Device for a specimen, system and use

Abstract

The present invention relates to a device for receiving a sample body, comprising a linear displacement unit and a sample receiving unit mounted thereon. The sample receiving unit comprises a base plate with a support column arranged thereon and a first and second support plate. A cross member, to which a holding bracket is arranged, is arranged on the support column. The sample receiving unit further comprises a rotation unit with at least two rotation shafts, wherein the rotation unit is configured to receive a coated sample body. The sample body can be arranged on the device by means of the holding bracket in such a way that the layer thickness of the coating of a sample body can be determined using a light source.

Description

[0001] The present invention relates to a device for receiving a sample body, wherein the device comprises a linear displacement unit and a sample receiving unit mounted thereon. The sample receiving unit comprises a support column arranged on a base plate, as well as a first and a second support plate. A cross member, to which a holding bracket is arranged, is arranged on the support column. The sample receiving unit further comprises a rotation unit with at least two rotation shafts, wherein the rotation unit is configured to receive a coated sample body and rotate it so that the layer thickness of the coating on the sample body can be determined using a light source.

[0002] The device according to the invention is designed to receive coated sample bodies and position them so that a stationary light source can measure or determine the layer thickness of the coated sample body. Furthermore, the present invention encompasses a system comprising a device according to the invention and a light source. Furthermore, the use of a device or system for measuring the layer thickness of a sample body is encompassed. State of the art

[0003] It is known from the prior art that sample bodies, such as syringes and vials, are coated, in particular with a silicone layer, which is usually applied inside the sample body. Such coatings serve, on the one hand, to reduce friction between the syringe body and the syringe plunger. On the other hand, such coatings within such sample bodies enable the complete removal of solutions contained within the sample body, for example, using a syringe, since the coating ensures that the adhesion of the solutions to the vial walls is reduced.

[0004] For quality assurance and to determine the storage stability of ready-to-use solutions in sample bodies, it is necessary to determine the layer thickness with which the sample body is coated inside the sample body. Sample bodies are usually provided with a silicone layer. Silicone layers have the advantage of being inert compared to most conventional solvents and many pharmaceutical active ingredients. However, after a certain storage time, the silicone layers can at least partially dissolve or otherwise detach from the sample body. To ensure consistent quality, it is very important that the sample bodies have a certain layer thickness. The layer thickness is conventionally determined by measuring the layer thickness of the sample bodies. One method used for this is lasers (monochromatic light), which then measure the sample body.Based on the reflection or absorption of the emitted light, the layer thickness of the sample can be determined using conventional, state-of-the-art methods. For this purpose, the light source is usually coupled to an evaluation unit. Evaluation units can be, for example, computers, laptops, tablets, etc., with software installed on them that can evaluate the measurement data to determine the layer thickness.

[0005] In the prior art systems for determining the layer thickness of a sample body, the light source is fixed in position. This means that the sample body is moved, with the light source always only measuring a specific area on one surface of the sample body. Using the monochromatic light, points of a few micrometers on the surface of the sample body are then gradually irradiated and measured as the sample body is moved, and the layer thickness of the sample body is then determined from the measurement results. In order to obtain accurate measurement results, it was previously necessary to readjust the evaluation unit used to evaluate the measurement results several times. This is because moving the sample body on the sample body holder often required a new zero measurement for adjustment in order to obtain accurate measurement results.However, this is extremely time-consuming, expensive and therefore undesirable.

[0006] It was therefore an object of the present invention to circumvent the problems known from the prior art. In particular, it was an object to improve a conventional setup for determining the layer thickness of sample bodies such that the layer thickness of a sample body can be determined without having to perform a new zero measurement when moving the sample body on the sample body support device.

