JP4660084B2 - Decontamination method and continuous aseptic apparatus - Google Patents

Description

  The present invention relates to a method for decontaminating an object to be decontaminated in the sealed chamber by introducing a decontamination gas into the sealed chamber, and an apparatus for decontamination.

  As a method of decontaminating a decontamination object in a sealed chamber, hydrogen peroxide gas as a decontamination gas is generated by a gas generator, and this hydrogen peroxide gas is introduced into the sealed chamber to be decontaminated. There is known a method of bringing it into contact (see, for example, Patent Document 1).

  On the other hand, various materials necessary for manufacturing pharmaceuticals and medical devices (for example, empty syringe outer cylinders used for manufacturing prefilled syringes) are packaged with packaging materials while maintaining aseptic conditions ( A configuration for distribution has been proposed.

  In such a configuration, when the material is traded in the state of being wrapped in the packaging material and the material is actually used at the manufacturing site, the outer surface of the packaging material is decontaminated and placed in the aseptic room, and the packaging is performed in the aseptic room. The material is removed, and the internal material is taken out and maintained in a sterile state.

Japanese Patent Publication No.61-4543

  However, when the decontamination method in which the above-described hydrogen peroxide gas is brought into contact with an object to be decontaminated is applied to the case where the outer surface of the packaging material is decontaminated, the hydrogen peroxide gas permeates the packaging material, and finally the internal It may reach the material. If the hydrogen peroxide gas comes into contact with the material in this way, the material may be altered or corroded, so the method of decontamination by bringing the hydrogen peroxide gas into contact with the outer surface of the packaging material is actually It was not done on.

  Then, an object of this invention is to provide the decontamination method which can fully decontaminate the outer surface of a packaging material, and the apparatus which can implement | achieve it, without affecting the material to be included.

  In the present invention, a decontamination object formed by packaging a decontaminated material with a packaging material while maintaining aseptic conditions is placed in a decontamination sealed chamber in which the room and the outside are hermetically shut off, and is removed. An aqueous solution in which the dyeing gas is dissolved is evaporated to generate a decontamination gas, the decontamination gas is introduced into the decontamination sealed chamber, and the introduced decontamination gas is condensed in the decontamination sealed chamber. The decontamination chamber and the outer surface of the decontamination object are decontaminated by forming a condensate layer in a thin film on the inner wall of the decontamination chamber and the outer surface of the decontamination object packaging material. It is the decontamination method characterized.

  As described above, when the decontamination gas as a gas is not brought into contact with the outer surface of the packaging material and the liquid condensate is brought into contact with the decontamination, the packaging material has a low permeability with respect to the liquid. In contrast, the decontamination component is less likely to penetrate into the packaging material as compared with the conventional configuration in which the gas is contacted. Therefore, according to the present invention, the internal material is not altered by the decontamination component. Further, in the decontamination method for forming the condensate layer, the decontamination level of the decontamination target can be properly grasped by managing the amount of decontamination gas condensed. The above decontamination includes chemical T-phase decontamination, sterilization, sterilization, sterilization, and the like.

  Also, a decontamination method for generating a decontamination gas by evaporating an aqueous solution in which a decontamination gas having a boiling point higher than water is dissolved, wherein a condensate layer once formed on the outer surface of the packaging material of the decontamination object After evaporating part or all after a predetermined time has elapsed, and after performing the evaporation process, the decontamination gas is condensed again in the decontamination sealed chamber, and a condensate layer is formed on the outer surface of the packaging material of the decontamination object. A configuration is proposed in which a decontamination step including a recondensing step for re-formation is repeatedly performed a predetermined number of times to decontaminate the outer surface of the packaging material of the decontamination target.

