Methods and apparatus for analyzing devices used in spraying pharmaceutical fluid products

Abstract

The present invention relates to a method for analyzing an apparatus for spraying a pharmaceutical fluid product, comprising the following steps: - providing a nozzle (1) for spraying a pharmaceutical fluid product, the nozzle (1) including a nozzle (2); - providing a receiving surface (10) including a plurality of separate contact areas (12) separated by gaps (13), the contact areas (12) being capable of being coated with a heat-sensitive material; - bringing the receiving surface (10) to a temperature T2; - passing a compressed gas flow (F1) through the nozzle (2) of the nozzle (1), the compressed gas flow (F1) being at a temperature T1 different from T2; - sending the compressed gas flow (F1) at temperature T1 onto the receiving surface (10) at temperature T2; - visualizing the impact zone of the compressed gas flow (F1) on the receiving surface (10); and - analyzing the visualization of the impact zone to determine whether the nozzle (1) conforms to a predetermined specification.

Description

Technical Field

[0001] This invention relates to an apparatus and method for analyzing sprays generated by a device for spraying drug fluid. Background Technology

[0002] Devices for spraying drug fluids are well known. They typically include a nozzle with orifices mounted on a container holding the fluid product to be dispensed. Particularly in nasal spray applications, the therapeutic effect of the spray fluid product can depend on the nature of the spray produced when the device is actuated. At the end of the assembly line, i.e., once the spraying device has been assembled and just before being sent to the drug fluid manufacturer for assembly into the appropriate reservoir, a certain number of samples of the assembled device are known to be laboratory-tested to check whether the characteristics of the spray correspond to predefined production specifications.

[0003] The drawback of this system is that it is an assembled device, which in turn damages devices that cannot be delivered to customers after testing.

[0004] Furthermore, the system requires manual inspection of the device under test, and is therefore not entirely suitable for full automation.

[0005] To overcome this drawback, document WO2018 / 130791 proposes visualizing the hot or cold compressed airflow delivered through the nozzle using strioscopy. This method allows estimation of the spray angle, but not its geometry or symmetry. This also presents the disadvantage of requiring a strioscopy stage, which is relatively complex and expensive, difficult to integrate into the assembly line of the fluid jetting device, and therefore involves random testing only on a portion of the manufactured device, or slowing down the assembly line, which is generally undesirable.

[0006] Documents EP3047912, JPH0599802 and JPS54127347 describe other prior art devices. Summary of the Invention

[0007] The purpose of this invention is to overcome the above-mentioned disadvantages.

[0008] In particular, the object of the present invention is to provide an apparatus and method for analyzing a liquid pharmaceutical product that is sprayed without damaging the device being tested.

[0009] Another object of the present invention is to provide a substantially automated apparatus and method for analysis.

[0010] The present invention also aims to provide an apparatus and method for analysis that can test 100% of the spraying equipment without slowing down the assembly line to a considerable extent.

[0011] Another object of the present invention is to provide an apparatus and method for analysis that are simple and / or inexpensive to manufacture, assemble and use.

[0012] Therefore, a method for analyzing an apparatus for spraying a pharmaceutical fluid product is provided, comprising the following steps:

[0013] A nozzle is provided for a device for spraying pharmaceutical fluid products, the nozzle including a spray orifice.

[0014] A receiving surface is provided, comprising a plurality of separate contact areas separated by gaps, the contact areas being coated with a heat-sensitive material.

[0015] Make the receiving surface reach temperature T2.

[0016] The compressed gas flow is forced through the nozzle orifice of the nozzle, and the compressed gas flow is at a temperature T1 different from T2.

[0017] An airflow of compressed gas at temperature T1 is sent to a receiving surface at temperature T2, making the impact zone of the compressed gas airflow on the receiving surface visible.

[0018] Analyze the visualization of the impact zone to determine whether it conforms to the predetermined specifications.

[0019] The present invention also provides a method for analyzing an apparatus for spraying a pharmaceutical fluid product, comprising the following steps:

[0020] A nozzle is provided for a device for spraying pharmaceutical fluid products, the nozzle including a spray orifice.