[0007] These and other problems of the prior art are solved by the subject matter of the independent patent claims. Preferred embodiments are part of the dependent patent claims or are described in more detail below. Description of the invention

[0008] According to the invention, a device for receiving a sample body is proposed, which has at least one linear displacement unit and a sample receiving unit. The sample receiving unit further comprises at least one base plate, a first carrier plate and a second carrier plate mounted thereon, a carrier column and a cross member, a rotation unit, and a holding bracket. The sample receiving unit is displaceably mounted on the linear displacement unit. The carrier column is arranged substantially orthogonally on the base plate. The first carrier plate is displaceably mounted at least partially on the carrier column. The cross member is arranged on the carrier column, and the holding bracket is arranged on the cross member. The rotation unit is arranged on the second carrier plate and comprises two rotation shafts.The rotation unit is configured to receive a sample body, and the holding bracket is configured to at least partially position and fix a sample body on the rotation unit so that the sample body can be measured by a stationary light source, i.e. the layer thickness can be determined.

[0009] Surprisingly, it was found that, using a device according to the invention, sample bodies arranged thereon can be measured simply and without great expenditure of time with regard to their layer thickness, without the measuring system, which, in addition to the device, also comprises a stationary light source and an evaluation unit, having to be constantly readjusted or adjusted.

[0010] Furthermore, the present invention comprises a system comprising a light source and a device according to the invention, wherein the light source is designed to determine the layer thickness of a sample body, in particular a silicone layer.

[0011] The present invention also encompasses the use of a device according to the invention and a system according to the invention in measuring the layer thickness of a sample body. Detailed description of the invention

[0012] The device according to the invention for holding a sample body has at least one linear displacement unit and a sample receiving unit. The sample receiving unit comprises a base plate, a first and a second support plate, a support column, a cross member, a rotation unit, and a holding bracket. The sample receiving unit is mounted on the linear displacement unit. The linear displacement unit has a first end and an opposite second end. A first axis, along which the sample receiving unit can be displaced, extends between the first and second ends.

[0013] In a preferred embodiment, the linear displacement unit has guide rails on which the sample receiving unit is mounted. It may be preferable for the linear displacement unit to have a motor configured to move the sample receiving unit along the first axis. The motor can be an electric motor, for example, and is preferably arranged at the first or second end of the linear displacement unit.

[0014] The sample receiving unit further comprises a support column arranged substantially orthogonally on the base plate of the sample receiving unit. In a preferred embodiment, the sample receiving unit has at least two support columns, more preferably at least four support columns. In this embodiment, the base plate is further preferably configured as a rectangle, and the four support columns are each arranged at the four corners of the rectangular base plate.

[0015] According to the invention, the sample receiving unit comprises a first and a second support plate, wherein the second support plate is mounted on the first support plate. The first support plate is at least partially mounted on the support column. In a preferred embodiment, in which the sample receiving unit comprises four support columns, the first support plate is at least partially mounted on the four support columns.

[0016] The sample receiving unit comprises a cross member arranged on at least one support column. In particular, the cross member is arranged orthogonally to the support column. In a preferred embodiment, in which the device according to the invention comprises two support columns, the cross member is arranged between the two support columns and is in contact with both support columns. In a further preferred embodiment, in which the device comprises four support columns, the sample receiving unit preferably has two cross members, wherein more preferably both cross members are arranged parallel to one another and both cross members are each connected to two support columns.

[0017] The first support plate is movable along a second axis. The second axis runs orthogonally to the first axis and extends from the base plate toward the cross member. Movement along the second axis can be performed manually, for example. For this purpose, the first support plate is moved along the second axis, in particular, by exerting pressure. It is also possible for the first support plate to be moved by means of a motor. The second support plate is mounted on the first support plate. Thus, when the first support plate moves, the second support plate moves along with it.

[0018] In a preferred embodiment, a bearing, in particular a ball bearing, is arranged between the first support plate and the second support plate. In this embodiment, it can be further preferred that the second support plate is arranged such that it can be displaced along a third axis, which extends orthogonally to the first axis and the second axis. In this preferred embodiment, the first support plate is arranged at least partially on the support columns, wherein preferably the second support plate does not touch the support columns and is arranged such that it can be displaced between them along the third axis. Likewise, in a further preferred embodiment, it can be provided that the second support plate is also displaceable along the first axis, which extends from the first end to the second end of the linear displacement unit.

