CN109306319A - The fast check system of medical device sterile and its application method - Google Patents
The fast check system of medical device sterile and its application method Download PDFInfo
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- CN109306319A CN109306319A CN201811357918.6A CN201811357918A CN109306319A CN 109306319 A CN109306319 A CN 109306319A CN 201811357918 A CN201811357918 A CN 201811357918A CN 109306319 A CN109306319 A CN 109306319A
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- C12M23/00—Constructional details, e.g. recesses, hinges
- C12M23/02—Form or structure of the vessel
- C12M23/08—Flask, bottle or test tube
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Abstract
A kind of fast check system of medical device sterile, it include: sterility test automatic tester and culture bottle, the culture bottle is for containing culture medium and sterile biological indicator bacteria piece, for the culture bottle for being placed in sterility test automatic tester, the sterility test automatic tester carries out vibration culture to culture bottle；The sterility test automatic tester further includes vibration section, temperature control portion, test section；The vibration section, temperature control portion and test section are connected with MCU chip respectively.The present invention can be realized carries out automatic, quickly sterile monitoring to medical instrument, sterile biological indicator bacteria piece etc. respectively, compared to detection means such as visual results in conventional stationary culture, system of the present invention can improve detection limit, be greatly shortened detection cycle, reduce macroscopic subjectivity misjudgment, reduce biochemical cultivation case using time etc..Currently, the quick Sterility testing technical research of automation for medical device product is still in blank.
Description
Technical field
The present invention relates to a kind of fast check system of medical device sterile and its application methods, belong to the technology of medical instrument detection
Field.
Background technique
The sterilization validation and sterilising cycle monitoring needs of most of medical instrument use bionidicator, and biology refers to after sterilizing
Show that the sterility test of object is of great significance for the sterilizing of medical instrument.When establishing sterilizing dose for sterilizing or to verify this one
When the conventional validity or product of amount are let pass, all need to carry out sterility test to microbial administration bacterium piece.When sun occurs in sterility test
Property result when, although practical pollution is possible to be operated by test atmosphere, personnel etc. and bring into, can suspect bionidicator not
It is complete to kill, it is therefore desirable to need to further to carry out retrospective survey to the sterilizing validity of the sterilizing batch, exclude deviation or again true
Determine sterilizing dose.
The conventional method of sterilized bio indicator bacteria piece sterility test is there are problems at present, except requirement detection cycle compared with
Long (generally 7 days), there is also visual results subjectivities for sterility test by force, is not easy to judge, culture medium is prepared and quality control
Make cumbersome, false negative and false positive results easily occur, it is more demanding to personnel's operation the problems such as.
There is a problem of that about qualitative accurate, detection inaccuracy, those skilled in the art start to develop for the prior art
New monitoring device is studied with the sterilizing situation of timely learning medical instrument to be measured.
Summary of the invention
In view of the deficiencies of the prior art, the present invention discloses a kind of fast check system of medical device sterile.
Invention additionally discloses a kind of experimental methods that medical device sterile detection is carried out using above system.
The invention also discloses a kind of culture bottles suitable for the fast check system of above-mentioned medical device sterile.
The present invention can be realized carries out automatic, quickly sterile monitoring to medical instrument, sterile biological indicator bacteria piece etc. respectively,
Compared to detection means such as visual results in conventional stationary culture, system of the present invention can improve detection and limit, significantly
Shorten detection cycle, reduce the misjudgment of macroscopic subjectivity, reduce biochemical cultivation case using time etc..Currently, needle
Blank is still in the quick Sterility testing technical research of the automation of medical device product.
