JP6531810B2 - Sterile working system - Google Patents

Description

  The present invention relates to an aseptic work system for performing operations such as culture of human cells and tissues in an aseptic work room isolated from an external atmosphere and maintained aseptically.

  Conventionally, as disclosed in, for example, Patent Document 1, the aseptic work system is divided into an aseptic work room whose interior is maintained aseptic, and a pass box connected to the aseptic work room. The communication portion formed between the aseptic working room and the pass box and the inlet portion provided on the outer wall of the pass box can be sealed by the opening and closing members. On the surface of the articles carried into the aseptic work room, first, in the pass box, the attached microorganisms are removed by the decontamination gas (decontamination vapor). Thereafter, when the aeration is performed in the pass box to remove the decontamination components remaining on the article and the inner wall surface of the pass box, the pass box and the aseptic work room are communicated and the article is transferred to the aseptic work room .

  According to such a conventional aseptic work system, the inside of the pass box is filled with the decontamination steam to remove the microbes, and the pass box is opened to the outside environment not only for the articles but also for the delivery of the articles. To sterilize the inner wall and maintain the condition and connect the pass box with the aseptic work room, set up in an environment of grade D, which is slightly cleaner than the general environment, and carry out human cell / tissue culture work. It is possible to carry out.

JP, 2010-51351, A

  Aeration in the pass box must be carried out until removal of the decontamination vapor to both the article and the inner wall surface is completed, and if the concentration of the decontamination vapor becomes lower, the rate of decrease in concentration will be slower, so There is a problem that it takes a long time for work. In the case of a culture container containing cells and the like, there is a concern about the adverse effect of prolonged exposure to an inappropriate temperature state due to the supply of decontamination vapor and aeration. Furthermore, since such a culture vessel does not have sufficient airtightness, there is also a concern that the gasified decontamination medium may flow into the inside and affect it.

  An object of the present invention is to shorten the time required for the decontamination operation of the articles carried into the aseptic work room, and to make it possible to select an appropriate decontamination medium and decontamination method according to the articles to be carried in.

  The aseptic work system according to the present invention includes an aseptic work room in which the inside is maintained aseptically, and a decontamination operation room for removing microorganisms adhering to articles carried into the aseptic work room from the outside. ing. The decontamination operation room includes a first operation room provided with an inlet communicating with the external environment, a second operation room connected to the first operation room and provided with a closable outlet, and It is connected to a pressure adjusting means for adjusting the pressure in the first operation chamber and the second operation chamber, as well as having a closeable communication portion for communicating the first operation chamber with the second operation chamber. The pressure adjusting means is configured to adjust the pressure by supplying and discharging air to and from the first operation chamber and the second operation chamber. When the communication unit is opened and the first operation chamber and the second operation chamber are communicated, the second operation chamber is started from the state in which the outlet portion is closed and the air supply and discharge to the first operation chamber and the second operation chamber is maintained. To stop or reduce the amount of exhaust to generate an air flow from the second operation chamber to the first operation chamber.

When the communication part is opened and the first operation chamber and the second operation chamber are communicated, the exhaust of the second operation chamber is stopped or the amount of exhaust is reduced, and the supply of the first operation chamber is stopped or the amount of supply May be reduced. Alternatively, the exhaust of the second operation chamber may be stopped and the air supply of the first operation chamber may be stopped, and the air supply amount of the second operation chamber may be larger than the exhaust amount of the first operation chamber.
Preferably, the pressure adjusting means comprises a first air supply / discharge means for supplying / discharging to the first operation chamber, and a second air supply / discharge means for supplying / discharging to the second operation chamber. The pressure control means may adjust the second operation chamber to have a higher pressure than the first operation chamber and to be gradually reduced in pressure from the aseptic work chamber. Further, it is preferable that the pressure in the first operation chamber, the second operation chamber and the aseptic work chamber be maintained higher than the external environment by the pressure adjusting means.

  As a first decontamination operation in the first operation chamber, decontamination gas is filled in the first operation chamber and made to act on the articles carried into the aseptic work chamber, and as the second decontamination operation in the second operation chamber, The remaining decontamination component may be removed. Alternatively, as the first decontamination operation in the first operation room, the first decontamination medium is used to remove the microorganisms attached to the articles carried into the aseptic work room, and the second decontamination operation in the second operation room As a second decontamination medium different from the first decontamination medium, microorganisms attached to the article may be removed.

  According to the present invention, it is possible to shorten the time required for the decontamination operation of the articles carried into the aseptic work room, and to make it possible to select an appropriate decontamination medium and decontamination system according to the articles to be carried in.

FIG. 1 is a layout view showing each component of a sterile operation system to which a first embodiment according to the present invention is applied. FIG. 2 is a diagram showing a fluid supply circuit for supplying and discharging decontamination gas and clean gas in the aseptic work system shown in FIG. 1; It is a figure for demonstrating the effect | action of the aseptic working system to which 1st Embodiment is applied.

