Method for manufacturing a roll of a membrane unit

Abstract

The present invention relates to a method for manufacturing a roll (1) or sheet of a membrane unit (2) for a membrane product (3), such as a lateral flow test, from a roll (6) or sheet of a membrane material (7) by means of a primary manufacturing arrangement (9), wherein the roll (6) or sheet of the membrane material (7) is processed into the roll (1) or sheet of the membrane unit (2) in a primary processing routine, and in the primary processing routine for generating the membrane unit (2), a fluid structure (11), in particular a hydrophobic structure, for defining the flow of fluid through the membrane material (7) is introduced into the membrane material (7) by a processing tool (12), and the evaluation routine is carried out by an evaluation arrangement (15) comprising 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) is generated by the sensor arrangement (16), evaluation data (19) is generated by the evaluation control (17), and it is proposed that the evaluation data (19) represents the deviation of the predetermined geometric characteristics of the fluid structure (11) in each evaluation image (18) with respect to the fluid structure (11) in a reference image (21).

Description

Technical Field

[0001] The present invention relates to a method for manufacturing a roll or sheet of a membrane unit for a membrane product, such as a lateral flow test, according to the general part of claim 1, a method for manufacturing a membrane product from a roll of such a membrane unit according to claim 15, a method for evaluating a membrane unit for a membrane product, such as a lateral flow test, according to the general part of claim 21, a primary manufacturing arrangement according to claim 22, and a secondary manufacturing arrangement according to claim 23.

Background Art

[0002] Membrane units are part of membrane products and are often designed as lateral flow tests. These lateral flow tests are simple assays used to detect target analytes in liquid samples (such as saliva, blood, urine, etc.). A common example of a lateral flow assay is a home pregnancy test.

[0003] A known membrane unit and its manufacturing method (EP3171169A1), which is the starting point of the present invention, serves to provide a fluid structure in the form of a recessed structure by a processing tool. The fluid structure includes channels for separating flow paths.

Summary of the Invention

[0004] In order to achieve high reproducibility in fluid management, it is necessary to realize the arrangement of the fluid structure with high precision. In the known method, this precision is supported by detecting reference points on or outside the boundary of the membrane unit based on a camera.

[0005] The known method is the simplest to implement, but it cannot prevent positioning errors that occur after the detection of the reference points. The positioning error of the processing tool for introducing the fluid structure into the membrane material cannot be detected.

Problems to be Solved by the Invention

[0006] Accordingly, an object of the present invention is to detect a deviation from a predetermined geometric characteristic of a fluid structure with a small hardware investment.

Means for Solving the Problem

[0007] The above problem is solved by a method for manufacturing a roll or sheet of a membrane unit according to the general part of claim 1 having the characteristics of the characteristic part of claim 1.

[0008] First, according to the present invention, the proposed method according to the first teaching is carried out by a primary manufacturing arrangement. A roll or sheet of membrane material is processed into a roll or sheet of membrane unit in a primary processing routine. In the primary processing routine for generating the membrane unit, the above-described fluid structure, particularly the hydrophobic structure, for defining the flow of fluid through the membrane material is introduced into the hydrophilic membrane material by a processing tool, and the evaluation routine is carried out by an evaluation arrangement having a sensor arrangement and an evaluation control.

[0009] The basic idea of the present invention is to directly detect a deviation from a predetermined geometric characteristic of a fluid structure by directly generating an evaluation image of the fluid structure. According to this, it is the fluid structure itself that is measured in consideration of the above deviation. The detected deviation may be the basis of a feedback loop for improving the accuracy of future manufacture of the membrane unit. Alternatively, or additionally, the detected deviation may also be the basis for adaptation of subsequent processing steps.

[0010] More specifically and most importantly, in the evaluation routine, an evaluation image of the fluid structure of the membrane unit is generated by the sensor arrangement, evaluation data is generated by the evaluation control, and this evaluation data represents the deviation of the predetermined geometric characteristics of the fluid structure in the evaluation image from the fluid structure in the reference image.

[0011] Therefore, the detection of deviations is performed based on the generation of evaluation data generated based on the correlation between each evaluation image and the reference image. The reference image preferably represents the content of the evaluation image of a predetermined membrane unit having a desired predetermined geometric characteristic.

[0012] As a result, the proposed method not only accurately detects deviations from the predetermined geometric characteristics of the fluid structure. Also, since the evaluation image is based on a simple reflection with respect to the reference image, it can also be executed with a minimum hardware investment.

