CN103203034B - High-energy electronic ray disinfection device and application thereof - Google Patents
High-energy electronic ray disinfection device and application thereof Download PDFInfo
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- CN103203034B CN103203034B CN201310143880.3A CN201310143880A CN103203034B CN 103203034 B CN103203034 B CN 103203034B CN 201310143880 A CN201310143880 A CN 201310143880A CN 103203034 B CN103203034 B CN 103203034B
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Abstract
The invention relates to a high-energy electronic ray disinfection device and application thereof. The disinfection device comprises a loader, a conveying belt, a downloader and a ray shielding chamber, wherein a high-energy electronic accelerator is arranged in the ray shielding chamber; and a disinfection auxiliary gas storage box is also arranged in the ray shielding chamber. Under the condition that the main technology and performance indexes are consistent with the International advanced level, a product disinfected by the method and the device is excellent in reliability, environment friendliness, efficiency and disinfection uniformity; and the quality stability and the yield are greatly improved.
Description
Technical field
The invention belongs to three class medical apparatus sterilizing technical fields, be specifically related to a kind of high energy electron ray decontaminating apparatus and application thereof.
Background technology
Three class medical apparatus and instruments (as cardiac stent, hemodialyzer, blood taking tube etc.) complete after production, the bacterial content of product must be extremely low, at present in the world conventionally the method for use be product complete adopt after producing oxirane (ETO) smoked or with radioelement Cobalt 60(Co60) carry out irradiation sterilization.For ethylene oxide process, its major defect is easily residual on product, causes patient with rear easy generation anaphylaxis, and this kind of gas purging destroys atmosphere in addition, is that International Environmental Protection pact wants time limit inactive; And the method for radioelement Cobalt 60, its major defect is that the ray uniformity is poor, and working (machining) efficiency is low, and security of operation has a big risk; And because radiant intensity is self-assembling formation, so be difficult for accurately controlling, the processing of useless source is difficult in addition, the probability of later stage environmental pollution is large.Because three at present domestic class Safe of Medical Device standards are relatively low, therefore most three class medical apparatus and instruments all adopt epoxyethane fumigation method, and its sterilisation level is only equivalent to the primary level of developed country.But along with integrating with of medical apparatus and instruments national standard and international standard, to the extremely pending raising of the disinfection way of three current class medical apparatus and instruments.
Summary of the invention
The object of this invention is to provide a kind of high energy electron ray decontaminating apparatus and application thereof, a kind of with high energy electron ray the device to medical apparatus sterilizing and using method, thereby can make up the deficiencies in the prior art.
High energy electron ray decontaminating apparatus of the present invention, includes loader, conveyer belt and downloading machine, also includes beam shielded enclosure, the indoor high-energy electron accelerator that is provided with of this alpha ray shield.
Above-mentioned high-energy electron accelerator, its ray of launching is electron beam (EB), and its intensity is 5-10MeV, and its sterilization dose is 15-35KGY.
Described conveyer belt passes beam shielded enclosure, and is positioned at the below of high-energy electron accelerator.
Decontaminating apparatus of the present invention, in the indoor sterilization assist gas storage box that is also provided with of alpha ray shield.
Apparatus of the present invention are for carrying out irradiation sterilization to medical device product, its using method is as follows: first by loader, the product that will sterilize is loaded on conveyer belt, then enter beam shielded enclosure, open high-energy electron accelerator medical device product is carried out to irradiation sterilization.
The using method of apparatus of the present invention, is at the indoor sterilization assist gas that is filled with of alpha ray shield, described sterilization assist gas, and for including the mist of nitrogen and sulfur hexafluoride, its percent by volume respectively is that nitrogen is 87%, sulfur hexafluoride is 13%
With the product after method and apparatus of the present invention sterilization, in the situation that its major technique is consistent with performance indications and international most advanced level, reliably, environmental protection, efficiency is high, sterilisation uniformity good, and quality stability and accepted product percentage improve greatly.
