Closure system and kit

Abstract

The present invention relates to a closure system (3) for closing an opening (25) of a container (2), the closure system comprising a plug component (31), a retaining frame component (32), a cover component (33), and an integrity visualization component (35). The plug component (31) is made of an elastic material and has a plug portion (311) and a cover portion (312), the plug portion being configured to engage with the opening (25) of the container (2), and the cover portion being configured to abut a boundary surface (24) adjacent to the opening (25) of the container (2). The retaining frame component (32) is configured to be mounted to the container (2). The cover component (33) is reversibly mounted to the retaining frame component (32). The closure system (3) is configured in an assembled state, wherein the plug portion (311) of the plug component (31) engages with the opening (25) of the container (2), and the retaining frame component (32) is mounted to the container (2). The retaining bracket (32) is configured to apply force to the cover (312) of the plug member (31) when the closure system (3) is in the assembled state, to push the cover (312) of the plug member (31) onto the boundary surface (24) of the opening (25) of the container (2). The retaining bracket (32) has a hole (324) to allow access to the cover (312) of the plug member (31) when the closure system (3) is in the assembled state. When installed on the retaining bracket (32), the cover member (33) covers the hole of the retaining bracket (32). The integrity visualization member (35) is configured to indicate the integrity of the closure system (3) and is positioned between the cover (312) of the plug member (31) and the retaining bracket (32) when the closure system (3) is in the assembled state. The closed system (3) is configured such that the integrity indicated by the integrity visualization component (35) is identifiable.

Description

Technical Field

[0001] The present invention relates to closed systems, and more particularly to kits having containers and such closed systems.

[0002] Such closure systems include resilient plug members having a plug portion configured to fit into an opening of a container and a cover portion configured to adjoin a boundary surface adjacent to the opening of the container. Such closure systems can be used to tightly and securely close the opening of a container, specifically for liquids and gases, and more specifically, pharmaceutical or chemical liquids or other fluid substances. Background Technology

[0003] In many chemical or pharmaceutical applications, liquid substances (such as active pharmaceutical ingredients, chemicals, clinical trial materials, or other substances) are provided in specific containers (such as vials, reagent kits, etc.). These containers typically have a hollow interior and an opening through which access to the interior is made. The opening is usually surrounded by a boundary surface. The substance is filled into the container, and then the opening is sealed.

[0004] For closing containers, resilient stoppers are known to be used. Such stoppers provide a tight or even airtight seal to the opening and additionally allow material to be removed from the container by piercing the stopper with a needle and introducing the needle into the material. Typically, the stopper has an insert portion and a cover portion, wherein the insert portion is sized to fit tightly into the opening and the cover portion is shaped to adjoin the boundary surface of the opening. More specifically, pressing the stopper into the opening causes the cover portion to be compressed to a certain extent to create sufficient sealing. As required in many applications, this type of stopper and container allows for efficient aseptic filling and closure of the container. Furthermore, on an industrial scale, the dimensions of the container (such as a vial) and the stopper are often designed to be predetermined sizes. This effectively allows for automated processing using standard equipment.

[0005] To achieve a sufficient seal in the container after filling and closing, the stopper must be pressed into and / or onto the surface of the container. To maintain this pressure on the stopper, a cap or retainer is typically used, arranged on and around the stopper and opening. For example, it is known to arrange a rigid plastic cap around the head of a vial closed with a stopper. Thus, the head and at least a portion of the neck of the vial are typically completely covered by the plastic cap, which keeps the stopper under pressure. Alternatively, a metal cap formed with a crimp portion around the head of the container and the cover of the stopper is known to secure the stopper and press it against the container (crim cap).

[0006] One problem that can arise with containers closed using current stopper and cap solutions is the integrity of the closure, and more specifically, the inability to effectively verify or observe the material contained within. For example, it is possible to remove the cap of a container to access its interior, for instance, using a syringe that punctures the stopper, and then close the cap again. However, the integrity of the container closure can be crucial for ensuring that the container and the material contained within are in proper condition for applications such as medical use. Furthermore, ensuring integrity can be important for preventing or detecting tampering and / or counterfeiting.

[0007] Therefore, there is a need for a device or system that allows for ensuring the integrity of container closures. Summary of the Invention

[0008] According to the invention, this need is addressed by a closed system as defined by the features of the invention and a kit as defined by the features of the invention. Preferred embodiments are further subject matter.

[0009] In one aspect, the present invention is a closure system for closing the opening of a container. The container can be a container used for pharmaceutical or chemical research, development, or production, such as a reagent kit. Specifically, the container can be a vial.

[0010] As used herein, the term "vial" can refer to a small bottle in the literal sense, that is, a relatively small vessel or bottle, typically used to store pharmaceutical products or drugs in liquid, powder, or capsule form. Vials can be made of sterilizable materials such as glass or plastics, such as, for example, polypropylene, cyclic olefin copolymers, or cyclic olefin polymers.

[0011] The closure system includes a plug component, a retaining frame component, a cover component reversibly installable to the retaining frame component, and an integrity visualization component. In this respect and in the context of the following description, the term "component" may refer to a single unit. Such a single unit can be embodied by securing a plurality of parts or components (e.g., made of different materials) together, or by securing to a monolithic element made of a single material or a monolithic element made of one or more materials that are chemically or physically bonded during a manufacturing process (e.g., molding an opaque polymer over a transparent substrate), or vice versa.

