CN115494198A - Device and method for detecting resistance of low-temperature formaldehyde sterilization indicator - Google Patents

Device and method for detecting resistance of low-temperature formaldehyde sterilization indicator Download PDF

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Publication number
CN115494198A
CN115494198A CN202211428253.XA CN202211428253A CN115494198A CN 115494198 A CN115494198 A CN 115494198A CN 202211428253 A CN202211428253 A CN 202211428253A CN 115494198 A CN115494198 A CN 115494198A
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formaldehyde
valve
vacuum
detection
pressure
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刘春岩
张海军
杨敏
国旭
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Shinva Medical Instrument Co Ltd
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Shinva Medical Instrument Co Ltd
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    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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Abstract

The invention relates to a resistance detection device and method for a low-temperature formaldehyde sterilization indicator, belonging to the technical field of sterilization; the device comprises a detection chamber, a vacuum module, an emptying module, a formaldehyde filling module, a steam filling module and a control module, wherein a detection pressure sensor, a first heater and a detection temperature sensor are arranged in the detection chamber; the sterilization process of the formaldehyde sterilizer is simulated really, and the resistance detection result of the sterilization indicator conforms to the clinical sterilization requirement; the method comprises the following steps of starting, puncturing, pre-vacuum, formaldehyde filling, exposing, pulsing and air introducing; the whole detection process of the low-temperature formaldehyde sterilization indicator resistance detection device is carried out under negative pressure, so that the risk of formaldehyde contact of operators is reduced.

Description

Device and method for detecting resistance of low-temperature formaldehyde sterilization indicator
Technical Field
The invention relates to a device and a method for detecting resistance of a low-temperature formaldehyde sterilization indicator, belonging to the technical field of sterilization.
Background
The formaldehyde sterilization is one of the main low-temperature sterilization methods mastered by human at present, is used for sterilizing multiplexing temperature-intolerant medical instruments, and is widely applied in medical institutions. In order to monitor the quality of sterilization, sterilization effect indicators, including chemical and biological indicators, must be used in formaldehyde sterilization processes. Sterilization effectiveness indicators may be based on chemical or physical changes that occur during sterilization exposure, thereby revealing changes in one or more process variables for use in monitoring the quality of sterilization. The resistance of the indicator is a key parameter for quality control, and the resistance of the indicator is detected by using an indicator resistance detection device in the research, development and production processes. In the prior art, formaldehyde sterilization indicator resistance tests were performed using a liquid-phase-like test (soaking the sterilization indicator in formaldehyde solution). The problems of the prior art are that: 1. the liquid phase condition can not accurately simulate the formaldehyde concentration under the sterilization condition, and 2, the liquid phase test method exposes operating personnel to the formaldehyde environment and harms the health of the operating personnel.
Therefore, a device and a method for detecting resistance of a low-temperature formaldehyde sterilization indicator are urgently needed to solve the problems.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: the resistance detection device and the method for the low-temperature formaldehyde sterilization indicator solve the problem that the resistance of the formaldehyde sterilization indicator is not enough in the prior art; through the special structural design and control process and control flow for detecting the resistance of the sterilization indicator, the resistance of the indicator is detected, and the problems that the formaldehyde concentration under the actual sterilization condition cannot be accurately simulated under the liquid phase condition and the operator is exposed in the formaldehyde environment and the health of the operator is harmed by the liquid phase test method are solved.