  A sterile working system 100 according to a first embodiment of the present invention will be described below with reference to the drawings. FIG. 1 shows a schematic configuration of the aseptic working system 100. As shown in FIG. The aseptic working system includes an isolator 11 in which the aseptic working room 10 is maintained, and the inside of the aseptic working room 10 is maintained at an aseptic condition. The entrance side of the aseptic working room 10 is carried into the aseptic working room 10 from the outside of the aseptic working system. The pass box 110 in which the decontamination operation room 30 for removing the microorganisms adhering to the object is formed is connected, and is comprised. The decontamination operating chamber 30 is divided into a first operating chamber 31 and a second operating chamber 32. An incubator 20 for culturing human cells / tissues processed in the aseptic work room 10 is removable on the opposite side of the aseptic work room 10 to the decontamination work room 30. The first operation chamber 31 and the second operation chamber 32 may partition the interior of one pass box 110, or may be formed by connecting two independent pass boxes 110.

  On the wall of the aseptic work room 10, gloves 12, 13 are provided to perform various treatments on articles in the aseptic work room 10 from a clean booth (not shown) provided outside the aseptic work room 10. Provided. Similarly, gloves 34 and 35 are provided in the first operation chamber 31 and the second operation chamber 32 of the decontamination operation chamber 30, respectively.

  The first operation room 31 is located on the opposite side of the second operation room 32 to the aseptic work room 10, and the inlet 36 of the first operation room 31 can be closed by the first closing member 37. The second operation chamber 32 is connected to the first operation chamber 31, and the communication portion 38 communicating the first operation chamber 31 and the second operation chamber 32 can be closed by the second closing member 39. Further, the outlet 40 of the second operation chamber 32, that is, the connection portion with the aseptic work chamber 10, can be closed by the third closing member 41.

  The aseptic work room 10, the first operation room 31, and the second operation room 32 are configured such that the internal pressure thereof is adjusted by the pressure adjustment means described in detail later, and the pressure relationship of each room is the first operation The pressure in chamber 31 is higher than that in the external environment, the pressure in second operation chamber 32 is lower than that in first operation chamber 31, the pressure in aseptic work chamber 10 is higher than that in first operation chamber 31, and as a whole, it is higher than the external environment. It is controlled to be positive pressure. Thus, the flow of the atmosphere is shut off between the aseptic work room 10 and the first operation room 31 by maintaining the pressure in the intermediate second operation room 32 low. As a result, even when the aseptic working room 10 and the first operation room 31 are in communication, the contamination of the external environment is prevented from flowing into the aseptic working room 10, and pathogens such as viruses are aseptically operated. It can prevent flowing out of the room 10 to the outside environment.

  When the incubator 20 is attached, the incubator 20 is connected to the aseptic work room 10 through the connection 21. The opening of the partition wall between the aseptic work room 10 and the connection portion 21 is opened and closed by the first opening and closing member 22, and the opening and closing between the connection portion 21 and the incubator 20 is opened and closed by the second opening and closing member 23 provided in the incubator 20. .

  A configuration of a fluid supply circuit for supplying and exhausting decontamination gas (decontamination vapor) and clean gas to the aseptic work chamber 10, the decontamination operation chamber 30, and the connection portion 21 will be described with reference to FIG. . In the present embodiment, the decontamination gas is hydrogen peroxide vapor, and the bottle 60 stores the hydrogen peroxide aqueous solution. The hydrogen peroxide aqueous solution is supplied from the bottle 60 to the evaporator 63 in a constant amount by the pump 62 provided in the decontaminating agent supply passage 61, and is evaporated by heating by the evaporator 63 to become hydrogen peroxide vapor. The circulation passage 72 is connected to the suction port of the evaporator 63, and the generated hydrogen peroxide vapor is supplied from the evaporator 63 by the operation of the circulation blower 74 provided in the circulation passage 72. The decontamination gas supply passage 64 connected to the discharge port of the evaporator 63 is connected to the aseptic work room 10, the first operation room 31, and the second operation room 32 via opening and closing valves 65, 66, and 67, respectively.

  A gas supply chamber 14 is provided on the top surface of the aseptic work chamber 10, and a first branch passage 64a of the decontamination gas supply passage 64 is connected. A HEPA filter 15 is mounted in the gas supply chamber 14, and hydrogen peroxide vapor supplied to the gas supply chamber 14 is supplied to the aseptic work chamber 10 through the HEPA filter 15.

  Similarly, the gas supply chamber 42 is also formed on the top surface of the first operation chamber 31, and the second branch passage 64 b of the decontamination gas supply passage 64 is connected to the gas supply chamber 42. Further, the HEPA filter 43 is also provided in the gas supply chamber 42, and the hydrogen peroxide vapor supplied to the gas supply chamber 42 is supplied to the first operation chamber 31 through the HEPA filter 43. Similarly, with respect to the second operation chamber 32, hydrogen peroxide vapor is supplied from the third branch passage 64c of the decontamination gas supply passage 64 to the gas supply chamber 44, and is supplied to the second operation chamber 32 through the HEPA filter 45. Ru.

