JP3401139B2 - Leak test method and test apparatus for hollow fiber membrane module - Google Patents
Leak test method and test apparatus for hollow fiber membrane moduleInfo
- Publication number
- JP3401139B2 JP3401139B2 JP17269996A JP17269996A JP3401139B2 JP 3401139 B2 JP3401139 B2 JP 3401139B2 JP 17269996 A JP17269996 A JP 17269996A JP 17269996 A JP17269996 A JP 17269996A JP 3401139 B2 JP3401139 B2 JP 3401139B2
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- Japan
- Prior art keywords
- hollow fiber
- compartment
- fiber membrane
- pressure
- fluid
- 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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- Separation Using Semi-Permeable Membranes (AREA)
Description
【０００１】[0001]
【産業上の利用分野】本発明は、疎水性基材に親水性物
質が付着あるいは結合した、微細孔を有する多数の中空
繊維膜、ハウジング、該多数の中空繊維膜の端部をハウ
ジングに固定し該中空繊維膜を隔てた第１区画と第２区
画を形成する隔壁、第１流体入口、第１流体出口、第２
流体入口および第２流体出口を有する中空繊維膜モジュ
ールのリーク試験方法およびリーク試験装置に関する。
詳しくは、医療用に利用される血液透析、血液濾過、血
液濾過透析または血漿分離などに用いられる中空糸膜型
血液処理装置のリーク試験方法および装置に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a large number of hollow fiber membranes having a fine pore in which a hydrophilic substance is attached or bonded to a hydrophobic substrate, a housing, and the end portions of the large number of hollow fiber membranes are fixed to the housing. A partition forming a first section and a second section that separate the hollow fiber membrane, a first fluid inlet, a first fluid outlet, and a second
The present invention relates to a leak test method and a leak test apparatus for a hollow fiber membrane module having a fluid inlet and a second fluid outlet.
More specifically, the present invention relates to a leak test method and device for a hollow fiber membrane-type blood treatment device used for medical purposes such as hemodialysis, hemofiltration, hemofiltration / dialysis, or plasma separation.
【０００２】[0002]
【従来の技術】医療用に用いられる血液処理装置は、腎
不全患者の治療に用いられる血液透析器、血液濾過器、
血液濾過透析器、全身性エリテマトーデス、マクログロ
ブリン血症などの治療に用いられる血漿分離器などがあ
る。血液透析器は、血液中に蓄積した尿素などを主に拡
散により除去し、血液濾過器は、それを主に濾過により
除去し、血液濾過透析器は、拡散と濾過を組み合わせて
血液中の不要物質を除去することに用いられる。通常、
中空繊維膜内腔に血液を流し、中空繊維膜外部に透析液
を流通させることにより使用される。血漿分離器は、中
空繊維膜内腔に血液を流し、中空繊維膜を通過する病因
物質を含む血漿を血液より分離し、新鮮凍結血漿などと
交換し、血液中より、病因物質を除去する治療法に用い
られる。いずれの方法においても、物質交換を効率的に
行うため、多数の中空繊維膜が用いられ、その中空繊維
膜のただ１本が損傷するだけで、血液と中空繊維膜外液
が接触し、即ち血液のリークを招き、治療用具としての
機能が損なわれてしまう。2. Description of the Related Art A blood processing apparatus used for medical purposes includes a hemodialyzer, a hemofilter, and a hemodialyzer used for treating patients with renal failure.
There are hemofiltration dialyzer, systemic lupus erythematosus, plasma separator used for treatment of macroglobulinemia, etc. The hemodialyzer removes urea accumulated in the blood mainly by diffusion, the hemofilter mainly removes it by filtration, and the hemofiltration dialyzer combines diffusion and filtration to eliminate unnecessary substances in the blood. Used to remove material. Normal,
It is used by flowing blood through the hollow fiber membrane lumen and circulating a dialysate outside the hollow fiber membrane. A plasma separator is a treatment that allows blood to flow through the hollow fiber membrane lumen, separates plasma containing the etiological agent that passes through the hollow fiber membrane from blood, and replaces it with fresh frozen plasma to remove the etiological agent from the blood. Used in law. In any of the methods, a large number of hollow fiber membranes are used in order to efficiently perform substance exchange, and only one of the hollow fiber membranes is damaged to bring blood into contact with the liquid outside the hollow fiber membranes. This causes blood leakage and impairs the function as a therapeutic tool.
【０００３】中空繊維膜型血液処理装置の製造におい
て、中空繊維膜の損傷等によるリークを試験すること
は、製品の品質を高めるために重要な工程である。In the manufacture of a hollow fiber membrane blood processing apparatus, testing for leaks due to damage to the hollow fiber membrane is an important step for improving product quality.
【０００４】従来のリーク試験方法として、特開昭５８
−７５５５９号には中空繊維膜の臨界表面張力以上の表
面張力を有する液体を中空繊維膜外部空間に満たして、
中空繊維膜の空孔に連続的に該液体が浸透し始める圧力
より低い圧力で加圧し、中空繊維開口端に浸透発生する
液体を検出することによる方法が記載されているが、目
視で確認するため多数の中空繊維膜を確認することには
注意を時間と注意力を要した。特開昭６０−９４１０５
号には、中空繊維膜を隔てて気体や液体を供給し、圧力
や流量を検出する方法が記載されているが、気体や液体
を実質的に透過させない中空繊維膜のリークを検出する
方法としては簡便に試験することができるが、気体や液
体が透過する中空繊維膜においては、リークの有無を判
断する臨界値を設定することに困難性を有する。特開平
２−２８４０３５号には、膜の平均孔径が０．０１μｍ
以上の疎水性中空繊維膜において、膜を親水化できる高
沸点溶媒を０．１〜１０ｗｔ％溶解した液を用いて外部
より圧力をかけて試験を行うことが記載されている。高
沸点溶媒を用いなければならず、溶液調製、溶媒の除去
等の必要が生じ新たな作業が必要となる。特開平６−１
１７９５７号には、膜を隔てて微粒子を通過させ、通過
する微粒子の数を測定することが記載されている。血液
処理用に用いられる場合、試験に用いた微粒子が膜に残
存するので、異物混入の原因となる。A conventional leak test method is disclosed in Japanese Patent Application Laid-Open No. 58-58.
