Title of Invention

"AN ASSEMBLY FOR MAKING, MOUNTING AND FILLING A FLUID DISPENSER DEVICE AND A METHOD THEREOF"

Abstract 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.
Full Text A METHOD AND A FACILITY FOR MANUFACTURING, ASSEMBLING,
AND FILLING A FLUID DISPENSER DEVICE
The present invention relates to a method and a
facility for manufacturing, assembling, and filling a
fluid dispenser device.
Fluid dispenser devices are well known from the
state of the art. In particular in the field of
Pharmaceuticals, it can be essential to guarantee
absolute sterility for the fluid, i.e. the medication, to
be dispensed. For this purpose, it is known that filters
can be provided for air venting, and that actions of the
bactericide type can be applied to the fluid being
delivered, in particular at the dispensing orifice of the
device. However, an essential condition is also to
guarantee absolute sterility at the time of filling of
the device.
Machines exist that enable a reservoir to be made,
to be filled, and then to be closed, all of that being
performed in a sterile controlled atmosphere. That type
of machine, generally referred to as a Blow Fill Seal
(BFS) machine is, for example, used for packaging
physiological serum. Unfortunately, such BFS machines
are not adapted to fixing a dispensing member, such as a
pump or a valve, to the reservoir before or after
filling.
It is also known that a reservoir, such as a
syringe, can be pre-filled, and that the syringe can then
be assembled into a dispenser device, the inside of the
syringe being put into communication with the dispensing
member at the time the device is used, and in particular
by the stopper of the syringe being pierced. In which
case, firstly drawbacks exist that are inherent to
piercing an elastomer stopper, and secondly, since the
pre-filled syringe is not assembled continuously in the
controlled atmosphere, the sterility of the device, and
in particular of the piercing needle is not guaranteed.
An object of the present invention is to provide a
method and a facility for manufacturing, assembling, and
filling a fluid dispensing device that does not reproduce
the above-mentioned drawbacks.
Thus, an object of the present invention is to
provide a method and a facility for manufacturing,
assembling, and filling a fluid dispenser device that
guarantees absolute sterility for the fluid contained
inside the device, without any risk of contamination
during any step of the process.
The present invention thus provides a facility for
manufacturing, assembling, and filling a fluid dispenser
device comprising a fluid reservoir and a dispensing
member, 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.
Advantageously, the manufacturing unit is a unit for
molding, overmolding, blowing, folding, sealing, and/or
thermoforming.
Advantageously, the filling unit co-operates with
the reservoir, with the dispensing member or with a
filling element secured to said reservoir, and/or with
said dispensing member.
Advantageously, the fixing unit for fixing the
dispensing member is a snap-fastening, crimping, screwfastening,
sealing, or overmolding unit.
Advantageously, the facility further comprises a
dispensing member assembly unit operating continuously in
said controlled atmosphere with the other units.
The present invention also provides a method of
making a fluid dispenser device comprising a reservoir
and a dispensing member, 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.
Advantageously, the units are organized in a manner
such that the manufacturing unit makes the reservoir,
then the filling unit fills it, and then the fixing unit
fixes the dispensing member to the filled reservoir, all
of this being performed in a controlled atmosphere.
In a variant, the units are organized in a manner
such that the manufacturing unit makes the reservoir,
then the fixing unit fixes the dispensing member to the
empty reservoir, then the filling unit fills the
reservoir.
Advantageously, the units are organized such that
the manufacturing unit makes the reservoir, then the
fixing unit pre-assembles the dispensing member to the
reservoir, then the filling unit fills the reservoir, and
then the fixing unit definitively fixes the dispensing
member to the reservoir.
Advantageously, the filling unit co-operates with
the dispensing member to fill the reservoir through said
dispensing member.
Advantageously, the filling unit co-operates
directly with the reservoir in order to fill it.
In a variant, said filling unit co-operates with an
intermediate element secured to the reservoir and/or to
the dispensing member.
Advantageously, said intermediate element is a
flexible sleeve fixed in leaktight manner firstly to the
reservoir and secondly to the dispensing member, and
provided with a filling opening, said conical sleeve
being manufactured and fixed to the reservoir by the
manufacturing unit for manufacturing the reservoir, being
