Method for prion inactivation

FIELD: medicine.

SUBSTANCE: invention refers to medicine, particularly product cleaning from prions. A product having an amount of prions is placed in a sterilising chamber. Pressure in the sterilising chamber is decreased to a value below hydrogen peroxide vapour pressure, and a hydrogen peroxide solution is supplied to the sterilising chamber and contacts with the product for prion inactivation on the product.

EFFECT: method provides prion inactivation, especially on medical devices.

13 cl, 4 tbl, 23 dwg

 

The scope of the invention

The invention relates to the processing of products, and more particularly to the processing of products to inactivate them prion.

Description of the prior art

Most medical instruments sterilized before use. Most sterilized and sold in protective packaging to maintain their sterile condition until such time as the package will not be opened and the tool will be used during a medical procedure. Some tools are reused and must be sterilized before reuse. Common sterilization methods include high temperature steam, irradiation and chemical fumes, such as ethylene oxide and hydrogen peroxide.

Prions are protein infectious agents that cause similar fatal brain disease, known as pass-through spongiform encephalopathy (TSE). These diseases include disease of Creutzfeldt-Jakob disease (CJD) in humans, spongiform encephalopathy in cattle (BSE), also known as the disease of "mad cow", "scrape" (spongiform encephalopathy of sheep) and homologous disease of elk and deer. Consider that variant disease of Creutzfeldt-Jakob disease (CJDv) in humans caused by the same proteins that cause BSE in cattle is. Believe that prions are abnormal form of the protein, usually find the owner. However, unlike the normal form of the protein, abnormal proteins accumulate, particularly in nervous tissue, ultimately causing the death of nerve cells.

Conventional sterilization methods have not been successful in eliminating infectious prion properties. Considering the fact that prions do not contain DNA or RNA, they are usually not considered to be alive and not be killed in the usual sense in which imagine sterilization products destruction on them infectious microorganisms. Rather, the goal is to inactivation in some form of prion, for example, the destruction of one or more of its chemical bonds in order to make the prion unable to cause disease such as CJD or CJDv the owner.

A common methodology for the inactivation of prions includes treatment solutions are extremely high pH and temperature in an attempt to prion denaturing. The way that is folded prion, has a tendency to do inefficient denaturation of prion with typical agents, denaturing the protein. Increased temperature and pH methodology often have a damaging impact on the toolbar.

It was believed that sterilization device, which uses pairs of hydrogen peroxide and/or pairs of Perak the IDA hydrogen in combination with plasma, could not inactivate prions. Performed tests on a typical device, in which 59% hydrogen peroxide solution is supplied into the sterilization chamber under vacuum conditions to create an effective sterilizing vapor of hydrogen peroxide and in which steam at one point raised in the stage of plasma. This methodology has not been sufficient to inactivate prions on the tools to resolve their infectious properties.

Surprisingly, the present applicants have found that exposure to vapor of hydrogen peroxide higher concentrations and/or higher density plasma is effective for the inactivation of prions and giving the thus treated product characteristics the absence of infectivity in the case of diseases caused by prions.

A brief description of the invention

The way the inactivation of prions in accordance with the present invention involves the following stages: building a product on a certain amount of prions in the sterilization chamber; reducing the pressure in the sterilization chamber to a pressure below the vapor pressure of hydrogen peroxide; intake solution containing hydrogen peroxide in the sterilization chamber and ensure contact of the product with steam of hydrogen peroxide; and the inactivation of prions in the chamber by contact between prions and vapor of hydrogen peroxide.

PR is doctitle concentration of hydrogen peroxide in the solution, let the camera exceeds 70%, preferably 75%, preferably 80%, preferably 55%, and most preferably greater than 90%.

Preferably the temperature of the product during the stage of contact of the product with steam of hydrogen peroxide exceeds 30 º C, preferably 35, preferably 40 º C, and most preferably 45 º C.

In one aspect of the invention, the method also includes the initiation of a pair of hydrogen peroxide in the flaming phase and ensuring contact with prion hydrogen peroxide in the phase of plasma. Preferably, the plasma density is at least 10 mlvt/cm3preferably 20 mlvt/cm3preferably 30 mlvt/cm3preferably 40 mlvt/cm3and most preferably at least 50 mlvt/cm3.

Preferably, the plasma is in contact with prions for at least 2 minutes, preferably 3 minutes, and most preferably at least 4 minutes

Preferably, the plasma is generated between the anode and cathode, and the gap between them is less than 0.6 inches, maybe less than 0.5 inch. Also preferable is a gap of about 0.5 inch. Preferably the minimum distance between prions and the closest of the anode and the electrode is 1.5 inches, preferably 1 inch. The minimum distance between prions and the anode morecostly 1 inch or less.

Preferably the hydrogen peroxide also provides sterilization of the product.

The concentration of the at least part of the hydrogen peroxide can be increased before providing contact prion with him, preferably by selective removal of water from the solution and pumping out the water from the sterilization chamber.

Gases surrounding the prions can be excited in phase plasma and then to contact with prions.

The stage of reducing the pressure in the sterilization chamber and the inlet of the solution in the sterilization chamber includes a cycle, and this cycle is repeated one or more times.

Preferably pairs of hydrogen peroxide which is in contact with the product has a concentration of 10 mg/l or more, preferably 15 mg/l or more, preferably 20 mg/l or more, most preferably 25 mg/l or more.

Preferably the method also includes a step of condensation of part of a pair of hydrogen peroxide on the product, and the concentration of this condensed hydrogen peroxide is at least 80 wt.% of hydrogen peroxide, preferably at least 85 wt.%, preferably, at least 90 wt.%, and most preferably at least 95 wt.%. Preferably, at least part, if not all, of the hydrogen peroxide, which condense on the product, again converted into steam by the exhaust Cam is ture to a lower pressure.

The way the inactivation of prions in accordance with the present invention involves the following stages: building a product on a certain amount of prions in the sterilization chamber; ensure contact of the product with the plasma for the implementation of the inactivation of prions. Preferably, the plasma formed from a gas including hydrogen peroxide. Preferably, the plasma density is at least 10 mlvt/cm3preferably 20 mlvt/cm3preferably 30 mlvt/cm3preferably 40 mlvt/cm3and most preferably at least 50 mlvt/cm3. The plasma density is measured between the anode and the electrode when generating this image.

Brief description of drawings

Figure 1 is a block diagram of a sterilization device in accordance with the present invention;

figure 2 is a block diagram of the evaporator and the diffusion channel sterilization of the device shown in figure 1;

figure 3 is a block diagram of an alternative implementation of the sterilization device in accordance with the present invention;

figa is a block diagram of an alternative implementation of the sterilization device in accordance with the present invention;

FIGU is a view in section along the line 3B-3B in figa;

figure 4 is a block diagram of an alternative implementation of the sterilization device in accordance with the present invention;

figure 5 is a block diagram of an alternative implementation of the sterilization device in accordance with the present invention;

6 is a view in section along the line 6--6 of figure 5;

7 is a block diagram of an alternative implementation of the sterilization device in accordance with the present invention;

Fig is a view in section along the line 8--8 of figure 7;

Fig.9 is a block diagram of a sterilization device in accordance with the present invention;

figure 10 is a view in the neckline prom condenser/evaporator for use in the apparatus shown in Fig.9;

11 is a view of a cutout inlet of the condenser/evaporator for use in the apparatus shown in Fig.9;

Fig is a perspective view of an alternative inlet of the condenser/evaporator for use in the apparatus shown in Fig.9;

Fig is a view from the spatially separated parts of the condenser/evaporator shown in Fig;

Fig is a view in section along the line 14-14 Fig;

figa the submitted is an enlarged view in section of the valve device, shown in Fig;

Fig is a view from the spatially separated parts of thermoelectric heat pump and rod devices used in the condenser/evaporator shown in Fig;

Fig represents an alternative sterilization device in accordance with the present invention;

Fig represents an alternative sterilization device in accordance with the present invention;

Fig represents an alternative sterilization device in accordance with the present invention;

Fig represents an alternative sterilization device in accordance with the present invention;

Fig is a perspective view of an alternative inlet of the condenser/evaporator for use in the apparatus shown in Fig.9;

Fig is a valve unit used in the inlet of the condenser/evaporator shown in Fig;

Fig is a view of the cut valve unit shown in Fig used in the inlet of the condenser/evaporator shown in Fig; and

Fig is a block diagram for calculating the concentration of peroxide, which condenses after loading.