[0021] A receiving surface is provided, comprising a plurality of separate contact areas separated by gaps.

[0022] Make the receiving surface reach temperature T2.

[0023] The compressed gas flow is forced through the nozzle orifice of the nozzle, and the compressed gas flow is at a temperature T1 different from T2.

[0024] An airflow of compressed gas at temperature T1 is sent to a receiving surface at temperature T2.

[0025] A thermal camera is used to visualize the impact zone of the compressed gas flow on the receiving surface, and

[0026] Analyze the visualization of the impact zone to determine whether it conforms to the predetermined specifications.

[0027] Advantageously, the airflow of compressed gas is the airflow of compressed air.

[0028] Advantageously, the analytical steps include determining the geometry, and in particular the symmetry, of the impact zone of the compressed gas flow on the receiving surface.

[0029] Advantageously, the predetermined specification includes a predetermined planar range of the impact zone of the compressed gas flow on the receiving surface, in such a way that nozzles with a planar range similar to the predetermined planar range are classified as compliant, and nozzles with a planar range different from the predetermined planar range are classified as non-compliant.

[0030] Advantageously, the operating cycle includes the following steps:

[0031] An airflow of compressed gas at temperature T1 is sent to a receiving surface at temperature T2.

[0032] The first image of the receiving surface is captured by a camera.

[0033] The airflow of the second air at temperature T2 is sent to the receiving area.

[0034] Take a second image of the receiving surface, and

[0035] Subtract the second image from the first image to visualize the impact zone.

[0036] Advantageously, the operating cycle includes the following steps:

[0037] The airflow of the second air at temperature T2 is sent to the receiving area.

[0038] The first image of the receiving surface is captured by a camera.

[0039] An airflow of compressed gas at temperature T1 is sent to a receiving surface at temperature T2, and a second image of the receiving surface is captured.

[0040] Subtract the first image from the second image to visualize the impact zone.

[0041] The present invention also relates to an apparatus for analyzing a device for spraying a pharmaceutical fluid product, comprising:

[0042] A nozzle for a device used to spray pharmaceutical fluid products, the nozzle comprising a spray orifice.

[0043] The receiving surface includes multiple separate contact areas separated by gaps, and the contact areas are coated with a heat-sensitive material.

[0044] A temperature regulating device is used to bring the receiving surface to temperature T2.

[0045] An apparatus for generating a flow of compressed gas, such that the flow of compressed gas flows through the nozzle orifice onto a receiving surface at temperature T2, wherein the flow of compressed gas is at a temperature T1 different from T2.

[0046] Visualization devices, such as cameras, are used to visualize the impact zone of the compressed gas flow on the receiving surface, and

[0047] An analytical apparatus for visualizing the impact zone in order to determine whether the impact zone conforms to predetermined specifications.

[0048] The present invention also relates to an apparatus for analyzing a device for spraying a pharmaceutical fluid product, comprising:

[0049] A nozzle for a device used to spray pharmaceutical fluid products, the nozzle comprising a spray orifice.

[0050] The receiving surface includes multiple separate contact areas separated by gaps.

[0051] A temperature regulating device is used to bring the receiving surface to temperature T2.

[0052] An apparatus for generating a flow of compressed gas, such that the flow of compressed gas flows through the nozzle orifice onto a receiving surface at temperature T2, wherein the flow of compressed gas is at a temperature T1 different from T2.

[0053] A thermal camera is used to visualize the impact zone of compressed gas flow on a receiving surface, and

[0054] An analytical apparatus for visualizing the impact zone in order to determine whether the impact zone conforms to predetermined specifications.

[0055] Advantageously, the airflow of compressed gas is the airflow of compressed air.

[0056] Advantageously, the temperature regulating device includes means for generating a second airflow so as to generate a second airflow at temperature T2.

[0057] Advantageously, the temperature control device includes a heating wire and a resistor.

[0058] Advantageously, the receiving surface is formed by the ends of a plurality of points arranged in an array, the ends forming contact areas.

[0059] Advantageously, the point is fixed to the base.

[0060] Advantageously, the points are equidistant from each other and close to each other, thus forming a regular and dense array of contact areas on the receiving surface.

