The present invention relates to a safety cabinet used for the preparation of cells or the like, and a method for sterilizing the same.
When cells or microorganisms are handled in a research of pathogens or the like or in regenerative medicine or the like, an isolator or a safety cabinet is used.
In the isolator which is a closed system, an operator can perform an operation via an operation glove from outside an operation chamber which is isolated. In the isolator, when a handled patient tissue is changed, or the type of a handled pathogen is changed, it is necessary to sterilize the operation chamber or the glove by cleaning and disinfecting the inside of the operation chamber or the glove used in the operation. The sterilization is performed by supplying a sterilization gas to the operation chamber or the glove.
In the safety cabinet (class II cabinet for the countermeasure of biohazard) which is an open system, purified air from which dust, pathogens, and the like are filtered by a HEPA filter or the like is supplied to an operation chamber from an upper outlet port of the operation chamber formed inside the apparatus. Then, together with air in the operation chamber, air in a room where the safety cabinet is disposed is taken in from an operation bed front intake port, which is formed on a front side of an operation bed that is a lower surface of the operation chamber, through an operation opening formed in a front surface of the operation chamber, and inlet airflows are formed in the operation opening. In addition, when the intake air is exhausted outside the safety cabinet, air containing pathogens and the like is filtered by an exhaust HEPA filter or the like. The HEPA filter is the abbreviation of a high efficiency particulate air filter. A pathogen or the like, which is handled inside the operation chamber, is prevented from leaking outside the safety cabinet which is caused by the inlet airflows formed in the operation opening to infect an operator and to spread to the environment.
Patent Document 1 illustrates one example of the isolator, and Patent Document 2 illustrates one example of the safety cabinet.
Patent Document 1: JP 2010-69255 A
Patent Document 2: JP 2009-119391 A
In the isolator which is a closed system, it is possible to secure a sterility assurance level by sterilizing the operation chamber or the operation glove by supplying the sterilization gas thereto; however, since it is necessary to perform an operation via the operation glove attached to a front door, there is a problem in securing operability.
On the contrary, in the safety cabinet, since the operator inserts the hands from the operation opening below a front door, and performs an operation, a good operability is attained; however, in order to sterilize the operation chamber, it is necessary to sterilize the entirety of the room where the safety cabinet is installed, or in regular inspection, it is necessary for a service engineer to perform sterilization in a state where the front surface of the operation chamber is covered, and thus there is a problem in sterilizing the apparatus and securing the sterility assurance level.
Herein, the sterility assurance level (SAL) refers to the maximum survival probability of contaminating bacteria which is estimated to exist in a sterilized product processed in a proper sterilization step, and is expressed by 10−n. Currently, SAL: 10−6 is adopted internationally, and implies that the probability where microorganisms survive in a sterilized object after a sterilization operation is one millionth.
An object of the present invention is to provide a safety cabinet in which a good operability is attained and it is possible to secure a sterility assurance level.
In order to solve the problems, as one example of a “safety cabinet” of the present invention, there is provided a safety cabinet including an operation chamber, a front door that covers part of an opening of a front surface of the operation chamber, an operation opening below the front door, into which an operator can insert an hand and perform an operation, and a front slit, which takes in air inside the operation chamber and air in a room through the operation opening, on a front surface side of a lower portion of the operation chamber, the cabinet including sterilization gas generating means; and sealing means for sealing the operation opening during a sterilization operation.
In addition, as one example of a method for sterilizing a safety cabinet of the present invention, there is provided a method for sterilizing a safety cabinet including an operation chamber, a front door that covers part of an opening of a front surface of the operation chamber, an operation opening below the front door, into which an operator can insert an hand and perform an operation, and a front slit, which takes in air inside the operation chamber and air in a room through the operation opening, on a front surface side of a lower portion of the operation chamber, the method including a step of sealing the operation opening; a step of performing an airtightness test on the safety cabinet including the operation chamber; and a step of performing sterilization by supplying a sterilization gas to a flow path including the operation chamber when airtightness is confirmed by the airtightness test.
