JPH07250891A - Gamma ray sterilization of blood dialyzer - Google Patents
Gamma ray sterilization of blood dialyzerInfo
- Publication number
- JPH07250891A JPH07250891A JP6045570A JP4557094A JPH07250891A JP H07250891 A JPH07250891 A JP H07250891A JP 6045570 A JP6045570 A JP 6045570A JP 4557094 A JP4557094 A JP 4557094A JP H07250891 A JPH07250891 A JP H07250891A
- Authority
- JP
- Japan
- Prior art keywords
- membrane
- gamma ray
- gamma
- carbon dioxide
- irradiation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- External Artificial Organs (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は血液透析装置のガンマ線
滅菌方法に関するものである。さらに詳しくは、高分子
半透膜を用いた血液透析装置をガンマ線（γ線）照射に
よって滅菌する際に、膜劣化の生じない新規な滅菌方法
に関するものである。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a gamma ray sterilization method for a hemodialysis machine. More specifically, the present invention relates to a novel sterilization method that does not cause membrane deterioration when sterilizing a hemodialysis device using a semipermeable polymer membrane by irradiation with gamma rays (γ rays).
【０００２】[0002]
【従来の技術】従来、高分子半透膜を用いた血液透析装
置などの医療用具の代表的な滅菌方法としては、エチレ
ンオキサイドガス法、高圧水蒸気滅菌法およびガンマ線
照射法などがある。これらの方法はそれぞれ一長一短あ
るが、近年では残留毒性の少なさや簡便さの点から、高
圧水蒸気滅菌法とガンマ線照射法が多用されている。2. Description of the Related Art Conventionally, as a typical sterilization method for medical devices such as a hemodialyzer using a polymer semipermeable membrane, there are an ethylene oxide gas method, a high pressure steam sterilization method and a gamma ray irradiation method. Each of these methods has advantages and disadvantages, but in recent years, the high-pressure steam sterilization method and the gamma irradiation method have been widely used because of their low residual toxicity and simplicity.
【０００３】しかしながら、高圧水蒸気滅菌法の適用は
耐熱性にすぐれた膜材料のものに限定される。また、ガ
ンマ線照射法も、セルロース、セルロースエステル、ポ
リメチルメタクリレートなどの耐ガンマ線性に劣る膜材
料には不適当であることが知られている。However, the application of the high-pressure steam sterilization method is limited to the membrane material having excellent heat resistance. It is also known that the gamma ray irradiation method is also unsuitable for film materials having poor gamma ray resistance such as cellulose, cellulose ester, and polymethylmethacrylate.
【０００４】このような耐ガンマ線性の低い膜材料から
なる医療用具に対するガンマ線照射の方法として、例え
ば、特公平３−１０３４３号公報に、炭酸ガスや窒素な
どの不活性ガス雰囲気下で照射を行う方法が提案されて
いる。この公報の記載によれば、酸素などのガンマ線に
活性な気体の雰囲気下の照射では膜の酸化により膜劣化
が起るとされ、この特公平３−１０３４３号方法によ
り、膜劣化を抑えながら乾燥状態で滅菌することが可能
とされている。As a method of irradiating gamma rays on a medical device made of such a film material having low resistance to gamma rays, for example, Japanese Patent Publication No. 3-10343 discloses irradiation in an atmosphere of an inert gas such as carbon dioxide or nitrogen. A method has been proposed. According to the description in this publication, the film deterioration is caused by the oxidation of the film under irradiation of an atmosphere of a gas such as oxygen which is active for gamma rays. According to this Japanese Patent Publication No. 3-10343, drying is performed while suppressing the film deterioration. It is possible to sterilize in the state.
【０００５】しかしながら、この方法によって滅菌して
得られた血液透析膜は乾燥状態なので、実用に際して、
該透析膜の湿潤および気泡抜きを必要とするため、これ
らに手間がかかり、病院での使用に際して問題とされて
いる。However, since the hemodialysis membrane obtained by sterilization by this method is in a dry state, it is
Since the dialysis membrane needs to be moistened and degassed, it is troublesome and has been a problem for use in a hospital.
【０００６】また、特公昭５５−２３６２０号公報に
は、血液透析膜を湿潤状態でガンマ線照射できることが
示されている。この方法によれば、湿潤状態でセルロー
ス膜やポリメチルメタクリレート膜のガンマ線滅菌は可
能とされている。Further, Japanese Patent Publication No. 55-23620 discloses that a hemodialysis membrane can be irradiated with gamma rays in a wet state. According to this method, gamma ray sterilization of a cellulose membrane or a polymethylmethacrylate membrane in a wet state is possible.
