JP2706853B2 - Membrane filter integrity inspection method and inspection device - Google Patents
Membrane filter integrity inspection method and inspection deviceInfo
- Publication number
- JP2706853B2 JP2706853B2 JP315491A JP315491A JP2706853B2 JP 2706853 B2 JP2706853 B2 JP 2706853B2 JP 315491 A JP315491 A JP 315491A JP 315491 A JP315491 A JP 315491A JP 2706853 B2 JP2706853 B2 JP 2706853B2
- Authority
- JP
- Japan
- Prior art keywords
- filter
- gas pressure
- pressure
- fluid
- housing
- 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 - Fee Related
Links
Description
【０００１】[0001]
【産業上の利用分野】本発明は、メンブランフィルタ、
特にその微細孔の完全性検査方法及び検査装置に関す
る。The present invention relates to a membrane filter,
In particular, the present invention relates to a method and an apparatus for inspecting the integrity of the micropores.
【０００２】[0002]
【従来の技術】液体中の微生物、固形物をメンブランフ
ィルタを通過せしめて捕捉する方法が行われており、こ
の方法で流体を無菌化することも知られている。従来、
メンブランフィルタの完全性を検査する方法としては、
メンブランフィルタの微細孔を流体で満たし、該フィル
タに対してガス圧をかけた状態でフィルタの上流側すな
わち前方を塞止めして所定時間保持し、該ガス圧の低下
率を調べてフィルタの完全性を検査する方法（一般にプ
レッシャーホールド試験。以下P.H 試験という）があ
る。しかし、従来のP.H 試験法では、フィルタの下流側
すなわち後方が外気に開放された状態で検査が行われる
ので、フィルタ後方部分からの濾過システム（製品ライ
ン）への細菌汚染の虞がある。従って、この方法は、無
菌濾過システムにおいて濾過処理前等に非破壊で行う試
験法としては適切でない。2. Description of the Related Art A method of trapping microorganisms and solids in a liquid by passing through a membrane filter has been performed, and it is also known to sterilize a fluid by this method. Conventionally,
To check the integrity of the membrane filter,
Fill the micropores of the membrane filter with a fluid, close the upstream side, that is, the front of the filter with gas pressure applied to the filter and hold it for a predetermined time. There is a method for examining sex (generally, a pressure hold test; hereafter referred to as a PH test). However, in the conventional PH test method, since the inspection is performed in a state where the downstream side of the filter, that is, the rear side is open to the outside air, there is a risk of bacterial contamination from the rear part of the filter to the filtration system (product line). Therefore, this method is not suitable as a nondestructive test method in a sterile filtration system before filtration or the like.
【０００３】[0003]
【発明が解決しようとする課題】本発明は、上記従来技
術の事情に鑑み、メンブランフィルタの完全性を正確に
検査でき、かつ検査時における製品ラインへの細菌汚染
の問題のない、メンブランフィルタの完全性検査方法及
び検査装置の提供を目的とする。SUMMARY OF THE INVENTION The present invention has been made in consideration of the above-described circumstances of the prior art, and has been made in consideration of the above circumstances. It is intended to provide an integrity inspection method and an inspection apparatus.
【０００４】[0004]
【課題を解決するための手段】本発明者らは、前記のP.
H 試験を、フィルタにガス圧をかけると共に、フィルタ
後方を無菌的に、常圧よりも高く、かつ上記ガス圧より
低い一定のガス圧に保持した状態で行うことにより、フ
ィルタ前方のガス圧の低下率を調べてフィルタの完全性
を正確に検査することができると共に、フィルタ後方の
陽圧により、製品ラインへの細菌汚染の問題が解消され
ると知見を得た。Means for Solving the Problems The present inventors have proposed the above-mentioned P.
The H test is performed by applying a gas pressure to the filter and performing a test under aseptic conditions at the rear of the filter at a constant gas pressure higher than the normal pressure and lower than the gas pressure. It has been found that the integrity of the filter can be accurately checked by examining the rate of decline and that the positive pressure behind the filter eliminates the problem of bacterial contamination of the product line.