Detailed description

Figure 1 in the form of a flowchart shown sterilizes the injecting device 10, which is effective not only in the destruction of traditional infectious microorganisms, such as bacteria and viruses, but has been shown to be also effective for the inactivation of prions. It includes, in General, the sterilization chamber 12, an evaporator 14 and a vacuum pump 16. The vacuum pump 16 is capable of creating a vacuum in the chamber, preferably up to 0.5 Torr. Between the vacuum pump 16 and the chamber 12 is preferably a throttle valve 18 and, optionally, the measuring diaphragm 20. A throttle valve 18 preferably also has a good blocking ability. The pressure sensor 22, preferably located near the throttle valve 18 shows the vacuum in the chamber 12. The exhaust valve 23 using antimicrobial HEPA (high efficiency air filter), provides the possibility of occurrence of sterile air into the chamber 12. The evaporator 14 is connected with the chamber 12 through the elongated diffusion channel 24. Figure 2 diffusion channel 24 includes elements of temperature regulation 26 for regulating the temperature along the diffusion channel 24.

The vaporizers which are suitable for evaporation of liquid sterilizing agents, such as hydrogen peroxide solution, known in the field. Kohler et al., U.S. patent No. 6106772, and Nguyen et al., application for U.S. patent No. 09/728,973, filed December 10, 2000, included the s here as a reference, illustrate the vaporizers which are suitable for this application. In the simplest embodiment, the evaporator may include a small chamber in which injection solution of liquid hydrogen peroxide. Low pressure in the evaporator caused by the vacuum in the chamber, causes the evaporation of the hydrogen peroxide solution.

Preferably the evaporator 14 includes heating elements 28, which regulate the temperature in the evaporator to streamline the process of vaporization. Preferably when the evaporator 14 is connected with the diffusion channel 24 on a surface section provided with some form of insulation 30, so that the high temperature of the evaporator 14 without unnecessarily affect the temperature in the diffusion channel 24. The evaporator 14 and the diffusion channel 24 is preferably made of aluminum; thermal insulation 30 may take the form of polyvinyl chloride (PVC) joints connecting these two elements together.

In addition, it is preferable to turn on the heater 32 to the inside of the chamber 12, preferably near the bottom of the camera 12 to re-evaporation of condensed hydrogen peroxide inside the chamber 12.

The camera 12 preferably includes a mechanism (not shown) for formation of the plasma. Such a mechanism may include a source of radio-frequency or low-frequency energy as described is U.S. patent No. 4643867 Jacobs et al. or in published patent application U.S. No. 20020068012 Platt Jr. et al., included here as a reference.

The present invention achieves its favorable effect by enabling a certain amount of hydrogen peroxide, which evaporates from the solution in the evaporator 14, condense in the diffusion channel 24. After evaporation of the greater part of the hydrogen peroxide solution elements temperature regulation 26 raise the temperature of the diffusion channel to allow re-evaporation of condensed hydrogen peroxide. Water has a higher vapor pressure than the hydrogen peroxide, thus, the hydrogen peroxide vapor is condensed lighter than water. Thus, the material that condenses in the diffusion channel, will have a higher concentration of hydrogen peroxide than the initial concentration of hydrogen peroxide solution in the evaporator 14.

Items temperature regulation 26 in a simple form can include simple electroresistive heaters. In this case, low ambient temperature diffusion channel 24 provides a low temperature for condensation of hydrogen peroxide, the temperature regulation 26 later heat diffusion channel 24 for re-vaporization is now more highly concentrated the data of hydrogen peroxide from the diffusion channel 24. Because the vapor pressure of hydrogen peroxide decreases at lower temperatures, the lower the initial temperature in the diffusion channel 24 enables more low pressure in the chamber 24 without further prevent condensation of hydrogen peroxide in the diffusion channel. Lower pressure levels contribute effectively to the system, and thus, the elements of temperature regulation 26 may also include cooling the component to reduce the temperature of the diffusion channel below ambient. Suitable cooling components include thermoelectric coolers or typical mechanical cooling device. In this case, the diffusion channel 24 is first cooled preferably to about 10, and then after some time after the start of vaporization or even after completion of the diffusion channel 24 is heated preferably up to 50 º C or 110 º C.

In the vertical orientation, as shown in figure 2, the diffusion channel 24 could potentially cause condensation evaporating sterilizing agent in the cooler areas between the elements of temperature regulation 26 and then re-evaporation as it passes through the elements of the temperature regulation 26.

The following example illustrates the advantages of the regulation of heat diffusion channel.

PR is measures 1

Efficacy trials were conducted by placing the wrapped material CSR tray (3,5×10×20 inches), consisting of a representative medical devices, and subjects gleams in 20-liter aluminum camera (4,4×12×22 inches). Wire of stainless steel, length 1 inch, inoculated, at least 1×106spores of Bacillus stearothermophilus, was placed in the center of each of the subjects gleams. Effects with temperature diffusion channel and without it investigated and Teflon, poly(tetrafluorethylene) lumen having an inner diameter of 1 mm and a length of 700 mm, and with a gleam of stainless steel having an inner diameter of 1 mm and a length of 500 mm, All gaps were opened on both ends. Each of samples was subjected to a sterilization cycle in a 20-liter vacuum chamber, which is kept at 40 º C and 3 Torah within 5 minutes of 1.44 ml of 59% hydrogen peroxide solution in water was injectively at atmospheric pressure in the evaporator, which is maintained at 60 ° C. Then ran the 5-minute clock and the atmosphere in the chamber was pumped up to 3 Torr, which took less than 1 minute In one case, the diffusion channel 24 had an initial temperature of 30 º C in the first minute, while the atmosphere of the chamber was evacuated to 3 Torr and then heated to 50 º C to release the condensed peroxide from diffusion channel in the camera for OST is through part of the cycle, while the pressure was maintained at 3 Torr. In another case, the temperature in the diffusion channel was maintained at a level of 50 º C during the whole cycle. By maintaining the temperature in the diffusion channel at the level of 50 º C in the diffusion channel peroxide did not resist or contain a small amount. Sterilization efficiency was measured by incubation of samples in the growth medium at 55ºC and controlled growth of the test organism. Table 1 shows the results of these tests.

Table 1
The type of ground clearanceThe internal diameter and length50 º C in the diffusion channel during the whole process30 º C in the diffusion channel for 1 min, then increase to 50 º C
Teflon1×7002/20/3
Stainless steel1×5001/20/3

When the temperature in the diffusion channel is maintained at a high level during the whole process, all the samples tested in Teflon lumen, gave Polo is sustained fashion the results of tests for bacterial growth, pointing to the failure of sterilization, and one of the two samples in the Lumina of stainless steel gave a positive result. In the same conditions, but with the initial lower temperature of the diffusion channel, which began to heat up after 1 min after the start of diffusion, none of the samples did not give a positive test result. Condensation peroxide diffusion in the channel during the initial stage of evaporation, and then re-evaporation of condensed peroxide from diffusion channel in the camera significantly increased efficiency.

Additional efficiency can be achieved by the alternation of cold and warm areas in the diffusion channel 24, as illustrated in figure 2. Items temperature regulation 26, in simplest form, the heating elements are spaced from each other. Preferably also the diffusion channel is vertical in this regard. As the hydrogen peroxide solution is evaporated and passes through the diffusion channel 24, it is believed that it may alternately be condensed and re-vaporize as it passes through the heated and unheated portions of the diffusion channel 24. The diffusion channel can alternate enable alternate heating and cooling elements.

The heater 32 in the chamber 12 de is there similar heat diffusion channel 24. By regulating the temperature of the heater 32 peroxide may first be condensed in the heater 32 and then re-evaporate into the chamber 12 for peroxide concentration.

The preferred cycle would be a modification to the cycle described in U.S. patent No. 6365102 Wu et al., included here as a reference. A series of appendices pre-plasma energy to remove moisture between additions drying chamber 12. Then in the chamber 12 creates a vacuum in the evaporator 14 is injected solution of hydrogen peroxide. Alternatively, the peroxide solution can also inject at atmospheric pressure. A certain amount of the evaporated solution is condensed in a cold diffusion channel 24. Over a period of time sufficient for evaporation from the evaporator 14 most or all of the hydrogen peroxide solution, the diffusion channel 24 is heated by the elements of the temperature regulation 26, and condensed hydrogen peroxide solution re-evaporated. About this time the throttle valve 18 is closed, and the pump 16 is turned off to seal the chamber 12. A large part of the water fraction of the hydrogen peroxide solution was, therefore, removed from the chamber 12 by the vacuum pump 16, and the remaining hydrogen peroxide solution, which is re-evaporated from the diffusion channel 24 or from the heater 12 in the chamber 12, if it is present, it is no higher concentration of hydrogen peroxide, than the original solution. Preferably the regulating device on the basis of a computer (not shown) regulates the functions of the way for ease and repeatability.

