Adapter for a filter capsule

Abstract

An adapter comprising a body having a connecting portion configured to be coupled to a filter capsule, wherein the connecting portion surrounds an opening in the body, the opening extending into a cavity. A vent is provided in the body configured to vent fluid from the cavity. A first fluid conduit projects externally from the body and extends a first distance into the cavity towards the opening, the first fluid conduit comprising a first inlet disposed at a first end of the first fluid conduit, wherein the first end of the first fluid conduit is located external to the body, and a first outlet disposed at a second end of the first fluid conduit opposed to the first end, wherein the second end of the first fluid conduit is located within the cavity.

Description

[0001] PAT-DB-081-WO-PCT 1

[0002] ADAPTER FOR A FILTER CAPSULE

[0003] TECHNICAL FIELD

[0004] The present disclosure relates to an adapter for a filter capsule, a filter assembly comprising said adapter, and a method of performing a non-destructive integrity test of a sterilised manifold assembly.

[0005] BACKGROUND

[0006] Pharmaceutical products, including bio-pharmaceutical products (also known as biological medical products or biologies) such as monoclonal antibodies, recombinant protein therapies, vaccines, cell and gene therapies and the like, are of a high value per unit measure, and are often provided in fluid form. It is known to use fluid delivery systems comprising pre-sterilised single-use manifolds and flow conduits for the processing and filling of biopharmaceutical and other such fluid products. The manifold and conduits provide a flow path for passage of the fluid from an upstream process step or container, such as a bag or mixer, through a filter and into containers or final filling.

[0007] The filter, usually a capsule filter encapsulated in a polymeric body (also referred to as a filter cartridge), is used to remove contaminants which might be present in the drug product as part of upstream, downstream purification processes or final filling. Contaminants may be particulate, microbial, or other undissolved materials. The efficiency of contaminant removal is attributed to the specification of the filter device used.

[0008] Due to recent regulatory changes, conducting a Pre-Use Post-Sterilization Integrity Test (PUP SIT), as well as a mandatory post-use filter integrity test, of the sterilizing grade filter(s) should be considered based on the criticality of the process step. If PUPSIT of a filter or a manifold assembly is failed for a particular batch of product, then filter retesting and potentially manifold replacement may occur - this can lead to production delays and the potential loss of valuable process fluids. Therefore, ensuring a PUPSIT is performed efficiently is paramount to successful implementation of a PUPSIT strategy within the process. Filter integrity testing relies on complete wetting of the filter membrane prior to the filter integrity test, otherwise test gas can move through the dry pores leading to an integrity test fail, where in reality the filter capsule may meet the manufacturer’s specification, but the membrane wetting is incomplete. PAT-DB-081-WO-PCT 2

[0009] Due to the potential increase in the frequency of PUPSIT operations required, there is a need to improve efficiency of the filter wetting process.

[0010] PAT-DB-081-WO-PCT 3

[0011] SUMMARY

[0012] Aspects of the present disclosure are set out in the accompanying independent and dependent claims. Combinations of features from the dependent claims may be combined with features of the independent claims as appropriate and not merely as explicitly set out in the claims.

[0013] According to a first aspect of the present disclosure, there is provided an adapter for a filter capsule, the adapter comprising: a body having a connecting portion configured to be coupled to a filter capsule, wherein the connecting portion surrounds an opening in the body, the opening extending into a cavity, a first fluid conduit that projects externally from the body and extends a first distance into the cavity towards the opening, the first fluid conduit comprising a first inlet disposed at a first end of the first fluid conduit, wherein the first end of the first fluid conduit is located external to the body and a first outlet disposed at a second end of the first fluid conduit opposed to the first end, wherein the second end of the first fluid conduit is located within the cavity, and a vent provided in the body configured to vent fluid from the cavity.

[0014] There is a general need with many filter applications to improve the efficiency with which fluid can be vented from a filter, to ensure that air is efficiently removed from the filter assembly.

[0015] In particular, the vent provided in the adapter can improve the efficiency of integrity testing (e.g. PUPSIT), or preparation for said integrity testing, of a filter capsule coupled thereto, as this vent provides an effective outlet for gas to escape from the filter media and the housing during wetting of the filter media. It will be appreciated that any gas that remains within the pores (i.e. pores remain dry) of a filter membrane during integrity testing can elevate the integrity testing results, leading to a false fail outcome. Moreover, increasing the efficiency with which gas is vented from the filter media and the filter capsule reduces cycle time of the integrity test operation; this has potential operational cost benefits for the end user. PAT-DB-081-WO-PCT 4

[0016] The adapter may equivalently be referred to as a connector, or connector element.

