Patent Description:
A closure device for closing a container is provided, which in one embodiment, includes a preassembled stopper. Another embodiment relates to a container equipped with such a closure device.

In the field of containers for medication, a glass or polymeric bottle can be used to store an active ingredient in freeze-dried form, in powder form, or in the form of a liquid solution. Such a bottle must be closed off in a leak-tight manner, so as to maintain its contents in a satisfactory state of preservation, until the date on which it is used. In order to close a bottle hermetically, a closure device can be used that comprises an elastomeric stopper that has the function of sealing the opening of the container from the ingress or egress of gas, liquids, and bacteria. Such a device may further comprise a means for maintaining the container in a sealed condition, such as a crimped aluminum seal or plastic cap, that is designed to be held in place around the stopper so as to isolate the stopper from the outside and so as to oppose removal of the stopper.

When using such a closure device for freeze-dried pharmaceutical substances, for example, each container is filled with a quantity of substance for freeze-drying, and then the respective stopper is placed on or in the neck of the container in such a manner as to be secured thereto, while also preserving communication between the outside environment and the inside of the container. Containers filled and pre-stopped in this way are then placed in batches on the shelves of a freeze drier inside which the substances are dehydrated. During freeze-drying of the contents of a container, vacuum cold-drying is performed to help ensure that the water is extracted from the substance by sublimation and evaporation.

Once the substances have been dehydrated within the freeze drier, pressure is applied to all of the stoppers of the containers in such a manner so as to help ensure that the containers are stopped hermetically by each stopper being engaged on or within the opening of the neck of the corresponding container. Such stopping in batches is generally performed with the elastomeric stopper alone, without the sealing means. After removing the containers from the freeze drier, additional processing is performed to position the seal in place on each container. However, it is desirable to avoid such an additional operation. Thus, it has been envisaged to place the corresponding sealing means on each of the stoppers of the pre-stopped containers before freeze drying them, so that the sealing means may be applied substantially simultaneously while the stoppers are being pressed into place inside the freeze drier.

When the sealing means are applied, so as to be affixed around the neck of the corresponding container, friction creates resistance to this movement, the magnitude of which varies as a function firstly of the manufacturing tolerances of the component parts of the seal, and secondly of the pre-positioning of the parts when they are installed on the neck of the container. Thus, when a presser plate is used inside the freeze drier to lock the seals on a large number of corresponding containers, certain seals may not lock correctly in view of the manufacturing tolerances of the component parts of the seals and in view of the operating clearances of the presser plate. Also, the dimensional variations in the containers themselves and in the stoppers that are used further complicate the closure of a batch of containers.

Therefore, there is a need for improved closure devices which provide for secure and stable positioning of a sealing means on a vial stopper.

<CIT> Al describes a fixing device for closing off a fluid reservoir formed with a neck provided with an external peripheral reinforcement defining with the rest of the neck a lower shoulder, said fixing device comprising a ring fixing to hold a closure member on the neck, the fixing ring comprising a peripheral skirt which is engaged axially around the neck to below the lower shoulder, said skirt being provided with attachment elements each forming a contact zone capable of potentially coming into engagement with the neck under the lower shoulder for fixing the ring on the neck, characterized in that the contact zones are located at different axial heights, so that certain contact zones come into operative engagement under the lower shoulder, while other areas of contact remain inoperative. With reference to claim <NUM>, <CIT> discloses a fixing device for sealing a fluid reservoir having a neck with an opening and a shoulder comprising: a sealing member; and an assembly configured to surround both the sealing member and the neck in a sealed condition, the assembly comprising: a ring fixing containing the sealing member and comprising a plurality of short flaps, and a locking collar comprising a rib telescopically mounted over the ring, the rib being configured to radially deflect the short flaps to engage them under the shoulder when the locking collar is engaged axially around the neck of the fluid reservoir.

The invention is defined by a closure device for sealing a container having a neck with an opening and an annular collar. The closure device comprises a stopper and a cap assembly. The cap assembly is configured to surround both the stopper and the neck in a sealed condition. The cap assembly comprises a ring and a crown. The ring contains the stopper and comprises a plurality of locking tabs. The crown comprises a skirt telescopically mounted over the ring and configured to radially deflect the plurality of locking tabs inwardly under the annular collar when the crown is axially displaced towards the neck of the container. A first locking tab of the plurality of locking tabs has a first axial height and a second locking tab of the plurality of locking tabs has a second axial height, wherein the first axial height is less than the second axial height. Preferred embodiments are defined by dependent claims <NUM>-<NUM>. The invention is also defined by a method of sealing a container comprising a neck with an annular collar with a closure device according to claim <NUM>, the method comprising: inserting the neck of the container into the ring; and applying an axial force until the stopper is inserted into an opening in the neck of the container and the plurality of locking tabs are radially deflected under the annular collar.