  In the present invention, the evaporation step performed after the elapse of a predetermined time from the formation of the condensate layer, the decontamination gas generated by gasification of the condensate layer permeates the packaging material and reaches the internal material. Run before. Accordingly, the predetermined time is set to be shorter than the time during which the gas penetrates the packaging material and reaches the internal material. By adopting such a configuration, penetration can be prevented, and alteration of materials can be avoided more reliably. Moreover, it has been known that in such a configuration, the higher the concentration of the solute (decontamination component) in the formed condensate layer, the higher the decontamination effect. Here, since the decontamination gas used in the present invention has a boiling point higher than that of water, in the initial stage of the condensation process, a high solute concentration (the weight, volume and number of moles of dissolved decontamination gas with respect to the total amount of aqueous solution). Fraction) condensate layer is formed, after which the solute concentration begins to decline. Under such circumstances, as described above, it is possible to prevent a decrease in the solute concentration by executing the evaporation step of evaporating the once formed condensate layer. This is because when the condensate layer is evaporated, the water contained in the condensate layer is vaporized first, whereas the decontamination gas condensate remains in the condensate layer, and the condensate layer as a whole This is due to the higher solute concentration. Here, once the condensate layer once formed is evaporated, the decrease in concentration can be completely cut off. If only a part of the condensate layer is evaporated, a part of the high concentration condensate layer can remain. . Furthermore, the present invention is characterized in that a recondensing step for re-forming the condensate layer is performed. By performing such a process, the decontamination gas is condensed again, so that a high-concentration condensate layer having a high decontamination effect can be formed again. Therefore, by repeatedly performing the decontamination process consisting of the evaporation process and the recondensation process in this way, the material is not altered by the decontamination gas, and the solute concentration in the condensed liquid layer is prevented from decreasing. Thus, a condensate layer having a high solute concentration can be formed and maintained, and a high decontamination effect can be obtained.

  Also, a decontamination chamber that is in communication with the decontamination sealed chamber and forms a packaging material removal chamber in which the chamber is decontaminated, is placed in a closed state, and is placed in the decontamination sealed chamber and the decontamination sealed chamber. After decontamination of the outer surface of the packaging material of the object and decontamination, both chambers are changed from the shut-off state to the communication state, and the decontaminated object is transferred from the decontamination sealed chamber to the packaging material removal chamber. A configuration is proposed in which both chambers are again shut off and then the packaging material removal chamber removes the packaging material of the object to be decontaminated to take out the internal materials.

  By adopting such a configuration, it is possible to take out the contained material without being contaminated in the packaging material removal chamber while maintaining the sterility, and it is possible to perform the subsequent work quickly and safely. Become.

  In addition, the present invention provides a decontamination sealed chamber in which a room for decontamination is supplied and a decontamination target is supplied by being sealed with a packaging material while the decontaminated material is maintained in a sterilized state while the room and the outside are hermetically shut off. A gas generator for evaporating an aqueous solution in which a decontamination gas having a boiling point higher than that of water is dissolved to generate a decontamination gas, and introducing the decontamination gas into the decontamination sealed chamber, and a decontamination sealed chamber The decontamination gas is introduced into the decontamination sealed chamber and the decontamination gas is condensed in the sealed chamber. Automatic control contents to decontaminate the decontamination chamber and decontamination object outer surface by forming a condensate layer on the inner wall of the decontamination chamber and the outer surface of the decontamination object packaging material The decontamination target after the decontamination of the outer surface of the packaging material of the decontamination object. Transferred from the chamber to the packaging material removing chamber is communicated 設無 filtering apparatus, characterized in that the removal of packaging material in the packaging material removing chamber.

  By adopting such a configuration, the liquid condensate is less likely to permeate the packaging material than the gaseous decontamination gas for the reasons described above, so that the internal material is not altered by the decontamination component. . Moreover, in the packaging material removal chamber, the material contained while maintaining the aseptic condition can be taken out without being contaminated, and the subsequent work can be performed quickly and safely.

  In addition, the gas generator evaporates an aqueous solution in which a decontamination gas having a boiling point higher than that of water is dissolved to generate a decontamination gas, and generates an unsaturated gas that is not saturated in the decontamination sealed chamber. Consecutive sterilization apparatus equipped with charging means, wherein the condensation control means forms a condensate layer on the outer surface of the packaging material of the object to be decontaminated placed in the decontamination sealed chamber, and then inputs the unsaturated gas The unit is filled with an unsaturated gas and the condensed liquid layer once formed on the outer surface of the packaging material to be decontaminated is partially or completely evaporated after elapse of a predetermined time. There is proposed a configuration having automatic control contents in which a series of decontamination steps for condensing gas again and re-forming a condensed liquid layer on the outer surface of the packaging material of the decontamination object are repeatedly executed a predetermined number of times.

