Method for producing web of membrane unit

Abstract

The invention relates to a method for producing a web (1) or sheet of a membrane unit (2) for a membrane product (3), such as a lateral flow test product, from a web (6) or sheet of a membrane material (7) by means of a main production arrangement (9), in which in a main processing routine the web (6) or sheet of the membrane material (7) is processed into the web (1) or sheet of the membrane unit (2), wherein in the main processing routine, in order to produce the membrane unit (2), a fluid structure (11), in particular a hydrophobic structure, for defining a fluid flow through the membrane material (7) is introduced into the membrane material (7) by means of a processing tool (12), and wherein an evaluation routine is carried out by means of an evaluation arrangement (15) comprising a sensor arrangement (16) and an evaluation control (17). According to the invention, in the evaluation routine, an evaluation image (18) of the fluid structure (11) of the membrane unit (2) is generated by means of the sensor arrangement (16) and evaluation data (19) is generated by means of the evaluation control (17), and the evaluation data (19) represents a deviation of the fluid structure (11) in the respective evaluation image (18) from a predefined geometric characteristic of the fluid structure (11) in a reference image (21).

Description

Technical Field

[0001] The present invention relates to a method for producing a roll or sheet of membrane units for membrane products according to the preamble of claim 1, the membrane product being such as a lateral flow test product, a method for producing a membrane product from a roll of membrane units according to claim 15, a method for evaluating a membrane unit for a membrane product according to the preamble of claim 21, the membrane product being such as a lateral flow test product, a main production arrangement according to claim 22 and an auxiliary production arrangement according to claim 23. Background Art

[0002] The membrane unit is part of a membrane product that is typically designed as a lateral flow test product. These lateral flow tests are simple assays used to detect target analytes in liquid samples such as saliva, blood, or urine. A common example of a lateral flow assay is a home pregnancy test product.

[0003] The known membrane element and the known production method thereof (EP 3 171 169 A1) which are the starting point of the present invention provide a flow structure in the form of a recessed structure by means of a processing tool. The flow structure comprises channels for separating flow channels.

[0004] In order to achieve high reproducibility in fluid management, the geometry of the fluid structure must be realized with high precision. In known methods, this precision is supported by camera-based detection of reference points located on the membrane element or on the outer boundary of the membrane element.

[0005] Although the known method is the simplest to implement, it cannot prevent positioning errors that occur after the detection of the reference point. Any positioning errors of the processing tool that introduces the fluid structure into the membrane material cannot be detected.

[0006] It is therefore an object of the present invention to detect any deviation from predefined geometrical properties of a fluid structure with low hardware investment. Summary of the invention

[0007] In order to solve the above-mentioned problems, a method for producing a roll or sheet of a membrane unit according to the preamble of claim 1 has the features of the characterizing part of claim 1 .

[0008] First, according to the invention, the proposed method according to the first teaching is carried out by means of a main production arrangement. In the main processing routine, a coil or sheet of membrane material is processed into a coil or sheet of membrane units. In the main processing routine, in order to produce the membrane unit, the above-mentioned fluid structures (in particular hydrophobic structures) for defining the fluid flow through the membrane material are introduced into the hydrophilic membrane material by means of a processing tool, wherein an evaluation routine is carried out by means of an evaluation arrangement with a sensor arrangement and an evaluation control.

[0009] Now, the basic idea of ​​the invention is to directly detect deviations from predefined geometrical properties of the fluid structure by directly generating an evaluation image of the fluid structure. Thus, it is the fluid structure itself that is measured, taking into account the above-mentioned deviations. This detected deviation can be the basis for a feedback loop in order to improve the accuracy of future production of membrane units. Alternatively or additionally, this detected deviation can also be the basis for the adaptation of subsequent process steps.

[0010] In more detail and most importantly, in an evaluation routine, an evaluation image of the fluid structure of the membrane unit is generated with the aid of a sensor arrangement, and with the aid of the evaluation control, evaluation data are generated, which are representative of deviations of predefined geometrical properties of the fluid structure in the evaluation image relative to the fluid structure in the reference image.

[0011] Hence, the detection of deviations is performed based on the generation of evaluation data, which is generated based on the correlation of the respective evaluation image with the reference image.Preferably, the reference image represents the content of the evaluation image of a predetermined film unit having desired predefined geometrical properties.

[0012] Therefore, the proposed method not only provides accurate detection of deviations from predefined geometrical properties of fluid structures, it can also be performed with minimal hardware investment, since it is based on a simple reflection of the evaluation image with respect to a reference image.

[0013] The evaluation image typically comprises an array of image data according to claim 2, which may well be generated by an optical sensor, such as a camera sensor according to claim 3. The term "image data" is to be understood in a broad sense, i.e. such that according to a variant of claim 2, the image data may be pixel data including information about intensity and / or color. The information about intensity may be described by a continuous or binary variable. In another variant, the image data may also be distance data or the like.