【０００５】本発明は、上記知見に基づいてなされたも
ので、その要旨は、メンブランフィルタの微細孔を流体
で満たし、該フィルタに対して、その微細孔が完全でな
い場合にこれに満たされた流体の表面張力に打ち勝ち、
かつ微細孔が完全である場合にこれに満たされた流体の
表面張力に打ち勝たない流入側ガス圧をかけた状態でフ
ィルタの上流側を塞止め、所定時間における上記塞止め
られた部分のガス圧の低下率を調べてフィルタの完全性
を検査する方法において、フィルタ後方を無菌的に、常
圧よりも高く、かつ該ガス圧より低い一定の流出側ガス
圧に保持した状態で上記の検査を行うことを特徴とする
メンブランフィルタの完全性検査方法である。The present invention has been made based on the above findings, and the gist of the present invention is to fill the pores of a membrane filter with a fluid and fill the pores of the membrane filter if the pores are not complete. Overcome the surface tension of the fluid,
And when the micropores are complete, the upstream side of the filter is closed in a state where the inflow gas pressure that does not overcome the surface tension of the fluid filled therein is closed, and the gas in the closed portion for a predetermined time is In the method of checking the integrity of the filter by checking the rate of pressure decrease, the above-described inspection is performed in a state where the rear of the filter is aseptically maintained at a constant outlet gas pressure higher than the normal pressure and lower than the gas pressure. This is a method for testing the integrity of a membrane filter.
【０００６】[0006]
【実施例】以下、本発明の検出方法及び検出装置の実施
例を図面を参照して説明する。図１は、本発明のフィル
タの検出装置の実施例を示すブロック図である。図２
は、濾過工程及び検査工程における流入側圧力検出器及
び流出側圧力検出器の検出値を示すグラフである。図２
において、太線はフィルタが完全な場合の流入側圧力検
出器の検出値を示し、一点鎖線はフィルタが不完全な場
合の流入側圧力検出器の検出値を示し、細線は流出側圧
力検出器の検出値を示す。DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Embodiments of the detection method and the detection device according to the present invention will be described below with reference to the drawings. FIG. 1 is a block diagram showing an embodiment of a filter detecting device according to the present invention. FIG.
5 is a graph showing detection values of an inflow-side pressure detector and an outflow-side pressure detector in a filtration step and an inspection step. FIG.
, The bold line shows the detection value of the inflow-side pressure detector when the filter is complete, the dashed line shows the detection value of the inflow-side pressure detector when the filter is incomplete, and the thin line shows the detection value of the outflow-side pressure sensor. Indicates the detected value.
【０００７】ハウジング１内にはメンブランフィルタ２
が取付けられる。流体は、ハウジング１に開設した入口
部３から流入してフィルタ２の周囲に流れ、流体中の汚
染物質等がフィルタ２に捕捉される。濾過されて無菌的
に処理された流体は、フィルタ２を通り、ハウジング１
の出口部４から流出するように構成される。ハウジング
１の入口部３には、配管５及び６が分岐して繋げられ
る。配管５は、流体を上記入口部３に流入するためのも
ので、開閉弁７を備える。配管６は、入口部３に所定ガ
ス圧を達成するようにガスを供給するためのもので、開
閉弁８、無菌フィルタ９、圧力制御弁３０及びコンプレ
ッサ１０を備える。無菌フィルタ９は、必ずしも備える
必要はない。In the housing 1, a membrane filter 2 is provided.
Is attached. The fluid flows from the inlet 3 opened in the housing 1 and flows around the filter 2, and contaminants and the like in the fluid are captured by the filter 2. The filtered and aseptically processed fluid passes through filter 2 and into housing 1.
Is configured to flow out of the outlet portion 4 of the circumstance. Pipes 5 and 6 are branched and connected to the inlet 3 of the housing 1. The pipe 5 is for flowing a fluid into the inlet 3 and includes an on-off valve 7. The pipe 6 is for supplying gas to the inlet section 3 so as to achieve a predetermined gas pressure, and includes an on-off valve 8, a sterile filter 9, a pressure control valve 30, and a compressor 10. The aseptic filter 9 need not always be provided.
【０００８】また、入口部３に臨んで流入側圧力検出器
１１が取付けられる。検出器１１と圧力制御弁３０及び
開閉弁８との間には、検出器１１の検出に基づいて、入
口部３に所定のガス圧を達成するように圧力制御弁３０
を調節し、かつ検出器１１が入口部３が上記のガス圧に
達したことを検出した場合に、開閉弁８を閉じるように
構成された制御系１２が組まれる。Further, an inflow side pressure detector 11 is attached to face the inlet portion 3. The pressure control valve 30 is provided between the detector 11 and the pressure control valve 30 and the on-off valve 8 so as to achieve a predetermined gas pressure at the inlet 3 based on the detection of the detector 11.
