[0001] The present invention relates to a closure system for bottles containing lyophilized
or liquid products, particularly injectable or perfusable pharmaceutical products.
[0002] Bottles or vials containing pharmaceutical products such as lyophilized or liquid
products for injection or perfusion are generally closed by means of a perforable
rubber plug, for example by means of a needle, held on the neck of the bottle by means
of an aluminium capsule that completely covers the rubber plug. The aluminium capsules
generally have a portion that may be removed by tearing, which allows access to the
rubber plug.
[0003] The main drawback of aluminium capsules consists in the fact that the steps of mounting
the capsule on the rubber plug and on the neck of the bottle cannot be executed in
conditions of sterilisation and the absence of undesired particles because the folding
and cutting operations of the aluminium sheets for making the capsules and the mounting
thereof on the mouth of the bottle involve the generation of aluminium powders which
are incompatible with the conditions of sterilisation and the absence of undesired
particles required for the type of products contained in the bottle itself. Such aluminium
capsules make it therefore difficult to minimise the level of particle contamination
admitted into controlled-atmosphere environments, such as a cleanroom.
[0004] Another drawback of aluminium capsules consists in the fact that the operator who
removes the removable portion risks being injured with the sharp edges of the aluminium
sheet.
[0005] On the other hand, also the use of capsules made of materials of the
plastic type are not free from drawbacks. Such a capsule is disclosed in
WO97/31839.
[0006] In particular, capsules made of plastic often are not capable of supporting the temperatures
that can be reached in autoclave sterilisation processes, which may reach up to 140°C,
or in any case they undergo deformations such as to put at risk the sterilisation
conditions of the bottle itself. In order to resist the sterilisation processes, the
plastic capsules must have more rigid structures that require a significant force
of application in order to be mounted securely on the neck of the bottle, which force
of application cannot generally be obtained with normal capsuling machines. The implementation
of capsuling machines with increased force of application results in a significant
increase of the set-up costs of the processing plant. Moreover, the use of an increased
force could result in problems of the bottles or the capsules themselves breaking.
[0007] Plastic capsules are also known that have several and numerous components mutually
assembled with one another in various operations which however, on the one hand do
not ensure an adequate resistance to the autoclave sterilisation, and on the other
hand, result in an apparent increase of the production and assembly times and costs
of the capsule itself.
[0008] It is the object of the present invention to make a closure system for bottles containing
lyophilized or liquid products, particularly injectable or perfusable pharmaceutical
products, that is easier to make and mount on bottles, and therefore is more economically
competitive when compared to the known technique, and in particular to the plastic
capsule.
[0009] It is another object of the present invention to make a closure system for bottles
that does not result in the formation of powder during the mounting on the bottles.
[0010] It is another object of the present invention to make a closure system that is capable
of providing the amplest guarantees of reliability and safety in use.
[0011] It is another object of the present invention to make a closure system that allows
the bottle to be subjected to autoclave sterilisation procedures.
[0012] These objects according to the present invention are achieved by making a closure
system for bottles containing lyophilized or liquid products, particularly injectable
or perfusable pharmaceutical products, as disclosed in claim 1.
[0013] Further features are provided in the dependent claims.
[0014] Further features and advantages shall be more apparent from the description of two
preferred, but not exclusive, embodiments of a closure system for bottles, illustrated
as an example and not for limiting purposes with reference to the accompanying drawings,
in which:
figure 1 is a front view of a bottle provided with a first embodiment of a closure
system, according to the invention;
figure 2 is a perspective view of the outer capsule of the closure system illustrated
in figure 1, according to the invention;
figure 3 is a perspective view of the inner capsule of the closure system illustrated
in figure 1;
figure 4 is a front sectional view of the closure system of figure 1, according to
the invention;
figure 5 is a front sectional view of a variant of the closure system illustrated
in figure 1, according to the invention;
figure 6 is a perspective view of a variant of the inner capsule of the closure system
illustrated in figure 1 or in figure 7, according to the invention;
figure 7 is a front view of a bottle provided with a second embodiment of a closure
system, according to the invention;
figure 8 is a perspective view of the outer capsule of the closure system illustrated
in figure 7, according to the invention;
figure 9 is a front sectional view of the closure system of figure 7, according to
the invention;
figure 10 is a front sectional view of a variant of the closure system illustrated
in figure 7, according to the invention.
