Sealing insert for a container

Abstract

The disclosure provides an insert for sealing of a container, comprising a centrally arranged conical funnel, wherein the upper end of the conical funnel is surrounded by a collar, and wherein the lower end of the conical funnel transits into a cylindrical channel, wherein an area around a lower end of the cylindrical channel is surrounded by an annular margin which pro- vides on its outer circumference a sealing lip, wherein guiding rips extend radially from the conical funnel and cylindrical channel for connecting the collar surrounding the upper end of the conical funnel and the upper side of the annular margin, and wherein below the lower side of the annular margin an embossed piercing area with lid extends downwards, wherein the em- bossed piercing area comprises a predetermined breaking line surrounding the lid, wherein the predetermined sealing line is partly covered by thickened material forming a hinge for the lid. Another object of the present disclosure relates to a system for sealing of a container and han- dling of liquids within the container, comprising an insert as described above; and pipette tips, wherein a lower section of the pipette tip has a smaller diameter than an upper section of the pipette tip, and wherein only the lower end of the pipette tip is suitable having a smaller diam- eter to pass through the cylindrical channel. Another object of the present disclosure relates to a method for storing and handling liquids in a reagent container, comprising the steps of provid- ing a liquid in the reagent container; sealing the container with an insert as described above; arranging a pipette tip on a pipette, wherein a lower end of the pipette tip has a smaller diameter than an upper part of the pipette tip; piercing of the piercing area with embossed lid with the pipette tip's lower end; and moving the pipette tip's lower end into the liquid for aspirating liquid.

Description

SEALING INSERT FOR A CONTAINERDESCRIPTIONField of the Disclosure

[0001] The disclosure relates to a sealing insert for a container.Brief description of the related art

[0002] Automated analyser systems for use in clinical diagnostics and life sciences are produced by a number of companies. For example, STRATEC® SE, Birkenfeld, Germany, produces a number of devices for specimen handling and detection for use in automated analyser systems and other laboratory instrumentation.

[0003] Automatic analyser systems in clinical diagnostics and life science have to be supplied with different reagents to run biochemical processes. The reagents are usually stored in consumable bottles, or containers. The reagent containers can be of different sizes and are transported into the analyser system positioned in a rack. In general, the cover of each of the reagent containers has to be removed prior to loading into the analyser system. Thus, the reagent containers are in an open state supplied in the analyser system. As a result, due to the open state of the reagent containers, reagent evaporates and the concentration of the reagents changes, which may adversely affect the results of an analysis.

[0004] Typical reagent containers are sealed with a foil or film. The foil is punctured by a pipettor when approaching the reagent container for the first time. Thus, the opening size can be as small as the diameter of a needle of the pipettor. Alternatively, the foil can be removed by a user prior to inserting the particular reagent container into the analyser system or the rack, respectively. Consequently, in foil sealed reagent containers, an open state is always present during their presence in the analyser system. The reagent may evaporate on its entire upper surface because the entire upper surface of the liquid is exposed to the environment.

[0005] Preferably, disposable needle tips are used when pipetting through the foil, because a contact between the foil and the whole needle of the pipettor cannot be avoided. When using pipettors with fixed needles, a cleaning of the whole needle is inevitable following every use. Such cleaning process is time-consuming, costly, and related to the use of huge amounts of cleaning fluid.

[0006] An elastic septum which is attached to a lid of the container can also be used for sealing of the reagent container. This septum has either an opening gap or a predetermined breaking point which opens when the pipette pierces the reagent container’s septum for the first time. The opening gap or breaking point is usually formed as a line, a cross, or a star. The opening gap of the septum is not completely closed after removing a pipette’s tip. However, due to the elasticity of the used material, the septum closes almost completely, when the needle or the pipette’s tip is removed from the reagent container. The reagents are thus basically protected from evaporation. It is to be noted that, the use of an elastic septum for sealing of a reagent container results in a contact between the needle of the pipettor and the septum. The use of reusable needles (i.e., pipettors with fixed needles) requires a cleaning of the needle after every use. Such cleaning processes are time-consuming, costly, and related to the consumption of a lot of cleaning fluid.

