Preconfigured disposable filter device

Abstract

A disposable filter device (10) comprises a plurality of disposable filter bladders (12) connected to one another by rigid lines, at least a portion of which is securely seated in a grid universally preset by a support (14). The filter capsule (12) is pre-configured in particular with respect to the filter type, the structure type and / or the structure size and / or the connection of the filter capsule (12) for a desired filtration process.

Description

[0001] This application is a divisional application of patent application No. 201880034096.X, filed on May 15, 2018, with the title "Pre-configured disposable filtration device". TECHNICAL FIELD

[0002] The present invention relates to a pre-configured disposable filtration device, in particular for large volume filtration processes. BACKGROUND

[0003] Generally, in the pharmaceutical manufacture of high-quality active substances, disposable processes are increasingly used due to the high flexibility that can be achieved thereby and the saving of time, input and operating outlay, such as cleaning and its verification and inspection. Disposable systems used for this purpose ("disposables", "single use systems") are to be distinguished from reusable systems which, after a single use, cannot simply be cleaned, but must be cleaned, sterilized and tested for each continued use. Disposable systems are desirable not only for small-volume processes, but also for larger scales, where the cost of such systems should not unreasonably increase.

[0004] In processes with bioreactors, which can now also be provided as disposable reactors in sizes of 500, 1000 and 2000 liters, there is a need for filtration of the culture medium and after cell harvesting, for which a total filtration volume of several thousand liters is to be filtered. There is a need for filters with correspondingly high total filtration areas. Such large filtration processes with total filtration areas of up to 50 m2are currently carried out with equipment in which filter candles (e.g. multiple wheel systems) are used in a stainless steel housing. The equipment is therefore still designed to be reusable. This results in disadvantages such as low flexibility, high cleaning outlay, production standstill due to cleaning, etc. To date, no corresponding disposable solution is available for use in this scale. 2

[0005] The disposable filtration device presented in WO 2017 / 032560 A1, which can be completely pre-sterilized, easily connected and integrity tested, provides a remedy, which is designed for large volume filtration processes. The disposable filtration device comprises a plurality of standard-sized disposable filtration capsules, which are connected to one another by lines and are supported by a rigid carrier. Different types of filtration capsules can also be used within the same device. The lines between the filtration capsules can be configured as rigid pipes or formed by a plurality of uniform inflow and / or outflow devices.

[0006] ​EP 2 915 571 A1 shows a reusable filter device with a frame structure for accommodating a plurality of filter modules. The individual filter modules can be connected with a distribution pipe in a parallel arrangement, a series arrangement or a combination of both.

[0007] From DE 33 21 038 C2 it is known that a reusable filter cartridge filter group can be connected in parallel or sequentially by valves, wherein the filter respectively comprises a plurality of filter cartridges.

[0008] US 4 909 937 A shows a reusable filter device, wherein the individual filter areas can be selectively tested for integrity. For this purpose, intermediate areas are provided between the filter cassettes, which can be filled with fluid for flushing, sterilization, etc. The intermediate areas are connected via connections. All connections and delivery lines can be provided with shut-off valves.

[0009] From EP 0 051 373 A2 a reusable device for testing filters in one housing is disclosed, in which also the prescribed filtration process is carried out. SUMMARY

[0010] The main object of the present application is to provide a disposable filter device designed for a large-volume filtration process, which can be designed individually for the desired filtration process and its requirements.

[0011] The object is achieved by a disposable filter device according to the application. Advantageous and object-compliant design solutions of the disposable filter device according to the application are given herein.

[0012] The disposable filter device according to the application comprises a plurality of disposable filter capsules which are connected to one another by rigid lines, at least a part of the filter capsules being fixedly arranged in a grid which is generally preconfigured by a holder. The filter capsules, in particular in terms of filter type, structure type and / or structure size, and / or the connection of the filter capsules, are preconfigured for the desired filtration process.

[0013] The present application is based on the insight that in a large disposable filtration device an efficient construction for performing a special, individualized designed filtration process can be realized, which has suitable holders which in principle can accommodate different disposable filter capsules and suitable line members which can realize different flow paths for variably connecting the filter capsules. The disposable filtration device according to the present application is optimized in particular with regard to space requirements and handling. Due to the pre-set grid for the filter capsules, the preferably rigid connecting lines can be very short, so that material and installation effort is minimized. After assembly of the filter capsules and their connecting pieces, the modularly constructed disposable filtration device can be enclosed as a whole, in particular airtight, and then pre-sterilized (in particular by gamma ray sterilization or hot steam sterilization), so that it can be put into operation immediately after delivery without having to add or secure further components.

[0014] According to an advantageous aspect of the present application, at least some of the filter capsules can differ in filter type, structure type and / or structure size. Different structure types should also include different connection types and / or different filter types. Through the selection possibilities for the filter capsules, the individual filtration steps can be optimally adapted to the respective requirements (flow rate, permeability, filter area, etc.).

[0015] The variably composed lines also contribute to the diversity of the filtration processes which can be realized with the aid of the disposable filtration device according to the present application. The lines can form a plurality of line branches with the associated filter capsules, which are successively or in parallel flowed through.

[0016] With the aid of the disposable filtration device according to the present application, it is also possible to perform several processes or sub-processes simultaneously. For this case it is proposed that the lines form at least two separate, mutually independent line branches with the associated filter capsules.

[0017] According to a particularly preferred embodiment form of the present application, the pre-set grid is a 3x3 grid for up to nine filter capsules and the lines are pre-configured in such a way that three or fewer filter capsules arranged in a row of the grid belong to a line branch. On this basis, a large number of practical constructions can be realized in a compact form. For example, a plurality of disposable filtration units according to the present application can be combined with one another and connected in parallel or in series. Through the construction as a grid, a modular combination of a plurality of filtration devices can be realized particularly compactly. Other grids are generally conceivable, for example a 1x2, 1x3, 1x4, 1x5, 1x6, 2x2, 2x3, 2x4, 2x5, 2x6, 3x4, 3x5, 3x6, 4x4, 4x5, 4x6, 5x5, 5x6 or 6x6 grid.

[0018] The pre-configuration of the disposable filtration device according to the application has already been able to provide that at least two parallel line branches have a common inlet and / or a common outlet. It is then no longer necessary to combine the line branches before commissioning.

[0019] It is possible to propose in a specific configuration that only sterile filtration capsules or only pre-filtration capsules are used. However, a configuration with a combination of at least one sterile filtration capsule and at least one pre-filtration capsule is generally particularly advantageous.