[0015] With reference to the mentioned drawings, the closure system for bottles containing
lyophilized or liquid products, particularly injectable or perfusable pharmaceutical
products, indicated as a whole with reference number 1, comprises:
- a perforable closure body 3 adapted to close the mouth 5 of a bottle 7;
- an inner capsule 9, able to be fitted onto the neck 11 of the bottle 7, configured
to hold the closure body 3 in a sealed closure configuration of the mouth 5 of the
bottle 7, in which the inner capsule 9 comprises an opening 13 adapted for allowing
access to the closure body 3;
- an outer capsule 15, able to be fitted onto the inner capsule 9.
[0016] According to the invention, the outer capsule 15 is made in a single body and comprises
an upper disc-shaped portion 17 configured to close the opening 13 of the inner capsule
9 and a lower portion 19 able to be fitted around the inner capsule 9. Moreover, according
to the invention, the outer capsule 15 comprises a breaking line 21 between the upper
disc-shaped portion 17 and the lower portion 19.
[0017] As shown in the accompanying drawings, advantageously the outer capsule 15 closes
and covers the inner capsule 9 both at the top and at the sides.
[0018] Advantageously, the inner capsule 9 comprises, on its lateral surface, a plurality
of through-openings 33.
[0019] Advantageously, the lower portion 19 of the outer capsule 15 is fitted around the
inner capsule 9, and is fitted around the inner capsule 9 so as to completely cover
the side thereof, and in particular the lateral through-openings 33.
[0020] Advantageously, the outer capsule 15 is fitted around the inner capsule 9 with interference
so that the outer capsule 15 and the inner capsule 9 define a single body capable
of giving resistance to the forces that develop, for example during the autoclave
sterilisation.
[0021] Advantageously, the outer capsule 15 is made of a material of the plastic type through
injection moulding.
[0022] Preferably, the outer capsule 15 is made of a material of the polypropylene type.
[0023] Advantageously, the breaking line 21 comprises a plurality of bridges 23 made through
the aforesaid injection moulding.
[0024] In particular, the outer capsule 15 may be made in a single injection moulding step
together also with the bridges 23.
[0025] Alternatively, or additionally, the breaking line 21 may comprise a weakened line
defined by an incision, or partial cut, of the outer capsule 15 executed in a step
successive to the one of the injection moulding of the outer capsule 15 itself.
[0026] The breaking line 21 allows easily separating the upper disc-shaped portion 17 of
the outer capsule 15 from the lower portion 19 fitted around the inner capsule 9.
This allows exposing the opening 13 of the inner capsule 9 and allows the access and
perforation, for example by means of a needle, of the closure body 3.
[0027] The lower portion 19 of the outer capsule 15 may comprise, substantially at the breaking
line 21, a band 25 having a radial thickness substantially less than the radial thickness
of the remaining part of the lower portion 19.
[0028] Advantageously, as shown in the accompanying drawings, the lower portion 19 of the
outer capsule 15 comprises, substantially at the breaking line 21, a band 25 having
a radial thickness that narrows in the axial direction 27 of approach to the breaking
line 21.
[0029] The reduction of the thickness of the wall of the outer capsule 15 at the breaking
line 21 further facilitates the separation of the upper disc-shaped portion 17 from
the lower portion 19.
[0030] In particular, the upper disc-shaped portion 17 may be raised upwards and pulled
off from the lower portion 19 by acting with the fingertip on the lower perimeter
edge 24 of the upper disc-shaped portion 17 itself, which edge 24 is exposed with
respect to the lateral wall of the lower portion 19, due to the narrowing of the thickness
thereof approaching the breaking line 21.
[0031] If the breaking line 21 were defined by a plurality of bridges 23, the rotation of
the upper disc-shaped portion 17 with respect to the central axis 27 would produce
the same separating effect of the upper disc-shaped portion 17 with respect to the
lower portion 19 because it would cause the breaking of the bridges 23 themselves.
[0032] Advantageously, the inner capsule 9 comprises a plurality of elastically deformable
tabs 29 projecting radially towards the inside of the inner capsule 9 itself. Such
tabs 29 are configured to engage with the finish 31 of the bottle 7.
