EP1355825B1 - Assembly and method for making, mounting and filling a fluid product dispensing device - Google Patents

Description

The present invention relates to an assembly and a manufacturing method, mounting and filling a fluid dispenser device, as for example known from document US-A-4788811.

Fluid dispensing devices are well known in the state of the art. In the pharmaceutical field in particular, it can it is essential to guarantee the absolute sterility of the product, in this case the medicine, to distribute. To do this, it is known to provide filters for the venting of air, as well as actions of the bactericidal type on the outgoing product, especially at the dispensing orifice of the device. However, a essential condition is also to guarantee absolute sterility at the time filling the device.

There are machines for making a tank and filling it, before sealing it, all in a sterile controlled atmosphere. This kind of machines, usually called BFS (Blow Fill Seal) machines, is by example used for conditioning physiological saline. These machines BFS are however not suitable for fixing a distribution device, such as a pump or valve, on the tank before or after filling.

On the other hand, it is also known to pre-fill a tank, such than a syringe and then assemble that syringe into a device dispensing, the interior of the syringe being placed in communication with the organ distribution when the device is used, and in particular by piercing the syringe cap. In this case, there are on the one hand disadvantages inherent in drilling through an elastomeric plug, and on the other hand, the assembly of the pre-filled syringe not being carried out continuously in the controlled atmosphere, the sterility of the device, and particular of said piercing needle is not guaranteed.

The object of the present invention is to provide an assembly and a method for manufacturing assembly, and filling of a distribution device fluid product which does not reproduce the aforementioned drawbacks.

Thus, the present invention aims to provide a set and a process for manufacturing, mounting and filling a device distribution of fluid product which guarantees absolute sterility of the product contained inside the device, without any risk of contamination during any stage of the process.

The present invention therefore relates to a manufacturing assembly, assembly and filling of a fluid dispenser device comprising a product reservoir and a dispensing member, such as a pump or valve, characterized in that the assembly includes a tank manufacturing, a unit for filling said tank and a unit for fixing of said dispensing member to said reservoir, said units operating in continuous in a controlled atmosphere.

Advantageously, the tank manufacturing unit is a molding, overmolding, blowing, folding, welding and / or thermoforming.

Advantageously, the filling unit cooperates with the reservoir, the dispensing member or a filling element integral with said reservoir and / or said distribution member.

Advantageously, the unit for fixing the dispensing member is a latching, crimping, screwing, welding or overmolding unit.

Advantageously, the assembly further comprises an assembly unit distribution device, operating continuously in said controlled atmosphere with said other units.

a) fournir une unité de fabrication de réservoir, une unité de remplissage dudit réservoir et une unité de fixation dudit organe de distribution sur ledit réservoir,

b) agencer lesdites unités et les faire coopérer de telle sorte qu'elles opèrent en continu dans une atmosphère contrôlée.

The present invention also relates to a method for producing a device for dispensing a fluid product comprising a reservoir and a dispensing member, such as a pump or a valve, characterized in that said method comprises the following steps:

a) supplying a tank manufacturing unit, a filling unit for said tank and a unit for fixing said dispensing member to said tank,

b) arranging said units and making them cooperate so that they operate continuously in a controlled atmosphere.

Advantageously, the units are arranged in such a way that the unit of manufacturing realizes the tank, then the filling unit fills it, then the unit fixing fix the dispensing member on the filled tank, while controlled atmosphere.

Alternatively, the units are arranged such that the unit of manufacturing produces the reservoir, then the fixing unit fixes the dispensing on the empty tank, then the filling unit fills the tank.

Advantageously, the units are arranged in such a way that the unit of manufacturing produces the reservoir, then the fixing unit pre-assembles the dispensing on the tank, then the filling unit fills the tank, then the fixing unit permanently fixes the dispensing member to the reservoir.

Advantageously, the filling unit cooperates with the distribution to fill the reservoir through said distribution member.

