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 for a pharmaceutical fluid spraying device, said spray head having a spray orifice, to provide a receiving surface having a perforated plate having a plurality of holes, each hole being associated with a ball, in particular made of polystyrene, guided in a guide channel, in particular made of glass, said guide channels extending parallel to each other to a transparent window behind which a camera is arranged, to charge said perforated plate with an electrostatic charge to attract said balls against said holes by static electricity, to pass a gas stream through said spray orifice of said spray head, and send it onto said receiving surface, said balls being contacted by said gas stream being displaced on said window,to visualize the impact zone of said compressed gas flow on said receiving surface formed by said balls moved on said glass, and to analyze said visualization of said impact zone to determine whether said impact zone conforms or does not conform to predetermined specifications.

[0013] Advantageously, said gas flow is a compressed gas flow.

[0014] Advantageously, said gas flow is a compressed air flow.

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

[0016] Advantageously, said predetermined specifications include a predetermined planar extent of the impact area of ​​said gas flow on said receiving surface, so 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 perforated plate to earth to remove all electrical charges, charge said perforated plate with an electrostatic charge to attract said balls against said holes, generate said gas flow and send it through said spray head onto said receiving surface, each ball contacted by said gas flow detaching from said perforated plate and being guided onto said glass, visualize said impact zone by taking an image of the balls on said glass using said camera.

[0018] This document also relates to an analysis device for a pharmaceutical fluid spraying device comprising: a spray head of a device for spraying a pharmaceutical fluid product, said spray head comprising a spray orifice, a receiving surface comprising a perforated plate having a plurality of holes, each hole being associated with a ball, in particular made of polystyrene, guided in a guide channel, in particular made of glass, said guide channels extending parallel to each other to a transparent window, an electrical device for charging said perforated plate with an electrostatic charge to attract said balls by static electricity against said holes in said perforated plate, means for generating a gas flow to pass a gas flow through said spray orifice of said spray head and send it onto said receiving surface, said balls contacted by said gas flow being displaced on said window,a camera for visualizing the impact zone of said compressed gas flow on said receiving surface by taking an image of the beads displaced by said gas flow on said glass, and analytical means for analyzing said image of said impact zone to determine whether said impact zone conforms or does not conform to predetermined specifications.

[0019] Advantageously, said gas flow is a compressed air flow.

[0020] Advantageously, said holes are equidistant and close to each other, thus forming a regular and dense network of holes on said receiving surface.

[0021] Advantageously, the said means of generating the compressed gas flow are adapted to generate pulses of adjustable duration, in particular from 50 to 300 ms.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] The present invention provides for passing a gas flow F1, preferably compressed, through each spray head 1, and directing this gas flow F1, exiting the spray orifice 2 in the form of a conical spray, towards a receiving surface 10. Advantageously, the gas flow F1 is a compressed air flow, but it is understood that according to the invention, any suitable gas other than air could be used.

[0026] THE figures 1 et 2 show a test device according to an advantageous embodiment.

[0027] In this example, a spray head 1 is arranged opposite a receiving surface 10. Means for generating a gas flow F1 20 are provided to pass a gas flow F1 through the spray head 1.

[0028] The receiving surface 10 forms a plane comprising a perforated plate 11 having a plurality of holes 12. This perforated plate 11 can be electrically charged with an electrostatic charge. Each hole 12 is associated with a ball 13, preferably made of polystyrene, guided in a guide channel 14, preferably made of glass. The guide channels 14 all extend parallel to each other to a transparent window 15, advantageously connected to ground. When the perforated plate 11 is not charged, the balls 13 are arranged on the window 15. When the perforated plate 11 is charged, the balls 13 are attracted by static electricity against the holes 12 of the perforated plate 11. When a ball 13 is contacted by the gas flow F1, it detaches from the perforated plate 11 and is moved onto the window 15.Thus, the pattern of balls on the glass 15 after the sending of the gas flow F1 onto the receiving surface 10 corresponds perfectly to the impact zone of said gas flow F1 on the receiving surface 10.

[0029] Behind the glass 15, there is a camera 30, to visualize this pattern of balls and therefore the impact zone.

[0030] It should be noted that the orientation of the test device is not necessarily that shown on the figures 1 et 2 , an advantageous orientation being vertical, with the gas flow F1 arriving from above on the perforated plate 11.

[0031] Before each analysis, the perforated plate 11 is connected to earth to eliminate all electrical charges from the receiving surface 10. This causes all the balls 13 to fall back onto the glass 15.

[0032] Next, the perforated plate 11 is charged by applying an electrostatic charge by means of a suitable electrical device 18, which attracts each ball 13 against its respective hole 12 of the perforated plate 11.

[0033] A gas flow F1, in particular compressed air, is then generated and sent through the spray head 1 to the receiving surface 10. The force of the gas flow F1 dislodges the balls 13 from the perforated plate 11, which is subjected to an electrostatic charge. In other words, each ball 13 that comes into contact with said gas flow F1 will detach from the perforated plate 11 and be guided by its respective guide channel 14 against the glass 15.