[0007] A combination of an elastic septum and an opening mechanism is also known in the prior art for sealing reagent containers, wherein the opening mechanism is attached to the lid of the reagent containers. The lid has an annular wedge-shaped part, by which the septum can be spread. The lid including the wedge-shaped part is biased by a coil spring in an upper position, in which the septum is closed. By pressing the lid against the biasing force of the coil spring towards a lower position, the septum is spread. Thus, the opening of the septum is not accomplished by the needle of the pipettor, but by the lid itself. The needle itself is thus not in contact with the septum. If the resistance holding the lid in the lower position is removed, the lid returns to the upper position by the biasing force of the coil spring. The septum is closed again. However, the opening mechanism for actuating the lid of the reagent container in a pipettor having three axes has a complex structure. Since the reagent containers are located in a single position in the analyser system, a separate drive unit for opening and closing the elastic septum is necessary.

[0008] It is also known to use a folding or sliding mechanism for opening the lid of a reagent container in the analyser system. These configurations are normally used in analyser systems having the reagent containers arranged in a carousel. In such an arrangement, the pipettor is located at a fixed position and the reagent containers are rotated into the respective position below the pipettor by a rotational drive of the carousel. Within the rotational movement of the reagent container towards or away from the pipettor, the lid can be pushed against a fixed stop for actuating the folding or sliding mechanism of the lid into an opening or closing state. Thus, in a rotational loading system, the fixed stop can be arranged before the fixed pipettor, which causes an opening of the lid, and / or after the fixed pipettor, which causes a closing of the lid. Such folding or sliding mechanism for opening and closing the lid of a reagent container in the analyser system is described, for example, in the published European patent application EP 0 909 584 A2. However, with the one-time opening of the reagent container, for example during the loading and removal of the reagent containers from the analyser system, evaporation of the reagents cannot be prevented. Further, for an analyser system having a pipettor system with three axes, the above cannot be applied. For such a pipettor, since the reagent containers are located at one position, the lid cannot be pushed against the fixed stop. Thus, an additional drive concept is necessary. As a result, the analyser system becomes even more complex.

[0009] A further example for sealing of a reagent container is disclosed in U.S. Patent Application Publication No. 2011 / 0293478 Al . This document refers to a tube which is inserted into a reagent container. The tube includes in its top portion an annular rim for bearing on the top end of the neck of the reagent container and means for centring in the neck of the reagent container. The tube has on its upper and lower end a slot, respectively. A suction needle is brought over the reagent container, to lie on the axis of the reagent container, and it is lowered into the container through the inserted tube close to the bottom thereof. The slot at the upper end of the tube enables an air flow between the neck of the reagent container and the annular rim, thereby enabling air to enter the container while the reagent is being sucked up from the reagent-taking needle. To facilitate taking reagent from the container, the bottom end of the tube includes the lower slot through which reagent passes. With the lower slot of the tube, the liquid can be drawn in, and with the upper slot of the tube, the necessary pressure exchange can take place. By providing a tube inserted in the reagent container, the surface of the liquid, which is in contact with the environment, can be minimized. However, the reagents are not completely protectedfrom evaporation, since the surface of the liquid contacting the environment is merely minimized. Indeed, the reagent located in the tube can evaporate and may cause a difference in the concentration of the reagent.

[0010] Published U.S. Patent Application US 2017 / 0266664 Al discloses a device for sealing a reagent container storing and providing liquids, in particular in an analyser system. The disclosure also relates to a reagent container using such a device for sealing, a cartridge for holding such a reagent container, and a method for removing a liquid from such a reagent container. The instant disclosure provides a device for sealing a reagent container comprising an annular member configured to be inserted into the reagent container, wherein the annular member is configured to being movably coupled to the reagent container relative to its longitudinal center axis; an opening passing from a top end of the annular member to a bottom end of the annular member; and a sealing element arranged between the top end and the bottom end of the annular member for sealing the opening.

[0011] Published U.S. Patent US 11,000,851 B2 relates to a method for reconstituting a lyophilized reagent contained within a reagent well comprises the steps of drawing a diluent into a pipette tip attached to an automated pipettor and dispensing the diluent into the reagent well containing the lyophilized reagent. The reagent well has an internal side wall, a bottom wall, and an open upper end and includes one or more retention features disposed about the periphery of the internal side wall and defining a central opening into the well that permits passage of the pipette tip into the reagent well. The one or more retention features are integrally formed with the internal side wall, and each of the one or more retention features extends over a portion of the lyophilized reagent, thereby retaining the lyophilized reagent within the reagent well. It is disadvantageous that a cap according to this document will be fixed to the upper end of a receptacle for receiving a fluid.