[0013] The evaluation image generally includes an array of image data according to claim 2 and may be generated by an optical sensor such as a camera sensor according to claim 3. The term "image data" should be understood in a broad sense, and according to a modification of claim 2, the image data may be pixel data including information regarding intensity and / or color. The information regarding intensity is described by a continuous variable or a binary variable. In another modification, the image data may be distance data or the like.

[0014] According to claim 4, the reference image is preferably generated by a reference routine, for example, based on the averaging of evaluation images of a number of membrane units. The idea here is to derive the reference image from the already generated evaluation data rather than from CAD data. Advantageously, when the original data of the fluid structure for defining the flow of the fluid through the membrane unit or membrane material to be tested is not available, a reference image based on an averaging-based reference routine is used.

[0015] Furthermore, this reference image can be usefully used in a method for determining the relative spread of deviations regarding different geometric dimensions, or in a process related to the arrangement of the membrane unit or fluid structure within the housing of the final membrane product, or the arrangement of components (reagents, labeling substances, antibodies, etc.) on the fluid structure. Therefore, the reference image can be used, for example, when setting up or adjusting a machine for inserting each membrane unit into its respective housing or post-processing (such as impregnation) the fluid structure.

[0016] Since CAD data is always subject to systematic error and thus prone to the influence of systematic error as there is always a discrepancy remaining between the model and the real world, it has been proven that higher accuracy can be obtained for such applications with this reference image. However, despite many advantages and beneficial uses, it should be noted that in certain evaluation applications, this reference image may not be very suitable because the systematic error is not immediately detected and large positive or negative deviations are corrected.

[0017] Therefore, alternatively, according to claim 5, the reference image may be an artificial image derived (directly) especially from CAD data. The CAD data may include model geometry, derived geometry and metadata. The CAD data may be 2D or 3D, composed of wireframe, solid surfaces, and / or represented by polygons or voxels. The CAD data may include base splines or analytical geometries and gaps between surfaces, and the format may be ASCII or binary. It may include PMI and UDA data, and output the data in a sharable format such as 3D PDF or WebGL so that anyone can view it with a 3D viewer.

[0018] With this extraction method, for example, the reference image can preferably be derived directly. With this embodiment, for example, it becomes possible to detect systematic errors and discrepancies in the machine setup and respond to them immediately. Therefore, for example, defective products and waste can be avoided because it is not necessary to manufacture the entire roll or sheet first to determine whether there are errors. Another possibility is to compare the reference image generated from the evaluation image with the CAD data to check whether the reference image complies sufficiently with the plan.

[0019] This can be used, for example, to detect missing structures. Furthermore, this allows errors to be logged during the manufacturing process. A reference image generated from actual data (an averaging-based reference image) is advantageous, for example, when the relative spread of deviations is important, but using a CAD-based reference image allows the absolute spread to be easily checked.

[0020] Claims 6 to 10 relate to preferred variants regarding the definition of evaluation data. Claim 6 defines the degree of deviation between the evaluation image and the reference image, while Claims 7 to 10 each relate to the deviation in specific geometric features. According to Claims 7 and 8, the evaluation data represents the deviation in the form of a shift and / or rotation of the fluid structure in each evaluation image relative to the fluid structure in the reference image. This shift and / or rotation deviation can serve as the basis for the adaptation of previous or subsequent processing steps.

[0021] According to Claim 11, the detected deviations are also marked on the respective evaluation images and / or reference images, simplifying the diagnosis of the cause of the deviation.

[0022] Claims 12 and 13 are directed to a preferred method for deriving the evaluation image. In particular, it is preferred that the evaluation image is obtained from the raw image by performing a cropping step. In this way, the raw image is reduced by image information that is not used for the generation of the evaluation data.

[0023] Claim 14 proposes the above feedback loop. This measure can minimize the detected deviation if such adaptation is possible in the primary manufacturing arrangement. However, it may also be possible to leave the deviation as it is and adapt subsequent processing steps so that the deviation is fully compensated.

[0024] The second teaching according to claim 15 is independently important and is so claimed, and relates to a method of manufacturing the membrane product such as a lateral flow test from a roll or sheet of the membrane unit.

[0025] In this second teaching, it is essential that the belt or sheet of the membrane unit is processed by at least one secondary processing routine based on evaluation data. Preferably, the evaluation data is used to adapt at least one secondary processing routine, and more preferably, is used to support the manufacture of the same membrane product (claim 16). In other words, the evaluation data generated within the method according to the first teaching is applied to the method according to the second teaching.

[0026] Claims 17 to 20 relate to preferred variants of the secondary processing routine. Claim 17 relates to a simple measure to improve the accuracy of the membrane product by discarding the membrane unit in which a predetermined degree of deviation is detected.

