Device and method for testing of fluid dispenser devices

Abstract

A testing device for the testing of fluid dispenser devices, said testing device comprising: - fixing means (10) for fixing a fluid dispenser device comprising a body (1) and a dispensing orifice (2); - weighing means (20) for weighing said fluid dispenser device before and after each actuation or group of actuations; - first positioning means (30) for moving said fluid dispenser device; - second positioning means (30') for moving an adapter (40) adapted to connect to said dispensing orifice (2) of the fluid dispenser device; - shaking means (50) for shaking said fluid dispenser device before each actuation or group of actuations; and - actuating means (60) for actuating said fluid dispenser device.

Description

[0001] Device and method for testing of fluid dispenser devices

[0002] The invention concerns a device and a method for testing fluid dispenser devices.

[0003] Fluid dispenser devices are well-known, and comprise in particular pMDI (pressurized Metered Dose Inhaler) devices, which usually comprise a metering valve fixed on a canister, this sub-assembly being placed in a body provided with a mouthpiece.

[0004] Such testing devices are intended to replicate the standard operating user procedures when using a fluid dispenser device, in particular a pMDI device, and measure the key parameters.

[0005] Existing testing devices have several limitations and / or drawbacks:

[0006] - the existing mounting fixtures cannot easily accommodate a varying range of fluid dispenser body types and often require the expense and time of having bespoke parts commissioned before testing is able to begin; in some cases, for example with fluid dispenser devices with protective caps which are tethered and hang below the device, there are no available mounting options and therefore the fluid dispenser device cannot be tested;

[0007] - the range of adjustability provided by the current devices is too limited to accommodate the varying sizes of anatomical mouththroat models, mouthpiece adapters, impactors and dose collection units, in particular height and alignment limitations;

[0008] - the positioning of the actuating means is limited in its adjustability and therefore is difficult for it to align properly with the canister of the fluid dispenser device;

[0009] - the current devices do not provide a reading of the force to actuate the fluid dispenser device or the shot weight and therefore are limited in the data they provide.

[0010] One goal of the present invention is to provide a device and a method for testing fluid dispenser devices that do overcome the above drawbacks. Another goal of the present invention is to provide such a device and such a method that allow the testing of any existing fluid dispenser devices and the use of any existing anatomical mouth-throat models, mouthpiece adapters and impactors.

[0011] The present invention also aims to provide such a device that is simple and cheap to manufacture and to assemble, an easy to use in a reliable manner.

[0012] The present invention also aims to provide such a method that provides reliable testing results.

[0013] The present invention thus provides a testing device for the testing of fluid dispenser devices, said testing device comprising: fixing means for fixing a fluid dispenser device comprising a body and a dispensing orifice; weighing means for weighing said fluid dispenser device before and after each actuation or group of actuations; first positioning means for moving said fluid dispenser device; second positioning means, for moving an adapter adapted to connect to said dispensing orifice of the fluid dispenser device; shaking means for shaking said fluid dispenser device before each actuation or group of actuations; and actuating means for actuating said fluid dispenser device.

[0014] Advantageously, the device further comprises a touchscreen and a built-in computer for controlling the testing device and exporting of testing data.

[0015] Advantageously, said fixing means comprise a spring-loaded arm to allow easy insertion and removal of the fluid dispenser device.

[0016] Advantageously, said fixing means include at least one removeable insert allowing to accommodate a range of fluid dispenser devices with varying body geometry.

[0017] Advantageously, said first positioning means comprise a plate and two motorized axis allowing the device to position the fluid dispenser device in the X and Y directions. Advantageously, said weighing means comprise an analytical balance for the measurement of the fluid dispenser's shot weight after each actuation or group of actuations.

[0018] Advantageously, said shaking means shake the fluid dispenser device in a rotational manor about a Z axis, which is a horizontal axis in the normal use of the testing device.

[0019] Advantageously, said shaking means allow the fluid dispenser to be shaken by up to 180° either side of a vertical datum.

[0020] Advantageously, said actuating means are able to apply up to a maximum of 250N force in order to actuate the fluid dispenser device.

