Holder for a plurality of medical injection devices

Abstract

The disclosure relates to a holder for a plurality of medical injection devices (40) adapted for ejecting a medical solution through a needle, said holder comprising:  at least one device plate (10, 10A, 10B) comprising a plurality of sample sites (14), each sample site (14) presenting o a retaining structure adapted to maintain an individual medical device (40) on the sample site (14) in a testing position wherein each medical injection device (40) is arranged on the device plate (10, 10A, 10B) such that an outlet allowing to eject a medical solution is located on a bottom surface of the medical injection device (40), and o a throughhole (16) arranged to be aligned with said outlet and adapted for the passage of medical solution ejected from the outlet, and  a set of pillars (20, 20A, 20B) adapted for supporting the device plate (10, 10A, 10B).

Description

[0001] HOLDER FOR A PLURALITY OF MEDICAL INJECTION DEVICES

[0002] TECHNICAL FIELD

[0003] The disclosure relates to a holder for supporting a plurality of medical injection devices during thermal and mechanical testing procedures.

[0004] TECHNICAL BACKGROUND

[0005] Medical solutions are often administered by automatic medical injection devices such as on-body injectors, disposable automatic injectors or automatic prefilled syringes.

[0006] Before distributing and using an automatic injection device with a particular medical solution, validation tests need to be carried out to ensure the safety and reliability of the injection device.

[0007] For instance, the validation tests investigate the interaction between the injection device and the medical solution during storage and in particular temperature and mechanical conditions. Tests at elevated temperature and / or under mechanical vibration may be carried out to simulate an accelerated ageing process and to investigate the long-term effects of a storage of the medical solution in contact with the material of the injection device. Further, on-body injection devices need to be tested in an environment corresponding the body temperature and the movement of the patient wearing such a device. These tests are designed to investigate the interaction of the medical solution with the container material at human body temperature and / or a possible contamination of the medical solution by the container material.

[0008] Mechanical effects due to the movement of the patient also have to be taken into account. Such movements may affect the mechanical precision of the injection and for example impact the quantity of the medical solution delivered to the patient. They can also influence the interaction of the medical solution with the material of the injection device. In addition to a thermal treatment, the automatic injection devices are therefore exposed to mechanical testing such as vibrational or shaking tests.

[0009] Thermal, mechanical and / or humidity tests are typically performed in a test chamber which can be heated to the appropriate temperature and humidity and / or simulate mechanical vibration and / or other particular conditions.

[0010] During and / or after these tests, it is necessary to collect samples of the ejected medical solution in order to analyze their chemical composition and their precise quantity. In certain cases, the injection devices are subject to continuous testing after collecting of one or more samples of ejected liquid. The ejection of liquid may occur in an autonomous way, for example after a predefined period of time, or be initiated by a user.

[0011] In order to carry out reliable testing, it is necessary to perform the same test simultaneously on a plurality of injection devices. This ensures that the devices are tested under similar conditions, which is necessary for reproducible testing. The number of injection devices tested simultaneously may also be imposed by regulatory requirements. The injection devices should be arranged in a stable manner in order to maintain their position accurately during mechanical testing. The injection devices need to be placed in the same orientation, for example with the needle or outlet in downward direction. The user should be able to manipulate a set of injection devices and place them simultaneously in one or several test chambers in a simple way, avoiding unnecessary weight or complex adjustment procedures. It is further necessary to and minimize external contamination and / or potential loss of medical solution.

[0012] Currently, there is no equipment available to reliably test a plurality of injection devices under thermal and mechanical conditions as described above, allowing to collect samples of ejected liquid during and / or after a treatment.

[0013] SUMMARY OF THE DISCLOSURE

[0014] A goal of the present disclosure is to provide a holder for a plurality of medical injection devices designed to overcome the drawbacks mentioned above.

