CN112168997A - Isolator and hydrogen peroxide gas sterilization method - Google Patents

Isolator and hydrogen peroxide gas sterilization method Download PDF

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Publication number
CN112168997A
CN112168997A CN202011003609.6A CN202011003609A CN112168997A CN 112168997 A CN112168997 A CN 112168997A CN 202011003609 A CN202011003609 A CN 202011003609A CN 112168997 A CN112168997 A CN 112168997A
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isolator
hydrogen peroxide
peroxide gas
concentration
saturation
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CN112168997B (en
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王诗华
张旭
任江良
顾天宇
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Hangzhou Dongsheng Biotechnology Co ltd
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Hangzhou Dongsheng Biotechnology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • A61L2/208Hydrogen peroxide

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Disinfection, Sterilisation Or Deodorisation Of Air (AREA)

Abstract

The application relates to the technical field of sterile isolators, in particular to an isolator and a hydrogen peroxide gas sterilization method. The method specifically comprises the steps of obtaining a sterilization instruction input by an experimenter; according to the sterilization instruction, obtaining sterilization parameters, wherein the sterilization parameters at least comprise a concentration threshold value and a concentration fluctuation range; continuously introducing hydrogen peroxide gas into the isolator to enable the concentration of the hydrogen peroxide in the air inside the isolator to reach the concentration threshold value; after the concentration of the hydrogen peroxide gas in the isolator reaches the concentration threshold value, maintaining the concentration of the hydrogen peroxide gas in the isolator within the concentration fluctuation range so that the hydrogen peroxide gas can sterilize and disinfect the inside of the isolator; after the hydrogen peroxide gas sterilizes the interior of the isolator, the hydrogen peroxide gas in the isolator is removed. The method achieves the purpose of enhancing the reliability of the hydrogen peroxide gas sterilization process by controlling the concentration of the hydrogen peroxide gas.

Description

Isolator and hydrogen peroxide gas sterilization method
Technical Field
The application relates to the technical field of sterile isolators, in particular to an isolator and a hydrogen peroxide gas sterilization method.
Background
In the aseptic production and detection process, the production and detection environment is required to be in an aseptic state, an aseptic isolator is generally adopted, and after biological decontamination, a continuous aseptic environment is provided for aseptic production and detection operation in an online hydrogen peroxide gas sterilization mode.
In the related art, when the sterile isolator is sterilized by using hydrogen peroxide gas, the hydrogen peroxide gas for sterilization is introduced at a constant first rate, after the hydrogen peroxide gas is continuously introduced at the first rate for a period of time, the hydrogen peroxide gas is introduced into the sterile isolator at a constant second rate, and the second rate is less than the first rate; sterilizing the interior of the isolator by means of high-concentration hydrogen peroxide gas so as to change the interior of the isolator into a sterile environment;
since the rate of hydrogen peroxide gas introduced into the isolator is constant, and the environment conditions of the isolator for sterilization each time are not necessarily completely the same, the reliability of the sterilization process performed by the hydrogen peroxide gas on the inside of the isolator is poor.
Disclosure of Invention
Aiming at the defects in the related art, the application provides the isolator and the hydrogen peroxide gas sterilization method, which can ensure that the hydrogen peroxide gas has better reliability in the sterilization process of the interior of the isolator.
The above object of the present invention is achieved by the following technical solutions:
in a first aspect, the present application provides an isolator comprising:
the operation panel is used for receiving a sterilization instruction input by an experimenter;
the hydrogen peroxide generator is used for introducing hydrogen peroxide gas into the isolator;
the induction module is used for monitoring and feeding back the concentration of the hydrogen peroxide gas in the isolator in real time;
the processing module is used for obtaining sterilization parameters according to the sterilization instruction, wherein the sterilization parameters at least comprise a concentration threshold value and a concentration fluctuation range, and the processing module is in communication connection with the operation panel, the hydrogen peroxide generator and the induction module;
the processing module is also used for controlling the hydrogen peroxide generator to continuously introduce hydrogen peroxide gas into the isolator so as to enable the concentration of the hydrogen peroxide gas in the isolator to reach the concentration threshold value;
after the concentration of the hydrogen peroxide gas in the isolator reaches the concentration threshold value, the processing module is further used for controlling the hydrogen peroxide generator to maintain the concentration of the hydrogen peroxide gas in the isolator within the concentration fluctuation range so that the hydrogen peroxide gas can sterilize and kill the inside of the isolator;
and the residue removing module is used for removing the hydrogen peroxide gas in the isolator after the hydrogen peroxide gas sterilizes the inside of the isolator, and the removing module is in communication connection with the processing module.
The concentration of the hydrogen peroxide gas introduced into the isolator is controlled, so that the concentration of the hydrogen peroxide gas is stabilized in a concentration fluctuation range, and the aim of enhancing the reliability of the hydrogen peroxide gas sterilization process is fulfilled.
Further, the isolator further includes:
the drying module is used for introducing dry compressed air into the isolator so as to reduce the air humidity in the isolator, and is in communication connection with the processing module;
before the hydrogen peroxide generator continuously injects hydrogen peroxide gas into the isolator, the processing module is also used for controlling the drying module to dehumidify the isolator.
When the air humidity in the isolator is too high, the concentration lifting rate of the hydrogen peroxide gas can be reduced, even the concentration of the hydrogen peroxide gas can not be lifted to a concentration threshold value in serious conditions, and on the basis, in order to improve the lifting rate of the concentration of the hydrogen peroxide gas as much as possible, the blocking effect of the hydrogen peroxide gas when the hydrogen peroxide gas is introduced into the isolator is weakened, and the hydrogen peroxide gas is dehumidified in the isolator in advance before the hydrogen peroxide gas is introduced into the isolator.
