Substrate with a marking element, container comprising it, and method for producing the same

Abstract

The present invention relates to a substrate with a marking element, a container comprising the same, and a method for producing the same. The marking element extends over at least one first surface area and at least one second surface area of the substrate; on the first surface area, the substrate has at least one first roughness value; on the second surface area, the substrate has at least one second roughness value; in at least one height profile of the substrate along at least one cutting line that at least partially passes through the first surface area and the second surface area, the height of the substrate along a first part of the height profile corresponding to the first surface area is greater than the height of the substrate along a second part of the height profile corresponding to the second surface area; in the height profile, the absolute value of the height difference between the maximum height point or at least one average height of the second part and the minimum height point or at least one average height of the first part is defined as the depth value; the ratio of the depth value to the second roughness value is between 2 and 35.

Description

FIELD OF THE INVENTION

[0001] The present invention relates to a substrate having a marking element, a container comprising such a substrate, and a method for producing a substrate having a marking element, preferably a substrate according to the present invention. BACKGROUND OF THE INVENTION

[0002] In the prior art, it is common practice to use identification components to make objects, such as containers, identifiable. This is particularly important in the pharmaceutical field, where containers (such as vials, syringes, cartridges, etc.) for containing pharmaceutical compositions are typically required to have components that allow each individual container to be identified. For example, this is very important for the automatic handling of containers during filling, routing, storage, dispensing, and for ensuring quality and safety standards, which typically require a high level of traceability for each container throughout its life cycle. The identification components are typically designed in the form of marking elements, which are used to meet the above requirements.

[0003] So far, it has generally been the case that a label is attached to each container and a unique identification code, such as a barcode, is printed on the label. In other applications, unique identification codes have been directly transferred to the container by means of a printing process using ink. Thus, both methods require printed codes. Once a connection is established between the container and the unique identification code, the container can be identified by reading the corresponding unique identification code.

[0004] However, attaching a label to a surface or using a printer during use is often slow and complex and thus typically represents a bottleneck on the production line. The size of these printed codes is often limited by the printing method and cannot be sufficiently reduced to create the required small codes. In particular, for small containers, it is difficult or even impossible to provide a sufficiently large area to which the label can be adhered. Containers often exhibit complex geometries, which makes it difficult to attach an identification code to the container using a label or a printer.

[0005] In addition, it has proven that during further processing or use of the container, if the container is exposed to water or other extreme conditions, there is a risk that the label of the container will come off or the code printed directly on the container using ink will disappear. Additionally, it has also proven that a common problem is that the codes provided by these known techniques fade over time.

[0006] These drawbacks lead to situations where the container can no longer be identified because the label has been completely lost or because they are no longer readable. This is especially true in the pharmaceutical field where the use of unidentified substances is not tolerated. However, especially in this field, the cost of handling containers containing the corresponding compositions is too high. In addition to this, picking out unidentified containers can lead to system downtime or at least require additional resources. In any case, the use of such traditional marking elements can lead to an increase in service costs.

[0007] Even more seriously, the disappearance of the unique identification code leads to incorrect identification and subsequent incorrect assignment of the container. Worst of all, this can pose a serious health risk to the patient.

[0008] In the art, it is also known that techniques can be used that allow the provision of a marking element directly in the surface of the container, for example by means of laser ablation techniques and the like. Here, the marking element includes a part engraved in the surface (usually of the container or the substrate) and a part that is untreated in this regard. The different parts together represent the encoded information. The marking element arranged on the container in this way is indeed inexpensive in the production process and has advantages in terms of durability. However, for glass containers such as glass bottles used in the pharmaceutical industry, it has proven to be complex to engrave a marking element in the surface of the container for subsequent reliable reading of the marking element. In fact, the use of a conventional barcode scanner is often accompanied by the following problem: due to its transparency, the engraved marking element cannot be recognized on the glass surface. In other words, barcode readers often have problems in recognizing the marking element on the transparent glass surface and thus reading its data.

[0009] Given the above problems with the reading procedure, although the marking element engraved in the glass surface of the container has obvious advantages compared to, for example, a label stuck on the surface of the container or a code printed directly on the surface of the container, the first two options are still preferred. Summary of the Invention

[0010] Therefore, the object of the present invention is to overcome the above disadvantages by providing a substrate having a marking element, which on the one hand can be engraved in the surface of the substrate, yet can be read in a safe, reliable but still fast manner, in particular with conventional devices such as barcode scanners. In addition, it is desired that there are no restrictions on the geometry and size of the substrate. Another object of the present invention is to provide a container comprising such a substrate and to provide a method for producing a substrate having a marking element.

[0011] According to a first aspect of the present invention, the problem is solved by means of a substrate having marking elements, wherein the marking elements extend over at least one first surface area of the substrate and at least one second surface area of the substrate; wherein, on the first surface area, the substrate has at least one first roughness value for at least one surface roughness of the first surface area; and on the second surface area, the substrate has at least one second roughness value for the surface roughness of the second surface area; wherein, in at least one height profile of the substrate along at least one cutting line that at least partially passes through the first surface area and the second surface area, the height of the substrate along a first part of the height profile corresponding to the first surface area is greater than the height of the substrate along a second part of the height profile corresponding to the second surface area; wherein, in the height profile, the absolute value of the height difference between the maximum height point or at least one average height of the second part and the minimum height point or at least one average height of the first part is defined as the depth value; and wherein the ratio of the depth value to the second roughness value is between 2 and 35.

[0012] Accordingly, the present invention is based on the unexpected finding that transparent substrates, such as glass, can also be used in combination with marking elements if both the geometric parameters and the surface parameters are controlled for the engraved part of the substrate, the marking elements having parts directly engraved in the surface of the substrate and parts that are untreated in this respect. It has been unexpectedly demonstrated that these parameters significantly affect the optical properties of the corresponding engraved part for the electromagnetic radiation impinging thereon, in particular for the amount of electromagnetic radiation reflected and / or scattered. In particular, these two parameters seem to be related to each other.

[0013] More particularly, the inventors have found that the contribution of the engraved part of the marking element to the signal at the receiver side strongly depends on the ratio of the depth value of the engraved part to the surface roughness value of the surface of that part. In this regard, it has been found that if the value of this ratio is between 2 and 35, the contribution of the engraved part to the signal received in the receiver can be significantly enhanced compared to the contribution of other parts without any marking elements, and thus, an unexpected improvement in the contrast of the marking element can be achieved.

[0014] In one embodiment, preferably, the value of the ratio is between 2 and 20, preferably between 2 and 15, more preferably between 3 and 10, between 4 and 15 or between 5 and 10.

[0015] In particular, in this way, by simply adjusting the corresponding geometric and surface properties of the engraved part, the contrast of the marking element can be advantageously set.

[0016] Even more unexpectedly, the said range of values seems to be widely effective, independent of the size of the said marking element, independent of the specific glass substrate, and also independent of the device used to provide the marking element and to read data from the marking element.

[0017] In particular, the method according to the present invention allows the setting of marking elements on a substrate, such as a glass substrate, preferably on the substrate of a pharmaceutical container such as a vial, using commercially available devices, provided that the commercially available devices allow the control of the depth and surface roughness of the engraved part. For example, a laser can be used to accomplish this task. Thus, the reading of the marking elements can also be accomplished by commercially available devices. For example, a conventional barcode scanner can be used for this purpose. Thus, according to the method of the present invention, substrates having such marking elements can be used in every existing industrial environment without any modification to the equipment. Since there is no need to modify or otherwise change the existing infrastructure, this makes the method particularly useful and flexible.

