Method and device for disinfecting and / or sterilising electronic components

Abstract

The invention relates to a method for disinfecting and / or sterilising electronic components, said method comprising the method steps of: placing an electronic component 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 electronic components; and a device for disinfecting and / or sterilising electronic components. The invention also relates to: a disinfected electronic component 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 electronic component; and a sterilised electronic component 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 ELECTRONIC COMPONENTS

[0002] The invention relates to a method for disinfecting and / or sterilizing electronic components, comprising the steps of placing an electronic component 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 electronic components, as well as a device for disinfecting and / or sterilizing electronic components. The invention also relates to a disinfected electronic component with residues of the treatment medium and / or reaction products of the treatment medium and fewer than 2000 germs per m². 2on the surface of the disinfected electronic component as well as a sterilized electronic component 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 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 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. This paper applies the advantages of the peracetic acid-ethanol vacuum process for the disinfection and / or sterilization of electronic components.

[0006] Task

[0007] It is therefore an object of the present invention to provide a method for disinfecting and / or sterilizing electronic components with which electronic components 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 electronic components, with which electronic components can be disinfected and / or sterilized reliably and cost-effectively. It is also an object of the present invention to provide a disinfected electronic component. It is also an object of the present invention to provide a sterilized electronic component. This object is achieved by means of the method for disinfecting and / or sterilizing electronic components 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 electronic components comprises five process steps: In the first process step, an electronic component is placed in an evacuable process chamber. For the purposes of this document, an electronic component is a component, system, or product that has electrical components. It can be sealed, sealed, or encapsulated. Optionally, exposed electronic components can also be accessible. 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 electronic component to be disinfected and / or sterilized. The placement of an electronic component can be performed automatically, remotely, and / or manually by a user. The process chamber can be equipped with suitable receptacles for this purpose.

[0010] The difference between disinfection and sterilization is that during sterilization of an object, all microorganisms, including their persistent forms (spores), are killed or irreversibly inactivated. The electronic component 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 electronic components would not be sterile. During the disinfection treatment of an electronic component, 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 goal of disinfection is to reduce the number of germs by at least a factor of 10. 5 to reduce.

[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 peracetic acid can be introduced into the process chamber to produce the peracetic acid in situ.

[0013] The fourth step involves performing the disinfection and / or sterilization process. Optionally, the process parameters (pressure and temperature in the process chamber) are kept constant during a specific exposure time. This serves to eliminate bacteria, viruses, and viruses from the electronic component. 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 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.

[0015] In one embodiment 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 electronic components.

[0016] In a further embodiment of the invention, the electronic components are packaged in sterilization pouches before being placed in the process 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 electronic components 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 items from contamination. The sterilization bags are lightweight and easy to store, making them convenient to use in any environment.

[0017] In a further embodiment of the invention, the process chamber is sealed after the electronic component has been placed in the process chamber. After sealing, the process chamber is sealed gas-tight.

[0018] 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 electronic component, the temperature in the process chamber drops, so it is heated again to a process temperature of 40°C - 65°C, preferably 50°C - 55°C.

[0019] 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.

[0020] 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.

[0021] 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 maintained 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 maintained 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 transitions to the gas phase. This ensures that even hard-to-reach areas of the electronic component are disinfected and / or sterilized.

[0022] 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 electronic component and cannot escape uncontrollably when the process chamber is opened, thus preventing the operator or a bystander from inhaling the solution when opening the door or access. 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.

[0023] In a further embodiment of the invention, after introducing ambient air up 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. In a further embodiment of the invention, the method steps according to claims 14 and 15 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.

[0024] 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.

[0025] In a further development of the invention, the treatment medium is discharged. The treatment medium is thus removed from the process chamber.

[0026] In a further embodiment of the invention, a neutralization medium is introduced to neutralize the treatment medium. PAA is an acid, so a base is optionally used as the neutralization medium. 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.

[0027] 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 19.

[0028] The software program according to the invention is suitable for implementing the method for controlling processes using defined values ​​and / or curves for pressure, injection quantities (with defined concentrations), temperature, and PES concentration in the chamber, as well as using 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 electronic components. The object is further achieved by means of the device for disinfecting and / or sterilizing electronic components. Advantageous embodiments of the invention are set forth in the subclaims.