[0033] Advantageously, the tabs 29 are obtained at the through-openings 33 on the lateral
surface of the inner capsule 9.
[0034] The tabs 29 are preferably equally distributed angularly around the central axis
27.
[0035] Advantageously, also the inner capsule 9 is made of a material of the plastic type,
and preferably of the polycarbonate type, through injection moulding.
[0036] The through-openings 33 obtained at the tabs 29 allow facilitating the removal of
the tabs 29 themselves from the injection mould.
[0037] Moreover, by engaging with the finish 31 of the bottle 7, the tabs 29 allow the inner
capsule 9 to hold the closure body 3 in a sealed closure configuration against the
mouth 5 of the bottle 7.
[0038] The fact that the tabs 29 are elastically deformable, also due to the presence of
the through-openings 33, allows easily fitting the inner capsule 9 on the neck 11
of the bottle 7. Indeed, in step of pressure applying the inner capsule 9 onto the
neck 11 of the bottle 7, the finish 31 exerts a force in horizontal direction on the
tabs 29 themselves, which force deforms the tabs 29 radially outwards until they exceed
the finish 31. Once they have exceeded the finish 31, the tabs 29 may return to their
rest configuration projecting radially towards the inside of the inner capsule 9,
in which configuration they engage at the bottom with the finish 31 of the bottle
7.
[0039] Advantageously, the portion of cylindrical wall 54 of the inner capsule 9 which lies
at the bottom of the tabs 29 has an increased cross-section with respect to the cross-section
of the overlying tabs 29. Thereby, the resistance is ensured to the forces which develop
during the autoclave sterilisation.
[0040] Advantageously, the tabs 29 project radially towards the inside of the inner capsule
9 itself with an inclination which is less than or equal 30° with respect to the underlying
portion of cylindrical wall 54, that is with respect to the vertical direction. Thereby,
the resistance is further ensured to the forces which develop during the autoclave
sterilisation. The closure body 3 may be a rubber gasket 30, as shown in figures 4
and 9, or a rubber plug 32 as shown in figures 5 and 10.
[0041] The rubber gasket 30 and the rubber plug 32 are advantageously held at the top against
the mouth 5 of the bottle 7 by the inner capsule 9.
[0042] The rubber plug 32 also has a lower portion which is inserted, with interference,
into the mouth 5 of the bottle 7.
[0043] Advantageously, the tabs 29 are adapted to hold the closure body 3 on the mouth 5
of the bottle 7, thus ensuring the seal of the liquid contained inside the bottle
7, also under the action of the internal pressure generated during the autoclave sterilisation
treatment.
[0044] The lower portion 19 of the outer capsule 15 comprises at least one rib 35 projecting
radially towards the inside of the outer capsule 15, configured to engage in a corresponding
seat 37 obtained on the outer surface of the inner capsule 9.
[0045] Preferably, there are provided at least two ribs 35 and two corresponding seats 37.
[0046] Advantageously, the ribs 35 develop circumferentially around the whole lower portion
19 of the outer capsule 15, like the corresponding seats 37 develop circumferentially
around the whole outer surface of the inner capsule 9.
[0047] Thereby, when the outer capsule 15 is fitted onto the inner capsule 9, the two components
are firmly constrained to each other and define an assembly that can be handled as
though it were a single body.
[0048] Advantageously, the inner capsule 9 may comprise a rib 45 projecting radially towards
the inside of the capsule configured to hold, by interference, the closure body 3.
Preferably, such rib 45 develops circumferentially around the whole inner capsule
9.
[0049] Due to the holding by interference of the closure body 3 by the inner capsule 9,
the outer capsule 15, inner capsule 9 and closure body 3 assembly define an assembly
that can be handled as though it were a single body.
[0050] As shown in figures 5 and 10, alternatively to the tabs 38, the disc-shaped upper
portion 17 may comprise, at its face that faces the opening 13 of the inner capsule
9, a cylindrical wall 41 axially protruding towards the edge 39 of the opening 13
and configured to engage with such edge 39.
[0051] The cylindrical wall 41 ensures the centring of the disc-shaped upper portion 17
of the outer capsule 15 with respect to the edge 39 of the opening 13.
