Method and device for disinfecting and / or sterilising objects

Abstract

The invention relates to a method for disinfecting and / or sterilising objects, said method comprising the method steps of: placing an object in a process chamber that can be evacuated; evacuating the process chamber; introducing a treatment medium; carrying out the disinfection and / or sterilisation process; and increasing the pressure in the process chamber, wherein the concentration of the treatment medium is monitored while the disinfection and / or sterilisation process is carried out. The invention also relates to: a software programme for carrying out the method for disinfecting and / or sterilising objects; and a device for disinfecting and / or sterilising objects. The invention also relates to: a disinfected object comprising residues of the treatment medium and / or reaction products of the treatment medium and fewer than 2000 germs per m2 on the surface of the disinfected object; and a sterilised object comprising residues of the treatment medium and / or reaction products of the treatment medium and a germ-free surface.

Description

[0001] METHOD AND DEVICE FOR DISINFECTING AND / OR STERILIZING OBJECTS

[0002] The invention relates to a method for disinfecting and / or sterilizing objects, comprising the steps of placing an object in an evacuable process chamber, evacuating the process chamber, introducing a treatment medium, performing the disinfection and / or sterilization process, and increasing the pressure in the process chamber, wherein the concentration of the treatment medium is monitored during the disinfection and / or sterilization process. The invention further relates to a software program for performing the method for disinfecting and / or sterilizing objects, as well as a device for disinfecting and / or sterilizing objects. The invention also relates to a disinfected object with residues of the treatment medium and / or reaction products of the treatment medium and fewer than 2000 germs per m 2on the surface of the disinfected object as well as a sterilized object with residues of the treatment medium and / or reaction products of the treatment medium and a germ-free surface.

[0003] State of the art

[0004] The peracetic acid-ethanol vacuum sterilization procedure is an established and cost-effective sterilization method for allogeneic bone grafts and also provides adequate antibacterial, antifungal, and antiviral protection for allogeneic soft tissue grafts.

[0005] During disinfection and / or sterilization using PES under negative pressure, the PES enters the gas phase even at low temperatures under strong negative pressure. This process is used to achieve the best possible disinfection and / or sterilization of products at a gentle temperature. Introduced in the 1980s [Starke R, Hackensellner HA, von Versen R. Experimental studies on the disinfection of transplant material with peracetic acid. Z Exp Chir Transplant Artificial Organs. 1984;17(5):254-8.], to date more than 60 disinfections have been carried out using peracetic acid (PES, CH3CO3H) and ethanol.000 allogeneic bone transplants were sterilized

[0131] , Several studies demonstrate the sufficient efficacy and safety of the procedure and could not demonstrate any adverse effect on the structural and biomechanical properties of the transplants [132, 133], Viral protection was also confirmed in the sterilization of soft tissue transplants such as Achilles tendon, cartilage and skin

[0152] , Furthermore, Scheffler et al. could not demonstrate any impairment of the structural and material properties of human BPTB allografts after sterilization with the peracetic acid-ethanol negative pressure procedure in an in vitro study

[0153] , Furthermore, in another in vitro study, PES showed no cytotoxic or pro-inflammatory effect on human patellar tendon allografts [98. In this paper, the advantages of the peracetic acid-ethanol vacuum process are applied for the disinfection and / or sterilization of objects, e.g. trousers or gloves.

[0006] Task

[0007] It is therefore an object of the present invention to provide a method for disinfecting and / or sterilizing objects with which objects can be disinfected and / or sterilized reliably and cost-effectively.

[0008] It is also an object of the present invention to provide a device for disinfecting and / or sterilizing objects with which objects can be disinfected and / or sterilized reliably and cost-effectively.

[0009] It is also an object of the present invention to provide a disinfected object. It is also an object of the present invention to provide a sterilized object.

[0010] The object is achieved by means of the method for disinfecting and / or sterilizing objects according to claim 1. Advantageous embodiments of the invention are set out in the subclaims.

[0011] The method according to the invention for disinfecting and / or sterilizing objects comprises five method steps: In the first method step, an object is placed on a holder in an evacuable process chamber of a device for disinfection and / or sterilization. For the purposes of this document, an object is a component that optionally has internal surfaces. An object is, for example, a piece of clothing, particularly for use in laboratories and / or medical facilities. An object is therefore, for example, trousers, a jacket, a headgear, or a glove. The process chamber can be evacuated and opened and closed in a gas-tight manner. The volume of the process chamber can be variably selected depending on the dimensions of the object to be disinfected and / or sterilized. The placement of an object can be carried out automatically, remotely, and / or manually by a user. The process chamber can have suitable holders for this purpose.

[0012] The difference between disinfection and sterilization is that during sterilization, all microorganisms, including their persistent forms (spores), are killed or irreversibly inactivated. The object is then generally free of viable microorganisms; a maximum of one in 10 6 Germs survive, meaning that only one in 1,000,000 treated objects would not be sterile. When an object is disinfected, pathogenic germs are also killed or irreversibly inactivated. However, the number of germs to be eliminated is a factor of 10 smaller than with sterilization. The goal of disinfection is to reduce the number of germs by at least a factor of 10. 5In the second process step, the process chamber is evacuated. Preferably, a negative pressure of less than 300 mbar, preferably less than 150 mbar, and particularly preferably less than 50 mbar, is generated in the process chamber.

[0013] In the third process step, a treatment medium is introduced. For the purposes of this document, a treatment medium is peracetic acid or a peracetic acid-containing mixture with a peracetic acid content of at least 2 vol.%, preferably at least 3 vol.%, and particularly preferably at least 4 vol.% peracetic acid.

[0014] Alternatively, the starting substances of peracetic acid can be introduced into the process chamber to produce the peracetic acid in situ.

[0015] The fourth step involves performing the disinfection and / or sterilization process. For this purpose, the process parameters (pressure and temperature in the process chamber) are kept constant during a specific exposure time. This serves to eliminate germs, bacteria, and viruses on the object. Only the pressure increases due to the evaporation of the PES. Optionally, the pressure change can be avoided by appropriate pumping.

[0016] In the fifth process step, the pressure in the process chamber is increased. During the pressure increase, the process chamber contains a concentration of the treatment medium that is lower than the concentration of the treatment medium in the process chamber during the holding time of the process. Preferably, the concentration of the treatment medium during or after the pressure increase in the process chamber is more than a factor of 10, particularly preferably more than 30, lower than the concentration of the treatment medium during the holding time.

