusted depending on the relative humidity).

[0127] At least part of the water supply system can be decontaminated with liquid sterilizing agent.

[0128] The process can take place at 37°C or slightly higher temperatures (for example 50°C), so that no cooling time (or only a relatively short cooling time) is necessary.

[0129] In general, the process can also be faster than sterilization routines that are carried out at, for example, 180°C.

[0130] The insulation thickness of the device can be reduced compared to heat sterilization (for example at 180°C).

[0131] The material selection for the overall system can be expanded, since 180°C resistance has very high requirements, which is not necessary in embodiments of the invention.

[0132] It is understandable that it is possible to have lower surface temperatures on the device (e.g. incubator) during the process than with sterilizations at approximately 180°C.

[0133] Overall, it may also be more suitable for cleanroom applications than processes at 180°C (no risk of increased particle release and disruption of cleanroom airflow due to thermal effects).

[0134] The invention is also defined by the following numbered embodiments.

[0135] The following refers to process embodiments. These embodiments are identified by a V followed by a number. When process embodiments or V-embodiments are mentioned below, these embodiments are meant.

[0136] VI. Methods for reducing the germ density in the usable space of a device, comprising

[0137] Heating the usable space to a process temperature such that the relative humidity in the usable space is below an upper humidity limit;

[0138] Regulation of the relative humidity in the usable space to an initial target value for an initial duration, whereby a humidification system introduces an active ingredient;

[0139] Disabling relative humidity control; and

[0140] Degradation of the active ingredient in the usable space for a degradation period.

[0141] This means that the relative humidity in the usable space is regulated to an initial target value for an initial duration, while a humidification system introduces an active ingredient, for example by evaporation or nebulization (especially atomization).

[0142] V2. Procedure according to the aforementioned procedural form, wherein the procedure further comprises

[0143] Insertion of an active ingredient container containing an active ingredient liquid, and insertion of a waste container to collect waste liquids.

[0144] V3. Procedure according to one of the aforementioned procedural forms, wherein the procedure further comprises

[0145] Inserting a dismantling unit into the usable space of the device.

[0146] V4. Method according to the above method embodiment, wherein the dismantling unit is introduced into the usable space before heating.

[0147] V5. Method according to one of the two aforementioned method embodiments, wherein the insertion of the extraction unit into the usable space comprises the electrical connection of the extraction unit to the device.

[0148] V6. Method according to one of the 3 above method implementations, wherein the degradation unit is designed to degrade the active substance.

[0149] V7. Method according to one of the foregoing method embodiments, wherein heating the usable space to the process temperature includes increasing the process temperature until the relative humidity at the process temperature is below the upper humidity limit.

[0150] V8. A method according to any of the preceding method embodiments, wherein heating the usable space to the process temperature comprises heating the usable space to an initial value for the process temperature, wherein the initial value is provided by the user. V9. A method according to the preceding method embodiment, wherein the initial value is at least 37°C.

[0151] V10. Method according to one of the two above method implementation forms, wherein during and / or after heating to the initial value the relative humidity in the usable space is determined and compared with the upper humidity limit.

[0152] Vv. Method according to the above method embodiment, wherein, if the relative humidity does not fall below the upper humidity limit, the process temperature is increased until the relative humidity falls below the upper humidity limit.

[0153] V12. Method according to method implementation form V7 or V12, wherein the process temperature is increased stepwise until the upper humidity limit is undershot.

[0154] V13. Method according to method implementation form V7 or V12, wherein increasing the process temperature includes determining the process temperature from a current relative humidity and temperature using the vapor pressure curve.

[0155] V14. Method according to one of the above method embodiments, wherein the process temperature is greater than or equal to the initial value and is selected such that the relative humidity at the process temperature is below the upper humidity limit.

[0156] V15. Method according to one of the above method embodiments, wherein the process temperature is at least 37°C.

[0157] V16. Method according to one of the preceding embodiments, wherein the process temperature is a maximum of 75°C, preferably a maximum of 65°C, and more preferably a maximum of 55°C.

[0158] V17. Method according to one of the above method embodiments, wherein the relative humidity is not controlled during heating.

[0159] V18. Method according to one of the above method embodiments, wherein the upper moisture limit is in the range of 45% to 75% relative humidity, preferably in the range of 45% to 60% relative humidity, more preferably in the range of 45% to 55% relative humidity.

[0160] V19. Method according to one of the above method embodiments, wherein the process temperature is kept constant after heating at least until the active ingredient is degraded in the usable space.

[0161] V20. Method according to one of the above method implementation forms, wherein the method further comprises: increasing the relative humidity in the usable space to a value above a lower humidity limit.

[0162] V21. Method according to the foregoing embodiment,

[0163] where the increase of the relative humidity in the usable space to a value above a lower humidity limit is carried out before the relative humidity is regulated to a first target value for an initial duration.

[0164] V22. Method according to one of the two preceding embodiments,

[0165] where the increase of the relative humidity in the usable space to a value above a lower humidity limit is carried out after the usable space has been heated to the process temperature.

[0166] V23. Method according to one of the 3 preceding embodiments,

[0167] where the increase in relative humidity in the usable space to a value above a lower humidity limit includes the evaporation of water.

[0168] V24. Method according to one of the 4 preceding embodiments, wherein the lower moisture limit is in the range of 30% to 40% relative humidity.

[0169] V25. Method according to one of the 5 preceding embodiments, wherein the increase of the relative humidity in the usable space to a value above a lower humidity limit is carried out before the regulation of the relative humidity in the usable space to a first target value.

[0170] V26. Method according to one of the above method implementation forms, wherein the first target value is a first amount above the humidity at the beginning of the control of the relative humidity to a first target value.

[0171] V27. Method according to the above embodiment, wherein the first amount is in the range of 10%-40% relative humidity, more preferably in the range of 15%-30% relative humidity, and even more preferably in the range of 15%-25% relative humidity.