The resistance detection device for the low-temperature formaldehyde sterilization indicator comprises a detection chamber, a vacuum module, an air returning module, a formaldehyde filling module, a steam filling module and a control module, wherein a detection pressure sensor, a first heater and a detection temperature sensor are arranged in the detection chamber;
the vacuum module comprises a vacuum pumping pump and a vacuum pumping valve, one end of the vacuum pumping valve is connected with the sterilization chamber body through a pipeline, and the other end of the vacuum pumping valve is connected with the vacuum pumping pump;
the formaldehyde filling module comprises a formaldehyde solution bag, a puncture mechanism, a puncture valve, a formaldehyde vaporization device, a gas storage tank and a formaldehyde filling valve which are sequentially arranged, wherein a third heater and a formaldehyde temperature sensor are arranged in the formaldehyde vaporization device, and a fourth heater, a gas storage temperature sensor and a gas storage pressure sensor are arranged in the gas storage tank;
the steam filling module comprises a steam generating device and a steam filling valve, and a second heater and a steam temperature sensor are arranged in the steam generating device;
the air return module comprises an air return valve, and the air return valve is connected with the detection chamber and the atmospheric pressure;
the control module is used for controlling the work of the detection chamber, the vacuum module, the air returning module, the formaldehyde filling module and the steam filling module.
The resistance detection device for the low-temperature formaldehyde sterilization indicator is used for operating the resistance detection method for the low-temperature formaldehyde sterilization indicator; the resistance detection device for the low-temperature formaldehyde sterilization indicator provided by the invention can be used for detecting the resistance of the indicator and solving the problems that the formaldehyde concentration under the actual sterilization condition cannot be accurately simulated under the liquid phase condition and the operator is exposed in the formaldehyde environment and the health of the operator is harmed by the liquid phase test method.
Preferably, the vacuum module further comprises a secondary vacuum pumping valve, one end of the secondary vacuum pumping valve is connected with the formaldehyde filling module through a pipeline, and the other end of the secondary vacuum pumping valve is connected with the vacuum pumping pump.
The secondary vacuum valve is used for pressure control of the filling module.
Preferably, the steam generating device is connected to a water source through a water supply valve.
The water supply valve is used for supplying water to the steam generating device.
Preferably, the air return valve is connected to atmospheric pressure through an air filter.
The air filter is used for filtering the atmosphere entering the emptying module.
The invention discloses a method for detecting the resistance of a low-temperature formaldehyde sterilization indicator, which is used for the device for detecting the resistance of the low-temperature formaldehyde sterilization indicator and comprises the following steps:
step S1, starting
Starting the equipment, selecting a test program, and heating the first heater, the second heater, the third heater and the fourth heater to a set temperature;
step S2, puncturing
The puncture mechanism punctures the formaldehyde solution bag, opens the puncture valve, and closes the puncture valve after the formaldehyde solution enters the formaldehyde vaporizing device;
step S3, pre-vacuum
Opening a vacuum pumping pump and a vacuum pumping valve, and closing the vacuum pumping pump and the vacuum pumping valve after a detection pressure sensor of the detection chamber reaches a detection pressure set value;
step S4, filling formaldehyde
When a gas storage pressure sensor of the gas storage tank reaches a gas storage pressure set value, opening a formaldehyde filling valve, and closing the formaldehyde filling valve after the pressure of a detection chamber is the detection set pressure within fixed time;
step S5, exposing
Maintaining the pressure of the detection chamber for a set time;
step S6, steam cleaning
Starting a vacuum pump and a vacuum valve to vacuumize the detection chamber, closing the vacuum pump and the vacuum valve after the set value of the detection pressure is reached, starting a steam filling valve, injecting water vapor into the detection chamber, vacuumizing again after the set pressure is reached, and repeatedly pulsing to the set times;
step S7, air introduction
And opening the return valve, returning the pressure of the detection chamber to the atmospheric pressure, and ending the test procedure.
The resistance detection method of the low-temperature formaldehyde sterilization indicator provided by the invention truly simulates the sterilization process of a formaldehyde sterilizer, and the resistance detection result of the sterilization indicator better meets the clinical sterilization requirement. The whole detection process is carried out under negative pressure, so that the risk of formaldehyde contact of operators is reduced.
Preferably, the test procedure comprises a 60 ℃ or 78 ℃ test procedure.
The test program is divided into 60 ℃ or 78 ℃ test program according to the sterilization process of the formaldehyde sterilizer, the first heater, the second heater, the third heater and the fourth heater are heated to the set temperature of 60 +/-2 ℃ in the 60 ℃ test program, and the first heater, the second heater, the third heater and the fourth heater are heated to the set temperature of 78 +/-2 ℃ in the 78 ℃ test program.
