JPH10225628A - Crossed filter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To facilitate an integrity test just before filter operation by providing a filter connecting solid-fluid mixture feeding piping and fluid recovery piping and a filter membrane completeness testing device connecting pressurized test fluid feeding piping and test fluid discharge piping through valves upstream and downstream of a filter assembly. SOLUTION: Dry gaseous nitrogen is caused to flow through a filter assembly 37 from a gas cylinder. Liquid which is dissolved in water and wets a fluorine base hydrophobic membrane analyzes moisture or the like in nitrogen on the upstream side to verify the removal thereof. Valves 2, 3 are closed and valves 1, 4 are opened to feed pure water of entering liquid from a valve 1 and the pure water is filled into so that a filter membrane 35 is submerged without being directly contacted with nitrogen or other gas. The valves 1, 4 are closed and the valves 2, 3 are opened to raise nitrogen pressure through a valve 6. After a completeness test is finished, steam is fed from a valve 21 to subject the filter membrane 35, the filter assembly 37 and piping or the like around them to sterilization treatment. After verifying non-leakage, filter operation is started. In this way, a completeness test is performed by valve opening/closing operation only.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a filtration device having a filter assembly for separating solids from a solid / fluid mixture containing fine solids, and an integrity test device for inspecting the physical properties and performance of the filter membrane. Regarding a device that is cross-connected by sharing a filter assembly, in another aspect, a device that is also cross-connected by a sterilizer sharing this filter assembly, wherein each device is opened and closed by opening and closing a predetermined valve disposed in place. A cross-filtration device characterized in that each device can be subjected to a single functional operation, namely a filtration operation, a filter membrane integrity test operation of the filter assembly and / or a sterilization operation.

[0002]

2. Description of the Related Art Conventionally, before applying a filter disc, a filter cartridge, or a disposable filter to a filtration device, a filter membrane integrity test is performed on a filter membrane as a filter element to confirm a predetermined filtration performance. (Japanese Industrial Standard JI
As described in SK3802, the integrity of the filter membrane has been confirmed with a dedicated device for testing to ensure that the filter has no physical defects and has a rated removal performance. That is, in order to secure an appropriate filtration operation, a first confirmation, which is also referred to as a pre-filtration performance confirmation of the filter membrane, has been performed.

[0003] Next, after the first confirmed filter membrane is applied to the filtration device to perform a predetermined filtration operation to recover a fluid, the immediately preceding filtration operation is performed again under the predetermined performance of the filter membrane. The integrity of the filter membrane has been confirmed using a dedicated device for filter membrane integrity testing. That is, a second check, which is also called a performance check after filtration, has been performed. Confirmation of the filter performance before and after the operation of the filtration device is indispensable for giving certainty to the filtration operation, and has been evaluated as such.

[0004]

By the way, during the first confirmation of the filter disk or the filter cartridge or further the disposable filter, and before the filter is removed from the device dedicated to the integrity test and incorporated into the filtration device, these components may not have the integrity test atmosphere. It was unavoidable to be contaminated by contacting the surrounding environment thereafter with, for example, dust or bacteria derived from the air. Therefore, in the case where such contamination must be removed, a step of providing an operation for the purpose of "cleaning, sterilizing, sterilizing or aseptic" (hereinafter simply abbreviated as "sterilization") of the filtration device is indispensable, especially in a field where microbial contamination is hindered. It has been adopted as a thing. That is, after the filter disk, the filter cartridge, or the disposable filter, which has been subjected to the first confirmation, is incorporated into the filtration device, a pre-filtration process for sterilizing the filtration device is performed using “pure water, hot water, steam or a reagent suitable for sterilization. Gas (for example, diluted ethylene oxide gas) or liquid (for example, alcohol) "(hereinafter simply referred to as a sterilizing reagent)
Is applied, and as a result, the filtration operation can be performed in a sterilized state.

However, the filter pretreatment for sterilization sometimes damages the filter membrane and prevents the filter from maintaining a predetermined filtration performance. The second after operation
For the first time in the confirmation, it was found that the filter membrane subjected to the filtering operation did not satisfy the predetermined performance. At that time, the recovered fluid does not achieve the predetermined solid separation, and requires a re-filtration operation. In particular, when handling a solid / fluid mixture that tends to change with time, it has naturally been desired to avoid such repetition of the filtration operation.

