A method for conducting a filter test and a sterile filter set including a procedure for carrying out the method

Abstract

The present invention relates to a method for conducting a filter test, wherein a) a plurality of hoses (5) are or are to be 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), and at least one fluid container (19), at least one discharge container (21) and a filter testing device (23) are provided in the second clean room (17.2); b) at least a first hose (5.1) of the plurality of hoses (5) is or is to be fluidly connected at at least a first end to the sterile filter set (1); and c) at least one first hose (5.1) of the plurality of hoses (5) is or is to be fluidly connected at at least a second end to the at least one fluid container (19). d) at least one second hose (5.2) of the plurality of hoses (5) is fluidly connected or will be connected at at least one first end to the sterile filter set (1), and at least one second hose (5.2) of the plurality of hoses (5) opens at at least one second end to at least one discharge container (21); e) the filter set (1) is flushed by passing a flushing fluid from the at least one fluid container (19) through the filter set (1) to the at least one discharge container (21); f) after flushing the filter set (1), the second end of the at least one first hose (5.1) is disconnected from the fluid container (19) and fluidly connected to a filter testing device (23); g) a filter test is performed using the filter testing device (23).

Description

[Technical Field]

[0001] The present invention relates to a method for performing a filter test and a sterile filter set that includes instructions for performing the method. [Background technology]

[0002] Annex 1 of the EU GMP Guidelines, "Manufacture of Sterile Medicinal Products," is considered the key European regulation for the manufacture of sterile medicinal products. Work to revise Annex 1 of the EU GMP Guidelines is underway as of the date of determining the priority of this property right, and method requirements related to Pre-Use / Post-Sterilization Integrity Testing (PUPSIT) are being discussed. Summary of the Invention

[0003] Pre-use / post-sterilization integrity testing (PUPSIT) is a method of filter testing that is performed after the elements required for filtration have been sterilized and before the filtration of the fluid that will be used for that element. Specifically, filter testing is used to verify filters, particularly the membranes incorporated into the filter, and to confirm the integrity and / or functionality of the filter.

[0004] Known devices for implementing the PUPSIT method are complex and have a large number of components, in particular more than 20. Furthermore, the known devices are very specifically adapted to the application and / or space for which they are constructed, and therefore cannot be flexibly adapted to different applications and / or different spaces.

[0005] Furthermore, known devices for performing the PUPSIT method are equipped with plastic elements and / or silicone hoses. The drawback is that such devices are not thermally stable and therefore cannot be steam sterilized. Furthermore, such devices can only be used in specially equipped cleanrooms of class A, or in isolators, which require more space, or in cleanrooms of lower cleanroom classes.

[0006] Furthermore, flexible adaptation of known devices to changed test conditions and / or structural modifications of known devices are only partially possible.

[0007] It is therefore an underlying object of the present invention to provide a method for performing a filter test and a sterile filter set with instructions for performing such a method, which at least partially overcomes and preferably avoids the above-mentioned drawbacks.

[0008] This problem is solved by providing the present technical teachings, in particular the teachings of the independent claims and the embodiments disclosed in the dependent claims and the specification.

[0009] This problem is solved by creating a method for conducting a filter test, in which, in step a), a plurality of hoses are or will be laid from a first cleanroom of a first, higher cleanroom class to 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 waste container, and a filter testing device are provided in the second cleanroom. In step b), at least a first hose of the plurality of hoses is or will be fluidly connected at at least a first end to the sterile filter set. In step c), the at least one first hose of the plurality of hoses is or will be fluidly connected at at least a second end to the at least one fluid container. In step d), at least a second hose of the plurality of hoses is fluidly connected or connectable at least at a first end to the sterile filter set, and the at least a second hose of the plurality of hoses opens at at least a second end to the at least one discharge container. In step e), the filter set is flushed by passing a flushing fluid, particularly a predetermined amount of flushing fluid, from the at least one fluid container through the filter set to the at least one discharge container. In step f), after flushing the filter set, the second end of the at least one first hose is disconnected from the fluid container and fluidly connected to the filter testing device. In step g), a filter test is performed using the filter testing device.

[0010] This method can be advantageously used to perform filter testing after sterilization and before use in a simple and fast manner. Furthermore, this method is advantageous because it requires only a small number of components to implement, which also allows for flexible adaptation to cleanrooms of various sizes.

[0011] Furthermore, it is possible to carry out the method using existing elements, in particular hoses and valves, so that advantageously no special elements have to be provided.

[0012] Furthermore, it is advantageous that during the implementation of the method, in particular sterile connections, in particular hose connections to the filter set, in particular connections to the valves, and / or fluid connections within the filter set, are not opened in the first clean room. In particular, it is advantageous that during the implementation of the method, in particular sterile connections do not need to be opened in the first clean room. In particular, it is advantageous that after this connection is made, it is not necessary to disconnect one of the hoses from the filter set. This advantageously prevents fluids or gases from leaking into the first clean room.

[0013] In particular, this method makes it possible to direct a predetermined amount of flushing fluid to the filter set, which can be used advantageously to verify in particular that the flushing of the filter set complies with guidelines.

[0014] A clean room is understood to be a room in which the concentration of airborne particles, especially aerosols, is controlled and maintained below a predetermined threshold. In particular, clean rooms are classified based on predetermined thresholds, whereby clean rooms are assigned to clean room classes. In particular, a higher clean room class is higher than a lower clean room class, meaning that the predetermined threshold for the higher clean room class is lower than the threshold for the lower clean room class.

[0015] In one embodiment, a cleanroom of cleanroom class A is used as the first cleanroom, and the cleanroom class is determined according to the version of Annex 1 of the EU GMP guidelines in effect on the priority date of this priority claim. Alternatively or additionally, a cleanroom of cleanroom class B or C is used as the second cleanroom. This advantageously allows the method to be implemented in a small first cleanroom of a first, higher cleanroom class. This allows the method to be implemented cost-effectively. Furthermore, this allows the method to be implemented universally and flexibly adapted to cleanrooms of different sizes.

[0016] In one embodiment, at least one hose of the plurality of hoses, particularly all hoses of the plurality of hoses, is configured as a Teflon hose. Alternatively or additionally, at least one hose of the plurality of hoses, particularly all hoses of the plurality of hoses, includes at least one tri-clamp fitting. Teflon is advantageously inert and thermally stable, particularly in contrast to the silicone hoses of known devices. It can therefore be sterilized by steam. Furthermore, Teflon hoses are advantageously sterilizable, particularly in contrast to the silicone hoses of known devices, particularly from the outside with hydrogen peroxide (H2O2).

[0017] In one embodiment, compressed air is directed to a filter set during a filter test. Specifically, the compressed air is first passed through an air filter and then directed to the filter set. Specifically, an Opticap Sterile XL150 Millipore Express air filter is used as the air filter, which allows a maximum pressure of 6.9 bar to be applied to the air filter.

[0018] In one embodiment, at least one of the hoses is provided with a quick release coupling, in particular an MPC coupling.

[0019] In one embodiment, the first valve and / or the second valve is a multi-way valve, in particular a three-way valve, in particular an M-block or a T-block.

[0020] According to a further development of the invention, it is planned that steps a) to g) are carried out aseptically, in particular in a sterile environment and / or under sterile conditions.

[0021] In one embodiment of the method, all steps of the method are performed aseptically, in particular in a sterile environment and / or under sterile conditions.

[0022] In particular, the filter set, and in particular all of its components, are autoclaved separately or partially assembled before step a), after which the filter set is assembled and connected under sterile conditions in a first clean room.