[0012] The stopper component is made of an elastic material and has an insertion portion and a cover portion. The insertion portion is configured to fit into and specifically fit tightly into the opening of the container, and the cover portion is configured to be adjacent to the boundary surface adjacent to the opening of the container.

[0013] Regarding stopper components, the term "elasticity" can refer to the properties of the material used to make the stopper component. More specifically, such material properties can be elastoplastic, and specifically compressible. Advantageously, the material of the stopper component allows for sterilization and maintenance of aseptic conditions. The stopper component can be embodied as a single piece, i.e., as an integral element. The insert portion can be substantially cylindrical, such that it matches the geometry of the opening. To allow the cover portion to abut the boundary surface, the cover portion typically projects laterally or radially above the insert portion. It can be generally disc-shaped.

[0014] The closure system is configured to be in an assembled state, wherein the plug portion of the plug component fits into the opening of the container, and the retaining frame is installed into the container.

[0015] When the closure system is in the assembled state, the retaining structure is configured to be mounted to the container and apply force to the cover of the plug member to push the cover of the plug member against the boundary surface of the container opening. Furthermore, when the closure system is in the assembled state, the retaining structure has a hole for access to the cover of the plug member.

[0016] Depending on the material properties and geometry of the plug component, the force applied by the retaining structure to the cover of the plug component can range from about 10 Newtons (N) to about 100 N. For example, the force can be about 15 N. In this way, the plug component can be compressed between the boundary surfaces of the retaining structure and the container, thereby achieving and maintaining a proper seal between the plug component and the container.

[0017] When installed on the retaining frame component, the cover component covers the holes in the retaining frame component. When the closed system is in the assembled state, the integrity visualization component is configured to indicate the integrity of the closed system and is configured to be positioned between the cover component and the retaining frame component.

[0018] The closed system is constructed such that the integrity indicated by the integrity visualization component is identifiable.

[0019] As used herein, the term "integrity" can refer to the original or initial state of a container closure. Thus, integrity can be achieved when the original or initial state of the closure is given. Specifically, a container with integrity can involve ensuring that the container has not been previously opened, or that the interior of the container has not been previously entered, for example, by a needle passing through a stopper component.

[0020] The term "identifiable," when used in conjunction with an integrity visualization component, can specifically refer to the visibility of the integrity visualization component, or its state, from outside the closed system in its assembled state. More particularly, advantageously, the integrity visualization component can be seen by a user or operator without opening the container or otherwise compromising its tightness.

[0021] By utilizing integrity visualization components, the closure system of this invention allows for the effective identification of the presence of integrity in container closures. Improper operation of the closed container can prevent damage to the container's quality or suitability, and in particular, damage to the material disposed therein. Furthermore, any operation on the closure (e.g., an operation used to copy the contents of the container) can be prevented or detected. In this way, the closed container is tamper-proof.

[0022] Preferably, the cover member is made of a rigid material. It can also be a substantially disc-shaped element and may be provided with connecting structures to engage corresponding connecting structures of the retaining frame member. For example, such connecting structures can be threaded connections, bayonet closures, clips, etc. Connections can also be made by welding and / or by applying force, heat, and / or ultrasonic vibration. With the aid of such a cover member, the retaining frame member (and in particular its holes) can be securely closed and protected.

[0023] The covering member preferably has a transparent window portion, which is configured such that the integrity visualization member is visible through the window portion of the covering member when the closed system is in the assembled state. Such a window portion allows for effective identification of the integrity of the closed system even in the assembled and fully closed state.

[0024] In a preferred embodiment, the integrity visualization member is an integrity masking member configured to adhere to the retaining frame member such that the orifice of the retaining frame member is covered. By acting as an integrity masking member, the integrity visualization member can provide the orifice of the retaining frame member closed or sealed until the integrity of the closure is negated. In other words, such embodiments allow the integrity of the closed system to be ensured until the integrity masking member is removed, allowing the interior of the container to enter through the orifice of the retaining frame member and through the plug member. When the integrity masking member is removed, the integrity of the closed system is no longer indicated.

[0025] Preferably, the closure system is configured such that, in the assembled state of the closure system, when the integrity masking member is adhered to the retaining frame member, the integrity masking member is visible through a window portion of the cover member, and when the integrity masking member is peeled off from the retaining frame member or otherwise removed, the plug member is visible through a window portion of the cover member. Such a configuration of the closure system can be achieved, for example, by arranging the window portion adjacent to an opening in the retaining frame member. For example, such an arrangement can be embodied by a central (e.g., circular) window portion.

[0026] Thus, at least a portion of the cover of the plug component, visible through the hole in the retaining frame, has the plug color. When the integrity masking component is adhered to the retaining frame, a portion of the integrity masking component facing away from the hole in the retaining frame has the masking color, and the plug color differs from the masking color. By involving this type of coloring, the integrity of the closure system can be effectively identified by the color visible in the window portion of the closure component.

