Method for carrying out a filter test, and sterile filter set with instructions for carrying out such a method

Abstract

The invention relates to a method for carrying out a filter test, wherein: a plurality of hoses (5) is laid from a first clean room (17.1) of a first higher clean room class to a second clean room (17.2) of a second lower clean room class, a sterile filter set (1) is provided in the first clean room (17.1), a fluid container (19), a discharge container (21) and a filter test device (23) are provided in the second clean room (17.2), a first hose (5.1) is connected to the filter set (1) and the fluid container (19), a second hose (5.2) is connected to the filter set (1) and the discharge container (21), the filter set (1) is flushed in that a flushing fluid is conducted out of the fluid container (19) through the filter set (1) and into the discharge container (21), after the filter set (1) has been flushed, the first hose (5.1) is disconnected from the fluid container (19) and is connected to the filter test device (23), and a filter test is carried out using the filter test device (23).

Description

[0001] DESCRIPTION

[0002] Procedure for performing a filter test and sterile filter set with instructions for performing such a procedure

[0003] 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.

[0004] 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, which is ongoing on the date determining the priority of this patent, the requirements for procedures related to Pre-Use / Post-Sterilization Integrity Testing (PUPSIT) are being discussed.

[0005] Pre-Use / Post-Sterilization Integrity Testing (PUPSIT) is a method for conducting a filter test after sterilization of the elements required for filtration and before filtration of a fluid using the elements. In particular, a filter test is used to check a filter, especially a membrane incorporated into the filter, to ensure its integrity and / or functionality.

[0006] Known devices for performing PUPSIT methods are complex in design and comprise a plurality of elements, particularly more than 20. Furthermore, the known devices are very specifically adapted to a specific use and / or space in which the device is installed. Thus, it is not possible to flexibly adapt the device to a different use and / or for placement in a different space.

[0007] Furthermore, known devices for performing PUPSIT processes comprise plastic elements and / or silicone tubes. A disadvantage is that such devices are not thermally stable and therefore cannot be steam sterilized. Furthermore, such devices can only be used in specially equipped Class A cleanrooms or isolators with increased space requirements, or in a cleanroom with a lower cleanroom class.

[0008] Furthermore, a flexible adaptation of the known devices to changed test conditions and / or a change in the design of the known devices is only partially possible.

[0009] The invention is therefore based on the object of providing a method for carrying out a filter test and a sterile filter set with instructions for carrying out such a method, wherein the aforementioned disadvantages are at least partially remedied, preferably avoided.

[0010] The object is achieved 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.

[0011] The object is achieved in particular by providing a method for carrying out a filter test, wherein in a step a) a plurality of hoses are or will be laid from a first cleanroom of a first, higher cleanroom class into a second cleanroom of a second, lower cleanroom class. Furthermore, in the first step a) a sterile filter set is provided in the first cleanroom. Additionally, in the first step a) at least one fluid container, at least one drain container and a filter test device are provided in the second cleanroom. In a step b), at least one first hose of the plurality of hoses is or will be fluidly connected to the sterile filter set by at least one first end. In a step c), the at least one first hose of the plurality of hoses is or will be fluidly connected to the at least one fluid container by at least one second end.In a step d), at least one second tube of the plurality of tubes is or will be fluidically connected to the sterile filter set with at least one first end, wherein the at least one second tube of the plurality of tubes opens into the at least one drainage container with at least one second end. In a step e), the filter set is rinsed by passing a rinsing fluid, in particular a predetermined amount of rinsing fluid, from the at least one fluid container through the filter set into the at least one drainage container. In a step f), after the filter set has been rinsed, the second end of the at least one first tube is separated from the fluid container and fluidically connected to the filter testing device. In a step g), a filter test is carried out using the filter testing device.

[0012] Advantageously, the method allows for a simple and rapid filter test after sterilization and before use. Furthermore, only a small number of elements are required to perform the method. This also allows the method to be flexibly adapted to cleanrooms of various sizes.

[0013] Furthermore, it is possible to carry out the process with existing elements, in particular hoses and valves, which advantageously means that no special elements have to be provided.

[0014] Furthermore, during the implementation of the method, advantageously no particularly aseptic connections, in particular connections of hoses to the filter set, in particular to valves, and / or fluidic connections within the filter set, are opened in the first clean room. In particular, it is advantageously not necessary to open a particularly aseptic connection in the first clean room during the implementation of the method. In particular, it is advantageously not necessary to disconnect a connection from one of the plurality of hoses to the filter set after this connection has been established. This advantageously prevents a fluid or a gas from escaping in the first clean room.

[0015] In particular, the method makes it possible to direct a predetermined amount of flushing fluid through the filter set. This advantageously allows the flushing of the filter set to be controlled, particularly in compliance with guidelines.

[0016] A cleanroom is understood to be a room in which the concentration of airborne particles, in particular aerosols, is controlled and kept below predefined thresholds. In particular, a cleanroom is classified based on the predefined thresholds, whereby a cleanroom class can be assigned to a cleanroom. In particular, a higher cleanroom class compared to a lower cleanroom class is understood to mean that the predefined thresholds in the higher cleanroom class are lower than in the lower cleanroom class. In one embodiment, a cleanroom of cleanroom class A is used as the first cleanroom, whereby the cleanroom class is determined in accordance with the version of Annex 1 of the EU GMP Guide valid on the date determining the priority of the present intellectual property right. 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 allows the process to be implemented universally and flexibly adapted to cleanrooms of various sizes.

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

[0018] In one embodiment, compressed air is passed through the filter set during the filter test. Specifically, the compressed air is first passed through an air filter and then into the filter set. Specifically, a Millipore Express Opticap XL 150 air filter is used as the air filter, which can be pressurized to a maximum 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, in particular 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, steps a) to g) are carried out aseptically—in particular in an aseptic environment and / or under aseptic conditions. In one embodiment of the method, all steps of the method are carried out aseptically—in particular in an aseptic environment and / or under aseptic conditions.

[0022] In particular, the filter set, especially all components of the filter set, is autoclaved individually or partially assembled before step a). The filter set is then assembled and connected under aseptic conditions in the first cleanroom.