  By performing such an evaporation process, it can be avoided that the condensate in the condensate layer is gasified and the gas permeates the packaging material. Moreover, the condensed liquid layer is formed by repeatedly evaporating a part or all of the condensed liquid layer once formed, and repeatedly performing a decontamination process for re-forming the condensed liquid layer on the outer surface of the packaging material of the decontamination target. It is possible to prevent a decrease in the solute concentration, to form a condensate layer having a high solute concentration, and to obtain a high decontamination effect. The predetermined time is determined to be shorter than the time during which the gas penetrates the packaging material and reaches the internal material.

  In addition, a configuration in which the gas generator generates hydrogen peroxide gas is proposed.

  With this configuration, for example, the sealing structure of the decontamination sealed chamber is simplified and the decontamination effect is stabilized as compared with, for example, ultraviolet decontamination equipment. In addition, with this configuration, the size of the decontamination target is not easily limited.

  Since the decontamination method of the present invention is configured to decontaminate the outer surface of the packaging material by forming a condensate layer on the outer surface of the packaging material so that the decontamination gas penetrates the packaging material, the internal material There is an excellent effect that can prevent the deterioration of the material.

  Furthermore, a decontamination process comprising an evaporation step for evaporating a condensed liquid layer once formed on the outer surface of the packaging material of the decontamination object after a predetermined time, and a recondensing step for re-forming the condensed liquid layer after execution of the evaporation step. When it is configured to repeat the process, the condensate in the condensate layer has the effect of preventing gasification and alteration of the internal materials, and it can hold a high concentration condensate layer, There is an excellent effect that the outer surface of the packaging material can be sufficiently decontaminated.

  If a packaging material removal chamber is formed and the decontamination target is decontaminated, then the packaging material removal chamber removes the decontamination target packaging material and takes out the internal material. It is possible to take out the material while maintaining the aseptic condition in the material removal chamber, and to immediately proceed with the subsequent work on the material, which has the effect of dramatically improving the work efficiency.

  Further, the continuous aseptic apparatus of the present invention comprises a condensation control means for decontaminating the outer surface of the packaging material by forming a condensate layer on the outer surface of the packaging material, and a decontamination target from the decontamination sealed chamber. Since it is configured to include a packaging material removal chamber that is transferred and removes the packaging material, the internal material is not affected by the decontamination gas. In addition, after the decontamination object is decontaminated, the internal material can be taken out while maintaining the aseptic condition immediately in the packaging material removal chamber connected to the sealed chamber, and the work can be advanced, so the work efficiency has been greatly improved. Has the effect of improving.

  In addition, when the condensing control means evaporates the condensate layer and after the evaporation, the decontamination gas is reformed on the outer surface of the packaging material of the object to be decontaminated, the condensate in the condensate layer is gasified. Thus, there is an effect that it is possible to prevent the internal material from being altered, and it is also possible to prevent a decrease in the solute concentration of the condensate layer and to obtain a high decontamination effect.

  Further, when the gas generator is configured to generate hydrogen peroxide gas, for example, the sealing structure of the decontamination sealed chamber is simplified and the decontamination effect is stabilized as compared with the decontamination equipment using ultraviolet rays, for example. There is. Furthermore, hydrogen peroxide gas has a strong decontamination capability, is inexpensive and easily available, and has the advantage of having little influence on the environment.

  Below, the continuous sterilization apparatus 1 concerning this invention is demonstrated according to an accompanying drawing.

As shown in FIG. 1, the continuous aseptic apparatus 1 includes a decontamination sealed chamber 2 in which the room and the outside are hermetically shut off, and an isolator 3 that is connected to the chamber and communicates with each other. It is configured. And after decontaminating the decontamination target object 12 with SAL (sterility assurance level) of 10 ⁻³ to 10 ^{−6 in} the decontamination sealed chamber 2, the decontamination target object 12 is directly taken out without taking it outside. It transfers to the isolator 3 and performs a predetermined | prescribed operation | work about the decontamination target object 12 in the isolator 3. FIG. The isolator 3 constitutes a packaging material removal chamber according to the present invention.