Brief description of the drawings
Fig. 1: the population structure schematic diagram of apparatus of the present invention;
Wherein: 1, loader 2, conveyer belt 3, sterilization assist gas storage box 4, beam shielded enclosure 5, high-energy electron accelerator 6 downloading machines.
Detailed description of the invention
Device of the present invention as shown in Figure 1, include loader 1, conveyer belt 2 and the downloading machine 6 treating sterile products and carry, under the effect of loader 1 and downloading machine 6, conveyer belt 2 passes article for 4 from beam shielded enclosure, the material system such as material selection armored concrete or metal of beam shielded enclosure 4.High-energy electron accelerator 5 has been housed in beam shielded enclosure 4, and high-energy electron accelerator 5 is selected high energy linac, high energy circulating electrons accelerator or blossom type high-energy electron accelerator, and conveyer belt 2 is positioned at the below of high-energy electron accelerator 5.
In addition, in order to improve the effect of sterilization, at beam shielded enclosure 4, sterilization assist gas storage box 3 is also installed, sterilization assist gas storage box 3 can be arranged on the sidewall of beam shielded enclosure 4, in sterilization assist gas storage box 3, be useful on the opening that discharges gas, in sterilization assist gas storage box 3, store sterilization assist gas, in work, sterilization assisted gas cognition discharges in sterilization assist gas storage box 3, thereby makes the interior full sterilization assist gas that has of beam shielded enclosure 4.
When in use, first by loader 1, the product that will sterilize is loaded on conveyer belt 2, then deliver into beam shielded enclosure 4 by given speed, at this moment in beam shielded enclosure 4, started to have sterilization assist gas, and open high-energy electron accelerator 5, by the roentgenization of setting, specific as follows:
By packaged medical device product, this product is placed on conveyer belt 2 with loader 1, conveyer belt 2 delivers into this product the below of the high-energy electron accelerator 5 in beam shielded enclosure 4, the energy of cathode beam used is 5-10MeV, dosage is 15-35Kgy, under the actinism of sending at above-mentioned high-energy electron accelerator 5, thereby the destroyed object that reaches sterilization of the protein of antibacterial, this product after RADIATION PROCESSING is transported to downloading machine 5 by conveyer belt 2, obtains qualified medical device product.
After the touchstone GB 11737-2005 inspection of sterilization of medical instrument, the sterilization effect of device of the present invention meets medical and hygiene article radiation sterilization disinfection standard GB 16383-1996, the desired product of YY-T 0615-2007 completely.
Because medical apparatus and instruments in sterilization is under packed state, like this, due to the existence of wrapping paper, just need to strengthen the energy of electron ray and sterilization time and meet the standard of abundant sterilizing, so just cause consumption and the temporal waste of energy.In order to address this problem, when startup high-energy electron accelerator 5 carries out sterilizing, in beam shielded enclosure 4, being filled with sterilization assist gas carries out disinfection to medical apparatus and instruments, the stream of energetic electrons of utilizing accelerator to produce is destroyed the protein in antibacterial, thereby antibacterial is killed, make medical device product reach aseptic condition; Sterilization assist gas mainly plays and improves the scattering situation that electronics produces in the time penetrating, and prevents that electronics from producing ionization phenomena when through space, to improve uniformity.Described sterilization assist gas, is the mist of nitrogen and sulfur hexafluoride, and their percentage by volume respectively is that nitrogen is 87%, sulfur hexafluoride is 13%.Use result shows, medical device product is comparable conventionally sterilizing in air ambient by the method for filling sterilization assist gas environment, and the efficiency of electron beam can improve 5-8%.
Can reach 10-6 by its safety coefficient of medical device product of method and apparatus sterilization of the present invention, and can make the stability of product and qualification rate greatly improve.The product of this sterilization is mainly used in human body and implants, and has not only improved patient's quality of life, and has been the only way which must be passed of bringing benefit to the mankind, and mainly comprises cardiac stent, hemodialyzer, blood taking tube etc. in such medical apparatus and instruments.Show through clinical practice post analysis research: the medical apparatus and instruments anaphylaxis of sterilizing by this aspect is extremely low, human body rejection is low, can substitute original sterilization method completely.Therefore, the further research of this invention make its industrialization of crucial importance, of far-reaching significance.
