Isolator, and decontamination method of isolator

Abstract

To shorten time required for an aeration work.SOLUTION: Provided are an isolator 1 comprising: an aeration filter 3 provided in an operation chamber 2; a filter front chamber 4 which is provided so as to cover a primary side of the aeration filter 3; and decontamination means for feeding decontamination gas into the filter front chamber 4, and a decontamination method of the isolator 1. An exhaust port 4b of decontamination gas is provided for the filter front chamber 4. Decontamination gas is fed to the filter front chamber 4 and the exhaust port 4b is opened to allow decontamination gas fed to the filter front chamber 4 to be exhausted from the exhaust port 4b to decontaminate the filter front chamber 4.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to an isolator and a decontamination method for an isolator, and aims to shorten the decontamination work time for an isolator. More specifically, the present invention relates to an isolator and a decontamination method for an isolator that can shorten the time required for aeration in the decontamination work. [Background technology]

[0002] Conventionally, an isolator has an operation chamber that forms an internal sterile work space isolated from the external atmosphere, and aseptic operations such as those associated with cell culture required for regenerative medicine and the like are carried out in the sterile work space. In order to maintain a sterile state in the above-mentioned work space, it is necessary to decontaminate and sterilize the inside of the operation room, and then purify the outside air and bring it into the operation room to maintain a positive pressure inside.For this reason, the operation room is equipped with an air intake filter such as a HEPA filter in the ceiling, which captures fine particles and purifies the air. In addition, decontamination gas containing decontaminating components such as hydrogen peroxide vapor is used to decontaminate the inside of the control room, and in order to decontaminate the control room, it is necessary to decontaminate not only the inside of the control room but also the inside of the air intake filter installed on the ceiling. Therefore, conventionally, decontamination gas is supplied to the control room through an air intake filter to decontaminate the air intake filter and the inside of the control room, and then aeration is performed by passing purified gas through the air intake filter and the control room to remove any adhering decontamination components (Patent Document 1). Decontamination of the operation room, including the isolator's air intake filter, usually takes several hours, of which the time required for the aeration accounts for a significant proportion. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 6795756 Summary of the Invention [Problem to be solved by the invention]

[0004] Here, in order to maintain the sterility of the work space after decontamination, it is necessary to supply purified gas to the operation room to maintain a positive pressure inside, and to blow purified gas into every corner of the work room to ensure thorough ventilation. For this reason, for example, in the isolator of Patent Document 1, a plenum is formed by providing a filter front chamber of a predetermined volume that covers the primary side into which gas flows into the air intake filter installed on the ceiling of the operating room. When decontaminating an isolator equipped with such a filter front chamber, there is a risk that the filter front chamber may become a source of contamination because outside air directly flows into it, and there is also concern that the air intake filter may become contaminated immediately after decontamination. Therefore, it is necessary to decontaminate the inside of the filter front chamber in addition to decontaminating the air intake filter. In order to decontaminate the filter front chamber and the air intake filter, it is necessary to supply to the filter front chamber an amount of decontamination gas necessary to decontaminate the filter front chamber in addition to an amount of decontamination gas necessary to decontaminate the air intake filter. When the aforementioned amount of decontamination gas is supplied to the filter front chamber, all of the gas passes through the air intake filter, and the air intake filter adsorbs more decontamination components than are necessary to decontaminate the air intake filter. In addition, when decontaminating the control room, the amount of decontamination gas required to decontaminate the control room is supplied to the filter front chamber, but since the decontamination gas is supplied to the control room after passing through the air intake filter, a larger amount of decontamination gas is supplied in consideration of the fact that the decontamination components are adsorbed by the air intake filter. On the other hand, aeration takes a particularly long time to remove the decontamination components adsorbed to the air intake filter, so the challenge is to reduce the amount of decontamination components adsorbed to the air intake filter in order to reduce the aeration time spent on the air intake filter. In other words, the present invention aims to shorten the decontamination work time in isolators, with the aim of shortening the aeration time which accounts for a large proportion of the work time, and focuses particularly on the air intake filter to reduce the aeration time. [Means for solving the problem]

[0005] That is, the isolator according to the invention of claim 1 is an isolator comprising an operation chamber having a working space formed therein, an air intake filter provided at an air intake port formed in the operation chamber to purify gas, a filter front chamber provided so as to cover the primary side of the air intake filter, and decontamination means for supplying decontamination gas to the filter front chamber, a decontamination gas outlet that can be opened and closed by an opening and closing valve is provided in the filter front chamber; The decontamination means supplies decontamination gas to the filter front chamber, and the opening / closing valve of the exhaust port is opened to discharge the decontamination gas supplied to the filter front chamber from the exhaust port, thereby decontaminating the filter front chamber. A decontamination method for an isolator according to claim 4 is a decontamination method for an isolator including an operation room having a working space formed therein, an air intake filter provided at an air intake port formed in the operation room to purify gas, a filter front chamber provided to cover the primary side of the air intake filter, and decontamination means for supplying a decontamination gas to the filter front chamber, The decontamination gas supplied from the decontamination means can be supplied to the filter front chamber and the operation chamber, and an outlet for the decontamination gas is provided in the filter front chamber, a front chamber decontamination process in which a decontamination gas is supplied to the front filter chamber and an exhaust port of the front filter chamber is opened to allow the decontamination gas to flow through the front filter chamber; an air intake filter decontamination process in which a decontamination gas is supplied to the filter front chamber with the exhaust port of the filter front chamber closed, and the decontamination gas is passed through the air intake filter; an operation room decontamination step of stopping the supply of decontamination gas to the filter front chamber and supplying decontamination gas to the operation room, After the above-mentioned front chamber decontamination process, air intake filter decontamination process, and operation chamber decontamination process are carried out in sequence, an aeration process is carried out in which gas is passed through the air intake filter from the filter front chamber to the operation chamber. [Effects of the Invention]