Furthermore, the induction module is also used for monitoring and feeding back the air humidity and the hydrogen peroxide gas saturation in the isolator in real time;
the hydrogen peroxide generator is also used for introducing water vapor into the isolator so as to increase the air humidity in the isolator;
the sterilization parameters further comprise a saturation threshold and a saturation fluctuation range;
when the concentration of the hydrogen peroxide gas in the isolator is maintained in the concentration fluctuation range, the processing module is further used for controlling the drying module and the hydrogen peroxide generator to carry out preliminary adjustment on the air humidity in the isolator so as to adjust the saturation of the hydrogen peroxide gas in the isolator to the saturation threshold;
when the concentration of the hydrogen peroxide gas in the isolator is maintained in the concentration fluctuation range, the processing module is further used for controlling the drying module and the hydrogen peroxide generator to perform secondary adjustment on the air humidity in the isolator after the saturation of the hydrogen peroxide gas in the isolator is adjusted to the saturation threshold value, so that the saturation of the hydrogen peroxide gas in the isolator is maintained in the saturation fluctuation range.
Except that the change of concentration can cause the influence to the sterilization effect of hydrogen peroxide gas, the change of saturation also can cause the influence to the sterilization effect of hydrogen peroxide gas, so this application is after stabilizing the concentration of good hydrogen peroxide gas, corresponding completion again to the control of hydrogen peroxide gas saturation, this reliability that can further strengthen hydrogen peroxide gas sterilization process.
Further, the isolator further includes:
the circulating module is used for driving the gas in the isolator to circulate in the isolator, and is in communication connection with the processing module;
when the concentration of the hydrogen peroxide gas in the isolator is maintained in the concentration fluctuation range, the processing module is also used for controlling the circulating module to drive the gas in the isolator to flow in a one-way mode, so that the hydrogen peroxide gas in the isolator is uniformly dispersed in the inner space of the isolator.
The circulation module is arranged to enable the hydrogen peroxide gas to perform one-way circulation in the isolator, so that the hydrogen peroxide gas can be fully dissipated in the isolator, and similar sterilization treatment effects can be obtained at all positions in the isolator, so that the reliability of the hydrogen peroxide gas sterilization process is further enhanced.
Further, the isolator further includes:
the self-checking module is used for checking the air tightness of the isolator and is in communication connection with the processing module;
the operation panel is also used for receiving a self-checking instruction input by an experimenter;
and the processing module is also used for controlling the self-checking module to check the air tightness of the isolator according to the self-checking instruction.
Before the hydrogen peroxide gas is introduced into the isolator, the problem of poor sterilization effect of the hydrogen peroxide gas caused by the problem of leakage of the isolator is correspondingly avoided by checking the air tightness of the isolator, so that the reliability of the hydrogen peroxide gas sterilization process is further improved.
Further, the induction module is also used for monitoring and feeding back a relative pressure value in the isolator in real time;
the residue discharge module is also used for adjusting the relative pressure in the isolator so as to maintain the relative pressure in the isolator within a preset relative pressure range all the time.
The interference of different operating environments of the isolator on the hydrogen peroxide gas sterilization process is weakened by controlling the relative pressure in the isolator, so that the reliability of the hydrogen peroxide gas sterilization process is further enhanced.
In a second aspect, a hydrogen peroxide gas sterilization method is applied to an isolator mentioned in the first aspect, and the method includes:
acquiring a sterilization instruction input by an experimenter;
according to the sterilization instruction, obtaining sterilization parameters, wherein the sterilization parameters at least comprise a concentration threshold value and a concentration fluctuation range;
continuously introducing hydrogen peroxide gas into the isolator to enable the concentration of the hydrogen peroxide in the air inside the isolator to reach the concentration threshold value;
after the concentration of the hydrogen peroxide gas in the isolator reaches the concentration threshold value, maintaining the concentration of the hydrogen peroxide gas in the isolator within the concentration fluctuation range so that the hydrogen peroxide gas can sterilize and disinfect the inside of the isolator;
after the hydrogen peroxide gas sterilizes the interior of the isolator, the hydrogen peroxide gas in the isolator is removed.
Optionally, the sterilization parameters further include a saturation threshold and a saturation fluctuation range;
while the concentration of hydrogen peroxide gas in the isolator is maintained within the concentration fluctuation range,
preliminarily adjusting the air humidity in the isolator to adjust the hydrogen peroxide gas saturation in the isolator to the saturation threshold;
and adjusting the air humidity in the isolator for the second time so as to maintain the hydrogen peroxide gas saturation in the isolator within the saturation fluctuation range.
Optionally, during the hydrogen peroxide gas sterilization process, the method further comprises:
the relative pressure within the isolator is adjusted so that the relative pressure within the isolator is always maintained within a predetermined range.
Optionally, before continuously introducing hydrogen peroxide gas into the separator to make the hydrogen peroxide concentration in the air inside the separator reach the concentration threshold, the method further includes:
acquiring a self-checking instruction input by an experimenter;
and checking the air tightness of the isolator according to the self-checking instruction.
To sum up, the application comprises the following beneficial technical effects:
1. the concentration of the hydrogen peroxide gas is controlled through the mutual matching of the induction module, the processing module and the hydrogen peroxide generator, so that the sterilization process of the hydrogen peroxide gas in the isolator has better reliability;
2. the arrangement of the drying module is convenient for rapidly increasing the concentration of the hydrogen peroxide gas in the isolator;
3. the control of the hydrogen peroxide gas saturation is indirectly finished by controlling the air humidity in the isolator, so that the reliability of the hydrogen peroxide gas sterilization process is further enhanced;
4. through the arrangement of the circulating module, the hydrogen peroxide gas can be uniformly dissipated in the isolator, so that the reliability of the hydrogen peroxide gas sterilization process is further enhanced;
5. through the setting of self-checking module, avoid because of the isolator reveals the not good problem of hydrogen peroxide gas sterilization effect that leads to this guarantees that hydrogen peroxide gas possesses better reliability in the sterilization process that the isolator was gone on.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the description of the embodiments are briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.