And a control system 12 configured to close the on-off valve 8 when the detector 11 detects that the inlet 3 has reached the above gas pressure.
【０００９】ハウジング１の出口部４には、配管１３及
び１４が分岐して繋げられる。配管１３は、流体の濾過
工程で濾過された流体（製品）を流出するためのもの
で、開閉弁１５を備える。配管１４は、フィルタの検査
工程に流体及びガスを受入れるもので、開閉弁１６及び
無菌タンク１７を備える。無菌タンク１７には、配管２
０が繋げられ、配管２０には、タンク１７側より、流出
側圧力検出器２３、無菌フィルタ２１、圧力制御弁３１
及びコンプレッサ２２が配置される。Pipes 13 and 14 are branched and connected to the outlet 4 of the housing 1. The pipe 13 is for discharging the fluid (product) filtered in the fluid filtering step, and includes an on-off valve 15. The pipe 14 receives fluid and gas in the filter inspection process, and includes an on-off valve 16 and a sterile tank 17. The aseptic tank 17 has a pipe 2
0, and the pipe 20 is connected to the outflow side pressure detector 23, the aseptic filter 21, the pressure control valve 31 from the tank 17 side.
And a compressor 22.
【００１０】検出器２３と圧力制御弁３１との間には、
検出器２３のガス圧検出に基づき、無菌タンク１７内が
一定圧に保たれるように同弁を駆動するように構成され
た制御系２４が組まれる。これらの圧力制御機構によ
り、無菌タンク１７内は無菌的に一定のガス圧に保たれ
る。２５は、タンク１７の後方の配管に備えられた開閉
弁である。[0010] Between the detector 23 and the pressure control valve 31,
Based on the detection of the gas pressure by the detector 23, a control system 24 configured to drive the valve so that the inside of the sterile tank 17 is maintained at a constant pressure is assembled. By these pressure control mechanisms, the inside of the aseptic tank 17 is aseptically maintained at a constant gas pressure. Reference numeral 25 denotes an on-off valve provided on a pipe behind the tank 17.
【００１１】以上の装置に、その系内を滅菌処理するた
めの適当な滅菌装置を設けることができ、また、ハウジ
ング１を前後に２基以上設けてフィルタを連設すること
もできる。次に、前記の構成の検出装置によりフィルタ
の完全性を検査する場合の方法について述べる。説明
は、流体（製品）がフィルタ２で表面張力を達成できる
ものである場合に、これを濾過する際に、濾過工程の途
中でフィルタを検査する方法について行う。 （濾過工程）必ず、濾過工程、つまり流体を濾過して製
品を得る工程は、次のようにして行う。装置を、開閉弁
７、１５を開放、開閉弁８、１６を閉鎖の状態として、
流体を配管５からハウジング１の入口部３に送ってフィ
ルタ２で濾過し、濾過された流体を出口部４から流出し
て、配管１３から製品として回収する。上記の操作は無
菌的に実施される。 （検査工程）フィルタの検査は、上記の濾過工程の途中
に、次のようにして行う。 (1) 予め、流入側圧力検出器１１の設定値を、フィルタ
２の微細孔が完全でない場合にこれに満たされた流体の
表面張力に打ち勝ち、かつ微細孔が完全である場合にこ
れに満たされた流体の表面張力に打ち勝たないガス圧の
範囲Ｐx〜Ｐy の内から任意に選択されたＰ１に設定す
る。尚、上記ガス圧Ｐx 〜Ｐy 及びＰ１は、流体の粘
度、フィルタ２の種類・大きさ、ハウジング１の大きさ
に等に応じて、予め破壊試験等により求めればよい。 (2) コンプレッサ１０により前記のガス圧Ｐ１に相当す
るガス圧（以下元圧という）を、配管６内に無菌的にか
ける。また、無菌タンク１７内を、これに備えられた圧
力制御機構により、無菌的に一定のガス圧Ｐ２に保つ。
この場合、ガス圧Ｐ２は、大気圧よりも高くかつ前記の
ガス圧Ｐ１よりも低い所定の圧、つまり配管１４の後方
部分からの細菌汚染、及びフィルタ２での流体の逆流を
防止し得るガス圧で、かつ後述する流入側ガス圧の低下
率の検出を容易にする任意のガス圧である。The above-mentioned apparatus can be provided with an appropriate sterilizing apparatus for sterilizing the inside of the system. Further, two or more housings 1 can be provided at the front and rear to connect filters. Next, a method for checking the integrity of the filter by the detection device having the above-described configuration will be described. The description will be made on a method of inspecting a filter in the middle of a filtration step when filtering a fluid (product) that can achieve surface tension with the filter 2. (Filtration Step) The filtration step, ie, the step of obtaining a product by filtering a fluid, is always performed as follows. The device is opened and closed, and the on-off valves 8 and 16 are closed.
