Cartridge containing a pharmaceutical fluid and method for closing a second opening of the cartridge

Abstract

Cartridge (1) containing a pharmaceutical fluid and method for closing a second opening of a cartridge, the cartridge, comprising a vessel (2) being generally cylindrical, having a second end with a second opening (4), a piston (5) closing the first opening (3) and engaging sealingly an inner surface (13) of the vessel (2), a needle penetrable seal, closing the second opening (4), wherein the seal is a stopper (8) having, a closed top portion forming a flange (10) for sealingly engaging a front face of the second end, the front face extending circumferentially to the second opening (4), a circumferentially closed annular wall (11) extending inside the vessel (2), an outer surface (12) of the annular wall engaging sealingly an inner surface (13) of the vessel (2) close to the second end, the annular wall (11) leaving an inner free space around the middle axis, wherein for providing a safe and tight cartridge further the stopper (8) is held on the vessel (2) by means of a metallic overcap (19), an outer front face of the top portion having nub-like protrusions resting against an inner surface (18) of the overcap (19), wherein further the stopper (8) is completely covered by a spray applied coating layer (24).

Description

DescriptionCartridge containing a pharmaceutical fluid and method for closing a second opening of the cartridgeField of Disclosure

[0001] The disclosure relates first to a cartridge containing a pharmaceutical fluid, the cartridge comprising a vessel being generally cylindrical, having a length and a width, the length being greater than the width, a longitudinal middle axis, a first end with a first opening and a second end with a second opening, a piston closing the first opening and engaging sealingly an inner surface of the vessel, proximate the first opening, the piston being movable along the longitudinal middle axis, wherein the vessel further comprises an a needle penetrable seal, closing the second opening.

[0002] The disclosure relates also to a method for closing a second opening of cartridge containing a pharmaceutical fluid, the cartridge comprising a vessel being generally cylindrical, having a length and a width, the length being greater than the width, a longitudinal middle axis, a first end with a first opening and a second end with the second opening.Background

[0003] Cartridges as outlined before are known for example from US 2016 / 0 361 494 Al and US 2019 / 0 117514 Al.Summary

[0004] At a known cartridge the seal is a flat disc lying on a front face of the second opening. The plug is held on the vessel by means of a metallic overcap. The metallic overcap is engaging the outer front face of the plug.

[0005] Cartridges as mentioned need to preserve the pharmaceutical fluid without any ingress of substances, even possibly related to the closing of the cartridge. Moreover, in use, except for the fluid flowing through a needle pierced into the seal, the cartridge needs to be as tight as possible, irrespective also of a pressure increase caused by expelling the fluid with moving the piston.

[0006] The disclosure therefore is concerned with the object, to provide a cartridge as outlined being advantageously safe in view of ingress of substances as well as advantageously tight. The disclosure is also concerned with the object to provide an advantageously method for closing a second opening of a cartridge.

[0007] In view of this object, it is proposed first that the seal is a stopper having a top portion forming a flange for sealingly engaging a front face of the second end, the front face extending circumferentially to the second opening, having further a circumferentially closed annular wall extending inside the vessel, an outer surface of the annular wall engaging sealingly an inner surface of the vessel close to the second end, the annular wall leaving an inner free space around the middle axis, wherein further the stopper is held on the vessel by means of a metallic over cap, the over cap having a central opening allowing access to the stopper, an outer front face of the top portion having nub-like protrusions resting against an inner surface of the over cap, wherein further the stopper is completely covered by a spray applied coating layer.

[0008] In view of the object it is also proposed, concerning the method, that in a first step a stopper is completely covered with a spray applied coating layer, in a second step a combination of a metallic overcap with the stopper is made, with the stopper received inside the overcap, whereby the overcap is provided with a central opening and the stopper, on its outer front face, with nub-like protrusions, wherein further the combination is such that the nub-like protrusions provide afree space between an inner surface of the overcap and the outer front face, wherein in a further step the combination is crimped on the vessel, whereby the overcap is made to tightly cover the stopper under deformation of the nubs and reduction of the free space.

[0009] The stopper provides not only a sealing contact to the front face of the second opening but also to the inner surface of the vessel close to the second opening. The free space allows the fluid at the occasion of expelling the fluid by movement of the piston to exert a certain hydraulic pressure to the annular wall. At once is given a comparatively long sealing gap in fluid direction prior to a sealing surface, which is preferably a sealing plane, between the flange and the front face. The sealing plane is also angled to the sealing gap, which even under pressure hinders additionally the fluid to escape.

[0010] The spray applied coating layer, covering completely the stopper is also of advantage in view of preventing potential contamination of the fluid by elastomer material. Once the stopper is completely covered with the spray layer, no more any danger for creating particles is given. Even if there would occur in the assembled state some dislocation e.g. due to the crimping process, of a sealing surface of the stopper, there is no risk of a potential contact of the pharmaceutical fluid with a non-covered part of the stopper.

