CLOS ING ELEMENT FOR PHARMACEUTICAL CONTAINERS AND PROCESS FOR PRODUCING SUCH CLOS ING ELEMENT

DESCRIPTION

Field of the invention

The present invention relates to the pharmaceutical field and it relates , precisely, to a closing element , in particular a closure , or lid, or any other similar element for sealing a container such as a bottle , a vial , a small bottle , etc . that is intended to contain a pharmaceutical product .

Furthermore , the invention relates to a process for producing such a closing element for pharmaceutical containers .

Background of the invention

As known, many types of pharmaceutical containers exist that are used for containing pharmaceutical products in aseptic conditions . In particular, in order to be able to guarantee that the products contained within them are maintained in aseptic conditions , the containers as well as their closures have to be preliminarily sterili zed .

In order to be compliant with the law, once filled with the pharmaceutical product for which they are intended, the aforementioned pharmaceutical containers have to be hermetically sealed with closures that must be able to guarantee the integrity and the inviolability of their content until they are opened by the authori zed person . A very widespread type of closures for pharmaceutical containers comprises two distinct parts . More precisely, these closures provide a first part , normally a lid made of vulcani zed rubber, provided with a portion that , in working conditions , is housed within the container, and with another portion that , in use , is positioned in contact with the edge of the mouth of the pharmaceutical container . The closing element , furthermore , comprises a second part made of a metallic material , generally aluminium, which is superimposed to the aforementioned first part and fixed to the container, for example by crimping, in such a way that once removed it cannot be used anymore . More precisely, the second part of the closing element has , on the one hand, the aim to push the first part against the mouth of the pharmaceutical container in order to hermetically close the same and, on the other hand, it has the function of a seal , because it guarantees that it is not possible to reach the first part of the closing element without leaving any mark of the removal of the second part and, therefore , it guarantees the inviolability of the content of the pharmaceutical container .

However, the aforementioned type of closing members for pharmaceutical containers has many drawbacks .

Since , as described above , the containers for pharmaceutical use , as well as their closures , must be subj ected to processes for sterili zing the same , the aforementioned types of closure members which provide two members need to be subj ected to a process for sterili zing that is altogether long and complicated and that is , therefore , unavoidably highly expensive .

Furthermore , since the rubber, once vulcani zed cannot be recycled, the aforementioned type of closing members for pharmaceutical containers has a not-negligible environmental impact in particular due to the high quantity of vulcani zed rubber that is needed .

A further disadvantage of the closures for pharmaceutical containers formed by more components is that , at the moment to draw up the inventory, each component has to be registered separately with great loss of time and complications .

Some closures for pharmaceutical containers of known type are for example described in US3888377 , US2018 / 147115 and US2019/209435 .

The closures described in these documents are of the type that can be pierced by a needle to draw its content by a syringe . More in detail , the closures that are described in these documents are provided with a removable portion in order to expose , once removed, a portion made of rubber, or other material , suitable to be pierced by the needle . Therefore , these closures can be used only in the case that the pharmaceutical product contained within the pharmaceutical container is in liquid form and intended to be administered to the patient by inj ection .

Summary of the invention

It is , therefore , an obj ect of the present invention to provide a closing element for pharmaceutical containers that is able to overcome the drawbacks above disclosed of the closing members of prior art . It is , in particular, an obj ect of the present invention to provide a closing element for pharmaceutical containers that is able to simpli fy the processes for sterili zing the pharmaceutical containers and, therefore , to speed up the same in addition to reduce costs with respect to the closing members of prior art .

It is also an obj ect of the present invention to provide a closing element for pharmaceutical containers that is able to avoid that the pharmaceutical product which is contained in it , can be contaminated by extraneous substances until it is withdrawn from the pharmaceutical container .

It is another particular obj ect of the present invention to provide a closing element for pharmaceutical containers that is intended to store the pharmaceutical products in liquid, or solid, in particular powder, or gel , form .

It is another obj ect of the present invention to provide a closing element for pharmaceutical containers that is able to reduce the environmental impact with respect to analogous products of prior art .

It is an obj ect of the present invention to provide a process for producing such a closing element for pharmaceutical containers that is simple and cheap .

It is another obj ect of the invention to provide a system for storing a pharmaceutical product formed by a closing element according to the invention and a related pharmaceutical container having the same advantages indicated above .