[0021] Advantageously, said actuating means comprise a load cell to allow the force required to actuate the fluid dispenser to be measured.

[0022] Advantageously, said fluid dispenser device is a pMDI (pressurized Metered Dose Inhaler) device, said dispensing orifice is a mouthpiece and said adapter is a mouthpiece adapter.

[0023] The present invention also provides a method for the testing of fluid dispenser devices, said method comprising: fixing a fluid dispenser device comprising a body and a dispensing orifice in fixing means of a testing device; weighing said fluid dispenser device before and after each actuation or group of actuations with weighing means of said testing device; shaking said fluid dispenser device before each actuation or group of actuations with shaking means of said testing device; connecting said dispensing orifice to an adapter with first and / or second positioning means of said testing device; and actuating said fluid dispenser device with actuating means of said testing device.

[0024] Advantageously, said fluid dispenser device is a pMDI (pressurized Metered Dose Inhaler) device, said dispensing orifice is a mouthpiece and said adapter is a mouthpiece adapter.

[0025] Embodiments of the invention will be described below with reference to the accompanying drawings, given as non-limiting examples, in which: Figure 1 is a schematic perspective view of a testing device according to an advantageous embodiment;

[0026] Figure 2 is a detailed view of a first part of the device shown in figure 1 ;

[0027] Figure 3 is a detailed view of the device shown in figure 2;

[0028] Figure 4 is a side view of the first part shown in figure 2;

[0029] Figure 5 is view from the backside of the first part shown in figure 4;

[0030] Figure 6 is a partial view similar to figure 1 , showing a second part of the device;

[0031] Figure 7 is a partial view from the backside of the device shown in figure 6;

[0032] Figure 8 is a schematic view showing the testing device of figure 1 in use; and

[0033] Figures 9 to 11 show flow charts of respectively the initial device setup, the test setup and the test procedure.

[0034] The description hereafter will be made with reference to a testing device for pMDI devices, but the present invention could also apply to other type of fluid dispenser devices, e.g. nasal spray devices or nebulizers.

[0035] The testing device according to the described embodiment is intended to allow the semi-automated testing of pMDI devices, in particular by automatically shaking the inhaler, measuring its shot weight, positioning the pMDI to the mouthpiece and measuring the force required to actuate.

[0036] The testing device shall fulfill at least following user requirements:

[0037] - the user should be able to easily insert the pMDI into the holding fixture located on the device for testing;

[0038] - the user should be able to easily remove the pMDI from the holding fixture located on device once testing has been concluded;

[0039] - the user should be able to easily adjust the height and horizontal positioning of the pMDI once installed in the device so that it properly aligns to a mouthpiece adapter positioned on an anatomical throat model;

[0040] - the user should be able to program the testing parameters of the device prior to each testing run including the number of actuations, the actuation parameters, weighing parameters and shaking characteristics; - the user should be able to set the actuation parameters including the actuation stroke length, detection force, actuation velocity and hold time;

[0041] - the user should be able to set the characteristics of how the device shakes the pMDI including the angle of rotation, speed of rotation, velocity and acceleration;

[0042] - the user should be able to collect all test data after each testing run including the force to actuate and shot weight in a suitable format;

[0043] - the device should have a user interface which is intuitive and simple to use;

[0044] - the device should be safe to use and pose no harm to the user under normal operating conditions;

[0045] - any replaceable parts should be easy to install and remove.

[0046] Figure 8 illustrates a possible setup of the pMDI tester according to the invention when used in conjunction with a breath simulator 100. This figure 8 does not include electrical connections.

[0047] The embodiment shown in figure 8 shows a breath simulator 100, a flow controller (TPK) 110, a vacuum pump 120 and an air inlet 130. However, the breath simulator may be used on its own with the flow controller and vacuum pump. The pMDI device 1 shall be connected to a mouthpiece adapter 40 itself fixed on an anatomical throat 45 which is connected to an impactor 70. The impactor 70 can be a Next Generation Impactor, an Andersen Cascade Impactor or any appropriate impactor.