[0017] The first fluid conduit extends through the body into the cavity.

[0018] Optionally, the body and the cavity have a domed shape.

[0019] The first fluid conduit may be referred to as an inlet fluid conduit.

[0020] Optionally, the first outlet is disposed proximate the opening of the body.

[0021] Optionally, the first outlet is substantially flush with the opening of the body.

[0022] Optionally, the first distance is substantially equal to a maximum depth of the cavity, such that the first outlet is positioned in line with the opening of the body.

[0023] Optionally, the first distance is substantially equal to a maximum depth of the cavity, such that the first outlet is positioned substantially along the same plane as the opening of the body.

[0024] Optionally, the first fluid conduit is fluidly isolated from the vent. It will be appreciated that fluidly isolated means that the elements are not in fluid communication with each other.

[0025] Optionally, a first fluid flow path is provided for incoming fluid (e.g. liquid, gas or a mixture of liquid and gas) through the first inlet, along the first fluid conduit, out the first outlet and out the opening of the body.

[0026] Optionally, a second fluid flow path is provided for outgoing fluid from the cavity and out of the vent.

[0027] Optionally, the first fluid flow path is not in fluid communication with the second fluid flow path, or the first fluid flow path is fluidly isolated from the second fluid flow path. PAT-DB-081-WO-PCT 5

[0028] Optionally, the vent comprises a second fluid conduit that projects externally from the body.

[0029] Optionally, the second fluid conduit comprises a vent outlet disposed at a first end of the second fluid conduit, wherein the first end of the first second conduit is located external to the body.

[0030] Optionally, the second fluid conduit comprises a vent inlet disposed at a second end of the second fluid conduit opposed to the first end, wherein the vent inlet is in fluid communication with the cavity.

[0031] Optionally, the second end of the second fluid conduit is coupled to the body, such that the vent inlet is located at an interface between the cavity and the second fluid conduit.

[0032] Optionally, the second end of the second fluid conduit extends a second distance into the cavity, such that the vent inlet is located within the cavity, wherein the second distance is less than the first distance. Thus, the first fluid conduit extends farther into the cavity than the second fluid conduit or vent.

[0033] Optionally, the second fluid conduit projects from the body at a first angle relative to the first fluid conduit, wherein the first angle is greater than 0 degrees and less than 90 degrees.

[0034] Optionally, the first angle is between 30 degrees and 60 degrees. Optionally, the first angle is approximately 45 degrees.

[0035] Optionally, the first fluid conduit extends along a central axis of the body. Thus, a longitudinal axis of the first fluid conduit corresponds to a central axis of the body.

[0036] Optionally, a longitudinal axis of the vent (or the second fluid conduit) extends at a first angle relative to the longitudinal axis of the first fluid conduit. PAT-DB-081-WO-PCT 6

[0037] Optionally, the second fluid conduit projects from the body at a first angle relative to a central axis of the body, wherein the first angle is greater than 0 degrees and less than 90 degrees.

[0038] Optionally, the first angle is between 30 degrees and 60 degrees. Optionally, the first angle is approximately 45 degrees.

[0039] Optionally, the connecting portion comprises an annular clamping portion, the annular clamping portion comprising a recess for receiving a sealing element.

[0040] Optionally, the annular clamping portion is configured to form part of a tri-clamp fitting.

[0041] Optionally the connecting portion comprises a ferrule end, or a tri-clamp type ferrule end.

[0042] Optionally, the cavity and the first fluid conduit are each free from any membranes or filter elements.

[0043] Optionally, the adapter is free from any membranes or filter elements.

[0044] Optionally, the body, the vent and the first fluid conduit are integrally molded to form a unitary structure. Thus, the adapter may comprise a single unitary element.

[0045] Optionally, the first end of the first fluid conduit comprises a barbed hose fitting.

[0046] Optionally, the first end of the second fluid conduit comprises a barbed hose fitting.

[0047] According to a second aspect of the present disclosure, there is provided a filter assembly, comprising a filter capsule comprising a housing having an inlet orifice at a first end of the housing and an outlet orifice at a second end of the housing opposed to the first end and a filter media provided within the housing, and an adapter according to any embodiment or example of the first aspect of the disclosure, wherein the adapter is coupled to the housing such that the inlet orifice is in fluid communication with the cavity and the first PAT-DB-081-WO-PCT 7 outlet of the adapter. Thus, the first outlet of the adapter and the cavity are each in fluid communication with the filter media.