[0061] Advantageously, heat-sensitive materials are suitable for coatings that change color according to temperature.

[0062] Advantageously, the apparatus for generating the gas flow of compressed gas is suitable for generating pulses with adjustable duration, particularly from 50 ms to 300 ms. Attached Figure Description

[0063] These and other features and advantages will become more apparent from the detailed description given below with reference to the accompanying drawings and by way of non-limiting examples, and in which:

[0064] Figure 1 This is a schematic diagram of an apparatus for analyzing a jetting device according to an advantageous embodiment, in the first stage of an advantageous operating cycle.

[0065] Figure 2 It is similar to the second phase of the operation cycle. Figure 1 A schematic diagram of the diagram.

[0066] Figure 3 It is a timeline of the operation cycle according to the advantageous implementation method;

[0067] Figure 4 Thermal images obtained from the impact zone are shown, as well as

[0068] Figure 5 and Figure 6 These are schematic diagrams of the impact zones for compliant and non-compliant entities, respectively. Detailed Implementation

[0069] One object of this invention is to improve the quality of inspection of spraying devices. To this end, the invention envisions analyzing 100% of the devices without substantially slowing down the assembly line.

[0070] In a conventional manner, each spraying device includes a nozzle 1 with a spray hole 2. Typically, a spray profile (not shown) is provided upstream of the spray hole 2 to generate a spray at the outlet of the spray hole.

[0071] The present invention envisions a compressed gas flow F1 passing through each nozzle 1 and guiding the flow F1 in the form of a conical spray exiting the nozzle 2 toward a receiving surface 10, which is advantageously coated with a heat-sensitive material capable of changing color upon contact with the gas flow F1. Advantageously, the compressed gas flow F1 is a flow of compressed air; however, it should be understood that, according to the invention, any suitable gas other than air can be used.

[0072] In the context of this invention, the objective is to emphasize the compressed gas flow F1 at a temperature T1 different from the temperature T2 of the receiving surface 10, to observe the compressed gas flow F1 on the receiving surface 10 by the camera 20, and to analyze the observation by the analysis device 40.

[0073] The compressed gas flow F1 is at temperature T1, and when the gas flow F1 is discharged through the nozzle 2, the receiving surface 10 is at a temperature T2 that is different from T1.

[0074] exist Figures 1 to 3 In the example, the compressed gas flow F1 is at a temperature T1 close to the ambient temperature, and the receiving surface 10 is heated or cooled to a temperature T2 that is higher or lower than T1. For example, the receiving surface 10 is heated to a temperature T2 > T1.

[0075] In a variation, any combination of temperatures T1 and T2 can be envisioned, as long as the difference between these two temperatures, T1-T2 or T2-T1, is large enough to be detected by coating the receiving surface 10 with a heat-sensitive material and / or by a thermal camera. Thus, for example, the receiving surface 10 may be at ambient temperature T2, and the compressed gas flow F1 may be heated or cooled relative to that ambient temperature T2.

[0076] Figure 1 An apparatus according to an advantageous embodiment is shown.

[0077] In this example, the nozzle 1 is positioned opposite the receiving surface 10. A device 50 is provided for generating a compressed gas flow F1 so that the compressed gas flow F1 at temperature T1 passes through the nozzle 1. A camera 20 is positioned facing the receiving surface 10 and advantageously close to the nozzle 1 to capture an image of the receiving surface 10.

[0078] A temperature regulating device is provided to bring the receiving surface 10 to temperature T2 before and / or after the delivery of the compressed gas flow F1. Advantageously, a secondary airflow generating device 60 is provided to generate a secondary airflow F2 at a temperature T2 different from T1. This second airflow F2 is delivered to the receiving surface 10 via a nozzle 30, alternating with the compressed gas flow F1 through the nozzle 1, so as to bring the receiving surface 10 to temperature T2 before and / or after the delivery flow F1. In one variation, the regulating device may include a heating wire 15 and a resistor 16. Other regulating devices are also possible. Several different regulating devices can be combined to ensure that the receiving surface 10 is at temperature T2 when the compressed gas flow F1 is delivered at temperature T1.

