Patent Application
20130026167
The present invention relates to containers (including flexible bags and liners) for mixing of various solids, liquids, and gases and combinations thereof, and systems and methods for sealing such containers.
Various fields require use of containers for holding and processing substances. Mixing of components, such as different types of solids, liquids and/or gases, has numerous applications in different industries. For example, in the pharmaceutical industry, different types of drugs are mixed together. In the medical field, body fluids (such as blood) and/or drug components may be mixed. In the semiconductor field, wet solutions are combined with abrasives to make slurries and other processing fluids. The food industry also incorporates mixing operations into a number of applications, including mixing of water with dehydrated food for rehydration thereof.
Traditionally, mixing devices for industrial use have utilized glass tanks for processing small volumes of components, and a stainless steel tanks for larger volumes. Screws or impellers may be used to agitate and maintain powders within suspension, and to homogenize multiphase solutions. Prior to use, traditional mixing tanks must be washed and sterilized—such as employing an autoclave to wash and sterilize a small volume tank, or a water- and steam-based operation to wash and sterilize a larger volume tank. These wash, sterilize, and process operations, which are essential to the specified technologies, are typically time-consuming and expensive, and require highly qualified individuals for their performance. Further, periodic maintenance of mixing devices associated with the various technologies must be performed to ensure proper operation. In certain cases, washing/sterilizing operations as well as the maintenance of these mixing devices may represent more than a third of the total cost of operating and maintaining such mixing devices, which may be prohibitively expensive for given applications.
More recently, disposable containers (such as processing bags) have been developed to enable processing of substances without need for washing and sterilizing steps. For example, in biological processing, there is an ever-increasing need for disposable products, such as storage bags, which can range in size from ten to more than 3,000 liters. Current uses include storage of products or components awaiting further processing steps such as purification. Often, however, stored products or components (e.g., emulsions and suspensions) may undesirably separate into phases or components.
Various methods have been developed to maintain contents of disposable containers (e.g., processing bags) in mixed condition. For small volumes and/or low viscosity fluids, a magnetic stir bar or magnetically actuated stirring element may be used. For larger volumes and/or higher viscosity fluids, a mixing element may be operatively coupled with a mechanical driver and arranged to travel within an interior of the container.
Examples of disposable fluid processing containers and portions thereof are disclosed in U.S. Patent Application Publication No. 2009/0323466 entitled “SYSTEMS AND DEVICES FOR MIXING SUBSTANCES AND METHODS OF MAKING SAME” (and commonly assigned to the same assignee as the present application), and still further examples are shown in FIGS. 1 and 2A-2D.
Referring to
Another disposable processing container is shown in
Other conventional systems utilized to seal the openings in containers include snap-fitted caps (optionally in combination with gaskets), and screw caps (optionally including flexible seals).
Conventional sealing approaches are limited in their capability to promote ease of handling in combination with reliable sealing. Inadequate sealing of container openings can result from caps that are misaligned, screw caps with threads that become stripped or misconnected, and misalignment of caps with clamps and/or gaskets to containers. Such problems are exacerbated with flexible containers (e.g., bags or liners) that provide little or no support to counteract the forces incident to application of a cap to a container or clamping of the cap a container or fitment thereof.
A fitment is typically located at the top of a flexible container, and such container may be partially filled with material, thus leaving the fitment and mating parts unsupported and not horizontally level (since a partially filled non-rigid liner or bag will conform to an underlying surface). With a conventional sealing apparatus, a user may need to support a fitment with one hand while attempting to apply the sealing apparatus with one other hand. A user may need to align a gasket and cover while attaching and tightening a clamp. Another factor than can influence alignment of the parts and integrity of a resulting seal is differing dimensional tolerances of the part feature and related manufacturing variations. Although a flexible gasket will adopt subtle deformations, protrusions of the gasket may not always properly align to corresponding depressions or grooves in the fitment and cover, such that the gasket may be forced into an improper position whereby the desired seal is not created. Referring to
In many of the aforementioned applications, liquid-based compositions and process liquids may be exceedingly expensive or difficult to produce, and loss or contamination of fluid may require shutdown of a manufacturing process or manufacturing delays. There is a corresponding need in the art to provide containers adapted to retain a fluid-containing substance with caps or enclosure mechanisms that minimize contamination and loss of substances subject to storage in containers, including disposable containers such as bags and liners.
