Novel device

The invention relates to a container closure system of the type having an upwardly directed outlet delimited by a rim, the closure system comprising an elastomeric closure member adapted to be sealed to the outlet opening having a lower surface facing the interior of the container and an opposite upper surface facing the exterior of the container capable of being pierce with a needle; a clamp part connectable to the container and able to rest on the top surface of the closure member so as to hold the closure member in a position that closes the outlet opening, the clamp part having an aperture that exposes a certain area of ​​the top surface of the closure member when the clamp part is connected to the container, a cap connected to the clamp part and / or the container, covering said area of ​​the closure element, the cap at least partially covers the opening. The arrangement is characterized in that the cap (40) has a top wall (41) having a segment (46) connected to the rest of the cap (40) through one or more thin frangible links (47) that are easily breakable to allow sufficient detachment. segment (46) from the rest of the cap (40), allowing the region of the closure member (20) through the exposed opening (36). Furthermore, the invention also relates to a pharmaceutical container closed with such a system, methods of closing and filling such pharmaceutical containers, as well as the closure of such a container.

PL 204 401 B1

Description of the invention

The present invention relates to a system for closing containers, particularly drug vials, for the sterile storage of drugs or vaccines. The invention also relates to a pharmaceutical container, a method of closing containers, a method of filling pharmaceutical containers, and a container closure.

Drugs and vaccines are usually delivered in containers that are closed with elastomeric closure members through which a hollow needle can pass through which, by piercing part of the closure member, through which the drugs or vaccines are drawn for use, possibly after dissolving in a liquid supplied to the closure. container with a needle. Typically, such a container has an outlet delimited by a flange-shaped rim, and the closure member is held closed on the outlet by a flexible metal clip that surrounds the edge of the closure member and holds it tightly over the rim. Often the central portion of the closure member may be pierced by a needle, the clamp portion having a removable central portion which covers the central portion of the closure member before use and which can be removed immediately prior to use. Often this central part is connected to the rest of the clip around the circumference by easily frangible connections, allowing the central part to initially engage with the rest and detach it prior to use, evidence of tampering. The problem of this known device is that it is difficult to achieve a sterile seal between the central part and the closure member, so the user has to "sanitize the central part of the closure member immediately before use, for example by wiping with alcohol. French Patent No. FR-A-2516480 discloses a container with a clamp portion on its elastomeric closure, with a tear-off cap on a central opening in the clamp portion.

It is further known, e.g. from US-A-2002/0023409, to provide a pharmaceutical container having a closure member made of thermoplastic material. Such a container can be filled by a hollow needle through the closure member, the needle is then withdrawn and the remaining small opening can be closed by welding, e.g. using a focused laser beam. The object of the present invention is to improve the container shown here.

It is also an object of the invention to provide an improved container closure system which is simple to manufacture, assemble and reduce waste of the contents of the container.

It is also an object of the invention to provide a container closure system which at least partially overcomes the above-mentioned problems of the known systems and is particularly suitable for container closures that can be sealed by welding after filling with a hollow needle as described above.

The invention relates to a container closure system of the type having an upwardly directed outlet delimited by a rim, the closure system comprising an elastomeric closure member adapted to be sealed to the outlet opening having a lower surface facing the interior of the container and an opposite upper surface facing the exterior of the container capable of being pierce with a needle; a clamp part connectable to the container and able to rest on the top surface of the closure member so as to hold the closure member in a position that closes the outlet opening, the clamp part having an aperture that exposes a certain area of ​​the top surface of the closure member when the clamp part is connected to the container, a cap connected to the clamp part and / or the container, covering said area of ​​the closure element, the cap covering at least partially the opening, characterized in that the cap has a top wall having a segment connected to the rest of the cap by one or more thin breakable fasteners that are easily breakable to allow sufficient engagement of the segment from the rest of the cap; with access to the area of ​​the closing element through the exposed opening.

Preferably, the lower surface of this cap segment faces the upper surface of the top wall of the closure member when engaged with the clamp portion, has a convex sealing ridge for edge sealing which extends over a closed circumference such that when the cap is engaged with the clamp portion and / or the container, the sealing edge connects with the closure element to form, together with the closure element, a tight closure, but this segment, which includes a sealing ridge, is releasable from the clamp portion and / or the container.