Technical scheme is as follows:
A kind of fast check system of medical device sterile, comprising: sterility test automatic tester and culture bottle, the culture bottle are used
In containing culture medium and sterile biological indicator bacteria piece, the culture bottle is described for being placed in sterility test automatic tester
Sterility test automatic tester carries out vibration culture to culture bottle；
The sterility test automatic tester further includes vibration section, temperature control portion, test section；The vibration section, temperature control portion and
Test section is connected with MCU chip respectively；
The vibration section is for carrying out vibration culture to culture bottle；
The temperature control portion is used to control the temperature of culture；
The test section is used to carry out real-time absorbance detection to the culture medium in culture bottle, pH value detects,
End product of metabolism CO2The detection of the fluorescence intensity of Concentration Testing or substrate；Above-mentioned detection mode is prior art neck
The common detection methods in domain, therefore be clear for those skilled in the art；
The MCU chip is used for: so that technical staff is carried out process design according to different Sterility testing experiments, it is automatic to control
It makes the sterility test automatic tester and Sterility testing is carried out to the sample in the culture bottle or culture bottle；The MCU chip
In be also loaded with Test database and the corresponding threshold value of all kinds of Sterility testing normal conditions.
It is preferred according to the present invention, the system also includes display, the display for show experimental data or by
The corresponding experimental diagrams formed of experimental data that treated and image corresponding when detection data exceeds normal condition threshold value
Alarm, the display are connected with the MCU chip.The display can be selected can be aobvious with the touch industry of human-computer interaction
Test experience process can be artificially arranged in display screen, operator on the display, keep detection more intuitive efficient.It is described
The preferred stm32 cake core of MCU chip.
Preferred according to the present invention, the system also includes data transmission modules: for acquiring all kinds of Sterility testings in real time
Data, and the detection data is transmitted to the storage server outside system；The system also includes display, the display
For show detection data or it is processed after detection data corresponding to formation experimental diagrams, the display and the storage
Server is connected.When storing data is excessive, data class is excessive or data processing algorithm is complicated, then increase outside the system
If storage server, quick calling detection data or Test database and testing result are realized by data transmission module.
The test section is absorbance detection device, for detecting the absorbance in culture medium, measurement target culture medium
Absorbance determines medical instrument to be measured to define its turbidity, eventually by the absorbance threshold value set in MCU chip automatically
Aseptic result.
The sterility test automatic tester further includes the pH detection module for detecting pH value in culture bottle.
The sterility test automatic tester further includes for detecting culture bottle intracellular metabolite final product CO2Concentration CO2Inspection
Survey module.
The sterility test automatic tester further includes the Electronic Speculum module for detecting fluorescence labeling substrate.
A kind of culture bottle suitable for the fast check system of above-mentioned medical device sterile, the culture bottle include transparent vial body,
The transparent vial body upper end is provided with bottle cap, and the bottle cap and transparent vial body are connected through a screw thread；At the bottom of the transparent vial body
Portion is provided with pellosil circle, and the cross section of the pellosil circle is semiclosed shape, the pellosil circle and the transparent vial body
Bottom of bottle forms closed annular region, is provided with detection reagent in the annular region.The present invention by the pellosil circle with
The culture bottle combines, and forms it into closed structure, and when detecting colour developing, the color can be checked by bottom of bottle or bottle wall
Monitoring.
Preferred according to the present invention, the cross section of the pellosil circle is L shape.
Preferred according to the present invention, the cross section of the pellosil circle is arc-shaped.
Preferred according to the present invention, the pellosil circle is polymer matrix.
Preferred according to the present invention, the polymer matrix is to allow CO2The film of transmission, the detection reagent are pH value
Development process value colour reagent.CO2It can pass through pellosil, when there is microorganism growth in the culture bottle, the CO that releases2Infiltration
To pellosil after water saturation, hydrogen ion (H is generated+) change pellosil circle enclosure space in pH value, make the detection
Reagent color changes, and by color change calculating, whether there is or not microorganism growths.
It is preferred according to the present invention, it is also filled with culture medium in advance in the culture bottle.