[0048] Optionally, the filter assembly is a single use filter assembly.

[0049] The filter capsule may equivalently be referred to as a filter cartridge.

[0050] In the filter capsule, the filter media is encapsulated in an envelope, typically polymeric, with at least one inlet, at least one outlet and a least one vent. The filter assembly may be referred to as a capsule filter assembly.

[0051] The adapter may be removably coupled to the housing, such that the adapter can be removed from the housing and recoupled.

[0052] Optionally, the adapter may be clamped to the housing.

[0053] Optionally, the connecting portion of the adapter is clamped to the inlet orifice by a clamp and a seal element is provided between the adapter and the inlet orifice. Optionally, the seal element is a gasket.

[0054] Optionally, the inlet orifice, clamp, connecting portion and seal element form a triclamp fitting.

[0055] Optionally the inlet orifice comprises a ferrule end, and the connecting portion of the adapter comprises a complementary ferrule end.

[0056] Thus, the housing may comprise a complementary connecting portion surrounding the inlet orifice, the complementary connection portion configured to be coupled to, or clamped to, the connecting portion of the adapter.

[0057] Optionally, the adapter is integrally connected to the housing. The integral connection may be referred to as a permanent connection. PAT-DB-081-WO-PCT 8

[0058] Optionally, the integral connection may be formed by welding, moulding, or adhering the adapter to the housing.

[0059] Optionally, a portion of the housing proximate the inlet orifice has a reduced internal diameter relative to a remainer of the housing. The portion of the housing may be referred to as a neck.

[0060] Optionally, the housing further comprises at least one capsule vent configured to vent fluid from the housing.

[0061] According to a third aspect of the present disclosure, there is provided a method of removing gas from a filter assembly, the filter assembly according to any embodiment or example of the second aspect of this disclosure.

[0062] Optionally, the method may be referred to as a method of improving the efficiency of venting gas from a filter assembly.

[0063] The method comprises wetting the filter media by supplying a liquid to the first inlet of the first fluid conduit of the adapter, displacing, by the liquid, gas present in the filter media, and removing (or outputting) said displaced gas from the filter assembly via the vent of the adapter.

[0064] It will be appreciated that the displaced gas may be output together with liquid via the vent line of the adapter, such that fluid may be output via the vent line, said fluid including the displaced gas.

[0065] As stated above, the use of the adapter improves the efficiency of this wetting process, as it is more likely to result in complete membrane wetting by the efficient removal of gas from the filter media or filter membrane.

[0066] Optionally, the method may be, or may form part of, a method of preparing the filter assembly for a non-destructive integrity test. PAT-DB-081-WO-PCT 9

[0067] Optionally, the filter assembly may be sterilised prior to commencement of this method.

[0068] Optionally, the method comprises, before wetting the filter media, positioning the filter assembly such that the vent of the adapter is orientated substantially vertically. This assists the evacuation of fluid (e.g. gas) from the filter assembly.

[0069] Optionally, the method comprises, before wetting the filter media, positioning the filter assembly at an angle of approximately 45 degrees relative to a vertical axis.

[0070] According to a fourth aspect of the present disclosure, there is provided a method comprising: performing a method of preparing a filter assembly for a non-destructive integrity according to the third aspect of the present disclosure, to thereby wet the filter media, and subsequently performing a non-destructive integrity test of the filter assembly.

[0071] Performing the non-destructive integrity test may comprise performing any suitable type of test known in the art, or any type of PUPSIT known in the art.

[0072] The non-destructive integrity test may be a pressure-based non-destructive integrity test.

[0073] Optionally, performing the non-destructive integrity test comprises performing one or more of the following: a bubble test; a diffusion flow or forward flow test; or a pressure maintenance test.

[0074] PAT-DB-081-WO-PCT 10

[0075] BRIEF DESCRIPTION OF THE DRAWINGS

[0076] Embodiments of this disclosure will be described hereinafter, by way of example only, with reference to the accompanying drawings in which like reference signs relate to like elements and in which:

[0077] Figure 1 shows a front view of an adapter according to an embodiment of this disclosure;

[0078] Figure 2 shows an isometric view of the adapter in Figure 1; Figure 3 shows a plan view of the adapter in Figure 1;

[0079] Figure 4 shows a section view of the adapter along line Y-Y in Figure 3;

[0080] Figure 5 shows a section view of a filter assembly according to an embodiment of this disclosure;

[0081] Figure 6 shows a section view of an adapter according to another embodiment of this disclosure;

[0082] Figure 7 is a flowchart illustrating a method of removing gas from a filter assembly according to an embodiment of this disclosure.