[0023] According to a further development of the invention, it is provided that the filter set is subjected to 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.

[0024] Advantageously, this makes it possible to at least partially dry the first hose and filter set before performing the filter test. This ensures that the flushing fluid is removed from the hose.

[0025] In one embodiment of the method, a container, in particular a screw-top jar, is used, into which the compressed air escaping from the filter set and / or the 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.

[0026] According to a further development of the invention, at least one first product container is provided in the first clean room. Furthermore, at least one second product container is provided in the second clean room. In a step h), the filter set is or will be fluidically connected to the at least one first product container. In a step i), after the filter test, the second end of the first hose is fluidically separated from the filter test device and connected to the at least one second product container. In a step j), a product fluid is passed from the second product container through the filter set into the first product container, wherein the product fluid is filtered in the filter set.

[0027] Advantageously, the method allows for simple and rapid filtration of the product fluid after sterilization and the filter test. In particular, the product fluid is conveyed from the filter set into the first product container via a third tube.

[0028] In particular, steps h) to j) are carried out aseptically - in particular in an aseptic environment and / or under aseptic conditions.

[0029] Furthermore, during the filtration process, advantageously no aseptic connections, in particular connections of hoses to the filter set, in particular to valves, and / or fluidic connections within the filter set, are opened in the first clean room. In particular, it is advantageously not necessary to open a particularly aseptic connection in the first clean room during the filtration process.

[0030] According to a further development of the invention, the sterile filter set comprises at least one fluid filter, at least three tubes, and at least two valves. Furthermore, in step a), a first connection of the at least one fluid filter is or will be fluidly connected to a second connection of a first valve of the at least two valves. Furthermore, in step a), a second connection of the at least one fluid filter is or will be fluidly connected to a first connection of a second valve of the at least two valves. Furthermore, in step b), the first end of the first tube is or will be fluidly connected to a first connection of the first valve. Furthermore, in step d), the first end of the second tube is or will be fluidly connected to a second connection 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 rinsed with the flushing fluid from the fluid container, wherein the flushing fluid enters the filter set via the first connection of the first valve and exits the filter set via the second connection of the second valve, and wherein the flushing fluid is directed into the at least one drain container via the second hose. Furthermore, in step g), the first single-filter operating state is adjusted to perform the filter test.

[0031] In particular, in the first individual filter operating state, the flushing fluid or the particularly sterile compressed air enters the filter set via the first connection of the first valve. The flushing fluid or the particularly sterile compressed air is then conducted into the at least one fluid filter via the second connection of the first valve and the first connection of the fluid filter. The flushing fluid or the particularly sterile compressed air then enters the second valve via the second connection of the fluid filter and the first connection of the second valve and is conducted out of the filter set via the second connection of the second valve. In particular, in the first individual filter operating state, all other connections of the filter set not explicitly mentioned are blocked, so that the flushing fluid or the particularly sterile compressed air can only be conducted through the explicitly mentioned connections in the first individual filter operating state.

[0032] In one embodiment, a multi-way valve, in particular a 3-way valve, in particular an M-block, is used as at least one of the at least two valves, in particular as the at least two valves. Alternatively, a T-block is used as at least one of the at least two valves, in particular as the at least two valves.

[0033] 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 adjusted such that compressed air and / or an inert gas enters the filter set via the first connection of the first valve and exits the filter set via a third connection of the first valve.

[0034] In particular, the compressed air and / or the inert gas is passed only through the first valve to advantageously at least partially dry the first hose and / or the first valve. Preferably, the compressed air and / or the inert gas from the fluid container emptied during flushing is passed through the first valve.

[0035] In particular, in the second single-filter operating state, the compressed air and / or the inert gas enters the filter set via the first port of the first valve. The compressed air and / or the inert gas is then discharged from the filter set via the third port of the first valve. In particular, in the second single-filter operating state, the second port of the first valve is additionally blocked, so that the compressed air and / or the inert gas cannot be directed into the at least one fluid filter. Advantageously, this ensures that the at least one fluid filter remains wetted for the subsequent filter test.

[0036] In one embodiment, after step e) and before step f) in the first individual 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 connection of the first valve and exits the filter set via the second connection of the second valve. In particular, the compressed air and / or the inert gas is passed via the second connection of the first valve and the first connection of the fluid filter into the at least one fluid filter and via the second connection of the fluid filter and the first connection of the second valve into the second valve. Preferably, the compressed air and / or the inert gas, in particular at a pressure of at most 2.0 bar, is passed from the fluid container emptied during flushing through the filter set. Advantageously, this makes it possible to at least partially dry the at least one fluid filter.

[0037] According to a further development of the invention, it is provided that in step a) the third connection of the second valve is or becomes fluidically connected to a first connection of the first product container. Alternatively, in step h) the third connection of the second valve is or becomes fluidically connected to a first connection of the first product container. Furthermore, in step j), in a third individual 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 connection of the first valve and exits the filter set via the third connection of the second valve and is guided into the first product container.

[0038] 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 is then conducted into the at least one fluid filter via the second port of the first valve and the first port of the fluid filter. The product fluid then enters the second valve via the second port of the fluid filter and the first port of the second valve and is conducted from the filter set into the first product container via the third port of the second valve. In particular, 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 the third single-filter operating state, after passing through the filter set, the product fluid can only be conducted into the first product container.

[0039] According to a further development of the invention, prior to step j), the second hose is fluidically separated from the filter set. In one embodiment, prior to step j), the second hose is fluidically separated from the filter set and brought from the first cleanroom into the second cleanroom. In particular, the second hose is brought from the first cleanroom into the second cleanroom via at least one feedthrough opening.

[0040] According to a further development of the invention, it is provided that after step j) the second hose is fluidically separated from the filter set.

[0041] In one embodiment, after step j), the second hose is fluidically separated from the filter set and brought from the first cleanroom into the second cleanroom. In particular, the second hose is brought from the first cleanroom into the second cleanroom via at least one through-opening.

[0042] According to a further development of the invention, the first cleanroom is designed as a glove box. This advantageously makes it possible to make the first cleanroom small and thus operate it cost-effectively.