No. -75559, a hollow fiber membrane external space is filled with a liquid having a surface tension equal to or higher than the critical surface tension of the hollow fiber membrane,
A method is described in which the liquid is pressurized at a pressure lower than the pressure at which the liquid continuously starts to permeate the pores of the hollow fiber membrane and the liquid permeated at the open end of the hollow fiber is detected. Therefore, it took time and attention to check many hollow fiber membranes. JP-A-60-94105
In No. 6, a gas or liquid is supplied across the hollow fiber membrane to detect the pressure or flow rate, but as a method to detect the leak of the hollow fiber membrane that does not substantially permeate the gas or liquid. Can be easily tested, but it is difficult to set a critical value for determining the presence or absence of a leak in a hollow fiber membrane through which a gas or a liquid permeates. In JP-A-2-284035, the average pore size of the membrane is 0.01 μm.
It is described that in the above hydrophobic hollow fiber membrane, a test is conducted by applying pressure from the outside using a liquid in which 0.1 to 10 wt% of a high boiling point solvent capable of making the membrane hydrophilic is dissolved. Since a high boiling point solvent must be used, it becomes necessary to prepare a solution, remove the solvent, etc., and new work is required. Japanese Patent Laid-Open No. 6-1
No. 17957 describes passing fine particles through a membrane and measuring the number of fine particles passing through. When used for blood treatment, the fine particles used in the test remain in the membrane, which causes contamination by foreign substances.
【０００５】[0005]
【発明が解決しようとする課題】血液透析、血液濾過、
血液濾過透析または血漿分離などに用いられる、疎水性
基材に親水性物質が付着あるいは結合した、微細孔を有
する多数の中空繊維膜を用いた血液処理装置は、気体を
透過させ、また、多少の親水性をゆうするという特徴を
有するので、単に気体や液体の透過性を利用する方法で
は、臨界値の設定が難しく、また、親水化剤を利用する
ことは、使用した溶媒の調製、除去を必要とし作業が煩
雑となる。本発明は、上記の問題を解決したリーク試験
方法および装置を提供するものである。Problems to be Solved by the Invention Hemodialysis, hemofiltration,
A blood processing apparatus using a large number of hollow fiber membranes having a hydrophilic substance attached or bonded to a hydrophobic substrate, which is used for hemofiltration / dialysis or plasma separation, allows gas to permeate and slightly It is difficult to set the critical value by the method of simply using the permeability of gas or liquid because it has the characteristic of increasing the hydrophilicity of the solvent. Is required and the work becomes complicated. The present invention provides a leak test method and apparatus that solve the above problems.
【０００６】[0006]
【課題を解決するための手段】本発明は、この様な目的
を達成するために以下の様な中空繊維膜モジュールのリ
ーク試験方法およびリーク試験装置より構成される。In order to achieve such an object, the present invention comprises a leak test method and a leak test apparatus for a hollow fiber membrane module as described below.
【０００７】すなわち、本発明は、疎水性基材に親水性
物質が付着あるいは結合した、微細孔を有する多数の中
空繊維膜、ハウジング、該多数の中空繊維膜の端部をハ
ウジングに固定し該中空繊維膜を隔てた第１区画と第２
区画を形成する隔壁、第１流体入口、第１流体出口、第
２流体入口および第２流体出口を有し、該中空繊維膜の
細孔径が０．００１〜１μｍである中空繊維膜モジュー
ルのリーク試験方法であって、該第１流体入口および該
第２流体入口より該第１区画および第２区画に液体を充
填する液充填工程と、次いで該第１区画と該第２区画を
閉鎖系とし、さらに該第１区画と該第２区画の両区画ま
たは一方の区画を減圧する減圧工程と、次いで該第１区
画に気体を導入し該第１区画の液体を排除する排液工程
と、次いで該第１区画を閉鎖系とし、該第１区画に気体
を導入し所定の圧力まで加圧した後該第１区画を閉鎖系
とする加圧工程と、該第１区画の圧力を測定する測定工
程とを有する。That is, according to the present invention, a large number of hollow fiber membranes having fine pores in which a hydrophilic substance is attached or bonded to a hydrophobic substrate, a housing, and the end portions of the large number of hollow fiber membranes are fixed to the housing. A first section and a second section that separate the hollow fiber membrane
Partition walls forming a partition, a first fluid inlet, first fluid outlet, have a second fluid inlet and second fluid outlet, the hollow fiber membranes
A method for leak testing a hollow fiber membrane module having a pore size of 0.001 to 1 μm, which is a liquid filling step of filling a liquid into the first compartment and the second compartment from the first fluid inlet and the second fluid inlet. And then, the first compartment and the second compartment as a closed system, further decompressing step of decompressing both compartments or one of the first compartment and the second compartment, and then introducing gas into the first compartment Then, a draining step of removing the liquid in the first compartment, and then making the first compartment a closed system, introducing gas into the first compartment and pressurizing it to a predetermined pressure, and then making the first compartment a closed system. And a measuring step of measuring the pressure in the first section.
【０００８】また、本発明は、前記中空繊維膜モジュー
ルが血液透析器、血液濾過器、血漿分離器等を含む血液
処理器であり、該気体が除菌された窒素または空気であ
る。In the present invention, the hollow fiber membrane module is a blood treatment device including a hemodialyzer, a hemofilter, a plasma separator, etc., and the gas is nitrogen or air sterilized.
【０００９】また、本発明は、前記液充填工程に用いら
れる該液体が逆浸透水であり、前記減圧工程における減
圧する圧力が−５００〜−７４０ｍｍＨｇ以下である。Further, in the present invention, the liquid used in the liquid filling step is reverse osmosis water, and the depressurizing pressure in the depressurizing step is -500 to -740 mmHg or less.