  A gas generator 4 (see FIG. 2) is provided outside the decontamination sealed chamber 2. The gas generator 4 includes an evaporator 40, a liquid tank 42, and a blower 41. The liquid tank 42 contains hydrogen peroxide solution in which hydrogen peroxide gas having a boiling point higher than that of water is dissolved. Then, the hydrogen peroxide solution is dropped onto the heating surface (not shown) of the evaporation device 40 under gravity, thereby generating hydrogen peroxide gas, and this hydrogen peroxide gas is blown by the blower 41 to the decontamination sealed chamber. Hydrogen peroxide gas is sent into the room through a decontamination gas introduction pipe 6 that leads to the interior of the room 2. The evaporator 40 is configured to generate gas by flash evaporation (so-called rapid evaporation method), and a known technique is employed.

  Here, as shown in FIG. 7, the decontamination object 12 is formed by packaging the decontaminated material 10 with the packaging material 11 while maintaining the aseptic state, and the outer surface of the packaging material 11 is The decontamination chamber 2 is decontaminated, and after the decontamination, the packaging material 11 is removed by the isolator 3, and the material 10 is taken out while maintaining the aseptic state. Examples of the material 10 include a decontaminated syringe outer cylinder used for a prefilled syringe.

Next, the decontamination sealed chamber 2 of the continuous aseptic apparatus 1 will be described with reference to FIG.
The decontamination sealed chamber 2 includes a storage port 20 that can store the decontamination object 12 from the outside, and a discharge port 21 that can be transferred to the isolator 3 that communicates with the chamber. The storage port 20 is provided with a storage port door 22 that moves up and down to shut off the outside and the room. On the other hand, the discharge port 21 is also provided with a discharge port door 23 having the same mechanism as the storage port door 22. A packing (not shown) is provided between the outer wall of the decontamination sealed chamber 2 and the inner side surfaces of the doors 22 and 23. When the doors 22 and 23 are shielded, Is hermetically shut off. As this door mechanism, a known technique is preferably adopted.

  Further, a plurality of columnar transfer rollers 25 are arranged in the center of the decontamination sealed chamber 2 so that the longitudinal direction thereof is perpendicular to the depth direction of the sealed chamber 2. More specifically, the disposition position of the transfer roller 25 is set to be substantially the same height as a virtual line connecting the lower edge of the storage port 20 and the lower edge of the discharge port 21, and the storage port 20 extends to the discharge port 21. Is supported at predetermined intervals. Thereby, the decontamination object 12 stored from the storage port 21 moves on the transfer roller 25 and can be easily transferred to the discharge port 21.

  Further, in the decontamination sealed chamber 2, decontamination gas discharge pipes 6 a and 6 b that discharge the hydrogen peroxide gas generated by the gas generator 4 provided outside to the chamber are sealed in the decontamination sealed chamber. 2 in the depth direction. The decontamination gas discharge pipes 6 a and 6 b communicate with the decontamination gas introduction pipe 6. Here, the decontamination gas discharge pipes 6a and 6b are composed of a first decontamination gas discharge pipe 6a disposed at an indoor upper position and a second decontamination gas discharge pipe 6b disposed at a lower position in the room. It is configured. Further, both the decontamination gas discharge pipes 6a and 6b have a plurality of discharge ports 7 opened in the longitudinal direction, and the hydrogen peroxide gas supplied from the decontamination gas introduction pipe 6 is supplied to the decontamination object 12. It is configured to release. In addition to the first and second decontamination gas discharge pipes 6a and 6b, a decontamination gas discharge pipe may be provided at a side position in the room so that the hydrogen peroxide gas can be released from the vertical and horizontal directions. good.