[0043] In particular, the fluidic connection and / or separation of the hoses from the connectors is carried out using the gloves in the glove box.

[0044] 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 connection of the first fluid filter is or will be fluidly connected to the second connection of the first valve. Furthermore, in step a), a second connection of the first fluid filter is or will be fluidly connected to a first connection of the third valve. Furthermore, in step a), a second connection of the third valve is or will be fluidly connected to a first connection of the fourth valve. Furthermore, in step a), a first connection of the second fluid filter is or will be fluidly connected to a second connection of the fourth valve.Furthermore, in step a), a second port of the second fluid filter is or will be fluidly connected to the first port of the second valve. Furthermore, in step b), the first end of the first hose is or will be fluidly connected to the first port of the first valve. Furthermore, in step d), a first end of the first second hose is or will be fluidly connected to a third port of the fourth valve. Furthermore, in step d), a first end of the second second hose is or will be fluidly 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 adjusted such that the first fluid filter and the second fluid filter are flushed with the flushing fluid from the fluid container, wherein the flushing fluid enters the filter set via the first connection of the first valve and exits the filter set via the second connection of the second valve, wherein the flushing fluid is conducted into the at least one drain container via the second hose.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 flushing fluid from the fluid container, wherein the flushing fluid enters the filter set via the first connection of the first valve and exits the filter set via the third connection of the fourth valve, wherein the flushing fluid is conducted via the first, second hose into the at least one drain container. Furthermore, in a first sub-step gl), a first end of the third hose is or will be fluidly connected to a third connection 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 adjusted such that the first fluid filter can be tested, wherein in particular sterile compressed air enters the filter set via the first connection of the first valve and exits the filter set via the third connection of the fourth valve, wherein the second fluid filter is fluidically separated from the filter test device.In addition, 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 testing 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 connection of the third valve and exits the filter set via the second connection of the second valve, wherein the first fluid filter is fluidically separated from the filter testing device.

[0045] Specifically, in the first dual-filter operating state, the flushing fluid enters the filter set via the first port of the first valve. The flushing fluid is then directed into the first fluid filter via the second port of the first valve and the first port of the first fluid filter. The flushing fluid then enters the third valve via the second port of the first fluid filter and the first port of the third valve. The flushing fluid is then directed into the fourth valve via the second port of the third valve and the first port of the fourth valve. The flushing fluid is then directed into the second fluid filter via the second port of the fourth valve and the first port of the second fluid filter.The flushing 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 routed out of the filter set via the second port of the second valve. In particular, in the first dual-filter operating state, all other, not explicitly mentioned, ports of the filter set are blocked, so that the flushing fluid can only be routed through the explicitly mentioned ports in the first dual-filter operating state.

[0046] Specifically, in the second first dual-filter operating state, the flushing fluid enters the filter set via the first port of the first valve. The flushing fluid is then directed into the first fluid filter via the second port of the first valve and the first port of the first fluid filter. The flushing fluid then enters the third valve via the second port of the first fluid filter and the first port of the third valve. The flushing fluid is then directed into the fourth valve via the second port of the third valve and the first port of the fourth valve. The flushing fluid is then directed out of the filter set via the third port of the fourth valve.In particular, in the second first double filter operating state, all other connections of the filter set not explicitly mentioned are additionally blocked, so that the flushing fluid in the second first double filter operating state can only be passed through the explicitly mentioned connections.

[0047] In particular, in the second double filter operating state, the particularly sterile compressed air enters the filter set via the first connection of the first valve. The particularly sterile compressed air is then guided into the first fluid filter via the second connection of the first valve and the first connection of the first fluid filter. The particularly sterile compressed air then enters the third valve via the second connection of the first fluid filter and the first connection of the third valve. The particularly sterile compressed air is then guided into the fourth valve via the second connection of the third valve and the first connection of the fourth valve. The particularly sterile compressed air is then guided out of the filter set via the third connection of the fourth valve.In particular, in the second double filter operating state, the third connection of the first valve, the third connection of the third valve and the second connection 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.

[0048] In particular, in the third double filter operating state, the particularly sterile compressed air enters the filter set via the third connection of the third valve. The particularly sterile compressed air is then fed into the fourth valve via the second connection of the third valve and the first connection of the fourth valve. The particularly sterile compressed air is then fed into the second fluid filter via the second connection of the fourth valve and the first connection of the second fluid filter. The particularly sterile compressed air then enters the second valve via the second connection of the second fluid filter and the first connection of the second valve. The particularly sterile compressed air is then fed out of the filter set via the second connection of the second valve.In particular, in the third double filter operating state, the first connection of the third valve and the third connection 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.

[0049] In one embodiment, after step e) and before step f), in a fourth double filter operating state, the first valve is adjusted such that compressed air and / or an inert gas enters the filter set via the first connection of the first valve and exits the filter set via a third connection of the first valve.

[0050] 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 connection of the first valve and exits the filter set via a second connection of the second valve. Preferably, the compressed air and / or the inert gas from the fluid container emptied during flushing is passed through the filter set, in particular through the first fluid filter and the second fluid filter. This advantageously makes it possible to at least partially dry the two fluid filters.

[0051] 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 connection of the first valve and exits the filter set via the third connection of the fourth valve. Preferably, the compressed air and / or the inert gas from the fluid container emptied during flushing is passed through the filter set, in particular through the first fluid filter. This advantageously makes it possible to at least partially dry the first fluid filter.

[0052] In one embodiment, the second port of the third valve is or will be fluidly connected to the first port of the fourth valve by means of a fourth hose. In particular, a Teflon hose is used as the fourth hose, in particular with two Tri-Clamp connections and / or with at least one 90° bend, in particular at least two 90° bends.

[0053] In one embodiment, a multi-way valve, in particular a 3-way valve, in particular an M-block or a T-block, is used as at least one valve selected from a group consisting of the first valve, the second valve, and the fourth valve. In particular, a multi-way valve, in particular a 3-way valve, in particular an M-block or a T-block, is used as the first valve, the second valve, and the fourth valve.

[0054] In one embodiment, a 3-way valve is used as the third valve. Alternatively, an M-block is used as the third valve.