  The connection portion 21 is connected to the decontamination gas supply passage 64 via the open / close valve 24 and the HEPA filter 25. That is, the hydrogen peroxide vapor passing through the decontamination gas supply passage 64 is supplied to the internal space of the connection 21 through the HEPA filter 25.

  The fourth branch passage 64d of the decontamination gas supply passage 64 is disposed on the downstream side of the circulation blower 74 in the air supply direction so that the air is exhausted from the decontamination gas supply passage 64 when the circulation blower 74 operates. A pressure control valve 70 is provided to reduce the pressure of the aseptic working chamber 10, the first operating chamber 31, and the second operating chamber 32 to reduce the pressure. A catalyst 71 is provided at the open end of the fourth branch passage 64d to prevent outflow of harmful components to the outside of the aseptic work system 100.

  A gas discharge chamber 16 is provided on the lower surface of the aseptic work chamber 10, and a HEPA filter 17 is attached in the gas discharge chamber 16. The gas discharge chamber 16 is connected to a circulation passage 72 connected to the suction port of the evaporator 63, and the circulation passage 72 is provided with an open / close valve 73. Accordingly, the gas in the aseptic working chamber 10 is discharged to the gas discharge chamber 16 through the HEPA filter 17 by the air supply function of the circulation blower 74 and is returned to the evaporator 63 through the circulation passage 72.

  Similarly, the HEPA filter 47 is provided in the gas discharge chamber 46 formed on the lower surface of the first operation chamber 31, and the HEPA filter 49 is provided in the gas discharge chamber 48 formed on the lower surface of the second operation chamber 32. Be The gas discharge chambers 46, 48 are connected to the first and second branch passages 72a, 72b of the circulation passage 72, and the first and second branch passages 72a, 72b are provided with on-off valves 75, 76, respectively. Therefore, the gas in the first operation chamber 31 and the second operation chamber 32 is discharged to the gas discharge chambers 46 and 48 through the HEPA filters 47 and 49, and is returned to the evaporator 63 through the circulation passage 72.

  The third branch passage 72c of the circulation passage 72 is disposed on the upstream side of the circulation blower 74 in the air supply direction, so that the outside air is made to flow when the circulation blower 74 is activated to increase the air supply amount. And a pressure control valve 78 for adjusting the pressure in the first operating chamber 31 and the second operating chamber 32 to rise. The open end of the third branch passage 72c is open to the outside of the aseptic working system via the HEPA filter 79.

  A configuration for supplying clean gas to the aseptic work room 10, the first operation room 31, and the second operation room 32 will be described. A first gas supply passage 80 is connected to the gas supply chamber 14 of the aseptic work chamber 10. An air supply blower 81 is provided in the first gas supply passage 80, and an air flow control valve 82 is provided between the air supply blower 81 and the gas supply chamber 14. A catalyst 83 is provided at the open end of the first gas supply passage 80.

  With such a configuration, by opening the air volume adjustment valve 82 and operating the air supply blower 81, gas flows from the first gas supply passage 80 into the gas supply passage 14 from the outside, and this gas is detected by the HEPA filter 15. It is cleaned and supplied to the aseptic work room 10. Further, by adjusting the opening degree of the air flow rate adjustment valve 82 or the air flow rate of the air supply blower 81, the air supply amount to the aseptic work room 10 can be increased or decreased.

  An air supply fan 51 is provided in the gas supply chamber 42 of the first operation chamber 31, and a second gas supply passage 84 is connected to the air supply fan 51. An air flow control valve 85 is provided in the second gas supply passage 84, and a catalyst 86 is provided at the open end of the second gas supply passage 84. Similarly, an air supply fan 52 is provided in the gas supply chamber 44 of the second operation chamber 32, and a third gas supply passage 87 is connected to the air supply fan 52. An air flow control valve 88 is provided in the third gas supply passage 87, and a catalyst 89 is provided at the open end of the third gas supply passage 87.

  With such a configuration, the gas flow control valve 85 is opened and the air supply fan 51 is operated, whereby the gas flows from the second gas supply passage 84 into the gas supply chamber 42 from the outside, and this gas is detected by the HEPA filter 43. It is cleaned and supplied to the first operation chamber 31. Further, the amount of air supplied to the first operation chamber 31 can be increased or decreased by adjusting the degree of opening of the air volume adjusting valve 85 or the amount of air supplied from the air supply fan 51. Similarly, by opening the air flow control valve 88 and operating the air supply fan 52, gas is externally introduced from the third gas supply passage 87 into the gas supply chamber 44, and this gas is cleaned by the HEPA filter 45. It is supplied to the second operation chamber 32. Further, the amount of air supplied to the second operation chamber 32 can be increased or decreased by adjusting the degree of opening of the air volume adjusting valve 88 or the amount of air supplied from the air supply fan 52.