[0020] According to a particularly advantageous aspect of the application, a control filtration device, preferably in the form of a sterile filtration capsule, is provided in the line branch connected downstream. The task of the control filtration device is to ensure that a sterile filtrate is indeed produced as a "last process". The sterility of the filtrate can be confirmed by an integrity test of the control filtration device. That is to say, in the event of a passed integrity test of the control filtration device, it can be reliably assumed that it has properly fulfilled its function and that the filtrate is sterile.

[0021] It is advantageous in a specific configuration for a control filtration device, preferably in the form of a sterile filtration capsule, to be provided in each of a plurality of parallel line branches connected downstream, in particular when it turns out that the filter area of only one control filter is not sufficient.

[0022] In order to be able to achieve not only the use of a control filtration device connected downstream, but also its integrity independently of the remaining filtration capsules of the disposable filtration device without time-consuming retrofitting or other structural modifications, the application proposes that the control filtration device is part of a separate integrity test assembly for the control filtration device and comprises a sterilisable air filter. In the use of such an assembly, which can be fluidically separated from the remaining disposable filtration device, it is possible to perform an integrity test of the control filtration device before the prescribed filtration process, if desired (pre-use integrity test), since the sterilisable air filter prevents contamination of the still required control filtration device, and / or only after the prescribed filtration process (post-use integrity test).

[0023] Especially advantageous for such a separate construction of the control filter device and the integrity test which can be performed without modification is a construction in which at the inflow and outflow of the control filter device a first branch member on the inflow side and a second branch member on the outflow side are connected, wherein the outlet of the sterilizable air filter is connected at one of the two free ends of the first branch member via an intermediate access first shut-off valve, wherein optionally a waste container is connected at one of the two free ends of the second branch member via an intermediate access second shut-off valve, wherein by means of the other free end of the first branch member the assembly consisting of the control filter device, the air filter, the optional waste container, the first and second shut-off valves and the two branch members is connected via an intermediate access third shut-off valve with the outside of the disposable filtration plant. In general, irrespective of the specific shape or type of construction of the members, a branch member is to be understood as an arbitrary connecting piece by means of which a branching is achieved. For example, T- or Y-shaped connecting pieces or multi-way valves are to be included therein.

[0024] In the construction defined above, the remaining other free end of the second branch member preferably forms a filtrate outlet of the disposable filtration plant, which can be closed by means of a fourth shut-off valve.

[0025] However, the accessibility of the control filter device can be ensured by arranging the control filter device in a line branch outside.

[0026] However, the control filter device can also be arranged spatially separate from the pre-set grid for the filter capsules.

[0027] According to a further particularly advantageous aspect of the application, a central vent for the entire disposable filtration plant is provided. This is achieved by means of a sterilizable air filter arranged on the external interface in the upper part of the disposable filtration plant, which is used for venting the disposable filtration plant. Furthermore, the integrity of the entire disposable filtration plant can be tested via the sterilizable air filter.

[0028] Such a vent filter must be sufficiently protected so that it is not blocked. In this context, a blockage is to be understood as a certain film formation of water or the remaining medium on the felt supporting the air filter membrane. As a result, there is a restriction in the air flow or no air flow at all. This problem exists especially when the air filter membrane and the felt supporting the air filter membrane consist of gamma-sterilizable materials. The present application provides various possibilities which can be combined with one another if necessary to protect the air filter or to be able to foresee a possible blockage so that measures can be taken in time.

[0029] For example, between the external interface of the disposable filter device and the inlet of the air filter, it is possible to interpose a hydrophobic protective filter for protecting the air filter, which prevents water from passing through.

[0030] In particular, it is advantageous for the protective filter to be configured as a planar filter, which is configured without a supporting fleece, wherein the protective filter membrane is preferably formed from polyvinylidene fluoride (PVDF), polyethylene (PE), hydrophobic polyether sulfone (PESU) or polytetrafluoroethylene (PTFE). The materials mentioned ensure that a clogging due to a deposit of water on the membrane itself is largely avoided. Furthermore, because a supporting fleece is intentionally not provided, a film formation is excluded, which would otherwise be possible. By this it is ensured that the air filter connected downstream is not contacted with water and in turn does not clog, although a supporting fleece would be available there.

[0031] The following possibility of visual control is directed at the flow path located between the external interface of the disposable filter device and the air filter. In common filter devices, a possibility of visual control is not present, because the pressure-resistant hose material is opaque or only partially transparent. The possibility of visual control introduced here enables the operator to recognize a water ingress into the flow path leading to the air filter and to take timely measures before the air filter can be wetted and its functionality impaired.

[0032] It is thus possible to propose that a part of the flow path between the external interface and the air filter is configured as a viewing opening. The known term "viewing opening" denotes a transparent tube section and should not be understood as being limited in terms of material selection. In addition to real glass, transparent plastics can also be used to configure the tube section.

[0033] A further solution consists in providing at least one indicator reacting to water in the flow path located between the external interface and the air filter, for example by a clearly visible color change.

[0034] Instead of the fabric-reinforced, in turn opaque silicone hose usually used for connecting the air filter, it is also possible to propose that a part of the flow path located between the external interface and the air filter is formed by an at least partially transparent silicone hose, which is surrounded by a transparent supporting sheath. The sheath ensures that the silicone hose itself withstands high test pressures. Due to the transparency of the hose and the sheath, a passage of water can be recognized.

[0035] According to a further particularly advantageous aspect, the application also provides a disposable manifold, in particular for a disposable filtration device, composed of sterilizable plastic. The disposable manifold according to the application is one-piece and has at least one branch and / or at least one bend. A branch is to be understood here as a branch-off from the main path, and a bend is to be understood as a very strong bending or meandering of the main path, which causes a significant change in direction of the flow path, for example a 90° change in direction.

[0036] In contrast to known pipe connections, the disposable manifold according to the application enables a more compact construction of such a device with fewer connections, wherein known pipe connections can only form a multiple-way device in combination with additional angle pieces and a large number of connections, which in turn each require a seal. In practice, a space saving of up to 80% and a connection saving of up to 55% can be achieved. Furthermore, the process reliability is increased, while at the same time the complexity of the installation is reduced.

[0037] The disposable manifold according to the application is preferably designed to be pressure-stable, so that it can withstand a pressure of more than 5 bar, preferably more than 10 bar.

[0038] Preferably, a rupture disc is integrated in the disposable manifold according to the application. Such a rupture disc functions as a desired breaking point and can in principle be provided at any point on the disposable manifold, for example integrated in one of the inlet / outlet openings, or however also integrated into the side wall. It serves to protect the installation from damaging over / under pressure. In particular, the rupture disc can be provided between the filtration device and the air filter by means of a T-piece or the like, wherein the branch leads to the rupture disc.

