Needle-free access vials and caps for sterile sampling and storage of liquids.

Abstract

According to one embodiment of the present disclosure, a vial cap is configured to be sealingly attached to a tube set and a vial having a hollow interior configured to receive and store a liquid sample. The vial cap may include an axially extending cylindrical wall and a radially extending cap top disposed within the cylindrical wall, the cap top having an upper surface and a lower surface. The vial cap may include at least two external tubes extending upwardly from the upper surface of the cap top, each external tube defining a passageway configured to communicate with the tube set. The vial cap may further include at least two internal tubular structures extending downwardly from the lower surface of the cap top, each at least two internal tubular structures defining a passageway configured to communicate with one of the external tubes and the hollow interior.

Description

TECHNICAL FIELD

[0001] CROSS-REFERENCE TO RELATED APPLICATION This application claims priority to and is based on U.S. Patent Application No. 17 / 335,737, filed on June 1, 2021, the disclosure of which is incorporated herein by reference. BACKGROUND ART

[0002] Processing of biological cells and other liquids that require sterility often demands that the treatment be performed in an aseptically closed system. These aseptically closed systems may be composed of, for example, interconnected tubes and bags. Small samples of biological fluids or other fluids are often required for quality control (QC) to check that a process is functioning properly, to check process parameters such as cell viability and cell count, or to check that sterility has not been compromised and the product has not been contaminated or impaired in any way. These samples must be collected in a manner that does not compromise the sterility of the aseptically closed system, such that the sample can be aseptically separated from the closed system and removed for testing. In many cases, these samples need to undergo cryopreservation to enable testing of the samples at a later date. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEMS

[0003] According to one embodiment of the present disclosure, a vial cap is configured to be sealed and attached to a tube set and a vial having a hollow interior configured to receive and store a liquid sample. The vial cap may include an axially extending cylindrical wall and a radially extending cap top positioned within the cylindrical wall, the cap top having an upper and a lower surface. The vial cap may include at least two external tubes extending from the cap top, each external tube defining a passage configured to communicate with the tube set. The vial cap may further include at least two internal tubular structures extending downward from the lower surface of the cap top, each of the at least two internal tubular structures defining a passage configured to communicate with one of the external tubes and the hollow interior of the vial.

[0004] The above summary is not intended to describe each illustrated embodiment or all embodiments of the present disclosure.

[0005] The drawings included in this application are incorporated herein by reference and constitute part of this specification. They illustrate embodiments of the disclosure and, together with the description, serve to illustrate the principles of the disclosure. The drawings are illustrative of specific embodiments and do not limit the disclosure. [Brief explanation of the drawing]

[0006] [Figure 1A] This is a top perspective view of a vial cap according to one embodiment of the present disclosure. [Figure 1B] Figure 1A is a perspective view of the bottom of the vial cap. [Figure 2] Figure 1A is a cross-sectional view of the vial cap. [Figure 3] Figure 1A is a bottom view of the vial cap. [Figure 4A] This is a top perspective view of the vial cap attached to the vial. [Figure 4B] This is a top perspective view of the vial cap attached to a vial that is attached to a tube set. [Figure 5A] This is a top perspective view of a vial cap attached to a vial, showing a vial of a certain size; the vial in Figure 5A is larger than the vial in Figure 5B. [Figure 5B] This is a top perspective view of the vial cap attached to the vial, showing vials of different sizes; the vial in Figure 5A is larger than the vial in Figure 5B. [Figure 6] This is a bottom perspective view of a fluid system including a structure for holding a vial with a vial cap and tube set attached. [Figure 7] This is a cross-sectional view of a vial, a tube set, and a vial cap having a female thread and a cylindrical plug seal. [Figure 8] This is a partial cross-sectional view of a vial, a tube set, and a vial cap having an internal O-ring, according to another embodiment. [Figure 9] This is a partial cross-sectional view of a vial, a tube set, and a vial cap having an internal flat O-ring, according to another embodiment. [Figure 10] This is a partial cross-sectional view of a vial, a tube set, and a vial cap having a male thread and an external flat O-ring, according to another embodiment. [Figure 11] This is a partial cross-sectional view of a vial, a tube set, and a vial cap having a snap ring, according to another embodiment. [Figure 12] This is a partial cross-sectional view of a vial, a tube set, and a vial cap having an external plug or interference seal, according to another embodiment. [Figure 13] This is a partial cross-sectional view of a vial, a tube set, and a vial cap having a friction / push taper seal, according to another embodiment. [Figure 14A] This is a partial diagram showing an exemplary bayonet-type connection between a vial cap and a vial, according to another embodiment. [Figure 14B]This is a partial diagram showing an exemplary bayonet-type connection between a vial cap and a vial, according to another embodiment. [Figure 15A] This is a partial cross-sectional view of a vial, a tube set, and a vial cap having an internal dividing wall, according to another embodiment. [Figure 15B] Figure 15A is a bottom view of the vial cap. [Figure 16] This is a partial cross-sectional view of a vial, a tube set, and a vial cap having a radial port, according to another embodiment.

