JP3252647B2 - Liquid processor - Google Patents
Liquid processorInfo
- Publication number
- JP3252647B2 JP3252647B2 JP08800995A JP8800995A JP3252647B2 JP 3252647 B2 JP3252647 B2 JP 3252647B2 JP 08800995 A JP08800995 A JP 08800995A JP 8800995 A JP8800995 A JP 8800995A JP 3252647 B2 JP3252647 B2 JP 3252647B2
- Authority
- JP
- Japan
- Prior art keywords
- liquid
- liquid processor
- processor
- oxygen
- gas
- 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.)
- Expired - Lifetime
Links
Description
【０００１】[0001]
【産業上の利用分野】本発明はグリセリン、水、生理食
塩水等の膜保護剤をウエット状または半ウエット状に充
填した血液処理器や限外濾過器などの液体処理器を不活
性ガス雰囲気下で放射線滅菌するに際し、液体処理器の
透析液口部のキャップを改良した液体処理器である。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a liquid processing device such as a blood processing device or an ultrafiltration device filled with a membrane protective agent such as glycerin, water or physiological saline in a wet or semi-wet state in an inert gas atmosphere. This is a liquid processor in which the cap at the dialysis fluid port of the liquid processor is improved for radiation sterilization below.
【０００２】[0002]
【従来の技術】従来、液体処理器に水や生理食塩水等を
充填して放射線滅菌する方法として、特公昭55-23620号
公報が知られており、放射線滅菌により液体処理器が劣
化するのを防止する目的はある程度達成されている。か
かる湿潤状態での液体処理器の放射線滅菌とは別に、乾
燥状態での液体処理器の放射線滅菌として液体処理器を
不活性ガス雰囲気下で放射線滅菌する方法、すなわち特
公平３-10343号公報が知られている。そして、その一手
段として気体不透過性包装袋内に収容した液体処理器
に、更に脱酸素剤を収容して液体処理器を含む袋内部の
酸素を脱酸素した状態で放射線処理する方法として特公
平５-50946号公報が知られている。2. Description of the Related Art Conventionally, Japanese Patent Publication No. 55-23620 discloses a method for radiation sterilization by filling a liquid processor with water or physiological saline, and the radiation processor deteriorates the liquid processor. The purpose of preventing has been achieved to some extent. Apart from the radiation sterilization of the liquid processor in the wet state, a method of radiation sterilizing the liquid processor in an inert gas atmosphere as the radiation sterilization of the liquid processor in a dry state, that is, Japanese Patent Publication No. 3-10343 is disclosed. Are known. As one of the methods, a method of performing radiation treatment in a state in which a deoxidizer is further accommodated in a liquid processor accommodated in a gas-impermeable packaging bag and oxygen in the bag including the liquid processor is deoxygenated. Japanese Patent Publication No. Hei 5-50946 is known.
【０００３】[0003]
【発明が解決しょうとする課題】本発明はウエット状態
または半ウエット状態で不活性ガス雰囲気下に液体処理
器を放射線滅菌する方法である。従来、不活性ガス雰囲
気下で液体処理器を放射線処理する際には、液体処理器
の透析液入口および透析液出口を開口して液体処理器内
部を不活性ガスで置換したり、液体処理器内部の酸素を
脱酸素剤で除去してきたが、ウエット状態または半ウエ
ット状態で不活性ガス雰囲気下で液体処理器を放射線滅
菌した際には、透析液入口および透析液出口の口部付近
にグリセリン、生理食塩水あるいは水が滲み出てきて液
体処理器の外壁および包装袋内部に付着し、液体処理器
の操作時に手に付着する問題があった。本発明者はこれ
らの問題を解決するために、鋭意検討した結果本発明に
到達した。SUMMARY OF THE INVENTION The present invention is a method for radiation sterilizing a liquid processor in a wet or semi-wet state under an inert gas atmosphere. Conventionally, when a liquid processor is subjected to radiation treatment in an inert gas atmosphere, the dialysate inlet and the dialysate outlet of the liquid processor are opened to replace the inside of the liquid processor with an inert gas, The oxygen inside has been removed with a deoxidizer, but when the liquid processor is subjected to radiation sterilization in an inert gas atmosphere in a wet or semi-wet state, glycerin is placed near the dialysate inlet and dialysate outlet. However, there has been a problem that physiological saline or water oozes out and adheres to the outer wall of the liquid processor and the inside of the packaging bag, and adheres to a hand during operation of the liquid processor. The present inventor has made intensive studies in order to solve these problems, and has arrived at the present invention.
