METHOD AND DEVICE FOR THE ANALYSIS OF A DEVICE FOR SPRAYING A PHARMACEUTICAL LIQUID PRODUCT

Description

[0001] The present invention relates to a device and a method for analyzing spray generated by a device for spraying a pharmaceutical fluid product.

[0002] Pharmaceutical fluid spray devices are well-known. They generally consist of a spray head with a spray orifice, mounted on a reservoir containing the fluid product to be dispensed. Particularly in nasal spray applications, the therapeutic efficacy of the sprayed fluid product can depend on the properties of the spray generated when the device is actuation. As is known, at the end of the assembly line—that is, when the spray device is assembled—and just before being shipped to the pharmaceutical fluid product manufacturer for assembly onto a corresponding reservoir, a number of samples of the assembled devices are laboratory-tested to verify that the spray properties meet the predefined specifications.

[0003] One drawback of this system is that it concerns assembled devices, and therefore destructive of these devices which, after being tested, can no longer be delivered to the customer.

[0004] Furthermore, this system requires human verification of the devices tested, and is therefore not fully automatable.

[0005] To overcome this drawback, document WO2018130791 proposes using schlieren imaging to visualize a flow of hot or cold compressed air sent through a spray head. This method allows for the evaluation of the spray angle but not its geometry or symmetry. Furthermore, this method requires a relatively complex and expensive schlieren setup, which is difficult to integrate into an assembly line for a fluid spraying device. Consequently, it either necessitates random testing on only a portion of the manufactured devices or slows down the assembly line, which is generally undesirable.

[0006] Documents EP3047912, JPH0599802 and JPS54127347 describe other prior art devices.

[0007] The present invention aims to overcome the aforementioned drawbacks.

[0008] In particular, the present invention aims to provide a device and a method for analyzing a pharmaceutical fluid product spraying device that is non-destructive to the devices being tested.

[0009] The present invention also aims to provide a device and method of analysis that is largely automated.

[0010] The present invention also aims to provide a device and method of analysis which allows 100% of spraying devices to be tested without substantially slowing down the assembly line.

[0011] The present invention also aims to provide a device and method of analysis that is simple and / or inexpensive to manufacture, assemble and use.

[0012] The purpose of this document is therefore to describe a method for analyzing a device for spraying a liquid pharmaceutical product, comprising the following steps: to provide a spray head of a pharmaceutical fluid product spraying device, said spray head having a spray orifice, to provide a receiving surface having a plurality of discrete contact areas separated by voids, said contact areas being electrically conductive, to pass a stream of ionized gas through said spray orifice of said spray head, said stream of ionized gas being electron-charged, to send said stream of ionized gas onto said receiving surface, to visualize the impact area of ​​said stream of ionized gas on said receiving surface, and to analyze said visualization of said impact area to determine whether said impact area conforms or does not conform to predetermined specifications.

[0013] Advantageously, said ionized gas stream is a compressed gas stream.

[0014] Advantageously, said ionized gas flow is an ionized pulsed air flow.

[0015] Advantageously, said analysis step includes determining the geometry, including the symmetry, of the impact zone of said compressed gas flow on said receiving surface.

[0016] Advantageously, said predetermined specifications include a predetermined planar extent of the impact zone of said ionized gas flow on said receiving surface, such that spray heads for which said planar extent is similar to said predetermined planar extent are classified as compliant, and spray heads for which said planar extent is different from said predetermined planar extent are classified as non-compliant.

[0017] Advantageously, a usage cycle includes the following steps: connect said receiving surface to earth to remove all electrical charges, generate said ionized gas flow and send it through said spray head onto said receiving surface, detect each contact area which becomes charged with negative ions upon contact with said ionized gas flow, and visualize said impact area by means of a human-machine interface.

[0018] This document also relates to an analysis device for a pharmaceutical fluid spraying device comprising: a spray head of a pharmaceutical fluid product spraying device, said spray head comprising a spray orifice, a receiving surface comprising a plurality of discrete contact zones separated by voids, said contact zones being electrically conductive, grounding means for removing all electrical charges from said receiving surface before each analysis, means for generating an ionized gas flow to pass an ionized gas flow through said spray orifice of said spray head and send it onto said receiving surface, said ionized gas flow being electron-charged, processing means for visualizing the impact zone of said ionized gas flow on said receiving surface,and analytical means for analyzing said visualization of said impact zone to determine whether said impact zone conforms or does not conform to predetermined specifications.

[0019] Advantageously, said ionized gas flow is an ionized pulsed air flow.

[0020] Advantageously, said processing means include an amplifier and means for measuring potential difference for each contact zone.

[0021] Advantageously, each contact area of ​​said receiving surface is connected to said processing means by a cable with respective low impedance.

[0022] Advantageously, said receiving surface is formed by the ends of a plurality of points arranged in a network, said ends forming said contact zones.

[0023] Advantageously, these points are attached to a base connected to the ground.