  Furthermore, the low humidity gas is input into the chamber of the decontamination sealed chamber 2 from the low humidity gas input device 5 provided outside. Specifically, low-humidity gas discharge pipes 8a and 8b that discharge low-humidity gas are disposed in the room, and a plurality of discharge ports 9 are opened. Then, the low humidity gas is supplied into the room through the low humidity gas introduction pipe 8 communicating with the discharge pipes 8a and 8b. The low-humidity gas discharge pipes 8a and 8b are also composed of a first low-humidity gas discharge pipe 8a disposed at the indoor upper position and a second low-humidity gas discharge pipe 8b disposed at the indoor lower position, The low-humidity gas is distributed uniformly throughout the room. Moreover, it is good also as a structure which can arrange | position a low-humidity gas discharge | emission pipe | tube also in the indoor side position, and can discharge | release low-humidity gas from an up-down and left-right direction. This low-humidity gas is an unsaturated gas that does not saturate in the decontamination sealed chamber 2, and is set to a humidity lower than the humidity in the room. The low-humidity gas charging device constitutes the unsaturated gas charging means according to the present invention.

  Further, the decontamination sealed chamber 2 includes a control unit 28 having a central control unit CPU electrically connected to the gas generator 4 and the low-humidity gas input device 5, and each device 4, 5 and a predetermined Data is exchanged and predetermined information processing is executed. The control contents of the central control unit CPU will be described later.

  In addition, a temperature detection device 38 and a humidity detection device 39 for detecting the temperature and humidity of the decontamination sealed chamber 2 are provided, and each of them is electrically connected to the central control unit CPU, and detection data is transmitted to the central control unit CPU. It becomes the composition which is done. The control unit 28, the gas generator 4, the low-humidity gas supply device 5, the temperature detection device 38, and the humidity detection device 39 according to the present embodiment constitute a condensation control means according to the present invention.

  Further, in the decontamination sealed chamber 2, a gas discharge port 43 for discharging room gas at the time of aeration is opened, and the hydrogen peroxide component of the room gas is decomposed via the catalyst 44 to the outside. It is configured to be exhausted.

  Note that a glass window 13 (see FIG. 1) for the sealed chamber is formed on the wall surface of the sealed chamber 2 for decontamination so that the inside of the room can be seen from the outside.

Next, the isolator 3 connected to the decontamination sealed chamber 2 will be described with reference to FIG.
On the wall surface of the isolator 3 on the side of the decontamination chamber 2, a communication port 33 for allowing the decontamination target object 12 to be directly transferred from the decontamination chamber 2 is opened. The decontamination sealed chamber 2 and the isolator 3 are connected so that the discharge port 21 of the sealed chamber 2 is opposed to each other, and the respective chambers are communicated with each other. And if the above-mentioned discharge port door 23 is shielded, it will become the structure by which both chambers are interrupted | blocked airtightly. The connecting portion between the decontamination sealed chamber 2 and the isolator 3 is hermetically connected, and is configured such that the contaminated gas does not enter from the outside. A known technique is suitably applied to such a connection mechanism.

  In addition, the wall surface of the isolator 3 is provided with a removing means for removing the packaging material 11 of the decontamination object 12 that has been transferred into the room. Specifically, a glass window 30 is provided on the wall surface, and a base end portion of a work glove 32 that enables manual work is attached to a work hole 31 formed in the window glass 30 in a sealed manner. Then, a hand can be inserted into the work glove 32 and the internal work can be performed while confirming the decontamination object 12 through the glass window 30. In the center of the isolator 3, a work table 35 on which the decontamination object 12 transferred from the decontamination sealed chamber 2 is placed is disposed.

Next, the decontamination method according to the present invention will be described.
First, the decontamination object 12 is accumulated on the accumulation stand 36 (see FIG. 1) installed on the front side of the storage port 20 of the decontamination sealed chamber 2. Then, the accumulated decontamination object 12 is supplied and stored in the room by a predetermined amount from the storage port 20 while being packed with the packaging material 11. At this time, the discharge port door 23 is shielded to prevent the inside of the isolator 3 in the back and the outside from communicating with each other and contaminating the isolator 3. Further, when the decontamination object 12 is stored, it is preferable that the pressure in the decontamination sealed chamber 2 is set to be higher than that of the outside to prevent any foreign matter from entering from the storage port 20 during storage. It is.

