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. 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. 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 procedure for allogeneic bone transplants and also offers adequate antibacterial, antifungal, and antiviral protection for allogeneic soft tissue transplants.

[0005] During disinfection and / or sterilization using PES under negative pressure, the PES transforms into the gas phase at a low temperature 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 disinfection and / or sterilization methods have been developed 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 document, the advantages of the peracetic acid-ethanol vacuum process for the disinfection and / or sterilization of objects, especially those with internal surfaces, e.g. trousers or gloves, are applied.

[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. 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. This 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.

[0009] 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, an item 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(s) 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.

[0010] 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 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. 5 to reduce. The disinfectant treatment then eliminates the risk of infection from the object.

[0011] In 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. 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.

[0012] Alternatively, the starting substances of the peracetic acid can be introduced into the process chamber to allow the peracetic acid to be produced in situ.

[0013] In the fourth step, the disinfection and / or sterilization process is carried out. 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.

[0014] 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 below 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, below the concentration of the treatment medium during the holding time.

[0015] In a further development of the invention, the object has an inner surface. The object has an outer side and an inner side opposite the outer side, which have corresponding outer and inner surfaces. The object is, for example, a piece of clothing, e.g. trousers, with the trouser legs each having an outer side with an outer surface and an inner side with an inner surface. The inner surfaces of an object can only be disinfected and / or sterilized using previously known methods with great expenditure of time. In a further embodiment of the invention, when the object is placed on the holder, an inner surface of the object is aligned for the holder.In a further embodiment of the invention, the object has an opening leading to the interior surface of the object, wherein the receptacle is positioned such that parts of the receptacle are positioned in the opening. The parts of the receptacle positioned in the opening of the object thus allow access of the treatment medium to the opening of the interior surface and enable rapid and thorough disinfection and / or sterilization of the object.

[0016] In a further embodiment of the invention, the receptacle is positioned in the process chamber such that the opening is aligned with an inlet of the process chamber of the device for disinfection and / or sterilization. In particular, the receptacle ensures that the internal surface is accessible to the treatment medium and can be quickly and thoroughly disinfected and / or sterilized. This allows the treatment medium access to the opening of the internal surface and enables rapid and thorough disinfection and / or sterilization of the object.

[0017] In a further development of the invention, the object has a flexible wall, wherein the flexible wall forms an inner surface of the object on one side, and the receptacle is positioned such that parts of the receptacle space the flexible wall from other parts of the object. This ensures that the inner surface is accessible to the treatment medium and can be quickly and thoroughly disinfected and / or sterilized.

[0018] In an advantageous embodiment of the invention, the device for disinfection and / or sterilization has 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 memory that has a software program for controlling a method for disinfecting and / or sterilizing objects. In a further embodiment of the invention, the controller is coupled to a sensor unit, a pump, the inlet and / or an outlet, wherein 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 the sensor unit. 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.

[0019] In a further embodiment of the invention, the treatment medium is introduced depending on the determined concentration of the treatment medium in the gas phase. 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.

[0020] 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 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.

[0021] In a further embodiment of the invention, the objects are packaged in sterilization bags before being placed in the process chamber. In another aspect of the invention, the sterilization bags are permeable to vapors. Sterilization bags, also known as autoclave bags or laminated bags, 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 bags 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 bags 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 items from contamination. The sterilization bags are lightweight and easy to store, allowing them to be used conveniently in any environment.

[0022] In a further embodiment of the invention, the process chamber is closed after the object has been placed in the process chamber. After closing, the process chamber is sealed gas-tight.

[0023] In a further embodiment of the invention, the process chamber is heated to process temperature after it has been closed. Due to the placement of the object with the chamber open, 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.

[0024] In a further embodiment of the invention, the pressure in the process chamber is monitored. For this purpose, the process chamber is connected to a pressure sensor.

[0025] 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, is minimally 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.

[0026] 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 embodiment 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, in particular internal surfaces of the object, are disinfected and / or sterilized.

