A testing assembly and a method for testing an operation of a medicament delivery device

Abstract

A testing assembly for testing an operation of a medicament delivery device, the testing assembly comprising: a base plate; wherein a first cavity is arranged in the base plate; a support plate; wherein a second cavity is arranged in the support plate lined up with the first cavity along a longitudinal axis such that a channel extending along the longitudinal axis is formed by the first cavity and the second cavity; a pierceable barrier extending across the channel in the direction transverse to the longitudinal axis such that at least one of the first cavity and the second cavity is sealed by the pierceable barrier; and wherein the support plate comprises a support surface facing away from the pierceable barrier.

Description

[0001] TITLE

[0002] A TESTING ASSEMBLY AND A METHOD FOR TESTING AN OPERATION OF A MEDICAMENT DELIVERY DEVICE

[0003] TECHNICAL FIELD

[0004] The present disclosure generally relates to a testing assembly and a method fortesting an operation of a medicament delivery device, in particular, the testing assembly comprises a pierceable barrier.

[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 the 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 within 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.

[0010] There is hence provided a testing assembly fortesting an operation of a medicament delivery device, the testing assembly comprising: a base plate; wherein a first cavity is arranged in the base plate; a support plate; wherein a second cavity is arranged in the support plate lined up with the first cavity along a longitudinal axis such that a channel extending along the longitudinal axis is formed by the first cavity and the second cavity; wherein the channel is configured to receive at least a part of a medicament delivery member of the medicament delivery device during a testing operation of the medicament delivery device; a pierceable barrier extending across the channel in the direction transverse to the longitudinal axis such that at least one of the first cavity and the second cavity is sealed by the pierceable barrier. The pierceable barrier is configured to be pierced by the medicament delivery member of the medicament delivery device during the testing operation of the medicament delivery device. The support plate comprises a support surface facing away from the pierceable barrier. The support surface is positioned around the second cavity such that the support surface is configured to be in contact with a part of the medicament delivery device during the testing operation of the medicament delivery device.

[0011] Preferably, according to another embodiment, the pierceable barrier comprises a first surface facing to the first cavity and a second surface facing to the second cavity; wherein a length measured from the support surface to the first surface is predetermined to simulate a medicament delivery depth.

[0012] Preferably, according to another embodiment, the length measured from the support surface to the first surface is between 2mm to 12mm.

[0013] Preferably, according to another embodiment, the pierceable barrier is sandwiched between the support plate and the base plate.

[0014] Preferably, according to another embodiment, the support plate and the base plate are removably attachable to one another.

[0015] Preferably, according to another embodiment, the testing assembly comprises a rack assembly attached to the support plate such that a distance between the support plate and the base plate along in the direction of the longitudinal axis is adjustable by the rack assembly.

[0016] Preferably, according to another embodiment, the rack assembly comprises a guide track.

[0017] Preferably, according to another embodiment, at least one of the support plate and the base plate is movably attachable to the guide track such that the distance between the support plate and the base plate along in the direction of the longitudinal axis is adjustable by moving the at least one of the support plate and the base plate along the guide track.

[0018] Preferably, according to another embodiment, the rack assembly comprises a gauge configured to measure the distance between the support plate and the base plate.

[0019] Preferably, according to another embodiment, the gauge is a dial contact gauge.

[0020] Preferably, according to another embodiment, the gauge is an optical scale. Preferably, according to another embodiment, the base plate comprises a fastener configured to be attached to a container.

[0021] Preferably, according to another embodiment, the pierceable barrier is a membrane.

[0022] Another aspect of the invention provides a method fortesting an operation of a medicament delivery device, the method comprising the following steps in the following order: providing a medicament delivery device comprising a medicament container containing liquid and a medicament delivery member fluidly connected to the medicament container; wherein the medicament delivery device comprises a delivery assembly configured to expel the contained liquid upon being activated; providing the testing assembly according to any one of the preceding claims; aiming the medicament delivery member towards the pierceable barrier; providing a container having an opening facing towards the first surface of the pierceable barrier; pressing the medicament delivery device on the support surface; penetrating the pierceable barrier by a tip end of the medicament delivery member; activating the delivery assembly; and measuring an amount of expelled liquid within the container.

