EP1806294A1 - Stopper - Google Patents

Stopper Download PDF

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Publication number
EP1806294A1
EP1806294A1 EP07250071A EP07250071A EP1806294A1 EP 1806294 A1 EP1806294 A1 EP 1806294A1 EP 07250071 A EP07250071 A EP 07250071A EP 07250071 A EP07250071 A EP 07250071A EP 1806294 A1 EP1806294 A1 EP 1806294A1
Authority
EP
European Patent Office
Prior art keywords
stopper
container
collection device
liquid
tamper evident
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP07250071A
Other languages
German (de)
French (fr)
Inventor
Jean-Pierre Giraud
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CSP Technologies Inc
Original Assignee
CSP Technologies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CSP Technologies Inc filed Critical CSP Technologies Inc
Publication of EP1806294A1 publication Critical patent/EP1806294A1/en
Withdrawn legal-status Critical Current

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/002Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082Test tubes per se
    • B01L3/50825Closing or opening means, corks, bungs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14Process control and prevention of errors
    • B01L2200/141Preventing contamination, tampering
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/042Caps; Plugs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/044Connecting closures to device or container pierceable, e.g. films, membranes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2401/00Tamper-indicating means
    • B65D2401/15Tearable part of the closure
    • B65D2401/30Tamper-ring remaining connected to closure after initial removal

Definitions

  • This invention relates to a stopper for a container body, a container comprising the stopper and a method of obtaining a liquid sample, such as a milk sample, using the container and the stopper and to the use of the stopper.
  • Sample collection containers used for some laboratory testing are reusable.
  • the collection containers are typically made of glass or plastic.
  • a separate closure is typically applied to the container after sample collection.
  • the closure is a stopper, made of a flexible material such as rubbers or thermoplastic elastomers.
  • the closure or stopper comprises a body portion having a plug portion, which snugly engages in the mouth of the container, and an enlarged circular lip portion used to remove the closure from the container.
  • the flexible stoppers provide a leak proof seal for the sample container.
  • the flexible stopper can be pierced with a liquid collection device, such as a needle and syringe, to remove a portion of the sample from the container without removing the stopper.
  • a liquid collection device such as, for example, a needle attached to a syringe
  • the hole created by the liquid collection device is 'sealed' or 'resealed' by the stopper. This resealing property of the stopper is essential to maintain a leak proof container.
  • the stopper is removed, the remaining sample is dumped out of the container and both the container and the stopper are washed thoroughly and reused. It has been found that after repeated uses (and washing cycles), the stoppers may become brittle and may be prone to leaking.
  • One method of ensuring sample integrity is to incorporate a tamper evident feature into the container. Once a sample has been collected (and the closure applied to the container), a feature is needed to: (1) prevent the manual removal of the closure or (2) provide a visual indication that the closure was removed. Traditionally, a tamper evident security tape is applied across the closure and the container body. When the closure is opened, the security tape is broken. The security tape, however, is an extra component that must be manually applied. Moreover, it has been found that the security tape can interfere with the sampling liquid collection device that is used to penetrate the stopper closure.
  • the present invention provides a stopper for a container body wherein the stopper comprises an integrated tamper evident feature (i.e., a tamper evident feature built into the stopper), and the stopper can be penetrated by a liquid collection device to access the container body and can maintain a leak proof seal after removal of the liquid collection device.
  • the stopper comprises an integrated tamper evident feature (i.e., a tamper evident feature built into the stopper), and the stopper can be penetrated by a liquid collection device to access the container body and can maintain a leak proof seal after removal of the liquid collection device.
  • the invention provides a container comprising a body and a stopper according to the invention.
  • a method of obtaining a liquid sample from a sealed container comprising removing a liquid sample from a container comprising a stopper according to the invention using a liquid collection device.
  • a stopper according to the invention to maintain the integrity of a liquid sample in a container.
  • Fig. 1 shows a conventional currently used reusable rubber stopper (no tamper evidence).
  • Figs. 2 and 3 show a disposable tamper evident stopper (1) according to an embodiment of the present invention.
  • Fig. 2 shows the stopper in a state in which it has not been tampered with
  • Fig 3 shows the stopper (2) in a state in which it has been tampered with (on the left-hand side of Fig. 3)
  • the stopper (3) in a state in which it has not been tampered with (on the right-hand side of Fig. 3)).
  • Fig. 4 shows a disposable tamper evident stopper according to an embodiment of the present invention wherein the tamper evident stopper is on a reusable bottle (4), such as that manufactured by Bartec GmbH, and wherein the stopper is in a state in which it has not been tampered with.
  • Fig. 5 shows a disposable tamper evident stopper (5) according to an embodiment of the present invention wherein the tamper evident stopper is on a reusable bottle such as that manufactured by Bartec GmbH and wherein the stopper is in a state in which it has been tampered with.
  • Fig. 6 shows a disposable tamper evident stopper (6) according to an embodiment of the present invention wherein the tamper evident stopper is on a reusable bottle such as that manufactured by Bartec GmbH and wherein sampling through a septum is illustrated.
  • Fig. 7 shows a disposable tamper evident stopper (7) according to an embodiment of the present invention wherein the tamper evident stopper is on a reusable bottle such as that manufactured by Bartec GmbH and wherein an example method of removing the tamper evident stopper is illustrated.
  • Figs. 8 to 11 show a disposable tamper evident stopper according to other embodiments of the present invention.
  • Fig.8 shows a preferred embodiment according to the invention in which the stopper comprises two different materials, one material forming a central disc portion (8) and the other material forming a surrounding disc portion (9).
  • the materials are preferably polymers.
  • Fig.9 shows a cross-sectional view of the stopper according to Figure 8, where the central disc portion (8) is indicated by hashed lines. Typical dimensions are provided in mm.
  • Fig 10. shows a plan view of the stopper according to Figure 9.
  • the bridges or links (10) of the tamper evident features of a frangible web are shown with spaces (11) between the bridges (10).
  • Fig. 11 shows an expanded view of the stopper according to Figure 9.
  • the bridge or link (10) is clearly shown.
  • the stopper comprises a stopper body, a tamper evident feature and a septum.
  • the term "stopper” as used herein can refer to a stopper comprising one or all of these features.
  • the stopper is adapted to be penetrated by a liquid collection device and/or to maintain a leak proof seal after removal of the liquid collection device, such as a needle and syringe.
  • the stopper may comprise a slitted portion, preferably in a resilient or flexible material, such as a thermoplastic elastomer as defined herein, for entry of a liquid collection device.
  • Typical dimensions for the stopper according to the invention will vary according to the container body with which it is to be used.
  • the stopper is sized so that it is compatible, i.e., can form a seal, preferably leak proof, with commercially available containers.
  • the stopper has a diameter of 10 to 100 mm, such as 20 to 70 mm, preferably about 30 or 50 mm.
  • the stopper may have any suitable shape but is preferably substantially circular.
  • the stopper according to any embodiment of the invention may comprise a septum for entry of a liquid collection device, such as a needle and syringe.
  • the septum preferably has a diameter of from 5 to 95 mm, such as 15 to 65 mm, preferably 25 to 50 mm.
  • a particularly preferred diameter is from 10 to 15 mm, such as 12 mm.
  • the stopper and/or septum may comprise a material, such as at least one polymer, which is injection moulded, preferably co-moulded.
  • a material such as at least one polymer, which is injection moulded, preferably co-moulded.
  • at least one thermoplastic elastomer such as SEBS
  • at least one polyolefin such as polyethylene
  • the term "leak proof” is intended to mean that the stopper of the invention, in combination with a container body, passes the blue crystal dye test as set out in WO 01/15989 A1 , the contents of which are incorporated herein by reference, before and/or after penetration of the stopper with a liquid collection device.
  • a disposable (e.g., one-time use) stopper which has a tight fitting seal, maintains a leak proof seal after sampling with a liquid collection device, such as a needle and syringe, and has an integrated tamper evident feature built into the stopper.
  • the stopper may be adapted for penetration by a liquid collection device, such as a needle and syringe, to form a substantially leak proof seal.
  • the invention provides an injection-moulded stopper to create a leak proof seal with a container body.
  • a stopper may be co-moulded.