[0027] 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, so that the operator or a bystander does not inhale 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.

[0028] 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.

[0029] In a further embodiment of the invention, the process steps according to claims 23 and 24 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. 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 products can then be removed from the process chamber.

[0030] In a further development of the invention, the treatment medium is discharged. The treatment medium is thus removed from the process chamber.

[0031] 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.

[0032] 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 28.

[0033] 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 gas phase 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.

[0034] 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.

[0035] The device according to the invention for disinfecting and / or sterilizing objects has 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.

[0036] 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 solution 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.

[0037] 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.

[0038] 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.

[0039] The device further comprises a holder suitable for holding an object. The object is positioned and fixed in the process chamber by means of the holder in such a way that, optionally, an inner surface of the object is aligned with the holder, with the holder aligning the inner surface with the process chamber. The holder can be designed differently depending on the type and dimensions of the object.

[0040] In a further embodiment of the invention, the device has an outlet for discharging the treatment medium from the process chamber. The outlet is optionally connected to a filter and a pump through which the treatment medium can be discharged from the process chamber.

[0041] 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.

[0042] The control system is designed as a microcontroller with memory, containing a software program for controlling a process for disinfecting and / or sterilizing objects. To carry out the process, the pump, inlet, and / or outlet are controlled depending on the measured variables recorded by the sensors of a sensor unit.

[0043] In a further embodiment of the invention, the holder is suitable for accommodating objects with an internal surface such that the internal surface is accessible to the process chamber. In particular, the holder ensures that the internal surface is accessible to the treatment medium and can be quickly and thoroughly disinfected and / or sterilized.

[0044] In a further embodiment of the invention, a portion of the receptacle can be positioned in an opening of the object, with the opening of the object leading to the inner surface of the object. The portion of the receptacle positioned in the opening of the object thus allows access of the treatment medium to the opening of the inner surface and enables rapid and thorough disinfection and / or sterilization of the object.

[0045] In a further embodiment of the invention, the receptacle is positioned in the process chamber such that the opening and / or the inner surface of the object can be aligned with the inlet of the device for disinfection and / or sterilization. This allows access of the treatment medium to the opening of the inner surface and enables rapid and thorough disinfection and / or sterilization.

[0046] Sterilization of the object.

[0047] The task is still carried out by means of the disinfected object with an internal

[0048] Surface. An advantageous embodiment of the invention is set out in the subclaim.

[0049] The disinfected object with an internal surface has residues of the

[0050] Treatment medium and / or reaction products of the treatment medium and less than 2000 germs per m 2 on the surface of the disinfected object. The disinfected object according to the invention has no contamination on its

[0051] 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 2which 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.

[0052] The disinfected object is preferably an object from the following groups: masks,

[0053] Safety goggles / visors, surgical textiles, disposable protective gowns, lightweight hoods (fan filter system), fan filter devices, protective overalls (emergency services / fire brigade), surgical shoes,

[0054] Magnifying glasses for surgery, ventilation tubes, masks, bags, Pari-Boy nebulizer for inhalation therapy (with electronics), fever thermometers, full face masks, lung demand valves,

[0055] Compressed air breathing apparatus, but also electronic devices such as radios and smartphones.

[0056] The material of the disinfected object is: PP, PET / PETG, Nylon, PU / PU-

[0057] Foams, PVC foam, ABS, elastane, EPDM, silicone, rubber or metal, and / or a composite of the aforementioned materials.

[0058] The task is also carried out using the sterilized object with an internal

[0059] Surface dissolved. Advantageous embodiments of the invention are set out in the subclaims. The sterilized object with an internal surface has residues of the treatment medium and / or reaction products of the treatment medium and a germ-free surface. The sterilized object according to the invention has a contamination with bacteria 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).