[0055] In particular, it is easily possible to expand the filter set with an additional fluid filter, in particular a third fluid filter. For this purpose, analogous to the expansion with the second fluid filter, the additional fluid filter and two additional valves are arranged fluidically between the second fluid filter and the second valve.

[0056] According to a further development of the invention, in step e), after flushing 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. Thereafter, 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 flushing fluid from the fluid container. The flushing fluid enters the filter set via the third connection of the third valve and exits the filter set via the second connection of the second valve, the flushing fluid being conducted via the second hose into the at least one drain container.In particular, in the third first double-filter operating state, the flushing fluid enters the filter set via the third port of the third valve. The flushing fluid is then conducted into the fourth valve via the second port of the third valve and the first port of the fourth valve. The flushing fluid is then conducted into the second fluid filter via the second port of the fourth valve and the first port of the second fluid filter. The flushing 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 conducted out of the filter set via the second port of the second valve. In particular, in the third first double-filter operating state, all other ports of the filter set not explicitly mentioned are blocked, so that the flushing fluid can only be conducted through the explicitly mentioned ports in the third first double-filter operating state.

[0057] 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 connection of the third valve and exits the filter set via the second connection of the second valve. Preferably, the compressed air and / or the inert gas, in particular at a pressure of no more than 2.0 bar, is passed from the fluid container emptied during flushing through the filter set, in particular through the second fluid filter. This advantageously makes it possible to at least partially dry the second fluid filter.

[0058] According to a further development of the invention, after step e) and before the first sub-step g1), the filter set is set to a fourth double-filter operating state. In this case, the filter set is dried with an inert gas, in particular nitrogen.

[0059] Alternatively or additionally, after the third sub-step g3), the filter set is set to the fourth double-filter operating mode. The filter set is dried with an inert gas, in particular nitrogen.

[0060] 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 third valve and the fourth valve are supplied with the inert gas, the inert gas entering the filter set via the third connection of the third valve and exiting the filter set via the third connection of the fourth valve, the inert gas being conducted into the at least one drain container via the first, second hose. In particular, the inert gas is conducted into the fourth valve via the second connection of the third valve and the first connection of the fourth valve. In particular, in the fourth double-filter operating state, all other connections of the filter set not explicitly mentioned are additionally blocked, so that the inert gas can only be conducted through the explicitly mentioned connections in the fourth double-filter operating state.

[0061] In one embodiment, the inert gas, in particular nitrogen, enters the filter set via the third connection of the third valve and exits the filter set via the third connection of the fourth valve, wherein the first fluid filter is fluidically separated from the second fluid filter.

[0062] In particular, the inert gas, especially nitrogen, is fed into the filter set at a pressure of no more than 2.0 bar.

[0063] According to a further development of the invention, it is provided that in step a) the third connection of the second valve is or becomes fluidically connected to the first connection of the first product container. In addition, 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 connection of the first valve and exits the filter set via the third connection of the second valve and is guided into the first product container.

[0064] Specifically, in the fourth dual-filter operating mode, the product fluid enters the filter set via the first port of the first valve. The product fluid is then directed into the first fluid filter via the second port of the first valve and the first port of the first fluid filter. The product fluid then enters the third valve via the second port of the first fluid filter and the first port of the third valve. The product fluid is then directed into the fourth valve via the second port of the third valve and the first port of the fourth valve. The product fluid is then directed into the second fluid filter via the second port of the fourth valve and the first port of 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 guided out of the filter set via the third port of the second valve. In particular, in the fourth double filter operating state, all other, not explicitly mentioned ports of the filter set are blocked, so that in the fourth double filter operating state the product fluid can only be guided through the explicitly mentioned ports. In particular, in the fourth double 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 double filter operating state the product fluid can only be guided into the first product container after passing through the filter set.

[0065] According to a further development of the invention, it is provided that in step h) the third connection of the second valve is or becomes fluidically connected to a first connection of the first product container. In addition, 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 connection of the first valve and exits the filter set via the third connection of the second valve and is guided into the first product container.

[0066] The object is also achieved by providing a sterile filter set comprising at least one fluid filter, at least three tubes, at least two valves, and instructions for use. The instructions for use comprise instructions for carrying out a method according to the invention or a method according to one or more of the previously explained embodiments. In connection with the sterile filter set, the advantages already explained in connection with the method arise in particular.

[0067] The invention is explained in more detail with reference to the following drawings.

[0068] Fig. 1 shows a first embodiment of a sterile filter set,

[0069] Fig. 2 shows a flowchart of an embodiment of the method for performing a filter test,

[0070] Fig. 3 shows a schematic representation of the first embodiment of the sterile filter set with a fluid filter in a first process step,

[0071] Fig. 4 shows a schematic representation of the first embodiment of the sterile filter set with the fluid filter in a second process step, Fig. 5 shows a schematic representation of the first embodiment of the sterile filter set with the fluid filter in a third process step,

[0072] Fig. 6 shows a schematic representation of a second embodiment of the sterile filter set with two fluid filters in a first process step,

[0073] Fig. 7 shows a schematic representation of the second embodiment of the sterile

[0074] Filter sets with two fluid filters in a second process step,

[0075] Fig. 8 shows a schematic representation of the second embodiment of the sterile

[0076] Filter sets with two fluid filters in a third process step,

[0077] Fig. 9 shows a schematic representation of the second embodiment of the sterile filter set with two fluid filters in a fourth process step, and

[0078] Fig. 10 shows a schematic representation of the second embodiment of the sterile

[0079] Filter sets with two fluid filters in a fifth process step.

[0080] 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 conducting a filter test.

[0081] Optionally, the instructions for use 9 include, in particular, instructions for carrying out filtration using the sterile filter set 1.

[0082] In particular, a first connection 11.1 of the at least one fluid filter 3 is fluidically connected or connectable to a second connection 13.2 of the first valve 7.1. Furthermore, a second connection 11.2 of the at least one fluid filter 3 is fluidically connected or connectable to a first connection 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 connection 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 connection 15.2 of the second valve 7.2. In addition, a first end of a third hose 5.3 is preferably fluidically connected to a third connection 15.3 of the second

[0083] Valve 7.2 connected or connectable.