In particular, there is a need in the art to resolve cap and gasket misalignment when securing a cap to the opening or to a fitment of a container. Additionally, there is a need in the art for a sealing system that is easy to apply and remove, especially with a focus on non-rigid liners and bags where it is often difficult to apply a clamp (e.g., optionally including a tightening toggle) around a cap and fitment due to the lack of support conferred by a liner.
Moreover, a conventional flat cap arranged to close one end of a container fitment leaves a void or empty space within the interior of the fitment. When the container is filled with liquid contents up to the base of the fitment, the remaining void or empty space within the fitment provides a stagnant or dead volume proximate to the liquid contents. For example,
In consequence, the art continues to seek improvements in the sealing apparatuses for container openings to avoid contamination and leakage. It would also be a significant advance in the art, in applications in which high purity fluid-containing substances are consumed, to promote reliable and easy-to-use sealing mechanisms
The present invention relates in various aspects to caps for securing one or more openings in a container adapted to retain a fluid-containing substance, and containers and sealing apparatuses incorporating same.
In one aspect, the invention relates to a cap adapted to secure a gasket along an opening in a container (e.g., a container fitment), wherein at least part of a neck portion of the cap is of a conical or frustoconical shape to guide the cap into the opening, and the cap includes a gasket engaging member that cooperates with a corresponding engagement member of a gasket for secure placement of the gasket between the cap and the container opening.
In another aspect, the invention relates to container comprising: a flexible material bounding an interior volume; a fitment affixed to the flexible material and defining a passage bounded by a fitment wall extending between a proximal opening and a distal opening, the fitment comprising a rim adjacent to the proximal opening; a cap arranged for insertion into the tapered portion of the fitment wall, the cap comprising a neck portion and a lip portion that extends laterally outward relative to the neck portion, wherein at least part of the neck portion is conical or frustoconical in shape; and a gasket arranged for placement between the lip portion and the rim.
In another aspect, the invention relates to a container sealing apparatus arranged for sealing a container fitment including a proximal opening and a rim adjacent to the proximal opening, the container sealing apparatus comprising: a cap including a neck portion and a lip portion, wherein the neck portion is conical or frustoconical in shape and is adapted for insertion into the proximal opening of the container fitment, wherein the lip portion extends laterally outward relative to the neck portion; a gasket arranged for placement between the lip portion and the rim; and a closure retention element arranged to contact the lip portion of the cap and the rim of the container fitment with the gasket sealingly engaged therebetween.
In another aspect, the invention relates to a container sealing apparatus comprising: a cap including a neck portion, a lip portion, and at least one gasket securing feature, wherein the neck portion is conical or frustoconical in shape and is adapted for positioning within a threadless opening of a container, wherein the lip portion extends laterally outward relative to the neck portion and is adapted to inhibit the cap from traversing the opening of the container, and a gasket arranged for securement by the at least one gasket securing feature to seal the opening of said container.
In another aspect, the invention relates to an apparatus for delivery of a fluid-containing substance, the apparatus comprising: a flexible liner disposed within an overpack container defining an interstitial space between the liner and overpack container; and a fitment affixed to the liner, wherein the fitment defines a passage bounded by a wall extending between a proximal opening and a distal opening, wherein the fitment further comprises a rim adjacent to the proximal opening, and wherein said wall is tapered inward in a direction from the proximal opening toward the distal opening.
In another aspect, the invention relates to a container comprising: a fitment secured to a liner and arranged to receive a cap, wherein the fitment defines a passage bounded by an internally threadless fitment wall extending between a proximal opening and a distal opening, the fitment further comprising a rim adjacent to the proximal opening, wherein at least a portion of the fitment wall is tapered inward near the proximal opening; a cap adapted to be guided by the tapered wall of the fitment for positioning the cap to be received by the fitment, wherein the cap comprises a threadless neck portion and a lip portion that extends laterally outward relative to the neck portion, wherein at least part of the neck portion is conical or frustoconical in shape; and a gasket arranged for placement in between the lip portion and the rim.