Advantageously, the filling unit cooperates directly with the tank to fill it.

As a variant, the filling unit cooperates with an intermediate element integral with the reservoir and / or the dispensing member.

Advantageously, said intermediate element is a flexible sleeve tightly fixed on the one hand to the tank and on the other hand to the dispensing, and comprising a filling opening, said conical sleeve being manufactured and fixed to the tank by the tank manufacturing unit, fixed to the fixing member by the fixing unit when the dispensing member is pre-assembled on the tank, and deformed towards the inside of the tank by the unit fixing when the dispensing member is permanently fixed on said tank.

According to another embodiment, the method further comprises the step to supply a distribution unit assembly unit, operating continuously in said controlled atmosphere with said other units.

Advantageously, the units are arranged so that the unit of assembly of distribution organ realizes the distribution organ, then the unit of tank manufacture realizes a tank, then the fixing unit fixes said reservoir to said dispensing member, then the filling unit fills said tank.

Advantageously, the tank manufacturing unit and the fixing unit cooperate to directly manufacture, in particular by overmolding, the tank on said assembled distribution member.

• la figure 1 est une vue schématique montrant des étapes du processus de fabrication du réservoir, selon un mode de réalisation particulier de la présente invention,
• la figure 2 est une vue schématique du dispositif de distribution de produit fluide avec l'organe de distribution pré-assemblé sur le réservoir, avant remplissage,
• la figure 3 est une vue similaire à celle de la figure 2,
• la figure 4 est une vue du dispositif précédent, pendant le processus de remplissage,
• la figure 5 est une vue du dispositif précédent pendant le processus de fixation définitif de l'organe de distribution sur le réservoir, et
• la figure 6 est une vue schématique du dispositif assemblé et prêt à l'emploi.

Other characteristics and advantages of the present invention will appear more clearly in the following detailed description of a particular embodiment, given by way of nonlimiting example with reference to the accompanying drawings, in which,

• FIG. 1 is a schematic view showing steps in the process for manufacturing the tank, according to a particular embodiment of the present invention,
• FIG. 2 is a schematic view of the device for dispensing a fluid product with the dispensing member pre-assembled on the reservoir, before filling,
• FIG. 3 is a view similar to that of FIG. 2,
• FIG. 4 is a view of the previous device, during the filling process,
• FIG. 5 is a view of the previous device during the process of definitive fixing of the dispensing member to the reservoir, and
• Figure 6 is a schematic view of the device assembled and ready for use.

In the figures, a particular embodiment is shown of the invention. In this embodiment, a manufacturing assembly is provided, for mounting and filling a fluid dispenser device which includes a product reservoir 10 on which is assembled a distribution 20, such as a pump.

According to the invention, the assembly includes a manufacturing unit for tank 10, a unit for filling said tank 10 and a fixing unit of said pump 20 on said tank 10, said aforementioned units operating continuously in a controlled atmosphere, and in particular under sterile conditions. Thus, the assembly of the present invention makes it possible to carry out all stages of the manufacturing, filling and assembly process of the fluid distribution device in the same controlled atmosphere, without any interruption, which guarantees absolute sterility of the finished product.

With reference to the figures, which represent an embodiment in particular, the tank 10 is advantageously formed of a rigid shell, on which is attached a filling element 30 conical and flexible incorporating a filling opening 31.

Figure 1 shows schematically the manufacturing process of said filling element 30. From a sheet, in particular from a sheet of aluminum, the tank manufacturing unit first folds said aluminum sheet and then welds the contact points to form a deformable conical sleeve, incorporating at least one opening of filling 31. The sleeve 30 is then assembled on the reservoir 10, in advantageously the occurrence of a rigid tank, also by means of the unit tank manufacturing.

