CN105670916B - Aseptic packaging interlayer sterility test totally-enclosed membrane filter and its detection method - Google Patents
Aseptic packaging interlayer sterility test totally-enclosed membrane filter and its detection method Download PDFInfo
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- CN105670916B CN105670916B CN201410669116.4A CN201410669116A CN105670916B CN 105670916 B CN105670916 B CN 105670916B CN 201410669116 A CN201410669116 A CN 201410669116A CN 105670916 B CN105670916 B CN 105670916B
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Abstract
The present invention relates to Sterility testing field, more particularly to a kind of aseptic packaging interlayer sterility test totally-enclosed membrane filter and its detection method, including two Bacteria Incubators, air filters, Bacteria Incubator described in two connects one end of three-phase circulation device with air filter by conduit, and the other end of the three-phase circulation device connects aseptic sampling needle by detection pipe；The conduit sets retention to press from both sides at three-phase flowing valve.Present invention reduces secondary pollution of the operating process to leaching liquor, improves the recall rate of microorganism, can more preferably ensure experimental result.Flowing of the decoction in confined space is realized, avoids contacting with the external world, is played a significant role on microorganism pollution is prevented.Simultaneously on the operating time, the half experimental implementation time is shortened, substantially increases the checkability of the test sample sterility test, inspection pollution rate is reduced to less than 5% by original 20% 25%.
Description
Technical field
The present invention relates to Sterility testing field, the totally-enclosed film mistake of more particularly to a kind of aseptic packaging interlayer sterility test
Filter and its detection method.
Background technology
Soft bag double-layer aseptic package transfusion liquid bag, mainly including interior bag, filling medicament in interior bag, be enclosed on inner packing
The outer packaging bag of outer layer.Interlayer is negative pressure of vacuum structure between packing inside bag and outer packaging bag.Because it can be enclosed on outer packing
Bag is sterilized again, this ensure that inner packing is germ-free condition, strict medical space is required for some sanitary grades
It can ensure to reach germ-free condition using double-layer sterile outsourcing, medical personnel not needed after outer bag is eliminated again to defeated
The processing that carries out disinfection of liquid inner packing can be used directly, and improve the operating efficiency of medical personnel.
When carrying out the sterility test of double-layer sterile outsourcing interlayer, it is necessary to find a kind of effective, science, reasonable and operability
Strong detection method, you can so that influence of the operation to experimental result should be reduced when carrying out sterility test by membrane-filter procedure.Nothing
Bacterium checks membrane-filter procedure due to its totally enclosed membrane filtration device, and test liquid avoids contacting with the external world in locking device,
The sterility test result of test sample can more accurately be obtained.
The current method of inspection, in sterile outer bag open, aseptic sodium chloride solution is injected, makes bag table in solution impregnation
Face.Then membrane-filter procedure inspection is carried out with the external bag of bacteria gathering tank.But the problem of existing is, in injection sterile NaCl
Because vacuum-packed negative pressure appearance causes solution to be not easy the whole interior bag surface of infiltration during solution, also easily there is liquid spill
Situation.If test liquid is caused to leak in experimentation, then secondary pollution can be caused, influence the accuracy of experimental result.But
It is due to that experiment is limited to by experiment article, it is more additionally, due to test sample amount of inspection, cause Check-Out Time long, cause reality
Test result and false positive results easily occur, certain interference occurs in the judgement to experimental result.
The content of the invention
In view of the shortcomings of the prior art, present invention offer one kind avoids test liquid excessive, reduces the contaminated wind of test liquid
Aseptic packaging interlayer sterility test totally-enclosed membrane filter and its detection method of danger.
To achieve the above object, the technical solution adopted by the present invention is as follows：
A kind of totally-enclosed membrane filter of aseptic packaging interlayer sterility test, including two Bacteria Incubators, air mistake
Filter one end that device, Bacteria Incubator described in two and air filter connects three-phase circulation device by conduit, described three
Mutually the other end of circulation device connects aseptic sampling needle by detection pipe；The conduit sets retention to press from both sides at three-phase flowing valve.