[0024] Advantageously, said points are equidistant and close to each other, thus forming a regular and dense network of contact zones on said receiving surface.

[0025] Advantageously, the said means of generating the ionized gas flow are adapted to generate pulses of adjustable duration, in particular from 50 to 300 ms.

[0026] These features and advantages, and others, will become clearer in the following detailed description, made with reference to the attached drawings, given as non-limiting examples, and on which: there figure 1 is a schematic view of a device for analyzing a spraying device, according to an advantageous embodiment, before use, the figure 2 is a schematic view similar to that of the figure 1 , during use, the figure 3 shows a visualization of a compliant impact zone, and the figure 4 shows a visualization of a non-compliant impact zone.

[0027] One objective of the invention is to improve the quality of the inspection of spraying devices. To this end, the invention provides for the analysis of 100% of the devices, without substantial slowdown of the assembly line.

[0028] Typically, each spraying device includes a spray head 1 with a spray orifice 2. Generally, a spray profile (not shown) is provided upstream of said spray orifice 2 to generate a conical spray shape at the outlet of the orifice.

[0029] The present invention provides for passing a stream of ionized gas F1, preferably compressed, through each spray head 1, and directing this stream F1, exiting the spray orifice 2 in the form of a conical spray, towards a receiving surface 10. Advantageously, the stream of ionized gas F1 is a stream of ionized air, but it is understood that according to the invention, any suitable gas other than air could be used.

[0030] The ionized gas stream F1 is charged with electrons, and at the moment when this stream F1 is expelled through the spray orifice 2, the receiving surface 10 is devoid of electrical charges.

[0031] THE figures 1 et 2 show a test device according to an advantageous embodiment.

[0032] In this example, a spray head 1 is arranged opposite a receiving surface 10. Means for generating a stream of ionized gas F1 are provided to pass a stream of electron-charged ionized gas F1 through the spray head 1.

[0033] The receiving surface 10 forms a plane which has a plurality of contact zones 12 separated from each other by a plurality of voids 13. Each contact zone 12 is electrically conductive.

[0034] In the example shown, the receiving surface 10 is formed by the tips of a plurality of spikes 11 arranged in a network. These tips then form the contact areas 12. Each spike 11 thus forms an anode functioning like a lightning rod. These spikes 11 can be attached to a base 14, preferably insulating, which can be connected to earth before each analysis to eliminate all electrical charges from the receiving surface 10.

[0035] Advantageously, the points 11 are equidistant and close to each other, thus forming a regular and dense network of contact zones 12 on the receiving surface 10. The more points 11 there are and the smaller the contact zones 12 are, the more precise the definition of the impact zone of the ionized gas flow F1 on the receiving surface 10 and the more accurately the shape of this impact zone is reproduced.

[0036] The particular shape of the receiving surface 10, with a plurality of discrete contact zones 12 separated by voids 13, allows local contact of the ionized gas flow F1 on the contact zones 12, without dispersions and without perturbations of the flow, which makes the impact zone visible with high reliability.

[0037] To carry out conformity assessments, processing means 40 are provided to visualize the impact zone and analysis means 50 are provided to analyze the visualizations generated by the processing means 40 and thus determine whether the impact zone of the ionized gas flow F1 from said spray head 1 on the receiving surface 10 conforms or does not conform to predetermined specifications.

[0038] The processing means 40 may include an amplifier to amplify the electrical signals received from the receiving surface 10. Advantageously, each electrically conductive contact zone 12 is connected to said processing means 40 by a respective low impedance cable 30. The processing means 40 can thus calculate potential differences for each contact zone 12 which has become charged with negative ions upon contact with the ionized gas flow F1 and thus create a matrix forming a visualization of the impact zone.

[0039] The duration of the ionized gas pulse F1 is advantageously adjustable, notably from 50 to 300 ms.

[0040] Advantageously, several successive cycles are performed on the same spray head, for example, five cycles. The consistency or repeatability of the results also allows for the evaluation of the spray head's conformity.

[0041] The predetermined specifications may include a predetermined planar extent of the impact zone on the receiving surface 10, such that spray heads 1 for which the planar extent is similar to the predetermined planar extent are classified as compliant, and spray heads 1 for which the planar extent differs from the predetermined planar extent are classified as non-compliant. The geometry, and in particular the symmetry, of the impact zone may also be used in the conformity assessment. Other parameters may also be considered.

[0042] The analytical means 50 may include means for measuring the geometry of the impact zone of the ionized gas flow F1 on the receiving surface 10. For example, the centroid of the impact zone is determined, and the maximum and minimum distances from this centroid to the edge of the impact zone are measured. Comparing these distances with predetermined values ​​then allows the conformity of the tested device to be assessed. Thus, the conformity assessment takes into account not only the surface area of ​​the impact zone, but also its geometry, in particular its symmetry. This makes it possible to establish that a spray exiting a conforming spray head will have an acceptable conical shape, both in terms of the spray angle and its symmetry.

[0043] Image processing tools can potentially be used to perform this type of analysis.

