CN102633056A - Method for keeping cleanness of article and device - Google Patents
Method for keeping cleanness of article and device Download PDFInfo
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- CN102633056A CN102633056A CN2012100318335A CN201210031833A CN102633056A CN 102633056 A CN102633056 A CN 102633056A CN 2012100318335 A CN2012100318335 A CN 2012100318335A CN 201210031833 A CN201210031833 A CN 201210031833A CN 102633056 A CN102633056 A CN 102633056A
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Abstract
The invention provides a method for keeping the cleanness of an article. The method includes placing the to-be-protected article or a to-be-protected portion of the article in a container so that positive-pressure gas is kept in a space between the container and the to-be-protected article or the to-be-protected portion of the article; or at least covering a protecting layer on the outside of the container or the outside of a local portion of the container so that positive-pressure gas is kept between the protecting layer and the container or the local portion of the container; or at least covering two protecting layers on the outside of the container or the outside of the local portion of the container so that positive-pressure gas is kept among the protecting layers and/or between each protecting layer and the container or the local portion of the container. The invention further provides a relevant device applicable to the method. The method for keeping the cleanness of the article is simple, cost is low, the method is easy to implement, and the purpose that foreign matters cannot be easily adhered the protected object or the container covered with the protecting layers is guaranteed fundamentally. In addition, the device has the advantages of simple structure, low cost and reliable performances.
Description
Technical field
The present invention relates to the store method of article, particularly keep the method for article cleanliness level, be used for, the invention still further relates to the device that is used to keep the article cleanliness level such as fields such as aseptic preservations.
Background technology
In medicine and highly sophisticated device or special material field, extremely important to the maintenance of article cleanliness level, article there is pollution slightly, promptly possibly cause very serious consequence.
At medicine field, GMP (Good Manufacturing Practice) authentication is an important rule, from July 1st, 1998, does not obtain the enterprise of medicine GMP certificate of certification, the application of Board of Health's production new drug off the docket; The approval new drug, only issue New Drug Certificate, do not issue the approval number of the drug.In the GMP authentication, the aseptic maintenance of the cleaning of medicine is an important content, and it relates to each link of pharmaceutical production.In actual production process, the production of bulk drug and can often possibly not be at a place, and this just need be transported to another aseptic environments from an aseptic environments with pharmaceutical raw material, and in transport process, need inevitably to contact with external environment.Can the dust or the germ that how to guarantee external environment be brought in the filling environment, be an important ring that obtain the GMP authentication.
Prior art solutions is in gnotobasis, to protect bag at the container overcoat last layer of preserving pharmaceutical raw material or multilayer, when changing racking room over to, in the gnotobasis of different stage, successively takes off the protection bag.The shortcoming that adopts this method is to guarantee finally to be brought into the whether microbiological contamination of container of racking room; Because in transfer process; Even on the protection bag, very small hole occurs; Also possibly cause the pollution of container, thereby finally pollute product, promptly this transporting mode can't fundamentally solve the problem of in transport process, guaranteeing not microbiological contamination.Therefore, adopting this method transhipment medicine, be difficult to obtain the GMP authentication, is present problem demanding prompt solution.
In addition, except in the pharmaceutical raw material transport process, existing the problems referred to above, in the transhipment or preservation process of pharmaceutical raw material preservation, the preservation of medicine freak oil or other highly sophisticated devices or special material, all there is the problem that how to keep the article cleanliness level.
Summary of the invention
The objective of the invention is to provides a kind of method that keeps the article cleanliness level to above-mentioned deficiency.
Another object of the present invention is to provide a kind of device that keeps the article cleanliness level.
Be to realize above-mentioned purpose, the present invention at first provides a kind of method that keeps the article cleanliness level, and this method is that the position to be protected with article to be protected or article places container, makes between position to be protected and the container of article to be protected or article to keep barotropic gas; Or, outside container or outside container local, wrap up layer protective layer at least, make between the part of protective cover and container or container to keep barotropic gas; Or, outside container or outside container local, wrap up two-layer protective cover at least, make between part and the protective cover of container or container and/or keep barotropic gas between protective cover and the protective cover.
