An apparatus for testing a sub-assembly of a medicament delivery device

Abstract

An apparatus for testing a sub-assembly of a medicament delivery device; wherein the sub-assembly comprises an elongated housing containing a power source and a plunger rod connected to the power source; wherein the plunger rod is configured to be moved by the power source relative to the elongated housing in a proximal direction; the apparatus comprising: a holder configured to be attached to the housing of the sub-assembly; an elongated probe extending along a longitudinal axis from a first end to a second end; wherein the elongated probe is movable relative to the holder along the longitudinal axis; wherein the elongated probe is configured to be at least partially positioned into the housing of the sub-assembly; wherein the second end of the elongated probe is configured to be in contact with a proximal end of the plunger rod of the sub-assembly; a force sensor operably connected to the elongated probe; wherein the force sensor is configured to measure an output force applied on the elongated probe; and a controller configured to receive data from the force sensor and generate an output force profile based on the received data.

Description

[0001] TITLE

[0002] AN APPARATUS FOR TESTING A SUB- ASSEMBLY OF A MEDICAMENT DELIVERY DEVICE

[0003] TECHNICAL FIELD

[0004] The present disclosure generally relates to an apparatus for testing a sub-assembly of a medicament delivery device, in particular, the apparatus comprises an elongated probe connected to a force sensor.

[0005] BACKGROUND

[0006] Medicament delivery devices such as auto- injectors, insulin pens, or on-body devices are generally known for the self-administration of a medicament by patients without formal medical training. For example, patients suffering from diabetes or people who are undergoing an artificial fertilization procedure may require repeated injections of insulin or hormones. Other patients may require regular injections of other types of medicaments, such as a growth hormone. Therefore, medicament delivery devices for self-administration usually are arranged with multiple automatic functions and protection features. For example, a medicament delivery member guard is commonly used. The medicament delivery member guard is configured to cover a medicament delivery member, e.g., an injection needle so that a user will not accidentally be in contact with the medicament delivery member.

[0007] Testing an operation of a medicament delivery device is crucial for medicament delivery device development and / or quality control of the manufacture of medicament delivery devices. In particular, testing if the medicament delivery device can deliver an accurate dose of contained medicament of the medicament delivery device is important. Thus, there is a need to further improve the testing assembly and the testing method for testing the operation of a medicament delivery device.

[0008] SUMMARY

[0009] The invention is defined by the appended claims, to which reference should now be made. There is hence provided an apparatus for testing a sub-assembly of a medicament delivery device. The sub-assembly comprises an elongated housing containing a power source and a plunger rod connected to the power source; wherein the plunger rod is configured to be moved by the power source relative to the elongated housing in a proximal direction. The apparatus comprises: a holder configured to be attached to the housing of the sub-assembly; an elongated probe extending along a longitudinal axis from a first end to a second end. The elongated probe is movable relative to the holder along the longitudinal axis. The elongated probe is configured to be at least partially positioned into the housing of the sub-assembly. The second end of the elongated probe is configured to be in contact with a proximal end of the plunger rod of the sub-assembly. The apparatus comprises a force sensor operably connected to the elongated probe. The force sensor is configured to measure an output force applied on the elongated probe. The apparatus comprises a controller configured to receive data from the force sensor and generate an output force profile based on the received data.

[0010] The apparatus can therefore be used to measure the output force from the plunger rod and the power source and thereafter calculate a medicament delivery time and a deliverable dose of a medicament delivery device without having a medicament container containing medicament in the medicament delivery device.

[0011] The apparatus is configured to test the power source performance of the subassembly of the medicament delivery device. In particular to test the sub-assembly without a medicament container. Depending on the characters of contained medicament and the material of medicament containers, a force requirement to expel a specified medicament from a specified medicament container within a predetermined time period can be calculated. Thus, by testing the performance of the power source of the sub-assembly of the medicament delivery device, if the medicament delivery device can deliver an accurate dose within a predetermined time period can be tested without having the medicament. Furthermore, the apparatus can be used to test a sub-assembly of the medicament delivery device that is closer to a medicament delivery device in the market. For example, for testing a pen-type, handhold autoinjector, except a medicament container, all components of the autoinjector can be assembled in a manner of an autoinjector in the market. In this case, the elongated probe can protrude into the assembled autoinjector from a proximal end of the housing to be in contact with the proximal end of the plunger rod. Thus, the testing result of the apparatus can be closer to the power source performance that is used by an end user as most of the interaction between components are properly simulated.