[0006] According to the invention of claim 1, by providing the filter front chamber with a decontamination gas outlet that can be opened and closed by an opening and closing valve, the decontamination gas can be discharged from the filter front chamber without passing through the air supply filter. This reduces the amount of decontamination components adsorbed to the air intake filter compared to conventional methods, making it possible to shorten the aeration time and ultimately shorten the time required for decontamination. According to the invention of claim 4, the decontamination steps are carried out separately in the order of the antechamber decontamination step, the air supply filter decontamination step, and the operation room decontamination step. As a result, in the antechamber decontamination process, decontamination gas is discharged without passing through the air intake filter, and in the operation room decontamination process, decontamination gas is supplied without passing through the air intake filter, so that in the air intake filter decontamination process, only the amount of decontamination gas necessary to decontaminate the air intake filter can be supplied. As a result, fewer decontamination components are adsorbed to the air intake filter than in the past, making it possible to shorten the aeration time, and ultimately shortening the time required for decontamination. [Brief explanation of the drawings]

[0007] [Figure 1] Internal configuration diagram of an isolator according to a first embodiment [Figure 2] 1 is a diagram illustrating the work involved in the decontamination method of the first embodiment. [Figure 3] 1 is a diagram illustrating the work involved in the decontamination method of the first embodiment. [Figure 4] 1 is a diagram illustrating the work involved in the decontamination method of the first embodiment. [Figure 5] 1 is a diagram illustrating the work involved in the decontamination method of the first embodiment. [Figure 6] FIG. 10 is an internal configuration diagram of an isolator according to a second embodiment. [Figure 7] 10A and 10B are diagrams illustrating the work involved in the decontamination method of the second embodiment. [Figure 8] 10A and 10B are diagrams illustrating the work involved in the decontamination method of the second embodiment. [Figure 9] 10A and 10B are diagrams illustrating the work involved in the decontamination method of the second embodiment. [Figure 10] 10A and 10B are diagrams illustrating the work involved in the decontamination method of the second embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0008] The present invention will be described below with reference to the illustrated embodiment. FIG. 1 shows the internal structure of an isolator 1 that forms a sterile work space S inside that is isolated from the external atmosphere, and enables sterile operations such as those required for cell culture to be performed in the work space S that is maintained in a sterile state. The isolator 1 comprises an operation room 2 in which the work space S is formed, an air intake filter 3 provided on the ceiling of the operation room 2, a pre-filter chamber 4 provided to cover the air intake filter 3 on the primary side, i.e., outside the operation room 2, an exhaust filter 5 provided at the bottom of the operation room 2, and a post-filter chamber 6 provided to cover the exhaust filter 5 on the secondary side, i.e., outside the operation room 2. The operation room 2 and the pre-filter chamber 4 communicate with each other via an air intake port 2a opening in the ceiling of the operation room 2, and the air intake filter 3 is provided so as to cover the air intake port 2a. Similarly, the operation room 2 and the post-filter chamber 6 communicate with each other via an exhaust port 2b opening in the lower part of the operation room 2, and the exhaust filter 5 is provided so as to cover the exhaust port 2b.

[0009] The isolator 1 is provided with an air supply means 11 for supplying gas, and the air supply means 11 is composed of an air supply blower 11b provided in a pipe 11a and an air supply damper 11c for opening and closing the pipe 11a. One end of the pipe 11a is open to the outside, and the other end is connected to the filter front chamber 4, so that the outside air around the isolator 1 is supplied to the filter front chamber 4 by operating the air supply blower 11b. When the air supply means 11 supplies outside air to the filter front chamber 4, the internal pressure of the filter front chamber 4 rises, and the pressure exceeds the pressure loss of the air supply filter 3, causing gas to flow from the filter front chamber 4 to the air supply filter 3, and the gas (cleaned gas) that has been purified by passing through the air supply filter 3 flows out into the operation chamber 2. The filter front chamber 4 is configured as a plenum with a volume corresponding to the capacity of the air intake filter 3 and the open area of the primary side, and by increasing the pressure of the gas supplied from the piping 11a of the air intake means 11, the gas is allowed to flow at approximately equal pressure over the entire surface constituting the primary side of the air intake filter 3. The intake air filter 3 is a cleaning filter such as a HEPA filter that also captures fine particles in the air.

[0010] The isolator 1 is provided with an exhaust means 12 for exhausting gas, and the exhaust means 12 is composed of an exhaust blower 12b provided in a pipe 12a, an exhaust damper 12c for opening and closing the pipe 12a, and a catalyst 12d for removing decontaminating components of decontaminating gas such as hydrogen peroxide vapor, which will be described later. One end of the pipe 12a is connected to the post-filter chamber 6, and the other end is open to the outside, so that gas can be exhausted from the post-filter chamber 6 by operation of the exhaust blower 12b. The exhaust filter 5 provided at the exhaust port 2b captures dust particles and flying debris generated within the work space S, and in the event that outside air flows back from the piping 12a, it purifies the incoming gas, preventing contamination of the work space S inside the operation room 2.

[0011] The air supply filter 3, the exhaust filter 5, the air supply means 11, and the exhaust means 12 constitute an aeration means for circulating purified gas inside the operation room 2. A control means (not shown) controls the air flow rate of the air supply blower 11b and the exhaust blower 12b and the amount of opening of the air supply damper 11c and the exhaust damper 12c so that the amount of air supplied by the air supply means 11 always exceeds the amount of air exhausted by the exhaust means 12, thereby increasing the pressure inside the operation room 2 above the pressure around the isolator 1 and maintaining the work space S at a positive pressure. That is, the air supply means 11, the exhaust means 12 and the control means (not shown) constitute an air conditioning means for maintaining a positive pressure in the operation room 2.

[0012] The filter front chamber 4 is provided with multiple fans 13 above the air intake filter 3, and by operating these fans 13 during the decontamination work described below, the decontamination gas supplied to the filter front chamber 4 is caused to flow over the entire primary side of the air intake filter 3. In addition, a mesh screen 14 serving as a straightening screen is provided in the upper part of the operation room 2 at a predetermined distance from the secondary surface of the air intake filter 3, and the work space S is divided into an upper work space S1 above the mesh screen 14 and a lower work space S2 below it, and aseptic operations such as those required for cell culture are carried out in the lower work space S2. With this configuration, when aseptic operations are performed in the lower working space S2, the clean air supplied from the filter front chamber 4 to the operation room 2 via the air supply filter 3 is blown out with uniform pressure from the entire lower surface of the secondary side of the air supply filter 3 into the upper working space S1. The blown clean gas is rectified by the mesh screen 14 and flows out from the entire surface of the mesh screen 14 into the lower working space S2, forming a laminar flow (one-way flow) going from above to below. Due to the action of the laminar flow, dust particles and other flying particles generated during aseptic operations are captured by the exhaust filter 5 installed at the bottom of the operation room 2 without being blown up.

