JP6701126B2 - Isolator - Google Patents

Description

  The present invention relates to an isolator, and particularly to a technique effective for sterilizing a filter for air supply and exhaust in a sterilization process.

  Isolators are used when researching the pathogen or treating tissue that may be infected by the pathogen or the like in regenerative medicine. With the isolator, a worker can work from the outside of the work chamber through a glove that is a work attachment. For example, in regenerative medicine, the patient tissue to be handled may be infected with an infectious disease, and the working room should be cleaned before changing the patient tissue to be handled so that the pathogen of the infectious disease does not infect the patient tissue to be treated next. , It is necessary to disinfect and make it aseptic.

  Also, in the research, the pathogen is handled in the isolator work room. The pathogen refers to viruses, bacteria, fungi, etc., but each has its own unique characteristics, and the pathogen may affect other pathogens. When changing the type of pathogens handled in the same isolator, it is necessary to clean, disinfect and sterilize the work room, gloves used for work, bags for disposal, etc. Sterilization is performed by supplying a sterilizing gas to the working room and gloves.

  Patent Document 1 discloses an isolator that supplies decontamination (sterilization) gas to a working room of the isolator and then performs aeration to decompose the sterilization gas with a catalyst.

JP, 2014-198079, A

  In Patent Document 1, decontamination (hereinafter referred to as sterilization) gas is introduced into the aseptic chamber (working room) through the HEPA filter, but sterilization of the air supply HEPA filter and the exhaust HEPA filter. Moreover, sufficient consideration has not been given to effectively reducing the concentration of sterilizing gas.

  An object of the present invention is to provide an isolator that can effectively sterilize an air supply HEPA filter and an exhaust HEPA filter.

  In order to solve the above problems, as a preferred example of the present invention, a work chamber in which work is performed, a fan for giving an air flow into the work chamber, an air-tight damper for supplying air from the outside, and an external unit. An airtight damper for exhausting air to the air, an air supply filter for cleaning air from the airtight damper for air supply, an exhaust filter for cleaning air to the airtight damper for exhaust, and the air supply A first bypass circuit formed between the exhaust airtight damper and the exhaust airtight damper, a first valve provided in the first bypass circuit, and a control unit for controlling the first valve. The control unit is an isolator that controls the first valve to open when sterilizing the working chamber.

  According to the present invention, it is intended to realize an isolator capable of effectively sterilizing a supply air HEPA filter and an exhaust air HEPA filter.

The front view of the isolator concerning an Example. The right side view of an isolator. The figure which shows the flow of the airflow at the time of work of the isolator of FIG. The figure which shows the flow of the airflow at the time of sterilization of the isolator apparatus of FIG. The figure explaining switching of a bypass circuit. The figure explaining the flow of valve opening and closing of a bypass circuit.

  Prior to the description of the embodiments, an isolator to which the present invention is applied will be described. 1 and 2 are a front view and a side view showing an example of an isolator, respectively. 3 and 4 show internal cross-sectional views thereof.

  Regarding the isolator main chamber 10, a working chamber 12 for performing a work of handling a sample such as a pathogen is provided in a case (housing). An airtight damper 14 for air supply is provided on the upper part of the case to take in air from the outside of the isolator.

A fan 16 is provided above the work chamber 12, and a HEPA filter 18 and a punching plate 20 are provided downstream of the fan 16 to supply clean and rectified air to the work chamber 12.
A slit 100 is provided in the lower part of the work chamber 12, and the air discharged from the slit 100 returns to the upstream side of the fan 16 to circulate the air. Part of the air is discharged to the outside from the exhaust airtight damper 22 provided on the upper surface of the case.

  A front door 23 made of glass or resin is attached to the front side of the work chamber 12, an opening is formed in the front door 23, and a plurality of work gloves are attached (left side, center, right side in the figure). The globe port 24 is provided. Then, the globe port 24 is attached with a globe 25 in which the operator handles the sample in the working chamber (FIG. 2).

  A pass box 40 is attached to the side surface of the work chamber 12 via a connecting portion 48. The pass box 40 is provided with a circulation fan 42 and a HEPA filter 44 on the upper part, and a punching plate 46 on the lower part, so that air is circulated when the pass box is operated. A pass box side opening/closing door 26 is provided on the pass box side of the working chamber 12 so that a sample or the like can be loaded and unloaded through the pass box 40.

  The isolator includes a sterilizing gas generator 50 used during sterilization, and supplies a sterilizing gas such as hydrogen peroxide gas to the isolator main chamber 10 from a condition (outgoing) path 54.

  The sterilizing gas returns from the pass box 40 to the sterilizing gas generator 50 through the condition (return) path 52. The isolator main chamber 10 is provided with an aeration path 56 for removing sterilizing gas in the aeration process (FIG. 2).

  The aeration path 56 has a piping valve 30 provided above the aeration path 56, a fan 31 for circulating air through the aeration path 56, a catalyst 32 for decomposing hydrogen peroxide gas, and piping provided below the aeration path 56. A valve 33 is provided.

