CN204237785U - The totally-enclosed membrane filter of sterile packed interlayer sterility test - Google Patents
The totally-enclosed membrane filter of sterile packed interlayer sterility test Download PDFInfo
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- CN204237785U CN204237785U CN201420702730.1U CN201420702730U CN204237785U CN 204237785 U CN204237785 U CN 204237785U CN 201420702730 U CN201420702730 U CN 201420702730U CN 204237785 U CN204237785 U CN 204237785U
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- colony culture
- sterility test
- interlayer
- membrane filter
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- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Sampling And Sample Adjustment (AREA)
Abstract
The utility model relates to Sterility testing field, in particular to a kind of sterile packed interlayer sterility test totally-enclosed membrane filter and detection method thereof, comprise two colony culture devices, air filters, colony culture device described in two and air filter pass through one end of tubes connection three-phase circulation device, and the other end of described three-phase circulation device connects aseptic sampling needle by detector tube; Described conduit arranges near three-phase flowing valve place and retains folder.The utility model reduces the secondary pollution of operating process to vat liquor, improves the recall rate of microorganism, better can ensure experimental result.Realize the flowing of liquid at enclosed space, avoid and extraneous contact, preventing from microbial contamination plays a significant role.Simultaneously on the operating time, shorten the half experimental implementation time, substantially increase the checkability of this trial-product sterility test, make inspection pollution rate be reduced to less than 5% by original 20%-25%.
Description
Technical field
The utility model relates to Sterility testing field, particularly the totally-enclosed membrane filter of a kind of sterile packed interlayer sterility test.
Background technology
Soft bag double-layer aseptic package transfusion liquid bag, mainly comprises the medicament in interior bag, filling bag, is enclosed within the outer field outer packaging bag of internal packing.Between packing inside bag and outer packaging bag, interlayer is negative pressure of vacuum structure.Sterilizing is carried out again because it can be enclosed within outer packaging bag, this ensure that internal packing is sterile state, some sanitary grade are required that strict medical space uses double-layer sterile outsourcing can ensure to reach sterile state, after eliminating outer bag, do not need medical personnel again can directly use the disinfection of transfusion internal packing, improve the working efficiency of medical personnel.
When carrying out the sterility test of double-layer sterile outsourcing interlayer, need to find a kind of effectively, science, rationally and the detection method of strong operability, the impact of operation on experimental result when namely can carry out sterility test by membrane-filter procedure, should be reduced.Sterility test membrane-filter procedure is due to its totally enclosed membrane filtration device, and test liquid is avoided and extraneous contact in enclosed appts, more accurately can obtain the sterility test result of trial-product.
The current method of inspection, at aseptic outer bag open, injects aseptic sodium chloride solution, makes bag surface in solution impregnation.Then membrane-filter procedure inspection is carried out with the external bag of bacteria gathering tank.But Problems existing is, when injecting aseptic sodium chloride solution because vacuum-packed negative pressure appearance causes solution not easily to infiltrate whole interior bag surface, also easily there is the situation of liquid spill.If cause test liquid to leak in experimentation, so can cause secondary pollution, affect the accuracy of experimental result.But because experiment is by the limitation of experiment article, in addition because trial-product amount of inspection is more, causes proving time long, cause experimental result easily to occur false positive results, certain interference is occurred to the judgement of experimental result.
Utility model content
For the deficiencies in the prior art, the utility model provides one to avoid test liquid excessive, reduces the totally-enclosed membrane filter of sterile packed interlayer sterility test of the contaminated risk of test liquid.
For achieving the above object, the technical solution adopted in the utility model is as follows:
The totally-enclosed membrane filter of a kind of sterile packed interlayer sterility test, comprise two colony culture devices, air filters, colony culture device described in two and air filter pass through one end of tubes connection three-phase circulation device, and the other end of described three-phase circulation device connects aseptic sampling needle by detector tube; Described conduit arranges near three-phase flowing valve place and retains folder.Carrying out orthoselection by the control retaining folder is flow to aseptic sampling needle direction by air filter, or flows to colony culture device by aseptic sampling needle.Three-dimensional flowing valve ensures that test liquid flows in enclosed space, reduces the probability with environmental exposure, the frequency of decreasing pollution.