  A configuration for discharging gas from the aseptic work room 10, the first operation room 31, the second operation room 32, and the connection unit 21 will be described. A first gas discharge passage 90 is connected to the gas discharge chamber 16 of the aseptic work chamber 10, and an exhaust blower 91 is provided in the first gas discharge passage 90. An air flow control valve 92 and a catalyst 93 are provided between the exhaust blower 91 and the gas discharge chamber 16.

  With such a configuration, the gas passing through the HEPA filter 17 and the gas discharge chamber 16 from the aseptic work room 10 is released to the outside by the first gas discharge passage 90 by opening the air flow control valve 92 and operating the exhaust blower 91. Exhausted. In addition, by adjusting the opening degree of the air volume adjusting valve 92 or the air blowing amount of the exhaust blower 91, it is possible to increase or decrease the exhaust amount from the aseptic work room 10. An air supply / discharge unit for the aseptic work room 10 is configured by the air flow control valve 92, the exhaust blower 91, and the air flow control valve 82, which changes the air supply amount, and the air supply blower 81.

  An exhaust fan 53 is provided in the gas discharge chamber 46 of the first operation chamber 31, and a second gas discharge passage 94 is connected to the exhaust fan 53. An air flow control valve 95 and a catalyst 96 are provided in the second gas discharge passage 94. Similarly, an exhaust fan 54 is provided in the gas discharge chamber 48 of the second operation chamber 32, and a third gas discharge passage 97 is connected to the exhaust fan 54. The third gas discharge passage 97 is provided with an air flow control valve 98 and a catalyst 99.

  With such a configuration, the gas passing through the HEPA filter 47 and the gas discharge chamber 46 from the first operation chamber 31 is externally output by the second gas discharge passage 94 by opening the air flow control valve 95 and operating the exhaust fan 53. Discharged into Further, by adjusting the opening degree of the air flow rate adjustment valve 95 or the air flow rate of the exhaust fan 53, it is possible to increase or decrease the exhaust amount from the first operation chamber 31. A first air supply / exhaust device for the first operation chamber 31 is configured by the air flow rate adjustment valve 95 for increasing / decreasing the air discharge amount, the exhaust fan 53, the air flow rate adjustment valve 85 for changing the air supply amount, and the air supply fan 51 . Similarly, by opening the air flow control valve 98 and operating the exhaust fan 54, the gas that has passed through the HEPA filter 49 and the gas discharge chamber 48 from the second operation chamber 32 is discharged to the outside by the third gas discharge passage 97. Ru. In addition, by adjusting the opening degree of the air volume adjusting valve 98 or the air blowing amount of the exhaust fan 54, the exhaust amount from the second operation chamber 32 can be increased or decreased. A second air supply / exhaust device for the second operation chamber 32 is configured by the air volume adjustment valve 98 for increasing or decreasing the displacement, the exhaust fan 54, the air volume adjustment valve 88 for increasing or decreasing the air supply amount, and the air supply fan 52. .

  Furthermore, the air supply / discharge means for the aseptic work room 10, the first air supply / discharge means for the first operation room 31, and the second air supply / discharge means for the second operation room 32 increase / decrease the respective air supply and discharge amounts. Therefore, it is possible to adjust the pressure in each of the aseptic work room 10, the first operation room 31, and the second operation room 32, and this aseptic work including all the connected air supply and discharge means The pressure regulation means of the system 100 is configured. The operation of each of the air supply and discharge means is controlled in association with each other by control means (not shown). Thereby, the pressure of each chamber can be maintained in a predetermined range set in advance, and the pressure relationship between the chambers can be maintained in a predetermined state set in advance.

  A gas discharge passage 26 is connected to the side opposite to the decontamination gas supply passage 64 of the connection portion 21. The gas discharge passage 26 is provided with an on-off valve 27, and the open end of the gas discharge passage 26 is provided with a catalyst 28.

  Next, the operation of the present embodiment will be described with reference to FIGS. 2 and 3. In addition, illustration of the incubator 20 and the connection part 21 is abbreviate | omitted in FIG.

  Hydrogen peroxide vapor is supplied in advance and aeration is performed in all of the inside of the aseptic work room 10, the inside of the first operation room 31, and the inside of the second operation room 32, decontamination is performed, and the aseptic work room 10, air supply and discharge are performed by the first air supply and discharge means for the first operation chamber 31, and the second air supply and discharge means for the second operation chamber 32, respectively. The pressure is maintained by the pressure control means so that the internal pressure is maintained aseptically and the pressure in the aseptic working chamber 10 is the highest and then the pressure in the first operation chamber 31 becomes high. .