  The flow of air during normal work for processing a sample in the work chamber will be described with reference to FIG. Air is taken in from the outside of the isolator by the air-tight damper 14 for air supply. The fan 16 sends air into the fan case 65, and the downstream HEPA filter 18 and punching plate 20 send clean and aligned air into the working chamber 12.

  The air in the work chamber is discharged from the slit 100 provided in the lower part of the work chamber, returns to the upstream side of the fan 16 and circulates. Part of the air is discharged to the outside from the exhaust airtight damper 22. By supplying clean and aligned air to the working chamber 12 in this way, it is possible to prevent contamination of the sample during working.

  When the patient tissue to be handled is changed, or when the type of pathogen or the like to be handled is changed, it is necessary to sterilize the work room or the gloves used for the work. The flow of sterilization gas during sterilization will be described with reference to FIG. During sterilization, the air-tight damper 14 for air supply and the air-tight damper 22 for exhaust are closed to block the flow of air from the outside of the isolator.

  For example, hydrogen peroxide gas generated by the sterilizing gas generator 50 is supplied to the flow path of the isolator main chamber. The sterilizing gas flows through the fan case 65 by the fan 16, passes through the HEPA filter 18 and the punching plate 20, and is sent into the working chamber 12. At the time of sterilization, the opening/closing door 26 on the pass box side is opened, and the sterilizing gas in the working chamber is sent to the pass box 40 via the connecting portion 48.

  The sterilizing gas returns to the sterilizing gas generator 50 through the pass box 40. By circulating the sterilizing gas in the isolator including the work chamber 12 in this manner, it is possible to sterilize the isolator including the work chamber 12 and equipment such as work gloves.

The sterilization process is performed as follows.
(1) Dehumidification process Dry air reduces the humidity. Reducing the humidity keeps the required concentration of sterile gas (eg, hydrogen peroxide water gas) below the saturation level during subsequent conditioning and decontamination steps. The return air is dried and heated through the drying cartridge.
(2) Conditioning process While the sterilizing agent is being injected into the air stream, the dry air continues to circulate until just before the sterilizing gas leaves the device. The condition step is a step for quickly reaching the target sterilization concentration.
(3) Decontamination process The sterilizing agent is used to maintain the sterilization gas concentration in the entire isolator for a specified time, and the work room and work gloves are sterilized.
(4) Aeration step The injection of the sterilizing agent is stopped, and dry air is circulated for a certain period of time in order to reduce the concentration of sterilizing gas in the isolator and the connection hose.

  The circulation of the sterilizing gas by the bypass circuit will be described as a first embodiment with reference to FIG. FIG. 5 shows a peripheral structure of a fan case 65 provided with an airtight damper 14 for air supply and an airtight damper 22 for exhaust provided in the upper part of the working chamber of the isolator in FIG. 1, and a fan 16 provided below them. There is.

  The air-tight damper 14 for air supply is used when air is taken into the isolator main chamber 10 from the outside of the isolator. As shown in FIGS. 1 and 3, the fan 16 sends air, and the downstream HEPA filter 18 and the punching plate 20 send clean and aligned air into the working chamber 12. Air can be discharged from the airtight damper 22 for exhaust to the outside.

  The air supply motor damper 34 is provided in the air supply airtight damper 14, and opens and closes the air supply path of the air supply airtight damper 14 by controlling the power supply. The exhaust motor damper 35 is provided in the exhaust airtight damper 22, and opens and closes the exhaust path of the exhaust airtight damper 22 by controlling the power supply.

  The air supply HEPA filter 62 is provided below the air supply airtight damper 14 to remove dust, dust, etc. from the air supplied from the air supply airtight damper 14 to obtain clean air. The exhaust HEPA filter 63 is provided below the exhaust airtight damper 22 to remove dust, dust, etc. from the air and send clean air to the exhaust airtight damper 22.

  When the sterilization step is dehumidification/condition/decontamination, as described above, the air-supply airtight damper 14 and the air-exhaust airtight damper 22 are closed to shut off the air flow from the outside of the isolator.

  As shown in FIG. 5, the first bypass circuit 37 is sterilized between the airtight damper 14 for air supply and the airtight damper 22 for exhaust, which is formed separately from the fan case 65 in which the work chamber 12 and the fan 16 are arranged. It is a transmission line that sends air such as gas. The first bypass circuit 37 is provided with a first electric valve 36 that opens and closes the air flow of the first bypass circuit 37, and a control unit (PLC) 64 described later opens and closes the first electric valve 36. Take control.

  The control unit 64 controls to open the first electric valve 36. By doing so, by driving the fan 16 in the sterilization process, the flow of the sterilizing gas is changed from the fan case 65 to the exhaust HEPA filter 63, the exhaust airtight damper 22, the first bypass circuit 37, and the air supply airtight damper. 14. The flow returns to the fan case 65 via the air supply HEPA filter 62. Such a flow and the flow of the sterilizing gas shown in FIG. 4 circulate in the isolator.

  Therefore, the effect of sterilization on the air-supply airtight damper 14 and the air-exhaust airtight damper 22, the air-supply HEPA filter 62, and the exhaust HEPA filter 63 is enhanced.