[0015] T o that end, an object of the disclosure is a holder for a plurality of medical injection devices adapted for ejecting a medical solution through a needle, said holder comprising:

[0016] • at least one device plate comprising a plurality of sample sites, each sample site presenting a retaining structure adapted to maintain an individual medical device on the sample site in a testing position wherein each medical injection device is arranged on the device plate such that an outlet allowing to eject a medical solution is located on a bottom surface of the medical injection device, and a throughhole arranged to be aligned with said outlet and adapted for the passage of medical solution ejected from the outlet, and

[0017] • a set of pillars adapted for supporting the device plate.

[0018] Preferably, the retaining structure comprises a plurality of threaded bolts each engaging a respective threaded bore in the device plate, said threaded bolts being adapted for maintaining the medical injection device. In certain embodiments, the retaining structure comprises a spacer protruding from the device plate, the spacer being adapted to support the bottom surface of a medical injection device.

[0019] At least one device plate may be made of aluminum.

[0020] At least one pillar may be made of stainless steel.

[0021] The holder may comprise a plurality of device plates each supported by a respective set of pillars, the device plates supported by the respective set of pillars being stacked.

[0022] Preferably, each throughhole is configured to maintain a container inserted into the respective throughhole, said container being adapted for receiving the medical solution.

[0023] The holder may comprise at least one vial plate maintained horizontally below a device plate, said vial plate being configured for maintaining a plurality of vials, the opening of each vial being aligned with a delivery throughhole, each vial being configured to receive the medical solution ejected by a medical device received on a site of the device plate.

[0024] In certain embodiments, the vial plate comprises a plurality of counterbores, each counterbore being adapted to receive a vial and to maintain said vial aligned with a delivery throughhole.

[0025] Preferably, each vial plate is supported by a plurality of support feet arranged on a device plate directly below the vial plate.

[0026] Each support foot may be a threaded rod or a screw maintained in a threaded hole in the device plate directly below the vial plate.

[0027] In certain embodiments, the vial plate further comprises a plurality of counterbores arranged on the lower surface of the vial plate, each support foot being engaged in a respective counterbore.

[0028] The invention also refers to a process for testing a plurality of medical injection devices, comprising the following steps:

[0029] • arranging at least one medical injection device on a sample site on a holder as described above, each medical injection device being configured to eject a medical solution through an outlet in a bottom face of the medical device ,

[0030] • arranging at least one container on the holder such that the outlet for ejecting the medical solution is aligned with a respective throughhole and the medical solution is ejected through the throughhole and received in said at least one container, • introducing the holder comprising the at least one container and the at least one medical injection device in a test chamber,

[0031] • performing temperature and / or mechanical testing,

[0032] • injecting a medical solution into at least one container,

[0033] • performing an analysis of the quantity and / or the chemical composition of the medical solution contained in a container.

[0034] BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Further features and advantages will appear in the following detailed description, based on the appended drawings, wherein:

[0036] Figure 1 is a perspective view of a holder according to an embodiment of the invention.

[0037] Figure 2 is a perspective view of a holder comprising two device plates.

[0038] Figure 3 is a sectional view of a holder comprising two device plates.

[0039] Figure 4 is a perspective view of a holder comprising two device plates and a vial plate.

[0040] Figure 5 is a sectional view of a holder comprising two device plates and a vial plate.

[0041] Figure 6 illustrates an arrangement of a holder comprising a device plate and a vial plate.

[0042] Figure 7 illustrates the lower surface of a vial plate.

[0043] Figure 8 illustrates an arrangement of a holder comprising two device plates and a vial plate disposed under the second device plate.

[0044] Figure 9 is an exploded view of a holder comprising two device plates and a vial plate.

[0045] DETAILED DESCRIPTION OF EMBODIMENTS

[0046] For the sake of clarity and simplification we will use a top-to-bottom orientation as shown in figure 1 , corresponding to the usual handling position of the holder. In this position, the holder is arranged vertically with the medical injection device 40 positioned on top of the device plate 10. Thus, the terms “top”, “bottom”, “above”, “below”, “upper”, “lower” as well as “horizontal” and “vertical” will serve for the description, without however limiting the invention. The longitudinal axis L and the transverse axis T define a horizontal plane and the pillar axis P is vertical. Figure 1 illustrates a first embodiment of a holder according to the invention. The holder comprises a device plate 10 and a set of pillars 20 supporting the device plate. During the testing of the injection devices, the device plate 10 is held in a mainly horizontal position.