Thus obtained pairs of hydrogen peroxide in contact with the product 34 or articles 34 in the chamber 12, and carries out their sterilization. If these products 34 zone, limited to diffusion, such as long narrow openings, it may be preferable then to vent the chamber 12 and to allow sterile air to carry away with a vapor of hydrogen peroxide deeper into the zone, is limited to diffusion. Then the camera 12 is again exposed to vacuum and repeated an additional injection of hydrogen peroxide, preferably with consistent heat diffusion channel. After a period of time sufficient to perform a sterilization products 34, reduced by 6 orders of magnitude content of pathogenic organisms, such as Bacillus stearothermophilus, inside the chamber 12 is generated plasma, increasing by this sterilization and destroying hydrogen peroxide to water and oxygen.

Plasma is generated by the induction voltage between the anode 35 and the cathode, which in this case represents the inner wall 37 of the sterilization chamber 12. The anode 35 is a sheet of perforated metal, set with a gap and the first floor is the ski insulated from the inner wall 37. In the application for U.S. patent No. 20040262146, published December 30, 2004, the full contents of which are incorporated here by reference, described a particularly effective way of generating such a plasma. The plasma density is determined in the space between the anode and cathode.

Plate with a hole 20 can enhance the effect of the concentration of hydrogen peroxide during its vaporization. As described in U.S. patent No. 5851485 Lin et al., included here as a reference, adjustable or slow pumping of the atmosphere from the chamber 12 is initially removes more water than hydrogen peroxide from a solution, because water has a higher vapor pressure, leaving through this high concentration of hydrogen peroxide. Regulation of pumping can be difficult, since vacuum pumps are generally poor reduce the pumping speed, and throttle valves in this service it is difficult to regulate, and they are expensive. Location plate with a hole 20 in the flow channel to the pump 16 is limited to the amount of pumping from the chamber 12 by the pump 16, and by selecting the appropriate size holes 36 in the plate 20 can be adjusted up to speed, which effectively concentrates the hydrogen peroxide in the chamber 12.

The device 10A in figure 3, in most respects similar to the device 10 shown in figures 1 and 2, with the same h is s, marked additionally with the letter "a"also includes a plate with a hole 20A. However, to ensure prompt evacuation of the atmosphere from the chamber 12A while maintaining the benefits of an adjustable suction using a plate with a hole 20A, it includes 2 channel from the pump 16 to the chamber 12A. The first channel 40 includes a throttle valve 42, and the second channel 44 includes a throttle valve 46 and a plate with a hole 20A. Thus, during the initial pumping of the first throttle valve 42 is open, leaving the pump 16A freely connected to the camera 12. When the pressure in the chamber 12A approaches the vapor pressure, the first throttle valve 42 is closed, forcing through this pump 16A to evacuate their atmosphere through the orifice plates 20A and, thus, to pump the atmosphere chamber 12A with a slower, controlled rate, which is more suitable for the preferential removal of water from a solution of hydrogen peroxide and from the chamber 12A.

On figa and 3B shows the device 110, similar to the device shown in figure 1. Here, instead of using two channels, as in the device 10A in figure 3, the valve 112 includes a valve body 114, the valve seat 116 and the valve element 118, such as a throttle disk in the shape of a butterfly, plug or similar item. The hole 120 provided what about through the valve element. Thus, when the valve 112 is open, the evacuation can occur quickly, and when the valve 112 is closed, it may occur more slowly. This valve can also be used between the evaporator 14 and the chamber 12 for additional regulation preferential evaporation and removal of water from a germicidal solution.

Referring to figure 4, although a high concentration of the sterilizing solution helps to achieve the efficiency and quality of sterilization, concern the admission of steam into contact with the underlying sterilization items. Typically, low pressure (0.5 Torr to 10.0 Torr) inside the chamber 12 to facilitate the rapid diffusion of steam sterilizing agent to all areas within it.

Figure 4 illustrates the sterilization device 60 includes a chamber 62 having an evaporator 64, the vacuum pump 66 and coupled with it the exhaust valve 68. Preferably elongated, diffusion channel 70 with adjustable temperature, as previously described, connects the evaporator 64 with the chamber 62. The pump 66 is provided by a throttle valve 72 and a pressure sensor 74.

Sterilizable products 76 are placed in trays or containers 78. When preparing products 76 for sterilization are usually used 2 types of packaging. When one product 76 is placed in a tray having therein a number of holes, and then the tray wrap material, t is Kim as a wrapping material CSR, which skips sterilizing gases and blocks of contaminating microorganisms. A tray is described in U.S. patent No. 6379631 Wu, included here as a reference. Alternative packaging includes a resealable container with a few holes preferably on its upper and lower surface, each hole is covered with a semi-permeable membrane, which is permeable sterilizing gases and blocks the admission of contaminating microorganisms. Such container is described in U.S. patent No. 4704254 included here as a reference. The first type of packaging is often called a "tray"and the second "container". However, when used herein, the term "container" is intended to refer to any container, packaging or cavity suitable for holding articles to be sterilized in the chemical environment of steam.

The pump 66 is connected with the chamber 62 through the outlet 80. Outlet 80 includes one or more shelves 82 for holding and receiving one or more containers 78 and which is hydraulically connected through a throttle valve 72 by pump 66. The hole or preferably many holes 84 on the upper surfaces of the shelves 82 provide the ability to pump 66 to pump the atmosphere inside the chamber 62 through the holes 84 through the outlet 80 and out through the pump 66.

Containers 78 predpochtite the flax have holes 86 on the lower surface 88 and additional holes 90, at least one other surface. When the containers 78 are placed on the shelves, the atmosphere is pumped by pump 66 is removed partially through the holes 90 in the container 78 through the container in contact with the product or products in it and then out through the openings 86 in the nozzle 80 through apertures 84 therein. When pumped so the atmosphere contains a sterilizing gas, it enhances its penetration into the container 78 and the contact with its products 76.

Sterilizing gases pumped, thus, within the previously described cycle, as steam sterilizing solution and immediately before the second injection of hydrogen peroxide. This cycle may also, in addition, to provide pumping after some period of diffusion. After the introduction of steam sterilizing agent pressure in the chamber 62 increases a little due to the presence of additional gas, usually from about 0.5 Torr to about 10 Torr. Higher pressure levels as effective at higher load and temperature in the chamber.

Figure 5 and 6, an alternative construction in which the parts similar to parts in figure 4, indicated by the additional letter “b”) pipe 80 design, shown in figure 4, is replaced by a simple channel 92. The channel 92 is closed by the support 94 to container 78, and op is RA 94 has many through holes 96, so the camera 62b is in liquid communication with the pump 66b through the container 78, the support 94 and the channel 92. Bearing 94 may be removable.

7 and 8 (in which the positions of parts similar to parts of structures figs.4-6, indicated by the additional letter “C”) shows the bearing 100, located on the surface 102 in the chamber C, through which penetrates the channel s. Bearing 100 surrounds the channel s. Thus, a large part or the whole atmosphere, pumped by pump 66, passes through the container 78 in the space 104 formed between the container 78, the support 100 and the surface 102, and then into the pump C through the channel C.

Figure 9 depicts an alternative device, in which, similarly to the device shown in figure 1, a portion of the evaporated germicidal solution may be condensed. And the solvent, usually water, which does not condense as quickly removed from the atmosphere for the further concentration of germicide. Then germicide re-evaporated to obtain a more concentrated germicidal pair for a more effective sterilization. The device includes a sterilization chamber 200 that contains the load 202 of the objects to be sterilized. The source 204 liquid germicidal solution delivers the solution through the valve 206 in the first evaporator/condenser 208, where it is vaporized and then fed into the chamber 200. The valve 210 may be a p is euskotren to isolate the evaporator/condenser 208 from the camera 200. The camera 200 is also provided with release valve 212.

The vacuum pump 214 reduces the pressure in the chamber, as described with reference to the previous embodiments of. Between the pump 214 and the camera 200 has a second evaporator/condenser 2016 for condensing the evaporated solution. Preferably the valves 218 and 220 isolates the second evaporator/condenser 216, respectively, of the pump 214 and the camera 200.

Figure 10 is a simple version of the second evaporator/condenser 216 preferably includes walls 222, bounding the cavity 224 having an inlet 226 connected to the camera 200, and the issue 228 connected to the pump 214. Many of the guides of the partitions 230 provides a tortuous stream channel 232 through the evaporator/condenser 216. The temperature of the walls 222 and potentially guide walls 230 can be adjusted to enhance condensation and re-evaporation of the solution.

A similar structure with the inlet can also be used on the first evaporator/condenser 208. Figure 11 also illustrates a simple version of the first evaporator/condenser 208. It includes the cavity 240 having an inlet 242, connected to a source of a solution of 204 (not shown in figure 11), and the issue 244 connected to the camera 200 (not shown figure 11). Many guides partitions 246 provides a tortuous stream channel through the first choice of the evaporator/condenser 208. The temperature in the cavity 240 and potentially guide walls 246 can be adjusted to enhance condensation and re-evaporation of the solution.