In a still further aspect, any features of the foregoing aspects may be combined for additional advantage.
Other aspects, features and embodiments of the invention will be more fully apparent from the ensuing disclosure and appended claims.
Embodiments of the invention may be best understood by referring to the following description and accompanying drawings, which illustrate such embodiments. In general within the drawings, like numbers are intended to refer to like elements or structures. Reference numbers are the same for those elements that are the same across different Figures.
The disclosures of the following patents and patent applications are hereby incorporated by reference herein in their respective entireties: U.S. Pat. No. 7,431,494 entitled “FLEXIBLE MIXING BAG FOR MIXING SOLIDS, LIQUIDS, AND GASES;” U.S. Patent Application Publication No. 2010/0015696 entitled “DISPOSABLE BIOREACTOR;” U.S. Patent Application Publication No. 2009/0323466 entitled “SYSTEMS AND DEVICES FOR MIXING SUBSTANCES AND METHODS OF MAKING SAME;” U.S. Patent Application Publication No. 2003/0004608 entitled “LIQUID HANDLING SYSTEM WITH ELECTRONIC INFORMATION STORAGE;” and U.S. Provisional Patent Application No. 61/294,928 entitled “SUBSTANTIALLY RIGID COLLAPSIBLE LINER AND GUSSETED OR NON-GUSSETED WELD LINER AND METHODS OF MANUFACTURING THE SAME.”
The present invention relates in various aspects to caps, sealing mechanisms and containers adapted to retain liquids and liquid-containing substance, and systems incorporating same. Tapered (e.g., frustoconical) shapes may be utilized for fitment and/or cap portions to guide insertion of a cap into a fitment, in order to prevent misalignment of gasket alignment or sealing features.
Various embodiments of the present invention involve use of disposable and collapsible containers for retaining fluids and fluid-containing substances within an internal volume, such as a flexible fluid processing bag or liner.
A collapsible container may comprise a flexible or semi-flexible liner or bag, such as a thin film material. A collapsible container may be formed by techniques such as blow-molding or peripheral attachment of thin films. The term “collapsible” refers to a material that may be folded or compressed into a more compact shape. The term “flexible” refers to a material that is sufficiently supple or pliable to be repeatedly bent or flexed without breaking. A collapsible or flexible material may be elastic in character, with the term “elastic” referring to the property of a material where upon removal of an extending force, the material is capable of substantially recovering its original size and shape and/or exhibits a significant retractive force. A rigid or semi-rigid overpack or housing arranged to contain a collapsible liner may for example be formed of a high-density polyethylene or other polymer or metal, and the liner may be provided as a pre-cleaned, sterile collapsible bag of a single layer or multi-layer laminated film materials, including polymeric materials such as polyolefins, fluorinated polymers, polytetrafluoroethylene (PTFE), low-density polyethylene, PTFE-based multilaminates, polyamide, polyester, polyurethane, or the like, selected to be inert to the contained liquid or liquid-based material to be contained in the liner. While polymeric films are preferred materials for certain embodiments, exemplary materials of construction of a liner further include: metallized films, foils, polymers/copolymers, laminates, extrusions, co-extrusions, and blown and cast films. A liner or bag may comprise multiple materials that are laminated along faces thereof or joined along edges thereof, by conventional techniques such as thermal bonding, ultrasonic welding, hot plate welding, and the like. Rigid collapsible liners, and gusseted or non-gusseted weld liners, such as disclosed in U.S. Provisional Patent Application No. 61/294,928 filed on Jan. 14, 2010 (which is hereby incorporated by reference as if set forth fully herein), which have recently been developed and are known to Applicant, may also be used.
In certain embodiments, a fluid processing bag or liner may be constructed and arranged to cooperate with a support frame, wherein one or more hooks are utilized to support the liner. A bag or liner may be supported by a support frame with one or more hooks or support members (gussets, rings, and the like) being provided to secure the bag or liner.
Collapsible containers such as fluid processing bags and liner may also clear or substantially optically transparent to permit viewing of contents therein. In addition, both containers and liners may be adapted to accommodate sterilization procedures to eliminate or neutralize contaminants.