[0018] Therefore, even when the marking elements are set on a transparent substrate such as glass where reading is usually complex, controlling the geometric and surface properties ultimately allows the setting of high contrast of the marking elements. It is well known that the transparent substrate can also be made of polymers such as cycloolefin copolymer (COC) or cycloolefin polymer (COP).

[0019] In particular, no additional elements such as inks, coatings, etc. need to be applied to the marking elements to achieve or ensure high contrast. This results in an inexpensive and rapid manufacturing process. In addition, since no materials that may disappear are involved, there is no risk of anything (such as a peeling coating) disappearing over time.

[0020] It is well known that if the term "engraved part" (or the synonymous term "cavity") is used herein, it must be understood that, unless otherwise specified in the corresponding content, the second surface can be equivalent to or can be at least a part (such as the central part) of the surface area of the "engraved part".

[0021] In one embodiment, preferably, after applying a shear of 20% or more of the depth value (details are given below), even more preferably 40% or more, 50% or more, or 75% or more of the depth value of the shear to obtain morphological data (based on which the surface roughness is evaluated), a second surface area is obtained, and its second roughness value is used in the ratio. In other words, the shear is performed at a depth corresponding to the corresponding percentage of the depth value below the surface.

[0022] In one embodiment of the first aspect, optionally or additionally preferably, the surface roughness is the average surface roughness or the root mean square surface roughness on at least a part of the corresponding surface area.

[0023] If the surface roughness is defined as the average surface roughness or the root mean square surface roughness, reliable values of the surface roughness can be obtained. This is because the local variations of the surface roughness can be eliminated in this way. For example, in this way, the severity of the contribution of a single local variation of the surface roughness to the whole can be significantly reduced. In particular, well-known techniques can be used to evaluate and verify the roughness values.

[0024] Basically, the evaluation of the roughness value (or the average roughness value of a certain surface area) can be accomplished by evaluating the morphological profile of the corresponding substrate, especially the engraved part of the corresponding substrate. In particular, the evaluation is carried out after obtaining the "preferred" part of the surface of the engraved element (see the example of shearing below).

[0025] For example, an optical 3D profiler can be employed, which due to its characteristics allows for mapping the structure on the surface. This means that the lateral resolution of the profiler reaches 0.5 μm, and the depth resolution (e.g., along the z-axis) may be much less than 10 nm. Therefore, a field of view suitable for the structure size can be adopted.

[0026] For example, the following profiler can be used:

[0027] Manufacturer: ZYGO

[0028] Device type: "nexview"

[0029] Optical zoom: 0.5x (0.75x and 1.0x)

[0030] Objective lenses: 5.5x, 10x, 20x, and 50x Mirau

[0031] Camera: 1024×1024px 2

[0032] The application program that can be used for evaluation is based on the standard application program of the "Mx" software of such devices.

[0033] Now, discuss how to obtain the surface roughness value of a certain surface of the element engraved in the substrate according to a possible method.

[0034] To evaluate the roughness value of the engraved element (especially the bottom area of the engraved element), the image of the substrate surface obtained by white light interferometry (WLI) measurement is further processed as follows:

[0035] 1. Level the morphological data from the WLI measurement to the fourth order, thereby masking the surface area of the substrate that is not part of the engraved element. Therefore, it may also be beneficial to remove the curvature at the surface.

[0036] 2. Shear the topography data at a certain height, for example, -0.5 μm below the top surface of the substrate. In this step, if there is no surface area of the engraving element and the edge of the engraving element is less than 0.5 μm below the top surface, they are removed from the topography data. Thus, only the bottom area of the engraving element retains a depth of 0.5 μm or greater (which may be regarded as the bottom of the pit). Further evaluation is performed on this topography data.

[0037] 3. Perform fourth-order leveling on the obtained topography data again.

[0038] 4. Display an image of the topography data, which may appear in a "pan-like" shape.

[0039] 5. Now, according to the corresponding data in the topography data, the surface roughness of one or more engraving elements can be evaluated, for example, in the form of root mean square.

[0040] Those skilled in the art should understand that the surface area of each engraving element available for evaluating the corresponding surface roughness depends on the shear value.

[0041] In one embodiment, the engraving element is preferably a cavity engraved in the substrate.

[0042] In one embodiment, the size of the surface area of each engraving element reserved for final evaluation after applying the above steps can preferably be 4000 to 3000 μm 2 . In one embodiment of the first aspect, optionally or additionally preferably, the first roughness value is at least 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 times lower than the second roughness value. The first roughness value can be between 0.5 and 20 nm, preferably between 1 and 10 nm, more preferably between 1 and 5 nm. The second roughness value can be between 5 and 1000 nm, preferably between 100 and 700 nm, more preferably between 100 and 300 nm, or between 300 and 500 nm.

[0043] If parameters of the non-engraved part are also considered in addition to the parameters of the engraved part, the optical properties of the substrate part can be controlled even more precisely, thereby controlling the contrast of the marking element even more precisely as a whole. Optionally or additionally preferably, one or more roughness values of the second surface area (especially the engraved part) and the first surface area (especially the non-engraved part) are limited within a certain value range, which has proven to be beneficial for improving the contrast.

[0044] In an embodiment of the first aspect, optionally or additionally preferably, the height value is defined by the height at the maximum height point of the first part in the height profile. Wherein, the ratio of the height value to the depth value is between 100 and 2000, and / or the height is between 0.1 mm and 20 mm, more preferably between 0.5 mm and 15 mm, and most preferably between 0.7 mm and 1.7 mm.

[0045] If the height of the substrate is also considered, the optical properties of the substrate part can be controlled even more precisely, thereby controlling the contrast of the marking element even more precisely as a whole. This is especially the case if the height of the substrate and the depth of the engraved part are limited to a certain value range that has proven beneficial for improving the contrast.

[0046] Those skilled in the art should understand that in this application, the term "(substrate) height" can be used synonymously with the term "(substrate) thickness". Therefore, the height profile can also be understood as a thickness profile. Thus, for example, if the substrate with the marking element is considered as the wall of a container, such as a vial, it may be more preferable to use the term "thickness" because the wall of the container (in the form of a vial, for example) has a certain thickness. In addition, in this way, there will be no confusion with other "heights" (such as the height of the vial).

[0047] In a preferred embodiment, the height of the substrate is between 0.1 mm and 2 mm, more preferably between 0.6 mm and 1.7 mm.

[0048] In an embodiment of the first aspect, optionally or additionally preferably, above or below the first surface region, the substrate has at least one first ratio for at least one concentration ratio of two materials at at least one different depth in the first surface region or in the substrate located below it; and above or below the second surface region, the substrate has at least one second ratio for at least one concentration ratio of two materials at at least one different depth in the second surface region or in the substrate located below it.

[0049] If the ratios of the two materials are different for the first surface region and the second surface region (especially the engraved part and the non-engraved part), it has unexpectedly been proven that the marking element is more durable compared to other embodiments. Here, it may be advantageous to evaluate the ratio at or below a certain depth at the corresponding surface. Preferably, the depth is up to 1200 nm. This depth has been found to be particularly advantageous because for a depth up to 1200 nm, the material concentration may change significantly due to the preparation process of the substrate (such as thermal influence, shaping, etc.). However, more preferably, the depth is up to 800 nm or up to 400 nm. At these depths, the influence of the preparation process on the material is greater, which leads to a change in the concentration of different materials in the substrate.

[0050] In an embodiment of the first aspect, optionally or alternatively preferably, the substrate is designed such that the hydrolysis resistance is improved with respect to the first ratio and the second ratio, in particular compared to other substrate designs.