[0172] V28. Method according to one of the above method embodiments, wherein the first duration is in the range of 5 min to 120 min, preferably in the range of 30 min to 90 min, more preferably in the range of 40 to 70 min.

[0173] V29. Method according to one of the foregoing method embodiments, wherein the introduction of the active ingredient comprises evaporating or nebulizing an active ingredient liquid in the humidifier of the humidification system.

[0174] V30. A method according to any of the foregoing method embodiments, wherein the active ingredient liquid is provided in an active ingredient container and / or at an active ingredient port of the device. V31. A method according to any of the foregoing method embodiments, wherein the active ingredient liquid is an active ingredient solution.

[0175] V32. Method according to one of the foregoing method embodiments, wherein the active substance is a sterilizing agent.

[0176] V33. Method according to one of the foregoing method embodiments, wherein the active ingredient is hydrogen peroxide (H2O2).

[0177] V34. Procedure according to one of the foregoing procedural forms, wherein the procedure further comprises:

[0178] after the first period has expired,

[0179] Determining the current relative humidity in the usable space and

[0180] Regulation of the relative humidity to a second target value for a second duration, whereby the humidification system introduces an active ingredient liquid.

[0181] V35. Method according to the foregoing method implementation form, wherein the second target value is a second amount above the current relative humidity.

[0182] V36. Method according to the above embodiment, wherein the second amount is in the range of 10%-40% relative humidity, more preferably in the range of 15%-30% relative humidity, and even more preferably in the range of 15%-25% relative humidity.

[0183] V37. Method according to one of the 3 above method embodiments, wherein the second duration is in the range of 5 min to 120 min, preferably in the range of 30 min to 90 min, more preferably in the range of 40 to 70 min.

[0184] V38. Method according to one of the above method implementation forms, wherein the steps of deactivating the control, breaking down the active ingredient and rinsing only take place after the first and / or second duration has elapsed.

[0185] V39. Method according to one of the foregoing method embodiments, wherein the control of the relative humidity in the usable space to a first target value and / or a second target value comprises the active distribution of the air in the usable space of the device.

[0186] V40. Method according to one of the foregoing embodiments of the method and having the features of V29, wherein the method comprises diluting the active ingredient liquid prior to evaporation or nebulization.

[0187] V41. A method according to one of the foregoing method embodiments and having the features of V3, wherein the degradation of the active substance in the usable space comprises the activation of the neutralization unit. V42. A method according to one of the foregoing method embodiments, wherein the degradation of the active substance comprises a decomposition of the active substance.

[0188] V43. Method according to one of the above method implementation forms, wherein the degradation time is selected such that a residual concentration of the gaseous active substance in the usable space does not pose a danger to a user.

[0189] V44. Method according to one of the above method embodiments, wherein the degradation time is in a range of 10 min to 600 min, preferably in a range of 20 min to 400 min, more preferably in a range of 30 min to 240 min.

[0190] V45. Method according to one of the foregoing embodiments of the method, wherein the method further comprises: flushing at least a part of the supply lines to a humidifier of the humidification system.

[0191] V46. Method according to the foregoing embodiment, wherein the rinsing is bidirectional.

[0192] V47. Method according to one of the two embodiments of the method above, wherein the rinsing comprises emptying liquid lines into a waste container.

[0193] V48. ​​Method according to the foregoing embodiment, wherein the rinsing comprises filling the emptied liquid lines with fresh water.

[0194] V49. Method according to the foregoing method embodiment, wherein again the rinsing comprises emptying the liquid lines into the waste container.

[0195] V50. Method according to one of the 5 above method embodiments, wherein emptying and / or filling is carried out by means of a bidirectional pump.

[0196] V51. Method according to one of the preceding embodiments, wherein the method further comprises: locking a door to the usable space of the device, wherein the locking is carried out before heating the usable space to a process temperature.

[0197] V52. Method according to one of the preceding embodiments, wherein the method further comprises: performing an automatic check of the device, wherein the check is performed before heating the usable space to a process temperature and heating the usable space to a process temperature is performed only if the check is successful.

[0198] V53. Method according to the foregoing embodiment, wherein performing the automatic check comprises:

[0199] - Checking a temperature control system,

[0200] - Checking a humidity system,

[0201] - Checking a ventilation system, and / or - Checking the amount of water in a storage tank.

[0202] V54. Method according to one of the two preceding embodiments having the features of embodiment V3, comprising performing the automatic check:

[0203] - Checking the status of the mining unit.

[0204] V55. Method according to one of the 3 preceding embodiments, wherein the humidification system comprises a liquid sensor, wherein performing the automatic check comprises:

[0205] - Checking the status of the liquid sensor.

[0206] V56. Method according to one of the preceding embodiments, wherein at least during the first period an alarm system is active which monitors at least one function of the device.

[0207] V57. Method according to one of the foregoing method embodiments, wherein the device is a laboratory device.

[0208] V58. Method according to one of the foregoing method embodiments, wherein the device is an air conditioning or heating device.

[0209] V59. Method according to one of the foregoing method embodiments, wherein the device is an incubator.

[0210] The following refers to device configurations. These configurations are identified by a G followed by a number. When device configurations or G configurations are mentioned below, these configurations are meant.

[0211] Gl. Device encompassing

[0212] a usable space;

[0213] an active humidification system designed to increase relative humidity in the usable space;

[0214] a humidity sensor for measuring the relative humidity in the usable space;

[0215] a temperature control system designed to increase the temperature in the usable space; a temperature sensor for measuring the temperature in the usable space;

[0216] wherein the humidification system includes at least one active ingredient connection designed for connection to an active ingredient container containing an active ingredient liquid; and

[0217] the device is designed to introduce the active ingredient into the usable space via the humidification system.

