EP3661631A1

EP3661631A1 - Filtering apparatus comprising an integrated flow reducer, and method for completely imbibing a filter membrane

Info

Publication number: EP3661631A1
Application number: EP18746152.0A
Authority: EP
Inventors: Volkmar Thom; Thomas Loewe; Sebastian Handt; Maik Sommer
Original assignee: Sartorius Stedim Biotech GmbH
Current assignee: Sartorius Stedim Biotech GmbH
Priority date: 2017-08-01
Filing date: 2018-07-24
Publication date: 2020-06-10
Also published as: DE102017117419A1; WO2019025239A1; US11759733B2; US20200269166A1

Abstract

A filtering apparatus, in particular a disposable filtering apparatus, comprises a flow path in which a filter unit and an integrated flow reducer (10) are disposed one behind the other. The flow reducer (10) can be brought into a first operating position that allows for a defined first volumetric flow rate, and at least into a second operating position that allows for a defined second volumetric flow rate which is smaller than the first volumetric flow rate.

Description

Filtration device with integrated flow reducer

and method for completely wetting a filter membrane

The invention relates to a filtration device, in particular a disposable filtration device, with an integrated flow reducer. The invention further relates to a method for completely wetting a filter membrane in such a filtration device.

In the pharmaceutical industry, filtration devices are typically subjected to an integrity test prior to use. Alternatively or additionally, such a test can also be carried out after a filtration process. For an integrity test, a filter should be pre-wetted. For this, the filter unit is rinsed with a reference liquid (eg high-purity water). In such a flushing process, a filter is wetted more efficiently - and thus tested for integrity safer - when it is flushed against a back pressure. The back pressure ensures that trapped gas is better dissolved or bubbles can shrink and migrate through the filter membrane. Due to the reduced by the back pressure Transmembrandrucks (eg 0.5 bar at a purge pressure of 2.5 bar, achieved by 2 bar back pressure) significantly less water for safe wetting is necessary.

For the adjustment of the back pressure usually a controllable valve and a pressure sensor are provided downstream of the filter. With the aid of the control valve, the backpressure at a certain volume flow is adjusted to a desired value (eg to 2 bar).

In particular, when using disposable components (single use), the integration of a control valve and a pressure sensor is complicated and requires additional Konnektierungen. In addition, when using disposable components, saving water is of particular importance since sterile water must be provided in bags. The object of the invention is to enable a cost effective flushing of a filter unit and a more effective wetting of the filter membrane, which is particularly, but not exclusively, tuned to one-way applications. This object is achieved by a filtration device having the features of claim 1. Advantageous and expedient embodiments of the filtration device according to the invention are specified in the subclaims.

The filtration device according to the invention is designed in particular as a disposable filtration device and comprises a flow path in which a filter device and a, preferably integrated, flow reducer are arranged one behind the other. The flow reducer can be brought into a first operating position, which allows a defined first volume flow, and at least into a second operating position, which allows a defined second volume flow, which is less than the first volume flow. According to the invention, the ratio between the second volume flow (Spülbetriebsstellung) and the first volume flow (Filtrationbetriebsstellung) between 0.05 and 0.9.

The arrangement of the filter device and the flow reducer, preferably integrated into the filtration device, "consecutively" refers to the flow direction of the medium in the flow path The flow direction does not necessarily have to be the direction of flow in the intended filtration operation of the filter device In principle, the inlet and outlet are to be charged from both sides, ie in different directions, The decisive factor is that the flow reducer is arranged downstream of the filter device when the filter device is rinsed.

An "integrated" flow reducer in the sense of the invention means a flow reducer which does not have to be reconnected to the filtration device before it is used but is already an integral part of the filtration device Therefore, the entire filtration device, if designed as a disposable filtration device, including the Sterilize the flow reducer. This simplifies the handling of the filtration device quite considerably. The sterility of the flow reducer is not affected later by the switching between its two operating positions. The invention is based on the finding that when rinsing a

Filtering means a safer wetting results when a suitable back pressure is provided during the rinsing operation. The water savings achieved thanks to the more effective wetting can be up to 95%, so that the amount of flushing medium that is elaborately provided in bags can be drastically reduced.

The filtration device according to the invention has the advantage that the flow reducer for the proper filtration operation does not need to be removed, but can be easily switched from the "Spülbetriebsstellung" in the "Filtration operating position". The flow reducer can thus remain after flushing as an integral part in the filtration device.

In view of the preferred use in a disposable filtration device, it is advantageous that the flow reducer consists entirely of materials which are sterilizable, in particular by gamma-rays, superheated steam or autoclaving. Thus, the flow reducer can be sterilized together with the other components of the filtration device - or separately as a separate prefabricated unit.