[0007] The embodiments of this disclosure are adaptable to various modifications and alternative forms, the details of which are illustrated and described in detail in the drawings. However, it should be understood that this disclosure is not intended to limit itself to the specific embodiments described. Rather, the intention is to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of this disclosure. [Modes for carrying out the invention]

[0008] A problem with existing sampling containers is that, after they are filled with liquid samples and aseptically separated, it may be difficult or impossible to access the samples for testing without using sharp instruments such as syringes, scissors, or knives. Using sharp instruments to access samples poses a health and safety risk to the user, as they can easily cut and penetrate PPE (personal protective equipment) and the user's own skin. Furthermore, sharp instruments can become contaminated with biological fluids when penetrating the user's skin, potentially leading to infection, illness, or death of the user.

[0009] Embodiments of this disclosure solve this problem by eliminating the use of sharp instruments in accessing the samples collected by the present invention, while still providing functionality for sample collection, sterile isolation, and possible cryogenic storage.

[0010] Another problem encountered when collecting samples of biological fluids and other liquids in an aseptically closed system is the accuracy of the volume of collected liquid. These fluids are often very valuable not only because they are expensive to process, but also because they are often part of treatments used to cure a patient's illness or disease. The volume collected for sampling corresponds to the volume of treatment that the patient does not receive. Therefore, sample volumes are often small, and it is necessary to accurately control / measure the volume to ensure a sufficient volume for testing while reducing waste. Embodiments of the present disclosure incorporate features that provide repeatable capture of a correct volume of liquid for sampling.

[0011] A further problem with some existing sampling containers is that they are not suitable or reliable for low-temperature or cryogenic preservation of samples. Low-temperature or cryogenic preservation can cause seals to fail, compromise sterility, and allow the ingress of gas that can cause catastrophic failure during thawing of the product. Additionally, cryogenic preservation requires the use of liquids such as dimethyl sulfoxide (DMSO), which can cause degradation of the sample container if the materials are not chemically compatible. Embodiments of the present disclosure address these seal integrity issues by using materials with sufficient compatibility with DMSO and closely matched shrink properties, and additionally by providing a shape that helps control the volume of gas during filling, and thus the pressure during freezing.

[0012] Embodiments of the present disclosure provide quantifiable capture of fluid samples from a closed tube set in a small container or vial. For example, this vial may be used to capture small samples for the purpose of quality control (QC) checks of a biological process. Once detached from the tube set, embodiments of the present disclosure allow access to the sample without the use of needles or sharp instruments via the action of a screw cap. Embodiments of the present disclosure provide aseptic detachment from the tube set. Certain embodiments provide aseptic sealing of the container during detachment to maintain the sterility of the fluid in the container. Certain embodiments provide seal integrity across typical laboratory and processing temperatures, including cryogenic storage.