[0218] G2. Device according to the aforementioned device embodiments, wherein the humidification system further comprises at least one waste port designed for connection to a waste container, wherein the device is designed to flush at least part of the humidification system and to direct any waste liquid generated therein to the waste port.

[0219] G3. Device according to one of the foregoing device embodiments, wherein the humidification system comprises a humidifier designed to evaporate and / or atomize liquids.

[0220] G4. Device according to the aforementioned device design, wherein the humidifier is an evaporator and / or a nebulizer.

[0221] G5. Device according to one of the above device embodiments, wherein the humidification system includes a water connection designed for connection to a water reservoir which provides fresh water.

[0222] G6. Device according to one of the above device embodiments, wherein the humidification system comprises a pump.

[0223] G7. Device according to the above device embodiment, wherein the pump is a bidirectional pump.

[0224] It goes without saying that a bidirectional pump can pump in both directions.

[0225] G8. Device according to one of the two preceding device embodiments and with the features of embodiment G3, wherein the pump is designed to convey liquids from the active ingredient connection to the humidifier.

[0226] G9. Device according to one of the 3 above device embodiments and with the features of embodiments G3 and G5, wherein the pump is designed to pump liquids from the water connection to the humidifier.

[0227] G10. Device according to one of the foregoing device embodiments wherein the humidification system comprises a valve matrix designed to enable fluidic connections between different ports.

[0228] Gil. Device according to the above device embodiment wherein the valve matrix is ​​further designed to adjust the flow rate for at least one fluidic connection.

[0229] G12. Device according to one of the two device embodiments above and with the features of G6, wherein the valve matrix is ​​arranged between the pump and the drug port.

[0230] G13. Device according to one of the 3 preceding device embodiments and with the features of G5 and G6, wherein the valve matrix is ​​arranged between the pump and the water connection. G14. Device according to one of the 3 preceding device embodiments and with the features of G2 and G6, wherein the valve matrix is ​​arranged between the pump and the waste connection.

[0231] G15. Device according to one of the 5 device embodiments above, wherein the valve matrix comprises at least 2 valves.

[0232] G16. Device according to one of the above device configurations, wherein the device additionally includes an air distribution system designed to circulate the air in the usable space.

[0233] G17. Device according to the above device embodiment, wherein the air distribution includes a fan.

[0234] G18. Device according to one of the above device configurations, wherein the device further comprises a ventilation system designed to supply fresh air to the usable space.

[0235] G19. Device according to one of the foregoing device embodiments, wherein the device is designed to perform the method according to one of the foregoing method embodiments.

[0236] G20. Device according to one of the foregoing device embodiments, wherein the device comprises a processing unit designed to control the device.

[0237] G21. Device according to the foregoing device embodiment, wherein the processing unit is designed to carry out the process according to one of the foregoing process embodiments.

[0238] G22. Device according to one of the above device embodiments, wherein the active ingredient liquid is an active ingredient solution.

[0239] G23. Device according to one of the above device embodiments, wherein the active ingredient is a sterilizing agent.

[0240] G24. Device according to one of the above device embodiments, wherein the active ingredient is hydrogen peroxide (H2O2).

[0241] G25. Device according to one of the above device configurations, wherein the device is a laboratory device.

[0242] G26. Device according to one of the foregoing device embodiments, wherein the device is an air conditioning or heating device. G27. Device according to one of the foregoing device embodiments, wherein the device is an incubator.

[0243] G28. Device according to one of the preceding device embodiments having the features of embodiments G3 and G6, wherein the humidification system further comprises a liquid sensor arranged between the humidifier and the pump.

[0244] V60. Method according to one of the foregoing method embodiments, wherein the device is a device according to one of the foregoing device embodiments.

[0245] The following refers to system implementations. These embodiments are identified by an S followed by a number. When system implementations or S-implementations are mentioned below, these embodiments are meant.

[0246] 51. System comprehensive

[0247] Device according to one of the aforementioned device designs; and degradation unit designed to degrade an active ingredient within the usable space of the device.

[0248] 52. System according to the above system design, wherein the dismantling unit is designed to be placed in the usable space and electrically connected to the device.

[0249] 53. System according to one of the above system embodiments, wherein the degradation unit comprises a UV lamp.

[0250] 54. System according to one of the above system embodiments, wherein the degradation unit comprises a reaction partner and / or catalyst for the active ingredient.

[0251] 55. System according to the above system embodiment, wherein the degradation unit comprises a fan designed to direct air over the reactant and / or catalyst.

[0252] Embodiments of the present invention will now be described with reference to the accompanying drawings. These embodiments are intended to illustrate the present invention only by way of example, but not to limit it.

[0253] Fig. 1 shows a device with usable space, humidification system and temperature control system;

[0254] Fig. 2 shows an embodiment of a device according to the present invention;

[0255] Fig. 3 shows one embodiment of a method for reducing germ density; Fig. 4 shows another embodiment of a method for reducing germ density; and

[0256] Fig. 5 schematically illustrates a temperature and relative humidity profile during an implementation of the method for reducing microbial density. It should be noted that not all drawings bear all reference numerals. Instead, some reference numerals have been omitted in some of the drawings for the sake of brevity and simplicity. Embodiments of the present invention are now described with reference to the accompanying drawings.

[0257] Fig. 1 shows a device 1 with a usable space 10, a humidification system 14, and a temperature control system 16, designed to increase the relative humidity and / or temperature in the usable space 10. Additionally, the device 1 may, for example, also include a ventilation system 12, designed to supply fresh air (e.g., ambient air) to the usable space 10. It is understood that the device may also include further components; for example, the device 1 may additionally have a CO2 control system that allows the CO2 concentration in the usable space to be increased. The usable space can generally be accessed by a user outside the device via at least one door 106.

[0258] It is understood that the invention relates in principle to a device 1 comprising a usable space 10, an active humidification system 14 and a temperature control system 16, such as, for example, a laboratory, air conditioning or heating device in general. In particular, this can be an incubator.