[0011] When assembling, for closing the cartridge at the second opening, first a combination of the metallic over cap with the stopper received inside is provided for. This combination is thereafter applied to the vessel. Due to the nubs on the stopper, prior to being applied to the vessel, a certain distance except for the nubs is given between the inner surface of the overcap and the outer surface of the stopper. Only the nubs do contact in a direction of the middle axis an inner surface of the over cap. The nubs do provide a free space above the outer surfaceof the stopper avoiding direct contact especially of an edge of the central opening of the cap and the outer surface of the stopper. Concerning the stopper as such, thereby a certain distance to the inner surface of the overcap is secured as long as this combination is not yet fastened to the vessel. Even during transportation of such combinations which may exert a certain pressure or pushes on the parts, the danger that the stopper may suffer damage resulting for example in micro parts scraped off from the stopper is remarkably reduced.

[0012] Since moreover the stopper is completely covered by a coating layer, spray applied, no transition is given at the surface between different areas being coated and not coated, as it might be the case with a surface covered by a laminated film layer. No transition of different materials is given, at the surface of the stopper, which might also increase the danger of injuries at the stopper prior to being assembled to the vessel.

[0013] In a preferred embodiment, the front face of the vessel surrounding the second opening is running in a cross section radially outward axially decreasing, with a first acute angle to the middle axis. The front face is sloping radially outward. This provides additionally a sharp redirection between the sealing gap and the sealing plane.

[0014] In a further preferred embodiment, a flange surface of the flange being in an applied condition in contact with the front face is extending also in a nonapplied condition with a second acute angle to the middle axis corresponding preferably to the first acute angle. The concurrent extensions of the respective surfaces provides that no respective pre-stress is given in the flange of the stopper in the applied condition. This is also enhancing the sealing contact between the flange and the front face.Brief Description of the Drawings

[0015] The following detailed description of preferred embodiments is to provide further details as well as to enhance the understanding of the disclosure. The drawings are illustrating embodiments which are presently preferred:Fig. 1 a longitudinal cross-section of a cartridge,Fig. 2 a longitudinal cross-section of a combination of an overcap with a stopper prior to assembling to the vessel, andFig. 3 the cross-section of the stopper.Detailed Description of the illustrated embodiments

[0016] Shown and described is, first, with reference to figure 1, a cartridge 1.

[0017] The cartridge 1 does comprise a vessel 2, which is essentially cylindrical.

[0018] The vessel 2 has a middle axis a and is preferably rotationally symmetrical concerning the middle axis a. In the direction of the middle axis a, the vessel 2 further has a length 1. In a direction perpendicular to the length 1, the vessel has a width w and a first inner diameter di. The length 1 is greater than the diameter di. Preferably, the length 1 is two times or more, up to 10 or 15 times or more, greater than the diameter di.

[0019] The vessel 2 is preferably made of glass.

[0020] The vessel 2 does have a first opening 3 and a second opening 4. The first opening 3 has preferably a same diameter di as the remaining part of the vessel except for the region of the second opening 4.

[0021] Within the first opening 3, a piston 5 is provided for, closing the first opening 3. The piston 5 may be designed as the piston disclosed in US 2019 / 0 307964 Al.

[0022] The second opening 4 has preferably a second inner diameter d which is 95% or less of the first inner diameter di, up to 2 / 3 or less of the first inner diameter di.

[0023] The vessel 2 is preferably merging into the second inner diameter d by curved section 6 of its wall 7.

[0024] The second opening 4 is closed by a stopper 8. The stopper 8 is preferably a one part stopper. The stopper 8 may be a rubber part or made from thermoplastic material such as TPE. The material might be as described in WO 2015 / 003 752 Al. In each case, the stopper is resilient and able to elastically deform.

[0025] The stopper has a closed upper part 9 extending radially outward into a flange 10. Below the upper part 9 extends a circumferentially closed annular wall 11. The annular wall 11 extends into the vessel 2, engaging with its outer surface 12 an inner surface 13 of an essentially cylindrical part 14 of the vessel 2 adjoining the second opening 4. Preferably, the outer surface 12 of the annular wall 11 is also essentially cylindrical. Preferably, at a lower end, there is additionally some chamfer.

[0026] The annular wall 11 defines inside a free space 15 open to the inner of the vessel 2. The free space 15 is preferably conical, widening to the inner of the vessel 2 or in the direction to the first opening 3 respectively.

[0027] An outer diameter d3 of the annular wall 11 could be chosen such that the wall is lying with some pre-stress on the inner surface 13 of the vessel, in order to provide the desired sealing.

[0028] The stopper has on an outer front surface 16 of its upper part 9 protrusions designed as nubs 17. The nubs 17 are stand-alone protrusions being circumferentially surrounded by the not rised surface 16. In a non-assembled state as shown in Fig. 2, the nubs can lie against an inner surface 18 of an over cap 19. The nubs 17 leave air ways 20 from an outer edge 21 of the outer surface 16 up to opening edge 22 of an opening 23, preferably central in the over cap 19. In an assembled state as shown in figure 1, the nubs 17 maybe such deformed, that some, most or all of the airways are no more given.

