JPH04348252A - Method and device for inspecting integrity of membrane filter - Google Patents
Method and device for inspecting integrity of membrane filterInfo
- Publication number
- JPH04348252A JPH04348252A JP315491A JP315491A JPH04348252A JP H04348252 A JPH04348252 A JP H04348252A JP 315491 A JP315491 A JP 315491A JP 315491 A JP315491 A JP 315491A JP H04348252 A JPH04348252 A JP H04348252A
- Authority
- JP
- Japan
- Prior art keywords
- filter
- pressure
- gas pressure
- fluid
- inlet
- 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.)
- Granted
Links
- 238000000034 method Methods 0.000 title claims abstract description 22
- 239000012528 membrane Substances 0.000 title claims abstract description 17
- 239000012530 fluid Substances 0.000 claims abstract description 38
- 238000007689 inspection Methods 0.000 claims abstract description 21
- 238000001514 detection method Methods 0.000 claims abstract description 19
- 238000012360 testing method Methods 0.000 claims description 14
- 230000007423 decrease Effects 0.000 claims description 10
- 239000011148 porous material Substances 0.000 claims description 4
- 238000011016 integrity testing Methods 0.000 claims description 3
- 238000011144 upstream manufacturing Methods 0.000 claims description 3
- 238000011109 contamination Methods 0.000 abstract description 9
- 230000008569 process Effects 0.000 abstract description 5
- 230000009467 reduction Effects 0.000 abstract description 2
- 238000001914 filtration Methods 0.000 description 15
- 230000001580 bacterial effect Effects 0.000 description 7
- 238000010586 diagram Methods 0.000 description 3
- 238000011146 sterile filtration Methods 0.000 description 3
- 230000001066 destructive effect Effects 0.000 description 2
- 230000007246 mechanism Effects 0.000 description 2
- 238000010998 test method Methods 0.000 description 2
- 239000000356 contaminant Substances 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000009659 non-destructive testing Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Landscapes
- Separation Using Semi-Permeable Membranes (AREA)
Abstract
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
。[Industrial Application Field] The present invention provides membrane filters,
In particular, the present invention relates to a method and apparatus for inspecting the integrity of 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 has been used in which microorganisms and solid matter in a liquid are passed through a membrane filter and captured, and it is also known that the fluid can be sterilized by this method. Conventionally,
Methods to test the integrity of membrane filters include:
Fill the micropores of the membrane filter with fluid, apply gas pressure to the filter, block the upstream side of the filter, i.e., the front, and hold for a predetermined period of time. Check the rate of decrease in gas pressure to determine if the filter is completely closed. There is a method (generally pressure hold test, hereinafter referred to as P.H test) to test the sex. However, the conventional P. In the H test method, testing is performed with the downstream side of the filter, that is, the rear, open to the outside air, so there is a risk of bacterial contamination of the filtration system (product line) from the rear of the filter. Therefore, this method is not suitable as a non-destructive testing method before filtration treatment in a sterile filtration system.
【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 In view of the above-mentioned circumstances of the prior art, it is an object of the present invention to provide a membrane filter that can accurately test the integrity of the membrane filter and that does not cause the problem of bacterial contamination of the product line during the test. The purpose is to provide an integrity testing method and testing device.
【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 discovered the above-mentioned P
．． H. By applying gas pressure to the filter and conducting the test while maintaining the rear part of the filter at a constant gas pressure that is higher than normal pressure and lower than the above gas pressure, the gas pressure in front of the filter can be determined. It was discovered that the rate of decline can be used to accurately test filter integrity, 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 was made based on the above findings, and the gist thereof is to fill the micropores of a membrane filter with fluid, and to fill the micropores of the filter with fluid if the micropores are not completely filled. Overcoming the surface tension of fluid,
In addition, when the micropores are complete, the upstream side of the filter is blocked with a gas pressure on the inlet side that does not overcome the surface tension of the fluid filled in the pores, and the gas in the blocked portion is In a method of inspecting the integrity of a filter by examining the rate of pressure decrease, the above inspection is performed while the rear of the filter is maintained aseptically at a constant gas pressure on the outflow side that is higher than normal pressure and lower than the gas pressure. This is a membrane filter integrity inspection method characterized by performing the following steps.