  According to the present embodiment, by opening the first electric valve 36 of the first bypass circuit 37, hydrogen peroxide gas circulates in the air flow generated by the fan 16, and the HEPA filter 62 for air supply and the exhaust air are discharged. The effect of sterilizing the HEPA filter 63 can be enhanced.

  Further, since the control unit 64 controls the first electric valve 36 to open only in the initial stage (a few minutes) of the hydrogen peroxide spraying process, the hydrogen peroxide gas is prevented from circulating after sterilization. It is possible to suppress excessive adsorption of hydrogen peroxide gas on the supply HEPA filter 62 and the exhaust HEPA filter 63.

  Switching of the bypass circuit during aeration will be described as a second embodiment with reference to FIG.

  As shown in FIG. 5, the second bypass circuit 38 is formed separately from the fan case 65 in which the working chamber 12 and the fan 16 are arranged and the first bypass circuit 37, and the airtight damper 14 for air supply and the airtight damper for exhaust air. It is a transmission line that sends air to and from the damper 22. The second bypass circuit 38 is provided with a second electric valve 39 that opens and closes the flow of air in the second bypass circuit 38, and a catalyst 61 that decomposes hydrogen peroxide gas that is sterilizing gas. A control unit (PLC) 64 that controls the opening and closing of the second electric valve 39.

  The control unit 64 controls to open the second electric valve 39. Then, by driving the fan 16 during aeration, the flow of sterilizing gas flows from the fan case 65 through the second bypass circuit 38 in which the exhaust HEPA filter 63, the exhaust airtight damper 22, and the catalyst 61 are arranged. Then, the flow returns to the fan case 65 via the air-tight damper 14 for air supply and the HEPA filter 62 for air supply. Such a flow and the flow of the sterilizing gas in the aeration path 56 shown in FIG. 2 circulate in the isolator. The concentration of the sterilizing gas can be reduced by circulating the air flow.

  According to this embodiment, during the aeration during the sterilization process, the second electric valve 39 of the second bypass circuit 38 is opened, the inside of the air-tight damper 14 for air supply and the air-tight damper 22 for exhaust, and the HEPA for air supply. The hydrogen peroxide concentration can be reduced by aeration of the filter 62 and the exhaust HEPA filter 63. Further, in addition to the catalyst 32 provided in the aeration path 56, the catalyst 61 provided in the second bypass circuit 38 can reduce the hydrogen peroxide concentration.

  A control flow of the bypass circuit by the control unit (PLC) 64 will be described with reference to FIG. When the sterilization process (dehumidification/condition/decontamination) starts (step S1), the control unit (PLC) 64 controls to open the first electric valve 36 provided in the first bypass circuit 37, and The second electric valve 39 provided in the second bypass circuit 38 is controlled to be closed (step S2).

  In the dehumidification/condition/decontamination, the second bypass circuit 38 in which a catalyst for decomposing hydrogen peroxide gas is arranged is closed for effective sterilization.

It is determined whether the sterilization process (decontamination) is completed, and the control unit 64 controls the first electric valve 36 to open and the second electric valve 39 to close until the decontamination is completed. Control is performed (step S3).
When the sterilization process (decontamination) is completed, the control unit 64 controls to close the first electric valve 36 and to open the second electric valve 39 (step S4).

When the sterilization process (aeration) starts (step S5), the control unit 64 determines whether the sterilization process (aeration) is completed (step S6).
When the sterilization process (aeration) is completed, the control unit 64 controls the first electric valve 36 to be closed and the second electric valve 39 to be closed (step S7).

10... Isolator main room, 12... Working room, 14... Air-supply airtight damper, 16... Fan, 22... Exhaust airtight damper, 36... First electric valve, 37... First bypass circuit, 38... Second Bypass circuit, 39... Second electric valve, 40... Pass box, 48... Connection part, 50... Sterilization gas generator, 56... Aeration path, 62... Air supply HEPA filter, 63... Exhaust HEPA filter, 64 ...Control unit (PLC)

Claims (4)

A work chamber in which work is performed, a fan for giving an air flow into the work chamber, an airtight damper for supplying air from the outside, an airtight damper for exhausting air for discharging the outside, and the airtight for supplying air An air supply filter for cleaning the air from the damper, an exhaust filter for cleaning the air to the exhaust airtight damper, and a first filter formed between the air supply airtight damper and the exhaust airtight damper One bypass circuit, a first valve provided in the first bypass circuit, and a control unit for controlling the first valve,
A second bypass circuit is provided between the air-tight damper for air supply and the air-tight damper for exhaust, and a second valve and a catalyst for decomposing sterilizing gas are provided in the second bypass circuit. ,
The control unit controls to open the first valve when sterilizing the working chamber ,
An isolator characterized by controlling the second valve to open during aeration . 2. The isolator according to claim 1 , wherein when the first valve is opened, the control unit controls to close the second valve. The isolator according to claim 1, wherein the air supply airtight damper and the air exhaust airtight damper are closed when the first valve is opened. The isolator according to claim 1 or 2 , wherein during sterilization, the first filter is provided only while avoiding excessive adsorption of the sterilizing gas to the air supply filter or the exhaust filter. An isolator, wherein the control unit controls to open a valve.

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