Accordingly, if a filter membrane integrity test, which can be called an intermediate check, is introduced to check the performance of the filter membrane after the sterilization operation before filtration, and the filter operation is started thereafter, breakage of the filter membrane during filtration can be prevented. Even if it is unavoidable that we cannot cope with the resulting case,
Excluding this case, it is possible to appropriately shift to a predetermined filtration operation.

However, a filter disk, a filter cartridge, or a disposable filter held in a sterilized state in a filtration device is detached from the filtration device and set in a device exclusively for a filter membrane integrity test to be subjected to an intermediate check integrity test. In order to avoid re-contamination of the filter membrane, it is difficult to avoid the contamination of the filter device, the filter membrane integrity test device, the filter disk or filter cartridge, and the surrounding environment handling the disposable filter. Is required to do so. However, maintaining all of these devices in a sterile condition, including the surrounding environment, requires major special equipment improvements to avoid recontamination of the sterilized filter discs or cartridges or even disposable filters. An object of the present invention was to develop an apparatus that enables easy testing of the integrity of a filter membrane immediately before a filtration operation.

[0008]

In view of the above background, a filter disk or a filter cartridge or a disposable filter, which has been subjected to the first confirmation, is used exclusively for a filter membrane integrity test separately from the damage of the filter membrane during the sterilization operation. In the rare case that they are removed from the device and attached to the filtration device, they may be incorrectly set or damaged, and the process may be shifted to sterilization or filtration without knowing this. However, in some cases, it was not possible to achieve a predetermined filtration, and in some cases, a valuable solid / fluid mixture could be lost outside the system. .

As a result, the various fluids used for the filter membrane integrity test can be easily supplied in a sterilized state, and once the filter disk or the filter cartridge or the disposable filter is once attached to the filter, it is not necessary to remove the filter until the end of the filtration. In consideration of the above, at least a filtration device in which a solid / fluid mixture supply pipe and a fluid recovery pipe are connected via valves upstream and downstream of the filter assembly, and at least a pressurized test fluid which is upstream and downstream of the filter assembly via valves The present inventors have found a cross-filtration device comprising a filter membrane integrity test device in which a supply pipe and a test fluid discharge pipe are connected, and can solve the above problem. In particular, in the case where sterilization operation is indispensable, the present inventors have found a cross filtration device in which at least a sterilization device in which a sterilization reagent supply pipe and a sterilization reagent discharge pipe are connected via valves upstream and downstream of the above filter assembly is included. I came to.

[0010] As in the prior art, the filtration apparatus according to one aspect of the present invention has a filter assembly as a matter of course, and a solid / fluid mixture as a filtration material is supplied from the upstream of the filter assembly through a solid / fluid mixture supply pipe. The solids are captured on the filter membrane in the filter assembly by filtration, and the fluid passes through the filter membrane, and is discharged and collected from the downstream of the filter assembly through the fluid collection pipe.

However, in order to operate and operate a filter membrane integrity test device, which is an intersecting device to be described later, alone, the filtration device must be trimmed during the test. The pipe and the fluid recovery pipe need to be connected to the filter assembly via a valve. In addition, as long as the above-mentioned purpose of the cross filtration device is achieved, if necessary, further upstream and downstream of the filter assembly, various auxiliary equipment for filtration operation, for example, installation of exhaust valves and drain valves, temperature, pressure, flow rate and the like. A measuring element or the like may be attached.

A filter membrane integrity test apparatus according to one embodiment of the present invention shares the same filter assembly of the above-described filtration apparatus, and a pressurized test fluid is supplied to the upstream of the filter assembly via a pressurized test fluid supply pipe. The apparatus is configured such that the test fluid is discharged via a test fluid discharge pipe connected downstream thereof.

[0013] However, in order to operate and operate the above-described cross-linked filtration device alone, the filter membrane integrity test device must be trimmed during its filtration, thus providing a pressurized test fluid supply. The pipe and the test fluid discharge pipe need to be connected to the filter assembly via a valve. In addition, as long as the above purpose of the cross filtration device is achieved, further upstream and downstream of the filter assembly, if necessary, various auxiliary equipment for filter membrane integrity test, for example, the installation and temperature, pressure, A flow rate and other measuring elements may be attached.

