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.
In one aspect, a closure device is provided 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.
In another aspect, a closure device is provided for sealing a container having a neck with an opening and an annular collar. The closure device comprises a stopper having a flange and a cap assembly. The cap assembly is configured to surround both the stopper and the neck in a sealed condition and comprises a ring and a crown. The ring contains the stopper and includes a plurality of locking tabs. The crown comprises a skirt telescopically mounted over the and is configured to radially deflect the plurality of locking tabs inwardly under the annular collar. The ring also comprises an inner circumferential surface including a plurality of raised steps extending inwardly radially from the inner circumferential surface to a diameter that is less than or equal to the diameter of the stopper flange.
These and other aspects of the various embodiments disclosed herein will be apparent in view of the following description.
Various aspects and embodiments of the application will be described with reference to the following figures. It should be appreciated that the figures are not necessarily drawn to scale. 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. Structural features of systems and apparatuses described herein may be replaced with functionally equivalent parts. Moreover, it will be appreciated that features from the embodiments may be combined with each other without departing from the disclosure.
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 U.S. Pat. No. 8,714,384, the content of which is incorporated by reference herein in its entirety. For example, referring to
In
The device 50 also comprises a cap 52 aimed at covering and maintaining the stopper 51 and the neck 12 in a closed configuration. The stopper 51 is preferably pre-loaded into the cap 52 and held in an axial position prior to affixing the cap onto the neck 12 of the bottle 1, described in greater detail below. After filling the closure device 50 is applied to the neck 12 of each container 1, such that the stopper 51 does not completely fill the mouth 11. The stopper 51 is preferably provided with a vent 512 which communicates with the atmosphere on the exterior of the container 1. A plurality of filled containers 1 having a closure device 50 applied thereon may then be loaded into a lyophiliser 300, as illustrated in
After expelling a pre-determined amount of water, such that the product P is sufficiently dry, a press 301 may apply a force E2 over all of the closure devices 50 inside the lyophiliser, as represented in
Referring now to
As best viewed in
As best viewed in
Referring to
The circumferential wall of the ring skirt 532 is also provided with plurality of circumferential ribs 520 and a plurality of apertures 536 located at an axial height between the collar 531 and the locking tabs 534. Each of the apertures 536 includes an inwardly radially extending retaining arm 537 attached to the lower edge of the aperture 536.
As best viewed in
Prior to affixing the closure device 50 to a container, the stopper 51 is preloaded into the ring portion 53. In order to ensure that the stopper 51 remains within the ring portion 53, the previously mentioned retaining arms 537 extend inwardly to a diameter that is less than the diameter of the flange 510 of the stopper 51, thereby, retaining the stopper 51 within upper inner chamber of the ring portion 53. To further retain the stopper 51 within the upper chamber of the ring portion 53, the inner circumferential surface of the skirt 532 adjacent to the top portion of the ring 53 is provided with a plurality of raised steps 539. The raised steps 539 extends inwardly radially to a diameter that is less than or equal to the diameter of the stopper flange 510 in order to provide an interference fit between the stopper 51 and the inner chamber of the ring 53. However, it is preferred that the raised steps 539 are only present along a portion of the inner circumference of the upper chamber adjacent the top portion of the ring 53 in order to minimize the force necessary to compress the stopper flange 510 and lock the closure device 50 in the sealed condition. The raised steps 539 are present, with increasing preference in the order presented, about 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the inner circumference of the ring skirt 532.
After affixing the lid 56 to the crown 54 and loading the stopper 51 into the ring 53, the crown 54 is then telescopically mounted over the ring 53 the plurality of circumferential ribs 520 of the ring 53 mates with an inner circumferential groove 545 of the crown 54, thereby providing the closure device 50 in an assembled condition, as best viewed in
In practice, the geometry of ring 53, crown 54 and lid 56 is chosen in such a way that the maximum exterior diameter of the crown 54 has a value less than 13.5 mm, more preferably between 12.8 and 13.2 mm, and most preferably less than or equal to 12.8 mm. In these conditions, when one uses a vial 1 whose body 16 has a diameter equal to 13 mm, the closure device 50 mounted onto the vial 1 does not exceed or slightly exceeds the diameter of the vial 1. This reduces the likelihood that the bottles will be imbalanced and easily tip over when the closure device 50 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
Applying a force E2 has the effect of making the crown 54 move in the direction of the bottom 14 of each of the vials 1, as represented by the passage from the configuration in
The top section of the ring 53 contacts with the upper surface 511 of the stopper 51 which halts the progression of the ring 53 in the direction of the base 14. The continued application of the force E2 on the crown 54 of each device 50 has the effect of driving the external rib 535 of the ring out of the peripheral groove 5461 by elastic deformation of the skirt 533, which allows the crown 54 to successively attain the position of
This movement also has the effect of causing ledges 5431 below the openings 543 in the crown 54 to catch the undersurface 5313 of the annular collar 5311 of the ring 53. D531 shows the maximum diameter of the annular collar 5311. D543 shows the minimum diameter shared by the radially innermost points of each of the ledges 5431 towards an axis X52. The zones 5443 below the arcuate ledges 5431 are elastically deformed by sliding against the surface 5314 of the ring collar 5311, while passing from the configuration of
The result of this is a particularly effective locking of the crown 54 around the ring 53, in the configuration of
It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.
This application claims the benefit of and priority to U.S. Provisional Application No. 63/049,154, titled “CLOSURE DEVICE”, filed on Jul. 8, 2020, the entire content of which being incorporated by reference herein.
Filing Document | Filing Date | Country | Kind |
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PCT/US2021/040349 | 7/2/2021 | WO |
Number | Date | Country | |
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63049154 | Jul 2020 | US |