These and other obj ects are obtained by a closing element for a pharmaceutical container provided with a cavity delimited by a lateral wall and with an aperture through which it is possible to reach said cavity, said aperture being laterally delimited by an edge , said closing element having a main body comprising :

- a seal portion configured to be engaged to said pharmaceutical container, said seal portion being provided with a weakening line delimiting a first part and a second part of said seal portion, said second part being arranged to be removed disengaging the same from said first part at said weakening line ;

- a housing portion made at said first part of said seal portion;

- a sealing portion made of elastic material and configured to be housed, in use , within said housing portion and to be positioned in contact with said edge of said aperture ; whose main characteristic is that the aforementioned housing portion and the aforementioned sealing portion are firmly anchored to each other at respective engagement surfaces , in such a way to be removed integrally with each other from the pharmaceutical container, that said seal portion is arranged to be engaged to said pharmaceutical container at said second part and that the weakening line is positioned, in use , below the aforementioned edge , in such a way that when said second part of said seal portion is removed, the sealing element is still covered by the first part of the seal portion .

Further technical characteristics of the invention and the related embodiments are set out in the dependent claims .

In particular, the aforementioned housing portion faces , in use , towards the aforementioned edge of the aforementioned aperture .

Preferably, the housing portion and the sealing portion can be firmly anchored to each other at the aforementioned engagement surface by an inj ection moulding process .

Alternatively, the housing portion and the sealing portion can be firmly anchored to each other at the aforementioned engagement surface by a process di comoulding, in particular co-moulding of metal and plastic materials .

In particular, the aforementioned main body can be made of a metallic material . More in particular, the main body can be made of aluminium . In this way, it is possible , in particular, to simpli fy the process for sterili zing the pharmaceutical container .

Preferably, the aforementioned sealing portion can be made of rubber .

Preferably, the aforementioned weakening line can be configured in such a way to disengage , in particular in an irreversible way, the aforementioned second part from the aforementioned first part of the seal portion when the second part is caused to rotate tangentially to the aforementioned first part .

Advantageously, the second part of the seal portion can be provided with a grasp portion configured to be grasped by a user in order to pull the second part same , in particular causing it to rotate tangentially to the aforementioned first part as above disclosed, in such a way to separate it from the first part .

In particular, the aforementioned sealing portion can be provided with at least one through hole adapted to be positioned, in use , above the aforementioned aperture of the pharmaceutical container . More in particular, the aforementioned sealing portion can have an annular shape .

Alternatively, the aforementioned sealing portion can be a substantially flat shaped element .

Advantageously, the sealing portion can have a circular, or elliptical , or polygonal , for example rectangular, or square, cross section .

According to another aspect of the invention, a process for producing a closing element for a pharmaceutical container provided with a cavity laterally delimited by a lateral wall and with an aperture through which it is possible to reach the aforementioned cavity, said aperture being laterally delimited by an edge , said process comprising the steps of :

- disposing of a main body provided with a seal portion configured to be engaged, in use , to said lateral wall of said pharmaceutical container and with a housing portion;

- making on said main body a weakening line delimiting a first and a second part of a seal portion adapted to be engaged, in use , to the aforementioned pharmaceutical container, in order to close the aforementioned aperture ;

- disposing of a sealing portion made of elastic material within said housing portion and positioned in contact with the aforementioned edge of the aperture ;

- anchoring said housing portion and said sealing portion to each other at respective engagement surfaces .

According to a further aspect of the invention, a process for producing a closing element for a pharmaceutical container provided with a cavity laterally delimited by a lateral wall and with an aperture through which it is possible to reach the aforementioned cavity, said aperture being laterally delimited by an edge , said process comprising the steps of :

- positioning a main body, in particular made of metallic material , within a mould, said main body being provided with :

- a seal portion configured to be engaged, in use , to said pharmaceutical container, said seal portion being provided with a weakening line delimiting a first part and a second part of said seal portion, said seal portion being arranged to be engaged to said pharmaceutical container at said second part , said second part being arranged to be removed disengaging form said first part at said weakening line , said weakening line being positioned, in use , below said edge of said pharmaceutical container ;

- a housing portion provided at said first part of said seal portion and adapted to face , in use , towards said edge of said aperture ;

- inj ecting a predetermined quantity of a melted elastic material into the aforementioned main body at a housing portion; - solidi fying the elastic material within the housing portion forming a sealing portion, during said solidi fying step said housing portion and said sealing portion being adapted to firmly anchor to each other at respective engagement surfaces .