[0084] The procedure for performing a filter test is described in more detail using the following figures.

[0085] Figure 2 shows a flowchart of an embodiment of the method for performing a filter test.

[0086] 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.

[0087] In a second step b), the first tube 5.1 is fluidically connected to the sterile filter set 1 by its first end. Alternatively, the at least one first tube 5.1 is fluidically connected to the sterile filter set 1 by its first end.

[0088] In a third step c), the at least one first hose 5.1 is fluidically connected to the at least one fluid container 19 by at least one second end.

[0089] Alternatively, the at least one first hose 5.1 is fluidly connected to the at least one fluid container 19 by means of the at least one second end.

[0090] In a fourth step d), at least one second hose 5.2 of the plurality of hoses 5 is fluidically connected to the sterile filter set 1 by at least one first end. Alternatively, the at least one second hose 5.2 is fluidically connected to the sterile filter set 1 by at least one first end. Furthermore, the at least one second hose 5.2 opens into the at least one drain container 21 by at least one second end.

[0091] 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. In a sixth step f), after the filter set 1 has been rinsed, the second end of the at least one first hose 5.1 is separated from the fluid container 19 and fluidically connected to the filter testing device 23.

[0092] In a seventh step g), a filter test is carried out using the filter test device 23.

[0093] Preferably, the filter set 1 is subjected to compressed air and / or an inert gas after the fifth step e) and before the sixth step f) 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.

[0094] Preferably, at least one first product container 25.1 is provided in the first clean room 17.1. Alternatively or additionally, at least one second product container 25.2 is preferably provided in the second clean room 17.2.

[0095] 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.

[0096] 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.

[0097] 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, wherein the product fluid is filtered in the filter set 1.

[0098] In particular, steps h) to j) describe an optional filtration of a product fluid after a filter test has been carried out by means of steps a) to g).

[0099] Preferably, steps a) to g), in particular steps a) to j), are carried out aseptically.

[0100] Figures 3 to 5 show a schematic representation of the first embodiment of the sterile filter set 1 with a fluid filter 3 in three different process steps.

[0101] Identical and functionally equivalent elements are provided with the same reference numerals in all figures, so reference is made to the previous description. For clarity, the reference numerals for the connections have been shown only in Figure 3. The connections in Figures 4 and 5 are identical to the connections in Figure 3.

[0102] In Figures 3 to 5, the second hose 5.2 fluidically connects the second port 15.2 of the second valve 7.2 and the drain container 21. In addition, the third hose 5.3, in particular, fluidically connects the third port 15.3 of the second valve 7.2 and the first product container 25.1.

[0103] Figure 3 illustrates the fifth step e) of the method for performing a filter test, in particular rinsing the filter set 1. The first hose 5.1 fluidically connects the first port 13.1 of the first valve 7.1 and the fluid container 19.

[0104] In a first single filter operating state of the filter set 1 in Figure 3, the first valve

[0105] 7.1 and the second valve 7.2 are set such that the fluid filter 3 is flushed with the flushing fluid from the fluid container 19. In particular, the flushing fluid flows through the first connection

[0106] 13.1 of the first valve 7.1 into the filter set 1. The flushing fluid is then fed into the fluid filter 3 via the second connection 13.2 of the first valve 7.1 and the first connection 11.1 of the fluid filter 3. The flushing fluid then enters the second valve 7.2 via the second connection 11.2 of the fluid filter 3 and the first connection 15.1 of the second valve 7.2 and is discharged from the filter set 1 via the second connection 15.2 of the second valve 7.2. The flushing fluid is then fed into the drain container 21 via the second hose 5.2. In particular, in the first single-filter operating state, a 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 flushing fluid in the first single-filter operating state can be passed exclusively through the fluid filter 3 and into the drain tank 21.

[0107] In particular, after step e) and before step f) in the first individual filter operating state of the 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, in particular from the fluid container 19 emptied during flushing. The compressed air and / or the inert gas enters the filter set 1 via the first port 13.1 of the first valve 7.1. The compressed air and / or the inert gas is guided 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 and into 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. The compressed air and / or the inert gas is then fed from the filter set 1 via the second connection 15.2 of the second valve 7.2.The compressed air and / or the inert gas is then fed into the drain tank 21 via the second hose 5.2. 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 compressed air and / or the inert gas can be fed exclusively through the fluid filter 3 and into the drain tank 21 in the first single-filter operating state.

[0108] Alternatively or additionally, in particular after step e) and before step f), in a second individual filter operating state of the filter set 1, the first valve 7.1 is adjusted 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 the third port 13.3 of the first valve 7.1. In particular, in the second individual filter operating state, the second port 13.2 of the first valve 7.1 is additionally blocked, so that the compressed air and / or the inert gas cannot be directed into the fluid filter 3.

[0109] Figure 4 illustrates the seventh step g) of the method for conducting a filter test, in particular a filter test of the filter set 1. The first hose 5.1 fluidically connects the first port 13.1 of the first valve 7.1 and the filter test device 23.

[0110] In the first single-filter operating state of the filter set 1 in Figure 4, the first valve 7.1 and the second valve 7.2 are set such that the fluid filter 3 is supplied with the particularly sterile compressed air from the filter test device 23. The particularly sterile compressed air enters the filter set 1 via the first connection 13.1 of the first valve 7.1. The particularly sterile compressed air is then directed into the fluid filter 3 via the second connection 13.2 of the first valve 7.1 and the first connection 11.1 of the fluid filter 3. Subsequently, the particularly sterile compressed air, in particular together with flushing fluid flushed out of the fluid filter 3 by means of the sterile compressed air, enters the second valve 7.2 via the second connection 11.2 of the fluid filter 3 and the first connection 15.1 of the second valve 7.2 and is guided out of the filter set 1 via the second connection 15.2 of the second valve 7.2.The compressed air, which is particularly sterile, is then directed into the drain tank 21 via the second hose 5.2. 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 compressed air, which is particularly sterile, can be directed exclusively through the fluid filter 3 and into the drain tank 21 in the first single-filter operating state.

