Method for performing a filter test and sterile filter set with instructions for performing such a method

Abstract

Method for performing a filter test, wherein a) a plurality of hoses (5) are or are laid from a first cleanroom (17.1) of a first, higher cleanroom class to a second cleanroom (17.2) of a second, lower cleanroom class, wherein a sterile filter set (1) is provided in the first cleanroom (17.1), wherein at least one fluid container (19), at least one drain container (21) and a filter test device (23) are provided in the second cleanroom (17.2), wherein b) at least one first hose (5.1) of the plurality of hoses (5) is or becomes fluidically connected to the sterile filter set (1) with at least one first end, wherein c) the at least one first hose (5.1) of the plurality of hoses (5) is or becomes fluidically connected to the at least one fluid container (19) with at least one second end, wherein d) at least one second hose (5.2) of the plurality of hoses (5) is or becomes fluidically connected to the sterile filter set (1) with at least one first end, wherein the at least one second hose (5.2) of the plurality of hoses (5) opens into the at least one drain container (21) with at least one second end, wherein e) the filter set (1) is rinsed by passing a rinsing fluid from the at least one fluid container (19) through the filter set (1) into the at least one drain container (21), wherein f) after rinsing the filter set (1) the second end of the at least one first hose (5.1) is separated from the fluid container (19) and connected to the filter test device (23) in a flow-related manner, wherein g) a filter test is carried out using the filter test device (23).

Description

[0001] The invention relates to a method for carrying out a filter test and a sterile filter set with instructions for carrying out such a method.

[0002] Annex 1 of the EU GMP Guide, "Manufacture of Sterile Medicinal Products," is considered an important European regulation for the manufacture of sterile medicinal products. As part of a revision of Annex 1 of the EU GMP Guide, ongoing on the date determining the priority date of this intellectual property right, the requirements for procedures relating to pre-use / post-sterilization integrity testing (PUPSIT) are being discussed.

[0003] Pre-use / post-sterilization integrity testing (PUPSIT) is a procedure for performing a filter test after sterilizing the elements required for filtration and before filtering a fluid through these elements. Specifically, a filter test is used to verify the integrity and / or functionality of the filter, particularly its membrane.

[0004] Known devices for carrying out PUPSIT processes are complex in design and have a large number of elements, in particular more than 20 elements. Furthermore, the known devices are highly specific to a particular use and / or space in which the device is set up. Therefore, it is not possible to flexibly adapt the device to a different use and / or for placement in a different space.

[0005] Furthermore, known devices for carrying out PUPSIT processes incorporate plastic elements and / or silicone tubing. A disadvantage of these devices is that they are not thermally stable and therefore cannot be steam sterilized. Moreover, such devices are only suitable for use in specially equipped cleanrooms of cleanroom class A or isolators with a larger footprint, or in a cleanroom of a lower cleanroom class.

[0006] Furthermore, flexible adaptation of the known devices to changed test conditions and / or a modification of the design of the known devices is only partially possible.

[0007] German utility model DE 200 09 001 U1 discloses a device for arranging and testing several sterile filters connected in series. This device allows the integrity of each sterile filter connected in series to be tested simultaneously. Furthermore, US patent application US 2015 / 0 316 462 A1 discloses a dual-filter, dual-integrity test arrangement that enables in-situ testing of both filters with separate, dual membrane integrity systems. Additionally, US patent application US 2007 / 0 079 649 A1 discloses a filter housing with two or more filter layers. An outlet is provided between each pair of filter layers, through which gas or liquid can flow during an integrity test. Finally, international patent application WO 2022 / 136 565 A2 discloses a method and a device for an integrity test of a dual-filter capsule.A filter testing device for testing parallel filters in a cleanroom is known from US patent US 7,669,490 B2. Furthermore, a method and a device for testing the integrity of filter elements located in rooms with special safety requirements for cleanliness, sterility, or explosion protection are disclosed in German patent DE 44 13 081 C1.

[0008] The invention is therefore based on the objective of creating a method for carrying out a filter test and a sterile filter set with instructions for carrying out such a method, whereby the aforementioned disadvantages are at least partially eliminated, preferably avoided.

[0009] The problem is solved by providing the present technical teaching, in particular the teaching of the independent claims as well as the embodiments disclosed in the dependent claims and the description.

[0010] The problem is solved, in particular, by creating a method for performing a filter test, wherein in step a) a plurality of hoses are or are laid from a first cleanroom of a first, higher cleanroom class to a second cleanroom of a second, lower cleanroom class. Furthermore, in step a), a sterile filter set is provided in the first cleanroom. Additionally, in step a), at least one fluid container, at least one drain container, and a filter test device are provided in the second cleanroom. In step b), at least one hose of the plurality of hoses is or is connected to the sterile filter set via a fluid flow system at at least one end. In step c), the at least one hose of the plurality of hoses is or is connected to the at least one fluid container via a fluid flow system at at least one end.In step d), at least one second hose of the plurality of hoses is or is connected to the sterile filter set via a flow path, wherein the at least one second hose of the plurality of hoses with at least one second end opens into the at least one drain container. In step e), the filter set is rinsed by passing a rinsing fluid, in particular a predetermined quantity of rinsing fluid, from the at least one fluid container through the filter set into the at least one drain container. In step f), after rinsing the filter set, the second end of the at least one first hose is disconnected from the fluid container and connected via a flow path to the filter test device. In step g), a filter test is performed using the filter test device.

[0011] Advantageously, this method allows for a simple and quick filter test after sterilization and before use. Furthermore, it requires only a small number of components, making it easily adaptable to cleanrooms of varying sizes.

[0012] Furthermore, it is possible to carry out the process with existing elements, in particular hoses and valves, which advantageously means that no special elements need to be provided.

[0013] Furthermore, it is advantageously not necessary to open any connections, particularly aseptic connections, especially connections between hoses and the filter set, particularly with valves, and / or flow-related connections within the filter set, in the first cleanroom during the execution of the process. In particular, it is advantageously not necessary to open any connection, especially aseptic connections, in the first cleanroom during the execution of the process. In particular, it is advantageously not necessary to disconnect a hose or multiple hoses from the filter set after this connection has been established. This advantageously prevents a fluid or gas from escaping in the first cleanroom.

[0014] In particular, this method makes it possible to pass a predetermined amount of rinsing fluid through the filter set. This advantageously allows for control of the filter set rinsing process, ensuring compliance with relevant guidelines.

[0015] A cleanroom is defined as a room in which the concentration of airborne particles, particularly aerosols, is controlled and kept below predefined thresholds. Specifically, a cleanroom is classified according to these predefined thresholds, and a cleanroom class can be assigned to each cleanroom. A higher cleanroom class, compared to a lower cleanroom class, means that the predefined thresholds in the higher cleanroom class are lower than in the lower cleanroom class.

[0016] In one embodiment, a cleanroom of cleanroom class A is used as the first cleanroom, the cleanroom class being determined according to the version of Annex 1 of the EU GMP Guide valid on the date determining the priority date of this patent. Alternatively or additionally, a cleanroom of cleanroom class B or C is used as the second cleanroom. Advantageously, this makes it possible to carry out the process in a small first cleanroom of the first, higher cleanroom class. This allows the process to be carried out cost-effectively. Furthermore, it makes it possible to implement the process universally and to adapt it flexibly to cleanrooms of different sizes.

[0017] In one embodiment, at least one hose of the plurality of hoses, and in particular all hoses of the plurality of hoses, is designed as a Teflon hose. Alternatively or additionally, at least one hose of the plurality of hoses, and in particular all hoses of the plurality of hoses, has at least one Tri-Clamp connection. Advantageously, Teflon is inert and thermally stable—especially in contrast to silicone hoses of known devices—and can therefore be sterilized by steam. Furthermore, it is advantageously possible to sterilize a Teflon hose—especially in contrast to silicone hoses of known devices—particularly from the outside with H₂O₂.

[0018] In one embodiment of the filter test, compressed air is passed through the filter set. Specifically, the compressed air is first passed through an air filter and then into the filter set. A Millipore Express Opticap XL 150 air filter is used as the air filter, which can withstand a maximum pressure of 6.9 bar.

[0019] In one embodiment, at least one hose of the plurality of hoses has a quick coupling, in particular an MPC coupling.

[0020] In one embodiment, a multi-way valve, in particular a 3-way valve, especially an M-block or a T-block, is used as the first valve and / or the second valve.

[0021] According to a further development of the invention, it is provided that steps a) to g) are carried out aseptically - in particular in an aseptic environment and / or under aseptic conditions.

[0022] In one embodiment of the procedure, all steps of the procedure are carried out aseptically – in particular in an aseptic environment and / or under aseptic conditions.

[0023] In particular, the filter set, especially all components of the filter set, is autoclaved individually or partially assembled before step a). Subsequently, the filter set is assembled and connected in the first cleanroom under aseptic conditions.