[0017] According to the invention, the concentration of the treatment medium is monitored during the disinfection and / or sterilization process. Different concentrations of the treatment medium are provided for the disinfection and / or sterilization process in order to be able to design the disinfection and / or sterilization process flexibly. Depending on the type and dimensions of the object, different concentrations of the treatment medium are required to ensure thorough disinfection and / or sterilization. For this purpose, it is necessary to monitor the concentration of the treatment medium in the process chamber during the disinfection and / or sterilization process. The disinfection and / or sterilization device is equipped with suitable sensors for this purpose.

[0018] In a further development of the invention, the concentration of the treatment medium in the chamber is monitored. The disinfection and / or sterilization device is equipped with suitable sensors for this purpose.

[0019] In a further embodiment of the invention, the device for disinfection and / or sterilization comprises a sensor unit with a sensor, wherein the concentration of the treatment medium is measured with the sensor. The sensor is optionally a pressure sensor that detects the internal pressure of the sample chamber. The sensor can also be a chemical sensor that detects the concentration of a chemical substance to be determined.

[0020] In a further embodiment of the invention, the sensor is arranged in the sample chamber. Depending on the type and dimensions of the object, different concentrations of the treatment medium are required to ensure thorough disinfection and / or sterilization. To achieve this, it is necessary to monitor the concentration of the treatment medium in the process chamber during the disinfection and / or sterilization process.

[0021] In a further embodiment of the invention, the sample chamber has an outlet and a media outlet for discharging the treatment medium from the sample chamber, with a sensor arranged outside the sample chamber downstream of the outlet in the media outlet. The sensor in the media outlet detects the concentration of the treatment medium in the outlet. This makes it possible to record the consumption of the treatment medium during the disinfection and / or sterilization process and also determine whether the disinfection and / or sterilization process is complete. If the concentration of the treatment medium in the outlet is low, the disinfection and / or sterilization process is not yet complete; the concentration of the treatment medium in the sample chamber may need to be increased.When the concentration of the treatment medium in the outlet reaches the initial concentration of the treatment medium in the sample chamber, the disinfection and / or sterilization process is complete.

[0022] In one embodiment of the invention, a sensor of the sensor unit detects chemical parameters. In a further aspect of the invention, the sensor is a gas sensor.

[0023] In particular, the sensor detects the concentration of one or more definable gases.

[0024] In a further embodiment of the invention, a sensor of the sensor unit detects physical measurement data. The sensor detects physical variables such as, optionally, pressure and / or temperature in the sample chamber.

[0025] In a further embodiment of the invention, the device for disinfection and / or sterilization comprises a controller that is suitable and / or intended to execute a control program that controls the process parameters of the disinfection and / or sterilization method. The controller is designed as a microcontroller with a memory that contains a software program for controlling a method for disinfecting and / or sterilizing objects. To carry out the method, the method is controlled depending on the measured variables detected by the sensors of a sensor unit.

[0026] In a further embodiment of the invention, the controller is coupled to the sensor unit, a pump, an inlet, and / or the outlet. The controller is designed as a microcontroller with memory, which has a software program for controlling a method for disinfecting and / or sterilizing objects. To carry out the method, the pump, the inlet, and / or the outlet are controlled depending on the measured variables detected by the sensors of a sensor unit. In a further embodiment of the invention, the introduction of the treatment medium depends on the determined concentration of the treatment medium. The process chamber has a suitable sensor for determining the concentration.By introducing the treatment medium depending on its concentration in the process chamber, it is ensured that the concentration of the treatment medium is always correct in order to achieve rapid and thorough disinfection and / or sterilization of the object.

[0027] In a further development of the invention, the process chamber is preheated. In a further embodiment of the invention, the process chamber is preheated to the target temperature of the process of 35°C - 85°C, preferably 40°C - 75°C, and particularly preferably 50°C - 65°C. This accelerates the process for disinfecting and / or sterilizing objects.

[0028] In a further embodiment of the invention, the objects are packaged in sterilization pouches before being placed in the processing chamber. In another aspect of the invention, the sterilization pouches are permeable to vapors. Sterilization pouches, also known as autoclave pouches or laminated pouches, are used to protect objects from contamination. They are made of a material that can withstand high temperatures and steam sterilization. This makes them ideal for use in hospitals, dental offices, and other medical facilities. Sterilization pouches provide a safe and efficient way to protect the object from contamination. With their puncture-proof construction and moisture-resistant material, they are ideal for use in any environment. Sterilization pouches are puncture-resistant, so they will not be damaged during the sterilization process.The material of the sterilization bag is moisture- and bacteria-resistant, protecting the objects from contamination. The sterilization bags are lightweight and easy to store, allowing them to be used conveniently in any environment. In a further embodiment of the invention, the process chamber is sealed after the object has been placed in the process chamber. Once sealed, the process chamber is sealed gas-tight.

[0029] In a further embodiment of the invention, the process chamber is heated to process temperature after closing the process chamber. Due to the placement of the object, the temperature in the process chamber drops, so it is heated again to the process temperature of 40°C - 65°C, preferably 50°C - 55°C.

[0030] In a further embodiment of the invention, the pressure in the process chamber is monitored. The process chamber is connected to a pressure sensor for this purpose.

[0031] In an advantageous embodiment of the invention, the treatment medium is a PES solution. PES chemically disinfects, having an oxidizing effect on the microorganisms. It has a broad spectrum of activity, a short exposure time, and an irreversible effect. Furthermore, compared to other sterilization media, it is largely compatible with materials, can be added in precise amounts, and, due to the low concentration used (dilution with water), is minimally or non-damaging to the skin. Optionally, a mixture of peracetic acid, acetic acid, a strong oxidizing agent such as hydrogen peroxide, and water is used. The acids and the hydrogen peroxide are strong oxidizing agents that decompose microorganisms.

[0032] In a further embodiment of the invention, the process chamber is evacuated to a pressure of 1-50 mbar, preferably 10 mbar. In a further embodiment of the invention, the pressure in the process chamber is kept below the boiling point of the treatment medium after the treatment medium has been introduced. In a further development of the invention, the pressure is kept below the boiling point of the treatment medium throughout the entire disinfection and / or sterilization process. After the treatment medium has been introduced, the treatment medium immediately enters the gas phase. This ensures that even hard-to-reach areas of the object, especially internal surfaces of the object, are disinfected and / or sterilized.

[0033] In a further embodiment of the invention, after completion of the disinfection and / or sterilization process, the process chamber is flushed with ambient air, with the flushing preferably occurring at intervals. This ensures that the treatment medium has been completely removed from the process chamber and / or the object and cannot escape uncontrollably when the process chamber is opened, thus preventing the operator or a bystander from inhaling the solution when the door or access is opened. For the purposes of this document, a ventilation medium is air and technical gases. In a further aspect of the invention, ambient air is introduced during flushing up to a chamber pressure of 200-500 mbar.