[0023] Preferably, according to another embodiment, before the step of measuring an amount of expelled liquid within the container, the method comprises the following steps in the following order: holding the medicament delivery device immovable relative to the testing assembly until no more liquid is expelled; and removing the medicament delivery from the testing assembly such that the tip end of the medicament delivery member is moved past the pierceable barrier and moved away from the channel.

[0024] Preferably, according to another embodiment, before the step of measuring an amount of expelled liquid within the container, the method comprises a step of: measuring a length from the first end of the pierceable barrier to the tip end of the medicament delivery member.

[0025] Preferably, according to another embodiment, before the step of measuring an amount of expelled liquid within the container, the method comprises a step of: measuring a time period when the delivery assembly is activated until no more liquid is expelled.

[0026] Preferably, according to another embodiment, the step of measuring an amount of expelled liquid within the container comprises a step of: measuring the amount of expelled liquid by measuring the weight of the amount of expelled liquid with a measurement device.

[0027] Preferably, according to another embodiment, before the step of providing the testing assembly, the method comprises a step of: selecting the support plate from a group of support plates having different thicknesses measured along the longitudinal axis; and positioning the selected support plate to the pierceable barrier and the base plate to form the testing assembly.

[0028] Preferably, according to another embodiment, before the step of aiming the medicament delivery member towards the pierceable barrier, the method comprises a step of: adjusting a distance between the support plate and the base plate in the direction of the longitudinal axis to a predetermined distance.

[0029] Preferably, according to another embodiment, before the step of aiming the medicament delivery member towards the pierceable barrier, the method comprises a step of: moving the base plate and the support plate to a calibration position.

[0030] Preferably, according to another embodiment, the medicament delivery device is an autoinjector.

[0031] Preferably, according to another embodiment, the medicament delivery device is a handheld, pen-type auto-injector.

[0032] Preferably, according to another embodiment, wherein the autoinjector is configured to be activated by pressing against a skin of a user. 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-1 a (multiple sclerosis), sumatriptan (migraines), adalimumab (rheumatoid arthritis), darbepoetin alfa (anaemia), belimumab (lupus), peginterferon beta-1 a' (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, fam-trastuzumab 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. Exemplary drugs that could be included in the medicament delivery devices described herein include, but are not limited to, an immuno-oncology or bio-oncology 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.

[0033] 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 TCR therapies.

[0034] 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, IVAC, 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.

[0035] 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.

[0036] 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.

[0037] BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Embodiments of the inventive concept will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0039] Fig. 1 shows a cross-section view of the testing assembly of the invention.

[0040] Figs 2-3 show a perspective of the testing assembly of Fig. 1 .

[0041] Fig. 4 shows a perspective view of the testing assembly of Fig. 1 in use.

[0042] Figs 5-6 show different testing steps of the medicament delivery device.

[0043] Fig. 7 shows a perspective view of a testing equipment comprising the testing assembly of the invention in another embodiment.

[0044] Fig. 8 shows the testing assembly of Fig. 7.

[0045] Figs 9-12 show perspective views and a cross-section view of a medicament delivery device that can be tested by the testing assembly of the invention.

[0046] Figs 13-17 shows a perspective view of a testing equipment comprising the testing assembly of the invention in another embodiment.

[0047] DETAILED DESCRIPTION Figs 1-8 and 13-17 illustrate a testing assembly fortesting an operation of a medicament delivery device M. The medicament delivery device M can be an autoinjector, as shown in Figs 9-12, a safety syringe, an insulin pen and / or an on-body device. The testing assembly comprises a base plate 1 ; 1 1 a support plate 2; 2'; 2”; and a pierceable barrier 3. A first cavity 11 ; 1 T; 11 ” is arranged in the base plate 1 ; 1 1 A second cavity 21 ; 21 ' is arranged in the support plate 2; 2'; 2” lined up with the first cavity 11 ; 11 ’; 11 ” along a longitudinal axis L such that a channel extending along the longitudinal axis L is formed by the first cavity 11 ; 1 T; 11 ” and the second cavity 21 ; 21 The channel is configured to receive at least a part of a medicament delivery member N of the medicament delivery device M during a testing operation of the medicament delivery device M. The pierceable barrier 3 extends across the channel in the direction transverse to the longitudinal axis L such that at least one of the first cavity 11 ; 1 T; 11 ” and the second cavity 21 ; 21 ' is sealed by the pierceable barrier 3 The pierceable barrier 3 is configured to be pierced by the medicament delivery member N of the medicament delivery device M during the testing operation of the medicament delivery device M. The support plate 2; 2'; 2” comprises a support surface 22; 22'; 22” facing away from the pierceable barrier 3. The support surface 22; 22'; 22” is positioned around the second cavity 21 ; 21' such that the support surface 22; 22'; 22” is configured to be in contact with a part of the medicament delivery device M during the testing operation of the medicament delivery device M.