In a simple loop liquid germicidal solution, such as hydrogen peroxide and water is fed to the first evaporator/condenser 208, where it evaporates. And then flows into the chamber 200, which is at low pressure, as described with reference to the previously described herein options for implementation. During vaporization and for some time after the pump 214 continues to pump out the atmosphere from the chamber 200. By regulating the temperature and pressure of this water is evaporated from the solution is preferable to hydrogen peroxide, and water vapor is extracted from the device through the pump 214 to the concentration of hydrogen peroxide solution during the vapor phase. In addition, hydrogen peroxide, having a lower vapor pressure, will tend to condense faster than water vapor, in the first evaporator/condenser 208. Since the pump 214 continues to pump out the atmosphere from the camera 200, the evaporated hydrogen peroxide solution flows from the chamber into the second evaporator/condenser 216, where part of it is condensed. Due to the preferred condensation of hydrogen peroxide than water, more water vapor will pass through the capacitor 216 in second nirvanna condition and will be rolled back through the pump 214, thus, allowing additional concentration of hydrogen peroxide solution. At some point the pump is off, and the valve 218 is closed. Then the condensed hydrogen peroxide inside of the evaporator/condenser 216 is re-evaporated, preferably by heating of the capacitor 216. This hydrogen peroxide will have a higher concentration for a more effective sterilization load 202.

On Fig-15 illustrates the improved condenser/evaporator 250. In General, it includes the intake manifold 252, which is connected to a source of sterilizing solution agent 204 and which provides the initial evaporation, Department of condensation/re-vaporization 254, exhaust pipe 256 and control valve 258 through which the evaporator/condenser 250 connects to the camera 200. The resistive heater 260 is connected with the inlet manifold 252 and the outlet 256 to provide heat to facilitate the initial formation inside the intake manifold 252 and to prevent condensation in the exhaust pipe 256. Preferably the inlet manifold 252 and the outlet 256 is made of aluminum. In addition, the insulator 262 is provided between the inlet manifold 252 and the Department of condensation/re-vaporization 254.

Department of condensa the AI/re-vaporization 254 includes a housing 264, preferably made of aluminum, outdoor with the first side 266 and the second side 268. The first thermoelectric device 270 and the second thermoelectric device 272 is attached respectively to the first side 266 and the second side 268. Thermoelectric devices 270 and 272 are preferably in accordance with electrothermal Peltier effect, although they can be overridden by other classes of thermoelectric devices. With a bit more complexity, you can also use more conventional heat pumps, such as devices based on freon or ammonia.

First whip the node 274, which includes a plate 276 and many pins 278, protruding at right angles from it, attached to the first thermoelectric device 270, and a pin 278 extends laterally into the housing 264. The second pin node 280 is similarly attached to the second thermoelectric device 272, and the rods 278 extend laterally into the housing 264 and turned to the first pin node 274. Whip nodes 274 and 280 are preferably made of aluminum.

Preferably the pins 278 are worn out almost to the opposite platinum 276, not touching her. The pins 278 from pin nodes 274 and 280 are generally in parallel to each other with a gap between them, designed, along with the volume within the Department of the evaporator/on the Torno evaporator 254, to provide a preferred flow rate of the evaporated sterilizing agent through them to ensure efficient condensation on the pins 278. Preferably the flow rate is in the range from 0.1 m/s to 5 ft/s, and preferably provides a flow rate of 0.24 m/s

In a small capacitor with the length of the steam channel 3 inches time would be 1 with the preferred flow rate of 0.24 m/s This time should be sufficient for interaction vaporized sterilizing agent from the surfaces of the cooling condenser for condensing. For a typical volume injection of 2 ml of sterilizing agent to the surface area of the Department of the evaporator/re-evaporator 254 would be about 90 square inches to allow mass transfer for condensation. High temperature at low pressure in the initial evaporator inlet manifold 252) supports water and hydrogen peroxide in the vapor phase for delivery to the Department of condensation/re-vaporization 254. For example, the temperature of the evaporator 70 º C or more at a pressure of 125 Torr or below ensures that 59 wt.% solution of hydrogen peroxide and water in the vapor phase.

When steam enters the Department condensation/re-vaporization 254, which has more Nisku the temperature, the hydrogen peroxide condenses on the cooler surface, forming a concentrated solution. The temperature and pressure therein determine the concentration of the condensed solution. For example, at 50 º C and 13 Torr in the Department of condensation/re-volatilization of 254 concentration of condensed hydrogen peroxide would be 94 wt.%. At 30 º C and 3.8 Torr, the concentration of condensed hydrogen peroxide would also 94 wt.%. Since the pressure in the Department of condensation/re-vaporization 254 is reduced, then the temperature must be reduced to maintain the same concentration of the solution.

Hole 308 provides the advantage of a more concentrated solution of the flow restriction from the Department of condensation/re-vaporization 254 to provide a more controlled vaporization. Pressure changes in the Department of condensation/re-vaporization 254 and the evaporator due to pressure fluctuations in the vacuum pump are damped hole 308 to prevent the transfer by the emission of water vapour droplets of hydrogen peroxide from the Department of condensation/re-vaporization 254. Another advantage of restricting the flow hole 308 represents the achievement of a low pressure (less than 1 Torr) in the sterilization chamber 200 to improve the diffusion coefficient in the gaps, at the same time aderiva higher pressure in the evaporator/condenser 250 for operation at higher temperature level in the Department of condensation/re-vaporization 254. Without holes 308, the pressure in the sterilization chamber 200, and the evaporator/condenser 250 should be jointly reduced to the same low pressure, and the condenser reported to work at a very low temperature to maintain equilibrium solution. Lower condenser temperature are more difficult to manage, and this can cause ice formation or condensation, which requires more expensive design for protecting electrical equipment.

Seal 282 tightly presses the plate 276 in thermoelectric devices 272 to the housing 264. Hole 284 through the housing 264 is aligned with the hole 286 passing through the insulator 262, for accommodating chamber 288, limited housing 264, in liquid communication with the inlet manifold 252. The outlet channel 290 in the housing 264 connects the upper part of the chamber 288 with the second hole 292 through the insulator 262, which, in turn, is aligned with the outlet 256 for chamber 288 in liquid communication with the outlet 256. Safety thermo-switch 294 in the upper part of the housing 264 is connected by wires outside of the regulating device to turn off the heating of the evaporator/condenser 250 at a temperature above a predetermined temperature. Temperature sensors 295 and 297 measure the temperature respectively in the inlet manifold 252 and the Department of condensation/re-PA is obrazovaniya 254. The pressure sensor 296 is docked with the outlet 256. Radiators 298, having a section of hair dryers, attached to each of thermoelectric devices 270 and 272.

Exhaust pipe connected to the valve manifold 300, which provides 3 possible flow channel between the evaporator/condenser 250, exhaust pipe 256 and release valve 302 manifold from the valve manifold 300. Issue 302 valve manifold communicates with the main camera 200. Main channel 304 flow is regulated by valve 306, which can be opened to provide flow through the main channel 304 to release 302 valve manifold or close to lock this thread. The second channel passes through the opening 308 in the plate with the holes 310, which provides the restriction of the flow to enhance the ability of predominantly to remove water vapor from the evaporator/condenser 250. The third potential channel passes through the failing hard drive 312, which is designed to fracture in the event of a catastrophic overpressure inside the chamber 288, for example, in this unlikely phenomenon that oxidize sterilizing agent such as hydrogen peroxide, will ignite it. Hole 308 can be moved to a position inside the valve 306 off, similar to the valve described in reference to valve e is element 118 on figa and 3B.

When the main chamber is first evacuated atmosphere to a low pressure, sufficient for vaporization, such as to 0.4 Torr, and the valve 306 is closed, leaving the evaporator/condenser 250 is in fluid communication with the chamber 200 through hole 208. Intake manifold 252 is heated by the heater 260, and a quantity of a solution of sterilizing agent, such as a 59% solution of hydrogen peroxide/water injected into the intake manifold 252, where it evaporates and diffuses into the housing 264 through holes 286 and 284. Thermoelectric devices 270 and 272 at this time take away energy from the rods 278 and dissipate it through the heatsinks 298, thus enabling the vaporized sterilizing agent to re-condense on the rods 278.