[0012] The power source can be a compression spring and / or a gas canister and / or a motor.

[0013] Preferably, according to another embodiment, the force sensor comprises a load cell.

[0014] Preferably, according to another embodiment, the apparatus comprises a driver to move the elongated probe along the longitudinal axis.

[0015] Preferably, according to another embodiment, when the elongated probe receives force from the plunger rod, the controller is configured to control the driver to move elongated probe such that the elongated probe is moved out from the elongated housing of the sub-assembly with a predetermined speed.

[0016] Preferably, according to another embodiment, the elongated probe comprises a flange configured to be in contact with a delivery member guard of the subassembly.

[0017] Preferably, according to another embodiment, the apparatus comprises a second probe configured to be in contact with a delivery member guard of the subassembly; wherein the second probe is connected to the force sensor.

[0018] Preferably, according to another embodiment, the second probe is hingely connected to the elongated probe.

[0019] Preferably, according to another embodiment, the apparatus comprises a grip connected to the force sensor.

[0020] Preferably, according to another embodiment, the grip is configured to clamp on a cap of the sub-assembly.

[0021] Preferably, according to another embodiment, the driver is connected to the grip and the elongated probe. Preferably, according to another embodiment, the controller is configured to control the driver to move the grip in a first direction along the longitudinal axis.

[0022] Preferably, according to another embodiment, the controller is configured to control the driver to move the elongated probe in a second direction opposite to the first direction along the longitudinal axis.

[0023] Preferably, according to another embodiment, the force sensor is axially movable together with the elongated probe.

[0024] Preferably, according to another embodiment, the holder comprises a protrusion extending in a direction transverse to the longitudinal axis.

[0025] Preferably, according to another embodiment, the protrusion is configured to be at least partially positioned within a recess / cutout of the housing of the sub-assembly when the holder is attached to the housing.

[0026] Preferably, according to another embodiment, the protrusion is configured to be at least partially position within a window of the housing of the sub-assembly when the holder is attached to the housing.

[0027] Preferably, according to another embodiment, the apparatus comprises an information reader configured to capture information from the sub-assembly.

[0028] Preferably, according to another embodiment, the information reader comprises a camera configured to capture an image of the sub-assembly.

[0029] Preferably, according to another embodiment, the information reader comprises an information tag reader configured to read an information tag on of the sub-assembly.

[0030] Preferably, according to another embodiment, the information tag is a QR code, a Bar code, and / or an RFID / NFC tag.

[0031] Another aspect of the invention provides a method for testing a sub-assembly of a medicament delivery device, the method comprising the steps of: providing the apparatus according to any one of the preceding embodiments; providing a sub-assembly of the medicament delivery device comprising an elongated housing containing a power source and a plunger rod connected to the power source; wherein the plunger rod is configured to be moved by the power source relative to the elongated housing in a proximal direction; attaching the housing of the sub-assembly to the holder; moving the elongated probe into the housing until the second end of the elongated probe is in contact with a proximal end of the plunger rod; enabling the power source to output force to move the plunger rod relative to the elongated housing in the proximal direction; measuring the output force applied on the elongated probe from the plunger rod by the force sensor; and receiving force data from the force sensor and generating an output force profile based on the received data by the controller.

[0032] Preferably, according to another embodiment, the controller is configured to generate an energy profile based on the force profile and a distance of the plunger rod displacement.

[0033] Preferably, according to another embodiment, the controller is configured to generate an output force reading based on the force profile and a distance of the plunger rod displacement; and wherein the output force readings comprises one or more data points with predetermined meaning respectively.