[0111] Figure 5 illustrates the tenth step j) of the method, in particular filtering the product fluid in the filter set 1. The first hose 5.1 fluidically connects the first port 13.1 of the first valve 7.1 and the second product container 25.2.

[0112] In a third single-filter operating state of the filter set 1 in Figure 5, 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 the fluid filter 3. The product fluid enters the filter set 1 via the first connection 13.1 of the first valve 7.1. The product fluid is then fed into the fluid filter 3 via the second connection 13.2 of the first valve 7.1 and the first connection 11.1 of the fluid filter 3. The product fluid then enters the second valve 7.2 via the second connection 11.2 of the fluid filter 3 and the first connection 15.1 of the second valve 7.2 and is fed out of the filter set 1 via the third connection 15.3 of the second valve 7.2. The product fluid is then fed into the first product container 25.1 via the third hose 5.3. In particular, in the third single filter operating state, the third port 13.3 of the first valve 7.1 and the second connection 15.2 of the second valve 7.2 is blocked, so that the product fluid in the third single filter operating state can be directed exclusively into the first product container 25.1 after passing through the filter set 3.

[0113] Additionally, it is particularly possible for the second hose 5.2 to be 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 brought from the first clean room 17.1 into the second clean room 17.2, in particular via at least one through-opening.

[0114] Figures 6 to 10 show 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.

[0115] In particular, the first port 11.1 of the first fluid filter 3.1 is fluidly 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 fluidly connected to a first port 27.1 of a third valve 7.3. Furthermore, a second port 27.2 of the third valve 7.3 is fluidly connected to a first port 29.1 of a fourth valve 7.4. In particular, the second port 27.2 of the third valve 7.3 is fluidly 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. Furthermore, a second connection 31.2 of the second fluid filter 3.2 is fluidically connected to the first connection 15.1 of the second valve 7.2.Furthermore, a first end of the first hose 5.1 is fluidically connected to the first port 13.1 of the first valve 7.1. In addition, a fifth hose 5.5, in particular, fluidically connects the third port 15.3 of the second valve 7.2 and the first product container 25.1.

[0116] In particular, in Figures 6 to 9, a first end of a first second hose 5.2' is fluidically connected to a third connection 29.3 of the fourth valve 7.4. In addition, in particular in Figures 6 to 9, a first end of a second second hose 5.2" is fluidically connected to the second connection 15.2 of the second valve 7.2. In addition, in particular in Figures 6 to 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, in Figures 6 to 9, the first second hose 5.2' and the second second hose 5.2" fluidically connect the filter set 1 and the drain container 21 to one another. Alternatively, the first second hose 5.2' and the second second hose 5.2" are fluidically coupled to the second hose 5.2, wherein the second hose 5.2 opens into the drain container 21.

[0117] For clarity, the reference symbols for the connections have been shown only in Figure 6. The connections in Figures 7 to 9 are identical to the connections in Figure 6.

[0118] Figure 6 illustrates the fifth step e) of the method for performing a filter test, in particular flushing the filter set 1. The first hose 5.1 fluidically connects the first port 13.1 of the first valve 7.1 and the fluid container 19.

[0119] In a first double-filter operating state of the filter set 1 in Figure 6, 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. 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 guided 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 flushing fluid is then 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 flushing 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 directed out of the filter set 1 via the second port 15.2 of the second valve 7.2. The flushing fluid is then conducted 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 the flushing fluid in the first double-filter operating state flows exclusively through the first fluid filter 3.1, through the second fluid filter 3.2 and into the drain tank 21.

[0120] Alternatively or additionally, in step e), in a second, first double-filter operating state of the filter set 1 in Figure 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 container 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 guided 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 flushing fluid is then directed out of the filter set 1 via the third port 29.3 of the fourth valve 7.4. The flushing fluid is then directed into the drain tank 21 via the first, second hose 5.2' and in particular the second hose 5.2. In particular, 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 the flushing fluid can be directed exclusively through the first fluid filter 3.1 and into the drain tank 21 in the second, first double-filter operating state.

[0121] In particular, after step e) and before step f), in a fourth double-filter operating state of the filter set 1, the first valve 7.1 is adjusted 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 the third port 13.3 of the first valve 7.1. In particular, in the fourth double-filter operating state, the second port 13.2 of the first valve 7.1 is additionally 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.

[0122] Alternatively or additionally, in particular after step e) and before step f) in the 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 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 container 19 emptied during flushing. The compressed air and / or the inert gas enters the filter set 1 via the first connection 13.1 of the first valve 7.1. The compressed air and / or the inert gas is fed into the first fluid filter via the second connection 13.2 of the first valve 7.1 and the first connection 11.1 of the first fluid filter 3.1.

[0123] 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 the inert gas is fed via 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. The compressed air and / or the inert gas is then fed 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 into the second fluid filter 3.2. The compressed air and / or the inert gas is then fed via the second port 31.2 of the second fluid filter 3.2 and the first port

[0124] 15.1 of the second valve 7.2 into the second valve 7.2. The compressed air and / or the inert gas are then fed from the filter set 1 via the second connection 15.2 of the second valve 7.2. The compressed air and / or the inert gas are then fed into the drain tank 21 via the second hose 5.2". In particular, in the first double-filter operating state, the third connection 13.3 of the first valve 7.1, the third connection 15.3 of the second valve 7.2, the third connection 27.3 of the third valve 7.3, and the third connection 29.3 of the fourth valve 7.4 are blocked, so that the compressed air and / or the inert gas can be fed into the drain tank 21 exclusively through the first fluid filter 3.1 and the second fluid filter 3.2 in the first double-filter operating state.