[0048] The pierceable barrier is configured to block liquid from passing through. The pierceable barrier can thus be made of any suitable material, e.g., silicone or TPE, or Kapton Polyamide Tape. In one example, the pierceable barrier is a membrane. Preferably, the membrane is configured to simulate the skin / tissue of a targeted user group of the to-be-tested medicament delivery device.

[0049] A common way to test an operation of a medicament delivery device is to aim the medicament delivery member of the medicament delivery device towards a container and activate the medicament delivery device to expel the medicament contained within the medicament delivery device. The accuracy of the expelled dose is thereby tested by measuring the amount of the expelled medicament within the container. As, some medicaments are easily stuck to the medicament delivery member, e.g., a needle, thus, the last drop of the medicament might not fall into the container and therefore cannot be measured. However, in the real-use scenario, the medicament is delivered into a user's body tissue, thus, even if the medicament might be stuck to the medicament delivery member, when the user removes the medicament delivery device from the body tissue, the stuck last drop of the medicament will be filtered by the body tissue and being able to be absorbed by the user. Thus, the testing assembly as mentioned above provides the pierceable barrier to mimic the body tissue of the user, as shown in Fig. 6, during the testing, if there is any droplet stuck to the medicament delivery member when the tested medicament delivery device is removed from the testing assembly, the pierceable barrier can filter the droplet, thus the droplet falls into the container and is, therefore, able to be measured. Furthermore, when droplets stick to the medicament delivery member, a measurement of the length of the medicament delivery member might be inaccurate, as a length of the droplets might be miscalculated being the length of the medicament delivery member. Furthermore, when the medicament delivery device is an autoinjector, the medicament contained within the medicament delivery device might be expelled right after a cap of the medicament delivery device is removed (when the medicament delivery device is a needle, before the needle penetrates through the skin, for example) under the force of an energy source. However, such prematurely delivered medicament cannot be detected by the common testing method as mentioned above (namely that activating the medicament delivery device on top of a container without any other arrangement between the medicament delivery device and the container) as the prematurely delivered medicament also falls into the container and therefore can be measured. Such design defects can be detected by the testing assembly as well as the prematurely delivered medicament cannot pass the pierceable barrier and therefore cannot be measured as a part of the delivered dose.

[0050] One example of the testing assembly as shown in Figs 1-4, the base plate 1 optionally comprises a grip 10 for being gripped by an operator, a robot, or / and a tool, for example. Furthermore, in another example, as shown in Fig. 1 , the base plate 1 optionally comprises a fastener 12, 13 configured to be attached to a container C. In one example, the fastener 12, 13 is configured to be form-fitted to the container C. Alternatively, or additionally, the fastener can be press-fit or snap-fit to the container. In one example, the base plate optionally comprises a support protrusion 14 configured to support the pierceable barrier 3.

[0051] Alternatively, or additionally, the base plate can be fastened to the support plate. In this example, when the testing assembly can be used directly on a beaker (in this example, the beaker is the container C). In this example, the base plate is fastened to the beaker, and a medicament delivery operation can be carried out on the testing assembly and delivery the contained liquid into the beaker. In another example, instead of fastening the testing assembly by fastening the base plate to the container C, the testing assembly can be fixedly lined up with the container C by fastening the support plate to other equipment. For example, the support plate can be used in a testing equipment. In this example, the support plate can be placed on top of a testing platform or being attached to a testing ledge via a form-fit, snap-fit, press-fit, threaded engagement, and / or bayonet engagement. In this example, the base plate may not comprise the grip as the base plate can be fastened to the testing equipment via the support plate. In one example, the testing assembly optionally comprises a base attachment 4 having an opening 41 to be lined up with the first cavity 11 and the second cavity 21 along the longitudinal axis L; and a support plate grip 5. In this example, as shown in Fig, 1 , the support plate 2 is clamped between the support plate grip 5 and the base attachment 4. In another example, the pierceable barrier 3 is supported by the support plate 2, an inner surface 43 of the base attachment 4, and the support protrusion 14 of the base plate 1 . In one example, the base attachment 4 is configured to fasten the support plate 2 to the base plate 1 .