[0047] The device plate 10 is typically a board with two parallel surfaces, for example a rectangular plate. Preferably, the device plate 10 is made of aluminum which is lightweight and stable in the temperature and humidity range in which the testing of injection devices is typically carried out. The low weight allows for easy transport and manipulation during the testing procedure of the medical injection devices. Aluminum is further stable with respect to the mechanical solicitation to which the injection devices will be exposed. The surfaces of the device plate may be anodized to avoid external contamination.

[0048] The device plate 10 comprises a plurality of sample sites 14. Each sample site 14 is adapted to receive a single medical injection device 40 to be tested. For example, the device plate 10 may comprise sixteen sample sites for holding sixteen medical injection devices simultaneously on the device plate 10. The sample sites 14 may be oriented along the longitudinal axis L, along the transversal axis T, and / or in an oblique manner in the horizontal plane.

[0049] The medical injection device 40 may for example be a delivery device as described in the patent US 11 ,666,704 B1. Each medical injection device 40 comprises an outlet through which a medical solution can be injected into a patient or ejected into a container 61 . The ejection into a container allows for investigation of the quality and quantity of the medical solution during and / or after thermal and mechanical testing. Such a container may for example be an analysis or centrifugation tube, or a glass vial.

[0050] Each sample site 14 comprises a retaining structure 17, 18 to maintain a medical injection device 40 on the sample site 14 in a defined testing position. Typically, in the testing position, the medical injection devices 40 are arranged on the device plate 10 such that the outlet is located on a bottom surface of the medical injection device 40. In the testing position, the bottom surface of each injection device is oriented towards the device plate such that the outlet is facing a through hole.

[0051] The retaining structure 17,18 is typically a raised structure on the top surface of the device plate 10. The retaining structure may comprise a set of threaded bolts 17 such as threaded rods and / or screws fastened in a set of threaded holes in the device plate 10. Said bolts 17 are positioned to surround a medical device 40 positioned on the device plate 10 and to maintain the device 40 in place during testing. In a preferred embodiment, the bolts 17 are headless screws made from stainless steel. A headless screw can be easily fixed in a threaded bore in the device plate and allows for quick and easy insertion of the medical injection device.

[0052] The retaining structure may comprise a preformed edge integrated into the device plate, made for example by moulding or by additive manufacturing, one or more guide pins, or any other structure fixed on or integrated into the device plate for maintaining the medical injection devices in a fixed position during testing.

[0053] The retaining structure may further comprise one or more spacers 18 for supporting the medical injection device 40 on its bottom face. Such spacers 18 may be used to hold the medical injection device 40 in a particular position which allows for a controlled ejection of a medical solution in a particular direction. Such a particular position may be horizontal or tilted with respect to the device plate. The spacers may also be adapted to compensate any raised or rounded structures on the bottom face of the injection device.

[0054] The retaining structure may also allow to prevent the medical injection device from vibrating inside the sample site or hitting the sample plate or the retaining structure during mechanical testing.

[0055] Each sample site 14 further comprises a throughhole 16 located in the device plate 10. When an injection device is maintained on a sample site 14, the outlet for injecting a medical solution is aligned with the throughhole 16 such that the medical solution is ejected through the throughhole 16. The medical solution is then collected in a container 61 arranged in or under the throughhole 16 as illustrated in figure 3, in order to extract the ejected medical solution for further analysis.

[0056] The spacers 18 allow to adjust the distance between the outlet of the medical injection device 40 and the throughhole 16 and the opening of the container 61.