[0259] The device 1 may further include an air distribution system, which may have a fan 102 designed to circulate the air in the usable space 10. The fan 102 may preferably be arranged in an air duct 104.

[0260] The temperature control system 16 can, for example, include a temperature control element arranged in a corresponding air duct 104, which tempers the air flowing past it, e.g., by heating or cooling it. Alternatively, the temperature control element can also be attached to the outside of an inner container that defines the usable space and thus heats one or more walls of the usable space 10. The temperature control element can, for example, be a heating element (e.g., a resistance heating element) or a Peltier system. Furthermore, the device 1 can include a temperature sensor (not shown) that enables the temperature in the usable space to be measured. This allows the temperature control system 16 to be controlled or regulated accordingly. It is understood that the temperature control system 16 can also include several temperature control elements.

[0261] The humidification system 14 can comprise a humidifier 141, a pump 142, and a water connection 144. The humidifier 141 can, in particular, comprise a nebulizer or evaporator that atomizes or evaporates liquid water, thereby increasing the relative humidity of the air in the usable space. The water can be provided in a water reservoir 145, which in some embodiments is enclosed by the device and in others is located within or external to it. The water from the water reservoir 145 can then be pumped to the humidifier 141 via the water connection 144, to which the water reservoir 145 can be connected, by means of the pump 142. Additionally, a first valve 143 can be provided, which is preferably arranged between the pump 142 and the water connection 144 and can selectively interrupt the fluid connection between them.

[0262] The device can also include a humidity sensor (not shown) for measuring the relative humidity in the usable space. This enables control or regulation of the relative humidity in the usable space by means of the humidification system 14, depending on the measured relative humidity.

[0263] The optional ventilation system 12 can, for example, include an air pump 124 that can supply air (e.g., ambient air) to the usable space 10. Preferably, the ventilation system 12 can also include a filter 122 that filters the supply air to prevent contamination of the usable space 10. The filter can, for example, be a membrane filter. Additionally, the device can include a pressure equalization opening 126, which can be part of the ventilation system. This advantageously prevents the pressure in the usable space from rising too high when supply air is actively introduced. Preferably, the pressure equalization opening 126 has a flow resistance that hinders or reduces continuous air exchange with the environment of the device 1, so that a corresponding air exchange primarily occurs when there is a pressure difference between the usable space and the environment, and is otherwise preferably strongly inhibited.

[0264] It is understood that the pump 124 could alternatively also draw air from the usable space, thereby allowing supply air to flow in through the pressure equalization opening 126. Particularly in such embodiments, the flow resistance can preferably be provided by a filter.

[0265] The present invention is based on the idea of ​​using the existing humidification system 14 in a device 1 for introducing an active substance (preferably a sterilizing agent) into the usable space 10.

[0266] With reference to Figure 2, the humidification system 14 may include an active ingredient connection 146 designed for connection to an active ingredient container 152. This active ingredient container 152 may contain an active ingredient liquid, preferably a sterilizing agent, more preferably hydrogen peroxide. The humidification system may also include more than one active ingredient container connection.

[0267] The active ingredient connection 146 can be connected to the pump 142 via at least one first valve 143. For example, the first valve 143 can be a 3-way valve that can selectively connect either the water connection 144 or the active ingredient connection 146 to the pump 142. Furthermore, the humidification system can include a waste connection 147 designed for connection to a waste container 153. The waste container 153 can be designed to collect waste liquids.

[0268] The waste container 153 can also be connected to the pump 142 via the first valve 143. Preferably, a second valve 148 can be provided, which can, for example, selectively connect either the waste port 147 or the active ingredient port 146 to the first valve.

[0269] More generally, a valve matrix 149 can be provided which can selectively connect the pump 142 fluidically to the water connection 144, the active ingredient connection 146 and the waste connection 147.

[0270] Preferably, the pump 142 can be bidirectional. This allows, in particular, effective flushing of at least part of the supply lines.

[0271] Optionally, a liquid sensor can be installed between pump 142 and evaporator 141. This sensor should be located as close as possible to evaporator 141 and should detect the liquid column level during rinsing. It is intended to compensate for fluctuations in the flow rate of pump 142 and ensure that a hose connecting evaporator 141 to pump 142 is always filled with rinsing water up to a defined point.

[0272] Overall, the device can therefore also be designed to simultaneously pump liquids from more than one container and / or reservoir. In other words, the device 1, and in particular the humidification system 14, can be designed so that liquids can be pumped simultaneously from multiple connections by the pump 142; for example, liquid can be pumped simultaneously from the active ingredient connection 146 and the water connection 144. For example, an active ingredient liquid can be produced by mixing two or more liquids. In particular, a concentrated active ingredient solution can also be diluted with water. This can advantageously make it possible to provide more active ingredient with the same active ingredient container size, or, for example, the same amount of active ingredient in a smaller active ingredient container 152.

[0273] In general, the present invention can in particular comprise a system which, in addition to the device 1, also includes a degradation unit designed to degrade or break down the active ingredient in the usable space 10 of the device 1. The degradation unit can also be referred to as a neutralization unit or decomposition unit.

[0274] The degradation unit can be placed in the usable space 10 and electrically connected to the device 1. For example, the degradation unit can include a UV lamp which uses UV radiation to decompose the active ingredient (e.g., hydrogen peroxide), so that after the microbial density in the usable space has been reduced, a safe atmosphere can be established before a user opens the door 106 to usable space 10. Preferably, the degradation unit can include a reactant or catalyst designed to degrade or break down the active ingredient. More preferably, the degradation unit can include a fan that actively draws air over the reactant or catalyst to increase efficiency. This allows a safe atmosphere to be established in the usable space more quickly.