[0060] In a further aspect of the invention, the inner surface contains residues of the medium and / or reaction products of the treatment medium and is germ-free. In a further development of the invention, the sterilized object and the inner surface contain residues of peracetic acid or residues of reaction products of peracetic acid. In an optional development, the concentration of the treatment medium and / or reaction products of the treatment medium 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 .

[0061] The sterilized object is an object from the following groups: masks, safety goggles / visors, surgical textiles, disposable protective gowns, lightweight hoods (fan filter systems), fan filter devices, protective overalls (emergency services / fire department), surgical shoes, surgical loupes, ventilation tubes, masks, and bags, Pari-Boy nebulizers for inhalation therapy (with electronics), clinical thermometers, full-face masks, lung governing devices, 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.

[0062] 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.

[0063] They show:

[0064] Fig. 1 : Device for disinfection and / or sterilization of objects

[0065] Fig. 2: Device for disinfection and / or sterilization of objects,

[0066] Control connected to vacuum pump

[0067] Fig. 3: Embodiment of an object arranged in the device

[0068] Fig. 4 a: Embodiment of an object arranged in the device

[0069] Fig. 4 a: Embodiment of an object arranged in the device

[0070] Fig. 5: Device for disinfection and / or sterilization of objects,

[0071] Pressure and temperature sensors

[0072] Fig. 6: Device for disinfection and / or sterilization of objects, pressure and temperature sensors, HEPA filter in media discharge Fig. 7: Example of the method for disinfection and / or sterilization of objects

[0073] Fig. 8 a: Example of a recording

[0074] Fig. 8 b: Example of a recording

[0075] Fig. 1 and Fig. 2 show embodiments of the device 1 according to the invention for disinfecting and / or sterilizing objects 2. 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 for discharging the treatment medium from the process chamber 10.

[0076] The process chamber 10 has a first inlet 100, which is connected to a reservoir for the treatment medium via a first connection 110. 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.

[0077] For disinfection and / or sterilization of objects 2, the object 2 is placed on a holder 800 in the process chamber 10. Optionally, the object 2 is packaged in a vapor-permeable sterilization bag before being placed in the process chamber 10 in order to prevent contaminating the object 2 during and after disinfection and / or sterilization and to easily and safely place a contaminated object 2 into the process chamber 10.

[0078] 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 of the exemplary embodiments shown here, the treatment medium is a mixture of peracetic acid and water. 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 chamber in order to allow the peracetic acid to form in situ.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.

[0079] 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.

[0080] A further exemplary 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 the one presented in the previous exemplary embodiment (see Fig. 2). In this exemplary embodiment, an object 2 to be disinfected and / or sterilized is arranged on a suitable holder 800 in the process chamber 10. In this exemplary embodiment, the object 2 is a pair of trousers as part of a surgical textile; the material of the trousers 2 is a composite of rubber and silicone. The material of the object 2 forms a flexible wall 22, which is impermeable to gas. On the outside, the object 2 has the outer surface 24, and on the inside the inner surface 23. At a first end, the object 2 has an opening 21 (waistband), on the side opposite the first end, the object 2 has two openings 21 which open into the trouser legs.The openings 21 lead to the inner surface 23 of the object 2.

[0081] The receptacle 800 itself is designed such that the object 2 arranged on the receptacle 800 is aligned with the inner surface 23 towards the receptacle 800. Parts of the receptacle 800 are positioned in the respective openings 21. The object 2 is arranged on the receptacle 800 such that the flexible wall 22 is arranged such that the openings 21 and thus the inner surface 23 are accessible for a gas flow. When the receptacle 800 is arranged in the process chamber 10, the receptacle 800 is positioned such that at least one, in this embodiment two openings 21 - the openings 21 that open into the trouser legs - are aligned with the inlet 100. In this way, the inner surface 23 is easily accessible for the treatment medium. The object 2 is disinfected and / or sterilized using the method described in Fig. 1 and Fig. 2.

