WO2021216821A1

WO2021216821A1 - Containment systems

Info

Publication number: WO2021216821A1
Application number: PCT/US2021/028562
Authority: WO
Inventors: Raymond Protasiewicz; Brian Costello; Alex LYNESS; Christopher Evans
Original assignee: West Pharmaceutical Services, Inc.
Priority date: 2020-04-24
Filing date: 2021-04-22
Publication date: 2021-10-28

Abstract

A containment system includes a vial and a lid. The vial may have a neck, an annular collar projecting from the neck, and an opening. The lid includes a base having a bottom surface and a first and second arm attached to the base, each of the first and second arms having a proximate portion and a distal catch. The base is between the proximate portion and the distal catch. In an installed condition, the bottom surface of the base is in sealing contact with the top surface of the vial, and the distal catches capture the annular collar to prevent separation of the lid from the vial. The lid is configured such that urging the proximate portion of the first arm towards the proximate portion of the second arm causes at least one distal catch to release the annular collar, thereby allowing separation of the lid from the vial.

Description

CONTAINMENT SYSTEMS

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Application No. 63/015,046, filed on April 24, 2020, the disclosure of which is incorporated herein by reference.

BACKGROUND

[0002] Various embodiments disclosed herein are directed to containment systems for aseptic filling. More specifically, the various embodiments are directed to containment systems for the filling by hand of treatments, such as advanced therapies, within aseptic environments. Advanced therapies are a class of drug products made from human cell, gene and tissue for highly personalized medicines. The treatments are often produced in very small batch sizes and filled in containers, e.g. ten to one-hundred 2-10 ml vials, that are typically sealed with an elastomeric stopper and a metal seal crimped over the stopper.

[0003] Crimp top vials have historically been used for large volumes within a sterile automated filling environment, and therefore, supplied in large quantity bags. This poses a problem for low quantity manual, hand filling operations. The components of containment systems, e.g. vials, stoppers, etc., should be opened under a biosafety cabinet or laminar flow hood (per good aseptic technique) which can take up excess working room under the hood. Additionally, once the bags are opened, the components must remain under the hood to maintain sterility and will not be usable for future fills. It is preferable to first label the containers outside the hood prior to hand filling to mitigate risk of mislabeling the contents of a vial, which can be especially dangerous for patients; however, this may not be an option for bags of unsealed containers that must be opened under the hood. Furthermore, during the hand filling process, good aseptic technique requires operators not to reach over open vials to prevent contamination, thereby increasing the complexity of hand filling operations.

[0004] Thus, there is a need for improvement to containment systems that may meet the demands in hand filling operations described within aseptic environments. SUMMARY

[0005] According to one aspect, a containment system configured to be filled in aseptic environments comprises: a vial comprising a neck, an annular collar radially projecting from the neck, and an opening bounded by a top surface; and a lid comprising a base having a bottom surface and a first and second arm attached to the base, each of the first and second arms comprising a proximate portion and a distal catch, wherein the base is between the proximate portion and the distal catch. In an installed condition, the bottom surface of the base is in sealing contact with the top surface of the vial, and the distal catch of each of the first and second arms captures the annular collar to prevent separation of the lid from the vial. The lid is configured such that urging the proximate portion of the first arm towards the proximate portion of the second arm causes at least one distal catch to release the annular collar, thereby allowing separation of the lid from the vial.

[0006] According to another aspect, a containment system configured to be filled in aseptic environments comprises a vial comprising a neck, an annular collar radially projecting from the neck, an opening bounded by the annular collar, and a top surface; and an elastomeric lid comprising a base portion having an inner circumferential surface and a tab radially projecting from the base portion. In an installed condition, a bottom surface of the base portion is in sealing contact with the top surface of the vial, and the inner circumferential surface is in sealing contact with the annular collar.