[0027] Alternatively or additionally, claims 18 to 20 show measures to improve the accuracy of the membrane product by parameterizing the secondary processing routine. Particularly advantageous is that by applying the method for manufacturing a roll or sheet of the membrane unit, the filling accuracy of the bioactive material into the membrane unit (claim 19) can be fundamentally increased, saving bioactive materials such as antibodies, and since bioactive materials are usually a major cost factor in lateral flow test manufacturing, the cost can be reduced.

[0028] The latter measure is more complex to implement, but results in a relatively small amount of membrane units being discarded and high-precision results. Another teaching according to claim 21 is likewise independently important and is directed to a method of evaluating the membrane unit of the membrane product, and this method has already been described with respect to the first teaching. All the explanations given with respect to the first teaching are fully applicable to this third teaching.

[0029] According to claims 22 and 23, a primary manufacturing arrangement for executing a method according to the first teaching and a secondary manufacturing arrangement for executing a method according to the second teaching are so claimed. All the explanations given for the first two teachings are fully applicable.

Brief Description of the Drawings

[0030] Hereinafter, embodiments of the present invention will be described with reference to the drawings.

Figure 1

Figure 2

Figure 3

Figure 4

[0031] The proposed method serves to manufacture a roll (not shown) or a sheet 1 of a membrane unit 2 for a membrane product 3 such as a lateral flow test. Such a membrane product 3 is shown in an exploded view in FIG. 1a. The membrane product 3 is composed of a housing 4 provided with a window 5 and a sample pad 6 made of a porous material, and guides a sample liquid L from an inlet point P to the membrane unit 2.

[0032] The membrane unit 2 is manufactured from a roll or a sheet of a membrane material 7 applied to a membrane carrier 8. Here, the membrane material 7 is a hydrophilic, preferably porous material such as nitrocellulose. Such a membrane material 7 leads to a consistent lateral suction of samples and reagents by capillary force. The membrane carrier 8 is preferably made of a hydrophobic material.

[0033] The proposed manufacture of the roll or sheet 1 of the membrane unit 2 is carried out by the primary manufacturing arrangement 9 shown at the bottom of Figure 2. According to the proposed method, the roll or sheet of the membrane material 7 is processed into the roll or sheet 1 of the membrane unit 2 in a primary processing routine. Here, preferably, it is preferable to process the roll, although it is not explicitly shown in the drawings. In contrast to each roll, each sheet is basically provided in a planar shape.

[0034] Here, preferably, all controllable components of the primary manufacturing arrangement 9 are controlled by the electronic process control 10. In the primary processing routine for generating the membrane unit 2, a fluid structure 11, particularly a hydrophobic structure, defining the flow of fluid through the membrane material 7, is introduced into the membrane material 7 by the processing tool 12. The fluid structure 11 preferably defines a flow path 13 through which the flow of fluid through the membrane material 7 is induced.

[0035] Preferably, the fluid structure 11 is a recessed structure which here takes the form of the structure of the channel 14. Figures 1b, c show such a fluid structure 11 of the channel 14. Here, preferably, each flow path 13 is defined by the channel 14 representing the lateral boundaries of each flow path 13.

[0036] Alternatively, the channel 14 can be replaced by other structures within the membrane material 7 suitable for defining the flow path 13. For example, the membrane material 7 preferably includes regions having hydrophobic properties as the boundaries of the flow path 13. These regions may be regions filled with polymer or regions where the polymer is enhanced.

[0037] The processing tool 12 can operate based on various principles such as mechanical, chemical, or optical principles. Such mechanical and chemical principles preferably include printing and / or chemical etching. Based on the optical operating principle, applications such as laser etching and laser-induced photopolymerization are preferred, for example. For all these principles, it is important that the resulting fluid structure 11 can be detected by the evaluation arrangement 15 as described below.

[0038] The evaluation arrangement 15 is provided with a sensor arrangement 16 and an evaluation control 17. The evaluation arrangement 15 serves to execute an evaluation routine. What is important for the present invention is that in the evaluation routine, an evaluation image 18 of the fluid structure 11 of the membrane unit 2 is generated by the sensor arrangement 16.

[0039] Furthermore, in the present invention, it is important that evaluation data 19 is generated by the evaluation control 17, and the evaluation data 19 represents a deviation 20 of a predetermined geometric characteristic of the fluid structure 11 of the evaluation image 18 with respect to the fluid structure of the reference image 21.

[0040] For the sake of simplicity in explaining the present invention, the actual fluid structure shown in FIG. 2 and the fluid structures in the respective evaluation images 18 are each indicated by the reference number 11.