[0029] The device according to the invention for disinfecting and / or sterilizing electronic components 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 electronic component to be disinfected and / or sterilized.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] The problem is further solved by means of the disinfected electronic component. An advantageous embodiment of the invention is set forth in the subclaim.

[0034] The disinfected electronic component has residues of the treatment medium and / or reaction products of the treatment medium of less than 2000 germs per m 2on the surface of the disinfected electronic component. The disinfected electronic component according to the invention has 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 2 which corresponds to a germ reduction of 84% to 99.9%. In a further development of the invention, the disinfected electronic component contains residues of peracetic acid or residues of reaction products of peracetic acid.

[0035] This object is also achieved by means of the sterilized electronic component. An advantageous embodiment of the invention is set forth in the subclaim.

[0036] The sterilized electronic component has residues of the treatment medium and / or reaction products of the treatment medium and a germ-free surface. The sterilized electronic component according to the invention has a contamination level of 0 on its surface if the probability of a surviving germ is less than 1:1,000,000 (<= 10 -6 per unit of the electronic component).

[0037] In a further development of the invention, the sterilized electronic component 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. Embodiments of the device according to the invention and of the method for disinfecting and / or sterilizing electronic components are shown in simplified schematic form in the drawings and are explained in more detail in the following description.

[0038] They show:

[0039] Fig. 1 : Device for disinfection and / or sterilization of electronic components

[0040] Fig. 2: Device for disinfection and / or sterilization of electronic components, pressure and temperature sensors

[0041] Fig. 3: Device for disinfection and / or sterilization of electronic components, with HEPA filter

[0042] Fig. 4: Example of an electronic component

[0043] Fig. 5: Example of the method for disinfection and / or sterilization of electronic components

[0044] Fig. 1 shows an embodiment of the device 1 according to the invention for disinfecting and / or sterilizing electronic components. 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. The outlet 300 can be opened or closed and is connected to the controller 600. In addition to a U1, the controller 600 has a microcontroller and a memory containing a suitable software program for carrying out a disinfection and / or sterilization process for electronic components 2.

[0045] The process chamber 10 has a first inlet 100, which is connected to a reservoir for the treatment medium via a first connection 110. The second inlet 200, which is connected to the reservoir for the aeration medium via the second connection 210, is also connected to the controller 600. The inlets 100, 200, like the outlet 300, can each be opened or closed via valves controlled by the controller 600.

[0046] For the disinfection and / or sterilization of electronic components 2 (see Fig. 4), the electronic component 2 is placed in the process chamber 10, e.g., in a suitable receptacle in the process chamber 10. Preferably, the electronic component 2 is packaged in a vapor-permeable sterilization bag before being placed in the process chamber 10 in order to prevent contaminating the electronic component 2 during and after disinfection and / or sterilization and to be able to handle the contaminated electronic component easily and safely in the decontamination process.

[0047] 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, water, and optionally other components. 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 generate the peracetic acid in situ.

[0048] 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.

[0049] For the disinfection and / or sterilization of electronic components 2, the electronic component 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 chamber contains a concentration of the treatment medium that is below the concentration of the treatment medium in the chamber during the holding time of the process. The concentration of the treatment medium during orAfter increasing the pressure in the chamber 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 electronic component 2 removed.

[0050] Further embodiments of the device 1 according to the invention for disinfecting and / or sterilizing electronic components are shown in Fig. 2 and Fig. 3. The devices 1 shown here correspond to the one presented in the previous embodiment (see Fig. 1), 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. In addition, 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 (Fig. 2). In a further embodiment, the device 1 has a HEPA filter 700, which is arranged in the line between the pump 320 and the outlet 300 (Fig. 3).