The temperature of the intake manifold 252 can be adjusted for slow evaporation of the sterilizing agent, thus allowing the water to evaporate faster and flow through the evaporator 250 and out through the hole 308 for the concentration of residual sterilizing agent. Department of condensation/re-vaporization 254 effectively concentrates the sterilizing agent in order to accelerate the process. You can use the quick vaporization in the intake manifold, still achieving a high degree of concentration.

the Condensate on the rods 278 tends to have a higher concentration of sterilizing agent. After some time, when the initial loading solution sterilizing agent has evaporated and part of it was condensed on the rods 278, thermoelectric devices 270 and 272 are reversed to supply heat to the rods 278 and re-evaporation of the sterilizing agent. At this time, the heat sink 298 will still contain the heat that was extracted during the previous stage, and this heat can be used in thermoelectric devices 270 and 272 for very efficient heating rods 278 and re-evaporation of the sterilizing agent. This additional efficiency significantly increases the energy of the device and enables a smaller and more compact evaporator/condenser 250 to provide adequate heating and cooling. After sterilizing agent is re-evaporated, the valve 306 is opened to allow effective diffusion of steam sterilizing agent in the main camera 200.

If the second evaporator/condenser 216, then its structure is preferably mimics the structure of the evaporator/condenser 250 without intake manifold 252. In this device, after the initial diffusion in the main camera 200, the terminals within the second condenser 216 would be chilled, and the pump 214 joined to the preferred extraction of water vapor from condenser is located sterilizing agent. After a certain period of time, after condensation of the sterilizing agent, the rods would be heated to re-evaporation of the sterilizing agent, and the pump 214 is turned off. This re-vaporized sterilizing agent would have a slightly higher concentration and then re-diffundiruet would be in the camera 200 for additional strengthening of the sterilization process.

Other design devices. Fig illustrates an alternate implementation, which increases the effectiveness of the conservation and concentration of germicidal solution. In this device, the camera 314 containing the load 316 has a first condenser/evaporator 318 connected to the source 320 germicidal solution, and the second condenser/evaporator 322. The first condenser/evaporator 318 isolated from the source 320 valve 323 and the camera 314 valve 324. He also connected with a suction pump 325 and isolated from it by the valve 326. The second condenser/evaporator 322 is isolated from chamber 314 valve 327 and is connected to a pump 325 and isolated from it by valve 328. Also the exhaust hole 329.

Fig illustrates a similar device 330 using one condenser/evaporator 332 (structure, similar to the condenser/evaporator 250 additional issue), coupled with sterilization to the measure 334, adapted to receive the load 336 instruments to be sterilized. Vacuum pump 338 is connected with the chamber 334 through valve 340 and the condenser/evaporator 332 through valve 342. The three-way valve can replace the valves 340 and 342. Source germicidal solution 344 is connected to the condenser/evaporator 332, and the camera 334 has an outlet 346. During the initial vaporization and condensation of germicide source 344 valve 342 is closed. After the diffusion of steam into the chamber 334 valve 340 may be closed, and the pump 338 is used for pumping vapor from the chamber through the condenser/evaporator 332 in its condensing mode for additional concentration germicide. Then concentrated germicide re-evaporates and diffuses back into the chamber 334.

The second condenser/evaporator 216, shown in figure 9, can be used to maximize the use of germicide when carrying out the sterilization process with two full cycles of vacuum, injection, diffusion and release. Before the release during the first cycle of the pump 214 operates at the cooling of the condenser/evaporator 216 for condensation therein germicide. Valves 220 and 218 are closed during the release process. During subsequent pumping of the condenser/evaporator is maintained refrigerated to prevent unnecessary evaporation and removal is from the device germicide.

The device shown on Fig and 17, provide the possibility of holding more germicide between cycles in dahlblom process. Before the release in the first cycle, germicide is condensed in the condenser/evaporator 332. However, during subsequent pumping it can be isolated from the pump through the valve 342, thus minimizing the tendency of the pump 338 to pump saved germicide from the device during pumping.

In each of the devices of this type stage condensation and concentration of evaporated germicide and then re-evaporation may optionally be repeated for additional concentration germicide.

Fig illustrates the device 350, arranged in an alternative way. In this device 350 condenser/evaporator 352 is connected through valve 354 with the sterilization chamber 356, adapted to receive the boot 358 and with the release of the 360. Vacuum pump 362 is connected to the condenser/evaporator 352 through valve 364, but does not have a separate connection with the chamber 356. Source 366 germicide connects to the condenser/evaporator, 352.

On Fig illustrated device 370 arranged on Fig with condenser/evaporator 372, which is connected through valve 374 with the sterilization chamber 376, adapted for the of Riem download 378 and with the release of 380. Vacuum pump 382 is connected to the condenser/evaporator 372 through valve 384, but does not have a separate connection with the chamber 356. Instead inlet for germicide through the condenser/evaporator 372, inside the chamber 376 presents the source 386 solution germicide. The source can be simple, such as a container containing a quantity of a solution of liquid germicide. Preferably it is coated with a semipermeable membrane or filter, so that the liquid germicide can not accidentally sprayed from it, but at the same time as germicide evaporated under low pressure in the chamber, the vapors generated thus can pass through the membrane into the chamber. In both devices the condenser/evaporator 352 or 372 concentrates germicide through the condensation and re-evaporation of germicide, as described above.

Fig illustrates another variant implementation inlet of the condenser/evaporator 400. He is in many respects similar to the condenser/evaporator, shown in Fig. However, as shown primarily on Fig and 22, it illustrates the valve 402 regulating hole. Valve module 404 contains the exhaust valve 406, collapsing the disk 408 and the valve 404, which regulates the hole.

On Fig shows a stand-alone valve module 404 and 3 collector channel, which connect the clap is hydrated block 404 with the rest of the condenser/evaporator 400: manifold channel 410 reset high pressure, which leads to the bursting disk, the smaller the upper manifold channel 412, which leads to the exhaust control valve 406, and a lower side of the collector channel 414, which leads to the hole 416 and the valve 402 governing the hole.

Fig best illustrates the valve 402 regulating hole. The valve seat 418 on the valve block 404 surrounds the hole 416. The valve element 420 on the valve 402 governing the hole can pass toward the valve seat 418 for tight stops him and blocking fluid communication through the opening 416. Cleansing the pin 422 penetrates through the hole 416, when the valve 402 regulating hole is closed, to clean out the hole 416 and maintain it in the condition, free from foreign material. The annular guide 424 connected to the valve element 420, slides inside the channel 426 inside the valve block 404 for correct alignment cleansing pin 422 hole 416. This view also illustrates the valve seat 428 for the exhaust control valve 406 and the outlet channel 430 manifold, which leads to the sterilization chamber (not shown Fig-22).

The operation of the sterilization cycle is almost the same as described above with respect to the device shown in Fig-15. However, after the initial evaporation of the sterilizing agent in muscloskeletal 252 (see Fig), the valve 402 regulating hole is closed, thereby isolating the condenser/evaporator 400 from the sterilization chamber (not shown in Fig-22). This condition can often be controlled by monitoring the pressure inside the condenser/evaporator 400, and assuming that when we reached a certain pressure, then evaporate essentially all of the sterilizing agent. Then the pressure in the sterilization chamber is reduced, preferably approximately 0.5 Torr. The exhaust control valve 406 is then opened and the pins 278 (see Fig) are heated to evaporate the condensed sterilizing agent and pass it through the exhaust control valve 406 and the outlet channel 430 to the sterilization chamber.

By reducing the pressure in the sterilization chamber before the introduction of the main mass of the sterilizing agent, it was found that it is possible to reduce the total duration of the cycle. The closing of the valve 402 regulating hole, and reducing the pressure in the sterilization chamber may require additional time. However, a lower pressure provides more favorable conditions for the diffusion of sterilizing agent in areas with limited diffusion, such as gaps to be sterilized instruments. It was found that the time saved through increased efficiency of diffusion, m is likely to more than cover the loss of time to reduce the pressure in the sterilization chamber. The speed of the sterilization cycle is an important factor for users of the sterilizer.

Water vapor in the sterilization chamber can affect the time required to reduce the pressure therein. This water vapor typically occurs downloaded from instruments that were not properly dried. If removal of water vapor requires additional time, it may be indicated to the user in order to remind him of the need to be more vigilant when drying load for future cycles. There may be downloading water vapor, which may require too much time for its removal or effective removal. In this case, the cycle should be abolished, and the user is informed about the reason of this.

Table 2 shows the control points for the three different cycles - instant or very fast, cycle, not including the processing gaps, short cycle, which includes only the processing gaps, which represent a minor problem, and long cycle for sterilization devices with more problematic and narrow Lumina. During the initial evacuation to remove air from the sterilization chamber and the evaporator/condenser 400, the exhaust control valve 406 remains open. When the pressure reaches P1, the discharge adjusting the second valve 406 is closed, but valve 402 regulating the aperture remains open; it begins the evaporation and concentration of the sterilizing agent. After reaching the pressure P2 inside the evaporator/condenser 400 is controlled by the pressure PC within the chamber. If it is higher than the value given in table 2, the valve 402 regulating hole is closed, the pumping continues until, until it reaches the PC, and then the exhaust control valve 406 is opened to move the sterilizing agent in the sterilization chamber. Otherwise, the exhaust control valve 406 immediately opens. If the pressure in the chamber exceeds the level "RS-cancel" at a time when the pressure in the evaporator/condenser reaches the level of P2, it is assumed that the sterilization chamber contains too much water, and the cycle is canceled.