A kind of experimental method carrying out medical device sterile detection using above system, comprising:
1) automatic experiment flow is arranged according to experiment theme in operator；Existing Sterility testing device testing process is opposite
It is single, whenever encountering different strain or inhomogeneity Sterility testing is tested, need operator's design by self process, hand
Dynamic record automatically records experimental data, therefore experiment flow has certain differentiation, so that experimental result and statistical result
There is also othernesses, however, being still difficult to meet different strain and Sterility testing experiment if experiment flow simple syndication is unified
The needs of theme, for this purpose, the present invention makes full use of customized type thinking combination internet data performance, by the Sterility testing system
It is designed as both having ensure that the diversification of experiment condition in this way according to the experiment flow that matches of different test experience demands,
In turn ensure the uniformity of operator's process under single experiment condition；
2) corresponding Test database is selected according to strain and the theme of experiment, the Test database stores all kinds of inspections
Survey the corresponding experiment conclusion of experimental result, for by real-time detection to data compared with the Test database, obtain
Corresponding experiment conclusion；
3) culture bottle is subjected to pre-processing according to experiment theme, is put into middle progress in the sterility test automatic tester
Vibration culture；The number of days of the vibration culture and the condition of culture carry out automatically according to the experiment flow；
4) after vibration culture, the test section starts absorbance detection according to the experiment flow automatically, pH value is shown
The detection of color method value thanks to final product CO2The detection of the fluorescence intensity of Concentration Testing and/or substrate；
5) MCU chip compares collected detection data and the Test database；The MCU chip will
Collected detection data is for statistical analysis；When the detection data is beyond the range for corresponding to categorical data in Test database
When, the MCU chip instruction user carries out selective storing data, once it stores, the detection threshold value in the Test database
It will be recalculated according to preset data processing method or algorithm；The method handled detection data can go out
It is set before factory, alternatively, operator is edited automatically according to actual experiment demand and is written in the MCU chip；
6) when the detection data exceeds the detection threshold value in the Test database, the medical device sterile is examined fastly
System is alarmed.
It is preferred according to the present invention, in step 1), the operator according to experiment need to setting experiment flow into
Row modification is saved or is deleted.The system can also be uploaded to network to data and the experiment flow being set as needed
Database directly carries out choice experiment convenient for technical staff of the same trade.
It is preferred according to the present invention, it updates the Test database by internet before step 1) and/or updates and examine
Measured data parser.
The technical advantages of the present invention are that:
1, system of the present invention greatly improves detection limit and shortens detection cycle, by conventional Sterility testing from 7 days left sides
It is right to improve within 24 hours, significantly improve the efficiency of medical device sterile detection.
2, system of the present invention uses customized type thinking, by experiment flow design load in the MCU chip, is convenient for
Operation is transferred and is modified, and the present invention makes full use of customized type thinking combination internet data performance, by the Sterility testing system
It is designed as both having ensure that the diversification of experiment condition in this way according to the experiment flow that matches of different test experience demands,
In turn ensure the uniformity of operator's process under single experiment condition.
3, design of the present invention to detection data and Test database: when the detection data is beyond right in Test database
When answering the range of categorical data, the MCU chip instruction user carries out selective storing data, once storage, the testing number
It will be recalculated according to preset data processing method or algorithm according to the detection threshold value in library.
4, the present invention carries out Sterility testing to the sample in culture bottle or culture bottle in the way of vibration culture, and mentions
One of an important factor for high detection efficiency.
5, system of the present invention includes a variety of test sections, selects detection the most suitable to join according to the needs of different experiments
Number monitoring, and detection in automatic realizing system avoid changing the influence to experimental result because of external environment.
6, the present invention has also carried out corresponding technological improvement to culture bottle, complies with culture sterile biological indicator bacteria piece
With the technical requirements of vibration culture: the culture bottle combines pH value colour developing and dynamic cultivation method, reduces macroscopic subjectivity
Property misjudgment；Optimize sterility test process, reduce the workload of testing crew, using the culture bottle of research and development, without preparing training
Support base；Design culture bottle is screw thread mouth, so as to screw off bottle stopper, convenient for direct plungeing into for bacterium piece.