FIG. 1 is a schematic structural diagram of an isolator according to a first embodiment of the present invention;
FIG. 2 is a schematic structural diagram of a circulation module in the isolator according to the first embodiment of the present invention;
FIG. 3 is a flow chart of a hydrogen peroxide gas sterilization method according to a second embodiment of the present invention;
fig. 4 is a flow chart of a hydrogen peroxide gas sterilization method in the third embodiment of the present invention.
Detailed Description
The present application is described in further detail below with reference to the attached drawings.
The first embodiment is as follows:
referring to fig. 1, an isolator disclosed in the present application specifically includes:
an operation panel 101 for receiving a sterilization instruction input by an experimenter;
a hydrogen peroxide generator 102 for generating hydrogen peroxide gas and introducing the hydrogen peroxide gas into the isolator;
the processing module 104 is used for controlling the hydrogen peroxide generator 102 to control the concentration of the hydrogen peroxide gas in the isolator according to the sterilization instruction so that the hydrogen peroxide gas can complete the sterilization and disinfection process of the interior of the isolator;
the sensing module 103 is used for monitoring and feeding back the concentration of the hydrogen peroxide gas in the isolator to the processing module 104 in real time;
a residue removing module 105, which is used for removing the hydrogen peroxide gas in the isolator after the hydrogen peroxide gas carries out sterilization and disinfection on the interior of the isolator;
the operation panel 101, the hydrogen peroxide generator 102, the sensing module 103 and the residue discharge module 105 are all in communication connection with the processing module 104.
The operation panel 101 is installed on an outer surface of the isolator, and in practical application, the operation panel may be a touch screen or a tablet computer, or may be other electronic devices capable of receiving and transmitting a sterilization instruction, and the specific operation panel 101 is not limited in the embodiment of the present application;
it should be noted that, the acquisition of the self-test instruction may be realized by a way of tapping a keyboard, or even by a way of voice recognition, besides a way of sliding or clicking a touch screen, and the specific acquisition way of the sterilization instruction is not limited in the embodiment of the present application.
The residual discharge module 105 comprises a residual discharge fan and an exhaust valve, the sterilized hydrogen peroxide gas is driven by the residual discharge fan and is discharged outside through a residual discharge pipeline communicated with the isolator, and the exhaust valve is arranged to regulate and control the residual discharge rate of the hydrogen peroxide gas.
Optionally, in order to facilitate the installation of the isolator in the laboratory, a decomposition device with a function of decomposing hydrogen peroxide gas may be further configured in the residue discharge module 105, and the decomposition device is composed of a catalyst for decomposing hydrogen peroxide and a container for containing the catalyst; since the decomposition device can decompose hydrogen peroxide into oxygen and water, the residue discharge module 105 can still clean the hydrogen peroxide gas remaining in the separator without connecting an external residue discharge pipeline.
In practical applications, the catalyst may be manganese dioxide, palladium alumina or other catalysts with the effect of decomposing hydrogen peroxide gas, and the specific catalyst components are not limited in the examples of the present application.
The hydrogen peroxide generator 102 is installed in a chamber opened at one side of the isolator, and at least comprises: the sterilizing device comprises a storage device for storing sterilizing agent, a vaporizing device for vaporizing the sterilizing agent into hydrogen peroxide gas, a material conveying device for conveying the sterilizing agent from the storage device to the vaporizing device, and a gas supply device for conveying the hydrogen peroxide gas to the isolator;
in practical applications, the sterilizing agent may be a 30% hydrogen peroxide solution or a 35% food grade hydrogen peroxide solution, and the specific sterilizing agent is not limited in the embodiments of the present application;
the material conveying device can be a peristaltic pump or a variable-frequency water pump, and the embodiment of the application does not limit the specific material conveying device;
the vaporizing device comprises an evaporating disc and a heating mechanism for heating the evaporating disc, the evaporating disc is heated by the heating mechanism, then the sterilizing agent in the material storage device is conveyed into the evaporating disc by the material conveying device, the sterilizing agent is converted from a liquid state into a gaseous state (hydrogen peroxide gas) at the evaporating disc under the action of high temperature, and then the gaseous sterilizing agent (hydrogen peroxide gas) is introduced into the isolator through the gas supply device;
the air supply device comprises a plurality of first pressure regulating valves, a first bag type filter and a first air supply hose; the first air supply hose is mainly used for communicating the first bag type filter with the plurality of first pressure regulating valves, and clean and dry compressed air flows through the first air supply hose; the first pressure regulating valve indirectly controls the speed of introducing the hydrogen peroxide gas into the isolator mainly by controlling the flow rate of the dry compressed air; the first bag filter is used for cleaning the dried compressed air so as to enable the dried compressed air to be in a sterile state.
Correspondingly, in order to enable the experimenter to know the rate of hydrogen peroxide gas input by the hydrogen peroxide generator 102 in time, a flow meter for detecting the flow rate of compressed air is further arranged among the first pressure regulating valves, the flow meter can acquire and transmit the flow rate of the compressed air in real time, and then the processing module 104 receives the compressed air transmitted by the flow meter and displays the compressed air to the experimenter through the operation panel 101;
in practical application, the flowmeter may be a glass rotameter, the first pressure regulating valve may be an electromagnetic valve or an electric ball valve, and the heating mechanism may be a heating core;
the compressed air in the air supply device is actually present as a carrier gas, and is used for sufficiently diffusing the hydrogen peroxide gas generated by the vaporization device and reducing the probability of condensation of the hydrogen peroxide gas; and on the other hand, the hydrogen peroxide gas generated by the vaporization device is transported into the isolator.