Table 2
Examples of set points of temperature and pressure
InstantShortLong
Load statusSurface1 mm ×150 mm, SS
1 mm ×350 mm plastic
1 mm ×500 mm, SS
1 mm ×500 mm plastic
The evaporator temperature70 º C70 º C70 º C
The temperature of the condenser58º52º43º
P1
The pressure of the evaporator/condenser to remove air
140 Torr140 Torr140 Torr
P2
The pressure of the evaporator/condenser for the concentration of sterilizing agent
22 Torr16 Torr10 Torr
RS
The pressure in the chamber to select move, additional vacuum or cancel
of 1.5 Torrof 0.6 Torrof 0.3 Torr
RS-cancel
The pressure in the chamber to cancel cycle
8 Torr6 Torr4 Torr
The temperature in the condenser to move concentrated sterilizing agent68º68º68º

The concentration of the Ara in the way can also be measured in mg/L. Preferably it ranges from 6 mg/l to 25 mg/l or even higher, with the most preferred value of from about 20 mg/l to 25 mg/L.

At these concentrations, part of the injected hydrogen peroxide will condense on the to-be-sterilized objects. Subsequent pumping of the atmosphere from the chamber causes the re-evaporation of this condensed hydrogen peroxide, thereby further increasing the hydrogen peroxide concentration in wt.%. On Fig presents the block diagram for the calculation of the concentration of condensed hydrogen peroxide, based on the following equations 1-10.

(1) p=a+bw+cw2+dw3(where p is the density and w wt.% H2About2)

(2) a=Ja+Kat+Lat2+Mat3

(3) b=Jb+Kbt+Lbt2+Mbt3(where t is the solution temperature in ° C)

(4) c=Jc+Kct+Lct2+Mct3

(5) d=Jd+Kdt+Ldt2+Mdt3

The coefficients for the equations 1-5 are shown in table 3.

(where phorepresents the vapor pressure of H2About2in Torr and T is the temperature in degrees Kelvin)

(where pwo- vapor pressure N2About2in Torr and T is the temperature in degrees Kelvin)./p>

(where P is the total vapor pressure in Torr

Xwthe water concentration in wt.%

rwthe activity coefficient of water

rhthe activity coefficient of hydrogen peroxide)

(where R is the universal gas constant [62,36 Torr·l/mol·K]

In0=-752+0,97t=-1017+0,97T (where t is the temperature in degrees Celsius and T is the temperature in K)

In1=85

In2=13)

In addition to the effectiveness of such devices for disposal of infectious microorganisms, they are also effective for the inactivation of prions. Conducted experiments comparing known methodology with highly concentrated vapor of hydrogen peroxide according to the present description.

Preparation of steel wire

Soft wire of stainless steel (1.4301; diameter 0.25 mm; Forestandent, Pforzhein, Germany) were placed in the sterilizer Sterrad 100S GMP, plasma sterilizer gaseous hydrogen peroxide. Then the steel wire aseptically cut into fragments of length 30 mm

Wire was contaminated by immersion in freshly prepared 10% homogenates of brain tissue from hamsters with spongiform encephalopathy in phosphate buffered saline (PBS) for 16 h at room temperature; is infected with a wire then was dried in air for at least 1 hour re the further processing.

Purification was performed in the made for testing the order of the washing machines, closed devices of the two containers. The lower container served as an open tank, the working volume of 10 l was pumped into the upper container, and then he was free to drain back into the lower container through the opening at the bottom of the upper container. Round tripod with wire, fixed on the edge, was placed inside the top of the container and the lid tightly closed top container during the washing process.

After each treatment the wire once were washed 1 x PBS followed by washing 3 times with double-distilled water.

Implantation wire

Processed wire is then implanted into thalamus hamsters using stereotaxic apparatus for small animals (coordinates: bregma, -2,0 mm; mediolaterally, 2.0 mm and dorsoventrally, 6.0 mm). The same position was chosen for intracerebral injection of brain homogenates affected spongiform encephalitis in the brain of hamsters syringe and for controls.

Animals were a deeply anestesiologi 10% ketamine (SANOfi-CEVA GmbH, Dusseldorf, Germany) during operation.

Observation of animals

Hamsters implanted with wires contained 3-4 per cage in biological safety level 3 with free access to standard diet and water. Ispy is been created animals initially observed twice a week and daily 60 days after implantation. Hamsters with certain characteristics spongiform encephalitis was identified as terminally ill and were subjected to euthanasia.

Sravnivayete pattern

Samples wires with prions were treated in the following ways to evaluate their effectiveness in the inactivation of prions on the wires.

12 animals were used for each treatment and 5 animals were used as control.

1. The cleaning solution Neodisher V 4009/1; 1%; 55ºC for 10 min (control).

2. Neodisher V 4009/1; 1%; 55ºC for 10 min and the impact of cleaning solution STERRAD NX - Advanced Cycle (advanced series) (38 min).

3. Neodisher V 4009/1; 1%; 55ºC for 10 min and cleaning solution STERRAD 100 S - Long Cycle (long cycle).

4. The cleaning solution Alka One; 1%, 55ºC for 10 min (control).

5. Alka One; 1%, 55ºC for 10 min and the impact of STERRAD NX - enhanced cycle (38 min).

6. Alka One; 1%, 55ºC for 10 min and the impact of the STERRAD 100 S - long cycle.

7. Effect only STERRAD NX - enhanced cycle (38 min); without washing.

8. Effect only STERRAD NX - dual enhanced loop (38 min); without washing.

9. Effect only STERRAD 100 S - long cycle; without washing.

10. Effect only STERRAD 100 S - double long cycle; without washing.

Neodisher V 4009/1 is an alkaline cleaning solution supplied is a company Chemische Fabrik Dr. Weigert GmbH & Co, Hamburg, Germany. Alka One is an alkaline cleaning solution supplied by the company Borer Chemie AG, Zuchwil, Switzerland. STERRAD 100 S supplied by the Department of advanced sterilization products Ethicon, Inc. (ASP), Irvine, CA. Its long cycle includes a 15-minute pre-exposure plasma power density of about 9,5 mW/cm3and two half-cycles 100S, and his double long cycle includes 2 long cycle. Each half cycle 100S includes 6-minute injection 59% peroxide, a 10-minute diffusion and 2-minute exposure to plasma power density of about 9,5 mW/cm3. The temperature in the chamber is maintained approximately 45 º C during the whole process.

STERRAD NX also comes ASP. It improved cycle includes 2 politicla NX, and its dual enhanced loop includes 2 advanced cycle. Each politicl NX includes a process of concentration, which focuses injected 59% peroxide to about 90%, the 7-minute stage of the transportation of the concentrated peroxide in a sterilizer, a 30-second diffusion, and 4-minute exposure to plasma power density of about 50 mW/cm3. The temperature in the chamber is maintained approximately 50 º C during the whole process. Due to higher temperature in the chamber, a higher concentration of liquid peroxide, higher power density plasmas and more prolonged exposure to the plasma, to load in the sterilizer STERRAD NX really affects more effective and energy sterilization environment than sterilization STERRAD 100 s the Results of these tests are shown in table 4, which shows the lifetime, in days, hamsters (in accordance with the received data) after the introduction of processed wires. Numbers shown in bold indicate dead animals as a result of conflict with other animals.

The results showed that treatment with vapor hydrogen peroxide of high concentration STERRAD NX is effective for the inactivation of prions, as processing of the alkaline cleaning solution.

The invention has been described with reference to preferred options for implementation. Obviously, after reading and understanding the preceding detailed description of the other experts can make modifications and changes. It is assumed that the invention should be considered as including all such modifications and changes as they fall under the scope of the attached claims of the invention or its equivalents.

1. The way the inactivation of prions without the use of alkaline cleaning solutions, which includes stages:
premises products, having on it some amount of prions in sterilization the second camera;
reducing the pressure in the sterilization chamber to a pressure below the vapor pressure of hydrogen peroxide;
intake of a solution comprising hydrogen peroxide, in the evaporator and form a pair of hydrogen peroxide;
increasing the concentration of hydrogen peroxide before providing contact prion;
ensure contact of the product with steam of hydrogen peroxide;
condensation of part of a pair of hydrogen peroxide on the product, and the concentration of this condensed hydrogen peroxide is at least 80 wt.%, of hydrogen peroxide; and
the inactivation of prions in the chamber by contact between prions and vapor of hydrogen peroxide.