A sterilizer according to one aspect of the present invention shares the same filter assembly of the above-described filter, and a sterilizing reagent is supplied to the upstream of the filter assembly via a sterilizing reagent supply pipe and connected to the downstream thereof. The apparatus is configured to discharge a sterilizing reagent via a sterilizing reagent discharging pipe.

However, in order to function and operate the above-mentioned crossed devices, the filtration device or the filter membrane integrity test device alone, the sterilizer must be trimmed during its filtration or test. Therefore, the sterilizing reagent supply pipe and the sterilizing reagent discharge pipe need to be connected to the filter assembly via a valve. In addition, as long as the above-mentioned purpose of the cross filtration device is achieved, various auxiliary equipment for sterilization operation such as installation of exhaust valves and drain valves, temperature, pressure, flow rate and the like may be further provided upstream and downstream of the filter assembly as necessary. May be attached.

[0016] Thus, the filtration device can be demarcated by closing the respective valves of the filter membrane integrity test device and the sterilization device upstream and downstream of the filter assembly so that the filtration device can function properly.
In the filter membrane integrity test operation, the sterilization device and the filtration device upstream and downstream of the filter assembly can be closed by closing the respective valves so that the filter membrane integrity test device can function properly and the sterilization operation can be performed. In this case, by closing the valves of the filtration device and the filter membrane integrity test device, these devices can be cut off and the sterilization device can function properly. In other words, the filter membrane integrity test of the intermediate confirmation can be performed only by opening and closing the valve, and the sterilized state after the sterilization can be easily maintained.

It is to be noted that the pipes and valves upstream and downstream of the filter assembly provided for each device may be shared as much as possible, or may be replaced with a three-way valve or the like.
For example, if mention is made of a combination of a filtration device and an integrity test device, other equipment of the integrity test except for the filter assembly, piping is arranged in series upstream and downstream of the filter assembly of the filtration device, that is, It does not imply a combination of both devices that do not intersect.

Here, the filter assembly is a housing or holder provided with various supports, fasteners and the like as necessary, since a filter membrane (microfiltration membrane) as a filtration element cannot be applied directly to the filtration device. A filter cartridge that is a disposable filter with a filter membrane and a housing integrated, and a filter element such as a pleated or cylindrical filter element that is designed to be replaceable. Is a generic term for a cartridge filter in which a filter is stored in a cartridge or a holder filter in which a filter disk which is a sheet-shaped filter element is stored in a holder.
It is determined according to IS K3832. For example, in FIGS. 1 to 4, the filter assembly 37 has a filter membrane 35 housed in a sealed housing 36, and the filter membrane 35 partitions an upstream side and a downstream side. The liquid or gas to be filtered is introduced into the upstream side through the valve 1 or the valve 5, and the filter membrane 3
The liquid or gas which has passed through 5 is directed as a purified stream through valve 3 or further through valve 8 to a predetermined location.

Further, the other devices connected to the filter assembly and the cut-off filter membrane integrity test device include a "bubble point test device for microfiltration membrane elements and modules" and a "diffusion of microfiltration membrane elements and modules." Flow rate test device "and" intrusion liquid flow rate test device for microfiltration membrane elements and modules ", and bubble generation observation and pressure for judging the nominal performance of the filter membrane derived from the maximum pore size and porosity of the filter membrane This is an apparatus provided with measurement means for change measurement and fluid flow measurement.

That is, the bubble point test of the microfiltration membrane element and the module is to sufficiently wet the filter membrane of the microfiltration membrane element and the module with an appropriate liquid, pressurize with an appropriate gas, and generate air bubbles from the micropores of the filter membrane. This is a test for confirming the integrity of the filter membrane by measuring the differential pressure when the gas comes off, and the device used for that is a bubble point test device for microfiltration membrane elements and modules. FIG.
Test gas source 31, gas pressure regulator 32, thermometer 3
3, pressure gauge 34, filter assembly 37, valves 2, 4,
An example of an apparatus configuration including a pipe provided with 6, 7 and a measuring cylinder 39 has been shown. As is clear from the above, the pressurized test fluid in this test is a gas, and usually air or nitrogen is employed.
A pipe provided with valves 2, 6, and 7 upstream of is a pressurized test fluid supply pipe. On the other hand, the discharge of the test fluid means that these gases, that is, the normal air and nitrogen described above are diffused out of the system as bubbles in the liquid of the measuring cylinder 39 through the fine holes of the filter membrane 35, A pipe 38 provided with the valve 3 and the pressure gauge 34 downstream of the filter assembly 37 for discharge is a fluid outlet pipe. Further details are disclosed in Japanese Industrial Standard JIS K3832.