[0079] The receiving surface 10 is formed into a plane, which includes a plurality of contact areas 12 separated from each other by a plurality of gaps 13. In an advantageous embodiment, the contact areas 12 are coated with a heat-sensitive material.

[0080] In the example shown, the receiving surface 10 is formed by the ends of a plurality of points 11 arranged in an array. These ends then form a contact area 12. These points 11 can be integral with the base 14. Advantageously, a temperature regulating device 15 can operate on the base 14.

[0081] Advantageously, the points 11 are equidistant from each other and close to each other, thereby forming a regular and dense array of contact areas 12 on the receiving surface 10. The more points 11 there are and the smaller the contact areas 12 are, the more accurately the impact zone of the compressed gas flow F1 on the receiving surface 10 will be defined, and the better the shape of the impact zone will be reproduced.

[0082] In a variation of point 11, a perforated plate or grid can be used to form the receiving surface 10, in which case these portions separate the holes that form the contact area 12.

[0083] The heat-sensitive material used to coat the contact area 12 can be a coating suitable for changing color according to temperature. Therefore, when the receiving surface 10 is at temperature T2, the contact area 12 can have a first color, and when the gas flow F1 of compressed gas at temperature T1 reaches the receiving surface 10, the contact area 12 contacted by the gas flow F1 changes color, making it possible to observe the impact area of ​​the gas flow F1 on the receiving surface 10. The camera 20 then makes it possible to capture an image of this impact area, particularly a thermal image.

[0084] In another embodiment, the contact area 12 is not covered by a heat-sensitive material, and the camera 20 is a thermal camera capable of detecting the temperature difference between the compressed gas flow F1 at temperature T1 and the receiving area 10 at temperature T2.

[0085] The specific shape of the receiving surface 10, having multiple separate contact areas 12 separated by gaps 13, means that the airflow of compressed gas F1 can make local contact on the contact areas 12 without causing dispersion and disturbance to the airflow, which makes the impact area visible with great reliability.

[0086] To perform compliance assessments, an analysis device 40 is advantageously provided to analyze images from camera 20 and thereby determine whether the impact zone on the receiving surface 10 from the compressed gas flow F1 generated by the nozzle 1 conforms to predetermined specifications. Specifically, an image of the receiving surface 10 before the flow F1 is sent can be provided from an image of the receiving surface 10 after the flow F1 has been sent, which allows the impact zone to be isolated from the flow F1. In a variant, an image after the flow of the second air F2 at temperature T2 has been sent can be subtracted from an image after the compressed gas flow F1 at temperature T1 has been sent.

[0087] Figure 3An advantageous operating cycle is illustrated, wherein a first pulse of compressed gas flow F1 at temperature T1 is sent to the receiving surface 10 at time t1, and a first image is captured at the same time t1. Then, at time t2, a second air flow F2 at temperature T2 is sent to the receiving surface 10, and a second image is captured simultaneously.

[0088] In the variant, a first image can be captured after a second airflow F2 is sent at temperature T2, and a second image can be captured when a compressed gasflow F1 is sent at temperature T1.

[0089] The duration of the pulse of compressed gas F1 is advantageously adjustable, particularly from 50 ms to 300 ms. The duration of the second airflow F2 is also advantageously adjustable.

[0090] Advantageously, multiple consecutive cycles can be performed on the same nozzle, such as five cycles.

[0091] The consistency or repeatability of the results also makes it possible to assess the compliance of the nozzle.

[0092] The predetermined specifications may include a predetermined planar range of the impact zone on the support surface 10, such that nozzles 1 with a planar range similar to the predetermined planar range are classified as compliant, and nozzles 1 with a planar range different from the predetermined planar range are classified as non-compliant. The geometry of the impact zone (especially its symmetry) may also be used for compliance evaluation. Other parameters may also be envisioned.