[0039] The disposable manifold according to the application can be assembled into any composite piece in a pressure-stable and torsion-resistant manner, for example by means of TRI clamps, screw connections or welding. Alternatively, sterile connectors can be placed directly on the open ends of the disposable manifold.

[0040] According to a preferred embodiment, at least one bend is formed on the open end of the disposable manifold.

[0041] When the disposable manifold according to the application is provided at the uppermost point of the device, it can also be used to vent the entire disposable filtration device. In this case, the disposable manifold is provided with a separate venting outlet, which points upwards in the installed position.

[0042] According to an advantageous refinement, the disposable manifold is formed from transparent plastic, in order to better observe the venting process, for example. BRIEF DESCRIPTION OF DRAWINGS

[0043] Further features and advantages of the present application will become apparent in the light of the following description and referenced drawings. In the drawings:

[0044] Figure 1 Schematic representation of a perspective view of a disposable filtering device;

[0045] Figures 2a to 2d Schematic representation of different variants of a first embodiment of a disposable filtering device according to the application without support in side view or top view;

[0046] Figures 3a to 3c Schematic representation of different variants of a second embodiment of a disposable filtering device according to the application without support in side view or top view;

[0047] Figure 4a and 4b Schematic representation of different variants of a third embodiment of a disposable filtering device according to the application without support in top view;

[0048] Figures 5a to 5c Schematic representation of different variants of a fourth embodiment of a disposable filtering device according to the application without support in side view or top view;

[0049] Figure 6 Schematic representation of different variants of a fifth embodiment of a disposable filtering device according to the application without support in top view;

[0050] Figures 7a to 7f Schematic representation of different variants of a sixth embodiment of a disposable filtering device according to the application without support in side view or top view

[0051] Figures 8a to 8h Schematic representation of different variants of a seventh embodiment of a disposable filtering device according to the application without support in side view or top view;

[0052] Figures 9a to 9c Schematic representation of different variants of an eighth embodiment of a disposable filtering device according to the application without support in top view;

[0053] Figure 10 Schematic representation of different variants of a ninth embodiment of a disposable filtering device according to the application without support in side view;

[0054] Figure 11 Schematic representation of a perspective view of a first embodiment of a manifold according to the application;

[0055] Figure 12a and 12b a comparison between a combination of a pipe junction according to the application and a conventional combination of pipe junctions is shown in a top view; and

[0056] Figure 13 a schematic illustration of an arrangement of a pipe junction according to the application with disposable containers. DETAILED DESCRIPTION

[0057] A disposable filter device 10 is shown in Figure 1 which is similar to the device known from WO 2017 / 032560 Al. A plurality of filter capsules 12 is held in position by a rigid holder 14 in a preset arrangement (grid). The term "filter capsule" is generally understood here and shall mean any independently mountable unit with at least one filter.

[0058] The holder 14 comprises at least two opposite side walls 16 which are connected to each other by transverse struts 18, wherein the side walls 16 can have feet 26. A handle (not shown) can also be provided on the holder 14 in order to simplify handling. On the transverse struts 18, holding mechanisms 20 for the respective filter capsules 12 are provided.

[0059] The filter capsules 12 are connected to each other completely or at least mostly by rigid, pressure-stable conduits 22. The course of the conduits 22 is determined by the prescribed operation of the filter device (parallel or series connection of the filter capsules 12), wherein the conduits 22 have the necessary branches 24 to the respective filter capsules 12. If necessary, the conduits 22 are fixed on the holder 14.

[0060] The rigid holder 14, the rigid housing of the filter capsules 12 and the main components of the rigid conduits 22 are preferably each formed from the same material. The material and, if necessary, further materials used in the device 10 (for example for possible flexible hose lines) are sterilizable, in particular by means of gamma-ray sterilization, or are resistant to high-pressure heating. The filter device 10 can thus be sterilized and encapsulated in the preassembled, i.e. connected, state.

[0061] A pipe junction according to the application is shown in Figure 2aA further embodiment of the filter device 10 is schematically shown, however, without the holder 14. Here, instead of the ducts 22 and branches 24, rigid inflow and outflow devices 30, 32 are provided, which consist of sterilizable, in particular gamma sterilizable, plastic. More precisely, for each filter capsule 12 shown here by means of a filter candle 28 accommodated therein, there is a self inflow device 30 and a self outflow device 32, which match the inflow and outflow interfaces of the end sides of the respective filter capsule 12. The inflow devices 30 and the outflow devices 32 are identically or at least largely identically configured. The inflow devices 30 and the outflow devices 32 each have two opposite outer interfaces 34. A plurality of inflow and outflow devices 30, 32 can be connected to one another under controlled conditions by means of suitable connecting members 36, for example TRI clamp connections. For this purpose, there is a seal (not shown) between the inflow and outflow devices 30, 32, respectively. Alternatively, the inflow and outflow devices 30, 32 can also be connected, for example, by clamping, screwing or welding. In this way, any number of filter capsules 12 can be combined together. The unnecessary outer interfaces 34 are sealed by means of suitable closure pieces 38. The closure pieces 38 or blind covers are likewise arranged by means of suitable connecting members 36. The inflow and outflow devices 30, 32 can be configured in one piece as a set or as a prefabricated unit. In particular, they can be configured in one piece or pre-installed before the plurality of inflow devices 30 and / or outflow devices 32 are arranged on the filter capsules 12.

[0062] In particular, in embodiments with a plurality of connected inflow devices 30 and / or outflow devices 32, the inflow devices and / or outflow devices can also be referred to as series connection covers, which offer a number of advantages compared to other line connections. In particular, large ducts 22 and connecting members 36 are not required or at least required to a lesser extent. The series connection covers enable parallel flow to a plurality of filter capsules 12 and can be combined arbitrarily in terms of the construction size and construction type of the filter capsules 12. Overall, the series connection covers of the disposable filter device 10 provide a more compact, smaller construction size, also because the holder 14 can be smaller. Since fewer components are required when using series connection covers, the disposable filter device 10 is overall more environmentally friendly and easier to install.

[0063] Figures 2b to 10 Further examples of different configurations (arrangements) of the disposable filter device 10 are schematically shown, in which the same reference signs are used for corresponding components.

[0064] In all embodiments, at least the filter capsules 12 designed for the main filtration process are housed in a pre-set grid that can be held in place by a support 14 or another retaining device. The filter capsules 12 themselves (filter type, structural type, structural dimensions, etc.) and the connections between them are freely pre-configurable via conduits 22 or inlet and outlet devices 30, 32. The conduits 22 or inlet and outlet devices 30, 32 define the flow path through each filter capsule 12, which can form different pipeline branches that are sequentially or in parallel. Furthermore, all embodiments share the characteristic that they can be delivered to customers by the supplier in a sterile condition. This is achieved, for example, by encapsulating disposable filtration equipment and subsequently sterilizing it using gamma rays.