[0014] According to the method according to claim 4, it is preferred that the reference image is generated in a reference routine, for example based on averaging evaluation images of a plurality of membrane units. The idea here is to derive the reference image not from CAD data but from already generated evaluation data. Advantageously, if the original data of the membrane unit or fluid structure to be tested for defining the fluid flow through the membrane material are not available, a reference image based on an average-based reference routine is used. In addition, advantageously, the reference image can be used in a method for determining the relative difference relative to the deviation of different geometric dimensions, or in processes related to the positioning of the membrane unit or fluid structure in the housing of the final membrane product or the positioning of components (e.g. reagents, marker substances, antibodies) on the fluid structure. Thus, the reference image can be used, for example, for setting or adjusting a machine with which the membrane unit is inserted into a corresponding housing or the fluid structure is post-processed (e.g. impregnated). It has been shown that the reference image allows higher precision in such applications, because the CAD data suffer from systematic errors due to the differences that have always been left between the model and the real world. However, even though there are many advantages or beneficial applications, it should be noted that for certain evaluation applications this reference image may not be very suitable, since systematic errors are not immediately detectable and larger positive or negative deviations are compensated.

[0015] Thus, alternatively, according to claim 5, the reference image may be an artificial image, in particular derived (directly) from CAD data. The CAD data may include model geometry, derived geometry and metadata. The CAD data may be 2D or 3D, may consist of wireframes, solid surfaces and / or may be represented by polygons or voxels. The CAD data may contain underlying splines or analytical geometry, gaps between faces, and may be in ASCII or binary format. It may contain PMI and UDA data, and this data may be exported to a shareable format such as 3D PDF and WebGL for anyone to view in a 3D viewer. By this extraction, for example, preferably, the reference image may be directly derived. This embodiment allows for the detection of systematic errors and differences in, for example, machine settings, and may allow for an immediate reaction to them. Thus, for example, scrap and waste may be avoided, since an entire coil or sheet is not first produced to determine that an error exists. Another possibility is to compare the reference image generated from the evaluation image with the CAD data to check whether the reference image sufficiently corresponds to the plan. This may be used, for example, to detect missing structures. Furthermore, this allows errors to be recorded during the production process. While reference images generated from real data (average-based reference images) may be advantageous, CAD-based reference images allow absolute differences to be examined more easily, for example if relative differences in deviations are of interest.

[0016] Claims 6 to 10 relate to preferred variants regarding the definition of the evaluation data. While claim 6 defines the degree of deviation between the evaluation image and the reference image, claims 7 to 10 each relate to deviations of specific geometrical features. According to claims 7 and 8, the evaluation data represent deviations in the form of a shift and / or rotation of the fluid structure in the respective evaluation image relative to the fluid structure in the reference image. Such deviations of shift and / or rotation can easily serve as a basis for adapting preceding or subsequent process steps.

[0017] According to the method as claimed in claim 11 , even detected deviations are marked in the corresponding evaluation image and / or reference image, which simplifies the diagnosis of the cause of the deviation.

[0018] Claims 12 and 13 relate to preferred ways of generating the evaluation image. It is particularly preferred that the evaluation image is derived from the original image by performing a cropping step. In this way, the original image is reduced by image information that is not used to generate the evaluation data.

[0019] Claim 14 proposes the above-mentioned feedback loop. With this measure, the detected deviation can be minimized very well if the main production arrangement allows such an adaptation. However, it is quite possible to leave the deviation as is and only adapt the subsequent process steps so that the deviation is fully compensated by the adaptation of the subsequent steps.

[0020] A second teaching according to claim 15, which has independent importance and is therefore claimed, relates to a method for producing the above-mentioned membrane products, such as lateral flow test products, from rolls or sheets of the above-mentioned membrane units.

[0021] For this second teaching, it is necessary to process the strip or sheet of the film unit in at least one auxiliary processing routine based on the evaluation data. Preferably, the evaluation data is used to adapt the at least one auxiliary processing routine, further preferably in order to support the production of the same film product (claim 16). In other words, the evaluation data that have been generated within the method according to the first teaching are now applied to the method according to the second teaching.

[0022] Claims 17 to 20 relate to preferred variants regarding the auxiliary processing routine. Claim 17 relates to a simple measure of improving the accuracy of the film product by discarding those film units for which a predefined degree of deviation has been detected.

[0023] Alternatively or additionally, claims 18 to 20 show measures for improving the precision of the membrane product by parameterizing auxiliary processing routines. It is particularly advantageous that by applying the method of the invention for producing a roll or sheet of membrane units, the precision of filling the membrane units with biologically active materials (claim 19) can be radically improved, thus saving biologically active materials, such as antibodies, and thus saving costs, since biologically active materials are usually the main cost factor in the production of lateral flow test products.

[0024] The latter measures are more complex to implement; however, they lead to good accuracy results with a relatively small number of discarded membrane units.

[0025] Another teaching according to claim 21, which also has independent importance, relates to a method for evaluating a membrane unit for a membrane product, which method has been explained with respect to the first teaching. All explanations given with respect to the first teaching are fully applicable to this third teaching.

[0026] A main production arrangement for carrying out the method according to the first teaching and an auxiliary production arrangement for carrying out the method according to the second teaching are claimed according to claims 22 and 23. All explanations given up to the first two teachings fully apply. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In the following, embodiments of the present invention are explained with reference to the accompanying drawings. In the accompanying drawings:

[0028] Figure 1 : A membrane product having a membrane unit, as an example, wherein a) is an exploded view, b) is a top view according to arrow B, c) is a cross-sectional view according to arrow CC,

[0029] Figure 2 : Schematic diagram of the proposed method for producing a roll of membrane units,

[0030] Figure 3 :according to Figure 2 Schematic diagram of the method shown is the step of extracting the evaluation image from the original image; and

[0031] Figure 4 :according to Figure 2 Schematic diagram of the method showing the steps of generating evaluation data. DETAILED DESCRIPTION

[0032] The proposed method is used to produce a roll (not shown) or sheet 1 of membrane elements 2 for a membrane product 3, such as a lateral flow test product. Figure 1a is shown in exploded view. The membrane product 3 comprises a housing 4 with a window 5 and a sample pad 6 made of a porous material to guide the sample liquid L from the entry point P to the membrane unit 2. The membrane unit 2 is made of a coil or sheet of a membrane material 7 applied to a membrane carrier 8. Here and preferably, the membrane material 7 is hydrophilic, preferably a microporous material, such as nitrocellulose. This membrane material 7 causes consistent lateral wicking of samples and reagents by capillary force. The membrane carrier 8 is preferably made of a hydrophobic material.

[0033] The production of the coil or sheet 1 of the proposed membrane unit 2 is carried out by means of a main production arrangement 9 which is arranged in Figure 2 The lower part is shown.

[0034] According to the proposed method, in the main processing routine, a coil or sheet of film material 7 is processed into a coil or sheet 1 of a film unit 2. Here and preferably, processing the coil is preferred, which is, however, not explicitly shown in the drawings. Unlike the corresponding coil, the corresponding sheet is provided in a substantially planar manner.

[0035] Here and preferably, all controllable components of the main production arrangement 9 are controlled by an electronic process control 10 .

[0036] In the main processing routine, in order to produce the membrane unit 2, a fluid structure 11, in particular a hydrophobic structure, for defining a fluid flowing through the membrane material 7 is introduced into the membrane material 7 by means of a processing tool 12. Preferably, the fluid structure 11 defines a flow line 13, in which the fluid flow through the membrane material 7 is guided.

[0037] Preferably, the fluid structure 11 is a recessed structure, here preferably in the form of a channel 14 . Figure 1 b. Figure 1 c shows such a fluid structure 11 of a channel 14. Here and preferably, each flow line 13 is defined by a channel 14 which represents the lateral boundary of the respective flow line 13.

[0038] Alternatively, the channels 14 may be replaced by any other structure within the membrane material 7 which is suitable for defining the flow lines 13. For example, it is preferred that the membrane material 7 comprises regions with hydrophobic properties as boundaries of the flow lines 13. These regions may also be polymer-filled or polymer-rich regions.

[0039] The processing tool 12 can work according to different principles such as mechanical, chemical or optical principles. Such mechanical and chemical principles preferably include printing and / or chemical etching. Based on optical working principles, for example, it is preferred to apply laser etching, laser induced photopolymerization, etc. For all these principles, it is important that the resulting fluid structure 11 can be detected by the evaluation arrangement 15, as will be discussed below.

[0040] The evaluation arrangement 15 is provided with a sensor arrangement 16 and an evaluation control 17. The evaluation arrangement 15 is used to carry out an evaluation routine. It is essential to the invention that in an evaluation routine an evaluation image 18 of the fluid structure 11 of the membrane unit 2 is generated by means of the sensor arrangement 16.

[0041] It is further essential to the invention that evaluation data 19 are generated by means of the evaluation control 17 , wherein the evaluation data 19 represent deviations 20 of predefined geometrical properties of the fluid structure 11 in the evaluation image 18 relative to the fluid structure in the reference image 21 .

[0042] In order to simplify the description of the present invention, Figure 2 The actual fluid structure shown and the corresponding fluid structure in the evaluation image 18 are each denoted by the reference numeral 11 .

[0043] Typically, the evaluation images 18 each comprise an array of image data, each image data being assigned a position within the respective image border 22. The array may be a 1, 2 or 3-dimensional array. The image data may be pixel data comprising intensity information and / or color information, distance data, etc. Therefore, the sensor arrangement 16 comprises at least one sensor 23, here and preferably exactly one sensor 23, to generate the evaluation image 18.

[0044] It is further preferred that the at least one sensor 23 is an optical sensor, in particular a 2D camera sensor or a 3D camera sensor. As an alternative, the optical sensor can also be a laser sensor, which can provide the above distance information. The distance information generally refers to the distance in a direction perpendicular to the surface of the membrane unit 2, here and preferably Figure 2 Based on this distance information, it can be assessed whether the fluid structure 11 (here and preferably the structure of the channel 14) has the desired depth profile.

[0045] There are various possible ways to generate the reference image 21. Preferably, in the reference routine, the reference image 21 is defined based on the evaluation images 18 of a plurality of film units 2. In a particularly preferred embodiment, the reference image 21 is defined based on averaging the image information (preferably pixel data as described above) of the evaluation images 18 of a plurality of film units 2.

[0046] Image averaging is a digital image processing technique that is often used to enhance images that have been corrupted, particularly due to random noise or errors. The algorithm used in image averaging operates by calculating the average or arithmetic mean of the intensity values ​​for each pixel position or group of pixels in a set of evaluation images 18 of a plurality of film units 2. Thus, this method is used for feature-preserving error / noise removal that involves only pixels that meet a certain validity criterion.

[0047] Figure 2 It is shown that the sensor arrangement 16 transmits sensor data to an image unit 24 of the evaluation control 17 , which generates a reference image 21 and stores the reference image 21 in a reference image database 25 .

[0048] It is worth noting that the reference image 21 is generated from an evaluation image 18 based on a real membrane unit 2 with a real fluid structure 11. Therefore, it is not necessary to rely on CAD data, and it is not even intended here to generate the reference image 21. As mentioned above, CAD data always deviates from the geometric properties of the real world, which will cause undesirable systematic errors in the evaluation data.

[0049] Alternatively, it is possible that the reference image 21 is an artificial image, in particular an image derived from planning data, in particular CAD data, of a master machining routine. Thereby, said systematic errors can be detected and corrected.

[0050] Furthermore, it is possible to compare a reference image 21 defined from the evaluation image with a reference image derived from planning data (particularly CAD data) of the main machining routine. This embodiment allows combining the advantages of real images and artificial images by checking whether a reference image 21 generated from a real image is good enough and then using this reference image 21.

[0051] Depending on the application, the evaluation data 19 can be generated in different ways. In a simple method, the evaluation data 19 represents the deviation between the corresponding evaluation image 18 and the reference image 21. If these images 18, 21 are identical, the degree of deviation will be 0%. Therefore, a low degree of deviation corresponds to a high quality level of the film unit 2.

[0052] Figure 4 Shown based on Figure 3 Generation of evaluation data 19 for the evaluation image 18 shown. It should be noted that only for ease of understanding, Figure 3 and Figure 4 In FIG. 1 , it is assumed that the fluid structure 11 is represented by the bold optically detectable structure of the flow line 13. However, as Figure 1 As shown, the fluidic structure 11 may also be detectable based on geometrical properties of the channel 14 etc. The proposed method may be applied to any kind of detectable fluidic structure 11 .

[0053] exist Figure 4 In row I of , the corresponding evaluation image 18.1 is subtracted from the reference image 21 to obtain a result image 26. The quality grade can be derived from the degree of remaining pixels in the resulting image 26, for example, the more remaining pixels, the worse the quality of the corresponding film unit 2. Preferably, the quality grade is defined based on applying a mathematical operation to compare the corresponding evaluation image 18 and the reference image 21. The mathematical operation can also be the principle of calculating the "sum of squares of errors". Other mathematical principles can also be applicable to this. As will be pointed out below, the resulting quality grade can be the basis for further processing the corresponding film unit 2 into a film product 3 or for discarding the film unit 2 from further processing.

[0054] The definition of evaluation data 19 which provides a more accurate representation of the deviation in question is evaluation data 19 which represents the deviation in the form of a displacement and / or rotation of the fluid structure 11 in the corresponding evaluation image 18 relative to the fluid structure 11 in the reference image 21. Figure 4 , a preferred way of generating those evaluation data 19 is shown by the sequence of rows I, II and III. Here and preferably, the evaluation data 19 are generated based on aligning the fluid structure 11 in the respective evaluation image 18 with the fluid structure 11 in the reference image 21, thereby determining the displacement and / or rotation of the fluid structure 11 in the respective evaluation image 18 relative to the fluid structure 11 in the reference image 21. It is further preferred that the deviation of the determination of the displacement and / or rotation of the fluid structure 11 is performed in an iterative process based on a greedy principle.

[0055] according to Figure 4 , as described above, the evaluation image 18.1 is subtracted from the reference image 21 in row I. Since the first result image 26 comprises a considerable number of pixels, the fluid structure 11 in the evaluation image 18.1 is shifted by Δx, which results in a modified evaluation image 18.2. Subtracting the modified evaluation image 18.2 from the reference image 21 produces a second result image 27, which comprises significantly fewer pixels than the first result image 26. From the pixel distribution in the second result image 27 in row II, the next iteration step of rotating the fluid structure 11 by the angle Δy can be derived, which results in a modified evaluation image 18.3. Subtracting the modified evaluation image 18.3 from the reference image 21 results in a third result image 28, which contains hardly any pixels. Therefore, the evaluation data 19 include information about the shift Δx and / or the rotation angle Δy of the evaluation image 18, which is necessary to reach the reference image 21 as closely as possible.

[0056] According to a further preferred embodiment, the evaluation data 19 represent deviations in the form of a skewness of the fluid structure 11 in the respective evaluation image 18 relative to the fluid structure 11 in the reference image 21 .

[0057] As a further preferred alternative, the evaluation data 19 represent deviations in the form of the presence of imperfections and / or structural defects of the fluid structure 11 in the respective evaluation image 18 relative to the fluid structure 11 in the reference image 21 .

[0058] Many other ways of representing deviations are possible by means of the evaluation data 19. For example, the evaluation data 19 may represent deviations of geometrical properties such as straightness, parallelism, distance, depth profile or the like.

[0059] Check Figure 4 If there are systematic error sources in the main production arrangement 9 , the corresponding deviations can be well marked in the corresponding evaluation images 18 , which easily allows an analysis.

[0060] Therefore, preferably, the marked images are displayed via a user interface (not shown). Alternatively or additionally, the corresponding deviations may be marked in the reference image 21. Finally, the corresponding deviations may be marked as separate images, which may be Figure 4 Any of the resulting images 26, 27, 28 depicted in .

[0061] It is generally possible that in an evaluation routine, a raw image 29 of the film unit 2 is generated by means of the sensor arrangement 16 , which represents the evaluation image 18 . In this case, the raw image 29 of the film unit 2 , which has not been substantially data-processed, represents the evaluation image 18 .

[0062] Here, however, it is preferred that the evaluation image 18 is extracted from the original image 29 of the film element 2, such as Figure 3 Here and preferably, the corresponding evaluation image 18 is extracted from the corresponding original image 29 by defining a frame 30 within the original image 29, which frame 30 defines the image boundary 22 of the evaluation image 18. Figure 3 As shown and preferably, the image boundary 22 of the evaluation image 18 is a rectangle whose upper and lower boundaries are defined relative to a first predefined image structure 31 in the original image 29 and whose left and right boundaries are defined relative to a second predefined image structure 32 in the original image 29. Figure 3 In FIG. 2 , the original image 29 comprises a substrate 33 which is not part of the web or sheet of film material and therefore is not part of the film unit 2 . Figure 3 The substrate 33 is shown to be wider than the roll or sheet 1 in the y direction, so that the substrate 33 can be Figure 3Here and preferably, the first predefined image structure 31 defines the upper and lower boundaries of the image boundary 22. Also preferably, the second predefined image structure 32 is formed by Figure 3 29 . The distances "a" and "b" shown in 29 represent. The distance "a" represents the distance from the left boundary of the image boundary 22 to the outer left side of the fluid structure 11, while the distance "b" represents the distance between the left boundary and the right boundary of the image boundary 22. It should be understood that the above definition of the image boundary 22 of the evaluation image 18 is only an example. It is important to note that the extraction of the evaluation image 18 from the original image 29 is systematically performed for each evaluation image 18 and therefore also for the reference image 21, wherein the reference image 21 is preferably based on a plurality of evaluation images 18 as described above.

[0063] Just as a matter of completeness it may be pointed out that the raw image 29 may be derived from the sensor data of the sensor arrangement 16 after standard filtering, conversion of the color space etc.

[0064] There are various ways in which the evaluation data 19 may be used. Firstly, preferably, the evaluation data 19 are used by the master production arrangement 9 to adapt the master machining routine. This is further preferably done by parameterizing the master production arrangement 9 based on the evaluation data 19 so as to minimize detected deviations between the corresponding evaluation image 18 and the reference image 21.

[0065] like Figure 2 As shown, in Figure 4 The operations performed in rows I, II and III of are performed in the evaluation unit 34 of the evaluation control 17, which generates the above-mentioned evaluation data 19 and stores these evaluation data in the evaluation data database 40. In the evaluation data database 40, each membrane unit 2 is assigned a corresponding evaluation data item.

[0066] According to another teaching of independent importance, a method is claimed for producing the above-mentioned film product 3 from the roll or sheet 1 of the above-mentioned film unit 2 by means of an auxiliary production arrangement 36. According to this teaching, the film unit 2 is produced as described above.

[0067] For this second teaching, it is necessary to process the web or sheet 1 of the film unit 2 in at least one auxiliary processing routine based on the above-mentioned evaluation data 19. The auxiliary production arrangement 36 is only Figure 2 Shown in. Figure 2It is also shown that the coils or sheets 1 of the film units 2 are transferred from the main production arrangement 9 to the auxiliary production arrangement 36. In addition, the above-mentioned evaluation data 19, which are each assigned to a specific film unit 2, are also transferred from the main production arrangement 9 to the auxiliary production arrangement 36 via a data carrier 37, such as a CD, USB stick, etc. and / or via an Internet connection, in particular a cloud server 38.

[0068] The auxiliary processing routines may be performed externally, in particular at the production plant 44 of a customer who purchased the membrane unit 2 to produce the final membrane product 3 by further processing the membrane unit 2, for example by filling, cutting and / or inserting into a housing 4. In this way, the membrane unit 2 is transformed into the final membrane product 3.

[0069] As a result, the auxiliary production arrangement 36 preferably adapts the auxiliary processing routines to the evaluation data 19 in order to support the production of an always identical film product 3 .

[0070] Typically, the main production arrangement 9 and the auxiliary production arrangement 36 are separated from each other. However, the two production arrangements 9, 36 can also be at least partially integrated with each other.

[0071] The evaluation data 19 may be a basis for adapting the auxiliary machining routine in different preferred ways. According to a preferred embodiment, the adaptation of the auxiliary machining routine is based on a quality grade indicating the degree of deviation represented by the evaluation data 19 .

[0072] The corresponding membrane unit 2 can therefore be discarded from further processing as described above.

[0073] Alternatively or additionally, the auxiliary processing routine comprises an auxiliary process step of cutting the film material 7 into a plurality of individual cut film units 2, each cut film unit comprising a fluid structure 11. Preferably, the cutting step is adapted to the deviations represented by the evaluation data 19, so that the film units 2 are identical in terms of their fluid structures 11.

[0074] Again, alternatively or additionally, the auxiliary processing routine comprises an auxiliary process step of filling the membrane material 7 with a biologically active material, such as an antibody, at predetermined locations on the membrane unit 2. Preferably, the filling of the membrane material 7 is adapted to the detected deviations so that, if necessary, the placement of the biologically active material relative to the fluid structure 11 is the same for each membrane unit 2.

[0075] The term "biologically active material" is intended to mean any molecule representing a chemical partner (e.g., an antigen) that specifically reacts, in particular binds, to a target molecule to be tested (e.g., an antibody). Exemplary biologically active materials are proteins, in particular antibodies or antigens, or hormones, in particular amino acid derivatives or human chorionic gonadotropin (hCG). As an example, the latter can be applied to home pregnancy test products.

[0076] The term "filling" includes any means of applying a biologically active material to a film product, for example by printing, with the purpose of fixing said biologically active material at a specific location.

[0077] The method of the present invention for producing a roll or sheet 1 of a membrane unit 2 can be applied in a biotechnological and / or medical context. Exemplary membrane units 2 used in a biotechnological and / or medical context are lateral flow test products, such as pregnancy test products, drug test products or COVID-19 test products. These test products require the filling of the membrane unit 2 with a biologically active material. Using the proposed method, the accuracy of the filling can be fundamentally improved. As a result, the required amount of biologically active material, which is a major cost factor in the production of lateral flow test products, can be reduced.

[0078] Preferably, the auxiliary processing routine includes an auxiliary process step of inserting the cut film unit 2 into the cassette housing, preferably into Figure 1 In the housing 4 shown. Further preferably, provision is made that the insertion cutout membrane unit 2 is adapted to the detected deviation so that the fluid structure 11 is aligned with the structure of the housing 4 (preferably the window 5 etc.).

[0079] According to another teaching, a method for evaluating a membrane unit 2 for a membrane product 3, such as a lateral flow test product, is claimed. Likewise, separate teachings relate to a main production arrangement 9 and an auxiliary production arrangement 36, each of which has independent importance. With regard to these three teachings, reference may be made to all explanations given to the previous teachings.

[0080] The method may be a method for evaluating a membrane unit 2 or a plurality of membrane units 2 for a membrane product 3, such as a lateral flow test product, wherein the membrane unit 2 comprises a fluid structure 11 for defining a fluid flow through a membrane material 7, the fluid structure being in particular a hydrophobic structure, which has been introduced into the membrane material 7, wherein an evaluation routine is performed with the aid of an evaluation arrangement 15 having a sensor arrangement 16 and an evaluation control 17. In the evaluation routine, an evaluation image 18 of the fluid structure 11 of the membrane unit 2 or of the plurality of membrane units 2 is generated with the aid of the sensor arrangement 16, and evaluation data 19 are generated with the aid of the evaluation control 17, and the evaluation data 19 represent deviations of the fluid structure 11 in the evaluation image 18 from predefined geometrical properties of the fluid structure 11 in the reference image 21.

[0081] Preferably, the proposed main production arrangement 9 comprises a processing tool 12, by means of which the above-mentioned fluid structure 11 in the form of a recessed structure, preferably in the form of a structure of channels 14, is introduced into the membrane material 7. Further preferably, the main production arrangement 9 comprises an evaluation arrangement 15 with a sensor arrangement 16 and an evaluation control 17, by means of which evaluation data 19 are generated as described above.

[0082] Preferably, the proposed auxiliary production arrangement 36 comprises a cutting arrangement (not shown) for performing the auxiliary process step of cutting the membrane material 7 into a plurality of single cut membrane units 2. Alternatively or additionally, the auxiliary production arrangement 36 preferably comprises a filling arrangement (not shown) for performing the auxiliary process step of filling the membrane material 7 with a biologically active material at predetermined locations on the membrane unit 2.

Claims

1. A method for producing rolls or sheets (1) of membrane units (2) for membrane products (3), such as lateral flow test products, from rolls or sheets of membrane material (7) by means of a main production arrangement (9), in, The coil or sheet (7) of the film material is processed into a coil or sheet (1) of a film unit (2) in the main processing routine, wherein, in the main processing routine, a fluid structure (11), in particular a hydrophobic structure, for defining a fluid flow through the membrane material (7) is introduced into the membrane material (7) by means of a processing tool (12) in order to produce the membrane unit (2), wherein an evaluation routine is performed by means of an evaluation arrangement (15) having a sensor arrangement (16) and an evaluation control (17), It is characterized in that In the evaluation routine, an evaluation image (18) of the fluid structure (11) of the membrane unit (2) is generated by means of the sensor arrangement (16), and evaluation data (19) are generated by means of the evaluation control (17), and the evaluation data (19) represent deviations of predefined geometrical properties of the fluid structure (11) in the respective evaluation image (18) relative to the fluid structure (11) in a reference image (21).

2. The method according to claim 1, characterized in that The evaluation images (18) each include an array of image data, each image data being assigned a position within a corresponding image boundary (22), preferably, the image data being pixel data, distance data or the like.

3. The method according to any one of the preceding claims, characterized in that The sensor arrangement (16) comprises at least one sensor (23) for generating the evaluation image (18), preferably, the at least one sensor (23) is an optical sensor, in particular a camera sensor, a laser sensor or the like.

4. The method according to any one of the preceding claims, characterized in that In a reference routine, the reference image (21) is defined based on the evaluation images (18) of a plurality of film units (2), preferably based on averaging the evaluation images (18) of the plurality of film units (2).

5. The method according to any one of the preceding claims, characterized in that The reference image (21) is an artificial image, in particular an image derived from planning data, in particular CAD data, of the main machining routine, and / or the reference image (21) defined from the evaluation image is compared with a reference image derived from planning data, in particular CAD data, of the main machining routine.

6. The method according to any one of the preceding claims, characterized in that The evaluation data (19) represent a quality level regarding the degree of deviation between the corresponding evaluation image (18) and the reference image (21), preferably, the quality level is defined based on applying a mathematical operation to the corresponding evaluation image (18) and the reference image (21), preferably, the principle of "sum of squared errors" is applied to the evaluation image (18) and the reference image (21).

7. The method according to any one of the preceding claims, characterized in that The evaluation data (19) represent deviations in the form of a displacement and / or rotation of the fluid structure (11) in the respective evaluation image (18) relative to the fluid structure (11) in the reference image (21).

8. The method according to claim 7, characterized in that Based on aligning the fluid structure (11) in the corresponding evaluation image (18) with the fluid structure (11) in the reference image (21), the evaluation data (19) are generated, and thereby the offset and / or rotation of the fluid structure (11) in the corresponding evaluation image (18) relative to the fluid structure (11) in the reference image (21) is determined. Preferably, the determination of the offset and / or rotation of the fluid structure (11) is performed in an iterative process, preferably based on a greedy principle.

9. The method according to any one of the preceding claims, characterized in that The evaluation data (19) represent deviations in the form of a skewness of the fluid structure (11) in the respective evaluation image (18) relative to the fluid structure (11) in the reference image (21).

10. The method according to any one of the preceding claims, characterized in that The evaluation data (19) represent deviations in the form of the presence of imperfections and / or structural defects of the fluid structure (11) in the respective evaluation image (18) relative to the fluid structure (11) in the reference image (21).

11. The method according to any one of the preceding claims, characterized in that The deviations are marked in the respective evaluation image (18) and / or the reference image (21) and / or in a separate image, and the marked images are preferably displayed via a user interface.

12. The method according to any one of the preceding claims, characterized in that In the evaluation routine, a raw image (29) of the membrane unit (2) is generated by means of the sensor arrangement (16) which represents the evaluation image (18).

13. The method according to claim 12, characterized in that In the evaluation routine, a raw image (29) of the membrane unit (2) is generated with the aid of the sensor arrangement (16), wherein the evaluation image (18) is extracted from the sensor arrangement (16), preferably, the respective evaluation image (18) is extracted from the respective raw image (29) by defining a frame (30) within the raw image (29), the frame being an image boundary (22) of the evaluation image (18), further preferably, the image boundary (22) is a rectangle, the upper and lower boundaries of the image boundary are defined relative to a first predefined image structure (31) in the raw image (29), and the left and right boundaries of the image boundary are defined relative to a second predefined image structure (32) in the raw image (29).

14. The method according to any one of the preceding claims, characterized in that The evaluation data (29) are used by the master production arrangement (9) to adapt the master machining routine, preferably the master production arrangement (9) being parameterized based on the evaluation data (19) so as to minimize detected deviations between the respective evaluation image (18) and the reference image (21).

15. A method for producing a membrane product, such as a lateral flow test product, from a roll or sheet (1) of membrane elements (2) with the aid of an auxiliary production arrangement (36), the membrane element (2) having been produced according to the method of any of the preceding claims, characterised in that Based on the evaluation data (19), the roll or sheet (1) of the film unit (2) is processed in at least one auxiliary processing routine.

16. The method according to claim 15, characterized in that The auxiliary production arrangement (36) adapts the auxiliary processing routine to the evaluation data (19) in order to support the production of the same film product (3).

17. The method according to claim 15 or 16, characterized in that Depending on the detected quality grade, which indicates the maximum permissible degree of deviation, the corresponding membrane unit (2) can be discarded from further processing.

18. The method according to any one of claims 15 to 17, characterized in that: The auxiliary processing routine comprises an auxiliary process step of cutting the film material (7) into a plurality of single cut film units (2), each of which comprises a fluid structure (11), preferably, the cutting step being adapted to the detected deviation so that the film units (2) are identical in terms of the fluid structure (11) of the corresponding film units (2).

19. The method according to any one of claims 15 to 18, characterized in that The auxiliary processing routine comprises an auxiliary process step of filling the membrane material (7) with a bioactive material such as an antibody at a predetermined position on the membrane unit (2), preferably, the filling of the membrane material (7) is adapted to the detected deviation so that the placement of the bioactive material relative to the fluid structure (11) is the same for each membrane unit (2).

20. The method according to claim 15 or 19, characterized in that The auxiliary processing routine includes an auxiliary process step of inserting the incision membrane unit (2) into the housing (4), preferably, inserting the incision membrane unit (2) adapted to the detected deviation so that the fluid structure (11) is aligned with the structure of the housing (4), preferably the window (5) and the like.

21. A method for evaluating a membrane unit (2) for a membrane product (3), such as a lateral flow test product, wherein: The membrane unit (2) comprises a fluid structure (11), in particular a hydrophobic structure, for defining a fluid flow through the membrane material (7), the fluid structure having been introduced into the membrane material (7), wherein an evaluation routine is performed by means of an evaluation arrangement (15) having a sensor arrangement (16) and an evaluation control (17), It is characterized in that In the evaluation routine, an evaluation image (18) of the fluid structure (11) of the membrane unit (2) is generated by means of the sensor arrangement (16), and evaluation data (19) are generated by means of the evaluation control (17), and the evaluation data (19) represent deviations of predefined geometrical properties of the fluid structure (11) in the evaluation image (18) relative to the fluid structure (11) in the reference image (21).

22. A main production arrangement for carrying out the method according to any one of claims 1 to 14 for producing rolls or sheets (1) of membrane units (2) from rolls or sheets of membrane material (7).

23. An auxiliary production arrangement for carrying out the method according to any one of claims 15-20 for producing a membrane product (3), such as a lateral flow test product, from a roll or sheet (1) of membrane units (2).

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