A kind of new method of sterility test of system development of the present invention, can be greatly shortened detection cycle and improve inspection
Limit is surveyed, the launch period of enterprise is shortened, improves the safety guarantee of product, can be used for enterprise procurement article, intermediate product
With the sterile confirmation of terminal sterilization, it can also be used to the foundation of sterilizing dose and the confirmation of conventional sterilant validity.
Detailed description of the invention
Fig. 1 is the module connection figure of system described in the embodiment of the present invention 1；
Fig. 2 is the module connection figure of system described in the embodiment of the present invention 1；
Fig. 3 is the module connection figure of system described in the embodiment of the present invention 3；
Fig. 4,5 be culture bottle described in the embodiment of the present invention 2 structural schematic diagram；
Fig. 6 is the flow diagram of application method of the present invention；
In Fig. 4,5,1, transparent vial body；2, bottle cap；3, pellosil circle；4, indicator is detected；5, culture medium.
Specific embodiment
The present invention is described in detail below with reference to embodiment and Figure of description, but not limited to this.
Embodiment 1,
As shown in Figure 1, 2.
A kind of fast check system of medical device sterile, comprising: sterility test automatic tester and culture bottle, the culture bottle are used
In containing culture medium and sterile biological indicator bacteria piece, the culture bottle is described for being placed in sterility test automatic tester
Sterility test automatic tester carries out vibration culture to culture bottle；
The sterility test automatic tester further includes vibration section, temperature control portion, test section；The vibration section, temperature control portion and
Test section is connected with MCU chip respectively；
The vibration section is for carrying out vibration culture to culture bottle；
The temperature control portion is used to control the temperature of culture；
The test section is used to carry out real-time absorbance detection to the culture medium in culture bottle, pH value detects,
End product of metabolism CO2The detection of the fluorescence intensity of Concentration Testing or substrate；Above-mentioned detection mode is prior art neck
The common detection methods in domain, therefore be clear for those skilled in the art；
The MCU chip is used for: so that technical staff is carried out process design according to different Sterility testing experiments, is automatically controlled
The sterility test automatic tester carries out Sterility testing to the sample in the culture bottle or culture bottle；In the MCU chip
Also it is loaded with Test database and the corresponding threshold value of all kinds of Sterility testing normal conditions.
The system also includes display, the display be used for show experimental data or it is processed after experimental data institute
The experimental diagrams being correspondingly formed and corresponding image alarm, the display and institute when detection data exceeds normal condition threshold value
MCU chip is stated to be connected.The display can be selected can be with the touch industrial LCD of human-computer interaction, and operator can be
Test experience process is artificially set on the display, keeps detection more intuitive efficient.The preferred stm32 type core of MCU chip
Piece.
The test section is absorbance detection device, for detecting the absorbance in culture medium, measurement target culture medium
Absorbance determines medical instrument to be measured to define its turbidity, eventually by the absorbance threshold value set in MCU chip automatically
Aseptic result.
The sterility test automatic tester further includes the pH detection module for detecting pH value in culture bottle.
The sterility test automatic tester further includes for detecting culture bottle intracellular metabolite final product CO2Concentration CO2Inspection
Survey module.
The sterility test automatic tester further includes the Electronic Speculum module for detecting fluorescence labeling substrate.
Embodiment 2,
As shown in Figure 4,5.
Suitable for the culture bottle of system described in embodiment 1, including transparent vial body 1, it is provided in 1 upper end of transparent vial body
Bottle cap 2, the bottle cap 2 and transparent vial body 1 are connected through a screw thread；The bottom of the transparent vial body 1 is provided with pellosil circle 3,
The cross section of the pellosil circle 3 is semiclosed shape, and the bottom of bottle of the pellosil circle and the transparent vial body forms closed ring
Shape region is provided with detection reagent 4 in the annular region.
The pellosil circle is polymer matrix.The polymer matrix is to allow CO2The film of transmission, the detection
Reagent is pH value development process value colour reagent.CO2It can pass through pellosil, when there is microorganism growth in the culture bottle, release
CO out2Pellosil is infiltrated into after water saturation, generates hydrogen ion (H+) change pellosil circle enclosure space in pH value,
The detection reagent color is set to change, whether there is or not microorganism growths by color change calculating.
When producing the culture bottle, the silica gel ring 3 is wrapped up into the bottom that the detection reagent 4 fills in the culture bottle together
Portion makes the silica gel ring 3 form closed area, and then above-mentioned pH value development process value colour developing may be implemented.
As needed, also silica gel ring can be designed as various shapes, as shown in figure 4, the cross section of the pellosil circle is L
Shape.As shown in figure 5, the cross section of the pellosil circle is arc-shaped.
Also it is filled with culture medium 5 in advance in the culture bottle.
Embodiment 3,
As shown in Figure 3.
A kind of fast check system of medical device sterile as described in Example 1, difference are that the system also includes data biographies
Defeated module: for acquiring all kinds of Sterility testing data in real time, and the detection data is transmitted to the storage server outside system；
The system also includes display, the display be used to show detection data or it is processed after detection data corresponding formed
Experimental diagrams, the display is connected with the storage server.
Embodiment 4,
As shown in Figure 6.
A kind of experimental method carrying out medical device sterile detection using the system as described in embodiment 1,2,3, comprising:
1) automatic experiment flow is arranged according to experiment theme in operator；Existing Sterility testing device testing process is opposite
It is single, whenever encountering different strain or inhomogeneity Sterility testing is tested, need operator's design by self process, hand
Dynamic record automatically records experimental data, therefore experiment flow has certain differentiation, so that experimental result and statistical result
There is also othernesses, however, being still difficult to meet different strain and Sterility testing experiment if experiment flow simple syndication is unified
The needs of theme, for this purpose, the present invention makes full use of customized type thinking combination internet data performance, by the Sterility testing system
It is designed as both having ensure that the diversification of experiment condition in this way according to the experiment flow that matches of different test experience demands,
In turn ensure the uniformity of operator's process under single experiment condition；
2) corresponding Test database is selected according to strain and the theme of experiment, the Test database stores all kinds of inspections
Survey the corresponding experiment conclusion of experimental result, for by real-time detection to data compared with the Test database, obtain
Corresponding experiment conclusion；
3) culture bottle is subjected to pre-processing according to experiment theme, is put into the fast check system of the medical device sterile and carries out
Vibration culture；The number of days of the vibration culture and the condition of culture carry out automatically according to the experiment flow；
4) after vibration culture, the test section starts absorbance detection according to the experiment flow automatically, pH value is examined
It surveys, thank to final product CO2The detection of the fluorescence intensity of Concentration Testing and/or substrate；
5) MCU chip compares collected detection data and the Test database；The MCU chip will
Collected detection data is for statistical analysis；When the detection data is beyond the range for corresponding to categorical data in Test database
When, the MCU chip instruction user carries out selective storing data, once it stores, the detection threshold value in the Test database
It will be recalculated according to preset data processing method or algorithm；The method handled detection data can go out
It is set before factory, alternatively, operator is edited automatically according to actual experiment demand and is written in the MCU chip；
6) when the detection data exceeds the detection threshold value in the Test database, the medical device sterile is examined fastly
System is alarmed.
Embodiment 5,
Application method as described in Example 4, difference is, in step 1), the operator is according to experiment need
Setting experiment flow is modified, saves or be deleted.The system to data and can also be set as needed
Experiment flow is uploaded to network data base, directly carries out choice experiment convenient for technical staff of the same trade.
The Test database is updated by internet before step 1) and/or updates detection data parser.
Application examples 1,
It such as embodiment 1-5, needs to verify the detection system before carrying out Sterility testing, does base for subsequent detection
Plinth prepares.
It is cultivated because microbial administration bacterium piece need to direct plunge into culture medium, culture medium is made as nutrient broth (NB) in advance in culture bottle
Culture medium, loading amount and height carry out corresponding confirmatory experiment according to specific experiments.