[0012] Published German patent application DE 10 2011 050478 Al discloses a penetrable sealing element which is formed in conical or cylindrical section in section wise manner under formation of a channel. A penetration point is arranged at a closed end of the channel. The penetration point is formed as a nearly circular or rectangular or oval shaped material recess or material reduction. A rear section is arranged at an open end of the channel in circumferentialmanner. It is disadvantageous that a sealing element according to this document will be fixed to the upper end of a receptacle for receiving a fluid.

[0013] Published European patent application EP 4279 181 Al discloses a sealing for a reagent container and provides a sealing plug which can be adapted to the respective reagent container. Within the meaning of the present disclosure the terms plug, and stopper will be used synonymously. A liquid which is deposited in a reagent container like a container or tube is protected by a plug from both, evaporation, and oxidation by ambient air during its presence in the reagent container. In addition, when the reagent container is provided to the analyser, the plug reduces evaporation and oxidation of liquids like reagents. A system comprising the plug and a method for using the plug are also disclosed.

[0014] Published Korean patent application KR 2023 0132182 A discloses a test cartridge according to one preferred embodiment of the present invention comprises: a vial container; a solution distribution unit having an inlet that penetrates a punching layer of the vial container; a reagent reaction unit having at least one chamber containing a test reagent; and a container mounting unit having a container insertion space into which the vial container is inserted and a hook provided in the container insertion space to be hooked to a mounting groove of the vial container, and fitted to the test cartridge such that the inlet is located in the container insertion space, wherein when the vial container is inserted into the container insertion space, the container mounting unit supports the side of the vial container as the hook is caught in the mounting groove to hold the vial container such that the solution in the vial container flows in the direction of gravity. The vial container according to a preferred embodiment of the present invention includes a container body containing a solution and a container lid detachably coupled to the upper part of the container body and having at least one lid ventilation hole. The container body includes: a solution receiving unit containing the solution with the lower end portion having a funnel structure; a punching layer as a thin membrane structure, which closes the lower part of the solution receiving unit; a residue accommodating groove protruding toward the lower part of the solution receiving unit to surround the edge of the punching layer and forming a step with the punching layer; and an entry groove unit provided to face the solution receiving unit with the punching layer interposed therebetween. Accordingly, when the solution stored in the vial container flows into each chamber containing the test reagent, shaking of the vial container can be prevented to allow the solution to flow evenly into each chamber.

[0015] Another problem which is related to the use of a septum in a container stopper is a blockage of a needle or pipette tip by the parts of the septum which are cut out. Further, solids like magnetic beads which are solved in the liquid may attach to a container stopper.

[0016] It is also desirable to minimize evaporation of a liquid which is comprised in a sealed container. For minimizing the evaporation in a sealed container, it is desirable to minimize the space between the upper surface of a liquid and the sealing.

[0017] Thus, there is a need for the sealing of a reagent container which prevents evaporation of the liquid in a sealed container and minimizes evaporation of the liquid in an opened container.Object of the Disclosure

[0018] It is therefore the object of this disclosure to provide a sealing insert for preventing evaporation of a liquid in a sealed container and minimizing evaporation in an opened container even when fluid levels decrease while further allowing to aspirate the fluid from minimized dead volumes in the sealed container avoiding the requirement to wash a fixed needle in its entirety to save liquids and time.Summary of the Disclosure

[0019] The present disclosure provides an insert for sealing of a container, comprising a centrally arranged conical funnel, wherein the upper end of the conical funnel is surrounded by a collar, and wherein the lower end of the conical funnel transits into a cylindrical channel, wherein an area around a lower end of the cylindrical channel is surrounded by an annular margin connecting a sealing lip on its outer circumference with the cylindrical channel, wherein guiding rips extend radially from the conical funnel and cylindrical channel for connecting the collar surrounding the upper end of the conical funnel and an upper side of the annular margin facing the collar, and wherein below a lower side of the annular margin an embossed piercing area with lid extends downwards, wherein the embossed piercing area comprises a predetermined breaking line surrounding the lid, wherein the predetermined breaking line is partly covered by thickened material forming a hinge for the lid.