【０００４】[0004]
【課題を解決するための手段】すなわち、本発明は内部
に膜保護剤がウエット状または半ウエット状に充填され
てなる液体処理器を不活性ガス雰囲気下で放射線滅菌す
るに際して、液体処理器の透析液口部が気体透過性で液
体遮断性のキャップで密栓されてなる液体処理器であ
る。また、本発明は前記液体処理器において、液体処理
器と脱酸素剤とを気体不透過性包装袋内に収容して放射
線滅菌する液体処理器である。That is, the present invention relates to a method for sterilizing a liquid processing apparatus having a membrane protective agent filled therein in a wet or semi-wet state under an inert gas atmosphere by radiation sterilization. This is a liquid processor in which the dialysate port is sealed with a gas-permeable, liquid-blocking cap. Further, the present invention is the above-mentioned liquid processor, wherein the liquid processor and the oxygen absorber are accommodated in a gas-impermeable packaging bag and subjected to radiation sterilization.
【０００５】中空糸状、コイル状、プレート状等の半透
膜を内部に充填した液体処理器の血液入口および血液出
口を通常の気体遮断性材料のキャップで密栓するととも
に、透析液入口および透析液出口の口部に気体透過性で
液体遮断性材料のキャップで密栓する。気体透過性で液
体遮断性材料としてはシリコンゴム、ポリオレフィンゴ
ム、多孔性フッ素樹脂等が挙げられ、特にシリコンゴム
が好ましい。液体処理器の半透膜材料としては酢酸セル
ロース、酢酸セルロースけん化セルロース、キュプロフ
ァン、ポリスルホン、ポリエーテルスルホン、ポリウレ
タン、エチレン／ビニルアルコール共重合体、ポリアク
リロニトリル、ポリメチルメタクリレート、ポリビニル
アルコール、ポリプロピレン等が挙げられる。[0005] The blood inlet and the blood outlet of a liquid processor filled with a semi-permeable membrane such as a hollow fiber, a coil, and a plate are hermetically sealed with a cap made of a usual gas barrier material. The mouth of the outlet is sealed with a cap made of a gas-permeable and liquid-blocking material. Examples of the gas-permeable and liquid-blocking material include silicone rubber, polyolefin rubber, and porous fluororesin. Silicon rubber is particularly preferred. Cellulose acetate as the semipermeable membrane material in liquid processor, cellulose acetate saponified cellulose, cupro-fan, polysulfone, Po Li polyethersulfone, polyurethane, ethylene / vinyl alcohol copolymer, polyacrylonitrile, polymethyl methacrylate, polyvinyl alcohol, polypropylene, etc. Is mentioned.
【０００６】液体処理器の内部には、膜保護剤がウエッ
ト状または半ウエット状に充填されているが、膜保護剤
としては水、生理食塩水、グリセリン等が挙げられ、ウ
エット状または半ウエット状に液体処理器内部に充填さ
れている。液体処理器内部を不活性ガス雰囲気にするに
は、液体処理器を気体不透過性包装袋内に収容し、袋内
を窒素ガス、炭酸ガス、ヘリウム、アルゴン等の不活性
ガスで置換したり、気体不透過性包装袋内に脱酸素剤を
液体処理器とともに収容して、脱酸素剤が袋内の酸素を
吸着して袋内を不活性ガス雰囲気にする。液体処理器を
収容する気体不透過性包装袋としては、ポリ塩化ビニリ
デン、ポリビニルアルコ−ル、ポリアミド、ポリエステ
ル等の未延伸または延伸フイルムまたはシ−ト、あるい
はこれらの樹脂をコ−チングしたフイルムまたはシ−
ト、またはこれらのフイルムをラミネ−トしたフイルム
またはシ−ト、あるいはポリエステル／アルミニウム／
ポリエチレンのラミネ−トフイルムまたはシ−ト、アル
ミニウム箔、アルミニウム蒸着膜等の金属箔、金属蒸着
膜、あるいはそのラミネ−ト製品等が挙げられる。The inside of the liquid processor is filled with a membrane protective agent in a wet or semi-wet form. Examples of the membrane protective agent include water, physiological saline, glycerin and the like. The inside of the liquid processor is filled in a shape. To set the inside of the liquid processor to an inert gas atmosphere, the liquid processor is housed in a gas-impermeable packaging bag, and the inside of the bag is replaced with an inert gas such as nitrogen gas, carbon dioxide gas, helium, or argon. The oxygen-absorbing agent is accommodated in the gas-impermeable packaging bag together with the liquid processor, and the oxygen-absorbing agent adsorbs oxygen in the bag to make the interior of the bag an inert gas atmosphere. The gas-impermeable packaging bag containing the liquid processor may be an unstretched or stretched film or sheet of polyvinylidene chloride, polyvinyl alcohol, polyamide, polyester, or the like, or a film coated with these resins or See
Or a film or sheet obtained by laminating these films, or polyester / aluminum /
Examples thereof include a laminated film or sheet of polyethylene, an aluminum foil, a metal foil such as an aluminum evaporated film, a metal evaporated film, and a laminated product thereof.