[0083] PAT-DB-081-WO-PCT 11

[0084] DETAILED DESCRIPTION

[0085] Embodiments of this disclosure are described in the following with reference to the accompanying drawings. It will be appreciated that the drawings are provided for illustrative purposes and features are not shown to scale, unless a scale is explicitly referenced.

[0086] Figure 1 shows a front view of an adapter 100 for a filter capsule according to an embodiment of the present disclosure. The adapter 100 may be referred to as a connector. The adapter 100 comprises a body 102, a first fluid conduit 110 and a vent 120. The first fluid conduit 110 may be referred to as an inlet conduit. In this embodiment the vent 120 comprises a second fluid conduit, or an outlet conduit. However, in other embodiments the vent 120 may comprise an opening or aperture in the body 102 for receiving a vent line. Thus, the vent 120 may have any configuration suitable to facilitate connection to a vent line.

[0087] The first fluid conduit 110 and the vent 120 are configured to allow the passage of a fluid therethrough, wherein a fluid refers to a liquid, gas, or a mixture of liquid and gas.

[0088] The first fluid conduit 110 projects externally from the body 102 and extends along a central axis A-A of the body 102. Thus, the central axis A-A of the body 102 is a longitudinal axis of the first fluid conduit 110. The vent 120 also projects externally from the body 102. The vent 120 projects from the body 102 at a first angle (0) relative to the first fluid conduit 110. Thus, a longitudinal axis (B-B) of the vent 120 extends at a first angle relative to the longitudinal axis (A-A) of the first fluid conduit.

[0089] In the embodiment shown in Figure 1, the first angle (0) is approximately 45 degrees. However, in other embodiments the first angle may be any angle greater than 0 degrees and less than 90 degrees, such as between 20 degrees and 80 degrees, or between 30 degrees and 60 degrees.

[0090] As shown in Figure 2, which illustrates an isometric view of the adapter 100 in Figure 1, the body 102 comprises a connecting portion 106 configured to be coupled to a filter capsule (see Figures 4 and 5). The connecting portion 106 may form part of a tri-clamp fitting, such that the connecting portion 106 is a ferrule end and comprises a recess for receiving an annular gasket or seal. However, other types of clamps or fittings can be PAT-DB-081-WO-PCT 12 provided within the scope of the present disclosure. The connecting portion 106 surrounds or circumscribes an opening 108 in the body 102, the opening 108 extending into a cavity or internal chamber 104. As such, the body 102 could be referred to as a hollow body 102 having a cavity 104. In this embodiment the body 102 (and the cavity 104) are substantially dome shaped.

[0091] The first fluid conduit 110 extends a first distance into the cavity 104 towards the opening 108. Thus, the first fluid conduit 110 comprises a first inlet 114 disposed at a first end 112 of the first fluid conduit and a first outlet 118 disposed at a second end 116 of the first fluid conduit opposed to the first end 112. The first end 112 of the first fluid conduit is located external to the body 102, and the second end 116 of the first fluid conduit is located within the cavity 104 (as shown in Figure 2). In this embodiment, the first outlet 118 of the first fluid conduit 110 is provided proximate to the opening 108 of the adapter 100. The first outlet 118 may be flush (or in line) with the opening 108. Thus, the first distance may be substantially equal to a maximum depth of the cavity 104.

[0092] The vent 120 is provided to vent or output fluid (in particular gas) from the cavity 104. In this embodiment, the vent 120 (or second fluid conduit) comprises a first end 122 spaced from the body 102, and a second end 126 coupled to the body 102, wherein the second end 126 is opposed to the first end 122. The first end 122 of the vent 120 comprises a vent outlet 124. The second end 126 comprises a vent inlet (or opening) in fluid communication with the cavity 104, such that fluid (e.g. gas) in the cavity 104 is received into the second end 126 of the vent 120.

[0093] In this embodiment, as the second end 126 of the vent 120 is coupled to the body 102, the vent inlet is located at an interface between the cavity 104 and the vent 120. In other embodiments, the second end 126 of the vent 120 may extend a second distance into the cavity 104, wherein the second distance is less than the first distance, such that the first fluid conduit 110 extends farther into the cavity 104 than the vent 120.