Optionally, in order to enable the experimenter to know the consumption condition of the sterilizing agent in time, the hydrogen peroxide generator 102 may further be correspondingly provided with a gravity sensor for weighing the storage device; after the gravity sensor obtains the real-time weight of the storage device, the real-time weight is displayed on the operation panel 101 through the transmission of the processing module 104;
use this application during the isolator, the experimenter can in time learn the volume of the sterilizing agent that remains in the storage device according to the above-mentioned real-time weight that operating panel 101 demonstrates, this can make the experimenter can be comparatively timely supply to the sterilizing agent in the storage device.
The processing module 104 may be any Programmable Logic Controller (PLC) with a program control function, and the embodiment of the present application does not limit the specific processing module 104.
The sensing module 103 includes a first sensor for monitoring the concentration of the hydrogen peroxide gas in the isolator, and the first sensor may be a hydrogen peroxide concentration sensor or other sensors for monitoring the concentration of the hydrogen peroxide gas, and the embodiment of the present application does not limit the specific sensing module 103.
Further, the isolator according to the embodiment of the present application further includes a drying module 106 for introducing clean and dry compressed air into the isolator to reduce the humidity of the air in the isolator, wherein the drying module 106 is communicatively connected to the processing module 104;
the drying module 106 specifically includes a second bag filter, a second air supply hose, and a plurality of second pressure regulating valves, and in the actual application process, the dried compressed air is controlled by the plurality of second pressure regulating valves, and is firstly subjected to air filtration processing by the second bag filter, and then directly enters the isolator through the second air supply hose;
when the humidity in the isolator is relatively high, the increase of the concentration of the hydrogen peroxide gas in the isolator is hindered, so that the isolator mentioned in the embodiment of the application can quickly replace high-humidity air in the cabin by introduced clean and dry compressed air in a manner of arranging the drying module 106 under the condition of stabilizing the relative pressure in the isolator, so that the humidity of the air in the isolator can be quickly reduced, the dehumidification operation in the isolator can be completed before the hydrogen peroxide gas is introduced into the isolator, and the concentration of the hydrogen peroxide gas in the isolator can be quickly increased to the concentration threshold value in the process of introducing the hydrogen peroxide gas into the isolator.
Furthermore, the sterilization effect of the hydrogen peroxide gas is influenced by the concentration of the hydrogen peroxide gas and the saturation of the hydrogen peroxide gas, and the specific characteristics are that on the premise that the concentration of the hydrogen peroxide gas is kept stable, when the saturation of the hydrogen peroxide gas is too high, the condensation probability of the hydrogen peroxide gas introduced into the isolator is correspondingly increased, and the condensed and liquefied hydrogen peroxide can corrode experimental equipment in the isolator; when the saturation of the hydrogen peroxide gas is too small, the hydrogen peroxide gas cannot be in full contact with experimental equipment in the isolator, so that the sterilization effect of the hydrogen peroxide gas is lower than expected;
in order to perform corresponding adjustment and control on the saturation of the hydrogen peroxide gas in the isolator under the condition that the concentration of the hydrogen peroxide gas is controlled, so that the sterilization capacity of the hydrogen peroxide gas is fully exerted, the hydrogen peroxide generator 102 is also provided with a water storage device for storing purified water and a water delivery device for delivering the purified water from the water storage device to the vaporization device;
the sterilization parameters correspondingly comprise a saturation threshold value and a saturation fluctuation range;
in the practical application process, if the processing module 104 determines that the hydrogen peroxide gas saturation in the isolator is lower than the saturation threshold, the hydrogen peroxide generator 102 is controlled to continuously introduce water vapor into the isolator, and simultaneously, the injection rate of hydrogen peroxide is controlled according to the hydrogen peroxide gas concentration value fed back by the sensing module 103, so that the air humidity in the isolator is increased and the hydrogen peroxide gas saturation in the isolator is indirectly increased on the premise of maintaining the hydrogen peroxide gas concentration in the isolator cabin, and the specific process is as follows:
according to the hydrogen peroxide gas concentration and saturation feedback signals fed back by the induction module 103, respectively controlling the water delivery device and the material conveying device, feeding purified water in the water storage device and a sterilizing agent in the material storage device into the gasification device according to a certain proportion, so that the purified water and the hydrogen peroxide solution are converted from a liquid state to a gaseous state, and then introducing the purified water and the hydrogen peroxide solution into the isolator by virtue of the existence of the gas supply device, so that the air humidity in the isolator is increased and the hydrogen peroxide gas concentration is maintained, and the increase of the hydrogen peroxide gas saturation in the isolator is indirectly completed;
if the processing module 104 determines that the saturation of the hydrogen peroxide gas in the isolator is higher than the saturation threshold, the drying module 106 is controlled to continuously introduce clean and dry compressed air into the isolator so as to reduce the humidity of the air in the isolator and indirectly reduce the saturation of the hydrogen peroxide gas in the isolator;
after the hydrogen peroxide gas saturation in the isolator reaches the saturation threshold, the processing module 104 adaptively performs humidification and dehumidification operations in the isolator by controlling the hydrogen peroxide generator 102 and the drying module 106, so as to adjust the air humidity in the isolator and maintain the hydrogen peroxide saturation in the isolator within the saturation fluctuation range.