In addition, the diffusion flow rate test of the microfiltration membrane element and the module is to sufficiently wet the filter membrane of the microfiltration membrane element and the module with an appropriate liquid,
A test to confirm the integrity of the filter membrane by measuring the flow rate of gas permeating the secondary side by diffusion in an appropriate manner when an appropriate pressure difference below the bubble point is applied with an appropriate gas, Is a device for testing the diffusion flow rate of a microfiltration membrane element and a module. FIG. 2 shows an example of the device configuration. As is clear from the above, the pressurized test fluid in this test is a gas, and usually air or nitrogen is employed. In supplying the fluid, a pipe provided with valves 2, 6, and 7 upstream of the filter assembly 37 is used for the pressurized test. It is a fluid supply pipe. The specific configuration of the pressurized test fluid supply pipe is the same as that in FIG. On the other hand, the test fluid discharge refers to a phenomenon in which the liquid in the micropores of the filter membrane 35 is dissolved from the pressurized side and diffused on the low pressure side to generate a steady gas flow, and can be measured either upstream or downstream of the filter assembly. Downstream of the filter assembly for its discharge, the piping with valve 3, pressure gauge 34 and flower 40 is the fluid outflow piping. Further details are disclosed in Japanese Industrial Standard JIS K3833.

The infiltration liquid flow test of the microfiltration membrane element and the module is performed by pressurizing and supplying water or an aqueous solution having a composition range not wettable to the hydrophobic filter membrane of the microfiltration membrane element and the module in a completely dried state. The filter is measured by measuring the pressure at the time when the steady flow rate of the detected water or the aqueous solution of the non-wetting composition range is detected by infiltrating the water in contact with the pores of the filter membrane or the aqueous solution of the non-wetting composition range against the surface tension. This is a test to confirm the integrity of the membrane, and the equipment used for this is a microfiltration membrane element and an ingress liquid flow test equipment for the module. FIG. 3 shows an example of the device configuration. As is clear from the above, the pressurized test fluid in this test is a liquid, and water or various aqueous solutions having a composition range that does not wet the filter membrane are employed, and pressurization of these fluids comes into direct contact with the flexible membrane. Fluid, mainly gas, which transmits pressure via the filter assembly, is provided with a valve upstream of the filter assembly in supplying them, and is a pressurized test fluid supply pipe. Figure 1 shows the configuration of the pressurized test fluid supply pipe.
Since this is the same as the case described above, refer to the above description. However, in this example, the flow meter 41 is used on the pressurized test fluid supply pipe side, but may be used on the discharge side. On the other hand, the discharge of the test fluid is caused by the outflow downstream of the steady-state filter membrane, which is shown only when water in contact with the pores of the filter membrane or an aqueous solution in a non-wetting composition range penetrates against the surface tension and reaches a constant pressure before penetrating. The pipe provided with the valve 3 and the pressure gauge 34 downstream of the filter assembly for its discharge is the fluid outlet pipe. Further details are described in the examples.

Each test of the above-mentioned microfiltration membrane element and module can be variously modified without departing from each principle as already described in the Annex of Japanese Industrial Standard JIS. For the infiltration liquid flow test of the module, in addition to measuring the infiltration liquid flow upstream of the filter membrane and measuring it as the leachable liquid flow downstream, of course, the principle is widely applied to wet the hydrophilic filter membrane. It is also possible to apply various pressurized organic solvents or mixtures thereof as the intruding liquid, and, for safety, direct pressurization with an inert gas for safety.

Here, the present invention includes a filter device which is mounted in parallel with two or more filter assemblies in order to smoothly perform a filtering operation, and is used by switching when a pressure difference between before and after the filter increases. Accordingly, it also includes a filter membrane integrity test device or a cross filtration device having two or more crossings of the filter membrane integrity test device and the sterilization test device. in this case,
The filter membrane integrity test or sterilization process after the complete test can be performed in parallel with the filtration operation, and the waiting time between filter assembly switching and the subsequent filtration operation can be reduced, thereby increasing the efficiency of the filtration operation. Preferred from above. Further, it is possible to use a part of the integrity test device as a device dedicated to the integrity test.