[0052] Fig. 4 illustrates a use of the testing assembly. In this example, a medicament delivery device M is aiming to expel the medicament to a container C. The medicament delivery device M can be an autoinjector as shown in Figs 9-12. In this example, the medicament delivery device comprises a housing H extending from a proximal end (the end that is configured to be pointed towards the medicament delivery site of a user of the medicament delivery device) to a distal end (the end that is linearly opposite to the proximal end) along an axis, a delivery member guard being telescopic relative to the proximal end of the housing H, a medicament container B containing liquid, a medicament delivery member N fluidly communicated with the medicament container B during use of the medicament delivery device M. The medicament delivery device comprises a delivery assembly configured to expel the contained liquid upon being activated. In one example, the delivery assembly comprises a plunger rod P connected to an energy source E. The plunger rod P is held by a flexible arm F surrounded by a rotator R. In this example, the delivery assembly is activated when the delivery member guard S is moved in the distal direction relative to the housing H (as shown in Fig. 12) to turn the rotator and release the plunger rod P to being pushed by the energy source E to expel the contained liquid.

[0053] The testing assembly is positioned between the medicament delivery device M and the container C. The medicament delivery device M can be manually held by an operator or held by a robot / tool. In other words, the testing assembly can be used in an automatic testing machine or a manual testing arrangement. The amount of the expelled medicament is configured to be measured so that the delivered dose accuracy of the medicament delivery device can be inspected. In one example, an optional secondary pierceable barrier ? can be attached to the first cavity 11 , as shown in Fig. 5. In this example, after a medicament delivery device is tested, the container C, the base plate 1 and the secondary pierceable barrier 7 can be weighted together. In this example, the pierceable barrier 3 can provide a better seal and / or prevent the prematurely delivered liquid be measured; and the secondary pierceable barrier 7 can filter out the droplets stick to the delivery member. As the filtered droplets might stick to the secondary pierceable barrier 7 instead of falling into the container C, weighting the container C, the base plate 1 and the secondary pierceable barrier 7 can provide a more precise measurement of the delivered dose of the medicament delivery device.

[0054] In another example, as shown in Fig. 7, the testing assembly is used in a testing equipment. The testing equipment comprises a camera 63 configured to capture images of an operation of the medicament delivery device M; a back wall 64 configured to facilitate the use of the camera, a transparent shell 62 or a window configured to surround the container C such that the images of the operation of the medicament delivery device M can be captured by the camera 63. Optionally, a weight measurement is placed underneath the container C to measure the amount of the expelled liquid. The testing assembly as mentioned above is placed on top of the container C and / or on top of the transparent shell 62. Optionally a measurement device can be placed underneath the container C. As a result, the delivered dose of tested medicament delivery device can be measured. Furthermore, in another example, the testing equipment comprises a force measurement device configured to be in contact with the medicament delivery device and measure the force figures of the medicament delivery device during operation. For example, the force measurement device can push the medicament delivery device against the support surface. In one example where the medicament delivery device is configured to be activated by a movement of the delivery member guard, the force measurement device is configured to measure the force to activate the medicament delivery device. Furthermore, the testing assembly optionally comprises weight scale 68 positioned underneath the container C, as shown in Fig. 13. Preferably, the weight scale 68 is connected to a processing unit, e.g., a computer, by a wire or wirelessly such that the weight changes can be timely recorded.

[0055] In a preferred example, the pierceable barrier 3 comprises a first surface 31 facing to the first cavity 11 ; 1 T; 11 ” and a second surface 32 facing to the second cavity 21 ; 21 21 ”. A length A; A’ measured from the support surface 22; 22’; 22” to the first surface 31 is predetermined to simulate a medicament delivery depth. For example, the length A; A’ is 2 mm to 12 mm, or 2.5 mm to 8 mm.