PL 204 401 B1

The terms "up," top, "bottom, and similar derivative terms for directions like" vertical "refer to the normal configuration of a vertically oriented container with the outlet at the highest point and the base at the bottom.

Preferably, the cap is a cap having an upper wall and a circumferential sidewall, and the sidewall has a snap-on portion at its lower end for engagement with the clamping portion. Such latching means may be a projection on the cap and a corresponding groove on the clamp portion, or vice versa. Other snap-fit ​​means are known to those skilled in the art and may also be used.

The cap covers the closure area which is exposed through an opening in the clamp portion. The cap at least partially closes the opening, usually centrally located in the clamping portion, so as to cover the above-mentioned region of the closing member, usually the central one. A sealing ridge may be positioned on the cap and project downwardly from a lower surface of the top wall of the cap to which it abuts, and be above the closure member when the cap is engaged with the clamp portion, and may be integral with the cap. Alternatively, the sealing ridge may be positioned on the closure member and project upwardly from an upper surface of the closure member that is exposed by the aperture, and may be an integral part of the closure member, in which case the sealing ridge extends from below. The sealing ridge has a sealing edge which is substantially triangular in cross section, truncated parallel to the up-down direction, so that the sealing edge is the apex of the triangle. The sealing lip circumscribes a ring-shaped, for example circular, oval or closed polygon, rim, visible when looking up towards the lower surface of the top wall of the cap. The portion of the cap that includes the sealing ridge is made removable from the clamp portion and / or the container, ensured by the fact that preferably the top wall of the cap has a segment connected to the rest of the top wall and / or sidewall of the cap via one or more thin breakable connectors. the segment may be made integral with the cap and its removable part, which can readily be used to allow sufficient (partial or complete) detachment from the rest of the cap to allow access to an open area of ​​the closure member. Accordingly, the cap may be injection molded plastic, suitably the same as the clamp portion.

The container is a vial of the neck type directly below the exit port with a flanged rim with an upper surface and a lower surface extending transversely, usually circumferentially, with respect to the up-down axis. Such containers are very well known in the pharmaceutical industry. Correspondingly, the upper surface of the collar may be circumferentially bounded by an upward projecting projection. Such a protrusion can assist in seating and retaining the elastomeric closure element on the collar. Accordingly, the upper surface of the flange may have an upwardly projecting sealing ridge for cooperation with the downwardly facing surface of the closure element to improve the seal between the closure element and the flange.

The container may be made of glass, but is typically made of a hard, pharmaceutical grade plastic. A suitable type of polymer is cycloelefin copolymers ("COCs), a mixture thereof, or a mixture thereof with another polymer. Examples of such COC polymers are, for example, disclosed in, inter alia, US-A-5723189, EP-A-0436372 and EP-A-0556034. A suitably hard plastic approved for use in the pharmaceutical industry is the "Topas" cyclolefin copolymer manufactured by Celanese Corporation. For example, the known polymers COC Topas 8007 or Topas 6015, available e.g. from Ticona GmbH (DE), are suitable. Conditions for injection molding these polymers to make containers therefrom are known in the art.

The closure system preferably has a downwardly projecting plug portion fit into the container outlet and an outwardly projecting peripheral flange the downward facing surface of which is in engagement with an upper surface of the flanged rim of the container outlet. Suitably, the stopper part has an outer edge, e.g. of its circumferential flange, which conforms to the circumference of the flange. Upstream of such a flange, the closure may be flat, but preferably the closure member above the flange is convex upward when the rim is flanged, e.g. The stopper part is suitably cylindrical with the upper end of the hollow cylinder protruding further into the upper arched or conical part, e.g. so that the overall internal shape of the element closes

The vaulted top is in the form of a bell or a vault, or a cylinder with a closed vaulted top, or is in the form of a regular concave truncated cone.