[0065] First, before discussing the different aspects of the invention and the feasibility of specific applications, the different constructions themselves will be briefly described.

[0066] exist Figures 2b to 2d The top view exemplarily illustrates three different structural variations, which are based on... Figure 2a The embodiment of the disposable filtration device 10 shown herein has an upright filter capsule 12, with its inlet ports located at the upper end and its outlet ports located at the lower end. Figures 2b-2d (and the appendix, which will be discussed later) Figure 3b , 3c Of the following (4a, 4b, 5b, 5c, 6, 7b-7f, 8b-8h and 9a-9c), the filter capsule 12 is shown schematically only without a housing, in order to illustrate the arrangement of the (different) filter capsules 12.

[0067] According to Figure 2b In the modified scheme, a total of nine filter bags 12 are used, with three filter bags 12 arranged sequentially in each pipeline branch. These three pipeline branches are run in parallel and have a common inlet 40 and a common outlet 42. According to... Figure 2c The variant has only two parallel pipeline branches, according to Figure 2d The variant has only one pipeline branch. In all variants, the same type of filter capsule 12 with the same filter structure is used. Figures 2b to 2d The filter capsule shown is a filter capsule 12 with a sterile filter (hereinafter referred to as sterile filter capsule 12a); however, a filter capsule 12 with a pre-filter (hereinafter referred to as pre-filter capsule 12b) may also be provided.

[0068] exist Figures 3a to 3c The structure shown in the middle also has multiple parallel flow-through pipe branches. However, a pre-filter 12b is used here. Furthermore, according to...Figure 3b and 3c In the configuration of Figure 3b ) or only one filter capsule ( Figure 3c ) is provided per line branch. In addition, a further filter capsule is provided, here a sterile filter capsule 12a. This sterile filter capsule 12a is arranged behind the merging outlet 42 of the line branches in the flow direction, i.e. it is traversed by the filtrate of all line branches.

[0069] In the embodiment of Figures 3a to 3c different structural types of filter capsules 12 can be seen. The prefilter capsule 12b has an inflow interface and an outflow interface on opposite ends of its elongated base body. The structural type of the sterile filter capsule 12a thus differs in that its inflow interface and its outflow interface are arranged at the same end of the capsule. The base body of the capsule thus extends transversely to the interfaces, which are generally opposite each other. This structural type is referred to as "T-shaped".

[0070] The filter capsules 12 can also have only one inlet and only one outlet and are preferably integrated into the line lying flat. This structural type is referred to as "linear".

[0071] What linear and T-shaped filter capsules have in common is that a plurality of filter capsules can be connected in series by means of them. In the structural type with a series connection cover, the plurality of filter capsules is flowed through in parallel.

[0072] In the configuration of Figures 3a to 3c the sterile filter capsules 12a each have a function of controlling the filter, which will be discussed in more detail later.

[0073] In the configurations shown in Figure 4a and 4b the disposable filter device 10 has a plurality of line branches, as long as the line branches are independent of each other. Thus, each line branch has a separate inlet and a separate outlet. However, all line branches are fixed components of the preconfigured disposable filter device 10. The line branches have different types of filter capsules 12a, 12b, 12c, 12d and 12e, wherein the filter capsules can differ in filter type (prefilter, sterile filter, etc.), structural type (series connection cover, linear, T-shaped, etc.) and structural size.

[0074] The supplier can offer different processes themselves by means of this modular configuration or also one, two or more process steps. Thus, the customer can carry out different processes or sub-processes with different configurations within the unique disposable filter device 10. Here, the filter device 10 is particularly space-saving and its installation is particularly time-saving.

[0075] Figures 5a to 5c and Figure 6 The configuration of Fig. 2 has a combination of a plurality of sterile filter capsules 12a and one or more upstream pre-filter capsules 12b. The pre-filter capsules 12b are arranged in the inlet line branch from which two in parallel throughflowed line branches with sterile filters 12a branch off. The pre-filter capsules 12b are here configured as T-shaped capsules and are integrated by means of their inflow and outflow interfaces into the (here upper) inlet line branch, so that the opposite ends of the pre-filter capsules 12b hang down. However, a lying arrangement with linear capsules is also possible.

[0076] The configuration shown in Fig. 3 differs from the configuration of Fig. 2 in the arrangement of the inlet 40 and outlet 42 and the number of pre-filters 12b and sterile filters 12a. The sterile filter capsules 12a are connected downstream of the pre-filter capsules 12b, which are arranged in parallel inlet line branches. The sterile filter capsules 12a are arranged "upright", i.e. their inflow and outflow interfaces are integrated into the lower inlet line branch, so that the opposite ends of the sterile filter capsules 12a project upwards. However, a lying arrangement with linear filter capsules 12 is also possible. Figures 7a to Figure 7f Figures 5a to 6 The configuration shown in Fig. 4 differs from the configuration of Fig. 3 in the arrangement of the inlet 40 and outlet 42 and the number of pre-filters 12b and sterile filters 12a. The sterile filter capsules 12a are connected downstream of the pre-filter capsules 12b, which are arranged in parallel inlet line branches. The sterile filter capsules 12a are arranged "upright", i.e. their inflow and outflow interfaces are integrated into the lower inlet line branch, so that the opposite ends of the sterile filter capsules 12a project upwards. However, a lying arrangement with linear filter capsules 12 is also possible.

[0077] In the configuration of Fig. 5, the sterile filter capsules 12a are arranged in the middle line branch, while in the configuration according to Fig. 6, the sterile filter capsules 12a are arranged in the outer, easily accessible line branch. Figures 7a to 7e Figure 7f In the configuration shown in Fig. 7, the sterile filter capsules 12a are arranged in the middle line branch, while in the configuration according to Fig. 8, the sterile filter capsules 12a are arranged in the outer, easily accessible line branch.