It should be noted that the filtration device intersecting the integrity test device according to the present invention has a disadvantage that the solid / fluid mixture, which is a precious filtration material, is lost if the operation procedures and various controls of various valves concerned are not performed according to the manual. Therefore, it is more preferable to be performed under automatic control. In particular, according to the present invention, there is also a feature that the apparatus can intersect the filter as compactly as possible without considering the versatility that the dedicated apparatus for integrity test should have. Further, as the operation procedure of the filtration device of the present invention, it is possible to simplify the filtration operation such that the integrity test for the first confirmation is omitted and the sterilization treatment can be started.

[0026]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention is constructed and implemented by cross-connecting a filter assembly of a filter assembly with a filter membrane integrity tester of the filter assembly or further cross-connecting a sterilizer of the filter assembly. Above, the valves are arranged upstream and downstream of the filter assembly so that each device performs its function separately from the other functions. In addition,
The present invention essentially requires a filtration device cross-connected to a filter membrane integrity test device, and a juxtaposition by cross-connection of a sterilization device is a more preferred embodiment.

[0027]

FIG. 4 shows an example of a cross filtration device in which a filtration device, an intruding liquid flow rate test device and a sterilization device according to the present invention share a filter assembly 37, that is, are cross-connected. That is, the filtration device is connected to each equipment including pipes indicated by dotted lines having valves 11 and 13, and the infiltration liquid flow rate test device for the microfiltration membrane element and the module is connected to the valves 1 and 1.
Each equipment is connected and configured by a pipe indicated by a solid line having a 3, and further, each equipment is connected and configured by a pipe indicated by a dashed line having valves 21 and 23, and the filter assembly 37 is shared by any apparatus. The cross-filtration apparatus described is shown. The filter device of this embodiment is a device for producing sterilized air for pumping an injection drug solution or the like. The filter membrane 35 in the airtight housing 36 of the filter assembly 37 is a fluorine-based hydrophobic membrane having a nominal cylindrical pore diameter of 0.2 μm. Was set. The infiltration liquid flow rate test device for the filter membrane 35 gradually increases the pressure of the intrusion liquid pure water by the dry nitrogen from the gas cylinder 31, and pressurizes and penetrates into the holes of the filter membrane 35 to obtain the first steady pure water flow rate. Measure 200 μl / min and measure the differential pressure 144
kPa was read. Further, the sterilization device of the filter assembly 37 which is cross-connected is a device for heat sterilization by steam supply. Hereinafter, a procedure for using the cross filtration device of this embodiment will be described in detail.

First, a filter assembly 37 having a filter membrane 35 is attached to a cross filtration device and operated as an intrusion liquid flow test device. That is, the dry nitrogen gas 31 is allowed to flow from the gas cylinder to the filter assembly 37, except when it is determined that the filter membrane is sufficiently dried. At this time, the valves 7, 2, and 3 are opened, and the valve 32 is controlled by the regulator 32 to flow a predetermined amount and dry. Other valves should be closed, but occasionally opened and closed for a short period of time if necessary.
It is effective to remove the accumulation in space. In particular, the presence of a liquid that dissolves in water and wets the fluorine-based hydrophobic film cannot obtain accurate test results. Therefore, it is necessary to thoroughly analyze water and the like in downstream nitrogen to confirm the removal. Next, the valves 2 and 3 are closed, the valves 1 and 4 are opened, and the intrusion liquid pure water is introduced from the valve 1 into the intrusion pressure (P ₁ ) calculated from the nominal cylindrical hole diameter by the following equation, or the nominal intrusion pressure 27.
The filter is supplied from the upstream side of the filter assembly 37 under a pressure of less than 0 kPa, and the upstream filter membrane 35 is filled so as to be submerged so as not to be in direct contact with nitrogen or other gas. P ₁ = −4δ · cos θ / d (where δ is the surface tension, θ is the wetting angle and 90 ° <
θ and d are the maximum values of the assumed cylindrical hole diameter). That is, it can be achieved by sufficiently flowing pure water out of the valve 4.