In the event that the closure has a convex shape, the clamping portion preferably has an aperture top wall with a peripheral side wall projecting downwardly and having a snap-fit ​​connection for engaging with the container, the top wall and the convex upward portion of the closure member being shaped such that the upwardly convex portion bulges over the adjacent top surface of the top wall when the clamp portion and the closure member are in place. The bulging of the closure member over the top wall strengthens the seal between the closure member and the cap when they are in place. The lower surface of the clamp portion, where it is in contact with the closing element, may be contoured to conform to the shape of the upper surface of the closing element such that the clamping portion and the closing element cooperate together. Preferably, the upper wall of the clamping portion and the upwardly convex portion of the closing element are profiled to form a smooth convex shape. This smooth convex shape minimizes interference with the downward laminar airflow around the container assembly, closure member and clamp, which facilitates operation of the assembly in a sterile environment. The cap is connectable to the clamp part. For example, the cap may engage by snap means with the top wall or side wall of the clamp portion, or the connection area between the top wall and the side wall.

Preferably, at least an upwardly convex portion of the closure member adjacent to said area is made of a thermoplastic elastomeric material, such that the pierced opening resulting from the filling of the container with a needle can be thermally sealed, e.g. by a focused light beam, such as with a laser as described in US-A-2002.0023409. A suitable thermoplastic elastomer may be a styrene block copolymer thermoplastic elastomer as commonly used for container closure members. Suitable thermoplastic elastomeric material is a 50:50 weight ratio blend of the polymers "Engage supplied by Dupont-Dow, and" Dynaflex formerly known as "Kraton supplied by Shell, but now available from GLS (USA), which supplies this mixture containing dye, for example in gray to increase laser light absorption so that the thermoplastic elastomeric material can be heated by the laser light. Due to irradiation from a focused 980 nm laser beam, the thermoplastic elastomer material readily melts at about 180 ° C and solidifies on cooling.

The clamping portion is typically made of a mouldable plastic and is connectable to the above-mentioned rim delimiting the mouth of the container, e.g. by a snap fit under the downwardly facing surface of such a flange. The clamp portion has an upper wall with an opening, typically a central opening, having peripheral side walls projecting downwardly, and having snap-fit ​​means for engaging a container, e.g. with said flange. The clamp part is made of a resilient plastic such as polypropylene, polyamides etc. and is dimensioned so that when the clamp part is connected to the container it can elastically exert a compressive force on the container, for example a collar around the periphery of the outlet opening and on the container. a closure member to press them together and increase the seal between the closure member and the container.

A container in which the elastomeric closure cup is held in the closing position in the container by a resilient plastic clamping piece is considered novel and thus a further part of the present invention.

The pharmaceutical container according to the invention is characterized in that it has an outlet that can be closed by a closure system according to any of the above-mentioned solutions.

The inventive method for closing containers is characterized in that a container of the type with an upward outlet defined by a flange-like rim having upper and lower surfaces extending transversely with respect to an up-down axis is provided; an elastomeric closure member configured to seal with the outlet opening having a bottom surface facing the inside of the container and an opposite upper surface facing the outside of the container and adapted to be pierced by a needle is inserted into the mouth of the container; a clamping portion is provided adapted to engage a collar around the periphery of the container outlet in a resilient manner by a snap fit of the clamping portion beneath the downward facing surface of such collar, and capable of abutting against the top surface of the closure member so as to keep the closure member in the closed position 204 401 B1 for the outlet opening, the clamping portion is connected to the assembly of the container and the closure member by said snap-fit ​​connection; then, in addition to connecting the clamp portion to the assembly of the container and closure member, a cap is provided, connectable to the clamp portion and / or the container, to cover the closure member when connected, with the lower surface of the cap facing the upper surface of the closure member when connected. they are connected, the cap being connected to the clamp part by a snap fit between the cap and the clamp part.

The inventive method of filling pharmaceutical containers is characterized in that a hollow container assembly is provided having an elastomeric closure member formed to be sealed to the outlet opening, having a lower surface facing the container interior and an opposite upper surface facing the container exterior and adapted to be pierced by a needle. , and a clamping part connected to the container, able to rest on the top surface of the closure member so as to hold the closure member in position closing the outlet opening, the clamp portion having an opening that exposes an area of ​​the top surface of the closure member when the clamp portion is engaged with the container; inserting the filling needle down through the top wall area of ​​the closure element; injecting the liquid drug through the needle to fill the container to the appropriate volume; the needle is pulled out, leaving a pierced hole; engaging the cap with the clamp part and / or the container to cover said area of ​​the closure member by means of a snap fit between the cap and the clamp part.

Preferably, prior to use of the cap, a laser beam or other heat source is directed to the top surface of the closure member to melt the elastomeric material directly at the puncture site, sealing the remaining hole after puncture.