[0093] The analysis apparatus 40 may include means for measuring the geometry of the impact zone of the compressed gas flow F1 on the receiving area 10. For example, the centroid of the impact zone is determined, and the maximum and minimum distances from the centroid to the edge of the impact zone are measured. These distances are then compared with predetermined values, allowing the compliance of the device under test to be evaluated. Thus, the compliance assessment considers not only the surface of the impact zone but also its geometry, particularly its symmetry. This allows it to be determined that the spray exiting the compliance nozzle will have an acceptable conical shape, from the viewpoint of the spray angle and its symmetry. Advantageously, the temperature T1 and the flow rate of the compressed gas flow F1 can be adjusted to optimally suit the measurement of the impact zone at a given distance from the nozzle of the device under test, relative to the distance achievable by the liquid spray. This allows for the definition of parameter settings that enable the prediction as far as possible of the performance of each nozzle in its final use, i.e., the distribution of liquid in the form of a spray.

[0094] Alternatively, an image processing device can be used to perform this type of analysis.

[0095] Figure 4 and Figure 5 Images and diagrams obtained using the methods and apparatus of the present invention are shown, in which the planar extent and geometry of the impact zone, particularly its symmetry, can be evaluated.

[0096] This invention offers many advantages, and in particular:

[0097] It can inspect various types of spraying devices in an automated manner;

[0098] This allows the jetting device to be analyzed non-destructively;

[0099] It can analyze 100% of the spraying devices assembled on the assembly line without significantly slowing down the assembly line.

[0100] To assess the repeatability of the results, multiple consecutive tests can be performed on the same device.

[0101] It uses a compact and easily modifiable setup;

[0102] It uses simple and standard parts, and is therefore usually inexpensive;

[0103] This makes image processing robust and allows it to be performed in real time;

[0104] It ensures good repeatability and good distinguishability between compliant and non-compliant devices.

[0105] The invention has been described above with reference to several advantageous embodiments; however, it should be understood that any modifications may be made thereto by those skilled in the art without departing from the scope of the invention as defined by the appended claims.

Claims

1. A method for analyzing an apparatus for spraying a pharmaceutical fluid product, characterized in that, The method includes the following steps: A nozzle (1) is provided for a device for spraying a pharmaceutical fluid product, the nozzle (1) including a spray hole (2). A receiving surface (10) is provided, the receiving surface (10) comprising a plurality of separate contact areas (12) separated by gaps (13), the contact areas (12) being coated with a heat-sensitive material. The receiving surface (10) is brought to a second temperature. The compressed gas flow (F1) is passed through the nozzle (2) of the nozzle (1), and the compressed gas flow (F1) is at a first temperature different from the second temperature. The compressed gas flow (F1) at the first temperature is sent to the receiving surface (10) at the second temperature. Visualize the impact zone of the compressed gas flow (F1) on the receiving surface (10), and The visualization of the impact zone is analyzed to determine whether the impact zone conforms to predetermined specifications.

2. A method for analyzing an apparatus for spraying a pharmaceutical fluid product, characterized in that, The method includes the following steps: A nozzle (1) is provided for a device for spraying a pharmaceutical fluid product, the nozzle (1) including a spray hole (2). A receiving surface (10) is provided, the receiving surface (10) comprising a plurality of separate contact areas (12) separated by gaps (13). The receiving surface (10) is brought to a second temperature. The compressed gas flow (F1) is passed through the nozzle (2) of the nozzle (1), and the compressed gas flow (F1) is at a first temperature different from the second temperature. The compressed gas flow (F1) at the first temperature is sent to the receiving surface (10) at the second temperature. The impact zone of the compressed gas flow (F1) on the receiving surface (10) is visualized by means of a camera (20), and The visualization of the impact zone is analyzed to determine whether the impact zone conforms to predetermined specifications.

3. The method according to claim 1 or 2, wherein, The compressed gas flow (F1) is a compressed air flow.

4. The method according to claim 1 or 2, wherein, The analysis steps include determining the geometry of the impact zone of the compressed gas flow (F1) on the receiving surface (10).

5. The method according to claim 4, wherein, The analysis steps include determining the symmetry of the airflow (F1) of the compressed gas on the impact zone of the receiving surface (10).