[0034] Preferably, according to another embodiment, after the step of providing the subassembly, the method further comprises steps of: capturing information from the sub-assembly by the information reader; and reacting based on the captured information by the controller.

[0035] Preferably, according to another embodiment, the medicament delivery device is a hand-held, pen-type autoinjector, an insulin pen, a safety syringe, an infusion pump, an on-body device.

[0036] The medicament delivery devices described herein can be used for the treatment and / or prophylaxis of one or more of many different types of disorders. Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), hypercholesterolaemia, diabetes (e.g. type 2 diabetes), psoriasis, migraines, multiple sclerosis, anaemia, lupus, atopic dermatitis, asthma, nasal polyps, acute hypoglycaemia, obesity, anaphylaxis and allergies. Exemplary types of drugs that could be included in the medicament delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, antibodies, antibody-drug conjugates, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, protein analogues, protein variants, protein precursors, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies and / or protein derivatives. Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to (with non-limiting examples of relevant disorders in brackets): etanercept (rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis)), evolocumab (hypercholesterolaemia), exenatide (type 2 diabetes), secukinumab (psoriasis), erenumab (migraines), alirocumab (rheumatoid arthritis), methotrexate (amethopterin) (rheumatoid arthritis), tocilizumab (rheumatoid arthritis), interferon beta-1a (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin alfa (anaemia), belimumab (lupus), peginterferon beta-1a' (multiple sclerosis), sarilumab (rheumatoid arthritis), semaglutide (type 2 diabetes, obesity), dupilumab (atopic dermatitis, asthma, nasal polyps, allergies), glucagon (acute hypoglycaemia), epinephrine (anaphylaxis), insulin (diabetes), atropine and vedolizumab (inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis)) , ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, famtrastuzumab deruxtecan-nxki, pertuzumab, transtuzumab-pertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab. Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the medicament delivery devices described herein, for example, pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) may include one or more other active ingredients, or may be the only active ingredient present.

[0037] Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, an immuno-oncology or biooncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, enzymes, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

[0038] Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as HER-2 receptor modulators, interleukin modulators, interferon modulators, CD38 modulators, CD22 modulators, CCR4 modulators, VEGF modulators, EGFR modulators, CD79b modulators, Trop-2 modulators, CD52 modulators, BCMA modulators, PDGFRA modulators, SLAMF7 modulators, PD- 1 / PD-L1 inhibitors / modulators, B-lymphocyte antigen CD19 inhibitors, B-lymphocyte antigen CD20 modulators, CD3 modulators, CTLA-4 inhibitors, TIM-3 modulators, VISTA modulators, INDO inhibitors, LAG3 (CD223) antagonists, CD276 antigen modulators, CD47 antagonists, CD30 modulators, CD73 modulators, CD66 modulators, CDw137 agonists, CD158 modulators, CD27 modulators, CD58 modulators, CD80 modulators, CD33 modulators, APRIL receptor modulators, HLA antigen modulators, EGFR modulators, B-lymphocyte cell adhesion molecule modulators, CDw123 modulators, Erbb2 tyrosine kinase receptor modulators, mesothelin modulators, HAVCR2 antagonists, NY-ESO-1 0X40 receptor agonist modulators, adenosine A2 receptors, ICOS modulators, CD40 modulators, TIL therapies, or TOR therapies.

[0039] Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi- CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, I VAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini- BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

[0040] Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, those used for chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

[0041] Furthermore, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to "a / an / the element, apparatus, component, means, etc." are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, etc., unless explicitly stated otherwise.