In certain embodiments, a sealable volume between a fluid processing bag or liner, and a housing or overpack, may be pressurized to discharge the contents of the processing bag or liner to a desired point of use. Such point of use may include a process tool and/or any of various flow directing elements.
A collapsible container such as a fluid processing bag or liner according to one embodiment may define a compressible volume therein and is preferably adapted for selective material discharge therefrom. Such volume may be bounded or defined by at least one of a bag, a bladder, a bellows, a collapsible liner, a flexible container wall, and a movable container wall to permit compression or full collapse of the compressible volume. A container may include a collapsible liner or other substantially non-rigid element defining the compressible volume and disposed within a housing or overpack that may be generally rigid, or at least substantially more rigid than the liner.
In one embodiment, a liner may be semi-rigid and collapsible in character, but at least partially self-supporting.
In one embodiment, a liner may be arranged for use with a mixing element, such as a mixing paddle, agitator, impeller, magnetic stirbar, or the like. In one embodiment, a liner may include a sealed sleeve arranged to receive a mixing paddle arranged to travel within the interior volume of the liner to mix the contents therein, with the sleeve serving as a barrier between the mixing paddle and the contents of the interior volume of the liner.
Embodiments as disclosed can be utilized in various applications, for storage and transport of any liquids, fluid-containing substances, chemicals, or compositions within a container (e.g., a collapsible container such as a processing bag or liner).
In one embodiment, a cap for a container includes a neck portion, of which at least a part is conical or frustoconical in shape to help align the cap during insertion into an opening of a container to seal the opening. The term “container” in this context includes a processing bag or a liner. In one embodiment, a fitment (or other container access port) includes an inner wall of which at least a portion is tapered inward, from a larger dimension near a proximal opening (i.e., arranged closer to an outer edge of a fitment) to a smaller dimension near a distal opening (i.e., arranged farther from an outer edge of a fitment, and closer to the interior of a liner or container to which the fitment is mounted) to guide the cap during insertion of the neck portion thereof into the fitment or other container access port. In one embodiment, at least a portion of the inner wall of the fitment near the proximal opening is tapered inward at a similar or substantially equal angle as that of the conical or frustoconical shaped neck portion of a cap adapted to be received by the fitment. The cap may include a lip portion that extends laterally outward relative to the neck portion, and have an associated gasket arranged for compression against the lip portion (and against a rim of the fitment) when the cap is received by the fitment. At least a portion of the lip of the cap is greater in width (e.g., diameter), than a proximal opening of the fitment opening defined by the inner edge of the rim of the container or fitment.
A cap as described herein is preferably more rigid than an associated gasket. A cap may be manufactured from polymeric, fiber-reinforced, and/or composite materials by conventional techniques such as molding.
In one embodiment, a cap having a lip is arranged to secure a gasket between the lip and a rim of the fitment, wherein at least one of the lip and the rim includes at least one engaging member (or securing feature) for securing the gasket. The conical or frustoconical form of at least part of the neck of the cap helps to align a gasket during insertion of the cap into a fitment or other container port. The conical or frustoconical neck portion of the cap also helps continue this alignment while the user is securing the cap to the fitment or container port. With the neck of the cap closely matching a tapered shape of the inner wall of the fitment, the cap, gasket and fitment are prevented from moving out of a concentric alignment when being secured together. This permits a user to support a fitment with one hand, and utilize the other hand to depress the cap against the gasket and into the fitment, while concentric alignment between the fitment, gasket, and cap are maintained.
In one embodiment, the gasket does not extend beyond the outer diameter of the lip of the cap or beyond the outer diameter of the rim of the fitment or container when the gasket is sandwiched between the lip and the rim. In one embodiment, the gasket does not extend inside an inner diameter of the lip of the cap into the space occupied by the neck of the cap, or inside an inner diameter of the rim of the fitment (or container port) into the proximal opening of the fitment or port.