[0013] When performing aseptic operations in the working space S of the isolator 1 having the above configuration, the operation room 2 including the air supply filter 3 is decontaminated at the end of each specified operation to prevent contamination of the cells to be handled in the next operation. Therefore, the isolator 1 of this embodiment is provided with a decontamination means 15 that supplies decontamination gas to the filter front chamber 4 and the operation chamber 2. The decontamination means 15 includes a container 16 containing a liquid decontamination agent such as hydrogen peroxide water, an evaporator 17 for evaporating the decontamination agent, a pump 18 for supplying the required amount of decontamination agent from the container 16 to the evaporator 17, and an air blower 19 for blowing the decontamination gas such as hydrogen peroxide vapor evaporated in the evaporator 17. The pump 18 pumps the required amount of decontamination agent from the container 16 and drips it into the evaporator 17, thereby generating a decontamination gas of a predetermined concentration. A supply pipe 20 is connected to the evaporator 17, and a heater 21 is provided on the outer periphery of the supply pipe 20 to prevent the decontamination gas flowing inside from cooling and liquefying. The supply pipe 20 branches and is connected to an antechamber supply port 4a, which is a supply port for decontamination gas formed in the filter antechamber 4, and a first operation room supply port S1a and a second operation room supply port S2a, which are supply ports for decontamination gas formed in the upper work space S1 and the lower work space S2 in the work space S of the operation room 2. That is, the decontamination means 15 of this embodiment is configured to be able to supply decontamination gas to the filter front chamber 4 and the upper work space S1 and lower work space S2 of the operation room 2 individually. The branched portions of the supply pipe 20 are provided with first to third on-off valves B1 to B3, which are controlled by control means (not shown).

[0014] A circulation pipe 22 is provided between the post-filter chamber 6 and the air blower 19 of the decontamination means 15, and the circulation pipe 22 is provided with a fourth opening / closing valve B4 controlled by the control means. As a result, the decontamination gas that has flowed into the post-filter chamber 6 is circulated through the circulation pipe 22 by the blower 19 and circulated to the evaporator 17, so that the decontamination gas can be reused.

[0015] Furthermore, in the upper work space S1 and the lower work space S2 in the work space S of the filter front chamber 4 and the operation room 2, a front chamber outlet 4b is provided in the filter front chamber 4, and a first operation room outlet S1b and a second operation room outlet S2b are provided in the upper work space S1 and the lower work space S2, respectively, as decontamination gas outlets for discharging the decontamination gas, and branched exhaust piping 23 is connected to these front chamber outlet 4b and first and second operation room outlets S1b, S2b. The downstream end of the discharge pipe 23 is connected to the post-filter chamber 6, and the branched portions are provided with fifth to seventh on-off valves B5 to B7, which are controlled by the control means, respectively.

[0016] Here, the pressure loss in the intake air filter 3 and the exhaust air filter 5 is large and exceeds the pressure loss in the exhaust pipe 23 . As a result, when the front chamber supply port 4a and the front chamber exhaust port 4b of the filter front chamber 4 are open, when decontamination gas is supplied from the front chamber supply port 4a to the filter front chamber 4, the decontamination gas does not flow into the air intake filter 3, which has a large pressure loss, but is discharged from the front chamber exhaust port 4b. Similarly, when the first operation room supply port S1a and the first operation room discharge port S1b in the upper work space S1 of the operation room 2 are open, when decontamination gas is supplied to the operation room 2 from the first operation room supply port S1a, the decontamination gas does not flow into the air intake filter 3, which has a large pressure loss, but is discharged from the first operation room discharge port S1b. Furthermore, even when the second operation room supply port S2a and the second operation room discharge port S2b in the lower working space S2 of the operation room 2 are open, when decontamination gas is supplied to the operation room 2 from the second operation room supply port S2a, the decontamination gas does not flow into the exhaust filter 5, which has a large pressure loss, but is discharged from the second operation room discharge port S2b. Since the mesh screen 14 also causes pressure loss and inhibits ventilation, although there is some circulation of decontamination gas between the upper work space S1 and the lower work space S2, most of the decontamination gas supplied from the first operation room supply port S1a is discharged from the first operation room discharge port S1b, and most of the decontamination gas supplied from the second operation room supply port S2a is discharged from the second operation room discharge port S2b.

[0017] The following describes how to use the isolator 1 having the above-described configuration. First, the operation of the isolator 1 when performing aseptic operations in the operation room 2 will be described. When performing aseptic operations in the operation room 2, the decontamination means 15 is not used, and the first to third on-off valves B1 to B3 provided on the supply piping 20 of the decontamination means 15, the fourth on-off valve B4 on the circulation piping 22, and the fifth to seventh on-off valves B5 to B7 on the discharge piping 23 are closed. In this state, the air supply blower 11b of the air supply means 11 is operated and the air supply damper 11c is opened, whereby the outside air (air) around the isolator 1 flows into the filter front chamber 4. The outside air that flows into the filter front chamber 4 increases the internal pressure of the filter front chamber 4 and flows into the air intake filter 3, where it is purified as it passes through the air intake filter 3, and flows out as purified gas from the entire secondary side of the air intake filter 3 into the upper working space S1, where it is rectified as it passes through the mesh screen 14, forming a downward laminar flow and being blown out into the lower working space S2. The clean air blown into the lower working space S2 is sucked into the exhaust filter 5 and flows into the post-filter chamber 6 by opening the exhaust damper 12c of the exhaust means 12 and operating the exhaust blower 12b, and is then discharged to the outside via the piping 12a. In addition, when performing aseptic operations in the operation room 2, the air flow rate of the air supply blower 11b and the exhaust blower 12b and the opening amount of the air supply damper 11c and the exhaust damper 12c are controlled to maintain a positive pressure inside the operation room 2 relative to the surrounding area of the isolator 1, thereby maintaining a sterile state inside.