[0057] The container 61 for collecting the medical solution may be a sample tube or centrifugation tube comprising a top flange. The tube may be suspended in the throughhole and held in position by the top flange. Alternatively, the container 61 may be a tube or another type of container fixed to the sample plate by means of clamps or other fixtures, with the opening of the container positioned above, inside or below the throughhole of a sample site such that a medical solution can be ejected through the throughhole into the container. Preferably, each container 61 is arranged directly in a throughhole 16 and the injection device 40 is maintained such that the outlet is aligned with the throughhole 16 by means of the retaining structure 17, 18. This allows for an accurate alignment of the outlet of the injection device 40 with the container 61 , which enables a precise delivery of the medical solution into the container 61 . In this way, the user can perform a precise analysis of the dosage of the delivered medical solution. The positioning and alignment further allows for minimizing evaporation and / or external contamination of the medical solution.

[0058] The sample sites 14 on a device plate 10 are typically configured to receive identical medical injection devices. In certain embodiments, the sample sites may be configured to receive different embodiments of medical injection devices on the same device plate.

[0059] A plurality of vertical pillars 20 are fixed to the device plate 10 for supporting the device plate 10 parallel to the surface on which the holder is placed. For example, four pillars 20 may be disposed in the four corners of a rectangular device plate 10. The heigh of the pillars is greater than the height of the containers which are arranged below the device plate and to avoid contact between the containers and the surface bearing the pillars.

[0060] By way of an illustrative and non-limiting example, the pillars 20 are of cylindrical shape and can include attachments allowing to fix the pillars on the device plate 10. The pillars 20 are of equal height and may be fabricated from stainless steel or from aluminum which are robust materials which reliably support the mechanical and thermal conditions during the testing of the medical devices. The pillars 20 are secured to the device plate 10, for example by a set of screws 21 allowing for a quick and simple assembly of the holder.

[0061] Figure 2 illustrates a second embodiment comprising two device plates 10A, 10B and two sets of pillars 20A, 20B. This embodiment comprises two parts corresponding each to a holder according to the first embodiment described above. The two parts are stacked on top of each other along the pillar axis P. A first part comprising a first device plate 10A and corresponding first pillars 20A constitutes a bottom part A, and a second part comprising a second device plate 10B and corresponding second pillars 20B constitutes a top part B of the holder.

[0062] The pillars 20B of the top part B are preferably aligned with the pillars 20A of the bottom part A. The pillars 20B of the top part B are fastened to the bottom part A, for example by means of screws allowing for tight assembly and a stable connection between the parts A, B during mechanical testing. Preferably, the pillars 20B of the top part B comprise a threaded bore on their bottom surface which can be screwed onto a threaded pole on the top surface of the device plate 10A of the bottom part A, or onto the screw maintaining the pillars 20A on the device plate 10A.

[0063] Figure 3 shows a side view of a holder comprising a bottom part A and a top part B. A medical injection device 40 is maintained on the device plate 10B of the top part B. A container 61 is arranged in the corresponding throughhole 16 under the medical injection device 40. In this position, the medical injection device 40 can eject a medical solution into the container 61.

[0064] The distance d between the device plates 10A and 10B along the pillar axis P is greater than the height h of the container 61 plus the height H of a medical injection device 40, in order to avoid contact between the container 61 and the device plate 10A and / or a medical injection device 40 arranged on the device plate 10A of the bottom part A. The height of the pillars 20B is chosen accordingly.

[0065] In other embodiments (not illustrated), three or more holders are stacked on top of each other, constituting a bottom part, one or more intermediate parts, and a top part. The stacking and assembling is carried out in a similar way, maintaining the device plates parallel to each other at a distance greater than the height of a container and the height of a medical injection device, and securing the pillars on the top of the underlying part. It is possible to stack as many holders as allowed by the available space during the experiment or during transport of the holders maintaining medical injection devices.

[0066] The device plates of the stacked devices are maintained in a parallel and horizontal position. Each device plate is configured in the same way as the sample plate of the first embodiment described above.

[0067] A holder assembled by stacking of several parts allows to carry out simultaneous testing of a larger number of injection devices in the same test chamber, and to perform shaking and vibrational tests simultaneously under the same conditions on a larger number of medical injection devices. The number of parts may be adapted to the dimensions of the test chamber and to the number of devices to be tested simultaneously.

[0068] Figure 4 illustrates a third embodiment of the holder. The third embodiment comprises two or more device plates 10A, 10B stacked vertically as described for the second embodiment.