[0027] The integrity masking member is preferably configured to seal the orifices of the retaining structure when it adheres to it. This seal allows the plug member, which can pass through the orifices of the retaining structure, to remain clean or sterile. Once the integrity masking member is removed from the retaining structure, this allows safe access to the interior of the container through the plug member.

[0028] The integrity masking member preferably has a gripping lug configured to be held in place when the integrity masking member adheres to the retaining frame member, for use in peeling the integrity masking member off the retaining frame member. Such a gripping lug allows for easy peeling of the integrity masking member, particularly by the hand of an operator or other user.

[0029] The dimensions of the integrity masking member are preferably designed to cover the entire retaining structure member. This dimensional design allows for effective closure of the hole and effective stripping of the integrity masking member.

[0030] In another preferred embodiment, the integrity visualization member is configured to change shape in the assembled state of the closed system when the cover member is detached from the retaining frame member. This configuration of the integrity visualization member allows for the prevention of removal and reinstallation of the cover member without detecting or recognizing such actions.

[0031] Therefore, the integrity visualization component preferably includes a fracture structure configured to tear at least partially when the cover component is removed from the retaining structure. Such a fracture structure allows for effective, irreversible shape changes when the cover component is removed.

[0032] The integrity visualization component is preferably attached to the covering component. In particular, such a configuration allows for effective and safe implementation when embodied in a fractured structure.

[0033] In all embodiments, the integrity visualization component preferably comprises a foil. In various embodiments of the closed system, the foil allows for a fairly simple and efficient construction.

[0034] The retaining frame component can be made of a shape-retaining material. This retaining frame component may further have a plug contact portion, a clamping structure, and an intermediate portion between the plug contact portion and the clamping structure. As used in the context, the term "shape-retaining" refers to a material or structure capable of maintaining its shape when no force is applied. Specifically, the shape-retaining material can be dimensionally stable. Typically, the shape-retaining material has considerable rigidity. Specifically, the material of the retaining frame component can be more rigid than the material of the plug component. Additionally, the shape-retaining material advantageously has sufficient elasticity to allow clamping as described below. The shape-retaining material can be a metal, such as steel, and specifically stainless steel. The plug contact portion, clamping structure, and intermediate portion of the retaining frame component are advantageously embodied as a single piece, i.e., an integral element.

[0035] The stopper contact portion can be embodied as at least a portion of the cover of the stopper member that is planar or flat. For example, the stopper contact portion can have the shape of a circular disc or a flat ring, its dimensions designed to cover a portion of the stopper member positioned on the container's boundary surface when the stopper member is fitted into the container opening. Specifically, during installation, the cover of the stopper member can be axially positioned between the boundary surface and the retaining structure, wherein the stopper contact portion is advantageously designed to abut the entire surface of the cover of the stopper member, which is opposite to the surface contacting the boundary surface of the container. In this way, as described below, it can be achieved that a substantial portion of the stopper member is similarly compressed when the stopper contact portion is pushed onto the cover.

[0036] The clamping structure of the retaining frame can be configured to clamp into the corresponding structure of the container. In this regard, the term "clamping" refers to engaging or repositioning into or behind the corresponding structure or similar mechanism. Generally, such clamping typically involves elastically deforming or dislocating one element (such as the retaining frame) when moving two elements (such as the retaining frame and the container) together, and then elastically deforming the element back behind the structure of the second element once both elements are correctly positioned. More specifically, to allow such clamping, the clamping structure of the retaining frame can elastically deform or bend relative to other parts of the retaining frame. The clamping structure allows for a snap-fit ​​connection between the retaining frame and the container. Once clamped or snap-fitted into the container, the retaining element forms a form-fit connection with the container. Advantageously, when clamped into the container, the retaining element cannot be removed from the container without being broken or damaged.

[0037] The retaining structure can be configured such that when the plug portion of the plug member is fitted into the opening of the container and the clamping structure of the retaining structure is clamped in the corresponding structure of the container, the plug contact portion of the retaining structure applies force to the cover portion of the plug member to push the cover portion of the plug member onto a boundary surface adjacent to the opening of the container.

[0038] The middle portion of the retaining structure can be designed to surround the boundary surface of the container adjacent to the opening. In the case of a vial or similar container, the middle portion can be configured to surround the head of the vial, which at least partially includes the opening and the boundary surface. Therefore, the middle portion of the retaining structure is preferably configured to surround the head of the container.

[0039] The middle section of the structural component can be cylindrical. In this way, the middle section can be effectively designed to surround the head of the container, or for other reasons, such as the asymmetry of interconnected systems (e.g., vial transfer devices). Specifically, the middle section can have the shape of a small cylinder or ring. Regarding cylinders, the term "small" can refer to a cylinder having a height or axial length smaller than its diameter. Specifically, a cylinder can have a circular cross-section.

[0040] The clamping structure for retaining the structural member may include multiple tongues. For example, the number of tongues may range from about four to twelve, about four to eight, or about six. Such tongues allow for effective and secure clamping of the retaining structural member to the container. Specifically, the rigidity and flexibility of the clamping structure can be appropriately configured by means of such tongues. Furthermore, the tongues can be configured to prevent the retaining structural member from separating from the container while it is clamped to it.