[0018] 2 to 5 illustrate a method for decontaminating an isolator 1 according to the present invention. In the drawings, the first to seventh on-off valves B1 to B7 are indicated in a closed state by being filled in black, and the white ones are indicated in an open state. First, the control means performs a temperature raising operation to heat the circulation path of the decontamination gas, the filter front chamber 4, the air supply filter 3 and the operation room 2 in order to prevent the decontamination gas from liquefying due to condensation. The control means heats the evaporator 17 while stopping the supply of hydrogen peroxide solution, opens the first to third on-off valves B1 to B3 and the fourth on-off valve B4, starts blowing air using the air blower 19, and operates the heater 21 in the supply piping 20 to circulate the gas for a predetermined period of time, thereby raising the temperature of the supply piping 20, the filter front chamber 4, the air intake filter 3, the operation chamber 2, the exhaust filter 5, and the filter back chamber 6 to a predetermined temperature. In this case, the evaporator 17 is used as a heater, but a heater may be separately disposed in the filter front chamber 4 or the like.

[0019] FIG. 2 shows the state of the anterior chamber decontamination process in the decontamination work, in which decontamination gas is circulated through the filter anterior chamber 4. The control means operates the pump 18 of the decontamination means 15 to drip a liquid decontamination agent such as hydrogen peroxide water into the evaporator 17 to evaporate it, and supplies the vaporized decontamination gas to the supply pipe 20. Meanwhile, the control means opens the first on-off valve B1 of the supply pipe 20, the fourth on-off valve B4 of the circulation pipe 22, and the fifth on-off valve B5 of the discharge pipe 23. As a result, the decontamination gas flows through the supply pipe 20, passes through the first on-off valve B1 which is open, and flows into the filter front chamber 4 through the front chamber supply port 4a. Meanwhile, in the filter front chamber 4, the fifth on-off valve B5 of the discharge pipe 23 is open, and the filter rear chamber 6 to which the discharge pipe 23 is connected is suctioned by the air blower 19 connected to the circulation pipe 22. As a result, the decontamination gas in the filter front chamber 4 is drawn into the exhaust piping 23 from the front chamber exhaust port 4b, flows into the filter back chamber 6, and then flows through the circulation piping 22 and is circulated to the evaporator 17 by the blower 19. Here, the decontamination gas that has flowed into the filter front chamber 4 is discharged from the filter front chamber 4 to the discharge pipe 23 because the pressure loss of the air supply filter 3 exceeds the pressure loss of the exhaust pipe 23, and does not flow into the air supply filter 3. Therefore, unnecessary decontamination components are not adsorbed onto the air supply filter 3. The control means then maintains this state for a predetermined time, whereby the inside of the filter front chamber 4 is decontaminated by the flow of decontamination gas.

[0020] FIG. 3 shows the state of the air supply filter decontamination process in the decontamination work, in which decontamination gas is passed through the air supply filter 3. From the state shown in Figure 2, the control means closes the fifth on-off valve B5 of the discharge pipe 23 while leaving the first on-off valve B1 of the supply pipe 20 open, opens the sixth and seventh on-off valves B6 and B7, and operates all of the fans 13. As a result, the decontamination gas flows into the filter front chamber 4 from the front chamber supply port 4a, but because the fifth opening / closing valve B5 of the filter front chamber 4 is closed, the decontamination gas flows into the entire primary side of the air intake filter 3 due to the action of multiple fans 13, passes through the air intake filter 3 and flows out into the operation room 2. Meanwhile, in the operation room 2, the sixth and seventh on-off valves B6 and B7 of the exhaust piping 23 are opened, and the suction force of the blower 19 acts on the post-filter chamber 6, so that the decontamination gas is discharged from the first and second operation room exhaust ports S1b and S2b in the upper work space S1 and the lower work space S2, and then the decontamination gas is circulated from the post-filter chamber 6 through the circulation piping 22. As a result, the decontamination gas supplied to the air intake filter 3 passes through the entire air intake filter 3, and the control means maintains this state for a predetermined period of time, thereby allowing the decontamination components to be adsorbed in the amount required for decontamination according to the capacity of the air intake filter 3. It is also possible to open either one of the sixth and seventh on-off valves B6 and B7, and it is also possible to provide only one of the first and second operation chamber outlets S1b and S2b. In particular, since the mesh screen 14 causes a pressure loss, it is more efficient to exhaust the air from the first operation chamber outlet S1b above the mesh screen 14 in the filter decontamination process.

[0021] FIG. 4 shows the state of the operation room decontamination process in the decontamination work, in which decontamination gas is directly supplied to the operation room 2. From the state shown in FIG. 3, the control means closes the first on-off valve B1 of the supply pipe 20, first opens the second on-off valve B2, and then closes the seventh on-off valve B7 of the discharge pipe . As a result, the decontamination gas passes through the second on-off valve B2 of the supply piping 20, flows from the first operation room supply port S1a into the upper work space S1 above the mesh screen 14 of the operation room 2, and is discharged from the first operation room discharge port S1b of the upper work space S1. Thereafter, the decontamination gas is circulated from the post-filter chamber 6 by the circulation piping 22. At this time, since the pressure loss of the decontamination gas flowing into the upper working space S1 in the exhaust piping 23 is smaller than the pressure loss of the air supply filter 3 and the mesh screen 14, the decontamination gas is discharged from the upper working space S1 to the exhaust piping 23. Thereafter, the decontamination gas is circulated from the post-filter chamber 6 through the circulation pipe 22.