According to the present invention, it is possible to provide the safety cabinet in which a good operability is attained and it is possible to secure the sterility assurance level.
Tasks, configurations, and effects other than those described above become apparent from the description of the following embodiments.
Embodiments of the present invention will be described with reference to the drawings. Incidentally, in each drawing for describing the embodiments, as far as possible, the same names and reference signs will be assigned to the same configuration elements, and the repeated descriptions thereof will be omitted.
An operation chamber 12 in which a specimen such as a pathogen is handled is provided inside a case (housing). A front door 23 which covers part of an opening is provided in a front surface of the operation chamber 12. An operation opening 25, into which an operator can insert the hands and perform an operation, is provided below the front door 23. A circulation fan 16 is provided in an upper portion of the operation chamber 12, a circulation HEPA filter 18 and a punching plate 20 are provided downstream of the circulation fan 16, and a rectified flow of purified air is supplied to the operation chamber 12. A front slit (front intake port) 30a is provided on a front surface side of a lower portion of the operation chamber 12, and takes in air inside the operation chamber and air in a room through the operation opening 25. In addition, air inside the operation chamber is taken in from a back slit (rear intake port) 30b provided on a back surface side. The air taken in through the slits 30a and 30b returns upstream of the circulation fan 16 through ducts provided on a side surface and a back surface of the operation chamber, so that the air circulates. Part of the air is delivered to an exhaust HEPA filter 27 by an exhaust fan 26, and is exhausted to the outside from an airtight damper 22 for exhaust which is provided on an upper surface of the case. The front door 23 of the operation chamber 12 is made of, for example, glass or resin. The operator can see an operation, which is performed with the hands, therethrough. In addition, as illustrated by an arrow in
A sterilization airtight cover 24 which closes the opening 25 of the front surface of the operation chamber is provided as a distinguishing configuration of the present example. As illustrated in
Then, the safety cabinet of the present example includes a sterilization gas generation apparatus 50 which is to be used for sterilization. A sterilization gas such as hydrogen peroxide gas is supplied from a condition (outgoing) path 54 to the operation chamber 12, and is sprayed from a sterilization gas inlet port 32. The sterilization gas circulates through a flow path of the safety cabinet, and part of the sterilization gas returns to the sterilization gas generation apparatus 50 through a condition (returning) path 52. A safety cabinet 10 is provided with an aeration path for removing the sterilization gas after a sterilization step ends. For example, as illustrated in
In
When a handled patient tissue is changed, or the type of a handled pathogen or the like is changed, it is necessary to sterilize the inside of the operation chamber. The airtight damper 22 for exhaust is closed during sterilization. In addition, in addition to closing the front door 23, the sterilization airtight cover 24 is closed to shut off the flow of air between the safety cabinet and the outside. For example, hydrogen peroxide gas generated by the sterilization gas generation apparatus 50 is supplied from the condition (outgoing) path 54 to the operation chamber 12 of the safety cabinet. Then, the sterilization gas circulates from the operation chamber to the circulation fan 16 and the circulation HEPA filter 18 through the ducts, and part of the sterilization gas returns to the sterilization gas generation apparatus 50 through the condition (returning) path 52. As described above, the sterilization gas circulates through the safety cabinet including the operation chamber, and thus it is possible to sterilize the safety cabinet including the operation chamber.
Incidentally, in
In addition, in the present example, a HEPA filter has been described as a filter; however, any type of air filter may be used as long as purified air from which dust, pathogens, and the like are filtered can be supplied through the air filter.
The sterilization step is performed as follows.
(1) Dehumidification Step
Humidity is lowered by dry air. The required concentration of a sterilization gas (for example, hydrogen peroxide gas) is kept equal to or less than a saturation level in the following conditioning step and the following decontamination step by lowering the humidity. Returning air is dried and heated via a dry cartridge.