[0056] In this example, the support surface 22; 22' is configured to be in contact with the part of the medicament delivery device that is close to the medicament delivery member and around the medicament delivery member. For example, when the medicament delivery device comprises a delivery member guard, a proximal end of the delivery member guard will contact the support surface during the test. Alternatively, when the medicament delivery device does not have a delivery member guard, e.g., the medicament delivery device is designed to automatically retract the medicament delivery member into a housing of the medicament delivery device after use, a proximal end of the housing of the medicament delivery device will contact the support surface during the test. Thus, the support surface can be used to simulate a penetration start position of the medicament delivery member. As a result, the length measured from the support surface 22; 22’ to the first surface 31 can be used to simulate the effective medicament delivery depth, e.g., an injection depth.

[0057] Alternatively, or additionally, a medicament delivery depth can be simulated by the distance between the support plate 2” and the base plate 1 ”. In this example, the testing assembly comprises a gauge 65. The gauge 65 can be a contact gauge, e.g. a dial contact gauge, or contactless gauge, e.g., an optical scale. In one example where the gauge 65 is a dial contact gauge 65a, 65b, the gauge comprises a dial 65a and a probe 65b. The dial 65a is configured to move the probe 65b to be contact with at least one of the support plate and base plate. In a preferred example as shown in Fig. 13-15, the probe 65b is configured to be in contact with the base plate 1 ”. The dial 65 can be manually adjusted or controlled by a power source.

[0058] With the depth simulation as mentioned above, more designed function of a medicament delivery device can be tested. For example, when the medicament delivery device is designed to perform an intramuscular injection, the length measured from the support surface 22; 22’ to the first surface 31 or the distance between the base plate 1 ” and the support plate 2” can be designed to be a vertical length from a surface of the skin of the targeted patient group to the muscle tissue of the targeted patient group. Additionally, in the case that the medicament delivery device is designed for emergency use or military use, e.g., to deliver Epinephrine, the length measured from the support surface 22; 22’ to the first surface 31 or the distance between the base plate 1 ” and the support plate 2” can be designed to be a vertical length from a surface of clothes / uniform of the targeted user group to the muscle tissue of the targeted patient group as the device might need to penetrate through the clothes / uniform of the user.

[0059] As mentioned above, only the liquid medicament that passes through the pierceable barrier will fall into the container and thus being measured as the delivered dose, using the length A; A' measured from the support surface 22; 22' to the first surface 31 or the distance between the base plate 1 ” and the support plate 2” to simulate the medicament delivery depth can make sure the measured liquid medicament is able to reach the predetermined effective medicament delivery depth.

[0060] Furthermore, in another example, the pierceable barrier 3 is sandwiched between the support plate 2; 2’ and the base plate 1 ; T. Alternatively, the pierceable barrier 3 can be attached to either the support plate 2; 2’; 2” or the base plate 1 ; T; 1 ”.

[0061] In one example, the support plate 2 is removably attached to the base plate 1 . As shown in Figs 2-3. In this example, the length A measured from the support surface 22 to the first surface 31 can be adjusted by selecting a support plate 2 from a group of support plates having different geometry measured along the longitudinal axis L. For example, a support plate from a group of support plates having different thickness measured along the longitudinal axis L can be selected. Alternatively, or additionally, the support plate comprises a support wall 23, as shown in Fig. 2. In this example, the length A measured from the support surface to the first surface can be adjusted by selecting a support plate from a group of support plates having support surfaces positioned differently along the longitudinal axis L to the support wall, respectively.

[0062] Alternatively, as shown in Figs 7-8 and Figs 13-15, the testing assembly comprises a rack assembly 6; 6’ attached to the support plate 2’; 2” such that a distance G between the support 2’; 2” plate and the base plate 1 ’; 1 ” along in the direction of the longitudinal axis L is adjustable by the rack assembly 6; 6’. In this example, the length A’ measured from the support surface 22’ to the first surface 31 can be adjusted by adjusting the distance G between the support 2’plate and the base plate 1 ’along in the direction of the longitudinal axis L and / or the distance between the base plate 1 ” and the support plate 2” can be adjusted directly. In one example, the rack assembly comprises a guide track. In a preferred example, the guide track comprises a rack 60; 60’ having a guide rail 61 ; 61 ’. In one example, a connector 67 is slidable along the guide rail. The connector 67 is configured to be attached to at least one of the support plate and the base plate.

[0063] In one example, the rack assembly comprises an adjusting knob 66 operably connected to the connector 67. In this example, the at least one of the support plate and the base plate can be moved by a movement of the adjusting knob 66, e.g., the adjusting knob 66 can be rotated manually or by a power source.