【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。DESCRIPTION OF THE PREFERRED EMBODIMENTS Examples of the detection method and detection apparatus of the present invention will be described below with reference to the drawings. FIG. 1 is a block diagram showing an embodiment of a filter detection device of the present invention. FIG. 2 is a graph showing the detection values of the inflow side pressure detector and the outflow side pressure detector in the filtration process and the inspection process. In Figure 2, the thick line indicates the detection value of the inflow side pressure detector when the filter is complete, the dashed line indicates the detection value of the inflow side pressure sensor when the filter is incomplete, and the thin line indicates the outflow side pressure detection. Indicates the detection value of the device.
【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。[0007] Inside the housing 1 is a membrane filter 2.
is installed. Fluid flows in from an inlet 3 provided 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 treated fluid passes through the filter 2 and into the housing 1.
The water is configured to flow out from the outlet section 4 of the. At the inlet portion 3 of the housing 1, pipes 5 and 6 are branched and connected. The piping 5 is for flowing fluid into the inlet portion 3, and is provided with an on-off valve 7. The pipe 6 is for supplying gas to the inlet portion 3 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 sterile filter 9 does not necessarily need to 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。[0008] Further, an inflow side pressure detector 11 is installed facing the inlet portion 3. A pressure control valve 30 is installed between the detector 11 and the pressure control valve 30 and the on-off valve 8 to achieve a predetermined gas pressure at the inlet 3 based on the detection by the detector 11.
A control system 12 is provided which is configured to close the on-off valve 8 when the detector 11 detects that the inlet portion 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２０
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。[0009] Pipes 13 and 14 are branched and connected to the outlet portion 4 of the housing 1. The pipe 13 is for discharging the fluid (product) filtered in the fluid filtration step, and is provided with an on-off valve 15 . The piping 14 receives fluid and gas for the filter inspection process, and includes an on-off valve 16 and a sterile tank 17. The sterile tank 17 has piping 20
are connected to the piping 20, and an outlet pressure detector 23, a sterile filter 21, a pressure control valve 31, and a compressor 22 are arranged from the tank 17 side.
【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。Between the detector 23 and the pressure control valve 31,
Based on the gas pressure detected by the detector 23, a control system 24 is installed to drive the valve so that the inside of the sterile tank 17 is maintained at a constant pressure. These pressure control mechanisms keep the inside of the sterile tank 17 at a constant gas pressure in an sterile manner. 25 is an on-off valve provided in the piping at the rear of 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。[0011] The above-mentioned apparatus can be provided with a suitable sterilizer for sterilizing the inside of the system, and two or more housings 1 can be provided in front and behind to connect filters. Next, a method for inspecting the integrity of a filter using the detection device configured as described above will be described. A description will be given of a method of inspecting a filter during the filtration process when filtering a fluid (product) that can achieve surface tension with the filter 2. (Filtration Step) The filtration step, that is, the step of filtering a fluid to obtain a product, is always performed as follows. The device is in a state where on-off valves 7 and 15 are open and 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 filtered by the filter 2, and the filtered fluid flows out from the outlet 4 and is recovered as a product from the pipe 13. The above operations are performed aseptically. (Inspection Step) The filter is inspected as follows during the above-mentioned filtration step. (1) In advance, set the setting value of the inflow side pressure detector 11 so that it overcomes the surface tension of the fluid filling the filter 2 when the micropores are not perfect, and satisfies this when the micropores are complete. P1 is arbitrarily selected from a gas pressure range Px to Py that does not overcome the surface tension of the fluid. Note that the gas pressures Px to Py and P1 are as follows:
Viscosity of fluid, type and size of filter 2, housing 1
It may be determined in advance by a destructive test, etc., depending on the size, etc. (2) A gas pressure (hereinafter referred to as the original pressure) corresponding to the gas pressure P1 described above is applied aseptically into the pipe 6 by the compressor 10. Further, the inside of the sterile tank 17 is maintained at a constant gas pressure P2 in an aseptic manner 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 part of the pipe 14 and backflow of the fluid in the filter 2. This is an arbitrary gas pressure that facilitates the detection of the rate of decrease in the gas pressure on the inflow side, which will be described later.