For the generation of a suitable backpressure when flushing the filter device, the ratio between the second volume flow (Spülbetriebsstellung) and the first volume flow (Filtrationbetriebsstellung) should be between 0.05 and 0.5, preferably between 0.05 and 0.15.

According to a basic aspect of most preferred embodiments of the filtration device according to the invention, an adjustable actuator is provided, which assumes a defined first position in the first operating position of the flow reducer, in which it releases a first effective flow cross section. In the second operating position of the flow reducer, however, the actuator assumes a defined second position, in which it releases a second effective flow area that is (clearly) smaller than the first effective flow area. The provision of such an adjustable actuator allows a simple and quick change between the two operating positions of the flow reducer, without special measures must be taken, such as a reconstruction of the filtration device or the like.

For a comfortable switching between the operating positions of the flow reducer and / or the embedding of switching to an automated operation of the filtration device based on a control algorithm may optionally be provided a control device with which the actuator is automatically moved to the first position and the second position.

With regard to an extended range of applications of the flow reducer can be provided that the actuator in addition to the first and the second position can take other defined positions, in particular intermediate positions. The pressure can then be adjusted not only between two values, but over a selectable range.

According to a preferred concept for the technical implementation of the inventive concept, the actuator is movable with a sliding mechanism or a rotating mechanism in the defined positions. Sliding or turning movements can be carried out easily and quickly both manually and automatically. This means that switching the flow reducer between its operating positions does not require complex operations.

Thus, the various positions of the actuator and the associated different volume flows can be reproducibly achieved, the defined positions of the actuator are preferably designed as locking positions. Locking positions are robust against light touch, vibration and many other influences that could cause unintentional adjustment of the actuator. In addition, locking positions have the advantage that the user clearly recognizes from the haptic feedback that the actuator has taken a certain position.

The actuator can be converted, for example, with a biased actuator in the individual locking positions. To protect the sliding or rotating mechanism and optionally the actuating element, a protective cover which surrounds the corresponding components is advantageous. Preferably, the protective cover is formed from a deformable and sterilizable elastomer. The protective cover provides a flexible sterile barrier which nevertheless allows external actuation of the sliding or rotating mechanism.

According to a preferred embodiment of the invention, the actuator comprises a shutter with a through-hole, which can be inserted into a line section of the flow reducer. Similar to a slide projector, the orifice is introduced into the flow path to reduce the effective flow path to a certain extent. The volume flow can be adjusted as desired by appropriate design of the aperture (size and shape).

In another embodiment, the actuator comprises a body movable in a conduit section of the flow reducer and having a passage which is oriented in the first position of the actuator in the flow direction and in the second position of the actuator substantially transverse to the flow direction. This means that the passage in the first position of the actuator allows a substantially unhindered flow through the line section, while in the second position, the passage is rotated away from the flow path, so that the body of the actuator largely blocks the medium passage.

Thus, in the second position of the actuator, which corresponds to the purge operation, a certain small volume flow is ensured by the actuator over, the body and the passage of the actuator can be designed without special effort so that crescent-shaped through channels are provided.

The actuator may be formed according to a further embodiment as a disc which is rotatable in a line section of the flow reducer. The outer diameter of the disc is smaller by a defined amount than the inner diameter of the conduit section, and / or the outer contour of the disc has one or more outwardly extending recesses. By turning the disc from a first position, in which only the narrow side of the flow opposes, in a second position in which the Covering the majority of the flow cross-section of the line section, the desired reduction in the volume flow can be achieved in a simple manner.

The adjustment of different volume flows can also be achieved by an actuator with orifice sections, which cooperate with orifice sections at an outlet opening of the flow reducer. Such an embodiment comes with comparatively few components.

In the first position of the actuator, the respective aperture sections are largely one above the other, so that free spaces remain for a large volume flow. In the second position of the actuator, the diaphragm sections cover the free spaces as far as possible, leaving a defined free flow passage for a much smaller volume flow.

According to another concept for the technical implementation of the inventive concept, the flow reducer has a two-section divided line section with orifices facing each other. The actuator comprises an axially displaceable cone which, in the first position of the actuator, is less immersed in the mouth of one of the subsections than in the second position of the actuator. The volume flow depends on the position of the cone, as more of the available flow cross-section is blocked by the cone as the depth of immersion increases. Of course, the actuator does not have to have a perfect cone shape. As will be apparent to those skilled in the art, the actuator must have a generally increasing cross-section in the direction of displacement. Accordingly, the term "cone" is to be interpreted The cone can be attached to an axially positionable sleeve, which connects the two subsections to one another, thus serving both to position the cone and to seal the subsections of the conduit section.