[0034] In a further embodiment of the invention, after introducing ambient air to a pressure of 200-500 mbar, the process chamber is evacuated again to 1-100 mbar, preferably 10-40 mbar, particularly preferably 20 mbar. This also ensures that the treatment medium has been completely removed from the process chamber and cannot escape uncontrollably when the process chamber is opened.

[0035] In a further embodiment of the invention, the method steps according to claims 25 and 26 are repeated once, preferably three times, and particularly preferably five times. This also ensures that the treatment medium has been completely removed from the process chamber and cannot escape uncontrollably when the process chamber is opened.

[0036] In a further embodiment of the invention, after the rinsing process is completed, the pressure in the process chamber is increased to ambient pressure. The disinfected objects can then be removed from the process chamber.

[0037] In a further development of the invention, the treatment medium is discharged. The treatment medium is thus removed from the process chamber. In a further embodiment of the invention, a neutralization medium is introduced to neutralize the treatment medium. PES is an acid, so a base is optionally used as the neutralization medium. This also ensures that the treatment medium is completely removed from the process chamber and cannot escape uncontrollably when the process chamber is opened.

[0038] The object is also achieved by means of the software program for carrying out the method according to one or more of claims 1 to 29.

[0039] The software program according to the invention is suitable for implementing the process control method using defined values ​​and / or curves for pressure, injection quantities (with defined concentrations), temperature, and PES concentration in the chamber, as well as material and / or product information, their quantity, size, shape, etc., their degree of contamination and contamination, and / or their type of contamination (spores, viruses, etc.). The software program utilizes the hardware of the device for disinfecting and / or sterilizing objects.

[0040] The object is further achieved by means of the device for disinfecting and / or sterilizing objects. Advantageous embodiments of the invention are set forth in the subclaims.

[0041] The device according to the invention for disinfecting and / or sterilizing objects comprises an evacuable process chamber. The process chamber can be evacuated and opened or closed in a gas-tight manner. The volume of the process chamber can be variably selected depending on the dimensions of the object to be disinfected and / or sterilized.

[0042] The device further comprises a first connection and / or first reservoir for a treatment medium and a first inlet in the process chamber, wherein the first inlet is connected to a first connection and / or the first reservoir for the treatment medium. The treatment medium is preferably peracetic acid or a peracetic acid-containing mixture with a peracetic acid content of at least 2 vol.%, preferably at least 3 vol.%, and particularly preferably at least 4 vol.% peracetic acid. Alternatively, the starting substances of the peracetic acid can also be introduced into the process chamber to generate the peracetic acid in situ.

[0043] The device also has a second connection and / or second reservoir for a ventilation medium, as well as a second inlet in the process chamber, wherein the second inlet is connected to the second connection and / or the second reservoir for the ventilation medium and / or to the first connection and / or the first reservoir. The ventilation medium is preferably air, but technical gases, e.g., noble gases, are also possible.

[0044] The device further comprises a pump connected to one or more outlets, as well as a controller for controlling the first inlet, the second inlet, the first connection, the second connection, and / or the outlet. Optionally, the controller controls the temperature control and / or the pressure and / or the injection quantity and / or the concentration of a treatment medium in the chamber. Furthermore, the duration and number of process phases and cycles can be controlled by the controller.

[0045] The device further comprises a sensor unit. Depending on the type and dimensions of the object, different concentrations of the treatment medium are required to ensure thorough disinfection and / or sterilization. To this end, it is necessary to monitor the concentration of the treatment medium during the disinfection and / or sterilization process. The disinfection and / or sterilization device comprises a sensor unit with suitable sensors for this purpose. Optionally, a sensor in the sensor unit detects chemical parameters. In particular, the sensor detects the concentration of one or more definable gases. Optionally, another sensor in the sensor unit detects physical measurement data. The sensor detects physical parameters such as pressure and / or temperature in the sample chamber and / or the treatment medium.The concentration of peracetic acid in the gas phase can be measured using various methods: One possibility is to determine the peracetic acid concentration using an electrochemical cell. Sensors constructed in this way use the current generated during the reduction of peracetic acid to calculate the concentration in conjunction with the Nernst equation. The peracetic acid is reduced to acetic acid in the process. A sensor can also be constructed based on spectroscopic methods. It is known that spectroscopic methods can be used to determine the absorption bands of peracetic acid and the influence of acetic acid and hydrogen peroxide on the spectra. Measurements in both the infrared and UV range are possible. In the UV range, for example, a measurement at 340 nm in a vacuum is suitable for measuring peracetic acid; in the infrared range, a band at 1295 cm is suitable, among others. -1 .

[0046] In a further embodiment of the invention, the device comprises a media outlet for removing the treatment medium from the chamber. The media outlet is a tubular line connected to the sample chamber. Optionally, the media outlet is connected to a filter and a pump through which the treatment medium can be removed from the process chamber.

[0047] In a further embodiment of the invention, the controller is coupled to the sensor unit, the pump, the first inlet, the second inlet, and / or the outlet. The controller is designed as a microcontroller with a memory that contains a software program for controlling a method for disinfecting and / or sterilizing objects. To carry out the method, the pump, the inlet, and / or the outlet are controlled depending on the measured variables detected by the sensors of a sensor unit.

[0048] In a further embodiment of the invention, the sensor unit comprises a sensor. The sensor optionally detects physical variables such as pressure and / or temperature in the sample chamber and / or the treatment medium. The sensor can also be a chemical sensor that detects the concentration of a chemical substance to be determined.

[0049] In one embodiment of the invention, a sensor of the sensor unit is a pressure sensor. In a further aspect of the invention, the pressure sensor is arranged in the sample chamber. The pressure sensor detects the pressure in the sample chamber and / or the treatment medium.

[0050] In a further embodiment of the invention, a sensor is a chemical sensor that is suitable and / or intended to detect a chemical parameter. The chemical sensor detects the concentration of a chemical substance to be determined.

[0051] In a further embodiment of the invention, a sensor is a chemical sensor that is suitable and / or intended to detect a physical measurement value from which the concentration of the treatment medium in the chamber can be determined. Depending on the type and dimensions of the object, different concentrations of the treatment medium are required to ensure thorough disinfection and / or sterilization. For this purpose, it is necessary to monitor the concentration of the treatment medium during the disinfection and / or sterilization process.