[0041] Generally, each evaluation image 18 is composed of an array of image data to which positions within respective image boundaries 22 are assigned. This array is a one-dimensional, two-dimensional, or three-dimensional array. The image data may be pixel data including intensity information and / or color information, distance data, etc. Therefore, the sensor arrangement 16 includes at least one sensor 23, preferably exactly one sensor 23, to generate the evaluation image 18.

[0042] More preferably, at least one sensor 23 is an optical sensor, particularly a 2D camera sensor or a 3D camera sensor. Alternatively, the optical sensor may be a laser sensor capable of providing the above-described distance information. This distance information usually refers to the distance in a direction perpendicular to the surface of the membrane unit 2, and here preferably refers to the distance in the Z direction shown in FIG. 2. Based on this distance information, it is possible to evaluate whether the structure of the fluid structure 11, here preferably the channel 14, has a desired depth profile.

[0043] There are various methods for generating the reference image 21. In the reference routine, it is desirable to define the reference image 21 from the evaluation images 18 of a plurality of membrane units 2. In a particularly preferred embodiment, the reference image 21 is defined based on the image information of the evaluation images 18 of a plurality of membrane units 2, preferably the averaging of pixel data as described above.

[0044] Image averaging is a digital image processing technique often used particularly to improve images damaged by random noise or errors. The algorithm used for image averaging operates by calculating the average or arithmetic mean of the intensity values of each pixel position or pixel group within a set of evaluation images 18 of a number of membrane units 2. Thus, this method serves to remove errors / noise while retaining features, targeting only the pixels that meet some effectiveness criterion.

[0045] FIG. 2 shows that the sensor arrangement 16 transmits sensor data to the image unit 24 of the evaluation control 17, the image unit 24 generates the reference image 21, and the reference image 21 is stored in the reference image database 25.

[0046] Interestingly, the reference image 21 is generated from the evaluation image 18 based on the actual membrane unit 2 with the actual fluid structure 11. Therefore, it is not necessary to rely on CAD data for the generation of the reference image 21, nor is it the intention here. As described above, CAD data is always offset from the geometric properties of the real world and may induce undesirable systematic errors in the evaluation data.

[0047] Alternatively, the reference image 21 may be an artificial image, particularly an image derived from the planning data of the primary processing routine, particularly CAD data. This allows the detection and correction of the above systematic errors.

[0048] Furthermore, the reference image 21 defined from the evaluation image may be compared with the reference image derived from the planning data of the primary processing routine, particularly CAD data. In this embodiment, by checking whether the reference image 21 generated from the real image is sufficiently good and using that reference image 21, the advantages of the real image and the artificial image can be combined.

[0049] Depending on the application, the evaluation data 19 can be generated in various ways. In a simple approach, the evaluation data 19 represents the deviation between each evaluation image 18 and the reference image 21. If these images 18, 21 are identical, the degree of deviation is 0%. Therefore, a low degree of deviation means a high quality grade of the membrane unit 2.

[0050] Figure 4 shows the generation of the evaluation data 19 based on the evaluation image 18 shown in Figure 3. Note in Figures 3 and 4 that for ease of understanding, the fluid structure 11 is assumed to be represented by a thick optically detectable structure of the flow path 13. However, as shown in Figure 1, the fluid structure 11 can also be detected based on geometric properties such as the channel 14. The proposed method can be applied to any detectable fluid structure 11.

[0051] In row I of FIG. 4, each evaluation image 18.1 is subtracted from the reference image 21, leading to the result image 26. The quality grade is derived from the degree of remaining pixels in the result image 26. For example, the more remaining pixels there are, the lower the quality of each film unit 2. Preferably, the quality grade is defined by applying a mathematical operation that compares each evaluation image 18 with the reference image 21.

[0052] This mathematical operation is considered to be the principle of calculating the "total sum of squared errors". Other mathematical principles can also be applied here. As will be described later, the obtained quality grade may serve as a criterion for further processing each film unit 2 into a film product 3 or discarding the film unit 2 from further processing.

[0053] The definition of the evaluation data 19 that more accurately represents the deviation of the problem is the evaluation data 19 that represents the deviation in the form of the shift and / or rotation of the fluid structure 11 in each evaluation image 18 with respect to the fluid structure 11 in the reference image 21. A preferred method for generating these evaluation data 19 is shown in the order of rows I, II, and III in FIG. 4.

[0054] Here, preferably, the evaluation data 19 is generated based on aligning the fluid structure 11 in each evaluation image 18 with the fluid structure 11 in the reference image 21, thereby determining the shift and / or rotation of the fluid structure 11 in each evaluation image 18 with respect to the fluid structure 11 in the reference image 21. More preferably, the determination of the deviation of the shift and / or rotation of the fluid structure 11 is performed by an iterative process based on the greedy principle.