The axial positioning of the sleeve with the cone can be realized via a finely adjustable threaded connection. For this purpose, the sleeve has an internal thread which engages in an external thread on one of the sections of the line section, wherein the sleeve is preferably fixed to the other Subsection is connected and this subsection consequently follows the rotation of the sleeve.

It must be ensured in both positions that more or less medium can flow past the cone. A preferred design in this context provides that the cone is held with struts on the sleeve, wherein between the struts free spaces remain.

The line section in the flow reducer, whose flow cross-section is to be variable, can also be designed as a flexible hose. The actuator then reduces in its second position the effective flow cross-section of the hose by a certain amount for the rinsing operation, which can be achieved in different ways.

According to a first variant, the actuator is a hose clamp with two relatively deflectable terminal portions which engage the outer wall of the hose. With such a hose clamp, the effective flow cross section of the hose at the point of clamping can be purposefully reduced.

For the relative deflection of the terminal portions, these are preferably connected to each other via a hinge.

According to a second variant, the actuator is designed as a bendable joint rail with two substantially rigid sleeve sections and an interposed articulated joint. The two sleeve sections of the hinge rail each surround a section of the line section. Similar to a knee brace, an angle can be set that defines an angled end position of the two sleeve sections. With the aid of the joint rail, a defined bend with reduced flow cross-section can be created in the hose.

In both variants is advantageous that no additional seals are needed.

Yet another concept envisages that the actuator comprises movable flaps disposed in a conduit section of the flow reducer and by means of a force field generated outside the conduit section are deflectable. This embodiment is advantageous because no additional seals etc. are needed. The moving components of the actuator are located within the line section and can be controlled without contact. The force field necessary for this purpose can be provided by a force field generator arranged outside the line section.

According to a preferred embodiment of this embodiment, the flaps are hinged to a wall of the conduit section.

For a defined end position of the flaps can be provided that the deflection of the flaps is limited by flap stops.

In a further embodiment of the invention, a line section of the flow reducer comprises a main line section with a first valve as the actuator and a bypass line section for bypassing the first valve. The flow cross section of the bypass line section is (clearly) smaller than the flow cross section of the main line section. Such a construction of the flow reducer makes it possible to block the main line section for the rinsing operation, so that the rinsing medium can only flow through the bypass line section. Since this has a significantly smaller flow cross-section, the volume flow is correspondingly lower. For this basic functionality, the first valve should be able to fully open and fully close the main line section.

Optionally, a second valve may be provided in the bypass line section in order, if appropriate, to adapt the flow cross section and thus the volume flow in the flushing operation to the given requirements or to close the bypass line section in order to flow only over the main line section.

According to a development of this embodiment, the first valve and / or the second valve are designed such that they can assume a plurality of positions in which different flow cross-sections are released. As a result, more setting options are available, To extend the range of applications, the second valve could also close completely.

A method for completely wetting a filter membrane in a filtration device according to the invention in the context of a flushing process is characterized in that the flow reducer is in the flushing position, i. H. in the second operating position, which allows a defined second volume flow, which is less than the first volume flow. Thus, the purge of the filter device with reduced volume, so that the filter is completely wetted reliable. After the flushing process, the flow reducer is brought into the first operating position to carry out a filtration process.

This process for the complete wetting of a filter membrane is carried out while saving flushing medium, in particular water for injection (WFI, water for injection) by 10 to 95%, preferably by 50 to 95%, more preferably by 85 to 95% compared to the complete Wetting without pressure reduction.

Further features and advantages of the invention will become apparent from the following description and from the accompanying drawings, to which reference is made. In the drawings show schematically:

FIG. 1 a shows a first embodiment of a flow reducer for a filtration device according to the invention in a first operating position in the flow direction;

- Figure 1 b, the flow reducer of Figure 1 a in a second operating position;

- Figure 2a shows a second embodiment of a flow reducer for a filtration device according to the invention in a second operating position in perspective view;

FIG. 2b shows the flow reducer from FIG. 2a in a first operating position in the flow direction;

FIG. 2c shows the flow reducer from FIG. 2a in the second operating position in the flow direction; - Figure 2d, the actuator of the flow reducer of Figure 2a in a perspective view;

3a shows a third embodiment of a flow reducer for a filtration device according to the invention in a second operating position in a perspective view;

FIG. 3b shows the flow reducer from FIG. 3a in a first operating position in the flow direction;

FIG. 3c shows the flow reducer from FIG. 3a in the second operating position in the flow direction; - Figure 3d, the actuator of the flow reducer of Figure 3a in perspective view;