Preferably, the detection set pressure is 21.8KPa at 60 ℃ and 47.3KPa at 78 ℃.
The procedure pressure will be 21.8KPa at 60 deg.C and 47.3KPa at 78 deg.C according to the sterilization process of the formaldehyde sterilizer.
Preferably, the detection pressure setting value is 5.3KPa.
Preferably, in the fixed time in step S4, after the chamber pressure is detected to the detection set pressure, the method specifically includes: in 60s, the chamber pressure is 5.3KPa.
Preferably, the set pressure is at 60 ℃ for a test procedure pressure of 21.0 KPa and at 78 ℃ for a test procedure pressure of 45.5 KPa.
The set pressure was measured at 60 ℃ under 21.0 KPa and at 78 ℃ under 45.5KPa according to the sterilization process of the formaldehyde sterilizer.
Compared with the prior art, the invention has the following beneficial effects:
the method for detecting the resistance of the low-temperature formaldehyde sterilization indicator provided by the invention truly simulates the sterilization process of a formaldehyde sterilizer, and the resistance detection result of the sterilization indicator more conforms to the clinical sterilization requirement. The whole detection process is carried out under negative pressure, so that the risk of formaldehyde contact of operators is reduced.
The device for detecting the resistance of the low-temperature formaldehyde sterilization indicator is used for operating the method for detecting the resistance of the low-temperature formaldehyde sterilization indicator; the sterilization process of the formaldehyde sterilizer is truly simulated, and the resistance detection result of the sterilization indicator better meets the clinical sterilization requirement. The whole detection process of the low-temperature formaldehyde sterilization indicator resistance detection device is carried out under negative pressure, so that the risk of formaldehyde contact of operators is reduced.
Drawings
FIG. 1 is a schematic structural diagram of a resistance detection device for a low-temperature formaldehyde sterilization indicator according to the invention;
FIG. 2 is a graph of the operating pressure of the method for detecting resistance to low-temperature formaldehyde sterilization indicator according to the present invention.
In the figure: 501. a detection chamber; 521. a first heater; 11. a formaldehyde filling valve; 12. a puncture valve; 13. a steam filling valve; 14. a water supply valve; 15. a vacuum pumping valve; 16. a secondary vacuum pumping valve; 17. an air return valve; 20. a detection temperature sensor; 21. a steam temperature sensor; 22. a formaldehyde temperature sensor; 23. a gas storage temperature sensor; 30. detecting a pressure sensor; 31. a gas storage pressure sensor; 101. a formaldehyde vaporization device; 102. a gas storage tank; 121. a third heater; 122. a puncture mechanism; 123. a formaldehyde solution bag; 124. a fourth heater; 201. a steam generating device; 211. a second heater; 301. an air filter; 401. and (4) vacuumizing the pump.
Detailed Description
In order to more clearly illustrate the embodiments or technical solutions of the present invention, the drawings used in the description of the embodiments or technical solutions will be briefly introduced below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without creative efforts.
Example 1
As shown in fig. 1, the invention designs a resistance detection device for a low-temperature formaldehyde sterilization indicator, which comprises a detection chamber 501, a vacuum module, an emptying module, a formaldehyde filling module, a steam filling module and a control module, wherein the detection chamber 501 is internally provided with a detection pressure sensor 30, a first heater 521 and a detection temperature sensor 20;
the vacuum module comprises a vacuum pumping pump 401 and a vacuum pumping valve 15, one end of the vacuum pumping valve 15 is connected with the sterilization chamber body through a pipeline, and the other end of the vacuum pumping valve 15 is connected with the vacuum pumping pump 401;
the formaldehyde filling module comprises a formaldehyde solution bag 123, a puncture mechanism 122, a puncture valve 12, a formaldehyde vaporization device 101, a gas storage tank 102 and a formaldehyde filling valve 11 which are sequentially arranged, wherein a third heater 121 and a formaldehyde temperature sensor 22 are arranged in the formaldehyde vaporization device 101, and a fourth heater 124, a gas storage temperature sensor 23 and a gas storage pressure sensor 31 are arranged in the gas storage tank 102;
the steam filling module comprises a steam generating device 201 and a steam filling valve 13, wherein a second heater 211 and a steam temperature sensor 21 are arranged in the steam generating device 201;
the air return module comprises an air return valve 17, and the air return valve 17 is connected with the detection chamber 501 and the atmospheric pressure to provide air in the vacuum environment of the balanced detection chamber 501;
the control module comprises a touch display screen, a controller and a printer, and the controller is used for controlling the work of the detection chamber, the vacuum module, the emptying module, the formaldehyde filling module and the steam filling module; the display touch screen can display parameter values in the program running process, and can also set program parameters or open and close program functions; and the printer prints and records the parameter values of the program operation.