[0078] In the configuration shown in Fig. 9, the sterile filter capsules 12a are arranged in the middle line branch, while in the configuration according to Fig. 10, the sterile filter capsules 12a are arranged in the outer, easily accessible line branch. Figures 8a to 8h ​​In Fig. 1 a different configuration is shown in which at least one sterile filtration capsule 12a in the form of a T-shaped or linear capsule is provided, which functions as a control filter (in the following for simplicity: control filter), as will be explained later. At the inflow and outflow of this control filter a first branch member 44 on the inflow side and a second branch member 46 on the outflow side are connected. The outlet of a sterilizable, in particular gamma-sterilizable, air filter 50 is connected at one of the two free ends of the first branch member 44 via an intermediate interposed first shut-off valve 48. A waste bag 54 is connected at one of the two free ends of the second branch member 46 via an intermediate interposed second shut-off valve 52. By means of the other free end of the first branch member 44 the entire assembly, which in the following is called disposable control unit 58, consisting of the control filter, the air filter 50, the waste bag 54, the two branch members 44 and 46 and the first and second shut-off valves 48, 52 is connected via an intermediate interposed third shut-off valve 56 with the outlet interface (external interface 34) of the remaining disposable filtration device 10. The other free end of the second branch member 46 finally is the filtrate outlet of the disposable filtration device 10. This filtrate outlet can be closed by a fourth shut-off valve 60, which likewise is a component of the disposable control unit 58.

[0079] In Fig. 2 a configuration is shown in which the disposable control unit 58 is arranged between two parallel throughflowing line branches with a prefilter 12b. In Fig. 3 a configuration is shown in which the disposable control unit 58 is arranged in the outer, easily accessible line branch of the disposable filtration device 10. Both configurations are relatively space-saving. Figure 8b Figure 8c In Fig. 2 a configuration is shown in which the disposable control unit 58 is arranged between two parallel throughflowing line branches with a prefilter 12b. In Fig. 3 a configuration is shown in which the disposable control unit 58 is arranged in the outer, easily accessible line branch of the disposable filtration device 10. Both configurations are relatively space-saving.

[0080] Figures 8d to 8h In Fig. 4 different further configurations are shown in which one or more parallel arranged disposable control units 58 are attached to one or more (common) outlets 42 of the line branches upstream of the disposable filtration device 10. This means that the disposable control units 58 are arranged outside the grid pre-set by the holder 14 of the disposable filtration device 10 for the filtration capsules 12, respectively, wherein the control units 58 still are components of the disposable filtration device 10.

[0081] Figures 9a to 9c In Fig. 5 other configurations are shown with a plurality of line branches independent of each other (similar to in Fig. 2 and 3). Figure 4a and 4b ​In the case of a multi-line filter system, the line branches are respectively fixed components of a pre-configured disposable filter device 10. The line branches have different types of filter capsules 12a, 12b, 12c, 12d and 12e, wherein the filter capsules can be different in filter type (pre-filter, sterile filter, etc.), structure type (linear, T-shaped, etc.) and structure size. At each line branch a separate disposable control unit 58 is attached. The user can thus check the control filter of each individual line accordingly.

[0082] In Figure 10 A disposable filter device 10 without a holder 14 is shown in which a sterilizable, in particular gamma-sterilizable, air filter 62 is connected to the upper external interface 34. The external interface 34 of the air filter 62 is optionally formed at the inflow or outflow device 30, 32. The air filter 62 can individually realize the exhaust of the entire disposable filter device 10, or a plurality of such air filters 62 are provided at different external interfaces 34. Between the external interface 34 and the inlet of the air filter 62 an intermediate access of a protective filter 64 is provided for protecting the air filter 62.

[0083] The above-described configuration is only one option of a plurality of possible configurations. Many further combinations are possible within the disposable filter device 10.

[0084] In the following, special aspects and specific application possibilities of the present application are explained in detail.

[0085] The disposable filter device 10 is arbitrarily pre-configurable before sterilization and delivery to the customer. Different types of filter capsules 12 (filter type, structure type, size, etc.) can be used at the pre-set locations by the holder 14. It is noted here that the holder 14 itself is also arbitrarily configurable. For example, the holder can pre-set a 3x3 grid for filter capsules 12 as well as a 2x3 grid or any other grid. Many combinations of filter capsules 12 are also possible, in particular a combination of pre-filter capsules 12b and sterile filter capsules 12a in the same disposable filter device 10, or a combination with a plurality of sterile filter capsules 12a having the same porosity, for example 0.2 μιη, or different porosities, for example 0.2 μιη and 0.1 μιη, as in redundant sterile filtration.

[0086] The filter capsules 12 are clamped, welded, screwed, glued or otherwise stably fixed to the appropriate holding mechanism 20.

[0087] By means of the conduits 22 and / or the inflow and outflow devices 30, 32, different flow paths with one or more line branches can be defined, which can be successively or in parallel be flowed through. Depending on the requirements, within the disposable filter device 10, interconnected line branches or separate, independent flow paths (process chains) can be realized by means of the filter capsules 12.

[0088] In this way, a space-saving, completely pre-sterilizable setup for different process steps can be constructed within the compact disposable filter device 10.

[0089] After the setup agreed with the customer has been constructed in the holder 14, the entire disposable filter device 10 is delivered as a packaged, sterilized and ready-to-use unit. The customer can use the disposable filter device 10 immediately after opening the packaging, since no further components have to be integrated into the disposable filter device 10 for the filtration process desired by him.

[0090] As exemplarily shown in Figure 8a , the entire disposable filter device 10 can be arranged on a trolley 66 or other mobile device to achieve better local mobility and handling. As already mentioned, the disposable filter device 10 can alternatively or additionally also have a handle on the holder 14.

[0091] In the embodiment shown in Figures 3a to Figure 3c and Figures 8a to 8h , the sterile filter capsule 12a serving as control filter has the purpose of ensuring as a "last process" that a sterile filtrate has indeed been produced. The sterility of the filtrate is confirmed by the passing of the integrity test of the control filter.

[0092] The control filter is arranged downstream of the filter capsules 12 of the disposable filter device 10 which are designed for the actual filtration process for the following reasons: When the disposable filter device 10 is tested for integrity, it can be inferred from the expected total diffusion (ml / min) that all filter capsules 12 or filter candles 28 do not exceed their respective limit values, wherein the total diffusion is derived from the expected values of all filter capsules 12 or of the individual filter candles 28 arranged in the filter capsules. For example, a defective filter candle 28 can exceed its limit value, while one or more other filter candles are below their limit values, so that the values are compensated for as long as the expected values of the entire disposable filter device 10 are not exceeded in total. However, a defective filter candle 28, for example, allows bacteria to pass through, which would result in the filtrate not being sterile overall. Therefore, after the conventional filtration, a separate control filtration by means of a separate filter capsule 12, in particular a sterile filter capsule 12a, is provided, through which the entire filtrate finally flows. This separate control filter can be reliably tested for integrity as a separate unit without great outlay. In the case of a passed integrity test of the control filter, it can be assumed that the filtrate obtained overall is actually sterile.