Advantageously, the distribution member 20, which in this case is a pump, is then pre-assembled on said filling element 30 by the fixing the dispensing member to the tank. Figure 2 shows the pre-assembled position in which the filling element 30 connects the tank 10 to said distribution member 20. Preferably, the fixing of the element of filling, in this case the conical sleeve 30, on the reservoir 10 is performed in a sealed manner, and similarly, the pre-assembly of the distribution, in this case the pump 20, on said conical sleeve 30, is also waterproofed. The device in this pre-assembled position is also visible in Figure 3.

Referring then to FIG. 4, the filling unit is then applied to said pre-assembled device. This filling unit includes in the example shown in Figure 4 an external sleeve 51 which is applied tightly on the reservoir 10, as well as an internal sleeve 52 which is tightly applied to the dispensing member 20, which is held in the pre-assembled position by means of a support element 53 provided advantageously between the pump 20 and the reservoir 10. The filling unit then ensures the filling of the reservoir 10 by injecting the product P between the two sleeves 51 and 52, said product then being able to enter the reservoir to through a filling orifice 31 provided in the conical sleeve 30. Simultaneously, the air A initially contained in the tank 10 can escape, also leaving by an orifice 31 of the sleeve 30, then by evacuating towards the atmosphere between the two sleeves of the filling unit. The element of flexible conical filling 30 may thus include one or more orifices for filling 31.

When the device has been filled, a unit for fixing the distribution 20 on the reservoir 10 then applies an axial force F on the member distribution 20 to come fix it on the tank 10. For this purpose, the support member 53 of the filling unit is removed, and the force F can by example be applied to the pump 20 by the internal sleeve 52 of said filling unit, as visible in FIG. 5. The pump 20 is then moved in the direction of the reservoir 10 in order to catch on the neck by any suitable means, for example snap-fastening, crimping, welding, etc. The conical sleeve 30 deforms towards the inside of the reservoir 10 during this process of fixing the pump 20, as clearly visible on the figure 5.

FIG. 6 shows the device filled, assembled and ready for use, and which can advantageously be packaged in a sterile pouch so that the user, when he wishes to use the device, is certain that there has been no interruption of the controlled atmosphere during the whole process of manufacture, filling and assembly of the device.

Of course, the assembly and the method of manufacturing, mounting and filling described above are only one advantageous embodiment of the invention. Many variants can be envisaged to achieve this invention. In particular the type of tank can be arbitrary and is not necessarily a rigid shell. For example, the tank can be a pocket flexible, in particular in aluminum, a blister, a thermoformed shell, a blown tank, especially in a BFS machine, or any other tank usable in fluid dispenser devices. Likewise, the presence of the filling element 30 is not necessary, the unit of filling which can cooperate either directly with the distribution member 20 to fill the tank through it, either directly with a filling provided in the reservoir 10, for example at the bottom thereof. On the other hand, the chronology of the stages during the manufacturing process, mounting and filling is not necessarily the one described in the example discussed with reference to the figures. Thus, the filling unit could fill the tank before the dispensing member is assembled or pre-assembled on this one. Likewise, the distribution unit could be completely assembled on the empty tank, then the device can be filled, either directly at through an opening provided in the tank, or through the distribution as mentioned previously. Another variant would be to provide a distribution unit assembly unit which would also come operate continuously in a controlled atmosphere with the other units described above. This distribution unit assembly unit could then carry out the dispensing member, in this case the pump, then the reservoir could be attached to said pump by the fixing unit before the device is filled with the filling unit. In this variant, the tank manufacturing unit and the unit for fixing the dispensing member to the reservoir could cooperate to in fact directly fix, in particular by overmolding, the reservoir on the pump assembled by the distribution unit assembly unit.

The essential characteristic of the present invention is to achieve the entire manufacturing, assembly and filling process of a fluid dispensing device, in particular intended for dispensing pharmaceutical product, in a controlled atmosphere, in particular under sterile conditions. The order of the stages, the arrangement of the different units, and the particular shape of the constituent parts of the device are not limiting and a person skilled in the art could make various modifications to the assembly and to the process described with reference to the figures without departing from the scope of this invention as defined by the appended claims.