[0051] If the two ratios are selected in a suitable manner, the inventors have found that the durability with respect to hydrolysis resistance can be greatly improved. This allows for the provision of marking elements that are more robust against environmental influences.

[0052] In an embodiment of the first aspect, optionally or alternatively preferably, (i) the concentration ratio of two materials is the concentration ratio of material B to Si, Na to Si, Ca to Si, and / or Al to Si; (ii) the different depths are depths up to 2 μm, preferably up to 1 μm, more preferably up to 0.5 μm, even more preferably up to 0.2 μm below the corresponding surface regions; and / or (iii) the concentration ratio of the two materials is obtained and / or obtainable at at least one position of the corresponding surface region by means of at least one ToF-SIMS measurement, in particular at least one ToF-SIMS measurement of at least one surface layer at different depths.

[0053] Generally, on the first surface region and the second surface region of the substrate, both the first concentration ratio and the second concentration ratio of the two materials are different from the concentration ratio (bulk ratio) in the bulk of the substrate. For example, the bulk ratio can be measured at a depth of 10 μm. In a preferred embodiment, the second concentration ratio of the two materials reaches 90% of the bulk ratio of the concentration at a depth that is at most 90% of the depth at which the first concentration ratio of the two materials reaches 90% of the bulk ratio of the concentration. For example, the second concentration ratio of material B and Si reaches 90% of the bulk ratio of the material at a depth that is at most 85% of the depth at which the first ratio of material B and Si reaches 90% of the bulk ratio of the material. In other words, the relative amount of B is higher in the engraved part (e.g., cavity) than outside the engraved part. Boron increases the hydrolysis resistance of the substrate, such that a higher proportion of boron is required for the durability of the marking element.

[0054] The ratio of the two preferred materials results in an improved contrast of the marking element. If different depths are appropriately selected, a more reliable design can be achieved, thereby realizing a more reliable contrast.

[0055] It is known that it is preferred to use silicon (Si) as a reference parameter because it has been found that the amount, concentration and distribution of silicon are very stable for the parts of the marking elements in the second surface region and the first surface region (especially the engraved part and the non-engraved part) compared to other materials in the substrate, especially a glass substrate. In other words, the setting of the marking elements in the substrate does not affect the amount, concentration and distribution of silicon. Therefore, for the purpose of comparing different ratios and / or different depths of the same ratio, silicon is the best material as a reference marker in measuring the ratio of two materials.

[0056] The use of time-of-flight secondary ion mass spectrometry (ToF-SIMS) provides a commercially available and easy-to-use tool to determine the concentration ratio in an accurate manner. Here, those skilled in the art know that according to the sputtering time (e.g., 1480 s), a certain depth range (e.g., up to 740 nm) from the outer surface of the substrate into the substrate can be evaluated with respect to the concentration ratio. In other words, during the application of time-of-flight secondary ion mass spectrometry, more and more substrate material is removed from the top to the bottom. Thus, the material from deeper inside the substrate is analyzed over time.

[0057] In an embodiment of the first aspect, optionally or additionally preferably, the substrate at least partially comprises glass, especially silicate glass, such as aluminosilicate glass and / or borosilicate glass, and at least one polymer material such as cycloolefin copolymer (COC) or cycloolefin polymer (COP).

[0058] In an embodiment of the first aspect, optionally or additionally preferably, the marking element comprises at least one cavity engraved in the substrate, preferably in the form of at least one dot-like and / or line-like element; preferably, the marking element comprises a plurality of cavities engraved in the substrate, preferably in the form of a plurality of dot-like and / or line-like elements; wherein preferably, (i) the marking element is in the form of at least one matrix code, preferably at least one dot matrix code, at least one one-dimensional data code, at least one two-dimensional data code and / or at least one three-dimensional data code; (ii) the first surface region at least partially does not overlap with the surface of the cavity and / or the second surface region is at least a part, preferably the central part, of the surface of the cavity, or corresponds to the surface of the cavity, and / or (iii) the first surface region is at least a part of the surface corresponding to at least one region of the marking element, the at least one region representing the bit set to "zero" in the marking element, and / or the second surface region is at least a part of the surface corresponding to at least one region of the marking element, the at least one region representing the bit set to "one" in the marking element.

[0059] The cavities can be produced in the substrate, especially a glass substrate, by commercially available tools.

[0060] Optionally or alternatively preferably, the cavity extends 1 to 20 μm in at least one dimension. For example, the depth of the cavity may be between 1 and 20 μm (especially relative to the top position of the substrate). Alternatively, the cavity may have a platform-like region, and at least one edge or at least one diameter of the region is between 1 and 20 μm.

[0061] Optionally or alternatively preferably, at least one cavity has a dot-like or line-like design. In other words, the cavity can be designed as a hemispherical groove in the substrate, or designed as a channel (especially in the form of a perpendicular line) engraved on the surface of the substrate. Of course, in a preferred embodiment, more than one cavity can also be used as described herein. It is well known that the engraved part can be understood as the part having at least one cavity. In some embodiments, the engraved part can be the same as at least one cavity.

[0062] In an embodiment of the first aspect, optionally or alternatively preferably, the depth value and / or the maximum depth or average depth of the cavity is between 0.1 and 5 μm, preferably between 0.1 and 4 μm, between 0.1 and 3 μm, between 1 and 3 μm, between 1 and 2 μm, between 1.5 and 2.5 μm, between 2 and 3 μm, between 2 and 5 μm, and / or between 3 and 5 μm.

[0063] If the depth value or the depth of the cavity is limited within a certain value range that has been proven beneficial for improving the contrast, even further improved results can be achieved regarding the reading reliability.

[0064] In an embodiment of the first aspect, optionally or alternatively preferably, the marking element extends 0.1 mm to 50 mm, preferably 0.5 mm to 30 mm, more preferably 0.5 mm to 10 mm, and most preferably 0.5 mm to 5 mm in at least one direction along the surface of the substrate. The marking element is machine-readable and can be produced by or capable of being produced by at least one laser, and / or by or capable of being produced by at least one etching technique such as dry etching.

[0065] The machine-readable marking element can be widely used in industrial applications.

[0066] In addition, the corresponding lasers are commercially available, and the marking elements produced with the lasers are inexpensive and durable. The preferred types of lasers are diode-pumped solid-state (DPSS) lasers, fiber lasers, or flashlamp-pumped solid-state lasers. In fact, UV lasers may also be particularly preferred, which preferably have a wavelength of 250 to 500 nm. Since they are fast and reliable and allow the production of small structures, these lasers are suitable for ablation techniques. However, lasers having a wavelength between 250 and 600 nm may also be preferably used. CO2 lasers may also be employed in certain embodiments. Since there is no need to worry about contamination, dry etching techniques are also feasible in the pharmaceutical field. Laser ablation techniques and the like can produce very small marking elements, such as marking elements with dimensions of 5 mm or even only 1 mm in each dimension, and the information is encoded in the marking elements.

[0067] In particular, the laser ablation technique advantageously allows controlling the depth of the engraved part by controlling the corresponding ablation time, and controlling the surface roughness of the corresponding engraved part by controlling laser parameters (such as scanning frequency, laser power, beam width, scanning speed, original beam width, focal length, energy density, pulse duration and energy, pulse overlap, and laser wavelength). Therefore, precise control of the ratio is ensured, thus ensuring precise control of the contrast at the receiver.

[0068] In an embodiment of the first aspect, optionally or additionally preferably, the first surface region and the second surface region are adjacent to each other and / or connected to each other, in particular directly adjacent to each other and / or connected to each other.