[0064] Furthermore, the rack assembly 6’ can be placed on a sliding assembly 69. In this example, the sliding assembly 69 comprises a slider 69b connected to the rack 60, and a track 69a. The slider 69b is slidable within the track 69a.

[0065] In another example, the support plate 2; 2’ can be exchangeable. As medicament delivery devices in the market might comprise different shapes, more than one support plates can be provided and bundled as a testing kit. In this example, support plates having different shapes respectively can be chosen in accordance with the shape of the to-be-tested medicament delivery device. In another example, the support plate comprises a fastener configured to engage with a part of the medicament delivery device, e.g., the housing of the medicament delivery device, such that the medicament delivery device can be retained on the support plate in a way of being hand-held or worn by a user of the medicament delivery device in a real use scenario. Alternatively, or additionally, the base plate 1 ” comprises a holding plate 16” attachable to the base plate 1 ”, as shown in Figs 16-17. Preferably, the pierceable barrier 3 is attached to the holding plate 16”. In this example, holding plate 16” and / or the pierceable barrier 3 can be exchangeable. Thus, the pierceable barriers with different geometric, e.g., different shapes and / or thickness and / or made of different materials, can be exchanged easily for different testing purposes. Preferably, in this example, as shown in Fig. 17, the be plate 1 ” comprises a recess 15” to receive the holding plate 16” such that the pierceable barrier 3 can be positioned in the correct position. Alternatively, or additionally, the holding plate is attached to the base plate via magnet.

[0066] Another aspect of the invention provides a method fortesting an operation of a medicament delivery device, the method comprising the following steps in the following order: providing a medicament delivery device comprising a medicament container containing liquid and a medicament delivery member fluidly connected to the medicament container; wherein the medicament delivery device comprises a delivery assembly configured to expel the contained liquid upon being activated; providing the testing assembly according to any one of the above-mentioned examples; aiming the medicament delivery member towards the pierceable barrier; providing a container having an opening facing towards the first surface of the pierceable barrier; pressing the medicament delivery device on the support surface; penetrating the pierceable barrier by a tip end of the medicament delivery member; activating the delivery assembly; and measuring an amount of expelled liquid within the container.

[0067] It should be noted that the liquid contained within the medicament delivery device can be medicament or other liquid with a viscosity that is the same or similar to the targeted medicament.

[0068] In another example, before the step of measuring an amount of expelled liquid within the container, the method comprises the following steps in the following order: holding the medicament delivery device immovable relative to the testing assembly until no more liquid is expelled; and removing the medicament delivery from the testing assembly such that the tip end of the medicament delivery member is moved past the pierceable barrier and moved away from the channel. In another example, before the step of measuring an amount of expelled liquid within the container, the method comprises a step of: measuring a length from the first end of the pierceable barrier to the tip end of the medicament delivery member.

[0069] In another example, before the step of measuring an amount of expelled liquid within the container, the method comprises a step of: measuring a time period when the delivery assembly is activated until no more liquid is expelled. In this example, the medicament delivery time can be tested.

[0070] In a preferred example, the step of measuring an amount of expelled liquid within the container comprising a step of: measuring the amount of expelled liquid by measuring the weight of the amount of expelled liquid with a measurement device. Alternatively, the container comprises a printed scale for measuring the amount of expelled medicament in the container.

[0071] In another example, before the step of aiming the medicament delivery member towards the pierceable barrier, the method comprises a step of: moving the base plate and the support plate to a calibration position. In one example, the base plate is in contact with the support plate in the calibration position. Alternatively, a distance between the base plate and the support plate is predetermined in the calibration position.

[0072] 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.

[0073] Other aspects of the invention are defined by the following clauses.

[0074] 1 . A testing assembly for testing an operation of a medicament delivery device, the testing assembly comprising: a base plate; wherein a first cavity is arranged in the base plate; a support plate; wherein a second cavity is arranged in the support plate lined up with the first cavity along a longitudinal axis such that a channel extending along the longitudinal axis is formed by the first cavity and the second cavity; wherein the channel is configured to receive at least a part of a medicament delivery member of the medicament delivery device during a testing operation of the medicament delivery device; a pierceable barrier extending across the channel in the direction transverse to the longitudinal axis such that at least one of the first cavity and the second cavity is sealed by the pierceable barrier; wherein the pierceable barrier is configured to be pierced by the medicament delivery member of the medicament delivery device during the testing operation of the medicament delivery device; wherein the support plate comprises a support surface facing away from the pierceable barrier; wherein the support surface is positioned around the second cavity such that the support surface is configured to be in contact with a part of the medicament delivery device during the testing operation of the medicament delivery device.