6. The method according to claim 1 or 2, wherein, The predetermined specification includes a predetermined planar range of the airflow (F1) of the compressed gas on the receiving surface (10) of the impact zone, in such a way that nozzles (1) whose planar range is similar to the predetermined planar range are classified as compliant, and nozzles (1) whose planar range is different from the predetermined planar range are classified as non-compliant.

7. The method according to claim 1 or 2, wherein, Operation loop Includes the following steps: The compressed gas flow (F1) at a first temperature is sent to the receiving surface (10) at a second temperature. A first image of the receiving surface (10) is captured by camera (20). The airflow (F2) of the second air at the second temperature is sent to the receiving area. Take a second image of the receiving surface (10), and The second image is subtracted from the first image to visualize the impact zone.

8. The method according to claim 1 or 2, wherein, The operation cycle includes the following steps: An airflow (F2) of second air at a second temperature is sent to the receiving area. A first image of the receiving surface (10) is captured by camera (20). The compressed gas flow (F1) at a first temperature is sent to the receiving surface (10) at a second temperature. Take a second image of the receiving surface (10), and The first image is subtracted from the second image to visualize the impact zone.

9. An apparatus for analyzing a device used for spraying a pharmaceutical fluid product, characterized in that, The device includes: A nozzle (1) for a device for spraying a pharmaceutical fluid product, the nozzle (1) including a nozzle (2). The receiving surface (10) includes a plurality of separate contact areas (12) separated by gaps (13), said contact areas (12) being coated with a heat-sensitive material. A temperature regulating device is used to bring the receiving surface (10) to a second temperature. A device (50) for generating a compressed gas flow (F1) so that the compressed gas flow (F1) flows through the nozzle (1) through the nozzle (2) onto the receiving surface (10) at a second temperature, the compressed gas flow (F1) being at a first temperature different from the second temperature. A visualization device is used to visualize the impact zone of the compressed gas flow (F1) on the receiving surface (10), and The visualization analysis device (40) is used to analyze the impact zone in order to determine whether the impact zone conforms to a predetermined specification.

10. The apparatus according to claim 9, characterized in that, The visualization device is a camera.

11. An apparatus for analyzing a device used for spraying a pharmaceutical fluid product, characterized in that, The device includes: A nozzle (1) for a device for spraying a pharmaceutical fluid product, the nozzle (1) including a nozzle (2). The receiving surface (10) includes a plurality of separate contact areas (12) separated by gaps (13). A temperature regulating device is used to bring the receiving surface (10) to a second temperature. A device (50) for generating a compressed gas flow (F1) so that the compressed gas flow (F1) flows through the nozzle (1) through the nozzle (2) onto the receiving surface (10) at a second temperature, the compressed gas flow (F1) being at a first temperature different from the second temperature. Camera (20) is used to visualize the impact zone of the compressed gas flow (F1) on the receiving surface (10), and The visualization analysis device (40) is used to analyze the impact zone in order to determine whether the impact zone conforms to a predetermined specification.

12. The apparatus according to claim 9 or 11, wherein, The compressed gas flow (F1) is a compressed air flow.

13. The apparatus according to claim 9 or 11, wherein, The temperature regulating device includes a means (60) for generating a second airflow so as to generate a second airflow (F2) at the second temperature.

14. The apparatus according to claim 9 or 11, wherein, The temperature regulating device includes a heating wire and a resistor (16).

15. The apparatus according to claim 9 or 11, wherein, The receiving surface (10) is formed by the ends of a plurality of points (11) arranged in an array, the ends forming the contact area (12).

16. The apparatus according to claim 15, wherein, The point (11) and the base (14) form a whole.

17. The apparatus according to claim 15, wherein, The points (11) are equidistant from each other and close to each other, thereby forming a regular and dense array of contact areas (12) on the receiving surface (10).

18. The apparatus according to claim 9, wherein, The heat-sensitive material is a coating suitable for changing color according to temperature.

19. The apparatus according to claim 9 or 11, wherein, The device (50) for generating the airflow (F1) of compressed gas is adapted to generate pulses with adjustable duration.

20. The apparatus according to claim 19, wherein, The duration of the pulse ranges from 50ms to 300ms.

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