Example 2:
as shown in fig. 2, the invention designs a method for detecting the resistance of a low-temperature formaldehyde sterilization indicator, which is used for the device for detecting the resistance of the low-temperature formaldehyde sterilization indicator in the embodiment 1, and the method comprises the following steps:
step S1, starting
Starting the equipment, selecting a 60 ℃ test program, and heating the first heater 521, the second heater 211, the third heater 121 and the fourth heater 124 to a set temperature of 60 ℃;
step S2, puncturing
The puncture mechanism 122 punctures the formaldehyde solution bag 123, opens the puncture valve 12, and closes the puncture valve 12 after the formaldehyde solution enters the formaldehyde vaporizing device 101;
step S3, pre-vacuum
Starting the vacuum-pumping pump 401 and the vacuum-pumping valve 15, and closing the vacuum-pumping pump 401 and the vacuum-pumping valve 15 when the detection pressure sensor 30 of the detection chamber 501 reaches the detection pressure set value of 5.3 KPa;
step S4, filling formaldehyde
When the gas storage pressure sensor 31 of the gas storage tank 102 reaches a gas storage pressure set value, the formaldehyde filling valve 11 is opened, and within 60s, after the pressure of the detection chamber 501 is 21.8KPa, the formaldehyde filling valve 11 is closed;
step S5, exposing
Maintaining the pressure of the detection chamber 501 to a set time, wherein the set time is set by an operator according to the actual situation on site;
step S6, steam cleaning
Starting a vacuum pump 401 and a vacuum valve 15 to vacuumize the detection chamber 501, closing the vacuum pump 401 and the vacuum valve 15 after the set value of the detection pressure is reached, starting a steam filling valve 13, filling water steam into the detection chamber 501, vacuumizing again after the set pressure reaches 21.0 KPa, and repeatedly pulsing to a set number of times, wherein the set number of times is set by an operator according to the actual situation of a site;
step S7, air introduction
The return air valve 17 is opened, the detection chamber 501 is returned to atmospheric pressure, and the test procedure is ended.
Example 3
The invention designs another resistance detection method of a low-temperature formaldehyde sterilization indicator, which is used for the resistance detection device of the low-temperature formaldehyde sterilization indicator in the embodiment 1 and comprises the following steps:
step S1, starting
Starting the equipment, selecting a 78 ℃ test program, and heating the first heater 521, the second heater 211, the third heater 121 and the fourth heater 124 to a set temperature of 78 ℃;
step S2, puncturing
The puncture mechanism 122 punctures the formaldehyde solution bag 123, opens the puncture valve 12, and closes the puncture valve 12 after the formaldehyde solution enters the formaldehyde vaporizing device 101;
step S3, pre-vacuum
Starting the vacuum-pumping pump 401 and the vacuum-pumping valve 15, and closing the vacuum-pumping pump 401 and the vacuum-pumping valve 15 when the detection pressure sensor 30 of the detection chamber 501 reaches the detection pressure set value of 5.3 KPa;
step S4, filling formaldehyde
When the gas storage pressure sensor 31 of the gas storage tank 102 reaches the gas storage pressure set value, the formaldehyde filling valve 11 is opened, and within 60s, the formaldehyde filling valve 11 is closed after the pressure of the detection chamber 501 is 47.3KPa for detecting the set pressure;
step S5, exposing
Maintaining the pressure of the detection chamber 501 to a set time, wherein the set time is set by an operator according to the actual situation on site;
step S6, steam cleaning
Starting a vacuum pump 401 and a vacuum valve 15 to vacuumize the detection chamber 501, closing the vacuum pump 401 and the vacuum valve 15 after a set value of detection pressure is reached, starting a steam filling valve 13, injecting steam into the detection chamber 501, vacuumizing again after a set pressure of 45.5KPa is reached, repeatedly pulsing to a set number of times, wherein the set number of times is set by an operator according to actual conditions on site;
step S7, air introduction
The return air valve 17 is opened, the pressure in the detection chamber 501 returns to the atmospheric pressure, and the test procedure is ended.
The resistance detection device for the low-temperature formaldehyde sterilization indicator provided by the invention is described in detail above. The principles and embodiments of the present invention are explained herein using specific examples, which are presented only to assist in understanding the method and its core concepts. It should be noted that, for those skilled in the art, without departing from the principle of the present invention, it is possible to make various improvements and modifications to the present invention, and those improvements and modifications also fall within the scope of the claims of the present invention.

Claims (10)

1. The resistance detection device for the low-temperature formaldehyde sterilization indicator is characterized by comprising a detection chamber (501), a vacuum module, a return-to-air module, a formaldehyde filling module, a steam filling module and a control module, wherein a detection pressure sensor (30), a first heater (521) and a detection temperature sensor (20) are arranged in the detection chamber (501);
the vacuum module comprises a vacuum pumping pump (401) and a vacuum pumping valve (15), one end of the vacuum pumping valve (15) is connected with the sterilization chamber body through a pipeline, and the other end of the vacuum pumping valve is connected with the vacuum pumping pump (401);
the formaldehyde filling module comprises a formaldehyde solution bag (123), a puncture mechanism (122), a puncture valve (12), a formaldehyde vaporization device (101), a gas storage tank (102) and a formaldehyde filling valve (11) which are sequentially arranged, wherein a third heater (121) and a formaldehyde temperature sensor (22) are arranged in the formaldehyde vaporization device (101), and a fourth heater (124), a gas storage temperature sensor (23) and a gas storage pressure sensor (31) are arranged in the gas storage tank (102);
the steam filling module comprises a steam generating device (201) and a steam filling valve (13), wherein a second heater (211) and a steam temperature sensor (21) are arranged in the steam generating device (201);
the air return module comprises an air return valve (17), and the air return valve (17) is connected with the detection chamber (501) and the atmospheric pressure;
the control module is used for controlling the work of the detection chamber, the vacuum module, the air returning module, the formaldehyde filling module and the steam filling module.
2. The resistance detection device for the low-temperature formaldehyde sterilization indicator according to claim 1, wherein the vacuum module further comprises a secondary vacuum-pumping valve (16), one end of the secondary vacuum-pumping valve (16) is connected with the formaldehyde filling module through a pipeline, and the other end of the secondary vacuum-pumping valve is connected with the vacuum-pumping pump (401).
3. The low-temperature formaldehyde sterilization indicator resistance detecting device according to claim 1, wherein the steam generating device (201) is connected to a water source through a water supply valve (14).
4. The low-temperature formaldehyde sterilization indicator resistance detection device according to claim 1, wherein the back-air valve (17) is connected to atmospheric pressure through an air filter (301).