[0094] The adapter 100 is free from any filters, filter membranes, or valves. The purpose of the adapter is for the channeling of fluid into a filter capsule and outputting fluid (i.e. gas, liquid or a mixture thereof) from the filter capsule, rather than performing any filtration. PAT-DB-081-WO-PCT 13

[0095] The adapter 100 may be a unitary structure. In some embodiments, the adapter 100 may be integrally molded (i.e. to form a single structure). This may be advantageous as it eliminates any joins or seals between the components of the adapter 100, thereby reducing the risk of leaks.

[0096] A plan view of the adapter 100 is shown in Figure 3. As shown, in this embodiment the vent 120 and the first fluid conduit 110 are aligned along a central plane represented by line Y-Y, such that the respective longitudinal axes of both the vent 120 and the first fluid conduit 110 (see lines B-B and A-A in Figure 1) are provided in the central plane. The central plane may be referred to as the frontal plane.

[0097] Figure 4 shows a sectional view of the adapter along line Y-Y in Figure 3 (i.e. along the central plane) when coupled to a filter capsule 200. The adapter 100 and the filter capsule 200 together form a filter assembly. The adapter 100 is coupled to the filter capsule 200 such that the opening 108 and cavity 104 of the adapter are in fluid communication with an inlet orifice 208 in the filter capsule 200.

[0098] In Figure 4, the connecting portion 106 of the adapter 100 is clamped to a complementary connector 206 of the filter capsule 200. In this embodiment, the connecting portions 106, 206 form part of a tri-clamp fitting, with a tri-clamp gasket 150 provided between the two connecting portions 106, 206 to form a fluid-tight seal. In this embodiment, the connecting portion 106 of the adapter comprises a ferrule end, and the housing connector comprises a complementary ferrule end 206.

[0099] To wet the filer media, for example to prepare for a non-destructive integrity test of the filter assembly (or otherwise, a fluid is received at the inlet 114 of the first fluid conduit. It will be appreciated that said fluid must comprise a liquid, or a mixture of liquid and gas. The incoming fluid flows along a first fluid flow path 140 through the first fluid conduit 110 and into the inlet orifice 208 of the filter capsule. The incoming fluid then displaces gas that is present in the filter media (or filter membrane) and wets the filter media or filter membrane contained within the filter capsule 200 (not shown). Gas contained in the filter media and capsule volume (including said displaced gas) is evacuated (or output) from the filter assembly via a second fluid flow path 142. The gas (or a mixture of liquid and gas) flows out PAT-DB-081-WO-PCT 14 of the inlet orifice 208 of the filter capsule, into the cavity 104 of the adapter, along the vent (or second fluid conduit) 120 and out of the vent outlet 124.

[0100] As shown in Figure 4, the first fluid flow path 140 is isolated from (i.e. not in fluid communication with) the second fluid flow path 142. This isolation ensures that incoming fluid received at the inlet 114 does not travel along the vent 120 instead of into the filter capsule 200. The separation between the two fluid flow paths is achieved by the walls 130 of the first fluid conduit 110 dividing the first fluid flow path 140 from the cavity 104. As the first fluid conduit 110 extends further into the cavity 104 than the vent 120, this reduces the risk of fluid travelling from the first fluid conduit into the vent 120. This risk is minimized if the outlet 118 of the first fluid conduit is substantially flush with the opening 108 in the adapter 100, such that the internal walls 130 extend along the total depth of the cavity 104.

[0101] In Figures 1 to 3 the adapter 100 is shown in a "vertical" orientation, which corresponds to the adapter 100 being placed on a flat surface. However, in use, the filter capsule 200 and the adapter 100 coupled thereto are generally positioned at an angle offset from vertical, as shown in Figure 4. As such, in this embodiment the vent 120 is positioned on the adapter 100 such that, in use, the vent 120 is orientated substantially vertically. This improves the effectiveness of the vent 120, as gas, liquid or a mixture thereof is output more efficiently along the second flow path 142 if the vent 120 has a substantially vertical orientation compared to a substantially horizontal orientation (as gas generally rises upwards). Consequently, it is advantageous if the first angle (0 in Figure 1) between the longitudinal axis of the vent line 120 and the central axis (A-A) of the adapter 100 is selected to correspond (or be similar to) to the angle (relative to a vertical axis) at which the filter assembly will be orientated during use. In this embodiment, the operational angle of the filter assembly is approximately a 45 degree angle as shown in Figure 4, so the first angle is selected as approximately 45 degrees, to ensure that the vent line 120 is substantially vertical during use.

[0102] Figure 5 shows another embodiment of a filter assembly according to the present disclosure. In this embodiment, the adapter 100 is connected to a filter capsule 300 containing a filter media (not shown). The filter capsule has a housing 302, comprising an inlet orifice 308 and an outlet orifice 328. A portion 304 of the housing 302 proximate the inlet orifice 308 has a reduced internal diameter relative to a remainer of the housing 302. As such, the PAT-DB-081-WO-PCT 15 filter capsule 300 narrows towards the inlet orifice 308, such that a flow-restriction portion is provided proximate the coupling with the adapter 100.

[0103] As shown in Figure 5, the filter capsule 300 comprises a first capsule vent 320 and a second capsule vent 322 provided in the housing 302 for outputting fluid from the filter capsule 300. As such, the adapter vent 120 may not be the only vent for outputting fluid (e.g. gas, liquid or a mixture thereof) from the filter capsule, as one or more vents may also be provided in the filter capsule housing. The provision of the vent 120 in the adapter 100 improves the venting of fluid from the filter capsule in comparison to providing only the capsule vents 320, 322.

[0104] When the filter capsule 300 is placed upright on a flat surface, the first and second capsule vents 320, 322 have a substantially horizontal orientation (i.e. a longitudinal axis of the first and second capsule vents 320, 322 is substantially horizontal). The first and second capsule vents 320, 322 are therefore substantially perpendicular to the first fluid conduit 110. In other words, when the first fluid conduit 110 is perpendicular to a surface plane the capsule vents 320, 322 are orientated horizontally.

[0105] In Figure 5, the filter assembly is arranged at an approximately 45 degree angle offset from vertical, which is the operational angle of the filter assembly as described above, such that during use of the filter assembly the first and second capsule vents 320, 322 are orientated at an approximately 45 degree angle. In comparison, in the embodiment shown in Figure 5, the adapter vent 120 has a substantially vertical orientation during operation of the filter assembly, which as gas generally rises upwards, improves the efficiency and effectiveness of the vent 120 in comparison to the first and second capsule vents 320, 322. Thus, the first and second capsule vents 320, 322 form back-up or secondary vent lines for venting gas, liquid or a mixture thereof from the capsule. In some embodiments, the capsule vents 320, 322 may not be provided, or only a single capsule vent may be provided.

[0106] It will be appreciated that although Figures 4 and 5 show the adapter 100 as being clamped to the filter capsule 200, 300, other forms of connection may be utilized. For example, the adapter 100 may be permanently or integrally connected to the filter capsule housing 302. In some embodiments, the adapter 100 may be welded, fastened or adhered to PAT-DB-081-WO-PCT 16 the filter capsule. In other embodiments, the adapter and the filter capsule may form a single unitary structure. For example, the adapter may be molded to the filter capsule.

[0107] As shown in Figures 1 to 5, an external surface of each of the first end 112 of the first fluid conduit and the first end 122 of the vent each comprise a barbed hose connector (or a hosebarb connector). However, other types of connector fittings may be provided, depending on the type of coupling required for the system. For example, Figure 6 shows an embodiment of an adapter 100' where an external surface of the first end the first end 112' of the first fluid conduit and the first end 122' of the vent each provide a stepped barbed hose connector. Relative to Figures 1 to 5, the internal diameter of the first fluid conduit 110' and the vent 120' is narrower. It will be appreciated that the dimensions of the adapter can be selected depending on system requirements. Whilst Figures 1 to 6 show the vent and the first fluid conduit having substantially the same internal diameter, this is not essential. In other embodiments of this disclosure the vent and the first fluid conduit may have different internal and / or external diameters.

[0108] The filter assembly of the present disclosure is primarily configured for use in the pharmaceutical industry, wherein the capsule filter 200, 300 is used to remove contaminants which might be present in the pharmaceutical product (e.g. drug substance). The contaminants may, for example, be particulates or may be microbial. The filter assembly generally forms part of a single use manifold system, or single use manifold assembly. It is required to perform integrity testing of the filter assembly (and the wider system), wherein the integrity testing is generally a pressure based 'leak' test to verify that a filter assembly is fit for purpose. The acceptance criteria for a pass or fail is supplied by each filter manufacturer. The leak test may be conducted after the filter assembly has been sterilised (pre-use) and always post-use to verify the performance of the filter. However, recent regulation changes require both a pre-use and post use integrity test to be performed in applications that are considered to be high risk.

[0109] As shown in Figures 1 to 6, the present disclosure provides an adapter that connects to a filter capsule that facilitates effective priming of a filter membrane (or filter media) with liquid (optionally, prior to a non-destructive filter integrity test), whilst minimizing the occurrence of an air lock, with a common inlet and vent. This is achieved by the inclusion of an independent inlet fluid conduit 110 and vent 120 in the adapter. PAT-DB-081-WO-PCT 17

[0110] A method 500 according to an embodiment of this disclosure is shown in the flowchart in Figure 7. The method 500 is a method of removing gas from a filter assembly (e.g. filter capsule 200, 300).

[0111] The method 500 includes, at step 502, wetting the filter membrane in the filter capsule 200, 300 by supplying a fluid (e.g. a liquid, or a mixture of liquid and gas) to the first fluid conduit of the adapter. Before wetting the filter membrane, the filter assembly may be positioned such that the vent 120 of the adapter is orientated substantially vertically. In step 502, gas (e.g. air) present in the filter membrane is displaced by the liquid input to the first fluid conduit.

[0112] At step 504, the method comprises allowing said displaced gas to escape the filter capsule 200, 300 via the vent 120 of the adapter, during wetting of the filter membrane. Thus, steps 502 and 504 generally occur simultaneously (or at least overlapping in time). Said displaced gas may be output from the vent of the adapter together with liquid, such that fluid, not limited to gas only, can be output from the vent 120 in step 504.

[0113] Efficient removal of air and other gases from the filter membrane is important to ensure effective filter wetting. There are many different applications that require a preparation step of wetting the filter media, and removal of air from the filter system, before use of the filter system, which would be improved by the use of the adapter of the present disclosure.

[0114] In some embodiments, the method steps 502, 504 form a method of preparing the filter assembly for a non-destructive integrity test. Thus, in some embodiments, a further method step 506 of carrying out said non-destructive integrity test of the filter assembly may be provided. Such tests are well known in the art and any applicable test can be performed. For example, step 506 may comprise performing a bubble test, a diffusion flow or forward flow test and / or a pressure maintenance test. It will be appreciated that step 506 does not form part of the method of preparing the system for the non-destructive integrity test, such that in some embodiments the method ends at step 504. PAT-DB-081-WO-PCT 18

[0115] It will be appreciated that any gas that remains within the pores of a filter membrane during integrity testing (i.e. pores remain dry) can elevate the integrity testing results, leading to a false fail outcome. Thus, this risk is minimised by the more efficient removal of gas from the filter assembly in steps 502 and 504 of the present disclosure. Moreover, increasing the efficiency with which gas is removed from the filter media and the filter capsule reduces cycle time of the integrity test operation; this has potential operational cost benefits for the end user.

[0116] Accordingly, there has been described an adapter (or connector) comprising a body having a connecting portion configured to be coupled to a filter capsule, wherein the connecting portion surrounds an opening in the body, the opening extending into a cavity. A vent is provided in the body configured to vent fluid from the cavity. A first fluid conduit projects externally from the body and extends a first distance into the cavity towards the opening, the first fluid conduit comprising a first inlet disposed at a first end of the first fluid conduit, wherein the first end of the first fluid conduit is located external to the body, and a first outlet disposed at a second end of the first fluid conduit opposed to the first end, wherein the second end of the first fluid conduit is located within the cavity.

[0117] Also described is a filter assembly comprising the adapter, and methods of removing gas from a filter assembly

[0118] Although particular embodiments of this disclosure have been described, it will be appreciated that many modifications / additions and / or substitutions may be made within the scope of the claims.

Claims

PAT-DB-081-WO-PCT 19CLAIMS1. An adapter for a filter capsule, the adapter comprising: a body having a connecting portion configured to be coupled to a filter capsule, wherein the connecting portion surrounds an opening in the body, the opening extending into a cavity; a first fluid conduit that projects externally from the body and extends a first distance into the cavity towards the opening, the first fluid conduit comprising: a first inlet disposed at a first end of the first fluid conduit, wherein the first end of the first fluid conduit is located external to the body; and a first outlet disposed at a second end of the first fluid conduit opposed to the first end, wherein the second end of the first fluid conduit is located within the cavity and the first outlet is disposed proximate the opening of the body; and a vent provided in the body configured to vent fluid from the cavity.