In this manner, the automatic handling of a container, for example a container adapted to the closure system or with a closure member and clamping portion of the system described herein, by a conveyor system through which the container is transported to one or more stations, where operations such as filling with a needle or sealing punctured places with a laser, are facilitated by the base for the container and the construction.

In a further aspect of the invention, it has been found that the internal profile of the plug portion of the closure element can be important to ensure that a minimum amount of fluid remains trapped in the container when the fluid contents are drawn out with the needle.

Generally, the stopper portion of a container closure, for example as described above, is a hollow cylinder, and has a face facing outwardly against the neck of the container that engages the inner surface of the neck of the container, typically a cylindrically shaped outer surface that, when the closure member is in place, facing the cylindrical inner surface of the neck of the container and the inward facing surface, which faces the interior of the container, and which joins the neck-engaging surface where the inwardly-facing surface meets the neck surface of the container. Prior art stopper portions, e.g. as disclosed in EP-A-0956849, FIG. 4 and EP-A-0794129, when the closure member is in place, the surface facing the inside of the stopper part joins at an angle of 90 ° or less with the inside surface of the container neck immediately below the stopper part. This raises the problem that, depending on the wicking and the surface tension, the fluid content becomes trapped in this acute angle region and cannot be easily removed with a needle. A relatively large proportion of the contents can thus be trapped in a small container.

The container closure according to the invention is therefore characterized in that it has a stopper portion which has an outwardly facing neck engaging surface, which is cylindrical against the lower end of the stopper portion and which engages with the inner surface of the neck of the container when the closure member is in place opposite the cylindrical inner surface of the neck of the container and the surface facing inward, which is exposed to the inside of the container and which, when the closure member is in place in the container, engages at an angle of 120-160 ° with the inner surface of the neck of the container immediately below the stopper portion. Preferably this angle is 135 ° +/- 10 °.

This angle may be obtained by an outwardly facing, neck-engaging substantially cylindrical surface of the stopper portion at least adjacent the lower end of the stopper portion, and by an inwardly facing surface and outwardly engaging the neck.

The surface, forming an edge and connecting at an angle of less than 90 °. Typically this angle is 30-60 °, e.g. about 45 ° +/- 10 °. Of course, in practice it will be appreciated that when manufacturing the stopper portion from an elastomeric material, e.g. by injection molding, it may be necessary to deviate from making a very sharp edge, e.g. by making a rounding with a small radius, e.g. 0.5 mm or less. , or a small flat edge.

When the inwardly facing surface engages at an angle greater than 90 ° with the inner surface of the neck of the container immediately below the stopper portion, it has been found in this embodiment of the invention that this minimizes the tendency of surface tension and capillary effect to entrap the remaining fluid contents of the container between the closure and the inner surface. container.

The inventive container closure of the type having an upwardly directed outlet delimited by a rim is characterized in that the inlet opening is closed by a closure arrangement comprising an elastomeric closure member adapted to seally engage the outlet opening having a lower surface facing the container interior and an opposite upper surface. a pierceable needle facing the outside of the container; a clamp portion connectable to the container and bear against the top surface of the top wall of the closure member so as to hold the closure member in a position that closes the outlet opening, the clamp portion having an opening that exposes an area of ​​the top surface of the closure member top wall when a clamp portion is connected to the container, the cap at least partially covering the opening; optionally a cap, connectable to the clamp portion and / or the container, to cover said area of ​​the closure member; in conjunction with a support comprising a ring-shaped body having an internal circumference adapted to cooperate with the container bottom, the support having an external circumference which extends radially beyond the outer circumference of the container in a direction perpendicular to the outlet-end axis of the container therein container, and over substantially the same radial distance as the farthest extension radius of the container assembly and clamp portion and / or cap.

Moreover, the container support comprises a ring-shaped inner body with a rim that fits the container base and can be held therein, the base, the outer rim of which protrudes in a direction perpendicular to the mouth-end axis of the container therein, further than the outer circumference of the container has an upwardly facing surface.

Suitably, the outer periphery of the base extends radially over substantially the same distance as the outermost portion of the container or assembly thereof with the clamp portion or cap above the base. The design of the assembly of such a stand and clamp portion with similar external radial dimensions facilitates the rolling of the container, for example for labeling, and further helps to stably store together a plurality of containers in the correct position.