[0093] In addition or alternatively to the diffusion measurement, it is also possible to determine the so-called bubble point during the integrity test. The pores of the filter (0.2 μιη, for example, in the case of sterile filtration) are filled with wetting medium, which is most easily achieved by pressure flushing of the filter capsule 12a with pressure. For the test, the filter is preferably slowly pressurized from the inflow side. To squeeze the wetting medium out of the pores, a force (pressure difference of the two filter sides) is required. The pressure difference depends on the pore diameter. The pressure acting on the filter is increased, and as soon as a continuous bubble overflow is recognized, the pressure is read at the test device, for example, at a pressure gauge. Since the surface tension, the wetting angle and the pressure difference are known, the maximum pore of the membrane can be calculated theoretically and thus its quality can be determined. However, usually only the read pressure is compared with a limit value given by the filter manufacturer.

[0094] Depending on the configuration, two or more control filters can also be used in parallel.

[0095] The control filter is integrated into the disposable filter device 10, i.e. it is already a fixed component before the delivery of the sterilized disposable filter device 10. Therefore, the control filter does not have to be connected subsequently via a hose system, which can mean additional material and time outlay for building a reliable and stable connection. No additional holders or the like for fixing the control filter are required, since it is delivered together as a fixed part.

[0096] In Figures 8a to 9cIn the configuration shown in the figures, a particular advantage is that the integrity of the control filter (sterile filter capsule 12a) integrated into the disposable filtration device 10 can be tested without having to modify or disassemble components of the disposable filtration device 10. The integrity test can be performed directly before the prescribed use of the disposable filtration device 10 (pre-use integrity test) and / or after the use (post-use integrity test).

[0097] In the pre-use integrity test, the first shut-off valve 48 and the fourth shut-off valve 60 leading to the sterile air filter 50 at the filtrate outlet of the disposable control unit 58 are closed. The second shut-off valve 52 leading to the waste container 54 is open. After opening the third shut-off valve 56, the filter of the filter capsule 12, including the control filter, is wetted with a suitable liquid medium. The excess wetting medium enters the waste container 54. After wetting the filter, the third shut-off valve 56 is closed again, so that the disposable control unit 58 is fluidically separated from the rest of the disposable filtration device 10. The first shut-off valve 48 leading to the air filter 50 is opened. A test device is now connected to the inlet of the air filter 50, by means of which a test designed for the integrity test is performed, in particular a bubble point determination and / or a diffusion measurement of the control filter. In this case, sterile air is pumped into the disposable control unit 58 through the sterile air filter 50. During the integrity test, the liquid pressed through the control filter enters the waste container 54 and can be removed after the second shut-off valve 52 is closed. After the pre-use integrity test is completed, the first shut-off valve 48 leading to the air filter 50 is closed, and the third shut-off valve 56 and the fourth shut-off valve 60 are opened. The disposable filtration device 10, including the control filter, is now ready for the prescribed use.

[0098] Alternatively or in addition to the pre-use integrity test, a post-use integrity test can be performed after the filtration process in order to verify whether the control filter has failed. After the filtration process is completed, the third shut-off valve 56 and the fourth shut-off valve 60 at the filtrate outlet are closed. The first shut-off valve 48 leading to the air filter 50 and the second shut-off valve 52 leading to the waste container 54 are opened. Now, as described above, the integrity test can be performed by means of a test device connected to the inlet of the air filter 50. Alternatively, the filtrate can be disconnected before the test, and the waste container 54 can also be connected to the fourth shut-off valve 60 if necessary. In this case, in order to perform the post-use integrity test, the second shut-off valve 52 must be closed, and the fourth shut-off valve 60 must be opened. After the integrity test is completed, all open valves are closed in order that no liquid can escape uncontrolled when the entire disposable filtration device 10 is removed.

[0099] In the case of a control filter connected downstream according to the prior art via an additional hose system after use of the disposable filter device according to the regulations only, the execution of a pre-use integrity test makes no sense in principle, because the sterile system has to be disconnected, whereby the entire disposable filter device 10 would not be sterile. A post-use integrity test can be performed only after the control filter is separated from the hose system connected downstream of the disposable filter device 10. This is accompanied by additional time and work expenditure.

[0100] If the filter area of the control filter directly behind the prefilter capsule 12b and / or the sterile filter capsule 12a is insufficient, it is possible to connect two or more control filters in parallel flow in the disposable filter device 10 as well, as shown for example in Figure 8g and 8h . Each of the control filters in parallel can perform a pre-use integrity test and / or a post-use integrity test individually. The respective content applies to the construction shown in Figures 9a to Figure 9c , wherein a plurality of control filters are provided, which are attached to individual process chains of the disposable filter device 10, respectively.

[0101] In the disposable filter device 10, regardless of its specific construction, a sterilizable, in particular gamma-sterilizable, air filter 62 for venting is usually provided on one of the upper external interfaces 34, as shown schematically in Figure 10 . While in principle a plurality of such air filters 62 can also be provided, for the sake of simplicity it is assumed in the following that only one central air filter 62 is provided for all filter capsules 12 participating in the filter process according to the regulations, i.e. in addition to the possible control filter jointly arranged in the disposable control unit 58 with its own air filter 50. The air filter 62 is usually constructed as a candle filter having a pleated air filter membrane between two support felt sheets.

[0102] In principle, when filling the disposable filter device 10 with water or other liquids, it must be noted that the liquid can reach the air filter 62. The liquid can form a film on the support felt, thereby clogging the air filter 62. Due to the clogging of the air filter 62, no or only a small air flow is possible, whereby the essential function of the air filter 62 is limited. It should also be noted that the air filter 62 is also designed for testing the integrity of the participating filter capsules 12 or the entire disposable filter device 10 before or after starting or ending the filter process. Due to the clogging of the air filter, problems can arise in such tests.

[0103] In known filter devices it becomes difficult due to the fact that the air filter is usually coupled to the disposable filter device 10 by means of a fabric-reinforced hose. The use of a fabric-reinforced hose is due to the very high test pressure or the very high process pressure of the liquid filter. However, due to the fabric-reinforced hose, it is not visually possible for the operator to recognize whether water or another filter solution is moving towards the air filter. Therefore, it is not easy to switch off the filter process in time or to isolate the air filter by means of a valve or the like.

[0104] In the following, various possibilities are presented to avoid the problem of clogging the air filter 62 by water or filter medium. The individual solution aspects can also be combined with one another at will.

[0105] According to a first solution aspect, a protective filter 64 is interposed between the outer connection 34 and the inlet of the air filter 62, as shown in Figure 10 The protective filter 64 is configured as a planar filter without a supporting fleece or the like, wherein the air filter membrane can be formed from polyvinylidene fluoride (PVDF), polyethylene (PE), hydrophobic polyether sulfone (PESU) or polytetrafluoroethylene (PTFE). Since the protective filter 64 does not have a supporting fleece, the risk of clogging is minimized. The operator does not have to pay attention to possible clogging any more.