[0007] According to yet another aspect, a containment system configured to be filled in aseptic environments comprises a vial comprising a neck, an annular collar radially projecting from the neck, an opening bounded by the annular collar, and a top surface; and a lid comprising a base having a bottom surface, a first and second arm downwardly depending from the base, and a ring, each of the first and second arms having a first end attached to the base, a second end attached to the ring, and an inwardly extending catch. In an installed condition, the bottom surface of the base is in sealing contact with the top surface of the vial, and the catch of each of the first and second arms captures the annular collar to prevent separation of the lid from the vial. The ring is configured such that deformation of the ring urges the second end of the first arm away from the second end of the second arm and causes at least one catch to release the annular collar, thereby allowing separation of the lid from the vial. [0008] These and other aspects of the various embodiments disclosed herein will be apparent in view of the following description.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0009] 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 refer to the same or similar elements.

[0010] Figure 1A is a front plan view of a lid that may be used in a containment system according to a first embodiment.

[0011] Figure IB is a bottom plan view of the lid of Figure 1 A.

[0012] Figure 1C is a left side plan view of the lid of Figure 1 A.

[0013] Figure ID is a top plan view of the lid of Figure 1 A.

[0014] Figure IE is a bottom perspective view of the lid of Figure 1 A.

[0015] Figure 2A is a front plan view of the lid of Figure 1 A in an installed condition.

[0016] Figure 2B is a cross-sectional right-side view of the lid in an installed condition along axis A- A of Figure 2 A.

[0017] Figure 2C is a left side plan view of the lid of Figure 1 A in the installed condition.

[0018] Figure 2D is a cross-sectional front plan view of the lid in an installed condition along axis B-B of Figure 2C.

[0019] Figures 3A, 3B, and 3C are photographs illustrating a method of removing the lid of Figure 1 A from a vial. [0020] Figure 4 is a top perspective view of a lid that may be used in a containment system according to a second embodiment.

[0021] Figure 5A is a front plant view of a lid that may be used in a containment system according to a third embodiment.

[0022] Figure 5B is a bottom plan view of the lid of Figure 5 A.

[0023] Figure 6A is a front plan view of a lid that may be used in a containment system according to a fourth embodiment in an installed condition.

[0024] Figure 6B is a cross-sectional right-side view of the lid in an installed condition along axis A- A of Figure 6 A.

[0025] Figure 6C is a side plan view of the lid of Figure 6A in the installed condition.

[0026] Figure 6D is a cross-sectional front plan view of the lid in an installed condition along axis C-C of Figure 6C.

[0027] Figure 7A is a front plan view of a lid that may be used in a containment system according to a fifth embodiment.

[0028] Figure 7B is a top plan view of the lid of Figure 7A.

[0029] Figure 8A is a brace that may be combined with a lid that may be used in a containment system according to the various embodiments.

[0030] Figure 8B is a front plan view of the brace of Figure 8 A in an installed condition.

[0031] Figure 8C is a top plan view of the brace of Figure 8 A in an installed condition.

[0032] Figures 9A and 9B are top perspective views of a containment system according to another embodiment.

[0033] Figure 10A is a top perspective view of a containment system according to yet another embodiment. [0034] Figures 10B and IOC are top plan views of the containment system of Figure 10A.

DETAILED DESCRIPTION

[0035] 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.

[0036] 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.

[0037] 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.

[0038] Generally, the containment systems according to the various embodiments disclosed herein include a container, such as a vial, that may be temporarily sealed with a lid that is easily removed by a user prior to a hand filling operation within an aseptic environment. Various common materials known by those of skill in the art may be used to form the containers in the containment systems according to the various embodiments disclosed herein. The materials may include, but are not limited to glass, metals, or polymeric materials, including, but not limited to, stainless steel, aluminum, polyethylene, HDPE, LDPE, COP, COC, POM, PET, nylon, polypropylene, and combinations thereof.

[0039] The single-use, sacrificial lid assists in maintaining the internal sterility of the containers after being removed from sterile secondary packaging. The secondary packaging containing the containers may therefore be opened outside of a biosafety cabinet or laminar flow hood to be labeled prior to filling because the sacrificial lid prevents particulates or other forms of contamination from entering the container. After transferring the sealed containers to the biosafety cabinet or laminar flow hood, an operator may remove the temporary enclosure easily with a single hand prior to filling the container with a product. The sacrificial lid also reduces the risks associated with reaching over an open container during the hand filling process within an aseptic environment because the containers may be maintained in a sealed condition immediately prior to and after filling. The sacrificial, single-use lids may also potentially be used in an automated filling system providing the potential to increase scale of manufacture.

[0040] Referring now to Figures 1 A to IE, a lid 100 is illustrated that may be used to cover a container, such as a vial, in a containment system according to a first embodiment. The lid 100 includes a base portion having a top surface 102 and a bottom surface 103. The shape and area of the base portion is preferably sufficiently large to cover the opening of a container, such as a vial. An optional plug 104 may axially project from the bottom surface 103 of the base portion. The shape and dimensions of the plug 104 are preferably configured to mate, i.e. plug, the opening in the container.

[0041] The lid 100 further comprises a first arm 106a and a second arm 106b. The first and second arms 106a, 106b may be generally perpendicular to the base portion and preferably located in opposing relation around the perimeter of the base portion. Each of the first and second arms 106a, 106b has a proximate portion 108a, 108b located at a first top end of each of the first and second arms 106a, 106b, as well as a distal catch 110a, 110b located at an opposing second bottom end of the first and second arms 106a, 106b. The first and second arms 106a, 106b can both be attached in a hinged way or only one of the arms can be attached hingedly to the base portion at a point between the proximate portion 108a, 108b and distal catch 110a, 110b. The point of attachment of the first and second arms 106a, 106b to the base portion forms a fulcrum, thereby allowing the first and second arms 106a, 106b to operate as a lever, which will be discussed in further detail below. While in some embodiments, the first and second arms 106a, 106b may be parallel, in other embodiments, the first and second arms 106a, 106b may be angled relative to each other. For example, the first and second arms 106a, 106b may be oriented, such that the distance between the distal catches 110a, 110b is less than the distance between the proximate portions 108a, 108b to form a V-like configuration.

[0042] Because the user performing the manual filling operation may be wearing up to two layers of rubber gloves in an aseptic environment, the outer surface of the proximate portions 108a, 108b are preferably roughened or provided with a plurality of lateral ribs or grooves, for example, in order to facilitate gripping by the index finger and thumb of a user. The gripping features on the proximate portions 108a, 108b also reduce the likelihood of index finger or thumb of the user from slipping due to the tension created from the first and second arms 106a, 106b being flexed inward during removal of the lid 100 from the container. To further prevent slipping, the proximate portions 108a, 108b may also be configured to having a profile that is wider at the top compared to the bottom and to include an at least partially concave curvature to provide additional grip and an ergonomic surface. The first and second arms 106a, 106b may optionally include one or more longitudinal structural ribs that extend at least a portion of the length of the first and second arms 106a, 106b along the outer and/or inner surface to provide rigidity and prevent flexing of the first and second arms 106a, 106b when the proximate portions 108a, 108b are urged towards each other. This reduces the amount of force and distance that the arms need to be flexed for the distal catches 110a, 110b to spread apart, as will be explained in greater detail below.

[0043] The distal catch 110a, 110b located at the second bottom end of the first and second arms 106a, 106b projects from the inner surface of the first and second arms 106a, 106b radially and inwardly, generally parallel with the plane of the base portion. As best viewed in Figure 1 A, the distal catches 110a, 110b have a chamfered edge, such that they are provided with an angled surface.

[0044] Referring now to Figures 2A to 2D, the previously described lid 100 is illustrated in combination with a vial 120 in the installed condition. The vial 120 includes a neck having an annular collar 122 radially projecting outward from the neck of the vial 120. The vial 120 also includes an opening that is bounded by a top surface 124 of the vial 120. As best viewed in Figures 2B and 2D, the bottom surface 103 of the base portion of the lid 100 is in sealing contact with the top surface 124 of the vial 120. The plug 104 axially extending from the bottom surface 103 may, if desired, also sealingly conform to the inner surface around the opening of the vial 120. As best viewed in Figures 2A and 2D, the catches 110a, 110b include a face that abuts the bottom surface of the annular collar 122, thereby capturing the annular collar 122 and facilitating the sealing contact between the bottom surface 103 of the lid 100 and the top surface 124 of the vial 120. As previously mentioned, the catches 110a, 110b may include a chamfered edge that provides an inclined face or ramp to allow the lid 100 to facilitate attachment of the lid 100 to the vial 120. The chamfered edge is located and configured, such that the lid 100 may be applied axially onto the top surface 124 of the vial 100. Upon impinging the annular collar 122, the chamfered edges cause the catches 110a, 110b to deflect radially outwards. As the lid 100 is pressed down onto the vial 120, the catches 110a, 110b remain deflected as they slide along the circumferential surface of the annular collar 122. Upon reaching the installed condition, the catches 110a, 110b pass the bottom surface of the annular collar 122 and snap back to their relaxed position to capture the annular collar 122. Thus, it is preferred that the length of the distal portion of the first and second arms 106a, 106b located below the base portion are about equal to the height of the annular collar 122 to ensure sealing contact between the bottom surface 103 of the base portion of the lid 100 and the top surface 124 of the vial 120.

[0045] Referring now to Figures 3A to 3C, photographs demonstrating the steps of removing the lid 100 from the vial 120 are provided. It is an aspect of the various embodiments disclosed herein to enable a user to remove the lid 100 from the vial 120 with a single hand. This would allow a user who is manually filling the vial to use the opposite hand to operate a needle, pipette, or tweezers, for example, to fill the vial with a liquid or solid immediately after removing the lid. The vial may remain covered and sealed within the aseptic environment until the user is ready to fill the vial, which prevents the user from inadvertently reaching over an open vial and potentially contaminating the vial. After filling, the vial may then be closed using a stopper and transferred to elsewhere in the aseptic environment to then have a seal crimped over the top.

[0046] In a first step, the first and second arms 106a, 106b are pinched between the index finger and thumb of a user, for example, in order to urge the proximate portions 108a, 108b toward each other. In this embodiment, because the first and second arms 106a, 106b are hingedly connected to the base portion of the lid 100, urging the proximate portions 108a, 108b toward each other causes the distal catches 110a, 110b to spread apart. When the distance between the distal catches 110a, 110b is greater than the width of the annular collar 122, the catches 110a, 110b no longer contact the bottom surface of the annular collar 122, and the lid 100 may be lifted off of the top surface of the vial 120 in a second step to expose the opening.

[0047] It is preferred that the lid is not made from a resilient material. Preferably, the lid should be made from a material, such that the lid is permanently deformed after sufficiently urging the proximate portions of the first and second arms together, i.e. the first and second arms are no longer parallel. Examples of materials that may be used to form the lid according to various embodiments include, but are not limited to, metals or polymeric materials, including, but not limited to, stainless steel, aluminum, polyethylene, HDPE, LDPE, COP, COC, POM, PET, nylon, polypropylene, and combinations thereof. It is preferred that the lids described herein and included in the various embodiments are molded from polymeric materials using customary practices known by those of skill in the art, such as injection molding, for example. Furthermore, the hinged connection points between the first and second arms and the base portion of the lid may be frangible or weakened, such that the first and second arms remain bent or at least partially separate from the base portion to provide a single-use lid that cannot be used to re-seal the vial after filling. This ensures that a user will use an appropriate component, such as a stopper, to seal the vial after filling within the aseptic environment. The stoppered vial may subsequently be crimped with a metal seal in either a manual or automated process.

[0048] Weakening of the hinged connection may occur when distal portions of the first and/or second arms deflect outwardly upon applying the lid axially onto the top surface of the vial, as previously described. Because it is preferred that the lid is a single-use lid, the chamfered edge of the catches may be re-configured to avoid weakening of the hinged connection points before the lid is removed during the filling operation. For example, referring to the alternative embodiment of the lid 400 illustrated in Figure 4, the chamfered edges may be provided on the sides of the catches 406a, 406b. In order to attach the lid 400 to a container, such as a vial, the lid 400 may be slid horizontally in a direction parallel to the plane of the base portion over the top surface of the vial. The sealed contact between the bottom surface 403 of the lid 400 and the top surface of the vial may be achieved when the opening of the vial is coaxial with the base portion of the lid 400. The lid 400 may exclude the optional plug on the bottom surface 403 of the base portion because the plug may interfere with the ability of the lid 400 to slide into position. Alternatively, the plug 403 could be present, but just not as pronounced, i.e. have a low profile. The flexibility or compressibility of the material used to form the plug may withstand the forces applied to the plug as the lid is slid into place over the rigid vial opening.

[0049] To further prevent deformation of the lid and weakening of the hinged connection prior to filling (e.g. vibration in transit when shipped), the containment systems according the various embodiments may include a blocking feature that prevents the proximate portions of the first and second arms from being urged towards each other. For example, referring to Figures 8A to 8C, a brace 810 is illustrated. The brace 810 includes a foot portion 814 and a vertically extending wall 812. The wall 812 is preferably perpendicular to the top surface of the foot portion 814. In the installed condition, the foot portion 814 of the brace 810 sits on the top surface of the base portion of the lid 800, and the wall 812 is oriented, such that each vertical side of the wall 812 abuts one of the inner surfaces of the first and second arms 806a, 806b. Thus, the brace 810 prevents removal of the lid 800 from a container until the brace 810 is removed. The brace 810 remains between the first and second arms 806a, 806b preferably by interference or frictional fit, for example. Upon removing the brace 810, the first and second arms 806a, 806b are free and capable of being deformed to remove the lid from the container.

[0050] In order to promote the sealed contact between the bottom surface of the lid and the top surface of the vial, the lid may be provided with a layer of resilient material on the bottom surface of the base portion, as illustrated in the embodiment of Figures 5 A and 5B. The base portion of lid 500 may be made from a plurality of materials. The top portion 502 of the base portion may be made from the same non-resilient material as the previously described embodiments, while the bottom portion 503 may be made from a resilient material, such as an elastomeric material. The resilient material provides the bottom surface of the base portion and operates similar to a gasket, for example, to ensure a tight seal between the bottom surface of the base portion of the lid 500 and the top surface of the container, as well as account for small pressure changes within the container. The optional plug 504 extending axially from the bottom surface of the base portion may also be formed from the same or similar resilient material to further promote a seal with the opening of the container.

[0051] Examples of the elastomeric material for forming the bottom portion of the base portion of lid 500 include, but are not limited to, polyisoprene; polybutadiene; styrene-butadiene copolymers; ethylene-propylene copolymers; ethylene-propylene-diene copolymers; chlorosulphonated polyethylene; ethylene-vinyl acetate copolymer; styrene-isoprene copolymers; fluoroelastomers such as FKM, perfluoro-elastomers (FFKM) and tetrafluoro ethylene/propylene rubbers (FEPM); synthetic or natural rubbers, such as butyl rubber, isoprene rubber, butadiene rubber, halogenated butyl rubber (e.g., bromobutyl rubber), ethylene propylene terpolymer, silicone rubber; combinations thereof and the like. Preferably, the elastomeric material is a butyl or halobutyl elastomer. The elastomeric material may further comprise one or more additives such as a vulcanizing agent, a vulcanizing accelerator, a vulcanizing activator, a processing aid, a filler, and a reinforcing agent to improve or enhance the properties of the elastomeric material.

[0052] To further promote the seal between the lid and the container and provide additional protection to the sterile barrier, the container may be provided with a shroud or skirt to increase the contact area between the two components. For example, referring to Figures 6A to 6D, the lid 600 may include a skirt 605 that downwardly depends, i.e. axially projects, from the top surface 602 of the base portion. The height of the skirt 605 is greater than the thickness of the base portion and preferably less than or equal to the height of the annular collar 622 of the vial 620, so that the lid 600 may be easily removed from the vial 620 prior to a filling operation. The skirt 605 surrounds at least a portion of the perimeter of the base portion of the lid 600. The inner surface of the skirt 605 may also be provided with a resilient material, such as the previously described elastomeric material, to provide an interference fit between and promote sealing contact between the inner circumferential surface of the skirt and the outer surface of the annular collar 622. It is preferred that the first and second arms 606a, 606b of the lid 600 are disconnected from the skirt 605 or at least connected to the skirt 605 with a frangible connection that may be easily broken, so that the hinged connection between the first and second arms 606a, 606b and the base portion is able to operate as a fulcrum without excessively warping the skirt 605, such that it may be difficult to remove the lid 600 prior to a filling operation.

[0053] To further promote the single-use aspect of the lid included in the various embodiments, the lid may be provided with a locking feature that maintains the orientation of the first and second arms after the lid is removed from the container. Thus, the likelihood of the lid being reused on a container is reduced and instead, the single-use item is correctly disposed. For example, referring to Figures 7A and 7B, a lid 700 may include a first locking projection 712a comprising a pair of generally parallel cantilevered arms extending inwardly from an inner surface of the first arm 706a and a second locking projection 712b comprising a pair of generally parallel cantilevered arms extending inwardly from an inner surface of the second arm 706b. The first and second locking projections 712a, 712b are preferably configured to couple when the proximate portions 708a, 708b of the first and second arms 706a, 706b are urged towards each other. For example, the free end of the cantilevered first locking projection 712a may be provided with one or more catches 714, and the free end of the cantilevered second locking projection 716 may be provided with one or more apertures 716. When the proximate portions 708a, 708b of the first and second arms 706a, 706b are urged towards each other, one or both of the first and second locking projections 712a, 712b may be slightly deflected until the catches 714 are in registry with the corresponding apertures 716, thereby allowing the first and second locking projections 712a, 712b to return to their original orientation and engage, thereby locking the first and second locking projections 712a, 712b together. Once locked, the first and second arms 706a, 706b will also maintain their non-parallel orientation and the spread between the first and second distal catches 710a, 710b. As would be appreciated by those of skill in the art, each of the locking projections 712a, 712b may instead comprise a single cantilevered arm instead of a pair of cantilevered arms or the location of the male and female locking features at the respective free ends of the locking projections may be reversed. A lid 700 in a locked state would provide a visual indication to the user that the seal between the lid 700 and the container has been broken, as well as indicate to the user that the lid is ready to be removed with correct clearance between the catches 710a, 710b and annular collar around the vial opening and without any fear of catching the edge of the container and causing it to tip over.

[0054] According to another embodiment, the containment system may include an elastomeric cap for temporarily sealing the opening of a container. The elastomeric material used to form the cap may be the same or similar material used to form the resilient, gasket-like layer in the previously described embodiment of Figures 5A and 5B. For example, referring to Figures 9A and 9B, an elastomeric cap 900 is illustrated in the installed condition on a vial 920 having an annular collar 922. The cap 900 may include a base portion 902 having a bottom surface and an inner circumferential surface 906 that is in sealing contact with the top surface and outer circumferential surface of the annular collar 922. To facilitate removal, the cap 900 may also include a tab 904 radially extending from the base portion 902. The tab 904 is preferably sufficiently long to allow a user to grasp the tab 904 and peel the cap 900 off of the top of the container 920. The cap 900 may include a plurality of tabs. Alternatively, the cap 900 may include a single tab that extends partially or completely around the circumference of the base portion 902. To increase the sealing contact between the cap 900 and the container 920, the base portion 902 may also include a downwardly depending skirt having a height that is approximately equal to the height of the annular collar 922, as well as an optional lip that extends radially inwardly around at least a portion of the circumference of the skirt. The lip may contact the bottom surface of the annular collar 922 when the cap 900 is in the installed condition.

[0055] According to yet another embodiment illustrated in Figures 10 A to 10C, a lid 1000 may include a base portion having a bottom surface in contact with a top surface of a container 1200. The container 1200 may be in the form of a vial having an annular collar 1222 surrounding the opening of the container 1200. The lid further comprises at least two arms 1060a, 1060b downwardly depending and generally perpendicular to the base portion in the installed condition. The first and second arms 1060a, 1060b are preferably located in opposing relation and generally parallel to each other in the installed condition. Each of the arms 1060a, 1060b includes a catch 1100 projecting from an inner surface of the arms 1060a, 1060b. In the installed condition, each catch 1100 contacts the bottom surface of the annular collar 1222 to capture the opening of the vial 1200 and provide a sealing contact between the top surface of the vial 1200 and the bottom surface of the base portion. Similar to the previously described embodiments, each catch may have a chamfered edge, so that the lid 1000 may be attached by axially forcing the lid 1000 down onto the top surface of the vial 1200. The bottom surface of the base portion may also optionally include a resilient material, such as an elastomer, to provide a gasket-like layer and promote the sealing contact between the bottom surface of the base portion and the top surface of the vial 1200.

[0056] Each of the first and second arms 1060a, 1060b may include a first end at which it is hingedly attached to the base portion of the lid 1000 and a second opposing end. Each of the second opposing ends may be attached to a ring 1120 that surrounds the vial 1200. The second opposing ends are preferably attached in opposing relation around the ring 1120. The ring 1120 is preferably ovular. The lid 1000 also preferably includes at least two pads 1080a, 1080b located on the ring 1120. The pads 1080a, 1080b are preferably located in opposing relation on the ring 1120, and one of each pad is preferably located at the midpoint between the second ends of the first and second arms 1060a, 1060b. Most preferably, the second ends of the first and second arm 1060a, 1060b are located in opposing relation along the minor axis of the ovular ring 1120 and the pads 1080a, 1080b are located in opposing relation along the major axis of the ovular ring 1120. [0057] As best viewed in Figures 10B and IOC, the lid 1000 may be removed from the container 1200 by first urging the pads 1080a, 1080b towards each other. Urging the pads 1080a, 1080b towards each other causes the ring 1120 to deform from an ovular shape (Figure 10B) to a circular shape (Figure IOC). The deformation causes the first and second arms 1060a, 1060b to deflect outwards, away from the annular collar 1222. When the spread between catches 1100 is sufficiently wide, such that at least one of the catches 1100 will no longer interfere or is no longer in contact with the bottom surface of the annular collar 1222, the lid 1000 may be lifted off of the top surface of the container 1200 to expose the opening of the container 1200. Similar to the previously described embodiments, it is preferred that the lid 1000 is not made from a resilient material and/or that the first ends of the first and second arms 1060a, 1060b are frangible or weakened, so that after removal the catches 1100 do not return to their original orientation in the sealed condition, and the single-use lid 1000 cannot be re-used and instead disposed of correctly. The lid 1000 may be made from the same or similar materials previously described, such as a metal or polymeric material. Preferably the lid may be made from a plastic, such as polypropylene, to provide the flexibility required. Alternatively, the entire lid may be made from an elastomeric material, so that the lid may be molded as a single piece to reduce the cost and complexity of manufacture.

[0058] The components of the containment systems made according to the various embodiments may be manufactured, sterilized, assembled, and bulk packaged into secondary packaging appropriate to maintain the sterility and cleanliness of the components. For example, the lids and containers may be sterilized separately prior to attaching the lids to the containers. Once assembled, the containment systems may be sterilized again before and/or after bulk packaging by steam, EtOH, gamma irradiation or e-beam irradiation. The sterile bulk packaged product may then be introduced into the aseptic filling environments and opened to access the assembled containment systems, i.e. sealed containers.

[0059] 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.

Claims

We claim:

1. A containment system comprising: a vial comprising a neck, an annular collar radially projecting from the neck, and an opening bounded by a top surface; and a lid comprising a base having a bottom surface and a first and second arm attached to the base, each of the first and second arms comprising a proximate portion and a distal catch, wherein the base is between the proximate portion and the distal catch, wherein in an installed condition, the bottom surface of the base is in sealing contact with the top surface of the vial, and the distal catch of each of the first and second arms captures the annular collar to prevent separation of the lid from the vial, and wherein the lid is configured such that urging the proximate portion of the first arm towards the proximate portion of the second arm causes at least one distal catch to release the annular collar, thereby allowing separation of the lid from the vial.

2. The containment system of claim 1, wherein the first arm and second arm are parallel in the installed condition.

3. The containment system of claim 1, wherein the first arm and second arm are hingedly attached to opposing sides of the base.

4. The containment system of claim 1, wherein the proximate portion of the first and second arms comprises a finger pad to facilitate urging of proximate portions together.

5. The containment system of claim 1, wherein the distal catch of the first and second arm includes at least one chamfered edge.

6. The containment system of claim 1, wherein the bottom surface of the base comprises an elastomeric material, and the elastomeric material is in sealing contact with the top surface of the vial in the installed condition.

7. The containment system of claim 1, wherein the lid further comprises a skirt downwardly depending from the base, and the skirt circumferentially surrounds the annular collar in the installed condition.

8. The containment system of claim 7 further comprising an elastomeric material on an inner circumferential surface of the skirt.

9. The containment system of claim 1, wherein the lid further comprises a first locking projection extending from an inner surface of the proximate portion of the first arm and a second locking projection extending from an inner surface of the proximate portion of the second arm, and wherein urging the proximate portion of the first arm towards the proximate portion of the second arm causes the first locking projection to engage the second locking projection.

10. The containment system of claim 1 further comprising a removable brace between the first and second arms configured to prevent urging of the proximate portion of the first arm towards the proximate portion of the second arm.

11. A containment system comprising: a vial comprising a neck, an annular collar radially projecting from the neck, an opening bounded by the annular collar, and a top surface; and an elastomeric lid comprising a base portion having an inner circumferential surface and a tab radially projecting from the base portion, wherein in an installed condition, a bottom surface of the base portion is in sealing contact with the top surface of the vial, and the inner circumferential surface is in sealing contact with the annular collar.

12. The containment system of claim 11, wherein the tab projects around the entire circumference of the base portion.

13. The containment system of claim 11, wherein the base portion further comprises an inwardly radially projecting lip and in the installed condition, the lip is in sealing contact with the annular collar.

14. A containment system comprising: a vial comprising a neck, an annular collar radially projecting from the neck, an opening bounded by the annular collar, and a top surface; and a lid comprising a base having a bottom surface, a first and second arm downwardly depending from the base, and a ring, each of the first and second arms having a first end attached to the base, a second end attached to the ring, and an inwardly extending catch, wherein in an installed condition, the bottom surface of the base is in sealing contact with the top surface of the vial, and the catch of each of the first and second arms captures the annular collar to prevent separation of the lid from the vial, and wherein the ring is configured such that deformation of the ring urges the second end of the first arm away from the second end of the second arm and causes at least one catch to release the annular collar, thereby allowing separation of the lid from the vial.

15. The containment system of claim 14, wherein the first arm and second arm are parallel in the installed condition.

16. The containment system of claim 14, wherein the first arm and second arm are attached to opposing sides of the base.

17. The containment system of claim 14, wherein the ring comprises first and second pads between the first and second arms to facilitate deformation of the ring.

18. The containment system of claim 14, wherein the catch of the first and second arms includes at least one chamfered edge.

19. The containment system of claim 14, wherein the bottom surface of the base comprises an elastomeric material, and the elastomeric material is in sealing contact with the top surface of the vial in the installed condition.

20. The containment system of claim 14, wherein the ring is ovular.