fixed to the fixing member by the fixing unit while the
dispensing member is being pre-assembled to the
reservoir, and being deformed towards the inside of the
reservoir by the fixing unit while the dispensing member
is being definitively fixed to said reservoir.
In another implementation, the method further
comprises a step of providing a dispensing member
assembly unit that operates continuously in said
controlled atmosphere with the other units.
Advantageously, the units are organized in a manner
such that the dispensing member assembly unit makes the
dispensing member, then the reservoir manufacturing unit
makes a reservoir, then the fixing unit fixes said
reservoir to said dispensing member, and then the filling
unit fills said reservoir.
Advantageously, the reservoir manufacturing unit and
the fixing unit co-operate to manufacture the reservoir
on the assembled dispensing member in particular by
overmolding.
Other characteristics and advantages of the present
invention appear more clearly from the following detailed
description of a particular implementation given by way
of non-limiting example and with reference to the
accompanying drawings, in which:
Figure 1 is a diagrammatic view showing the steps in
the process of manufacturing the reservoir, in a
particular implementation of the present invention;
Figure 2 is a diagrammatic view of the fluid
dispenser device with the dispensing member pre-assembled
to the reservoir, prior to filling;
Figure 3 is a view similar to the Figure 2 view;
Figure 4 is a view of the preceding device, during
the filling process;
Figure 5 is a view of the preceding device during
the process of definitively fixing the dispensing member
to the reservoir; and
Figure 6 is a diagrammatic view of the device as
assembled and ready to use.
The figures show a particular implementation of the
invention. In this implementation, a facility is
provided for manufacturing, assembling, and filling a
fluid dispenser device which comprises a fluid reservoir
10 to which a dispensing member 20 such as a pump is
assembled.
In the invention, the facility comprises a unit for
manufacturing a reservoir 10, a unit for filling said
reservoir 10, and a unit for fixing said pump 20 to said
reservoir 10, said units operating continuously in a
controlled atmosphere, and in particular under sterile
conditions. Thus, the facility of the present invention
makes it possible to perform all of the steps in the
process of manufacturing, filling, and assembling the
fluid dispenser device in the same controlled atmosphere
without any interruption, thereby guaranteeing absolute
sterility for the finished product.
As shown in the figures, which show a particular
implementation, the reservoir 10 is advantageously formed
of a rigid shell which is fixed to a conical and flexible
filling element 30 that incorporates a filling
opening 31.
Figure 1 diagrammatically shows the process of
manufacturing said filling element 30. Starting from a
sheet, and in particular a sheet of aluminum, the
reservoir manufacturing unit firstly folds said sheet of
aluminum, and then contact points are bonded together to
form a deformable conical sleeve, incorporating at least
one filling opening 31. The sleeve 30 is then assembled
onto the reservoir 10, which in this example is
advantageously a rigid reservoir, also by means of the
reservoir manufacturing unit.
Advantageously, the dispenser member 20, which, in
this example, is a pump, is then pre-assembled onto said
filling element 30 by the unit for fixing the dispensing
member to the reservoir. Figure 2 shows the preassembled
position, in which the filling element 30
connects the reservoir 10 to said dispensing member 20.
Preferably, the filling element (in this example the
conical sleeve 30) is fixed to the reservoir in leaktight
manner, and similarly the dispensing member (in this
example the pump 20) is pre-assembled to the conical
sleeve 30 also in leaktight manner. The device in this
pre-assembled position can also be seen in Figure 3.
As shown in Figure 4, the filling unit is then
applied to the pre-assembled device. In the example
shown in Figure 4, said filling unit comprises an outer
sleeve 51 which is applied in leaktight manner to the
reservoir 10, and an inner sleeve 52 which is applied in
leaktight manner to the dispensing member 20, which is
held in the pre-assembled position by means of a support
element 53 advantageously provided between the pump 20
and the reservoir 10. The filling unit then fills the
reservoir 10 by injecting the fluid P between the sleeves
51 and 52, it then being possible for said fluid to
penetrate into the reservoir through a filling orifice 31
provided in the conical sleeve 30. Simultaneously, the
air A initially contained in the reservoir 10 can be
released by exiting also via an orifice 31 in the sleeve
30 and by then being removed to the atmosphere by flowing