[0106] According to a second solution aspect, a part of the flow path between the outer connection 34 and the air filter 62 is configured as a stable observation opening. As already mentioned at the outset, the observation opening is to be understood as a transparent tube section, which can be formed in particular from glass or transparent plastic. The observation opening enables a visual control by the operator, who can take measures as soon as he recognizes that water or another medium has risen to the air filter 62. Here, the set volume flow, the length of the line to the air filter 62 and the position of the observation opening in this line determine the period of time left to the operator for taking measures before the water or the medium reaches the air filter 62.

[0107] According to a third solution aspect, at least one water-reactive indicator is provided in the flow path between the outer connection 34 and the air filter 62. Such a water contact indicator is available as a tape that turns red when in contact with water or a blue gel (silicone gel) that turns light pink. Such an indicator enables a visual control by the operator, who can take appropriate measures if necessary.

[0108] According to a fourth solution aspect, instead of a fabric-reinforced silicone hose, a standard silicone hose is provided, which is at least partially transparent, surrounded by a likewise transparent support jacket. As a jacket, for example, a tear-resistant film, a stable shell or a tightly fitting tube is considered. The jacket prevents the standard silicone hose, which is practically only allowed for low pressures, from bursting at high pressures. Due to the transparent material of the hose and the jacket, visual control by the operator is still possible.

[0109] In Figure 11 a rigid plastic manifold 68 is exemplarily shown, which can be used in the disposable filtration device 10, but also in other disposable filtration devices, especially in the biopharmaceutical sector.

[0110] The main purpose of the manifold 68 is to establish a fluid connection between two or more disposable components. The essentially tubular manifold 68 replaces, among other things, conventional hose connections and is composed of a sterilizable, especially gamma- sterilizable plastic and is pressure-heat-resistant. The plastic can be opaque or transparent. The manifold 68 is designed in such a way that it reliably withstands the required test pressure (of the order of 10 bar, for example).

[0111] In contrast to conventional hose connections and also known simple connections, the manifold 68 has, according to the embodiment shown in Figure 11 , three branches 70, which is composed of a strongly curved flow extension. More precisely, here the manifold 68 has at its two longitudinal ends each a bend 72 in the form of a 90° bend. The bends 72 are thus not obtained by assembling individual components, but are already integral parts of the manifold 68.

[0112] Figure 12a and 12b A comparison between the combination of two manifolds 68 ( Figure 12a ) and the combination of conventional manifolds ( Figure 12b ) is shown, as it is required for the interface of six filter capsules 12 at the branches 70, respectively. The comparison shows that, in contrast to the combination of conventional manifolds, only two manifolds 68 have to be connected to each other and a significant space saving is achieved.

[0113] The connection of two manifolds 68 can be realized, for example, by TRI clamp connections. Aseptic connectors can also be placed directly at the ends of the manifolds 68 or their branches 70. Furthermore, other connection types are also possible, such as screwing or welding. In all cases, the connections are pressure-stable so that they can withstand the required test pressure. Since there are fewer connection sites than in the combination according to the prior art, there is no risk of the manifolds 68 twisting into each other. Thus, the mechanical load of the filter capsules 12 is minimized.

[0114] Obviously, other embodiments of the manifold 68 with only one or several, if necessary differently extending, integrated bends 72 and / or branches 70 are possible, which have the same and possibly further advantages in general.

[0115] In principle, valves or other components can be connected directly at the open end or branches 70 of the manifold 68, so that the core of the disposable filtration device 10 can be configured without hoses, which is then clearly pressure-stable.

[0116] Figure 13 The manifold 68 is exemplarily shown together with possible other applications of the disposable container 74, for example in the form of a bag.

[0117] As already mentioned, the different aspects of the application can be combined with one another arbitrarily, as far as this makes sense.

[0118] The use of the disposable filtration device 10 and its components, in particular the different embodiments of the manifold 68 according to the application, is not limited to the (bio)pharmaceutical field.

[0119] List of reference signs:

[0120] 10 disposable filtration device

[0121] 12 filter capsule

[0122] 12a sterile filter capsule

[0123] 12b pre-filter capsule

[0124] 12c-12e further filter capsules

[0125] 14 holder

[0126] 16 side wall

[0127] 18 cross strut

[0128] 20 holding mechanism

[0129] 22 duct

[0130] 24 branch

[0131] 26 leg

[0132] 28 filter candle

[0133] 30 inflow device

[0134] 32 outflow device

[0135] 34 external interface

[0136] 36 connection member

[0137] 38 closure

[0138] 40 inlet

[0139] 42 outlet

[0140] 44 first branch member

[0141] 46 second branch member

[0142] 48 first shut-off valve

[0143] 50 air filter for integrity testing

[0144] 52 second shut-off valve

[0145] 54 waste container

[0146] 56 third shut-off valve

[0147] 58 disposable control unit

[0148] 60 fourth shut-off valve

[0149] 62 air filter for venting

[0150] 64 protective filter

[0151] 66 trolley

[0152] 68 manifold

[0153] 70 branch

[0154] 72 bend

[0155] 74 disposable container

Claims

1. A disposable filtration device (10) having a plurality of disposable filter capsules (12) interconnected by rigid tubing, at least a portion of the filter capsules being securely mounted in a grid universally pre-set by a bracket (14), wherein the filter capsules (12) and / or the connection of the filter capsules (12) is pre-configured for a desired filtration process, and the tubing forms a plurality of tubing branches having associated filter capsules (12), the plurality of tubing branches being sequentially or in parallel through which flow occurs. Its features are, i) The disposable filtration device is provided with a sterilizable air filter (62) disposed on an external interface (34) at the upper part of the disposable filtration device (10) for venting the disposable filtration device (10) and for testing the integrity of the entire disposable filtration device (10) before or after the start of the filtration process, wherein a portion of the flow path between the external interface (34) and the air filter (62) constitutes an observation port, or at least one indicator that reacts to water is provided in the flow path between the external interface (34) and the air filter (62), or a portion of the flow path between the external interface (34) and the air filter (62) is formed by at least partially transparent silicone hoses surrounded by transparent support sleeves; as well as ii) One or more disposable control units (58) are provided in a downstream pipeline branch, the disposable control unit having a control filtration device, wherein the control filtration device is a sterile filter capsule (12a) and is part of an assembly having a first branch member (44) and a second branch member (46) respectively connected to the inlet and outlet of the control filtration device, and an additional sterilizable air filter (50) connected via an intermediate first shut-off valve (48) to one of the two free ends of the first branch member (44) for venting the control filtration device and / or for performing a pre-use integrity test on the control filtration device to separate the fluid from the remaining disposable filtration equipment, and a waste container (54) is provided at one of the two free ends of the second branch member (46) and connected via an intermediate second shut-off valve (52). The assembly consisting of the control filter, the air filter (50), the waste container (54), the first and second shut-off valves (48, 52), and the two branch components (44, 46) is connected to the external interface (34) of the disposable filter device (10) via a third shut-off valve (56) that is accessed from the other free end of the first branch component (44). Each pipeline branch is attached to a separate one-time control unit (58).