[0023] According to a further development of the invention, it is provided that after step e) and before step f) the filter set is exposed to compressed air and / or an inert gas, in particular nitrogen or helium, in order to at least partially dry the filter set with said compressed air and / or said inert gas.

[0024] It is desirable to allow the first hose and filter set to at least partially dry before conducting the filter test, to ensure that any flushing fluid is removed from the hose.

[0025] In one embodiment of the method, a container, in particular a bottle with a screw cap, is used into which the compressed air and / or inert gas leaking from the filter set is introduced and into which the flushing fluid, in particular the compressed air and / or inert gas, is carried away from the filter set.

[0026] According to a further development of the present invention, it is planned that 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 step h), the filter set is fluidly connected or connectable to the at least one first product container. In step i), after the filter test, the second end of the first hose is fluidly separated from the filter testing 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 and into the first product container, and the product fluid is filtered by the filter set.

[0027] The method advantageously allows for easy and rapid post-sterilization and post-filter test filtration of the product fluid.

[0028] In particular, the product fluid is conducted from the filter set to the first product container via a third hose.

[0029] In particular, steps h) to j) are carried out aseptically, in particular in a sterile environment and / or under sterile conditions.

[0030] Furthermore, it is advantageous that the sterile connections, in particular the hose connections to the filter set, in particular the connections to the valves, and / or the fluid connections within the filter set, are not opened in the first clean room during the filtration. In particular, it is advantageous that no connections, in particular sterile connections, need to be opened in the first clean room during the filtration.

[0031] According to a further development of the present invention, a sterile filter set is planned to include at least one fluid filter, at least three hoses, and at least two valves. Furthermore, in step (a), a first connection of the at least one fluid filter is or can 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 can 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 hose is or can be fluidly connected to the first connection of the first valve. Furthermore, in step (d), a first end of the second hose is or can be fluidly connected to a second connection of a second valve. Further, in step e), in a first single-filter operating state of the filter set, the first valve and the second valve are set so that at least one fluid filter is flushed with flushing fluid from the fluid container, the flushing fluid enters the filter set through the first connection of the first valve and exits the filter set through the second connection of the second valve, and the flushing fluid is conducted to at least one discharge container via the second hose. Further, in step g), the first single-filter operating state is set to perform a filter test.

[0032] In particular, in the first single-filter operating state, flushing fluid, or in particular sterile compressed air, enters the filter set through the first connection of the first valve. The flushing fluid, or in particular sterile compressed air, is then directed to at least one fluid filter through the second connection of the first valve and the first connection of the fluid filter. The flushing fluid, or in particular sterile compressed air, then enters the second valve through the second connection of the fluid filter and the first connection of the second valve and is discharged from the filter set through the second connection of the second valve. In particular, in the first single-filter operating state, all other filter set connections not explicitly mentioned are additionally closed, and in the first single-filter operating state, flushing fluid, or in particular sterile compressed air, can be directed only through the explicitly mentioned connections.

[0033] In one embodiment, at least one of the at least two valves, in particular at least two valves, is a multi-way valve, in particular a three-way valve, in particular an M-block. Alternatively, at least one of the at least two valves, in particular at least two valves, is a T-block.

[0034] According to a further development of the invention, after step e) and before step f), in the second single-filter operating state of the filter set, the first valve is configured so that compressed air and / or 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 first valve.

[0035] In particular, the compressed air and / or the inert gas is conducted only 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 the inert gas passes through the first valve from a fluid container emptied during flushing.

[0036] Specifically, in the second single-filter operating state, compressed air and / or inert gas enters the filter set via the first connection of the first valve. The compressed air and / or inert gas then leaves the filter set via the third connection of the first valve. Specifically, in the second single-filter operating state, the second connection of the first valve is further closed to prevent the compressed air and / or inert gas from entering the at least one fluid filter. Advantageously, the at least one fluid filter remains wet during a subsequent filter test.

[0037] In one embodiment, after step e) and before step f), in the first single-filter operating state of the filter set, the first and second valves are configured so that compressed air and / or inert gas enters the filter set through the first connection of the first valve and exits the filter set through the second connection of the second valve. In particular, the compressed air and / or inert gas is directed to the at least one fluid filter through the second connection of the first valve and the first connection of the fluid filter, and to the second valve through the second connection of the fluid filter and the first connection of the second valve. Preferably, the compressed air and / or inert gas is directed through the filter set from a fluid container emptied during flushing, particularly at a pressure of up to 2.0 bar. This advantageously allows at least a partial drying of the at least one fluid filter.

[0038] According to a further development of the present invention, in step a), the third connection of the second valve is or can be fluidly connected to the first connection of the first product container. Alternatively, in step h), the third connection of the second valve is or can be fluidly connected to the first connection 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 set so that the product fluid from the second product container is filtered by the at least one fluid filter, and 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 directed to the first product container.

[0039] Specifically, in the third single-filter operating state, the product fluid enters the filter set via the first connection of the first valve. The product fluid is then directed to at least one fluid filter via the second connection of the first valve and the first connection of the fluid filter. The product fluid then enters the second valve via the second connection of the fluid filter and the first connection of the second valve, and is directed from the filter set to the first product container via the third connection of the second valve. Specifically, in the third single-filter operating state, the third connection of the first valve and the second connection of the second valve are closed, so that in the third single-filter operating state, the product fluid can pass through the filter set and be directed only to the first product container.

[0040] According to a further embodiment of the invention, before step j), the second hose is fluidly separated from the filter set.

[0041] In one embodiment, before step j), the second hose is fluidly separated from the filter set and transported from the first clean room to the second clean room, particularly the second hose is transported from the first clean room to the second clean room via at least one through opening.

[0042] According to a further development of the invention, it is provided that after step j) the second hose is fluidly separated from the filter set.

[0043] In one embodiment, after step j), the second hose is fluidly separated from the filter set and is conveyed from the first clean room to the second clean room, particularly, the second hose is conveyed from the first clean room to the second clean room through at least one through opening.

[0044] According to a further development of the invention, the first clean room is configured as a glove box, which allows the first clean room to be configured on a small scale, which in turn allows for cost-effective operation.

[0045] In particular, the fluid connection and / or disconnection of the hose to the connection takes place via the glove box glove.

[0046] According to a further development of the present 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 a third hose. Furthermore, in step a), a first connection of the first fluid filter is or can 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 can be fluidly connected to the first connection of the third valve. Furthermore, in step a), the second connection of the third valve is or can be fluidly connected to the first connection of the fourth valve. Furthermore, in step a), a first connection of the second fluid filter is or can be fluidly connected to the second connection of the fourth valve. Furthermore, in step a), the second connection of the second fluid filter is or becomes fluidly connected to the first connection of the second valve. Furthermore, in step b), the first end of the first hose is or becomes fluidly connected to the first connection of the first valve. Furthermore, in step d), the first end of the first second hose is or becomes fluidly connected to the third connection of the fourth valve. Furthermore, in step d), the first end of the second second hose is or becomes fluidly connected to the second connection of the second valve.Further, in step e), 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 set so that the first fluid filter and the second fluid filter are flushed with the flushing fluid from the fluid container, the flushing fluid enters the filter set through the first connection of the first valve and exits the filter set through the second connection of the second valve, and the flushing fluid is guided to the at least one discharge container through the second second hose. Alternatively or additionally, in step e), 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 set so that the first fluid filter is flushed with the flushing fluid from the fluid container, 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, and the flushing fluid is introduced into the at least one discharge container via the first second hose.Furthermore, in a first substep g1), a first end of the third hose is or is fluidly connected to a third connection of the third valve; and further, in a second substep g2), in a second double filter operating state of the filter set, the first valve, the third valve and the fourth valve are set to enable testing of the first fluid filter, 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, and the second fluid filter is and further, in a third substep g3), in a third double filter operating state of the filter set, the second end of the third hose is fluidly connected to the filter testing apparatus, the second valve, the third valve and the fourth valve are set to enable testing of the second fluid filter, 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, and the first fluid filter is fluidly isolated from the filter testing apparatus.