[0048] It has to be noted that the use of a breath simulator is only optional, the same setup as shown in figure 8 but without such a breath simulator is also possible.

[0049] Figure 1 shows a testing device according to an advantageous embodiment of the invention.

[0050] This testing device is made for testing pMDI (pressurized Metered Dose Inhaler) devices. Such pMDI devices are well known, and usually comprise a metering valve fixed on a canister (not shown on the drawings), this subassembly being placed in a body 1 provided with a mouthpiece 2.

[0051] The testing device comprises following features: - fixing means 10 for fixing a pMDI device;

[0052] - weighing means 20 for weighing the pMDI device before and after each actuation or group of actuations, i.e. a limited number of consecutive actuations;

[0053] - first positioning means 30 for moving the pMDI device;

[0054] - second positioning means 30', for moving a mouthpiece adapter 40;

[0055] - shaking means 50 for shaking the pMDI device before each actuation or group of actuations;

[0056] - actuating means 60 for actuating the pMDI device.

[0057] Advantageously, a touchscreen 5 is provided for control of the testing device and exporting of testing data.

[0058] The device has a built-in computer which can be controlled for example via the touchscreen. The device will then be controlled via the touchscreen allowing the user to set the test parameters and begin the test.

[0059] The fixing means 10 advantageously comprise an easy-to-use quick release / insert mount for the pMDI device, as shown in figure 3.

[0060] The fixing means 10 preferably make use of a spring-loaded arm to allow the user to easily insert and remove the pMDI device 1 while also keeping it secure during testing.

[0061] The fixing means 10 includes two removeable inserts 11 allowing them to be interchanged to accommodate a range of pMDI devices with varying body geometry.

[0062] The fixing means can have a large foot 15 to ensure it can be securely positioned onto the weighing plate when weighing the pMDI device.

[0063] It has to be noted that preferably, the weighing is performed automatically by the testing device, but it could also be done manually by a user, who then could withdraw the pMDI device from the fixing means and place the pMDI device on the weighing means.

[0064] Advantageously, the fixing means 10 for the pMDI are designed such that nothing extends beyond the pMDI’s mouthpiece allowing any size of anatomical throat 45 to be used.

[0065] Of course, other types of fixing means could be used. The first positioning means 30 advantageously comprise a plate 31 and two motorized axis 32, 33 allowing the device to position the pMDI 1 in the X and Y directions where required, as shown in figure 1 .

[0066] The plate 31 supports the fixing means 10.

[0067] The first positioning means 30 allow the pMDI to be positioned in a suitable location, in particular allowing it to accommodate a wide variation of mouthpiece adapters 40 and anatomical mouth-throat models 45.

[0068] The Y-Axis can have a total travel of at least 300mm, preferably more than 380mm, allowing the device to accommodate a range of anatomical throat heights.

[0069] The X-Axis can have a total travel of at least 150mm, preferably more than 190mm of travel, allowing the device to retract the pMDI from the anatomical throat 45 and position the pMDI over the weighing module.

[0070] Both axis are controlled by two high precession stepper motors allowing for precise and accurate control of the position of the pMDI during the automated testing.

[0071] The rotation of the motors can then be transferred to linear motion, e.g. by the use of a lead screw. Each axis can also be supported by two linear rods to reduce any movement in the axis.

[0072] Of course, other types of first positioning means could be used.

[0073] The second positioning means include a plate 3T allowing the mouthpiece adapter 40 to be securely mounted to the device.

[0074] Said plate also supports an impactor 70 used to analyze the flow dispensed by the pMDI device upon actuation

[0075] To accommodate a range of mouthpiece adapters 40 or anatomical mouth-throat models 45, the second positioning means 30' comprises a plate 3T mounted on to linear rails, thus allowing the user to accurately position the mouthpiece adapter 40 relative to the pMDI device 1 .

[0076] Once in place the user can use a positional lock 75 to ensure the impactor remains in its set location.

[0077] Of course, other types of second positioning means could be used. The weighing means 20 comprise advantageously an analytical balance for the measurement of the pMDI’s shot weight after each actuation or group of actuations.