Furthermore, in order to make the hydrogen peroxide gas fully escape in the isolator and make each position in the isolator obtain similar sterilization effect, the isolator is also provided with a circulation module 107, the circulation module 107 is communicated with the air outlet 1021 of the hydrogen peroxide generator 102, and the circulation module 107 is also communicated with the treatment module 104; meanwhile, the sensing module 103 is disposed right below the circulating module 107;
the circulation module 107 specifically comprises a circulation fan 1071, a high-efficiency filter 1072, a flow equalizing membrane 1073 and an air return interlayer 1074;
as shown in fig. 2, when the hydrogen peroxide gas enters the isolator through the air outlet 1021 of the hydrogen peroxide generator 102, the hydrogen peroxide gas is driven by the circulating fan 1071 to pass through the high efficiency filter 1072 and then the flow equalizing membrane 1073, and finally uniform one-way flow is formed in the isolator; meanwhile, the hydrogen peroxide gas uniformly dispersed in the isolator passes through the air return interlayer 1074 and returns to the circulating fan 1071 again, so that the circulating flow of the hydrogen peroxide gas in the isolator is completed, and the hydrogen peroxide gas can be ensured to perform uniform sterilization and disinfection on the inside of the isolator;
it should be noted that fig. 2 is only used to briefly describe the specific structure of the circulation module 107, in practical applications, a plurality of outlets of the pipeline where the high-efficiency filter 1072 and the flow equalizing membrane 1073 are located may be uniformly arranged in the isolator cabin, so that the hydrogen peroxide gas driven by the circulation fan 1071 is uniformly dispersed in the isolator cabin.
Further, in order to ensure that the hydrogen peroxide gas can perform stable sterilization and disinfection on the inside of the isolator, a self-checking module 108 is further arranged in the isolator, is in communication connection with the processing module 104, and specifically comprises an air inlet fan, an air inlet valve and a filter;
the air inlet fan is mainly used for sending air in the surrounding environment of the isolator into the isolator, the introduction rate of environment fresh air is controlled by controlling the frequency of the air inlet fan, and the filter is used for filtering and cleaning the environment fresh air so as to avoid the environment fresh air from damaging the sterile environment in the isolator;
correspondingly, the sensing module 103 is also configured with a pressure sensor for monitoring the relative pressure in the isolator in real time; before introducing hydrogen peroxide gas into the isolator, the operation panel 101 receives a self-checking instruction input by an experimenter in advance; after that, the processing module 104 receives the self-checking instruction and correspondingly controls the self-checking module 108 to start, at this time, the self-checking module 108 continuously introduces the filtered environment fresh air into the isolator, so that the air pressure value in the isolator gradually increases;
when the pressure sensor monitors that the pressure value in the isolator reaches a preset pressure threshold value, the pressure sensor feeds back the pressure value to the processing module 104, and at the moment, the processing module 104 sends an instruction for closing the air inlet fan and the air inlet valve to close the air inlet fan and the air inlet valve; then, the isolator enters a pressure stabilization stage, the isolator enters a test stage after stabilization, the pressure sensor monitors the pressure drop value of the process, and after the test is finished, the processing module 104 automatically calculates the leakage rate and gives a result judgment;
if the processing module 104 determines that the result of the air tightness test in the isolator is not qualified after the inspection of the self-inspection module 108, an air tightness alarm is sent to the experimenter through the operation panel 101. If the air tightness test is linked with the automatic sterilization program of the isolator, the equipment can send out an alarm when the air tightness test is unqualified, and meanwhile, the automatic sterilization program cannot be started.
Before sterilizing and killing the inside of the isolator through hydrogen peroxide gas, the air tightness of the isolator is checked through the self-checking module 108, so that the personnel safety problem caused by the leakage of the isolator and the influence on a sterile detection result can be avoided.
Furthermore, in order to enhance the sterilization effect of the hydrogen peroxide gas, a flow control valve is correspondingly configured in the residue discharge module 105, and pipelines in which the exhaust fan and the exhaust valve are located and a pipeline in which the flow control valve is located are parallel pipelines;
in practical applications, the flow control valve is generally an electric proportional control valve, and in the sterilization process, after the pressure sensor monitors and feeds back the pressure value in the isolator in real time, the processing module 104 controls the flow control valve to adjust the relative pressure in the isolator, so that the relative pressure value in the isolator is always maintained within a predetermined relative pressure range, and at this time, the pipeline where the exhaust fan and the exhaust valve are located is in a closed state.
It should be noted that, no matter during the sterilization process of the hydrogen peroxide gas or after the sterilization of the hydrogen peroxide gas is completed, the internal air pressure of the isolator is always greater than the environmental air pressure, that is, the isolator is always in a positive pressure environment; in the practical application process, the isolator inevitably generates partial leakage points along with the increase of the service time, but because the isolator is always in a positive pressure environment, even if partial undetected leakage points exist, gas only flows from the inside of the isolator to the outside environment of the isolator under the action of pressure difference, and the adverse effect on the sterile environment inside the isolator when the leakage points are generated can be reduced.
Example two:
referring to fig. 3, in order to provide a hydrogen peroxide gas sterilization method disclosed in the present application, this embodiment is applied to the isolator described in the first embodiment, and the method described in this embodiment specifically includes:
201. and acquiring a self-checking instruction input by an experimenter.
202. And checking the air tightness of the interior of the isolator according to the self-checking instruction.
Specifically, A1, after closing the door of the isolator, obtaining self-checking parameters according to a self-checking instruction, wherein the self-checking parameters at least comprise a positive pressure threshold, a voltage stabilization time limit, a self-checking time limit and a qualified loss;
the positive pressure threshold is used for explaining a positive pressure value required to be achieved during self-inspection of the isolator;
the voltage stabilization time limit is used for explaining the time limit for maintaining the positive pressure threshold value after the isolator reaches the positive pressure threshold value;
the self-checking time limit is used for explaining the time limit of the isolator which needs to be naturally depressurized during self-checking;
the qualified loss is used for explaining the maximum pressure loss allowed in the self-checking time limit under the condition that the air tightness of the isolator is qualified;
a2, continuously introducing environmental fresh air into the isolator to enable the pressure value inside the isolator to reach the positive pressure threshold value;
a3, intermittently introducing environment fresh air into the isolator after the pressure value inside the isolator reaches the positive pressure threshold value, so that the air pressure value inside the isolator maintains the positive pressure threshold value until the pressure stabilizing time limit;
a4, stopping introducing the fresh air in the environment inside the isolator after the air pressure value inside the isolator maintains the positive pressure threshold value to the pressure stabilization time limit, so that the air pressure value inside the isolator naturally decreases within the self-checking time limit;
a5, collecting the current air pressure of the isolator,
a6, judging whether the current air pressure is less than or equal to the qualified loss, if so, directly executing the step A9; otherwise, go to step A7;
a7, generating a self-checking result for explaining that the air tightness of the isolator is unqualified, so that an experimenter can further check the problem that the air tightness of the isolator is unqualified according to the self-checking result;
a8, returning to the step A3 after the air tightness of the isolator is checked and repaired by experimenters;
and A9, generating a self-test result for indicating that the air tightness of the isolator is qualified.