[0069] For example, the first surface region may be the surface region (or a part thereof) of an untreated (i.e., non-engraved) substrate, and the second surface region may be the surface region (or a part thereof) of the substrate in the engraved region.

[0070] In an embodiment of the first aspect, optionally or additionally preferably, with respect to the first roughness value, the second roughness value, and / or the depth value, the first surface region and the second surface region are designed such that when a certain amount of electromagnetic radiation is emitted towards the first surface region or towards the second surface region by means of at least one electromagnetic radiation source, at least one first part or at least one second part of the certain amount of electromagnetic radiation is respectively reflected and / or scattered by the first surface region or the second surface region towards at least one receiver; wherein the first part of the certain amount is less than the second part of the certain amount; wherein preferably, the amount of electromagnetic radiation is an amplitude value, the amount of electromagnetic radiation is a power value, and / or the first part of the certain amount of electromagnetic radiation is 10, 100, 1000, or 10000 less than the second part of the certain amount of electromagnetic radiation.

[0071] In an embodiment of the first aspect, optionally or alternatively preferably, (i) a quantity of electromagnetic radiation is emitted towards and received by a receiver at a first surface region and a second surface region, such that a dark field technique can be employed to evaluate a first portion and a second portion of the quantity and / or (ii) the direction of emission of the electromagnetic radiation is not parallel or anti-parallel to the direction of reception of the electromagnetic radiation.

[0072] Preferably, the direction in which the receiver receives the electromagnetic radiation is selected such that the corresponding portion of the electromagnetic radiation does not include a directly reflected portion of the electromagnetic radiation impinging on the substrate, in particular the first surface region and / or the second surface region. This allows for the full utilization of the selected geometric and surface parameters and the corresponding optical properties.

[0073] In an embodiment of the first aspect, optionally or alternatively preferably, the electromagnetic radiation is in the visible, infrared or ultraviolet spectrum, in particular emitted by at least one laser, in particular at least one ultraviolet laser, diode-pumped solid-state (DPSS) laser, fiber laser or flashlamp-pumped solid-state laser, and / or is radiation in the microwave spectrum.

[0074] According to a second aspect of the invention, the problem is solved by a container, in particular a vial, syringe tube, cartridge or another pharmaceutical container, the container comprising a substrate having a marking element, in particular a substrate having a marking element according to the first aspect of the invention.

[0075] Thus, the invention is based on the unexpected finding that different types of containers can be provided with a marking element as long as they comprise a substrate that allows the marking element to be provided.

[0076] According to a third aspect of the invention, the problem is solved by a method for producing a substrate having a marking element, in particular a substrate having a marking element according to the first aspect and / or the second aspect of the invention, the method comprising the following steps:

[0077] - providing a substrate, in particular a glass substrate;

[0078] wherein the substrate has at least one first surface region, and on the first surface region, for at least one surface roughness of the first surface region, the substrate has at least one first roughness value;

[0079] - providing at least one material removal device, the material removal device being designed to remove material from at least one surface region of the substrate, the material removal device preferably comprising at least one laser, such as a UV laser, diode-pumped solid-state laser, fiber laser or flashlamp-pumped solid-state laser;

[0080] - Removing material from at least one region of the surface of the substrate, in particular in the vicinity of the first surface region, by means of a material removal device, thereby forming at least one cavity, wherein the cavity has at least one second surface region;

[0081] Wherein the material is removed from the surface of the substrate such that, on the second surface region, the substrate has at least one second roughness value for the surface roughness of the second surface region;

[0082] Wherein the material is further removed from the surface of the substrate such that, in at least one height profile of the substrate along at least one cutting line that at least partially passes through the first surface region and the second surface region, the height of the substrate along a first part of the height profile corresponding to the first surface region is greater than the height of the substrate along a second part of the height profile corresponding to the second surface region;

[0083] Wherein, in the height profile, the absolute value of the height difference between the maximum height point or at least one average height of the second part and the minimum height point or at least one average height of the first part is defined as the depth value;

[0084] Wherein the ratio of the depth value to the second roughness value is between 2 and 35.

[0085] The following preferred embodiments are recognized:

[0086] Preferably, the substrate is made of glass.

[0087] Optionally or additionally preferably, the substrate is contained in a container, preferably a vial (in other words, optionally or additionally preferably, the substrate is contained in a container made of glass, preferably a vial).

[0088] Optionally or additionally preferably, the marking element is a two-dimensional data code.

[0089] Other aspects are discussed below:

[0090] In the context of the present invention, every pharmaceutical composition considered appropriate by the person skilled in the art is contemplated. A pharmaceutical composition is a composition comprising at least one active ingredient. Preferred active ingredients are vaccines, antibodies or other biological agents. The pharmaceutical composition can be liquid or solid or both, wherein a liquid composition is particularly preferred herein. Preferred solid compositions are particulate such as powders, various tablets or various capsules. Another preferred pharmaceutical composition is a parenteral composition, i.e., a composition intended for administration by the parenteral route. Parenteral administration can be by injection (e.g., using a needle (usually a subcutaneous injection needle) and a syringe) or by insertion of an indwelling catheter.

[0091] Now discuss other relevant aspects related to the container. For the sake of discussion, assume that the container, preferably the container body, is preferably made of glass. In addition, assume that the container is preferably designed in the form of a vial. However, of course, other types of containers can also be used.

[0092] The above-mentioned pharmaceutical glass container is characterized by a sufficiently high strength, especially if the pharmaceutical glass container is filled in an automatic capping machine, where a large axial load is applied to the vial in the automatic capping machine. Higher axial loads can also be observed when the glass vial is used in an automatic sampling machine in a scientific laboratory or a medical institution, as well as during the stoppering, transportation, and storage of the glass vial. In addition to having a certain resistance to axial loads, the glass container should also exhibit a sufficiently high burst strength. For example, the burst pressure test is suitable for evaluating the strength of the container during freeze-drying to find the weakest point on the inner or outer surface of the container. If the pharmaceutical preparation is freeze-dried after being loaded into the glass container, the burst strength of the pharmaceutical glass container becomes important.

[0093] Since the use of glass containers in the pharmaceutical industry only allows a very low failure rate when mechanical stress or pressure changes are applied, the glass containers used for filling pharmaceutical preparations are characterized by a sufficiently high strength, especially the ability to withstand high axial loads and a sufficiently high burst strength.

[0094] In addition, in the lateral compression test described below, the glass container should have the ability to withstand a certain pressure.

[0095] In the pharmaceutical industry, containers are used for the primary packaging of drugs. Since glass containers ensure stability, visibility, durability, rigidity, moisture resistance, ease of capping, and economy, it is the most commonly used material traditionally. Glass containers used for medical purposes on the current market include glass containers made of glass tubes and blow-molded glass containers.

[0096] The glass vials used for drug packaging must pass many mechanical tests. For example, if the glass vials are used in an automatic sampling machine in a scientific laboratory or a medical institution, as well as during the stoppering, transportation, and storage of the glass vials, it may be necessary to determine a high axial load in the so-called "vertical compression test" (or also called "axial compression test"). In addition to having a certain resistance to axial loads, the glass container should also exhibit a sufficiently high burst strength, as determined in the so-called "burst pressure test". For example, if the pharmaceutical preparation is freeze-dried after being loaded into the glass container to find the weakest point on the inner or outer surface of the container, the burst pressure test is suitable.

[0097] Another mechanical test commonly used to determine the mechanical strength of glass bottles is the so-called "lateral compression test". For example, this test is used to determine the impact that a certain back pressure may have on glass bottles during transportation in a depyrogenation tunnel or on a filling line. In this test, the glass bottle is located between the upper and lower parts of the test tool, and the defined load is directly applied to the main body area of the glass bottle.