[0275] The device may also include a processing unit designed to send (and, if necessary, receive) data to, control, regulate, and / or monitor the humidification system 14, the temperature control system 16, the air distribution system, and / or the ventilation system 12. In particular, the processing unit 15 may be connected to the humidification system 14 and the temperature control system 16. These connections may be wired or wireless. Furthermore, the processing unit 15 may be connected to at least one sensor arranged to provide an indicative signal for at least one parameter within the usable space 10. The at least one sensor may, for example, be located within the usable space 10. The at least one sensor may, in particular, be the humidity sensor and / or the temperature sensor.

[0276] The processing unit can be designed to control at least one parameter for the conditions within the usable space 10. In particular, the processing unit can be designed to control the humidification system 14 and the temperature control system such that a predetermined setpoint is achieved for at least one parameter, in particular a temperature and / or relative humidity.

[0277] The processing unit can also be designed to control a mining unit that is electrically connected to the device.

[0278] The present invention also relates to a method for reducing the microbial density in the usable space of a device. With reference to Fig. 3, the method comprises heating the usable space to a process temperature (step 210). The process temperature can preferably initially correspond to a value, which can further preferably correspond to a temperature set by the user for subsequent processes, e.g., an incubation temperature, and is preferably at least 37°C. At this point, humidity control in the usable space is switched off; that is, in particular, it is not actively increased or maintained at a specific value.

[0279] Once the process temperature (especially the initial value) has been reached (or even during heating), the relative humidity in the usable space can be determined and compared with an upper humidity limit (step 212). If the relative humidity exceeds the upper humidity limit, the process temperature is increased to further reduce the relative humidity (step 214). The adjusted process temperature can be calculated, for example, based on the current relative humidity and temperature using the vapor pressure curve. Alternatively, the process temperature can be increased incrementally and the relative humidity monitored until it falls below the upper humidity limit.

[0280] In embodiments of the invention, a lower humidity limit may be used. For example, the process temperature could be 40 °C, and at this temperature the relative humidity (in step 212) could be 30%. If the upper humidity limit is, for example, 50%, no further adjustment according to step 214 takes place. Additionally, a lower humidity limit may be used. For example, this could be 40% in the example. As described, in the example, the relative humidity is 30% without further measures. If it is below the lower humidity limit (40% in the example), the relative humidity can be increased in step 216 by evaporating water until the relative humidity is above the lower humidity limit. The use of a lower humidity limit can advantageously result in the process producing more comparable relative humidity measurements.Moisture shows and also becomes more comparable in biological effectiveness.

[0281] The usable space is heated to a process temperature such that the relative humidity in the usable space is below the upper humidity limit (steps 210, 212, 214). Optionally, the relative humidity in the usable space can be set above a lower humidity limit (step 216). The final process temperature is then kept constant throughout the entire process. The relative humidity achieved as described (by setting the final process temperature and optionally evaporating water if a lower humidity limit is used) is used as the starting humidity during the process.

[0282] The present process can therefore be advantageously carried out at 37°C or slightly higher temperatures (e.g., 50°C), so that no, or at least no significant, cooling time is required before the device can be used for other processes after completion. This, among other things, allows the present process to be performed advantageously faster than a typical 180°C sterilization routine. Likewise, the material requirements for the overall system are lower, which expands the material selection, as it does not require 180°C resistance. Similarly, the insulation thickness of the device can be advantageously reduced compared to a device designed for corresponding heat sterilization.

[0283] The lower surface temperature inside the device during the process also makes it advantageous to treat materials not designed for temperatures around 180°C, thus expanding sterilization possibilities. Similarly, such a process can be advantageous for cleanroom applications, as the risk of increased particle release and disruption of cleanroom airflow due to thermal effects is significantly lower compared to sterilization at 180°C. Furthermore, adjusting the process temperature to keep the relative humidity below a certain upper limit allows the process to be automatically adapted to ambient conditions at the installation site, as the process temperature is adjusted based on the relative humidity. This makes it possible, for example, to use the process in tropical regions with high humidity without any special adjustments.

[0284] After the process temperature has stabilized and the relative humidity, i.e., the initial humidity, is below the upper humidity limit (and optionally above a lower humidity limit), the relative humidity in the working space is regulated to a first target value for an initial period (step 220). During this process, the humidification system introduces a supplied active ingredient, preferably H₂O₂, into the working space. In particular, the introduction of the active ingredient can include evaporation or nebulization (e.g., atomization) of a liquid active ingredient, preferably a FUCh solution. The first target value can preferably be a first amount above the initial humidity, i.e., the current relative humidity. Preferably, this first amount is in the range of 10%–40% relative humidity, more preferably in the range of 15%–30% relative humidity, and even more preferably in the range of 15%–25% relative humidity.

[0285] By using the sterilization fluid to increase the relative humidity, an active ingredient (preferably H₂O₂) contained within it is released into the workspace. This can then reach relevant surfaces and reduce the microbial density (and thus the microbial load). Furthermore, a suitable fan or air distribution system within the device can circulate the air in the workspace, ensuring even distribution of the active ingredient. Once the relative humidity has reached the initial target value, it is maintained at a constant level for the first period.

[0286] Optionally, the active ingredient liquid can also be mixed from at least two different containers and / or reservoirs. In particular, a highly concentrated active ingredient solution can be diluted with water, for example. For this purpose, several containers and / or reservoirs can be connected simultaneously to the pump, which delivers these liquids to the humidifier, via one or more valves, e.g., a valve matrix.

[0287] The present method advantageously requires only one sensor for the relative humidity in the usable space, which is typically already present if a humidification system is in place. In particular, no sensor is needed to also measure the active ingredient concentration. Instead, the method can be regulated and / or controlled solely via the humidity sensor.

[0288] After the first period has elapsed, the above process can optionally be repeated (if necessary). In particular, the current relative humidity in the usable space can be determined, and then the relative humidity can be regulated to a second target value for a second period (step 230). This can advantageously further reduce the microbial density and, for example, enable the sterilization of surfaces in the usable space. The second target value can also preferably be a second amount higher than the current relative humidity. As before, this second amount is preferably in the range of 10%–40% relative humidity, more preferably in the range of 15%–30% relative humidity, and even more preferably in the range of 15%–25% relative humidity. The first and second amounts can preferably be identical.