[0055] According to FIG. 4, the evaluation image 18.1 is subtracted from the reference image 21 as described above. Since the first result image 26 contains a considerable number of pixels, the fluid structure 11 in the evaluation image 18.1 is shifted by Δx, leading to the modified evaluation image 18.2. Subtracting the modified evaluation image 18.2 from the reference image 21 generates a second result image 27 composed of significantly fewer pixels than the first result image 26.

[0056] From the pixel distribution of the second result image 27 in row II, the next iterative step of rotating the fluid structure 11 by an angle Δγ can be derived, which leads to the modified evaluation image 18.3. Subtracting the modified evaluation image 18.3 from the reference image 21 generates a third result image 28 that contains few pixels. Therefore, the evaluation data 19 is composed of information regarding the shift by Δx and / or rotation by the angle Δγ of the evaluation image 18 required to approach the reference image 21 as closely as possible.

[0057] According to another preferred embodiment, the evaluation data 19 represents the deviation in the form of the distortion degree of the fluid structure 11 in each evaluation image 18 with respect to the fluid structure 11 in the reference image 21.

[0058] As another preferred alternative, the evaluation data 19 represents the deviation in the form of the imperfection and / or the presence of structural defects of the fluid structure 11 in each evaluation image 18 with respect to the fluid structure 11 in the reference image 21.

[0059] Many other approaches of representing the deviation by the evaluation data 19 are possible. For example, the evaluation data 19 can represent the deviation in geometric characteristics such as linearity, parallelism, distance, depth profile, etc.

[0060] Looking at the result images 26, 27, 28 in rows I, II, and III of FIG. 4, it becomes clear that each deviation is marked in each evaluation image 18, whereby it is possible to easily analyze whether there is a cause of systematic error in the primary manufacturing arrangement 9.

[0061] Therefore, the marked image is preferably displayed via a user interface (not shown). Alternatively, or additionally, each deviation may be marked on the reference image 21. Finally, each deviation is marked as a separate image and becomes one of the result images 26, 27, 28 shown in FIG. 4.

[0062] Generally, in the evaluation routine, it is possible for the raw image 29 of the membrane unit 2 representing the evaluation image 18 to be generated by the sensor arrangement 16. In this case, the raw image 29 of the membrane unit 2 that has not been substantially processed represents the evaluation image 18.

[0063] However, here, preferably, the evaluation image 18 is extracted from the raw image 29 of the membrane unit 2 as shown in FIG. 3. Here, preferably, each evaluation image 18 is extracted from the respective raw image 29 by defining a frame 30 within the raw image 29, and this frame 30 defines the image boundary 22 of the evaluation image 18.

[0064] As shown in FIG. 3, also preferably, the image boundary 22 of the evaluation image 18 is rectangular, and its upper and lower boundaries are defined with respect to a first predetermined image structure 31 within the raw image 29, and its left and right boundaries are defined with respect to a second predetermined image structure 32 within the raw image 29. In FIG. 3, the raw image 29 includes a substrate 33 that is not part of the roll or sheet of the membrane material and thus not part of the membrane unit 2 either.

[0065] FIG. 3 shows that the substrate 33 may be detected as a beam that is wider in the y - direction than the roll or sheet 1, such that the substrate 33 extends above and below the roll or sheet 1 in FIG. 3. Here, preferably, the first predetermined image structure 31 defines the upper and lower limits of the image boundary 22. Alternatively preferably, the second predetermined image structure 32 is represented by the distances "a" and "b" shown in FIG. 3. The distance "a" represents the distance from the left - hand boundary of the image boundary 22 to the outer left - hand side of the fluid structure 11, and the distance "b" represents the distance between the left - hand and right - hand boundaries of the image boundary 22.

[0066] It should be noted that the above definition of the image boundary 22 of the evaluation image 18 is merely an example. What is important is that the extraction of the evaluation image 18 from the raw image 29 is carried out systematically for each evaluation image 18, and as a result, preferably, it is also carried out for the reference image 21 based on a plurality of evaluation images 18 as described above.

[0067] To achieve perfection, it should be noted that the raw image 29 may be derived from the sensor data of the sensor arrangement 16 after performing standard filtering, color space conversion, etc.

[0068] There are various ways to use the evaluation data 19. First of all, it is preferable that the evaluation data 19 is used to adapt the primary processing routine by the primary manufacturing arrangement 9. More preferably, this is done by parameterizing the primary manufacturing arrangement 9 based on the evaluation data 19 in order to minimize the detected deviation between each evaluation image 18 and the reference image 21.