Various aspects and embodiments of the application will be described with reference to the following figures. The figures depict one or more implementations in accord with the present concepts, by way of example only, not by way of limitations. In the figures, like reference numerals may refer to the same or similar elements.

Certain terminology is used in the following description for convenience only and is not limiting. The words "lower," "bottom," "upper" and "top" designate directions in the drawings to which reference is made. The words "inwardly," "outwardly," "upwardly" and "downwardly" refer to directions toward and away from, respectively, the geometric center of the liquid transfer device, and designated parts thereof, in accordance with the present disclosure. Unless specifically set forth herein, the terms "a," "an" and "the" are not limited to one element, but instead should be read as meaning "at least one. " The terminology includes the words noted above, derivatives thereof and words of similar import.

It should also be understood that the terms "about," "approximately," "generally," "substantially" and like terms, used herein when referring to a dimension or characteristic of a component of the disclosure, indicate that the described dimension/characteristic is not a strict boundary or parameter and does not exclude minor variations therefrom that are functionally similar. At a minimum, such references that include a numerical parameter would include variations that, using mathematical and industrial principles accepted in the art (e.g., rounding, measurement or other systematic errors, manufacturing tolerances, etc.), would not vary the least significant digit.

It will also be appreciated by those skilled in the art that modifications may be made to the exemplary embodiments described herein without departing from the invention which is defined by the appended set of claims.

Generally, the closure devices according to the various embodiments disclosed herein comprise a stopper and sealing means provided in the form of a cap assembly. The stopper is loaded within the cap assembly, and the closure device may be applied to the opening of a container, such as a vial, to capture an annular collar around the neck of the container and maintain the stopper in a sealed condition.

The closure devices according to the various embodiments disclosed herein may be used in typical filling and lyophilization processes, such as those described in <CIT>. For example, referring to <FIG>, different stages of packaging a product P in glass bottles constituting the containers is illustrated. The bottles <NUM> may alternatively be made of a ceramic or a polymeric material, such as polyethylene (PE), polyethylene terephthalate (PET), glycol-modified polyethylene terephthalate (PETG), high density polyethylene (PEHD) and the like.

In <FIG>, bottle <NUM> is in the process of being filled with product P, for example, a medication. Pipette <NUM> is introduced into bottle <NUM> through its mouth <NUM> which is defined by a neck <NUM> presenting an outer collar <NUM>. X1 shows the symmetrical axis of bottle <NUM>. When a predetermined quantity of product P has been introduced into bottle <NUM>, pipette <NUM> is withdrawn and a closure device <NUM>, as illustrated in <FIG>, is placed on neck <NUM>. The device <NUM>, comprises an elastomeric stopper <NUM> adapted to be partially introduced into the mouth <NUM>, while remaining on the side <NUM> of the collar <NUM> opposite the bottom <NUM> of the bottle <NUM>. A filling line may include a plurality of pipettes in order to simultaneously fill multiple containers. Similarly, an automated filling line may also be capable of simultaneously applying a plurality of stoppers and cap assemblies to the container after the containers are filled with product.

The device <NUM> also comprises a cap <NUM> aimed at covering and maintaining the stopper <NUM> and the neck <NUM> in a closed configuration. The stopper <NUM> is preferably pre-loaded into the cap <NUM> and held in an axial position prior to affixing the cap onto the neck <NUM> of the bottle <NUM>, described in greater detail below. After filling the closure device <NUM> is applied to the neck <NUM> of each container <NUM>, such that the stopper <NUM> does not completely fill the mouth <NUM>. The stopper <NUM> is preferably provided with a vent <NUM> which communicates with the atmosphere on the exterior of the container <NUM>. A plurality of filled containers <NUM> having a closure device <NUM> applied thereon may then be loaded into a lyophiliser <NUM>, as illustrated in <FIG> as one lot of bottles <NUM>. In <FIG>, three bottles represent one lot which can comprise several hundred, or even several million, bottles used in the lyophiliser <NUM>. Moreover, the bottles may be loaded into a lyophiliser on several stacked shelves. After loading the containers <NUM> into the lyophiliser, the internal temperature and pressure within the lyophiliser is reduced until the water present in each bottle <NUM> is vaporized and exits the container through the vents <NUM> in the stoppers <NUM> and the space between cap <NUM> and the collar <NUM>, as represented by the arrows F1 in <FIG>.