[0078] Of course, other types of weighing means could be used.

[0079] Before and after each actuation or group of actuations, the testing device will automatically place the pMDI onto the weighing means 20 for measurement of the shot weight as part of the testing procedure. As previously described, the weighing could also be done by a user, who could manually place the pMDI device on the weighing means.

[0080] The weight is then logged and recorded by the computer and can be made visible via the touchscreen 5 and in the data file once the testing has been concluded.

[0081] Preferably, the weighing means have a readability and repeatability of 0.1 mg with a maximum weight capacity of 220g.

[0082] The weighing means 20 can also have an external control unit for the purposes of calibration and control when the device is not in use.

[0083] The shaking means 50 allow the device to shake the pMDI device prior to each actuation or group of actuations during the testing procedure.

[0084] Advantageously, the shaking means 50 shake the pMDI device in a rotational manner about the Z Axis, as shown on figure 5. The shaking mechanism should be able to rotate the pMDI from a set datum in predetermined angle in both directions up to a maximum 180 degrees in each direction.

[0085] The shaking means 50 is preferably able to adjust the speed at which it rotates up to a speed of 500 RPM.

[0086] The shaking means 50 allow the pMDI to be shaken by up to 180° either side of the vertical datum. The shaking mechanism 50 thus allows the user to define how the device will be shaken within 360 degrees of rotation.

[0087] During the test method setup, the user can set the shaking parameters including the start and end angle of which the pMDI will be shaken, the speed of which the pMDI is shaken and the number of rotations per shake. The shaking mechanism can be controlled via a stepper motor 51 for precise control of the angle, shown on figure 5.

[0088] Of course, other types of shaking means could be used.

[0089] The actuating means 60 advantageously comprise a linear stepper motor connected to a rod capable of extending up to 50mm to allow it to actuate pMDIs of a range of sizes and lengths.

[0090] The linear stepper motor allows the distance of the rod to be precisely and accurately controlled.

[0091] The actuating means 60 should be able to apply up to a maximum of 250N force to the top of the pMDI canister in order to actuate the pMDI.

[0092] Of course, other types of actuating means could be used.

[0093] The device can advantageously comprise a load cell 65 to allow the force required to actuate the pMDI to be measured. This is then logged and recorded by the computer and can be access via the touchscreen 5 or the data file.

[0094] The rod's end 61 which meets the top of the pMDIs canister can be interchanged with any shaped end to accommodate varying canister geometry.

[0095] The positioning of the linear stepper motor can be adjusted in multiple angles allowing it to suitably align with a range of pMDI devices.

[0096] Once the test is completed, the user can export the test data to a data file. The user interface should allow any data collected during a test run to be exported in a format which can be opened on a standard PC or laptop.

[0097] The device can include connecting ports 7, for example USB and / or RJ45 connections, allowing the user to save the collected information to either a network or a USB stick.

[0098] On the rear of the device, there is a connection port to connect to a breath simulator 100. This then allows the device to trigger the breath simulator 100 when required as set by the user in the test method.

[0099] In the case of emergency, an emergency stop 6 is preferably present on the side of the device which will shut power off to the device. The present invention allows the testing device to accommodate the use of varying anatomical mouth-throat models, including Oropharyngeal Consortium Large (OPC L), Medium (OPC M) and Small (OPC S), Alberta Idealized Throat (AIT), Virginia Commonwealth University Large (VCU L), Medium (VCU M) and Small (VCU S), United States Pharmacopeia (USP) and VivoLab (Frank models) and other types of anatomical mouth-throat models. The device is also able to perform Delivered Dose Uniformity (DDU) with a Dose Uniformity Sampling Apparatus (DUSA).

[0100] Figures 9 to 11 show in a detailed manner the preferred operating steps when using a testing device as described above.

[0101] Figure 9 provides details for the initial device setup, with the manual actions on the left side and the automated actions on the right side.

[0102] The steps of this initial setup are listed in figure 9.

[0103] Figure 10 shows in a similar way the test setup procedure.

[0104] The steps of this test setup are listed in figure 10.

