CN109439531A - A kind of device applied to medical device product sterility test - Google Patents
A kind of device applied to medical device product sterility test Download PDFInfo
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- CN109439531A CN109439531A CN201811332503.3A CN201811332503A CN109439531A CN 109439531 A CN109439531 A CN 109439531A CN 201811332503 A CN201811332503 A CN 201811332503A CN 109439531 A CN109439531 A CN 109439531A
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- liquid
- collection bag
- test
- medical device
- sterility test
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- 238000012360 testing method Methods 0.000 title claims abstract description 57
- 230000036512 infertility Effects 0.000 title claims abstract description 35
- 238000007789 sealing Methods 0.000 claims abstract description 21
- 241001411320 Eriogonum inflatum Species 0.000 claims abstract description 15
- 239000012528 membrane Substances 0.000 claims abstract description 10
- 230000001954 sterilising effect Effects 0.000 abstract description 22
- 238000010828 elution Methods 0.000 abstract description 16
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 16
- 239000003480 eluent Substances 0.000 abstract description 12
- 238000013190 sterility testing Methods 0.000 abstract description 12
- 239000007788 liquid Substances 0.000 abstract description 10
- 238000000034 method Methods 0.000 abstract description 10
- 238000002360 preparation method Methods 0.000 abstract description 9
- 238000012546 transfer Methods 0.000 abstract description 8
- 238000012864 cross contamination Methods 0.000 abstract description 7
- -1 that is Substances 0.000 abstract description 5
- 239000000047 product Substances 0.000 description 37
- 238000012545 processing Methods 0.000 description 8
- 230000010355 oscillation Effects 0.000 description 7
- 238000010586 diagram Methods 0.000 description 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 4
- 238000004140 cleaning Methods 0.000 description 4
- 239000011780 sodium chloride Substances 0.000 description 4
- 238000002627 tracheal intubation Methods 0.000 description 4
- 210000004907 gland Anatomy 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 230000001580 bacterial effect Effects 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 206010036790 Productive cough Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 238000013100 final test Methods 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 239000013067 intermediate product Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 230000002572 peristaltic effect Effects 0.000 description 1
- 238000004886 process control Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000004064 recycling Methods 0.000 description 1
- 210000003802 sputum Anatomy 0.000 description 1
- 208000024794 sputum Diseases 0.000 description 1
- 210000003437 trachea Anatomy 0.000 description 1
Classifications
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
- C12Q1/22—Testing for sterility conditions
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- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Engineering & Computer Science (AREA)
- Microbiology (AREA)
- Public Health (AREA)
- Biotechnology (AREA)
- Immunology (AREA)
- Analytical Chemistry (AREA)
- Molecular Biology (AREA)
- Physics & Mathematics (AREA)
- Biophysics (AREA)
- Epidemiology (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Examining Or Testing Airtightness (AREA)
Abstract
A kind of device applied to medical device product sterility test, including liquid-collection bag, liquid-collection bag one end are equipped with sealing device, and the other end is equipped with bottle stopper, and bottle stopper with membrane filter for being connected.Compared with prior art, the Sterility testing device of this patent is easy to operate, brings and uses, liquid-collection bag is without sterilization treatment；The preparation procedure for simplifying product test liquid, that is, eluent to be measured does not need to be then transferred in vial after sterilizing transfer vessel elution, and operation is succinct, easy to get started；Simplify operation and also reduce the probability of cross contamination during test, the false positive rate during test is substantially reduced, so that sterility test is easier to be succeeded.
Description
Technical field
It is field of biological detection that this patent, which is related to medical instrument, and in particular to one kind is applied to medical device product without bacterial examination
The device looked into.
Background technique
Existing inspection technology scheme, according to the Pharmacopoeia of the People's Republic of China (version in 2015) general rule 1101 without bacterial examination
Method requirement is looked into, utensil and experimental article used in sterility test more emphasize reviewer's sterile working level and laboratory
The ability of sterilization process control leads to Medical treatment device due to the difference of personnel ability and laboratory sterilization managerial ability
Uncontrollable cross contamination risk is relatively high during tool sterility test, cause the false positive probability of sterility test result compared with
Height leads to final test failure, causes very negative impact to laboratory testing capability.