[0034] The camera 30 then takes an image of this window 15, with the balls 13 having been impacted by the gas flow F1 forming on said window 15 the impact zone.

[0035] After each use, the perforated plate 11 and the glass 15 are grounded, and then an electrostatic charge is applied again to the perforated plate 11 to attract the balls against the holes 12 in the perforated plate 11. The device is then ready for the next use. Optionally, the position of the balls 13 can be checked with the camera 30, and if all the balls 13 are pressed against the perforated plate 11, a new test can be performed.

[0036] Advantageously, the holes 12 are equidistant and close to each other, thus forming a regular and dense network of holes 12 on the receiving surface 10. The more holes 12 there are and the smaller these holes 12 are, and therefore the more balls 13 there are and the smaller these balls are, the more precise the definition of the impact zone of the gas flow F1 on the receiving surface 10 and the more accurately the shape of this impact zone is reproduced.

[0037] To carry out conformity assessments, a camera 30 is provided to visualize the impact area and analytical means 40 are provided to analyze the visualizations generated by the camera 30 and thus determine whether the impact area of ​​the gas flow F1 from said spray head 1 on the receiving surface 10 conforms or does not conform to predetermined specifications.

[0038] The duration of the F1 gas pulse is advantageously adjustable, notably from 50 to 300 ms.

[0039] Advantageously, several successive cycles can be 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.

[0040] 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.

[0041] The analytical means 40 may include means for measuring the geometry of the impact zone of the 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.

[0042] Image processing tools can potentially be used to perform this type of analysis.

[0043] 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.

[0044] The present invention offers numerous advantages, including: It allows automated conformity control on various types of spraying devices; it allows non-destructive analysis of said spraying devices; it allows 100% of spraying devices assembled on an assembly line to be analyzed without substantial slowdown of the line; it allows 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 robust image processing, which can be carried out in real time; it ensures good repeatability and good discrimination of conforming and non-conforming devices.

[0045] 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, characterised 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 comprising a perforated plate (11) comprising a plurality of holes (12), each hole (12) being associated with a ball (13), in particular made of polystyrene, guided in a guide channel (14), in particular made of glass, said guide channels (14) extending parallel to one another until reaching a transparent pane (15) behind which a camera is arranged (30), - charging said perforated plate (11) with an electrostatic charge to attract by static electricity said balls (13) to said holes (12), - passing a gas stream (F1) through said spray orifice (2) of said spray head (1), and sending it onto said receiving surface (10), said balls (13) that are hit by the gas stream (F1) being moved to said pane (15), - visualising the impact zone for said compressed gas stream (F1) on said receiving surface (10) that is formed by the balls (13) that have been moved to the pane (15), 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, wherein said gas stream (F1) is a compressed gas stream.

3. The method as claimed in claim 1 or claim 2, wherein said gas stream (F1) is a compressed air stream.

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

5. The method as claimed in any one of the preceding claims, wherein said predetermined specifications comprise a predetermined planar extent of the impact zone for said gas stream (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, wherein an operating cycle comprises the following steps: - connecting said perforated plate to ground in order to eliminate any electrical charges, - charging said perforated plate (11) with an electrostatic charge to attract said balls (13) to said holes (12), - generating said gas stream (F1) and sending it through said spray head (1) onto said receiving surface (10), each ball (13) that is hit by said gas stream (F1) detaching from said perforated plate (11) and being guided onto said pane (15), - visualising said impact zone by taking an image of the balls (13) on said pane (15) by means of said camera (30).

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 perforated plate (11) comprising a plurality of holes (12), each hole (12) being associated with a ball (13), in particular made of polystyrene, guided in a guide channel (14), in particular made of glass, said guide channels (14) extending parallel to one another until reaching a transparent pane (15), - an electrical device (18) for charging said perforated plate (11) with an electrostatic charge to attract said balls (13) by static electricity to said holes (12) of said perforated plate (11), - means (20) for generating a gas stream (F1) in order to pass a gas stream (F1) through said spray orifice (2) of said spray head (1) and sending it onto said receiving surface (10), said balls (13) that are hit by the gas stream (F1) being moved to said pane (15), - a camera (30) for visualising the impact zone for said compressed gas stream (F1) on said receiving surface (10) by taking an image of the balls (13) that have been moved by said gas stream (F1) to the pane (15), and - analysing means (40) for analysing said image 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, wherein said gas stream (F1) is a compressed air stream.

9. The device as claimed in claim 7 or claim 8, wherein said holes (12) are equidistant from and close to one another, thereby forming a regular and dense array of holes (12) on said receiving surface (10).

10. The device as claimed in any one of claims 7 to 9, wherein said means (50) for generating a compressed gas stream (F1) are adapted to generate pulses of adjustable duration, in particular from 50 to 300 ms.