【０００７】また、脱酸素剤としては酸素の吸収時他の
ガス成分が発生したり、放射線照射により、脱酸素剤の
活性を失ったりしないものが好ましい。例えば活性金属
を主成分とし触媒によりその反応速度がコントロ−ルさ
れるのが好ましい。活性金属としては鉄、亜鉛、銅、錫
等が挙げられ、特に活性酸化鉄を主成分とするものが好
ましい。かかる脱酸素剤としてエ−ジレス（三菱ガス化
学社製）が挙げられる。液体処理器の透析液口部が気体
透過性の活栓で密封されているので不活性ガスあるいは
脱酸素剤の酸素の吸着は活栓を通じて自由に行われ、液
体処理器内部は不活性ガスで置換された状態になる。特
に、液体処理器と脱酸素剤が収容された袋の場合には、
半透膜の微細孔から徐々に放出される酸素も即座に脱酸
素剤で吸着されるので長期間にわたって袋内部を無酸素
状態にすることができる。しかも活栓は液体遮断性であ
るので、ウエット状態または半ウエット状態にある液体
処理器の内部に充填された生理食塩水やグリセリン等が
血液処理器の外側に保管中または放射線処理時に滲み出
て液体処理器の外壁あるいは包装袋の内側に付着し、液
体処理器に触れた場合手が汚れることはない。放射線滅
菌は特にガンマ線照射による滅菌が好ましい。It is preferable that the oxygen scavenger does not generate other gas components when oxygen is absorbed or does not lose the activity of the oxygen scavenger due to irradiation with radiation. For example, it is preferable that the reaction rate is controlled by a catalyst containing an active metal as a main component. Examples of the active metal include iron, zinc, copper, tin, and the like, and particularly preferable are those containing active iron oxide as a main component. Ageless (manufactured by Mitsubishi Gas Chemical Company) is mentioned as such a deoxidizer. Since the dialysate port of the liquid processor is sealed with a gas permeable stopcock, the adsorption of inert gas or oxygen of the oxygen scavenger can be freely performed through the stopcock, and the inside of the liquid processor is replaced with the inert gas. State. In particular, in the case of a bag containing a liquid processor and an oxygen scavenger,
Oxygen gradually released from the micropores of the semi-permeable membrane is also immediately adsorbed by the oxygen scavenger, so that the inside of the bag can be made oxygen-free for a long period of time. In addition, since the stopcock is liquid-blocking, physiological saline or glycerin filled inside the liquid processor in a wet or semi-wet state oozes out during storage or radiation treatment outside the blood processor. It adheres to the outer wall of the processor or the inside of the packaging bag, and does not stain the hands when touching the liquid processor. Radiation sterilization is particularly preferably sterilization by gamma irradiation.
【０００８】[0008]
【作用】液体処理器の透析液口部を気体透過性で液体遮
断性材料のキャップで密栓した後に、液体処理器を気体
不透過性包装袋内に脱酸素剤とともに収容する。液体処
理器内部の酸素は液体処理器の気体透過性材料のキャッ
プを経て袋内部の脱酸素剤に吸着される。そして、液体
処理器内部は膜透孔内部まで不活性ガスで充満される。
その後、袋の外側から液体処理器をガンマ線照射するこ
とによって滅菌処理は終了する。液体処理器内部のグリ
セリンや生理食塩水はキャップが液体遮断性であるので
液体処理器外部に洩れることはない。After closing the dialysate port of the liquid processor with a gas-permeable, liquid-blocking material cap, the liquid processor is housed in a gas-impermeable packaging bag together with an oxygen absorber. Oxygen inside the liquid processor is adsorbed by the oxygen scavenger inside the bag via the cap of the gas permeable material of the liquid processor. Then, the inside of the liquid processor is filled with the inert gas up to the inside of the membrane through-hole.
Thereafter, the sterilization process is completed by irradiating the liquid processor with gamma rays from outside the bag. Glycerin and physiological saline inside the liquid processor do not leak out of the liquid processor because the cap has a liquid blocking property.