[0022] After supplying decontamination gas to the upper working space S1 for a predetermined time, the control means then closes the second on-off valve B2 of the supply pipe 20 and opens the third on-off valve B3, closes the sixth on-off valve B6 of the exhaust pipe 23 and opens the seventh on-off valve B7. As a result, the decontamination gas passes through the third on-off valve B3 of the supply piping 20 and flows into the lower work space S2 below the mesh screen 14 of the operation room 2 from the second operation room supply port S2a, and is discharged from the second operation room discharge port S2b of the lower work space S2. At this time, since the pressure loss of the decontamination gas flowing into the lower working space S2 in the exhaust piping 23 is smaller than the pressure loss of the mesh screen 14 and the exhaust filter 5, the decontamination gas is discharged from the lower working space S2 to the exhaust piping 23. Thereafter, the decontamination gas is circulated from the post-filter chamber 6 through the circulation pipe 22.

[0023] Here, in the operation room 2, pressure loss occurs due to the mesh screen 14, so that the decontamination gas is difficult to spread between the upper working space S1 and the lower working space S2 with the mesh screen 14 sandwiched therebetween. Therefore, in this embodiment, a first operation room supply port S1a and a first operation room discharge port S1b are provided for the upper work space S1, and a second operation room supply port S2a and a second operation room discharge port S2b are provided for the lower work space S2 to improve the efficiency of air supply and exhaust, but this configuration is not necessarily required. In other words, it is possible to provide either one of the first operation chamber supply port S1a, the second operation chamber supply port S2a, and the second and third on-off valves B2 and B3, and it is also possible to provide either one of the first operation chamber discharge port S1b, the second operation chamber discharge port S2b, and the sixth and seventh on-off valves B6 and B7. In any case, by providing a first operation room supply port S1a and a second operation room supply port S2a and supplying decontamination gas directly to the operation room 2 without passing through the air supply filter 3, unnecessary decontamination components will not be adsorbed onto the air supply filter 3. In addition, by providing a first operation room exhaust outlet S1b and a second operation room exhaust outlet S2b, the decontamination gas is discharged directly from the operation room 2 without passing through the exhaust filter 5, so that unnecessary decontamination components are not adsorbed onto the exhaust filter 5.

[0024] FIG. 5 shows an exhaust filter decontamination step in a decontamination operation in which decontamination gas is passed through the exhaust filter 5. The control means closes the sixth and seventh on-off valves B6 and B7 of the discharge pipe 23 from the state shown in FIG. As a result, the decontamination gas passes through the second and third on-off valves B2 and B3 of the supply piping 20 and flows into the operation chamber 2 from the first and second operation chamber supply ports S1a and S2a, but since the sixth and seventh on-off valves B6 and B7 are closed and the post-filter chamber 6 is being sucked into the air blower 19 connected to the circulation piping 22, the decontamination gas flows into the exhaust filter 5 and is adsorbed, and then is circulated from the post-filter chamber 6 by the circulation piping 22. The control means maintains this state for a predetermined time, allowing the exhaust filter 5 to adsorb the decontaminating components in an amount necessary for decontamination according to the capacity of the exhaust filter 5. The post-filter chamber 6 can also be decontaminated at the same time. When transitioning from the decontamination process to the aeration process, before stopping the supply of decontamination gas by the decontamination means 15, the second and third on-off valves B2 and B3 are closed and the first on-off valve B1 is opened, and the supply piping 20 is connected to the filter front chamber 4, and then the supply of decontamination gas is stopped. This stops the supply of decontamination gas and prevents gas that does not contain decontamination components from flowing directly into the operation room 2 without passing through the air supply filter 3, thereby preventing contamination of the operation room 2.

[0025] In this way, after sequentially executing the antechamber decontamination process, the air intake filter decontamination process, the operation chamber decontamination process, and the exhaust filter decontamination process to decontaminate the filter antechamber 4, the air intake filter 3, the operation chamber 2, and the exhaust filter 5 shown in Figures 2 to 5, the control means stops the supply of decontamination gas and transitions to the holding process in the decontamination work. In the holding step, the first to third on-off valves B1 to B3 of the supply pipe 20, the fourth on-off valve B4 of the circulation pipe 22, and the fifth to seventh on-off valves B5 to B7 of the discharge pipe 23 are all kept closed for a predetermined time.

[0026] Once the retention step is completed, the decontamination work proceeds to the aeration step, in which the decontamination components are removed. In the aeration process, the first to third on-off valves B1 to B3 of the supply pipe 20, the fourth on-off valve B4 of the circulation pipe 22, and the fifth to seventh on-off valves B5 to B7 of the exhaust pipe 23 are all kept closed, and in this state, the air intake blower 11b of the air intake means 11 is operated and the air intake damper 11c is opened to introduce outside air into the filter pre-chamber 4, and the exhaust blower 12b of the exhaust means 12 is operated and the exhaust damper 12c is opened to exhaust gas from the filter post-chamber 6. As a result, the outside air (air) introduced into the filter front chamber 4 by the air supply means 11 fills the filter front chamber 4, flows into the air supply filter 3, passes through the air supply filter 3, is purified, and flows into the operation chamber 2. At the same time, the gas in the post-filter chamber 6 is exhausted by the exhaust means 12, and the gas in the operation chamber 2 passes through the exhaust filter 5 and is exhausted to the outside via the post-filter chamber 6 and piping 12a. In this case too, the control means controls the air flow rate of the intake air blower 11b and the exhaust air blower 12b and the opening amount of the intake air damper 11c and the exhaust air damper 12c so that the pressure inside the operation room 2 is always higher than the pressure around the isolator 1. The control means continues this operation for a predetermined time to remove the decontamination components from the filter front chamber 4, the operation chamber 2, the air supply filter 3, and the exhaust filter 5. The decontamination components in the gas blown by the exhaust blower 12b are decomposed by the catalyst 12d and released to the outside. In the aeration step, it is also possible to perform aeration including the circulation pipe 22 and the discharge pipe 23 by opening all of the first to seventh on-off valves B1 to B7.