After expelling a pre-determined amount of water, such that the product P is sufficiently dry, a press <NUM> may apply a force E2 over all of the closure devices <NUM> inside the lyophiliser, as represented in <FIG> and <FIG>. The force E2 is evenly applied on the devices <NUM> parallel to the longitudinal axis X1 of the bottles <NUM> and the necks <NUM>. This axial force E2 exerted by the press <NUM> inside the lyophiliser may be pneumatically controlled or by a mechanical jack <NUM>, for example. The force E2 applied by the press <NUM> causes axial displacement of the closure devices <NUM> towards their respective containers <NUM>. As a result, the elastomeric stoppers <NUM> are first inserted to a depth within the openings <NUM> in each container <NUM>, such that the vents <NUM> are no longer exposed and the contents P of the containers <NUM> are isolated from the exterior of the containers <NUM>, and second, further depression of the closure devices <NUM> by the press <NUM> causes the caps <NUM> to capture the respective necks <NUM> of each container <NUM>, thereby compressing and sealing the stoppers <NUM> against the top sides <NUM> of the necks <NUM> of the containers <NUM>.

Referring now to <FIG>, a closure device <NUM> according to an embodiment is illustrated. As previously described, the closure device comprises an elastomeric stopper <NUM>, a ring portion <NUM>, a crown portion <NUM>, and a lid <NUM>. The lid <NUM> is attached to the crown portion <NUM> and is preferably configured to be easily removed by one hand of the user, for example. The closure device <NUM>, and more particularly each component of the closure device <NUM> as described in detail herein, is preferably made of a plastic material, and more preferably a thermoplastic material such as, but not limited to, PE, PET, PETG, PEHD, polypropylene (PP) or acrylonitrile butadiene styrene (ABS). More preferably, the closure device <NUM> is made of a pharma grade polypropylene material, and more particularly a pharma grade polypropylene material that is free of contaminants or critical substances (e.g., bisphenol A or formaldehyde).

As best viewed in <FIG>, the lid <NUM> comprises a top portion that may optionally include a plurality of notches <NUM> around the perimeter of the top surface of the top portion. The notches <NUM> may facilitate the centering and application of force by an automated manufacturing line to attach the lid <NUM> to the crown <NUM>. A lid skirt <NUM> may downwardly extend from the top portion of the lid <NUM>, and a plurality of axially extending cuts <NUM> may be provided in the lid skirt <NUM> to more easily deform and separate the lid <NUM> from the crown <NUM> when a user intends to access the stopper <NUM>. The lid <NUM> may further comprise a plurality of deformable tabs <NUM> that extend axially from the underside of the top portion of the lid <NUM> for attaching the lid <NUM> to the crown <NUM>.

As best viewed in <FIG>, the crown <NUM> includes a top portion having a centrally located aperture <NUM>, as well as a crown skirt <NUM> downwardly extending from the top portion and is intended to constitute the external peripheral envelope of the closure device <NUM>. The circumferential wall of the crown skirt <NUM> includes a plurality of radially inwardly protruding arcuate ledges <NUM> for providing a surface that may be captured by the ring portion <NUM> in the sealed condition, described in greater detail below. Above each ledge <NUM> is an opening <NUM>. The ledges <NUM> and openings <NUM> are preferably equidistantly spaced about a common circumference of the skirt <NUM>. Referring to <FIG>, the lid <NUM> and crown <NUM> are illustrated in the assembled condition. The plurality of tabs <NUM> are inserted through the aperture <NUM> of the crown <NUM> and the tabs <NUM> are deformed in order to provide each of the tabs <NUM> with a lip <NUM> that captures the underside of the top portion of the crown <NUM>.

Referring to <FIG>, the ring portion <NUM>, similar to the crown portion <NUM>, includes a top portion having a centrally located aperture <NUM> and a skirt portion <NUM> downwardly extending from the top portion. The ring portion <NUM> includes a circular interior section whose internal diameter is sufficient to allow it to surround the collar <NUM> of the vial <NUM>. The top portion is further provided with a collar <NUM> configured to catch the ledges <NUM> of the crown <NUM> when the closure device <NUM> is in the sealed condition, described in greater detail below. A bottom portion <NUM> of the ring <NUM> located on an opposing end of the ring <NUM> relative to the top portion includes a plurality of axially extending resilient locking tabs <NUM>, wherein the distal end of the locking tabs <NUM> (i.e. the end of the locking tabs <NUM> closest to the bottom portion <NUM>) are preferably hingedly attached to the bottom portion <NUM>. Each of the locking tabs <NUM> are located within a window <NUM> in the circumferential wall of the ring skirt <NUM>. As best viewed in <FIG>, the ring <NUM> preferably comprises two pairs of locking tabs 534a and 534b, wherein the locking tabs 534a of the first pair being located in opposing relation to each other about the circumference of the ring skirt <NUM> and the locking tabs 534b of the second pair being located in opposing relation to each other about the circumference of the ring skirt <NUM>. The locking tabs 534a of the first pair have an axial height X and a circumferential width A, and the locking tabs 534b of the second pair have an axial height Y and a circumferential width B, wherein the axial height X is less than the axial height Y and the circumferential width A is less than the circumferential width B.