【０００９】[0009]
【実施例１】中空糸型血液透析器（膜面積1.9m2）の血
液口部をブチルゴム製のキャップで密栓し、透析液口部
はシリコンゴムキャップ（厚さ1.4mm）で密栓した。か
かる血液透析器をポリエステル／アルミニウム／ポリエ
チレンのラミネートシートからなる袋に収容した。袋内
にはエージレスも収容した。１日後、２日後、３日後、
７日後、14日後、21日後に袋を開封せずに透析器の透析
液口のキャップの上に薄いゴムを貼り、その上からマイ
クロシリンジを使い、透析器内部の気体をサンプリング
して酸素濃度を測定した。酸素濃度分布は東レ酸素分析
計LF-700を使用した。その結果を表１に示す。Example 1 The blood port of a hollow fiber type hemodialyzer (membrane area 1.9 m 2 ) was sealed with a butyl rubber cap, and the dialysate port was sealed with a silicone rubber cap (1.4 mm thick) . The hemodialyzer was housed in a bag made of a laminated sheet of polyester / aluminum / polyethylene. Ageless was also housed in the bag. After one day, two days, three days,
After 7 days, 14 days and 21 days, without opening the bag, put a thin rubber on the dialysate port cap of the dialyzer, use a micro syringe to sample the gas inside the dialyzer, and measure the oxygen concentration. Was measured. The oxygen concentration distribution used Toray oxygen analyzer LF-700. Table 1 shows the results.
【実施例２】実施例１におけるシリコンゴムキャップの
厚さを0.5mmにし、実施例１と同様な方法で透析器の酸
素濃度を測定したときの結果を表１に示す。Example 2 Table 1 shows the results when the thickness of the silicone rubber cap in Example 1 was set to 0.5 mm and the oxygen concentration of the dialyzer was measured in the same manner as in Example 1.
【００１０】[0010]
【表１】 [Table 1]
【００１１】表１から明らかなように、血液処理器内部
の酸素は気体透過性のゴム栓を通過して袋内の脱酸素剤
に吸着され、シリコンゴムキャップの厚さが1.4mmのと
きには３週間、0.5mmのときには３日で血液処理器内部
の酸素濃度は０になった。As it is apparent from Table 1, the oxygen inside the blood treating device is attracted through the gas permeable rubber stopper oxygen scavenger in the bag, when the thickness of the silicon rubber cap is 1.4 mm 3 At 0.5 mm / week, the oxygen concentration inside the blood processor became 0 in 3 days at 0.5 mm.
【００１２】[0012]
【発明の効果】ウエットまたは半ウエット状態の液体処
理器を不活性ガス雰囲気下で放射線滅菌する場合、本発
明液体処理器を使用することによって、液体処理器内部
から膜処理剤が滲み出て液体処理器外壁あるいは包装袋
内部に付着し、包装袋の開封時または液体処理器に触れ
たとき手が汚れることがない。According to the present invention, when a wet or semi-wet liquid processor is subjected to radiation sterilization in an inert gas atmosphere, the use of the liquid processor of the present invention allows the membrane treatment agent to ooze out of the inside of the liquid processor and become liquid. It adheres to the outer wall of the processor or to the inside of the packaging bag, and the hands are not stained when opening the packaging bag or touching the liquid processor.
Claims (1)
ェット状に充填されてなる液体処理器を不活性ガス雰囲
気下で放射線滅菌するに際して、液体処理器の透析液口
部が気体透過性で液体遮断性のキャップで密栓されてな
り、該液体処理器と脱酸素剤とを気体不透過性包装袋内
に収容して放射線滅菌してなる液体処理器。When a liquid treatment device having a membrane protective agent filled therein in a wet or semi-wet state is subjected to radiation sterilization in an inert gas atmosphere, the dialysate port of the liquid treatment device is gas permeable. Do not seal with a liquid blocking cap.
The liquid processor and the oxygen absorber in a gas-impermeable packaging bag.
A liquid processor that is housed in a container and sterilized by radiation .
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP08800995A JP3252647B2 (en) | 1995-04-13 | 1995-04-13 | Liquid processor |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP08800995A JP3252647B2 (en) | 1995-04-13 | 1995-04-13 | Liquid processor |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH08280795A JPH08280795A (en) | 1996-10-29 |
| JP3252647B2 true JP3252647B2 (en) | 2002-02-04 |
Family
ID=13930832
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP08800995A Expired - Lifetime JP3252647B2 (en) | 1995-04-13 | 1995-04-13 | Liquid processor |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3252647B2 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5110645B2 (en) * | 2005-08-10 | 2012-12-26 | 旭化成メディカル株式会社 | Hollow fiber membrane blood purification device |
| JP2007248175A (en) * | 2006-03-15 | 2007-09-27 | Sekisui Chem Co Ltd | Blood examination container |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS58152936U (en) * | 1982-04-06 | 1983-10-13 | 旭メデイカル株式会社 | body fluid purification device |
| JPS62204754A (en) * | 1986-03-03 | 1987-09-09 | 株式会社ニツシヨ− | Radiation sterilization of medical instrument |
-
1995
- 1995-04-13 JP JP08800995A patent/JP3252647B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| JPH08280795A (en) | 1996-10-29 |
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