2. The adapter of claim 1, wherein the first distance is substantially equal to a maximum depth of the cavity, such that the first outlet is positioned substantially along the same plane as the opening of the body.

3. The adapter of any preceding claim, wherein the first fluid conduit is fluidly isolated from the vent.

4. The adapter of any preceding claim, wherein: a first fluid flow path is provided for incoming fluid through the first inlet, along the first fluid conduit, out the first outlet and out the opening of the body; a second fluid flow path is provided for outgoing fluid from the cavity and out of the vent; and wherein the first fluid flow path is not in fluid communication with the second fluid flow path.

5. The adapter of any preceding claim, wherein the vent comprises a second fluid conduit that projects externally from the body, the second fluid conduit comprising: a vent outlet disposed at a first end of the second fluid conduit, wherein the first end of the first second conduit is located external to the body;PAT-DB-081-WO-PCT 20 a vent inlet disposed at a second end of the second fluid conduit opposed to the first end, wherein the vent inlet is in fluid communication with the cavity.

6. The adapter of claim 5, wherein the first end of the first fluid conduit comprises a barbed hose fitting, and the first end of the second fluid conduit comprises a barbed hose fitting.

7. The adapter of claim 5 or claim 6, wherein the second end of the second fluid conduit is coupled to the body, such that the vent inlet is located at an interface between the cavity and the second fluid conduit.

8. The adapter of claim 5 or claim 6, wherein the second end of the second fluid conduit extends a second distance into the cavity, such that vent inlet is located within the cavity, wherein the second distance is less than the first distance.

9. The adapter of any one of claims 5 to 8, wherein the second fluid conduit projects from the body at a first angle relative to the first fluid conduit, wherein the first angle is greater than 0 degrees and less than 90 degrees.

10. The adapter of claim 9, wherein the first angle is between 30 degrees and 60 degrees.

11. The adapter of claim 9 or claim 10, wherein the first angle is 45 degrees.

12. The adapter of any preceding claim, wherein the first fluid conduit extends along a central axis of the body.

13. The adapter of any one of claims 5 to 8, wherein the second fluid conduit projects from the body at a first angle relative to a central axis of the body, wherein the first angle is greater than 0 degrees and less than 90 degrees.

14. The adapter of claim 13, wherein the first angle is between 30 degrees and 60 degrees, or wherein the first angle is 45 degrees.PAT-DB-081-WO-PCT 2115. The adapter of any preceding claim, wherein the connecting portion comprises an annular clamping portion, the annular clamping portion comprising a recess for receiving a sealing element.

16. The adapter of claim 15, wherein the annular clamping portion is configured to form part of a tri-clamp fitting.

17. The adapter of any preceding claim, wherein the cavity and the first fluid conduit are each free from any membranes or filter elements.

18. The adapter of any preceding claim, wherein the body, the vent and the first fluid conduit are integrally molded to form a unitary structure.

19. A filter assembly, comprising: a filter capsule comprising: a housing having an inlet orifice at a first end of the housing and an outlet orifice at a second end of the housing opposed to the first end; and a filter media provided within the housing; and an adapter according to any preceding claim, wherein the adapter is coupled to the housing such that the inlet orifice is in fluid communication with the cavity and the first outlet of the adapter.

20. The filter assembly of claim 19, wherein the connecting portion of the adapter is clamped to the inlet orifice by a clamp and a seal element is provided between the adapter and the inlet orifice.

21. The filter assembly of claim 20, wherein the inlet orifice, clamp, connecting portion and seal element form a tri-clamp type fitting.

22. The filter assembly of claim 19, wherein the adapter is integrally connected to the housing.

23. The filter assembly of any of claims 19 to 22, wherein a portion of the housing proximate the inlet orifice has a reduced internal diameter relative to a remainer of the housing.PAT-DB-081-WO-PCT 2224. The filter assembly of any of claims 19 to 23, wherein the housing further comprises at least one capsule vent configured to vent fluid from the housing.

25. A method of removing gas from a filter assembly, the filter assembly according to any of claims 19 to 24, the method comprising: wetting the filter media by supplying a liquid to the first inlet of the first fluid conduit of the adapter, displacing, by the liquid, gas present in the filter media, and outputting said displaced gas from the filter assembly via the vent of the adapter.

26. The method of claim 25, wherein the method is, or forms part of, a method of preparing the filter assembly for a non-destructive integrity test.

27. The method of claim 25 or claim 26, further comprising, before wetting the filter media, positioning the filter assembly such that the vent of the adapter is orientated substantially vertically.

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