- Figure 4a shows a fourth embodiment of a flow reducer for a filtration device according to the invention in a second operating position in a perspective view; FIG. 4b shows the flow reducer from FIG. 4a in a first operating position in the flow direction;

FIG. 4c shows the flow reducer from FIG. 4a in the second operating position in the flow direction;

FIG. 4d that of the actuator of the flow reducer from FIG. 4a in perspective front and rear view;

- Figure 5a shows a fifth embodiment of a flow reducer for a filtration device according to the invention in a first operating position in semi-transparent side view;

FIG. 5b shows the flow reducer from FIG. 5a in the first operating position in the flow direction;

- Figure 6a shows a sixth embodiment of a flow reducer for a filtration device according to the invention in a first operating position in a partially sectioned side view;

FIG. 6b shows the flow reducer from FIG. 6a in a second operating position; - Figure 7 shows a seventh embodiment of a flow reducer for a filtration device according to the invention in a second operating position in a partially sectioned side view;

8a shows an eighth embodiment of a flow reducer for a filtration device according to the invention in a first operating position in side view;

FIG. 8b shows the flow reducer from FIG. 8a in a second operating position; and

- Figure 9 shows a ninth embodiment of a flow reducer for a novel inventive filtration device in side view.

All of the subsequently described embodiments of a flow reducer 10 for a filtration device have in common that they can replace a hitherto conventional separate control valve of a filter device of the filtration device for setting a defined backpressure during rinsing of the filter device.

The flow reducer 10 is disposed in the same flow path as the filter device downstream of it and is firmly integrated into the filtration device. In particular, in view of the preferred use of the flow restrictor 10 in a disposable filtration device, the flow restrictor 10 is made entirely from sterilizable materials. Thus, the entire disposable filtration device, including the flow reducer 10, may be sterilized before or after packaging the filtration device, optionally together with the packaging material, for example by gamma irradiation, superheated steam or autoclaving. The flow reducer 10 can switch between a first operating position, which releases a defined first effective flow cross section, and a second operating position, which releases a defined second effective flow cross section, which is significantly smaller than the first effective flow cross section. For rinsing the filter device, the flow reducer 10 is brought into the second operating position with a reduced flow cross-section, so that the volume flow through the flow reducer 10 is reduced. Thus, the pressure with which the flushing medium through the filter device is pressed, a defined back pressure opposite. For example, a flushing pressure of 2.5 bar may be predetermined and the flow reducer 10 counteracts this pressure in its second operating position with a back pressure of 2 bar, so that the filter device is finally wetted with the flushing medium at a resulting pressure of 0.5 bar.

The back pressure is achieved by the targeted reduction of the volume flow. The ratio between the volume flow during purging operation to the volume flow at the intended filtration operation is between 0.05 and 0.9, preferably between 0.05 and 0.5, more preferably between 0.05 and 0.15.

In most cases, filter devices have a dedicated input and a dedicated output, between which at least one filter membrane is arranged. The terms "input" and "output" refer to the intended filtration operation. For the rinsing should here but also a possible reverse feed is basically included, d. H. an inlet of the flushing medium through the outlet and an exit through the inlet.

To change between the two operating positions of the flow reducer 10, no components have to be added or removed, and no connections or disconnections need to be made. The sterility of the flow reducer 10 is not affected by the switching.

FIGS. 1 a and 1 b show a first embodiment of such a flow reducer 10 for a filtration device with at least one filter device. The flow reducer 10 is arranged downstream of the filter device and comprises a line section 12 with a defined flow cross section, which is usually determined by the inner diameter. Through the line section 12, the medium that has been previously pressed by the filter device flows.

The flow reducer 10 also comprises an actuator 14, here in the form of a diaphragm 16 with a passage opening 18. The actuator 14 may be between a defined first position, which is shown in Figure 1 a, and a defined second position, shown in Figure 1 b is to be moved. In the first position of the line section 12 is largely unhindered passable from the medium flowing through. The actuator 14 protrudes at most slightly into the line section 12 and reduces the flow cross-section of the line section 12 at this point only insignificantly or not at all. In the second position, the actuator 14 is completely inserted into the conduit section 12 and extends substantially over the entire flow cross-section - with the exception of the small passage opening 18 with a defined cross-section.

In principle, further positions of the actuator 14 can be provided, in particular intermediate positions with a relation to the first position reduced, compared to the second position but enlarged effective flow cross-section.

The defined positions of the actuator 14 are detent positions provided by a detent / slide mechanism. The latching / sliding mechanism has an actuating element 20, which is coupled to the actuator 14, here a type of pushbutton, which is prestressed by means of a spring element. By manual operation of the push button, the actuator 14 from the first detent position (Fig. 1 a) in the second detent position (Fig. 1 b) are transferred. By re-actuation optionally returns the actuator 14 in the first detent position, etc.