According to still another aspect of the invention, a system for storing a product , in particular a pharmaceutical product, comprises :

- a pharmaceutical container provided with a cavity delimited by a lateral wall and with an aperture through which it is possible to reach said cavity, said aperture being laterally delimited by an edge ;

- a closing element as described above arranged to close said aperture of said pharmaceutical container .

Preferably, the pharmaceutical container, in particular made of metallic material , such as aluminium, or an aluminium alloy, can be provided with an end portion which protrudes from the aforementioned edge . More in particular, the aforementioned end portion can be configured to protrude from the aforementioned edge up to a free end .

More in detail , the aforementioned end portion can be shaped in such a way to bend towards the pharmaceutical container, in particular towards a portion having a reduced cross section, or neck, of the pharmaceutical container same . The free end of the end portion can be , in particular, positioned at a predetermined distance d from the lateral wall , in particular from the aforementioned portion having a reduced cross section, or neck of the pharmaceutical container . Advantageously, the aforementioned seal portion can be arranged to be engaged, in particular by crimping, to the pharmaceutical container at the aforementioned free end of the end portion .

In particular, the main body of the closing element and the pharmaceutical container can be made of the same material or, however, of two materials that can be sterili zed, in particular two metallic materials that can be sterili zed, for example aluminium, or an aluminium alloy .

Brief description of the drawings

The invention will be now illustrated with the following description of an exemplary embodiment thereof , exempli fying but not limitative , with reference to the attached drawings wherein :

Fig . l diagrammatically shows a side elevation perspective view of a pharmaceutical container provided with a closing element according to the invention in a disassembled configuration;

Fig . 2 diagrammatically shows a side elevation perspective view of the pharmaceutical container and the closing element of figure 1 in an assembled configuration;

Fig . 3 diagrammatically shows a longitudinal cross section view of the pharmaceutical container and the closing element of figure 2 ;

Fig . 4 diagrammatically shows an enlargement of the pharmaceutical container and the closing element of figure 3 to highlight some technical aspects ; Fig . 5 diagrammatically shows a side elevation perspective view of a pharmaceutical container provided with an embodiment of the closing element alternative to that one of figure 2 ;

Fig . 6 diagrammatically shows a side elevation perspective view of the pharmaceutical container and the closing element of figure 5 during an initial stage of the removal step of the seal portion;

Fig . 7 diagrammatically shows a longitudinal cross section view of the pharmaceutical container and the closing element of figure 6 ;

Fig . 8 diagrammatically shows an enlargement of the pharmaceutical container and the closing element of figure 7 to highlight some technical aspects ;

Fig . 9 diagrammatically shows a side elevation perspective view of the pharmaceutical container and the closing element of figure 5 at the end stage of the removal step of the seal portion;

Fig . 10 diagrammatically shows a longitudinal cross section view of the pharmaceutical container and the closing element of figure 9 ;

Fig . 11 diagrammatically shows an enlargement of the pharmaceutical container and the closing element of figure 10 to highlight some technical aspects ;

Fig . 12 diagrammatically shows a side elevation perspective view of a pharmaceutical container provided with a further embodiment of the closing element alternative to that of figure 2 ;

Fig . 13 diagrammatically shows a side elevation perspective view of the pharmaceutical container and the closing element of figure 12 during an initial stage of the removal step of the seal portion;

Fig . 14 diagrammatically shows a longitudinal cross section view of the pharmaceutical container and the closing element di figure 12 ;

Fig . 15 diagrammatically shows a longitudinal cross section view of a pharmaceutical container provided with still another alternative embodiment of the closing element according to the invention;

Fig . 16 diagrammatically shows an enlargement of the pharmaceutical container and the closing element of figure 15 to highlight some technical aspects ;

Fig . 17 diagrammatically shows a perspective view of a possible alternative embodiment of the sealing element that can be used for the closing element according to the invention;

Fig . 18 diagrammatically shows a longitudinal cross section view of a possible embodiment alternative to that one of figure 16 of a pharmaceutical container to which the closing element according to the invention can be applied;