Positive alarm point is determined according to parameters such as specified strain, culture medium and culture bottles: for example, existing to spores of bacillus subtilin
Growth curve in fast check system is studied, according to bacterium amount, CO2The relationship of concentration and color change determines reasonable positive report
Alert point.
Negative alarm point is determined according to parameters such as specified strain, culture medium and culture bottles: taking reasonable serial dilution
Spores of bacillus subtilin 1mL is inoculated in respectively in NB culture bottle, is placed in culture instrument and is cultivated, sees whether to detect and record detection
Time.The detection time for the highest dilution grade spores of bacillus subtilin that will be detected is determined as negative alarm multiplied by certain safety coefficient
Point.
Application examples 2,
Such as embodiment 1-4, need to carry out specificity verifying to the detection system before carrying out Sterility testing:
1) aseptic inspection is carried out to culture bottle, the purpose of this test is to verify the aseptic of culture bottle itself, to same
A collection of culture bottle takes 5 bottles to be placed in system of the present invention at random and cultivates, and has seen whether positive alarm.
2) growth promotion test is carried out to culture bottle
The purpose of this test is to verify in the case where there is sample effects, and the culture medium in culture bottle is under given conditions
To the growth promotion ability of particular types microorganism: taking 5 bottles of culture bottle equipped with NB, open bottle cap, be inoculated with 1ml respectively and be less than
Hay bacillus (ATCC9372) gemma of 100cfu, adds sterilized microbial administration bacterium piece, is placed in the system and cultivates,
Positive alarm is seen whether.
3) detection limit verifying, the purpose of this verifying are to prove that the recall rate of new system is higher than conventional method, positive detection
Time is shorter than conventional method:
The spores of bacillus subtilin 1mL for taking reasonable serial dilution, is inoculated in respectively in NB culture bottle, while being inoculated with sterilizing
Bacterium piece, each 30 bottles of each gradient.It is placed in system of the present invention and cultivates, record detection positive alarm and detection time.
Meanwhile the spores of bacillus subtilin 1mL of respective series dilution gradient is taken, it is inoculated in NB test tube, is inoculated with simultaneously respectively
Sterilize bacterium piece, each each 30 pipe of gradient.It is placed in 37 a DEG C stationary culture, it is positive to see whether detection, and record detection time.
4) reproducibility is verified
In different experiments, a certain number of test organisms are inoculated in culture bottle, using new method, or respectively by different people
Member, or in different time, test, detection data is analyzed to evaluate reproducibility.
5) representative sample is verified
Be inoculated in culture bottle different manufacturers, different batches do not sterilize and sterilized biological indicator, check different
Applicability of the bacterium piece to instrument.
Claims (10)
1. a kind of fast check system of medical device sterile, which is characterized in that the system comprises: sterility test automatic tester and training
Bottle is supported, the culture bottle is for containing culture medium and sterile biological indicator bacteria piece, and the culture bottle is for being placed in sterility test
In automatic tester, the sterility test automatic tester carries out vibration culture to culture bottle；
The sterility test automatic tester further includes vibration section, temperature control portion, test section；The vibration section, temperature control portion and detection
Portion is connected with MCU chip respectively；
The vibration section is for carrying out vibration culture to culture bottle；
The temperature control portion is used to control the temperature of culture；
The test section is used to carry out real-time absorbance detection to the culture medium in culture bottle, pH value detects,
End product of metabolism CO2The detection of the fluorescence intensity of Concentration Testing or substrate；
The MCU chip is used for: so that technical staff is carried out process design according to different Sterility testing experiments, is automatically controlled institute
It states sterility test automatic tester and Sterility testing is carried out to the sample in the culture bottle or culture bottle；In the MCU chip also
It is loaded with Test database and the corresponding threshold value of all kinds of Sterility testing normal conditions.