5. A method for detecting resistance of a low-temperature formaldehyde sterilization indicator, which is used for the device for detecting resistance of a low-temperature formaldehyde sterilization indicator as defined in any one of claims 1 to 4, and is characterized by comprising the following steps:
step S1, starting
Starting equipment, selecting a test program, and heating a first heater (521), a second heater (211), a third heater (121) and a fourth heater (124) to a set temperature;
step S2, puncturing
The puncture mechanism (122) punctures the formaldehyde solution bag (123), opens the puncture valve (12), and closes the puncture valve (12) after the formaldehyde solution enters the formaldehyde vaporizing device (101);
step S3, pre-vacuum
Starting a vacuum pumping pump (401) and a vacuum pumping valve (15), and closing the vacuum pumping pump (401) and the vacuum pumping valve (15) after a detection pressure sensor (30) of a detection chamber (501) reaches a detection pressure set value;
step S4, filling formaldehyde
When a gas storage pressure sensor (31) of the gas storage tank (102) reaches a gas storage pressure set value, a formaldehyde filling valve (11) is opened, and the formaldehyde filling valve (11) is closed after the pressure of a detection chamber (501) is a detection set pressure within a fixed time;
step S5, exposing
Maintaining the pressure in the detection chamber (501) for a set time;
step S6, steam cleaning
Starting a vacuum pump (401) and a vacuum valve (15) to vacuumize a detection chamber (501), closing the vacuum pump (401) and the vacuum valve (15) after a set value of detection pressure is reached, starting a steam filling valve (13), injecting steam into the detection chamber (501), vacuumizing again after a set pressure is reached, and repeatedly pulsing to a set number of times;
step S7, air introduction
And opening the air return valve (17), returning the pressure of the detection chamber (501) to the atmospheric pressure, and ending the test program.
6. The method of detecting resistance to a low temperature formaldehyde sterilization indicator of claim 5, wherein the test procedure comprises a 60 ℃ or 78 ℃ test procedure.
7. The method of claim 6, wherein the test set pressure is 21.8KPa at 60 ℃ and 47.3KPa at 78 ℃.
8. The method of detecting resistance to a low temperature formaldehyde sterilization indicator of claim 6, wherein the detection pressure setting is 5.3KPa.
9. The method for detecting resistance of a low-temperature formaldehyde sterilization indicator according to claim 6, wherein in the step S4, after the pressure in the detection chamber (501) reaches the detection set pressure within a fixed time, the method specifically comprises the following steps: the pressure in the detection chamber (501) is 5.3KPa within 60 s.
10. The method of claim 6, wherein the set pressure is 21.0 KPa at 60 ℃ and 45.5KPa at 78 ℃.
CN202211428253.XA 2022-11-15 2022-11-15 Device and method for detecting resistance of low-temperature formaldehyde sterilization indicator Pending CN115494198A (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070098591A1 (en) * 2005-10-31 2007-05-03 Georg Frinke Method and apparatus for low energy vaporization of liquid oxidizing agents or solutions
CN102565289A (en) * 2012-02-02 2012-07-11 山东新华医疗器械股份有限公司 Detector used for detecting comprehensive resistance of oxirane sterilization indicator
CN109720658A (en) * 2018-11-27 2019-05-07 上海翡诺医药设备有限公司 A kind of hydrogen peroxide vacuum and low temperature disinfection system and method
CN110974991A (en) * 2019-12-30 2020-04-10 张家港华菱医疗设备股份公司 Low-concentration formaldehyde sterilization system and use method thereof
CN215350923U (en) * 2021-09-08 2021-12-31 山东新华医疗器械股份有限公司 Low-temperature steam formaldehyde sterilizer

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070098591A1 (en) * 2005-10-31 2007-05-03 Georg Frinke Method and apparatus for low energy vaporization of liquid oxidizing agents or solutions
CN102565289A (en) * 2012-02-02 2012-07-11 山东新华医疗器械股份有限公司 Detector used for detecting comprehensive resistance of oxirane sterilization indicator
CN109720658A (en) * 2018-11-27 2019-05-07 上海翡诺医药设备有限公司 A kind of hydrogen peroxide vacuum and low temperature disinfection system and method
CN110974991A (en) * 2019-12-30 2020-04-10 张家港华菱医疗设备股份公司 Low-concentration formaldehyde sterilization system and use method thereof
CN215350923U (en) * 2021-09-08 2021-12-31 山东新华医疗器械股份有限公司 Low-temperature steam formaldehyde sterilizer

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