[0052] As shown instead in figures 4 and 9, the disc-shaped upper portion 17 of the outer
capsule 15 may comprise, at its face facing the opening 13 of the inner capsule 9,
a plurality of tabs 38 axially projecting towards the edge 39 of the opening 13 and
configured to engage with such edge 39.
[0053] Advantageously, the tabs 38 are also folded around the edge 39 of the opening 13,
for example in assembly step between the outer capsule 15 and the inner capsule 9.
[0054] The engagement of the tabs 38 of the outer capsule 15 with the edge 39 of the opening
13 of the inner capsule 9 further stabilizes the coupling between inner capsule 9
and outer capsule 15.
[0055] In particular, such coupling provides the upper disc-shaped portion 17 with increased
resistance to the internal pressure that is generated in vertical direction in the
bottle 7, and therefore increased resistance to the push that acts on the closure
body 3 during the autoclave sterilisation treatment.
[0056] The presence of the tabs 38 or of the cylindrical wall 41 does not however prevent
the separation of the upper disc-shaped portion 17 of the outer capsule 15 from the
lower portion 19 because such tabs 38, or such cylindrical wall 41, are removed from
the edge 39 of the opening 13 when the upper disc-shaped portion 17 of the outer capsule
15 is removed.
[0057] In the variant of inner capsule 9 illustrated in figure 6, there are advantageously
provided a plurality of bodies 47 projecting axially and radially towards the inside
of the capsule 9, which are configured to hold the closure body 3 in the inner capsule
9.
[0058] In the embodiment illustrated in figures 7 to 10, the closure system 1 comprises
a tamper-evident ring 43 associated with the outer capsule 15. The tamper-evident
ring 43 is advantageously associated with the lower edge of the outer capsule 15 by
means of a plurality of bridges 49.
[0059] The tamper-evident ring 43 comprises advantageously an undercut 51 configured to
engage with the lower edge 53 of the inner capsule 9.
[0060] The tamper-evident ring 43 serves the purposes of emphasizing any attempts to tamper
with the closure system 1.
[0061] When the bottle 7 is used, the operator, or patient, lifts the edge 24 of the upper
disc-shaped portion 17 of the outer capsule 15 with his/her fingertip, thus breaking
any bridges 23 that join such upper portion to the lower portion 19 and removing the
tabs 38, or the circular wall 41, from the edge 39 of the opening 13 of the inner
capsule 9.
[0062] Thereby, the opening 13 of the inner capsule 9 is exposed and it is possible to perforate
the closure body 3 with a needle at the opening 13 of the inner capsule 9 to introduce
it into the mouth 5 of the bottle 7 in order to suck the liquid contained in the bottle
7.
[0063] The closure system object of the present invention has the advantage of being made
completely of a material of the plastic type and of being pressure applied onto the
bottles, without generating powders that are incompatible with the sterility requirements
of the product contained in the bottle itself, as instead happens in the case of closure
systems at least partially made of aluminium.
[0064] Another advantage of the invention consists in the fact that the outer capsule, inner
capsule and closure body assembly may be applied as though they were a single body,
in a single step, to the bottle, directly in the cleanroom, immediately after the
filling of the bottle with the product required. The application of the aforesaid
assembly may also be executed in completely automated manner.
[0065] Another advantage again of the invention consists in the fact that the tabs on the
inner capsule on the one hand, allow the closure system to resist in a satisfactory
manner to the stresses generated during the autoclave sterilisation process, and on
the other hand, to be easily pressure applied to the neck of the bottle.
[0066] A further advantage of the closure system according to the invention consists in
the fact of being made in a minimum number of pieces that are easy to assemble with
one another, that is rubber outer capsule, inner capsule and closure body.
[0067] The fact that the number of separate components of the closure system is minimised
makes both the production of the closure system and its assembly on the bottle more
economical and quicker.
[0068] Another advantage again of the invention consists in the fact that the closure system
has multiple elements that may emphasize possible tampering therewith, such as for
example the bridges of the outer capsule or the bridges that connect the outer capsule
to the tamper-evident ring.
[0069] The closure system thus conceived is susceptible to many modifications and variants,
all falling within the invention; moreover, all the details can be replaced by technically
equivalent elements. In practice, the materials used, as well as their sizes, can
be of any type according to the technical requirements.