The fluid is sent from the pipe 5 to the inlet 3 of the housing 1 and is filtered by the filter 2. The filtered fluid flows out of the outlet 4 and is collected as a product from the pipe 13. The above operation is performed aseptically. (Inspection step) The inspection of the filter is performed as follows during the filtration step. (1) The set value of the inflow-side pressure detector 11 is previously satisfied when the micropores of the filter 2 are not perfect, which overcomes the surface tension of the fluid filled therein, and when the micropores are complete, the preset value is satisfied. It is set to P1 arbitrarily selected from the range of gas pressures P x to P y that do not overcome the surface tension of the fluid. Incidentally, the gas pressure P x to P y and P1, the viscosity of the fluid, the type and size of the filter 2, in response to such a size of the housing 1, may be obtained in advance by a destructive test, and the like. (2) The compressor 10 aseptically applies a gas pressure (hereinafter referred to as an original pressure) corresponding to the gas pressure P1 to the inside of the pipe 6. Further, the inside of the aseptic tank 17 is aseptically maintained at a constant gas pressure P2 by a pressure control mechanism provided therein.
In this case, the gas pressure P2 is a predetermined pressure higher than the atmospheric pressure and lower than the gas pressure P1, that is, a gas that can prevent bacterial contamination from the rear portion of the pipe 14 and backflow of the fluid in the filter 2. And any gas pressure that facilitates detection of the rate of decrease of the inflow-side gas pressure described below.
【００１２】ガス圧Ｐ２は上記機能を効果的に達成する
上で0.1 〜0.5 kg／cm2 程度であるのがよい。尚、通常
無菌タンク１７内は、装置内への細菌汚染を防ぐ意味
で、前記濾過工程の間を通して、上記のように無菌的に
一定のガス圧に保つのがよい。上記の場合に、開閉弁２
５は閉鎖の状態である。 (3) 濾過工程から検査工程への移行においては、上記の
状態で開閉弁７、１５を閉鎖、開閉弁８、１６を開放の
状態に同時に切替える。The gas pressure P2 is preferably about 0.1 to 0.5 kg / cm 2 in order to achieve the above function effectively. Normally, the inside of the aseptic tank 17 is preferably maintained aseptically at a constant gas pressure throughout the filtration step as described above in order to prevent bacterial contamination in the apparatus. In the above case, the on-off valve 2
5 is a closed state. (3) In the transition from the filtration step to the inspection step, the on-off valves 7, 15 are closed and the on-off valves 8, 16 are simultaneously switched to the open state in the above state.
【００１３】これにより、ハウジング１の入口部３にコ
ンプレッサ１０からの元圧が開放され、入口部３に残留
する流体は、このガス圧によりフィルタ２を通して出口
部４から無菌タンク１７へと送られる。上記の切替えの
際は、フィルタ２の微細孔に流体が満されることによる
流体の表面張力が今だ働かない状態のため、入口部３の
ガス圧（以下流入側ガス圧という）は、前記ガス圧Ｐ１
より低く、濾過工程におけるそれよりも低い値にまで降
下する（前記開閉弁の切換え時を示す図２の位置Ａ参
照）。As a result, the original pressure from the compressor 10 is released to the inlet 3 of the housing 1, and the fluid remaining in the inlet 3 is sent from the outlet 4 to the aseptic tank 17 through the filter 2 by this gas pressure. . At the time of the switching, since the surface tension of the fluid due to the fluid being filled in the micropores of the filter 2 still does not work, the gas pressure at the inlet 3 (hereinafter referred to as the inflow-side gas pressure) is Gas pressure P1
It drops to a lower value than that in the filtration process (see position A in FIG. 2 when the on-off valve is switched).