【００１０】もう一つの本発明は、疎水性基材に親水性
物質が付着あるいは結合した、微細孔を有する多数の中
空繊維膜、ハウジング、該多数の中空繊維膜の端部をハ
ウジングに固定し該中空繊維膜を隔てた第１区画と第２
区画を形成する隔壁、第１流体入口、第１流体出口、第
２流体入口および第２流体出口を有し、該中空繊維膜の
細孔径が０．００１〜１μｍである中空繊維膜モジュー
ルのリーク試験に用いる試験装置であって、液体供給手
段、気体供給手段、圧力検知手段、減圧手段、該液体供
給手段と該第１流体入口を連絡し閉塞手段を有する第１
流体送液手段、該液体供給手段と該第２流体入口を連絡
し閉塞手段を有する第２流体送液手段、該減圧手段と該
第１流体出口を連絡し閉塞手段を有する第１流体排出手
段、該減圧手段と該第２流体出口を連絡し閉塞手段を有
する第２流体排出手段、該該第１流体出口と該試験装置
外部とを連絡し閉塞手段を有する第１開放手段、該第２
流体出口と該試験装置外部とを連絡し閉塞手段を有する
第２開放手段、該気体供給手段と該第１区画とを連絡し
閉塞手段を有する第１送気手段、該気体供給手段と該第
２区画とを連絡し閉塞手段を有する第２送気手段、およ
び該第１区画と圧力検知手段とを連絡し閉塞手段を有す
る圧力測定手段を有する。According to another aspect of the present invention, a large number of hollow fiber membranes having fine pores in which a hydrophilic substance is attached or bonded to a hydrophobic substrate, a housing, and end portions of the large number of hollow fiber membranes are fixed to the housing. A first section and a second section separating the hollow fiber membrane
Partition walls forming a partition, a first fluid inlet, first fluid outlet, have a second fluid inlet and second fluid outlet, the hollow fiber membranes
A test device used for a leak test of a hollow fiber membrane module having a pore diameter of 0.001 to 1 μm, which comprises a liquid supply means, a gas supply means, a pressure detection means, a pressure reduction means, the liquid supply means and the first fluid inlet. For communicating with and having a closure means
Fluid sending means, second fluid sending means communicating with the liquid supplying means and the second fluid inlet and having a closing means, first fluid discharging means having communicating means with the pressure reducing means and the first fluid outlet and having a closing means A second fluid discharge means that connects the decompression means and the second fluid outlet and has a closing means; a first opening means that has a closing means that connects the first fluid outlet and the outside of the test apparatus;
Second opening means for connecting the fluid outlet to the outside of the test apparatus and having a closing means, first air feeding means for connecting the gas supply means and the first section and having a closing means, the gas supply means and the first It has a second air supply means which is in communication with the two compartments and has a closing means, and a pressure measuring means which is in communication with the first compartment and the pressure detecting means and has a closing means.
【００１１】本発明に用いられる中空繊維の疎水性基材
は、ポリエチレン、ポリメチルメタクリレート、ポリス
チレン、ポリプロピレン、ポリスルホン、ポリアミド等
を用いることができる。その他、疎水性材料を用いるこ
とができる。As the hollow fiber hydrophobic substrate used in the present invention, polyethylene, polymethylmethacrylate, polystyrene, polypropylene, polysulfone, polyamide or the like can be used. In addition, a hydrophobic material can be used.
【００１２】本発明に用いられる親水性物質は、ポリビ
ニルピロリドン、ポリエチレングリコール、ポリプロピ
レングリコールなどの親水性高分子、グリセリン、糖ア
ルコールなどの多価アルコールなどを用いることができ
る。その他、疎水性基材に親水性を賦与することができ
るものを使用することができる。As the hydrophilic substance used in the present invention, hydrophilic polymers such as polyvinylpyrrolidone, polyethylene glycol and polypropylene glycol, and polyhydric alcohols such as glycerin and sugar alcohol can be used. In addition, a material that can impart hydrophilicity to the hydrophobic substrate can be used.
【００１３】本発明の中空繊維膜の細孔径は、０．００
１〜１μｍである。０．００１μｍより小さい場合に
は、通気性が非常に低いので、膜を隔てた通気量の測
定、あるいは気体や液体による加圧時の圧力変化測定す
る方法を簡便に利用することができる。１μｍより大き
い場合は、容易に水を通過させることができるので、膜
を隔てた通水量の測定による方が簡便であり、また、他
の微粒子を用いることにより検査制度が向上する。The pore diameter of the hollow fiber membrane of the present invention is 0.00
It is 1 to 1 μm. If it is smaller than 0.001 μm, the gas permeability is very low, so that the method of measuring the gas flow rate across the membrane or measuring the pressure change at the time of pressurization with a gas or liquid can be simply used. If it is larger than 1 μm, water can easily pass through it. Therefore, it is easier to measure the amount of water passing through the membrane, and the inspection system is improved by using other fine particles.
【００１４】[0014]
【作用】本発明の作用を、以下に詳しく説明する。The operation of the present invention will be described in detail below.
【００１５】疎水性基材に親水性物質が付着あるいは結
合した、微細孔を有する多数の中空繊維膜を用いた血液
処理装置のリーク試験は、気体を用いて行う場合、微細
孔を気体が通過するのでリークの有無を判断する明確な
基準を設定することが困難であり、一方、水を用いて行
う場合には、膜は若干の親水性を有するので、微細孔が
徐々に濡れてきてしまい、この場合もリークの有無を判
断する明確な基準を設定することが困難である。In a leak test of a blood treatment apparatus using a large number of hollow fiber membranes having fine pores in which a hydrophilic substance is attached or bonded to a hydrophobic substrate, when a gas is used, the gas passes through the fine pores. Therefore, it is difficult to set a clear standard for determining the presence or absence of leaks.On the other hand, when water is used, the membrane has a slight hydrophilic property, and the micropores gradually become wet. In this case as well, it is difficult to set a clear standard for determining the presence or absence of a leak.