[0098] For example, in a glass bottle, especially in the outer surface of the glass bottle, the tensile stress may need to exceed 150 Mpa to break the bottle. In the context of the present invention, the glass container according to the present invention can have any size or shape considered suitable by those skilled in the art. Preferably, the top region of the glass container includes an opening that allows the drug composition to be inserted into the internal volume of the glass container. The glass container includes a glass tube having a first end and another end as the container part, and a glass bottom that closes the glass tube at the other end. Preferably, the glass container is of a one-piece design and is prepared by: providing a glass tube and shaping one end of the glass tube (the end that will become the opening of the glass container) to obtain a top region, a connecting region, a neck region, and a shoulder region; subsequently, shaping the other end of the glass tube to obtain a closed glass bottom. The preferred glass container is a pharmaceutical glass container, more preferably selected from the group consisting of vials, ampoules, or combinations thereof, and particularly preferably a vial.

[0099] In the context of the present invention, the glass of the container can be any type of glass and can consist of any material or combination of materials that are considered suitable by a person skilled in the art. Preferably, the glass is suitable for pharmaceutical packaging. Particularly preferably, according to the definition of glass types in section 3.2.1 of the European Pharmacopoeia (7th edition, 2011), the glass is of type I, more preferably type I b. Additionally or alternatively, the glass is selected from the group consisting of borosilicate glass, aluminosilicate glass, soda-lime glass, and fused silica or a combination of at least two thereof. For use herein, aluminosilicate glass is such a glass that, based on the total weight of the glass, the content of Al2O3 is greater than 8 wt%, preferably greater than 9 wt%, particularly preferably between 9 wt% and 20 wt%. Based on the total weight of the glass, the content of B2O3 in the preferred aluminosilicate glass is less than 8 wt%, preferably at most 7 wt%, particularly preferably between 0 wt% and 7 wt%. For use herein, borosilicate glass is such a glass that, based on the total weight of the glass, the content of B2O3 is at least 1 wt%, preferably at least 2 wt%, more preferably at least 3 wt%, more preferably at least 4 wt%, even more preferably at least 5 wt%, particularly preferably between 5 wt% and 15 wt%. Based on the total weight of the glass, the content of Al2O3 in the preferred borosilicate glass is less than 7.5 wt%, preferably less than 6.5 wt%, particularly preferably between 0 wt% and 5.5 wt%. On the other hand, based on the total weight of the glass, the content of Al2O3 in the borosilicate glass is between 3 wt% and 7.5 wt%, preferably between 4 wt% and 6 wt%.

[0100] A further preferred glass according to the present invention is substantially free of boron (B). In this context, the expression "substantially free of B" means that the glass does not contain B intentionally added to the glass composition. This means that B can still be present as an impurity, but preferably the content of B does not exceed 0.1 wt%, more preferably does not exceed 0.05 wt%, based on the weight of the glass. BRIEF DESCRIPTION OF THE DRAWINGS

[0101] Various aspects of the present invention will be apparent to those skilled in the art upon reading the following detailed description of the preferred embodiments with reference to the accompanying schematic diagrams, wherein:

[0102] Figure 1a a schematic diagram of a glass substrate having a marking element is shown;

[0103] Figure 1b shows Figure 1a an enlarged portion of the substrate shown;

[0104] Figure 2a a schematic diagram of an enlarged portion of a first glass substrate having a marking element with a morphological overlay indication is shown;

[0105] Figure 2b shows the depth profile of a first glass substrate along Figure 2a the cutting line shown Figure 2a ;

[0106] Figure 2c shows Figure 2a the rendering of the first glass substrate;

[0107] Figure 3 shows Figure 2a the ToF - SIMS measurement of the first glass substrate;

[0108] Figure 4a shows a schematic view of an enlarged portion of a second glass substrate, the second glass substrate having a marking element with a morphological overlay indication;

[0109] Figure 4b shows along Figure 4a the cutting line shown Figure 4a the depth profile of the second glass substrate; and

[0110] Figure 4c shows Figure 4a the rendering of the second glass substrate. DETAILED DESCRIPTION

[0111] Figure 1a shows a schematic view of a substrate, in particular a glass substrate 1, having a marking element 3. This schematic view can be an image obtained by means of scanning microscope techniques. Here, the marking element 3 is designed in the form of a two - dimensional data code, which includes bits for encoding information, namely "zeros" 5 and "ones" 7, as is known to those skilled in the art. Generally, a "zero" is represented by the form of an untreated rectangular surface area of the substrate 1, while a "one" is represented by the form of a treated rectangular surface area of the substrate 1, as described in more detail below. Each corresponding rectangular surface area may have the same size, for example 80×120 μm 2 or 100×100 μm 2 . However, the rectangular surface areas may also be larger, for example each edge being 2000 to 4000 μm or even larger (e.g., 2000×3000 μm 2 ).

[0112] Figure 1b Shows in an enlarged view Figure 1aThe area marked as A in the figure. As can be seen therefrom, the glass substrate 1 includes a plurality of first surface regions 9 (only a part is marked in the figure), and the first surface regions have a surface roughness with a specific first roughness value. The first surface region 9 can be a part of the surface region of the substrate representing a bit set to "zero", or it can also be the entire part of the surface region representing a bit set to "zero".

[0113] The glass substrate 1 also includes a plurality of second surface regions 11 (only a part is marked in the figure), and the second surface regions have a surface roughness with a specific second roughness value. It should be particularly noted that each second surface region 11 is at least a part of the surface of the cavity 13 that has been engraved on the surface of the glass substrate 1 by a laser ablation technique.

[0114] For Figure 1a and Figure 1b the substrate 1 shown, a plurality of cavities (for example, an array of 4×3 = 12 cavities) are used to indicate the bits set to "one" in data encoding. However, those skilled in the art should understand that a single cavity can also be used to indicate the bits set to "one", and / or a single cavity can be constructed in such a way that many cavities are formed on the substrate and these cavities have a large overlapping part, so as to finally obtain a single large cavity.

[0115] Only in the latter case, a single cavity represents the bits set to "one". Otherwise, for Figure 1a and Figure 1b the substrate shown, a plurality of cavities, that is, a plurality of second surface regions 11, are used to represent the bits with a value of "one".

[0116] In Figure 1a and Figure 1b the substrate 1 shown, obviously, many single cavities 13 merge with each other. However, of course, it is also possible (which is also obvious from the drawings) that some directly adjacent cavity pairs of the cavities 13 (which represent a single bit set to "one") do not overlap or merge. As a result, between these at least relatively separated cavities, and also within the surface region representing the bits with a value of "one", there may be a surface region of the substrate that is not processed due to the lack of cavities, because of the connection region between two cavities that both belong to the same "one". However, for the purposes of the present invention, such an unprocessed surface region is not the first surface region. On the contrary, the first surface region must be understood as at least a part of the surface region representing the bits set to "zero".

[0117] The specific implementation of the cavities for setting the bits to "one", especially the degree of their overlap, can be controlled by adjusting the corresponding laser parameters, such as scanning frequency, laser power, beam width, scanning speed, original beam width, focal length, energy density, pulse duration and energy, pulse overlap, and laser wavelength.

[0118] In summary, it can be considered that Figure 1a and Figure 1b the marked element 3 as shown can extend over multiple first surface regions of the substrate (i.e., all untreated regions representing "zero") and multiple second surface regions (i.e., treated regions in the form of cavities 13).