Such a cradle typically has an upward facing surface and a bottom surface that are substantially flat and parallel. Such a tray is useful to aid machine operators in holding the container, for example by supporting the upward surface of the tray against pressing the tray downward, for example, through a portion of a conveyor. If the container is handled in a sterile environment provided by laminar downward flow of air, this allows the container to be retained on its support by a portion located below the closure in the direction of air flow, which reduces the risk of contamination of the contents as it flows out of the device until the container is closed. Also, in the case of the above-described method of filling the containers, the surface facing upwards facilitates the resistance of the container with the force of pulling the needle upwards by abutting the upward surface against some abutment against an element of the operating machine.

Further, the container assembly has a base that can engage the inner periphery of the ring-shaped base.

For example, such a container may have a base with an upper surface forming the bottom of the interior of the container and a lower surface from which a connecting portion extends downwardly, adapted to engage an inner rim of such a base, for example a plug and connector socket arrangement between the connecting portion and the inner rim of the base.

If the container is to be transported through a conveyor system, a stream of purified air is usually directed downwards over the conveyor and the containers placed thereon to maintain the sterility of the environment. Such a stand has the advantage that it can be easily

The closure is gripped by the gripping means of the conveyor, allowing the container to be held such that the closure is at the highest point in the airflow, minimizing the risk of contamination of the closure with microorganisms.

The subject of the invention is illustrated by the exemplary embodiments in the drawing, in which fig. 1 shows a longitudinal section of the container and the closure system of the container according to the present invention, fig. 2 - a closure cap according to the invention, shown in different positions, fig. 3 - a container with a perspective view of the inserted closure member and clamp part, fig. 4 - container with closure member and clamp part as shown in fig. Fig. 3 and with the cap in place, in perspective view, Fig. 5 - the container and closure, clamping part and cap of Fig. 4, with the cap partially removed, Fig. 6 - longitudinal section of a partially assembled assembly of the container and closure member according to the invention.

Fig. 1 shows a container 10 of generally cylindrical shape. At its upper end, as shown, the container has an outlet 11 with a neck 12 located immediately below. The container 10 is shown oriented in a known manner, with the outlet at its highest point and the base at the bottom. High-capacity containers 10 may have a wider body section below the neck 12, as is well known in the art. The outlet 11 is surrounded by a protruding rim 13 in the form of a flange having an upper surface 13A and a lower surface 13B. The upper surface 13A of the rim 13 is delimited by a circumferential projection 14. A sealing ridge 15 extends upward from the upper surface 13A of the rim 13 having a substantially triangular cross section along a vertical axis and in the form of a circular ring concentric with the cylindrical container 10. The upper inner edge 12A of the neck 12 in the area of ​​the junction between the neck 12 and the rim 13 has an upwardly obtuse conical profile for piloting the entrance of the stopper portion 21 (will be described) of the projection of the closure element 20.

The stopper portion 21 of the closure element 20 inserted into the outlet 11 and protruding in some way at the bottom of the neck 12 is integrally made of a thermoplastic elastomer. The stopper portion 21 fits closely to the neck 12 to thereby create a tight seal between the closure member and the neck. The closure member 20 has a protruding flange 22 which is shaped and dimensioned such that the flange 22 fits comfortably over the protrusion 14. The flange 22 has an upper surface and a lower surface. When the closure member 20 is in the position shown in Fig. 1, the lower surface of flange 22 fits over the upper surface 13A of the rim 13 and the sealing ridge 15 presses and deforms the elastomeric material of the lower surface of the flange 22, promoting an effective seal between the upper surface 13A and the lower surface of the flange. 22.

The stopper portion 21 has a substantially hollow and bell-shaped interior 21A. The top 23 of the closure element 20, centrally located inside the collar 22, is convex and frusto-conical with a flat top surface. The upper portion of the interior 21A of the stopper portion substantially conforms to the upwardly convex shape of the upper portion 23. The upper end of the cylindrical interior 21A is closed by an upper wall 24 which is thin enough to be pierced with a hollow needle (not shown) through which the container 10 can be filled when the closure member 20 is inserted therein.