[0082] Fig. 4 shows further exemplary embodiments of the design and arrangement of receptacles 800 in the process chamber 10. The device 1 shown here corresponds to the device 1 presented in the previous exemplary embodiment (see Fig. 2, Fig. 3). The object 2 to be disinfected and / or sterilized is a surgical mask (Fig. 4 a) or a surgical glove (Fig. 4 b). These differently designed objects 2 are arranged on receptacles 800 that are also designed differently from one another (see Fig. 8).

[0083] The arrangement of the object 2 on the holder 800 is such that the respective openings 21 of the object 2 allow access to the inner surface 23 of the flexible wall 22. The inner surface 23 faces the holder 800, and the outer surface 24 faces away from the holder 800. In addition, the holder 800 is designed and arranged in the process chamber 10 such that the individual parts and / or regions of the object 2 arranged on the holder 800 do not touch one another, i.e. the flexible wall 22 is spaced apart from all parts of the object 2. In the exemplary embodiment shown in Fig. 4 b, for example, the individual fingers of the glove 2 are arranged at a distance from one another on the holder 800. As a result, both the outer surface 22 and the inner surface 23 are easily accessible to the treatment medium.When the receptacle 800 is arranged in the process chamber 10, the receptacle 800 is also positioned such that the opening 21 is aligned with the inlet 100. The object 2 is also disinfected and / or sterilized using the method described in Fig. 1 and Fig. 2. Fig. 5 and Fig. 6 show exemplary embodiments of the device 1 according to the invention for disinfecting and / or sterilizing objects 2. The devices 1 shown here correspond to those presented in the previous exemplary embodiment (see Fig. 2 to Fig. 6), 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, and a sensor unit 500 with two sensors 510, 520, which are also connected to the controller 600 (Fig. 5). In a further embodiment, the device 1 additionally has a HEPA filter 700, which is arranged in the line between pump 320 and outlet 300 (Fig. 6).

[0084] 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.

[0085] 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.

[0086] 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 further development of the invention, the injection quantity and / or the concentration of a 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 at least partially not exceeded in order to prevent condensation of the PES solution. This state is kept constant for part of the process duration. This serves to eliminate germs, 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.

[0087] By means of the temperature sensor 510, the controller 600 continuously detects the temperature in the process chamber 10 during the process and regulates the temperature in the process chamber 10 via the heating device 400. The pressure in the process chamber 10 is detected by the pressure sensor 520 and also regulated by the controller 600 by either opening the inlet 100 or reducing the pressure in the chamber via the outlet 300 and the pump 320.

[0088] In a further embodiment, the sensor device 500 can have a chemical sensor. Using the chemical sensor, the concentration of the treatment medium (PES solution) in the process chamber 10 is continuously detected and monitored by the controller 600. This makes it possible to record the consumption of the treatment medium during the process and also to determine whether the disinfection and / or sterilization process is complete. If the concentration of the treatment medium 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. For this purpose, the first inlet 100 is opened by means of 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 remains high, the disinfection and / or sterilization process is complete.

[0089] 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., the aeration medium does not contain any 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 Optionally, a neutralizing medium, e.g., a gaseous base, can be introduced before the rinsing process with the aeration medium to neutralize the treatment medium. The air inlet or outlet 300 preferably occurs via a HEPA filter. 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.

[0090] Fig. 7 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).

[0091] 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 inner surface 23 and outer surface 24. 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. 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 no on its inner surface 23 and outer surface 24 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 2 Surface, 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 the object 2).

[0092] The disinfection and sterilization process is generally carried out depending on the object 2 to be sterilized / disinfected, the general conditions, and predeterminable requirements according to processes specifically optimized in the controller 600 and the sequence. For this purpose, different cycles, intervals, and process parameters can be set via a software program stored in the controller 600 or, if necessary, individually via 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, among other things, be carried out in cycles. 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.