【０００７】しかしながら、本発明者らの検討によれ
ば、単に飽和含水量以上の湿潤状態でガンマ線照射する
だけでは、ガンマ線照射によりある程度膜が劣化するの
は避けられず、膜性能の実質的な低下を完全に抑制する
のは困難であるという事実が確認された。However, according to the study by the present inventors, it is unavoidable that the film is deteriorated to some extent by gamma ray irradiation by merely irradiating the gamma ray in a wet state having a saturated water content or more, and the film performance is substantially reduced. The fact that it is difficult to control the decline completely was confirmed.
【０００８】[0008]
【発明が解決しようとする課題】本発明者らは、かかる
実情に鑑みて、湿潤状態で膜劣化を来さないガンマ線照
射滅菌法を提供すべく鋭意研究の結果、炭酸ガスを溶解
した水溶液中でガンマ線照射を行った場合、炭酸ガス雰
囲気中で照射した場合に比べて滅菌効果が高く、かつ、
膜劣化は純水中で行った場合よりも抑えられるという新
事実を見いだし、本発明を完成するに到った。In view of such circumstances, the present inventors have earnestly studied to provide a gamma irradiation sterilization method that does not cause film deterioration in a wet state, and as a result, in the aqueous solution in which carbon dioxide gas is dissolved. When gamma-ray irradiation is performed with, the sterilization effect is higher than when irradiated in a carbon dioxide gas atmosphere, and
The inventors have found a new fact that the film deterioration can be suppressed more than in the case of performing it in pure water, and completed the present invention.
【０００９】[0009]
【課題を解決するための手段】すなわち、本発明は、高
分子半透膜を用いた血液透析用装置を滅菌するに際し
て、炭酸ガスを飽和溶解量の２０重量％以上溶解させた
水溶液中に前記高分子半透膜を湿潤した状態で、ガンマ
線照射を施すことを特徴とする透析装置の滅菌方法であ
る。That is, according to the present invention, when sterilizing a hemodialysis apparatus using a polymer semipermeable membrane, the above-mentioned method is used in an aqueous solution in which carbon dioxide gas is dissolved at 20% by weight or more of a saturated dissolution amount. A method for sterilizing a dialysis device, which comprises irradiating with gamma rays in a wet state of a polymer semipermeable membrane.
【００１０】本発明の滅菌方法が適用される透析装置に
おいて用いられる高分子半透膜は、血液透析用に使用さ
れるものであれば、特に制限はないが、なかでもセルロ
ース、セルロースジアセテート、セルローストリアセテ
ートなどのセルロース類、ポリメチルメタクリレート、
ポリビニルアルコール、ポリサルホン、ポリアクリロニ
トリル、ポリエチレン、ポリアミドなどの合成高分子類
が有効であり、特に、セルロースジアセテート、セルロ
ーストリアセテートなどのセルロースエステルが好適で
ある。The polymer semipermeable membrane used in the dialysis apparatus to which the sterilization method of the present invention is applied is not particularly limited as long as it is used for hemodialysis. Among them, cellulose, cellulose diacetate, Cellulose such as cellulose triacetate, polymethylmethacrylate,
Synthetic polymers such as polyvinyl alcohol, polysulfone, polyacrylonitrile, polyethylene, and polyamide are effective, and cellulose esters such as cellulose diacetate and cellulose triacetate are particularly preferable.
【００１１】この高分子半透膜の形態は限定されない
が、血液透析に有効に使用される中空繊維膜が好まし
い。The form of the polymer semipermeable membrane is not limited, but a hollow fiber membrane effectively used for hemodialysis is preferable.
【００１２】本発明方法では、これらの高分子半透膜
は、飽和溶解量の少なくとも２０重量％、好ましくは少
なくとも４０重量％、の炭酸ガスを溶解した水溶液中に
浸漬・湿潤した状態で、ガンマ線照射が行われる。In the method of the present invention, these polymer semipermeable membranes are dipped in an aqueous solution containing at least 20% by weight, preferably at least 40% by weight of the saturated dissolution amount of carbon dioxide gas and dipped in an aqueous solution, and gamma rays are used. Irradiation is performed.
【００１３】本発明方法において用いられる炭酸ガスを
溶解した水溶液は、限外濾過水や逆浸透濾過水などに、
直接、炭酸ガスまたは空気を溶解度限界まで吹き込み溶
解させて調製すれば良い。また、炭酸水溶液を用いても
よい。The aqueous solution in which carbon dioxide gas is dissolved used in the method of the present invention is ultrafiltered water, reverse osmosis filtered water, or the like.
It may be prepared by directly blowing carbon dioxide gas or air to the solubility limit to dissolve. Alternatively, a carbonated aqueous solution may be used.