2. The method according to claim 1, where the hydrogen peroxide also provides sterilization of the product.

3. The method according to claim 1, wherein a increased concentration of hydrogen peroxide is carried out by selective removal of water from the solution and pumping out the water from the sterilization chamber.

4. The method according to claim 1, in which the stage of reducing the pressure in the sterilization chamber and the inlet of the solution in the sterilization chamber includes a cycle, and in which the cycle repeats.

5. The method according to claim 4, in which the cycle is repeated more than once.

6. The method according to claim 1, wherein during stage contact of the product with steam of hydrogen peroxide vapor has a concentration of 10 mg/l or more.

7. The method according to claim 6, in which at the time of the study the contact of the product with steam of hydrogen peroxide vapor has a concentration of 15 mg/l or more.

8. The method according to claim 7, where, during the stage of contact of the product with steam of hydrogen peroxide vapor has a concentration of 20 mg/l or more.

9. The method of claim 8, where, during the stage of contact of the product with steam of hydrogen peroxide vapor has a concentration of 25 mg/l or more.

10. The method according to claim 1, wherein the concentration of this condensed hydrogen peroxide is at least 85 wt.% peroxide of hydrogen.

11. The method according to claim 10, in which the concentration of this condensed hydrogen peroxide is at least 90 wt.% peroxide of hydrogen.

12. The method according to claim 11, in which the concentration of this condensed hydrogen peroxide is at least 95 wt.% peroxide of hydrogen.

13. The method according to claim 1, further comprising an evaporation of at least part of this condensed hydrogen peroxide pumping sterilization chamber to a lower pressure.



 

Same patents:

FIELD: medicine.

SUBSTANCE: product containing a liquid aqueous preparation containing a prostaglandin derivative having at least one fluorine atom in a molecule, or a salt of the prostaglandin derivative at least one fluorine atom in a molecule, and the liquid aqueous preparation is kept in a polymer container sterilised by gas ethylene oxide. A method for preparing a product containing prostaglandin with inhibited reduction of the prostaglandin concentration.

EFFECT: reduction of the prostaglandin concentration is effectively inhibited in the product.

10 cl, 1 tbl, 7 ex

Sterilising system // 2392970

FIELD: medicine.

SUBSTANCE: invention refers to sterilisation of various products. A sterilising system comprises a sterilisation chamber, connected with vacuum pump and evaporator with the evaporator accommodating a body, first path of a body to chamber outlet, second path of the body to chamber outlet and sterilisation controller. The first path of a body to chamber outlet is limited by a diffusion restraint and contains a first valve, and the second path of a body to chamber outlet contains a second valve used to connect the body to the sterilisation chamber for fluid motion without a diffusion barrier. The controller is programmed to perform the following process stages: connection of the evaporator and the sterilisation chamber via fluid through the diffusion restraint only, evaporation of a sterilising solution in the evaporator, closure of the first valve and decompression in the sterilisation chamber when evaporation is essentially completed.

EFFECT: invention allows reducing time for sterilisation cycle.

3 cl, 22 dwg, 2 tbl, 1 ex

FIELD: medicine.

SUBSTANCE: invention refers to medical equipment, namely to a syringe, particularly to a syringe designed as pre-filled and thereafter steam-sterilised in an autoclave, and also to a kit containing a package and said syringe in presented package. The syringe comprises a body, a rod, an internal chamber and carrier. The body has a cylindrical lateral wall and an open upper downstream end with an internal ring collar nearby, and lower downstream end closed with a transverse apertured wall. The rod forms a plunger arranged on the same end with a piston that forms a seal and has at least two sealing rings that fix the borders of at least one annular chamber. The rod is introduced inside of the body while travelling there along. The internal chamber is designed to be filled at least partially. The borders of the chamber borders are limited by the piston and a crosswall of the body. Carrier is formed in the body of the syringe and ensures communication of the annular chamber, or the piston chambers with area outside of the body, or with the internal chamber of the body as the piston is inside of the body and adjoins the ring collar. The kit comprises actually microorganism-impermeable at least partially steam permeable package and said syringe. And said syringe is enclosed in said package, and its internal chamber is filled with contents at least partially.

EFFECT: invention allows for damp heat sterilisation of areas between rings of the syringe piston and as a result considerably reduces amount of heat required for sterilisation.

8 cl, 7 dwg

FIELD: medicine, surgery.

SUBSTANCE: invention can be applied to septic wounds, cavities, and fistulas sanitation. The means comprise aqueous antiseptic solution, including 2.7-3.3% hydrogen peroxide, 0.9-10.0% sodium chloride, and carbon dioxide giving positive pressure 0.2 atm at +8°C.

EFFECT: invention provides safe and effective sanitation conditions, facilitates biological masses elimination, renders expressed geyser-like, dehydrating and antiseptic action.

1 ex

FIELD: technological processes.

SUBSTANCE: device is intended for sterilisation of packages with gaseous sterilising agent during whole process of sterilisation. At that mentioned device contains heating zone, sterilisation zone and zone of ventilation. At that device additionally contains detector of environment temperature for determination of environment temperature outside the device. Device also contains meter of concentration for measurement of sterilising agent concentration in the zone of sterilisation. Besides, device contains the first control unit for regulation of sterilising agent amount, which is supplied to zone of sterilisation. At that control unit supplies sterilising agent on the basis of measurements, which are obtained from the environment temperature detector and from concentration meter. Declared invention is also related to the method of packages sterilisation.

EFFECT: group of inventions provides more reliable method of sterilisation; improved control of gas flows in different zones and between them and improved control of packages heating.

54 cl, 2 dwg

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EFFECT: increased efficiency by avoiding loading of apparatus channels.

3 cl, 2 dwg

FIELD: medical engineering.

SUBSTANCE: device has casing 1, door 2, power frame 11 of the door, locking bracket 3 and mechanism for blocking the locking bracket 5 doors mounted on opposite axles of forcing frame axles rotatable about vertical chamber axis, and mechanism for locking and fixing the door 4 mounted on in the central locking bracket part. Destructor set is mounted on casing back wall and inlet and outlet nipples. The mechanism for blocking and locking door 4 is designed as three-cam handle fastened in case-shaped bushing conjugated with lead screw. Hemispheric lead screw end is placed into matching hemispheric recess of door-fastening member. The mechanism 5 for blocking locking bracket 3 is designed as rotating threaded upright mounted on forcing frame axle.

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5 cl, 7 dwg

FIELD: sterilization and transportation of small-size light-weight objects such as bottle plugs, possibly in food making, biotechnology, pharmaceutical industry branch.

SUBSTANCE: method for sterilizing small-size objects by means of ozone-air mixture for further neutralizing ozone by its natural dissociation in air in the same closed gas circuits having unit for cleaning and drying air, compressor, ozone-air mixture generator and sterilizing chamber. Objects are transported from sterilization chamber along other closed gas circuit that also includes discharging cyclone and sterilized-air compressor. Continuous process is realized due to using two or more sterilizing chambers taking part in operation of said gas circuits in automatic mode according to cyclic diagram of process parameters.

EFFECT: possibility for performing continuous process of sterilizing and transporting objects with use of ozone and compressed air in extensive rational technological cycle while eliminating influence of ozone upon air on working zone.

4 cl, 3 dwg

FIELD: disinfection and sterilization of medical designation objects such as complex-shape tools for surgery, stomatology, tubular members and articles such as endoscopes, laparoscopes, catheters and so on objects including thermolabile articles.

SUBSTANCE: apparatus for disinfecting and sterilizing includes chamber whose inner surface reflects UV -irradiation; pulse UV-lamps arranged inside chamber in quartz tubes by rows (at least two lamps in each row); latticed trays for treated objects; electric power source connected through high-voltage conductors with pulse UV-lamps; automatic control unit made with possibility for setting repetition frequency of high-voltage pulses of power source; device for spraying antiseptic matter. Said device is communicated through pipelines with antiseptic matter sprayers mounted on inner surface of chamber in such a way that aerosol provided by them in chamber may perform vortex motions. Sterilized ozonated air created by cooling of pulse lamps is fed inside working chamber. Biologically active aerosol-gas mixture generated at sterilization process is pumped through inner cavities of treated object.

EFFECT: shortened time period for sterilizing and disinfecting, possibility for treating complex-shape objects with deep cavities and tubular objects.

4 cl, 1 dwg

FIELD: medicine.