1. Closure system (1) for bottles containing lyophilized or liquid products, particularly
injectable or perfusable pharmaceutical products, comprising:
- a perforable closure body (3) adapted for closing the mouth (5) of a bottle (7);
- an inner capsule (9), able to be fitted onto the neck (11) of said bottle (7), configured
to hold said closure body (3) in a sealed closure configuration of said mouth (5)
of said bottle (7), said inner capsule (9) comprising an opening (13) adapted for
allowing access to said closure body (3);
- an outer capsule (15), able to be fitted onto said inner capsule (9);
wherein said outer capsule (15) is made in a single body and comprises an upper disc-shaped
portion (17) configured to close said opening (13) of said inner capsule (9) and a
lower portion (19) fitted around said inner capsule (9), said outer capsule (15) comprising
a breaking line (21) between said upper disc-shaped portion (17) and said lower portion
(19),
characterised in that the lower portion (19) of the outer capsule (15) completely covers the side of the
inner capsule (9).
2. Closure system (1), according to claim 1, characterised in that said outer capsule (15) is made of a material of the plastic type through injection
moulding.
3. Closure system (1), according to claim 1 or 2, characterised in that said breaking line (21) comprises a plurality of bridges (23) made through said injection
moulding.
4. Closure system (1), according to claim 1 or 2, characterised in that said breaking line (21) comprises a weakened line made through incision following
said injection moulding.
5. Closure system (1), according to one or more of the previous claims, characterised in that said lower portion (19) of said outer capsule (15) comprises, substantially at said
breaking line (21), a band (25) having a radial thickness substantially less than
the radial thickness of the remaining part of said lower portion (19).
6. Closure system (1), according to one or more of the previous claims, characterised in that said lower portion (19) of said outer capsule (15) comprises, substantially at said
breaking line (21), a band (25) having a radial thickness that narrows in the axial
direction (27) of approach to said breaking line (21).
7. Closure system (1), according to one or more of the previous claims, characterised in that said inner capsule (9) comprises a plurality of elastically deformable tabs (29)
projecting radially towards the inside of said inner capsule (9), said tabs (29) being
configured to engage with the bottle finish (31) of said bottle (7), said tabs (29)
being obtained at through-openings (33) present on the lateral surface of said inner
capsule (9) .
8. Closure system (1), according to one or more of the previous claims, characterised in that said lower portion (19) of said outer capsule (15) comprises at least one rib (35)
projecting radially towards the inside of said outer capsule (15) configured to engage
in a corresponding seat (37) obtained on the outer surface of said inner capsule (9).
9. Closure system (1), according to one or more of the previous claims, characterised in that said disc-shaped upper portion (17) comprises, at its face that faces said opening
(13) of said inner capsule (9), a cylindrical wall (41) projecting axially towards
the edge (39) of said opening (13) and configured to engage with said edge (39).
10. Closure system (1), according to one or more of the previous claims, characterised in that said disc-shaped upper portion (17) comprises, at its face that faces said opening
(13) of said inner capsule (9), a plurality of tabs (38) projecting axially towards
the edge (39) of said opening (13) and configured to engage with said edge (39) and
folded around said edge (39) of said opening (13).
11. Closure system (1), according to one or more of the previous claims, characterised in that a tamper-evident ring (43) is associated with said outer capsule (15) .
1. Verschlusssystem (1) für Flaschen, die lyophilisierte oder flüssige Produkte, insbesondere
injizierbare oder perfundierbare pharmazeutische Produkte, enthalten, umfassend:
- einen perforierbaren Verschlusskörper (3), der zum Verschließen der Öffnung (5)
einer Flasche (7) geeignet ist,
- eine innere Kapsel (9), die an dem Hals (11) der Flasche (7) angebracht werden kann,
die ausgebildet ist, um den Verschlusskörper (3) in einer abgedichteten Verschlusskonfiguration
der Öffnung (5) der Flasche (7) zu halten, wobei die innere Kapsel (9) eine Öffnung
(13) umfasst, die geeignet ist, den Zugang zu dem Verschlusskörper (3) zu ermöglichen,
- eine äußere Kapsel (15), die auf die innere Kapsel (9) aufsetzbar ist,
wobei
die äußere Kapsel (15) in einem einzigen Körper hergestellt ist und einen oberen scheibenförmigen
Abschnitt (17) umfasst, der ausgebildet ist, um die Öffnung (13) der inneren Kapsel
(9) zu schließen, und einen unteren Abschnitt (19), der um die innere Kapsel (9) herum
angebracht ist, wobei die äußere Kapsel (15) eine Bruchlinie (21) zwischen dem oberen
scheibenförmigen Abschnitt (17) und dem unteren Abschnitt (19) umfasst,
dadurch gekennzeichnet, dass der untere Abschnitt (19) der äußeren Kapsel (15) die Seite der inneren Kapsel (9)
vollständig bedeckt.