[0289] Subsequently, i.e., after the first or second duration has elapsed, the humidity control is deactivated and the active ingredient is degraded in the usable space (step 240). Preferably, the active ingredient is degraded by means of a degradation unit. The degradation unit can be introduced into the usable space of the device at the beginning of the process and electrically connected to it. This advantageously makes it possible to degrade the active ingredient to such an extent that a residual concentration of the gaseous active ingredient that is harmless to a user is reached. For this purpose, the degradation unit can preferably be time-controlled.

[0290] After the active ingredient has broken down, the supply lines to a humidifier (e.g., an evaporator) of the humidification system can be at least partially emptied into a waste container and flushed, particularly bidirectionally (step 250). This means that fresh water can be pumped from a suitable reservoir to the humidifier and then into the waste container. This process can be repeated several times to remove any remaining traces of the active ingredient liquid from the humidifier's supply lines.

[0291] Finally, the waste container and the active ingredient container can be disposed of and the device can be used again in normal operation.

[0292] The processing unit of the device can preferably be designed to carry out the process for reducing germ density.

[0293] The present invention thus advantageously utilizes existing components of devices to enable the reduction of microbial density. More precisely, an existing humidification system can be advantageously extended to also enable the reduction of microbial density and, in particular, disinfection and sterilization. Furthermore, the use of parts of the humidification system can advantageously allow at least a portion of the piping system, which is normally used for water, to be decontaminated with liquid sterilizing agent, or the microbial density in these parts of the piping system to be reduced accordingly.

[0294] Overall, the present method advantageously enables an automated and regulated process that can be controlled via the device (e.g. the incubator).

[0295] Fig. 4 shows a more detailed flowchart of an exemplary embodiment of the method for reducing the microbial density in the usable space of a device. The method is described below with regard to the sterilization of the surfaces in the usable space; however, it should be understood that only a reduction of the microbial density or disinfection of the usable space is possible, i.e., sterilization is not necessarily required.

[0296] Initially, the user inserts an active ingredient container and a waste container into the device (step 202). In other words, the user can insert a cartridge containing a liquid active ingredient (also called a sterilizing agent), such as hydrogen peroxide, and connect a waste cartridge for liquids. The active ingredient container typically contains a solution of the active ingredient (preferably H₂O₂) and water. Additionally, the user may insert a degradation unit (also called a decomposition unit or neutralization unit) into the device's operating chamber and connect it electrically. The degradation unit is designed to render the active ingredient harmless to the user (e.g., to neutralize and / or decompose it).For example, the degradation unit may include or consist of a UV lamp, or alternatively include a fan with a reaction partner for the active ingredient or a catalyst to actively convey the air over it.

[0297] Subsequently, safety checks may be carried out (step 206). For example, it may be verified that the usable space of the device is closed and secured against unauthorized opening, and / or that the dismantling unit has been placed and connected in the usable space. Additionally or alternatively, it may be verified whether other device openings are closed (for example, feedthrough openings accessible to the user), whether an internal device fan is functioning, and / or whether an optional liquid sensor between pump 142 and evaporator 141 is functioning.

[0298] The conditioning of the sterilization chamber can then begin. As a first step, the chamber, and in particular the air within it, is heated to an initial value (i.e., to an initial process temperature) (step 210). This initial temperature is at least 37°C and can be set by the user (e.g., the initial process temperature can correspond to a user-selected incubation temperature). Humidity control is deactivated during heating. During heating or after the process temperature has been reached, the current relative humidity in the chamber can be determined and compared to the upper humidity limit (step 212). The upper humidity limit can be, for example, 55% relative humidity. If the humidity falls below the upper limit, the process temperature remains at its initial setting.

[0299] If the relative humidity is not below the upper humidity limit, i.e., the upper humidity limit is exceeded, the process temperature is increased accordingly to reduce the relative humidity in the usable space below the upper humidity limit (step 214). The process temperature can be calculated from the measured values ​​of the current relative humidity and temperature using the vapor pressure curve, or the process temperature can be increased incrementally and the relative humidity checked until the upper humidity limit is reached. Reducing the relative humidity below the corresponding upper humidity limit ensures that a necessary margin to the saturation limit is maintained, since the relative humidity in the usable space increases during the introduction of the active ingredient (e.g., by evaporating an active ingredient solution), and saturation of the air must be avoided.

[0300] In this embodiment, it can also be optionally provided that a lower humidity limit is used, i.e., that it is checked whether the relative humidity is above a lower humidity limit. For example, this could be 30% or 40%, with a lower humidity limit of 40% being assumed in the following example. If, for example, a temperature of 40 °C is set in step 210 and this results in a relative humidity of 30% (with an upper humidity limit of 55% and a lower humidity limit of 40%), this does not lead to a further increase in the process temperature according to step 214. However, the relative humidity can be increased according to step 216 by evaporating water. The humidity thus achieved is, in this example, the starting humidity.

[0301] The relative humidity at the start of step 220 (i.e., after completion of step 212, which may have been repeated several times, and after the optional step 216) is the starting humidity, and the corresponding process temperature is kept constant for the remainder of the process.

[0302] The actual sterilization process (or, more generally, the reduction of microbial density) can then begin by regulating the relative humidity to an initial target value (step 220). For this purpose, the liquid from the active ingredient container (e.g., H₂O₂ cartridge) is pumped to the humidifier, which evaporates or nebulizes it, thus introducing the active ingredient into the work area. The initial target value can be set at a (fixed) amount (e.g., 15%–25% relative humidity) above the current relative humidity.