The circumferential wall of the ring skirt <NUM> is also provided with plurality of circumferential ribs <NUM> and a plurality of apertures <NUM> located at an axial height between the collar <NUM> and the locking tabs <NUM>. Each of the apertures <NUM> includes an inwardly radially extending retaining arm <NUM> attached to the lower edge of the aperture <NUM>.

As best viewed in <FIG> and <FIG>, the ring <NUM> may further comprise a circular protuberance <NUM> on the bottom surface of the top portion around the centrally located aperture <NUM>. The protuberance <NUM> ensures that an evenly distributed force is applied to the top surface of the stopper <NUM>, when the closure device is in a sealed condition. As illustrated in <FIG>, the circular protuberance <NUM> is in the form of a continuous circle. In other embodiments, such as the ring illustrated in <FIG>, the circular protuberance may comprise a plurality of segments 538a, 538b, 538c, 538d, 538e. The segments are preferably of equal size and spaced evenly to ensure the aforementioned evenly distributed force when the closure device in the sealed condition. Increasing the space between each of the plurality of segments also reduces the force necessary to compact the closure device and achieve the sealed condition.

Prior to affixing the closure device <NUM> to a container, the stopper <NUM> is preloaded into the ring portion <NUM>. In order to ensure that the stopper <NUM> remains within the ring portion <NUM>, the previously mentioned retaining arms <NUM> extend inwardly to a diameter that is less than the diameter of the flange <NUM> of the stopper <NUM>, thereby, retaining the stopper <NUM> within upper inner chamber of the ring portion <NUM>. To further retain the stopper <NUM> within the upper chamber of the ring portion <NUM>, the inner circumferential surface of the skirt <NUM> adjacent to the top portion of the ring <NUM> is provided with a plurality of raised steps <NUM>. The raised steps <NUM> extends inwardly radially to a diameter that is less than or equal to the diameter of the stopper flange <NUM> in order to provide an interference fit between the stopper <NUM> and the inner chamber of the ring <NUM>. However, it is preferred that the raised steps <NUM> are only present along a portion of the inner circumference of the upper chamber adjacent the top portion of the ring <NUM> in order to minimize the force necessary to compress the stopper flange <NUM> and lock the closure device <NUM> in the sealed condition. The raised steps <NUM> are present, with increasing preference in the order presented, about <NUM>% or less, <NUM>% or less, <NUM>% or less, <NUM>% or less, <NUM>% or less, <NUM>% or less, <NUM>% or less, <NUM>% or less, <NUM>% or less, or <NUM>% or less of the inner circumference of the ring skirt <NUM>.

After affixing the lid <NUM> to the crown <NUM> and loading the stopper <NUM> into the ring <NUM>, the crown <NUM> is then telescopically mounted over the ring <NUM> the plurality of circumferential ribs <NUM> of the ring <NUM> mates with an inner circumferential groove <NUM> of the crown <NUM>, thereby providing the closure device <NUM> in an assembled condition, as best viewed in <FIG>.

In practice, the geometry of ring <NUM>, crown <NUM> and lid <NUM> is chosen in such a way that the maximum exterior diameter of the crown <NUM> has a value less than <NUM>, more preferably between <NUM> and <NUM>, and most preferably less than or equal to <NUM>. In these conditions, when one uses a vial <NUM> whose body <NUM> has a diameter equal to <NUM>, the closure device <NUM> mounted onto the vial <NUM> does not exceed or slightly exceeds the diameter of the vial <NUM>. This reduces the likelihood that the bottles will be imbalanced and easily tip over when the closure device <NUM> is applied or during lyophilization.

A method of sealing a vial using a closure device according to another embodiment disclosed herein will be described with reference to <FIG>. In the configuration in <FIG>, a crown <NUM> is in a holding configuration in which external ribs <NUM> of a ring <NUM> remain inserted in an inner peripheral groove <NUM> of the crown <NUM>. In this configuration, the crown <NUM> does not interact with locking tabs <NUM> of the ring <NUM>.