[0027] Here, in the aeration step, it is known that removing the decontamination components adsorbed on the intake air filter 3 and the exhaust air filter 5 takes the longest time. Therefore, in this embodiment, in the decontamination work shown in FIGS. 2 to 5, the antechamber decontamination process, the air supply filter decontamination process, the operation room decontamination process, and the exhaust filter decontamination process are carried out sequentially and individually. In other words, in the antechamber decontamination process and the operation room decontamination process, decontamination gas is supplied directly from the antechamber supply port 4a and the first and second operation room supply ports S1a and S2a, and the decontamination gas is not allowed to flow into the intake filter 3 or exhaust filter 5, and in the intake filter decontamination process and the exhaust filter decontamination process, the intake filter 3 and the exhaust filter 5 are each allowed to adsorb the decontamination components in the amount required for decontamination. This prevents unnecessary decontamination components from being adsorbed onto the intake filter 3 and exhaust filter 5, reducing the amount of decontamination components adsorbed onto the intake filter 3 and exhaust filter 5, thereby shortening the time required for aeration and ultimately shortening the overall decontamination time.

[0028] In contrast to this, in the past, decontamination gas was supplied to the filter front chamber 4, and the decontamination gas was passed from the filter front chamber 4 through the air supply filter 3 and flowed into the operation room 2, and the decontamination gas in the operation room 2 was circulated to the filter back chamber 6 via the exhaust filter 5, so that all of the decontamination was carried out together, resulting in a large amount of excess decontamination components being adsorbed onto each filter. In other words, the decontamination gas used to decontaminate the filter anterior chamber 4 and the decontamination gas required to decontaminate the operation room 2 and exhaust filter 5 pass through the air intake filter 3 in excess, and in addition, the decontamination gas required to decontaminate the operation room 2 and exhaust filter 5 is supplied in excess in consideration of being adsorbed by the air intake filter 3. Furthermore, the decontamination gas used to decontaminate the filter front chamber 4, the air supply filter 3, and the operation room 2 passes through the exhaust filter 5 in excess. In other words, the intake air filter 3 and the exhaust air filter 5 adsorb more decontaminating components than are necessary for decontaminating them, which causes the aeration process to take longer.

[0029] 6 is a diagram illustrating an isolator 1 according to the second embodiment. In the following description, explanations of members and the like common to the first embodiment will be omitted. The isolator 1 of this embodiment has an air supply chamber 31 adjacent to and above the filter front chamber 4, and the air supply chamber 31 and the filter front chamber 4 are separated by a partition plate 32, and a plurality of communication ports 32a are formed in the partition plate 32 at approximately equal intervals, and each communication port 32a is provided with a fan 33. The air supply means 11 is configured to supply outside air (air) to the air supply chamber 31, and the outside air supplied to the air supply chamber 31 is blown towards the filter front chamber 4 by a plurality of fans 33.

[0030] In addition, the decontamination means 15 of this embodiment is configured by installing an evaporator 17 inside the air supply chamber 31, and the pump 18 drips a liquid decontamination agent such as hydrogen peroxide water contained in a container 16 into the evaporator 17, thereby generating a decontamination gas such as hydrogen peroxide vapor inside the air supply chamber 31. Furthermore, it does not have the supply pipe 20 connected to the evaporator 17 as shown in the first embodiment, but instead has a supply pipe 34 whose upstream end is connected to the air supply port 4c of the filter front chamber 4, branches off at the downstream side, and is connected to the first operation chamber supply port S1a and the second operation chamber supply port S2a of the operation chamber 2, respectively. The supply pipe 34 is provided with a heater 35 on its outer periphery, similar to the supply pipe 20, and the branched passages are provided with second and third on-off valves B2 and B3 controlled by a control means. Furthermore, the isolator 1 of this embodiment does not include the circulation pipe 22, and therefore does not include the fourth on-off valve B4 and the air blower 19 either. Furthermore, instead of the exhaust piping 23 of the first embodiment, a front chamber exhaust pipe 36 is connected to the front chamber exhaust port 4b, and a fifth on-off valve B5 is provided in the front chamber exhaust pipe 36, and a catalyst 36a that decomposes decontamination components is provided downstream of the fifth on-off valve B5. Similarly, a first discharge pipe 37 is connected to the first operation chamber discharge outlet S1b, and a sixth on-off valve B6 and a catalyst 37a are provided in the first discharge pipe 37, while a second discharge pipe 38 is connected to the second operation chamber discharge outlet S2b, and a seventh on-off valve B7 and a catalyst 38a are provided in the second discharge pipe 38.

[0031] 7 to 10 are diagrams illustrating a decontamination method for an isolator 1 according to the second embodiment. Note that the decontamination method according to the second embodiment involves substantially the same operations as the decontamination method according to the first embodiment, and therefore only the differences will be described. FIG. 7 shows a front chamber decontamination process in a decontamination operation in which decontamination gas is passed through the filter front chamber 4. The control means closes the second and third on-off valves B2 and B3 of the supply pipe 34, opens the fifth on-off valve B5 at the front chamber discharge port 4b of the filter front chamber 4, and closes the sixth and seventh on-off valves B6 and B7. As a result, the decontamination gas generated by the evaporator 17 provided in the air supply chamber 31 fills the air supply chamber 31 and is supplied to the filter front chamber 4 by the fan 33. Since the pressure loss of the air intake filter 3 is greater than the pressure loss of the front chamber exhaust pipe 36, the decontamination gas that flows into the filter front chamber 4 flows into the front chamber exhaust pipe 36 from the front chamber outlet 4b without flowing into the air intake filter 3, and the decontamination components are decomposed by the catalyst 36a and exhausted to the outside. By doing this, similar to the front chamber decontamination process shown in Figure 2 in the first embodiment, the filter front chamber 4 is decontaminated by the decontamination gas, and unnecessary decontamination components are not adsorbed onto the air supply filter 3.