[0020] In an embodiment, the insert comprises at least one embossed stirring fin is arranged on the lower side of the annular margin between sealing lip and the embossed piercing area.

[0021] The collar of an insert according to the resent disclosure has in an embodiment a smaller diameter than the annular margin with sealing lip.

[0022] It is intended that the guiding rips extend in their middle part up to the outer circumference of sealing lip, wherein the outer upper and lower part of guiding rips are recessed below collar and above annular margin.

[0023] It is envisaged that the embossed lid has a reduced material thickness in an embodiment in comparison to the annular margin of the insert from which it extends.

[0024] The embossed lid has polygonal shape regarding its surrounding circumference in an embodiment.

[0025] It is intended that the outer circumference of the annular margin of an insert according to the present disclosure is circular, wherein the insert is made of a polymer or silicone in an embodiment.

[0026] Another object of the present disclosure relates to a system for sealing of a container and handling of liquids within the container, comprising an insert as described above; and pipette tips, wherein a lower section of the pipette tip has a smaller diameter than an upper section of the pipette tip, and wherein only the lower end of the pipette tip is suitable having a smaller diameter to pass through the cylindrical channel.

[0027] The system comprises in an embodiment a reagent container with a stop for the insert at the reagent container’s inner surface.

[0028] Another object of the present disclosure relates to a method for storing and handling liquids in a reagent container, comprising the steps of providing a liquid in the reagent con-tainer; sealing the container with an insert as described above; arranging a pipette tip on a pipette, wherein a lower end of the pipette tip has a smaller diameter than an upper part of the pipette tip; piercing of the piercing area with embossed lid with the pipette tip’s lower end; and moving the pipette tip’s lower end into the liquid for aspirating liquid.

[0029] The method comprises in an embodiment the step of moving the insert downwards by a shoulder of a pipette tip referring to the transition area of a pipette tip where the smaller diameter of a pipette tip’s end widens towards its upper end.

[0030] In another embodiment, the method comprises the step of mixing the liquid by moving the sealed container and creating turbulences in the liquid by embossed stirring fins of the sealing insert and / or fins arranged at the bottom of the container.

[0031] The method also relates to including a step of resuspending solid particles in the liquid.

[0032] Still other aspects, features, and advantages of the present disclosure are readily apparent from the following detailed description, simply by illustrating preferable embodiments and implementations. The present disclosure is also capable of other and different embodiments and its several details can be modified in various obvious respects, all without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature, and not as restrictive. Additional objects and advantages of the disclosure will be set forth in part in the description which follows and in part will be obvious from the description, or may be learned by practice of the disclosure.Summary of the Figures

[0033] The disclosure will be described based on figures. It will be understood that the embodiments and aspects of the disclosure described in the figures are only examples and do not limit the protective scope of the claims in any way. The disclosure is defined by the claims and their equivalents. It will be understood that features of one aspect or embodiment of the disclosure can be combined with a feature of a different aspect or aspects of other embodiments of the disclosure, in which:

[0034] FIG.1 shows a perspective view onto a sealing insert according to the present disclosure.

[0035] FIG. 2 shows a cross-sectional view through a sealing insert according to the disclosure for a reaction container.

[0036] FIG. 3 shows a perspective view onto an insert’s lower part.

[0037] FIG. 4 shows an embodiment of the embossed piercing are in more detail.

[0038] FIG. 5 shows the measured average difference per day for six empty containers, closed with a regular DSC which was pierced for controlling condensed water.

[0039] FIG. 6 shows measured average difference per day for six empty containers, closed with a DSC according to the present disclosure which was pierced for controlling condensed water.

[0040] FIG. 7 shows the measured average difference per day for six containers filled with 1.5 ml PBS, closed with a regular DSC which was pierced.

[0041] FIG. 8 shows the measured average difference per day for six containers filled with 1.5 ml PBS, closed with a DSC according to the present disclosure which was pierced.Detailed Description of the Disclosure and the Figures

[0042] The technical problem is solved by the independent claims. The dependent claims cover further specific embodiments of the disclosure.

[0043] The present disclosure provides a sealing insert which can be adapted to the diameter of the respective reagent container. Within the meaning of the present disclosure the sealing insert may also be designated as insert or stopper which will be used synonymously. A liquid which is deposited in a reagent container like a container or tube is protected by an insert according to the present disclosure from evaporation during its presence inside the reagent container.

