CN102240407B - Electron beam sterilization method for blood purifying product - Google Patents
Electron beam sterilization method for blood purifying product Download PDFInfo
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- CN102240407B CN102240407B CN 201010171227 CN201010171227A CN102240407B CN 102240407 B CN102240407 B CN 102240407B CN 201010171227 CN201010171227 CN 201010171227 CN 201010171227 A CN201010171227 A CN 201010171227A CN 102240407 B CN102240407 B CN 102240407B
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Abstract
The invention relates to an electron beam sterilization method for a blood purifying product. According to the electron beam sterilization method disclosed by the invention, a dialyzer can be sterilized by using electron beams through two-side radiation and a method for dislocating a higher-density part of the blood purifying product, and therefore, a sterile effect can be achieved and materials are less damaged.
Description
Technical field
The present invention relates to a kind of electron beam sterilization method, relate in particular to a kind of electron beam sterilization method for the blood purification product.
Background technology
Dialyser product sterilization is unusual the key link, is the special procedure in producing.Sterilizing methods commonly used has: ethylene oxide sterilizing, steam sterilization, radiation sterilization etc.
Ethylene oxide sterilizing is kind of the violent material of reaction: molecular formula: CH
2-CH
2-O, inflammable, explosive toxic gas.Sterilization mechanism: ETO can with the proteins react of microorganism, hindered the normal chemical reaction of bacterioprotein and metabolism, thereby caused microbial death, belong to chemosterilization.After adopting ethylene oxide sterilizing, have certain residue, its residue can cause human body, as hypotension, cough, perspiration, respiratory system, skin pruritus, tumor, vomiting, stomachache etc.Therefore for lowland reduces residue, the product after enterprise needs sterilization finished ventilates and deposits, and according to different conditions, needs to ventilate and does not wait in several days.Therefore because of the direct hazardness of its residue, enterprise need have enough zones to place product to carry out release, clearance cycle of residue long, international manufacturing enterprise is in superseded ETO method progressively.
High pressure steam sterilization is high temperature and the penetration capacity of utilizing water vapour pure in the special high-pressure steam sterilization equipment, causes the irreversible denaturation with the protein in the microbial cell inside and outside the sterilization object, nucleic acid etc., with killing microorganisms.Since steam sterilization to consider material toleration, need vapour source and process complexity etc. not to be widely adopted,
The radiation sterilization of China's medical apparatus and instruments is that its total amount of China is to adopt the sterilization of ETO method more than 90% at present from the sterilization of disposable use medical apparatus and instruments starting.Along with coming into force of the international environmental protection pact of Meng Teer, external manufacturing enterprise is progressively eliminating the ETO method, then adopts radiation sterilization.
Polymer Synthesizing film dialyser extensive use radiation sterilization owing to the radiation resistance of membrane material at present.More medical apparatus and instruments employing γ of enterprise sterilization in the radiation sterilization.γ sterilization than ETO, steam sterilization relatively has simple etc. the advantage of obvious noresidue, technology, but equally also has long, big to the influence of the material problem of sterilising cycle.
Except the γ sterilization, also has the electron beam irradiation sterilization in the radiation sterilization techniques.The technology of electron beam irradiation sterilization and equipment are the new techniques that nearest 10 years maturations are got up and are employed, because its influence to material is littler, dosage is accurate, and sterilization time is lacked (a few time in second), scheduling of production is flexible, be convenient to timely sterilization, realize lower sterilizing dose easily, being more suitable in the application to the very high medical apparatus and instruments of security requirement, is the developing direction of medical device product sterilization from now on.
Electron beam is as novel irradiation sterilization technology, and its degree of influence to material is little, processing cost is low, the advantage of timely sterilization etc., accepted by esbablished corporation both at home and abroad gradually.But because low, the pockety shortcoming of electron beam penetration power, therefore to be applied to blood purification product product be one of these those skilled in the art direction of being devoted to study to the sterilization method that this is advanced always.
Summary of the invention
Purpose of the present invention provides a kind of electron beam sterilization method for the blood purification product exactly in order to address the above problem, solved low, the pockety shortcoming of electron beam penetration power.
The object of the present invention is achieved like this: a kind of electron beam sterilization method for the blood purification product may further comprise the steps:
A. the placement of blood purification product: the blood purification product is arranged in some layers, and the density major part of every layer of blood purification product and the dislocation of the appropriate section of other layers are placed;
B. the sterilization of blood purification product: the above-mentioned blood purification product that places is carried out the sterilization of bilateral electron beam irradiation.
Above-mentioned electron beam sterilization method for the blood purification product, wherein, the density major part of the product of blood purification described in the steps A is its both ends.
Above-mentioned electron beam sterilization method for the blood purification product, wherein, it is with the some layers of stepped arrangement of blood purification product that the dislocation of the product of blood purification described in the steps A is placed.