[0042] BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Embodiments of the inventive concept will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0044] Fig. 1 shows a cross-section view of a medicament delivery device;

[0045] Fig. 2 shows a cross-section view of a sub-assembly of the medicament delivery device of Fig. 1 and an elongated probe of an apparatus of the disclosure connecting to a force sensor of the apparatus of the disclosure; Fig. 3 shows a perspective view of a holder of the apparatus of the disclosure;

[0046] Fig. 4 shows a perspective view of the holder of Fig. 3 holding a sub-assembly of a medicament delivery device;

[0047] Fig. 5 shows a perspective view of a grip of apparatus of the disclosure;

[0048] Fig. 6 shows a perspective view of the holder of Fig. 3 holding the sub-assembly of Fig. 4;

[0049] Fig. 7 shows a perspective view of the holder of Fig. 3 holding the sub-assembly of Fig. 4 and the elongated probe of Fig. 2;

[0050] Fig. 8-9 show perspective views of the apparatus and the sub-assembly of Fig. 4;

[0051] Fig. 10 shows a schematic view of the apparatus with a second probe and a second force sensor;

[0052] Fig. 11A-D shows an operation sequence of the apparatus;

[0053] Figs 12-13 show a relation between the measured force profile and the displacement of the elongated probe when measuring a sub-assembly of a medicament delivery device;

[0054] Fig. 14 shows a relation between the measured force profile and the displacement of the plunger rod when measuring the other sub-assembly of the other medicament delivery device; and

[0055] Fig. 15 shows a perspective view of a dummy syringe.

[0056] Fig. 16 shows a schematic view of the apparatus with a second probe in another embodiment.

[0057] DETAILED DESCRIPTION

[0058] Figs 1-15 illustrate an apparatus for testing a sub-assembly of a medicament delivery device. The sub-assembly comprises an elongated housing 20 containing a power source 21 and a plunger rod 22 connected to the power source 21; wherein the plunger rod 22 is configured to be moved by the power source 21 relative to the elongated housing 20 in a proximal direction, as shown in Fig. 1. In the example as shown in Fig. 1, the power source 21 is a compression spring. Alternatively, or additionally, the power source can be other type of springs, e.g., a torsion spring or a tension spring, or a gas canister, or any other suitable power source. The apparatus comprises a holder 13 configured to be attached to the housing 20 of the sub-assembly; an elongated probe 12; 12’ extending along a longitudinal axis L from a first end 12a to a second end 12b; a force sensor 15 operably connected to the elongated probe 12; 12’; and a controller configured to receive data from the force sensor 15 and generate an output force profile based on the received data, as shown in Fig. 7. The elongated probe 12; 12’ is movable relative to the holder 13 along the longitudinal axis L. The elongated probe 12; 12’ is configured to be at least partially positioned into the housing 20 of the sub-assembly and the second end 12a of the elongated probe 12; 12’ is configured to be in contact with a proximal end 22a of the plunger rod 22 of the sub-assembly, as shown in Fig. 2. The force sensor 15 is configured to measure an output force applied on the elongated probe 12; 12’. The apparatus can be used to test a sub-assembly of the medicament delivery device that is closer to a medicament delivery device in the market. For example, Fig. 1 shows a pen-type, handhold autoinjector in the market. The autoinjector comprises the sub-assembly as mentioned above, a medicament container M connected to a delivery member N, a delivery member guard 24 to cover the delivery member N, Fig. 2 shows the sub-assembly that can be tested by the apparatus. As shown in Fig. 2, except a medicament container M with the delivery member N, all components of the autoinjector can be assembled in a manner of an autoinjector in the market. In this case, the elongated probe 12; 12’ can protrude into the assembled autoinjector from a proximal end of the housing to be in contact with the proximal end 22a of the plunger rod 22. Thus, the testing result of the apparatus can be closer to the power source 21 performance that is used by an end user as most of the interaction between components are properly simulated. It should be noted that, with information of the medicament, e.g., viscosity, volume, and / or the predetermined medicament delivery time, and / or the information of the medicament container, e.g., the material of the medicament container, the diameter of the medicament container, and / or the size of a delivery member connected to the medicament container, the medicament delivery time, and if the power source can deliver the predetermined dose of the medicament can be tested by the apparatus without having a medicament container and the medicament in the sub-assembly. In one example, the apparatus comprises a driver to move the elongated probe 12; 12’ along the longitudinal axis L. When the elongated probe 12; 12’ receives force from the plunger rod 22, the controller is configured to control the driver to move elongated probe 12; 12’ such that the elongated probe 12; 12’ is moved out from the elongated housing 20 of the sub-assembly with a predetermined speed. In one example, the controller is configured to control the movement of the driver to mimic the resistance from a predetermined medicament within a predetermined medicament container. Alternatively, the elongated probe 12; 12’ is configured to be moved purely by the plunger rod 22 under the power source 21.