[0044] A container according to the present disclosure has preferably a cylindrical shape with a constant diameter which is open at an upper end and closed on the opposite end. The sealing insert according to the present disclosure is intended to be inserted from the open upper end into a container.

[0045] The sealing insert according to the present disclosure can be made of a polymer or silicone, which allows the manufacture by injection moulding employing a moulding tool called a mould which comprises two halves or plates. The polymer is selected from the group comprising acrylic (PMMA), acrylonitrile butadiene styrene (ABS), styrene butadiene styrene copolymer (SBS), nylon (polyamide, PA), polycarbonate (PC), polyethylene (PE), ultra-high-molec- ular-W eight polyethylene (UHMW-PE), polyethylene terephthalate (PET), polyether ether ketone (PEEK), polybutylene terephthalate (PBT), perfluoro alkoxy polymer (PF A), perfluorinated ethylene propylene (PFEP), polyoxymethylene (POM), polypropylene (PP), polyphenylene sulfide (PPS), polyphthalamide (PPA), polystyrene (PS) , polyether block amide (PEBA), thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), high density polyethylene (HDPE), low density polyethylene (LDPE), High Impact Polystyrene (HIPS), Thermoplastic Rubber (TPR), Liquid Silicone Rubber (LSR), High Consistency Rubber (HCR), styrene acrylonitrile copolymer, acrylonitrile acrylate (ASA), polyimide (PI), thermoplastic polyimide (TPI), Syndiotactic polystyrene (SPS), liquid Silicone Rubber (LSR), high consistency rubber (HCR), polytrimethylene terephthalate (PTT), poly(p-phenylene ether (PPE). In or for an injection moulding machine, polymers are plasticized in an injection unit and injected into a mould. The cavity of the mould determines the shape and surface texture of the finished part. The polymer materials need to be treated carefully to prevent oxidation or decomposition as a result of heat or sheer stresses. Heat and pressure are applied to press molten polymer into the structured surface of the master. Depending on the polymer, the thickness of the part and complexity of the structures the cycle time can be a few seconds (e.g. for isothermal moulding of optical discs) up to several minutes (for example for variothermal moulding of thick parts with high aspect ratio microstructures). After a suitable filling, cooling and hardening time (noting that cooling and hardening take place together for thermoplastics), the heat and pressure are removed, and the finished plastics structure is ejected from the mould. The injection moulding process can then be repeated using the same master.

[0046] It is to be noted that there is a difference between the storage and the use of a liquid in a reagent container. Evaporation is to be prevented during storage of a liquid in a reagent container. Evaporation is to be reduced during use of the liquid in a reagent container after opening of the embossed lid, so that evaporation is reduced at this step.

[0047] The reduction of evaporation is achieved by the design of the cylindrical channel, that is both narrow by adjusting the diameter to the minimum that still lets the needle pass through it, and also by its length, that is long enough to create a gas barrier that prevents exchange of vapor gas from the inside of the container to the open air once the embossed lid is opened..

[0048] The opening of the lid results from piercing of the piercing area comprising a predetermined breaking line with a material which is smaller compared to the surrounding material of the embossed lid. The embossed lid is fixed to the sealing insert by a kind of a hinge which is formed by an area with thickened material along the otherwise predetermined breaking line.

[0049] FIG.1 shows a perspective view onto a sealing insert 1 according to the present disclosure. Insert 1 has a conical shaped funnel 20 with respect to its upper opening 2 so that the opening 2 has a larger diameter at its top than at its bottom. The conical shaped funnel 20 transits into a cylindrical channel 10 comprising a lid 15 at its bottom end (cf. FIG. 2). The cylindrical channel has at least the length of the conical funnel. Evaporation is reduced by the tall, narrow shape of the cylinder, that creates a gas barrier that prevents exchange of vapor gas from the inside of the container to the open air once the pipette tip opens the embossed lid by piercing. A shorter, wider, more conical cylinder like the one disclosed in EP 4 279 181 Al would not achieve the same effect.