[0075] 2. The testing assembly according to clause 1 , wherein the pierceable barrier comprises a first surface facing to the first cavity and a second surface facing to the second cavity; and wherein a length measured from the support surface to the first surface is predetermined to simulate a medicament delivery depth.

[0076] 3. The testing assembly according to clause 2, wherein the length measured from the support surface to the first surface is between 2mm to 12mm.

[0077] 4. The testing assembly according to clause 1 or 2, wherein the pierceable barrier is sandwiched between the support plate and the base plate.

[0078] 5. The testing assembly according to any one of the preceding clauses, wherein the support plate and the base plate are removably attachable to one another.

[0079] 6. The testing assembly according to any one of clauses 1-4, wherein the testing assembly comprises a rack assembly attached to the support plate such that a distance between the support plate and the base plate along in the direction of the longitudinal axis is adjustable by the rack assembly.

[0080] 7. The testing assembly according to clause 6, wherein the rack assembly comprises a guide track; wherein at least one of the support plate and the base plate is movably attachable to the guide track such that the distance between the support plate and the base plate along in the direction of the longitudinal axis is adjustable by moving the at least one of the support plate and the base plate along the guide track.

[0081] 8. The testing assembly according to any one of clauses 6-7 comprising: a gauge configured to measure the distance between the support plate and the base plate.

[0082] 9. The testing assembly according to clause 8, wherein the gauge is a dial contact gauge. 10. The testing assembly according to clause 8, wherein the gauge is an optical scale.

[0083] 11 . The testing assembly according to any one of the preceding clauses, wherein the base plate comprises a fastener configured to be attached to a container.

[0084] 12. The testing assembly according to any one of the preceding clauses, wherein the pierceable barrier is a membrane.

[0085] 13. A method fortesting an operation of a medicament delivery device, the method comprising the following steps in the following order: providing a medicament delivery device comprising a medicament container containing liquid and a medicament delivery member fluidly connected to the medicament container; wherein the medicament delivery device comprises a delivery assembly configured to expel the contained liquid upon being activated; providing the testing assembly according to any one of the preceding clauses; aiming the medicament delivery member towards the pierceable barrier; providing a container having an opening facing towards the first surface of the pierceable barrier; pressing the medicament delivery device on the support surface; penetrating the pierceable barrier by a tip end of the medicament delivery member; activating the delivery assembly; and measuring an amount of expelled liquid within the container.

[0086] 14. The method according to clause 13, wherein before the step of measuring an amount of expelled liquid within the container, the method comprises the following steps in the following order: holding the medicament delivery device being immovable relative to the testing assembly until no more liquid is expelled; and removing the medicament delivery from the testing assembly such that the tip end of the medicament delivery member is moved past the pierceable barrier and moved away from the channel.

[0087] 15. The method according to clauses 13 or 14, wherein before the step of measuring an amount of expelled liquid within the container, the method comprises a step of: measuring a length from the first end of the pierceable barrier to the tip end of the medicament delivery member. The method according to any one of clauses 13-15, wherein before the step of measuring an amount of expelled liquid within the container, the method comprises a step of: measuring a time period when the delivery assembly is activated until no more liquid is expelled. The method according to any one of clauses 13-16, wherein the step of measuring an amount of expelled liquid within the container comprising a step of: measuring the amount of expelled liquid by measuring the weight of the amount of expelled liquid with a measurement device. The method according to any one of clauses 13-17, wherein before the step of providing the testing assembly, the method comprises a step of: selecting the support plate from a group of support plates having different thicknesses measured along the longitudinal axis; and positioning the selected support plate to the pierceable barrier and the base plate to form the testing assembly. The method according to any one of clauses 13-18, wherein before the step of aiming the medicament delivery member towards the pierceable barrier, the method comprises a step of: moving the base plate and the support plate to a calibration position. The method according to any one of clauses 13-19, wherein before the step of aiming the medicament delivery member towards the pierceable barrier, the method comprises a step of: adjusting a distance between the support plate and the base plate in the direction of the longitudinal axis to a predetermined distance.