[0041] Thus, each tongue in the clamping structure of the retaining frame can move elastically relative to the central portion of the retaining frame. Specifically, the retaining frame can be configured such that when clamped to a container, the central portion remains substantially undeformed while the tongues move elastically. The elastic mobility of the tongues can be provided, for example, by the tongues bending outwards and / or by the tongues tilting around the joint. Specifically, the tongues can be elastically moved by at least partially deforming in an elastic manner, i.e., tending to move back to their original shape and / or position. Due to material properties, the tongues can allow a certain degree of normal relaxation.

[0042] Furthermore, each tongue in the clamping structure of the retaining frame can elastically move relative to the central portion of the retaining frame. Specifically, the tongues can elastically move in a radial or outward direction.

[0043] An aperture can be provided in the stopper contact portion of the retaining frame. When the stopper component is fitted into the opening and the retaining frame is clamped onto the container, the aperture can specifically be located adjacent to the surface of the stopper component's cover, corresponding to the container's opening. Thus, the aperture can be located next to the portion of the stopper contact portion adjacent to the surface of the stopper component's cover, which is opposite to the surface of the boundary contacting the container. In this way, the accessible portion of the stopper component can be easily accessed and cleaned, for example, by wiping with alcohol. For example, the aperture in the stopper contact portion can be a circular central aperture in the stopper contact portion, which is a flat ring.

[0044] The cover of the stopper component may have a circumferential retainer recess that faces away from the boundary surface adjacent to the opening when the insert portion of the stopper component is fitted into the opening of the container. Regarding the retainer recess, the term "facing away" specifically refers to a direction opposite to the direction toward the boundary surface adjacent to the opening of the container. For example, the cover may be generally disc-shaped, having a top side and a bottom side opposite the top side. Thus, the retainer recess can be positioned on the top side of the cover. The retainer recess allows the stopper component to collapse when pushed by the retainer component. Specifically, at the portion where the stopper contact portion of the retainer component applies force to the stopper component, the retainer recess may collapse according to the applied force. In this way, well-defined compression of the stopper component can be achieved, and the risk of damage to the stopper component upon compression can be reduced.

[0045] The cap portion of the stopper component may have a circumferential container notch that faces the boundary surface adjacent to the opening when the insert portion of the stopper component is fitted into the opening of the container. The container notch allows the stopper component to collapse when pushed against the boundary surface of the container. Specifically, collapse may occur at or adjacent to the boundary surface of the container notch, depending on the force applied to the stopper component. In this way, well-defined compression of the stopper component can be achieved, and the risk of damage to the stopper component upon compression can be reduced.

[0046] The stopper assembly can be equipped with a cage notch and a container notch. Thus, the cage notch of the stopper assembly's cover can be radially offset relative to the container notch of the stopper assembly's cover. This prevents a substantial reduction in the stability of the stopper assembly. Furthermore, this offset positioning allows for cleverly designed collapse on both sides of the cover, thereby reducing the overall compressibility of the stopper. In this way, for the same applied force, the stopper compresses more than a solid stopper. This is advantageous because it allows for the use of thicker stoppers to compensate for tolerances in rigid components.

[0047] The cover portion of the stopper component may have an edge portion having a front and a back side. The front side is configured to abut a boundary surface adjacent to the opening of the container, and the back side is opposite to and corresponds to the front side of the edge portion. The stopper contact portion of the retaining structure is configured to abut the complete back side of the edge portion of the stopper component when the insert portion of the stopper component engages with the opening of the container and the clamping structure of the retaining structure is held in the corresponding structure of the container. This complete abutment allows for effective and uniform compression of the stopper component.

[0048] The retaining frame can be configured to terminate substantially adjacent to the clamping structure when the plug portion of the plug member engages with the opening of the container and the clamping structure of the retaining frame is held in the corresponding structure of the container. When the container is equipped with a head having a boundary surface adjacent to the opening extending into the neck, the retaining frame can be configured to either not extend substantially above the neck of the container or terminate at the beginning of the neck. In this way, it is possible to achieve: the neck remains free, which allows for efficient disposal of the closed container and attachment to standard or conventional accessories (such as transfer kits), and proper optical inspection of the entire interior of the container, including the neck, before, during, or after the transfer of the container contents.

[0049] In another aspect, the present invention is a kit comprising a container and a closure system as described above, wherein the container includes an opening for access to the interior of the container and a boundary surface adjacent to the opening.

[0050] The aforementioned effects and benefits of the closure system according to the invention and its preferred embodiments can be effectively achieved by means of the kit according to the invention. Attached Figure Description

[0051] The closure system and kit according to the invention are described in more detail below with reference to exemplary embodiments and the accompanying drawings, wherein:

[0052] Figure 1 A side view of a first embodiment of a kit according to the invention is shown, the kit including a first embodiment of a closing system according to the invention;

[0053] Figure 2 It shows Figure 1 Exploded side view of the kit and closed system;

[0054] Figure 3 It shows Figure 1 An exploded perspective view of the kit and closed system;

[0055] Figure 4 It shows Figure 1 A perspective view of a portion of the kit and closure system, with a section cut open to reveal the internal structure;