In the prior sterilization process, except for the reasons of insufficient hydrogen peroxide gas concentration, insufficient hydrogen peroxide gas maintaining time and the like, the sterilization process can also fail due to the leakage problem of the isolator, and the situation that the sterilization process fails due to the leakage of the isolator can be correspondingly avoided by checking the air tightness condition of the isolator before introducing the hydrogen peroxide gas into the isolator, so that the sterilization and disinfection effects of the hydrogen peroxide gas on the interior of the isolator can be effectively ensured in the subsequent treatment process;
in addition, it should be noted that, in order to facilitate the responsibility determination of the self-checking result in the later stage, the self-checking result also carries identity information for explaining the experimenter who inputs the self-checking instruction, and the identity information at least includes the name, the job number and the job title of the experimenter.
203. The relative air pressure in the isolator is adjusted so that the relative air pressure value in the isolator is always maintained in a preset relative air pressure range.
Specifically, the relative air pressure range may be any interval in [20,50], and the numerical unit thereof is pascal (Pa);
preferably, the optimal relative gas pressure range is [38,42] in units of pascals (Pa).
204. And acquiring a sterilization instruction input by an experimenter.
205. The interior of the separator is dehumidified.
Specifically, a preset humidity limit value is obtained;
the humidity of the air in the isolator is reduced to a humidity limit value by introducing clean compressed air.
The above Humidity limit is defined as [35,45] in Relative Humidity percentage (% RH, Relative Humidity);
preferably, the optimal humidity limit is 40% RH;
in the process of introducing hydrogen peroxide gas into the isolator, if the air humidity in the isolator is too high, the hydrogen peroxide gas is condensed in the isolator, so that not only can experimental equipment placed in the isolator be corroded by hydrogen peroxide solution, but also the increase of the concentration of the hydrogen peroxide gas in the isolator is hindered;
when the humidity of the air in the isolator is too low, the sterilization effect of the hydrogen peroxide gas on bacteria is weakened;
based on the above two reasons, before the hydrogen peroxide gas is introduced into the isolator, the humidity of the air inside the isolator can be adjusted, so that the humidity of the air inside the isolator is reduced to the preset humidity, which not only can improve the sterilization effect of the hydrogen peroxide gas, but also can correspondingly reduce the obstruction to the increase of the concentration of the hydrogen peroxide gas in the isolator.
206. And obtaining the sterilization parameters according to the sterilization instructions.
Wherein the sterilization parameters at least comprise a concentration threshold, a first sterilization time limit, a concentration upper limit value and a concentration lower limit value;
the above concentration threshold is used to describe the optimum concentration of hydrogen peroxide gas during sterilization, and has a value in the range of 550,650 in ppm (parts per million concentration);
the first sterilization time limit is used to illustrate that the minimum time limit for maintaining the concentration threshold is required when the hydrogen peroxide gas achieves the expected sterilization effect, and the value range is [25,55] and the unit is min (minute);
the upper concentration limit is used to describe the maximum concentration of hydrogen peroxide gas that is allowed to reach while maintaining the concentration threshold, and is in the range of [630,700] in ppm (parts per million concentration);
the lower concentration limit is used to describe the minimum concentration of hydrogen peroxide gas allowed to reach while maintaining the above concentration threshold, and is in the range of [500,600] in ppm (parts per million concentration);
it is to be noted that the lower concentration limit value is always smaller than the concentration threshold value, and the upper concentration limit value is always larger than the concentration threshold value, and the lower concentration limit value and the upper concentration limit value together constitute a concentration fluctuation range.
207. And continuously introducing hydrogen peroxide gas into the isolator to enable the concentration of the hydrogen peroxide in the air inside the isolator to reach a concentration threshold value.
Specifically, the hydrogen peroxide gas is continuously introduced into the isolator at a maximum rate, so that the concentration of the hydrogen peroxide in the air inside the isolator quickly reaches a concentration threshold value.
As the hydrogen peroxide gas is continuously introduced into the isolator at the maximum speed, the concentration of the hydrogen peroxide in the isolator can quickly rise, the time for the concentration of the hydrogen peroxide in the isolator to reach the concentration threshold value can be correspondingly shortened, and the preparation efficiency of the hydrogen peroxide gas before sterilization is improved.
208. The concentration of the hydrogen peroxide gas in the isolator is maintained within the concentration fluctuation range, so that the hydrogen peroxide gas can sterilize and disinfect the inside of the isolator.
Specifically, after the hydrogen peroxide concentration in the air inside the isolator reaches the concentration threshold value, the hydrogen peroxide concentration in the air inside the isolator is maintained within the concentration fluctuation range, and the maintaining process is continued to the first sterilization time limit.
Exemplarily, assuming a concentration threshold of 600ppm, an upper concentration limit of 650ppm, a lower concentration limit of 550ppm, a concentration fluctuation limit of 20ppm, a first sterilization time limit of 30 min;
after the hydrogen peroxide concentration in the air inside the isolator reaches 600ppm indicated by a concentration threshold value, generating a concentration fluctuation range of [670,530] according to an upper concentration limit value, a lower concentration limit value and a concentration fluctuation limit;
the hydrogen peroxide concentration in the air inside the separator was then maintained within this concentration fluctuation range, and this maintenance process was continued for 30 min.