Basically - as well as in all embodiments described below - also an automated actuation of the actuator 14 or the actuator 20 in conjunction with a control device possible.

A protective sheath 22, such as a deformable and sterilizable elastomer, surrounds the detent / slide mechanism including the actuator 20. The protective sheath 22 serves as an outer sterile barrier and protects the interior of the flow restrictor 10 from potential contamination.

In the first operating position of the flow reducer 10, in which the actuator 14 assumes its first position, the filter device can be used as intended for filtration with a predetermined medium pressure, ie without substantial back pressure. In the second operating position of the flow reducer 10, in which the actuator 14 assumes its second position, the actuator 14 blocks most of the flow cross section in the line section 12. The medium can only flow through the small passage opening 18 in the aperture 16. Due to the now significantly reduced effective flow cross-section and the consequent reduced volume flow in the line section 12, a defined back pressure is built up. In this second operating position of the flow reducer 10, the flushing takes place.

The flow reducer 10 is preferably delivered in the second operating position (flushing position), in order then to be transferred after flushing to a single step into the first operating position (filtration position).

In describing the following embodiments of the flow reducer 10, the general principles described above apply as well. Therefore, only the constructive differences are discussed. Thus, in the second embodiment shown in Figs. 2a to 2d, the actuator 14 is formed differently and the slide mechanism is replaced by a rotary mechanism basically similar to that of a stopcock.

The actuator 14 shown separately in Figure 2d here has a substantially cylindrical contour. The otherwise massive body 24 of the actuator 14 has a likewise substantially cylindrical passage 26, whose axis is perpendicular to the axis of the cylindrical body 24. The body 24 and / or the passage 26 may in principle be shaped differently, for. B. conical.

The actuator 14 is received in the conduit section 12 of the flow reducer 10 in a mating socket 28 in which the actuator 14 can rotate about the axis of the body 24. For turning the actuator 14, an actuating element 20 is again provided, here a kind of toggle handle, which is connected to the body 24 of the actuator 14.

The socket 28 in the line section 12 and the body 24 and the passage 26 of the actuator 14 are coordinated so that in a first position of the actuator 14, which is shown in Figure 2b, the axis of the passage 26 parallel to the axis of the line section 12 (Fig. flow direction) runs. In this position, the medium can flow unhindered through the passage 26 of the actuator 14, since the diameter of the passage 26 transversely to the flow direction substantially corresponds to the diameter of the conduit section 12, so that the flow path in the conduit section 12 is completely released.

In the second position shown in Figures 2a and 2c, the actuator 14 is rotated by 90 °. In this position, the body 24 of the actuator 14 blocks the flow path for the most part. Only the two remaining, viewed in the flow direction sickle-shaped through channels 30 allow a significantly reduced defined volume flow through the line section 12th

As in the embodiment described above, in principle also other positions of the actuator 14, in particular intermediate positions may be provided, and the defined positions of the actuator 14 may be formed as locking positions. This also applies to all other embodiments.

The third embodiment of the flow reducer 10 shown in FIGS. 3a to 3d is very similar to the second embodiment. The body 24 of the actuator 14 is formed here as a disc with a defined thickness. The outer diameter of the body 24 is smaller than the inner diameter of the conduit portion 12 by a defined amount, and / or the outer contour of the body 24 is adapted to extend one or more recesses from outside to inside.

To enable the greatest possible flow, the actuator 14 is rotated by means of the actuating element 20 (toggle handle) in the first position shown in Figure 3b, in which the cylinder axis of the body 24 is transverse to the flow direction, so that the actuator 14, the flow through the line section 12 only slightly affected.

For the flushing operation, the actuator 14 is rotated to the position shown in Figure 3c, in which the cylinder axis of the body 24 is oriented parallel to the flow direction. A defined flow rate is due to the smaller compared to the interior of the line section 12 outer diameter or the Recess (s) reached, thereby creating a free annular channel or one or more differently shaped channels around the body 24, through which the medium can flow.

In the fourth embodiment shown in FIGS. 4a to 4d, a rotatable actuator 14 is likewise provided. The actuator 14 is here substantially hollow cylindrical, but has inwardly projecting diaphragm sections 32. A cover 34 of the flow reducer 10 is matched to the actuator 14 and has an outlet opening, which is also partially hidden by aperture portions 36. The actuator 14 can from the first position shown in Figure 4b, in which the

Aperture sections 32, 36 of the actuator 14 and the lid 34 are largely one above the other (filtration operation of the filter device), in the second position shown in Figure 4c, in which cover the aperture portions 32 of the actuator 14, the free spaces 38 between the aperture portions 36 of the lid 34 as far as possible (Flushing operation), to be rotated (eg by 90 °) and vice versa. In the second position, in any case, a defined small free flow passage 40 remains - in the illustrated embodiment, a central flow passage 40 - to maintain a reduced flow rate. This embodiment can be manufactured with comparatively few components.