Applying a force E2 has the effect of making the crown <NUM> move in the direction of the bottom <NUM> of each of the vials <NUM>, as represented by the passage from the configuration in <FIG> and <FIG> to that of <FIG> and <FIG>. The E2 force is transmitted from the crown <NUM> to the ring <NUM> because of the interference fit between the peripheral groove <NUM> and the external ribs <NUM> which cooperate. Thus, external ribs <NUM> and the peripheral mouth <NUM> constitute the force transmission means E2 from the crown <NUM> to the ring <NUM>. The force E2 exerted on each device <NUM> has the effect of sliding the tabs <NUM> of the ring <NUM> along the outer surface of the vial collar <NUM>, and ultimately under the vial collar <NUM>. The retaining arms <NUM> also impinge and slide along the outer surface of the vial <NUM>, thereby causing the retaining arms <NUM> to deflect radially outwards and into their respective apertures <NUM>, such that the retaining arms <NUM> no longer contact or interfere with the bottom surface of the stopper flange <NUM> and allow the stopper to be inserted into the opening of the vial <NUM>.

The top section of the ring <NUM> contacts with the upper surface <NUM> of the stopper <NUM> which halts the progression of the ring <NUM> in the direction of the base <NUM>. The continued application of the force E2 on the crown <NUM> of each device <NUM> has the effect of driving the external rib <NUM> of the ring out of the peripheral groove <NUM> by elastic deformation of the skirt <NUM>, which allows the crown <NUM> to successively attain the position of <FIG>. This allows the edge <NUM> of the crown <NUM> to make contact with the surfaces <NUM> of the different locking tabs <NUM>, as represented in <FIG>. The continuation of this movement has the effect of making the surfaces <NUM> slide against the edge <NUM>, which flaps the tabs <NUM> radially towards the axis X1, by moving their free side <NUM> against the inferior peripheral surface <NUM> of the collar <NUM>, as represented in <FIG>. Thus, the edge <NUM> allows the locking tabs <NUM> to be put into an active configuration where they immobilise the cap <NUM> on the neck <NUM>.

This movement also has the effect of causing ledges <NUM> below the openings <NUM> in the crown <NUM> to catch the undersurface <NUM> of the annular collar <NUM> of the ring <NUM>. D531 shows the maximum diameter of the annular collar <NUM>. D543 shows the minimum diameter shared by the radially innermost points of each of the ledges <NUM> towards an axis X52. The zones <NUM> below the arcuate ledges <NUM> are elastically deformed by sliding against the surface <NUM> of the ring collar <NUM>, while passing from the configuration of <FIG> to the configuration of <FIG>. The resiliency of zones <NUM> cause the zones <NUM> to revert to their original shape after the ledges <NUM> are below the annular collar <NUM>, such that the annular collar <NUM> provides a catch or stop preventing any separation between the crown <NUM> and the ring <NUM> that may occur from vertical axial displacement of the crown <NUM> relative to the ring <NUM>. Therefore, if a withdrawal force E3 of the crown <NUM> is exerted on the closure device, as represented in <FIG>, both the ledges <NUM> will be impeded by the annular collar <NUM> and the locking <NUM> will be impeded by the vial collar <NUM>.

The result of this is a particularly effective locking of the crown <NUM> around the ring <NUM>, in the configuration of <FIG>. Once the closure device <NUM> is mounted on the neck <NUM> of a vial <NUM>, the only way to access the stopper <NUM>, and through this, the contents of the vial <NUM>, is to remove the lid <NUM> by separating the lid <NUM> from the crown <NUM>.

Claim 1:
A closure device for sealing a container (<NUM>) having a neck (<NUM>) with an opening and an annular collar (<NUM>) comprising:
a stopper (<NUM>); and
a cap assembly configured to surround both the stopper (<NUM>) and the neck (<NUM>) in a sealed condition, the cap assembly comprising:
a ring (<NUM>) containing the stopper (<NUM>) and comprising a plurality of locking tabs (<NUM>), and
a crown (<NUM>) comprising a skirt (<NUM>) telescopically mounted over the ring (<NUM>), the skirt (<NUM>) being configured to radially deflect the plurality of locking tabs (<NUM>) inwardly under the annular collar (<NUM>) when the crown (<NUM>) is axially displaced towards the neck (<NUM>) of the container (<NUM>),
wherein a first locking tab (534a) of the plurality of locking tabs (<NUM>) has a first axial height (X) and a second locking tab (534b) of the plurality of locking tabs (<NUM>) has a second axial height (Y) and the first axial height (X) is less than the second axial height (Y).