【００１６】この様な膜の場合、一度微細孔を親水化す
ることにより、微細孔は、微細孔中の水を押し出す圧力
（バブルポイント）までは気体不透過性となり、バブル
ポイント以下の膜間圧力差を与えて、気体が通過するか
どうかを圧力の変化等を観察することにより、リークの
有無を容易に判断することができるようになる。膜を親
水化する方法として、親水化することができる液体を水
に混合することが提案されているが、特に人体に用いる
血液処理装置では、親水化のために混合する液体が生体
にとって異物となる場合が多く、リーク試験の後血液処
理装置から除去しなければならない。In the case of such a membrane, once the fine pores are made hydrophilic, the fine pores become gas impermeable up to the pressure (bubble point) for pushing out the water in the fine pores, and the inter-membrane below the bubble point is reached. By giving a pressure difference and observing a change in pressure as to whether or not a gas passes, it is possible to easily determine the presence or absence of a leak. As a method of hydrophilizing a membrane, it has been proposed to mix a liquid capable of hydrophilizing with water, but particularly in a blood processing apparatus used for the human body, the liquid mixed for hydrophilizing is a foreign substance to the living body. In many cases, it must be removed from the blood processing device after the leak test.
【００１７】本発明は、水のみを血液処理装置に充填
し、減圧することにより、膜微細孔内に残留した気体を
取り除き、微細孔へ水を充填することを特徴としてい
る。そして、リーク試験を精度よく実施できる、水充填
後に減圧する圧力を検討した。また、親水化の後、膜を
隔てた２室のどちらかの水を追い出し、気体により所定
圧まで加圧し、所定の圧力を発生する圧力マスターの圧
力を血液処理装置の加圧した室の圧力と比較し、一定時
間後の圧力の変化を読み、その圧力の変化が所定値以内
であればリークなしと判定し、所定値以上であればリー
クありと判断することができる。The present invention is characterized in that only the water is filled in the blood processing apparatus and the pressure is reduced to remove the gas remaining in the membrane micropores and to fill the micropores with water. Then, the pressure for reducing the pressure after filling with water, which enables the leak test to be performed accurately, was examined. In addition, after hydrophilization, the water in either of the two chambers separated by the membrane is expelled and pressurized with gas to a prescribed pressure, and the pressure of the pressure master that generates the prescribed pressure is the pressure of the pressurized chamber of the blood processing apparatus. The change in pressure after a certain period of time is read, and if the change in pressure is within a predetermined value, it can be determined that there is no leak, and if it is at least a predetermined value, it can be determined that there is a leak.
【００１８】[0018]
【実施の態様】図を用いて本発明のリーク試験方法およ
びリーク試験装置を説明する。DESCRIPTION OF THE PREFERRED EMBODIMENTS The leak test method and leak test apparatus of the present invention will be described with reference to the drawings.
【００１９】図１は中空繊維膜型血液処理装置の１例で
ある。血液処理装置１は、中空繊維膜４、外筒５、第１
流体出入口７１、７２を有するヘッダー６１、６２、中
空繊維膜４を外筒５に固定し、中空繊維膜４を隔てた第
１区画２と第２区画３とを形成する隔壁８１を有する。
外筒５には第２流体出入口７３、７４を有する。FIG. 1 shows an example of a hollow fiber membrane type blood processing apparatus. The blood processing apparatus 1 includes a hollow fiber membrane 4, an outer cylinder 5, and a first
The headers 61 and 62 having the fluid inlets and outlets 71 and 72, and the partition wall 81 that fixes the hollow fiber membrane 4 to the outer cylinder 5 and forms the first section 2 and the second section 3 that separate the hollow fiber membrane 4 are provided.
The outer cylinder 5 has second fluid inlets / outlets 73, 74.
【００２０】図２は、本発明に関わるリーク試験装置の
模式図である。リーク装置２０は、液体供給手段９、気
体供給手段１０、圧力検知手段６、減圧手段８、該液体
供給手段９と該第１流体入口７２を連絡し閉塞手段１２
２を有する第１流体送液手段１０５、該液体供給手段９
と該第２流体入口７４を連絡し閉塞手段１２３を有する
第２流体送液手段１０６、該減圧手段８と該第１流体出
口７１を連絡し閉塞手段１２６を有する第１流体排出手
段１０８、該減圧手段８と該第２流体出口７９を連絡し
閉塞手段１２７を有する第２流体排出手段１１０、該該
第１流体出口７１と該試験装置外部とを連絡し閉塞手段
１２５を有する第１開放手段１０９、該第２流体出口７
３と該試験装置外部とを連絡し閉塞手段１２４を有する
第２開放手段１０７、該気体供給手段１０と該第１区画
とを連絡し閉塞手段１２１、１２８を有する第１送気手
段１０１、１０２、該気体供給手段１０と該第２区画と
を連絡し閉塞手段１２８、１２１、１２２、１２３を有
する第２送気手段１０１、１０２、１０５、１０６、お
よび該第１区画と圧力検知手段６とを連絡し閉塞手段１
２１を有する圧力測定手段１０２を有する。第１流体排
出手段１０８には、圧力計１１が設けられている。FIG. 2 is a schematic diagram of a leak test apparatus according to the present invention. The leak device 20 connects the liquid supply unit 9, the gas supply unit 10, the pressure detection unit 6, the decompression unit 8, the liquid supply unit 9 and the first fluid inlet 72, and the closing unit 12.
First fluid sending means 105 having 2, and the liquid supply means 9
To the second fluid inlet 74 and a second fluid feed means 106 having a closing means 123, the pressure reducing means 8 to the first fluid outlet 71 and a first fluid discharging means 108 having a closing means 126, A second fluid discharge means 110 which connects the pressure reducing means 8 and the second fluid outlet 79 and has a closing means 127, and a first opening means which connects the first fluid outlet 71 to the outside of the test apparatus and has a closing means 125. 109, the second fluid outlet 7
3 and the outside of the test apparatus, the second opening means 107 having the closing means 124, and the first air supply means 101, 102 having the closing means 121, 128 connecting the gas supply means 10 and the first section. , Second gas supply means 101, 102, 105, 106 that connect the gas supply means 10 and the second compartment and have closing means 128, 121, 122, 123, and the first compartment and the pressure detection means 6. Contact means 1
It has a pressure measuring means 102 having 21. The first fluid discharge means 108 is provided with the pressure gauge 11.