[0047] Specifically, in the first double filter operating state, flushing fluid enters the filter set through the first connection of the first valve. The flushing fluid is then directed to the first fluid filter via the second connection of the first valve and the first connection of the first fluid filter. The flushing fluid then enters the third valve via the second connection of the first fluid filter and the first connection of the third valve. The flushing fluid then enters the fourth valve via the second connection of the third valve and the first connection of the fourth valve. The flushing fluid then enters the second valve via the second connection of the fourth valve and the first connection of the second fluid filter. The flushing fluid then enters the second valve via the second connection of the second fluid filter and the first connection of the second valve, and is discharged from the filter set via the second connection of the second valve. In particular, in the first double filter operating state, all other filter set connections not expressly mentioned are additionally closed, and in the first double filter operating state, flushing fluid can be conducted only through the expressly mentioned connections.

[0048] Specifically, in the second first double filter operating state, the flushing fluid enters the filter set through the first connection of the first valve. The flushing fluid is then directed to the first fluid filter through the second connection of the first valve and the first connection of the first fluid filter. The flushing fluid then enters the third valve through the second connection of the first fluid filter and the first connection of the third valve. The flushing fluid is then directed into the fourth valve through the second connection of the third valve and the first connection of the fourth valve. The flushing fluid then exits the filter set through the third connection of the fourth valve. Specifically, in the second first double filter operating state, all other filter set connections not explicitly mentioned are additionally closed, and in the second first double filter operating state, the flushing fluid can only be directed through the explicitly mentioned connections.

[0049] In particular, in the second double filter operating state, sterile compressed air enters the filter set via the first connection of the first valve. The sterile compressed air is then directed to the first fluid filter via the second connection of the first valve and the first connection of the first fluid filter. The 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 sterile compressed air is then directed to the fourth valve via the second connection of the third valve and the first connection of the fourth valve. The sterile compressed air then exits 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 closed, so that in the second double filter operating state, the sterile compressed air passes only through the first fluid filter, and the second fluid filter is fluidly isolated from the first fluid filter.

[0050] In particular, in the third double filter operating state, the sterile compressed air enters the filter set via the third connection of the third valve. The sterile compressed air is then directed to the fourth valve via the second connection of the third valve and the first connection of the fourth valve. The sterile compressed air is then directed to the second fluid filter via the second connection of the fourth valve and the first connection of the second fluid filter. The 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 sterile compressed air then exits 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 closed, allowing the sterile compressed air to pass only through the second fluid filter, and the first fluid filter is fluidically isolated from the second fluid filter.

[0051] In one embodiment, after step e) and before step f), in a fourth double filter operating state, the first valve is configured to allow compressed air and / or inert gas to enter the filter set via the first connection of the first valve and exit the filter set via the third connection of the first valve.

[0052] In a further embodiment, after step e) and before step f), in the first double-filter operating state of the filter set, the first, second, third, and fourth valves are configured to allow compressed air and / or inert gas to enter the filter set through the first connection of the first valve and exit the filter set through the second connection of the second valve. Preferably, the compressed air and / or inert gas is guided through the filter set, particularly through the first and second fluid filters, from the fluid container emptied during flushing. This allows at least partial drying of the two fluid filters.

[0053] 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, second, third, and fourth valves are configured so that compressed air and / or inert gas enters the filter set through the first connection of the first valve and exits the filter set through the third connection of the fourth valve. Preferably, the compressed air and / or inert gas is guided through the filter set, particularly through the first fluid filter, from the fluid container emptied during flushing. This allows the first fluid filter to at least partially dry.

[0054] In one embodiment, the second connection of the third valve is or can be fluidly connected to the first connection of the fourth valve by means of a fourth hose, in particular a Teflon hose with two tri-clamp fittings and / or a Teflon hose with at least one 90° bend, in particular at least two 90° bends, is used as the fourth hose.

[0055] In one embodiment, at least one valve selected from the group consisting of the first valve, the second valve, and the fourth valve is a multi-way valve, particularly a three-way valve, particularly an M-block or a T-block. In particular, a multi-way valve, particularly a three-way valve, particularly an M-block or a T-block is used as the first valve, the second valve, and the fourth valve.

[0056] In one embodiment, a three-way cock is used as the third valve. Alternatively, an M-block is used as the third valve.

[0057] In particular, it is easy to extend the filter set with further fluid filters, in particular a third fluid filter, by means of an additional fluid filter and two valves fluidly arranged between the second fluid filter and the second valve, as in the case of extension with a second fluid filter.

[0058] According to a further embodiment of the present invention, in step e), after flushing the filter set in the first first double filter operating state and / or the second first double filter operating state, the second end of the third hose is fluidly connected to the fluid container. Then, 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 configured to flush the second fluid filter with the flushing fluid from the fluid container. Thus, 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, and the flushing fluid is directed to the at least one discharge container via the second second hose.

[0059] Specifically, in the third first double filter operating state, the flushing fluid enters the filter set through the third connection of the third valve. The flushing fluid is then directed to the fourth valve through the second connection of the third valve and the first connection of the fourth valve. The flushing fluid is then directed to the second fluid filter through the second connection of the fourth valve and the first connection of the second fluid filter. The flushing fluid enters the second valve through the second connection of the second fluid filter and the first connection of the second valve, and is discharged from the filter set through the second connection of the second valve. Specifically, in the third first double filter operating state, all other filter set connections not explicitly mentioned are additionally closed, and in the third first double filter operating state, the flushing fluid can be directed only through the explicitly mentioned connections.

[0060] In one embodiment, after step e) and before step f), in the third first double filter operating state of the filter set, the first, second, third, and fourth valves are configured to allow compressed air and / or inert gas to enter the filter set through the third connection of the third valve and exit the filter set through the second connection of the second valve. Preferably, the compressed air and / or inert gas is guided through the filter set, particularly through the second filter, from a fluid container emptied during flushing, particularly at a pressure of up to 2.0 bar. This advantageously allows the second fluid filter to at least partially dry.

[0061] According to a further development of the invention, it is provided that after step e) and before the first substep g1), the filter set is set in a fourth double filter operating state, in which case the filter set is dried using an inert gas, in particular nitrogen.

[0062] Alternatively or additionally, after the third substep g3), the filter set is conditioned in a fourth double filter operating state, in which case the filter set is dried with an inert gas, in particular nitrogen.

[0063] In the fourth double-filter operating state of the filter set, the first, second, third, and fourth valves are configured to supply inert gas to the third and fourth valves. The inert gas enters the filter set through the third connection of the third valve and exits the filter set through the third connection of the fourth valve. The inert gas is directed to at least one discharge container via the first second hose. Specifically, the inert gas is directed to the fourth valve via the second connection of the third valve and the first connection of the fourth valve. Specifically, in the fourth double-filter operating state, all other connections of the filter set not explicitly mentioned are additionally closed, and in the fourth double-filter operating state, the inert gas can pass only through the explicitly mentioned connections.