[0050] The sealing insert is pushed downwards by a shoulder of a pipette tip referring to the transition area of a pipette tip where the smaller diameter of a pipette tip’s end widens towards its upper end. The pipette tip presses the conical surface with this transition area. Moving the sealing insert downwards in this manner reduces the air chamber between the bottom surface of the insert and the liquid while the container is constantly emptied. Besides the advantage of having only to wash the tip of the pipette instead of the complete pipette, evaporation is also reduced by minimizing the air between insert and liquid.

[0051] Opening 2 is surrounded by collar 6 which outer circumference has a smaller diameter than the outer circumference of sealing lip 5. Sealing lip 5 is arranged at the outer circumference of an annular margin 11 through which the cylindrical channel 10 passes. Annular margin 11 comprises an upper side 12 facing collar 6 (cf. FIG. 2) and a lower side 13 from which side walls 27 extend (cf. FIG. 3) connecting the sealing lip 5 with the cylindrical channel 10. Vertically arranged guiding rips 35 extend radially from the conical shaped funnel 20 and cylindrical channel 10 in a manner that they connect collar 6 and annular margin 11. The guiding rips 35 extend in their middle part up to the outer circumference of sealing lip 5, wherein the outer upper and lower part of guiding rips 35 below collar 6 and above annular margin 11 are recessed. The guiding elements 35 prevents tilting of the sealing insert 1 during its moving inside a reagent container. The recessed parts of guiding element 35 improve the contact of sealing lip 5 with the inner surface of a container because during introducing the sealing insert 1 into a container, the pressure which is applied to the insert 1 is directly transferred to the annular margin 11 and thus to sealing lip 5. The embossed lid (not shown) which is arranged at the lower end of cylindrical channel 10 is not exposed to the pressure due to the guiding rips transferring the pressure to annular margin 11.

[0052] FIG. 2 shows a cross-sectional view through a sealing insert according to the present disclosure. Conical shaped funnel 20 is arranged below collar 6. Conical shaped funnel 26 transits into cylindrical channel 10. Annular margin 11 surrounds cylindrical channel 10 and the outer circumference of annular margin 11 comprises sealing lip 5. Upper side 12 of annular margin 11 faces collar 6.

[0053] The area at the end of cylindrical channel 10 comprises the embossed piercing area 25 with lid 15 that is surrounded by predetermined breaking line 26. Annular margin 11 can be disc-shaped in an embodiment and comprises a circular surface, comprising a sealing lip 5 on its outer end surrounding the circular surface which connects the sealing lip 5 with the cylindrical channel 10. The static friction of the sealing insert 1 is caused by the guiding rips 35 and sealing lip 5 allowing a vertical displacement or movement of sealing insert 1 in a reagent container. The sealing lip 5 shown in FIG. 1 and FIG. 2 provides the seal to the environment.

[0054] FIG. 3 shows a perspective view onto an insert’s lower part. The embossed piercing area 25 with lid 15 that is surrounded by side wall 27 which is extending from the lower side 13 ofthe annular margin 11 (comp. FIG. 1) which can be slanted with respect to a fictional horizontal line in an embodiment for easier piercing with pipette tip 45. It is to be noted that side wall 26 is not extending below the lower end of stirring fins 30. A predetermined breaking line 26 can be influenced by the type and depth of the embossing for the force required for piercing. During piercing, the material of a hinge 16 which is formed by a thickened material at an area of the predetermined braking line 26 remains attached to the embossed piercing area 25. Thus, there is no risk of separated material from the sealing insert entering the liquid and thus possibly causing the pipetting tip for instance to clog. The separated material of the lid 15 will remain attached to at least one side wall 27 of the embossed piercing area 25 and fold away. In the case of alternative solutions employing a foil for sealing, it may otherwise happen in a worst case that the needle or pipette tip is blocked by the "punched out" piece of the foil.

[0055] FIG. 3 shows the bottom side 13 of the sealing insert with stirring fins 30, the embossed piercing area 25 with lid 15, and sealing lip 5. The fins 30 can be used for creating turbulences in an automated reagent system with stirrer drive for the resuspension of microparticles which may be part of the liquid in the reagent container. Turbulences created by rotation of the reagent container around its vertical axis of symmetry can be caused following overhead storage, to dislodge and resuspend the located or adherent microparticles in the liquid again..