[0069] The holder further comprises a vial plate 30 disposed under the upper device plate 10B. When the holder comprises more than two device plates, respective vial plates can be disposed under one or more device plates, with exception of the bottom device plate 10A.

[0070] The vial plate 30 is configured to support one or more vials 31 to be arranged under each throughhole 16 and to receive the medical solution ejected from a medical device 40. In this case, the container for receiving the medical solution is a typically a vial 31 , or another type of container suitable to be supported by the vial plate. The container is not directly fixed to the throughhole 16 or to the device plate. Such a vial is for example a glass vial which may, in an illustrative and non-limiting example, receive 1.5 ml of liquid.

[0071] The vial plate 30 may comprise a set of counterbores 35, as illustrated figure 6, in which a vial 31 can be inserted and maintained. The counterbores 35 are arranged according to the sample sites on the device plate 10B, such that each counterbore 35 is aligned with one throughhole 16 on the device plate 10B.

[0072] The vial plate 30 is typically a board with two parallel surfaces, for example an essentially rectangular plate. Preferably, the vial plate 30 is not in contact with the pillars 20B supporting the device plate 10B when the holder is mounted. Therefore, the vial plate 30 may present cut-off corners or cut-outs in the zone of the pillars 20B. This allows to maintain the vial plate 30 and the vials 31 maintained therein in a stable position, in particular during mechanical testing such as shaking or vibration.

[0073] Preferably, the vial plate 30 is made of aluminum which is lightweight and stable in the temperature and humidity range in which the testing of injection devices is typically carried out. Aluminum is further stable with respect to the mechanical solicitation to which the injection devices will be exposed. The surfaces of the vial plate 30 may be anodized to avoid external contamination.

[0074] As illustrated in figure 5, the vial plate 30 is arranged parallel to the corresponding device plate 10B in a horizontal plane. The distance dvbetween the vial plate 30 and the sample plate 10B above the vial plate 30 is chosen to maintain the opening of each vial 31 directly below the corresponding throughhole 16 in the sample plate 10B, or that the vial protrudes into the throughhole such that the opening of the vial is close to the outlet of the medical injection device. This allows to ensure a proper delivery of the medical solution into the vial 31 and prevent from evaporating parts of the medical solution, and to avoid any external contamination.

[0075] With reference to figure 6, the vial plate 30 is supported by a set of support feet 33 parallel to the pillar axis P. By way of an illustrative and non-limiting example, a set of support feet 33 for one vial plate comprises four support feet. A support foot 33 may be a rod, for example a threaded rod, or a screw. The support feet 33 are fixed on the device plate 10A directly below the vial plate 30. Advantageously, the device plate 10A below the vial plate 30 comprises a set of threaded holes 32, arranged on the top surface of the device plate 10A, parallel to the pillar axis P. Each support foot 33 is screwed into a threaded hole 32 on the device plate 10A. Alternatively, the device plate 10A may comprise holes parallel to the pillar axis P, in which the support feet 30 can tightly inserted or clipped, for example cylindrical bores. These fastening methods allow for securely maintaining the support feet 33 in place during the testing of the medical devices 40. The position of the holes 32 may be chosen close to the edge of the vial plate 30 for providing a stable support, and such that the support feet 30 do not interfere with the positioning of the medical devices 40 on the sample sites 14 when arranged on the device plate 10A below the vial plate 30. For example, one or two holes 32 may be arranged close to each edge on the upper surface of a rectangular device plate 10A, or close to the corners of the device plate 10A.

[0076] With reference to figure 7, the lower surface 38 of the vial plate 30 comprises a set of counterbores 39 parallel to the pillar axis P. The counterbores 39 are arranged such that each counterbore 39 in the vial plate 30 faces a hole 32 in the lower device plate 10A when the holder is mounted. In this way, each support foot 33 can be engaged in a respective counterbore 39 when the vial plate 30 is positioned on the support feet 33, the vial plate 30 being parallel to the lower device plate 10A. The support feet 33 are oriented parallel to the pillar axis P. For example, one or two counterbores 39 may be arranged close to each edge on the bottom surface of a rectangular vial plate 30, or close to the corners of the vial plate 30. Typically, the counterbores 396 are not threaded and the support feet 33 may be tightly inserted into the counterbores 39 to maintain the vial plate 30 in a stable position in particular during mechanical testing. This enables a simple assembly, as the support feet 33 cannot be rotated around their longitudinal axis once they are screwed into the device plate 10A.