[0051] For the disinfection and / or sterilization of electronic components 2, after the electronic component 2 has been placed in the process chamber 10 and evacuated, the temperature in the process chamber 10 is heated by means of the heating device 400 after the process chamber 10 has been closed 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 the electronic component 2 is placed in the process chamber 10. In the next method 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 a treatment medium in the process chamber 10 is controlled using 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 rises. During part of the process, the pressure and temperature in the process chamber 10 are controlled by the controller 600 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 condition is kept constant for part of the process duration. This serves to eliminate particles, bacteria, and viruses on the electronic component 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 appropriate pumping using the pump 320. Using 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 controlled 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.

[0052] 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 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 and 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 intake or exhaust via an outlet 300 preferably occurs 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 the electronic component 2 from contamination. Optionally, a neutralization medium, e.g., a gaseous base, can be introduced before the purging process with the aeration medium to neutralize the treatment medium.

[0053] Fig. 4 shows an electronic component 2 that can be disinfected and / or sterilized using the method and device 1 according to the invention (see Fig. 1 to Fig. 3). In this exemplary embodiment, the electronic component 2 is a commercially available smartphone 2 as a prototype. The smartphone 2 has a first connection 21 for headphones, a second connection 22 for a USB cable, and a third connection 23 for a charging cable. The first connection 21 and second connection 22 are connected to the circuit board 24, and the third connection 23 is connected to the power supply 25 (battery), which is also connected to the circuit board 24. The circuit board 24 is also connected to the display 26, the microphone 27, and the loudspeaker 28. The aforementioned components of the smartphone 2 are arranged in a housing.

[0054] After performing the method with the device 1 according to the invention, the electronic component 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 mg / m 2 and in a particularly preferred embodiment below 0.05 ml / m 2 or below 0.16 mg / m 2 . The disinfected electronic component 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 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 electronic component 2 according to the invention has a contamination with None 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 electronic component 2).

[0055] 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 electronic component 2, protected by the splash-proof housing in this embodiment, have as little contamination with germs as the outer surfaces after carrying out the method.

[0056] Figure 5 shows an embodiment of the method according to the invention for disinfecting and / or sterilizing electronic components 2, which is carried out in three cycles. The graph shows the spore / virus / bacteria concentration on the internal and external surfaces of the electronic component 2 (ordinate) versus time (abscissa).

[0057] The disinfection and sterilization process is generally carried out depending on the product 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 electronic component 2 has a high germ load, different disinfection and / or sterilization cycles may have to be run, since the PAA solution is consumed at a high germ load, so that the subsequent addition of PAA may be necessary. This step will be carried out in cycles, among other things. During the process, the treatment agent (PAA) 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 electronic component 2 as well as difficult-to-reach and complex geometries of the electronic component 2.

[0058] 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

[0059] Spore suspension SAL 10 6

[0060] 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 possibility 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), which is 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.

[0061] 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.

[0062] 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.

[0063] 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. No growth or proliferation of the spores was subsequently detected in any of the spore strips tested at different PES concentrations and different processing times.

[0064] Additionally, untreated test samples were included in each experiment. This ensured that the samples were inoculated with spores.

[0065] 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 .

[0066] 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.

[0067] 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.

[0068] The disinfection or sterilization system according to the invention is designed so that different concentrations of PAA can be specifically adjusted in the vacuum of the process chamber. The combination of special injection technology, a customized vacuum process, and process cycles ensures that the disinfectant and / or sterilizing agent mixture is reliably distributed even in inaccessible areas, thus enabling the PAA to exhibit very high effectiveness against biogenic contaminants even at low temperatures of 40°C to 65°C, preferably 50°C to 55°C.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] • 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.

[0073] • Standardized, validatable procedure (no manual disinfection, e.g. wipe disinfection)

[0074] • 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 necessary), the PPE materials or material combinations as well as the surfaces and.

[0075] Geometries). e. The disinfection and / or sterilization of PPE is possible in the new reprocessing system in the sterilization bag, thus ensuring safe and contamination-free handling.