【００２１】さらに、圧力検知手段６には所定の圧力を
発生させる差圧マスター７が圧力伝達手段１０３により
連絡されている。Further, a differential pressure master 7 for generating a predetermined pressure is connected to the pressure detecting means 6 by a pressure transmitting means 103.
【００２２】液体供給手段は、通常使用される送液ポン
プ等を用いることができる。減圧手段は、通常使用され
る真空ポンプ等を用いることができる。As the liquid supply means, a commonly used liquid feed pump or the like can be used. A vacuum pump or the like which is normally used can be used as the pressure reducing means.
【００２３】閉塞手段としては、通常の配管バルブ等、
流体制御用に用いられるものを使用することができる。As the closing means, a normal piping valve or the like,
What is used for fluid control can be used.
【００２４】以下にリーク試験の各工程を説明するが、
リーク試験に先立ち、各手段と流体出入口を上記に従っ
て接続する。Each step of the leak test will be described below.
Prior to the leak test, each means and fluid inlet / outlet are connected as described above.
【００２５】（液充填工程）閉塞手段１２１、１２６、
１２７、１２８を閉、閉塞手段１２２、１２３、１２
４、１２５を開として、送液手段９を作動させ図示しな
い貯液槽より逆浸透水を第１区画、第２区画にそれぞれ
送液し、逆浸透水を充填し、送液手段９を停止する。(Liquid filling step) Closing means 121, 126,
Closing 127, 128, closing means 122, 123, 12
4, 125 are opened, and the liquid feeding means 9 is operated to feed the reverse osmosis water from the storage tank (not shown) to the first compartment and the second compartment, respectively, to fill the reverse osmosis water, and stop the liquid feeding means 9. To do.
【００２６】閉塞手段１２１、１２３、１２４、１２
６、１２７、１２８を閉、閉塞手段１２２、１２５を開
として、送液手段９を作動させ図示しない貯液槽より逆
浸透水を第１区画に送液し、第１区画に逆浸透水を充填
し、次いで 閉塞手段１２１、１２２、１２５、１２
６、１２７、１２８を閉、閉塞手段１２３、１２４を開
として、逆浸透水を第２区画に送液し、逆浸透水を充填
し、送液手段９を停止してもよい。Closing means 121, 123, 124, 12
6, 127, 128 are closed and the closing means 122, 125 are opened, and the liquid feeding means 9 is operated to feed the reverse osmosis water from the storage tank (not shown) to the first compartment, and the reverse osmosis water is fed to the first compartment. Fill and then the closure means 121, 122, 125, 12
6, 127, 128 may be closed and the closing means 123, 124 may be opened to feed the reverse osmosis water to the second compartment, fill the reverse osmosis water, and stop the fluid sending means 9.
【００２７】（減圧工程）閉塞手段１２１、１２２、１
２３、１２４、１２５、１２８を閉、閉塞手段１２６、
１２７を開とし、減圧手段８を作動させ、第１区画およ
び第２区画を所定の圧力まで減圧し、減圧手段８を停止
する。(Decompression step) Closing means 121, 122, 1
23, 124, 125, 128 closed, closure means 126,
127 is opened, the decompression means 8 is operated, the first and second compartments are decompressed to a predetermined pressure, and the decompression means 8 is stopped.
【００２８】中空繊維膜の細孔径、親水性物質の付着量
と特性により、所定の圧力は変わるが、血液透析濾過器
の場合、−５００〜−７４０ｍｍＨｇが好ましい。The predetermined pressure varies depending on the pore size of the hollow fiber membrane, the amount of the hydrophilic substance attached and the characteristics, but in the case of a hemodialysis filter, -500 to -740 mmHg is preferable.
【００２９】（排液工程）閉塞手段１２２、１２３、１
２４、１２６、１２７を閉、閉塞手段１２８、１２１、
１２５を開として、送気手段１０を作動させ、除菌され
た窒素あるいは空気を送り、第１区画の逆浸透水を排液
し、送気手段１０を停止する。(Drainage process) Closing means 122, 123, 1
24, 126, 127 closed, closing means 128, 121,
125 is opened, the air supply means 10 is operated, the sterilized nitrogen or air is sent, the reverse osmosis water in the first compartment is drained, and the air supply means 10 is stopped.
【００３０】（加圧工程）閉塞手段１２２、１２３、１
２５、１２６、１２７を閉、閉塞手段１２８、１２１、
１２４を開として、送気手段１０を作動させ、除菌され
た窒素あるいは空気を送り、圧力検知手段６が所定の圧
力に達したら、送気手段１０を停止し、閉塞手段１２８
を閉とする。(Pressure step) Closing means 122, 123, 1
25, 126, 127 are closed, closing means 128, 121,
When 124 is opened, the air supply unit 10 is operated to send sterilized nitrogen or air, and when the pressure detection unit 6 reaches a predetermined pressure, the air supply unit 10 is stopped and the closing unit 128 is used.
Is closed.
【００３１】所定の圧力は、中空繊維膜のバブルポイン
トより低ければよいが、検査精度の向上、作業の効率
化、装置の簡便化のために、１．０〜２．０ｋｇ／ｃｍ
２が好ましい。The predetermined pressure may be lower than the bubble point of the hollow fiber membrane, but it is 1.0 to 2.0 kg / cm for improving inspection accuracy, improving work efficiency, and simplifying the apparatus.
2 is preferred.
【００３２】（測定工程）差圧マスター７に所定の圧力
を発生させ、所定時間経過後、圧力検知手段６に検知さ
れた第１区画の圧力と比較し、差圧を求め、リークの有
無を判定する。(Measuring Step) A predetermined pressure is generated in the differential pressure master 7, and after a predetermined time elapses, it is compared with the pressure in the first section detected by the pressure detecting means 6 to obtain the differential pressure, and whether there is a leak or not. judge.