  When the first closing member 37 is opened and the article A required for the work is carried into the first operation chamber 31 in the aseptic work chamber 10, the communication portion 38 between the first operation chamber 31 and the second operation chamber 32 is The second operating chamber 32 is closed by the second closing member 39, and the outlet 40 of the second operating chamber 32 is closed by the third closing member 41. When the article A is carried into the first operation chamber 31 from the inlet 36, the first closing member 37 is closed, and the first operation chamber 31 is shut off from the outside with keeping airtight (step (1)). In this state, the first operation chamber 31 is communicated with the outside environment by opening the first closing member 37, but the inside of the first operation chamber 31 is maintained at a positive pressure by the pressure adjusting means. The atmosphere of the external environment never flows in. Further, the second closing member 39 is closed so that the second operation chamber 32 does not communicate with the external environment.

  In step (2), the first decontamination operation is performed on the article A stored in the first operation chamber 31. That is, the open / close valves 66 and 75 are opened and the circulation blower 74 is operated, and the hydrogen peroxide vapor generated in the evaporator 63 is supplied to the first operation chamber 31 through the second branch passage 64b, and the first branch passage It returns to the evaporator 63 via 72a. At the same time, the air flow control valves 85 and 95 are closed, the air supply fan 51 and the exhaust fan 53 are stopped, and the pressure in the first operation chamber 31 is controlled by the open / close control operation of the pressure control valves 70 and 78 to a positive pressure. Maintained. The first operation chamber 31 is filled with hydrogen peroxide vapor and acts on the article A, whereby the surface of the article A and the first closing member 37 are opened to expose the first operation chamber 31 exposed to the external atmosphere. Microbes on the inner wall of the

  When the supply of the predetermined amount of hydrogen peroxide vapor is completed, initial aeration is performed in the first operation chamber 31. At this time, the operation of the pump 62 for feeding the hydrogen peroxide solution is stopped, but for a predetermined time, the on-off valves 66 and 75 are opened and the circulation blower 74 is operated to perform aeration in the piping. Further, the air flow control valves 85 and 95 are opened to a predetermined opening degree, and the air supply fan 51 and the exhaust fan 53 are operated with a predetermined air flow. As a result, while the pressure state is maintained, the air outside the environment outside the aseptic work system 100, which flows in via the second gas supply passage 84, is supplied to the first operation chamber 31 after being cleaned by the HEPA filter 43. At the same time, the gas containing the hydrogen peroxide component in the first operation chamber 31 passes through the second gas discharge passage 94, and the catalyst 96 removes harmful components and discharges it to the outside of the aseptic work system 100. Initial aeration is performed until the residual concentration of the hydrogen peroxide component in the room decreases to a predetermined concentration. The air supply amount and the air discharge amount at this time are adjusted to be larger than those in the case where the pressure relationship is maintained between normal chambers which are not in the decontamination operation.

  In step (3), the second closing member 39 is opened, and the article A is transferred from the first operation chamber 31 to the second operation chamber 32 through the communicating portion 38. The movement of the article A at this time is performed by opening the communication portion 38 to cause the first operation chamber 31 and the second operation chamber 32 to communicate with each other and closing the inlet portion 36 and the outlet portion 40. Just before this, in the second operation chamber 32, the air volume adjustment valves 88 and 98 are opened at a predetermined opening degree, and the air supply fan 52 and the exhaust fan 54 are operated with a predetermined air flow rate. The positive pressure lower than that of the first operation chamber 31 is maintained, and the initial aeration is continued in the first operation chamber 31. In the present embodiment, the air volume adjustment valves 85 and 98 are closed in response to the opening operation of the second closing member 39 from this state, and the air supply fan 51 and the exhaust fan 54 are stopped. The amount of air supplied by the air fan 52 is adjusted by the pressure adjusting means so as to be larger than the amount of air discharged by the air amount adjusting valve 95 and the exhaust fan 53.

  Therefore, when the second closing member 39 is opened, a strong air flow is generated from the upper portion of the second operation chamber 32 toward the lower portion of the first operation chamber 31, and the decontamination component in the first operation chamber 31 is generated. The atmosphere containing the oxygen is prevented from flowing into the second operation chamber 32. Thus, the gas in the first operation chamber 31 is prevented from being drawn with the opening operation of the second closing member 39, and the decontamination component remaining in the first operation chamber 31 flows into the second operation chamber 32. There is nothing to do. Also during this time, the positive pressure state against the external environment of the second operation chamber 32 and the first operation chamber 31 is maintained.

  As described above, in order to generate the air flow from the second operation chamber 32 to the first operation chamber 31, in this example, the air volume adjustment valves 88 and 95 are opened and the air volume adjustment valves 85 and 98 are closed. 52 and the exhaust fan 53 are driven and the air supply fan 51 and the exhaust fan 54 are stopped. However, as another example, the air supply valves 51 and 52 and the exhaust fans 53 and 54 may all be driven, and the air volume adjustment valves 85 and 98 may be opened with a relatively small opening degree. That is, by making the air supply amount of the second operation chamber 32 larger than the air supply amount of the first operation chamber 31 and making the air discharge amount of the first operation chamber 31 larger than the air discharge amount of the second operation chamber 32. The pressure in the second operation chamber 32 may be adjusted to be higher than the pressure in the first operation chamber 31 so that an air flow from the second operation chamber 32 toward the first operation chamber 31 is generated. Also in this case, the sum of the supply amounts of the first operation chamber 31 and the second operation chamber 32 is larger than the sum of the displacement, so that the positive pressure is higher than the external environment.