  When the decontamination object 12 is supplied into the room, the storage door 22 is shielded, and the room and the outside are shut off in an airtight manner. Next, the low humidity gas is released into the room, and the room is dehumidified. By adopting such a configuration, the hydrogen peroxide gas concentration in the room is increased, and the hydrogen peroxide concentration is stabilized in the room. When the humidity in the decontamination sealed chamber 2 reaches a predetermined humidity, the introduction of the low-humidity gas is interrupted, and this time, the introduction of hydrogen peroxide gas is started.

  Here, the central control unit CPU controls the gas generation device 4 according to a predetermined operation program, and a predetermined amount of hydrogen peroxide gas is introduced so that the condensed liquid layer m of the hydrogen peroxide gas becomes the outer surface of the packaging material 11. To be formed. Further, the condensed liquid layer m is stably held on the outer surface of the packaging material 11 (see FIG. 4). Thereby, decontamination is started on the outer surface of the packaging material 11.

In accordance with the operation program, the central control unit CPU transmits a signal for starting the introduction of the low-humidity gas (unsaturated gas) to the low-humidity gas introduction device 5 when a predetermined time has elapsed since the formation of the condensate layer m. Then, by introducing a low-humidity gas into the room, the condensate layer m once formed is partially evaporated (evaporation step). At this time, the boiling point of hydrogen peroxide is 150 ° C., which is higher than the boiling point of water, and the water contained in the condensate layer m is easier to vaporize than the hydrogen peroxide solution. The concentration becomes higher. Further, the predetermined time is set to a time shorter than “a time when the condensate in the condensate layer m is gasified and the gas permeates the packaging material and reaches the internal material”. By executing the evaporation step after the elapse of the time determined in this way, it is possible to prevent the condensate in the condensate layer m from being gasified and deteriorating the internal material 10.

Furthermore, when a predetermined time has elapsed after the execution of this evaporation step, the central control unit CPU transmits a signal for stopping the introduction of the low-humidity gas to the low-humidity gas introduction device 5 according to the operation program, and also overoxidizes the gas generation device 4. A signal to start charging hydrogen gas is transmitted. Then, the hydrogen peroxide gas is condensed again in the decontamination sealed chamber 2 to re-form the condensate layer m on the outer surface of the packaging material 11 (recondensing step). As a result, the condensate layer m having a high hydrogen peroxide concentration is re-formed. Then, the central controller CPU performs automatic control that repeatedly executes the decontamination process consisting of the evaporation process and the recondensation process a predetermined number of times without altering the material 10 inside the packaging material 11. A high decontamination effect can be obtained by maintaining the high-concentration condensate layer m for a long time. In addition, the predetermined frequency | count of a decontamination process is set to the frequency | count sufficient and sufficient to decontaminate to SAL of the packaging material 11 outer surface 10 ^<-3 > ^-10 < ^-6 >.

  After performing the decontamination process and decontamination of the object 12 to be decontaminated, low-humidity gas is introduced and aeration is performed in the decontamination sealed chamber 2. That is, the room gas is exhausted from the gas exhaust port 43. When the aeration is completed, the outlet door 23 is opened, and the decontaminated object 12 is transferred from the decontamination sealed chamber 2 onto the work table 35 of the isolator 3. Then, after the transfer, the outlet door 23 is closed, and the packaging material 11 of the stored decontamination object 12 is removed by the isolator 3 through the work glove 32, and the internal material 10 is taken out. Various operations are performed by the isolator 3. When the decontamination object 12 is transferred from the decontamination sealed chamber 2 to the isolator 3, the pressure in the isolator 3 is made higher than the pressure in the decontamination sealed chamber 2, and some foreign matter enters the isolator 3. The structure which prevents is suitable.