[0052] In a further embodiment of the invention, the chemical sensor is arranged in the chamber or in the media outlet for discharging the treatment medium from the chamber. The chemical sensor in the media outlet detects the concentration of the treatment medium in the outlet. This makes it possible to record the consumption of the treatment medium during the disinfection and / or sterilization process and also to determine whether the disinfection and / or sterilization process is complete. If the concentration of the treatment medium in the outlet is low, the disinfection and / or sterilization process is not yet complete; the concentration of the treatment medium in the sample chamber may need to be increased. If the concentration of the treatment medium in the outlet is high, reaching the initial concentration of the treatment medium in the sample chamber, the disinfection and / or sterilization process is complete.

[0053] The problem is further solved by means of the disinfected object. Advantageous embodiments of the invention are set forth in the subclaims.

[0054] The disinfected object has a surface roughness Rz with Rz <= 10 μm, preferably with Rz <= 5 μm and particularly preferably with Rz 1 μm and / or with a porosity with a pore size P with 10 nm <= P <= 500 μm, preferably with 25 nm <= P <= 100 μm and particularly preferably with 50 nm <= P <= 50 μm and / or a pore volume V based on the total volume of the object with V >= 70%, preferably V >= 55% and particularly preferably V >= 40%. The disinfected object also has residues of the treatment medium and / or reaction products of the treatment medium of less than 2000 germs per m 2 on the surface of the disinfected

[0055] The disinfected object according to the invention has a contamination with

[0056] None on its surface of less than 2000 germs per m 2 preferably from small

[0057] 1000 germs per m 2 and especially preferably less than 500 germs per m 2 which corresponds to a germ reduction of 84% to 99.9%. In a further development of the invention, the disinfected object contains residues of peracetic acid or residues of reaction products of peracetic acid.

[0058] The roughness values ​​Rz given in this document were measured using the tactile

[0059] cutting method (see DIN EN ISO 25178-601). The values ​​given in this document for the

[0060] The values ​​mentioned as porosity with the parameters pore volume and pore size were determined by means of mercury porosimetry according to DIN ISO 15901-1, whereby the

[0061] Pore ​​size information refers to the average pore size.

[0062] In a further aspect of the invention, the porosity is an open porosity, ie the

[0063] Object has cavities that are connected to each other and to the environment. The disinfected object is an object from the following groups: masks,

[0064] Safety goggles / visors, surgical textiles, disposable protective gowns, lightweight hoods (fan filter system), fan filter devices, protective overalls (emergency services / fire brigade), surgical shoes,

[0065] REVISED SHEET (RULE 91) ISA / EP Surgical loupes, ventilation tubes, masks, and bags, Pari-Boy nebulizers for inhalation therapy (with electronics), thermometers, full-face masks, lung demand valves, compressed air breathing apparatus, and also electronic devices such as radios and smartphones. The material of the disinfected object is: PP, PET / PETG, nylon, PU / PU foams, PVC foam, ABS, elastane, EPDM, silicone, rubber, or metal, or a composite of the aforementioned materials.

[0066] The object is further achieved by means of the sterilized object. Advantageous embodiments of the invention are set forth in the subclaims.

[0067] The sterilized object has a surface roughness Rz with Rz <= 10 μm, preferably with Rz <= 5 μm and particularly preferably with Rz <= 1 μm and / or a porosity with a pore size P with 10 nm <= P <= 500 μm, preferably with 25 nm <= P <= 100 μm and particularly preferably with 50 nm <= P <= 50 μm and / or a pore volume V based on the total volume of the object with V >= 70%, preferably V >= 55% and particularly preferably V >= 40%. The sterilized object also has residues of the treatment medium and / or reaction products of the treatment medium and a germ-free surface.

[0068] The sterilized object according to the invention has a contamination with germs on its surface of 0 if the probability of a surviving germ is less than 1 :1,000,000 (<= 10-6 per unit of the object.

[0069] In a further development of the invention, the sterilized object contains residues of peracetic acid or residues of peracetic acid reaction products. In an optional development, the concentration of the treatment agent and / or reaction products of the treatment agent is below 0.1 ml / m 2 or below 0.32 mg / m 2 and in a particularly preferred embodiment below 0.05 ml / m 2 or below 0.16 mg / m 2

[0070] In a further aspect of the invention, the porosity is open porosity, meaning the object has cavities that communicate with each other and with the environment. The sterilized object is an object from the following groups: masks, safety goggles / visors, surgical textiles, disposable protective gowns, lightweight hoods (blower filter systems), blower filter devices, protective overalls (emergency services / fire departments), surgical shoes, surgical loupes, ventilation tubes, masks, and bags, Pari-Boy nebulizers for inhalation therapy (with electronics), clinical thermometers, full-face masks, lung demand valves, compressed air breathing apparatus, and also electronic devices such as radios and smartphones. The material of the sterilized object is: PP, PET / PETG, nylon, PU / PU foams, PVC foam, ABS, elastane, EPDM, silicone, rubber, or metal, or a composite of the aforementioned materials.

[0071] Embodiments of the device according to the invention and of the method for disinfecting and / or sterilizing objects are shown in a simplified schematic form in the drawings and are explained in more detail in the following description.

[0072] They show:

[0073] Fig. 1 : Device for disinfection and / or sterilization of objects, sensor unit in process chamber

[0074] Fig. 2: Device for disinfection and / or sterilization of objects, sensor unit in process chamber, vacuum pump connected to control unit

[0075] Fig. 3: Device for disinfection and / or sterilization of objects, sensor unit in process chamber, vacuum pump connected to control system, chemical sensor in media discharge

[0076] Fig. 4: Device for disinfection and / or sterilization of objects, sensor unit in process chamber, vacuum pump connected to control system, chemical sensor in media discharge, heating device in the process chamber

[0077] Fig. 5: Device for disinfection and / or sterilization of objects, sensor unit in process chamber, vacuum pump connected to control system, chemical sensor and HEPA filter in media discharge, heating device in the process chamber

[0078] Fig. 6: Embodiment of the method for disinfection and / or sterilization of objects

[0079] Fig. 1 and Fig. 2 show embodiments of the device 1 according to the invention for disinfecting and / or sterilizing objects. The device 1 has the process chamber 10, which is designed to be evacuatable and has a volume of 50 liters, although 100 liters are also possible. For evacuation, the vacuum pump 320, designed as a rotary pump, is connected via the outlet connection 310 to the outlet 300 of the process chamber 10 (Fig. 1). The vacuum pump 320 is connected to the controller 600 (Fig. 2). The outlet 300 can be opened or closed and is connected to the controller 600. The device 1 has the media discharge 330 for discharging the treatment medium from the process chamber 10.