[0024] According to a further development of the invention, it is provided that the filter set is supplied with compressed air and / or an inert gas, in particular nitrogen or helium, after step e) and before step f) in order to at least partially dry the filter set by means of the compressed air and / or the inert gas.

[0025] This makes it advantageous to at least partially dry the first hose and the filter set before the filter test is carried out. This ensures that the rinsing fluid is removed from the hose.

[0026] In one embodiment of the method, a container, in particular a screw-top jar, is used into which the compressed air and / or inert gas escaping from the filter set is introduced and which in particular receives the rinsing fluid transported from the filter set by the compressed air and / or inert gas.

[0027] According to a further development of the invention, at least one first product container is provided in the first cleanroom. Furthermore, at least one second product container is provided in the second cleanroom. In step h), the filter set is or is fluidically connected to the at least one first product container. In step i), after the filter test, the second end of the first hose is fluidically disconnected from the filter test device and connected to the at least one second product container. In step j), a product fluid is passed from the second product container through the filter set into the first product container, whereby the product fluid is filtered in the filter set.

[0028] Advantageously, the method makes it possible to perform a simple and quick filtration of the product fluid after sterilization and after the filter test.

[0029] In particular, the product fluid is routed from the filter set into the first product container via a third hose.

[0030] In particular, steps h) to j) are carried out aseptically - especially in an aseptic environment and / or under aseptic conditions.

[0031] Furthermore, it is advantageous that no connections, particularly aseptic connections, especially connections between hoses and the filter set, particularly with valves, and / or flow-related connections within the filter set, are opened in the first cleanroom during filtration. In particular, it is advantageously not necessary to open any aseptic connections in the first cleanroom during filtration.

[0032] According to a further development of the invention, the sterile filter set comprises at least one fluid filter, at least three hoses, and at least two valves. Furthermore, in step a), a first port of the at least one fluid filter is fluidly connected to a second port of a first valve of the at least two valves. Furthermore, in step b), the first end of the first hose is fluidly connected to a first port of the first valve. Furthermore, in step d), the first end of the second hose is fluidly connected to a second port of the second valve.Additionally, in step e), in a first single-filter operating state of the filter set, the first valve and the second valve are adjusted such that the at least one fluid filter is flushed with the flushing fluid from the fluid container, the flushing fluid entering the filter set via the first port of the first valve and exiting the filter set via the second port of the second valve, and the flushing fluid being directed via the second hose into the at least one drain container. Furthermore, in step g), the first single-filter operating state is set to perform the filter test.

[0033] In the first single-filter operating state, the rinsing fluid or, in particular, sterile compressed air enters the filter set via the first connection of the first valve. Subsequently, the rinsing fluid or, in particular, sterile compressed air is directed via the second connection of the first valve and the first connection of the fluid filter into the at least one fluid filter.

[0034] The rinsing fluid or, in particular, sterile compressed air then enters the second valve via the second port of the fluid filter and the first port of the second valve, and is discharged from the filter set via the second port of the second valve. Specifically, in the first single-filter operating state, all other ports of the filter set not explicitly mentioned are blocked, so that the rinsing fluid or, in particular, sterile compressed air can only be routed through the explicitly mentioned ports in this first single-filter operating state.

[0035] In one embodiment, at least one of the at least two valves, in particular a multi-way valve, in particular a 3-way valve, in particular an M-block, is used. Alternatively, at least one of the at least two valves, in particular a T-block, is used.

[0036] According to a further development of the invention, it is provided that after step e) and before step f) in a second single-filter operating state of the filter set, the first valve is set such that compressed air and / or an inert gas enters the filter set via the first port of the first valve and exits the filter set via a third port of the first valve.

[0037] In particular, the compressed air and / or inert gas is only passed through the first valve in order to advantageously at least partially dry the first hose and / or the first valve. Preferably, the compressed air and / or inert gas is passed through the first valve from the fluid container emptied during purging.

[0038] In the second operating state of the individual filter, compressed air and / or inert gas enters the filter set via the first port of the first valve. The compressed air and / or inert gas is then discharged from the filter set via the third port of the first valve. In this second operating state, the second port of the first valve is also blocked, preventing compressed air and / or inert gas from entering the at least one fluid filter. This advantageously ensures that the at least one fluid filter remains wet for the subsequent filter test.

[0039] In one embodiment, after step e) and before step f), in the first single-filter operating state of the filter set, the first valve and the second valve are adjusted such that compressed air and / or an inert gas enters the filter set via the first port of the first valve and exits the filter set via the second port of the second valve. Specifically, the compressed air and / or the inert gas is directed into the at least one fluid filter via the second port of the first valve and the first port of the fluid filter, and into the second valve via the second port of the fluid filter and the first port of the second valve. Preferably, the compressed air and / or the inert gas, particularly at a pressure of no more than 2.0 bar, is directed through the filter set from the fluid reservoir emptied during rinsing. Advantageously, this makes it possible to at least partially dry the at least one fluid filter.

[0040] According to a further development of the invention, in step a) the third port of the second valve is or becomes fluidically connected to a first port of the first product container. Alternatively, in step h) the third port of the second valve is or becomes fluidically connected to a first port of the first product container. Furthermore, in step j) in a third single-filter operating state of the filter set, the first valve and the second valve are adjusted such that the product fluid from the second product container is filtered by means of the at least one fluid filter, wherein the product fluid enters the filter set via the first port of the first valve and exits the filter set via the third port of the second valve and is directed into the first product container.

[0041] In particular, in the third single-filter operating state, the product fluid enters the filter set via the first port of the first valve. The product fluid then flows through the second port of the first valve and the first port of the fluid filter into the at least one fluid filter. Subsequently, the product fluid enters the second valve via the second port of the fluid filter and the first port of the second valve, and is then discharged from the filter set into the first product container via the third port of the second valve. Specifically, in the third single-filter operating state, the third port of the first valve and the second port of the second valve are blocked, so that in this third single-filter operating state, the product fluid, after passing through the filter set, can only flow into the first product container.

[0042] According to a further development of the invention, it is provided that before step j) the second hose is separated from the filter set in terms of flow technology.

[0043] In one embodiment, prior to step j), the second hose is fluidically separated from the filter set and brought from the first cleanroom to the second cleanroom. Specifically, the second hose is brought from the first cleanroom to the second cleanroom via at least one feedthrough opening.

[0044] According to a further development of the invention, it is provided that after step j) the second hose is separated from the filter set in terms of flow technology.

[0045] In one embodiment, after step j), the second hose is fluidically separated from the filter set and brought from the first cleanroom to the second cleanroom. In particular, the second hose is brought from the first cleanroom to the second cleanroom via at least one feedthrough opening.

[0046] According to a further development of the invention, the first cleanroom is designed as a glove box. Advantageously, this makes it possible to design the first cleanroom to be small and therefore also to operate it cost-effectively.

[0047] In particular, the fluid-related connecting and / or disconnecting of the hoses from the connections is carried out via the gloves of the glove box.

[0048] According to a further development of the invention, the at least one filter set comprises a first fluid filter, a second fluid filter, the first valve, the second valve, a third valve, a fourth valve, the first hose, a first second hose, a second second hose, and the third hose. Furthermore, in step a), a first port of the first fluid filter is fluidly connected to the second port of the first valve. Furthermore, in step a), a second port of the first fluid filter is fluidly connected to a first port of the third valve. Furthermore, in step a), a second port of the third valve is fluidly connected to a first port of the fourth valve. Furthermore, in step a), a first port of the second fluid filter is fluidly connected to a second port of the fourth valve.Furthermore, in step a), the second port of the second fluid filter is or will be fluidically connected to the first port of the second valve. Furthermore, in step b), the first end of the first hose is or will be fluidically connected to the first port of the first valve. Furthermore, in step d), the first end of the first second hose is or will be fluidically connected to a third port of the fourth valve. Furthermore, in step d), the first end of the second second hose is or will be fluidically connected to the second port of the second valve.Additionally, in step e), in a first double-filter operating state of the filter set, the first valve, the second valve, the third valve and the fourth valve are set such that the first fluid filter and the second fluid filter are flushed with the flushing fluid from the fluid container, the flushing fluid entering the filter set via the first port of the first valve and exiting the filter set via the second port of the second valve, the flushing fluid being directed via the second hose into the at least one drain container.Alternatively or additionally, in step e), in a second first double-filter operating state of the filter set, the first valve, the second valve, the third valve, and the fourth valve are adjusted such that the first fluid filter is flushed with the backwash fluid from the fluid container, the backwash fluid entering the filter set via the first port of the first valve and exiting the filter set via the third port of the fourth valve, with the backwash fluid being directed via the first second hose into the at least one drain container. Furthermore, in a first sub-step g1), a first end of the third hose is or is connected fluidically to a third port of the third valve.In addition, in a second sub-step g2), in a second double-filter operating state of the filter set, the first valve, the third valve and the fourth valve are set such that the first fluid filter can be tested, in particular sterile compressed air enters the filter set via the first port of the first valve and exits the filter set via the third port of the fourth valve, wherein the second fluid filter is fluidically separated from the filter test device.Additionally, in a third sub-step g3), in a third double-filter operating state of the filter set, a second end of the third hose is fluidically connected to the filter test device, and the second valve, the third valve, and the fourth valve are adjusted such that the second fluid filter can be tested, wherein, in particular, sterile compressed air enters the filter set via the third port of the third valve and exits the filter set via the second port of the second valve, with the first fluid filter being fluidically separated from the filter test device.

[0049] Specifically, in the initial dual-filter operating state, the backwash fluid enters the filter set via the first port of the first valve. The backwash fluid then flows through the second port of the first valve and the first port of the first fluid filter into the first fluid filter. Next, the backwash fluid flows through the second port of the first fluid filter and the first port of the third valve into the third valve. Then, the backwash fluid flows through the second port of the third valve and the first port of the fourth valve into the fourth valve. Finally, the backwash fluid flows through the second port of the fourth valve and the first port of the second fluid filter into the second fluid filter.The backwash fluid then enters the second valve via the second port of the second fluid filter and the first port of the second valve, and is discharged from the filter set via the second port of the second valve. Specifically, in the first operating state of the first dual filter, all other ports of the filter set not explicitly mentioned are blocked, so that in this first operating state, the backwash fluid can only be routed through the explicitly mentioned ports.

[0050] In the second operating state of the first dual-filter system, the backwash fluid enters the filter set via the first port of the first valve. It then flows through the second port of the first valve and the first port of the first fluid filter into the first fluid filter. Next, the backwash fluid flows through the second port of the first fluid filter and the first port of the third valve into the third valve. Finally, the backwash fluid flows through the second port of the third valve and the first port of the fourth valve into the fourth valve. The backwash fluid then exits the filter set via the third port of the fourth valve.In particular, in the second first double filter operating state, all other, not explicitly mentioned connections of the filter set are also blocked, so that the backwash fluid in the second first double filter operating state can only be routed through the explicitly mentioned connections.

[0051] In the second dual-filter operating state, the sterile compressed air enters the filter set via the first port of the first valve. It then flows through the second port of the first valve and the first port of the first fluid filter into the first fluid filter. Next, the sterile compressed air flows through the second port of the first fluid filter and the first port of the third valve into the third valve. Finally, the sterile compressed air flows through the second port of the third valve and the first port of the fourth valve into the fourth valve. The sterile compressed air is then discharged from the filter set via the third port of the fourth valve.In particular, in the second double-filter operating state, the third port of the first valve, the third port of the third valve and the second port of the fourth valve are blocked, so that the particularly sterile compressed air in the second double-filter operating state can only be passed through the first fluid filter and that the second fluid filter is fluidically separated from the first fluid filter.

[0052] In the third dual-filter operating state, the sterile compressed air enters the filter set via the third port of the third valve. It then passes through the second port of the third valve and the first port of the fourth valve into the fourth valve. Next, the sterile compressed air passes through the second port of the fourth valve and the first port of the second fluid filter into the second fluid filter. Finally, the sterile compressed air enters the second valve via the second port of the second fluid filter and the first port of the second valve. The sterile compressed air is then discharged from the filter set via the second port of the second valve.In particular, in the third double-filter operating state, the first port of the third valve and the third port of the fourth valve are blocked, so that the particularly sterile compressed air in the third double-filter operating state can only be passed through the second fluid filter and that the first fluid filter is fluidically separated from the second fluid filter.

[0053] In one embodiment, after step e) and before step f), in a fourth double-filter operating state, the first valve is set such that compressed air and / or an inert gas enters the filter set via the first port of the first valve and exits the filter set via a third port of the first valve.

[0054] In a further embodiment, after step e) and before step f), in the first double-filter operating state of the filter set, the first valve, the second valve, the third valve, and the fourth valve are adjusted such that compressed air and / or an inert gas enters the filter set via the first port of the first valve and exits the filter set via a second port of the second valve. Preferably, the compressed air and / or the inert gas is passed from the fluid reservoir, which is emptied during rinsing, through the filter set, in particular through the first fluid filter and the second fluid filter. Advantageously, this makes it possible to at least partially dry the two fluid filters.

[0055] In a further embodiment, after step e) and before step f), in the second first double-filter operating state of the filter set, the first valve, the second valve, the third valve, and the fourth valve are adjusted such that compressed air and / or an inert gas enters the filter set via the first port of the first valve and exits the filter set via the third port of the fourth valve. Preferably, the compressed air and / or the inert gas is passed from the fluid reservoir emptied during rinsing through the filter set, particularly through the first fluid filter. Advantageously, this makes it possible to at least partially dry the first fluid filter.

[0056] In one embodiment, the second port of the third valve is fluidically connected to the first port of the fourth valve by means of a fourth hose. In particular, the fourth hose is a Teflon hose with, in particular, two Tri-Clamp connections and / or with at least one 90° bend, and in particular at least two 90° bends.

[0057] In one embodiment, at least one valve selected from a group consisting of the first valve, the second valve, and the fourth valve is a multi-way valve, in particular a 3-way valve, especially an M-block or a T-block. Specifically, the first valve, the second valve, and the fourth valve are each multi-way valves, in particular 3-way valves, especially an M-block or a T-block.

[0058] In one embodiment, a 3-way valve is used as the third valve. Alternatively, an M-block is used as the third valve.

[0059] In particular, it is easy to expand the filter set by adding another fluid filter, especially a third fluid filter. For this purpose, analogous to the addition of the second fluid filter, the additional fluid filter and two further valves are arranged in a flow-optimized manner between the second fluid filter and the second valve.

[0060] According to a further development of the invention, in step e) after rinsing the filter set in the first double-filter operating state and / or the second double-filter operating state, the second end of the third hose is fluidically connected to the fluid container. Subsequently, in a third double-filter operating state of the filter set, the first valve, the second valve, the third valve, and the fourth valve are adjusted such that the second fluid filter is flushed with the rinsing fluid from the fluid container. The rinsing fluid enters the filter set via the third port of the third valve and exits the filter set via the second port of the second valve, with the rinsing fluid being directed via the second hose into the at least one drain container.

[0061] In particular, during the third operating state of the first dual-filter system, the backwash fluid enters the filter set via the third port of the third valve. It then flows through the second port of the third valve and the first port of the fourth valve into the fourth valve. Next, the backwash fluid flows through the second port of the fourth valve and the first port of the second fluid filter into the second fluid filter. Finally, the backwash fluid enters the second valve via the second port of the second fluid filter and the first port of the second valve, and is then discharged from the filter set via the second port of the second valve. Specifically, during the third operating state of the first dual-filter system, all other ports of the filter set not explicitly mentioned are blocked, so that the backwash fluid can only flow through the explicitly mentioned ports.

[0062] In one embodiment, after step e) and before step f), in the third first double-filter operating state of the filter set, the first valve, the second valve, the third valve, and the fourth valve are adjusted such that compressed air and / or an inert gas enters the filter set via the third port of the third valve and exits the filter set via the second port of the second valve. Preferably, the compressed air and / or the inert gas, particularly at a pressure of no more than 2.0 bar, is passed from the fluid reservoir emptied during rinsing through the filter set, particularly through the second fluid filter. Advantageously, this makes it possible to at least partially dry the second fluid filter.

[0063] According to a further development of the invention, it is provided that after step e) and before the first sub-step g1), the filter set is set to a fourth double-filter operating state. In this process, the filter set is dried with an inert gas, in particular nitrogen.

[0064] Alternatively or additionally, after the third sub-step g3), the filter set is set to the fourth double-filter operating state. In this process, the filter set is dried with an inert gas, in particular nitrogen.

[0065] In the fourth dual-filter operating state of the filter set, the first, second, third, and fourth valves are adjusted such that the third and fourth valves are pressurized with the inert gas, with the inert gas entering the filter set via the third port of the third valve and exiting the filter set via the third port of the fourth valve. The inert gas is then routed through the first second hose into the at least one drain container. Specifically, the inert gas is routed into the fourth valve via the second port of the third valve and the first port of the fourth valve. Furthermore, in the fourth dual-filter operating state, all other ports of the filter set not explicitly mentioned are blocked, so that the inert gas can only be routed through the explicitly mentioned ports.

[0066] In one embodiment, the inert gas, in particular nitrogen, enters the filter set via the third port of the third valve and exits the filter set via the third port of the fourth valve, wherein the first fluid filter is fluidically separated from the second fluid filter.

[0067] In particular, the inert gas, especially nitrogen, is introduced into the filter set at a pressure of no more than 2.0 bar.

[0068] According to a further development of the invention, it is provided that in step a) the third port of the second valve is or becomes fluidically connected to the first port of the first product container. Additionally, in step j) in a fourth double-filter operating state of the filter set, the first valve, the second valve, the third valve, and the fourth valve are adjusted such that the product fluid from the second product container is filtered by means of the first fluid filter and the second fluid filter, wherein the product fluid enters the filter set via the first port of the first valve and exits the filter set via the third port of the second valve and is directed into the first product container.

[0069] In the fourth dual-filter operating state, the product fluid enters the filter set via the first port of the first valve. It then flows through the second port of the first valve and the first port of the first fluid filter into the first fluid filter. Next, the product fluid enters the third valve via the second port of the first fluid filter and the first port of the third valve. Then, the product fluid flows through the second port of the third valve and the first port of the fourth valve into the fourth valve. Finally, the product fluid flows through the second port of the fourth valve and the first port of the second fluid filter into the second fluid filter.The product fluid then enters the second valve via the second port of the second fluid filter and the first port of the second valve, and is discharged from the filter set via the third port of the second valve. Specifically, in the fourth dual-filter operating state, all other ports of the filter set not explicitly mentioned are blocked, so that the product fluid can only pass through the explicitly mentioned ports. In particular, in the fourth dual-filter operating state, the third port of the first valve, the second port of the second valve, the third port of the third valve, and the third port of the fourth valve are blocked, so that in the fourth dual-filter operating state, the product fluid, after passing through the filter set, can only be discharged into the first product container.

[0070] According to a further development of the invention, it is provided that in step h) the third port of the second valve is or becomes fluidically connected to a first port of the first product container. Additionally, in step j) in the fourth double-filter operating state of the filter set, the first valve, the second valve, the third valve, and the fourth valve are adjusted such that the product fluid from the second product container is filtered by means of the first fluid filter and the second fluid filter, wherein the product fluid enters the filter set via the first port of the first valve and exits the filter set via the third port of the second valve and is directed into the first product container.

[0071] The problem is also solved by providing a sterile filter set comprising at least one fluid filter, at least three hoses, at least two valves, and instructions for use. The instructions for use include directions for carrying out a method according to the invention or a method according to one or more of the embodiments described above. The advantages of the sterile filter set are particularly evident in the advantages already described in connection with the method.

[0072] The invention is explained in more detail with reference to the following drawing. The drawing shows: Fig. Figure 1 shows a first embodiment of a sterile filter set, Fig. Figure 2 shows a flowchart of an exemplary embodiment of the method for performing a filter test, Fig. Figure 3 shows a schematic representation of the first embodiment of the sterile filter set with a fluid filter in a first process step, Fig. Figure 4 shows a schematic representation of the first embodiment of the sterile filter set with the fluid filter in a second process step, Fig. Figure 5 shows a schematic representation of the first embodiment of the sterile filter set with the fluid filter in a third process step, Fig. Figure 6 shows a schematic representation of a second embodiment of the sterile filter set with two fluid filters in a first process step, Fig. Figure 7 shows a schematic representation of the second embodiment of the sterile filter set with two fluid filters in a second process step, Fig. Figure 8 shows a schematic representation of the second embodiment of the sterile filter set with two fluid filters in a third process step, Fig. Figure 9 shows a schematic representation of the second embodiment of the sterile filter set with two fluid filters in a fourth process step, and Fig. Figure 10 shows a schematic representation of the second embodiment of the sterile filter set with two fluid filters in a fifth process step.

[0073] Fig. Figure 1 shows a first embodiment of a sterile filter set 1. The sterile filter set 1 comprises at least one fluid filter 3, at least two tubes 5, preferably at least three tubes 5, at least two valves 7, in particular a first valve 7.1 and a second valve 7.2, and instructions for use 9. The instructions for use 9 include instructions for carrying out a filter test.

[0074] Optionally, the instructions for use 9 include in particular instructions for carrying out filtration using the sterile filter set 1.

[0075] In particular, a first port 11.1 of the at least one fluid filter 3 is fluidically connected or connectable to a second port 13.2 of the first valve 7.1. Furthermore, a second port 11.2 of the at least one fluid filter 3 is fluidically connected or connectable to a first port 15.1 of the second valve 7.2. Furthermore, a first end of a first hose 5.1 is fluidically connected or connectable to a first port 13.1 of the first valve 7.1. Furthermore, a first end of a second hose 5.2 is fluidically connected or connectable to a second port 15.2 of the second valve 7.2. Additionally, preferably a first end of a third hose 5.3 is fluidically connected or connectable to a third port 15.3 of the second valve 7.2.

[0076] The procedure for performing a filter test is described in more detail using the following figures.

[0077] Fig. Figure 2 shows a flowchart of an exemplary embodiment of the method for performing a filter test.

[0078] In a first step a), the sterile filter set 1 is provided in a first cleanroom 17.1 of a first, higher cleanroom class. Furthermore, at least one fluid container 19, at least one drain container 21, and a filter test device 23 are provided in a second cleanroom 17.2 of a second, lower cleanroom class. Additionally, a plurality of hoses 5 are routed from the first cleanroom 17.1 to the second cleanroom 17.2. Alternatively, the plurality of hoses 5 are routed from the first cleanroom 17.1 to the second cleanroom 17.2.

[0079] In a second step b), the first tube 5.1 is connected at its first end to the sterile filter set 1 in a flow-oriented manner. Alternatively, at least one first tube 5.1 is connected at its first end to the sterile filter set 1 in a flow-oriented manner.

[0080] In a third step c), the at least one first hose 5.1 is fluidically connected to the at least one fluid container 19 with at least one second end. Alternatively, the at least one first hose 5.1 is fluidically connected to the at least one fluid container 19 with at least one second end.

[0081] In a fourth step d), at least one second hose 5.2 of the plurality of hoses 5 is connected to the sterile filter set 1 with at least one first end in a flow-related manner. Alternatively, the at least one second hose 5.2 is connected to the sterile filter set 1 with at least one first end in a flow-related manner. Furthermore, the at least one second hose 5.2 opens into the at least one drain container 21 with at least one second end.

[0082] In a fifth step e), the filter set 1 is rinsed by passing a rinsing fluid from the at least one fluid container 19 through the filter set 1 into the at least one drain container 21.

[0083] In a sixth step f), after rinsing the filter set 1, the second end of the at least one first hose 5.1 is separated from the fluid container 19 and connected to the filter test device 23 in terms of flow.

[0084] In a seventh step g), a filter test is carried out using the filter test device 23.

[0085] Preferably, after the fifth step e) and before the sixth step f), the filter set 1 is supplied with compressed air and / or an inert gas in order to at least partially dry the filter set 1, in particular the first hose 5.1 and the first valve 7.1, by means of the compressed air and / or the inert gas.

[0086] Preferably, at least one first product container 25.1 is provided in the first cleanroom 17.1. Alternatively or additionally, at least one second product container 25.2 is preferably provided in the second cleanroom 17.2.

[0087] In an optional eighth step h), the filter set 1 is fluidically connected to the at least one first product container 25.1. Alternatively, the filter set 1 is fluidically connected to the at least one first product container 25.1.

[0088] In an optional ninth step i), after the filter test, the second end of the first hose 5.1 is fluidically separated from the filter test device 23 and connected to the at least one second product container 25.2.

[0089] In an optional tenth step j), a product fluid from the second product container 25.2 is passed through the filter set 1 into the first product container 25.1, whereby the product fluid is filtered in the filter set 1.

[0090] In particular, steps h) to j) describe an optional filtration of a product fluid after a filter test has been carried out using steps a) to g).

[0091] Preferably, steps a) to g), in particular steps a) to j), are carried out aseptically.

[0092] Fig. 3, Fig. 4 to Fig. Figure 5 shows a schematic representation of the first embodiment of the sterile filter set 1 with a fluid filter 3 in three different process steps.

[0093] Identical and functionally equivalent elements are provided with the same reference symbols in all figures, so reference is made to the preceding description.

[0094] For clarity, the reference symbols for the connections were only shown in Fig. 3 shown. The connections in the Fig. 4 and Fig. 5 are identical to the connections in Fig. 3.

[0095] In the Fig. 3, Fig. 4 to Fig. The second hose 5.2 connects the second port 15.2 of the second valve 7.2 and the discharge container 21 in a flow-related manner. Additionally, the third hose 5.3 connects the third port 15.3 of the second valve 7.2 and the first product container 25.1 in a flow-related manner.

[0096] In Fig. Figure 3 shows the fifth step e) of the procedure for carrying out a filter test, in particular a rinsing of the filter set 1. The first hose 5.1 connects the first port 13.1 of the first valve 7.1 and the fluid container 19 in a flow-related manner.

[0097] In the first single-filter operating state of filter set 1 in Fig. 3. The first valve 7.1 and the second valve 7.2 are adjusted such that the fluid filter 3 is flushed with the flushing fluid from the fluid container 19. Specifically, the flushing fluid enters the filter set 1 via the first port 13.1 of the first valve 7.1. The flushing fluid then flows into the fluid filter 3 via the second port 13.2 of the first valve 7.1 and the first port 11.1 of the fluid filter 3. Subsequently, the flushing fluid enters the second valve 7.2 via the second port 11.2 of the fluid filter 3 and the first port 15.1 of the second valve 7.2 and is discharged from the filter set 1 via the second port 15.2 of the second valve 7.2. Finally, the flushing fluid is directed into the drain container 21 via the second hose 5.2. In particular, in the first single-filter operating state, a third connection 13.3 of the first valve 7.1 and the third connection 15.3 of the second valve 7.2 is blocked so that in the first single-filter operating state the rinsing fluid can only pass through the fluid filter 3 and into the drain container 21.

[0098] In particular, after step e) and before step f), in the first single-filter operating state of filter set 1, the first valve 7.1 and the second valve 7.2 are adjusted such that the fluid filter 3 is at least partially dried with compressed air and / or an inert gas, especially from the fluid reservoir 19 emptied during rinsing. The compressed air and / or the inert gas enters filter set 1 via the first port 13.1 of the first valve 7.1. The compressed air and / or the inert gas is directed into fluid filter 3 via the second port 13.2 of the first valve 7.1 and the first port 11.1 of fluid filter 3, and into the second valve 7.2 via the second port 11.2 of fluid filter 3 and the first port 15.1 of the second valve 7.2. The compressed air and / or inert gas is then routed from filter set 1 via the second connection 15.2 of the second valve 7.2.The compressed air and / or inert gas is then routed via the second hose 5.2 into the drain container 21. Specifically, in the first single-filter operating state, the third port 13.3 of the first valve 7.1 and the third port 15.3 of the second valve 7.2 are blocked, so that in the first single-filter operating state the compressed air and / or inert gas can only be routed through the fluid filter 3 and into the drain container 21.

[0099] Alternatively or additionally, particularly after step e) and before step f), in a second single-filter operating state of filter set 1, the first valve 7.1 is adjusted such that compressed air and / or an inert gas enters filter set 1 via the first port 13.1 of the first valve 7.1 and exits filter set 1 via the third port 13.3 of the first valve 7.1. In particular, in this second single-filter operating state, the second port 13.2 of the first valve 7.1 is also blocked, so that the compressed air and / or the inert gas cannot be directed into the fluid filter 3.

[0100] In Fig. Figure 4 shows the seventh step (g) of the procedure for carrying out a filter test, in particular a filter test of the filter set 1. The first hose 5.1 connects the first port 13.1 of the first valve 7.1 and the filter test device 23 in a flow-related manner.

[0101] In the first single-filter operating state of filter set 1 in Fig. 4. The first valve 7.1 and the second valve 7.2 are adjusted such that the fluid filter 3 is supplied with the sterile compressed air from the filter test device 23. The sterile compressed air enters the filter set 1 via the first port 13.1 of the first valve 7.1. The sterile compressed air is then directed into the fluid filter 3 via the second port 13.2 of the first valve 7.1 and the first port 11.1 of the fluid filter 3. Subsequently, the sterile compressed air, particularly together with rinsing fluid flushed out of the fluid filter 3 by means of the sterile compressed air, enters the second valve 7.2 via the second port 11.2 of the fluid filter 3 and the first port 15.1 of the second valve 7.2 and is directed out of the filter set 1 via the second port 15.2 of the second valve 7.2. The sterile compressed air is then directed via the second hose 5.2 into the drain container 21.In particular, in the first single-filter operating state, the third port 13.3 of the first valve 7.1 and the third port 15.3 of the second valve 7.2 are blocked, so that the particularly sterile compressed air in the first single-filter operating state can only be directed through the fluid filter 3 and into the drain container 21.

[0102] In Fig. Figure 5 is the tenth step j) of the process, in particular the filtration of the product fluid in the filter set 1, as shown. The first hose 5.1 connects the first port 13.1 of the first valve 7.1 and the second product container 25.2 in a flow-related manner.

[0103] In a third single-filter operating state of filter set 1 in Fig. In step 5, the first valve 7.1 and the second valve 7.2 are adjusted such that the product fluid from the second product container 25.2 is filtered by the fluid filter 3. The product fluid enters the filter set 1 via the first port 13.1 of the first valve 7.1. It then flows through the second port 13.2 of the first valve 7.1 and the first port 11.1 of the fluid filter 3 into the fluid filter 3. Subsequently, the product fluid enters the second valve 7.2 via the second port 11.2 of the fluid filter 3 and the first port 15.1 of the second valve 7.2 and is discharged from the filter set 1 via the third port 15.3 of the second valve 7.2. Finally, the product fluid flows through the third hose 5.3 into the first product container 25.1. In particular, in the third single-filter operating state, the third port 13.3 of the first valve 7.1 and the second port 15.2 of the second valve 7.2 is blocked so that, in the third single-filter operating state, the product fluid can only be directed into the first product container 25.1 after passing through filter set 3.

[0104] Additionally, it is particularly possible that the second hose 5.2 is disconnected from the second port 15.2 of the second valve 7.2 before the product fluid is filtered. In particular, the second hose 5.2 is then moved from the first cleanroom 17.1 to the second cleanroom 17.2, especially via at least one feedthrough opening.

[0105] Fig. 6, Fig. 7, Fig. 8, Fig. 9 to Fig. Figure 10 shows a schematic representation of a second embodiment of the sterile filter set 1 with a first fluid filter 3.1 and a second fluid filter 3.2 in five different process steps.

[0106] In particular, the first port 11.1 of the first fluid filter 3.1 is fluidically connected to a second port 13.2 of the first valve 7.1. Furthermore, a second port 11.2 of the first fluid filter 3.1 is fluidically connected to a first port 27.1 of a third valve 7.3. Additionally, a second port 27.2 of the third valve 7.3 is fluidically connected to a first port 29.1 of a fourth valve 7.4.

[0107] In particular, the second port 27.2 of the third valve 7.3 is fluidically connected to the first port 29.1 of the fourth valve 7.4 by means of a fourth hose 5.4. Furthermore, a first port 31.1 of the second fluid filter 3.2 is fluidly connected to a second port 29.2 of the fourth valve 7.4. A second port 31.2 of the second fluid filter 3.2 is also fluidly connected to the first port 15.1 of the second valve 7.2. Furthermore, a first end of the first hose 5.1 is fluidly connected to the first port 13.1 of the first valve 7.1. Additionally, a fifth hose 5.5 fluidly connects the third port 15.3 of the second valve 7.2 and the first product container 25.1.

[0108] In particular, the Fig. 6, Fig. 7, Fig. 8 to Fig. 9 furthermore, a first end of a first second hose 5.2' is fluidically connected to a third port 29.3 of the fourth valve 7.4. Additionally, particularly in the Fig. 6, Fig. 7, Fig. 8 to Fig. 9 a first end of a second hose 5.2'' is fluidically connected to the second port 15.2 of the second valve 7.2. Additionally, particularly in the Fig. 6, Fig. 7, Fig. 8 to Fig. 9. A first end of the third hose 5.3 is fluidically connected to a third connection 27.3 of the third valve 7.3. Furthermore, they connect in the Fig. 6, Fig. 7, Fig. 8 to Fig. 9. The first second hose 5.2' and the second second hose 5.2'' are fluidically connected to the filter set 1 and the drain container 21. Alternatively, the first second hose 5.2' and the second second hose 5.2" are fluidically connected to the second hose 5.2, with the second hose 5.2 leading into the drain container 21.

[0109] For clarity, the reference symbols for the connections were only shown in Fig. 6 is shown. The connections in the Fig. 7, Fig. 8 to Fig. 9 are identical to the connections in Fig. 6.

[0110] In Fig. Figure 6 shows the fifth step e) of the procedure for carrying out a filter test, in particular a rinsing of the filter set 1. The first hose 5.1 connects the first port 13.1 of the first valve 7.1 and the fluid container 19 in a flow-related manner.

[0111] In the first dual-filter operating state of filter set 1 in Fig. 6. The first valve 7.1, the second valve 7.2, the third valve 7.3, and the fourth valve 7.4 are adjusted such that the first fluid filter 3.1 and the second fluid filter 3.2 are flushed with the flushing fluid from the fluid reservoir 19. In particular, the flushing fluid enters the filter set 1 via the first port 13.1 of the first valve 7.1. The flushing fluid is then directed into the first fluid filter 3.1 via the second port 13.2 of the first valve 7.1 and the first port 11.1 of the first fluid filter 3.1. The flushing fluid then enters the third valve 7.3 via the second port 11.2 of the first fluid filter 3.1 and the first port 27.1 of the third valve 7.3, and is routed to the fourth valve 7.4 via the second port 27.2 of the third valve 7.3 and the first port 29.1 of the fourth valve 7.4. The flushing fluid then exits the system via the second port 29.2 of the fourth valve 7.4 and the first port 31.The flushing fluid is directed from port 1 of the second fluid filter 3.2 into the second fluid filter 3.2. Subsequently, the flushing fluid enters the second valve 7.2 via port 15.1 of the second valve 7.2 and is directed out of the filter set 1 via port 15.2 of the second valve 7.2. The flushing fluid is then directed via the second hose 5.2'' and, in particular, the second hose 5.2 into the drain container 21. In particular, in the first double-filter operating state, the third port 13.3 of the first valve 7.1, the third port 15.3 of the second valve 7.2, the third port 27.3 of the third valve 7.3 and the third port 29.3 of the fourth valve 7.4 are blocked, so that in the first double-filter operating state the rinsing fluid can only be directed through the first fluid filter 3.1, through the second fluid filter 3.2 and into the drain container 21.

[0112] Alternatively or additionally, in step e) a second first double filter operating state of filter set 1 is entered. Fig. 6. The first valve 7.1, the second valve 7.2, the third valve 7.3, and the fourth valve 7.4 are adjusted such that the first fluid filter 3.1 is flushed with the flushing fluid from the fluid reservoir 19. In particular, the flushing fluid enters the filter set 1 via the first port 13.1 of the first valve 7.1. The flushing fluid is then directed into the first fluid filter 3.1 via the second port 13.2 of the first valve 7.1 and the first port 11.1 of the first fluid filter 3.1. Subsequently, the flushing fluid enters the third valve 7.3 via the second port 11.2 of the first fluid filter 3.1 and the first port 27.1 of the third valve 7.3, and is then directed into the fourth valve 7.4 via the second port 27.2 of the third valve 7.3 and the first port 29.1 of the fourth valve 7.4. The rinsing fluid is then routed from filter set 1 via the third connection 29.3 of the fourth valve 7.4.The rinsing fluid is then directed via the first second hose 5.2' and, in particular, the second hose 5.2 into the drain container 21. Specifically, in the second first double-filter operating state, the third port 13.3 of the first valve 7.1, the third port 27.3 of the third valve 7.3, and the second port 29.2 of the fourth valve 7.4 are blocked, so that in the second first double-filter operating state, the rinsing fluid can only be directed through the first fluid filter 3.1 and into the drain container 21.

[0113] In particular, after step e) and before step f), in a fourth double-filter operating state of filter set 1, the first valve 7.1 is set such that compressed air and / or an inert gas enters filter set 1 via the first port 13.1 of the first valve 7.1 and exits filter set 1 via the third port 13.3 of the first valve 7.1. In particular, in this fourth double-filter operating state, the second port 13.2 of the first valve 7.1 is also blocked, so that the compressed air and / or the inert gas cannot be directed into the first fluid filter 3.1 and / or the second fluid filter 3.2.

[0114] Alternatively or additionally, particularly after step e) and before step f), in the first double-filter operating state of filter set 1, the first valve 7.1, the second valve 7.2, the third valve 7.3, and the fourth valve 7.4 are adjusted such that the first fluid filter 3.1 and the second fluid filter 3.2 are at least partially dried with compressed air and / or an inert gas, in particular from the fluid reservoir 19 emptied during rinsing. The compressed air and / or the inert gas enters filter set 1 via the first port 13.1 of the first valve 7.1. The compressed air and / or inert gas is routed via the second port 13.2 of the first valve 7.1 and the first port 11.1 of the first fluid filter 3.1 into the first fluid filter 3.1 and via the second port 11.2 of the first fluid filter 3 and the first port 27.1 of the third valve 7.3 into the third valve 7.3.The compressed air and / or inert gas is routed through the second port 27.2 of the third valve 7.3 and the first port 29.1 of the fourth valve 7.4 into the fourth valve 7.4. Then, the compressed air and / or inert gas is routed through the second port 29.2 of the fourth valve 7.4 and the first port 31.1 of the second fluid filter 3.2 into the second fluid filter 3.2. Next, the compressed air and / or inert gas is routed through the second port 31.2 of the second fluid filter 3.2 and the first port 15.1 of the second valve 7.2 into the second valve 7.2. Finally, the compressed air and / or inert gas is routed from filter set 1 through the second port 15.2 of the second valve 7.2. Finally, the compressed air and / or inert gas is routed through the second hose 5.2'' into the drain container 21. In particular, in the first double filter operating state, the third port 13.3 of the first valve 7.1, the third port 15.3 of the second valve 7.2, the third port 27.3 of the third valve 7.3 and the third port 29.3 of the fourth valve 7.4 are blocked, so that the compressed air and / or the inert gas in the first double filter operating state can only be directed through the first fluid filter 3.1 and the second fluid filter 3.2 into the drain container 21.

[0115] Alternatively or additionally, particularly after step e) and before step f), in the second first double-filter operating state of filter set 1, the first valve 7.1, the second valve 7.2, the third valve 7.3, and the fourth valve 7.4 are adjusted such that the first fluid filter 3.1 is at least partially dried with compressed air and / or an inert gas, particularly from the fluid reservoir 19 emptied during rinsing. The compressed air and / or inert gas enters filter set 1 via the first port 13.1 of the first valve 7.1. The compressed air and / or inert gas is directed into the first fluid filter 3.1 via the second port 13.2 of the first valve 7.1 and the first port 11.1 of the first fluid filter 3.1, and into the third valve 7.3 via the second port 11.2 of the first fluid filter 3.1 and the first port 27.1 of the third valve 7.3. The compressed air and / or inert gas is supplied via the second connection 27.The compressed air and / or inert gas is directed from the third valve 7.3 and the first port 29.1 of the fourth valve 7.4 into the fourth valve 7.4. Then, the compressed air and / or inert gas is directed from filter set 1 via the third port 29.3 of the fourth valve 7.4. Afterward, the compressed air and / or inert gas is directed via the first second hose 5.2' into the drain container 21. Specifically, in the second first double-filter operating state, the third port 13.3 of the first valve 7.1, the third port 27.3 of the third valve 7.3, and the second port 29.2 of the fourth valve 7.4 are blocked, so that in the second first double-filter operating state, the compressed air and / or inert gas can only be directed through the first fluid filter 3.1 into the drain container 21.

[0116] In Fig. Figure 7 represents an additional process step of the fifth step e) of the procedure for carrying out a filter test, in particular a rinsing of the filter set 1. The first hose 5.1 is fluidically separated from the fluid container 19. Furthermore, the third hose 5.3 fluidically connects the third port 27.3 of the third valve 7.3 and the fluid container 19.

[0117] In a third first double-filter operating state of filter set 1 in Fig. In step 7, the second valve 7.2, the third valve 7.3, and the fourth valve 7.4 are adjusted such that the second fluid filter 3.2 is flushed with the flushing fluid from the fluid reservoir 19. Specifically, the flushing fluid enters the filter set 1 via the third port 15.3 of the third valve 7.3. The flushing fluid is then directed into the fourth valve 7.4 via the second port 27.2 of the third valve 7.3 and the first port 29.1 of the fourth valve 7.4. Finally, the flushing fluid is directed into the second fluid filter 3.2 via the second port 29.2 of the fourth valve 7.4 and the first port 31.1 of the second fluid filter 3.2. The rinsing fluid then enters the second valve 7.2 via the second port 31.2 of the second fluid filter 3.2 and the first port 15.1 of the second valve 7.2, and is routed out of the filter set 1 via the second port 15.2 of the second valve 7.2. The rinsing fluid is then routed via the second hose 5.2'' and in particular the second hose 5.2 into the drain container 21. In particular, in the third first double filter operating state, the third port 15.3 of the second valve 7.2, the first port 27.1 of the third valve 7.3 and the third port 29.3 of the fourth valve 7.4 are blocked, so that in the third first double filter operating state the rinsing fluid can only be directed through the second fluid filter 3.2 and into the drain container 21.

[0118] In particular, after step e) and before step f), in the third first double-filter operating state of filter set 1, the second valve 7.2, the third valve 7.3, and the fourth valve 7.4 are adjusted such that the second fluid filter 3.2 is at least partially dried with compressed air and / or an inert gas, especially from the fluid reservoir 19 emptied during rinsing. The compressed air and / or inert gas enters filter set 1 via the third port 27.3 of the third valve 7.3. The compressed air and / or inert gas is directed into the fourth valve 7.4 via the second port 27.2 of the third valve 7.3 and the first port 29.1 of the fourth valve 7.4. The compressed air and / or inert gas is then routed through the second port 29.2 of the fourth valve 7.4 and the first port 31.1 of the second fluid filter 3.2 into the second fluid filter 3.2. Subsequently, the compressed air and / or inert gas is routed through the second port 31.The compressed air and / or inert gas is directed from the second fluid filter 3.2 and the first port 15.1 of the second valve 7.2 into the second valve 7.2. Subsequently, the compressed air and / or inert gas is directed from the filter set 1 via the second port 15.2 of the second valve 7.2. Afterwards, the compressed air and / or inert gas is directed via the second hose 5.2'' into the drain container 21. Specifically, in the third first double-filter operating state, the third port 15.3 of the second valve 7.2, the first port 27.1 of the third valve 7.3, and the third port 29.3 of the fourth valve 7.4 are blocked, so that in the third first double-filter operating state, the compressed air and / or inert gas can only be directed through the second fluid filter 3.2 into the drain container 21.

[0119] In Fig. Figure 8 shows a second sub-step (g2) of the seventh step (g) of the method for carrying out a filter test, in particular a filter test of the filter set 1. The first hose 5.1 connects the first port 13.1 of the first valve 7.1 and the filter test device 23 in a flow-related manner.

[0120] In a second dual-filter operating state of filter set 1 in Fig. 8. The first valve 7.1, the third valve 7.3, and the fourth valve 7.4 are adjusted such that the first fluid filter 3.1 is supplied with the sterile compressed air from the filter test device 23, while the second fluid filter 3.2 is fluidically separated from the filter test device 23. The sterile compressed air enters the filter set 1 via the first port 13.1 of the first valve 7.1. The sterile compressed air is then directed into the first fluid filter 3.1 via the second port 13.2 of the first valve 7.1 and the first port 11.1 of the first fluid filter 3.1. Finally, the sterile compressed air enters the third valve 7.3 via the second port 11.2 of the first fluid filter 3.1 and the first port 27.1 of the third valve 7.3. The sterile compressed air is then supplied via the second port 27.2 of the third valve 7.3 and the first port 29.1 of the fourth valve 7.The compressed air, particularly sterile, is directed into the fourth valve 7.4. Subsequently, it is directed from the filter set 1 via the third port 29.3 of the fourth valve 7.4. The compressed air, particularly sterile, is then directed, particularly together with the rinsing fluid flushed out of the first fluid filter 3.1 by means of the sterile compressed air, via the first second hose 5.2' and, in particular, the second hose 5.2 into the drain container 21. Specifically, in the second double-filter operating state, the third port 13.3 of the first valve 7.1, the third port 27.3 of the third valve 7.3, and the second port 29.2 of the fourth valve 7.4 are blocked, so that in the second double-filter operating state, the compressed air, particularly sterile, can only be directed through the first fluid filter 3.1 and into the drain container 21.

[0121] In Fig. Figure 9 shows a third sub-step (g2) of the seventh step (g) of the method for carrying out a filter test, in particular a filter test of the filter set 1. The third hose 5.3 connects the third port 27.3 of the third valve 7.3 and the filter test device 23 fluidically.

[0122] In a third dual-filter operating state of filter set 1 in Fig. 9. The second valve 7.2, the third valve 7.3, and the fourth valve 7.4 are adjusted such that the second fluid filter 3.2 is supplied with the sterile compressed air from the filter test device 23, while the first fluid filter 3.1 is fluidically separated from the filter test device 23. The sterile compressed air enters the filter set 1 via the third port 27.3 of the third valve 7.3. The sterile compressed air is then directed into the fourth valve 7.4 via the second port 27.2 of the third valve 7.3 and the first port 29.1 of the fourth valve 7.4. Finally, the sterile compressed air is directed into the second fluid filter 3.2 via the second port 29.2 of the fourth valve 7.4 and the first port 31.1 of the second fluid filter 3.2. The sterile compressed air then enters via the second connection 31.2 of the second fluid filter 3.2 and the first connection 15.The compressed air, particularly sterile, is fed into the second valve 7.2 via the second port 15.2 of the second valve 7.2. Subsequently, the sterile compressed air, particularly together with the rinsing fluid flushed out of the second fluid filter 3.2 by means of the sterile compressed air, is directed from the filter set 1 via the second port 15.2 of the second valve 7.2. The sterile compressed air is then directed via the second hose 5.2 and, in particular, the second hose 5.2 into the drain container 21. In the third double-filter operating state, the third port 15.3 of the second valve 7.2, the first port 27.1 of the third valve 7.3, and the third port 29.3 of the fourth valve 7.4 are blocked, so that in the third double-filter operating state, the sterile compressed air can only be directed through the second fluid filter 3.2 and into the drain container 21.

[0123] In Fig. Figure 10 is the tenth step j) of the process, in particular the filtration of the product fluid in the filter set 1. The first hose 5.1 connects the first port 13.1 of the first valve 7.1 and the second product container 25.2 in a flow-related manner.

[0124] Furthermore, the first second hose 5.2' and the second second hose 5.2'' are flow-wise separated from filter set 1. Therefore, in Fig. 10 the second hose 5.2, the first second hose 5.2' and the second second hose 5.2'' not shown.

[0125] In a fourth dual-filter operating state of filter set 1 in Fig.10. The first valve 7.1, the second valve 7.2, the third valve 7.3, and the fourth valve 7.4 are adjusted such that the product fluid from the second product container 25.2 is filtered by the first fluid filter 3.1 and the second fluid filter 3.2. The product fluid enters filter set 1 via the first port 13.1 of the first valve 7.1. It then passes through the second port 13.2 of the first valve 7.1 and the first port 11.1 of the first fluid filter 3.1 into the first fluid filter 3.1. Finally, the product fluid enters the third valve 7.3 via the second port 11.2 of the first fluid filter 3.1 and the first port 27.1 of the third valve 7.3. The product fluid is then routed through the second port 27.2 of the third valve 7.3 and the first port 29.1 of the fourth valve 7.4 into the fourth valve 7.4. Subsequently, the product fluid is routed through the second port 29.2 of the fourth valve 7.4.The product fluid is routed from the second fluid filter 3.2 to the second fluid filter 3.2 via the second fluid filter 3.2 and the first valve 7.2 via the second valve 7.2 via the first valve 7.2 and is routed out of the filter set 1 via the third valve 7.2 via the third valve 7.2 via the third valve 7.2. The product fluid is then routed via the fifth hose 5.5 into the first product container 25.1. In particular, in the fourth double-filter operating state, the third port 13.3 of the first valve 7.1, the second port 15.2 of the second valve 7.2, the third port 27.3 of the third valve 7.3 and the third port 29.3 of the fourth valve 7.4 are blocked, so that in the fourth double-filter operating state, the product fluid can only be directed into the first product container 25.1 after passing through the filter set 3.

Claims

[1] Method for performing a filter test, wherein a) a plurality of hoses (5) are or are laid from a first cleanroom (17.1) of a first, higher cleanroom class to a second cleanroom (17.2) of a second, lower cleanroom class, wherein a sterile filter set (1) is provided in the first cleanroom (17.1), wherein at least one fluid container (19), at least one drain container (21) and a filter test device (23) are provided in the second cleanroom (17.2), wherein b) at least one first hose (5.1) of the plurality of hoses (5) is or becomes fluidically connected to the sterile filter set (1) with at least one first end, wherein c) the at least one first hose (5.1) of the plurality of hoses (5) is or becomes fluidically connected to the at least one fluid container (19) with at least one second end, wherein d) at least one second hose (5.2) of the plurality of hoses (5) is or becomes fluidically connected to the sterile filter set (1) with at least one first end, wherein the at least one second hose (5.2) of the plurality of hoses (5) opens into the at least one drain container (21) with at least one second end, wherein e) the filter set (1) is rinsed by passing a rinsing fluid from the at least one fluid container (19) through the filter set (1) into the at least one drain container (21), wherein f) after rinsing the filter set (1) the second end of the at least one first hose (5.1) is separated from the fluid container (19) and connected to the filter test device (23) in a flow-related manner, wherein g) a filter test is carried out using the filter test device (23). [2] Method according to claim 1, wherein steps a) to g), in particular all steps, are carried out aseptically. [3] Method according to one of the preceding claims, wherein the filter set (1) is supplied with compressed air and / or an inert gas after step e) and before step f) in order to at least partially dry the filter set (1) by means of the compressed air and / or the inert gas. [4] Method according to any of the preceding claims, wherein at least one first product container (25.1) is provided in the first cleanroom (17.1), wherein at least one second product container (25.2) is provided in the second cleanroom (17.2), wherein h) the filter set (1) is or will be fluidically connected to the at least one first product container (25.1), wherein i) after the filter test, the second end of the first hose (5.1) is fluidically separated from the filter test device (23) and connected to at least one second product container (25.2), wherein j) a product fluid from the second product container (25.2) is passed through the filter set (1) into the first product container (25.1), whereby the product fluid is filtered in the filter set (1). [5] Method according to any one of the preceding claims, wherein - the sterile filter set (1) comprises at least one fluid filter (3), at least three hoses (5) and at least two valves (7), wherein - in step a) a first connection (11.1) of the at least one fluid filter (3) is fluidically connected to a second connection (13.2) of a first valve (7.1) which is or will be connected to at least two valves (7), wherein - in step a) a second connection (11.2) of the at least one fluid filter (3) is fluidically connected to a first connection (15.1) of a second valve (7.2) which is or will be connected to at least two valves (7), wherein - in step b) the first end of the first hose (5.1) is or becomes fluidically connected to a first port (13.1) of the first valve (7.1), wherein - in step d) the first end of the second hose (5.2) is or becomes fluidically connected to a second port (15.2) of the second valve (7.2), wherein - in step e) in a first single-filter operating state of the filter set (1) the first valve (7.1) and the second valve (7.2) are set such that the at least one fluid filter (3) is flushed with the flushing fluid from the fluid container (19), wherein the flushing fluid enters the filter set (1) via the first port (13.1) of the first valve (7.1) and exits the filter set (1) via the second port (15.2) of the second valve (7.2), wherein the flushing fluid is directed via the second hose (5.2) into the at least one drain container (21), wherein - in step g) the first single filter operating state is set in order to perform the filter test. [6] Method according to one of the preceding claims, wherein after step e) and before step f) in a second single-filter operating state of the filter set (1) the first valve (7.1) is set such that compressed air and / or an inert gas enters the filter set (1) via the first port (13.1) of the first valve (7.1) and exits the filter set (1) via a third port (13.3) of the first valve (7.3), wherein the compressed air and / or the inert gas is in particular only passed through the first valve (7.1) to dry the first hose (5.1). [7] Method according to any one of claims 4 to 6, wherein - in step a) or in step h) the third port (15.3) of the second valve (7.2) is or becomes fluidically connected to a first port of the first product container (25.1), wherein - in step j) in a third single-filter operating state of the filter set (1) the first valve (7.1) and the second valve (7.2) are set such that the product fluid from the second product container (25.2) is filtered by means of the at least one fluid filter (3), wherein the product fluid enters the filter set (1) via the first port (13.1) of the first valve (7.1) and exits the filter set (1) via the third port (15.3) of the second valve (7.2) and is directed into the first product container (25.1). [8] Method according to one of claims 4 to 7, wherein before or after step j) the second hose (5.2) is fluidically separated from the filter set (1) and preferably brought from the first cleanroom (17.1) to the second cleanroom (17.2), in particular via at least one feedthrough opening. [9] Method according to one of the preceding claims, wherein the first cleanroom (17.1) is designed as a glove box and in particular the fluidic connection and / or separation of the hoses (5) from the connections is carried out via the gloves of the glove box. [10] Method according to any one of the preceding claims, wherein - that at least one filter set (1) comprises a first fluid filter (3.1), a second fluid filter (3.2), the first valve (7.1), the second valve (7.2), a third valve (7.3), a fourth valve (7.4), the first hose (5.1), a first second hose (5.2'), a second second hose (5.2'') and a third hose (5.3), wherein - in step a) a first connection (11.1) of the first fluid filter (3.1) is or becomes fluidically connected to the second connection (13.2) of the first valve (7.1), wherein - in step a) a second connection (11.2) of the first fluid filter (3.1) is or becomes fluidically connected to a first connection (27.1) of the third valve (7.3), wherein - in step a) the second port (27.2) of the third valve (7.3) is or becomes fluidically connected to a first port (29.1) of the fourth valve (7.4), wherein - in step a) a first connection (31.1) of the second fluid filter (3.2) is or becomes fluidically connected to a second connection (29.2) of the fourth valve (7.4), wherein - in step a) a second connection (31.2) of the second fluid filter (3.2) is or becomes fluidically connected to the first connection (15.1) of the second valve (7.2), wherein - in step b) the first end of the first hose (5.1) is or becomes fluidically connected to the first port (13.1) of the first valve (7.1), wherein - in step d) the first end of the first second hose (5.2') is or becomes fluidically connected to a third port (29.3) of the fourth valve (7.4), wherein - in step d) the first end of the second hose (5.2'') is or becomes fluidically connected to the second port (15.2) of the second valve (7.2), wherein - in step e) in a first double-filter operating state of the filter set (1) the first valve (7.1), the second valve (7.2), the third valve (7.3) and the fourth valve (7.4) are set such that the first fluid filter (3.1) and the second fluid filter (3.2) are flushed with the flushing fluid from the fluid container (19), the flushing fluid entering the filter set (1) via the first port (13.1) of the first valve (7.1) and exiting the filter set (1) via the second port (15.2) of the second valve (7.2), the flushing fluid being directed via the second hose (5.2'') into the at least one drain container (21) and / or in step e) in a second double-filter operating state of the filter set (1) the first valve (7.1), the second valve (7.2), the third valve (7.3) and the fourth valve (7.4) be set so that the first fluid filter (3.1) be rinsed with the rinsing fluid from the fluid container (19), wherein the rinsing fluid enters the filter set (1) via the first port (13.1) of the first valve (7.1) and exits the filter set (1) via the third port (29.3) of the fourth valve (7.4), wherein the rinsing fluid is directed via the first second hose (5.2') into the at least one drain container (21), wherein. - in a first partial step g1) a first end of the third hose (5.3) is or becomes fluidically connected to a third port (27.3) of the third valve (7.3), wherein - in a second sub-step g2) in a second double-filter operating state of the filter set (1) the first valve (7.1), the third valve (7.3) and the fourth valve (7.4) are set such that the first fluid filter (3.1) can be tested, wherein in particular sterile compressed air enters the filter set (1) via the first port (13.1) of the first valve (7.1) and exits the filter set (1) via the third port (29.3) of the fourth valve (7.4), wherein the second fluid filter (3.2) is fluidically separated from the filter test device (23), wherein - in a third sub-step g3) in a third double-filter operating state of the filter set (1) a second end of the third hose (5.3) is fluidically connected to the filter test device (23) and the second valve (7.2), the third valve (7.3) and the fourth valve (7.4) are set such that the second fluid filter (3.2) can be tested, wherein in particular sterile compressed air enters the filter set (1) via the third port (27.3) of the third valve (7.3) and exits the filter set (1) via the second port (15.2) of the second valve (7.2), wherein the first fluid filter (3.1) is fluidically separated from the filter test device (23). [11] Method according to claim 10, wherein in step e) after rinsing the filter set (1) in the first first double-filter operating state and / or the second first double-filter operating state, the second end of the third hose (5.2) is fluidically connected to the fluid container (19), wherein in a third first double-filter operating state of the filter set (1), the first valve (7.1), the second valve (7.2), the third valve (7.3), and the fourth valve (7.4) are adjusted such that the second fluid filter (3.1) is rinsed with the rinsing fluid from the fluid container (19), wherein the rinsing fluid enters the filter set (1) via the third port (27.3) of the third valve (7.3) and exits the filter set (1) via the second port (15.2) of the second valve (7.2), wherein the rinsing fluid flows via the second hose (5.2) into the at least one drain container (21) is directed. [12] Method according to claim 10 or 11, wherein before the first partial step g1) and / or after the third partial step g3) the filter set (1) is set to a fourth double-filter operating state, wherein the filter set (1) is dried with an inert gas, in particular with nitrogen, wherein in particular the inert gas, in particular nitrogen, enters the filter set (1) via the third port (27.3) of the third valve (7.3) and exits the filter set (1) via the third port (29.3) of the fourth valve (7.4), wherein the first fluid filter (3.1) is fluidically separated from the second fluid filter (3.2). [13] Method according to claim 4 and one of claims 10 to 12, wherein - in step a) or in step h) the third port (15.3) of the second valve (7.2) is or becomes fluidically connected to a first port of the first product container (25.1), wherein - in step j) in a fourth double-filter operating state of the filter set (1) the first valve (7.1), the second valve (7.2), the third valve (7.3) and the fourth valve (7.4) are set such that the product fluid from the second product container (25.2) is filtered by means of the first fluid filter (3.1) and the second fluid filter (3.2), wherein the product fluid enters the filter set (1) via the first port (13.1) of the first valve (7.1) and exits the filter set (1) via the third port (15.3) of the second valve (7.2) and is directed into the first product container (25.1). [14] Sterile filter set (1) comprising at least one fluid filter (3), at least three hoses (5), at least two valves (7) and instructions for use (9) comprising instructions for carrying out the method according to one of the preceding claims.

Images