FIGS. 5a and 5b show a fifth embodiment of the flow reducer

10th

The line section 12 of the flow reducer 10 is here divided into two mutually opposite end portions 42, 44. The first section 42 is fixedly connected to an axially projecting sleeve 46. The protruding part of the sleeve 46 is provided with an internal thread 48, which engages in an external thread 50 of the second section 44. In this way, by rotation of the sleeve 46, one section 42 can be moved in the axial direction toward or away from the other section 44, depending on the direction of rotation. The sleeve 46 provides a sterile barrier for the sleeve interior by sealing the threaded barrel. This ensures that the transition between the two sections 42, 44 regardless of the axial position of the sleeve 46 is tight and there is no risk of contamination.

As can be seen in particular from FIG. 5 b, an actuator 14 in the form of a cone (needle), whose tip 52 points in the direction of the second subsection 44 of the line section 12, is arranged in the sleeve 46. The actuator 14 is here held by a four-point lock with struts 54, the leaves exposed in the flow direction 56 spaces.

In a first position of the actuator 14 this protrudes not at all or only in a relatively small extent in the free mouth of the second portion 44 into it. The medium can flow largely unhindered from the first section 42 into the sleeve 46 and there through the intermediate spaces 56 into the second section 44. This position corresponds to the intended filtration operation of the filter device.

For the flushing operation, the actuator 14 is displaced by turning the sleeve 46 by a defined amount in the direction of the second portion 44 (in Figure 5a to the left). The now far into the mouth of the second portion 44 immersed actuator 14 minimizes the effective flow area so that builds up a desired back pressure.

FIGS. 6a and 6b show a sixth embodiment of the flow reducer 10. The line section 12 of the flow reducer 10 is formed here as a flexible hose. On the outer wall 58 engages on two opposite sides of an actuator 14 in the form of a hose clamp. The hose clamp has two terminal portions 60, 62 which are interconnected via a hinge 64. The hose clamp can be angled defined by a grid in the joint 64.

In the first position shown in FIG. 6a (filtration operation of the filter device), the flow cross-section of the line section 12 is practically unimpaired. In the second position (flushing operation) shown in FIG. 6b, one of the terminal sections 60 is pivoted by a specific clamping angle α in the direction of the other terminal section 62. The clamping achieved in this way reduces the effective Flow cross-section of the line section 12 at the clamping, whereby the desired flow reduction is induced.

FIG. 7 shows a seventh embodiment of the flow reducer 10. Similar to the above-described sixth embodiment, the piping portion 12 of the flow reducer 10 is formed as a flexible hose. The desired defined change of the effective flow cross-section, in order to allow a normal filtration operation of the filter device with a high volume flow and a purging operation with a significantly reduced volume flow, takes place here with an actuator 14 in the form of an angled hinge rail. The joint rail is constructed in the manner of a knee orthosis with two substantially rigid sleeve portions 66, 68 and an interposed articulation 70. The two sleeve portions 66, 68 each surround a portion of the line section 12. Using the articulated joint 70, the flexible line section 12 by a certain Angle α are bent, whereby the effective flow area is reduced by a certain amount. The two buckling positions and optionally provided further positions, in particular intermediate positions, are preferably designed as locking positions.

In the eighth embodiment shown in FIGS. 8a and 8b, an actuator 14 in the form of movable flaps 72, 74 is provided in the conduit section 12 of the flow reducer 10, which are mounted on the wall 80 of the conduit section 12 by means of joints 76, 78. By deflection of the flaps 72, 74, the effective flow cross-section can be influenced. The flaps 72, 74 can be deflected by a force field 82, which penetrates the wall 80 of the conduit section 12. The force field 82 is caused by electromagnetic interaction, for example, by means of a force field generator 84 arranged outside the line section 12.

In order to achieve a defined narrowing of the effective flow cross section starting from the first operating position of the flow reducer 10 shown in FIG. 8 a, a force field 82 of sufficient strength is generated. The flaps 72, 74 are deflected by a predetermined amount. The deflection can be limited for example by flap stops. The Narrowing leads to a flow resistance increased by a defined amount, which corresponds to the second operating position of the flow reducer 10.

For this embodiment, no additional seals, etc. are needed because the movable components of the actuator 14 are disposed within the line section 12 and the force is not mechanically, but without contact.