The clamp portion 30 holds the closure member 20 in place relative to the rim 13. The clamp portion 30 has a generally circular top wall 31 in plan view, from the rim of which extends downward side wall 32. At the lower end of sidewall 32 is a snap-fit ​​33, which is a wedge-shaped, inwardly projecting projection, portion of a projection, or tooth capable of engaging under the lower surface 13B of rim 13 to hold the clamping portion 30 in place in the assembly of container 10 and closure member 20. The clamping part 30 to facilitate this is made of a resilient plastic material. The clamping portion 30 has two areas of downward facing surfaces, namely an upper downward facing surface 34 and a lower downward facing 35 which rests on a corresponding upper surface of the upper wall 24 of the closure element 20 and the upper surface of the flange 22, to hold closure member 20 in place with respect to collar 22.

In the upper wall 31 of the clamping portion 30 there is a central circular opening 36 through which the central conical upper portion 23 of the closure element 20 protrudes such that the central region 24A of the upper wall 24 is exposed by the opening 36. The upper surface of the closure member 20 is so profiled. that the top 23 of the closure element 20 protrudes bulging upwards through the opening 36. The inner circumference of the opening 36, adjacent to the top facing downwards

The surface 34 is also shaped to conform to the outer profile of the upper part of the closure element 20 such that the closure element 20 and the clamping part 30 cooperate smoothly.

As shown, the lower surface of the clamping portion 30, where it contacts the upper surface of the closing element 20, is contoured to conform in shape to the upper surface of the closing element 20, with the clamping portion 30 and the closing element 20 working together. Moreover, Fig. 6 shows most clearly that the upper surface of the clamping part 30 and the convex part of the closing element 20 are profiled so as to form slight reliefs.

Around the periphery of the top wall 31 of the clamp portion 30 is a groove 37 with which the cap 40 engages.

The cap 40 is in the form of a cap having an upper wall 41 with a peripheral side wall 42 at its lower end which includes a latch portion 43 which is a wedge-shaped inwardly projecting beak, beak portion or tooth adapted to cooperate with a groove 37 of the clamping portion 30 for holding cap 40 in place on clamp portion 30. To facilitate this, cap 40 is made of a resilient plastic material.

The lower surface of the top wall 41 has a sealing ridge 44 projecting downward therefrom. As can be seen when looking up towards the lower surface, the sealing ridge 44 is circular in plan view and has a triangular cross section so as to define a sealing edge terminating at a lower sealing sharp edge. When the cap 40 contacts the clamping portion 30 through snap-fit ​​connections 43 and groove 37, the resilience of the cap material 40 forces the cap 40 against the central area 24A of the upper portion 23 of the closure element 20 and the sealing ridge 44 acts on the elastomeric central area 24A and presses, deforming it, to thereby form a seal against the central area 24A. Thereby, a seal 45 is created between the cap 40 and the closure member 20. The seal between the sealing ridge 44 and the central region 24A is sufficient that contaminants such as microorganisms, viruses, etc. cannot pass through them, and the closure 45 can remain. sterile.

The assembly consisting of the container 10, the closure member 20 and the clamping part 30 shown in Figures 1 and 2 is assembled as described below. First, the container 10 and closure member 20 are provided, preferably in a sterile condition, although the assembly of the container 10 and closure member 20 may be sterilized after assembly, e.g. by irradiation. The stopper portion 21 of the closure element 20 is then inserted downstream into the neck 12 of the container 10 until the lower surface of the flange 22 of the closure element 20 abuts the upper surface of the rim 13 around the mouth of the container, abutting in the area delimited by the projection 14, a conical support taper. positioning and entry of stopper part 21 into the neck 12. The clamping portion 30 is now pressed down over the closure member 20 so that the side wall 32 drops around the projection 14 and the snap fit 33 engages under the rim 13 to hold the closure member 20 securely in place.