The valves 1 and 4 are closed, the valve 3 is opened, and the valve is operated in the same manner as in the drying operation to gradually increase the pressure of the supply nitrogen through the valve 6. During this time, the pseudo flow rate is occasionally detected by the flow meter 32, and it is observed that the flow rate stops soon.
The expansion of the system mainly due to pressure resulted in apparent flow observations, and such flow was not steady, and the differential pressure at which the first steady flow after further pressure increase was taken as test data. After the completion of the integrity test, steam of 202 kPa is supplied from the valve 21 to sterilize the filter membrane 35 as well as the filter assembly 37 or the piping around the filter assembly 37. Valve 23 is a steam drain valve. Normally, other valves should be closed, but pipes where steam may condense and accumulate water may be opened occasionally for closed pipes.If there is no valve, joints etc. may be loosened temporarily to condense water. It is important to ensure steam sterilization by discharging steam. In addition,
The steam supply pipes and equipment were equipped with heat insulating material and the sterilization operation was completed in a short time. After the sterilization operation is completed, the infiltration liquid flow test is performed again by sterilization and other related operations to confirm that there is no leak in the filter membrane as well as the cross filtration device, but the procedure is the same as described above. However, it is essential to pay attention to the fact that the filter membrane is dry. If an intrusion pressure similar to that in the first confirmation is measured, the flow shifts to a filtration operation. The valves 11, 13 were opened, the other valves were closed, the solids were filtered off, and purified air could be produced via valve 13.

[0030]

According to the cross filtration device according to the present invention, the filter assembly is completed only once from the first filter membrane integrity test to the end of the filtration, so that various fluids and solids accompanying the installation failure are required. The risk of leakage of the fluid mixture out of the system can be dealt with in the first filter membrane integrity test, with each subsequent operation being a simple operation of opening and closing valves installed upstream and downstream of the filter assembly. It was decided that it was possible. That is, the integrity test of the filter membrane before and after the sterilization operation can be performed simply by opening and closing the valve, and naturally, the leakage of the sterilization reagent can be avoided, and the re-contamination that was conventionally inevitable after the sterilization operation can be easily avoided. As a result, the filtration operation itself can be performed after confirming the performance of the filter membrane after sterilization by an integrity test. In addition, by arranging a plurality of filter assemblies in parallel with the filtration device, a filter membrane integrity test and sterilization operation of the filter assembly before use for filtration can be performed during the filtration operation. There is also an effect that the filter assembly can be switched and switched smoothly and efficiently.
Furthermore, the above-mentioned parallel arrangement has made it possible to use a part as a single filter membrane integrity test apparatus.

[Brief description of the drawings]

FIG. 1 is a diagram of a bubble point test apparatus for a microfiltration membrane element and a module.

FIG. 2 is a diagram illustrating a diffusion flow rate test apparatus for a microfiltration membrane element and a module.

FIG. 3 is a diagram of an infiltration liquid flow rate test apparatus for a microfiltration membrane element and a module.

FIG. 4 is a diagram of a cross filtration device.

[Explanation of symbols]

 1 to 8, 11, 13, 21, 23: Various valves 31 Dry nitrogen cylinder (gas source for test) 32 Gas pressure regulator 33 Thermometer 34 Pressure gauge 35 Filter membrane 36 Housing 37 Filter assembly 38 Tube 39 Measuring cylinder 40 Gas Flow meter 41 Liquid flow meter

Claims (5)

[Claims] 1. A filtration device having at least a solid / fluid mixture supply pipe and a fluid recovery pipe connected upstream and downstream of a filter assembly via a valve, respectively, and at least pressurized through a valve upstream and downstream of the filter assembly, respectively. A cross filtration device comprising a test membrane integrity test device connected to a test fluid supply pipe and a test fluid discharge pipe. 2. The cross filtration device according to claim 1, wherein a sterilization device is connected to at least a sterilization reagent supply pipe and a sterilization reagent discharge pipe via upstream and downstream of the filter assembly via valves. 3. The cross filtration device according to claim 1, wherein the filter membrane integrity test device is a bubble point test device for microfiltration membrane elements and modules. 4. The cross-filtration device according to claim 1, wherein the filter membrane integrity test device is a microfiltration membrane element and a diffusion flow rate test device for a module. 5. A cross-filtration device according to claim 1 or 2, wherein the filter membrane integrity test device is a microfiltration membrane element and module intrusion liquid flow rate test device.