  Here, another configuration is proposed. That is, as shown in FIG. 5, a decontamination region α in the decontamination sealed chamber 2 where the gas discharge pipes 8a, 8b and the like are disposed and hydrogen peroxide gas is released, and the subsequent stage ( It is a structure provided with the aeration area | region (beta) formed in the isolator 3 side. More specifically, aeration means for removing the condensate layer m formed on the outer surface of the packaging material 11 of the decontamination object 12 is disposed in the aeration region β. As this aeration means, as shown in FIG. 5, louvers 46a and 46b for releasing hot air generated by a hot air input device 45 provided outside the decontamination sealed chamber 2 are proposed. The louvers 46a and 46b are composed of a first louver 46a disposed at an upper position in the room and a second louver 46b disposed at a lower position in the room. The louvers 46a and 46b are removed by the transfer roller 25. Hot air is jetted from the up and down direction to the outer surface of the dyed object 12 to be decontaminated. Thereby, the condensate liquid layer m formed on the outer surface is blown off, and the condensate liquid layer m is removed from the decontamination object 12 after decontamination, and aeration is completed.

  Then, after the aeration, the decontamination target 12 is transferred from the discharge port 21 to the isolator 3. With this configuration, since it is not necessary to aerate the entire decontamination sealed chamber 2, the aeration time is shortened, and the decontamination target 12 is temporarily retained in the sealed chamber 2 for aeration. There is no need. Accordingly, the decontamination object 12 is sequentially supplied into the sealed chamber 2, and the rotation number of the transfer roller 25 and the opening / closing timing of the doors 22 and 23 are made to correspond to this, and the same number as the supplied number is transferred to the isolator 3. It is possible to continuously execute the steps to be performed in a series of flows. Thereby, the decontamination time can be greatly shortened as a whole. In addition, it is good also as a structure which replaces with the structure which ejects hot air as another structure, and ejects water vapor | steam. In the case of such a configuration, water vapor is jetted onto the outer surface of the packaging material 11 of the decontamination object 12, and then the hydrogen peroxide solution remaining on the outer surface is masked, and the hydrogen peroxide gas concentration is set in the isolator 3. It is a configuration that apparently decreases.

  Furthermore, as another configuration, a configuration in which the aeration means is UV irradiation devices 47a and 47b as shown in FIG. 6 is proposed. More specifically, each of the UV irradiation devices 47a and 47b includes a first UV irradiation device 47a disposed at an indoor upper position and a second UV irradiation device 47b disposed at a lower indoor position. Decontamination object after decontamination by irradiating the outer surface of the decontamination object 12 transferred by the transfer roller 25 with ultraviolet rays from above and below to decompose the condensed liquid layer m formed on the outer surface. The aeration is executed for No. 12.

  In addition, it is good also as a structure which combined the structure which ejects the hot air mentioned above, the structure which ejects water vapor | steam, and the structure which irradiates an ultraviolet-ray variously.

  By the way, when the decontamination object 12 accumulated on the accumulation stand 36 is decontaminated again, the discharge port door 23 is put in a shielding state, the decontamination sealed chamber 2 and the isolator 3 are shut off, and then the storage port The door 22 is opened, and the decontamination object 12 is stored in the decontamination sealed chamber 2.

  Moreover, in this invention, it is good also as a structure which evaporates all the condensed liquid layers m once formed in the evaporation process. With such a configuration, it is possible to completely prevent a decrease in the hydrogen peroxide concentration in the condensate liquid layer m.

  Moreover, as a decontamination gas in the case of performing the decontamination process which consists of an evaporation process and a recondensation process, if it is a decontamination gas whose boiling point is higher than water, it can use suitably. In addition, as a decontamination gas for decontamination by forming the condensate layer m on the outer surface of the packaging material 11, gasification of a decontamination agent such as formaldehyde, ethylene oxide, peracetic acid aqueous solution, ozone water, etc. good.

1 is a side view of a decontamination apparatus 1. FIG. It is a vertical side view of the decontamination sealed chamber 2. 3 is a cross-sectional view of the isolator 3. FIG. It is a vertical side view of the decontamination target object 12 in which the condensate layer m is formed on the outer surface of the packaging material 11. It is a vertical side view of the decontamination sealed chamber 2 provided with louvers 46a and 46b from which hot air is ejected. It is a vertical side view of the decontamination sealed chamber 2 in which the UV irradiation devices 47a and 47b are disposed. It is a vertical side view of the decontamination object 12 consisting of the material 10 and the packaging material 11.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Consecutive aseptic device 2 Decontamination sealed chamber 3 Isolator 4 Gas generator 5 Low-humidity gas input device 10 Material 11 Packaging material 12 Decontamination object m Condensate layer