[0056] At the same time, the fins 30 protrude so that the insert does not rest on sealing lip 5 in an "upright" position when a stopper is placed on a surface (e.g. in automated conveyor lines for mechanical insertion of the stoppers) in order to avoid damage of sealing lip 5. Care has also been taken to ensure that the mass distribution is asymmetrical in a way to facilitate transport and orientation on a vibratory feeder line in an upright orientation meaning that the upper end is orientated to the top.

[0057] FIG. 4 shows an embodiment of the embossed piercing are 25 in more detail. Predetermined breaking line 26 is indicated. Hinge 16 is arranged at one side covering partly the predetermined braking line 26. Hinge 16 is formed by thickened material.

[0058] The described insert is intended to be part of a system comprising the insert and a correspondingly shaped pipette needle. Further a reagent container may be part of the system,I F poaterint- & RechtsanwalteI Intellectual Property Attorneys wherein the reagent container comprises a circumferential stop located above the inserted insert which serves as a stop to prevent the insert from sliding up or out of the reagent container.

[0059] The sealing insert of the present disclosure can be produced in a single step, so that production via injection molding is possible.Experimental Results

[0060] A dynamic sealing cap (DSC) as disclosed in EP 4279 181 Al was compared to a sealing insert according to the present disclosure. The setups listed in table 1 have been used:

[0061] Table 1 : Experimental setups

[0062] The experiments have been carried out inside a climate chamber to simulate the worst case conditions (cold and humid environment, warm and dry environment outside). For a better comparison, the hole of the DSC must be completely open, by cutting off the lids after piercing. Additionally, the 5 ml positions have been loaded with 5 ml container, closed with regular DSCs but not pierced and filled with 5ml DI water, to burden the shaker motors. During the whole test time, the temperature inside the bay is measured with a datalogger (see Figure 2-4 for placement).

[0063] The bay carrying the container has been cooling them at 10°C continuously and the shakers of all racks have been activated in “Keep Suspension” mode. The cooling and shaking of the bay will be interrupted for every weighting, so this should be done as quickly as possible and only rack by rack to keep the containers cool. Evaporation was measured during eight weeks by weighing according to table 2.STRATEC CONS. GM BH / Grifols Diagnostic Solutions, Inc. | F Poaterntt- &m Recahtsannwndlte Tegethoff30002.20714WO I Intellectual Property Attorneys

[0064] Table 2: Measurement conditions

[0065] Table 3 shows the measured results.

[0066] FIG. 5 shows the measured average difference per day for six empty containers, closed with a regular DSC which was pierced for controlling condensed water.

[0067] FIG. 6 shows measured average difference per day for six empty containers, closed with a DSC according to the present disclosure which was pierced for controlling condensed water.

[0068] FIG. 7 shows the measured average difference per day for six containers filled with 1.5 ml PBS, closed with a regular DSC which was pierced.

[0069] FIG. 8 shows the measured average difference per day for six containers filled with 1.5 ml PBS, closed with a DSC according to the present disclosure which was pierced.

[0070] The evaporation results using filled containers showed significant differences with respect to evaporation rates between both DSC designs. The DSC according to the present disclosure showed over the entire test period very constantly a 4- to 5-fold reduced evaporation rate in comparison with a regular DSC (2.1 mg / day versus 9,3 mg / day).

[0071] The results using empty containers showed no significant difference in condensation between pierced empty containers for the two different DSC designs. The total condensation observed over the entire period of eight weeks was about 2,2 mg for the regular DSC and 1,8 mg for the DSC according to the present disclosure. Thus, it was demonstrated that condensation has been minimal and does not play a significant role in empty containers.

[0072] The advantages of a system according to the present disclosure relate to- Preventing evaporation and leakage protection during storage and transport of a liquid in a reagent container before opening the embossed lid.- Reducing evaporation of a liquid in a reagent container when used in automatic analysers and thus increasing the stability in the processing of the liquids.- Reducing the dead volume in a container due to the use of a V-shaped (cone- shaped) bottom in the container.- Possibility to resuspend solid particles in a liquid.Adjustable sealing system.- No clogging of the pipetting needle by separated materials.Asymmetric mass distribution of the stopper to facilitate transport and orientation on a vibratory feeder path.- No need to wash the needle completely but only the tip of the needle, with significant improvements in terms of liquids and time spent.