Said article to be protected can be medicine, pharmaceutical raw material, pipe bracket, or highly sophisticated device, or some special materials, or the like any cleanliness that need to keep get article.For some article, its integral body that might not need protection, for example some precision instrument often only protects its part that relates to high-precision applications to get final product.Thereby, for these objects, only need its part be placed container, and make and form malleation between itself and the container and get final product.
The part of said container is a vessel port.For preserving article under some condition; Not necessarily need container whole be included among the protective cover some large-scale container for example, its bulky; Be not easy to its whole packing protective layer, and only need guarantee that its vessel port place does not have the foreign matter intrusion and gets final product.Thereby, in this case, only need be at the vessel port place packing protective layer, and make it keep barotropic gas to get final product.
In addition, according to above-mentioned protected mode, not necessarily need also can between protective cover, form barotropic gas directly with forming barotropic gas between object of protection and the protective cover, this can play a protective role equally.
Generally speaking, as long as keep barotropic gas, just can be so that foreign matter (dust, germ etc.) can not enter into positive pressure environment.Pressure is big more, can guarantee to a greater degree that then foreign matter can not enter into positive pressure environment.Preferably, the pressure of barotropic gas is than environmental stress height 10Pa, for example 15Pa at least.
And then the present invention also is provided for keeping the device of article cleanliness level, includes but not limited to:
Device 1: comprise container, on container, have sealable inflation interface, or on container, be connected with gas filled device.On said container, also pressure-detecting device can be set.
Device 2: the be wrapped in container that comprise the fastener that can match with container, closely links to each other with fastener outward or the local layer protective layer at least outward of container has sealable inflation interface, or on protective cover, is connected with gas filled device on protective cover.On said protective cover, also pressure-detecting device can be set.
Device 3: the be wrapped in container that comprise the fastener that can match with container, closely links to each other with fastener outward or the local at least two layers of protective cover outward of container; At least layer protective layer is provided with sealable inflation interface except that the innermost layer protective cover, or on this protective cover, is connected with gas filled device.In addition, the inflation interface also can be set on said innermost layer protective cover or be connected with gas filled device, this mode can make protected object obtain the more protection of multilayer.
In the said apparatus, gas filled device can have pressure regulator or stabiliser, can make pressure continue to maintain under the specified pressure through this gas filled device.The gas that also can add certain pressure in addition through the inflation interface on the protective cover, and it is airtight to inflate interface, thus make it obtain malleation.Pressure-detecting device is set on protective cover, detects the air pressure of barotropic gas with this device, monitor force at any time, if pressure loss shows that then this object of protection has been in unsafe state, it might receive foreign matter and get into.Or might be stained with foreign matter on the container, the container that is stained with foreign matter is brought into clean room after, then can cause the pollution in this space.
Also can be provided with fastener at said vessel port place in the said apparatus 1.Said container can be hard or soft material, is soft material at the vessel port place at least perhaps.This container can be fixed to object to be protected place, especially article local location to be protected through fastener like this.
Fastener also can be contained on the base plate in the said apparatus, like this container or object to be protected is placed on the base plate, and is fastening again, charges into gas, can in transport process, protect the transhipment object better.
In the present invention, said malleation or barotropic gas are meant its air pressure greater than ambient pressure, for example, and usually greater than 1 barometric pressure (ambient pressure).
Said protective cover is meant can blocks dust and/or the isolation layer of germ, and can form barotropic gas therein.The rete that for example various High molecular materials are processed, the perhaps composite material of cloth bag or macromolecule membrane and other materials, for example outer for the cloth internal layer be the composite material of High molecular material.
The inventive method is simple, and cost is low, and is easy to implement, and can guarantee fundamentally that protected object or the container that coats protective cover are difficult to be stained with foreign matter.Apparatus of the present invention also have simple in structure, and cost is low, the advantage of dependable performance.
Description of drawings
Fig. 1 is the structural representation of one of cleanliness level holding device embodiment of the present invention;
Fig. 2 is the structural representation that the present invention has the cleanliness level holding device of gas filled device;
Fig. 3 is the structural representation that the present invention has the cleanliness level holding device of fastener;
Fig. 4 is the cleanliness level holding device structural representation in the embodiment of the invention 2;
Fig. 5 is the structural representation of the present invention's portable cleanliness level holding device of being convenient to transport;
Fig. 6 is the structural representation of the another kind of the present invention portable cleanliness level holding device being convenient to transport;
Wherein, 1. container; 2. pressure-detecting device; 3. can airtight inflation interface; 4. gas filled device; 5. protective cover; 6. fastener; 7. vessel port; 8. base plate; 9. wheel.