[0044] THE figures 3 et 4 Each illustrates a schematic representation obtained with the method and device of the invention, on which it is possible to evaluate the planar extent and geometry, in particular the symmetry, of the impact zone. figure 3 shows a visualization of the impact zone for a compliant device and the figure 4 shows such a visualization for a non-compliant device.

[0045] The present invention offers numerous advantages, including: It allows for automated conformity control on various types of spraying devices; it allows for non-destructive analysis of said spraying devices; it allows for the analysis of 100% of spraying devices assembled on an assembly line, without substantial slowdown of the latter; it allows for several successive tests to be carried out on the same device to evaluate the repeatability of the results; it uses a compact and easily adaptable assembly; it uses simple and standard components, therefore generally inexpensive; it allows for robust image processing, which can be carried out in real time; it ensures good repeatability and good discrimination of conforming and non-conforming devices.

[0046] The present invention has been described with reference to an advantageous embodiment, but it is understood that a person skilled in the art may make any modifications to it, without departing from the scope of the present invention as defined by the attached claims.

Claims

1. A method for analysing a device for spraying a pharmaceutical fluid product, characterized in that it comprises the following steps: - providing a spray head (1) for a device for spraying a pharmaceutical fluid product, said spray head (1) comprising a spray orifice (2), - providing a receiving surface (10) comprising a plurality of discrete contact zones (12) separated by voids (13), said contact zones (12) being electrically conductive, - passing a flow of ionised gas (F1) through said spray orifice (2) of said spray head (1), said flow of ionised gas (F1) being charged with electrons, - sending said flow of ionised gas (F1) onto said receiving surface (10), - visualising the impact zone for said flow of ionised gas (F1) on said receiving surface (10), and - analysing said visualisation of said impact zone in order to determine whether or not said impact zone complies with predetermined specifications.

2. The method as claimed in claim 1, in which said flow of ionised gas (F1) is a flow of compressed air.

3. The method as claimed in claim 1 or claim 2, in which said flow of ionised gas (F1) is a flow of ionised pulsed air.

4. The method as claimed in any one of the preceding claims, in which said step for analysis comprises determining the geometry, in particular the symmetry, of the impact zone for said flow of compressed gas (F1) on said receiving surface (10).

5. The method as claimed in any one of the preceding claims, in which said predetermined specifications comprise a predetermined planar extent of the impact zone for said flow of compressed gas (F1) on said receiving surface (10), in a manner such that the spray heads (1) for which said planar extent is similar to said predetermined planar extent are classified as compliant, and the spray heads (1) for which said planar extent is different from said predetermined planar extent are classified as non-compliant.

6. The method as claimed in any one of the preceding claims, in which an operating cycle comprises the following steps: - connecting said receiving surface (10) to ground in order to eliminate any electrical charges, - generating said flow of ionised gas (F1) and sending it through said spray head (1) onto said receiving surface (10), - detecting each contact zone (12) which becomes charged with negative ions in contact with said flow of ionised gas(F1), and - visualising said impact zone by means of a man-machine interface.

7. A device for analysing a device for spraying a pharmaceutical fluid product, characterized in that it comprises: - a spray head (1) for a device for spraying a pharmaceutical fluid product, said spray head (1) comprising a spray orifice (2); - a receiving surface (10) comprising a plurality of discrete contact zones (12) separated by voids (13), said contact zones (12) being electrically conductive, - grounding means for eliminating any electrical charges from said receiving surface (10) before each analysis, - means (20) for generating a flow of ionised gas (F1) in order to pass a flow of ionised gas (F1) through said spray orifice (2) of said spray head (1) and sending it onto said receiving surface (10), said flow of ionised gas (F1) being charged with electrons, - processing means (40) for visualising the impact zone for said flow of ionised gas (F1) on said receiving surface (10), and - means (50) for analysis for the analysis of said visualisation of said impact zone in order to determine whether or not said impact zone complies with predetermined specifications.

8. The device as claimed in claim 7, in which said flow of ionised gas (F1) is a flow of ionised pulsed air.

9. The device as claimed in claim 7 or claim 8, in which said processing means (40) comprise an amplifier and means for measuring the potential difference for each contact zone (12).

10. The device as claimed in any one of claims 7 to 9, in which each contact zone (12) of said receiving surface (10) is connected to said processing means (40) by a respective low impedance cable (30).

11. The device as claimed in any one of claims 7 to 10, in which said receiving surface (10) is formed by the ends of a plurality of points (11) disposed in an array, said ends forming said contact zones (12).

12. The device as claimed in claim 11, in which said points (11) are integral with a grounded base (14).

13. The device as claimed in claim 11 or claim 12, in which said points (11) are equidistant from and close to one another, thereby forming a regular and dense array of contact zones (12) on said receiving surface (10).

14. The device as claimed in any one of claims 7 to 13, in which said means (50) for generating a flow of ionised gas (F1) are adapted to generate pulses of adjustable duration, in particular from 50 to 300ms.