【００３３】差圧を求める経過時間は、５〜３００秒、
好ましくは１５〜１００秒が好ましい。これより短い場
合、圧力が安定せず、これより長い場合は、測定環境由
来のノイズ等による値のばらつき等により作業効率が低
下する。The elapsed time for obtaining the differential pressure is 5 to 300 seconds,
It is preferably 15 to 100 seconds. When the pressure is shorter than this, the pressure is not stable, and when it is longer than this, the work efficiency is lowered due to variations in values due to noise and the like derived from the measurement environment.
【００３４】[0034]
【実施例】図２のリーク試験装置を用い中空繊維膜を用
いた中空繊維膜型血液処理装置のリーク試験を行った。EXAMPLE A leak test of a hollow fiber membrane type blood treatment apparatus using a hollow fiber membrane was conducted using the leak test apparatus of FIG.
【００３５】用いた血液処理装置の中空繊維膜はポリス
ルホンからなり、ポリビニルピロリドンが付着してい
る。内径 約２００μｍ、外径約３００μｍであった。The hollow fiber membrane of the blood treating apparatus used was made of polysulfone and had polyvinylpyrrolidone attached thereto. The inner diameter was about 200 μm and the outer diameter was about 300 μm.
【００３６】血液処理装置は、中空繊維膜有効長約２７
ｃｍ、中空繊維膜本数約１０，０００本、外筒の材質は
ポリカーボネート、第１流体出入口ヘッダーの材質はポ
リプロピレンであった。The blood processing apparatus has a hollow fiber membrane effective length of about 27.
cm, the number of hollow fiber membranes was about 10,000, the material of the outer cylinder was polycarbonate, and the material of the first fluid inlet / outlet header was polypropylene.
【００３７】逆浸透水を用い、減圧工程圧力を−４００
〜−７２０ｍｍＨｇとし、加圧工程圧力２．０ｋｇ／ｃ
ｍ２、測定工程６０秒の条件で、各減圧値につき８０個
の血液処理装置のリーク試験を行った。結果を表１に示
す。Reverse osmosis water was used and the depressurization process pressure was set to -400
~ -720 mmHg, pressurizing process pressure 2.0 kg / c
A leak test of 80 blood processing devices was performed for each reduced pressure value under the condition of m 2 and measurement step of 60 seconds. The results are shown in Table 1.
【００３８】[0038]
【表１】 [Table 1]
【００３９】表１より、−４５０ｍｍＨｇではばらつき
が大きく、判断ができないが、−５００ｍｍＨｇ以下で
は、判断が可能であることがわかった。さらに−７００
ｍｍＨｇでは、安定した試験結果が得られた。From Table 1, it was found that when -450 mmHg, the variation is large and the judgment cannot be made, but when it is -500 mmHg or less, the judgment is possible. Furthermore -700
With mmHg, stable test results were obtained.
【００４０】[0040]
【発明の効果】本発明は、疎水性基材に親水性物質が付
着あるいは結合した、微細孔を有する多数の中空繊維
膜、ハウジング、該多数の中空繊維膜の端部をハウジン
グに固定し該中空繊維膜を隔てた第１区画と第２区画を
形成する隔壁、第１流体入口、第１流体出口、第２流体
入口および第２流体出口を有し、該中空繊維膜の細孔径
が０．００１〜１μｍである中空繊維膜モジュールのリ
ーク試験方法であって、該第１流体入口および該第２流
体入口より該第１区画および第２区画に液体を充填する
液充填工程と、次いで該第１区画と該第２区画を閉鎖系
とし、さらに該第１区画と該第２区画の両区画または一
方の区画を減圧する減圧工程と、次いで該第１区画に気
体を導入し該第１区画の液体を排除する排液工程と、次
いで該第１区画を閉鎖系とし、該第１区画に気体を導入
し所定の圧力まで加圧した後該第１区画を閉鎖系とする
加圧工程と、該第１区画の圧力を測定する測定工程とを
有するので、水のみで微細孔を有する中空繊維膜モジュ
ールのリークの有無を判断することができる。INDUSTRIAL APPLICABILITY According to the present invention, a large number of hollow fiber membranes having fine pores in which a hydrophilic substance is attached or bound to a hydrophobic substrate, a housing, and the end portions of the large number of hollow fiber membranes are fixed to the housing. partition walls forming a first compartment and a second compartment across the hollow fiber membranes, a first fluid inlet, first fluid outlet, have a second fluid inlet and second fluid outlet, the pore size of the hollow fiber membranes
Is a leak test method for a hollow fiber membrane module having a thickness of 0.001 to 1 μm, and a liquid filling step of filling a liquid into the first compartment and the second compartment from the first fluid inlet and the second fluid inlet, Next, a pressure reducing step of decompressing both the first compartment and the second compartment or both compartments of the first compartment and the second compartment, and then introducing gas into the first compartment A drainage step of removing the liquid in the first compartment, and then adding the first compartment as a closed system, introducing gas into the first compartment and pressurizing to a predetermined pressure, and then making the first compartment as a closed system. Since the pressure step and the measurement step of measuring the pressure in the first section are included, it is possible to determine whether or not there is a leak in the hollow fiber membrane module having fine pores only with water.
【００４１】また、本発明は、前記中空繊維膜モジュー
ルが血液透析器、血液濾過器、血漿分離器等を含む血液
処理器であり、該気体が除菌された窒素または空気であ
るので、水のみで試験することによる安全性が確保され
る。Further, according to the present invention, the hollow fiber membrane module is a blood treatment device including a hemodialyzer, a hemofilter, a plasma separator and the like, and the gas is sterilized nitrogen or air. Safety is ensured by testing only.