[0013] Embodiments of needleless vial caps that can be attached to vials or other containers for sterile sampling and storage of liquids in vials are shown in Figures 1 to 16, with a first embodiment shown in Figures 1 to 7 and alternative embodiments shown in Figures 8 to 16. Referring to Figures 1A to 7, the vial cap 1 includes an axially extending cylindrical wall 12 and a radially extending cap upper 14 positioned within the cylindrical wall 12 and having an upper surface 16 and a lower surface 18 that divide the vial cap 1 into an upper internal portion 40 and a lower internal portion 42. The vial cap 1 further includes a seal, such as a cylindrical plug seal 2, configured to form an airtight seal to a container, vessel or vial 7 even under cryogenic conditions (Figure 7). Specifically, the cylindrical plug seal 2 is molded into a cylindrical shape, extends downward from the lower surface 18 of the cap upper 14, is oriented concentrically with the cylindrical wall 12, and is spaced inward from the cylindrical wall 12. The cylindrical plug seal 2 provides a seal with the inner cylindrical surface 20 of the vial 7. The vial cap 1 may have threads 3 on the inner surface of the cylindrical wall 12 of the vial cap 1, which are configured to provide a mechanical connection to the vial 7 by screwing onto the corresponding male thread surface 22 of the vial 7, so that the open end of the vial 7 contacts, is captured, and sealed by the cylindrical plug seal 2. The vial 7 may have a hollow interior 24 configured to receive and store liquid and / or gas.

[0014] Additional alternative connections and seals between a vial cap and a vial are shown in FIGS. 8 to 14B.

[0015] Referring to FIG. 8, a vial cap 101 and a vial 107 can include an internal O-ring seal 102 that seals the connection between the vial cap 101 and the vial 107.

[0016] Referring to FIG. 9, a vial cap 201 and a vial 207 can include an internal flat O-ring seal 202 that seals the connection between the vial cap 201 and the vial 207, and the internal flat O-ring seal 202 is disposed on an upper surface of the vial 207 and a lower surface 218 of a cap top 214.

[0017] Alternatively, as shown in FIG. 10, the connection between a vial cap 301 and a vial 307 may be formed by threads 303 on an outer surface of a lower cylindrical wall 312A of the vial cap 301 configured to connect to an internal thread surface 322 of the vial 307. The embodiment of FIG. 10 further includes a seal in the form of a flat O-ring seal 302 between the upper surface of the vial 307 and a bottom shelf 312C below an upper cylindrical wall 312B, and the upper cylindrical wall 312B has a diameter larger than the diameter of the lower cylindrical wall 312A.

[0018] Referring to FIG. 11, the connection between a vial cap 401 and a vial 407 includes an inwardly projecting snap ring 403 on the vial cap 401, which is configured to engage with a corresponding groove 422 on an outer surface of the vial 407.

[0019] Referring to Figure 12, the connection between the vial cap 501 and the vial 507 includes threads 503 on the outer surface of the lower cylindrical wall 512A of the vial cap 501, as shown in Figure 10. A seal is formed by an external cylindrical plug seal 502 extending from the upper cylindrical wall 512B, the upper cylindrical wall 512B having a larger diameter than the lower cylindrical wall 512A, and the upper surface of the vial 507 engages with a bottom shelf 512C between the upper cylindrical wall 512B and the lower cylindrical wall 512A.

[0020] Referring to Figure 13, the connection between the vial cap 601 and the vial 607 includes a friction / push seal 602 between the tapered outer surface 603 on the vial 607 and the corresponding tapered inner surface 622 on the vial cap.

[0021] Referring to Figure 13, the connection between the vial cap 601 and the vial 607 includes a friction / push seal 602 between the tapered outer surface 603 on the vial 607 and the corresponding tapered inner surface 622 on the vial cap.

