FR2473016A1 - Inviolable closure for container of injectable pharmaceutical prod. - accessible only by displacement of two part metal foil capsule - Google Patents

Abstract

Guaranteed inviolability closure for a necked container of pharmaceutical prod. to be injected to a patient with a hypodermic needle syringe, is of the type comprising a rubber plug through which the needle can be inserted. The plug is capped with a two-part, metal foil capsule. The inner part of the capsule is in the form of a ferrule clamped around the container neck and covering the plug except for a central aperture obscured by a detachable outer capsule part. Improvement is that the outer part now has an annular fold tucked under the edge of the aperture in the inner part. This ensures that the outer part cannot reveal the plug without inner part being obviously displaced.

Description

Improvement of devices for tamper-evident closure of containers.

 The present invention relates to an improvement to devices for the tamper-proof closure of containers.

 Certain injectable pharmaceutical products are usually packaged in a vial comprising a stopper intended to allow a withdrawal with a syringe and a needle through a stopper or an elastic seal, in particular of rubber.

 This type of stopper notably comprises a stopper or a rubber disc, held on the bottle by a thin metal cap crimped on the neck of the bottle. There are currently several types of capsules.

 In the case of a double two-piece capsule, the outer capsule provided with a tear-off tab is crimped onto the ring of the bottle and holds an inner capsule in place which has a hole allowing the rubber seal to appear.

 In the case of its use for an injection, the external capsule is torn by means of the tab and the joint is punctured through the hole in the internal capsule.

 This type of capsule does not ensure the inviolability of the bottle, as it suffices to slightly lift the tab of the external capsule and to puncture the stopper or the rubber seal through the hole in the lid of the inner capsule to take a sample undetectable with the naked eye.

There is also a closure device comprising a cap with folded edges which can be placed on the bottle neck and which comprises in a central recess a removable insert made of plastic material which engages by an annular groove in the edge of the central recess, said added part forming part of an outer capsule disposed on the
cap.

This provision also does not ensure an invio
total lability given that the removable insert is in
plastic material.

 The present invention relates to a closure device comprising a double capsule which makes it possible to remedy.

these disadvantages
According to the present invention, the outer capsule has a stamped central portion forming a boss engaged in the central opening of the inner capsule and the peripheral edge of which is folded down and crimped against the inner edge delimiting the orifice of the inner capsule.

 This device according to the invention is intended to ensure the inviolability of the packaging, because it is necessary to tear off the outer capsule to have access to the central orifice of the inner capsule, the passage of the trocars through the rubber stopper. 'then performing without difficulty.

 This device also ensures the integrity of the central part of the rubber stopper which is thus sheltered from external pollution due to the presence of the circular crimping cord which assures the assembly of the two capsules between them.

Other characteristics and advantages of the invention will be better understood on reading the following description of an embodiment and with reference to the accompanying drawings, in which
Figure 1 is a perspective view in section of the outer capsule of the closure device for containers according to the invention;
Figure 2 is a perspective view in section of the inner capsule of the closure device;
Figure 3 is a perspective view in section of the plug of elastic material
Figure 4 is a longitudinal sectional view of the closure device mounted at the top of a bottle
Figure 5 is a sectional view on a large scale of a detail of the closure device; and
Figure 6 is a sectional view of the closure device during disassembly of the outer capsule.

 The container closure device according to the invention comprises, before the installation of the various members, an external capsule 1 shown in FIG. 1 and which comprises in its central part a circular zone stamped in the form of a bowl and constituting on the side of the inner face a boss 2. At its periphery, the outer capsule -present a relatively short skirt 3 and comprising a bead 4 formed by the edge rolled on itself.

 The closing device also comprises an inner capsule 5 having a central circular opening 6 into which the boss 2 of the outer capsule 1 can be engaged, and a skirt 7 having a greater height than the skirt 3 of the capsule l . In known manner, the closure device comprises a rubber stopper 8 which is engaged in the neck of the bottle 9 and which has an edge 8a projecting over the ring 10 of the neck of the bottle.

 To mount the closing device, the boss 2 of the capsule 1 is engaged in the central orifice 6 of the capsul.e 5 and the peripheral edge 2a is folded back and crimped against the inner edge delimiting the orifice 6 of the inner capsule 5.

 These operations of assembling the capsules and crimping the boss 2 are carried out before the bottle 9 is placed on the neck.

 The cap 8 being engaged in the neck of the bottle 9 as shown in Figures 4 and 5, the capsules assembled by their central part by means of the folded edge 2a spnt engaged on the cap 8 and the ring 10 of the neck. Next, the lower edge 7a of the skirt 7 of the capsule 5 is folded over and crimped onto the ring 10 of the neck of the bottle, thus constituting a tamper-evident device for closing a container.

 The circular crimping cord 2a of the outer capsule 5 constitutes a relief relief ring compressing at 11 the elastic plug 8 and pocketing the passage of dust and polluting foreign bodies.

 To use the product in the bottle, simply grasp or push with the thumb the skirt 3 by the bead 4 and tear off the capsule 1, which causes the release of the edge 2a of 1 ' orifice 6 of the capsule 5 as shown in FIG. 6.

After this action on the outer capsule 1, the capsule 5 remains in place on the neck of the bottle 9 and the central orifice 6 which is released allows access to the elastic stopper 8 and to insert a trocar or a syringe needle 9 through the central part of the stopper to extract the product from the bottle,
Of course, various modifications can be made by those skilled in the art to the device or process which has just been described, only by way of nonlimiting example and without departing from the scope of the invention.

Claims (3)

1. Improvement to devices for the tamper-evident closure of containers capable of containing products withdrawn by means of a syringe and a needle through a stopper or an elastic seal, said devices comprising an inner capsule on which a capsule is disposed outer, said inner capsule having a skirt crimped at its lower part on the neck of the container and comprising in its upper wall a central opening, characterized in that the outer capsule has a stamped central part forming a boss engaged in the central opening of the inner capsule and the peripheral edge of which is folded down and crimped against the inner edge delimiting the orifice of the inner capsule. 2. Improvement to the devices for the tamper-proof closure of containers according to claim 1, characterized in that the outer capsule has a skirt partially covering the skirt of the inner capsule, said skirt of the outer capsule having a bead formed by the rolled edge on itself of said skirt. 3. Improvement of devices for. the tamper-evident closure of containers according to claim 1, characterized in that the circular crimping bead of the outer capsule on the inner capsule constitutes a relief sealing ring compressing the plug or the elastic seal.