[0056] Figure 5 A side view of a second embodiment of a kit according to the invention is shown, the kit including a second embodiment of a closing system according to the invention;

[0057] Figure 6 It shows Figure 5 An exploded perspective view of the kit and closed system; and

[0058] Figure 7 It shows Figure 5 A perspective view of a portion of the kit and closure system, with a section cut open to reveal the internal structure. Detailed Implementation

[0059] In the following description, certain terms are used for convenience and are not intended to limit the invention. The terms “right,” “left,” “up,” “down,” “below,” and “above” refer to directions in the figures. Terms include explicitly mentioned terms and their derivatives, as well as terms with similar meanings. Additionally, spatial relative terms such as “below,” “below,” “below,” “above,” “on top,” “near,” “far,” etc., may be used to describe the relationship between one element or feature and another element or feature as shown in the figures. These spatial relative terms are intended to cover different positions and orientations of the device in use or operation, in addition to those shown in the figures. For example, if the device in the figures is flipped, an element described as “below” or “below” other elements or features will be “above” or “above” other elements or features. Thus, the exemplary term “below” can cover both above and below positions and orientations. The device may be oriented in other ways, and the spatial relative descriptive terms used herein will be interpreted accordingly. Similarly, descriptions of movement along and around various axes include various specific device positions and orientations.

[0060] To avoid repetition in the description of the accompanying drawings and various aspects, as well as the illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. The omission of an aspect in the description or drawings does not imply that that aspect is missing in the embodiment that includes it. Rather, the aspect may be omitted for clarity and to avoid lengthy descriptions. In this context, the following description applies to the remainder of this specification: if reference numerals in the drawings are not explained in the directly relevant parts of the specification for the purpose of clarifying the drawings, reference may be made to preceding or following sections of the specification. Furthermore, for clarity, if reference numerals in the drawings do not provide all features of a component, reference may be made to other drawings showing the same component. Similar reference numerals in two or more drawings denote the same or similar elements.

[0061] Figure 1A first embodiment of a kit 1 according to the invention is shown, the kit comprising a glass or plastic vial 2 as a container and a first embodiment of a closure system 3 according to the invention. Figure 1 In the illustration, kit 1 and closure system 3 are depicted as being in an assembled state, with closure system 3 installed onto vial 2.

[0062] The vial 2 has a body 23 and a neck 22. The body has a hollow interior 231, and the neck extends into a head 21, which serves as a head portion. A closure system 3 is attached to the head 21 of the vial 2, thereby covering the head 21. The closure system 3 includes a plastic retainer 32 as a retaining structure and a cap-like cover 33 as a covering member. The retainer 32 has a generally cylindrical central portion 323 and a clamping structure having downwardly extending tongues 322 regularly distributed around the central portion 323. Furthermore, the closure system 3 defines a central axis 34, which is aligned with the rotational central axis of the vial 2 when the closure system 3 is in the assembled state. The cover 33 includes a frame portion 331 and a transparent body portion 332.

[0063] like Figure 2 As can be seen, the closure system 3 further includes an elastic plug 31 as a plug component. The plug 31 has an insertion portion 311 and a generally disc-shaped cover portion 312. The cover portion 312 extends radially above the insertion portion 311, thereby forming a generally annular edge portion 3121 having a downwardly oriented front side and a corresponding upwardly oriented back side.

[0064] The head 21 of vial 2 extends radially above the neck 22 of vial 2. Between the body portion 332 of cover 33 and the holder 32, an integrity masking member 35 is arranged as an embodiment of an integrity visualization member. The integrity masking member 35 consists of foil forming a sealing portion 351 and a gripping lug 352.

[0065] In addition, such as Figure 3 As best seen, the vial 2 has a circular or cylindrical opening 25 at its head 21, which allows access to the interior 231 of the body 23. The boundary surface 24 adjacent to the opening 25 is designed as a flat, upward-oriented surface.

[0066] The retainer 32 is made of a rigid but somewhat elastic plastic material. The retainer has a generally disc-shaped plug contact portion 321 with a central hole 324. A middle portion 323 extends between the plug contact portion 321 and a clamping structure with a tongue 322. The cover 312 of the plug 31 is equipped with a retainer centering structure 3121 on its top side.

[0067] The frame portion 331 of the cover 33 is substantially annular, and the main body portion 332 is substantially disc-shaped. More specifically, the frame portion 331 and the main body portion 332 are formed such that the main body portion 332 fits into the frame portion 331 to form a single cover 33. Thus, in the cover 33, the main body portion 332 provides a transparent circular window portion at the center.

[0068] The sealing portion 351 of the integrity masking member 35 is circular and adheres to the top surface of the plug contact portion 321 of the retainer 32. Thus, the integrity masking member 35 seals the hole 324 of the retainer 32. Furthermore, the color of the integrity masking member 35 is distinctly different from the color of the plug 31.

[0069] exist Figure 4 In the diagram, the closure system 3 is shown in an assembled state, with a partial cross-section revealing how the individual components of the closure system 3 interact. Thus, the insertion portion 311 of the stopper 31 is configured to fit tightly into the opening 25 of the vial 2. Specifically, the size of the insertion portion 311 is designed such that it is compressed when pushed into the opening 25. The cover portion 312 abuts the boundary surface 24 adjacent to the opening 25 of the vial 2. The insertion portion 311 has a downwardly opening dome-shaped cavity.

[0070] The tongue 322 is held in the neck 22 of the vial 2 below the head 21. More specifically, the tongue 322 has inwardly extending teeth arranged in the neck 22 and below the head 21. During installation, the tongue 322 is temporarily bent or misaligned radially relative to the middle portion 322, wherein—due to the elasticity of the plastic material—once the retainer 32 is fully moved onto the vial 2, the tongue is locked below the head 21. This establishes a form-fit connection between the retainer 32 and the vial 2, which prevents the removal of the retainer 32.

[0071] The dimensions of the middle portion 323 of the retainer 32 are designed such that the stopper contact portion 321 applies force to the cover portion 312 of the stopper 31. More specifically, the stopper contact portion 321 pushes the edge portion 3121 of the cover portion 312 of the stopper 31 onto the boundary surface 24 adjacent to the opening 25 of the vial 2. Thus, the back side of the edge portion 3121 abuts the stopper contact portion 321, and the front side of the edge portion 3121 is adjacent to the boundary surface 24. The force applied by the retainer 32 to the stopper 31 deforms the edge portion 3121 of the cover portion 321 of the stopper 32. In this way, a strong and tight connection is achieved between the cover portion 321 and the boundary surface 24. The centering structure 3124 of the cover portion 312 of the stopper 31 extends into the hole 324 of the stopper contact portion 321 of the retainer 32.

[0072] The frame portion 331 of the cover 33 has a radial annular groove, and the main body portion 332 is disposed in the radial annular groove to be fixed to the frame portion 331. Thus, the central window portion of the cover 33 is located on top of and adjacent to the sealing portion 351 of the integrity shielding member 35 adhered to the retainer 32. In this way, the integrity shielding member 35 is visible through the window portion or the main body portion 351.

[0073] In the operation of kit 1, to access the interior 231 of vial 2, the cover 33 is removed from the holder 32, making the integrity masking member 35 accessible. The integrity masking member 35 is then peeled off the holder 32 by tearing open the gripping lug 352. This exposes the hole 324, through which the stopper 31 is accessible. The needle of a syringe can now pierce the stopper 31 into the vial 2, and the substance disposed within the interior 231 of the vial 2 can be drawn. After the cover 33 is reinstalled to the holder 32, the stopper 31 is visible through the window portion of the cover 33. And because the color of the stopper 31 is significantly different from the color of the integrity masking member 35, it can be immediately identified from the outside that the integrity of the closed system has not been provided, meaning the interior 231 of vial 2 may have been entered.

[0074] Figure 5 A second embodiment of the kit 10 according to the present invention is shown. The kit 10 includes a vial 20 and a second embodiment of the closure system 30 according to the present invention in an assembled state.

[0075] Vial 20 is a 13mm (nominal head diameter) vial made of glass or plastic. The vial has a body 230 and a neck 220, the body having a hollow interior 2310, and the neck extending into a head 210, which serves as the head portion. A closure system 30 is attached to the head 210 of the vial 20. The closure system 30 includes a metal retainer 320 as a retaining element and a cap-like cover 330 as a covering element. The retainer 320 has a substantially cylindrical central portion 3230 and a clamping structure with upwardly extending tongues 3220 regularly distributed around the retainer 320. Furthermore, the closure system 30 defines a central axis 340, which, when the closure system 30 is in the assembled state, is aligned with the rotational central axis of the vial 20. The cover 330 includes a frame portion 3310.

[0076] exist Figure 6In the exploded view, the kit 10 is shown. It can be seen that the head 210 of the vial 20 extends radially above its neck 220 and is equipped with radial indentations 2110 at its outer periphery. The vial 20 further has an opening 250 at the head 210, which allows access to the interior 2310 of the body 230. The boundary surface 240 adjacent to the opening 250 has a flat, upwardly oriented surface.

[0077] The closure system 30 further includes a resilient plug 310 as a plug component, the resilient plug having an insertion portion 3110 and a generally disc-shaped cover portion 3120. The cover portion 3120 extends radially above the insertion portion 3110, thereby forming a generally annular edge portion having a downwardly oriented front side and a corresponding upwardly oriented back side. The cover portion 3120 of the plug 310 is equipped with a retainer centering structure 31210 on its top side.

[0078] The retainer 320 is made of stainless steel. The retainer has a generally disc-shaped plug contact portion 3210 with a central hole 3240 surrounded by a first mating structure 3250. An intermediate portion 3230 extends between the plug contact portion 3210 and a clamping structure having a tongue 3220.

[0079] The frame portion 3310 of the cover 330 has an outer ring portion and a central disk portion, wherein an annular gap is located between the outer ring portion and the disk portion. The cover further has a shaped transparent body 3320, such that the body portion 3320 fits into the frame portion 3310 to form a single cover 330. Thus, the body portion 3320 provides a transparent annular window portion between the ring portion and the disk portion of the frame portion 3310.

[0080] The integrity visualization component 350 is mounted to the underside of the cover 330. The integrity visualization component 350 is made of foil 3510, which has a ring-shaped or annular shape and is sized to cover the window portion of the cover 330. The foil 3510 is provided with alternating radial cuts 3520 extending from the inner and outer ends as a fracture structure. The foil 3510 has a distinctive color.

[0081] Figure 7 A closed system 30 in an assembled state is shown, partially cut away to reveal how the individual components of the closed system 30 interact. Thus, the insertion portion 3110 of the stopper 310 is configured to fit tightly into the opening 250 of the vial 20. Specifically, the insertion portion 3110 is sized such that it is compressed when pushed into the opening 250. A cover portion 3120 abuts the boundary surface 240 adjacent to the opening 250 of the vial 20. The insertion portion 3110 has a downwardly opening dome-shaped cavity.

[0082] As previously described, the middle portion 3230 of the retainer 320 extends between the stopper contact portion 3210 and the clamping structure having a tongue 3220. The tongue 3220 clamps into the indentation 2110 of the head 210 of the vial 20. More specifically, the tongue 3220 extends upward and bends inward toward the axis 340. During installation, the tongue 3220 is temporarily bent outward or misaligned in the radial direction relative to the middle portion 3230, wherein—due to the elasticity of stainless steel—once the retainer 320 is fully moved onto the head 210 of the vial 20, the tongue engages in the indentation 2110. Thus, a form-fit connection is established between the retainer 320 and the vial 20, which prevents the retainer 320 from being removed from the vial 20.

[0083] The retainer 320's central portion 3230 is sized such that the stopper contact portion 3210 applies force to the cover portion 3120 of the stopper 310. More specifically, the stopper contact portion 3210 pushes the edge portion of the cover portion 3120 of the stopper 310 onto the boundary surface 240 adjacent to the opening 250 of the vial 20. Thus, the back side of the edge portion abuts the stopper contact portion 3210, and the front side of the edge portion abuts the boundary surface 240. The force applied by the retainer 320 to the stopper 310 deforms the edge portion of the cover portion 3210 of the stopper 320. In this way, a strong and tight connection is achieved between the cover portion 3210 and the boundary surface 240.

[0084] The body 3310 of the cover 330 is equipped with a downwardly oriented second mating structure 3330, which corresponds to the first mating structure 3250 of the retainer 320. The first mating structure 3330 is designed to receive the second mating structure 3250 to properly align and orient the cover 330 to the retainer 320, such that the cover 330 is securely and reversibly mounted to the retainer 320 and the hole 3240 of the retainer 320 is closed. An integrity visualization member 350 is arranged between the retainer 320 and the cover 330.

[0085] In operation of kit 10, to access the interior 2310 of vial 20, the cover 330 is removed from the holder 320. More specifically, to remove the cover 330, the cover is deformed relative to the holder 320. Through this deformation, the shape of foil 3510 changes due to the cut 3520 provided in foil 3510. Specifically, foil 3510 is torn or misaligned at the cut 3520.

[0086] After removing the cover 330, the hole 3240 of the retainer 320 is exposed, and the stopper 310 is accessible through the hole 3240. A syringe needle can now pierce the stopper 310 into the vial 20, and the substance disposed within the interior 2310 of the vial 20 can be drawn. After reinstalling the cover 330 to the retainer 320, the reshaped or torn foil 3510 is visible through the window portion of the cover 330. In this way, it can be effectively identified from the outside that the integrity of the closure system 30 has not been provided, i.e., the interior 2310 of the vial 20 may have been entered.

[0087] The description and accompanying drawings illustrating aspects and embodiments of the invention should not be construed as limiting the scope of the claims. In other words, while the invention has been described and illustrated in detail in the accompanying drawings and the foregoing description, such description and illustration are to be considered illustrative or exemplary rather than restrictive. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the spirit and scope of this specification and the claims. In some cases, well-known circuits, structures, and techniques have not been shown in detail so as not to obscure the invention. Therefore, it should be understood that changes and modifications can be made by those skilled in the art within the scope and spirit of the appended claims. Specifically, the invention covers further embodiments having any combination of features from the various embodiments described above and below.

[0088] This disclosure also covers all other features shown in the figures. Although they may not be described in the preceding or following description, they are individual. Furthermore, single alternatives to the embodiments described in the figures and description, and single alternatives to their features, may be excluded from the subject matter of this invention or from the subject matter of this disclosure. This disclosure includes the subject matter consisting of the features defined in the claims or exemplary embodiments, as well as the subject matter including said features.

[0089] Furthermore, in the claims, the term "comprising / including" does not exclude other elements or steps, and the indefinite article "a / an" does not exclude multiple. A single unit or step can perform the function of several features listed in the claims. The mere fact that certain measures are listed in mutually different dependent claims does not indicate that a combination of these measures cannot be advantageous. Terms related to attributes or values, such as "substantially," "about," "approximately," etc., also precisely define the attribute or exact value, respectively. In the context of a given numerical value or range, the term "about" refers to a value or range, for example, within 20%, 10%, 5%, or 2% of the given value or range. Components described as coupled or connected may be electrically or mechanically directly coupled, or they may be indirectly coupled via one or more intermediate components. Any reference numerals in the claims should not be construed as limiting the scope.

Claims

1. A closing system (3; 30) for closing an opening (25; 250) of a container (2; 20), said closing system comprising: A stopper component (31; 310), said stopper component being made of an elastic material and having an insertion portion (311; 3110) and a cover portion (312; 3120), said insertion portion being configured to fit into said opening (25; 250) of said container (2; 20), said cover portion being configured to adjoin a boundary surface (24; 240) adjacent to said opening (25; 250) of said container (2; 20). A retaining structure component (32; 320) is configured to be mounted to the container (2; 20), and A cover member (33; 330) reversibly mountable to the retaining frame member (32; 320). The closure system (3; 30) is configured in an assembled state, wherein the plug portion (311; 3110) of the plug component (31; 310) engages with the opening (25; 250) of the container (2; 20), and the retaining structure component (32; 320) is installed in the container (2; 20). The retaining structure (32; 320) is configured such that, when the closure system (3; 30) is in the assembled state, a force is applied to the cover (312; 3120) of the plug member (31; 310) to push the cover (312; 3120) of the plug member (31; 310) onto the boundary surface (24; 240) of the opening (25; 250) of the container (2; 20). The retaining structure member (32; 320) has holes (324; 3240) to allow access to the cover (312; 3120) of the plug member (31; 310) when the closure system (3; 30) is in the assembled state, and When installed onto the retaining bracket (32; 320), the covering member (33; 330) covers the hole in the retaining bracket (32; 320). The feature is that it includes an integrity visualization component (35; 350), which is configured to indicate the integrity of the closed system (3; 30) and is configured to be positioned between the covering component (33; 330) and the retaining structure component (32; 320) when the closed system (3; 30) is in the assembled state. The closed system (3; 30) is configured such that the integrity indicated by the integrity visualization component (35; 350) is identifiable. The integrity visualization component (35; 350) is an integrity masking component (35) configured to adhere to the retaining structure component (32; 320) such that the holes (324; 3240) of the retaining structure component (32; 320) are covered.

2. The closure system (3; 30) according to claim 1, wherein the covering member (33; 330) is made of a rigid material.

3. The closure system (3; 30) according to claim 1, wherein the covering member (33; 330) has a transparent window portion, the transparent window portion being configured such that when the closure system (3; 30) is in the assembled state, the integrity visualization member (35; 350) is visible through the window portion of the covering member (33; 330).

4. The closure system (3; 30) according to claim 3, wherein the closure system is configured such that, in the assembled state of the closure system (3; 30), when the integrity masking member is adhered to the retaining frame member (32; 320), the integrity masking member (35) is visible through the window portion of the covering member (33; 330), and when the integrity masking member (35) is detached from the retaining frame member (32; 320), the plug member (31; 310) is visible through the window portion of the covering member (33; 330).

5. The closed system (3; 30) according to claim 4, At least a portion of the cover (312; 3120) of the plug component (31; 310) visible through the hole (324; 3240) of the retaining structure member (32; 320) has the color of a plug. When the integrity masking member (35) is adhered to the retaining frame member (32; 320), a portion of the hole (324; 3240) of the integrity masking member (35) facing away from the retaining frame member (32; 320) has a masking color, and The color of the plug is different from the color of the mask.

6. The closure system (3; 30) according to any one of claims 1 to 5, wherein the integrity masking member (35) is configured to seal the hole (324; 3240) of the retaining frame member (32; 320) when the integrity masking member (35) is adhered to the retaining frame member (32; 320).

7. The closure system (3; 30) according to any one of claims 1 to 5, wherein the integrity masking member (35) has a gripping lug (352) configured to be held when the integrity masking member (35) is adhered to the retaining frame member (32; 320) for peeling the integrity masking member (35) off the retaining frame member (32; 320).

8. The closure system (3; 30) according to any one of claims 1 to 5, wherein the integrity masking member (35) is sized to cover the entire retaining frame member (32; 320).

9. The closure system (3; 30) according to claim 1, wherein the integrity visualization member (35; 350) is attached to the cover member (33; 330) when the integrity visualization member (35; 350) is configured in the assembled state of the closure system (3; 30) to change shape when the cover member (32; 320) is detached from the retaining frame member (33; 330).

10. The closure system (3; 30) according to any one of claims 1 to 5, wherein the integrity visualization component (35; 350) comprises foil (351, 352; 3510).

11. The closed system (3; 30) according to claim 1, wherein when the integrity visualization member (35; 350) includes a fracture structure (3510, 3520), the integrity visualization member (35; 350) is provided with alternating radial cuts (3520) as a fracture structure.

12. The closed system (3; 30) according to claim 11, wherein the integrity visualization component (35; 350) has a ring-shaped or annular shape.

13. The closure system (3; 30) according to claim 12, wherein the alternating radial cuts (3520) extend from the inner and outer ends of the integrity visualization member (35; 350) having a ring-like or annular shape.

14. The closure system (3; 30) according to claim 13, wherein the integrity visualization component (35; 350) is made of foil (3510).

15. A kit comprising a container (2; 20) and a closure system (3; 30) according to any of the preceding claims, wherein the container (2; 20) includes an opening (25; 250) for access to the interior of the container (2; 20) and a boundary surface (24; 240) adjacent to the opening (25; 250).

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