  • More than one material, such as a polymer, for example, two different materials, may be co-moulded to form the stopper.
  • the tamper evident feature may comprise an indicator and/or barrier to entry, which, if breached or missing, provides visible evidence to consumers that tampering has occurred.
  • the tamper evident feature may be intended to provide a visual indication of package integrity when handled in a reasonable manner during manufacture, distribution and retail supply.
  • the visual indication may be accompanied by appropriate precautionary label statements to describe the tamper evident feature(s) to the consumer and to warn that the absence of or damage to such feature(s) at the time of purchase is an indication of possible tampering with the product.
  • the tamper evident feature may prevent the manual removal of the stopper (i.e., by hand) and/or provide a visual indication that the stopper has been removed.
  • the tamper evident feature typically comprises a moulded, preferably plastic, portion of any shape, for example a full or partially annular portion, that is connected to and/or integrated with and/or co-moulded with the stopper body and which can be disconnected under force, such as that in excess of the typical forces experienced during manufacture, packaging and transport of the stopper e.g., by the human hand when attempting to remove the stopper from a container body.
  • the plastic may be a polymer, such as a thermoplastic elastomer or polyolefin, as defined herein for the stopper.
  • the moulded portion is only connected to the stopper by at least one breakable or frangible bridge, preferably at least two, more preferably at least six bridges such as at least 12 bridges (i.e., with no material between them).
  • the bridges may each have a length of, for example, from 1 to 15 mm, such as about 2 to 10 mm, such as about 2 mm.
  • the thickness of each bridge may be about 0.1 to 1 mm, such as about 0.3 mm.
  • the bridges may be distributed symmetrically or asymmetrically around the stopper.
  • the portion may optionally be connected to the stopper at fixed positions.
  • the moulded portion may optionally comprise an arm portion substantially parallel to the external surface of the stopper.
  • the bridges are breakable or frangible in the sense that when it is attempted to remove the stopper from a container body, they fracture, break or rupture visibly and irreversibly. Accordingly, the fixed positions do not change in the same way as the bridges upon removal of the stopper.
  • the tamper evident feature comprises a lip having an outer rim and the outer rim of the lip comprises an opposing frangible web connected to the stopper.
  • the frangible web may be connected to the stopper at one or more positions, such as at least two, preferably at least six or twelve.
  • the connection may be via bridges or spokes.
  • the web may, for example, comprise at least part of the circumference of a stopper.
  • a stopper assembly including an outer rim of the lip having an opposing frangible web connected to the top of the stopper.
  • the frangible web may break when the stopper is initially lifted from the container.
  • the tamper evident feature may prevent the stopper from being removed by hand without the use of a tool or through automatic means.
  • the centre of the stopper may comprise an indentation, for example, the stopper may have a small indentation i.e., less than 20%, preferably less than 10% of the surface area of the top surface of the stopper in use.
  • a liquid collection device such as a needle and syringe, may penetrate the stopper to access a sample inside a container.
  • the container body comprises a reusable bottle such as of the type manufactured by Bartec GmbH.
  • the stopper can be pierced by a liquid collection device and upon removal of the liquid collection device (and any sample therein) reseals or becomes resealed, such that the stopper remains leak proof.
  • the stopper is disposable i.e., it is designed or adapted to be used once, for example to seal a container body and for one sample to be withdrawn.
  • the stopper is preferably comprised of flexible material or materials such as at least one thermoplastic elastomer as defined herein.
  • the stopper of the invention is formed from or comprises one material.
  • the stopper comprises at least two different materials.
  • the materials may be polymers, preferably polymers that can be injection moulded.
  • the different polymers may be selected from a thermoplastic elastomer, such as for example, styrenic block copolymers, such as SBS and SEBS, thermoplastic polyolefins, thermoplastic vulcanisates, thermoplastic polyurethanes, thermoplastic copolyesters, thermoplastic polyether block amides, a polyolefin, such as polypropylene or polyalkylene.
  • the stopper comprises a thermoplastic elastomer and a polyolefin such as polyethylene.
  • a first material such as a polymer
  • a second material such as a polymer
  • the first and second materials, such as polymers are different and may be any suitable polymer, such as those indicated above.