The container 10 and the closure system in the form of the closure member 20, the clamp portion 30 and the cap 40 can then be used as described below. The assembly of the empty container 10, closure member 20 and clamping piece 30 is provided as shown in Fig. 6. The assembly can be sterilized by any appropriate commonly known methods, both before (i.e. as separate pieces) and after assembly. In a sterile environment, such as a sterile air stream, a filling needle (not shown) can then be inserted downward through the top wall of closure member 20 and fluid medication can be injected therethrough to fill container 10 to the desired volume. Known inflation needles suitable for this application may furthermore have an air exit passage to release displaced air from inside the container 10. After the container 10 has been filled in this way, the needle is withdrawn. The container can be held in place against this pull-out force by pressing against the top surface 53 of the base 50. The elastomeric material of the top wall 24 clamps around a puncture hole (not shown) in the closure member 20, while in a still sterile environment, a laser beam or other heat source is directed to the portion of the top surface of top wall 24 where the piercing has occurred to melt it. elastomeric material directly at the puncture site, and thus seal the hole formed after the puncture. Then, while still in a sterile environment, the cap 40 is attached to the clamp portion as shown in Figure 1.

PL 204 401 B1

Immediately prior to use of the medicament, segment 46 is raised as described above, and an injection needle connected to a syringe (not shown) can be inserted through the central region 24A in accordance with the known manner of using containers with an elastomeric closure.

Since the central area 24A was held in the sterile closure 45 until the segment has been lifted, there is no need for a user to wipe with sanitizer the area of ​​the closure member 20 to be pierced, i.e. the central area 24A, as was necessary with prior art systems. closing containers.

Figures 2A-2E show a plan view, a side view with an upward-facing plane shown in Fig. 2A, and three perspective views, respectively, of a cap 40. As can be seen more clearly in Fig. 2, 3 and 4, where the lower portion of the side wall 42 and its latch portion 43 protrude in the form of a continuous ring, the segment 46 of the top wall 41 of the cap 40, including that portion of the top wall 41 which has a sealing ridge 44 on the bottom surface, is made as segment connected to the rest of the cap 40 by thin frangible links 47 which are integrally formed plastic bridges. The circumferential edge of this segment 46 may be raised, as shown, whereby the thin frangible links break and the segment 46 lifts off the closure member 20. This breaks the seal between the sealing ridge 44 and the central area 24A of the top wall 24 of the closure member 20 and exposes it. central region 43A, leaving cap 40 held on clamp portion 30 by the snap-on latch portion 43 of side wall 42.

Figures 1-6 show a relatively small capacity container 10 having a substantially cylindrical shape. For stability and to assist automatic handling, e.g. during filling and cap 40 application operations, the base of the container 10 is mounted in a ring-shaped support 50 extending outwardly from the generally cylindrical container 10 at its bottom. The base 50 has an inner rim 51 such that the base of the container 10 can fit there and be securely held, and has an outer rim 52 that projects transversely to the bottom-end axis of the container 10 introduced therein beyond the outer dimension of the container. The stand 50 has an upper surface 53 and a lower surface 54 that are substantially flat and parallel. The container 10 has its own base 16 having an upper surface forming the inner surface of the container bottom 10, and a lower surface from which an integral interlocking member 17 extends downwardly which is pinchable or snap-fit ​​with the inner rim 51 of the base 50. In Figs. 1 and 3, 6 it is shown that the outer periphery 52 of the base 50 projects radially by substantially the same distance as the radius of the farthest extension of the clamp portion 30.

Figure 1A shows the portion of Figure 1 adjacent the lower end of the stopper portion 21 and illustrates a further aspect of the present invention wherein the stopper portion 21 has an outwardly facing neck engaging surface 21B which, when the closure member 20 is in place, it faces the cylindrical inner surface 12A of the neck 12 of the container. The closure member further has a surface 21C facing the inside of the container which is exposed to the inside of the container and which, as shown in Fig. 1, when the closure is in place, is bordered by an angle "A greater than 90 [deg.], Having about 135. °, with the inner surface 12A of the neck 12 of the container immediately below the stopper portion 21.

This angle "A is formed by an outwardly facing surface 21B of the stopper portion 21 engaging the neck, which is substantially cylindrical and extending to the lower end of the stopper portion, and an inwardly facing surface 21C, the outwardly facing surface 21B of the neck forming the closing edge. an angle of 180 ° minus A, for example about 45 ° in between.

This shape of the stopper portion has been found to minimize the tendency of surface tension and capillary effect causing residual liquid in the container to remain trapped between the closure and the interior surface of the container. To assist the cylindrical stopper portion 21 to conform to the container neck 12, the container neck 12 has a slightly conical profile, slightly wider at the top at the outlet than at the bottom at the end adjacent to the stopper portion.