In the process of hydrogen peroxide gas sterilization, the concentration of hydrogen peroxide in the isolator is controlled within a numerical range close to the concentration threshold value, so that the hydrogen peroxide gas can keep a more stable sterilization effect on bacteria, the probability of condensation of the hydrogen peroxide gas in the isolator can be correspondingly reduced, and the risk of corrosion of experimental equipment in the isolator is reduced.
209. The hydrogen peroxide gas in the isolator is purged.
Specifically, after the hydrogen peroxide gas sterilizes the inside of the isolator, the first pressure regulating valve is closed, and the residual removing module 105 is used for removing the hydrogen peroxide gas, so that the concentration of the hydrogen peroxide gas inside the isolator is quickly reduced to be below the warning concentration.
The above-mentioned alert concentration has a value range of [0,10] in ppm (parts per million concentration);
preferably, the optimal warning concentration is 1 ppm.
Example three:
referring to fig. 4, in order to provide a hydrogen peroxide gas sterilization method disclosed in the present application, the present embodiment is based on the scheme of the second embodiment, and optimized and improved, and in particular, a saturation threshold, a second sterilization time limit, a saturation upper limit value, and a saturation lower limit value are added to the sterilization parameters; while step 300 is also performed synchronously during the execution of step 208, the following further elaborations will be made:
the saturation threshold is used for explaining the optimal saturation during the sterilization of the hydrogen peroxide gas;
the second sterilization time period mentioned above is used to illustrate the minimum time period required to maintain the saturation threshold for hydrogen peroxide gas to achieve the desired sterilization effect, and is less than the first sterilization time period mentioned in example one;
the saturation upper limit value is used for explaining the highest saturation allowed to be reached when the hydrogen peroxide gas maintains the saturation threshold value, and the saturation upper limit value is always larger than the saturation threshold value;
the lower saturation limit value is used for explaining the lowest saturation allowed by the hydrogen peroxide gas when the hydrogen peroxide gas maintains the saturation threshold value, and the lower saturation limit value is always smaller than the saturation threshold value;
and the execution process of step 300 may be:
after the hydrogen peroxide saturation in the air inside the isolator is maintained within the concentration fluctuation range, preliminarily adjusting the air humidity in the isolator to adjust the hydrogen peroxide gas saturation in the isolator to the saturation threshold;
obtaining a saturation fluctuation range according to the saturation upper limit value and the saturation lower limit value;
and adjusting the air humidity in the isolator for the second time to maintain the hydrogen peroxide saturation in the air in the isolator within the saturation fluctuation range, and continuing the maintaining process until the second sterilization time limit.
The process of step 200 is mainly used for adjusting and maintaining the saturation of the hydrogen peroxide gas in the process of maintaining the concentration of the hydrogen peroxide gas, so that the probability of condensation of the hydrogen peroxide gas on the surface of the experimental equipment is reduced under the condition that the hydrogen peroxide gas has a relatively stable sterilization effect;
regarding the hydrogen peroxide gas in the isolator, the concentration of the hydrogen peroxide gas and the humidity inside the isolator influence the saturation value of the hydrogen peroxide gas, and correspondingly, the saturation of the hydrogen peroxide gas also influences the concentration of the hydrogen peroxide gas and the humidity inside the isolator;
in the practical application process, if the saturation of the hydrogen peroxide gas is controlled first and then the concentration of the hydrogen peroxide gas is controlled, the saturation and the concentration of the hydrogen peroxide gas interfere with each other, and the expected control effect cannot be achieved by both of the saturation and the concentration, which is actually characterized in that the saturation of the hydrogen peroxide gas has severe numerical fluctuation in the concentration adjustment process of the hydrogen peroxide gas; the concentration of the hydrogen peroxide gas is limited by the saturation of the hydrogen peroxide gas, so that the concentration adjustment rate is slow, and the situation that the concentration threshold cannot be reached can also occur;
in order to avoid the problems, the method of firstly controlling the concentration and then controlling the saturation is adopted, the concentration of the hydrogen peroxide gas is firstly controlled, and after the concentration of the hydrogen peroxide gas is well controlled, the saturation of the hydrogen peroxide gas is indirectly controlled by adjusting the humidity inside the isolator, so that the concentration and the saturation of the hydrogen peroxide gas can obtain better control effect.
Compared with the hydrogen peroxide gas sterilization method mentioned in the related art, the method in the second embodiment or the third embodiment of the application performs three steps of self-checking, pressure stabilizing and dehumidifying in sequence before introducing the hydrogen peroxide gas into the isolator, so that the sterilization capability of the hydrogen peroxide gas can be ensured to be stably exerted, and the obstruction caused by the increase of the concentration of the hydrogen peroxide gas can be reduced;
after the air pressure value and the concentration of the hydrogen peroxide gas in the isolator are stably controlled, the third embodiment of the application further stabilizes the sterilization effect of the hydrogen peroxide gas by controlling the saturation of the hydrogen peroxide gas, so that the sterilization process of the hydrogen peroxide gas in the isolator has better reliability and repeatability.
The above description is only exemplary of the present application and should not be taken as limiting the present application, as any modification, equivalent replacement, or improvement made within the spirit and principle of the present application should be included in the protection scope of the present application.

Claims (10)

1. An isolator, comprising:
the operation panel is used for inputting a sterilization instruction by an experimenter;
the hydrogen peroxide generator is used for generating hydrogen peroxide gas and introducing the hydrogen peroxide gas into the isolator cabin;
the induction module is used for monitoring and feeding back the concentration of the hydrogen peroxide gas in the isolator in real time;
the processing module is used for obtaining sterilization parameters according to the sterilization instruction, wherein the sterilization parameters at least comprise a concentration threshold value and a concentration fluctuation range, and the processing module is in communication connection with the operation panel, the hydrogen peroxide generator and the induction module;
the processing module is also used for controlling the hydrogen peroxide generator to continuously introduce hydrogen peroxide gas into the isolator so as to enable the concentration of the hydrogen peroxide gas in the isolator to reach the concentration threshold value;
after the concentration of the hydrogen peroxide gas in the isolator reaches the concentration threshold value, the processing module is further used for controlling the hydrogen peroxide generator to maintain the concentration of the hydrogen peroxide gas in the concentration fluctuation range so that the hydrogen peroxide gas can sterilize and kill the inside of the isolator;
and the residue removing module is used for removing the hydrogen peroxide gas in the isolator after the hydrogen peroxide gas sterilizes the inside of the isolator, and the removing module is in communication connection with the processing module.