  • the first polymer is a thermoplastic elastomer and the second polymer is different, such as a polyolefin, for example polyethylene. It is preferred that the first polymer comprises a central disc and the second polymer forms a surrounding annular disc.
  • a stopper according to the invention preferably comprises a thermoplastic elastomer, such as SEBS, in an amount of from 10 wt.% to 95 wt.%, preferably from 30 to 90 wt.%, such as from 50 to 85 wt.%, for example, about 80 wt.%, based on the total weight of the stopper, and about 90 wt.% to 5 wt.%, preferably 70 to 10 wt.%, such as from 50 to 15 wt.%, for example about 20 wt.% polyolefin such as polypropylene.
  • SEBS thermoplastic elastomer
  • the stopper may be composed of about 80% SEBS and about 20% polypropylene.
  • the base of the stopper may be made from a polyolefin, such as polyethylene, which, if tampered with, would readily show alteration and/or damage to the stopper base.
  • the plug of the stopper of the invention may be made from a flexible thermoplastic elastomer material, which, when pierced by a liquid collection device allows for gathering of a sample from a container.
  • the container body or container may be made from any suitable material, such as plastic or glass.
  • the container is made or constructed from a plastics material, such as polyolefins, for example polyethylene and/or polyurethane.
  • the container may be adapted for liquid samples and/or the stopper according to the invention.
  • the container body is a reusable bottle.
  • the container body and/or the stopper according to the invention are preferably clean (i.e., substantially uncontaminated with, for example, milk or milk fat) and/or sterile before use.
  • the stopper according to the invention typically forms a leak proof seal with the container body.
  • the container body preferably contains a liquid.
  • the volume of liquid containable by the container is typically from 1 ml to 1000 ml, such as from 10 ml to 800 ml, preferably from 50 to 500 ml, for example, 100 ml, 200 ml, or 300 ml.
  • a particularly preferred liquid is milk although other liquids, such as a biological solution, could also be included.
  • a liquid collection device such as a needle and syringe, can be inserted through the stopper according to the invention and access liquid contained in the container.
  • a sample of the liquid in the container can then be withdrawn into the liquid collection device and the device removed from the stopper.
  • a leak proof seal is formed after the removal of the liquid collection device from the stopper.
  • the stopper according to the invention can be used to maintain the integrity of a liquid sample in a container. In other words, it may not be possible for a liquid sample to be compromised or tampered with, without this being visible or evident.
  • a tamper evident stopper or lid (1) that fits into a conventional or existing reusable bottle or vial (4) (in this example, a bottle manufactured by Bartec GmbH) is shown.
  • the stopper (1) may simply be placed (pressed into) the bottle or vial (4).
  • the stopper may be pierced by a liquid collection device, such as a needle and syringe, for sampling (e.g., milk sampling) and may reseal.
  • the stopper is pierced by a liquid collection device for milk sampling and must reseal.
  • the stopper may be disposable.
  • the lid is disposable in a preferred embodiment.
  • the stopper may be composed of about 80% SEBS (a thermoplastic elastomer) and about 20% PP (polypropylene).
  • a disposable tamper evident stopper according to other embodiments of the present invention is shown.
  • the central disc portion (8) may comprise or consist of a thermoplastic elastomer, as defined above in the defined amounts.
  • the thermoplastic elastomer for example SEBS, comprises from about 10 to 95 wt.% based on the weight of the stopper, such as about 80 wt.% (for example, the TPE in the central disc of the stopper may be TPE shore A55 in an amount of 0.1 to 10g, such as 0.2g).
  • the surrounding disc portion (9) may comprise or consist of a different polymer from TPE, such as polyethylene.
  • Preferably (9) comprises the different polymer, such as polyethylene, in an amount of about from about 90 to 5 wt.% of the stopper, such as about 90 wt.% (or 2.0g), for example, the weight ratio of material (9) to material (8) may be from 20:1 to 5:1 such as about 10:1, i.e., about 2.0g (9) (such as polyethylene) when the amount of (8) is 0.2g.
  • the polyethylene may have a base density of g 7.
  • Figure 9 shows suitable dimensions (in mm) for a stopper according to the invention. These dimensions may, separately or in combination, form further embodiments of the invention.