[0032] FIG. 8 shows an air intake filter decontamination process in a decontamination operation in which decontamination gas is passed through the air intake filter 3. From the state shown in FIG. 7, the control means closes the fifth on-off valve B5 at the front chamber exhaust port 4b and opens the sixth and seventh on-off valves B6 and B7 at the first and second operation chamber exhaust ports S1b and S2b of the operation chamber 2. As a result, the decontamination gas generated by the evaporator 17 in the air supply chamber 31 is blown by each fan 33 and flows into the filter front chamber 4, and as the pressure in the filter front chamber 4 increases due to the second, third, and fifth on-off valves B2, B3, and B5 being closed, the gas flows into the air supply filter 3. The decontamination gas that passes through the air intake filter 3 and flows into the operation room 2 does not flow into the exhaust filter 5 because the exhaust damper 12c of the exhaust means 12 is closed and the exhaust blower 12b is not operating, and part of it is discharged from the first operation room exhaust outlet S1b, and the decontamination gas that passes through the mesh screen 14 is discharged from the second operation room exhaust outlet S2b, and the decontamination components are decomposed by the catalysts 37a and 38a, respectively, and are discharged from the first and second exhaust pipes 37 and 38. In this manner, just the amount of decontamination gas required to decontaminate the air intake filter 3 is supplied to the air intake filter 3, similar to the air intake filter decontamination process shown in FIG. 3 according to the first embodiment. In addition, it is possible to have either the configuration consisting of the first operation chamber exhaust outlet S1b of the operation chamber 2, the first exhaust pipe 37, the sixth on-off valve B6, and the catalyst 37a, or the configuration consisting of the second operation chamber exhaust outlet S2b, the second exhaust pipe 38, the seventh on-off valve B7, and the catalyst 38a.

[0033] FIG. 9 shows the operation room decontamination process in the decontamination work, in which decontamination gas is directly supplied to the operation room 2. The control means opens the second and third on-off valves B2 and B3 of the supply pipe 34 from the state shown in FIG. As a result, the decontamination gas generated by the evaporator 17 in the air supply chamber 31 is blown by each fan 33 and flows into the filter pre-chamber 4, and does not flow into the air supply filter 3 which has a large pressure loss, but flows into the supply piping 34 from the air supply port 4c which has a smaller pressure loss than the air supply filter 3, and then flows into the upper work space S1 and the lower work space S2 from the first operation supply port S1a and the second operation supply port S2a of the operation room 2, respectively. The gas then fills the upper work space S1 and the lower work space S2 of the operation room 2 and is discharged from the first and second operation room exhaust outlets S1b and S2b, where the decontamination components are decomposed by the catalysts 37a and 38a, respectively, and then exhausted from the first and second exhaust pipes 37 and 38. 4 according to the first embodiment, the operation room 2 is decontaminated with the decontamination gas. In this case, the decontamination gas is also directly supplied to the operation room 2 and directly exhausted from the operation room 2, so that unnecessary decontamination components are not adsorbed on the air supply filter 3 or the exhaust filter 5. In addition, it is possible to have either one of the configuration consisting of the first operation supply port S1a and the second on-off valve B2 of the operation chamber 2, or the configuration consisting of the second operation supply port S2a and the third on-off valve B3, and further it is possible to have either one of the configuration consisting of the first operation chamber discharge port S1b, the first discharge pipe 37, the sixth on-off valve B6, and the catalyst 37a, or the configuration consisting of the second operation chamber discharge port S2b, the second discharge pipe 38, the seventh on-off valve B7, and the catalyst 38a.

[0034] FIG. 10 shows an exhaust filter decontamination step in a decontamination operation in which decontamination gas is passed through the exhaust filter 5. The control means closes the upper sixth and seventh on-off valves B6 and B7 from the state shown in FIG. 9, operates the exhaust blower 12b of the exhaust means 12, and opens the exhaust damper 12c. As a result, the decontamination gas generated by the evaporator 17 in the air supply chamber 31 is blown by each fan 33 and flows into the filter front chamber 4, then flows through the supply piping 34 from the air supply port 4c of the filter front chamber 4 and flows into the operation chamber 2 from the first operation supply port S1a and the second operation supply port S2a. The decontamination gas that flows into the upper working space S1 of the operation room 2 passes through the mesh screen 14, and together with the decontamination gas that flows into the lower working space S2, passes through the exhaust filter 5 by the suction action of the exhaust blower 12b of the exhaust means 12 and flows into the post-filter chamber 6, flows into the piping 12a, and the decontamination components are decomposed by the catalyst 12d and exhausted to the outside. 5 according to the first embodiment, the exhaust filter 5 adsorbs the minimum amount of decontamination gas required to decontaminate the exhaust filter 5. At the same time, the post-filter chamber 6 is also decontaminated. It is to be noted that the operation chamber 2 may be provided with either the configuration consisting of the first operation supply port S1a and the second on-off valve B2 or the configuration consisting of the second operation supply port S2a and the third on-off valve B3.

[0035] After the antechamber decontamination process, the air supply filter decontamination process, the operation room decontamination process, and the exhaust filter decontamination process are performed in this manner, a holding process is performed for a predetermined time, as in the first embodiment, and then the process moves to the aeration process. In the aeration process, the second, third, fifth, sixth and seventh on-off valves B2, B3, B5, B6 and B7 are closed, the air supply blower 11b of the air supply means 11 is operated and the air supply damper 11c is opened to supply outside air to the air supply chamber 31. Furthermore, by operating each fan 33, outside air is sent from the air supply chamber 31 to the filter front chamber 4, increasing the internal pressure of the filter front chamber 4 and causing the outside air to flow into the air supply filter 3, which then passes through the air supply filter 3 and supplies clean air to the operation chamber 2. At the same time, the exhaust blower 12b of the exhaust means 12 is operated and the exhaust damper 12c is opened to exhaust air from the post-filter chamber 6, thereby passing the gas in the operation chamber 2 through the exhaust filter 5 and exhausting it. By carrying out aeration in this manner for a predetermined period of time, the decontamination components adhering to the walls and contents in the operation room 2 and the mesh screen 14 are removed, as well as the decontamination components adsorbed on the air supply filter 3 and the exhaust filter 5. The removed decontamination components are decomposed by the catalyst 12d provided in the exhaust means 12.

[0036] In this second embodiment, as in the first embodiment, by carrying out the filter pre-chamber decontamination process, the air intake filter decontamination process, the operation room decontamination process, and the exhaust filter decontamination process, the air intake filter 3 and the exhaust filter 5 are adsorbed with the decontamination components in the amount required for decontamination, and therefore the amount of decontamination components adsorbed on the air intake filter 3 and the exhaust filter 5 is reduced, making it possible to shorten the time required for aeration and ultimately shorten the decontamination time.