[0059] Some of the medicament delivery devices in the market are configured to be triggered (released the power source to enable the medicament expelling operation) by moving the delivery member guard relative to the housing. For example, the medicament delivery device is configured to be triggered by pressing the delivery member guard 24 against a delivery site, or the medicament delivery device is configured to be triggered by pressing the delivery member guard against a delivery site and then pressing a button. In one example, the elongated probe 12 comprises a flange 12c; 12’c configured to be in contact with a delivery member guard 24 of the sub-assembly, as shown in Figs 7-9 and Fig. 16. In this example, the flange 12c is configured to be in contact with the proximal end of the delivery member guard 24 and presses the delivery member guard 24 to move relative to the housing 20. In other words, the movement of the flange 12c; 12’c is configured to mimic the action to trigger the medicament delivery operation by the end user. As a result, the force profile of triggering the medicament delivery operation can be measured.

[0060] Alternatively, or additionally, the apparatus comprises a second probe 16 configured to be in contact with a delivery member guard 24 of the sub-assembly. In this example, the second probe 16 comprises an enlarged front end 16a dimensioned to be matched to the width of the delivery member guard 24 to be tested such that the enlarged front end 16a of the second probe 16 can be in contact with the delivery member guard 24 and thereby moves the delivery member guard 24 relative to the housing 20 of the sub-assembly. In this example, the second probe 16 is connected to the force sensor 15. In a preferred example, the second probe 16 is hingely connected to the elongated probe 12’, as shown in Fig. 10. In one example, the elongated probe 12’ comprises the flange 12’c configured to be in contact with a delivery member guard 24 as mentioned in above example. In one example, a hinge 17 connected to the elongated probe 12’ and the second probe 16 is connected to the force sensor 15. In this example, the elongated probe 12’ can be used to measure the power source performance of the sub-assembly as shown in Figs 11A- 11 B. After the plunger rod is fully extended, as shown in Fig. 11C, the second probe 16 can be used to measure a delivery member guard overridden force, as shown in Fig. 11D. As some of the medicament delivery devices in the market, e.g., disposable autoinjectors, are designed to use a delivery member guard to cover a delivery member of the medicament delivery device to avoid any potential injury of users by the delivery member. Usually, after the medicament delivery operation, the delivery member guard of the medicament delivery device is locked relative to the housing of the medicament delivery device such that the user is prevented from being injured by the used delivery member. In this case, it is crucial that the force to break the lock between the housing and the delivery member guard (the delivery member guard overridden force) has to be high such that the user will not unintentionally overcome the delivery member guard overridden force.

[0061] Furthermore, the second probe can be used with the elongated probe having the flange as mentioned above. In this example, the force profile of triggering the medicament delivery operation can be measured via the flange of the elongated probe. The performance of the power source is further measured via the elongated probe as mentioned above. After the plunger rod is fully extended, the second probe can be used to measure the delivery member guard overridden force.

[0062] In another example, the apparatus comprises a delivery member guard holder 19. As shown in Figs 11A-11B, the delivery member guard holder 19 is configured to be engaged with the delivery member guard such that the delivery member guard is retained in a pressed position by the delivery member guard holder 19.

[0063] In another example, the apparatus comprises a grip 14 connected to the force sensor. The grip 14 is configured to clamp on a cap 25 of the sub-assembly, as shown in Fig. 5. In this example, the force to remove the cap 25 from the housing 20 can be measured. In another example, the driver is connected to the grip and the elongated probe. In this example, the controller is configured to control the driver to move the grip in a first direction along the longitudinal axis; and the controller is configured to control the driver to move the elongated probe in a second direction opposite to the first direction along the longitudinal axis. In one example, the force sensor is axially movable together with the elongated probe.