between the two sleeves of the filling unit. The
flexible conical filling element 30 may thus be provided
with one or more filling orifices.
Once the device has been filled, a fixing unit for
fixing the dispensing member 20 to the reservoir 10 then
applies an axial force F to the dispensing member 20 so
as to fix it to the reservoir 10. For this purpose, the
support element 53 for supporting the filling unit is
removed, and the force F may, for example, be applied to
the pump 20 by the inner sleeve 52 of said filling unit,
as shown in Figure 5. The pump 20 is then moved towards
the reservoir 10 so as to be fastened to the neck by any
suitable means, e.g. snap-fastening, crimping, sealing,
etc. The conical sleeve 30 is deformed towards the
inside of the reservoir 10 during this process of fixing
the pump 20, as can be seen clearly in Figure 5.
Figure 6 shows the device as filled, assembled, and
ready to use, which device may advantageously be packaged
in a sterile bag so that, when the user wishes to use the
device, said user is certain that there has been no
interruption in the controlled atmosphere throughout the
entire process of manufacturing, filling, and assembling
the device.
Naturally, the above-described manufacturing,
assembling, and filling method and facility constitute
merely an advantageous implementation of the invention.
Numerous variants may be imagined for implementing the
invention. In particular, the reservoir may be of any
type, and is not necessarily constituted by a rigid
shell. For example, the reservoir may be a flexible
pouch, in particular made of aluminum, a blister pack, a
thermoformed shell, a blown reservoir, in particular
blown in a BFS machine, or any other reservoir that can
be used in fluid dispenser devices. Similarly, the
presence of the filling element 30 is not necessary, it
being possible for the filling unit to co-operate either
directly with the dispensing member 20 so as to fill the
reservoir therethrough, or directly with a filling
orifice provided in the reservoir 10, e.g. through the
bottom of said reservoir. In addition, the chronological
order of the steps in the manufacturing, assembling, and
filling method is not necessarily as described in the
example given with reference to the figures. Thus, the
filling unit may fill the reservoir before the dispensing
member is assembled or pre-assembled thereto. Similarly,
the dispensing member may be fully assembled to the empty
reservoir, and then the device may be filled, either
directly through an orifice provided in the reservoir, or
through the dispensing member as mentioned above.
Another variant is to provide a dispensing member
assembly unit which also operates continuously in a
controlled atmosphere, with the other above-described
units. Such a dispensing member assembly unit may then
make the dispensing member, (the pump in this example),
and then the reservoir may be fixed to said pump by the
fixing unit before the device is filled by the filling
unit. In this variant, the unit for manufacturing the
reservoir, and the unit for fixing the dispensing member
to the reservoir may co-operate so as to cause the
reservoir to be fixed directly, e.g. by overmolding, to
the pump assembled by the dispensing member assembly
unit.
The essential characteristic of the present
invention is for all of the processes of manufacturing,
assembling, and filling a fluid dispenser device, in
particular for dispensing a pharmaceutical, to be
performed in a controlled atmosphere, and in particular
under sterile conditions. The order of the steps, the
configurations of the various units, and the particular
shapes of the component portions of the device are not
limiting, and the person skilled in the art may make
various modifications to the method and facility
described with reference to the figures, without going
beyond the ambit of the present invention, as defined by the accompanying claims.



CLAIMS
I/ 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
10
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).
ll/ 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.


Documents:


Patent Number 222708
Indian Patent Application Number 01154/DELNP/2003
PG Journal Number 36/2008
Publication Date 05-Sep-2008
Grant Date 20-Aug-2008
Date of Filing 24-Jul-2003
Name of Patentee VALOIS S.A.S.
Applicant Address B.P.G, LE PRIEURE, F-27110 LE NEUBOURG, FRANCE.
Inventors:
# Inventor's Name Inventor's Address
1 PASCAL BRUNA 15 AVENUE, DES CANADIENS, F-76300 SOTTEVILLE LES ROUEN, FRANCE
2 DOMINIQUE HIBON 17, RUE DE LA FONTAINE HEDIN, F-78910 FLEXANVILLE, FRANCE
3 HERVE PACAUD 10 ALLEE DU PALLADIO, F-95290 L-ISLE ADAM, FRANCE
PCT International Classification Number B65B 55/02
PCT International Application Number PCT/FR02/00257
PCT International Filing date 2002-01-22
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 01/01143 2001-01-29 France