Claims (16)

1. A facility for manufacturing, assembling, and filling a fluid dispenser device comprising a fluid reservoir (10) and a dispensing member (20), such as a pump or a valve, said facility being characterized in that it comprises a manufacturing unit for manufacturing a reservoir, a filling unit for filling said reservoir, and a fixing unit for fixing said dispensing member to said reservoir, said units operating continuously in a controlled atmosphere.
2. A facility according to claim 1, in which the manufacturing unit is a unit for molding, overmolding, blowing, folding, sealing, and/or thermoforming.
3. A facility according to claim 1 or claim 2, in which facility the filling unit co-operates with the reservoir (10), with the dispensing member or with a filling element (30) secured to said reservoir (10), and/or with said dispensing member (20).
4. A facility according to one of claims 1 to 3, in which the fixing unit for fixing the dispensing member (20) is a snap-fastening, crimping, screw-fastening, sealing, or overmolding unit.
5. A facility according to any preceding claim, further comprising a dispensing member assembly unit operating continuously in said controlled atmosphere with the other units.
6. A method of making a fluid dispenser device comprising a reservoir (10) and a dispensing member (20), such as a pump or a valve, said method being characterized in that it comprises the following steps:

   a) providing a manufacturing unit for manufacturing a reservoir, a filling unit for filling said reservoir, and a fixing unit for fixing said dispensing member to said reservoir;

   b) organizing said units and causing them to cooperate in a manner such that they operate continuously in a controlled atmosphere.
7. A method according to claim 6, in which the units are organized in a manner such that the manufacturing unit makes the reservoir (10), then the filling unit fills it, and then the fixing unit fixes the dispensing member (20) to the filled reservoir, all of this being performed in a controlled atmosphere.
8. A method according to claim 6, in which the units are organized in a manner such that the manufacturing unit makes the reservoir (10), then the fixing unit fixes the dispensing member (20) to the empty reservoir, then the filling unit fills the reservoir (10).
9. A method according to claim 6, in which the units are organized such that the manufacturing unit makes the reservoir (10), then the fixing unit pre-assembles the dispensing member (20) to the reservoir (10), then the filling unit fills the reservoir (10), and then the fixing unit definitively fixes the dispensing member (20) to the reservoir (10).
10. A method according to claim 8 or claim 9, in which the filling unit co-operates with the dispensing member (20) to fill the reservoir (10) through said dispensing member (20).
11. A method according to claim 8 or claim 9, in which the filling unit co-operates directly with the reservoir (10) in order to fill it.
12. A method according to claim 8 or claim 9, in which the filling unit co-operates with an intermediate element (30) secured to the reservoir (10) and/or to the dispensing member (20).
13. A method according to claim 12, in which said intermediate element (30) is a flexible sleeve fixed in leaktight manner firstly to the reservoir (10) and secondly to the dispensing member (20), and provided with a filling opening (31), said conical sleeve (30) being manufactured and fixed to the reservoir (10) by the manufacturing unit for manufacturing the reservoir, being fixed to the fixing member (20) by the fixing unit while the dispensing member (20) is being pre-assembled to the reservoir (10), and being deformed towards the inside of the reservoir (10) by the fixing unit while the dispensing member (20) is being definitively fixed to said reservoir (10).
14. A method according to claim 6, further comprising a step of providing a dispensing member assembly unit that operates continuously in said controlled atmosphere with the other units.
15. A method according to claim 14, in which the units are organized in a manner such that the dispensing member assembly unit makes the dispensing member (20), then the reservoir manufacturing unit makes a reservoir (10), then the fixing unit fixes said reservoir to said dispensing member (20), and then the filling unit fills said reservoir (10).
16. A method according to claim 15, in which the reservoir manufacturing unit and the fixing unit cooperate to manufacture the reservoir (10) on the assembled dispensing member (20) in particular by overmolding.

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