[0125] Alternatively or additionally, in particular after step e) and before step f), in the second 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 first fluid filter 3.1 is at least partially dried with compressed air and / or an inert gas, in particular from the fluid container 19 emptied during flushing. The compressed air and / or the inert gas enters the filter set 1 via the first connection 13.1 of the first valve 7.1. The compressed air and / or the inert gas is fed via the second connection 13.2 of the first valve 7.1 and the first connection 11.1 of the first fluid filter 3.1 into the first fluid filter 3.1 and via the second connection 11.2 of the first fluid filter 3 and the first connection 27.1 of the third valve 7.3 into the third valve 7.3. The compressed air and / or the inert gas is fed via the second connection

[0126] 27.2 of the third valve 7.3 and the first connection 29.1 of the fourth valve 7.4 into the fourth valve 7.4. The compressed air and / or inert gas is then fed via the third connection

[0127] 29.3 of the fourth valve 7.4 from the filter set 1. The compressed air and / or the inert gas is then fed into the drain tank 21 via the first, second hose 5.2'. In particular, 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 the compressed air and / or the inert gas can be fed into the drain tank 21 exclusively through the first fluid filter 3.1 in the second, first double-filter operating state.

[0128] Figure 7 shows an additional method step of the fifth step e) of the method for performing a filter test, in particular, rinsing the filter set 1. The first hose 5.1 is fluidically separated, in particular, from the fluid container 19. Furthermore, the third hose 5.3 fluidly connects the third port 27.3 of the third valve 7.3 and the fluid container 19.

[0129] In a third, first double-filter operating state of the filter set 1 in Figure 7, 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 is flushed with the flushing fluid from the fluid container 19. In particular, 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 guided 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 flushing fluid is then guided into the fourth valve 7.4 via the second port 29.2 of the fourth valve 7.4 and the first port

[0130] 31.1 of the second fluid filter 3.2 into the second fluid filter 3.2. The flushing fluid then flows through the second connection 31.2 of the second fluid filter 3.2 and the first connection

[0131] 15.1 of the second valve 7.2 into the second valve 7.2 and is connected via the second connection

[0132] 15.2 of the second valve 7.2 from the filter set 1. 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 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 the flushing fluid in the third first double-filter operating state can be directed exclusively through the second fluid filter 3.2 and into the drain container 21.

[0133] In particular, after step e) and before step f), in the third first double-filter operating state of the 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, in particular from the fluid container 19 emptied during flushing. The compressed air and / or the inert gas enters the filter set 1 via the third port 27.3 of the third valve 7.3. The compressed air and / or the inert gas is fed 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 fed 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 compressed air and / or inert gas is then fed into the second fluid filter 3.2 via the second port 31.2 of the second fluid filter 3.2 and the first connection 15.1 of the second valve 7.2 into the second valve 7.2. The compressed air and / or the inert gas is then passed from the filter set 1 via the second connection 15.2 of the second valve 7.2. The compressed air and / or the inert gas is then passed via the second hose 5.2" into the drain container 21. In particular, in the third first double-filter operating state, the third connection 15.3 of the second valve 7.2, the first connection 27.1 of the third valve 7.3, and the third connection 29.3 of the fourth valve 7.4 are blocked, so that the compressed air and / or the inert gas can be passed into the drain container 21 exclusively through the second fluid filter 3.2 in the third first double-filter operating state.

[0134] Figure 8 shows a second sub-step g2) of the seventh step g) of the method for

[0135] Performing a filter test, in particular a filter test of filter set 1, is shown. The first hose 5.1 fluidically connects the first port 13.1 of the first valve 7.1 and the filter test device 23.

[0136] In a second double-filter operating state of the filter set 1 in Figure 8, 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 is supplied with the particularly sterile compressed air from the filter test device 23, wherein the second fluid filter 3.2 is fluidically separated from the filter test device 23. The particularly sterile compressed air enters the filter set 1 via the first connection 13.1 of the first valve 7.1. The particularly sterile compressed air is then guided into the first fluid filter 3.1 via the second connection 13.2 of the first valve 7.1 and the first connection 11.1 of the first fluid filter 3.1. The particularly sterile compressed air then enters the third valve 7.3 via the second connection 11.2 of the first fluid filter 3.1 and the first connection 27.1 of the third valve 7.3. The particularly sterile compressed air is then supplied via the second connection 27.2 of the third valve 7.3 and the first connection 29.1 of the fourth valve 7.4 into the fourth valve 7.4. The particularly sterile compressed air is then passed from the filter set 1 via the third connection 29.3 of the fourth valve 7.4. The particularly sterile compressed air, in particular together with the rinsing fluid flushed out of the first fluid filter 3.1 by means of the sterile compressed air, is then passed via the first second hose 5.2' and in particular the second hose 5.2 into the drain container 21. In particular, in the second double-filter operating state, the third connection 13.3 of the first valve 7.1, the third connection 27.3 of the third valve 7.3, and the second connection 29.2 of the fourth valve 7.4 are blocked, so that the particularly sterile compressed air can be passed exclusively through the first fluid filter 3.1 and into the drain container 21 in the second double-filter operating state.

[0137] Figure 9 shows a third sub-step g2) of the seventh step g) of the method for performing a filter test, in particular a filter test of the filter set 1. The third hose 5.3 fluidically connects the third port 27.3 of the third valve 7.3 and the filter test device 23.

[0138] In a third double-filter operating state of the filter set 1 in Figure 9, 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 is supplied with the particularly sterile compressed air from the filter test device 23, wherein the first fluid filter 3.1 is fluidically separated from the filter test device 23. The particularly sterile compressed air enters the filter set 1 via the third port 27.3 of the third valve 7.3. The particularly sterile compressed air is then fed 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 particularly sterile compressed air is then fed 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 particularly sterile compressed air 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. The particularly sterile compressed air, in particular together with the flushing fluid flushed out of the second fluid filter 3.2 by means of the sterile compressed air, is then guided out of the filter set 1 via the second port 15.2 of the second valve 7.2. The particularly sterile compressed air is then guided into the drain container 21 via the second hose 5.2" and in particular the second hose 5.2. In particular, 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 the particularly sterile compressed air in the third double-filter operating state flows exclusively through the second fluid filter 3.2 and into the drain tank 21.

[0139] Figure 10 illustrates the tenth step j) of the method, in particular filtering the product fluid in the filter set 1. The first hose 5.1 fluidically connects the first port 13.1 of the first valve 7.1 and the second product container 25.2.

[0140] Furthermore, in particular the first second hose 5.2' and the second second hose 5.2" are fluidically separated from the filter set 1. Therefore, the second hose 5.2, the first second hose 5.2' and the second second hose 5.2" are not shown in Figure 10.