  After step (3), in step (4), the second closing member 39 is closed, and individual aeration for the article A is performed in the second operation chamber 32 as a second decontamination operation. At this time, with regard to the first operation chamber 31, the air volume adjustment valves 85 and 95 are opened at a predetermined opening degree, the air supply fan 51 and the exhaust fan 53 are operated at a predetermined air flow rate, and the inner wall surface is opened following the initial aeration. Aeration is resumed on the subject. With regard to the second operation chamber 32, the air volume adjustment valves 88 and 98 are opened at a predetermined opening degree, and the air supply fan 52 and the exhaust fan 54 are operated at a predetermined air flow rate. At this time, the air supply amount and the air discharge amount are controlled to be larger than when maintaining the pressure relationship with the aseptic work room 10 and the first operation room 31, and the ventilation efficiency is enhanced, and a large amount of fresh gas is generated in a short time. The decontamination component is removed from the article A in a short time by bringing the article A into contact with the article A. Also during this time, both the first operation chamber 31 and the second operation chamber 32 are maintained at a positive pressure than the external environment.

  When the individual aeration in the second operation chamber 32 is completed, step (5) is performed, the third closing member 41 is opened, and the article A is carried into the aseptic work chamber 10. At this time, with respect to the first operation chamber 31, the air volume adjustment valves 85 and 95 are maintained in the open state, and the air supply fan 51 and the exhaust fan 53 are continuously driven to continue aeration. On the other hand, with regard to the second operation chamber 32, the opening degree of the air volume adjustment valves 88 and 98 and the air flow rate of the air supply fan 52 and the exhaust fan 54 are adjusted to reduce the air supply amount and the air discharge amount. Is returned to the control when maintaining.

  After step (5), the third closing member 41 is closed, and the article A is used in the aseptic work room 10.

  When supplying the decontamination gas to the first decontamination operation (step (2)) in the first operation chamber 31 described above or the aseptic work chamber 10, the first operation chamber 31, and the second operation chamber 32, that is, When air is supplied by the circulation blower 74, pressure control in the aseptic work room 10, the first operation room 31, and the second operation room 32 comprises pressure control valves 70, 78 whose operation is controlled by control means (not shown). It is regulated by the control regulation means. That is, when the pressure becomes higher than the set value, the pressure control valve 70 is opened, gas is released from the fourth branch passage 64d, and when the pressure becomes lower than the set value, the pressure control valve 78 is opened. Then, the outside air is introduced from the third branch passage 72c, and the pressure in each chamber is maintained at a positive pressure than the external environment.

  In the case where the interior is decontaminated with the incubator 20, the decontamination gas is supplied to the internal space of the connection portion 21 to decontaminate a portion exposed to the external environment before communicating with the aseptic work room 10. To be done. First, the front face of the incubator 20 on which the second opening / closing member 23 is provided is closely attached to and connected to the connection portion 21, and an internal space sealed in the connection portion 21 is formed. Next, with the first opening and closing member 22 of the aseptic working chamber 10 and the second opening and closing member 23 of the incubator 20 closed, the pressure control valve 78 is opened to operate the circulation blower 74 and the evaporator 63 is generated. The hydrogen peroxide vapor is sent to the decontamination gas supply passage 64, and the open / close valve 24 is opened to supply the hydrogen peroxide vapor to the internal space of the connection portion 21. As a result, the microorganisms in the entire internal space of the connecting portion 21 including the outside of the first opening and closing member 22 exposed to the external environment and the periphery thereof and the outside of the second opening and closing member 23 and the periphery thereof are removed. Thereafter, the open / close valve 27 is opened, and the supply of the aqueous hydrogen peroxide solution to the evaporator 63 by the pump 62 is stopped, the air is blown by the circulation blower 74, and aeration is performed for a predetermined time. When this series of decontamination work is completed, the operator puts a hand in the glove 12 and opens the first opening and closing member 22 by the glove operation, and then opens the second opening and closing member 23. To store articles such as culture vessels.

  As described above, in the present embodiment, the decontamination operation chamber 30 for removing the microorganisms attached to the article A carried into the aseptic work chamber 10 is divided into the first operation chamber 31 and the second operation chamber 32. After the decontamination operation using hydrogen peroxide vapor (decontamination gas) is performed on the article A in the first operation room 31 as the first decontamination operation, the article A is transferred to the second operation room 32 and the second An individual aeration is performed on the article A as a decontamination operation of The object of aeration in the second operation chamber 32 is only the article A, and in the first operation chamber 31, aeration is performed independently of the second operation chamber 32. That is, in the decontamination operation room 30 in which the decontamination operation has been performed, it is not necessary to perform aeration on both the article and the decontamination operation room 30, and the time required for the decontamination operation and aeration for the article A can be shortened. it can.