2. the fast check system of a kind of medical device sterile according to claim 1, which is characterized in that the system also includes aobvious
Show device, the display be used to show experimental data or it is processed after the corresponding experimental diagrams formed of experimental data and when inspection
Measured data exceeds corresponding image alarm, the display when normal condition threshold value and is connected with the MCU chip.
3. the fast check system of a kind of medical device sterile according to claim 1, which is characterized in that the system also includes numbers
According to transmission module: being transmitted to the clothes of the storage outside system for acquiring all kinds of Sterility testing data in real time, and by the detection data
Business device；The system also includes display, the display be used for show detection data or it is processed after detection data institute it is right
The experimental diagrams that should be formed, the display are connected with the storage server.
4. the fast check system of a kind of medical device sterile according to claim 1, which is characterized in that the test section is extinction
Detection device is spent, for detecting the absorbance in culture medium, measures the absorbance of target culture medium to define its turbidity, finally
Determine the aseptic result of medical instrument to be measured automatically by the absorbance threshold value set in MCU chip.
5. the fast check system of a kind of medical device sterile according to claim 1, which is characterized in that the sterility test is automatic
Detector further includes the pH detection module for detecting pH value in culture bottle；
The sterility test automatic tester further includes for detecting culture bottle intracellular metabolite final product CO2Concentration CO2Detect mould
Block；
The sterility test automatic tester further includes the Electronic Speculum module for detecting fluorescence labeling substrate.
6. a kind of culture bottle suitable for the fast check system of medical device sterile as described in claim 1, which is characterized in that the training
Feeding bottle includes transparent vial body, the transparent vial body upper end is provided with bottle cap, the bottle cap and transparent vial body are connected through a screw thread；
The bottom of the transparent vial body is provided with pellosil circle, the cross section of the pellosil circle is semiclosed shape, the pellosil
The bottom of bottle of circle and the transparent vial body forms closed annular region, is provided with detection reagent in the annular region.
7. culture bottle as claimed in claim 6, which is characterized in that the cross section of the pellosil circle is L shape.
8. culture bottle as claimed in claim 6, which is characterized in that the cross section of the pellosil circle is arc-shaped；
Preferably, the pellosil circle is polymer matrix；
Preferably, the polymer matrix is to allow CO2The film of transmission, the detection reagent are the colour developing examination of pH value development process value
Agent；
Preferably, it is also filled with culture medium in advance in the culture bottle.
9. carrying out the experimental method of medical device sterile detection using system as described in claim 1 characterized by comprising
1) automatic experiment flow is arranged according to experiment theme in operator；
2) corresponding Test database is selected according to strain and the theme of experiment, it is real that the Test database stores all kinds of detections
Test the corresponding experiment conclusion of result, for by real-time detection to data compared with the Test database, corresponded to
Experiment conclusion；
3) culture bottle is subjected to pre-processing according to experiment theme, be put into the sterility test automatic tester in vibrated
Culture；The number of days of the vibration culture and the condition of culture carry out automatically according to the experiment flow；
4) after vibration culture, the test section starts absorbance detection, pH value development process according to the experiment flow automatically
Value detection thanks to final product CO2The detection of the fluorescence intensity of Concentration Testing and/or substrate；
5) MCU chip compares collected detection data and the Test database；The MCU chip will acquire
The detection data arrived is for statistical analysis；
6) when the detection data exceeds the detection threshold value in the Test database, the fast check system of medical device sterile
It alarms.
10. utilizing experimental method as claimed in claim 9, which is characterized in that in step 1), the operator is according to experiment
It needs that setting experiment flow is modified, saves or deleted；
Preferably, the Test database is updated by internet before step 1) and/or updates detection data parser.
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| CN113174322A (en) * | 2021-04-13 | 2021-07-27 | 浙江泰林医学工程有限公司 | Rapid sterility detection system and method |
| CN113637722A (en) * | 2021-06-15 | 2021-11-12 | 山东省医疗器械和药品包装检验研究院 | Method for detecting sterility of pipeline and container medical instruments |
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