[0105] Finally, figure 11 shows in a detailed manner the automated test procedure, with the method steps of the present invention:

[0106] - weighing the pMDI; the weighing can take place before and after each actuation or group of actuations;

[0107] - shaking the pMDI; the shaking can take place before and after each actuation or group of actuations;

[0108] - connecting the pMDI to the mouthpiece adapter;

[0109] - actuating the pMDI.

[0110] Where in the foregoing description, elements or means are mentioned which have known, obvious or foreseeable equivalents, then such equivalents are herein incorporated as if individually set forth. Reference should be made to the claims for determining the true scope of the present invention, which should be construed so as to encompass any such equivalents. It will also be appreciated by the reader that features of the invention that are described as preferable, advantageous, convenient or the like are optional and do not limit the scope of the independent claims. Moreover, it is to be understood that such optional features, whilst of possible benefit in some embodiments of the invention, may not be desirable, and may therefore be absent, in other embodiments.

Claims

Claims1. A testing device for the testing of fluid dispenser devices, characterized in that said testing device comprises:- fixing means (10) for fixing a fluid dispenser device comprising a body (1 ) and a dispensing orifice (2);- weighing means (20) for weighing said fluid dispenser device before and after each actuation or group of actuations;- first positioning means (30) for moving said fluid dispenser device;- second positioning means (30'), for moving an adapter (40) adapted to connect to said dispensing orifice (2) of the fluid dispenser device;- shaking means (50) for shaking said fluid dispenser device before each actuation or group of actuations; and- actuating means (60) for actuating said fluid dispenser device.

2. The device according to claim 1 , further comprising a touchscreen (5) and a built-in computer for controlling the testing device and exporting of testing data.

3. The device according to claim 1 or 2, wherein said fixing means (10) comprise a spring-loaded arm to allow easy insertion and removal of the fluid dispenser device.

4. The device according to claim 3, wherein said fixing means (10) include at least one removeable insert (11 ) allowing to accommodate a range of fluid dispenser devices with varying body geometry.

5. The device according to any one of the preceding claim, wherein said first positioning means (30) comprise a plate (31 ) and two motorizedaxis (32, 33) allowing the device to position the fluid dispenser device in the X and Y directions.

6. The device according to any one of the preceding claims, wherein said weighing means (20) comprise an analytical balance for the measurement of the fluid dispenser's shot weight after each actuation or group of actuations.

7. The device according to any one of the preceding claims, wherein said shaking means (50) shake the fluid dispenser device in a rotational manor about a Z axis, which is a horizontal axis in the normal use of the testing device.

8. The device according to claim 7, wherein said shaking means (50) allow the fluid dispenser to be shaken by up to 180° either side of a vertical datum.

9. The device according to any one of the preceding claims, wherein said actuating means (60) are able to apply up to a maximum of 250N force in order to actuate the fluid dispenser device.

10. The device according to any one of the preceding claims, wherein said actuating means (60) comprise a load cell (65) to allow the force required to actuate the fluid dispenser to be measured.

11. The device according to any one of the preceding claims, wherein said fluid dispenser device is a pMDI (pressurized Metered Dose Inhaler) device, said dispensing orifice (2) is a mouthpiece and said adapter (40) is a mouthpiece adapter.

12. A method for the testing of fluid dispenser devices, characterized in that said method comprises:- fixing a fluid dispenser device comprising a body (1 ) and a dispensing orifice (2) in fixing means (10) of a testing device;- weighing said fluid dispenser device before and after each actuation or group of actuations with weighing means (20) of said testing device;- shaking said fluid dispenser device before each actuation or group of actuations with shaking means (50) of said testing device;- connecting said dispensing orifice (2) to an adapter (40) with first and / or second positioning means (30, 30') of said testing device; and - actuating said fluid dispenser device with actuating means (60) of said testing device.

13. The method according to claim 12, wherein said fluid dispenser device is a pMDI (pressurized Metered Dose Inhaler) device, said dispensing orifice (2) is a mouthpiece and said adapter (40) is a mouthpiece adapter.

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