【００１４】流出側圧力検出器２３により検出される無
菌タンク１７内のガス圧（以下、流出側ガス圧という）
は、開閉弁の切替えにより僅かに上昇した後、前記のガ
ス圧Ｐ２に安定される（図２参照）。 (4)(3)の操作が一定時間続けられると、ハウジング１の
入口部３の流体が徐々になくなり、フィルタ２に流体の
表面張力が働きだして、入口部３の流入側ガス圧は徐々
に高まる。The gas pressure in the sterile tank 17 detected by the outlet pressure detector 23 (hereinafter referred to as the outlet gas pressure).
Is slightly increased by switching of the on-off valve, and then stabilized at the gas pressure P2 (see FIG. 2). (4) If the operation of (3) is continued for a certain period of time, the fluid in the inlet portion 3 of the housing 1 gradually disappears, and the surface tension of the fluid acts on the filter 2, so that the gas pressure on the inflow side of the inlet portion 3 gradually decreases. To increase.
【００１５】そして、フィルタ２に流体の表面張力が完
全に働くようになると、流入側ガス圧がガス圧P1に達
し、流入側圧力検出器１１の検出に基づいて開閉弁８が
とじられて、ハウジング１の入口部３がガス圧Ｐ１をか
けた状態で塞止められる（図２の開閉弁８の閉鎖時を示
す位置Ｂ参照)。尚、(3)(4)操作の際に、無菌タンク1 ７
に送られる流体は同タンクに蓄えるか、或いは開閉弁２
５をタンク１７の圧力低下を来さない状態で開放／閉鎖
して、装置外に排出すればよい。 (5)(4)で開閉弁８が閉じられた後、所定の検査時間Ｔ１
における流入側ガス圧（ガス圧Ｐ１）の低下率を調べて
フィルタ２の完全性を検査する。即ち、フィルタ２の微
細孔が完全である場合は、時間Ｔ１における流入側ガス
圧の低下率は小さく（図２の太線参照）。一方、微細孔
が不完全である場合は上記低下率は大きくなる（図２の
一点鎖線参照）。When the surface tension of the fluid completely acts on the filter 2, the gas pressure on the inflow side reaches the gas pressure P1, and the on-off valve 8 is closed based on the detection of the inflow side pressure detector 11, The inlet 3 of the housing 1 is closed with the gas pressure P1 applied thereto (see a position B in FIG. 2 showing the closed state of the on-off valve 8). When performing (3) and (4), the sterile tank 17
The fluid sent to the tank is stored in the same tank or the on-off valve 2
5 may be opened / closed in a state where the pressure of the tank 17 does not drop, and may be discharged out of the apparatus. (5) After the on-off valve 8 is closed in (4), a predetermined inspection time T1
The integrity of the filter 2 is checked by examining the rate of decrease in the gas pressure on the inflow side (gas pressure P1) at. That is, when the fine pores of the filter 2 are complete, the rate of decrease in the inflow gas pressure at the time T1 is small (see the thick line in FIG. 2). On the other hand, when the micropores are incomplete, the above-mentioned reduction rate increases (see the dashed line in FIG. 2).
【００１６】従って、予め採用する流体、フィルタ２、
及びガス圧Ｐ１とＰ２との差圧等に応じて、フィルタ２
が完全である場合と不完全である場合との差別化ができ
る検査時間Ｔ１及び流入側ガス圧の低下率を調べてお
き、これらを基にして、各々のフィルタ２について上記
検査を行って完全性を調べることができる。また、以上
の検査工程を通して、無菌タンク１７内を無菌的に一定
のガス圧Ｐ２に保つことにより、前記検査を可能とし、
かつ配管１４の後方部分からの細菌汚染を防止すること
ができる。Therefore, the fluid, filter 2,
Filter 2 according to the pressure difference between gas pressures P1 and P2, etc.
Inspection time T1 and the decrease rate of the inflow side gas pressure which can differentiate between the case where the filter is complete and the case where the filter is incomplete are checked in advance, and based on these, the above-described test is performed for each filter 2 to complete the test. Gender can be checked. Through the above-mentioned inspection process, the above-mentioned inspection is made possible by maintaining the inside of the aseptic tank 17 aseptically at a constant gas pressure P2,
In addition, bacterial contamination from the rear portion of the pipe 14 can be prevented.
