Filter assembly, medical product comprising filter assembly, and manufacturing method for filter assembly and medical product

Abstract

The present disclosure relates to a filter assembly (2) for a medical product (26), preferably for a closed transfer system (26a), the filter assembly (2) having a filter housing (4), preferably made of plastic, with a receiving space (6), and a filter insert (8) which is arranged in the receiving space (6) of the filter housing (4), wherein the filter insert (8) has a first filter element (10), preferably an activated carbon filter, which is provided and designed to bind harmful or toxic vapors and / or gases and / or aerosols in order to purify air, and a second filter element (12), preferably a glass fiber filter, which is provided and designed to prevent particles of the first filter element (10) from escaping from the filter housing (4). The present disclosure further relates to a medical product (26) comprising the filter assembly (2), to a method for manufacturing a filter assembly (2) for a medical product (26), and to a method for manufacturing a medical product (26) comprising a filter assembly (2).

Description

[0001] Filter assembly, medical device with filter assembly and

[0002] Manufacturing process for filter assembly and medical device

[0003] Description

[0004] The disclosure relates to a filter assembly for a medical product, a medical product with the filter assembly, a manufacturing method of a filter assembly for a medical product, and a manufacturing method of a medical product with a filter assembly.

[0005] Background of the Revelation

[0006] CMR drugs, which are used, for example, in cancer therapy, primarily damage growth-intensive tumor cells during therapeutic application. Many of these drugs themselves have carcinogenic properties due to their mechanism of action. To prevent contact with CMR drugs by individuals not undergoing treatment, so-called "closed system transfer devices" (CSTDs) are increasingly being used in the manufacture and administration of ready-to-use preparations. An important feature of these systems is a pressure equalization mechanism designed to prevent the release of toxic vapors, gases, and aerosols when transferring the liquid drugs between medication containers, such as syringes and glass vials.When a liquid is transferred into a medication container, a corresponding amount of air escapes via the CSTD so that the pressure in the medication container remains constant.

[0007] Some CSTDs utilize additional filtration technology for this purpose. Activated carbon filters are often used to adsorb the molecules of toxic vapors, gases, and aerosols, thus releasing only purified air into the environment. This protects individuals not undergoing treatment from contact with CMR drugs. Due to their material properties, certain activated carbon filters (e.g., fabrics made of activated carbon fibers) tend to generate and release numerous small particles, fibers, and dust during both cutting and handling. Due to their mobility, these can migrate into the fluid channel of a CSTD during further manufacturing steps, transport, or use. Therefore, there is a risk that fluids being transferred will absorb them and thus be administered (intravenously) to a patient, which can lead to embolism.Compliance with limit values ​​for particles in the liquid channel is normatively defined (see ISO 22413 / 8536-4).

[0008] In a previous design of a CSTD, the activated carbon filter is placed in a plastic housing (side case), pressed into place with a cap, and thus held tightly in place. The finished subassembly is then ultrasonically welded to the side of a simple transfer device (similar to a mini-spike). Both the assembly and joining processes lead to a significant release of activated carbon particles.

[0009] Brief description of the revelation

[0010] In view of the problems described above, it is therefore an object of the disclosure to prevent, as far as possible, the entry of particles into a medical product, in particular a CSTD, and at the same time to free air escaping from the medical product from toxic vapors and / or gases and / or aerosols as far as possible.

[0011] This object is achieved by a filter assembly according to claim 1, a medical product with the filter assembly according to claim 7, a manufacturing method of a filter assembly according to claim 12, and a manufacturing method of a medical product with a filter assembly according to claim 15. Advantageous embodiments are claimed in the dependent claims and / or described below in the description. The disclosed filter assembly for a medical product, preferably for a closed transfer system, comprises a filter housing, preferably made of plastic, with a receiving space, and a filter insert arranged in the receiving space of the filter housing.The filter insert comprises a first filter element, preferably an activated carbon filter, which is provided and configured to bind harmful or toxic vapors and / or gases and / or aerosols in order to purify air, and a second filter element, preferably a glass fiber filter, which is provided and configured to prevent particles of the first filter element from escaping from the filter housing.

[0012] It should be understood that the filter insert comprises (at least) two filter elements, wherein the second filter element is configured to prevent particles of the first filter element from escaping from the filter housing. In other words, the second filter element is configured to prevent particles of the first filter element that detach from the first filter element from escaping from the filter housing, or in other words, to intercept them before they would escape from the filter housing. This can preferably be achieved by the second filter element having a fine fabric structure, wherein the holes / pores in the fabric are smaller than (certain) particles of the first filter element.For example, a limit value can be defined as to the size up to which particles of the first filter element are not allowed to pass through the second filter element, and the fabric structure of the second filter element can be designed accordingly, so that, for example, only very few and / or very fine particles of the first filter element can pass through the second filter element. The second filter element can therefore function as a sieve for particles of the first filter element. However, the disclosure is not limited to a second filter element that captures particles of the first filter element in a mechanical manner, as described above by way of example; rather, the second filter element can also, for example, prevent particles of the first filter element from escaping from the filter housing, for example by chemically binding or dissolving them.