The specific embodiment
Come further to set forth the present invention below in conjunction with concrete embodiment.Should be appreciated that these embodiment only are used to explain the present invention, and can not limit protection scope of the present invention.
As shown in Figure 1, the device of the maintenance article cleanliness level in this example comprises container 1, and on container, having can airtight inflation interface 3, on said container 1, also is provided with pressure-detecting device 2 (pressure differential indicator).Through can airtight inflation interface 3, can in container 1, charge into pure air, or nitrogen or other unreactable gass, after inflation finishes, interface 3 sealings can be made its inner malleation that forms.Through pressure-detecting device 2, can obtain pressure information at any time, guarantee that container 1 keeps malleation.
Its another kind of embodiment is as shown in Figure 2; On container 1, connect gas filled device 4; The malleation of continuing for container 1 through gas filled device 4; Especially have that air pressure detects and the gas filled device 4 of automatically regulating air pressure, can make through this gas filled device 4 that pressure continues to maintain under the specified pressure in the container 1.In use, article to be protected are placed container 1, make container 1 airtight after, open gas filled device 4, regulate air pressure, the air pressure in the container 1 is got final product, for example than the big 10Pa of ambient pressure greater than ambient pressure.
Its another embodiment is as shown in Figure 3, and this container 1 is a flexible container, is provided with fastener 6 in vessel port, other with more than identical.This container can be fastened on the position that article need localised protection with it through the fastener 6 of vessel port, through charging into barotropic gas, can make its part receive protection.
As shown in Figure 4; Device in this example comprises the fastener 6 that can match with vessel port 7, is wrapped in vessel port 7 layer protective layer 5 outward with fastener 6 closely links to each other; On protective cover 5, have sealable inflation interface 3, on said protective cover 5, also be provided with pressure-detecting device 2.Through inflation interface 3, can between vessel port 7 and protective cover 5, charge into pure air in use, or nitrogen or other unreactable gass, after inflation finishes, interface 3 sealings can be made its inner malleation that forms.Through pressure-detecting device 2, can obtain pressure information at any time, guarantee to keep malleation between vessel port 7 and the protective cover 5.Through protection to vessel port 7, can prevent that foreign matter from entering into vessel port 7 places, guarantee the cleaning of vessel port 7.
In addition, the device in this example also can wrap up entire container, between container and protective cover, pours pure air, forms malleation, thereby can prevent that foreign matter from touching container, guarantees the cleaning of container.
This routine device is similar with embodiment 2; But many layer protective layer than the device of embodiment 2; Independently sealable inflation interface is set respectively on internal layer protective cover and container; Thereby can between protective cover, charge into barotropic gas, can also between container and protective cover, charge into barotropic gas, more even can in container, charge into barotropic gas.
In actual use, can be successively between container, container and first protective cover, first protective cover and second protective cover, form and charge into barotropic gas.
Embodiment 4
As shown in Figure 5; This routine device comprises protective cover 5 (protective case); On protective cover 5, just having can airtight inflation interface 3 and pressure-detecting device 2 (pressure differential indicator); Protective cover 5 bottoms are provided with fastener 6 (fastener), and fastener 6 is installed on the base plate 8, and base plate has the wheel 9 that can arbitrarily rotate for 8 times.
As shown in Figure 6, cleanliness level holding device and Fig. 4 in this example are similar, but fastener 6 (fastener) is in protective cover 5, and this fastener 6 can directly be buckled on the vessel port.
With article to be protected is that the medicine pipe bracket is an example, in gnotobasis, this pipe bracket is packed in the leakproof tank, seals vessel port (using sealable container cover).The protective cover top of this routine device is opened flatly, with cover plate be fastener up, vessel port is put into this device from the protective cover opening part down, and fastener tightly is buckled in the vessel port place, with the closure of openings of protective cover.In protective cover, charge into nitrogen, pressure is kept and is that environment pressure reduction is 20Pa, wraps up layer protective layer outside again.It is passed through the sterile workshop that outdoor environment is transferred to another place, at first remove the outermost layer protective cover at 100,000 grades of level dust-free workshops, change thousand grades of dust-free workshops over to, from the top protective cover is opened, loosening fasteners takes out container again.Detection receptacle is whether microbiological contamination outward, and the result shows that it does not dye any bacterium or fungi.