[0080] The controller 600 comprises a U1, a microcontroller, and a memory containing a suitable software program for carrying out a disinfection and / or sterilization process for objects 2. The process chamber 10 comprises a first inlet 100, which is connected to a reservoir for the treatment medium via a first connection 110. The first inlet 100 is connected to the controller 600. Also connected to the controller 600 is the second inlet 200, which is connected to the reservoir for the aeration medium via the second connection 210. The inlets 100, 200, like the outlet 300, can each be opened or closed via valves, controlled by the controller 600. Additionally, a sensor unit 500 with a temperature sensor 510 and a pressure sensor 520 is arranged in the process chamber 10 and is also connected to the controller 600.

[0081] For disinfection and / or sterilization of objects 2, the object 2 is placed in the process chamber 10, e.g. in a suitable receptacle in the process chamber 10. Preferably, the object 2 is packaged in a vapor-permeable sterilization bag before being placed in the process chamber 10 in order to avoid contaminating the object 2 during and after disinfection and / or sterilization and to be able to place the contaminated object easily and safely in the process chamber 10.

[0082] The process chamber 10 is then sealed gas-tight and evacuated to 20 mbar by means of the vacuum pump 320. The treatment medium is then introduced by the controller 600 sending a signal to open the first inlet 100. The first inlet 200 is connected to the reservoir for the treatment medium. In all embodiments shown here, the treatment medium is a mixture of peracetic acid and water and, if appropriate, other components. The treatment medium is preferably peracetic acid or a peracetic acid-containing mixture with a peracetic acid content of at least 2 ol%, preferably at least 3 ol%, and particularly preferably at least 4 vol% peracetic acid. Alternatively, the starting substances of the peracetic acid can also be introduced into the chamber in order to generate the peracetic acid in situ.

[0083] Due to the low pressure in the process chamber 10, the solution is converted into a gaseous state, thus filling the process chamber 10 and carrying out the oxidation process on the objects to be disinfected. Different concentrations of PES are provided for the process to allow for flexible disinfection and / or sterilization processes. The first inlet 100 is closed again after the treatment medium has been introduced.

[0084] For the disinfection and / or sterilization of the objects 2, the object 2 is left in the process chamber 10 for between 5 minutes and 120 minutes at constant pressure and temperature and exposed to the PES atmosphere. The pressure in the process chamber 10 is then increased by the controller 600 sending a signal to open the second inlet 200. The second inlet 200 is connected to the reservoir for the aeration medium. The aeration medium is air in all embodiments; technical gases, e.g. noble gases, are also possible. When the pressure is increased, the process chamber 10 contains a concentration of the treatment medium that is below the concentration of the treatment medium in the process chamber 10 during the holding time of the process. The concentration of the treatment medium during orAfter increasing the pressure in the process chamber 10 by a factor of more than 10, particularly preferably by more than 30, below the concentration of the treatment medium during the holding time. The process chamber 10 can be opened and the object 2 removed.

[0085] A further embodiment of the device 1 according to the invention for disinfecting and / or sterilizing objects 2 is shown in Fig. 3. The device 1 shown here corresponds to that presented in the previous embodiment (see Fig. 2), only the media discharge 330 for discharging the treatment medium from the process chamber 10 has a sensor 530 which is connected to the controller 600.

[0086] The sensors 510, 520 are arranged in the process chamber 10 and record physical measured values ​​in the process chamber 10. The sensor 510 is a temperature sensor for recording and monitoring the temperature within the process chamber 10. The sensor 520 is a pressure sensor for recording and monitoring the pressure within the process chamber 10. The sensor 530 arranged outside the process chamber 10 in the media discharge 330 is a chemical sensor for recording and monitoring the concentration of the treatment medium (PES) in the media discharge 330. Alternatively, the sensor 530 is arranged in a bypass to the process chamber (10).

[0087] Further embodiments of the device 1 according to the invention for disinfecting and / or sterilizing objects 2 are shown in Fig. 4 and Fig. 5. The devices 1 shown here correspond to the one presented in the previous embodiment (see Fig. 3), except that the process chamber 10 has a heating device 400, which is designed as a resistance heater and is connected to the controller 600 (Fig. 4). In a further embodiment, the device 1 additionally has a HEPA filter 700, which is arranged in the line between the pump 320 and the outlet 300 (Fig. 5).

[0088] For disinfection and / or sterilization of objects 2, after placing the object 2 in the process chamber 10 and evacuating it, the temperature in the process chamber 10 is heated by means of the heating device 400 after closing the process chamber 10 to a temperature of 50°C to 55°C, alternatively to a temperature of 40°C to 65°C. To shorten the heating process, the process chamber 10 can be preheated before placing the object 2 in the process chamber 10.

[0089] In the next process step, the treatment medium (PES solution) is admitted into the process chamber 10 via the first inlet 100. In an advantageous development of the invention, the injection quantity and / or the concentration of the treatment medium in the process chamber 10 is controlled with the help of the controller 600. Furthermore, the duration and number of process phases and cycles are controlled. The PES solution immediately begins to boil and the pressure in the process chamber 10 increases. By means of the controller 600, the pressure and temperature in the process chamber 10 are controlled during part of the process such that the boiling curve of the PES solution is not exceeded in order to prevent the PES solution from condensing. This state is kept constant for part of the process duration. This serves to eliminate particles, bacteria and viruses on the object 2. Only the pressure in the process chamber 10 increases due to the evaporation of the PES.Optionally, this pressure change can be avoided by pumping out the pressure using pump 320.

[0090] Using temperature sensor 510, controller 600 continuously measures the temperature in process chamber 10 during the process and regulates the temperature in process chamber 10 via heater 400. The pressure in process chamber 10 is measured by pressure sensor 520 and also regulated by controller 600 by either opening inlet 100 or reducing the pressure in the chamber via outlet 300 and pump 320. Using chemical sensor 530, the concentration of the treatment medium (PES solution) in media discharge 330 is continuously measured and monitored by controller 600. For this purpose, outlet connection 310 is constantly open during the process.

[0091] This allows the consumption of the treatment medium during the process to be recorded and also to determine whether the disinfection and / or sterilization process is complete. If the concentration of the treatment medium in the media outlet 330 is low, the disinfection and / or sterilization process is not yet complete; the concentration of the treatment medium in the sample chamber 10 may need to be increased. To do this, the first inlet 100 is opened via the inlet connection 110 under the control of the controller 600, and additional treatment medium is fed into the sample chamber 10. If the concentration of the treatment medium in the media outlet 330 is high, reaching the initial concentration of the treatment medium in the sample chamber, the disinfection and / or sterilization process is complete.