[0019] The sample receiving unit further comprises a holding bracket arranged on the cross member. In particular, the holding bracket is arranged orthogonally on the cross member. The holding bracket is designed to at least partially fix or position a sample body on the rotation unit belonging to the sample receiving unit. In a preferred embodiment, the sample receiving unit of the device according to the invention comprises two holding brackets. In a further preferred embodiment, in which the sample receiving unit comprises at least two support columns, in which both support columns are connected to one another via a cross member, the holding bracket is displaceable along the first axis. In a further preferred embodiment, this can be achieved by means of a guide track arranged on the cross member, which allows the holding bracket to be moved along the first axis.First, second and third axes in the sense of the present invention mean the three axes of a Cartesian coordinate system which are orthogonal to one another, analogous to the X, Y and Z axes of a Cartesian coordinate system.

[0020] In a further preferred embodiment, in which the sample receiving unit comprises at least four support columns which are arranged in the four corners of a rectangular base plate, and in which two support columns are each connected to one another via a cross member, and wherein the cross members run parallel to one another, the holding bracket, more preferably at least two holding brackets, are in contact with both cross members. It may also be preferred that at least one of the holding brackets is arranged to be movable along the first axis, for example along a guide track arranged on the cross member. It may also be preferred that both holding brackets are movable along the first axis.

[0021] The sample receiving unit of the device according to the invention comprises a rotation unit arranged on the second carrier plate. The rotation unit comprises at least two rotation shafts and is configured to receive a coated sample body so that a stationary light source can measure or irradiate the sample body. The rotation shafts are designed in particular such that they run parallel to one another and a sample body can rest on them. In a preferred embodiment, the rotation shafts can be rotated clockwise or counterclockwise by means of a motor. A sample body within the meaning of the present invention is an elongated body with a first end and an opposite second end, between which a rotation axis extends.By rotating the rotating shafts, a sample body arranged on the rotating unit can be examined for layer thickness using a light source. When the sample body is irradiated using a stationary light source, a sample body arranged on the rotating unit can be rotated along its axis of rotation by turning the rotating shafts clockwise or counterclockwise, thus measuring the entire circumference of the sample body. By moving the sample holder unit along the first axis, the entire surface area of ​​the sample body can be measured. It is possible to first rotate the sample body and then move the sample holder unit along the first axis, or to first measure the sample body from its first end to its second end using the light source and then rotate the sample body around the axis of rotation.

[0022] In a preferred embodiment, the support column(s) has(have) a guide rail. It is preferred that all support columns have a guide rail. The first support plate is preferably mounted on the guide rail; in particular, it is preferred that the first support plate is mounted on the guide rails of all support columns, with a sample receiving unit with a total of four support columns being preferred. The first support plate can be moved along the second axis along the guide rails.

[0023] In a preferred embodiment, the cross member has a guide track; preferably, the device comprises two cross members arranged parallel to one another, each with a guide track. The guide track is designed so that the holding bracket can be arranged on the guide track and so that the holding bracket is movable along the guide track. The holding bracket is designed to fix a sample body on the rotation unit. The holding bracket can have different designs, particularly depending on the shape of the sample body. It may be preferred for the holding bracket to be at least partially coated, for example with a Teflon layer. The Teflon layer can prevent perforations from occurring on the outer surface of a sample body when fixing or positioning it on the rotation unit.This also prevents the specimen from being rotated by the rotation unit if it is fixed too tightly between the holding bracket and the rotation unit.

[0024] In a preferred embodiment, at least one support roller is arranged on each of the two rotating shafts. More preferably, the support roller is displaceable along the first axis. It may be further preferred that at least two support rollers are arranged on each of the two rotating shafts. The support rollers are designed so that a sample body rests thereon. By rotating the rotating shafts clockwise or counterclockwise, the support rollers are also rotated clockwise or counterclockwise. By rotating the rotating shafts, in a state according to application, a sample body located on the rotating unit is rotated about its axis of rotation and can be measured with regard to the layer thickness using a light source. It may be further preferred that support surfaces are arranged on the support rollers, in particular in the form of rubber rings, which at least partially encircle the support rollers.These have the advantage of preventing unintentional displacement of the specimen, particularly in the direction of the first axis, when the rotating shafts rotate. It is preferred that the support rollers on the rotating shafts be movable along the first axis.