This example is apparatus of the present invention to be applied to high pressure shift on the car; Particularly; This high pressure Trolley is provided with 1 second kind of cleanliness level holding device of the foregoing description, and gas filled device can be gas cylinder or other self-fillers, can dispose with car; Through make in the container or container and protective cover between keep suitable pressure and do not invade insulating space to guarantee external environment condition gas, thereby guarantee the clean level of clean article.
Claims (10)
1. method that keeps the article cleanliness level, this method are that the position to be protected with article to be protected or article places container, it is characterized in that, make between position to be protected and the container of article to be protected or article to keep barotropic gas; Or, outside container or outside container local, wrap up layer protective layer at least, make between the part of protective cover and container or container to keep barotropic gas; Or, outside container or outside container local, wrap up two-layer protective cover at least, make between part and the protective cover of container or container and/or keep barotropic gas between protective cover and the protective cover.
2. method according to claim 1 is characterized in that, the part of said container is a vessel port.
3. method according to claim 1 and 2 is characterized in that, the pressure of said barotropic gas is than environmental stress height 10Pa at least.
4. the transfer method of a medicine or its raw material, it adopts each described method of claim 1～3 to keep medicine or pharmaceutical raw material cleanliness level, and transhipment medicine or pharmaceutical raw material.
5. a device that keeps the article cleanliness level comprises container, it is characterized in that, on container, has sealable inflation interface, or on container, is connected with gas filled device.
6. device according to claim 5 is characterized in that, on container, is provided with pressure-detecting device.
7. device that keeps the article cleanliness level; Outer or the local outer layer protective layer at least of container of be wrapped in container that it comprises the fastener that can match with container, closely links to each other with fastener; On protective cover, have sealable inflation interface, or on protective cover, be connected with gas filled device.
8. device according to claim 7 is characterized in that, on said protective cover, is provided with pressure-detecting device.
9. device that keeps the article cleanliness level; Outer or the local at least two layers of outer protective cover of container of be wrapped in container that it comprises the fastener that can match with container, closely links to each other with fastener; At least layer protective layer is provided with sealable inflation interface except that the innermost layer protective cover, or on this protective cover, is connected with gas filled device.
10. device according to claim 9 is characterized in that, on said protective cover, is provided with pressure-detecting device.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100318335A CN102633056A (en) | 2012-02-13 | 2012-02-13 | Method for keeping cleanness of article and device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100318335A CN102633056A (en) | 2012-02-13 | 2012-02-13 | Method for keeping cleanness of article and device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102633056A true CN102633056A (en) | 2012-08-15 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2012100318335A Pending CN102633056A (en) | 2012-02-13 | 2012-02-13 | Method for keeping cleanness of article and device |
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| CN (1) | CN102633056A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104139893A (en) * | 2014-07-11 | 2014-11-12 | 东南大学 | Super-clean vacuum component packaging and storing method |
| WO2017177565A1 (en) * | 2016-04-11 | 2017-10-19 | 深圳市辰中科技有限公司 | Environment maintaining system and method for precision production |
| CN113692383A (en) * | 2019-04-17 | 2021-11-23 | 伊科斯克有限公司 | Method and package for packaging one or more animal skins |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104139893A (en) * | 2014-07-11 | 2014-11-12 | 东南大学 | Super-clean vacuum component packaging and storing method |
| CN104139893B (en) * | 2014-07-11 | 2016-02-03 | 东南大学 | A kind of ultra-clean vacuum component packing and storing method |
| WO2017177565A1 (en) * | 2016-04-11 | 2017-10-19 | 深圳市辰中科技有限公司 | Environment maintaining system and method for precision production |
| CN113692383A (en) * | 2019-04-17 | 2021-11-23 | 伊科斯克有限公司 | Method and package for packaging one or more animal skins |
| CN113692383B (en) * | 2019-04-17 | 2024-07-05 | 伊科斯克有限公司 | Method and package for packaging one or more animal skins |
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Application publication date: 20120815 |