  • the bridges or connecting portions (10) are shown as being preferably symmetrically distributed around the periphery of the stopper, with spaces (11) in between the bridges.
  • Figure 11 is an expanded view of one of the bridges (10) with an indication of the thickness for a suitable frangible web bridge.
  • the stopper according to the invention may be made using a co-moulding or two-shot moulding process, such as two shot injection moulding.
  • a co-moulding or two-shot moulding process such as two shot injection moulding.
  • Two shot injection moulding processes are known in the art and provide the ability to produce complex mouldings at the same time during one machine cycle. Thus, mouldings with more than one colour or with different materials combined in one moulding can be produced. Therefore, a two-shot mould may allow for the reduction in assembly steps and costs and may eliminate post-moulding assemblies (such as snap-fits, ultrasonic welding, adhesives, screws and/or bolts).
  • the two-shot moulding process may also enhance the tamper evident feature (e.g., such a moulded plastic portion for the tamper evident feature may reduce or eliminate the possibility of unseen tampering; in addition, any desired rubber portion may remain).

Abstract

There is provided a stopper for a container body wherein the stopper comprises an integrated tamper evident feature, and the stopper can be penetrated by a liquid collection device to access the container body and can maintain a leak proof seal after removal of the liquid collection device. The invention also relates to a container comprising a body and a stopper according to the invention. The container may comprise a liquid, such as milk, for sampling. Thus, the invention also provides a method for obtaining a liquid sample from a sealed container by removing a liquid sample from a container and stopper according to the invention. The stopper can therefore be used to maintain the integrity of a sample.

Description

  • This invention relates to a stopper for a container body, a container comprising the stopper and a method of obtaining a liquid sample, such as a milk sample, using the container and the stopper and to the use of the stopper.
  • Sample collection containers used for some laboratory testing are reusable. The collection containers are typically made of glass or plastic. A separate closure is typically applied to the container after sample collection. In some cases the closure is a stopper, made of a flexible material such as rubbers or thermoplastic elastomers. Typically the closure or stopper comprises a body portion having a plug portion, which snugly engages in the mouth of the container, and an enlarged circular lip portion used to remove the closure from the container.
  • These flexible stoppers provide a leak proof seal for the sample container. Moreover, the flexible stopper can be pierced with a liquid collection device, such as a needle and syringe, to remove a portion of the sample from the container without removing the stopper. After the liquid collection device, such as, for example, a needle attached to a syringe, is removed from the stopper, the hole created by the liquid collection device is 'sealed' or 'resealed' by the stopper. This resealing property of the stopper is essential to maintain a leak proof container. Once testing has been completed, the stopper is removed, the remaining sample is dumped out of the container and both the container and the stopper are washed thoroughly and reused. It has been found that after repeated uses (and washing cycles), the stoppers may become brittle and may be prone to leaking.
  • An important use for this type of container and closure is for the collection and laboratory testing of milk samples. Milk samples are tested for overall quality and fat content in the milk. The value of the milk (i.e., 'Milk Payment') is based on the quality and the fat content. Since the livelihood of the dairy industry is based on the outcome of these Milk Payment tests, it is critical that the sample integrity and chain of custody is maintained throughout the collection and testing process.
  • One method of ensuring sample integrity is to incorporate a tamper evident feature into the container. Once a sample has been collected (and the closure applied to the container), a feature is needed to: (1) prevent the manual removal of the closure or (2) provide a visual indication that the closure was removed. Traditionally, a tamper evident security tape is applied across the closure and the container body. When the closure is opened, the security tape is broken. The security tape, however, is an extra component that must be manually applied. Moreover, it has been found that the security tape can interfere with the sampling liquid collection device that is used to penetrate the stopper closure.
  • There remains a need for improved stoppers for use with containers. In particular, there is a need for improved stoppers where the stoppers can be sampled several times without leaking and/or being tamper evident to deliver a better performance. It is also desirable to provide stoppers that can be produced cost effectively.
  • The listing or discussion of an apparently prior-published document in this specification should not necessarily be taken as an acknowledgement that the document is part of the state of the art or is common general knowledge.