[0022] Referring to Figures 14A and 14B, a partial view of an exemplary bayonet connection between a vial cap and a vial is shown, according to another embodiment, having corresponding opposing external or internal bayonet projections 734 and opposing external or internal bayonet slots or grooves 736 that connect to each other through engagement and slight rotation of projections 734 in slots or grooves 736 located at the connecting ends of the vial cap and vial.

[0023] Referring again to Figures 1 to 7, the vial cap 1 may also have two or more ports 4 within the vial cap 1 that allow fluid or gas to enter and exit the hollow interior 24 of the vial 7. One port 4 is typically used as an inlet for introducing fluid or gas, and the other port 4 is used as an outlet that allows the fluid or gas to flow out of the vial 7 again. The ports 4 may be identical in configuration. It is their connectivity in the fluid system that determines which port 4 is the inlet and which is the outlet.

[0024] Two or more ports 4 may include a latched external tube or spigot 5 extending from the top of the cap 14. The ports 4 may extend upward from the upper surface 16 of the top of the cap 14 and may be configured to allow connection of the fluid passage within them to the tube set 8 for fluid connectivity to the fluid system. The ports 4 may further be configured as two internal tubular structures, i.e., chimneys 6, which extend downward from the lower surface 18 of the top of the cap 14, forming an internal divider or fluid separator 25 between the ports 4 and serving as an internal fluid passage between the external tube 5 and the hollow interior 24 of the vial 7. The chimneys 6 ensure that the liquid entering from the inlet port 4 fills the vial 7 before entering and exiting through the outlet port 4. If a gas follows the liquid, the gas will push the liquid out of the chimney 6, but leave the liquid below the chimney 6 in the vial 7 (Figure 7). This creates a metered volume of liquid 10 and a metered gas head volume 11 remaining in the vial 7, allowing the liquid to expand during the freezing process.

[0025] An alternative embodiment of the vial cap 801 is shown in Figures 15A and 15B, which has a fluid separator 825 extending across the inner diameter of the vial cap 801 instead of two internal tubular structures or chimneys. The fluid separator 825 separates the internal portion of the vial cap 801 into two internal fluid passages 844, providing the same metering function as the two internal tubular structures or chimneys discussed above.

[0026] Referring again to Figures 1 to 7, in some embodiments, the upper cap 14 is located at the fluid connection between the outer tube 5 and the chimney 6, spaced apart from the upper edge 26 and lower edge 28 of the cylindrical wall 12. The outer tube 5 can extend upward from the upper surface 16 of the upper cap 14, and the outer tube 5 is located within the cylindrical wall 12, with its upper end 30 spaced below the upper edge 26 of the cylindrical wall 12 to protect the outer tube 5 from lateral loads and breakage.

[0027] An alternative embodiment of the vial cap 901 is shown in Figure 16, in which the outer tube 905 extends upward and then radially from the top of the cap 914.

[0028] Referring again to Figures 1 to 7, the chimney 6 can extend downward from the lower surface 18 of the upper cap 14, and the chimney 6 is positioned within the cylindrical wall 12, with its lower end 32 extending beyond the lower edge 28 of the cylindrical wall 12. Alternatively, the length of the chimney 6 can be adjusted to define the capture volume within the vial 7, so the lower end 32 may terminate before the lower edge 28 of the cylindrical wall. The chimney 6 may be joined along its entire length so as to be configured to fit into a small space while satisfying good injection molded part design principles.

[0029] Referring to Figure 6, a fluid system including a structure or frame 9 for holding a vial 7 with a vial cap 1 and tube set 8 attached. The frame 9 may be a disposable plastic frame 9 that 1) holds the vial 7 / vial cap 1 and tube set 8 in an easily handleable manner, and 2) allows the tubes of tube set 8 to span an automated tube seal and separate device, enabling aseptic sealing and removal of the vial. Alternatively, a manual tube seal and separate device may be used. The vial 7 / vial cap 1 is only lightly held by the frame 9 and can be easily removed once sealed and separated from tube set 8. The wall 36 separating the vial 7 can also be used to assist in labeling the vial body, which can be difficult to do with gloved hands in a cleanroom environment. It should be noted that Figure 6 shows a portion of the complete frame 9.