Preferably, described detector tube arranges air filter near aseptic sampling needle place.
Utilize totally-enclosed membrane filter described above to detect the method for sterile packed interlayer, comprise the steps:
Step 1: will retain the conduit clamping two colony culture devices, joins double-layer sterile outsourcing interlayer from air filter by aseptic sampling needle by air;
Step 2: again aseptic sodium chloride solution is joined double-layer sterile outsourcing interlayer from air filter by aseptic sampling needle, rinse interlayer;
Step 3: with retaining folder, air filter being clamped, opening germ collector and the sodium chloride solution after step rinse is joined in two colony culture devices along pipeline; Microorganism is trapped in colony culture device by the millipore filtration below colony culture device, by bacteria gathering device plug jam-pack bottom;
Step 4: with the conduit retaining folder clamping air filter and colony culture device, by substratum suction filtration in colony culture device, with retaining the conduit clamping colony culture device, also carry out sign respectively by substratum suction filtration to colony culture device;
Step 5: cut off conduit near tank body 10cm place scissors at two colony culture devices, and the catheter stopper that will rupture is at cock cap place, top;
Step 6: two colony culture devices are placed in incubator and cultivate, observations.
Preferably, in step 4, suction filtration is different to the described kinds of culture medium in two colony culture devices, and one is THIOGLYCOLLIC ACID salt broth, and another kind of is improvement Martin substratum.THIOGLYCOLLIC ACID salt broth colony culture device is placed in 30-35 DEG C to cultivate 14 days, improvement Martin culture medium culturing device is placed in 23-28 DEG C and cultivates 14 days,
The beneficial effects of the utility model:
The totally-enclosed membrane filter of sterile packed interlayer sterility test of the present utility model, reduces the secondary pollution of operating process to vat liquor, improves the recall rate of microorganism, better can ensure experimental result.Operationally more easily implement, reduce experiment Item Cost than original working method and reduce experimenter's operation.Optimize the accuracy reliability that experimentation ensure that experimental result.Compared with traditional detection method, detection method disclosed in the utility model realizes the flowing of liquid at enclosed space, avoids and extraneous contact, is preventing from microbial contamination plays a significant role.Simultaneously on the operating time, shorten the half experimental implementation time, substantially increase the checkability of this trial-product sterility test, make inspection pollution rate be reduced to less than 5% by original 20%-25%.
Accompanying drawing explanation
Accompanying drawing 1 is the structural representation of totally-enclosed membrane filter of the present invention;
Wherein, 1-1 is a colony culture device; 1-2 is another colony culture device; 2 is air filter; 3 is conduit; 4 is three-phase circulation device; 5 is detector tube; 6 is aseptic sampling needle; 7 for retaining folder; 8 is air filter; 9 is millipore filtration; 10 is bacteria gathering device plug.
Embodiment
The utility model is set forth further below in conjunction with embodiment
Embodiment:
The totally-enclosed membrane filter of a kind of sterile packed interlayer sterility test, comprise two colony culture devices, air filter 2, colony culture device described in two and air filter 2 are connected one end of three-phase circulation device 4 by conduit 3, the other end of described three-phase circulation device 4 connects aseptic sampling needle 6 by detector tube 5; Described conduit 3 arranges near three-phase flowing valve 4 place and retains folder 7.Carrying out orthoselection by the control retaining folder 7 is flow to aseptic sampling needle 6 direction by air filter 2, or flows to colony culture device by aseptic sampling needle 6.Three-dimensional flowing valve ensures that test liquid flows in enclosed space, reduces the probability with environmental exposure, the frequency of decreasing pollution.Described detector tube 5 arranges air filter 8 near aseptic sampling needle 6 place.