【００４２】また、本発明は、前記液充填工程に用いら
れる該液体が逆浸透水であり、前記減圧工程における減
圧する圧力が−５００〜−７４０ｍｍＨｇ以下であるの
で、リークの有無の判断が効率的に安定して行うことが
できる。Further, according to the present invention, since the liquid used in the liquid filling step is reverse osmosis water and the pressure for depressurizing in the depressurizing step is -500 to -740 mmHg or less, it is efficient to judge whether or not there is a leak. Stable.
【００４３】もう一つの本発明は、疎水性基材に親水性
物質が付着あるいは結合した、微細孔を有する多数の中
空繊維膜、ハウジング、該多数の中空繊維膜の端部をハ
ウジングに固定し該中空繊維膜を隔てた第１区画と第２
区画を形成する隔壁、第１流体入口、第１流体出口、第
２流体入口および第２流体出口を有し、該中空繊維膜の
細孔径が０．００１〜１μｍである中空繊維膜モジュー
ルのリーク試験に用いる試験装置であって、液体供給手
段、気体供給手段、圧力検知手段、減圧手段、該液体供
給手段と該第１流体入口を連絡し閉塞手段を有する第１
流体送液手段、該液体供給手段と該第２流体入口を連絡
し閉塞手段を有する第２流体送液手段、該減圧手段と該
第１流体出口を連絡し閉塞手段を有する第１流体排出手
段、該減圧手段と該第２流体出口を連絡し閉塞手段を有
する第２流体排出手段、該該第１流体出口と該試験装置
外部とを連絡し閉塞手段を有する第１開放手段、該第２
流体出口と該試験装置外部とを連絡し閉塞手段を有する
第２開放手段、該気体供給手段と該第１区画とを連絡し
閉塞手段を有する第１送気手段、該気体供給手段と該第
２区画とを連絡し閉塞手段を有する第２送気手段、およ
び該第１区画と圧力検知手段とを連絡し閉塞手段を有す
る圧力測定手段を有するので、水のみで、微細孔を有す
る中空繊維膜モジュールのリークの有無を判断すること
ができる。According to another aspect of the present invention, a large number of hollow fiber membranes having fine pores in which a hydrophilic substance is attached or bonded to a hydrophobic substrate, a housing, and the end portions of the large number of hollow fiber membranes are fixed to the housing. A first section and a second section separating the hollow fiber membrane
Partition walls forming a partition, a first fluid inlet, first fluid outlet, have a second fluid inlet and second fluid outlet, the hollow fiber membranes
A test device used for a leak test of a hollow fiber membrane module having a pore diameter of 0.001 to 1 μm, which comprises a liquid supply means, a gas supply means, a pressure detection means, a pressure reduction means, the liquid supply means and the first fluid inlet. For communicating with and having a closure means
Fluid sending means, second fluid sending means communicating with the liquid supplying means and the second fluid inlet and having a closing means, first fluid discharging means having communicating means with the pressure reducing means and the first fluid outlet and having a closing means A second fluid discharge means that connects the decompression means and the second fluid outlet and has a closing means; a first opening means that has a closing means that connects the first fluid outlet and the outside of the test apparatus;
Second opening means for connecting the fluid outlet to the outside of the test apparatus and having a closing means, first air feeding means for connecting the gas supply means and the first section and having a closing means, the gas supply means and the first A hollow fiber having fine pores only with water, since it has a second air supply means which communicates with two compartments and has a clogging means, and a pressure measuring means which communicates the first compartment with a pressure detection means and has a clogging means. It is possible to determine whether or not there is a leak in the membrane module.
【図１】本発明に関わる中空繊維膜モジュールの断面図
である。FIG. 1 is a cross-sectional view of a hollow fiber membrane module according to the present invention.
【図２】本発明に関わる中空繊維膜モジュールのリーク
試験装置の１実施例の概略図である。FIG. 2 is a schematic view of one example of a leak test device for a hollow fiber membrane module according to the present invention.
１ 中空繊維膜モジュール ２ 第１区画 ３ 第２区画 ４ 中空繊維膜 ５ 外筒 ６１、６２ 出入口ヘッダー ７１、７２、７３、７４ 流体出入口 ８１、８２ 隔壁 ６ 圧力検知手段 ７ 差圧マスター ８ 減圧手段 ９ 液体供給手段 １０ 気体供給手段 １２１〜１２８ 閉塞手段 1 Hollow fiber membrane module 2 first section 3 second division 4 hollow fiber membranes 5 outer cylinder 61, 62 doorway header 71, 72, 73, 74 Fluid inlet / outlet 81, 82 partition walls 6 Pressure detection means 7 Differential pressure master 8 decompression means 9 Liquid supply means 10 Gas supply means 121-128 blocking means
Claims (4)
合した、微細孔を有する多数の中空繊維膜、ハウジン
グ、該多数の中空繊維膜の端部をハウジングに固定し該
中空繊維膜を隔てた第１区画と第２区画を形成する隔
壁、第１流体入口、第１流体出口、第２流体入口および
第２流体出口を有し、該中空繊維膜の細孔径が０．００
１〜１μｍである中空繊維膜モジュールのリーク試験方
法であって、該第１流体入口および該第２流体入口より
該第１区画および第２区画に液体を充填する液充填工程
と、次いで該第１区画と該第２区画を閉鎖系とし、さら
に該第１区画と該第２区画の両区画または一方の区画を
減圧する減圧工程と、次いで該第１区画に気体を導入し
該第１区画の液体を排除する排液工程と、次いで該第１
区画を閉鎖系とし、該第１区画に気体を導入し所定の圧
力まで加圧した後該第１区画を閉鎖系とする加圧工程
と、該第１区画の圧力を測定する測定工程とを有するこ
とを特徴とする中空繊維膜モジュールのリーク試験方
法。1. A large number of hollow fiber membranes having a hydrophilic substance attached or bonded to a hydrophobic substrate and having fine pores, a housing, and end portions of the large number of hollow fiber membranes are fixed to a housing to form the hollow fiber membrane. partition walls forming a first compartment and a second compartment spaced, first fluid inlet, first fluid outlet, the pore diameter of the second fluid inlet and second have a fluid outlet, said hollow fiber membrane is 0.00
A method for leak testing a hollow fiber membrane module having a size of 1 to 1 μm , comprising a liquid filling step of filling a liquid into the first compartment and the second compartment from the first fluid inlet and the second fluid inlet, and then the first A decompression step of decompressing one compartment and the second compartment as a closed system, and further decompressing both compartments of the first compartment and the second compartment or one compartment, and then introducing gas into the first compartment Drainage step to remove the liquid of
A pressure step in which the compartment is a closed system, gas is introduced into the first compartment and the pressure is increased to a predetermined pressure, and then the first compartment is the closed system; and a measurement step in which the pressure in the first compartment is measured. A method for leak testing a hollow fiber membrane module, which comprises:
血液濾過器、血漿分離器等を含む血液処理器であり、該
気体が除菌された窒素または空気であることを特徴とす
る請求項１記載の中空繊維膜モジュールのリーク試験方
法。2. The hollow fiber membrane module is a hemodialyzer,
2. A leak test method for a hollow fiber membrane module according to claim 1, wherein the leak treatment method is a blood treatment device including a blood filter, a plasma separator, etc., and the gas is sterilized nitrogen or air.