[0076] LIST OF REFERENCE SYMBOLS

[0077] Device for disinfection and / or sterilization of electronic components

[0078] Trial Chamber

[0079] First entry

[0080] First connection

[0081] Second entrance

[0082] Second connection

[0083] Outlet

[0084] Outlet connection

[0085] pump

[0086] Heating device

[0087] Sensor unit

[0088] Temperature sensor

[0089] pressure sensor

[0090] steering

[0091] HEPA filter

[0092] Electronic component

[0093] First connection

[0094] Second connection

[0095] Third connection

[0096] circuit board

[0097] Power supply / battery

[0098] Display

[0099] Microphone

[0100] Speaker

Claims

PATENT CLAIMS 1. Process for the disinfection and / or sterilization of electronic components (2) comprising the following process steps: Placing an electronic component (2) in an evacuable Process chamber (10), Evacuation of the trial chamber (10), Introducing a treatment medium, • Carrying out the disinfection and / or sterilization process, Increasing the pressure in the process chamber (10) 2. Method for disinfecting and / or sterilizing electronic components (2) according to claim 1, characterized in that the process chamber (10) is preheated.

3. Method for disinfection and / or sterilization of electronic components (2) according to claim 2, characterized in that the process chamber (10) is heated to the desired temperature of 35°C - 85°C, preferably 40°C - 75°C and particularly preferably 50°C - 65°C.

4. A method for disinfecting and / or sterilizing electronic components according to one or more of the preceding claims, characterized in that the electronic components (2) are packaged in sterilization bags before being placed in the process chamber (10). REVISED SHEET (RULE 91) ISA / EP 5. A method for disinfecting and / or sterilizing electronic components (2) according to claim 4, characterized in that the sterilization bags are permeable to vapors.

6. Method for disinfection and / or sterilization of electronic components (2) according to one or more of the preceding claims, characterized in that the process chamber (10) after the placement of the electronic components (2) in the Process chamber (10) is closed.

7. Method for disinfection and / or sterilization of electronic components (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.

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

9. Method for disinfecting and / or sterilizing electronic components (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.

10. Method for disinfecting and / or sterilizing electronic components (2) according to one or more of the preceding claims, characterized in that REVISED SHEET (RULE 91) ISA / EP the process chamber (10) to a pressure of 1 - 300mbar, preferably 10-250mbar and particularly preferably 10-50mbar.

11. A method for disinfecting and / or sterilizing electronic components (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.

12. Method for disinfection and / or sterilization of electronic components (2) according to claim 11, characterized in that the pressure during a part of the process duration of the disinfection and / or Sterilization process is kept below the boiling curve of the treatment medium.

13. A method for disinfecting and / or sterilizing electronic components (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.

14. A method for disinfecting and / or sterilizing electronic components (2) according to claim 13, characterized in that during rinsing, ambient air is introduced up to a chamber pressure of 200 - 800 mbar, preferably 200 - 700 mbar and particularly preferably 200 - 500 mbar. REVISED SHEET (RULE 91) ISA / EP 15. Method for disinfection and / or sterilization of electronic components (2) according to claim 14, characterized in that after introducing the ambient air up to a pressure, the process chamber (10) is evacuated again to 1 - 500 mbar, preferably 10 - 400 mbar, particularly preferably 50 - 250 mbar.

16. A method for disinfecting and / or sterilizing electronic components (2) according to one or more of claims 13 to 15, characterized in that the method steps according to claims 14 and 15 are repeated once, preferably three times and particularly preferably five times.

17. Method for disinfection and / or sterilization of electronic components (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.

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

19. Method for disinfecting and / or sterilizing electronic components (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. REVISED SHEET (RULE 91) ISA / EP 20. Software program for carrying out the method according to one or more of claims 1 to 19.

21. Device (1) for disinfection and / or sterilization of electronic components (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).

22. Disinfected electronic component (2) 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 of the disinfected electronic component (2).

23. Disinfected electronic component (2) according to claim 22, characterized in that REVISED SHEET (RULE 91) ISA / EP the disinfected electronic component (2) contains residues of peracetic acid or residues of reaction products of peracetic acid.

24. Sterilized electronic component (2) with residues of the treatment medium and / or reaction products of the treatment medium and a germ-free Surface.

25. Sterilized electronic component (2) according to claim 24, characterized in that the sterilized electronic component (2) has residues of peracetic acid or residues of reaction products of peracetic acid. REVISED SHEET (RULE 91) ISA / EP

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