[0092] After the end of the process, the process chamber 10 is flushed intermittently with the aeration medium (air). The aeration medium is preferably germ-free, i.e., it contains no microorganisms and / or viruses larger than 0.45 micrometers, preferably 0.22 micrometers. For this purpose, ambient air is admitted into the process chamber 10 via the second inlet 200, controlled by the controller 600, to a pressure in the process chamber 10 of 200 mbar to 500 mbar, preferably 300 mbar. Subsequently, the air is pumped down to 1 mbar to 100 mbar, preferably approximately 40 mbar, particularly preferably approximately 20 mbar. This rinsing process is carried out one to five times, preferably three times, to ensure that the treatment medium has been completely removed from the process chamber 10, cannot escape uncontrollably when the process chamber 10 is opened, and the operator or a bystander does not inhale the solution when opening the door or access.In a further development, the aeration medium is introduced until the concentration of the treatment medium in the chamber is between 0.5 g / m and 4 g / m. 3 ; preferably between 1 g / m 3 and 3 g / m 3 ; particularly preferably between 1.5g / m 3 and 2.5 g / m 3 The air inlet or outlet via an outlet 300 and the media discharge 330 preferably occur via HEPA filters. The HEPA filter 700 serves to protect the environment and persons from germs during the negative pressure generation at the start of the process and also to protect object 2 from contamination.

[0093] Fig. 6 shows an embodiment of the method according to the invention for disinfecting and / or sterilizing objects 2, which is carried out in three cycles. The graph shows the spore / virus / bacteria concentration C on the internal and external surfaces of object 2 (ordinate) versus time t (abscissa).

[0094] After performing the method with the device 1 according to the invention, the object 2 has traces of the treatment agent (PES) and / or reaction products of the treatment agent with other substances on its surface. In an optional development, the concentration of the treatment agent and / or reaction products of the treatment agent is below 0.1 ml / m 2 or below 0.32 ml / m 2 and in a particularly preferred embodiment below 0.05 ml / m 2 or below 0.16 ml / m 2 .

[0095] The disinfected object 2 according to the invention has, after carrying out the method with the device 1 according to the invention, a contamination with bacteria on its surface of less than 2000 germs per m 2 preferably less than 1000 germs per m 2 and especially preferably less than 500 germs per m 2surface, which corresponds to a germ reduction of 84% to 99.9%. The sterilized object 2 according to the invention has a contamination with germs on its surface of 0 if the probability of a surviving germ is less than 1:1,000,000 (<= 10' 6 per unit of object 2).

[0096] The disinfected and / or sterilized object 2 has a surface roughness Rz with Rz <= 10μm, preferably with Rz <= 5μm and particularly preferably with Rz <= 1 μm and / or with a porosity with a pore size P with 10nm <= P <= 500μm, preferably with 25nm <= P <= 100μm and particularly preferably with 50nm <= P <= 50μm and / or a pore volume V based on the total volume of the object with V >= 700%, preferably V >= 55% and particularly preferably V >= 40%.

[0097] The method according to the invention, which can be carried out by means of the device 1 according to the invention, is so effective that even the inner surfaces of the object 2, protected by the splash-proof housing, have as little contamination with germs as the outer surfaces after carrying out the method.

[0098] The disinfection and sterilization process is generally carried out depending on the object to be sterilized / disinfected, the general conditions, and predefined requirements according to processes specifically optimized in the controller 600 and the procedure. For this purpose, different cycles, intervals, and process parameters can be set using a software program stored in the controller 600 or, if necessary, individually using the III of the controller 600. For example, if the object 2 has a high germ load, different disinfection and / or sterilization cycles may have to be run, since the PES solution is used up at a high germ load, so that the subsequent addition of PES may be necessary. This step will be carried out in cycles, among other things. During the process, the treatment agent (PES) will be pumped out and added, or aeration will take place.In addition, the cycle sequence is also suitable for small volumes of both the process chamber 10 and the object 2 as well as difficult-to-reach and complex geometries of the object 2.

[0099] Table 1: Overview of validation tests for disinfection of spore strips SAL 10 5 Table 2: Overview of validation tests for disinfection of laboratory equipment sprinkled with

[0100] Spore suspension SAL 10 6

[0101] When an object is disinfected, pathogenic germs are also killed or irreversibly inactivated, but the number of germs to be eliminated is a factor of 10 smaller than in sterilization. The aim of disinfection is to reduce the number of germs by at least a factor of 10 5to reduce the risk of infection. The disinfectant treatment then eliminates the risk of infection from the object. The effectiveness of the disinfectant treatment is defined by the probability of the presence of hostile microorganisms. This probability is expressed by the sterility assurance level (SAL), an SAL of at least 10 5 defines a disinfection, a SAL of at least 10 6 sterilization, i.e. the lower the SAL value, the higher the safety.

[0102] The disinfectant and sterilizing agent used in the device presented here is peracetic acid (PAA) in a solution diluted with water. PAA disinfects chemically, having an oxidizing effect on microorganisms and / or viruses. It has a broad spectrum of activity, a short exposure time, and an irreversible effect. Furthermore, compared to other sterilizing agents, it is largely compatible with materials, can be added in precise amounts, and, due to the low concentrations used (dilution with water), is minimally or non-damaging to the skin.

[0103] The validation tests of the "disinfection and sterilization device" were conducted with spores of the bacterium Geobacillus stearothermophilis. Bacterial spores exhibit very high resistance (C) to chemical disinfection and / or sterilization. If bacterial spores can be successfully disinfected in the processes, it can be assumed that the process will also successfully disinfect microorganisms with moderate resistance (A), such as lipophilic viruses, vegetative bacteria, fungi (including spores), indicator organisms such as E. faecium, S. aureus, P. aeruginosa, and A. niger, as well as microorganisms with high resistance (B), such as mycobacteria, hepatitis B virus, and hydrophilic viruses such as the indicator virus polio.

[0104] The validation experiments were initially carried out with bio-indicator spore strips 6x36mm, on each of which a colony forming unit (CFU) of 10 5of Geobacillus stearothermophilus. The spore strips were each packaged in a sterilization bag. Different processing times and different concentrations of PES were tested in the experiments. All experiments were conducted at a chamber temperature of 50-55°C.

[0105] In all spore strips tested at different PES concentrations and different processing times, no growth or proliferation of the spores could be detected subsequently.

[0106] Additionally, untreated test samples were included in each experiment. This ensured that the samples were inoculated with spores.