[0069] As shown in FIG. 2, the operations performed in rows I., II., and III. of FIG. 4 are executed by the evaluation unit 34 of the evaluation control 17. The evaluation unit 34 generates the above-mentioned evaluation data 19 and stores those evaluation data in the evaluation data database 40. In the evaluation data database 40, each evaluation data item is assigned to each film unit 2.

[0070] According to another important teaching independently, a method of manufacturing the above-mentioned film product 3 from the roll or sheet 1 of the film unit 2 by the secondary manufacturing arrangement 36 is thus claimed. According to this teaching, the film unit 2 is manufactured as described above.

[0071] In this second teaching, it is important that the roll or sheet 1 of the film unit 2 is processed by at least one secondary processing routine based on the above-mentioned evaluation data 19. The secondary manufacturing arrangement 36 is only shown in FIG. 2. FIG. 2 also shows that the roll or sheet 1 of the film unit 2 is transferred from the primary manufacturing arrangement 9 to the secondary manufacturing arrangement 36.

[0072] Furthermore, the above-described evaluation data 19, which are respectively assigned to the specific membrane units 2, are also transferred from the primary manufacturing arrangement 9 to the secondary manufacturing arrangement 36 via a data carrier 37 such as a CD, a USB stick, and / or via an Internet connection, in particular via a cloud server 38.

[0073] The secondary processing routine can be executed externally, in particular at the manufacturing plant 44 of the customer who purchased the membrane unit 2, to further process the membrane unit 2 to produce the final membrane product 3, for example by filling, cutting, and / or inserting into the housing 4. In this way, the membrane unit 2 is converted into the final membrane product 3.

[0074] As a result, it is preferable for the secondary manufacturing arrangement 36 to adapt the secondary processing routine to the evaluation data 19 in order to always support the production of the same membrane product 3.

[0075] Generally, the primary manufacturing arrangement 9 and the secondary manufacturing arrangement 36 are separated from each other. However, these two manufacturing arrangements 9, 36 may be at least partially integrated with each other.

[0076] The evaluation data 19 may serve as a basis for adapting the secondary processing routine in various preferred ways. According to a preferred embodiment, the adaptation of the secondary processing routine is performed based on a quality grade indicating the degree of deviation represented by the evaluation data 19. As a result, each membrane unit 2 may be discarded from further processing as described above.

[0077] Alternatively or additionally, the secondary processing routine includes a secondary processing step of cutting the membrane material 7 into individual cut-out membrane units 2 each including a fluid structure 11. Preferably, this cutting step is adapted to the deviation represented by the evaluation data 19 such that the membrane units 2 are identical from the perspective of the fluid structure 11 of each membrane unit 2.

[0078] Alternatively, or additionally, the secondary treatment routine includes a secondary treatment step of filling the membrane material 7 at a predetermined position on the membrane unit 2 with a bioactive material such as an antibody. Preferably, the filling of the membrane material 7 is adapted according to the detected deviation, and if necessary, the placement of the bioactive material with respect to the fluid structure 11 is made the same for each membrane unit 2.

[0079] The term "bioactive material" means a molecule that represents a chemical partner (such as an antigen) that specifically reacts, particularly binds, with a target molecule (such as an antibody) to be tested. Representative bioactive materials are proteins, particularly antibodies or antigens, or hormones, particularly amino acid derivatives or human chorionic gonadotropin (hCG). As an example, the latter can be applied to home pregnancy tests.

[0080] The term "filling" includes any measure of applying a bioactive material onto a membrane product, for example by printing, for the purpose of fixing the bioactive material at a specific position.

[0081] The method of the present invention for manufacturing the roll or sheet 1 of the membrane unit 2 is applicable in the fields of biotechnology and / or medicine. Examples of membrane units 2 used in the fields of biotechnology and / or medicine include lateral flow tests such as pregnancy tests, drug tests, or COVID-19 tests. In these tests, it is necessary to fill the membrane unit 2 with a bioactive material. By using the proposed method, the accuracy of filling can be fundamentally improved. As a result, the required amount of bioactive material, which is a major cost factor in the manufacture of lateral flow tests, can be reduced.

[0082] Preferably, the secondary treatment routine includes a secondary treatment step of inserting the cut-out membrane unit 2 into a cartridge housing, preferably the housing 4 shown in FIG. 1. More preferably, the insertion of the cut-out membrane unit 2 is performed in accordance with the detected deviation such that the fluid structure 11 is aligned with the structure of the housing 4, preferably a window 5 or the like.