2. The isolator as in claim 1, further comprising:
the drying module is used for introducing clean and dry compressed air into the isolator so as to reduce the humidity of the air in the isolator to a preset humidity limit value, and is in communication connection with the processing module;
before the hydrogen peroxide generator continuously injects hydrogen peroxide gas into the isolator, the processing module is also used for controlling the drying module to dehumidify the isolator.
3. The isolator as claimed in claim 2, wherein the sensing module is further configured to monitor and feed back the humidity and saturation of the air in the isolator in real time;
the hydrogen peroxide generator is also used for introducing water vapor into the isolator so as to increase the air humidity in the isolator;
the sterilization parameters further comprise a saturation threshold and a saturation fluctuation range;
when the concentration of the hydrogen peroxide gas is maintained in the concentration fluctuation range, the processing module is further used for controlling the drying module and the hydrogen peroxide generator to preliminarily adjust the air humidity in the isolator so as to adjust the saturation of the hydrogen peroxide gas in the isolator to the saturation threshold;
when the concentration of the hydrogen peroxide gas in the isolator is maintained in the concentration fluctuation range, the processing module is further used for controlling the drying module and the hydrogen peroxide generator to perform secondary adjustment on the air humidity in the isolator after the saturation of the hydrogen peroxide gas in the isolator is adjusted to the saturation threshold value, so that the saturation of the hydrogen peroxide gas in the isolator is maintained in the saturation fluctuation range.
4. The isolator as in claim 3, further comprising:
the circulating module is used for driving the gas in the isolator to circulate in the isolator, and is in communication connection with the processing module;
when the concentration of the hydrogen peroxide gas in the isolator is maintained in the concentration fluctuation range, the processing module is also used for controlling the circulating module to drive the gas in the isolator to flow in a one-way mode, so that the hydrogen peroxide gas in the isolator is uniformly dispersed in the inner space of the isolator.
5. The isolator as in claim 4, further comprising:
the self-checking module is used for checking the air tightness of the isolator and is in communication connection with the processing module;
the operation panel is also used for receiving a self-checking instruction input by an experimenter;
and the processing module is also used for controlling the self-checking module to check the air tightness of the isolator according to the self-checking instruction.
6. The isolator of claim 5, wherein the sensing module is further configured to monitor and feed back a relative pressure value within the isolator in real time;
the residue discharge module is also used for adjusting the relative pressure value in the isolator so as to enable the relative pressure value in the isolator to be always maintained in a preset relative pressure range.
7. A method for hydrogen peroxide gas sterilization, the method being applied to an isolator, the method comprising:
acquiring a sterilization instruction input by an experimenter;
according to the sterilization instruction, obtaining sterilization parameters, wherein the sterilization parameters at least comprise a concentration threshold value and a concentration fluctuation range;
continuously introducing hydrogen peroxide gas into the isolator to enable the concentration of the hydrogen peroxide in the air inside the isolator to reach the concentration threshold value;
after the concentration of the hydrogen peroxide gas in the isolator reaches the concentration threshold value, maintaining the concentration of the hydrogen peroxide gas in the isolator within the concentration fluctuation range so that the hydrogen peroxide gas can sterilize and disinfect the inside of the isolator;
after the hydrogen peroxide gas sterilizes the interior of the isolator, the hydrogen peroxide gas in the isolator is removed.
8. The method of claim 7, wherein the sterilization parameters further include a saturation threshold and a saturation fluctuation range;
while the concentration of hydrogen peroxide gas in the isolator is maintained within the concentration fluctuation range,
preliminarily adjusting the air humidity in the isolator to adjust the hydrogen peroxide gas saturation in the isolator to the saturation threshold;
and adjusting the air humidity in the isolator for the second time so as to maintain the hydrogen peroxide gas saturation in the isolator within the saturation fluctuation range.
9. The method of claim 8, wherein during hydrogen peroxide gas sterilization, the method further comprises:
the relative pressure within the isolator is adjusted so that the value of the relative pressure within the isolator is always maintained within a predetermined relative pressure range.
10. The method of claim 9, wherein prior to continuing to introduce hydrogen peroxide gas into the isolator to bring the concentration of hydrogen peroxide in the air inside the isolator to the concentration threshold, the method further comprises:
acquiring a self-checking instruction input by an experimenter;
and checking the air tightness of the isolator according to the self-checking instruction.
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CN111065419A (en) * 2018-04-24 2020-04-24 株式会社日立产机系统 Sterilizing gas purifying closed system device
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* Cited by examiner, † Cited by third party
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CN1033941A (en) * 1987-12-30 1989-07-19 美国消毒器公司 The best sterilization of hydrogen peroxide vapor
JPH08271464A (en) * 1995-03-30 1996-10-18 Taiyo Toyo Sanso Co Ltd Method and apparatus for detecting concentration of vapor of hydrogen peroxide
CN103203035A (en) * 2008-08-20 2013-07-17 松下健康医疗器械株式会社 Isolator
CN204278043U (en) * 2014-11-07 2015-04-22 胡钦凤 Aseptic processing isolator
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CN111467539A (en) * 2020-05-21 2020-07-31 湖南大学 Hydrogen peroxide gas disinfection system and method suitable for disinfecting medical mask

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