【００１７】尚、前記の操作(4) のように、単に流入側
圧力検出器１１の検出に基づいて開閉弁８を閉じる場合
は、フィルタ２の表面張力が完全に達成されない時点で
開閉弁８が閉じ、開閉弁８の閉鎖後に流入側ガス圧がガ
ス圧Ｐ１から外れる虞がある。上記の場合は、(3) の操
作で開閉弁を切替えて（図２の位置Ａ）から、フィルタ
２の表面張力が完全に達成されて、流入側ガス圧がガス
圧Ｐ１に安定するまでの所定時間を予め求めておき、こ
れをタイマー（図示せず）に付して、これと開閉弁８の
閉鎖とを連動させることができる。即ち、上記タイマー
が所要時間をカウントし、かつ流入側圧力検出器１１が
ガス圧Ｐ１を検出した場合に、開閉弁８を閉じる制御を
かければよい。これによって、流入側ガス圧をガス圧Ｐ
１に安定させた状態で、フィルタ２の検査を実施でき
る。In the case where the on-off valve 8 is simply closed based on the detection of the inflow-side pressure detector 11 as in the above-mentioned operation (4), the on-off valve 8 cannot be completely closed when the surface tension of the filter 2 is not completely achieved. Is closed, and the inflow gas pressure may deviate from the gas pressure P1 after the on-off valve 8 is closed. In the above case, from the time when the on-off valve is switched by the operation (3) (position A in FIG. 2), the time until the surface tension of the filter 2 is completely achieved and the inflow gas pressure is stabilized at the gas pressure P1. A predetermined time is obtained in advance, and this is attached to a timer (not shown), and this can be linked with the closing of the on-off valve 8. That is, when the timer counts the required time and the inflow-side pressure detector 11 detects the gas pressure P1, it is only necessary to perform control to close the on-off valve 8. As a result, the inflow side gas pressure is reduced to the gas pressure P
Inspection of the filter 2 can be performed in a state where it is stabilized at 1.
【００１８】また、(4) の操作で開閉弁８を閉じた直後
に、流入側ガス圧をチェックする機能を装置に付加して
もよい。即ち、開閉弁８の閉鎖後に流入側ガス圧をチェ
ックし、これがフィルタ２の完全性を検査可能なガス圧
Ｐ１（Ｐx 〜Ｐy ）から外れる場合は、検査を中止すれ
ばよい。更に、フィルタ２の完全性を検査可能なガス圧
のＰx 〜Ｐy の全てついて、前記(5) の操作における検
査時間Ｔ１及びガス圧の低下率を求めておき、上記の開
閉弁８の閉鎖後における流入側ガス圧のチェック値を、
これらに適合してフィルタ２の完全性を検査してもよ
い。Further, a function of checking the inflow side gas pressure immediately after the on-off valve 8 is closed by the operation (4) may be added to the apparatus. That is, check the inlet side gas pressure after closing of the on-off valve 8, if this is out of the testable gas pressure the integrity of the filter 2 P1 (P x ~P y) , it may be discontinued test. Further, for all the gas pressures P x to P y at which the integrity of the filter 2 can be inspected, the inspection time T1 and the gas pressure decrease rate in the operation (5) are determined in advance, and the on-off valve 8 Check the inlet gas pressure after closing
The integrity of the filter 2 may be checked in conformity with these.
【００１９】前記のように、この検査方法及び装置によ
れば、流体（製品）がフィルタで表面張力を達成できる
ものである場合は、製品を用いてフィルタの検査ができ
る。したがって、この種製品の無菌濾過システムにおけ
るフィルタの検査を、非破壊（インライン）で簡便、確
実になし得る。尚、製品がフィルタで表面張力を達成で
きないものである場合は、検査時に、別途表面張力を達
成できる流体をハウジング内に導入して、フィルタの検
査を行えばよい。As described above, according to the inspection method and apparatus, when the fluid (product) can achieve surface tension with the filter, the filter can be inspected using the product. Therefore, the inspection of the filter in the aseptic filtration system of this kind of product can be performed nondestructively (inline) simply and reliably. When the product cannot achieve the surface tension with the filter, the filter may be inspected by separately introducing a fluid capable of achieving the surface tension into the housing during the inspection.
【００２０】以上、本発明に関して述べた点は、本発明
の一例であって、これに種々の応用変形が加え得ること
はいうまでもない。The points described above with respect to the present invention are merely examples of the present invention, and it goes without saying that various application modifications can be made thereto.