2. Verschlusssystem (1) nach Anspruch 1, dadurch gekennzeichnet, dass die äußere Kapsel (15) aus einem Material vom Kunststofftyp durch Spritzgießen hergestellt
ist.
3. Verschlusssystem (1) nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass die Bruchlinie (21) eine Vielzahl von durch das Spritzgießen hergestellte Brücken
(23) umfasst.
4. Verschlusssystem (1) nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass die Bruchlinie (21) eine geschwächte Linie umfasst, die durch Einschneiden nach dem
Spritzgießen hergestellt wird.
5. Verschlusssystem (1) nach einem oder mehreren der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der untere Abschnitt (19) der äußeren Kapsel (15) im Wesentlichen an der Bruchlinie
(21) ein Band (25) mit einer radialen Dicke aufweist, die wesentlich geringer ist
als die radiale Dicke des verbleibenden Teils des unteren Abschnitts (19).
6. Verschlusssystem (1) nach einem oder mehreren der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der untere Abschnitt (19) der äußeren Kapsel (15) im Wesentlichen an der Bruchlinie
(21) ein Band (25) mit einer radialen Dicke umfasst, die sich in axialer Richtung
(27) der Annäherung an die Bruchlinie (21) verengt.
7. Verschlusssystem (1) nach einem oder mehreren der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass die innere Kapsel (9) eine Vielzahl elastisch verformbarer Laschen (29) umfasst,
die radial zum Inneren der inneren Kapsel (9) vorstehen, wobei die Laschen (29) so
ausgebildet sind, dass sie mit der Flaschenmündung (31) der Flasche (7) in Eingriff
kommen, wobei die Laschen (29) an Durchgangsöffnungen (33) gewonnen werden, die an
der Seitenfläche der inneren Kapsel (9) vorhanden sind.
8. Verschlusssystem (1) nach einem oder mehreren der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der untere Abschnitt (19) der äußeren Kapsel (15) mindestens eine Rippe (35) umfasst,
die radial zur Innenseite der äußeren Kapsel (15) vorsteht und ausgebildet ist, um
in einen entsprechenden Sitz (37) einzugreifen, der auf der Außenfläche der inneren
Kapsel (9) gewonnen wird.
9. Verschlusssystem (1) nach einem oder mehreren der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der scheibenförmige obere Abschnitt (17) an seiner der Öffnung (13) der inneren Kapsel
(9) zugewandten Seite eine zylindrische Wand (41) aufweist, die axial zum Rand (39)
der Öffnung (13) vorsteht und ausgebildet ist, um mit dem Rand (39) in Eingriff zu
kommen.
10. Verschlusssystem (1) nach einem oder mehreren der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der scheibenförmige obere Abschnitt (17) an seiner der Öffnung (13) der inneren Kapsel
(9) zugewandten Seite eine Vielzahl von Laschen (38) umfasst, die axial zum Rand (39)
der Öffnung (13) vorstehen und so ausgebildet sind, dass sie mit dem Rand (39) in
Eingriff kommen und um den Rand (39) der Öffnung (13) gefaltet sind.
11. Verschlusssystem (1) nach einem oder mehreren der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der äußeren Kapsel (15) ein manipulationssicherer Ring (43) zugeordnet ist.