SUBSTANCE: method involves taking things under disinfection into chamber, sealing the chamber, filling it with ozone and making ozone-air mixture circulate. The chamber is degassed after having finished disinfection and the things are unloaded. The chamber is filled and things are kept in the chamber with normal climatic environment factors being supported in the chamber. When filling the chamber with ozone, air rarefaction is created in the chamber and supported until ozone concentration in the chamber reaches 2g/m3. Then, ozone-air mixture circulation is supported and the things under disinfection are hold under ozone action within 2-6 h when the chamber is loaded with 40 to 120 kg per 10 m3, respectively.

EFFECT: enhanced effectiveness of disinfection.

27 cl, 9 dwg, 2 tbl

FIELD: medicine.

SUBSTANCE: formulation for producing an antiseptic contains, wt %: manganese chloride - 0.7 % to 1.0 %; potassium iodate - 34.8 % to 42.4 %; potassium chloride - 44.8 % to 54.9 %; sodium dihydrophosphate - 5.6 % to 15.7 %. In the second version of the declared invention, the formulation for preparing the antiseptic contains, wt %: manganese chloride - 0.7 % to 0.9 %; ammonium persulphate - 32.7 % to 39.9 %; potassium chloride - 47.1 % to 57.5 %; sodium dihydrophosphate - 5.0 % to 15.1 %; silver nitrate - 0.4 % to 0.6 %. For preparing a reception of a potassium permanganate solution of the required concentration, said compositions are filled in with a required amount of water. Said compositions can be packed either in sachets in the form mixed powders, or in solid gelatinous capsules to be open before use with the contents poured out in warm water.

EFFECT: extended range of antiseptics combined with higher use reliability and safety.

14 cl, 2 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to biotechnology and represents a disinfectant preparation for neutralising spores and vegetative cells Bacillus anthracis, representing an aqueous solution containing mixed bacteriophages Bacillus anthracis OZR-1, Bacillus anthracis F-2, Bacillus anthracis "ФАУТ" in activity relation (PFU/cm3) of Bacillus anthracis OZR-1: Bacillus anthracis F-2: Bacillus anthracis "ФАУТ" = 1: (0.2-1): (0.1-1). and a spore germination activator L-alanine.

EFFECT: invention provides prolonged disinfecting action while being safe.

2 cl, 5 ex

FIELD: medicine.

SUBSTANCE: invention refers to an antimicrobial agent. The antimicrobial agent. A method for prevention or inhibition of growth and/or proliferation of gram-positive bacteria and/or gram-negative bacteria. A substratum which contacts with microorganisms and/or which preferentially shall be free from microorganism accumulation and/or adhesion. Application of the antimicrobial agent. An integrated kit for application in processing a surface of the device with the antimicrobial agent. A method for making the antimicrobial device.

EFFECT: agent exhibits an effective antimicrobial action and can be applied for coating the surfaces and substrata of various devices, such as medical devices and food treatment devices for prevention or accumulation and/or inhibition of growth and/or proliferation and/or viability of microorganisms and/or skinning effect.

13 cl, 20 ex

FIELD: medicine.

SUBSTANCE: invention refers to disinfectants. A tissue used with disinfectant solutions has synthetic fibres and disinfectant release impregnation which make the tissue resistant to an active disinfectant. Particularly, the tissue is resistant when used in disinfectant quaternary ammonium solutions and in disinfectant bleaching solutions. Also, a method of manufacturing such tissue is disclosed.

EFFECT: invention allows making tissue compatible with disinfectant solutions, and especially disinfectant bleaching solutions.

19 cl, 5 tbl, 11 dwg, 7 ex

FIELD: medicine; pharmaceutics.

SUBSTANCE: invention concerns a two-fluid foam for local application on a skin, including from 10 to 98% wt. of a non-polar fluid distinct from fuel, and from 2 to 88% wt of a continuous phase of the polar fluid including C1-C4 alcohol, liquid polyethylene alcohol, ethylene alcohol or propylene glycol, or their admixtures, in quantity of at least 65% wt concerning mass of a continuous phase where the two-fluid foam is stabilised by surface-active substance in quantity from 0.05% to 2% wt in reliance on all composition which is chosen from adducts castor oil/poly (alkylene glycol), containing from 20 to 50 alkoxy groups, C8-C24 fatty acid or adducts the hydrogenated castor oil/poly (alkylene glycol), containing from 20 to 60 alkoxy groups, or from their admixtures. The stable dispersion having content of C1-C4 of alcohol, liquid polyethyleneglycol, ethyleneglycol or glycol propylene, at least 65% wt, and including from 1 to 80% wt of a two-fluid foam and from 99 to 20% wt of water gel.

EFFECT: received compositions include high content of alcohol for medical and cosmetic use.

19 cl, 28 ex

FIELD: medicine, virology, pharmacy.

SUBSTANCE: invention relates to using derivatives of dithiocarbamate of the formula: R1R2NCS2H and oxidized forms of these compounds, in particular, their dimmers and their pharmaceutically compatible salts for preparing an agent used in treatment or prophylaxis of infection caused by RNA-containing viruses that damage respiratory tract and inducing disease. Also, invention relates to a disinfecting agent containing dithiocarbamate compound and a method for disinfection of surfaces, media and cell cultures.

EFFECT: valuable medicinal properties of compounds.

19 cl, 14 dwg, 14 ex

FIELD: medicine, virology, pharmacy.

SUBSTANCE: invention relates to using derivatives of dithiocarbamate of the formula: R1R2NCS2H and oxidized forms of these compounds, in particular, their dimmers and their pharmaceutically compatible salts for preparing an agent used in treatment or prophylaxis of infection caused by RNA-containing viruses that damage respiratory tract and inducing disease. Also, invention relates to a disinfecting agent containing dithiocarbamate compound and a method for disinfection of surfaces, media and cell cultures.

EFFECT: valuable medicinal properties of compounds.

19 cl, 14 dwg, 14 ex

FIELD: medicine; pharmaceutics.

SUBSTANCE: invention concerns a two-fluid foam for local application on a skin, including from 10 to 98% wt. of a non-polar fluid distinct from fuel, and from 2 to 88% wt of a continuous phase of the polar fluid including C1-C4 alcohol, liquid polyethylene alcohol, ethylene alcohol or propylene glycol, or their admixtures, in quantity of at least 65% wt concerning mass of a continuous phase where the two-fluid foam is stabilised by surface-active substance in quantity from 0.05% to 2% wt in reliance on all composition which is chosen from adducts castor oil/poly (alkylene glycol), containing from 20 to 50 alkoxy groups, C8-C24 fatty acid or adducts the hydrogenated castor oil/poly (alkylene glycol), containing from 20 to 60 alkoxy groups, or from their admixtures. The stable dispersion having content of C1-C4 of alcohol, liquid polyethyleneglycol, ethyleneglycol or glycol propylene, at least 65% wt, and including from 1 to 80% wt of a two-fluid foam and from 99 to 20% wt of water gel.

EFFECT: received compositions include high content of alcohol for medical and cosmetic use.

19 cl, 28 ex

FIELD: medicine.

SUBSTANCE: invention refers to disinfectants. A tissue used with disinfectant solutions has synthetic fibres and disinfectant release impregnation which make the tissue resistant to an active disinfectant. Particularly, the tissue is resistant when used in disinfectant quaternary ammonium solutions and in disinfectant bleaching solutions. Also, a method of manufacturing such tissue is disclosed.

EFFECT: invention allows making tissue compatible with disinfectant solutions, and especially disinfectant bleaching solutions.

19 cl, 5 tbl, 11 dwg, 7 ex

FIELD: medicine.

SUBSTANCE: invention refers to an antimicrobial agent. The antimicrobial agent. A method for prevention or inhibition of growth and/or proliferation of gram-positive bacteria and/or gram-negative bacteria. A substratum which contacts with microorganisms and/or which preferentially shall be free from microorganism accumulation and/or adhesion. Application of the antimicrobial agent. An integrated kit for application in processing a surface of the device with the antimicrobial agent. A method for making the antimicrobial device.

EFFECT: agent exhibits an effective antimicrobial action and can be applied for coating the surfaces and substrata of various devices, such as medical devices and food treatment devices for prevention or accumulation and/or inhibition of growth and/or proliferation and/or viability of microorganisms and/or skinning effect.

13 cl, 20 ex

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to biotechnology and represents a disinfectant preparation for neutralising spores and vegetative cells Bacillus anthracis, representing an aqueous solution containing mixed bacteriophages Bacillus anthracis OZR-1, Bacillus anthracis F-2, Bacillus anthracis "ФАУТ" in activity relation (PFU/cm3) of Bacillus anthracis OZR-1: Bacillus anthracis F-2: Bacillus anthracis "ФАУТ" = 1: (0.2-1): (0.1-1). and a spore germination activator L-alanine.

EFFECT: invention provides prolonged disinfecting action while being safe.

2 cl, 5 ex

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