【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２５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。[0012] The gas pressure P2 is preferably about 0.1 to 0.5 kg/cm2 in order to effectively achieve the above function. Incidentally, the inside of the sterile tank 17 is preferably kept aseptically at a constant gas pressure as described above throughout the filtration process in order to prevent bacterial contamination into the apparatus. In the above case, the on-off valve 25 is in a closed state. (3) In the transition from the filtration step to the inspection step, the on-off valves 7 and 15 are closed and the on-off valves 8 and 16 are opened at the same time 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
）。[0013] As a result, the source pressure from the compressor 10 is released to the inlet part 3 of the housing 1, and the fluid remaining in the inlet part 3 is sent to the sterile tank 17 through the filter 2 from the outlet part 4 by this gas pressure. . At the time of the above switching, the surface tension of the fluid due to the fluid filling the micropores of the filter 2 is not working yet, so the gas pressure at the inlet section 3 (hereinafter referred to as inflow side gas pressure) is Gas pressure P1
lower than that in the filtration step (see position A in FIG. 2, which shows the switching of the on-off valve).
【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。Gas pressure in the sterile tank 17 detected by the outflow side pressure detector 23 (hereinafter referred to as outflow side gas pressure)
The gas pressure increases slightly by switching the on-off valve, and then stabilizes at the gas pressure P2 (see FIG. 2). (4) When the operation in (3) continues for a certain period of time, the fluid in the inlet part 3 of the housing 1 gradually disappears, the surface tension of the fluid begins to act on the filter 2, and the gas pressure on the inlet side of the inlet part 3 gradually decreases. increases.
【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２５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 comes to work completely 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 by the inflow side pressure detector 11. The inlet portion 3 of the housing 1 is blocked while applying the gas pressure P1 (see position B in FIG. 2, which shows when the on-off valve 8 is closed). In addition, during (3) and (4) operations, the fluid sent to the sterile tank 17 is stored in the same tank, or the on-off valve 25 is opened/closed without causing a pressure drop in the tank 17. It can be discharged outside the device. (5) After the on-off valve 8 is closed in (4), the integrity of the filter 2 is inspected by checking the rate of decrease in the inflow side gas pressure (gas pressure P1) during a predetermined inspection time T1. That is, when the micropores of the filter 2 are complete, the rate of decrease in the inflow side gas pressure at time T1 is small (see the thick line in FIG. 2). on the other hand,
If the micropores are incomplete, the above reduction rate will increase (
(See the dash-dotted line in Figure 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。[0016] Therefore, the fluid, filter 2, and
The filter 2
Check the inspection time T1 and the rate of decrease in inlet gas pressure that can differentiate between complete and incomplete cases, and based on these, perform the above inspection on each filter 2 to make sure it is complete. You can check the gender. In addition, by keeping the inside of the sterile tank 17 at a constant gas pressure P2 in an aseptic manner throughout the above inspection process, the inspection can be performed and 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Ｐ１に安定させた状態で、フィルタ２の検査を実
施できる。If the on-off valve 8 is simply closed based on the detection by the inflow side pressure detector 11 as in the above-mentioned operation (4), the on-off valve 8 will close when the surface tension of the filter 2 is not completely achieved. is closed, and there is a possibility that the inflow side gas pressure will deviate from the gas pressure P1 after the on-off valve 8 is closed. In the above case, (3
) to switch the on-off valve (position A in Figure 2), then
A predetermined time period until the surface tension of the filter 2 is completely achieved and the gas pressure on the inflow side stabilizes at the gas pressure P1 is determined in advance, and this time is set on a timer (not shown), and the on-off valve is 8 can be linked with the closure. That is, when the timer counts the required time and the inflow side pressure detector 11 detects the gas pressure P1, the on-off valve 8 may be closed. Thereby, the filter 2 can be inspected while the inflow side gas pressure is stabilized at the gas pressure P1.