[0013] It should also be understood that air can pass through the filter insert, i.e., flow through the first and second filter elements, whereby air flowing through the first filter element is purified by toxic vapors and / or gases and / or aerosols being bound / adsorbed by the first filter element. However, the disclosure is not limited to this; a gas mixture other than (breathing) air can also be purified. The disclosure is further not limited to the binding of toxic vapors and / or gases and / or aerosols. Toxic vapors and / or gases and / or aerosols can, for example, also be chemically dissolved / deactivated and / or converted into non-toxic substances by the first filter element. In other words, the first filter element is designed to remove harmful, in particular toxic, components from air or another gas mixture. The second filter element can also be designed to (partially) fulfill this function.

[0014] It is further understood that a plurality of second filter elements may also be provided, or the second filter element may consist of a plurality of parts, or further filter elements may be provided in addition to the second filter element, which are designed to prevent particles of the first filter element from escaping from the filter housing.

[0015] It should further be understood that the second filter element and, if applicable, further filter elements that have the same function are configured (have / fulfill the function) such that air (or another gas) that comes into contact with the first filter element cannot leave the filter housing without being filtered by the second filter element and, if applicable, freed from particles of the first filter element, i.e., particles that have detached from the first filter element. In other words, the first filter element is encapsulated by the second filter element (and further corresponding filter elements). In other words, this means that the second filter element (or another corresponding filter element) is provided on the way from the first filter element out of the filter housing and / or the receiving space.

[0016] In other words, it is within the meaning of the disclosure that, due to the second filter element (and / or additional filter elements that have the same function), hardly any, in particular no, particles from the first filter element can leave the filter housing and / or the receiving space of the filter housing after assembly / manufacturing. In other words, this means that preferably all openings / paths of the filter housing through which air (from the first filter element) can leave the filter housing are equipped with the second filter element (or additional filter elements that have the same function) or are hermetically sealed after assembly of the filter assembly.

[0017] The advantages of the disclosure are that air flowing through the filter insert is cleaned by a first filter element, whereby toxic vapors, gases, and aerosols are removed from the air by the first filter element, so that they no longer pose a danger to, for example, the user of a medical product with the filter assembly or to a patient. In addition, no particles of the first filter element, or only a few and / or specific particles, for example with a size smaller than a certain threshold, can escape from the filter housing and / or enter a medical product connected to the filter insert. The filter assembly with the contained filter insert as an assembly makes it possible for no particles (of the first filter element) to be present or to enter after cleaning / sterilizing this assembly.can be released, so that the sterile assembly can no longer be contaminated / re-contaminated by escaping particles from the first filter element. This means that the assembly can remain / be kept sterile while it is being mounted on a medical device, for example, without releasing particles (from the first filter element) and thus contaminating a clean room or the medical device, for example. Furthermore, this prevents particles (from the first filter element) from becoming detached before or during use of the filter assembly and, for example, being administered to a patient via an infusion fluid.

[0018] The first filter element is preferably an activated carbon filter. This can be produced, for example, by sintering or from woven fibers. However, the disclosure is not limited thereto. The first filter element can also be made, for example, of aluminum oxide and potassium permanganate, or the filtration can be carried out, for example, by ionization. The second filter element is preferably a glass fiber filter. However, the disclosure is not limited thereto; the second filter element can also be, for example, a porous membrane made of plastic.

[0019] Particularly preferably, the filter insert comprises exactly two filter elements: the first filter element and the second filter element. In other words, the filter insert particularly preferably comprises no further filter elements. It is understood that in this case, the first filter element and the second filter element are each formed as a single piece.

[0020] Preferably, the filter elements of the filter insert (i.e., the first filter element, the second filter element, and possibly further, e.g., third filter elements) are formed separately from one another. However, the disclosure is not limited thereto; the filter insert can also be formed as a single piece and have multiple filter layers, with the filter elements then each constituting a filter layer of the single-piece filter insert.

[0021] The first and second filter elements can each be designed in such a way that a gas, preferably air, can only flow through them in a certain direction, for example only axially and not radially. For example, the fabric or pores / holes (in the fabric) can be arranged in such a way that only one direction of flow is possible.

[0022] The second filter element can be hydrophobic, so that liquid cannot pass through the filter insert, the second filter element does not absorb liquids, and / or the first filter element does not come into contact with liquid. A hydrophobic membrane, for example, made of plastic, can also be attached in front of / to the second filter element, achieving the same effect.

[0023] The filter housing is preferably made of plastic. However, it is not limited to this and can be made of, for example, preferably sterilizable metal or a combination of materials.

[0024] The filter insert preferably has a cylindrical shape, i.e. the first and second filter elements (and optionally further filter elements) are preferably round discs with a circle as their base and particularly preferably form a cylinder when stacked, in other words with their bases placed on top of one another. The receiving space of the filter housing then preferably also has a cylindrical shape, or in other words is a cylinder / cylindrical. The direction in the direction of stacking the filter elements, or in other words the direction perpendicular to the bases of the stacked filter elements, is referred to below as the stacking direction or axial direction. The filter elements or bases may also not lie directly on top of one another. There may therefore also be space between them. The receiving space and / or the filter insert may also have other shapes.

[0025] They preferably each have the shape of a (straight) prism or several stacked (straight) prisms. The first and second filter elements can therefore, for example, also have a rectangular base area and be rectangular disks / plates which, when stacked together, form a cuboid extending in the stacking direction. The receiving space is then preferably also a cuboid extending in the axial direction. In other words, the shape of the receiving space is preferably a counterpart of the filter insert, i.e. the shape and / or size of the receiving space can arise by subtracting / extruding the stacked filter insert from / into a solid body, the filter housing, in the stacking direction / axial direction. The receiving space is therefore designed so that the filter insert is / will be arranged in the receiving space.The size of the cross-sectional area of ​​the receiving space, i.e. the area perpendicular to the direction of extrusion or the stacking direction, preferably corresponds to the base area of ​​the filter elements so that as little air as possible can flow through the receiving space and past the filter elements. The length of the receiving space in the axial direction, i.e. along the direction / axis of extrusion or in the stacking direction, can have some play or space, for example to insert a fixing element into the receiving space. The filter housing can also be in the shape of a tube or hollow cylinder, i.e. the receiving space is then the interior / part of the interior of the tube or hollow cylinder and the filter insert is / is arranged in the tube or hollow cylinder.

[0026] The receiving space can also have different cross-sectional areas in the axial direction. For example, a first section can have a cross-section corresponding to the shape and size of the base area of ​​the first filter element, and a second section can have a cross-section corresponding to the shape and size of the base area of ​​the second filter element. This means that, for example, the first and second filter elements can also have different shapes and / or sizes. The filter elements and the receiving space can (each) form a clearance, transition, or interference fit.

[0027] The first and second filter elements of the filter insert are preferably arranged one behind the other / in series in the receiving space in the axial direction. The receiving space preferably has a first axial end and a second axial end. The filter assembly can (preferably) be attached to a medical product and / or contained in a medical product, wherein air can flow out of the medical product via the filter assembly, and in particular the receiving space. In the following, an axial end of the receiving space through which air flows into the receiving space upon such an outflow from a medical product and / or which, upon such an outflow, is part of the region of the receiving space through which air flows at least before it reaches the first filter element, is referred to as the second axial end, and correspondingly the other axial end is referred to as the first axial end.

[0028] The filter assembly preferably further comprises a fixing element configured to fix the filter insert in the receiving space. The fixing element preferably holds the filter insert in its position in (at least one direction in) the axial direction in the receiving space, or in other words, the fixing element preferably prevents axial slippage of the filter insert in the receiving space. The filter insert is preferably fixed in the axial direction at the second end of the receiving space by a contact surface, i.e., at the second end of the receiving space, it rests against, for example, a contact surface of the filter housing / a wall of the filter housing and is fixed at the first end by the fixing element. A further fixing element may also be provided at the second end of the receiving space, for example, a washer or attachable cap, which fixes the filter insert at the second end of the receiving space.The filter insert can then not slip in the axial direction. However, the filter insert can also be fixed, for example, by the filter housing, for example by means of a press fit. In this case, the receiving space can be axially limited / protected / covered, for example, by a limiting element that does not (additionally) fix the filter insert. The filter insert is preferably held in position perpendicular to the axial direction due to the shape and size of the cross-sectional area of ​​the receiving space, and in the axial direction due to the at least one fixing element. Thus, the filter insert is firmly fixed in its position in the receiving space.

[0029] The filter housing can have a filter insert opening through which the filter insert can be inserted into the receiving space. Preferably, the filter insert opening is the first axial end of the receiving space, meaning that the filter insert can be inserted into the receiving space via the first axial end of the receiving space, or in other words, the first axial end is then an opening of the receiving space to the environment.

[0030] Preferably, the fixing element is a cap configured to close / close the filter insert opening of the receiving space, particularly preferably in an airtight manner. The cap is preferably pressed / compressed into the filter insert opening, thereby fixing the filter insert. Preferably, the cap can be placed on and / or into the receiving space / the filter insert opening / the filter housing; particularly preferably, the cap can also be attached and removed multiple times, for example, to replace the filter elements. Preferably, the filter insert opening is the first axial end of the receiving space, and the cap closes it, particularly preferably in an airtight manner.

[0031] Alternatively or additionally, the filter insert can also have, for example, a further, third filter element which, like the second filter element, is designed to prevent particles of the first filter element from escaping from the filter housing, i.e., has the same function. The fixing element then preferably fixes the filter insert in its position in the receiving space, but preferably does not seal the filter insert opening in an airtight manner, for example, so that air can escape from the receiving space via the third filter element, filtered by the third filter element. The third filter element prevents particles of the first filter element of the filter insert from leaving the filter housing, for example, via the filter insert opening.

[0032] The filter assembly, preferably the filter housing, preferably has a first and a second line, wherein the lines each provide a connection between an environment outside the filter housing and the receiving space of the filter housing. In other words, a fluid, preferably air, can flow through one of the lines into the receiving space from an environment outside the filter assembly, flow through the filter insert, and flow out again (filtered) through another and / or the same line. The lines therefore represent a connection from the receiving space / filter insert to the environment. The lines therefore also include a direct connection, i.e. when the receiving space is open at at least one end and thus forms a direct connection to the environment. The lines can therefore, for example, be channels / passages in the filter housing, or represent a direct connection / contact point between the receiving space and the environment.The lines can begin and end on opposite sides / walls of the filter housing, or they can be arranged side by side on one side / wall of the filter housing. All or individual lines can also be formed in the fixing element, for example, as recesses / holes / openings. The filter assembly can also have more than two lines or just one.

[0033] The filter housing preferably has a wall (as an outer wall / outer surface), which is referred to below as the rear wall, which is designed to be attached to a medical product, preferably by means of ultrasonic welding and / or for example with a plug-in connection or gluing. Preferably, a line, which is referred to as the first line, is designed to be connected airtight to an air duct of a medical product, so that air can then flow from the air duct of the medical product (only) into the first line and via it into the receiving space of the filter housing. Preferably, the first line runs from the rear wall to the receiving space. Preferably, the other line, which is referred to as the second line, runs from the receiving space to an outer surface of the housing, wherein this outer surface is preferably angularly offset from the rear wall and can, for example, be opposite it.

[0034] The filter insert is preferably arranged in the filter housing, and in particular the receiving space, such that a gas, preferably air, which flows through the first filter element, then flows through the second filter element or, for example, a third filter element, which has the same function as the second filter element, namely preventing particles of the first filter element from escaping from the filter housing, to flow out of the filter housing / the receiving space. This means that the activated carbon filter is encapsulated or, to put it another way, there is no way for air, for example, from the activated carbon filter to escape from the filter housing / outwards, preferably out of the receiving space, without flowing through the second filter element or another filter element that is provided and configured to prevent particles of the first filter element from escaping from the filter housing.When gas flows through the filter assembly in one flow direction, it preferably flows through one of the two lines into the receiving space, then first through the second filter element or the third filter element, which has the same function as the second filter element, then through the first filter element, then also through the second filter element or the third filter element, which has / fulfills the same function as the second filter element, and then leaves the receiving space and the filter assembly via the other of the two lines.

[0035] The second filter element is preferably arranged at or near the second axial end of the receiving space. The first line in the receiving space preferably ends at the second end or near the second end, so that a gas, preferably air, flowing through the first line into the receiving space, as it continues to flow in this flow direction, first flows through the second filter element and then through the first filter element. It then preferably flows again through the second filter element and then out via the second line, or through the third filter element and then out via the second line. The disclosure further relates to a medical product having the filter assembly as described above.

[0036] The medical device preferably has a housing, preferably made of plastic, to which the filter assembly is attached, preferably by ultrasonic welding and / or, for example, by plugging (plug-in connection) and / or an adhesive connection. The filter assembly can also be provided in the housing of the medical device or as part of the housing.

[0037] The housing of the medical product preferably has an air duct which is connected to an environment outside the medical product via the filter insert of the filter assembly. In other words, a gas, preferably air, can leave the medical product filtered through the air duct via the filter assembly, in particular the filter insert. The air duct can also be a space or container of the medical product from which air can flow out. If the pressure in the air duct is higher than that in the environment of the medical product, a gas, preferably air, can preferably flow out of the medical product and the filter assembly into the environment in a filtered manner via the first line of the filter housing, which is preferably connected to the air duct, to equalize the pressure in the air duct. After flowing through the first filter element, it flows through the second filter element or a filter element that has / fulfills the same function.

[0038] The medical device may comprise a liquid filter membrane, which is preferably arranged in the air channel of the medical device and is configured to prevent liquid (via the connected first line of the filter housing) from reaching the filter insert and / or individual filter elements. The liquid filter membrane thus allows gases such as air to pass through, but not liquids.

[0039] Preferably, the medical device is a closed transfer system for transferring liquids between medication containers or between a medication container and a patient. However, the medical device is not limited to this and can also be, for example, a medication container withdrawal spike, a container / bag spike, a drip chamber, or a Primestop cap.

[0040] The disclosure further relates to a manufacturing method of a filter assembly, preferably as described above, for a medical product, wherein the filter assembly comprises a filter housing, preferably made of plastic, with a receiving space and a filter insert. The filter insert comprises a first filter element, preferably an activated carbon filter, which is provided and configured to bind harmful or toxic vapors and / or gases and / or aerosols in order to purify the air, and a second filter element, preferably a glass fiber filter, which is provided and configured to prevent particles of the first filter element from escaping from the filter housing.The manufacturing method comprises the following steps in this order: arranging the filter insert of the filter assembly in the receiving space so that a gas flowing through the first filter element subsequently flows through the second filter element; and fixing the filter insert in the receiving space with a fixing element.

[0041] The step of arranging the filter insert of the filter assembly in the receiving space so that a gas which flows through the first filter element subsequently flows through the second filter element of the manufacturing method of the filter assembly is preferably carried out in such a way that firstly the second filter element is inserted through the filter insert opening, which is preferably the first axial end of the receiving space, into the receiving space, preferably at the second axial end, and then or during this time the first filter element is arranged in the receiving space between the first axial end and the second filter element.

[0042] After or during the arranging step, a fixing element, preferably in the form of a cap, can be pressed / inserted / inserted into the filter housing, thereby fixing the filter insert(s) in the receiving space and particularly preferably sealing the filter insert opening in an airtight manner. Alternatively, for example, after the first filter element has been arranged or during the arrangement, a third filter element, which has / fulfills the same function as the second filter element, can be arranged between the first axial end and the first filter element or at the axial end of the receiving space, and then the filter elements / filter insert are preferably fixed with the fixing element.

[0043] The first filter element is thus fixed and encapsulated after the steps of arranging and fixing.

[0044] The manufacturing process for the filter assembly preferably includes, as a subsequent step, cleaning the filter assembly, preferably using a CO2 snow jet. Additionally or alternatively, the filter assembly can also be cleaned by other means, for example, using compressed air or ionized air.

[0045] Since the first filter element is encapsulated, particles that become detached from the first filter element cannot leave the filter housing / accommodating space and the filter assembly remains clean after cleaning (and free of such particles apart from the encapsulated space of the activated carbon filter).

[0046] The disclosure further relates to a manufacturing method of a medical product, preferably as described above, comprising a filter assembly, wherein the filter assembly comprises a filter housing, preferably made of plastic, with a receiving space, and a filter insert. The filter insert comprises a first filter element, preferably an activated carbon filter, which is provided and configured to bind harmful or toxic vapors and / or gases and / or aerosols in order to purify the air, and a second filter element, preferably a glass fiber filter, which is provided and configured to prevent particles of the first filter element from escaping from the filter housing.The manufacturing method comprises the following steps in this order: manufacturing the filter assembly, preferably as described above; cleaning the filter assembly, preferably by CO2 snow jet cleaning; and attaching the filter assembly to the housing of the medical device, preferably by ultrasonic welding.

[0047] The filter assembly cleaning step of a medical device manufacturing process may also include cleaning methods other than CO2 snow jet cleaning, such as cleaning with compressed air or ionized air.

[0048] The step of attaching the filter assembly to the medical device housing of the medical device manufacturing process may also include attachment methods other than ultrasonic welding, for example, gluing or clipping.

[0049] Short description of the characters

[0050] The disclosure is explained in more detail below using preferred embodiments and with reference to the attached figures.

[0051] Fig. 1a shows a filter assembly according to the present disclosure in a preferred embodiment;

[0052] Fig. 1 b shows the filter assembly from Fig. 1a in an exploded view;

[0053] Fig. 2a shows the filter assembly from Fig. 1 a in a front view with section planes AA and BB marked;

[0054] Fig. 2b shows the corresponding sectional view AA from Fig. 2a;

[0055] Fig. 2c shows the corresponding sectional view BB from Fig. 2a;

[0056] Fig. 3 shows the sectional view from Fig. 2c enlarged and with a flow path through the filter assembly;

[0057] Fig. 4a shows a medical product with the filter assembly of Fig. 1a in an exploded view;

[0058] Fig. 4b shows the medical device assembled with the filter assembly of Fig. 4a; Fig. 5a shows an exploded view of a filter assembly in an alternative embodiment according to the present disclosure;

[0059] Fig. 5b shows the filter assembly from Fig. 5a in a front view with a section plane AA;

[0060] Fig. 5c shows the corresponding sectional view AA from Fig. 5b;

[0061] Fig. 6a shows an exploded view of a filter assembly in another alternative embodiment according to the present disclosure;

[0062] Fig. 6b shows the filter assembly from Fig. 6a in a front view with a section plane AA;

[0063] Fig. 6c shows the corresponding sectional view AA from Fig. 6b;

[0064] Fig. 7a shows an exploded view of a filter assembly in another alternative embodiment according to the present disclosure;

[0065] Fig. 7b shows the filter assembly from Fig. 7a in a front view with a section plane AA;

[0066] Fig. 7c shows the corresponding sectional view AA from Fig. 7b.

[0067] The figures are schematic and serve only to facilitate understanding of the disclosure. The features of the various embodiments may be interchangeable.

[0068] Detailed description of the preferred embodiments

[0069] Fig. 1a shows a filter assembly 2 in a preferred embodiment with a filter housing 4 made of plastic. Fig. 1b shows the filter assembly 2 from Fig. 1a in an exploded view. The filter housing 4 has a receiving space 6. Arranged in the receiving space 6 is a filter insert 8 which has a first filter element 10 in the form of an activated carbon filter and a second filter element 12 in the form of a glass fiber filter. The first filter element 10 and the second filter element 12 are each disc-shaped and, when stacked together / lined up at the base surfaces of the discs / circular surfaces, form a cylinder. Accordingly, the receiving space 6 is also cylindrical. The filter assembly 2 further has a fixing element 14 in the form of a cap 14a, which is pressed into the filter housing 4. The receiving space 6 has a first axial end 16 and a second axial end 18, wherein the cap 14a hermetically seals the first axial end 16 of the receiving space 6.The filter insert 8 can be inserted into and removed from the receiving space 6 via the first axial end 16. The first axial end 16 is therefore a filter insert opening 20. The fixing element 14 in the form of the cap 14a can be inserted and removed onto / into the filter housing 4 / the filter insert opening 20 in order to

[0070] Filter insert opening 20 to insert the filter insert 8 or the first filter element 10 and / or the second filter element 12 into the receiving space 6, for example, to remove it and / or to replace it.

[0071] Fig. 2a shows a front view of filter assembly 2 from Fig. 1a. The front view shows the section planes AA and BB.

[0072] Fig. 2b shows the corresponding sectional view AA from Fig. 2a. The encapsulated first filter element 10 can be seen, which is arranged between the cap 14a and the second filter element 12. At the second axial end 18 of the receiving space 6, the filter insert 8 rests against a contact surface 22 of the filter housing 4. The filter insert 8 is thus fixed in the filter housing 4 in the direction(s) perpendicular to the axial direction, i.e. radially, by the shape of the receiving space 6 and fixed in the axial direction by the cap 14a and the contact surface 22. The filter insert 8 is therefore fixed in its position in the receiving space 6 (non-slip). Fig. 2c shows the corresponding sectional view BB from Fig. 2a. The filter housing 4 has a rear wall 24 which is designed to be attached to a medical product 26.A first line 28 (shown in dashed lines) runs from the rear wall 24 to the second axial end 18 of the receiving space 6, so that air can flow from the receiving space 6 via the first line 28 out of the filter housing 4 into the environment and also in the opposite direction from the outside / environment into the receiving space 6. A second line 30 (shown in dashed lines) runs from the receiving space 6 out of the filter housing 4 into the environment, so that air can flow from the receiving space 6 via the second line 30 out of the filter housing 4 into the environment and also in the opposite direction from the outside / environment into the receiving space 6. The second line 30 ends on / in an outer wall of the filter housing 4 at an angle offset from the rear wall 24.

[0073] Fig. 3 shows the sectional view from Fig. 2c enlarged. The first filter element 10 is encapsulated, which means that no air can escape from the first filter element 10 out of the filter housing 4, in particular the receiving space 6, without flowing through the second filter element 12. This ensures that no particles or, for example, only a few very small particles that detach from the first filter element 10 can escape; the second filter element 12 filters out the (other / most) particles from the escaping air and captures them. The second filter element 12 is interposed between the first filter element 10 and the first line 28 and the second line 30, which are the only paths from the receiving space 6 into the environment outside the filter assembly 2.A flow / flow direction of air from the environment via the first line 28 through the second filter element 12, the first filter element 10, again the second filter element 12 and via the second line 30 back out of the filter housing 4 into the environment is illustrated as an arrow. After flowing through the first filter element 10, the air also flows through the second filter element 12. The second filter element 12 is designed to be flowed through preferentially or more easily in the axial direction, thus ensuring that air is also directed to the first filter element 10. The first filter element 10 is an activated carbon filter which is intended and designed to bind harmful or toxic vapors and / or gases and / or aerosols in order to purify the air, and the second filter element 12 is a glass fiber filter which is designed to prevent particles from the first filter element 10 from escaping from the filter housing 4.

[0074] Fig. 4a shows a medical product 26 in the form of a closed transfer system 26a (CSTD Vial Adapter), which has a housing 32, with the filter assembly 2 from Fig. 1a in an exploded view. The rear wall 24 of the filter housing 4 is attached to the housing 32 of the closed transfer system 26a by means of a plug connection and ultrasonic welding. An air duct 34 in the housing 32 of the closed transfer system 26a is connected to the first line 28 of the filter assembly 2, so that air, at an increased pressure in the air duct 34, flows (only) into the first line 28, then through the filter insert 8, and through the second line 30 out of the closed transfer system 26a. A liquid filter membrane 35 is arranged in the air duct 34 and is designed to prevent liquid from reaching the filter insert 8. The liquid filter membrane 35 allows gases, such as air, to pass through, but does not allow liquids to pass through.

[0075] Fig. 4b shows the closed transfer system 26a assembled with the filter assembly 2 from Fig. 4a.

[0076] Fig. 5a shows an exploded view of a filter assembly 2 according to an alternative embodiment. The filter assembly 2 comprises a cylindrical filter housing 4 with a cylindrical receiving space 6 and a filter insert 8 arranged in the receiving space 6 with three filter elements. The filter insert 8 has a first filter element 10 and a second filter element 12, which are the same as in the embodiment of Fig. 1a, except that the second filter element 12 does not have to have a preferred flow direction. The filter insert 8 further has a third filter element 36, which is provided and configured to prevent particles of the first filter element 10 from escaping from the filter housing 4, in particular from the receiving space 6. The third filter element 36 is therefore identical in function and properties to the second filter element 12.The first filter element 10 is therefore encapsulated, meaning that no air can escape from the first filter element 10 out of the filter housing 4, in particular the receiving space 6, without flowing through the second filter element 12 or third filter element 36. The receiving space 6 has a first axial end 16 and a second axial end 18, with a fixing element 14 being inserted into the filter housing 4 at the first axial end 16 of the receiving space 6. The filter insert 8 can be inserted into and removed from the receiving space 6 via the first axial end 16. The axial end 16 is therefore a filter insert opening 20. The fixing element 14 can be plugged into / onto and unplugged from the filter housing 4 in order to insert, remove or replace the filter insert 8 or the first filter element 10 and / or the second filter element 12 and / or the third filter element 36 into the receiving space 6 via the filter insert opening 20, for example.The filter assembly 2 has a first line 28 and a second line 30. The first line 28 runs from a rear wall 24 of the filter housing 4 into the receiving space 6, in this case as an opening in the filter housing 4, wherein the rear wall 24 is configured to be attached to a medical product 26. The fixing element 14 has the second line 30 as a recess, which connects the receiving space 6 to the environment. The filter insert 8 is axially fixed in the receiving space 6 by the fixing element 14 at the first axial end 16 of the receiving space 6 and the rear wall 24 at the second axial end 18 of the receiving space 6.

[0077] Fig. 5b shows the filter assembly 2 from Fig. 5a in a front view (rotated by 180 degrees around the axial axis compared to Fig. 5a) with a sectional plane AA.

[0078] Fig. 5c shows the corresponding sectional view AA from Fig. 5b. The arrow indicates the flow / direction of air from the environment via the first line 28 through the filter insert 8 (shown as a single piece) and back out of the filter housing 4 via the second line 30 into the environment. In this and the reverse flow direction, after the first filter element 10 has been flowed through, the second filter element 12 or the third filter element 36 is flowed through.

[0079] Fig. 6a shows an exploded view of a filter assembly 2 according to an alternative embodiment. The components and structure of the filter assembly 2 essentially correspond to the embodiment of Fig. 1a, i.e., a filter insert 8 with the two filter elements 10, 12. However, the filter housing 4 corresponds to that of the embodiment of Fig. 5a, although here the second line 30, like the first line 28, is arranged in the rear wall 24. For this purpose, the fixing element 14 is a cap 14a without an opening, which hermetically seals the filter insert opening 20.

[0080] Fig. 6b shows the filter assembly 2 from Fig. 6a in a front view with a section plane AA.

[0081] Fig. 6c shows the corresponding sectional view AA from Fig. 6b. The arrow indicates the flow / direction of air from the environment via the first line 28 through the filter insert 8 (shown as a single piece) and back out of the filter housing 4 via the second line 30 into the environment. In this and the reverse flow direction, after the first filter element 10 has been flowed through, the second filter element 12 is flowed through.

[0082] Fig. 7a shows an exploded view of a filter assembly 2 according to an alternative embodiment. The components and structure of the filter assembly 2 essentially correspond to the embodiment of Fig. 5a. The filter assembly 2 has a filter insert 8 with three filter elements 10, 12, 36, which correspond to those in the embodiment of Fig. 5a, with the first filter element 10 being longer; the filter housing 4 and the receiving space 6 are adapted accordingly. Furthermore, the first and second lines 28, 30 are designed as round openings centered on the rotation axis (in the axial direction) of the filter housing 4, so that the filter insert 8 can be flowed through in a straight line. The first line 28 is an opening in the rear wall 24 of the filter housing 4. The second line 30 is an opening in the fixing element 14.

[0083] Fig. 7b shows the filter assembly 2 from Fig. 7a in a front view with a section plane AA.

[0084] Fig. 7c shows the corresponding sectional view AA from Fig. 7b. The arrow indicates the flow / direction of air from the environment via the first line 28 through the filter insert 8 (shown as a single piece) and back out of the filter housing 4 via the second line 30 into the environment. In this and the reverse flow direction, after the first filter element 10 has been flowed through, the second filter element 12 or the third filter element 36 is flowed through.

[0085] List of reference symbols

[0086] 2 Filter assembly

[0087] 4 filter housings

[0088] 6 Recording room

[0089] 8 filter insert

[0090] 10 first filter element

[0091] 12 second filter element

[0092] 14 Fixing element

[0093] 14a cap

[0094] 16 first axial end

[0095] 18 second axial end

[0096] 20 filter insert opening

[0097] 22 contact area

[0098] 24 Rear wall

[0099] 26 medical device

[0100] 26a closed transfer system

[0101] 28 first line

[0102] 30 second line

[0103] 32 housings

[0104] 34 Air duct

[0105] 35 liquid filter membrane

[0106] 36 third filter element

Claims

Claims 1. Filter assembly (2) for a medical product (26), preferably for a closed transfer system (26a), wherein the filter assembly (2) has a filter housing (4), preferably made of plastic, with a receiving space (6) and a filter insert (8) which is arranged in the receiving space (6) of the filter housing (4), wherein the filter insert (8) has a first filter element (10), preferably an activated carbon filter, which is provided and configured to bind harmful or toxic vapors and / or gases and / or aerosols in order to purify the air, and a second filter element (12), preferably a glass fiber filter, which is provided and configured to prevent particles of the first filter element (10) from escaping from the filter housing (4).

2. Filter assembly (2) according to claim 1, wherein the filter assembly (2) further comprises a fixing element (14) which is configured to fix the filter insert (8) in the receiving space (6).

3. Filter assembly (2) according to one of claims 1 or 2, wherein the filter housing (4) has a filter insert opening (20) and the filter insert (8) can be introduced into the receiving space (6) through the filter insert opening (20).

4. Filter assembly (2) according to claim 2 in conjunction with claim 3, wherein the fixing element (14) is a cap (14a) and the cap (14a) is designed to hermetically seal the filter insert opening (20) of the receiving space (6), preferably by pressing.

5. Filter assembly (2) according to one of claims 1 to 4, wherein the filter assembly (2), preferably the filter housing (4), has a first line (28) and a second line (30), wherein the lines (28, 30) each provide a connection between an environment outside the filter housing (4) and the receiving space (6) of the filter housing (4).

6. Filter assembly (2) according to one of claims 1 to 5, wherein the filter insert (8) is arranged in the filter housing (4) such that a gas flowing through the first filter element (10) subsequently flows through the second filter element (12) for outflow from the filter housing (4).

7. Medical product (26) with the filter assembly (2) according to one of claims 1 to 6.

8. The medical product (26) of claim 7, wherein the medical product (26) comprises a housing (32), and the filter assembly (2) is attached to the housing (32).

9. Medical product (26) according to claim 8, wherein the housing (32) has an air duct (34) which is in communication with an environment outside the medical product (26) via the filter insert (8) of the filter assembly (2), and at a higher pressure in the air duct (34) than the environment outside the medical product (26), a gas, preferably air, flows out of the medical product (26) from the air duct (34) filtered by the filter insert (8) to equalize the pressure, wherein it flows through the second filter element (12) after flowing through the first filter element (10).

10. The medical product (26) according to claim 9, wherein the medical product (26) further comprises a liquid filter membrane (35) arranged in the air channel (34) and configured to prevent liquid from reaching the filter insert (8).

11. The medical product (26) according to any one of claims 7 to 10, wherein the medical product (26) is a closed transfer system (26a) for transferring liquids between medication containers or between a medication container and a patient.

12. Manufacturing method of a filter assembly (2), preferably according to one of claims 1 to 6, for a medical product (26), wherein the filter assembly (2) comprises a Filter housing (4), preferably made of plastic, with a receiving space (6) and a filter insert (8), wherein the filter insert (8) has a first filter element (10), preferably an activated carbon filter, which is provided and configured to bind harmful or toxic vapors and / or gases and / or aerosols in order to purify the air, and a second filter element (12), preferably a glass fiber filter, which is provided and configured to prevent particles of the first filter element (10) from escaping from the filter housing (4), wherein the manufacturing method comprises the following steps in this order: Arranging the filter insert (8) of the filter assembly (2) in the receiving space (6) so that a gas flowing through the first filter element (10) subsequently flows through the second filter element (12); and Fixing the filter insert (8) in the receiving space (6) with a fixing element (14).

13. Manufacturing method according to claim 12, wherein the manufacturing method further comprises, as a subsequent step, cleaning the filter assembly (2), preferably by means of CO2 snow jet cleaning.

14. Manufacturing method according to claim 12 or 13, wherein the step of fixing the filter insert (8) in the receiving space (6) with a fixing element (14) also includes an airtight sealing of a filter insert opening (20), through which the filter insert (8) can be inserted into the receiving space (6), with the fixing element (14).

15. Manufacturing method of a medical product (26), preferably according to one of claims 7 to 11, with a filter assembly (2), wherein the filter assembly (2) has a filter housing (4), preferably made of plastic, with a receiving space (6) and a filter insert (8), wherein the filter insert (8) has a first filter element (10), preferably an activated carbon filter, which is provided and configured to bind harmful or toxic vapors and / or gases and / or aerosols in order to purify the air, and a second filter element (12), preferably a glass fiber filter, which is provided and configured to prevent particles of the first filter element (10) from escaping from the filter housing (4), the manufacturing process comprising the following steps in this order: Producing the filter assembly (2), preferably in a manufacturing method according to one of claims 12 to 14; Cleaning the filter assembly (2), preferably by means of CO2 snow jet cleaning; and Attaching the filter assembly (2) to the housing (32) of the medical product (26), preferably by means of ultrasonic welding.

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