[0093] Fig. 8 shows embodiments of different holders 800 for holding different objects 2. A holder 800 is optionally manufactured individually for each object type (e.g. trousers, mask, glove). In these embodiments, a holder 800 for a surgical mask (see Fig. 4 a) and a holder 800 for a surgical glove (see Fig. 4 b) are shown. In these embodiments, the holders 800 are made of a wire mesh, wherein the wire is a stainless steel that is acid and temperature resistant. The wire mesh allows access of the treatment agent to the inner surface 23 of the object 2 arranged on the holder. Other possible materials for the holder 800 are structurally stable plastics, e.g. ABS, silicone, nylon.

[0094] 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

[0095] Spore suspension SAL 10 6

[0096] 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 with sterilization. The aim of disinfection is to reduce the number of germs by at least a factor of 10. 5 to reduce the risk of infection. The disinfectant treatment then eliminates the risk of infection from object 2. 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' 5defines a disinfection, a SAL of at least 10 -6 sterilization, ie the lower the SAL value, the higher the safety.

[0097] The disinfectant and sterilizing agent used in the device 1 presented here is peracetic acid (PAA) in a solution diluted with water. PAA disinfects chemically, having an oxidizing effect on microorganisms. It has a broad spectrum of activity, a short exposure time, and an irreversible effect. Furthermore, compared to other sterilizing 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.

[0098] Validation tests of the "disinfection and sterilization device" were conducted using 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.

[0099] 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.

[0100] No growth or multiplication of spores was subsequently detected in any of the spore strips tested at different PES concentrations and different processing times. Additionally, untreated test samples were included in each run. This ensured that the samples were inoculated with spores.

[0101] 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 the pipette) 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 .

[0102] 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.

[0103] In various experiments, 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.

[0104] 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 inaccessible areas, thus enabling the PES to exhibit very high effectiveness against biogenic contaminants even at low temperatures of 40°C to 65°C, preferably 50°C to 55°C.

[0105] 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.

[0106] Due to the combination of the aforementioned advantages, this innovative disinfection and sterilization system – in contrast to previously used 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 tabletop 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.

[0107] The future PES treatment system will include, in particular, the following process-specific and application-related innovations: a. A novel, very broadly applicable chemical low-temperature disinfection and / or sterilization system. • The PES as a reactive component can either be generated 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., which are killed quickly and efficiently. The individual components (hydrogen peroxide and acetic acid) for the in-situ production of PES are globally available, inexpensive chemicals that can be handled safely while taking the necessary occupational safety measures into account.

[0108] • Gaseous PES is characterized by a high sterilizing effect. The use of gaseous PES in an automated vacuum process within a closed system ensures both minimized handling and safe effectiveness.

[0109] • Standardized, validatable procedure (no manual disinfection, e.g. wipe disinfection)

[0110] • 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 during 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 results in 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 handling.

[0111] LIST OF REFERENCE SYMBOLS

[0112] Device for disinfection and / or sterilization of objects

[0113] Trial Chamber

[0114] First entry

[0115] First connection

[0116] Second entrance

[0117] Second connection

[0118] Outlet

[0119] Outlet connection

[0120] pump

[0121] Heating device

[0122] Sensor unit

[0123] Temperature sensor

[0124] pressure sensor

[0125] steering

[0126] HEPA filter

[0127] Recording

[0128] object

[0129] opening

[0130] Flexible wall

[0131] Internal surface

[0132] External surface

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, • Evacuating the process chamber (10), • Introducing a treatment medium, • Carrying out the disinfection and / or sterilization process, • Increasing the pressure in the process chamber (10).

2. Methods for disinfection and / or sterilization of objects (2) according to Claim 1 , characterized in that the object (2) has an inner surface (23), 3. Method for disinfection and / or sterilization of objects (2) according to one or more of the preceding claims, characterized in that when placing the object (2) on a holder (800) an internal Surface (23) of the object (2) is aligned to the recording (800).