[0107] In addition to the validation experiments with the spore strips SAL 10 5In addition, various disposable products were sprinkled with a spore suspension. These included an inoculation loop, a 3 ml disposable pipette, a microreaction tube with a lid (Eppi), and a piece of a nose and mouth mask. The spore suspension was an alcoholic solution and was inoculated with Geobacillus stearothermophilus at a CFU / ml of at least 10 6 Due to the small amount, the samples were each dripped with two drops of the suspension (in the case of the pipette and the Eppi, the suspension was dripped into them) and then placed in a sterilization bag. One drop corresponds to 0.05 ml, thus two drops correspond to a unit of 0.1 ml. Consequently, the CFU per item is approximately 10 5 .

[0108] The samples were tested using some of the spore strip tests listed above. After treatment, the swabs from the samples were placed in a nutrient solution in an external laboratory for seven days, similar to the spore strips, and then examined for any spore growth.

[0109] In various tests, spore growth was observed after seven days. This is due to the relatively low PES concentration in the process chamber and the short process duration. The disinfection or sterilization system according to the invention is designed so that different concentrations of PES can be specifically adjusted in the vacuum of the process chamber. The combination of special injection technology, an adapted vacuum process, and process cycles ensures that the disinfectant and / or sterilizing agent mixture is reliably distributed even to all inaccessible areas, thus ensuring that the PES exhibits very high effectiveness against biogenic contaminants even at low temperatures of 40°C to 65°C, preferably 50°C to 55°C.

[0110] The disinfection or sterilization system according to the invention, including the disinfection and / or sterilization processes and associated equipment technology, thus has the following decisive advantages: high effectiveness, low-temperature processes (also suitable for thermolabile polymers), low operating costs, short process times, individual adaptation of the disinfection and / or sterilization programs to different requirements, very good scalability (from mobile table-top devices to mobile room-sized systems), and general use of a reliable, trouble-free process.

[0111] Due to the combination of the aforementioned advantages, this innovative disinfection and sterilization system – unlike existing methods – is ideally suited for numerous existing and new applications. For example, infection control in small to large healthcare and nursing facilities, where the entire spectrum from compact desktop devices to large systems is required. The same applies to applications in fire departments and disaster relief, where the systems and equipment must be particularly robust and reliable, and in some cases, mobile.

[0112] The PES treatment system will in future include the following process-specific and application-related innovations: a. Novel, very widely applicable chemical low-temperature disinfection and / or sterilization system

[0113] • The PES as a reactive component can be produced either in low concentrations during in-situ mixing of the various input materials or adjusted to higher concentrations by targeted mixing from a storage container in the system. PES reacts with the bacteria, viruses, spores, etc., killing them quickly and efficiently. The individual components (hydrogen peroxide and acetic acid) for in-situ production of PES are globally available, inexpensive chemicals that can be handled safely while observing the necessary occupational safety regulations.

[0114] • Gaseous PES is characterized by a high sterilizing effect. The use of gaseous PES in an automated vacuum process of a closed system ensures both hazard-minimized handling and safe effectiveness.

[0115] • Standardized, validatable procedure (no manual disinfection, e.g. wipe disinfection)

[0116] • The ingredients (hydrogen peroxide and acetic acid) can be easily removed quantitatively from the reprocessing system and treated products, so that the reprocessed protective clothing can be reused without endangering the emergency services. b. Mobile, customized disinfection and / or sterilization device technology can be used for rapid PES disinfection and / or sterilization in almost all application and operating conditions, even on-site in the event of major disasters. c. Integrated monitoring and documentation system for the disinfection and / or sterilization process, i.e. with regard to the protective effect after the reprocessing of the PPE d. The special design and process management of this chemical-physical reprocessing method (PAS, vacuum, temperature) in conjunction with the specially coordinated reprocessing system ensures short treatment times of sometimes 8-25 minutes.These treatment times depend on the processing objective (disinfection to sterilization, if applicable), the PPE materials or material combinations, as well as the surfaces and geometries. e. Disinfection and / or sterilization of PPE is possible in the new processing system in the sterilization bag, thus ensuring safe and contamination-free processing.

[0117] Handling.

[0118] Various objects were treated with the method according to the invention in order to disinfect and sterilize them.

[0119] The following process parameters were used in the disinfection process:

[0120] The following process parameters were used in the sterilization process:

[0121] The objects covered are summarized in the following tables:

[0122]

[0123] LIST OF REFERENCE SYMBOLS

[0124] Device for disinfection and / or sterilization of objects

[0125] Trial Chamber

[0126] First entry

[0127] First connection

[0128] Second entrance

[0129] Second connection

[0130] Outlet

[0131] Outlet connection

[0132] pump

[0133] Media discharge

[0134] Heating device

[0135] Sensor unit

[0136] Temperature sensor

[0137] Pressure sensor inside

[0138] Chemical sensor outside

[0139] steering

[0140] HEPA filter

[0141] Recording

[0142] object

Claims

PATENT CLAIMS 1. Methods for disinfection and / or sterilization of objects (2) with the Procedural steps: • Placing an object (2) in an evacuable process chamber (10) of a device (1) for disinfection and / or sterilization, • Evacuation of the process chamber (10), Introducing a treatment medium, • Carrying out the disinfection and / or sterilization process, • Increasing the pressure in the process chamber (10), whereby during the execution of the disinfection and / or The concentration of the treatment medium is monitored during the sterilization process.

2. Methods for disinfection and / or sterilization of objects (2) according to Claim 1, characterized in that the concentration of the treatment medium in the process chamber (10) is monitored.

3. Method for disinfection and / or sterilization of objects (2) according to one or more of the preceding claims, characterized in that the device (1) for disinfection and / or sterilization comprises a sensor unit (500) with a sensor (520), wherein the concentration of the treatment medium is measured with the sensor (520).

4. Method for disinfection and / or sterilization of objects (2) according to one or more of the preceding claims, characterized in that the sensor (520) is arranged in the process chamber (10) 5. Method for disinfection and / or sterilization of objects (2) according to one or more of the preceding claims, characterized in that the device (1) has an outlet (300) and a media discharge (330) for Discharge of the treatment medium from the process chamber (10), wherein a sensor (530) outside the process chamber (10) after the outlet (300) in the media discharge (330) and / or a bypass to the process chamber (10) is arranged.

6. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that a sensor (530) of the sensor unit (500) detects chemical measurement variables. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that the sensor (530) is a gas sensor.

8. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that a sensor (510, 520) of the sensor unit (500) detects physical measurement data.

9. Method for disinfection and / or sterilization of objects (2) according to one or more of the preceding claims, characterized in that the device (1) for disinfection and / or sterilization has a controller (600) which is suitable and / or intended to execute a control program which controls the process parameters of the method for disinfection and / or sterilization.