【００２１】[0021]
【発明の効果】本発明の請求項(1) 及び(2) 記載のフィ
ルタの完全性検査方法及び検査装置によれば、フィルタ
の完全性を正確に検査することができると共に、フィル
タ後方部分からの製品ラインへの細菌汚染の問題が解消
される。従って、無菌濾過システムにおいて濾過処理の
前又は途中に非破壊（インライン）で行う試験法として
極めて有効である。According to the filter integrity inspection method and the inspection apparatus described in claims (1) and (2) of the present invention, the integrity of the filter can be accurately inspected, and the filter can be inspected from the rear part. The problem of bacterial contamination of existing product lines is eliminated. Therefore, it is very effective as a nondestructive (in-line) test method before or during the filtration treatment in a sterile filtration system.
【００２２】また、請求項(3) 記載の空気圧の制御が可
能な無菌タンクを採用した装置によれば、検査時に、同
タンクで流体を受入れつつ、フィルタ後方の無菌性及び
ガス圧の保持を安定に達成することができる。According to the apparatus employing a sterile tank capable of controlling the air pressure according to claim (3), at the time of inspection, the tank can receive fluid and maintain the sterility and the gas pressure behind the filter. It can be achieved stably.
【図１】本発明のフィルタの検出装置の実施例を示すブ
ロック図である。FIG. 1 is a block diagram showing an embodiment of a filter detection device according to the present invention.
【図２】濾過工程及び検査工程における流入側圧力検出
器及び流出側圧力検出器の検出値を示すグラフ図であ
る。 １・・・ハウジング ２・・・メンブランフィルタ ３・・・入口部 ９・・・無菌フィルタ １１・・・流入側圧力検出器 １７・・・無菌タンク ２４・・・制御系FIG. 2 is a graph showing detection values of an inflow-side pressure detector and an outflow-side pressure detector in a filtration step and an inspection step. DESCRIPTION OF SYMBOLS 1 ... Housing 2 ... Membrane filter 3 ... Inlet part 9 ... Sterile filter 11 ... Inlet side pressure detector 17 ... Sterile tank 24 ... Control system
フロントページの続き (56)参考文献 特開 昭60−58530（ＪＰ，Ａ) 特開 昭64−25035（ＪＰ，Ａ) 特開 昭63−132137（ＪＰ，Ａ)Continuation of the front page (56) References JP-A-60-58530 (JP, A) JP-A-64-25035 (JP, A) JP-A-63-132137 (JP, A)
Claims (3)
し、該フィルタに対して、その微細孔が完全でない場合
にこれに満たされた流体の表面張力に打ち勝ち、かつ微
細孔が完全である場合にこれに満たされた流体の表面張
力に打ち勝たない流入側ガス圧をかけた状態でフィルタ
の上流側を塞止め、所定時間における上記塞止められた
部分のガス圧の低下率を調べてフィルタの完全性を検査
する方法において、フィルタ後方を無菌的に、常圧より
も高く、かつ該ガス圧より低い一定の流出側ガス圧に保
持した状態で上記の検査を行うことを特徴とするメンブ
ランフィルタの完全性検査方法。1. The method of claim 1, wherein the micropores of the membrane filter are filled with a fluid and the filter overcomes the surface tension of the filled fluid if the micropores are not complete and the micropores are complete. The upstream side of the filter is closed while applying the inflow gas pressure that does not overcome the surface tension of the fluid filled therein, and the rate of decrease in the gas pressure of the closed portion during a predetermined time is examined to check the filter. In the method for checking the integrity, the above-mentioned test is performed in a state where the rear of the filter is aseptically maintained at a constant outflow gas pressure higher than the normal pressure and lower than the gas pressure. Integrity check method.
に入口部及び出口部を備え、入口部から流入した流体が
フィルタで濾過されて出口部から流出するように構成さ
れたハウジング、ハウジングの入口部に繋がる、該入口
部に対して一定のガス圧を供給する圧力供給装置、圧力
供給装置から該入口部へのガス圧供給を停止するための
停止装置、該入口部の圧力を検出する検出装置、検出装
置の検出に基づいて、停止装置を駆動するための制御装
置、及びハウジングの出口部に繋がる、該出口部を無菌
的に一定のガス圧に保持するための圧力制御装置からな
るメンブランフィルタの完全性検査装置。2. A housing having a membrane filter mounted therein and an inlet section and an outlet section, wherein a fluid flowing through the inlet section is filtered by the filter and flows out of the outlet section. The housing is connected to the inlet section of the housing. A pressure supply device for supplying a constant gas pressure to the inlet portion, a stop device for stopping gas pressure supply from the pressure supply device to the inlet portion, a detection device for detecting the pressure of the inlet portion, Based on the detection of the device, a membrane filter consisting of a control device for driving the stop device and a pressure control device connected to the outlet portion of the housing for maintaining the outlet portion at a constant gas pressure aseptically is completely provided. Sex test equipment.