[0064] In another example, the holder 13 comprises a protrusion 13a extending in a direction transverse to the longitudinal axis L, as shown in Figs 3-4. The protrusion 13a is configured to be at least partially positioned within a recess / cutout 23 of the housing 20 of the sub-assembly when the holder 13 is attached to the housing 20. It is common that most of the medicament delivery devices are arranged with a window 23 such that the end user can observe the medicament accommodated within the housing 20. In this example, the holder 13 is configured to be engaged with the window 23, e.g., the protrusion 13a in positioned within the window 23 to avoid applying unnecessary radial clamping force to the housing 20.

[0065] Furthermore, in another example, the apparatus can be used with a testing kit comprising multiple elongated probes. Each of the multiple elongated probes is geometrically different from one another. Similarly, in another example, the testing kit also comprises multiple holders. Each of the multiple holders is geometrically different from one another. As a result, the apparatus together with the testing kit can be used to test different types of medicament delivery devices without medicament containers. In one example, the multiple elongated probes and / or the multiple holders comprise multiple information tags 12e, 13b, e.g., Bar code, QR code, RFID / NFC tags, respectively. In this example, the apparatus can be operated automatically. For example, the apparatus comprises an information reader, and a pick-and-place robot. In this example, the information reader is configured to capture information from the sub-assemblies. In this example, the controller is configured to react based on the captured information. For example, the controller can choose the testing method based on the information, and / or the controller can generate a warning signal if the sub-assemblies is not matched with a predetermined information, and / or start / step an action of the apparatus, and / or the controller can record the captured information and / or the controller can send out the captured information to a remote server and / or a device nearby.

[0066] In this example, the sub-assemblies of the medicament delivery devices can be transported to the apparatus either by manually carry and place or by a conveying belt. The information reader can capture the information from the sub-assemblies, e.g., capture information from the information tags 27 of the sub-assemblies and the controller can fetch the testing receipt accordingly. The testing receipt can be either stored in a memory of the apparatus or retrieved from a remote server. The testing receipt contains the testing items, e.g., a measuring method of the power source performance, testing criteria, requirements of testing tools, e.g., a geometrical requirement of the elongated probe, and / or a geometrical requirement of the holder. In this example, the information reader can read the information tags on the holders and / or the elongated probes, the pick-and-place robot might be used to select the corresponding testing tools based on the testing receipt and the information tags. Alternatively, or additionally, the apparatus is arranged with a fixed setup of testing tools. In this example, the information reader can read the information tag from the sub-assemblies and if the information from the sub-assemblies doesn’t match the setup of the testing tools, the controller can reject the sub-assemblies, e.g., by providing a warning signal and / or stopping all actions of the apparatus. In one example, instead of reading one or more information tags of the sub-assemblies, the information reader can capture the information from the sub-assemblies by a camera configured to capture an image of the sub-assemblies. In this example, the controller is acted based on information from a result of image recognition.

[0067] Furthermore, in another example, the apparatus optionally comprises a second force sensor 18, as shown in Fig. 10. This example is more suitable to test a subassembly of a medicament delivery device comprising a button 26. In this example, the force to use the button 26 to initiate the operation of the power source can be tested. For example, the button is configured to be pressed to release the power source or in one example where the sub-assembly comprises the delivery member guard, the power source is released by pressing the delivery member guard and pressing the button.

[0068] In another example, the sub-assembly is assembled with a dummy syringe 30, as shown in Fig. 15. The dummy syringe 30 can be a part of the testing kit or be preassembled to the sub-assembly before the sub-assembly is transported to a site for testing.

[0069] The dummy syringe 30 can be used to further mimic the medicament delivery device during use by the end user. The dummy syringe 30 can also be used to limit the movement of the plunger rod such that the plunger rod will not fall out from the housing of the sub-assembly. In this example, the dummy syringe 30 comprises a sleeve body 30 with a neck portion 31 having a diameter being smaller than the rest of the sleeve body 30. In this example, a diameter of the plunger rod is greater than the neck portion 31 of the dummy syringe 30 and is smaller than the diameter of the rest of the sleeve body 30 of the dummy syringe 30. In another example, the dummy syringe comprises a flange 32 extending from the sleeve body 30.