[0030] The vial cap 1 may further include at least one window 38 positioned through an axially extending cylindrical wall 12. The window 38 may be rectangular in shape and is configured to allow the manufacture or injection molding of the vial cap 1. A component of an injection molding tool called a slider (not shown) slides in and out of these windows 38 to form undercuts for engaging ports 4. Where the slider moves in and out over the top 14 of the cap, the surface is slightly tapered.

[0031] Embodiments of this disclosure are not limited to those described above. For example, some embodiments have more ports. In some embodiments, the vial cap may be made of plastic or other polymers or other materials such as metal. In some embodiments, the tube set may include plastic or other suitable materials. In some embodiments, the vial cap may have other attachment methods, such as being welded, snapped, glued, or pressed. In some embodiments, there may be other access methods, such as a push-up lid, a tear-off lid, a pop-off / snap-off lid, a pull-out lid, or multiple access such as top and bottom caps on the vial. In some embodiments, other metering may be included, such as no chimney or chimneys of different lengths or shapes. In some embodiments, other tube connections may be included, such as no hook, welded, solvent-bonded, or overmolded. In some embodiments, different sizes and threads may be configured to fit other types / size containers. In some embodiments, dissimilar materials with different shrinkage rates may be used between the vial cap and the vial.

[0032] Accordingly, embodiments of the present disclosure enable access to captured samples without requiring sharp instruments such as needles. Sharp instruments such as needles pose a safety risk to the user and a risk of sterility breach to sterile processes. Embodiments of the present disclosure provide access to liquid samples simply by unscrewing a vial cap or via tube welding. Certain embodiments may be used to capture metered small volumes from a fluid tube system. For example, embodiments may be used to capture quality control (QC) samples, capture sterile samples, capture samples for cryogenic storage or other purposes for future inspection and evaluation, or to prepare aliquots of larger samples.

[0033] All features disclosed herein, including the attached claims, abstract and drawings, and references incorporated by reference, as well as all steps of any method or process disclosed herein, may be combined in any combination, except for any combination in which at least part of such features and / or steps are mutually exclusive.

[0034] Including references incorporated by reference, accompanying claims, abstract, and drawings, each feature disclosed herein may be replaced by an alternative feature serving the same, equivalent, or similar purpose unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is merely an example of a general set of equivalent or similar features.

[0035] The present invention is not limited to the details of the embodiments described above. The present invention extends to novel features or combinations of features disclosed herein, or novel steps of methods or processes so disclosed herein, including the references incorporated by reference, the appended claims, abstract and drawings. All of the above references in all sections of this application are incorporated herein by reference in their entirety for all purposes.

[0036] While specific embodiments are illustrated and described herein, those skilled in the art will understand that any arrangement calculated to achieve the same objective may substitute for the specific embodiments illustrated. This application is intended to cover modifications or variations of the subject matter. Accordingly, the present invention is intended to be defined by the appended claims and their legal equivalents, as well as by the following exemplary embodiments. The embodiments of the above-described embodiments of the present invention are merely illustrative of the principle and are not intended to be limiting. Further modifications of the present invention disclosed herein are conceivable to those skilled in the art, and all such modifications are considered to be within the scope of the present invention.