【００１４】本発明方法において、前記の炭酸ガスが溶
解している水に、必要に応じｐＨ調節剤や水腐敗防止剤
を添加してもかまわない。In the method of the present invention, a pH adjusting agent or a water decay inhibitor may be added to the water in which the carbon dioxide gas is dissolved, if necessary.
【００１５】本発明方法の実用的な実施態様の一つは、
上記の中空繊維膜を用いた血液透析器（モジュール）内
に、炭酸ガスを含む水溶液を充填し、必要に応じて密封
後、その状態でモジュールごとガンマ線照射を行って滅
菌する方法である。One of the practical embodiments of the method of the present invention is
This is a method in which a hemodialyzer (module) using the above hollow fiber membrane is filled with an aqueous solution containing carbon dioxide, sealed if necessary, and then sterilized by gamma irradiation together with the module in that state.
【００１６】水溶液の温度は常温付近またはそれ以下の
温度が好ましい。あまり高温（例えば５０℃以上）に加
熱すると溶解した炭酸ガスが抜けるおそれがあるので適
当でない。The temperature of the aqueous solution is preferably around room temperature or lower. Heating at too high a temperature (for example, 50 ° C. or higher) may cause the dissolved carbon dioxide gas to escape, which is not suitable.
【００１７】ガンマ線照射の条件は、通常採用されてい
る条件でよい。例えば、高分子半透膜がセルロースエス
テル中空繊維膜の場合、１０〜５０KGray 程度の照射で
十分である。The conditions for gamma ray irradiation may be those normally adopted. For example, when the polymer semipermeable membrane is a cellulose ester hollow fiber membrane, irradiation at about 10 to 50 KGray is sufficient.
【００１８】[0018]
【発明の効果】以上のごとき本発明方法によれば、ガン
マ線照射に際して高分子半透膜の劣化がなく、効果的な
滅菌が行える。しかも、本発明方法で滅菌された血液透
析装置は、湿潤および気泡抜きなどを必要せず、すぐに
使用に供することができる。According to the method of the present invention as described above, effective sterilization can be performed without deterioration of the polymer semipermeable membrane upon gamma ray irradiation. Moreover, the hemodialysis apparatus sterilized by the method of the present invention does not require wetting or degassing and can be immediately used.
【００１９】本発明方法により膜の劣化を伴わずに効果
的に滅菌できる機構は未だ明かではないが、水中に溶解
している炭酸イオンが適度のガンマ線吸収作用を有して
いるため、膜の劣化を抑制しながら、滅菌作用の邪魔を
せずに、効果的な滅菌が行えるものと推定される。Although the mechanism by which the method of the present invention can effectively sterilize the membrane without degrading the membrane has not been clarified yet, since the carbonate ion dissolved in water has an appropriate gamma ray absorbing action, It is presumed that effective sterilization can be performed while suppressing deterioration and without disturbing the sterilization action.
【００２０】[0020]
【実施例】以下に、実施例および比較例によって本発明
方法をより具体的に説明する。ただし、これらの実施例
および比較例は本発明の理解を助けるためのものであっ
て、これらの記載によって本発明の範囲が限定されるも
のではない。EXAMPLES Hereinafter, the method of the present invention will be described more specifically with reference to Examples and Comparative Examples. However, these examples and comparative examples are for helping understanding of the present invention, and the scope of the present invention is not limited by these descriptions.
【００２１】なお、例中の「ＳＣ７万」は、デキストラ
ン（分子量７万）に対する膜のフルイ係数を意味する。
また、耐圧テストは、透過液側に空気で圧力をかけ、気
泡の発生する時点での圧力を検出することで行った。In the examples, "SC70,000" means the sieving coefficient of the film for dextran (molecular weight 70,000).
The pressure resistance test was performed by applying pressure to the permeate side with air and detecting the pressure at the time when bubbles were generated.
【００２２】［実施例１，比較例１］セルローストリア
セテートからなる中空繊維を内蔵した血液透析装置（モ
ジュール）に、飽和量の炭酸ガスを溶解した常温の逆浸
透濾過水を充填・密封したのち、25KGray のガンマ線を
照射して滅菌を実施した。[Example 1, Comparative Example 1] A hemodialysis apparatus (module) containing hollow fibers made of cellulose triacetate was filled and sealed with room temperature reverse osmosis filtered water in which a saturated amount of carbon dioxide was dissolved. Sterilization was performed by irradiating with 25KGray of gamma rays.
【００２３】また、比較のため、窒素を吹き込むことに
より溶存炭酸ガスを除去した水溶液を用いて、同様にガ
ンマ線照射を行った。For comparison, gamma ray irradiation was similarly performed using an aqueous solution from which dissolved carbon dioxide was removed by blowing nitrogen.