[0077] We will now describe the setup and assembly of a holder for testing a plurality of medical devices. The parts of the holder are illustrated in an exploded view in figure 9. In certain embodiments, some of the illustrated parts are not used.

[0078] A first device plate 10A constituting the bottom device plate is provided. The device plate 10A comprises a plurality of throughholes 16 according to the positions of the medical injection devices 40 to be arranged on the first device plate 10A for testing. The device plate 10A may comprise preformed structures forming a retaining structure or part of a retaining structure. The device may further comprise holes or threaded bores adapted for fixing parts of a retaining structure. During assembly, parts of a retaining structure such as threaded bolts 17 and / or spacers 18 may be mounted on the first device plate 10A by an operator.

[0079] The first device plate 10A is mounted on a set of pillars 20A, for example by means of a set of screws 21 A which are each inserted into a bore from the upper side of the first device plate and secured into a respective pillar 20A. A plurality of containers such as sample tubes or centrifugation tubes are inserted into or fastened to the throughholes 16. A plurality of medical injection devices 40 is arranged on the sample sites of the first device plate 10A, such that each outlet of a medical injection device 40 faces a container and the liquid ejected from the outlet is received by the container.

[0080] Alternatively, the first device plate 10A remains empty, and is not loaded with containers and medical injection devices. This is in particular the case when all ejected liquid samples shall be collected in vials which require support by a vial plate.

[0081] One or more subsequent device plates 10B may be provided with a respective retaining structure 17, 18 and mounted on respective sets of pillars 20B by means of the screws 21 B. These subsequent device plates 10B may be loaded with a plurality of containers and a plurality of injection devices 40. The device plates 10B mounted on their respective sets of pillars 20B may be stacked along the pillar axis P onto the first device plate 10A.

[0082] Alternatively, the subsequent device plates may be loaded with a plurality of injection devices 40, without providing containers in the throughholes 16 for receiving the medical solution ejected from the outlet of each injection device 40. In this case, as illustrated in figure 8, a vial plate 30 is mounted onto the first device plate 10A. For this purpose, the operator fixes a set of support feet 33 into the support holes 32 on the top surface of the first device plate 10B. The vial plate 30 is positioned on the support feet 33, with one counterbore 39 on the lower side 38 of the vial plate 30 facing each support foot 33. Each support foot 33 is inserted into a counterbore on the bottom surface of the vial plate 30 to fix the vial plate 30 on the device plate 10A.

[0083] The vial plate 30 is loaded with a plurality of vials 31 , for example by inserting one vial 31 into each counterbore 35 on the top surface 37 of the vial plate 30.

[0084] A second device plate 10B with a respective set of pillars 20B may then be mounted onto the first device plate 10B. The second device plate 10B may be mounted with medical injection devices 40 whose outlets are facing the throughholes 16 in the second device plate 10B. If more device plates are to be used in combination with vial plates, a second vial plate may be mounted onto the second device plate, in a similar manner to the first vial plate. The second vial plate may then be loaded with a plurality or vials, and a third device plate may be mounted on the second device plate and loaded with medical injection devices.

[0085] Further device plates, and, if applicable, further vial plates may be stacked to set up a holder according to the number of medical injection devices to be tested and according to the dimensions of the test chamber and testing equipment.

[0086] During a testing procedure, the holder loaded with a plurality of medical injection devices 40 may be inserted into one or more test chambers, undergo thermal and mechanical testing, and be transported between different preparation, testing, and analysis sites. The medical injection devices may be programmed before or after being mounted onto the respective sample sites of the holder and eject a predefined dose of a medical solution according to a programmed schedule.