Totally-enclosed membrane filter detects the method for sterile packed interlayer, comprises the steps:
Step 1: will folder 7 be retained clamp the conduit 3 of two colony culture devices, air is joined double-layer sterile outsourcing interlayer from air filter 2 by aseptic sampling needle 6;
Step 2: again aseptic sodium chloride solution is joined double-layer sterile outsourcing interlayer from air filter 2 by aseptic sampling needle 6, rinse interlayer;
Step 3: clamped by air filter 2 with retaining folder 7, opens germ collector and joins in two colony culture devices by the sodium chloride solution after step 2 rinse along pipeline; Microorganism is trapped in colony culture device by the millipore filtration 9 below colony culture device, by bacteria gathering device plug 10 jam-pack bottom;
Step 4: with the conduit 3 retaining folder 7 and clamp air filter 2 and colony culture device 11, by 100ml THIOGLYCOLLIC ACID salt broth suction filtration in colony culture device 11, with the conduit 3 retaining folder 7 and clamp colony culture device 11,100ml to be improved in Martin's substratum suction filtration to colony culture device 12 and to carry out sign respectively;
Step 5: cut off conduit 3 near tank body 10cm place scissors at two colony culture devices, and the catheter stopper that will rupture is at cock cap place, top;
Step 6: THIOGLYCOLLIC ACID salt broth colony culture device is placed in 30-35 DEG C and cultivates 14 days, is placed in 23-28 DEG C and cultivates 14 days, observations by improvement Martin culture medium culturing device.
Step 7: should observe and record whether have bacteria growing day by day between incubation period.As after adding trial-product or in culturing process, substratum occurs muddy, cultivate after 14 days, can not from determining whether microorganism growth in appearance, in the appropriate transferred species of this nutrient solution desirable to fresh culture of the same race, microbial culture 2 days, fungus culture 3 days, whether the fresh culture of the same race observing inoculation there is muddiness again; Or get nutrient solution smear, dyeing, microscopy, has judged whether bacterium.
The totally-enclosed membrane filter of the utility model sterile packed interlayer sterility test, while raising the efficiency, reduction operates the pollution caused greatly, effectively can improve the rate of being up to the standards.Inspection pollution rate is made to be reduced to less than 5% by original 20%-25%.
Claims (2)
1. the totally-enclosed membrane filter of sterile packed interlayer sterility test, it is characterized in that, comprise two colony culture devices, air filter (2), colony culture device described in two and air filter (2) are connected one end of three-phase circulation device (4) by conduit (3), the other end of described three-phase circulation device (4) connects aseptic sampling needle (6) by detector tube (5); Described conduit (3) arranges near three-phase flowing valve (4) place and retains folder (7).
2. the totally-enclosed membrane filter of sterile packed interlayer sterility test according to claim 1, is characterized in that, described detector tube (5) arranges air filter (8) near aseptic sampling needle (6) place.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201420702730.1U CN204237785U (en) | 2014-11-20 | 2014-11-20 | The totally-enclosed membrane filter of sterile packed interlayer sterility test |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201420702730.1U CN204237785U (en) | 2014-11-20 | 2014-11-20 | The totally-enclosed membrane filter of sterile packed interlayer sterility test |
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| Publication Number | Publication Date |
|---|---|
| CN204237785U true CN204237785U (en) | 2015-04-01 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201420702730.1U Expired - Fee Related CN204237785U (en) | 2014-11-20 | 2014-11-20 | The totally-enclosed membrane filter of sterile packed interlayer sterility test |
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| Country | Link |
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| CN (1) | CN204237785U (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
-
2014
- 2014-11-20 CN CN201420702730.1U patent/CN204237785U/en not_active Expired - Fee Related
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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Legal Events
| Date | Code | Title | Description |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20150401 Termination date: 20191120 |