[0303] The disinfectant liquid (also called sterilization fluid) is evaporated (or nebulized), thereby increasing the humidity in the work area. The disinfectant is then released into the work area and reaches the surfaces to be sterilized. The disinfectant can be advantageously distributed evenly throughout the work area by the device's air distribution system.

[0304] The relative humidity is then held at the first target value for an initial period (step 224), i.e., the relative humidity is kept constant.

[0305] After the first period, the process can be repeated to ensure, for example, sterilization or a log12 reduction. For this, the current relative humidity is determined and then adjusted to a second target value (step 230). This second target value is again a fixed amount (e.g., 15%–25% relative humidity) higher than the current relative humidity. This causes the active ingredient concentration in the working chamber to increase again. The relative humidity is then maintained at the second target value for a second period (step 234), i.e., the relative humidity is kept constant. After the second period, the humidity control can be deactivated. Subsequently, the degradation of the active ingredient in the working chamber is started (step 240). For this, a degradation unit placed in the working chamber can preferably be activated by a device controller for a degradation period (i.e., a specific time) (step 244).The degradation period can preferably be chosen so that the residual concentration of the gaseous active ingredient poses no danger to the user, for example when opening a door to the usable area.

[0306] The corresponding liquid lines to the humidifier (e.g., evaporator) can then be flushed (step 250). For this, the liquid lines can be emptied into the waste container and filled with fresh water from a water tank, which can then be pumped back into the waste container. This process can be repeated several times.

[0307] Finally, the active ingredient container and waste container can be removed and disposed of (step 260).

[0308] Figure 5 illustrates an exemplary temperature and relative humidity profile in the usable space of a device during the implementation of the microbial reduction method. It should be understood that this is a purely exemplary and schematic representation, and changes in temperature and / or relative humidity, for example, are typically not linear.

[0309] Initially, the air in the usable space is at 25°C and approximately 65% ​​relative humidity. The air is then heated to the process temperature. First, the temperature is heated to an initial value of at least 37°C, which corresponds to this value in the present example. As the temperature in the usable space increases, the relative humidity decreases. In this example, after reaching the initial value of 37°C, it is checked whether the relative humidity is below a corresponding upper humidity limit (FG), which in this example is 55% relative humidity. Alternatively, the relative humidity can also be compared with the upper limit during the heating process. In this case, the relative humidity is still slightly above the upper humidity limit (FG). Therefore, the process temperature is adjusted, and the usable space is heated further. After reheating to approximately...At 43°C, the relative humidity is below the upper humidity limit FG. Accordingly, the actual reduction of the microbial load can then begin. For this purpose, the relative humidity is regulated to an initial target value Zi for an initial period Ti, which is, for example, a first amount Fi above the current humidity (also called starting humidity). During this process, an active ingredient liquid, preferably a solution, is evaporated using the device's humidification system. This allows the active ingredient to be introduced into the usable space.

[0310] After the initial duration Ti has elapsed, the relative humidity can be determined and increased again, for example, to ensure a sufficient reduction in microbial density for sterilization. In other words, starting from the current relative humidity, the relative humidity can be adjusted to a second target value Z2 for a second duration T2. ​​This second target value Z2 can, for example, be a second amount F2 above the current relative humidity. Increasing the relative humidity introduces more active ingredient into the working chamber.

[0311] In the present example, the first duration Ti is identical to the second duration T2, and the first amount Fi is identical to the second amount F2. However, these can also be chosen differently from each other.

[0312] The active ingredient can then be broken down in the usable space, and the humidification system's pipes can be flushed as described above. During this process, the temperature can advantageously be kept constant to prevent condensation within the usable space. Due to the device's airtight seal, the humidity typically does not drop during the active ingredient breakdown.

[0313] The present invention thus makes it possible to use existing components of a humidification system for reducing the germ density in the usable space. Parts of the piping system can also be advantageously cleaned with the active ingredient liquid used. Furthermore, high temperatures can be avoided, which simplifies the material selection for the device, reduces the required insulation thickness, and also enables the treatment of objects that cannot withstand high temperatures of approximately 180°C. Likewise, longer cooling phases can be eliminated, allowing the device to be ready for use again more quickly.

[0314] The process can automatically adapt to the conditions of the installation site (especially the relative humidity of the environment) and adjust the process temperature accordingly. Overall, this advantageously enables automatic execution of the process via the device's own control system.

[0315] An example process might proceed as follows:

[0316] 1. A user inserts a cartridge containing liquid sterilizing agent (e.g. hydrogen peroxide) and connects a waste cartridge for liquids.

[0317] A degradation unit (for example, a decomposition unit) is introduced into the usable space and electrically connected to the device; it can include, for example:

[0318] • a fan with a reaction partner for sterilizing agents or with a catalyst to actively move the air over it

[0319] • a UV lamp.

[0320] 2.1 Start of conditioning phase: Heating to sterilization temperature (user-set incubation temperature, for example, at least 37°C), humidity control is switched off. 2.2 Checking the starting humidity

[0321] It is understandable that the humidity in the usable space increases during the evaporation process in step 3. Before starting this evaporation, it can be ensured that there is a margin to the saturation point. The evaporation cycle should be carried out twice. Therefore, it can be advantageous to choose a relatively low starting humidity level.

[0322] During heating or after reaching the sterilization temperature, the current humidity in the usable space is compared with an upper limit - this could, for example, be 55% relative humidity, i.e., 55% rH.

[0323] If the upper limit is exceeded, the temperature is increased in this case. This reduces the relative humidity in the usable space. A new sterilization temperature can then be determined. Possible methods for determining the new sterilization temperature are:

[0324] • Calculate the target temperature from the measured value of the current relative humidity and temperature using the vapor pressure curve or

[0325] • Gradually increase the temperature of the device and check the relative humidity again until the starting humidity limit is undershot.

[0326] If the upper limit is undershot, the sterilization temperature remains as described in section 2.1.