It is that aseptic sampling needle direction is flowed to by air filter by retaining the control pressed from both sides come M8003 line, or by aseptic sampling needle
Flow to Bacteria Incubator.Three-dimensional flowing valve ensures that test liquid flows in closing space, reduces the probability contacted with environment, reduces
The frequency of pollution.
Preferably, described detection pipe sets air cleaner at aseptic sampling needle.
Another object of the present invention is to disclose a kind of to detect without bacterium bag using totally-enclosed membrane filter described above
The method of clamping layer, comprises the following steps：
Step 1：The conduit for clamping two Bacteria Incubators will be retained, air is adopted from air filter by sterile
Sample pin is added to double-layer sterile outsourcing interlayer；
Step 2：Aseptic sodium chloride solution is added to outside double-layer sterile from air filter by aseptic sampling needle again
Sandwich layer, rinse interlayer；
Step 3：Air filter is clamped with retention folder, opens germ collector by the sodium chloride solution edge after step rinse
Pipeline is added in two Bacteria Incubators；Microorganism is trapped in Bacteria Incubator by the miillpore filter below Bacteria Incubator
In, bacteria gathering device plug is stoppered into bottom；
Step 4：The conduit of air filter and Bacteria Incubator is clamped with retention, culture medium is filtered to collection bacterium training
Support in device, the conduit of Bacteria Incubator is clamped with retention, culture medium is filtered into Bacteria Incubator and carries out sign respectively；
Step 5：Conduit is cut with scissors at tank body 10cm in two Bacteria Incubators, and fracture catheter stopper is being pushed up
At end plug cap；
Step 6：By two Bacteria Incubators, incubator culture is placed in, observes result.
Preferably, filtered in step 4 to the kinds of culture medium difference in two Bacteria Incubators, one kind is sulphur ethanol
Hydrochlorate broth, another kind are improvement Martin's culture medium.THIOGLYCOLLIC ACID salt broth Bacteria Incubator is placed in 30-
35 DEG C are cultivated 14 days, and improvement Martin's medium culture device is placed in into 23-28 DEG C cultivates 14 days, observes result.
Beneficial effects of the present invention：
The totally-enclosed membrane filter of the aseptic packaging interlayer sterility test of the present invention, reduces operating process to leaching liquor
Secondary pollution, improve the recall rate of microorganism, can more preferably ensure experimental result.Operationally it is easier to implement, than original
Operating method reduces experiment Item Cost and reduces experimenter's operation.Optimize experimentation and ensure that the accurate of experimental result
Property reliability.Compared with traditional detection method, detection method disclosed by the invention realizes flowing of the decoction in confined space, avoids
Contact with the external world, played a significant role on microorganism pollution is prevented.Simultaneously on the operating time, half experiment is shortened
Operating time, the checkability of the test sample sterility test is substantially increased, inspection pollution rate is reduced by original 20%-25%
To less than 5%.
Brief description of the drawings
Accompanying drawing 1 is the structural representation of the totally-enclosed membrane filter of the present invention；
Wherein, 1-1 is a Bacteria Incubator；1-2 is another Bacteria Incubator；2 be air filter；3 be to lead
Pipe；4 be three-phase circulation device；5 be detection pipe；6 be aseptic sampling needle；7 be retention folder；8 be air cleaner；9 be miillpore filter；
10 be bacteria gathering device plug.
Embodiment
Technical scheme is expanded on further with reference to embodiments
Embodiment：
The totally-enclosed membrane filter of a kind of aseptic packaging interlayer sterility test, as shown in figure 1, including two collection bacterium cultures
Device, air filter 2, Bacteria Incubator and air filter 2 described in two connect three-phase circulation device 4 by conduit 3
One end, the other end of three-phase circulation device 4 passes through detection pipe 5 and connects aseptic sampling needle 6；The conduit 3 is close to three-phase flow
Retention folder 7 is set at port valve 4.Come M8003 line it is that aseptic sampling needle is flowed to by air filter 2 by the control for retaining folder 7
6 directions, or Bacteria Incubator is flowed to by aseptic sampling needle 6.Three-dimensional flowing valve ensures that test liquid flows in closing space, drops
The low probability contacted with environment, reduce the frequency of pollution.Described detection pipe 5 sets air filtration at aseptic sampling needle 6
Device 5.
The method of totally-enclosed membrane filter detection aseptic packaging interlayer, comprises the following steps：
Step 1：It will retain and press from both sides 7 conduits 3 for clamping two Bacteria Incubators, air is passed through into nothing from air filter 2
Bacterium sampling needle 6 is added to double-layer sterile outsourcing interlayer；
Step 2：Aseptic sodium chloride solution is added to double-layer sterile from air filter 2 by aseptic sampling needle 6 again
Outsourcing interlayer, rinse interlayer；
Step 3：Air filter 2 is clamped with retention folder 7, opens germ collector the sodium chloride after step 2 rinse is molten
Liquid is added in two Bacteria Incubators along pipeline；Microorganism is trapped in collection bacterium by the miillpore filter 9 below Bacteria Incubator
In incubator, bacteria gathering device plug 10 is stoppered into bottom；
Step 4：Air filter 2 and Bacteria Incubator 1-1 conduit 3 are clamped with retention folder 7, by 100ml sulphur ethanol
Hydrochlorate broth is filtered into Bacteria Incubator 1-1, Bacteria Incubator 1-1 conduit 3 is clamped with retention folder 7, by 100ml
Improvement Martin culture medium filters into Bacteria Incubator 1-2 and carries out sign respectively；
Step 5：Conduit 3 is cut with scissors at tank body 10cm in two Bacteria Incubators, and fracture catheter stopper is existed
At the cock cap of top；
Step 6：THIOGLYCOLLIC ACID salt broth Bacteria Incubator is placed in into 30-35 DEG C to cultivate 14 days, Martin will be improved
Medium culture device is placed in 23-28 DEG C and cultivated 14 days, observes result.
Step 7：Whether should day by day observe and record during culture has bacteria growing.Such as after test sample is added or cultivating
There is muddiness in Cheng Zhong, culture medium, after cultivating 14 days, it is impossible to determine whether microorganism growth from the appearance, can use the nutrient solution and fit
Measure transferred species into fresh culture of the same race, Bacteria Culture 2 days, fungal culture 3 days, observe inoculation fresh culture of the same race whether
Occurs muddiness again；Or nutrient solution smear is taken, dye, microscopy, determine whether bacterium.
The method of the present invention substantially reduces behaviour due to reducing the operating procedure in checking process while efficiency is improved
Polluted caused by making, inspection qualification rate can be effectively improved.Inspection pollution rate is set to be reduced to less than 5% by original 20%-25%.
Claims (2)
- A kind of 1. method that aseptic packaging interlayer is detected using totally-enclosed membrane filter, it is characterised in thatThe totally-enclosed membrane filter includes two Bacteria Incubators, air filter (2), the collection bacterium culture described in two Device and air filter (2) connect three-phase by conduit (3) and circulated one end of device (4), the three-phase circulation device (4) it is another End connects aseptic sampling needle (6) by detection pipe (5)；The conduit (3) sets retention folder (7) close to three-phase flowing valve (4) place；The method of the detection aseptic packaging interlayer comprises the following steps：Step 1：The conduit (3) for pressing from both sides (7) and clamping two Bacteria Incubators will be retained, air is passed through from air filter (2) Aseptic sampling needle (6) is added to double-layer sterile outsourcing interlayer；Step 2：Aseptic sodium chloride solution is added to double-layer sterile from air filter (2) by aseptic sampling needle (6) again Outsourcing interlayer, rinse interlayer；Step 3：Air filter (2) is clamped with retention folder (7), opens germ collector the sodium chloride after step 2 rinse is molten Liquid is added in two Bacteria Incubators along pipeline；Microorganism is trapped in collection by the miillpore filter (9) below Bacteria Incubator In bacterium incubator, bacteria gathering device plug (10) is stoppered into bottom；Step 4：The conduit (3) of air filter (2) and Bacteria Incubator 2 (1-2) is clamped with retention folder (7), by culture medium Filter in Bacteria Incubator 1 (1-1), Bacteria Incubator 1 (1-1) conduit (3) is clamped with retention folder (7), culture medium is taken out Filter in Bacteria Incubator 2 (1-2) and carry out sign respectively；Step 5：Conduit (3) is cut with scissors at tank body 10cm in two Bacteria Incubators, and fracture catheter stopper is being pushed up At end plug cap；Step 6：By two Bacteria Incubators, incubator culture is placed in, observes result.
- 2. the method according to claim 1 that aseptic packaging interlayer is detected using totally-enclosed membrane filter, its feature are existed In suction filtration is different to the kinds of culture medium in two Bacteria Incubators in step 4, and one kind is THIOGLYCOLLIC ACID salt fluid culture Base, another kind are improvement Martin's culture medium.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410669116.4A CN105670916B (en) | 2014-11-20 | 2014-11-20 | Aseptic packaging interlayer sterility test totally-enclosed membrane filter and its detection method |
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| CN201410669116.4A CN105670916B (en) | 2014-11-20 | 2014-11-20 | Aseptic packaging interlayer sterility test totally-enclosed membrane filter and its detection method |
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| CN105670916B true CN105670916B (en) | 2018-01-09 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106010955B (en) * | 2016-07-22 | 2018-12-11 | 牛刚 | Sterile cabin pharmaceutical sterile test is enriched with Operation Van |
| CN107384757A (en) * | 2017-08-02 | 2017-11-24 | 山东省食品药品检验研究院 | Aspergillus niger spore culture, the device and method for separating and preparing suspension |
| CN108998365B (en) * | 2018-08-09 | 2024-03-29 | 牛刚 | Sterile rapid detection device, drug and food sterile rapid detection method |
| CN109126475B (en) * | 2018-08-15 | 2021-08-27 | 河南省医疗器械检验所 | Method for detecting liquid bacteria interception capability of air filter/membrane for transfusion |
| CN109439531B (en) * | 2018-11-09 | 2023-12-08 | 广东省医疗器械质量监督检验所 | Be applied to aseptic inspection's of medical instrument product device |
| CN110141508A (en) * | 2019-05-20 | 2019-08-20 | 崔文馨 | Sterile purification air physiological saline |
| CN113388663B (en) * | 2021-06-09 | 2024-02-20 | 深圳善康医药科技股份有限公司 | Sterile inspection method and sterile filter device for insoluble implant |
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| CN2332725Y (en) * | 1996-11-04 | 1999-08-11 | 叶大林 | Bacteria gathering culture dish |
| CN201186930Y (en) * | 2007-11-20 | 2009-01-28 | 沈佳特 | Bacteria gathering culture dish with self-locking jig |
| JP5218153B2 (en) * | 2009-02-26 | 2013-06-26 | 株式会社日立プラントテクノロジー | Microorganism detection apparatus, detection method, and sample container used therefor |
| CN201692722U (en) * | 2010-04-30 | 2011-01-05 | 贵州科伦药业有限公司 | Sterile filtration puncture needle |
| CN202070211U (en) * | 2011-04-13 | 2011-12-14 | 宁海县白石药检仪器厂 | Sealing/opening dual-purpose sterility test thin film filter |
| CN204237785U (en) * | 2014-11-20 | 2015-04-01 | 华仁药业股份有限公司 | The totally-enclosed membrane filter of sterile packed interlayer sterility test |
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