Fig . 19 diagrammatically shows an enlargement of the pharmaceutical container and the closing element of figure 18 to highlight some technical aspects ;

Fig . 20 diagrammatically shows a longitudinal cross section view of a possible embodiment alternative to that one of figure 19 of the closing element according to the invention;

Fig . 21 diagrammatically shows an enlargement of the pharmaceutical container and the closing element of figure 20 to highlight some technical aspects ;

Fig . 22 diagrammatically shows a block diagram of the main steps of the process , according to the invention, for producing the closing element for pharmaceutical containers ;

Fig . 23 diagrammatically shows a block diagram of the main steps of another process , according to the invention, for producing the closing element for pharmaceutical containers ;

Fig . 24 diagrammatically shows a possible layout of a plant for producing the closing element for pharmaceutical containers according to the invention .

Detailed description of some exemplary embodiments of the invention

As diagrammatically shown in figure 1 , a closing element 1 , according to the invention, for a pharmaceutical container 50 , such as a bottle , a vessel , a small bottle , a flask, provided with a cavity 55 delimited by a lateral wall 51 and an aperture 52 laterally delimited by an edge 53 , through which it is possible to reach the aforementioned cavity 55 . The closing element 1 comprises , in particular, a main body 10 comprising a seal portion 15 configured to be engaged to the lateral wall 51 of the pharmaceutical container 50 , for example by crimping . In particular, the aperture 52 of the aforementioned pharmaceutical container 50 can have a diameter equal to , or greater than 20 mm, for example comprised between 20 mm and 220 mm .

The closing element 1 comprises , furthermore , a housing portion 11 , in particular facing, in use , towards the aforementioned edge 53 of the aperture 52 , and a sealing portion 20 made of an elastic material and configured to be housed, in use , within the housing portion 11 . More in particular, the sealing portion 20 i s adapted to be positioned, in use , in contact with the edge 53 of the aperture 52 in such a way to tightly close the pharmaceutical container 50 .

According to the invention, the main body 10 and the aforementioned sealing portion 20 , which is housed within the housing portion 11 , are firmly anchored to each other at respective engagement surfaces 16 and 26 by an inj ection moulding, or co-moulding, process , in particular a co-moulding process of metal and plastic materials . In this way, at the moment of removing the closing element 1 from the closing position of the aperture 52 , the seal portion 15 and the sealing element 20 are removed integrally with each other . In particular, the main body 10 can be made of a metallic material , preferably aluminium, or an aluminium alloy .

Advantageously, the aforementioned sealing portion 20 can be made of rubber, preferably butyl rubber .

As diagrammatically shown, for example , in figure 19 , the seal portion 15 comprises a first part 15a and a second part 15b mutually engaged to each other in a removable way at an engagement portion 19 . More precisely, the seal portion 15 is engaged to the pharmaceutical container 50 , in particular to the neck of this , at the second part 15b . The seal portion 15 is provided with a weakening line 18 , in particular a portion having a reduced thickness , or a pre-cut line . The weakening line 18 delimits the first and the second part 15a and 15b, in the sense that it indicates the limit between the first and the second part 15a and 15b, of the seal portion 15 .

In particular, when a user grasps the second part 15b and pulls it , he/ she causes the same to be removed, i . e . its separation from the first part 15a at the weakening line 18 . Therefore , the closing element 1 is disengaged from the pharmaceutical container 50 and can be removed from the closing position of the aperture 52 when desired .

According to an embodiment , the weakening line 18 , and therefore the engagement portion 19 , can be configured in such a way to be broken disengaging the second part 15b of the seal portion 15 from the first part 15a, when a rotation of the second part 15b tangentially to the first part 15a is caused .

In a preferred embodiment , the weakening line 18 can be obtained by reducing locally the thickness of the seal portion 15 , whereby when the user grasps the second part 15b and applies a determined force on the same , it causes it to be separated from the first part 15a at the weakening line 18 .

In particular, the removal of the second part 15b, that means the breaking of the engagement portion 19 , can be obtained by rotating the second part 15b with respect to the first part 15a, in such a way to cause the two parts 15a and 15b of the seal portion 15 to be separated from each other . In particular, the technical solution provided by the present invention allows to avoid that , during the removal of the seal portion 15 , some particles of the material of which it is made of , can enter the pharmaceutical container 50 contaminating its content .