[0083] According to another teaching, a method for evaluating a membrane unit 2 for a membrane product 3, such as a lateral flow test, is claimed as such. Here too, separate teachings are directed to the primary manufacturing arrangement 9 and the secondary manufacturing arrangement 36, each having independent importance. For these three teachings, all the explanations given in the previous teachings can be referred to.

[0084] The method may be a method for evaluating a membrane unit 2 or a plurality of membrane units 2 of a membrane product 3, the membrane unit 2 including a fluid structure 11 for defining a flow of fluid through the membrane material 7, in particular a hydrophobic structure introduced into the membrane material 7, and the evaluation routine is performed by an evaluation arrangement 15 comprising a sensor arrangement 16 and an evaluation control 17.

[0085] In the evaluation routine, an evaluation image 18 of the fluid structure 11 of the membrane unit 2 or the membrane unit 2 is generated by the sensor arrangement 16, and evaluation data 19 is generated by the evaluation control 17, the evaluation data 19 representing the deviation of the predetermined geometric characteristics of the fluid structure 11 in the evaluation image 18 from the fluid structure 11 in the reference image 21.

[0086] Preferably, the proposed primary manufacturing arrangement 9 includes a processing tool 12, whereby the above-mentioned fluid structure 11 in the form of a recess structure, preferably in the form of the structure of the channel 14, is introduced into the membrane material 7. More preferably, the primary manufacturing arrangement 9 includes an evaluation arrangement 15 comprising a sensor arrangement 16 and an evaluation control 17, whereby the evaluation data 19 is generated as described above.

[0087] The proposed secondary manufacturing arrangement 36 preferably includes a cutting arrangement (not shown) for performing a secondary processing step of cutting the membrane material 7 into a single cut-out membrane unit 2. Alternatively or additionally, the secondary manufacturing arrangement 36 preferably includes a filling arrangement (not shown) for performing a secondary processing step of filling the membrane material 7 with a bioactive material at a predetermined position on the membrane unit 2.

Claims

1. A method for manufacturing a roll or sheet (1) of a membrane unit (2) for a membrane product (3), such as a lateral flow test, from a roll or sheet of a membrane material (7) by a primary manufacturing arrangement (9), comprising: The roll or sheet of the membrane material (7) is processed into the roll or sheet (1) of the membrane unit (2) in a primary processing routine. In a primary processing routine for generating the membrane unit (2), a fluid structure (11), particularly a hydrophobic structure, for defining the flow of fluid through the membrane material (7) is introduced into the membrane material (7) by a processing tool (12), and an evaluation routine is executed by an evaluation arrangement (15) comprising 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) is generated by the sensor arrangement (16), evaluation data (19) is generated by the evaluation control (17), and the evaluation data (19) represents the deviation of the geometric characteristics of the fluid structure (11) in each evaluation image (18) from the fluid structure (11) in a reference image (21). The method as described above.

2. The method according to claim 1, characterized in that each evaluation image (18) comprises an array of image data with positions within respective image boundaries (22) assigned thereto, and preferably the image data is pixel data, distance data, etc.

3. The method according to claim 1 or 2, characterized in that the sensor arrangement (16) comprises at least one sensor (23) for generating the evaluation image (18), and preferably the at least one sensor (23) is an optical sensor, particularly a camera sensor, a laser sensor, etc.

4. The method according to any one of claims 1 to 3, characterized in that in a reference routine, a reference image (21) is defined from the evaluation images (18) of a plurality of membrane units (2), and preferably the reference image (21) is defined based on the averaging of the evaluation images (18) of a plurality of membrane units (2).

5. The method according to any one of claims 1 to 4, characterized in that the reference image (21) is an artificial image, particularly an image derived from the planning data of the primary processing routine, particularly CAD data, and / or the reference image (21) defined from the evaluation images is compared with a reference image obtained from the planning data of the primary processing routine, particularly CAD data.

6. The evaluation data (19) represents a quality grade regarding the degree of deviation between each evaluation image (18) and the reference image (21), and preferably, the quality grade is defined by applying a mathematical operation to each evaluation image (18) and the reference image (21), and preferably, the principle of "total sum of squared errors" is applied to the evaluation image (18) and the reference image (21), the method according to any one of claims 1 to 5.

7. The method according to any one of claims 1 to 6, characterized in that the evaluation data (19) represents a deviation in the form of a shift and / or rotation of the fluid structure (11) in each evaluation image (18) with respect to the fluid structure (11) in the reference image (21).

8. The evaluation data (19) is generated based on aligning the fluid structure (11) in each evaluation image (18) with the fluid structure (11) in the reference image (21), thereby determining a shift and / or rotation of the fluid structure (11) in each evaluation image (18) with respect to the fluid structure (11) in the reference image (21), and preferably, the determination of the shift and / or rotation of the fluid structure (11) is performed by an iterative process, preferably based on the greedy principle, the method according to claim 7.