【００２４】それぞれ照射前後での膜性能変化および繊
維物性変化を各々２回調べた結果を表１に示す。Table 1 shows the results obtained by examining twice the change in the membrane performance and the change in the physical properties of the fiber before and after irradiation.
【００２５】[0025]
【表１】 [Table 1]
【００２６】表１の結果から明らかなように、炭酸ガス
含有水中で照射した場合（実施例１）は、炭酸ガスを含
まない水中で線照射を行った場合（比較例１）に比べ
て、ガンマ線照射後の耐圧性保持が良好で、膜劣化が極
めて起りににくいことが明かになった。As is clear from the results shown in Table 1, when irradiation was carried out in carbon dioxide-containing water (Example 1), compared to when irradiation was carried out in water containing no carbon dioxide (Comparative Example 1), It was revealed that the pressure resistance was maintained well after the gamma ray irradiation, and the film deterioration was extremely unlikely to occur.
【００２７】前記実施例１において、滅菌結果を判定す
るためにガンマ線照射後のサンプルを寒天培地で５日間
培養し、コロニー生成の有無を調べたが、全く生成は認
められなかった。したがって、実施例１のガンマ線照射
条件でも実用上問題のない滅菌効果が達成されているこ
とが実証された。In Example 1, in order to determine the sterilization result, the sample after gamma ray irradiation was cultured in an agar medium for 5 days and examined for colony formation, but no formation was observed. Therefore, it was demonstrated that the sterilization effect without any practical problems was achieved even under the gamma ray irradiation conditions of Example 1.
───────────────────────────────────────────────────── フロントページの続き (72)発明者 松田 裕生 山口県岩国市日の出町２番１号 帝人株式 会社岩国研究センター内 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Hiroo Matsuda 2-1, Hinodemachi, Iwakuni-shi, Yamaguchi Teijin Limited Iwakuni Research Center
Claims (2)
ンマ線照射により滅菌するに際して、炭酸ガスを飽和溶
解量の２０重量％以上溶解させた水溶液中に湿潤した状
態で前記高分子半透膜にガンマー線照射を施すことを特
徴とする血液透析装置のガンマ線滅菌方法。1. When sterilizing a hemodialyzer using a polymer semipermeable membrane by gamma ray irradiation, the polymer semipermeable membrane is moistened in an aqueous solution in which carbon dioxide gas is dissolved at 20 wt% or more of the saturated dissolution amount. A method for sterilizing gamma rays in a hemodialysis device, which comprises irradiating the membrane with gamma rays.
繊維膜であることを特徴とする請求項１記載のガンマ線
滅菌方法。2. The gamma ray sterilization method according to claim 1, wherein the polymer semipermeable membrane is a cellulose ester hollow fiber membrane.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP6045570A JPH07250891A (en) | 1994-03-16 | 1994-03-16 | Gamma ray sterilization of blood dialyzer |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP6045570A JPH07250891A (en) | 1994-03-16 | 1994-03-16 | Gamma ray sterilization of blood dialyzer |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPH07250891A true JPH07250891A (en) | 1995-10-03 |
Family
ID=12723012
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP6045570A Pending JPH07250891A (en) | 1994-03-16 | 1994-03-16 | Gamma ray sterilization of blood dialyzer |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH07250891A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH11139987A (en) * | 1997-09-04 | 1999-05-25 | Becton Dickinson & Co | Additive formulation and its use |
| US6986868B2 (en) | 1998-11-20 | 2006-01-17 | Coloplast A/S | Method for sterilizing a medical device having a hydrophilic coating |
| EP1131112B2 (en) † | 1998-11-20 | 2006-11-29 | Coloplast A/S | A method for sterilising a medical device having a hydrophilic coating |
| DE102013106247A1 (en) * | 2013-06-14 | 2014-12-18 | B. Braun Avitum Ag | Filter device for blood and the like body fluids |
-
1994
- 1994-03-16 JP JP6045570A patent/JPH07250891A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH11139987A (en) * | 1997-09-04 | 1999-05-25 | Becton Dickinson & Co | Additive formulation and its use |
| JP4575529B2 (en) * | 1997-09-04 | 2010-11-04 | ベクトン・ディキンソン・アンド・カンパニー | Additive formulation and method of use |
| US6986868B2 (en) | 1998-11-20 | 2006-01-17 | Coloplast A/S | Method for sterilizing a medical device having a hydrophilic coating |
| EP1131112B2 (en) † | 1998-11-20 | 2006-11-29 | Coloplast A/S | A method for sterilising a medical device having a hydrophilic coating |
| US9138510B2 (en) | 1998-11-20 | 2015-09-22 | Coloplast A/S | Sterilized ready-to-use catheter |
| DE102013106247A1 (en) * | 2013-06-14 | 2014-12-18 | B. Braun Avitum Ag | Filter device for blood and the like body fluids |
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