A ninth embodiment of the flow reducer 10 is shown in FIG. The line section 12 of the flow reducer 10 here comprises a main line section 86 with an actuator 14 in the form of a first valve 88 and a bypass line section 90 for bypassing the first valve 88. The bypass line section 90 has a substantially smaller flow cross section than the main line section 86 and optionally has a second valve 92 on.

According to a first variant of this embodiment, the first valve 88 is used in the main line section 86 as a pure shut-off valve. In normal filtration operation of the filter device, the first valve 88 is fully open and completely closed in the flushing operation. In this case, the medium can only flow through the bypass line section 90, which leads to a reduced flow through the flow reducer 10 with a corresponding increase in pressure (back pressure). The degree of flow reduction is determined by the flow area and the length of the bypass line section 90. Optionally, the resulting flow can be varied by the second valve 92 in the bypass line section 90.

In a second variant of the ninth embodiment, the flow through the main conduit section 86 may be varied by means of the first valve 88. That is, the first valve 88 may occupy one or more intermediate positions so that the resulting flow through the flow reducer 10 and the pressure may be adjusted over a selectable range. The various valve positions are designed as locking positions to allow reproducible settings. The optionally existing second valve 92 may be formed so that it can take one or more intermediate positions, preferably designed as defined locking positions. There are even more setting options available. The above-described embodiments of a flow reducer 10 for a filtration device are exemplary and therefore not restrictive. For example, certain features of the various embodiments may be combined.

LIST OF REFERENCE NUMBERS

10 flow reducers

12 line section

14 actuator

16 aperture

18 passage opening

20 actuator

22 protective cover

24 bodies

26 passage

28 version

30 passageways

32 panel sections

34 lid

36 panel sections

38 spaces

40 flow passage

42 first subsection

44 second subsection

46 sleeve

48 internal thread

50 external thread

52 tip

54 struts

56 spaces

58 outer wall

60 first terminal section

62 second terminal section

64 joint first sleeve portion second sleeve portion

articulated

first flap

second flap

first joint

second joint

wall

force field

Force field generator

Main line section first valve

Bypass line section second valve

Claims

claims

1 . Filtration device having a flow path in which a filter device and a flow reducer (10) are arranged one behind the other, wherein the flow reducer (10) in a first operating position, which allows a defined first volume flow, and at least in a second operating position, the one defined second volume flow, which is less than the first volume flow, wherein the ratio between the second volume flow and the first volume flow is between 0.05 and 0.9.

2. Filtration device according to claim 1, characterized in that the filtration device is a disposable filtration device.

3. Filtration device according to claim 1 or 2, characterized in that the flow reducer (10) is integrated in the filtration device.

4. Filtration device according to one of the preceding claims, characterized in that the flow reducer (10) consists entirely of materials which can be sterilized, in particular by gamma rays, superheated steam or autoclaving.

5. Filtration device according to one of the preceding claims, characterized in that the ratio between the second volume flow and the first volume flow between 0.05 and 0.5, preferably between 0.05 and 0.15.

6. Filtration device according to one of the preceding claims, characterized by an adjustable actuator (14) in the first operating position of the flow reducer (10) has a defined first position in which it releases a first effective flow area, and in the second operating position of the flow reducer ( 10) assumes a defined second position, in which it releases a second effective flow cross section which is smaller than the first effective flow cross section.

7. Filtration device according to claim 6, characterized by a control device with which the actuator (14) can be moved automatically in the first position and in the second position.

8. Filtration device according to claim 6 or 7, characterized in that the actuator (14) next to the first and the second position can take more defined positions, in particular intermediate positions.

9. Filtration device according to one of claims 6 to 8, characterized in that the actuator (14) is movable with a sliding mechanism or a rotating mechanism in the defined positions.

10. Filtration device according to one of claims 6 to 9, characterized in that the defined positions of the actuator (14) are formed as locking positions.

1 1. Filtration device according to claim 10, characterized in that the actuator (14) with a prestressed actuating element (20) can be transferred into the locking positions.

12. Filtration device according to one of claims 9 to 1 1, characterized by a protective cover (22) surrounding the sliding or rotating mechanism and optionally the actuating element (20), wherein the protective cover (22) is preferably formed from a deformable and sterilizable elastomer ,

13. Filtration device according to one of claims 6 to 12, characterized in that the actuator (14) comprises a diaphragm (16) having a passage opening (18) which can be inserted into a line section (12) of the flow reducer (10).

14. Filtration device according to one of claims 6 to 12, characterized in that the actuator (14) comprises a in a line section (12) of the flow reducer (10) movable body (24) having a passage (26), in the first position the actuator (14) in the flow direction and in the second position of the actuator (14) is aligned substantially transverse to the flow direction.