Claims

CLAIMS1 . A testing assembly for testing an operation of a medicament delivery device, the testing assembly comprising: a base plate; wherein a first cavity is arranged in the base plate; a support plate; wherein a second cavity is arranged in the support plate lined up with the first cavity along a longitudinal axis such that a channel extending along the longitudinal axis is formed by the first cavity and the second cavity; wherein the channel is configured to receive at least a part of a medicament delivery member of the medicament delivery device during a testing operation of the medicament delivery device; a pierceable barrier extending across the channel in the direction transverse to the longitudinal axis such that at least one of the first cavity and the second cavity is sealed by the pierceable barrier; wherein the pierceable barrier is configured to be pierced by the medicament delivery member of the medicament delivery device during the testing operation of the medicament delivery device; wherein the support plate comprises a support surface facing away from the pierceable barrier; wherein the support surface is positioned around the second cavity such that the support surface is configured to be in contact with a part of the medicament delivery device during the testing operation of the medicament delivery device.

2. The testing assembly according to claim 1 , wherein the pierceable barrier comprises a first surface facing to the first cavity and a second surface facing to the second cavity; and wherein a length measured from the support surface to the first surface is predetermined to simulate a medicament delivery depth.

3. The testing assembly according to any one of the preceding claims, wherein the support plate and the base plate are removably attachable to one another.

4. The testing assembly according to any one of claims 1-2, wherein the testing assembly comprises a rack assembly attached to the support plate such that a distance between the support plate and the base plate along in the direction of the longitudinal axis is adjustable by the rack assembly.

5. The testing assembly according to claim 4, wherein the rack assembly comprises a guide track; wherein at least one of the support plate and the base plate is movably attachable to the guide track such that the distance between the support plate and the base plate along in the direction of the longitudinal axis is adjustable by moving the at least one of the support plate and the base plate along the guide track.

6. The testing assembly according to any one of claims 4-5 comprising: a gauge configured to measure the distance between the support plate and the base plate.

7. The testing assembly according to any one of the preceding claims, wherein the base plate comprises a fastener configured to be attached to a container.

8. The testing assembly according to any one of the preceding claims, wherein the pierceable barrier is a membrane.

9. A method fortesting an operation of a medicament delivery device, the method comprising the following steps in the following order: providing a medicament delivery device comprising a medicament container containing liquid and a medicament delivery member fluidly connected to the medicament container; wherein the medicament delivery device comprises a delivery assembly configured to expel the contained liquid upon being activated; providing the testing assembly according to any one of the preceding claims; aiming the medicament delivery member towards the pierceable barrier; providing a container having an opening facing towards the first surface of the pierceable barrier; pressing the medicament delivery device on the support surface; penetrating the pierceable barrier by a tip end of the medicament delivery member; activating the delivery assembly; and measuring an amount of expelled liquid within the container.

10. The method according to claim 9, wherein before the step of measuring an amount of expelled liquid within the container, the method comprises the following steps in the following order: holding the medicament delivery device being immovable relative to the testing assembly until no more liquid is expelled; and removing the medicament delivery from the testing assembly such that the tip end of the medicament delivery member is moved past the pierceable barrier and moved away from the channel.11 . The method according to claims 9 or 10, wherein before the step of measuring an amount of expelled liquid within the container, the method comprises a step of: measuring a length from the first end of the pierceable barrier to the tip end of the medicament delivery member.

12. The method according to any one of claims 9-12, wherein the step of measuring an amount of expelled liquid within the container comprising a step of: measuring the amount of expelled liquid by measuring the weight of the amount of expelled liquid with a measurement device.

13. The method according to any one of claims 9-13, wherein before the step of providing the testing assembly, the method comprises a step of: selecting the support plate from a group of support plates having different thicknesses measured along the longitudinal axis; and positioning the selected support plate to the pierceable barrier and the base plate to form the testing assembly.

14. The method according to any one of claims 9-14, wherein before the step of aiming the medicament delivery member towards the pierceable barrier, the method comprises a step of: moving the base plate and the support plate to a calibration position.

15. The method according to any one of claims 9-15, wherein before the step of aiming the medicament delivery member towards the pierceable barrier, the method comprises a step of: adjusting a distance between the support plate and the base plate in the direction of the longitudinal axis to a predetermined distance.

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