[0070] Another aspect of the disclosure provides a method or testing a sub-assembly of a medicament delivery device, the method comprising the steps of: providing the apparatus according to any of above mentioned examples; providing a sub-assembly of the medicament delivery device comprising an elongated housing containing a power source and a plunger rod connected to the power source; wherein the plunger rod is configured to be moved by the power source relative to the elongated housing in a proximal direction; attaching the housing of the sub-assembly to the holder; moving the elongated probe into the housing until the second end of the elongated probe is in contact with a proximal end of the plunger rod; enabling the power source to output force to move the plunger rod relative to the elongated housing in the proximal direction; measuring the output force applied on the elongated probe from the plunger rod by the force sensor; and receiving force data from the force sensor and generating an output force profile based on the received data by the controller.

[0071] In some medicament delivery devices, the relation between the output force from the plunger rod and the plunger rod displacement is closer to a linear relation, as shown in Fig. 14. In this case, the output force profile can be simply the measurement of the output force as the medicament delivery time, and the deliverable dose can be calculated based on the information about the targeted medicament and the targeted medicament container as mentioned above.

[0072] Preferably, in this example, the controller is configured to generate an output force reading based on the force profile and a distance of the plunger rod displacement; and wherein the output force readings comprises one or more data points with predetermined meaning, e.g., a start point and / or an end point, respectively.

[0073] In another example, the controller is configured to generate an energy profile based on the force profile and a distance of the plunger rod displacement. As in some other medicament delivery devices, the relation between the output force from the plunger rod and the plunger rod displacement is not a smooth linear relation, as shown in Figs 12-13. In this example, the output force profile is generated by the output force measurement and the plunger rod displacement information within an effective medicament delivery period as shown in Fig. 13.

[0074] Figs 12-13 show the relation between the moving distance of the elongated probe and the force measurement of the force sensor. As shown in Fig. 12, the elongated probe is moved toward the plunger rod (the moving distance of the elongated probe is presented as plus numbers) starts pressing the medicament delivery device from a point 1 to point 2, thus, the force measurement at point 2 reflects to the force to trigger the medicament operation (the force to cause the power source to release and move the plunger rod). Point 3 reflects the force received by the elongated probe when the plunger rod is released. Afterward, the elongated probe starts to be moved in the opposite direction (the moving distance of the elongated probe is presented as minus numbers) by the plunger rod and / or the driver of the apparatus. As a plunger rod in a medicament delivery device might be spaced apart from the medicament container with a distance depending on the multiple factors, e.g., medicament delivery devices are transported by air transportation or maritime transportation. The movement of the elongated probe from point 3 to point 4 in Fig. 12 represents the movement of the plunger rod before being in contact with the medicament container. From point 4 to point 6 in Fig. 12, the movement of the elongated probe represents the movement of the plunger rod to expel the medicament. Thus, the absolute moving distance of the elongated probe represents a distance of the plunger rod displacement during expelling medicament. Point 6 is defined as a position that the plunger rod is fully extended. Thus, the effective medicament delivery period is defined from point 4 to point 6. As mentioned above, the controller is configured to generate an energy profile based on the force profile and the distance of the plunger rod displacement, in the example as shown in Figs 12-13, the energy profile is the area A in Fig. 13. In one preferred example, the apparatus is configured to test a medicament delivery device with the following orders of the testing items:

[0075] 1. Cap removal force by the force sensor and the gripper;

[0076] 2. Delivery member guard pre-use force or activation force; 3. Button activation force by the second force sensor;

[0077] 4. Plunger rod force / energy; and

[0078] 5. Delivery member guard override force / deflection.