2. The disposable filtration device (10) according to claim 1, characterized in that, At least some of the filter capsules (12) are different in terms of filter type, structure type and / or structural size.

3. The disposable filtration device (10) according to claim 1 or 2, characterized in that, The pipeline forms at least two separate, independent pipeline branches with their respective filter capsules (12).

4. The disposable filtration device (10) according to claim 1 or 3, characterized in that, The grid is a 3×3 grid for up to nine filter bags (12), and the pipeline is pre-configured such that three or fewer filter bags (12) in a row of the grid belong to pipeline branches.

5. The disposable filtration device (10) according to any one of claims 1, 3 to 4, characterized in that, At least two parallel pipeline branches have a common inlet (40) and / or a common outlet (42).

6. The disposable filtration device (10) according to any one of the preceding claims, characterized in that, All filter capsules (12) are sterile filter capsules (12b).

7. The disposable filtration device (10) according to any one of claims 1 to 5, characterized in that, All filter capsules (12) are pre-filter capsules (12a).

8. The disposable filtration device (10) according to any one of claims 1 to 5, characterized in that, It has a combination of at least one sterile filter capsule (12b) and at least one pre-filter capsule (12a).

9. The disposable filtration device (10) according to any one of the preceding claims, characterized in that, Control and filtration devices are installed in several parallel pipeline branches connected downstream.

10. The disposable filtration device (10) according to any one of the preceding claims, characterized in that, The other free end of the second branch member (46) forms the filtrate outlet of the disposable filtration device (10), which can be closed by a fourth shut-off valve (60).

11. The disposable filtration device (10) according to any one of the preceding claims, characterized in that, The control and filtration device is located in an external pipeline branch.

12. The disposable filtration device (10) according to any one of claims 1 to 10, characterized in that, The control filtration device is positioned outside a pre-defined grid for the filter capsule (12).

13. The disposable filtration device (10) according to claim 1, characterized in that, A hydrophobic protective filter (64) is inserted between the external interface (34) and the inlet of the air filter (62) to protect the air filter (62).

14. The disposable filtration device (10) according to claim 13, characterized in that, The protective filter (64) is configured as a planar filter without supporting felt, wherein the protective filter membrane is formed of polyvinylidene fluoride (PVDF), polyethylene (PE), hydrophobic polyethersulfone (PESU) or polytetrafluoroethylene (PTFE).

15. The disposable filtration device (10) according to any one of the preceding claims, characterized in that, The disposable filtration device is provided with at least one disposable manifold (68).

16. The disposable filtration device (10) according to claim 15, characterized in that, The disposable manifold (68) is made of sterilizable plastic and is a one-piece assembly including at least one branch (70) and / or at least one bend (72).

17. The disposable filtration device (10) according to claim 16, characterized in that, The disposable manifold (68) is designed to be pressure-stable, enabling it to withstand pressures greater than 5 bar.

18. The disposable filtration device (10) according to claim 16 or 17, characterized in that, A safety plate is integrated into the disposable manifold (68).

19. The disposable filtration device (10) according to any one of claims 16 to 18, characterized in that, The disposable manifold (68) is pressure-stable and torsion-resistantly assembled with another disposable manifold (68) by means of TRI clamp connection, spiral connection or welding, or a sterile connector is directly installed on the end of the disposable manifold (68).

20. The disposable filtration device (10) according to any one of claims 16 to 19, characterized in that, At least one bend (72) is formed at the open end of the disposable manifold (68).

21. The disposable filtration device (10) according to any one of claims 16 to 20, characterized in that, The plastic material forming the disposable manifold (68) is transparent.

22. The disposable filtration device (10) according to claim 1, characterized in that, The first branch member (44) or the second branch member (46) is a T-shaped or Y-shaped connecting pipe or a multi-way valve.

23. A method for performing a pre-use integrity test on a control filter in a disposable filtration device according to any one of claims 1 to 22, the method comprising the following steps: a) Set the first shut-off valve (48) at the sterilizable air filter (50) and the fourth shut-off valve (60) at the corresponding filtrate outlet of the disposable control unit (58) to the closed state. b) Set the second shut-off valve (52) at the waste container (54) to the open state. c) After opening the third shut-off valve (56), wet the filter of the filter bag (12), including the control filter, with a suitable liquid medium and allow excess wetting medium to enter the waste container (54). d) After wetting the filter, the disposable control unit (58) is separated from the rest of the disposable filtration device (10) by closing the third shut-off valve (56). e) Set the first shut-off valve (48) at the air filter (50) to the open state. f) Connect the test equipment for integrity testing to the inlet of the air filter (50), the integrity test being in particular a diffusion measurement and / or a determination of the bubble point of the control filter. g) After completing the integrity test in step f), close the first shut-off valve (48) at the air filter (50) and open the third shut-off valve (56) and the fourth shut-off valve (60).

24. The method of claim 23, wherein in step f), air sterilized by a sterile air filter (50) is pumped into the disposable control unit (58), and liquid pressurized through the control filter during the integrity test enters the waste container (54) and can be removed after the second shut-off valve (52) is closed.

25. A method for performing a post-use integrity test on a control filter in a disposable filtration device according to any one of claims 1 to 22, the method comprising the following steps: A) After completing the filtration process, i) close the third shut-off valve (56) and the fourth shut-off valve (60) at the filtrate outlet and open the first shut-off valve (48) at the air filter (50) and the second shut-off valve (52) at the waste container (54), or ii) disconnect the filtrate and connect the waste container (54) to the fourth shut-off valve (60), close the second shut-off valve (52) and open the fourth shut-off valve (60). B) Connect the test equipment for integrity testing to the inlet of the air filter (50), the integrity test being in particular diffusion measurement and / or determination of the bubble point of the control filter. C) Optionally, after the integrity test is completed, close all open valves.

26. A method for performing an integrity test on a control filter in a disposable filtration device according to any one of claims 1 to 22, the method comprising the following steps: AA) Perform the method according to claim 23 or 24, BB) The desired filtration process is performed using the disposable filtration device, and CC) performs the method of claim 25.

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