[0037] [Implementation Method] (1) A container cap configured to be sealed to a tube set and a container having a hollow interior configured to receive and store a liquid sample, wherein the container cap is A cylindrical wall extending in the axial direction, A radially extending cap upper portion disposed within the cylindrical wall, the cap upper portion having an upper surface and a lower surface, the cap upper portion dividing the container cap into an upper internal portion located within the cylindrical wall above the upper surface of the cap upper portion and a lower internal portion located within the cylindrical wall below the lower surface of the cap upper portion, The cap comprises at least two external tubes extending from the top of the cap, each external tube defining an external fluid passage configured to be fluidly connected to the tube set, A container cap, wherein the lower internal portion includes at least one fluid separator extending downward from the lower surface of the upper part of the cap, the at least one fluid separator defining at least two internal fluid passages, each configured to be fluidly connected to one of the external fluid passages and to the hollow interior of the container, each internal fluid passage configured to provide measurement of fluid volume within the container to which it is attached. (2) Further comprising at least one seal configured to seal the connection between the container cap and the container, The container cap according to Embodiment 1, wherein the at least one seal includes at least one of a cylindrical plug seal, an internal O-ring, an external O-ring, an internal flat O-ring, and an external flat O-ring. (3) The at least one seal includes a cylindrical plug seal that extends downward from the lower surface of the upper part of the cap, is concentrically spaced away from the cylindrical wall and is spaced inward from the cylindrical wall, The container cap according to Embodiment 2, wherein the cylindrical plug seal is configured to form a seal to the inner surface of the container. (4) The connection portion includes at least one of the female thread, male thread, snap ring, interference connection portion, friction connection portion, and bayonet connection portion on the container cap, The container cap according to Embodiment 2, wherein the container cap is configured to capture and seal the open end of the container. (5) The container cap according to Embodiment 1, wherein the outer tube extends from the upper surface of the upper part of the cap.

[0038] (6) The container cap according to Embodiment 5, wherein the upper end of each outer tube includes a hooked port. (7) The at least one fluid separator is formed between two internal tubular structures extending downward from the lower surface of the upper part of the cap, The container cap according to Embodiment 1, wherein the internal tubular structure extends downward from the lower surface of the cap and is configured to separate the fluid passage. (8) The container cap according to embodiment 7, wherein the internal tubular structures are joined together along their entire length. (9) A container assembly configured to be sealed and attached to a tube set, wherein the container assembly is A container having a hollow interior configured to receive and store liquid samples, Includes a container cap configured to be connected to the container, The aforementioned container cap is A cylindrical wall extending in the axial direction, A radially extending cap upper portion disposed within the cylindrical wall, the cap upper portion having an upper surface and a lower surface, the cap upper portion dividing the container cap into an upper internal portion located within the cylindrical wall above the upper surface of the cap upper portion, and a lower internal portion located within the cylindrical wall below the lower surface of the cap upper portion, The cap comprises at least two external tubes extending from the top of the cap, each external tube defining an external fluid passage configured to be fluidly connected to the tube set, A container assembly wherein the lower internal portion includes at least one fluid separator extending downward from the lower surface of the upper part of the cap, the at least one fluid separator defines at least two internal fluid passages, each configured to be fluidly connected to one of the external fluid passages and to the hollow interior of the container, each internal fluid passage configured to provide measurement of fluid volume within the container to which it is attached. (10) Further comprising at least one seal configured to seal the connection between the container cap and the container, The container assembly according to Embodiment 9, wherein the at least one seal includes at least one of a cylindrical plug seal, an internal O-ring, an external O-ring, an internal flat O-ring, and an external flat O-ring.

[0039] (11) The at least one seal includes a cylindrical plug seal that extends downward from the lower surface of the upper part of the cap, is concentrically spaced away from the cylindrical wall and is spaced inward from the cylindrical wall, The container assembly according to embodiment 10, wherein the cylindrical plug seal is configured to form a seal to the inner surface of the container. (12) The connection portion includes at least one of a female thread, a male thread, a snap ring, an interference connection portion, a friction connection portion, and a bayonet connection portion on the container cap, The container assembly according to embodiment 10, wherein the container cap is configured to capture and seal the open end of the container. (13) The container assembly according to embodiment 9, wherein the outer tube extends from the upper surface of the top of the cap. (14) The container assembly according to embodiment 13, wherein the upper end of each outer tube includes a hooked port. (15) The at least one fluid separator is formed between two internal tubular structures extending downward from the lower surface of the upper part of the cap, The container assembly according to embodiment 9, wherein the internal tubular structure extends downward from the lower surface of the cap and is configured to separate the fluid passage.