[0327] Optionally, a lower humidity limit can also be used. This could, for example, be 40% RH. If the humidity level is below the lower humidity limit, the relative humidity can be increased, for example by evaporating water until the lower humidity limit is exceeded.

[0328] The initial humidity is achieved by using an upper humidity limit (and increasing the temperature as long as this limit is exceeded) and optionally by using a lower humidity limit (and evaporating water as long as this limit is not reached). The humidity achieved in this way is the initial humidity.

[0329] The temperature determined as described (sterilization temperature) is kept constant by the incubator throughout the entire subsequent process.

[0330] 3. Start of the sterilization process

[0331] The humidity control is activated, and liquid is dispensed from the H₂O₂ cartridge. The H₂O₂ cartridge can also be referred to as a secondary reservoir (with a primary reservoir containing water). The target relative humidity can be set by a fixed amount (e.g., 15–25% RH) above the current relative humidity. The sterilizing fluid evaporates, thereby increasing the humidity in the work area. The active ingredient is released into the work area and reaches the surfaces to be sterilized. The normal ventilation of the unit distributes the agent evenly throughout the work area. This humidity level is maintained at a constant level.

[0332] After a set period of time, the sterilization process is repeated by measuring the current relative humidity again and increasing the target value by a fixed amount (e.g., 15-25% RH). This increases the concentration of the active ingredient in the usable space again.

[0333] This humidity level will be kept constant for a set period of time.

[0334] 4. Degradation of the sterilizing agent

[0335] After a sterilization period, the humidity control is deactivated. The decomposition unit installed in the usable space is activated by the device control for a specific period.

[0336] The time is chosen so that the residual concentration of gaseous H2O2 poses no danger to the user.

[0337] 5. The liquid lines to the evaporator are emptied (into a waste container) and filled with fresh water from the water tank, which is then pumped back into the waste container. This can be repeated several times.

[0338] 6. Dispose of the cartridge containing the remaining sterilizing agent and the waste cartridge.

[0339] If a relative term such as "approximately", "essentially", or "approximately" is used in this description or the claims, such a term should also be interpreted as including the exact term. That is to say, for example, "essentially exactly" should be interpreted as also including "(exactly) exactly".

[0340] Whenever steps are cited in the claims above or in the attached claims, it should be noted that the order in which the steps are cited in this text may be arbitrary. That is to say, the order in which the steps are cited may be random unless otherwise specified or it is clear to a person skilled in the art. That is to say, if, for example, the present document states that a method comprises steps (A) and (B), this does not necessarily mean that step (A) is carried out before step (B), but it is also possible that step (A) is carried out (at least partially) simultaneously with step (B) or that step (B) is carried out before step (A). Furthermore, if it is stated that one step (X) precedes another step (Z), this does not mean that there is no step between steps (X) and (Z).This means that "step (X) before step (Z)" encompasses the situation where step (X) is executed directly before step (Z), but also the situation where (X) is executed before one or more steps (Yl), ..., followed by step (Z). Similar considerations apply when terms like "after" or "before" are used.

[0341] While a preferred embodiment has been described above with reference to the accompanying drawings, the person skilled in the art will understand that this embodiment has been provided for illustrative purposes only and should in no way be construed as limiting the scope of the present invention as defined by the claims.

Claims

Claims 1. Method for reducing the germ density in the usable space of a device, comprising Heating the usable space to a process temperature such that the relative humidity in the usable space is below an upper humidity limit; Regulation of the relative humidity in the usable space to an initial target value for an initial duration, whereby a humidification system introduces an active ingredient; Disabling relative humidity control; and Degradation of the active ingredient in the usable space for a degradation period.

2. The method of claim 1, wherein heating the usable space to the process temperature comprises increasing the process temperature until the relative humidity at the process temperature is below the upper humidity limit.

3. Method according to one of the preceding claims, wherein the relative humidity is not controlled during heating.

4. Method according to one of the preceding claims, wherein the process temperature is kept constant after heating at least until the active ingredient is degraded in the usable space.

5. A method according to any one of the preceding claims, wherein the method further comprises: Increasing the relative humidity in the usable space to a value above a lower humidity limit.

6. Method according to one of the preceding claims, wherein the first target value is a first amount above the humidity at the beginning of the control of the relative humidity to a first target value.

7. Method according to one of the preceding claims, wherein the introduction of the active ingredient comprises evaporating or nebulizing an active ingredient liquid in the humidifier of the humidification system.

8. Method according to any of the preceding claims, wherein the active ingredient is hydrogen peroxide (H2O2).

9. A method according to any one of the preceding claims, wherein the method further comprises: after the first period has expired, Determining the current relative humidity in the usable space and Control of the relative humidity to a second target value for a second duration, wherein the humidification system introduces an active ingredient liquid, the second target value being a second amount above the current relative humidity.

10. Method according to any of the preceding claims, wherein the method further comprises: locking a door to the usable space of the device, wherein the locking is performed before heating the usable space to a process temperature, and wherein the method further comprises: performing an automatic check of the device, wherein the check is performed before heating the usable space to a process temperature and the heating of the usable space to a process temperature is performed only if the check is successful.

11. Method according to any of the preceding claims, wherein the device is an air conditioner or heating device or an incubator.

12. Device encompassing a usable space; an active humidification system designed to increase relative humidity in the usable space; a humidity sensor for measuring the relative humidity in the usable space; a temperature control system designed to increase the temperature in the usable space; a temperature sensor for measuring the temperature in the usable space; wherein the humidification system comprises at least one active ingredient connection designed for connection to an active ingredient container containing an active ingredient liquid; and the device is designed to introduce the active ingredient into the usable space via the humidification system.

13. Device according to claim 12, wherein the device is designed to perform the method according to any one of claims 1 to 11.

14. System comprehensive Device according to one of claims 12 and 13; and Degradation unit designed to break down an active ingredient within the usable space of the device.

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