10. Method for disinfection and / or sterilization of objects (2) according to one or more of the preceding claims, characterized in that the control (600) is coupled to a sensor unit (500), a pump (320), the inlet (100) and / or an outlet (300), wherein for carrying out the method the control of the pump (320), the inlet (100) and / or the outlet (300) depending on the measured variables detected by the sensors of the sensor unit (500).

11. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that the introduction of the treatment medium takes place as a function of the determined concentration of the treatment medium.

12. Method (400) for disinfecting and / or sterilizing objects according to one or more of the preceding claims, characterized in that the process chamber (10) is preheated.

13. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that the process chamber (10) is heated to the desired temperature of 40°C - 65°C, preferably 50°C - Preheat to 55°C.

14. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that the object (2) is packaged in sterilization bags before being placed in the process chamber (10).

15. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that the sterilization bags are permeable to vapors.

16. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that the process chamber (10) is closed after the object (2) has been placed in the process chamber (10).

17. Method for disinfection and / or sterilization of objects (2) according to one or more of the preceding claims, characterized in that the process chamber (10) after closing the process chamber (10) on Process temperature is heated.

18. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that the pressure in the process chamber (10) is monitored.

19. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that the treatment medium is a PES solution.

20. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that the process chamber (10) is evacuated to a pressure of 1 - 50 mbar, preferably 10 mbar.

21. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that the pressure after the introduction of the treatment medium is kept partially below the boiling curve of the treatment medium.

22. Procedures for disinfection and / or sterilization of objects (2) according to Claim 11, characterized in that the pressure is kept below the boiling curve of the treatment medium during the entire process duration and / or part of the process duration of the disinfection and / or sterilization process.

23. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that after completion of the disinfection and / or sterilization process, the process chamber (10) is rinsed intermittently with ambient air.

24. Method for disinfection and / or sterilization of objects (2) according to one or more of the preceding claims, characterized in that during rinsing ambient air is introduced up to a chamber pressure of 200 - 500 mbar.

25. Method for disinfection and / or sterilization of objects (2) according to one or more of the preceding claims, characterized in that after introducing the ambient air up to a pressure of 200 - 500 mbar, the Process chamber (10) is evacuated again to 1 - 100mbar, preferably 10 - 40mbar, particularly preferably 20m bar.

26. A method for disinfecting and / or sterilizing objects (2) according to one or more of claims 22 to 24, characterized in that the method steps according to claims 24 and 25 are repeated once, preferably three times and particularly preferably five times.

27. Method for disinfection and / or sterilization of objects (2) according to one or more of the preceding claims, characterized in that after completion of the rinsing process, the pressure in the process chamber (10) is Ambient pressure is increased.

28. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that the treatment medium is discharged.

29. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that a neutralization medium is introduced in order to neutralize the treatment medium.

30. Software program for carrying out the method according to one or more of claims 1 to 29.

31. Device (1) for disinfection and / or sterilization of objects (2) comprising • an evacuable process chamber (10), • a first connection (110) and / or first reservoir for a Treatment medium • a first inlet (100) in the process chamber (10); wherein the first Inlet (100) with a first connection (110) and / or the first Reservoir for the treatment medium is connected • a second connection (210) and / or second reservoir for a aeration medium • a second inlet (200) in the process chamber (10), wherein the second Inlet (200) with the second connection (210) and / or the second Reservoir for the aeration medium and / or the first Connection (110) and / or the first reservoir. • a pump (320) connected to one or more outlets (300) • a controller (600) for controlling the first inlet (100), the second Inlet (200), the first port (110), the second port (210) and / or the outlet (300). • a sensor unit (500).

32. Device (1) for disinfection and / or sterilization of objects (2) according to Claim 31 , characterized in that the device (1) has an outlet (300) and a media discharge (330) for Discharge of the treatment medium from the process chamber (10).

33. Device (1) for disinfection and / or sterilization of objects (2) according to Claim 31 or 32, characterized in that the control (600) with the sensor unit (500), the pump (320), the first inlet (100), the second inlet (200) and / or the outlet (300).

34. Device (1) for disinfecting and / or sterilizing objects (2) according to one or more of claims 31 to 33, characterized in that the sensor unit (500) has a sensor (520).

35. Device (1) for disinfection and / or sterilization of objects (2) according to Claim 34, characterized in that a sensor (520) of the sensor unit (500) is a pressure sensor.

36. Device (1) for disinfection and / or sterilization of objects (2) according to Claim 35, characterized in that the pressure sensor (520) is arranged in the process chamber (10).

37. Device (1) for disinfection and / or sterilization of objects (2) according to one or more of claims 31 to 36, characterized in that a sensor (530) is a chemical sensor which is suitable and / or intended to detect a chemical measurement variable.

38. Device (1) for disinfection and / or sterilization of objects according to one or more of claims 31 to 37, characterized in that a sensor (530) is a chemical sensor which is suitable and / or intended to detect a physical measurement variable from which the concentration of the treatment medium in the process chamber (10) can be determined.

39. Device for disinfecting and / or sterilizing objects according to claim 37 or 38, characterized in that the chemical sensor (530) is arranged in the process chamber (10) or in the media discharge (330) for discharging the treatment medium from the process chamber (10).

40. Disinfected object (2) with a surface roughness Rz with Rz <= 10μm, preferably with Rz <= 5μm and particularly preferably with Rz 1 μm and / or with a porosity with a pore size P with 10nm <= P <= 500μm, preferably with 25nm <= P <= 100μm and particularly preferably with 50nm P <= 50μm and / or a pore volume V based on the total volume of the object with V >= 70%, preferably V >= 55% and particularly preferably V >= 40% and with Residues of the treatment medium and / or reaction products of the treatment medium and less than 2000 germs per m 2 on the surface.

41. Disinfected object (2) with an internal surface (23) according to claim 40, characterized in that the disinfected object (2) contains residues of peracetic acid or residues of reaction products of peracetic acid.

42. Disinfected object (2) according to claim 40 or 41, characterized in that the porosity is an open porosity.

43. Sterilized object (2) with a surface roughness Rz with Rz <= 10μm, preferably with Rz <= 5μm and particularly preferably with Rz 1 μm and / or with a porosity with a pore size P with 10nm <= P <= 500μm, preferably with 25nm <= P <= 100μm and particularly preferably with 50nm <= P <= 50μm and with residues of the medium and / or reaction products of the medium and / or a pore volume V based on the total volume of the object with V >= 70%, preferably V >= 55% and particularly preferably V >= 40% and a germ-free surface.

44. Sterilized object (2) with an internal surface (23) according to claim 43, characterized in that the sterilized object (2) contains residues of peracetic acid or residues of reaction products of peracetic acid.

45. Sterilized object (2) according to claim 43 or 44, characterized in that the porosity is an open porosity.

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