[0141] In a fourth double-filter operating state of the filter set 1 in Figure 10, 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. The product fluid enters the filter set 1 via the first port 13.1 of the first valve 7.1. The product fluid is then guided 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 product 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. The product fluid is then fed 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 product fluid is then 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 product 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 directed out of the filter set 1 via the third port 15.3 of the second valve 7.2. The product fluid is then directed into the first product container 25.1 via the fifth hose 5.5. 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 the product fluid in the fourth double filter operating state, after passing through the filter set 3, flows exclusively into the first product container 25.1 can be directed.

Claims

CLAIMS 1. A method for carrying out a filter test, wherein a) a plurality of hoses (5) are or will be laid from a first cleanroom (17.1) of a first, higher cleanroom class into 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 will be 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 will be 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) the plurality of hoses (5) is or becomes fluidically connected with at least one first end to the sterile filter set (1), wherein the at least one second hose (5.2) of the plurality of hoses (5) opens into the at least one drainage container (21) with at least one second end, wherein e) the filter set (1) is rinsed by conducting a rinsing fluid from the at least one fluid container (19) through the filter set (1) into the at least one drainage 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 fluidically connected to the filter testing device (23), wherein g) a filter test is carried out by means of the filter testing device (23).

2. The 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 subjected to 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 one of the preceding claims, wherein at least one first product container (25.1) is provided in the first clean room (17.1), wherein at least one second product container (25.2) is provided in the second clean room (17.2), wherein h) the filter set (1) is fluidically connected to the at least one first product container (25.1) is or will be connected, 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 the at least one second product container (25.2), wherein j) a product fluid is passed from the second product container (25.2) through the filter set (1) into the first product container (25.1), wherein the product fluid is filtered in the filter set (1).

5. Method according to one of the preceding claims, wherein - the sterile filter set (1) comprises at least one fluid filter (3), at least three tubes (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 or becomes fluidically connected to a second connection (13.2) of a first valve (7.1) of the at least two valves (7), wherein - in step a) a second connection (11.2) of the at least one fluid filter (3) is or becomes fluidically connected to a first connection (15.1) of a second valve (7.2) of the at least two valves (7), wherein - in step b) the first end of the first hose (5.1) is or will be fluidically connected to a first connection (13.1) of the first valve (7.1), wherein - in step d) the first end of the second hose (5.2) is or will be fluidically connected to a second connection (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 adjusted such that the at least one fluid filter (3) is rinsed with the rinsing fluid from the fluid container (19), wherein the rinsing fluid enters the filter set (1) via the first connection (13.1) of the first valve (7.1) and exits the filter set (1) via the second connection (15.2) of the second valve (7.2), wherein the rinsing fluid is guided 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 carry out 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 connection (13.1) of the first valve (7.1) and exits the filter set (1) via a third connection (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) in order to dry the first hose (5.1).

7. Method according to one of the preceding claims, wherein - in step a) or in step h), the third connection (15.3) of the second valve (7.2) is or becomes fluidically connected to a first connection 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 adjusted 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 connection (13.1) of the first valve (7.1) and exits the filter set (1) via the third connection (15.3) of the second valve (7.2) and is guided into the first product container (25.1).

8. Method according to one of the preceding claims, 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 clean room (17.1) into the second clean room (17.2), in particular via at least one through-opening.

9. Method according to one of the preceding claims, wherein the first clean room (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 one of the preceding claims, wherein - the 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 connection (27.2) of the third valve (7.3) is or becomes fluidically connected to a first connection (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 will be fluidically connected to the first connection (13.1) of the first valve (7.1), wherein - in step d) the first end of the first second hose (5.2') is or will be fluidically connected to a third connection (29.3) of the fourth valve (7.4), wherein - in step d) the first end of the second hose (5.2") is or will be fluidly connected to the second connection (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 rinsed with the rinsing fluid from the fluid container (19), wherein the rinsing fluid enters the filter set (1) via the first connection (13.1) of the first valve (7.1) and exits the filter set (1) via the second connection (15.2) of the second valve (7.2), wherein the rinsing fluid is guided into the at least one drain container (21) via the second hose (5.2") 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) must be adjusted so that the first fluid filter (3.1) are rinsed with the rinsing fluid from the fluid container (19), wherein the rinsing fluid enters the filter set (1) via the first connection (13.1) of the first valve (7.1) and exits the filter set (1) via the third connection (29.3) of the fourth valve (7.4), wherein the rinsing fluid is guided via the first second hose (5.2') into the at least one drain container (21), wherein. - in a first sub-step g1) a first end of the third hose (5.3) is or will be fluidically connected to a third connection (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 adjusted 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 connection (13.1) of the first valve (7.1) and exits the filter set (1) via the third connection (29.3) of the fourth valve (7.4), wherein the second fluid filter (3.2) is fluidically separated from the filter testing 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 in such a way that the second fluid filter (3.2) can be tested, whereby in particular sterile compressed air is supplied via the third connection (27.3) of the third valve (7.3) enters the filter set (1) and exits the filter set (1) via the second connection (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. The method according to claim 10, wherein in step e) after flushing the filter set (1) in the first double-filter operating state and / or the second 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 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 flushed with the flushing fluid from the fluid container (19), wherein the flushing fluid enters the filter set (1) via the third connection (27.3) of the third valve (7.3) and exits the filter set (1) via the second connection (15.2) of the second valve (7.2), wherein the flushing fluid flows into the at least one drain container via the second hose (5.2"). (21).

12. The method according to claim 10 or 11, wherein before the first sub-step g1) and / or after the third sub-step g3), the filter set (1) is set in 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, is supplied via the third connection (27.3) of the third valve (7.3) into the filter set (1) and exits the filter set (1) via the third connection (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 one of claims 10 to 12, wherein - in step a) or in step h), the third connection (15.3) of the second valve (7.2) is or becomes fluidically connected to a first connection 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 connection (13.1) of the first valve (7.1) and exits the filter set (1) via the third connection (15.3) of the second valve (7.2) and is guided into the first product container (25.1).

14. Sterile filter set (1) with at least one fluid filter (3), at least three tubes (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.

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