In certain embodiments, a cap defines a recess arranged to facilitate manipulation of the cap by a user, and the recess is externally accessible when the cap is mated with the container (i.e., at a fitment or container port). The recess may extend from a top surface of the cap, and into the neck portion thereof, with the container neck material maintaining a barrier between the recess and contents of the container when the cap is inserted into a container fitment. Such a recess permits one or more fingers of a user to be inserted into the recess for securement or removal of the cap. Such a recess may additionally or alternatively afford room for one or more walls or handles to be added to provide a gripping surface. One or more segmenting walls or handles may be used as a means for easily managing a cap when inserting or removing same from a container or fitment assembly. In one embodiment, a portion of a handle or segmenting wall may extend upward from the cap opposite the neck. One or more segmenting walls may be arranged to divide the recess into a plurality of segments. Such segmenting wall(s) may extend inward from lateral walls of the cap bounding the recess, and/or may extend upward from a bottom wall of the recess. In one embodiment, one or more segmenting walls may separate the recess into two, three, four, or more recess segments each arranged to receive at least one finger or a user. In one embodiment, a recess defined in a cap may be devoid of any handle or segmenting wall, to allow a user to insert one or more fingers into the recess for manipulation of a cap by contact with the bottom and/or side walls of the recess.
In one embodiment, a container cap includes a neck portion that is conical or frustoconical in shape, a lip portion of the cap and a rim of the fitment are devoid of gasket retaining features, and an annular gasket having flat top and bottom surfaces is disposed between the lip and the rim. The neck portion of the cap is inserted through an aperture defined by the gasket and into a proximal opening of the fitment. The outer diameter of the upper end of the neck portion (i.e., below the lip portion) is preferably close in dimension to the inner diameter of the proximal opening of the fitment, to promote axial alignment between the cap, the gasket, and the fitment as the neck portion of the cap is inserted into the fitment.
In one embodiment, the height of the cap from a distal end to the bottom of the lip is similar to the height of a fitment, and is preferably substantially equal to the combined height of the fitment and associated gasket, so that upon insertion of the neck portion cap into the fitment, the inserted portion of the cap occupies the majority of the internal volume of the fitment. In various embodiments, the portion of the internal volume of the fitment that is occupied by the portion of the cap inserted into the fitment is at least about 50%, more preferably at least about 65%, more preferably at least about 80%, more preferably at least about 90%, and more preferably at least about 95%.
In one embodiment disclosed in
Although the assembly shown in
Various caps are described hereinafter. It is to be understood that such caps may be utilized in conjunction with a gasket and a fitment (or other container opening) similar to those illustrated and described in connection with
Although various assemblies shown herein depict gaskets having protrusions arranged for mating with corresponding recesses defined in a rim of a fitment and a lip of a cap, respectively, it is to be understood that such a gasket may additionally or alternatively include one or more recesses (not shown) arranged for mating with corresponding protrusions (not shown) of the rim and lip, respectively. Multiple protrusions and/or depressions may be provided on a single surface if desired. Combinations of corresponding protrusions and recesses as mentioned herein represent examples of engaging members or gasket securing features, as may cooperate with one another to secure a gasket in position between a rim and lip to promote positive sealing.
In further embodiments, gaskets with flat upper and/or lower surfaces may be utilized, without presence of any gasket retaining features associated with a cap and/or fitment.
Various dimensional arrows are provided in
While the invention has been has been described herein in reference to specific aspects, features and illustrative embodiments of the invention, it will be appreciated that the utility of the invention is not thus limited, but rather extends to and encompasses numerous other variations, modifications and alternative embodiments, as will suggest themselves to those of ordinary skill in the field of the present invention, based on the disclosure herein. Any of various elements or features recited herein is contemplated for use with other features or elements disclosed herein, unless specified to the contrary. Correspondingly, the invention as hereinafter claimed is intended to be broadly construed and interpreted, as including all such variations, modifications and alternative embodiments, within its spirit and scope.
This application claims priority to U.S. Provisional Patent Application No. 61/318,871 filed on Mar. 30, 2010, the entirety of which is hereby incorporated by reference herein, for all purposes.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/US11/30138 | 3/28/2011 | WO | 00 | 9/28/2012 |
| Number | Date | Country | |
|---|---|---|---|
| 61318871 | Mar 2010 | US |