[0119] Similarly, for Figure 1a and Figure 1b the substrate as shown, it can be considered that the surface regions representing "zero" are the first surface regions, but it cannot be considered that the surface regions representing "one" are the second surface regions (because the rectangular surface regions representing "one" here also have portions that are not part of the cavity 13 but are part of the untreated surface region of the substrate 1 between two cavities).

[0120] It is known that in Figure 1a the two dimensions of the plane, the extension of the marked element 3 is 1 mm.

[0121] As shown in more detail below for two different exemplary glass substrates, the surface roughness of the first surface region and the second surface region has two different values.

[0122] Figure 2a A schematic enlarged view of a first substrate, in particular a glass substrate 1', with a marked element 3' is shown. This first substrate is generally similar to the ordinary glass substrate and its marked element described with reference to Figure 1a and Figure 1b . Therefore, Figures 2a to 2c the same structural features in Figures 1a to 1b are denoted by the same reference numerals as those used in

[0123] but with a single dash. An image of the substrate can be obtained by white light interferometry. Figure 2a The glass substrate 1' in

[0124] has been processed using a first laser with a first set of parameters. Therefore, the cavity 13' may be typical for this first laser and the first set of parameters used. Figure 2aIt can be concluded that the untreated surface area of the substrate 1' (e.g., the first surface area 9' where there is a "zero" position) has a small variation (the color remains almost unchanged), while in its central region, the second surface area of the cavity 13' has a variation in depth between -700 nm and -1000 nm (of course, towards the boundary of the cavity, the depth value becomes the reference value of the untreated surface into which the cavity seamlessly enters). In other words, relative to the untreated surface of the substrate, the depth of the cavity varies between 900 nm and 1200 nm at least in the central region of the corresponding cavity.

[0125] Figure 2b shows the depth profile of the substrate along Figure 2a the cutting line 15' in Figure 2a , which at least partially passes through the first surface area 9' and a plurality of second surface areas 11' (in fact,

[0126] the cutting line 15' in Figure 2b passes through six different second surface areas 11' due to passing through six different cavities 13', however, not all the cavities and second surface areas are marked in the figure).

[0127] It can be clearly seen from the depth profile of Figure 2b that the depth of the substrate along the first part 17' of the depth profile corresponding to the first surface area 9' is less than the depth of the substrate along the second part 19' of the depth profile corresponding to the (uppermost) second surface area 11' of the (topmost) cavity 13', through which the cutting line 15' passes respectively.

[0127] Of course, once the (constant) thickness of the untreated substrate 1' is known, it is easy to convert the Figure 2b depth profile into the height profile of the substrate 1'. Basically, this conversion can be done by simply adding an offset on the vertical axis so that the untreated substrate surface has a value corresponding to the thickness of the untreated substrate. Therefore, all the aforementioned evaluations based on the Figure 2b depth profile can also be carried out in a similar manner based on the corresponding height profile.

[0128] The preferred thickness of such a profile can be between 0.1 mm and 2 mm, more preferably between 0.6 mm and 1.7 mm.

[0129] According to Figure 2b the depth profile, the depth of at least one cavity 13' and the surface roughness of both the first surface area 9' and the second surface area 11' can be determined. Of course, the average value of the surface roughness on a plurality of cavities 13' and the average value of the cavity depths on a plurality of cavities 13' can also be determined.

[0130] For example, according to white light interferometry ( Figure 2a ) and / or depth profile ( Figure 2b)The cavity depth is determined to be 1 μm, and the first roughness value is 2 nm (here, the root mean square (rms) value over the area of the first surface region of 28131 μm 2 ), and the second roughness value is 460 nm (here, the root mean square (rms) value over the area of the second surface region of 27913 μm 2 ). The absolute value of the difference between the maximum height point of the second part and the minimum height point of the first part is defined as the depth value. Of course, in a preferred embodiment, the minimum height point of the second part and the maximum height point of the first part are also defined as the depth values. It is also possible to use the average value on the corresponding part instead of the maximum or minimum value.

[0131] This results in a ratio of the depth value to the second roughness value of approximately 2.2, which is within the preferred value range.

[0132] Of course, it is also possible to analyze the substrate by atomic force microscopy instead of white light interferometry to obtain an image and height / depth profile of the substrate through subsequent analysis.

[0133] Figure 2c shows Figure 2a the rendering of the first glass substrate 1' shown. Based on this figure, the second roughness value can be analyzed even more precisely.

[0134] From Figure 2a the schematic diagram shown, the rendering is obtained by applying fourth-order leveling in combination with a mask to the surface region of the substrate 1' without cavities.

[0135] Next, the surface region without cavities and the boundaries of the cavities with a surface depth of up to 0.5 μm relative to the substrate are discarded. The remaining elements are the bottom of the cavity 13' and the boundaries of the cavity 13' with a surface depth of at least 0.5 μm relative to the substrate. In other words, according to Figure 2a the schematic diagram, only the elements at least 0.5 μm below the surface of the substrate are retained.

[0136] Next, the data is leveled again by fourth-order.

[0137] Since the method adopted here has been described in detail above, it is not necessary to repeat it, and reference can be made to the information provided above.

[0138] Because only the bottom (and part of the boundary) of the cavity exists, the Figure 2a schematic diagram of the first glass substrate 1' shown obtained in this way is preferably used to evaluate the second roughness value. It may be regarded as a pot-like shape. Since there may be different boundaries of the cavity, compared with Figure 2a the schematic diagram (together with Figure 2b the height profile), the roughness value can be determined more easily and accurately.

[0139] For the second roughness value, based on Figure 2c A root mean square (rms) value of 200 nm was evaluated.

[0140] Obviously, depending on the way of evaluation, the root mean square value of the second roughness may have different results. More specifically, the roughness value depends on how many cavities are observed, that is, on the choice of the corresponding surface area for evaluation. Thus, by choosing an appropriate shear, a certain and similar result can be obtained.

[0141] Figure 3 It shows that for different sputtering times (shown on the horizontal axis in the figure) Figure 2a The results of a time-of-flight secondary ion mass spectrometry (ToF-SIMS) measurement performed inside the cavity 13' of the substrate 1' shown (i.e., on the second surface area) and outside the cavity 13' on the first surface area are respectively measured for boron (B) with reference to the concentration of silicon (Si) in the substrate at the corresponding measurement positions. In other words, the relative distribution (course) of the boron signal is measured. The corresponding measurement results relative to the reference material are shown on the vertical axis. Because silicon is not seriously affected by the corresponding laser ablation technology, the reference material here is silicon. Therefore, the concentration of silicon is stable over the entire substrate. As known to those skilled in the art, ToF-SIMS measurements only provide qualitative results rather than quantitative results.

[0142] Therefore, for a single ratio of material at a single location on the surface, only the relative distribution of the measurements obtained during the sputtering time over depth can be evaluated. However, no comparison can be made at different locations. Figure 3 The sputtering time is 1480s.

[0143] exist Figure 3 The conclusion drawn from evaluating each measurement result inside the cavity (curve R1) and outside the cavity (curve R2) is that the boron concentration is greater at the outer surface than below the surface (inside and outside the cavity). However, no assessment can be made based on the relative distribution of R1 and R2.

[0144] In order to obtain Figure 3 In the data set, a sputtering time of one second corresponds to a depth of about 1.5 nm. This means that the relative concentration of boron obtained with a sputtering time of 100 seconds is the relative concentration at a depth of 150 nm below the substrate surface.

[0145] However, the inventors have found that the durability of the marking elements according to the invention is improved in terms of resistance to dishwasher cycles compared to conventional marking elements engraved in the surface. In particular, it has been found that steam sterilization can be applied more frequently and to a greater extent if the marking elements are designed according to the method of the invention.