[0040] (16) The container assembly according to embodiment 15, wherein the internal tubular structures are joined together along their entire length. (17) A fluid system, Frame and, At least one set of tubes supported by the frame, Includes at least one container assembly supported by the frame, The aforementioned container assembly is A container having a hollow interior configured to receive and store liquid samples, The container cap includes, configured to be connected to the container, A cylindrical wall extending in the axial direction, A radially extending cap upper portion disposed within the cylindrical wall, the cap upper portion having an upper surface and a lower surface, the cap upper portion dividing the container cap into an upper internal portion located within the cylindrical wall above the upper surface of the cap upper portion, and a lower internal portion located within the cylindrical wall below the lower surface of the cap upper portion, The cap comprises at least two external tubes extending from the top of the cap, each external tube defining an external fluid passage configured to be fluidly connected to the tube set, The lower internal portion includes at least one fluid separator extending downward from the lower surface of the upper part of the cap, the at least one fluid separator defining at least two internal fluid passages, each configured to be fluidly connected to one of the external fluid passages and to the hollow interior of the container, each internal fluid passage configured to provide measurement of fluid volume within the container to which it is attached, a fluid system.

Claims

1. A container cap configured to be sealed to a tube set and a container having a hollow interior configured to receive and store a liquid sample, wherein the container cap is A cylindrical wall extending in the axial direction, A radially extending cap upper portion disposed within the cylindrical wall, the cap upper portion having an upper surface and a lower surface, the cap upper portion dividing the container cap into an upper internal portion located within the cylindrical wall above the upper surface of the cap upper portion and a lower internal portion located within the cylindrical wall below the lower surface of the cap upper portion, The cap includes at least two external tubes extending from the top of the cap, each external tube defining an external fluid passage configured to be fluidly connected to the tube set, The lower internal portion includes at least one fluid separator extending downward from the lower surface of the upper part of the cap, the at least one fluid separator defining at least two internal fluid passages, each configured to be fluidly connected to one of the external fluid passages and to the hollow interior of the container, each internal fluid passage being configured to provide measurement of fluid volume within the container to which it is attached. A container cap in which one end of the outer tube functions as a fluid inlet and the other end of the outer tube functions as a fluid outlet, and after filling the container with liquid, gas is filled in so that the amount of liquid remaining in the container reaches the liquid level of the introduced liquid at the bottom of the fluid separator, and the amount of remaining liquid is the subject of measurement.

2. The present invention further includes at least one seal configured to seal the connection between the container cap and the container, The container cap according to claim 1, wherein the at least one seal includes at least one of a cylindrical plug seal, an internal O-ring, an external O-ring, an internal flat O-ring, and an external flat O-ring.

3. The at least one seal includes a cylindrical plug seal that extends downward from the lower surface of the upper part of the cap, is concentrically spaced away from the cylindrical wall, and is spaced inward from the cylindrical wall. The container cap according to claim 2, wherein the cylindrical plug seal is configured to form a seal to the inner surface of the container.

4. The connection portion includes at least one of the female thread, male thread, snap ring, interference connection portion, friction connection portion, and bayonet connection portion on the container cap. The container cap according to claim 2, wherein the container cap is configured to capture and seal the open end of the container.

5. The container cap according to claim 1, wherein the outer tube extends from the upper surface of the upper part of the cap.

6. The container cap according to claim 5, wherein the upper end of each outer tube includes a hooked port.

7. The at least one fluid separator is formed between two internal tubular structures extending downward from the lower surface of the upper part of the cap. The container cap according to claim 1, wherein the internal tubular structure extends downward from the lower surface of the upper part of the cap and is configured to separate the internal fluid passage.

8. The container cap according to claim 7, wherein the internal tubular structures are joined together along their entire length.