[0073] The foregoing description of the preferred embodiment of the disclosure has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the disclosure. The embodiment was chosen and described in order to explain the principles of the disclosure and its practical application to enable one skilled in the art to utilize the disclosure in various embodiments as are suited to the particular use contemplated. It is intended that the scope of the disclosure be defined by the claims appended hereto, and their equivalents. The entirety of each of the aforementioned documents is incorporated by reference herein.STRATEC CONS. GM BH / Grifols Diagnostic Solutions, Inc. F | Poaterntt- &m Recahtsannwndlte Tegethoff30002.20714WO I Intellectual Property AttorneysReference Numerals1 insert2 insert opening5 sealing lip6 collar10 cylindrical channel11 annular margin12 upper side13 lower side15 lid16 hinge20 conical shaped funnel25 embossed piercing area26 predetermined breaking line27 side wall 30 stirring fin 35 guiding rip

Claims

STRATEC CONS. GM BH / Grifols Diagnostic Solutions, Inc. | F Poaterntt- &m Recahtsannwndlte Tegethoff30002.20714WO I Intellectual Property AttorneysCLAIMS1. An insert for sealing of a container, comprising a centrally arranged conical funnel, wherein the upper end of the conical funnel is surrounded by a collar, and wherein the lower end of the conical funnel transits into a cylindrical channel, wherein an area around a lower end of the cylindrical channel is surrounded by an annular margin connecting a sealing lip on its outer circumference with the cylindrical channel, wherein guiding rips extend radially from the conical funnel and cylindrical channel for connecting the collar surrounding the upper end of the conical funnel and an upper side of the annular margin facing the collar, and wherein below a lower side of the annular margin an embossed piercing area with lid extends downwards, wherein the embossed piercing area comprises a predetermined breaking line surrounding the lid, wherein the predetermined breaking line is partly covered by thickened material forming a hinge for the lid.

2. The insert of claim 1, wherein at least one embossed stirring fin is arranged on the lower side of the annular margin between sealing lip and the embossed piercing area.

3. The insert of claim 1 or 2, wherein the collar has a smaller diameter than the annular margin with sealing lip.

4. The insert of any one of claims 1 to 3, wherein the guiding rips extend in their middle part up to the outer circumference of sealing lip, wherein the outer upper and lower part of guiding rips are recessed below collar and above annular margin.

5. The insert of any one of claims 1 to 4, wherein the embossed lid has a reduced material thickness in comparison to the annular margin of the insert from which it extends.

6. The insert of any one of claims 1 to 5, wherein the embossed lid has polygonal shape regarding its surrounding circumference.

7. The insert of any one of claims 1 to 6, wherein the outer circumference of the annular margin is circular.STRATEC CONS. GM BH / Grifols Diagnostic Solutions, Inc. | F Poaterntt- &m Recahtsannwndlte Tegethoff30002.20714WO I Intellectual Property Attorneys8. The insert of any one of claims 1 to 7, wherein the insert is made of a polymer or silicone.

9. A system for sealing of a container and handling of liquids within the container, comprising an insert according to any one of claims 1 to 8; and pipette tips, wherein a lower section of the pipette tip has a smaller diameter than an upper section of the pipette tip, and- wherein only the lower end of the pipette tip is suitable having a smaller diameter to pass through the cylindrical channel.

10. The system of claim 9, further comprising a reagent container with a stop for the insert at the reagent container’s inner surface.

11. A method for storing and handling liquids in a reagent container, comprising the steps of- Providing a liquid in the reagent container;Sealing the container with an insert according to any one of claims 1 to 8;Arranging a pipette tip on a pipette, wherein a lower end of the pipette tip has a smaller diameter than an upper part of the pipette tip;- Piercing of the piercing area with embossed lid with the pipette tip’ s lower end; and- Moving the pipette tip’s lower end into the liquid for aspirating liquid.

12. The method of claim 11, wherein the insert is moved downwards by a shoulder of a pipette tip referring to the transition area of a pipette tip where the smaller diameter of a pipette tip’s end widens towards its upper end.

13. The method of claim 11 or 12, comprising the step of mixing the liquid by moving the sealed container and creating turbulences in the liquid by embossed stirring fins of the sealing insert and / or fins arranged at the bottom of the container.

14. The method of claim 13, wherein solid particles in the liquid are resuspended.

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