[0064] In one embodiment, an inert gas, particularly nitrogen, enters the filter set through the third connection of the third valve and exits the filter set through the third connection of the fourth valve, wherein the first fluid filter is fluidly isolated from the second fluid filter.

[0065] In particular, an inert gas, in particular nitrogen, is introduced into the filter set at a pressure of up to 2.0 bar.

[0066] According to a further development of the present invention, in step a), the third connection of the second valve is or can be fluidly connected to the first connection of the first product container. Furthermore, 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 set so that product fluid from the second product container is filtered using the first fluid filter and the second fluid filter. The product fluid enters the filter set via the first connection of the first fluid valve and exits the filter set via the third connection of the second valve and is directed to the first product container.

[0067] Specifically, in the fourth double filter operating state, the product fluid enters the filter set through the first connection of the first valve. The product fluid is then directed to the first fluid filter via the second connection of the first valve and the first connection of the first fluid filter. The product fluid then enters the third valve via the second connection of the first fluid filter and the first connection of the third valve. The product fluid then enters the fourth valve via the second connection of the third valve and the first connection of the fourth valve. The product fluid then enters the second valve via the second connection of the second fluid filter and the first connection of the second valve, and then exits the filter set via the third connection of the second valve. In particular, in the fourth double filter operating state, all connections of the other filter sets not expressly mentioned are additionally closed, and the product fluid can only pass through the connections expressly mentioned in the fourth double filter operating state. In particular, in the fourth double filter operating state, the third connection of the first valve, the second connection of the second valve, the third connection of the third valve, and the third connection of the fourth valve are closed, and in the fourth double filter operating state, the product fluid can only flow into the first product container after passing through the filter sets.

[0068] According to a further development of the invention, in step h), the third connection of the second valve is or is designed to be fluidly connected to the first connection of a first product container. Furthermore, 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 set so that the product fluid from the second product container is filtered using the first fluid filter and the second fluid filter, and the product fluid enters the filter set via the first connection of the first valve and leaves the filter set via the third connection of the second valve and is directed to the first product container.

[0069] The problem is also solved by creating a sterile filter set comprising at least one fluid filter, at least three hoses, at least two valves and instructions for use, the instructions including instructions for carrying out the method according to the invention or according to one or more of the embodiments described above, with the sterile filter set in particular deriving the advantages already described in relation to the method. [Brief explanation of the drawings]

[0070] The following figures explain the invention in more detail. [Figure 1] 1 shows a first embodiment of a sterile filter set. [Figure 2] 1 shows a flow diagram of an embodiment of a method for performing a filter test. [Figure 3] FIG. 1 shows a schematic diagram of a first embodiment of a sterile filter set with a fluid filter in a first process step. [Figure 4] 1 shows a schematic diagram of a first embodiment of a sterile filter set with a fluid filter in a second process step. [Figure 5]1 shows a schematic diagram of a first embodiment of a sterile filter set with a fluid filter in a third process step. [Figure 6] FIG. 1 shows a schematic diagram of a second embodiment of a sterile filter set with two fluid filters in a first process step. [Figure 7] FIG. 1 shows a schematic diagram of a second embodiment of a sterile filter set with two fluid filters in a second process step. [Figure 8] FIG. 1 shows a schematic diagram of a second embodiment of a sterile filter set with two fluid filters in a third process step. [Figure 9] FIG. 1 shows a schematic diagram of a second embodiment of a sterile filter set with two fluid filters in a fourth process step. [Figure 10] FIG. 1 shows a schematic diagram of a second embodiment of a sterile filter set with two fluid filters in a fifth process step. DETAILED DESCRIPTION OF THE INVENTION

[0071] 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 hoses 5, preferably at least three hoses 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 provide instructions for performing a filter test.

[0072] Optionally, the instructions for use 9 include, among other things, instructions for performing filtration using the sterile filter set 1 .

[0073] In particular, the first connection 11.1 of the at least one fluid filter 3 is fluidly connected or connectable to the second connection 13.2 of the first valve 7.1. Furthermore, the second connection 11.2 of the at least one fluid filter 3 is fluidly connected or connectable to the first connection 15.1 of the second valve 7.2. Furthermore, the first end of the first hose 5.1 is fluidly connected or connectable to the first connection 13.1 of the first valve 7.1. Furthermore, the first end of the second hose 5.2 is fluidly connected or connectable to the second connection 15.2 of the second valve 7.2. Furthermore, the first end of the third hose 5.3 is preferably fluidly connected or connectable to the third connection 15.3 of the second valve 7.2.

[0074] The method for conducting the filter test is explained in more detail using the following diagram:

[0075] FIG. 2 is a flow diagram illustrating one embodiment of a method for performing a filter test.

[0076] In the first step a), a sterile filter set 1 is provided in a first clean room 17.1 of a first, higher clean room class. Furthermore, at least one fluid container 19, at least one discharge container 21, and a filter testing device 23 are provided in a second clean room 17.2 of a second, lower clean room class. Furthermore, a plurality of hoses 5 are laid from the first clean room 17.1 to the second clean room 17.2. Alternatively, a plurality of hoses 5 are laid from the first clean room 17.1 to the second clean room 17.2.

[0077] In a second step b), a first end of the first hose 5.1 is fluidly connected to the sterile filter set 1. Alternatively, a first end of the first hose 5.1 is fluidly connected to the sterile filter set 1.

[0078] In a third step c), at least one second end of the at least one first hose 5.1 is fluidly connected to at least one fluid container 19. Alternatively, at least one second end of the at least one first hose 5.1 is fluidly connected to at least one fluid container 19.

[0079] In a fourth step d), at least one first end of at least one second hose 5.2 of the plurality of hoses 5 is fluidly connected to the sterile filter set 1. Alternatively, at least one first end of the at least one second hose 5.2 is fluidly connected to the sterile filter set 1. Furthermore, the at least one second hose 5.2 opens at at least one second end into at least one discharge container 21.

[0080] In a fifth step e), the filter set 1 is flushed by passing a flushing fluid from at least one fluid container 19 through the filter set 1 into at least one drain container 21 .

[0081] In a sixth step f), after flushing the filter set 1, the second end of the at least one first hose 5.1 is disconnected from the fluid container 19 and fluidly connected to a filter testing device 23.

[0082] In a seventh step g), a filter test is carried out using the filter test device 23 .

[0083] Preferably, compressed air and / or inert gas is applied to the filter set 1 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, using compressed air and / or inert gas.

[0084] Preferably, at least one first product container 25.1 is provided in the first clean room 17.1. Alternatively or additionally, preferably, at least one second product container 25.2 is provided in the second clean room 17.2.

[0085] In an optional eighth step h), the filter set 1 is fluidly connected to at least one first product container 25.1. Alternatively, the filter set 1 is fluidly connected to at least one first product container 25.1.

[0086] In an optional ninth step i), after the filter test, the second end of the first hose 5.1 is fluidly isolated from the filter test device 23 and connected to at least one second product container 25.2.

[0087] In an optional tenth step j), the product fluid is passed from the second product container 25.2 through filter set 1 to the first product container 25.1, whereby the product fluid is filtered by filter set 1.

[0088] In particular, steps h) through j) describe optional filtration of the product fluid after the filter test according to steps a) through g) has been performed.

[0089] Preferably, steps a) to g), in particular steps a) to j), are carried out aseptically.

[0090] 3 to 5 show a schematic diagram of a first embodiment of a sterilizing filter set 1 with a fluid filter 3 in three different process steps.