  Next, a second embodiment will be described. As described above, in the first decontamination operation in the first operation chamber 31 in the first embodiment, the decontamination gas consisting of hydrogen peroxide vapor filled in the article A is made to act on the second operation chamber 32. The second decontamination operation is configured to perform individual aeration on the article A to remove the remaining decontamination components. On the other hand, in the second embodiment, in the first decontamination operation in the first operation chamber 31, the microorganisms attached to the article A are removed using the first decontamination medium, and in the second operation chamber 32. In the second decontamination operation, the second decontamination medium is used to remove the microorganisms attached to the article A.

  That is, in the case where the article A is a culture container containing cells, in the decontamination operation with the decontamination gas vaporized by heating, there is a concern about the adverse effect of the cells being exposed to a rapid temperature change, and culture If the container does not have sealing properties, decontamination gas may flow into the interior and affect cell culture. Therefore, in the second embodiment, a liquid decontamination medium is sprayed on the surface of the article or included in a non-woven fabric or the like to wipe it off. In this case, as in the case of the decontamination operation using the decontamination gas, the removal of microorganisms including the inside of the decontamination operation chamber 30 exposed to the external environment is not performed, but in the present embodiment the decontamination operation The chamber 30 is divided into a first operation chamber 31 and a second operation chamber 32, and a second operation chamber 32 is provided between the first operation chamber 31 exposed to the external environment and containing articles and the aseptic work chamber 10. Further, when the first operation chamber 31 and the second operation chamber 32 are communicated with each other, the air flow is generated from the second operation chamber 32 to the first operation chamber 31 by the pressure adjusting means, so that exposure to the external atmosphere is performed. The first operation room 31 and the aseptic work room 10 do not directly communicate with each other, and the atmosphere of the first operation room 31 does not flow into the second operation room 32 and the aseptic work room 10. As a result, the first operating chamber 31 whose cleanliness level is maintained higher than that of the grade D external environment is grade C, the second operating chamber 32 is grade B, and the aseptic working room 10 is grade A. can do.

  In addition, as a decontamination medium used in the second embodiment, general disinfection of a liquid at normal temperature such as alcohol (ethanol for disinfecting), oxyle (hydrogen peroxide aqueous solution), peracetic acid, sodium hypochlorite, etc. Liquids and germicides can be used.

  The second embodiment is used in combination with the first embodiment, and as in the case of a culture vessel containing cells as an article, when a gaseous decontamination medium such as hydrogen peroxide vapor can not be used as a decontamination medium, It is used when it can not be exposed to high temperature as a dyeing method. Specifically, in the same aseptic work system 100 as in the first embodiment, the inside of the aseptic work room 10, the first operation room 31, and the second operation room 32 are decontaminated, respectively, and positive pressure higher than the external environment is obtained. In the state where the pressure relationship among the chambers is maintained such that the pressure is maintained and the sterility is maintained, and the aseptic working chamber 10 has the highest pressure and then the pressure in the first operation chamber 31 becomes high, As in (1), the first closing member 37 is opened to store the article A such as a culture vessel in the first operation chamber 31. Next, in step (2), an external worker inserts a hand into the glove 34 and wipes the article A with an alcohol-impregnated non-woven fabric to remove microorganisms attached to the surface. This is the first decontamination operation in the second embodiment.

  Next, in step (3), as in the first embodiment, with the first closing member 37 and the third closing member 41 closed, the second closing member 39 is opened to make the article A the second operation room Move to 32. At this time, as in the case of the first embodiment, from the upper part of the second operation chamber 32 to the lower part of the first operation chamber 31 by the operation of the respective air supply and discharge means of the first operation chamber 31 and the second operation chamber 32. A strong air flow is generated to direct it, so that the atmosphere in the first operation chamber 31 opened to the outside environment does not flow into the second operation chamber 32 when the article A is stored. In the subsequent step (4), after closing the second closing member 39, an outside worker put a hand into the glove 35 and wiped the article A with a non-woven fabric impregnated with a peracetic acid solution to adhere to the surface Remove the microbes. This is the second decontamination operation in the second embodiment.

  As described above, by making the type of the decontamination medium used different between the first decontamination operation in the first operation chamber 31 and the second decontamination operation in the second operation chamber 32, various resistances are different. It is possible to remove all kinds of microorganisms, bacteria and viruses. When these microorganisms and the like can be sufficiently removed from the article A, the process proceeds to step (5), the third closing member 41 is opened, and the article A is carried into the aseptic work room 10.

  In the second embodiment, although the inside of the decontamination operating chamber 30 exposed to the external environment when the articles are carried in is not decontaminated along with the decontamination of the articles, the decontamination operating chamber 30 is When the first operation chamber 31 and the second operation chamber 32 are communicated with each other while dividing the first operation chamber 31 and the second operation chamber 32, an air flow is generated from the second operation chamber 32 toward the first operation chamber 31. Because the movement of the atmosphere is prevented, the atmosphere of the first operation chamber 31 opened to the outside environment does not flow into the second operation chamber 32, and the microbes to the aseptic operation chamber 10 as in the first embodiment. And the entry of bacteria and viruses can be reliably avoided. Therefore, in the aseptic work system 100 installed in a grade D grade environment, it is possible to adopt an appropriate decontamination medium and decontamination method other than the decontamination gas for decontamination of the articles to be carried in. In addition, after the decontamination process is performed in the first operation chamber 31, the decontamination process is performed again in the second operation chamber 32 using different types of decontamination media, so that a high decontamination effect can be obtained.

  The configuration of the aseptic work system 100 according to the present invention corresponding to the first and second embodiments is not limited to the configuration including the aseptic work room 10, the first operation room 31, and the second operation room 32, but the first It is also possible to provide an intermediate chamber such as an air lock chamber for avoiding direct communication between the front stage of the operation chamber 31 and between the aseptic work chamber 10 and the second operation chamber 32. Further, the pressure relationship among the chambers is not limited to the one in which the second operation chamber 32 is maintained at a lower pressure than the first operation chamber 31, but the pressure is lower than the aseptic work chamber 10 and positive pressure is applied to the external environment. If so, the first operation chamber 31 and the second operation chamber 32 may have the same pressure, and the second operation chamber 32 has a higher pressure than the first operation chamber 31, and the pressure is reduced stepwise from the aseptic work chamber 10. You may

DESCRIPTION OF SYMBOLS 10 Aseptic working room 30 Decontamination operation room 31 1st operation room 32 2nd operation room 36 Inlet part 38 Communication part 40 Exit part 51, 52 Air supply fan (pressure control means)
53, 54 Exhaust fan (pressure adjustment means)
85, 88, 95, 98 Air flow control valve (pressure control means)
A goods

Claims (8)

In an aseptic work system comprising: an aseptic work room whose interior is maintained aseptically; and a decontamination operation room for removing microorganisms adhering to articles brought into the aseptic work room from the outside.
The decontamination operation chamber includes a first operation chamber provided with an inlet portion communicating with the external environment, a second operation chamber connected to the first operation chamber and provided with a closable outlet portion, A closable communication portion for communicating the first operation chamber and the second operation chamber, and connected to pressure adjusting means for adjusting the pressure in the first operation chamber and the second operation chamber,
The pressure adjusting means is configured to adjust the pressure by supplying and discharging air to the first operation chamber and the second operation chamber,
When the communication portion is opened and the first operation chamber and the second operation chamber are communicated with each other, the outlet portion is closed and the air supply and discharge to the first operation chamber and the second operation chamber is maintained. An aseptic working system characterized in that the exhaust of the second operation chamber is stopped or the amount of exhaust is reduced to generate an air flow from the second operation chamber to the first operation chamber.   When the communication portion is opened and the first operation chamber and the second operation chamber are communicated, the exhaust of the second operation chamber is stopped or the amount of exhaust is reduced, and the air supply of the first operation chamber is stopped or The aseptic working system according to claim 1, wherein the air supply amount is reduced.   When the communication unit is opened and the first operation chamber and the second operation chamber are communicated, the exhaust of the second operation chamber is stopped and the air supply of the first operation chamber is stopped, and the second operation is performed. The aseptic working system according to claim 1, wherein the air supply amount of the chamber is made larger than the exhaust amount of the first operation chamber.   The apparatus according to claim 1, wherein the pressure adjusting means comprises a first air supplying / discharging means for supplying / discharging to the first operation chamber, and a second air supplying / discharging means for supplying / discharging to the second operation chamber. The aseptic working system according to any one of claims 1 to 3.   The pressure control means controls the second operation chamber to have a pressure higher than that of the first operation chamber so that the pressure is reduced stepwise from the aseptic work chamber. The aseptic working system according to 4. The aseptic working system according to claim 5, wherein the pressure of the first operation room, the second operation room, and the aseptic work room is maintained higher than the external environment by the pressure adjusting means. As a first decontamination operation in the first operation chamber, decontamination gas is filled in the first operation chamber and applied to an article to be carried into the aseptic work chamber;
The aseptic working system according to any one of claims 1 to 6 , wherein a decontamination component remaining in the article is removed as a second decontamination operation in the second operation chamber. As a first decontamination operation in the first operation chamber, the first decontamination medium is used to remove the microorganisms attached to the articles carried into the aseptic work chamber,
As a second decontamination operation in the second operation chamber, the second decontamination medium different from the first decontamination medium is used to remove the microorganisms attached to the article. An aseptic working system according to claim 6 .

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