【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, the device may be provided with a function of checking the gas pressure on the inlet side immediately after closing the on-off valve 8 in the operation (4). That is, the inflow side gas pressure is checked after the on-off valve 8 is closed, and if it deviates from the gas pressure P1 (Px - Py) at which the integrity of the filter 2 can be tested, the test may be stopped. Furthermore, for all of the gas pressures Px to Py at which the integrity of the filter 2 can be inspected, the above (5) is applied.
The inspection time T1 and the rate of decrease in gas pressure during the operation are determined, and the integrity of the filter 2 is inspected by matching the check value of the inlet side gas pressure after closing the on-off valve 8 to these values. good.
【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 this inspection method and apparatus, if the fluid (product) can achieve surface tension with the filter, the filter can be inspected using the product. Therefore, inspection of the filter in a sterile filtration system for this type of product can be easily and reliably performed non-destructively (in-line). If the product is a filter that cannot achieve the surface tension, the filter may be inspected by separately introducing a fluid that can achieve 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 regarding the present invention are merely examples of the present invention, and it goes without saying that various modifications can be made to the present invention.
【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。Effects of the Invention According to the filter integrity testing method and testing device described in claims (1) and (2) of the present invention,
The integrity of the filter can be accurately tested and the problem of bacterial contamination of the product line from the rear part of the filter is eliminated. Therefore, it is extremely effective as a non-destructive (in-line) test method performed before or during 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。[0022] Furthermore, according to the apparatus employing a sterile tank capable of controlling air pressure as described in claim (3), during an inspection, while receiving fluid in the tank, sterility and gas pressure can be maintained behind the filter. This 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 of 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 diagram showing detected values of an inflow side pressure detector and an outflow side pressure detector in a filtration process and an inspection process. 1... Housing 2... Membrane filter 3... Inlet section 9... Sterile filter 11... Inflow side pressure detector 17... Sterile tank 24... Control system
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。Claim 1: Filling the fine pores of a membrane filter with a fluid, the membrane filter can overcome the surface tension of the fluid filled if the fine pores are not perfect, and if the fine pores are perfect, The upstream side of the filter is blocked with a gas pressure on the inflow side that does not overcome the surface tension of the fluid filled in the filter, and the rate of decrease in gas pressure in the blocked area over a predetermined period of time is investigated. In the method for inspecting the integrity of a membrane filter, the above-mentioned inspection is carried out while the rear part of the filter is maintained aseptically at a constant gas pressure on the outflow side that is higher than normal pressure and lower than the gas pressure. integrity testing 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 attached therein and having an inlet and an outlet, the fluid flowing in from the inlet being filtered by the filter and flowing out from the outlet, which is connected to the inlet of the housing. , a pressure supply device that supplies a constant gas pressure to the inlet, a stop device that stops the gas pressure supply from the pressure supply device to the inlet, a detection device that detects the pressure of the inlet, and a detection device. A complete membrane filter consisting of a control device for driving a stop device based on the detection of the device, and a pressure control device connected to the outlet of the housing to maintain said outlet at a constant gas pressure in an aseptic manner. Sex testing device.
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 aseptically controlling the internal gas pressure.
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 true JPH04348252A (en) | 1992-12-03 |
| JP2706853B2 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) |
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|---|---|
| JP2706853B2 (en) | 1998-01-28 |
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