御可能な無菌タンクである請求項２記載の装置。3. The apparatus according to claim 2, wherein the pressure control device is a sterile tank capable of controlling the internal gas pressure in an aseptic manner.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP315491A JP2706853B2 (en) | 1991-01-16 | 1991-01-16 | Membrane filter integrity inspection method and inspection device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP315491A JP2706853B2 (en) | 1991-01-16 | 1991-01-16 | Membrane filter integrity inspection method and inspection device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH04348252A JPH04348252A (en) | 1992-12-03 |
| JP2706853B2 true JP2706853B2 (en) | 1998-01-28 |
Family
ID=11549438
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP315491A Expired - Fee Related JP2706853B2 (en) | 1991-01-16 | 1991-01-16 | Membrane filter integrity inspection method and inspection device |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2706853B2 (en) |
Families Citing this family (25)
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|---|---|---|---|---|
| TW362041B (en) * | 1996-12-27 | 1999-06-21 | Asahi Chemical Ind | Leakage inspection apparatus and method for filter film |
| US6324898B1 (en) * | 1999-12-21 | 2001-12-04 | Zenon Environmental Inc. | Method and apparatus for testing the integrity of filtering membranes |
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| KR101614520B1 (en) | 2008-07-24 | 2016-04-21 | 에보쿠아 워터 테크놀로지스 엘엘씨 | Frame system for membrane filtration modules |
| AU2010101488B4 (en) | 2009-06-11 | 2013-05-02 | Evoqua Water Technologies Llc | Methods for cleaning a porous polymeric membrane and a kit for cleaning a porous polymeric membrane |
| EP2563501B1 (en) | 2010-04-30 | 2019-05-15 | Evoqua Water Technologies LLC | Fluid flow distribution device |
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| WO2013049109A1 (en) | 2011-09-30 | 2013-04-04 | Siemens Industry, Inc. | Isolation valve |
| WO2013048801A1 (en) | 2011-09-30 | 2013-04-04 | Siemens Industry, Inc. | Improved manifold arrangement |
| WO2014004645A1 (en) | 2012-06-28 | 2014-01-03 | Siemens Industry, Inc. | A potting method |
| DE112013004713T5 (en) | 2012-09-26 | 2015-07-23 | Evoqua Water Technologies Llc | Membrane safety device |
| AU2013231145B2 (en) | 2012-09-26 | 2017-08-17 | Evoqua Water Technologies Llc | Membrane potting methods |
| AU2013101765A4 (en) | 2012-09-27 | 2016-10-13 | Evoqua Water Technologies Llc | Gas Scouring Apparatus for Immersed Membranes |
| WO2014105946A1 (en) * | 2012-12-27 | 2014-07-03 | Medi-Physics, Inc. | Dual-filter dual-integrity test assembly |
| WO2015050764A1 (en) | 2013-10-02 | 2015-04-09 | Evoqua Water Technologies Llc | A method and device for repairing a membrane filtration module |
| EP3241013B1 (en) * | 2014-12-30 | 2024-02-07 | EMD Millipore Corporation | Aseptic filter vent valve and port for integrity testing |
| WO2016109084A1 (en) | 2014-12-31 | 2016-07-07 | Emd Millipore Corporation | Interface module for filter integrity testing |
| WO2017011068A1 (en) | 2015-07-14 | 2017-01-19 | Evoqua Water Technologies Llc | Aeration device for filtration system |
| MY191758A (en) | 2016-01-22 | 2022-07-14 | Baxter Healthcare Sa | Sterile solution product bag |
| PL3405400T3 (en) | 2016-01-22 | 2020-07-27 | Baxter International Inc. | Method and machine for producing sterile solution product bags |
| WO2019229872A1 (en) * | 2018-05-30 | 2019-12-05 | 旭化成メディカル株式会社 | Leak detection device and leak detection method |
| CN114713037B (en) * | 2022-06-10 | 2022-09-20 | 北京先通国际医药科技股份有限公司 | Online filter membrane integrity testing device and method and application thereof |
-
1991
- 1991-01-16 JP JP315491A patent/JP2706853B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| JPH04348252A (en) | 1992-12-03 |
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