9. A container assembly configured to be sealed and attached to a tube set, wherein the container assembly is A container having a hollow interior configured to receive and store liquid samples, Includes a container cap configured to be connected to the container, The aforementioned container cap is A cylindrical wall extending in the axial direction, A radially extending cap upper portion disposed within the cylindrical wall, the cap upper portion having an upper surface and a lower surface, the cap upper portion dividing the container cap into an upper internal portion located within the cylindrical wall above the upper surface of the cap upper portion, and a lower internal portion located within the cylindrical wall below the lower surface of the cap upper portion, The cap includes at least two external tubes extending from the top of the cap, each external tube defining an external fluid passage configured to be fluidly connected to the tube set, The lower internal portion includes at least one fluid separator extending downward from the lower surface of the upper part of the cap, the at least one fluid separator defining at least two internal fluid passages, each configured to be fluidly connected to one of the external fluid passages and to the hollow interior of the container, each internal fluid passage being configured to provide measurement of fluid volume within the container to which it is attached. A container assembly in which one end of the outer tube functions as a fluid inlet and the other end of the outer tube functions as a fluid outlet, and after filling the container with liquid, gas is filled in so that an amount of liquid remains in the container such that the bottom of the fluid separator becomes the liquid level of the introduced liquid, and the amount of remaining liquid is the subject of measurement.

10. The present invention further includes at least one seal configured to seal the connection between the container cap and the container, The container assembly according to claim 9, wherein the at least one seal includes at least one of a cylindrical plug seal, an internal O-ring, an external O-ring, an internal flat O-ring, and an external flat O-ring.

11. The at least one seal includes a cylindrical plug seal that extends downward from the lower surface of the upper part of the cap, is concentrically spaced away from the cylindrical wall, and is spaced inward from the cylindrical wall. The container assembly according to claim 10, wherein the cylindrical plug seal is configured to form a seal to the inner surface of the container.

12. The connection portion includes at least one of the female thread, male thread, snap ring, interference connection portion, friction connection portion, and bayonet connection portion on the container cap. The container assembly according to claim 10, wherein the container cap is configured to capture and seal the open end of the container.

13. The container assembly according to claim 9, wherein the external tube extends from the upper surface of the upper part of the cap.

14. The container assembly according to claim 13, wherein the upper end of each outer tube includes a hooked port.

15. The at least one fluid separator is formed between two internal tubular structures extending downward from the lower surface of the upper part of the cap. The container assembly according to claim 9, wherein the internal tubular structure extends downward from the lower surface of the upper part of the cap and is configured to separate the internal fluid passage.

16. The container assembly according to claim 15, wherein the internal tubular structures are joined together along their entire length.

17. A fluid system, Frame and, A set of at least one tubes supported by the frame, Includes at least one container assembly supported by the frame, The aforementioned container assembly is A container having a hollow interior configured to receive and store liquid samples, The container cap includes, configured to be connected to the container, A cylindrical wall extending in the axial direction, A radially extending cap upper portion disposed within the cylindrical wall, the cap upper portion having an upper surface and a lower surface, the cap upper portion dividing the container cap into an upper internal portion located within the cylindrical wall above the upper surface of the cap upper portion, and a lower internal portion located within the cylindrical wall below the lower surface of the cap upper portion, The cap includes at least two external tubes extending from the top of the cap, each external tube defining an external fluid passage configured to be fluidly connected to the tube set, The lower internal portion includes at least one fluid separator extending downward from the lower surface of the upper part of the cap, the at least one fluid separator defining at least two internal fluid passages, each configured to be fluidly connected to one of the external fluid passages and to the hollow interior of the container, each internal fluid passage being configured to provide measurement of fluid volume within the container to which it is attached. A fluid system in which one end of the external tube functions as a fluid inlet and the other end of the external tube functions as a fluid outlet, and after filling the container with liquid, gas is filled in so that an amount of liquid remains in the container that reaches the liquid level of the introduced liquid at the bottom of the fluid separator, and the amount of remaining liquid is to be measured.

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