4. Method for disinfecting and / or sterilizing objects (2) according to one or more of the preceding claims, characterized in that the receptacle (800) aligns the inner surface (23) to 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 object (2) has an opening (21) which faces the inner surface (23) of the object (2), wherein the receptacle (800) is positioned such that parts of the receptacle (800) are positioned in the opening (21).

6. Method for disinfection and / or sterilization of objects (2) according to one or more of the preceding claims, characterized in that the receptacle (800) is positioned in the process chamber (10) in such a way that the Opening (21) is aligned with an inlet (100, 200) of the process chamber (10) of the device (1) for disinfection and / or sterilization.

7. Method for disinfection and / or sterilization of objects (2) according to one or more of the preceding claims, characterized in that the object (2) has a flexible wall (22), wherein the flexible wall (22) on one side represents an inner surface (23) of the object (2), wherein the receptacle (800) is positioned such that parts of the receptacle (800) the flexible wall (22) is spaced from other parts of the object (2).

8. 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 control (600) which is suitable and / or intended to carry out a control program which controls the process parameters of the disinfection and / or sterilization procedure.

9. 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).

10. Method for disinfection and / or sterilization of 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.

11. 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 preheated.

12. 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) is heated to the desired temperature 35°C - 85°C, preferably 40°C - 75°C and particularly preferably 50°C - 65°C.

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

14. 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.

15. 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).

16. 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) is closed after the process chamber (10) has been closed Process temperature is heated.

17. 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.

18. 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 or a PES-containing solution.

19. 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 - 80 mbar, preferably 10 mbar.

20. 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.

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

22. 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 disinfection and / or sterilization process, the process chamber (10) is rinsed with ambient air, wherein the rinsing preferably takes place at intervals.

23. 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.

24. 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 20mbar.

25. 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 23 and 24 are repeated once, preferably three times and particularly preferably five times.

26. 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.

27. 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.

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

29. Software program for carrying out the method according to one or more of claims 1 to 28.

30. 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). • one recording (800).

31. Device (1) for disinfection and / or sterilization of objects (2) according to Claim 30, characterized in that the device (1) has an outlet (300) and a media discharge for discharging the treatment medium from the process chamber (10).

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

33. Device (1) for disinfecting and / or sterilizing objects (2) according to one or more of claims 30 to 32, characterized in that the receptacle (800) is suitable for receiving objects (2) with an internal surface (23) such that the internal surface (23) is accessible to the process chamber (10).

34. Device (1) for disinfection and / or sterilization of objects (2) according to Claim 33, characterized in that a part of the receptacle (800) can be positioned in an opening (21) of the object (2), wherein the opening (21) of the object (2) faces the inner surface (23) of the object (2).

35. Device (1) for disinfection and / or sterilization of objects (2) according to Claim 34, characterized in that the receptacle (800) is positioned in the process chamber (10) such that the Opening (21) and / or the inner surface (23) of the object (2) for Inlet of the device (1) for disinfection and / or sterilization can be aligned.

36. Disinfected object (2) with an internal surface (23) 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 (23, 24) of the disinfected object (2).

37. Disinfected object (2) with an internal surface (23) according to claim 36, characterized in that the disinfected object (2) contains residues of peracetic acid or residues of reaction products of peracetic acid.

38. Disinfected object (2) with an internal surface (23) according to claim 36 or 37, characterized in that the inner surface (23) contains residues of the medium and / or reaction products of the medium and less than 2000 germs per m 2 on the inner surface (23) of the object (2).

39. Sterilized object (2) with an inner surface (23) with Residues of the treatment medium and / or reaction products of the treatment medium and a germ-free surface (23, 24).

40. Sterilized object (2) with an internal surface according to claim 39, characterized in that the inner surface (23) contains residues of the treatment medium and / or reaction products of the treatment medium and is germ-free.

41. Sterilized object (2) with an internal surface (23) according to claim 39 or 40, characterized in that the sterilized object (2) contains residues of peracetic acid or residues of reaction products of peracetic acid.

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