[0146] The inventors believe that the improvement in durability can be attributed to the fact that the measured ratio changes more outside the cavity than inside the cavity (between 0 s and 600 s, the vertical change in curve R2 is greater than that in curve R1). Additionally, it has also been observed that the ratio represented by curve R1 can reach a certain limit value more quickly, which also seems to be beneficial for the improvement in durability.

[0147] In other words, assuming that the relative concentration of the material in the unaffected base material is 1 (relative concentration in the whole), curve R2 reaches 90% of this final concentration 50 seconds later than curve R1.

[0148] Figure 4a A schematic view of a second glass substrate, in particular a magnified portion of the second glass substrate 1”, having a marking element 3” is shown. This second glass substrate is generally similar to the Figure 1a and Figure 1b described ordinary glass substrate and its marking element and the first glass substrate 1’ and its marking element described with reference to Figures 2a to 2c . Therefore, regarding Figures 4a to 4c the same structural features are denoted by the same reference numerals as those used in Figure 1a and Figure 1b and Figures 2a to 2c , but with double dashes. An image of Figure 4a can be obtained by white light interference technology.

[0149] The glass substrate 1” in Figure 4a has been processed using a second laser with a second set of parameters. Thus, the cavity 13” ( Figure 4a only one is marked in

[0150] may be typical for this second laser and the second set of parameters used. Figure 4a , 4b and 4c generally correspond to Figure 2a , 2b and 2c for the first laser. Therefore, the general properties of the two substrates 1’ and 1” obtained by processing using the first laser and the second laser respectively are the same. Thus, only the differences between the two substrates 1’ and 1” will be described below.

[0151] As can be clearly seen from Figure 4a , due to the use of another laser (i.e., the second laser), the surface area of the substrate 1” representing the bit “one” is produced as four vertical lines engraved on the substrate 1”. In fact, while the first laser produced four rows (each row having three cavities) for each “one”, the second laser can be said to have connected all these three cavities, which results in a single vertical engraved line.

[0152] Basically, there are no other changes in the general procedure. Again, Figure 4a also includes morphological information in the form of morphological coverage. Generally speaking, there are no other changes, so reference can be made to the above statements about Figure 2a .

[0153] Figure 4b Shows the depth profile of the second glass substrate 1" along the cutting line 15", and the cutting line 15" at least partially passes through the first surface area 9" and the second surface area 11" (i.e., the cavity 13"). In fact, even if a second laser (which forms a plurality of cavities connected to each other due to the second laser parameters) can be used to generate a single cavity 13", only one single cavity 13" (i.e., a vertical engraving line) is passed through by the cutting line 15".

[0154] From Figure 4b 's depth profile, it can be clearly seen that the depth of the substrate 1" along the first part 17" of the depth profile corresponding to the first surface area 9" is less than the depth of the substrate along the second part 19" of the depth profile corresponding to the second surface area 11" of the cavity 13", and the cutting line 15" passes through them respectively.

[0155] Of course, once the (constant) thickness of the untreated substrate 1" is known, Figure 4b 's depth profile can be easily converted into the height profile of the substrate 1". Refer to the above statements about Figure 2b .

[0156] According to Figure 4b 's profile, the depth of the cavity 13" and the surface roughness of both the first surface area 9" and the second surface area 11" can be determined. Of course, the average value of the surface roughness on multiple cavities 13" and the average value of the cavity depth on multiple cavities 13" can also be determined.

[0157] For example, according to white light interferometry and / or depth profile, the cavity depth is determined to be 2μm, the first roughness value is 13nm (here is the root mean square (rms) value of the area of the first surface area 5688μm 2 ), and the second roughness value is 559nm (here is the root mean square (rms) value of the area of the second surface area 5794μm 2 ). The absolute value of the difference between the maximum height point of the second part and the minimum height point of the first part is defined as the depth value. Of course, in a preferred embodiment, the minimum height point of the second part and the maximum height point of the first part are defined as the depth value. The average value on the corresponding part can also be used instead of the maximum or minimum value.

[0158] This results in a ratio of the depth value to the second roughness value of approximately 3.6, which is within the preferred value range.

[0159] Of course, the substrate can also be analyzed by an atomic force microscope instead of white light interference technology to obtain a height / depth profile through subsequent analysis.

[0160] Figure 4c shows Figure 4a the effect diagram of the second glass substrate shown. Based on this figure, the second roughness value can be analyzed even more precisely. For details on obtaining this figure, refer to the above statement regarding Figure 2c .

[0161] Regarding the second roughness value, a root mean square (rms) value of 610 nm is obtained.

[0162] Similarly, it is obvious that for the roughness value of the surface, appropriately defining the evaluation area leads to stable and reliable results.

[0163] Therefore, it is obvious that due to the different geometric and / or surface properties of the substrate and / or the marking element, using different lasers in the production process of the marking element results in different characteristic contrasts.

[0164] For implementing the present invention in its different embodiments, the features disclosed in the specification, the drawings, and the claims are essential either individually or in each combination thereof.

[0165] Reference signs:

[0166] 1, 1', 1'' substrate

[0167] 3, 3', 3'' marking element

[0168] 5 bit

[0169] 7 bit

[0170] 9, 9', 9'' surface area

[0171] 11, 11', 11'' surface area

[0172] 13, 13', 13'' cavity

[0173] 15', 15'' cutting line

[0174] 17', 17'' part

[0175] 19', 19'' part

[0176] A area

[0177] R1 curve

[0178] R2 curve

Claims

1. A substrate with a marking element, Among them, wherein the marking element extends over at least one first surface region of the substrate and at least one second surface region of the substrate; wherein, on the first surface region, for at least one surface roughness of the first surface region, the substrate has at least one first roughness value; on the second surface region, for the surface roughness of the second surface region, the substrate has at least one second roughness value; wherein, in at least one height profile of the substrate along at least one cutting line that at least partially passes through the first surface region and the second surface region, the height of the substrate along a first part of the height profile corresponding to the first surface region is greater than the height of the substrate along a second part of the height profile corresponding to the second surface region; wherein, in the height profile, the absolute value of the height difference between the maximum height point or at least one average height of the second part and the minimum height point or at least one average height of the first part is defined as the depth value; wherein the ratio of the depth value to the second roughness value is between 2 and 35; wherein the marking element includes at least one cavity engraved in the substrate; wherein the second surface region is at least a part of the surface of the cavity.

2. The substrate according to claim 1, Among them, wherein the surface roughness is the average surface roughness or the root mean square surface roughness on at least a part of the corresponding surface region.

3. The substrate according to claim 1, Among them, wherein the first roughness value is 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 times smaller than the second roughness value, the first roughness value is between 0.5 and 20 nm, and / or the second roughness value is between 5 and 1000 nm.

4. The substrate according to claim 3, Among them, wherein the first roughness value is between 1 and 10 nm, and / or the second roughness value is between 100 and 700 nm.

5. The substrate according to claim 3, Among them, wherein the first roughness value is between 1 and 5 nm, and / or the second roughness value is between 100 and 300 nm.

6. The substrate according to claim 3, Among them, wherein the second roughness value is between 300 and 500 nm.

7. The substrate according to claim 1, Among them, wherein the height value is defined by the height at the maximum height point of the first part in the height profile; wherein the ratio of the height value to the depth value is between 100 and 2000, and / or wherein the height value is between 0.1 and 20 mm.