(2) Conditioning Step
While a sterilizing agent is injected into the airflows, the dry air continues to circulate until immediately before the sterilization gas leaves an instrument. The conditioning step is a step for rapidly reaching a target sterilization concentration.
(3) Decontamination Step
For a specific time, the entire concentration of the sterilization gas inside the safety cabinet is maintained by the sterilizing agent, and the operation chamber, the HEPA filter, or the like is sterilized.
(4) Aeration Step
The injection of the sterilizing agent is stopped, and the aeration path including the catalyst unit which adsorbs the sterilization gas is connected. Then, the dry air circulates for a predetermined time, and the concentration of the sterilization gas inside the safety cabinet and a connection hose is lowered.
According to the present example, the safety cabinet including the operation opening in a lower portion of the front surface is configured such that sealing means for closing the operation opening during sterilization is provided and the sterilization gas can be supplied, and thus it is possible to provide the safety cabinet in which an operator can perform sterilization after an operation, a good operability is attained, and it is possible to secure a sterility assurance level. In addition, it is possible to save labor by automating the sterilization operation of the safety cabinet.
The safety cabinet 10 for manufacture (preparation) requires that an operation chamber is a purified space, has a high airtightness, and can be sterilized. On the contrary, the safety cabinet 40 for inspection requires that an operation chamber is a purified space and a specimen such as cells is contained inside the operation chamber. Therefore, the safety cabinet 10 for manufacture (preparation) and the safety cabinet 40 for inspection are coupled to each other via a coupling portion 42, and an opening and closing door is provided in the coupling portion. The opening and closing door is normally closed, and is to be open when the specimen is moved between the safety cabinet 10 for manufacture (preparation) and the safety cabinet 40 for inspection in an inspection step. In addition, during sterilization, the opening and closing door is sealed. During an operation and sterilization, the operation of the safety cabinet 10 for manufacture (preparation) is the same as that in Example 1.
According to the present example, the safety cabinet for manufacture (preparation) and the safety cabinet for inspection are coupled to each other, and different steps for manufacture (preparation) and inspection are shared via the coupling portion in a vacuum state, and thus it is possible to transfer the specimen in the purified spaces without contaminating the specimen, and it is possible to limit the application of a sterilization space only to the safety cabinet for manufacture (preparation). Therefore, it is possible to reduce a sterilization time.
The present example is configured such that the H2O2 catalyst unit 28 is disposed in a flow path for airflows induced by the exhaust fan 26 when the airtight damper 22 for exhaust is closed, and airflows which have passed through the H2O2 catalyst unit 28 are drawn into the intake port of the circulation fan 16.
The airtight damper 22 for exhaust is fully closed during sterilization. In the aeration step during sterilization, as illustrated by arrows in
According to the present example, the catalyst unit is disposed in the flow path for airflows induced by the exhaust fan when the airtight damper for exhaust is closed, and airflows which have passed through the catalyst unit are drawn into the intake port of the circulation fan through the flow path, and thus it is possible to efficiently lower the concentration of the sterilization gas, and to reduce the sterilization time of the aeration step. In addition, it is possible to also prevent the sterilization gas from remaining in the filter material of the circulation HEPA filter.
In addition, if during aeration, the flow rate of the exhaust fan is increased and the circulation fan operates intermittently or operates at a low flow rate, since the circulation efficiency of a circulation path of the catalyst unit improves, it is possible to reduce the time of the aeration step.
Furthermore, since the catalyst unit is accommodated inside the safety cabinet, it is possible to make the appearance look cleaner compared to a case where the catalyst unit is provided outside. In addition, it is not necessary to perform on-site work such as connecting the catalyst unit to the safety cabinet after the safety cabinet is installed.
Filing Document | Filing Date | Country | Kind |
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PCT/JP2017/025770 | 7/14/2017 | WO | 00 |