[0091] Identical elements with identical functions are labeled with the same reference characters in all figures, so please refer to the above description.

[0092] For clarity, the reference numerals of the connections are only drawn in Figure 3. The connections in Figures 4 and 5 are identical to those in Figure 3.

[0093] 3 to 5, the second hose 5.2 fluidly connects the second connection 15.2 of the second valve 7.2 with the discharge vessel 21. Furthermore, in particular the third hose 5.3 fluidly connects the third connection 15.3 of the second valve 7.2 with the first product container 25.1.

[0094] 3 shows the fifth step e) of the method for performing a filter test, in particular the flushing of the filter set 1. A first hose 5.1 fluidly connects the first connection 13.1 of the first valve 7.1 and the fluid container 19 to each other.

[0095] In the first, single-filter operating state of filter set 1 of FIG. 3, first valve 7.1 and second valve 7.2 are configured to flush fluid filter 3 with flushing fluid from fluid container 19. Specifically, flushing fluid enters filter set 1 via first connection 13.1 of first valve 7.1. The flushing fluid then enters fluid filter 3 via second connection 13.2 of first valve 7.1 and first connection 11.1 of fluid filter 3. The flushing fluid then enters second valve 7.2 via second connection 11.2 of fluid filter 3 and first connection 15.1 of second valve 7.2, and is discharged out of filter set 1 via second connection 15.2 of second valve 7.2. The flushing fluid then flows through second hose 5.2 into discharge container 21. In particular, in the first single filter operating state, the third connection 13.3 of the first valve 7.1 and the third connection 15.3 of the second valve 7.2 are closed, and in the first single filter operating state, the flushing fluid is conducted only through the fluid filter 3 to the discharge container 21.

[0096] In particular, in the first single-filter operating state of the filter set 1, after step e) and before step f), the first valve 7.1 and the second valve 7.2 are configured to at least partially dry the fluid filter 3 with compressed air and / or inert gas, particularly from the fluid container 19 emptied during flushing. The compressed air and / or inert gas enters the filter set 1 via the first connection 13.1 of the first valve 7.1. The compressed air and / or inert gas is directed to 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, and then to 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. The compressed air and / or inert gas is then discharged from the filter set 1 via the second connection 15.2 of the second valve 7.2. The compressed air and / or inert gas is then conducted via the second hose 5.2 to the discharge container 21. In particular, in the first single-filter operating state, the third connection 13.3 of the first valve 7.1 and the third connection 15.3 of the second valve 7.2 are closed, and the compressed air and / or inert gas is conducted to the discharge container 21 only through the fluid filter 3 in the first single-filter operating state.

[0097] Alternatively or additionally, in particular after step e) and before step f), in the second single-filter operating state of the filter set 1, the first valve 7.1 is set so that compressed air and / or inert gas enters the filter set 1 via the first connection 13.1 of the first valve 7.1 and leaves the filter set 1 via the third connection 13.3 of the first valve 7.1. In particular, in the second single-filter operating state, the second connection 13.2 of the first valve 7.1 is additionally closed, so that the compressed air and / or inert gas cannot be guided to the fluid filter 3.

[0098] 4 shows the seventh step g) of the method for performing a filter test, in particular a filter test of a filter set 1. A first hose 5.1 fluidly connects the first connection 13.1 of the first valve 7.1 and the filter test device 23 to each other.

[0099] In the first single-filter operating state of the filter set 1 of FIG. 4, the first valve 7.1 and the second valve 7.2 are configured to supply, in particular, sterile compressed air from the filter testing device 23 to the fluid filter 3. The sterile compressed air then enters the filter set 1 via the first connection 13.1 of the first valve 7.1. The sterile compressed air is then directed to 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 sterile compressed air, together with the flushing fluid expelled from the fluid filter 3 by the sterile compressed air, 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 then expelled from the filter set 1 via the second connection 15.2 of the second valve 7.2. The sterile compressed air is then expelled to the discharge container 21 via the second hose 5.2. In particular, in the first single filter operating state, the third connection 13.3 of the first valve 7.1 and the third connection 15.3 of the second valve 7.2 are closed, and in the first single filter operating state, in particular, sterile compressed air flows into the discharge container 21 only through the fluid filter 3.

[0100] Figure 5 shows the tenth step j) of the method, in particular the filtration of the product fluid in the filter set 1. A first hose 5.1 fluidly connects the first connection 13.1 of the first valve 7.1 and the second product container 25.2 to each other.

[0101] In the third, single-filter operating state of filter set 1 of FIG. 5, first valve 7.1 and second valve 7.2 are configured to filter product fluid from second product container 25.2 through fluid filter 3. This causes the product fluid to enter filter set 1 through first connection 13.1 of first valve 7.1. The product fluid then enters fluid filter 3 through second connection 13.2 of first valve 7.1 and first connection 11.1 of fluid filter 3. The product fluid then enters second valve 7.2 through second connection 11.2 of fluid filter 3 and first connection 15.1 of second valve 7.2, and exits filter set 1 through third connection 15.3 of second valve 7.2. The product fluid then flows through third hose 5.3 to first product container 25.1. In particular, in the third single filter operating state, the third connection 13.3 of the first valve 7.1 and the second connection 15.2 of the second valve 7.2 are closed, and in the third single filter operating state, the product fluid can only be directed to the first product container 25.1 after passing through the filter set 3.

[0102] Furthermore, it is possible, in particular, to disconnect the second hose 5.2 from the second connection 15.2 of the second valve 7.2 before the product fluid is filtered. In particular, the second hose 5.2 is conveyed from the first clean room 17.1 to the second clean room 17.2, in particular via at least one through-opening.

[0103] 6 to 10 show a second embodiment of a sterilizing filter set 1 with a first fluid filter 3.1 and a second fluid filter 3.2 in a schematic diagram in five different process steps.

[0104] Specifically, the first connection 11.1 of the first fluid filter 3.1 is fluidly connected to the second connection 13.2 of the first valve 7.1. Furthermore, the second connection 11.2 of the first fluid filter 3.1 is fluidly connected to the first connection 27.1 of the third valve 7.3. Furthermore, the second connection 27.2 of the third valve 7.3 is fluidly connected to the first connection 29.1 of the fourth valve 7.4. Specifically, the second connection 27.2 of the third valve 7.3 is connected to the first connection 29.1 of the fourth valve 7.4 by the fourth hose 5.4. Furthermore, the first connection 31.1 of the second fluid filter 3.2 is fluidly connected to the second connection 29.2 of the fourth valve 7.4. Furthermore, the second connection 31.2 of the second fluid filter 3.2 is fluidly connected to the first connection 15.1 of the second valve 7.2. Furthermore, a first end of the first hose 5.1 is fluidly connected to the first connection 13.1 of the first valve 7.1. Furthermore, a fifth hose 5.5 in particular fluidly connects the third connection 15.3 of the second valve 7.2 to the first product container 25.1.

[0105] As shown in FIGS. 6 to 9 , in particular, a first end of the first second hose 5.2′ is fluidly connected to the third connection 29.3 of the fourth valve 7.4. Furthermore, as shown in FIGS. 6 to 9 , a first end of the second second hose 5.2″ is fluidly connected to the second connection 15.2 of the second valve 7.2. Furthermore, as shown in FIGS. 6 to 9 , in particular, a first end of the third hose 5.3 is fluidly connected to the third connection 27.3 of the third valve 7.3. Furthermore, as shown in FIGS. 6 to 9 , the first second hose 5.2′ and the second second hose 5.2″ fluidly connect the filter set 1 and the discharge container 21 to each other. Alternatively, the first second hose 5.2′ and the second second hose 5.2″ are fluidly connected to the second hose 5.2, which opens into the discharge container 21.

[0106] For clarity, only the reference numerals of the connections are drawn in Figure 6. The connections in Figures 7 to 9 are identical to those in Figure 6.

[0107] 6 shows the fifth step e) of the method for performing a filter test, in particular flushing the filter set 1. A first hose 5.1 fluidly connects the first connection 13.1 of the first valve 7.1 and the fluid container 19 to each other.

[0108] In the first double filter operating state of filter set 1 of FIG. 6, first valve 7.1, second valve 7.2, third valve 7.3, and fourth valve 7.4 are configured to flush first fluid filter 3.1 and second fluid filter 3.2 with flushing fluid from fluid container 19. In particular, flushing fluid enters filter set 1 via first connection 13.1 of first valve 7.1. The flushing fluid then enters first fluid filter 3.1 via second connection 13.2 of first valve 7.1 and first connection 11.1 of first fluid filter 3.1. The flushing fluid 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, then passes through the second connection 27.2 of the third valve 7.3 and the first connection 29.1 of the fourth valve 7.4 to the fourth valve 7.4. The flushing fluid then passes through the second connection 29.2 of the fourth valve 7.4 and the first connection 31.1 of the second fluid filter 3.2 to the second fluid filter 3.2. The flushing fluid then passes through the second connection 31.2 of the second fluid filter 3.2 and the first connection 15.1 of the second valve 7.2 to the second valve 7.2, and then passes out of the filter set 1 via the second connection 15.2 of the second valve 7.2. The flushing fluid is then led to the discharge container 21 through the second second hose 5.2'' and in particular through the second hose 5.2. In particular, in the first 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 closed, so that in the first first double filter operating state the flushing fluid is led to the discharge container 21 only through the first fluid filter 3.1 and then through the second fluid filter 3.2.

[0109] Alternatively or additionally, in step e), in the second, first double filter operating state of filter set 1 of FIG. 6, first valve 7.1, second valve 7.2, third valve 7.3 and fourth valve 7.4 are configured to flush first fluid filter 3.1 with flushing fluid from fluid container 19. In particular, flushing fluid enters filter set 1 via first connection 13.1 of first valve 7.1. The flushing fluid is then conducted to first fluid filter 3.1 via second connection 13.2 of first valve 7.1 and first connection 11.1 of first fluid filter 3.1. The flushing fluid 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, and is then conducted to the fourth valve 7.4 via the second connection 27.2 of the third valve 7.3 and the first connection 29.1 of the fourth valve 7.4. The flushing fluid then leaves the filter set 1 via the third connection 29.3 of the fourth valve 7.4. The flushing fluid then flows through the first second hose 5.2' and, in particular, the second hose 5.2 to the discharge container 21. In particular, in the second first 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 closed, so that the flushing fluid is led to the discharge container 21 of the second first double filter operating state only through the first fluid filter 3.1.

[0110] In particular, after step e) and before step f), in a fourth double filter operating state of filter set 1, first valve 7.1 is set so that compressed air and / or inert gas enters filter set 1 via first connection 13.1 of first valve 7.1 and exits filter set 1 via third connection 13.3 of first valve 7.1. In particular, in the fourth double filter operating state, second connection 13.2 of first valve 7.1 is additionally closed, so that compressed air and / or inert gas cannot be directed to first fluid filter 3.1 and / or second fluid filter 3.2.

[0111] Alternatively or additionally, particularly 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 configured to at least partially dry the first and second fluid filters 3.1 and 3.2 with compressed air and / or inert gas, particularly from the fluid container 19 emptied during flushing. This allows compressed air and / or inert gas to enter the filter set 1 through the first connection 13.1 of the first valve 7.1. The compressed air and / or inert gas is then directed to 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, and then to 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 compressed air and / or inert gas is directed to the fourth valve 7.4 via the second connection 27.2 of the third valve 7.3 and the first connection 29.1 of the fourth valve 7.4. The compressed air and / or inert gas is then directed to the second fluid filter 3.2 via the second connection 29.2 of the fourth valve 7.4 and the first connection 31.1 of the second fluid filter 3.2. The compressed air and / or inert gas is then directed to the second valve 7.2 via the second connection 31.2 of the second fluid filter 3.2 and the first connection 15.1 of the second valve 7.2. The compressed air and / or inert gas is then discharged from the filter set 1 via the second connection 15.2 of the second valve 7.2. The compressed air and / or inert gas is then directed to the discharge container 21 via the second hose 5.2''.In particular, in the first 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 closed, so that in the first first double filter operating state, compressed air and / or inert gas can be led to the discharge container 21 only through the first fluid filter 3.1 and the second fluid filter 3.2.

[0112] Alternatively or additionally, in the second, first double-filter operating state of the filter set 1, particularly after step e) and before step f), the first valve 7.1, the second valve 7.2, the third valve 7.3, and the fourth valve 7.4 are configured to at least partially dry the first fluid filter 3.1 with compressed air and / or inert gas from the fluid container 19, particularly from a fluid container 19 emptied during flushing. This allows compressed air and / or inert gas to enter the filter set 1 through the valve connections via the first connection 13.1 of the first valve 7.1. The compressed air and / or inert gas is then guided to 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, and then to 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 compressed air and / or inert gas is directed to the fourth valve 7.4 via the second connection 27.2 of the third valve 7.3 and the first connection 29.1 of the fourth valve 7.4. The compressed air and / or inert gas is then discharged from the filter set 1 via the third connection 29.3 of the fourth valve 7.4. The compressed air and / or inert gas is then directed to the discharge container 21 via the first second hose 5.2'. In particular, in the second first 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 closed, so that in the second first double filter operating state, the compressed air and / or inert gas can be directed to the discharge container 21 only via the first fluid filter 3.1.

[0113] 7 shows an additional method step of the fifth step e) of the method for performing a filter test, in particular flushing of the filter set 1. The first hose 5.1 is fluidly isolated, in particular from the fluid container 19. Furthermore, a third hose 5.3 fluidly connects the third connection 27.3 of the third valve 7.3 to the fluid container 19.

[0114] In the third, first double-filter operating state of filter set 1 of FIG. 7, second valve 7.2, third valve 7.3, and fourth valve 7.4 are configured to flush second fluid filter 3.2 with flushing fluid from fluid container 19. Specifically, flushing fluid enters filter set 1 via third connection 15.3 of third valve 7.3. The flushing fluid is then directed to fourth valve 7.4 via second connection 27.2 of third valve 7.3 and first connection 29.1 of fourth valve 7.4. The flushing fluid is then directed to second fluid filter 3.2 via second connection 29.2 of fourth valve 7.4 and first connection 31.1 of second fluid filter 3.2. The flushing fluid then enters the second valve 7.2 via the second connection 31.2 of the second fluid filter 3.2 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 led to the discharge container 21 via the second hose 5.2″, and in particular via the second hose 5.2. 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 closed, so that in the third first double filter operating state, the flushing fluid can be led to the discharge container 21 only through the second fluid filter 3.2.

[0115] In the third, first double-filter operating state of the filter set 1, particularly after step e) and before step f), the second valve 7.2, the third valve 7.3, and the fourth valve 7.4 are configured to at least partially dry the second fluid filter 3.2 with compressed air and / or inert gas, particularly from the fluid container 19 emptied during flushing. The compressed air and / or inert gas enters the filter set 1 via the third connection 27.3 of the third valve 7.3. The compressed air and / or inert gas is then directed to the fourth valve 7.4 via the second connection 27.2 of the third valve 7.3 and the first connection 29.1 of the fourth valve 7.4. The compressed air and / or inert gas is then directed to the second fluid filter 3.2 via the second connection 29.2 of the fourth valve 7.4 and the first connection 31.1 of the second fluid filter 3.2. The compressed air and / or inert gas is then guided to the second valve 7.2 via the second connection 31.2 of the second fluid filter 3.2 and the first connection 15.1 of the second valve 7.2. The compressed air and / or inert gas is then discharged from the filter set 1 via the second connection 15.2 of the second valve 7.2. The compressed air and / or inert gas is then guided to the discharge container 21 via the second second hose 5.2''. 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 closed, so that in the third first double filter operating state, the compressed air and / or inert gas can be guided to the discharge container 21 only through the second fluid filter 3.2.

[0116] 8 shows the second sub-step g2) of the seventh step g) of the method for performing a filter test, in particular a filter test of a filter set 1. A first hose 5.1 fluidly connects the first connection 13.1 of the first valve 7.1 and the filter test device 23 to each other.

[0117] In the second double-filter operating state of filter set 1 of FIG. 8, first valve 7.1, third valve 7.3, and fourth valve 7.4 are configured to supply first fluid filter 3.1 with, among other things, sterile compressed air from filter testing device 23, while second fluid filter 3.2 is fluidly isolated from filter testing device 23. This allows sterile compressed air to enter filter set 1 via first connection 13.1 of first valve 7.1. The sterile compressed air is then directed to first fluid filter 3.1 via second connection 13.2 of first valve 7.1 and first connection 11.1 of first fluid filter 3.1. The sterile compressed air then enters third valve 7.3 via second connection 11.2 of first fluid filter 3.1 and first connection 27.1 of third valve 7.3. The sterile compressed air is then directed to the fourth valve 7.4 via the second connection 27.2 of the third valve 7.3 and the first connection 29.1 of the fourth valve 7.4. The sterile compressed air is then discharged from the filter set 1 via the third connection 29.3 of the fourth valve 7.4. The sterile compressed air, together with the flushing fluid discharged after flushing the first fluid filter 3.1 with the sterile compressed air, is then directed to the discharge container 21 via the first second hose 5.2' and the second hose 5.2. 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 closed, so that in the second double filter operating state, the sterile compressed air can be directed to the discharge container 21 only through the first fluid filter 3.1.

[0118] 9 shows the third sub-step g2) of the seventh step g) of the method for performing a filter test, in particular a filter test of a filter set 1. A third hose 5.3 fluidly connects the third connection 27.3 of the third valve 7.3 and the filter test device 23 to each other.

[0119] In the third double-filter operating state of filter set 1 of FIG. 9, second valve 7.2, third valve 7.3, and fourth valve 7.4 are configured so that second fluid filter 3.2 is supplied with, among other things, sterile compressed air from filter testing device 23, while first fluid filter 3.1 is fluidly isolated from filter testing device 23. This allows sterile compressed air to enter filter set 1 via third connection 27.3 of third valve 7.3. The sterile compressed air is then directed to fourth valve 7.4 via second connection 27.2 of third valve 7.3 and first connection 29.1 of fourth valve 7.4. The sterile compressed air is then directed to second fluid filter 3.2 via second connection 29.2 of fourth valve 7.4 and first connection 31.1 of second fluid filter 3.2. The particularly sterile compressed air then enters the second valve 7.2 via the second connection 31.2 of the second fluid filter 3.2 and the first connection 15.1 of the second valve 7.2. The particularly sterile compressed air is then discharged from the filter set 1 via the second connection 15.2 of the second valve 7.2 together with the flushing fluid discharged after flushing the second fluid filter 3.2 with the particularly sterile compressed air. The particularly sterile compressed air is then guided to the discharge container 21 via the second hose 5.2″ and the second hose 5.2″. In particular, in the third 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 closed, so that in the third double filter operating state, the particularly sterile compressed air can be guided to the discharge container 21 only through the second fluid filter 3.2.

[0120] Figure 10 shows the tenth step j) of the method, in particular the filtration of the product fluid in the filter set 1. A first hose 5.1 fluidly connects the first connection 13.1 of the first valve 7.1 and the second product container 25.2 to each other.

[0121] Furthermore, the first second hose 5.2′ and the second second hose 5.2″ are particularly fluidly 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 FIG. 10 .

[0122] In the fourth double-filter operating state of filter set 1 of FIG. 10, first valve 7.1, second valve 7.2, third valve 7.3, and fourth valve 7.4 are configured so that product fluid from second product container 25.2 is filtered by first fluid filter 3.1 and second fluid filter 3.2. This causes the product fluid to enter filter set 1 through first connection 13.1 of first valve 7.1. The product fluid is then directed to first fluid filter 3.1 via second connection 13.2 of first valve 7.1 and first connection 11.1 of first fluid filter 3.1. The product fluid then enters third valve 7.3 via second connection 11.2 of first fluid filter 3.1 and first connection 27.1 of third valve 7.3. The product fluid is then directed to the fourth valve 7.4 via the second connection 27.2 of the third valve 7.3 and the first connection 29.1 of the fourth valve 7.4. The product fluid is then directed to the second fluid filter 3.2 via the second connection 29.2 of the fourth valve 7.4 and the first connection 31.1 of the second fluid filter 3.2. The product fluid then enters the second valve 7.2 via the second connection 31.2 of the second fluid filter 3.2 and the first connection 15.1 of the second valve 7.2, and exits the filter set 1 via the third connection 15.3 of the second valve 7.2. The product fluid is then directed to the first product container 25.1 via the fifth hose 5.5. In particular, in the fourth double filter operating state, the third connection 13.3 of the first valve 7.1, the second connection 15.2 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 closed, so that in the fourth double filter operating state the product fluid can only be directed to the first product container 25.1 after passing through the filter set 3.

Claims

1. a) Multiple hoses (5) are laid or will be 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, a sterilization filter set (1) is provided in the first cleanroom (17.1), and at least one fluid container (19), at least one discharge container (21) and a filter testing device (23) are provided in the second cleanroom (17.2), b) At least one of the plurality of hoses (5) is fluidly connected to or connected to the sterilization filter set (1) at least at its first end. c) At least one first hose (5.1) of the plurality of hoses (5) is fluidically connected to or connected to at least one fluid container (19) at at least one second end, d) At least one second hose (5.2) of the plurality of hoses (5) is fluidly connected to or connected to the sterilization filter set (1) at at least one first end, and at least one second hose (5.2) of the plurality of hoses (5) is open to the at least one discharge container (21) at at least one second end, e) The filter set (1) is flushed by passing a flushing fluid from the at least one fluid container (19) through the filter set (1) to the at least one discharge container (21), f) After flushing the filter set (1), the second end of at least one first hose (5.1) is separated from the fluid container (19) and fluidly connected to the filter testing device (23), g) A method for performing a filter test, which involves performing a filter test using the filter testing apparatus (23).

2. The method according to claim 1, wherein steps a) to g), in particular all of the steps, are carried out under sterile conditions.

3. The method according to claim 1, wherein, after step e) and before step f), the filter set (1) is exposed to compressed air and / or the inert gas to at least partially dry the filter set (1) using compressed air and / or the inert gas.

4. At least one first product container (25.1) is provided in the first cleanroom (17.1), and at least one second product container (25.2) is provided in the second cleanroom (17.2), h) The filter set (1) is fluidly connected to or to the at least one first product container (25.1), i) After the filter test, the second end of the first hose (5.1) is fluidically separated from the filter test apparatus (23) and connected to the at least one second product container (25.2), j) The method according to claim 1, wherein a product fluid is passed from the second product container (25.2) through the filter set (1) to the first product container (25.1), and the product fluid is filtered by the filter set (1).

5. - The sterilization filter set (1) comprises at least one fluid filter (3), at least three hoses (5), and at least two valves (7), - In step a), the first connection portion (11.1) of the at least one fluid filter (3) is fluidly connected to or will be connected to the second connection portion (13.2) of the first valve (7.1) of the at least two valves (7), - In step a), the second connection portion (11.2) of the at least one fluid filter (3) is fluidly connected to or connected to the first connection portion (15.1) of the second valve (7.2) of the at least two valves (7), - In step b), the first end of the first hose (5.1) is fluidly connected to or to the first connection (13.1) of the first valve (7.1), - In step d), the first end of the second hose (5.2) is fluidly connected to or to the second connection (15.2) of the second valve (7.2), - In step e), in the first single filter operating state of the filter set (1), the first valve (7.1) and the second valve (7.2) are set so that the at least one fluid filter (3) is flushed with the flushing fluid from the fluid container (19), the flushing fluid enters the filter set (1) through the first connection (13.1) of the first valve (7.1) and exits the filter set (1) through the second connection (15.2) of the second valve (7.2), and the flushing fluid is led to the at least one discharge container (21) through the second hose (5.2). The method according to claim 1, wherein in step g), the first single filter operating state is set in order to perform the filter test.

6. The method according to claim 1, after step e) and before step f), in the second single filter operating state of the filter set (1), the first valve (7.1) is configured such that compressed air and / or inert gas enters the filter set (1) through the first connection (13.1) of the first valve (7.1) and exits the filter set (1) through the third connection (13.3) of the first valve (7.3), and the compressed air and / or in particular the inert gas is guided only through the first valve (7.1) to dry the first hose (5.1).

7. - In step a) or step h), the third connection (15.3) of the second valve (7.2) is fluidly connected to or to the first connection of the first product container (25.1), The method according to claim 1, wherein in step j), in the third single filter operating state of the filter set (1), the first valve (7.1) and the second valve (7.2) are configured such that the product fluid from the second product container (25.2) is filtered by the at least one fluid filter (3), and 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 led to the first product container (25.1).

8. The method according to claim 1, wherein, before or after step j), the second hose (5.2) is fluidly separated from the filter set (1) and preferably transported from the first cleanroom (17.1) to the second cleanroom (17.2), particularly through at least one through-opening.

9. The method according to claim 1, wherein the first cleanroom (17.1) is configured as a glove box, and the fluid connection and / or disconnection of the hose (5) to the connection is made via the glove of the glove box.

10. - 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), the third valve (7.3), the fourth valve (7.4), the first hose (5.1), the first second hose (5.2'), the second second hose (5.2''), and the third hose (5.3), - In step a), the first connection portion (11.1) of the first fluid filter (3.1) is fluidly connected to or to the second connection portion (13.2) of the first valve (7.1), - In step a), the second connection portion (11.2) of the first fluid filter (3.1) is fluidly connected to or to the first connection portion (27.1) of the third valve (7.3), - In step a), the second connection portion (27.2) of the third valve (7.3) is fluidly connected to or to the first connection portion (29.1) of the fourth valve (7.4), - In step a), the first connection portion (31.1) of the second fluid filter (3.2) is fluidly connected to or to the second connection portion (29.2) of the fourth valve (7.4), - In step a), the second connection portion (31.2) of the second fluid filter (3.2) is fluidly connected to or to the first connection portion (15.1) of the second valve (7.2), - In step b), the first end of the first hose (5.1) is fluidly connected to or to the first connection (13.1) of the first valve (7.1), - In step d), the first end of the first second hose (5.2') is fluidly connected to or to the third connection (29.3) of the fourth valve (7.4), - In step d), the first end of the second hose (5.2'') is fluidly connected to or to the second connection (15.2) of the second valve (7.2), - In step e), 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 configured 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 enters the filter set (1) through the first connection (13.1) of the first valve (7.1) and exits the filter set (1) through the second connection (15.2) of the second valve (7.2), and the flushing fluid enters the filter set (1) through the second second hose (5.2'') and exits the filter set (1). ) is led to and / or, in step e), 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 configured such that the first fluid filter (3.1) is flushed with the flushing fluid from the fluid container (19), the flushing fluid enters the filter set (1) through the first connection (13.1) of the first valve (7.1) and exits the filter set (1) through the third connection (29.3) of the fourth valve (7.4), and the flushing fluid is introduced into the at least one discharge container (21) through the first second hose (5.2'). - In the first substep g1), the first end of the third hose (5.3) is fluidly connected to or connected to the third connection (27.3) of the third valve (7.3), - In the second substep g2), in the 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 to allow testing of the first fluid filter (3.1), in particular, sterile compressed air enters the filter set (1) through the first connection (13.1) of the first valve (7.1) and exits the filter set (1) through the third connection (29.3) of the fourth valve (7.4), and the second fluid filter (3.2) is fluidly separated from the filter testing device (23). - The method according to claim 1, wherein in the third substep g3), when the third double filter of the filter set (1) is in operation, the second end of the third hose (5.3) is fluidly connected to the filter testing device (23), the second valve (7.2), the third valve (7.3) and the fourth valve (7.4) are set to allow testing of the second fluid filter (3.2), in particular sterile compressed air 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), and the first fluid filter (3.1) is fluidly separated from the filter testing device (23).

11. In step e), after flushing 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 fluidly connected to the fluid container (19), and in the 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 flushed with the second fluid filter The method according to claim 10, wherein a router (3.1) is configured to be flushed with the flushing fluid from the fluid container (19), the flushing fluid enters the filter set (1) through the third connection (27.3) of the third valve (7.3) and exits the filter set (1) through the second connection (15.2) of the second valve (7.2), and the flushing fluid is led to the at least one discharge container (21) through the second second hose (5.2'').

12. The method according to claim 10, wherein, before the first substep g1) and / or after the third substep g3), the filter set (1) is set to a fourth double filter operating state, the filter set (1) is dried with an inert gas, particularly nitrogen, the particularly inert gas, particularly nitrogen, enters the filter set (1) through the third connection (27.3) of the third valve (7.3) and exits the filter set (1) through the third connection (29.3) of the fourth valve (7.4), and the first fluid filter (3.1) is fluidly separated from the second fluid filter (3.2).

13. - In step a) or step h), the third connection (15.3) of the second valve (7.2) is fluidly connected to or to the first connection of the first product container (25.1), - The method according to claim 10, wherein in step j), when the fourth double filter of the filter set (1) is in operation, the first valve (7.1), the second valve (7.2), the third valve (7.3) and the fourth valve (7.4) are configured such that the product fluid from the second product container (25.2) is filtered using the first fluid filter (3.1) and the second fluid filter (3.2), and the product fluid enters the filter set (1) via the first connection (13.1) of the first valve (7.1), exits the filter set (1) via the third connection (15.3) of the second valve (7.2), and is led to the first product container (25.1).

14. A sterilization filter set (1) comprising at least one fluid filter (3), at least three hoses (5), at least two valves (7), and an instruction manual (9) including instructions for carrying out the method described in claim 1.

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