透水であり、前記減圧工程における減圧する圧力が−５
００〜−７４０ｍｍＨｇであることを特徴とする請求項
１または２記載の中空繊維膜モジュールのリーク試験方
法。3. The liquid used in the liquid filling step is reverse osmosis water, and the depressurizing pressure in the depressurizing step is -5.
The leak test method for a hollow fiber membrane module according to claim 1 or 2, wherein the leak test method is from 00 to -740 mmHg.
合した、微細孔を有する多数の中空繊維膜、ハウジン
グ、該多数の中空繊維膜の端部をハウジングに固定し該
中空繊維膜を隔てた第１区画と第２区画を形成する隔
壁、第１流体入口、第１流体出口、第２流体入口および
第２流体出口を有し、該中空繊維膜の細孔径が０．００
１〜１μｍである中空繊維膜モジュールのリーク試験に
用いる試験装置であって、液体供給手段、気体供給手
段、圧力検知手段、減圧手段、該液体供給手段と該第１
流体入口を連絡し閉塞手段を有する第１流体送液手段、
該液体供給手段と該第２流体入口を連絡し閉塞手段を有
する第２流体送液手段、該減圧手段と該第１流体出口を
連絡し閉塞手段を有する第１流体排出手段、該減圧手段
と該第２流体出口を連絡し閉塞手段を有する第２流体排
出手段、該該第１流体出口と該試験装置外部とを連絡し
閉塞手段を有する第１開放手段、該第２流体出口と該試
験装置外部とを連絡し閉塞手段を有する第２開放手段、
該気体供給手段と該第１区画とを連絡し閉塞手段を有す
る第１送気手段、該気体供給手段と該第２区画とを連絡
し閉塞手段を有する第２送気手段、および該第１区画と
圧力検知手段とを連絡し閉塞手段を有する圧力測定手段
を有することを特徴とする中空繊維膜モジュールのリー
ク試験装置。4. A large number of hollow fiber membranes having a hydrophilic substance attached or bonded to a hydrophobic substrate and having fine pores, a housing, and end portions of the large number of hollow fiber membranes are fixed to the housing to form the hollow fiber membrane. partition walls forming a first compartment and a second compartment spaced, first fluid inlet, first fluid outlet, the pore diameter of the second fluid inlet and second have a fluid outlet, said hollow fiber membrane is 0.00
A test apparatus for use in a leak test of a hollow fiber membrane module having a size of 1 to 1 μm, which comprises a liquid supply means, a gas supply means, a pressure detection means, a pressure reduction means, the liquid supply means and the first
First fluid delivery means communicating with the fluid inlet and having a closure means,
Second fluid sending means for communicating the liquid supply means with the second fluid inlet and having a closing means; first fluid discharging means for communicating the pressure reducing means with the first fluid outlet with a closing means; and the pressure reducing means A second fluid discharge means communicating with the second fluid outlet and having a closing means, a first opening means connecting the first fluid outlet with the outside of the test apparatus and having a closing means, the second fluid outlet and the test A second opening means for communicating with the outside of the device and having a closing means,
A first air supply means that connects the gas supply means and the first section and has a closing means, a second air supply means that connects the gas supply means and the second section and has a closing means, and the first A leak test apparatus for a hollow fiber membrane module, comprising a pressure measuring means having a block means for connecting the compartment and the pressure detecting means.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP17269996A JP3401139B2 (en) | 1996-07-02 | 1996-07-02 | Leak test method and test apparatus for hollow fiber membrane module |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP17269996A JP3401139B2 (en) | 1996-07-02 | 1996-07-02 | Leak test method and test apparatus for hollow fiber membrane module |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH1015059A JPH1015059A (en) | 1998-01-20 |
| JP3401139B2 true JP3401139B2 (en) | 2003-04-28 |
Family
ID=15946716
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP17269996A Expired - Fee Related JP3401139B2 (en) | 1996-07-02 | 1996-07-02 | Leak test method and test apparatus for hollow fiber membrane module |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3401139B2 (en) |
Cited By (2)
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| JP3664083B2 (en) * | 2001-02-01 | 2005-06-22 | 株式会社ジェイ・エム・エス | Leak test method for hollow fiber membrane module |
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Cited By (3)
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|---|---|---|---|---|
| CN106794287A (en) * | 2014-10-16 | 2017-05-31 | 旭化成医疗株式会社 | The filter method of hollow fiber membrane-type body fluid filter and protein solution |
| CN113310867A (en) * | 2021-05-14 | 2021-08-27 | 西南石油大学 | Experimental test method for simulating gas reservoir high-temperature high-pressure stratum reverse osmosis water absorption lock damage |
| CN113310867B (en) * | 2021-05-14 | 2022-03-18 | 西南石油大学 | Experimental test method for simulating gas reservoir high-temperature high-pressure stratum reverse osmosis water absorption lock damage |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH1015059A (en) | 1998-01-20 |
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