[0025] In a preferred embodiment, the rotation unit comprises a motor unit designed to rotate both rotation shafts so that both rotation shafts rotate clockwise or counterclockwise. The motor unit that drives the rotation unit is, for example, an electric motor.

[0026] In a further preferred embodiment, the sample receiving unit additionally comprises a spring roller, particularly preferably at least two spring rollers. In one embodiment, the spring roller is arranged on a support column and has a spring band which is arranged on the first support plate. The first support plate is displaceable along the second axis; the spring roller and the spring band, which connects the spring roller to the first support plate, allow the contact pressure of the first support plate against the holding bracket to be more precisely controlled. In a suitable application state, the first support plate, on which the second support plate is mounted and on which, in turn, the rotation unit is arranged, is displaced in the direction of the holding brackets. The holding brackets are designed to fix a sample body on the rotation unit so that a light source can measure the layer thickness of a sample body.The spring roller and the spring band, which connects the spring roller to the first carrier plate, regulates the contact pressure on the holding brackets and prevents the holding brackets from resting too tightly on the sample body or the rotation unit from pressing the sample body too tightly against the holding bracket.

[0027] The device according to the invention enables the layer thickness of coated specimens to be determined quickly and easily using conventional means, using a conventional setup comprising a light source and an evaluation unit. In particular, the device according to the invention enables a specimen to be positioned in such a way that it can be measured without multiple zero measurements or readjustment of the evaluation unit.

[0028] The present invention also encompasses a system comprising at least one device according to the invention and a light source, preferably a laser. The laser is designed to measure the layer thickness of a layer located in a sample body. In a further preferred embodiment, the system additionally comprises an evaluation unit, wherein the evaluation unit is in particular a computer configured to evaluate the measurement data from the light source. In yet another preferred embodiment, the system comprises the sample body itself, wherein the sample body is in particular a coated syringe or a coated vial.

[0029] Furthermore, the present invention encompasses the use of a device according to the invention or a system according to the invention for measuring the layer thickness of a sample body.

[0030] Further advantageous embodiments are explained with reference to the following figures.

[0031] Fig. 1 shows an embodiment of a preferred device 1 according to the invention for receiving a sample body. The device 1 comprises a linear displacement unit 2 and a sample receiving unit 3 mounted on the linear displacement unit 2. The sample receiving unit 3 further comprises a base plate 4, a first support plate 5, a second support plate 6, four support columns 7, and two cross beams 8. The base plate 4 of the sample receiving unit 3 is rectangular. A total of four support columns 7 are arranged at the four corners of the rectangular base plate 4. Furthermore, guide rails 14 are arranged on the support columns 7, on which guide rails the first support plate 5 is arranged so as to be movable upwards or downwards along the second axis.

[0032] “Downward” means in the direction of the base plate 4 and “upward” means in the direction of the cross members 8.

[0033] The sample receiving unit 3 is mounted on the linear displacement unit 2. The linear displacement unit 2 has guide rails 21 on which the sample receiving unit 3 can be moved along the first axis on the linear displacement unit 2. The linear displacement unit 2 has a motor 18 via which the sample receiving unit 3 can be moved along the first axis.

[0034] The sample receiving unit 3 comprises two crossbeams 8 arranged parallel to one another. The crossbeams 8 each connect two support columns 7 to one another. The crossbeams 7 and the support columns 8 are arranged orthogonally to one another. The two crossbeams 8 each have a guide track 15 on which two retaining brackets 10 are arranged. In this preferred embodiment, the retaining brackets 10 are arranged so as to be movable along the guide tracks 15 arranged on the crossbeams 8. The retaining brackets 10 are arranged on the guide tracks 15 of the two crossbeams 8.