[0029] The overcap 19 is to securely hold the stopper 8 in the second opening 4 of the vessel 2 in an assembled state as shown in figure 1. The overcap 19 is a metallic cap, preferably made from aluminum. The overcap 19 might be deep drawn into the configuration as shown in figure 2. In this configuration, the overcap 19 is cup-like formed, wherein a cup bottom has the preferably central opening 23. The central opening 23 might be punched out.

[0030] The metallic sheet, the overcap 19 is made from, is preferably comparatively thin. It might have a thickness of 0.5 mm or less. The thickness can be even as low as 0,2 mm or less, preferably is the thickness about 0,25 mm.

[0031] The stopper 8, further, is completely covered by a spray applied coating layer 24, see especially figure 3. The coating layer 24 serves predominantly to separate the stopper as such from the pharmaceutical fluid. It gives also some kind of protection, after having been applied to the molded or cured stopper, ontransportation ways. The coating layer 24 covers the stopper, including the nubs 17, without any surface part of the stopper as such left out.

[0032] A thickness of the coating layer 24 is preferably rather thin. The thickness can be in the range of some gm, for example 0,3 to 50 pm, preferably 10 to 30 |im, more preferably about 20 m. Further between 0,4 to 1 gm, especially0,6 gm. The thickness can also vary over the surface. For example, the surface parts, which are in use in direct contact with the pharmaceutical fluid can have greater thickness of the coating than the remaining surface parts.

[0033] Concerning the method for closing of the second opening, as shown in figure 2, the combination of the overcap 19 with the stopper 8, prior to assembly, is such that due to the nubs 17 a certain distance is given between the front face of the stopper 8 and the inner surface of overcap 19. In the crimped condition as shown in figure 1, the distance might be reduced to zero, at least the distance is remarkably reduced. Thereby, in the crimped version of figure 1, the edge 22 can be close to the front face of the stopper 8 or even lay directly on the front face of the stopper 8.

[0034] In the crimped condition according to figure 1, no more danger of relative movement between the crimp cap and the stopper and especially also of the edge 22 of the opening of the overcap relatively to the stopper 8 is given.Reference numerals1 cartridge2 vessel3 first opening d width4 second opening dl first inner diameter5 piston d2 second inner diameter6 curved section d3 outer diameter7 wall 1 length8 stopper w width9 upper part10 flange11 annular wall12 outer surface13 inner surface14 cylindrical part15 free space16 outer surface17 nubs18 inner surface19 overcap20 air ways21 outer edge22 opening edge23 central opening24 coating layer

Claims

Claims1. Cartridge (1) containing a pharmaceutical fluid, comprising a vessel (2) being generally cylindrical, having a length (1) and a width (w), the length (1) being greater than the width (w), a longitudinal middle axis, a first end with a first opening (3) and a second end with a second opening (4), a piston (5) closing the first opening (3) and engaging sealingly an inner surface (13) of the vessel (2), proximate the first opening (3), the piston (5) being movable along the longitudinal middle axis, wherein the vessel (2) further comprises a needle penetrable seal, closing the second opening (4), wherein the seal is a stopper (8) having, a closed top portion forming a flange (10) for sealingly engaging a front face of the second end, the front face extending circumferentially to the second opening (4), a circumferentially closed annular wall (11) extending inside the vessel (2), an outer surface (12) of the annular wall engaging sealingly an inner surface (13) of the vessel (2) close to the second end, the annular wall (11) leaving an inner free space around the middle axis, wherein further the stopper (8) is held on the vessel (2) by means of a metallic overcap (19), the overcap (19) having a central opening (23) allowing access to the stopper (8), an outer front face of the top portion having nub-like protrusions resting against an inner surface (18) of the overcap (19), wherein further the stopper (8) is completely covered by a spray applied coating layer (24).

2. Cartridge according to claim 1, wherein the front face is running in a cross section radially outward axially decreasing, with a first acute angle to the middle axis.

3. Cartridge according to claim 2, wherein a flange surface of the flange being in an applied condition in contact with the front face is extending also in a non-applied condition with a second acute angle to the middle axis corresponding to the first acute angle.

4. Method for closing a second opening (4) of a cartridge (1) containing a pharmaceutical fluid, the cartridge (1) comprising a vessel (2) being generally cylindrical, having a length (1) and a width (w), the length (1) being greater than the width (w), a longitudinal middle axis, a first end with a first opening (3) and a second end with the second opening (4), wherein in a first step a stopper (8) is completely covered with a spray applied coating layer, in a second step a combination of a metallic overcap (19) with the stopper (8) is made, with the stopper (8) received inside the overcap (19), whereby the overcap (19) is provided with a central opening (23) and the stopper (8), on its outer front face, with nub-like protrusions, wherein further the combination is such that the nub-like protrusions provide a free space between an inner surface (18) of the overcap (19) and the outer front face, wherein in a further step the combination is crimped on the vessel (2) whereby the overcap (19) is made to tightly covering the stopper (8) under deformation of the nubs (17) and reduction of the free space.

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