In particular, the seal portion 15 can be configured in such a way that once that the second part 15b is removed, the sealing element 20 is not exposed, and, therefore , it cannot be reached from the outside . This can be obtained, in particular, by positioning the weakening line 18 in a position such that when the second part 15b of the seal portion 15 is removed, the sealing element 20 remains covered, that means hidden, by the first part 15b, in particular entirely covered by the first part 15b .

This technical characteristic is an important novelty with respect to the prior art solutions where , instead, once that the removable part of the seal portion is removed, the sealing element is exposed to be perforated by a needle of a syringe in order to reach the pharmaceutical product contained within the pharmaceutical container and that , therefore , has to be necessarily in liquid form .

Preferably, the weakening line 18 can be made in such a way to be positioned, in use , below the edge 53 , or at least at the same height . In this way, at the moment to remove the second part 15b of the seal portion 15 , it is guaranteed that the sealing element 20 remains in a correct working position avoiding that extraneous bodies , in particular dust , dirty, which settles on the lateral wall 51 of the pharmaceutical container 50 , or on the seal portion 15 same , as well as other impurities , in particular metallic fragments of the material of which the pharmaceutical container 50 , and/or the closing element 1 , is made of , can enter the cavity 55 , contaminating its content .

In particular, as diagrammatically shown in the figures from 18 to 21 , the aforementioned pharmaceutical container 50 can be provided with an end portion 56 which protrudes from the edge 53 . More in particular, the aforementioned end portion 56 , starting from the aforementioned edge 53 from which it protrudes , bends towards the pharmaceutical container 50 , in such a way to be superimposed on a part of the lateral wall 51 of the pharmaceutical container 50 , in particular at least on a part of a portion having a reduced cross section, or neck 57 , of which the container same is provided of . More precisely, the end portion 56 protrudes from the edge 53 up to a free end 59 . Thi s is , preferably, positioned at a predetermined distance d from the lateral wall 51 of the pharmaceutical container, in particular the neck 57 of the same , i f present . In particular, the end portion 56 together with the pharmaceutical container 50 can delimit a cavity 58 .

In an embodiment of the invention, the weakening line 18 can be configured in such a way to be positioned, in use , at the end portion 56 , in particular between the edge 53 and the free end 59 of the end portion 56 .

In particular, the seal portion 15 , more precisely the second part 15b of this , can be engaged, for example by crimping, to the free end 59 of the end portion 56 , in such a way to ensure a firm anchoring of the seal portion 15 , and precisely of the second part 15b of this , to the pharmaceutical container 50 . As diagrammatically shown in the embodiments of the figures from 5 to 21 , the second part 15b of the seal portion 15 can be provided with a grasp portion 17 configured to be grasped by a user in order to cause the same to be rotated tangentially to the first part 15a, as disclosed above . For example, the grasp portion 17 can extend along a direction that is substantially radial to the main body 10 of the closing element 1 ( case that is shown in the figures from 5 to 11 ) or along a direction that is substantially tangential to the main body 10 (case that is shown as an example in the figures from 12 to 15 ) .

In particular, in working conditions , the sealing element 20 can extend between the opposite end portions 54a and 54b of the edge 53 of aperture 52 of the pharmaceutical container 50 and, therefore , be positioned upon the aperture 52 same for al l its length ( case that is shown, for example , in the figures 10 and 14 ) . For example , the sealing element 20 can have a substantially flat shape .

In an alternative embodiment that is diagrammatically shown in the figures from 15 to 21 , instead, the sealing element 20 can be provided with at least a hole 22 superimposed, in use , to the aperture 52 of the pharmaceutical container 50 . For example , the sealing element 20 can have an annular, or substantially annular, shape , in particular with a polygonal cross section, advantageously substantially square , or rectangular, or curved, in particular substantially elliptical , or circular, and can be placed on the edge 53 of the aperture 52 , but not upon this latter, or however, not upon the whole aperture 52 , leaving at least a part of the aperture 52 uncovered . Even though in the figures 15 and 16 , the sealing element is shown having a circular cross section, it is not excluded that it can have an elliptical , or polygonal , in particular square , or rectangular, cross section, cases that are not shown in the figure .