1. Système de fermeture (1) pour des bouteilles contenant des produits lyophilisés ou
liquides, en particulier des produits pharmaceutiques à injecter ou perfuser, comprenant
:
- un corps de fermeture à perforer (3) adapté pour fermer l'embouchure (5) d'une bouteille
(7) ;
- une capsule intérieure (9), adaptée pour être installée sur le goulot (11) de ladite
bouteille (7), configurée pour maintenir ledit corps de fermeture (3) dans une configuration
de fermeture hermétique de ladite embouchure (5) de ladite bouteille (7), ladite capsule
intérieure (9) comprenant une ouverture (13) adaptée pour permettre l'accès audit
corps de fermeture (3) ;
- une capsule extérieure (15), adaptée pour être installée sur ladite capsule intérieure
(9) ;
dans lequel
ladite capsule extérieure (15) est réalisée d'une seule pièce et comprend une portion
supérieure en forme de disque (17) configurée pour fermer ladite ouverture (13) de
ladite capsule intérieure (9) et une portion inférieure (19) installée autour de ladite
capsule intérieure (9), ladite capsule extérieure (15) comprenant une ligne de rupture
(21) entre ladite portion supérieure en forme de disque (17) et ladite portion inférieure
(19),
caractérisé en ce que la portion inférieure (19) de la capsule extérieure (15) couvre complètement le côté
de la capsule intérieure (9) .
2. Système de fermeture (1), selon la revendication 1, caractérisé en ce que ladite capsule extérieure (15) est réalisée en un matériau de type plastique par
moulage par injection.
3. Système de fermeture (1), selon la revendication 1 ou 2, caractérisé en ce que ladite ligne de rupture (21) comprend une pluralité de ponts (23) réalisés par ledit
moulage par injection.
4. Système de fermeture (1), selon la revendication 1 ou 2, caractérisé en ce que ladite ligne de rupture (21) comprend une ligne affaiblie réalisée par incision à
la suite dudit moulage par injection.
5. Système de fermeture (1), selon une ou plusieurs des revendications précédentes, caractérisé en ce que ladite portion inférieure (19) de ladite capsule extérieure (15) comprend, sensiblement
au niveau de ladite ligne de rupture (21), une bande (25) ayant une épaisseur radiale
sensiblement inférieure à l'épaisseur radiale de la partie restante de ladite portion
inférieure (19).
6. Système de fermeture (1), selon une ou plusieurs des revendications précédentes, caractérisé en ce que ladite portion inférieure (19) de ladite capsule extérieure (15) comprend, sensiblement
au niveau de ladite ligne de rupture (21), une bande (25) ayant une épaisseur radiale
qui s'étrécie dans la direction axiale (27) d'approche vers ladite ligne de rupture
(21).
7. Système de fermeture (1), selon une ou plusieurs des revendications précédentes, caractérisé en ce que ladite capsule intérieure (9) comprend une pluralité de languettes élastiquement
déformables (29) faisant saillie radialement vers l'intérieur de ladite capsule intérieure
(9), lesdites languettes (29) étant configurées pour s'engager avec la bouche de la
bouteille (31) de ladite bouteille (7), lesdites languettes (29) étant obtenues au
niveau d'ouvertures passantes (33) présentes sur la surface latérale de ladite capsule
intérieure (9).
8. Système de fermeture (1), selon une ou plusieurs des revendications précédentes, caractérisé en ce que ladite portion inférieure (19) de ladite capsule extérieure (15) comprend au moins
une nervure (35) faisant saillie radialement vers l'intérieur de ladite capsule extérieure
(15) configurée pour s'engager dans un siège correspondant (37) obtenu sur la surface
extérieure de ladite capsule intérieure (9).
9. Système de fermeture (1), selon une ou plusieurs des revendications précédentes, caractérisé en ce que ladite portion supérieure en forme de disque (17) comprend, au niveau de sa face
qui est orientée vers ladite ouverture (13) de ladite capsule intérieure (9), une
paroi cylindrique (41) faisant saillie axialement vers le bord (39) de ladite ouverture
(13) et configurée pour s'engager avec ledit bord (39).
10. Système de fermeture (1), selon une ou plusieurs des revendications précédentes, caractérisé en ce que ladite portion supérieure en forme de disque (17) comprend, au niveau de sa face
qui est orientée vers ladite ouverture (13) de ladite capsule intérieure (9), une
pluralité de languettes (38) faisant saillie axialement vers le bord (39) de ladite
ouverture (13) et configurées pour s'engager avec ledit bord (39) et enroulées autour
dudit bord (39) de ladite ouverture (13).
11. Système de fermeture (1), selon une ou plusieurs des revendications précédentes, caractérisé en ce qu'un anneau d'inviolabilité (43) est associé à ladite capsule extérieure (15).