8. The substrate according to claim 7, Among them, wherein the height value is between 0.5 and 15 mm.

9. The substrate according to claim 7, Among them, wherein the height value is between 0.7 and 1.7 mm.

10. The substrate according to any one of claims 1 - 9, Among them, above or below the first surface region, for at least one concentration ratio of at least two materials at at least one different depth in or below the first surface region of the substrate, the substrate has at least one first ratio; Wherein, above or below the second surface region, the substrate has at least one second ratio for at least one concentration ratio of two materials at at least one different depth of the substrate in or below the second surface region.

11. The substrate according to claim 10, wherein, (i) The concentration ratio of the two materials is the concentration ratio of material B to Si, Na to Si, Ca to Si, or Al to Si; (ii) The different depth is a depth up to 2 μm below the corresponding surface region; and / or (iii) The concentration ratio of the two materials is obtained and / or can be obtained at at least one position of the corresponding surface region by at least one ToF-SIMS measurement.

12. The substrate according to claim 11, wherein, The different depth is a depth up to 1 μm below the corresponding surface region.

13. The substrate according to claim 11, wherein, The different depth is a depth up to 0.5 μm below the corresponding surface region.

14. The substrate according to claim 11, wherein, The different depth is a depth up to 0.2 μm below the corresponding surface region.

15. The substrate according to any one of claims 1-9, Among them, The substrate at least partially comprises glass; and at least one polymer material.

16. The substrate according to claim 15, Among them, The substrate at least partially comprises silicate glass; and cycloolefin copolymer (COC) or cycloolefin polymer (COP).

17. The substrate according to claim 15, Among them, The substrate at least partially comprises aluminosilicate glass and / or borosilicate glass; and cycloolefin copolymer (COC) or cycloolefin polymer (COP).

18. The substrate according to any one of claims 1-9, The cavity is in the form of at least one dot-like and / or line-like element.

19. The substrate according to any one of claims 1-9, wherein, (i) The marking element is in the form of at least one one-dimensional data code, at least one two-dimensional data code, and / or at least one three-dimensional data code; (ii) The second surface region is the central part of the surface of the cavity, and / or (iii) The first surface region is at least a part of the surface corresponding to at least one region of the marking element, the at least one region representing the bit set to "zero" in the marking element, and / or the second surface region is at least a part of the surface corresponding to at least one region of the marking element, the at least one region representing the bit set to "one" in the marking element.

20. The substrate according to claim 19, wherein (i) The marking element is in the form of at least one matrix code.

21. The substrate according to claim 19, wherein, (i) The marking element is in the form of at least one dot matrix code.

22. The substrate according to any one of claims 1-9, Among them, The depth value and / or the maximum depth or average depth of the cavity is between 0.1 and 5 μm.

23. The substrate according to claim 22, wherein, The depth value and / or the maximum depth or average depth of the cavity is between 0.1 and 4 μm.

24. The substrate according to claim 22, wherein, The depth value and / or the maximum depth or average depth of the cavity is between 0.1 and 3 μm.

25. The substrate according to claim 22, wherein, The depth value and / or the maximum depth or average depth of the cavity is between 1 and 3 μm.

26. The substrate according to claim 22, wherein, The depth value and / or the maximum depth or average depth of the cavity is between 1 and 2 μm.

27. The substrate according to claim 22, wherein, The depth value and / or the maximum depth or average depth of the cavity is between 1.5 and 2.5 μm.

28. The substrate according to claim 22, wherein The depth value and / or the maximum depth or average depth of the cavity is between 2 and 3 μm.

29. The substrate according to claim 22, wherein The depth value and / or the maximum depth or average depth of the cavity is between 2 and 5 μm.

30. The substrate according to claim 22, wherein, The depth value and / or the maximum depth or average depth of the cavity is between 3 and 5 μm.

31. The substrate according to any one of claims 1-9, Among them, The marking element has an extension of 0.1 to 50 mm in at least one direction along the substrate surface, the marking element is machine-readable and is produced by or can be produced by at least one etching technique.

32. The substrate according to claim 31, wherein, The marking element has an extension of 0.5 to 30 mm in at least one direction along the substrate surface and is produced by or can be produced by at least one laser.

33. The substrate according to claim 31, wherein, The marking element has an extension of 0.5 to 10 mm in at least one direction along the substrate surface and is produced by or can be produced by dry etching.

34. The substrate according to claim 31, wherein The marking element has an extension of 0.5 to 5 mm in at least one direction along the substrate surface.

35. The substrate according to any one of claims 1-9, Among them, The first surface area and the second surface area are adjacent to and / or connected to each other.

36. The substrate according to any one of claims 1-9, Among them, Regarding the first roughness value, the second roughness value and / or the depth value, the first surface area and the second surface area are designed such that when a certain amount of electromagnetic radiation is emitted to the first surface area or the second surface area by means of at least one electromagnetic radiation source, at least one first part or at least one second part of the certain amount of electromagnetic radiation is reflected and / or scattered by the first surface area or the second surface area towards at least one receiver; wherein the first part of the certain amount is less than the second part of the certain amount; wherein the amount of electromagnetic radiation is an amplitude value or a power value, and / or the first part of the certain amount of electromagnetic radiation is 10, 100, 1000 or 10000 times lower than the second part of the certain amount of electromagnetic radiation; wherein (i) the certain amount of electromagnetic radiation is emitted towards the first surface area and the second surface area and received by the receiver, so that a dark field technique can be used to evaluate the first part and the second part of the certain amount, and / or (ii) the emission direction of the electromagnetic radiation is not parallel or anti-parallel to the reception direction of the electromagnetic radiation.

37. The substrate according to claim 36, Among them, The electromagnetic radiation is in the visible, infrared or ultraviolet spectrum, or the electromagnetic radiation is radiation in the microwave spectrum.

38. The substrate according to claim 37, Among them, The electromagnetic radiation is in the visible, infrared or ultraviolet spectrum and is emitted by at least one laser.

39. The substrate according to claim 38, Among them, The electromagnetic radiation is in the visible, infrared or ultraviolet spectrum and is emitted by at least one ultraviolet laser, a diode-pumped solid-state (DPSS) laser, a fiber laser or a flash-lamp-pumped solid-state laser.

40. A container comprises the substrate according to any one of claims 1-39.

41. The container according to claim 40, which is a vial, a syringe tube or a cartridge.

42. A method for producing a substrate according to any one of claims 1 - 39, comprising the following steps: - providing a substrate; wherein the substrate has at least one first surface region, and on the first surface region, with respect to at least one surface roughness of the first surface region, the substrate has at least one first roughness value; - providing at least one material removal device, which is designed to remove material from at least one surface region of the substrate; and - by means of the material removal device, removing material from at least one region of the surface of the substrate, thereby forming at least one cavity, which has at least one second surface region; wherein material is removed from the surface of the substrate such that on the second surface region, with respect to the surface roughness of the second surface region, the substrate has at least one second roughness value; wherein further material is removed from the surface of the substrate such that in at least one height profile of the substrate along at least one cutting line that at least partially passes through the first surface region and the second surface region, the height of the substrate along a first part of the height profile corresponding to the first surface region is greater than the height of the substrate along a second part of the height profile corresponding to the second surface region; wherein in the height profile, the absolute value of the height difference between the maximum height point or at least one average height of the second part and the minimum height point or at least one average height of the first part is defined as the depth value; wherein the ratio of the depth value to the second roughness value is between 2 and 35.

43. The method according to claim 42, wherein, The substrate is a glass substrate.

44. The method according to claim 42, wherein, The material removal device includes at least one laser.

45. The method according to claim 42, wherein, The material removal device includes a UV laser, a diode - pumped solid - state laser, a fiber laser, or a flash - lamp - pumped solid - state laser.

46. The method according to claim 42, wherein, Removing material near the first surface region, thereby forming at least one cavity.

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