[0037] In each of the above embodiments, the upper work space S1 and the lower work space S2 separated by the mesh screen 14 are provided with first and second operation room supply ports S1a, S2a and first and second operation room discharge ports S1b, S2b, respectively, but it is also possible to omit the second operation room supply port S2a from the lower work space S2 and omit the first operation room discharge port S1b from the upper work space S1. For example, if a supply port and an exhaust port are provided in either the upper work space S1 or the lower work space S2, it will be difficult for the decontamination gas to pass through the mesh screen 14 and spread throughout. However, with the above configuration, when the decontamination gas is flowed into the upper work space S1 from the first operation room supply port S1a, the decontamination gas passes through the mesh screen 14 and flows into the lower work space S2, and is then discharged from the second operation room exhaust port S2b. This means that the decontamination gas can be efficiently circulated through the operation room 2 while reducing the number of required components.

[0038] Furthermore, the isolator 1 of the second embodiment does not include the circulation piping 22 as in the first embodiment, but the circulation piping 22 may be provided between the post-filter chamber 6 and the evaporator 17 as in the first embodiment to circulate the decontamination gas. Conversely, the circulation piping 22 may be omitted from the isolator 1 of the first embodiment as in the second embodiment. Furthermore, the isolator 1 of the second embodiment may be provided with an exhaust pipe 23 as in the first embodiment, or conversely, the isolator 1 of the first embodiment may be configured as in the second embodiment and the exhaust pipe 23 may be omitted. As for the exhaust filter 5, even if decontamination components remain, it will not affect the aseptic operation in the operation room 2 as long as outside air does not flow back toward the operation room 2. Therefore, in both the first and second embodiments, it is possible to omit the first and second operation room exhaust ports S1b and S2b and allow the exhaust of decontamination gas during the operation room decontamination process to flow into the exhaust filter 5. In this case, the exhaust filter decontamination process is omitted, and it is possible that more decontamination components than necessary will be adsorbed onto the exhaust filter 5. However, the aeration process may be terminated even if decontamination components remain on the exhaust filter 5, as long as the decontamination components in the filter anteroom 4, air intake filter 3, and operation room 2 can be removed. [Explanation of symbols]

[0039] 1 Isolator 2 Control room 3 Air intake filter 4 Filter front chamber 4a Front chamber supply port 4b Front chamber discharge port 5 Exhaust filter 6 Filter rear chamber 15 Decontamination means 20 Supply piping 22 Circulation piping 23 Discharge piping S workspace S1 Upper workspace S1a 1st operation room supply port S1b 1st operation room outlet S2 Lower work space S2a 2nd operation room supply port S2b Second operation chamber outlet B1~B7 First to seventh opening and closing valves

Claims

1. An isolator comprising an operation chamber having a work space formed therein, an air intake filter provided at an air intake port formed in the operation chamber to purify gas, a filter front chamber provided to cover the primary side of the air intake filter, and decontamination means for supplying decontamination gas to the filter front chamber, a decontamination gas outlet that can be opened and closed by an opening and closing valve is provided in the filter front chamber; an isolator characterized in that the decontamination means supplies a decontamination gas to the filter front chamber, and an opening / closing valve of the exhaust port is opened to discharge the decontamination gas supplied to the filter front chamber from the exhaust port, thereby decontaminating the filter front chamber.

2. a decontamination gas supply port that can be opened and closed by an opening and closing valve is provided in the operation room; the decontamination means is configured to be able to supply decontamination gas from the supply port to the operation room, the exhaust port of the filter front chamber is closed, and the decontamination means supplies a decontamination gas to the filter front chamber to decontaminate the air intake filter; 2. The isolator according to claim 1, wherein the supply port of the operation chamber is opened and the operation chamber is decontaminated by supplying the decontamination gas into the operation chamber by the decontamination means.

3. A straightening screen is provided to divide the work space in the operation room into upper and lower sections, 3. The isolator according to claim 2, wherein a supply port for the decontamination gas is provided above the rectifying screen.

4. A decontamination method for an isolator comprising: an operation chamber having a work space formed therein; an air intake filter provided at an air intake port formed in the operation chamber to purify gas; a filter front chamber provided to cover a primary side of the air intake filter; and decontamination means for supplying a decontamination gas to the filter front chamber, The decontamination gas supplied from the decontamination means can be supplied to the filter front chamber and the operation chamber, and an outlet for the decontamination gas is provided in the filter front chamber, a front chamber decontamination process in which a decontamination gas is supplied to the front filter chamber and an exhaust port of the front filter chamber is opened to allow the decontamination gas to flow through the front filter chamber; an air intake filter decontamination process in which a decontamination gas is supplied to the filter front chamber with the exhaust port of the filter front chamber closed, and the decontamination gas is passed through the air intake filter; an operation room decontamination step of stopping the supply of decontamination gas to the filter front chamber and supplying decontamination gas to the operation room, A method for decontaminating an isolator, characterized in that after the above-mentioned front chamber decontamination process, air intake filter decontamination process, and operation chamber decontamination process are performed in sequence, an aeration process is performed in which gas is passed through the air intake filter from the filter front chamber to the operation chamber.

5. A decontamination gas outlet is provided in the operation room.

5. The method for decontaminating an isolator according to claim 4, wherein the operation room decontamination step includes supplying a decontamination gas to the operation room and opening an exhaust port of the operation room to allow the decontamination gas to flow through the operation room.

6. The isolator includes an exhaust filter provided at an exhaust port formed in the operation chamber to purify air, and a post-filter chamber provided to cover the secondary side of the exhaust filter, an exhaust filter decontamination step of supplying a decontamination gas to the operation room and passing the decontamination gas through the exhaust filter while the exhaust port of the operation room is closed; The above-mentioned front room decontamination process, air supply filter decontamination process, operation room decontamination process, and exhaust filter decontamination process are carried out in order.

6. The method for decontaminating an isolator according to claim 5, wherein in the aeration step, the gas is passed through the air supply filter to circulate from the pre-filter chamber to the operation chamber, and the gas is passed through the exhaust filter to circulate from the operation chamber to the post-filter chamber.

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