[0079] The inventive concept has mainly been described above concerning a few examples. However, as is readily appreciated by a person skilled in the art, other embodiments than the ones disclosed above are equally possible within the scope of the inventive concept, as defined by the appended claims.

Claims

CLAIMS1. An apparatus for testing a sub-assembly of a medicament delivery device; wherein the sub-assembly comprises an elongated housing containing a power source and a plunger rod connected to the power source; wherein the plunger rod is configured to be moved by the power source relative to the elongated housing in a proximal direction; the apparatus comprising: a holder configured to be attached to the housing of the sub-assembly; an elongated probe extending along a longitudinal axis from a first end to a second end; wherein the elongated probe is movable relative to the holder along the longitudinal axis; wherein the elongated probe is configured to be at least partially positioned into the housing of the sub-assembly; wherein the second end of the elongated probe is configured to be in contact with a proximal end of the plunger rod of the sub-assembly; a force sensor operably connected to the elongated probe; wherein the force sensor is configured to measure an output force applied on the elongated probe; and a controller configured to receive data from the force sensor and generate an output force profile based on the received data.

2. The apparatus according to claim 1, wherein the apparatus comprises a driver to move the elongated probe along the longitudinal axis; wherein when the elongated probe receives force from the plunger rod, the controller is configured to control the driver to move elongated probe such that the elongated probe is moved out from the elongated housing of the subassembly with a predetermined speed.

3. The apparatus according to claim 1 or 2, wherein the elongated probe comprises a flange configured to be in contact with a delivery member guard of the sub-assembly.

4. The apparatus according to claim 1 or 2, wherein the apparatus comprises a second probe configured to be in contact with a delivery member guard of the sub-assembly; wherein the second probe is connected to the force sensor.

5. The apparatus according to claim 4, wherein the second probe is hingely connected to the elongated probe.

6. The apparatus according to any one of the preceding claims, wherein the apparatus comprises a grip connected to the force sensor; wherein the grip is configured to clamp on a cap of the sub-assembly.

7. The apparatus according to claim 6 when dependent on claim 2, wherein the driver is connected to the grip and the elongated probe; wherein the controller is configured to control the driver to move the grip in a first direction along the longitudinal axis; and wherein the controller is configured to control the driver to move the elongated probe in a second direction opposite to the first direction along the longitudinal axis.

8. The apparatus according to any one of the preceding claims, wherein the force sensor is axially movable together with the elongated probe.

9. The apparatus according to any one of the preceding claims, wherein the holder comprises a protrusion extending in a direction transverse to the longitudinal axis; wherein the protrusion is configured to be at least partially positioned within a recess / cutout of the housing of the sub-assembly when the holder is attached to the housing.

10. The apparatus according to any one of the preceding claims, wherein the apparatus comprises an information reader configured to capture information from the sub-assembly.

11. A method for testing a sub-assembly of a medicament delivery device, the method comprising the steps of: providing the apparatus according to any one of the preceding claims; providing a sub-assembly of the medicament delivery device comprising an elongated housing containing a power source and a plunger rod connected to the power source; wherein the plunger rod is configured to be moved by the power source relative to the elongated housing in a proximal direction; attaching the housing of the sub-assembly to the holder;moving the elongated probe into the housing until the second end of the elongated probe is in contact with a proximal end of the plunger rod; enabling the power source to output force to move the plunger rod relative to the elongated housing in the proximal direction; measuring the output force applied on the elongated probe from the plunger rod by the force sensor; and receiving force data from the force sensor and generating an output force profile based on the received data by the controller.

12. The method according to claim 11, wherein the controller is configured to generate an energy profile based on the force profile and a distance of the plunger rod displacement.

13. The method according to claim 11 or 12, wherein the controller is configured to generate an output force reading based on the force profile and a distance of the plunger rod displacement; and wherein the output force readings comprises one or more data points with predetermined meaning respectively.

14. The method according to any one of claims 11-13, when dependent on claim 10, wherein after the step of providing the sub-assembly, the method further comprises steps of: capturing information from the sub-assembly by the information reader; and reacting based on the captured information by the controller.

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