In particular, the main body 10 of the closing element 1 and the pharmaceutical container 50 are made of the same material , advantageously aluminium, or an aluminium alloy . In this way, it is possible to simpli fy the process for sterili zing both the closing element 1 and the pharmaceutical container 50 and to assure that , even i f the product passes through the hole 22 of the sealing element 20 and reaches the main body 10 of the closing element 1 , the necessary sterile conditions for the product that is contained in it are , anyway, maintained, thus avoiding any contamination of the same and, therefore , assuring the absolute integrity of the same .

According to another aspect of the invention, a pharmaceutical container 50 and a closing element 1 as described above with reference to the figures from 1 to 20 form a system 100 for storing a pharmaceutical product .

According to another aspect of the invention, a process for producing a closing element 1 for a pharmaceutical container 50 , such as a bottle , a small bottle , a test tube , but also a vial , and similar containers that are used in the pharmaceutical field, of the type described above with reference to the figures from 1 to 16 , and, in particular, provided with a cavity

55 laterally delimited by a lateral wall 51 and an aperture 52 through which it is possible to reach the aforementioned cavity 55 , can comprise the steps that are diagrammatically indicated in the block diagram 300 of figure 22 .

In particular, the process , according to the invention, provides a step of disposing of a main body 10 provided with a seal portion 15 configured to be engaged, in use , to the lateral wall 51 of the pharmaceutical container 50 and with a housing portion 11 , in particular adapted to face , in use , towards the edge 53 of the aperture 52 , block 301 .

Furthermore , a step is provided of positioning a sealing portion made of elastic material within the aforementioned housing portion 11 , block 302 , and therefore , a step for anchoring the housing portion 11 and the sealing portion 20 to each other at respective engagement surfaces 16 and 26 , block 303 .

In a preferred embodiment of the invention, the process for producing can provide an inj ection moulding, or co-moulding in particular of plastic and metallic materials . More precisely, the process can provide , in particular, a step for positioning the aforementioned main body 10 within a mould, block 304 , and, then, a step for inj ecting an elastic material , for example rubber, preferably melted, into the aforementioned main body 10 at the housing portion 11 . Then, a solidi fying step of the aforementioned elastic material within the housing portion 11 will produce a sealing portion 20 . More in particular, at the end of the aforementioned inj ection moulding, or co-moulding, process , the solidi fying step produces the aforementioned firm anchoring of the housing portion 11 and the sealing portion 20 at the engagement surfaces 16 and 26 .

In figure 24 a possible layout is diagrammatically shown of a plant for producing the closing elements 1 for pharmaceutical containers according to the invention . In particular, according to an embodiment of the invention, it is possible to obtain the closing element 1 positioning a main body 10 within a mould 150 and inj ecting by an apparatus 200 , in particular provided with a push member 210 adapted to force a predetermined quantity of elastic material , preferably melted rubber, in particular melted butyl rubber, 155 , to pass through an inj ection mouth 215 , to be introduced within the mould 150 up to reaching a housing portion 11 of the main body 10 . In particular, the material can be introduced already melted, in particular through an inlet duct , for example a hopper 220 , or can be introduced at the solid state, for example in granules and can be , then, melted by a heating system, not shown in figure for clarity reasons , of which the apparatus 200 can be provided with .

In this way, once and solidi fied, the elastic material will form the aforementioned sealing element 20 . More precisely, during the solidi fication of the elastic material 155 , a firm anchoring will be obtained of the sealing element 20 and the main body 10 , and precisely at the aforementioned housing portion 11 , at the aforementioned respective engagement surfaces 16 and 26 .

The aforementioned weakening line 18 can be made on the container body 10 before introducing the same within the mould 150, or at the end of the moulding, or comoulding, process, i.e. once that the sealing element 20 has been firmly anchored to the same.

The foregoing description of a specific embodiment will so fully reveal the invention according to the conceptual point of view, so that others, by applying current knowledge, will be able to modify and/or adapt for various applications such an embodiment without further research and without parting from the invention, and it is therefore to be understood that such adaptations and modifications will have to be considered as equivalent to the specific embodiment. The means and the materials to realise the different functions described herein could have a different nature without, for this reason, departing from the field of the invention. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation.