EP3967290B1 - System and method for packaging medical bottle caps composed of a cover and a valve - Google Patents

Description

FIELD OF THE INVENTION

The present invention relates to a packaging system for packaging and dispensing medical caps. It also relates to a method for packaging medical caps. The invention relates more particularly to the packaging, with a view to their distribution, of caps composed of a cap and a stopper intended to close medical bottles.

TECHNOLOGICAL BACKGROUND OF THE INVENTION

Such caps are generally delivered in bulk and poured into a vibrating bowl, or simply placed in a tray, to then be placed, by hand or automatically by a machine, one by one on a bottle to close it.

These delivery solutions are not suitable when the caps are intended to close bottles intended for medical use. In this area, the caps and the bottles must be free of any contamination, in particular particles. However, if no particular precaution is taken, the contact and friction of the stoppers between them or of the stoppers against the surfaces of the plate or of the vibrating bowl, are likely to generate particles which can then end up in the bottles. This can have very serious consequences when the bottle is used to contain a medical solution intended to be taken up by a syringe, the particles then being able to end up in the syringe and then be injected into the body of a patient.

It is therefore important to have a solution for packaging and delivering bottle caps, and more generally medical elements, making it possible to limit the generation of particles.

We know documents EP2753550 And US10064787 trays and packaging systems for individually storing different types of medical items (syringes, bottles). These medical elements cannot contact each other and the generation of particles is thus reduced. EP2753550 seeks more particularly to reduce the contact surface between the medical elements and the surface of a plate to reduce the friction zones.

We also know from the document WO2014033766 , a packaging system according to the preamble of claim 1 and a method according to the preamble of claim 3, the packaging system comprising a tank and at least one tray, which holds stoppers for pharmaceutical vials.

OBJECT OF THE INVENTION

An object of the invention is to provide a tray as well as a packaging system which distinguishes itself from and improves this state of the art.

BRIEF DESCRIPTION OF THE INVENTION

• une cuve ayant une ouverture, un fond et une paroi périphérique
• au moins un plateau présentant chacun une pluralité de logements accueillant chacun un bouchon médical disposé de sorte que la coiffe délimite avec une face supérieure du plateau un compartiment fermé pour isoler individuellement l'obturateur, le plateau étant placé dans la cuve ; et
• un opercule poreux scellé sur le bord supérieur de la paroi périphérique de la cuve pour la refermer.

With a view to achieving this object, the object of the invention proposes a system for packaging medical caps formed of a cap surmounting a stopper, the packaging system comprising:

• a tank having an opening, a bottom and a peripheral wall
• at least one tray each having a plurality of housings each receiving a medical plug arranged so that the cap delimits with an upper face of the tray a compartment closed to individually isolate the obturator, the plate being placed in the tank; And
• a porous cover sealed on the upper edge of the peripheral wall of the tank to close it.

• la cuve est placée, sous vide, dans au moins une sache étanche.

According to other advantageous and non-limiting characteristics of the invention, taken alone or according to any technically feasible combination:

• the tank is placed, under vacuum, in at least one sealed bag.

• fournir une cuve présentant une ouverture, un fond et une paroi périphérique ;
• disposer un plateau présentant une pluralité de logement au fond de la cuve ;
• disposer au moins un bouchon dans un logement de manière à ce que la coiffe délimite avec une surface supérieure du plateau un compartiment fermé dans lequel est isolé l'obturateur ;
• sceller un opercule poreux sur un bord supérieur de la paroi périphérique de la cuve ;
• placer la cuve dans au moins une sache étanche, et mettre la sache sous vide.

According to yet another aspect, the object of the invention proposes a process for packaging caps formed of a cap surmounting a shutter, the process being characterized in that it comprises the following steps:

• providing a vessel having an opening, a bottom and a peripheral wall;
• arranging a tray having a plurality of housings at the bottom of the tank;
• arranging at least one stopper in a housing so that the cap delimits with an upper surface of the plate a closed compartment in which the shutter is isolated;
• sealing a porous seal on an upper edge of the peripheral wall of the vessel;
• place the tank in at least one waterproof bag, and put the bag under vacuum.

• l'opercule est rendu solidaire de la cuve par soudage sur le bord supérieur de la paroi périphérique de la cuve ;
• le procédé d'emballage comprend les étapes suivantes :
  • * disposer un plateau supplémentaire pour former un empilement de plateaux dans la cuve, le plateau supplémentaire venant en appui sur la coiffe des bouchons disposés dans les logements du plateau sous-jacent ;
  • * disposer au moins un bouchon dans un logement du plateau supplémentaire de manière à ce que la coiffe délimite avec une surface supérieure du plateau un compartiment fermé dans lequel est isolé l'obturateur.

According to other advantageous and non-limiting characteristics of the invention, taken alone or according to any technically feasible combination:

• the cap is secured to the vessel by welding to the upper edge of the peripheral wall of the vessel;
• the packaging process includes the following steps:
  • * have an additional plate to form a stack of plates in the tank, the additional plate resting on the cap of the caps arranged in the housings of the underlying plate;
  • * Have at least one stopper in a housing of the additional plate so that the cover delimits with an upper surface of the plate a closed compartment in which the shutter is isolated.

BRIEF DESCRIPTION OF FIGURES

Other characteristics and advantages of the invention will emerge from the detailed description of the invention which will follow with reference to the appended figures in which:
There figure 1 represents a packaging system according to the invention.

DETAILED DESCRIPTION OF THE INVENTION Presentation of medical caps

The medical caps 50 are here formed of a cap 51 surmounting a shutter 52. More particularly, the shutter 52 is formed in the cavity delimited by the cap 51. The cap 51 makes it possible to manipulate the cap 50 to close the opening of a container through the shutter 52 without touching the latter. This limits the risk of contaminating the shutter 52 during the handling of the stopper 50 and therefore the risks of contaminating the container. A detailed description of such plugs is for example available in the document FR2950865 . The cap 51 is composed of a head 51a, advantageously planar, as well as a side wall 51b extending axially from the periphery of the head 51a to delimit the cavity in which the shutter 52 is arranged.

Overview of the packaging system

As shown in the figure 1 , a packaging system 100 according to the invention comprises a tank 10, at least one plate 20 provided with housings 21, as well as a porous cover 40 arranged on the opening of the tank 10 to close it. Advantageously, in order to be able to store more medical caps 50, the tank 10 can comprise a plurality of trays 20, all of which are identical to one another. These trays 20 thus form a stack, each tray 20 being stacked on top of each other parallel to the bottom 10a of the tank 10. The tank 10 containing the trays 20, and closed by the porous seal 40, is intended to be placed in at least one airtight bag (and generally two of these bags) in which the air has been evacuated to place the assembly under vacuum.

Each of the trays 20 accommodates a plurality of medical plugs 50 stored individually in one of the housings 21 of the tray 20 without any contact being possible between them. Of course, the shape and volume of the housings 21 will be adapted so that they can accommodate the medical plug 50 in question.

Description of the tank

The tank 10 is a hollow packaging element intended to receive the trays 20 in which the medical plugs 50 are arranged. The tank 10 comprises an opening, a bottom 10a and a peripheral wall 10b thus delimiting its general shape. The peripheral wall 10b can be provided with a shoulder allowing the handling of the tank 10, in particular by automatic equipment. Advantageously, tank 10 has a parallelepipedal shape to optimize the space required to store a given number of medical plugs 50. The dimensions of tank 10 are chosen according to the number of medical plugs 50 that it is desired to package. These dimensions may comply with a norm or a standard so as to facilitate its use on an industrial scale. The height of the tank is chosen and/or adapted according to the number of trays 20 and/or the shape of the plugs 50 to be accommodated. Indeed, it is necessary that the head 51a of the caps 51 of the stoppers 50, arranged on the upper plate, is flush with the upper edge of the wall of the tank so that a subsequent vacuum allows the lid 40 to be pressed against the head of the caps. The tank 10 can be formed of a plastic material, for example based on polypropylene, amorphous polyethylene terephthalate, or a styrenic polymer such as polystyrene.

Description of delivery trays

There figure 1 represents a packaging system 100, in accordance with the invention, in which a stack of trays 20 is arranged in the tank 10. Each tray 20 comprises an upper face 20a and a lower face 20b.

The upper face 20a is provided with a plurality of housings 21 each intended to receive and wedge a single medical plug 50 in order to avoid any contact between two of these plugs 50. The housings 21 are typically arranged in rows on the upper face 20a of the plate 20 and here take the form of hollows 21. The lower face 20b of the plate 20 is advantageously flat to facilitate its pressing against the caps 50, and more particularly against the head 51a of the caps 51, of an underlying plate of the stack of plates. Alternatively, the lower face 20b of the plate 20 could, similar to the upper face 20a, be provided with a plurality of housings to better limit the movements of the medical plugs 50.

Optionally, the underside 20b of the plate intended to be placed against the bottom of the tank 10, which will be called "lower plate 20'", can be provided with reliefs to allow its wedging and/or its centering in the tank 10. Indeed, the bottom 10a of the tank 10 can be provided with centering elements, such as bosses, which can fit onto the reliefs of the lower plate 20'. The lower plate 20' (as well as the entire stack of plates) is thus immobilized in the tank 10, the friction between the plate 20' and the tank 10 is limited and the generation of particles is thus avoided.

The trays 20 can be made of a plastic material, for example based on polypropylene or thermoplastic elastomer. Advantageously, the material of the plate 20 has a lower hardness than that of the plugs 50.

Description of the operculum

The porous cover 40 is intended to be sealed, for example by plastic welding, on the upper edges of the wall 10b of the tank 10, once the latter has been filled with the trays 20 carrying the medical plugs 50. porous operculum aims to preserve the cleanliness of the medical caps 50 and prevent the introduction of particles into the tank 10. The air porosity of the cover 50 makes it possible to extract the air from the tank, during a following step of putting under empty. It can for example be made of Tyvek ^® , a material commonly used in the pharmaceutical industry.

Description of the packaging process

In order to reduce the contamination by particles as much as possible and to preserve the possible sterile character of the medical plugs 50, the various steps, the description of which follows, are preferably carried out in a controlled environment.

A first plate 20', the lower plate 20' of the stack, is placed on the bottom 10a of the tank 10. Medical plugs 50 are then or previously placed in the housings 21 of the first plate 20'. The medical caps 50 are arranged so that the cap 51 delimits with the upper surface 20a of the tray a closed compartment 53 to individually isolate the obturator 52 and protect it from any particulate contamination that could be generated within the packaging system 100 The medical plug 50 is here arranged so that the free end of the side wall 51b is in contact with the bottom of the housing 21.

Then, a second plate 20 is placed in the tank 10, the lower face 20b of the second plate bearing on the head 51a of the caps 51 of the medical plugs 50 placed in the housings 21 of the first plate. Medical caps 50 are placed in each housing 21 of the second plate 20, before or after this operation. This is repeated as many times as there are plates 20 to be placed in tank 10.

The porous cover 40 is then placed on the tank 10 to close it and then made integral with the upper edges of the wall 10b of the tank 10.

In a next step, the tank 10, the opening of which has been closed by the porous cover 40, is placed in at least one airtight bag (and preferably two bags for safety reasons), and the vacuum is carried out in this bag before sealing it hermetically. Putting the assembly under vacuum makes it possible to block the various components of the assembly 100 vertically, by pressing the porous cover 40 against the plugs 50 of the upper plate. Vacuuming also makes it possible to press the caps 50 against the upper surface 20a of the plate, on which they are placed, to form hermetic compartments 53 in which each shutter 52 is individually placed. Vacuuming also makes it possible to block horizontally the various components of the assembly 100 by deforming the peripheral wall 10b of the tank 10 to press it against the edge of the plates 20. The vacuum thus makes it possible to limit the friction between the various elements of the assembly 100 and therefore the generation of particles by friction by blocking their vertical and horizontal movement.

Opening the packaging system

To open the packaging system and access the medical caps 50 that it conditions, the tank 10 containing the stack of trays 20 is first extracted from the bag. The lid 40 is then removed to expose the medical caps 50. The medical plugs 50 can then be removed individually or row by row, manually and/or automatically by a machine. Once the board forming the upper tray of the stack emptied of its medical plugs 50, the latter is also removed to expose the medical plugs of the underlying tray. These operations are repeated until all the medical plugs 50 stored in the tank 10 have been removed.

Of course, the invention is not limited to the embodiments described and variant embodiments can be added thereto without departing from the scope of the invention as defined by the claims.

Although there is shown here a stack of trays in the tank, it is of course possible to have only one tray arranged in the tank.

Claims (5)

1. Packaging system (100) for medical stoppers (50) consisting of a cap (51) mounted on a plug (52), the packaging system (100) comprising:

   - a vessel (10) having an opening, a bottom (10a), and a peripheral wall (10b);

   - at least one tray (20), each of which has a plurality of cavities (21) that each receive a medical stopper (50), the tray (20) being placed in the vessel (10); and

   - a porous lid sealed on the upper edge of the peripheral wall (1 0b) of the vessel (10) to close it, the packaging system (100) being characterized in that each medical stopper (50) is arranged on the tray (20) such that the cap (51), together with an upper face (20a) of said tray (20), defines a closed compartment (53) for individually isolating the plug (52).
2. Packaging system (100) according to the preceding claim, wherein the vessel (10) is placed, under vacuum, in at least one sealed bag.
3. Method for packaging stoppers (50) consisting of a cap (51) mounted on a plug (52), the method comprising the following steps:

   a) providing a vessel (10) having an opening, a bottom (10a) and a peripheral wall (10b);

   b) arranging a tray (20) having a plurality of cavities (21) at the bottom of the vessel (10);

   c) arranging at least one stopper (50) in a cavity (21);

   d) sealing a porous lid (40) on an upper edge of the peripheral wall (10b) of the vessel (10);

   the packaging method being characterized:

   - in that the-at least one-stopper (50) is arranged in the cavity (21) such that the cap (51) of said stopper (50), together with an upper face (20a) of the tray (20), defines a closed compartment in which the plug (52) of said stopper (50) is isolated,

   - in that it further comprises, after step d), the following step: placing the vessel (10) in at least one sealed bag, and evacuating the bag.
4. Packaging method according to the preceding claim, wherein the lid (40) is rigidly connected to the vessel (10) by being welded onto the upper edge of the peripheral wall of the vessel (10).
5. Packaging method according to either claim 3 or claim 4, comprising the following steps:

   - arranging an additional tray to form a stack of trays (20) in the vessel (10), the additional tray abutting the cap (51) of the stoppers (50) arranged in the cavities (21) of the underlying tray (20);

   - arranging at least one stopper (50) in a cavity (21) of the additional tray such that the cap (51), together with an upper face (20a) of the tray (20), defines a closed compartment in which the plug (52) is isolated.

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