[0035] A rotation unit 9 is arranged on the second carrier plate 6. The rotation unit 9 comprises two rotation shafts 11, which are rotated clockwise or counterclockwise by the motor unit 17. In this embodiment, the motor unit 17 is an electric motor. A bearing (not shown) is arranged between the first carrier plate 5 and the second carrier plate 6. It can be seen that the second carrier plate 6 is not arranged on the four carrier columns 7 or does not touch them. The bearing, which is arranged between the first carrier plate 5 and the second carrier plate 6 (not shown), allows the second carrier plate 6 to be moved along the third axis. This has the effect, among other things, that a sample body 12 (not shown), which is arranged on the rotation unit 9, can be positioned by moving the second carrier plate 6 along the third axis so that it is arranged between the two holding brackets 10.This advantageous embodiment makes it possible for a light source, for example a laser, to irradiate a sample body with monochromatic light in order to determine the layer thickness of the coated sample body. The sample body can be measured over its entire extent. The sample receiving unit 3 can be moved along the first axis on the linear displacement unit 2, and a sample body 12 can be measured by a light source. Subsequently, the rotation unit 9 or the two rotation shafts 11 can rotate the sample body 12 by a specific amount clockwise or counterclockwise, so that the light source can again scan or measure the sample body 12.

[0036] Spring rollers 19 are arranged on two of the support columns 7. The two spring rollers 19 are each in contact with the first support plate 5 via a spring band 22 (not shown). The spring band 22 and the spring roller 19 can be used to control the contact pressure of the specimen 12 against the holding brackets 10. Among other things, this can prevent a specimen located in the rotation unit 9 from being damaged or perforated during a movement along the second axis in the direction of the holding brackets 10.

[0037] Fig. 2 and Fig. 3 show the device according to the invention according to the Fig. 1, with the proviso that a sample body 12 is arranged on the rotation unit 9. The Fig. 2 a specimen on the rotation unit, whereby the holding brackets and the specimen are not yet centered and the Fig. 3 shows a centered sample body, which is arranged on the rotation unit 9 and fixed by the holding brackets 10. In this embodiment, the sample body can be irradiated by a light source in order to determine the layer thickness of the sample body.

[0038] Support rollers 16 are arranged on the rotating shafts 11. These support rollers 16 are arranged on the rotating shafts so that they can be moved along the first axis. These ensure that the specimen 12 can be more easily adjusted or positioned under the holding brackets. The adjustment or positioning of the specimen 12 is achieved in particular by moving the second carrier plate 6 along the third axis, the support rollers 16, and by moving the holding brackets 10.

[0039] Fig. 4 and the Fig. 5 show a plan view of a device 1 according to the invention, wherein the Fig. 4 without a specimen 12 and the Fig. 5 with a sample body 12 resting on the rotation unit 9. The sample body 12 is arranged on the rotation shafts 11 of the rotation unit 9. In Fig. 5 shows that the sample body 12 is arranged on a total of four support rollers 16. Two support rollers 16 are arranged on each rotating shaft 11. It can be seen that the support rollers 16 are movable along the rotating shafts 11. The sample body 12 is fixed to the rotating shaft 11 by two holding brackets 10. The holding brackets 10 are arranged on two crossbeams 8. Spring rollers 19 with spring bands 20 are arranged on two support columns 7. The spring bands 20 are connected to the first carrier plate 5. This arrangement allows the contact pressure of the first carrier plate 5 in the direction of the holding brackets 10 to be controlled. This prevents damage to the sample body during adjustment of the sample body in the device according to the invention.