The technical solution of the prior art, General Introduction are as follows: 1, preparation sterility test test tool, such as vial,
Capping machine, corking, transfer vessel etc., articles described above are required to carry out sterilization treatment, sterilisation process and parameter in advance
Setting is variant because of Laboratory Instruments configuration, and test tool reaches sterility assurance level after the overall principle guarantees sterilizing. 2,
Utensil after sterilizing and medical device product to be detected are transferred in clean bench or Biohazard Safety Equipment, to product surface to be measured
It carries out disinfection after processing, opens packaging, by transferred product to be measured into the transfer vessel that sterilized, a certain amount of sterile physiological is added
Salt water carries out oscillation elution, after the completion of elution, then is transferred to eluent is sterile in vial, jumps a queue, gland processing.3, right
After the processing of sterile sleeve package sterilization, sterile sleeve is opened, sterile sleeve is installed to germ collector, then by sterile sleeve and glass
Eluent is filtered through membrane filter after the connection of glass bottle, carries out Sterility testing.4, subsequent operation is referring to pharmacopeia sterility test
Operation sequence.Disadvantage of the prior art is that 1, sterility test test tool sterilization treatment link, Preparatory work of experiment is cumbersome, labor
The reasons such as fatigue resistance is big, and the sterilizing of high pressure steam sterilization process is not thorough, it will the false positive during sterility test is caused, so that
Sterility test failure.2, after sterility test is sterilized with test tool, product test liquid is carried out in cleaning cabinet or Biohazard Safety Equipment
In preparation process, operation sequence is cumbersome, and sterile working Capability Requirement is high, harsher to personnel requirement, be easy to cause and tested
Cross contamination in journey causes sterility test false positive, so that sterility test fails.
Summary of the invention
In order to solve the above technical problems, this patent provides a kind of device applied to medical device product sterility test.It
Product test liquid preparation procedure to be measured can be simplified, so that operation is succinct.
The technical solution of the patent is as follows,
A kind of device applied to medical device product sterility test, including liquid-collection bag, liquid-collection bag one end are equipped with sealing device, separately
One end is equipped with bottle stopper, and bottle stopper with sterility test with membrane filter for being connected.
The Sterility testing device of this patent and medical device product to be detected are placed in cleaning cabinet or Biohazard Safety Equipment,
Medical device product to be detected is dismantled, the sealing device of liquid-collection bag is opened in sterile working, by medical device product to be detected
It is transferred in liquid-collection bag, then sealing device is closed, medical device product is in liquid-collection bag with a certain amount of sterile physiological later
Salt water carries out oscillation elution.To the processing of sterile sleeve package sterilization, sterile sleeve is opened after package sterilization processing, by sterile sleeve
On installation to germ collector, the sample introduction of membrane filter is needled into present apparatus bottle stopper, subsequent operation is grasped referring to pharmacopeia sterility test
Make program.It in existing technical solution, needs for medical device product to be detected to be transferred in the transfer vessel that sterilized, be added
A certain amount of sterile saline carries out oscillation elution, after the completion of elution, then is transferred to eluent is sterile in vial, adds
Plug, gland processing.Sterile sleeve filters eluent through membrane filter after connecting with vial, carries out Sterility testing.It compares
The Sterility testing device of the prior art, this patent is easy to operate, brings and uses, liquid-collection bag is without sterilization treatment；Simplify production to be measured
Product test liquid, that is, eluent preparation procedure does not need to be then transferred in vial after sterilizing transfer vessel elution, operation letter
It is clean, it is easy to get started；Simplify operation and also reduce the probability of cross contamination during test, substantially reduces the false positive during test
Rate, so that sterility test is easier to be succeeded.
Further, the sealing device is sealing strip.Sealing strip is common sealing device, is easily opened and closes.
It further, further include the converting interface with pump line, interface type includes but is not limited to female Luer, dialyzer
Interface, extracorporeal circulation pipeline interface etc., with have hose converting interface, interface type include but is not limited to female Luer, thoroughly
Parser interface, extracorporeal circulation pipeline interface etc..The inner cavity of some medical device products is not easy in liquid-collection bag through oscillation by hand
Mode be eluted, also some medical device products only need to guarantee that inner cavity is sterile, it is only necessary to clean inner cavity.
Further, the bottle stopper is bottle closure of rubber.Bottle closure of rubber repeats jack, no leakage.Bottle stopper contains protective cap.
Compared with prior art, the beneficial effect of this patent is, the Sterility testing device of this patent is easy to operate, brings
It uses, liquid-collection bag is without sterilization treatment；The preparation procedure for simplifying product test liquid, that is, eluent to be measured does not need to shift in sterilizing
It is then transferred in vial after container elution, operation is succinct, easy to get started；Simplify operation and also reduces cross contamination during test
Probability, substantially reduce test during false positive rate so that sterility test is easier to be succeeded.It is not only suitable for elution doctor
Device product outer surface is treated, is readily applicable to be not easy the inside eluted in cleaning medical device product, be applicable in comprehensive.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of this patent embodiment one.
Fig. 2 is the use state diagram of this patent embodiment one.
Fig. 3 is the structural schematic diagram of this patent embodiment two.
Fig. 4 is the structural schematic diagram of this patent embodiment three.
It include liquid-collection bag 1, sealing device 2, bottle stopper 3, sample introduction needle 4, membrane filter 5, sterile sleeve 6, germ collector in figure
7, hose 8, pump line 9, the first converting interface 10, the second converting interface 11, intubation 12, female Luer 13.
Specific embodiment
This patent is further described below in conjunction with attached drawing.Wherein, only for illustration, expression is only for attached drawing
It is schematic diagram, rather than pictorial diagram, it should not be understood as the limitation to this patent；It is attached in order to which the embodiment of this patent is better described
Scheme certain components to have omission, zoom in or out, does not represent the size of actual product；It will be understood by those skilled in the art that attached
It is understandable that some well-known structures and descriptions thereof may be omitted in figure.
Embodiment one
A kind of device applied to medical device product sterility test, as shown in Figure 1, including liquid-collection bag 1,1 one end of liquid-collection bag is set
There is sealing device 2, the sealing device 2 is that the sealing device is sealing strip.Sealing strip is common sealing device 2, is easy
It opens and closes.1 other end of liquid-collection bag is equipped with bottle stopper 3, and 4 one end of sample introduction needle passes through the bottle stopper 3 and is inserted into liquid-collection bag 1, it is preferable that
The bottle stopper 3 is bottle closure of rubber, and one end of sample introduction needle 4 is plastic spike, in this way, plastic spike is easier to insertion bottle closure of rubber
In, bottle closure of rubber repeats jack, no leakage, and bottle stopper 3 contains protective cap.
Liquid-collection bag with sealing strip includes several specifications, and length-width ratio and volume are more conform with medical instrument sample preparation
Situation, general volume are 400 ~ 800mL, are applied to syringe, the sterility test of the medical instruments such as surgical glove, strip character
The liquid-collection bag of 400 ~ 800mL volume be suitable for the sterility tests of the medical instruments such as trachea cannula, sputum aspirator tube.
As shown in Fig. 2, 4 other end of sample introduction needle connection membrane filter 5 is connected.Membrane filter 5 is arranged in sterile sleeve 6
On, sterile sleeve 6 is mounted on germ collector 7.
The use step of the Sterility testing device of this patent is: by the Sterility testing device of this patent and medical treatment to be detected
Device product is placed in cleaning cabinet or Biohazard Safety Equipment, dismantles medical device product to be detected, and liquid-collection bag is opened in sterile working
1 sealing device 2, medical device product to be detected is transferred in liquid-collection bag 1, then sealing device 2 is closed, medical later
Device product carries out oscillation elution with a certain amount of sterile saline in liquid-collection bag 1, and eluent is as next step for examination
Liquid.
After the package sterilization processing of sterile sleeve 6, sterile sleeve 6 is opened, sterile sleeve 6 is installed to germ collector 7,
Test liquid is filtered by the orientation wriggling pressurization of germ collector 7, after filtering, carries out Sterility testing by germ collector 7, subsequent
Operation is referring to pharmacopeia sterility test operation sequence.
In existing technical solution, needs for medical device product to be detected to be transferred in the transfer vessel that sterilized, add
Enter a certain amount of sterile saline, carry out oscillation elution, after the completion of elution, then is transferred to eluent is sterile in vial,
It jumps a queue, gland processing.Sterile sleeve 6 filters eluent through membrane filter 5 after connecting with vial, carries out Sterility testing.
Compared with prior art, the Sterility testing device of this patent is easy to operate, brings and uses, and liquid-collection bag 1 is without sterilization treatment；Simplify to
Product test liquid, that is, eluent preparation procedure is surveyed, does not need to be then transferred in vial after sterilizing transfer vessel elution, grasp
Make succinctly, it is easy to get started；Simplify operation and also reduce the probability of cross contamination during test, substantially reduces the vacation during test
Positive rate, so that sterility test is easier to be succeeded.
Embodiment two
It further include hose 8, pump line 9, the first converting interface 10 and the second converting interface 11 unlike embodiment.First converting interface
10 are connected to liquid-collection bag 1 by one section of hose 8, and the second converting interface 11 is connected to liquid-collection bag 1 by one section of pump line 9.Described first
Converting interface 10 can match different instrument interfaces from second interface according to actual needs.First converting interface 10, second converting interface 11
Type includes but is not limited to female Luer, dialyzer interface, extracorporeal circulation pipeline interface.The inner cavity of some medical device products is not
It is easily eluted by way of vibrating by hand in liquid-collection bag 1, also some medical device products only need to guarantee that inner cavity is sterile, only
It needs to clean inner cavity.The first converting interface 10 with hose 8 and the second converting interface 11 with pump line 9 are then for this
Situation.In one embodiment, the second converting interface 11 with pump line 9 is connect with liquid-collection bag 1, the hose 8 containing the first converting interface 10
At circulation line, liquid is flowed using peristaltic pump driving, sterile saline is allowed to carry out by the inner cavity of medical device product
Elution elutes effect for enhancing, pipeline can be placed on oscillator be ultrasonically treated in oscillation treatment or ultrasonic device or
Elution efficiency can be enhanced using other and recycling bacterium is not inhibited to handle in the device influenced.
Embodiment three
Unlike embodiment two, female Luer 13 is selected to be used as converting interface, intubation 12 is used as pump line 9 or hose 8, and Rule connects
Mouth 13 is connected to liquid-collection bag 1 by intubation 12.Intubation 12 protrudes into from the closure of openings item of liquid-collection bag 1.Embodiment three is also needle
The inner cavity of some medical device products is not easy to be eluted by way of vibrating by hand in liquid-collection bag 1, also some Medical treatment devices
Tool product only needs to clean the situation of inner cavity.
The Sterility testing device of this patent is easy to operate, brings and uses, and liquid-collection bag 1 is without sterilization treatment；Simplify production to be measured
Product test liquid, that is, eluent preparation procedure does not need to be then transferred in vial after sterilizing transfer vessel elution, operation letter
It is clean, it is easy to get started；Simplify operation and also reduce the probability of cross contamination during test, substantially reduces the false positive during test
Rate, so that sterility test is easier to be succeeded.Eluting medical device product external surfaces are not only suitable for, are readily applicable to clean
It is not easy the inside eluted in medical device product, is applicable in comprehensive.In addition, this sterility test device can not only be used to check medical treatment
Device product can also be used to check that the biological load of raw material in drug, with production process, intermediate product, accessory, workpiece etc. is commented
Estimate.Device does not need to adjust, and application range is expanded.
Obviously, above-described embodiment of this patent is only intended to clearly illustrate this patent example, and is not pair
The restriction of the embodiment of this patent.For those of ordinary skill in the art, may be used also on the basis of the above description
To make other variations or changes in different ways.There is no necessity and possibility to exhaust all the enbodiments.It is all this
Made any modifications, equivalent replacements, and improvements etc., should be included in patent claims within the spirit and principle of patent
Protection scope within.
Claims (6)
1. a kind of device applied to medical device product sterility test, which is characterized in that including liquid-collection bag, liquid-collection bag one end is set
There is sealing device, the other end is equipped with bottle stopper, and bottle stopper with membrane filter for being connected.
2. a kind of device applied to medical device product sterility test according to claim 1, which is characterized in that described
Sealing device is sealing strip.
3. a kind of device applied to medical device product sterility test according to claim 2, which is characterized in that also wrap
The converting interface with pump line is included, the converting interface connects liquid-collection bag by pump line.
4. a kind of device applied to medical device product sterility test according to claim 2, which is characterized in that also wrap
The converting interface with hose is included, the converting interface connects liquid-collection bag by hose.
5. a kind of device applied to medical device product sterility test according to claim 3 or 4, which is characterized in that
The type of converting interface includes female Luer, dialyzer interface, extracorporeal circulation pipeline interface.
6. a kind of device applied to medical device product sterility test according to claim 1, which is characterized in that described
Bottle stopper is bottle closure of rubber.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811332503.3A CN109439531B (en) | 2018-11-09 | 2018-11-09 | Be applied to aseptic inspection's of medical instrument product device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811332503.3A CN109439531B (en) | 2018-11-09 | 2018-11-09 | Be applied to aseptic inspection's of medical instrument product device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN109439531A true CN109439531A (en) | 2019-03-08 |
| CN109439531B CN109439531B (en) | 2023-12-08 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811332503.3A Active CN109439531B (en) | 2018-11-09 | 2018-11-09 | Be applied to aseptic inspection's of medical instrument product device |
Country Status (1)
| Country | Link |
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Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0014447A1 (en) * | 1979-02-05 | 1980-08-20 | Arvey Corporation | Sterilization pouch with insertable sterilization indicator |
| JP2000300245A (en) * | 1999-04-22 | 2000-10-31 | Sekisui Chem Co Ltd | Bag for examination |
| CN2856050Y (en) * | 2005-12-28 | 2007-01-10 | 广东环凯微生物科技有限公司 | Detection bag for microbes |
| CN101893589A (en) * | 2010-06-29 | 2010-11-24 | 中国人民解放军第三○二医院 | Sterility test method and totally closed bacteria collection ampoule incubator used thereby |
| CN105670916A (en) * | 2014-11-20 | 2016-06-15 | 华仁药业股份有限公司 | Fully closed membrane filter for sterile examination of sterile packaging interlayer and detection method of fully closed membrane filter |
| WO2018071732A1 (en) * | 2016-10-12 | 2018-04-19 | Verrix, Llc | Systems and methods for sterility assurance |
| WO2018091788A1 (en) * | 2016-11-15 | 2018-05-24 | Biron Jean Francois | Method for validating a sterilisation method comprising two successive contaminations |
| CN209481673U (en) * | 2018-11-09 | 2019-10-11 | 广东省医疗器械质量监督检验所 | A kind of device applied to medical device product sterility test |
-
2018
- 2018-11-09 CN CN201811332503.3A patent/CN109439531B/en active Active
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0014447A1 (en) * | 1979-02-05 | 1980-08-20 | Arvey Corporation | Sterilization pouch with insertable sterilization indicator |
| JP2000300245A (en) * | 1999-04-22 | 2000-10-31 | Sekisui Chem Co Ltd | Bag for examination |
| CN2856050Y (en) * | 2005-12-28 | 2007-01-10 | 广东环凯微生物科技有限公司 | Detection bag for microbes |
| CN101893589A (en) * | 2010-06-29 | 2010-11-24 | 中国人民解放军第三○二医院 | Sterility test method and totally closed bacteria collection ampoule incubator used thereby |
| CN105670916A (en) * | 2014-11-20 | 2016-06-15 | 华仁药业股份有限公司 | Fully closed membrane filter for sterile examination of sterile packaging interlayer and detection method of fully closed membrane filter |
| WO2018071732A1 (en) * | 2016-10-12 | 2018-04-19 | Verrix, Llc | Systems and methods for sterility assurance |
| WO2018091788A1 (en) * | 2016-11-15 | 2018-05-24 | Biron Jean Francois | Method for validating a sterilisation method comprising two successive contaminations |
| CN209481673U (en) * | 2018-11-09 | 2019-10-11 | 广东省医疗器械质量监督检验所 | A kind of device applied to medical device product sterility test |
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|---|---|
| CN109439531B (en) | 2023-12-08 |
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