[0087] The medical injection devices may then be unmounted. The containers, such as vials, sample or centrifugation tubes, are extracted from the holder. The quantity and composition of the liquid samples contained in the containers may be analyzed according to the testing protocol.

[0088] REFERENCES

[0089] US 11 ,666,704 B1

Claims

CLAIMS1 . A holder for a plurality of medical injection devices (40) adapted for ejecting a medical solution through a needle, said holder comprising:• at least one device plate (10, 10A, 10B) comprising a plurality of sample sites (14), each sample site (14) presenting o a retaining structure adapted to maintain an individual medical device (40) on the sample site (14) in a testing position wherein each medical injection device (40) is arranged on the device plate (10, 10A, 10B) such that an outlet allowing to eject a medical solution is located on a bottom surface of the medical injection device (40), and o a throughhole (16) arranged to be aligned with said outlet and adapted for the passage of medical solution ejected from the outlet, and• a set of pillars (20, 20A, 20B) adapted for supporting the device plate (10, 10A, 10B).

2. The holder according to claim 1 wherein the retaining structure comprises a plurality of threaded bolts (17) each engaging a respective threaded bore in the device plate (10, 10A, 10B), said threaded bolts (17) being adapted for maintaining the medical injection device (40).

3. The holder according to claim 1 or claim 2, wherein the retaining structure comprises a spacer (18) protruding from the device plate, the spacer being adapted to support the bottom surface of a medical injection device (40).

4. The holder according to any of the previous claims, wherein at least one device plate (10, 10A, 10B) is made of aluminum.

5. The holder according to any of the previous claims, wherein at least one pillar (20, 20A, 20B) is made of stainless steel.

6. The holder according to any of the previous claims, comprising a plurality of device plates (10, 10A, 10B) each supported by a respective set of pillars (20, 20A, 20B), the device plates (10, 10A, 10B) supported by the respective set of pillars (20, 20A, 20B) being stacked.

7. The holder according to any of the previous claims, wherein each throughhole (16) is configured to maintain a container (61) inserted into the respective throughhole (16), said container (61) being adapted for receiving the medical solution.

8. The holder according to any of claims 1 to 7, further comprising at least one vial plate (30) maintained horizontally below a device plate (10B), said vial plate (30) being configured for maintaining a plurality of vials (31), the opening of each vial (31) being aligned with a delivery throughhole (16), each vial (31) being configured to receive the medical solution ejected by a medical device (40) received on a site of the device plate (10B).

9. The holder according to claim 8, wherein the vial plate (30) comprises a plurality of counterbores (35), each counterbore (35) being adapted to receive a vial (31) and to maintain said vial (31) aligned with a delivery throughhole (16).

10. The holder according to claim 8 or claim 9 in combination with claim 6, wherein each vial plate (30) is supported by a plurality of support feet (33) arranged on a device plate (10A) directly below the vial plate (30).11 . The holder according to claim 10, wherein each support foot (33) is a threaded rod or a screw maintained in a threaded hole in the device plate (10A) directly below the vial plate (30).

12. The holder according to claim 10 or claim 11 , wherein the vial plate (30) further comprises a plurality of counterbores (39) arranged on the lower surface (38) of the vial plate (30), each support foot (33) being engaged in a respective counterbore (39).

13. A process for testing a plurality of medical injection devices, comprising the following steps:• arranging at least one medical injection device (40) on a sample site (14) on a holder according to any of claims 1 to 12, each medical injection device (40) being configured to eject a medical solution through an outlet in a bottom face of the medical device (40),• arranging at least one container (61 , 31) on the holder such that the outlet for ejecting the medical solution is aligned with a respective throughhole (16) and the medical solution is ejected through the throughhole (16) and received in said at least one container (61 , 31),• introducing the holder comprising the at least one container (61 , 31) and the at least one medical injection device (40) in a test chamber,• performing temperature and / or mechanical testing,• injecting a medical solution into at least one container (61 , 31), • performing an analysis of the quantity and / or the chemical composition of the medical solution contained in a container (61 , 31).

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