Filtration device according to claim 14, characterized in that the body (26) and the passageway (28) of the actuator in the second position provide crescent-shaped passageways (30).

16. Filtration device according to one of claims 6 to 12, characterized in that the actuator (14) in a line section (12) of the Flux reducer (10) is rotatable disc whose outer diameter is smaller by a defined amount than the inner diameter of the conduit section (12) and / or whose outer contour has one or more outwardly extending inwardly recesses.

17. Filtration device according to one of claims 6 to 12, characterized in that the actuator (14) has diaphragm sections (32) which cooperate with diaphragm sections (36) at an outlet opening of the flow reducer (10).

18. Filtration device according to claim 16, characterized in that in the first position of the actuator (14), the diaphragm sections (32, 36) are largely one above the other, so that free spaces (38) remain, and that in the second position of the actuator (14). the diaphragm sections (32, 36) largely cover the free intermediate spaces (38), leaving a defined free flow passage (40).

19. Filtration device according to one of claims 6 to 12, characterized in that the flow reducer (10) has a two subsections (42, 44) divided line section (12) having orifices facing each other, and that the actuator (14) has a axially displaceable cone comprises, which in the first position of the actuator (14) less far into the mouth of one of the sections (44) is immersed than in the second position of the actuator (14).

20. Filtration device according to claim 19, characterized in that the cone is attached to an axially positionable sleeve (46) which connects the two sections (42, 44) with each other.

21. Filtration device according to claim 20, characterized in that the sleeve (46) has an internal thread (48) which engages in an external thread (50) on one of the subsections (44).

22. Filtration device according to claim 21, characterized in that the sleeve (46) is fixedly connected to the other portion (42).

23. Filtration device according to one of claims 19 to 21, characterized in that the cone with struts (54) is held on the sleeve (46), between which free spaces remain.

24. Filtration device according to one of claims 6 to 12, characterized in that the flow reducer (10) has a line section (12) which is designed as a flexible hose and that the actuator (14) in the second position the effective flow cross-section of the hose to reduced a certain amount.

25. Filtration device according to claim 24, characterized in that the actuator (14) has a hose clamp with two relatively deflectable

Terminal portions (60, 62) which engage the outer wall (58) of the hose.

26. Filtration device according to claim 25, characterized in that the terminal portions (60, 62) via a joint (64) are interconnected.

27. Filtration device according to claim 24, characterized in that the actuator (14) is designed as a bendable joint rail with two substantially rigid sleeve sections (66, 68) and an interposed articulated joint (70), wherein the two sleeve sections (66, 68) each surrounded a portion of the line section (12).

28. Filtration device according to one of claims 6 to 12, characterized in that the actuator (14) comprises movable flaps (72, 74) which are arranged in a line section (12) of the flow reducer (10) and by means of an outside of the line section ( 12) generated force field (82) are deflectable.

29. Filtration device according to claim 28, characterized by a outside of the line section (12) arranged force field generator (84).

30. Filtration device according to claim 28 or 29, characterized in that the flaps (72, 74) by means of joints (76, 78) on a wall (80) of the line section (12) are mounted.

31. Filtration device according to one of claims 28 to 30, characterized in that the deflection of the flaps (72, 74) is limited by flap stops.

32. Filtration device according to one of claims 6 to 12, characterized in that a line section (12) of the flow reducer (10) has a

Main line section (86) having a first valve (88) as an actuator (14) and a bypass line portion (90) for bypassing the first valve (88), wherein the flow cross-section of the bypass line portion (90) is smaller than the flow cross-section of the main line section (86) ,

33. Filtration device according to claim 32, characterized in that the first valve (88) the main line section (86) completely open and can close completely.

34. Filtration device according to claim 32 or 33, characterized in that in the bypass line section (90), a second valve (92) is provided.

35. Filtration device according to one of claims 32 to 34, characterized in that the first valve (88) and / or the second valve (92) can assume a plurality of positions in which different flow cross sections are released.

36. A method for fully wetting a filter membrane in a filtration device according to one of the preceding claims as part of a purging process, characterized in that the flow reducer (10) is in the second operating position, which allows a defined second volume flow, which is less than the first volume flow such that the purge of the reduced volume filter means occurs to completely wet the filter membrane, the flow reducer (10) being brought to the first operating position after the purge operation to perform a filtration process.

37. The method according to claim 36, characterized in that the complete wetting of the filter membrane while saving flushing medium, in particular of water for injection purposes, by 10 to 95%, preferably by 50 to 95%, more preferably 85 to 95% compared to the complete wetting without pressure reduction takes place.