The inventive method successfully is applied to electron beam sterilization in the sterilization of blood purification product, its influence to material is little, dosage is accurate having kept, under the situation of advantages such as sterilization time is short, scheduling of production is flexible, also overcome low, the pockety shortcoming of electron beam penetration power, make the blood purification product arrive aseptic condition by electron beam sterilization method, less to its material damage simultaneously.
The specific embodiment
According to analysis, the influence that the electron beam penetration capacity is low after the blood purification product is sterilized is: when one-sided radiation, electron beam can not penetrate the bigger two ends of blood purified product density fully, thereby does not reach the sterilization purpose.Influence after the electron beam skewness is sterilized for the blood purification product is: when bilateral shines, though electron beam has penetrated the bigger two ends of blood purification product density, but may there be the excessive phenomenon of acceptable dose in remainder, and material is had certain damage.
At the problems referred to above, electron beam sterilization method of the present invention makes the bigger part of two ends density of the blood purification product of each layer of packing not overlap with the same section of the blood purification product of other layer, thereby reduces dosage when using electron beam to carry out the bilateral irradiation.
The inventive method comprises following steps: at first, the blood purification product is placed in the packing container, packing container is arranged in 1 to 10 layer with the blood purification product, guarantee that simultaneously the bigger part of two-layer blood purification product density staggers up and down, be stepped arranging, then the blood purification product carried out electron beam sterilization together with packing container.Electron beam carries out radiation from the packing container top with less dosage for the first time.For the second time packing container is turned over turnback and make the original bottom surface of packing container upwards, electron beam carries out radiation to the blood purification product from the top down with less dosage again.
The present invention makes the blood purification product arrive aseptic condition by above-mentioned electron beam sterilization method, and is less to its material damage simultaneously.
Above embodiment is only for the usefulness that the present invention is described, but not limitation of the present invention, person skilled in the relevant technique, under the situation that does not break away from the spirit and scope of the present invention, can also make various conversion or modification, therefore all technical schemes that are equal to also should belong to category of the present invention, should be limited by each claim.
Claims (1)
1. electron beam sterilization method that is used for the blood purification product may further comprise the steps:
A. the placement of blood purification product: the blood purification product is arranged in some layers, the density major part of every layer of blood purification product and the dislocation of the appropriate section of other layers are placed, that is: the blood purification product is placed in the packing container, packing container is arranged in 1 to 10 layer with the blood purification product, guarantee that simultaneously the bigger part of two-layer blood purification product density staggers up and down, be stepped arranging, then the blood purification product carried out electron beam sterilization together with packing container;
B. the sterilization of blood purification product: the above-mentioned blood purification product that places is carried out the sterilization of bilateral electron beam irradiation, that is: electron beam carries out radiation from the packing container top with less dosage for the first time, for the second time packing container being turned over turnback makes the original bottom surface of packing container upwards, electron beam carries out radiation to the blood purification product from the top down with less dosage again
The density major part of the product of blood purification described in the steps A is its both ends.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010171227 CN102240407B (en) | 2010-05-13 | 2010-05-13 | Electron beam sterilization method for blood purifying product |
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| CN 201010171227 CN102240407B (en) | 2010-05-13 | 2010-05-13 | Electron beam sterilization method for blood purifying product |
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| CN102240407A CN102240407A (en) | 2011-11-16 |
| CN102240407B true CN102240407B (en) | 2013-08-07 |
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| CN 201010171227 Active CN102240407B (en) | 2010-05-13 | 2010-05-13 | Electron beam sterilization method for blood purifying product |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103341187B (en) * | 2012-06-28 | 2016-06-22 | 四川远大蜀阳药业股份有限公司 | A kind of method of terminal inactivation of pathogenic microorganism |
| CN112023071A (en) * | 2020-09-27 | 2020-12-04 | 东南大学 | A method for inactivating pathogenic microorganisms in blood products |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1427729A (en) * | 2000-03-23 | 2003-07-02 | 科利昂特有限公司 | Method for sterilizing biological materials |
| CN1555273A (en) * | 2000-12-07 | 2004-12-15 | ��������ķ������ | Advanced oxidation of dangerous chemical and biological sources |
| TW200924802A (en) * | 2007-08-01 | 2009-06-16 | Asahi Kasei Kuraray Medical Co | Electron beam sterilization method |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070111196A1 (en) * | 2005-08-19 | 2007-05-17 | Javier Alarcon | Sterilization of Biosensors |
| DE102008007662A1 (en) * | 2008-02-06 | 2009-08-13 | Robert Bosch Gmbh | Apparatus and method for the treatment of moldings by means of high-energy electron beams |
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2010
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1427729A (en) * | 2000-03-23 | 2003-07-02 | 科利昂特有限公司 | Method for sterilizing biological materials |
| CN1555273A (en) * | 2000-12-07 | 2004-12-15 | ��������ķ������ | Advanced oxidation of dangerous chemical and biological sources |
| TW200924802A (en) * | 2007-08-01 | 2009-06-16 | Asahi Kasei Kuraray Medical Co | Electron beam sterilization method |
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| CN102240407A (en) | 2011-11-16 |
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