Claims (3)

Place the decontamination object, which is made by packing the decontaminated material with the packaging material while maintaining the aseptic condition, in the decontamination sealed room where the room and the outside are hermetically shut off, and add hydrogen peroxide water. A decontamination gas comprising hydrogen peroxide gas is generated by evaporation, the decontamination gas is introduced into the decontamination sealed chamber, and the introduced decontamination gas is condensed in the decontamination sealed chamber for decontamination. A decontamination method in which a condensate layer is formed in a thin film on the inner wall of the decontamination sealed chamber and the outer surface of the packaging material of the decontamination object, thereby decontaminating the decontamination chamber and the outer surface of the decontamination object packaging material. There,
When the condensate of the condensate layer is gasified and the predetermined time has elapsed, which is shorter than the time until the gas penetrates the packaging material and reaches the internal material, the unsaturated gas is put into the sealed chamber. by placing, an evaporation step of evaporating a portion of the condensate layer is once formed on the packaging material outside surface of the decontamination object,
A recondensing step in which after the evaporation step is performed, the decontamination gas is condensed again in the decontamination sealed chamber, and a condensed liquid layer is formed on the outer surface of the packaging material of the decontamination target.
A decontamination method characterized by decontaminating the outer surface of a packaging material of an object to be decontaminated by repeatedly executing a decontamination process consisting of a predetermined number of times . Form a packaging material removal chamber that communicates with the decontamination sealed chamber and the chamber is decontaminated,
Both chambers are shut off, the outer surface of the packaging material of the decontamination object placed in the decontamination sealed chamber and the decontamination sealed chamber is decontaminated, and after decontamination, both chambers are switched from the shut-off state to the communication state. After the decontamination object is transferred from the decontamination sealed chamber to the packaging material removal chamber, both chambers are shut off again, and then the decontamination object packaging material is removed in the packaging material removal chamber. The decontamination method according to claim 1, wherein the internal material is taken out. A decontamination sealed chamber in which a room for decontamination is supplied, in which the room and the outside are hermetically blocked, and the decontaminated material is packed in a packaging material while maintaining aseptic conditions;
A gas generator for evaporating hydrogen peroxide water to generate a decontamination gas composed of hydrogen peroxide gas, and for introducing the decontamination gas into the decontamination sealed chamber;
A packaging material removal chamber which communicates with the decontamination sealed chamber and the chamber is decontaminated;
The gas generator is charged with the decontamination gas in the decontamination sealed chamber, the decontamination gas is condensed in the sealed chamber, and the inner wall of the decontamination sealed chamber and the outer surface of the packaging material of the decontamination target are collected. Condensation control means equipped with automatic control content to decontaminate the decontamination sealed chamber and the outer surface of the packaging material of the decontamination object by forming a condensate layer into a thin film, and a decontamination object packaging material After decontamination of the outer surface, the decontamination object is transferred from the decontamination sealed chamber to the packaging material removal chamber, and the packaging material is removed in the packaging material removal chamber.
The gas generator includes an unsaturated gas injection means for generating a decontamination gas composed of hydrogen peroxide gas by evaporating the hydrogen peroxide water and generating an unsaturated gas that is not saturated in the decontamination sealed chamber. A continuous aseptic device,
Condensation control means
A condensate layer is formed on the outer surface of the packaging material of the object to be decontaminated placed in the decontamination sealed chamber, the condensate in the condensate layer gasifies, and the gas penetrates the packaging material and reaches the internal material. After a predetermined time, which is a shorter time than the time required to complete the process, the unsaturated gas is introduced into the sealed chamber, and once formed on the outer surface of the packaging material of the decontamination object. A series of decontamination processes that evaporate part of the condensate layer after a lapse of time, and then condense the decontamination gas again to re-form the condensate layer on the outer surface of the packaging material to be decontaminated, a predetermined number of times A continuous aseptic apparatus characterized by having automatic control contents that are repeatedly executed only .

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