Claims (4)
1. one kind uses the method for high energy electron ray decontaminating apparatus to medical device product irradiation sterilization, it is characterized in that, first by the loader (1) of high energy electron ray decontaminating apparatus, the product that will sterilize is loaded on conveyer belt (2), then enter beam shielded enclosure (4), open high-energy electron accelerator (5) medical device product is carried out to irradiation sterilization; And in beam shielded enclosure (4), be filled with sterilization assist gas, described sterilization assist gas, for including the mist of nitrogen and sulfur hexafluoride, its percent by volume respectively is that nitrogen is 87%, sulfur hexafluoride is 13%.
2. the method for claim 1, it is characterized in that described high energy electron ray decontaminating apparatus includes loader (1), conveyer belt (2) and downloading machine (6), also include beam shielded enclosure (4), high-energy electron accelerator (5) is installed in this beam shielded enclosure (4); Described conveyer belt (2) passes beam shielded enclosure (4), and is positioned at the below of high-energy electron accelerator (5), and sterilization assist gas storage box (3) is also installed in beam shielded enclosure (4); Described conveyer belt (2) passes beam shielded enclosure (4), and is positioned at the below of high-energy electron accelerator (5).
3. the method for claim 1, is characterized in that described high-energy electron accelerator (5), and its ray of launching is electron beam (EB).
4. method as claimed in claim 3, is characterized in that the intensity of described electron beam is 5-10MeV, and sterilization dose is 15-35KGY.
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CN201310143880.3A CN103203034B (en) | 2013-04-23 | 2013-04-23 | High-energy electronic ray disinfection device and application thereof |
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CN201310143880.3A CN103203034B (en) | 2013-04-23 | 2013-04-23 | High-energy electronic ray disinfection device and application thereof |
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CN103203034B true CN103203034B (en) | 2014-08-06 |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN105923213A (en) * | 2016-05-03 | 2016-09-07 | 重庆多普泰制药股份有限公司 | Electron irradiation sterilization device and sterilization method for medical hirudo |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN105288676A (en) * | 2014-07-31 | 2016-02-03 | 上海敏杰制药机械有限公司 | Conveying mechanism for normal-temperature powder particle sterilizer |
Citations (4)
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CN1903375A (en) * | 2005-07-29 | 2007-01-31 | 清华大学 | Shielding type electron beam radiation sterilizing apparatus |
CN101108254A (en) * | 2006-07-17 | 2008-01-23 | 清华大学 | Mobile electron beam irradiation sterilization equipment |
CN101193660A (en) * | 2005-04-19 | 2008-06-04 | 直线加速器技术公司 | Arrangement for sterilising objects by electron bombardment |
CN102065908A (en) * | 2008-04-10 | 2011-05-18 | 雅培糖尿病护理公司 | Method and system for sterilizing an analyte sensor |
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Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101193660A (en) * | 2005-04-19 | 2008-06-04 | 直线加速器技术公司 | Arrangement for sterilising objects by electron bombardment |
CN1903375A (en) * | 2005-07-29 | 2007-01-31 | 清华大学 | Shielding type electron beam radiation sterilizing apparatus |
CN101108254A (en) * | 2006-07-17 | 2008-01-23 | 清华大学 | Mobile electron beam irradiation sterilization equipment |
CN102065908A (en) * | 2008-04-10 | 2011-05-18 | 雅培糖尿病护理公司 | Method and system for sterilizing an analyte sensor |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN105923213A (en) * | 2016-05-03 | 2016-09-07 | 重庆多普泰制药股份有限公司 | Electron irradiation sterilization device and sterilization method for medical hirudo |
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