[0040] Fig. Figure 6 shows a rotation unit 9 with two rotation shafts 11. The two rotation shafts 11 are controlled by a motor unit 17 and can thus be rotated clockwise or counterclockwise. Two support rollers 16 are arranged on each of the rotation shafts 11. These rollers are slidably mounted on the rotation shafts 11. List of reference symbols: 1 Device for holding a sample body 2 linear displacement units 3 Sample collection unit 4 Base plate 5 first carrier plate 6 second carrier plate 7 Support column 8 cross members 9 Rotation unit 10 support brackets 11 Rotating shaft 12 specimens 13 camps 14 Guide rail 15 guideway 16 support roller 17 Motor unit 18 Engine 19 spring roller 20 spring band 21 Guide rail

Claims

[1] Device for receiving a sample body (1), at least comprising: - a linear displacement unit (2) having a first and an opposite second end, and - a sample receiving unit (3), wherein the sample receiving unit (3) comprises at least: - a base plate (4), - a first (5) and a second support plate (6) mounted thereon, - a support column (7), - a cross member (8), - a rotation unit (9), - a holding bracket (10), wherein the sample receiving unit (3) is mounted on the linear displacement unit (2), wherein the support column (7) is arranged substantially orthogonally on the base plate (4), wherein the first support plate (5) is mounted on the support column (7), wherein the cross member (8) is arranged on the support column (7), wherein the retaining bracket (10) is mounted on the cross member (8), wherein the rotation unit (9) is arranged on the second carrier plate (6), wherein the rotation unit (9) comprises at least two rotation shafts (11), wherein the rotation unit (9) is adapted to receive a sample body (12), wherein the holding bracket (10) is designed to fix a sample body (12) at least partially on the rotation unit (9), wherein the sample receiving unit (3) is mounted on the linear displacement unit (2) so as to be displaceable along a first axis, wherein the first axis extends from the first end to the opposite second end of the linear displacement unit (2), wherein the first support plate (5) is mounted on the support column (7) so as to be displaceable along a second axis, wherein the second axis is orthogonal to the first axis and extends from the base plate (4) in the direction of the cross member (8). [2] Device according to claim 1, wherein a bearing, in particular a ball bearing, is arranged between the first carrier plate (5) and the second carrier plate (6), and / or wherein preferably the second carrier plate (6) is arranged displaceably along a third axis, wherein the third axis extends orthogonally to the first and orthogonally to the second axis. [3] Device according to one of the preceding claims, comprising at least four support columns (7), preferably comprising at least two cross beams (8), wherein further preferably the two cross beams (8) run at least partially parallel to one another, wherein even more preferably each cross beam (8) is arranged between two support columns (7). [4] Device according to one of the preceding claims, wherein one or more of the support columns (7) have a guide rail (14), preferably all support columns (7), and / or wherein the first support plate (5) is arranged on the guide rail (14), and / or wherein one or more of the cross beams (8) have a guide track (15), wherein preferably the retaining bracket (10) is arranged on the guide track (15). [5] Device according to one of the preceding claims, comprising at least two retaining brackets (10), wherein at least one retaining bracket (10), preferably all retaining brackets (10), is displaceable along the first axis. [6] Device according to one of the preceding claims, wherein at least one support roller (16) is arranged on each of the two rotary shafts (11), wherein preferably the support roller (16) is displaceable along the first axis, wherein further preferably at least two support rollers (16) are arranged on each of the two rotary shafts (11). [7] Device according to one of the preceding claims, wherein the rotation unit (9) comprises a motor unit (17), wherein the motor unit (17) is designed to rotate both rotation shafts (11), wherein in particular both rotation shafts (11) rotate clockwise or counterclockwise. [8] Device according to one of the preceding claims, wherein the linear displacement unit (2) comprises a motor (18), wherein the motor (18) is adapted to displace the sample receiving unit (3) along the first axis. [9] Device according to one of the preceding claims, wherein the sample receiving unit (3) comprises a spring roller (19), in particular two spring rollers (19), wherein preferably each spring roller is arranged on a support column (7), wherein preferably both support columns (7) are connected to a cross member (8), wherein more preferably the spring roller (19) is connected to the first support plate (5) via a spring band (20). [10] System comprising a device according to one of claims 1 to 9 and a light source, wherein the light source is designed to determine the thickness of a layer, in particular a silicone layer, of a coated sample body. [11] System according to claim 10, additionally comprising a sample body, wherein the sample body is preferably a syringe or a vial. [12] Use of a device according to one of claims 1 to 9 or of a system according to one of claims 10 or 11, for measuring the layer thickness of a sample body.

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