9. The method according to any one of claims 1 to 8, characterized in that the evaluation data (19) represents a deviation in the form of the skewness of the fluid structure (11) in each evaluation image (18) with respect to the fluid structure (11) in the reference image (21).

10. The method according to any one of claims 1 to 9, characterized in that the evaluation data (19) represents a deviation in the form of the imperfection and / or the presence of structural defects of the fluid structure (11) in each evaluation image (18) with respect to the fluid structure (11) of the reference image (21).

11. The method according to any one of claims 1 to 10, characterized in that the deviation is marked on each evaluation image (18) and / or the reference image (21) and / or another image, and preferably, the marked image is displayed via a user interface.

12. The method according to any one of claims 1 to 11, characterized in that in the evaluation routine, a live image (29) of the membrane unit (2) is generated by the sensor arrangement (16), which represents the evaluation image (18).

13. In the evaluation routine, a raw image (29) of the membrane unit (2) is generated by the sensor arrangement (16), from which an evaluation image (18) is extracted. Preferably, each evaluation image (18) is extracted from the respective raw image (29) by defining a frame (30) within the raw image (29), i.e., the image boundary (22) of the evaluation image (18). More preferably, the image boundary (22) is rectangular, and its upper and lower boundaries are defined with respect to a first predetermined image structure (31) within the raw image (29), and its left and right boundaries are defined with respect to a second predetermined image structure (32) within the raw image (29). The method according to claim 12, characterized in that.

14. Evaluation data (29) is used to adapt the primary processing routine by the primary manufacturing arrangement (9). Preferably, the primary manufacturing arrangement (9) is parameterized based on the evaluation data (19) in order to minimize the detected deviation between each evaluation image (18) and the reference image (21). The method according to any one of claims 1 to 13, characterized in that.

15. A method for manufacturing a membrane product such as a lateral flow test from a roll or sheet (1) of the membrane unit (2) by a secondary manufacturing arrangement (36), wherein the membrane unit (2) is manufactured by the method according to any one of claims 1 to 14, and the roll or sheet (1) of the membrane unit (2) is processed by at least one secondary processing routine based on the evaluation data (19). The said method, characterized in that.

16. The method according to claim 15, characterized in that the secondary manufacturing arrangement (36) adapts the secondary processing routine to the evaluation data (19) and supports the manufacture of the same membrane product (3).

17. Depending on the detected quality grade representing the degree of the maximum allowable deviation, each membrane unit (2) may be discarded from further processing. The method according to any one of claims 15 or 16, characterized in that.

18. The secondary processing routine includes a secondary processing step of cutting the membrane material (7) into single cut-out membrane units (2), each including a fluid structure (11). Preferably, the cutting step is characterized in that the membrane unit (2) is adapted according to the detected deviation so as to be identical from the viewpoint of the fluid structure (11) of each membrane unit (2). The method according to any one of claims 15 to 17.

19. The secondary processing routine includes a secondary processing step of filling the membrane material (7) at a predetermined position on the membrane unit (2) with a bioactive material such as an antibody. Preferably, the filling of the membrane material (7) is adapted according to the detected deviation, and the arrangement of the bioactive material with respect to the fluid structure (11) is identical for each membrane unit (2). The method according to any one of claims 15 to 18.

20. The secondary processing routine includes a secondary processing step of inserting the cut-out membrane unit (2) into the housing (4). Preferably, the insertion of the cut-out 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 a window (5) or the like. The method according to any one of claims 15 to 19.

21. A method for evaluating a membrane unit (2) of a membrane product (3) such as a lateral flow test, wherein the membrane unit (2) includes a fluid structure (11) for defining the flow of fluid through the membrane material (7), in particular a hydrophobic structure introduced into the membrane material (7), and the evaluation routine is performed by 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) is generated by the sensor arrangement (16), and evaluation data (19) is generated by the evaluation control (17). The evaluation data (19) represents the deviation between a predetermined geometric characteristic of the fluid structure (11) in the evaluation image (18) and the fluid structure (11) in the reference image (21). The said method.

22. A primary manufacturing arrangement for performing the method according to any one of claims 1 to 14 for manufacturing a roll or sheet (1) of membrane units (2) from a roll or sheet of membrane material (7).

23. A secondary manufacturing arrangement for performing the method according to any one of claims 15 to 20 for manufacturing a membrane product (3), such as a lateral flow test, from a roll or sheet (1) of a membrane unit (2).

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