  • In a first aspect, the present invention provides a stopper for a container body wherein the stopper comprises an integrated tamper evident feature (i.e., a tamper evident feature built into the stopper), and the stopper can be penetrated by a liquid collection device to access the container body and can maintain a leak proof seal after removal of the liquid collection device.
  • In a further aspect, the invention provides a container comprising a body and a stopper according to the invention.
  • In another aspect, there is provided a method of obtaining a liquid sample from a sealed container comprising removing a liquid sample from a container comprising a stopper according to the invention using a liquid collection device.
  • In a yet further aspect of the invention, there is provided the use of a stopper according to the invention to maintain the integrity of a liquid sample in a container.
  • Fig. 1 shows a conventional currently used reusable rubber stopper (no tamper evidence).
  • Figs. 2 and 3 show a disposable tamper evident stopper (1) according to an embodiment of the present invention. Fig. 2 shows the stopper in a state in which it has not been tampered with, Fig 3 shows the stopper (2) in a state in which it has been tampered with (on the left-hand side of Fig. 3) and the stopper (3) in a state in which it has not been tampered with (on the right-hand side of Fig. 3)).
  • Fig. 4 shows a disposable tamper evident stopper according to an embodiment of the present invention wherein the tamper evident stopper is on a reusable bottle (4), such as that manufactured by Bartec GmbH, and wherein the stopper is in a state in which it has not been tampered with.
  • Fig. 5 shows a disposable tamper evident stopper (5) according to an embodiment of the present invention wherein the tamper evident stopper is on a reusable bottle such as that manufactured by Bartec GmbH and wherein the stopper is in a state in which it has been tampered with.
  • Fig. 6 shows a disposable tamper evident stopper (6) according to an embodiment of the present invention wherein the tamper evident stopper is on a reusable bottle such as that manufactured by Bartec GmbH and wherein sampling through a septum is illustrated.
  • Fig. 7 shows a disposable tamper evident stopper (7) according to an embodiment of the present invention wherein the tamper evident stopper is on a reusable bottle such as that manufactured by Bartec GmbH and wherein an example method of removing the tamper evident stopper is illustrated.
  • Figs. 8 to 11 show a disposable tamper evident stopper according to other embodiments of the present invention.
  • Fig.8 shows a preferred embodiment according to the invention in which the stopper comprises two different materials, one material forming a central disc portion (8) and the other material forming a surrounding disc portion (9). The materials are preferably polymers.
  • Fig.9 shows a cross-sectional view of the stopper according to Figure 8, where the central disc portion (8) is indicated by hashed lines. Typical dimensions are provided in mm.
  • Fig 10. shows a plan view of the stopper according to Figure 9. The bridges or links (10) of the tamper evident features of a frangible web are shown with spaces (11) between the bridges (10).
  • Fig. 11 shows an expanded view of the stopper according to Figure 9. The bridge or link (10) is clearly shown.
  • Among those benefits and improvements that have been disclosed, other objects and advantages of this invention will become apparent from the following description taken in conjunction with the accompanying figures. The figures constitute a part of this specification and include illustrative embodiments of the present invention and illustrate various objects and features thereof.
  • Detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely illustrative of the invention that may be embodied in various forms. In addition, each of the examples given in connection with the various embodiments of the invention is intended to be illustrative, and not restrictive. Further, the figures are not necessarily to scale, some features may be exaggerated to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention.
  • In one embodiment, the stopper comprises a stopper body, a tamper evident feature and a septum. The term "stopper" as used herein can refer to a stopper comprising one or all of these features.
  • In a preferred embodiment of the invention, the stopper is adapted to be penetrated by a liquid collection device and/or to maintain a leak proof seal after removal of the liquid collection device, such as a needle and syringe. For example, the stopper may comprise a slitted portion, preferably in a resilient or flexible material, such as a thermoplastic elastomer as defined herein, for entry of a liquid collection device.
  • Typical dimensions for the stopper according to the invention will vary according to the container body with which it is to be used. Preferably, the stopper is sized so that it is compatible, i.e., can form a seal, preferably leak proof, with commercially available containers. In a preferred embodiment of the invention, the stopper has a diameter of 10 to 100 mm, such as 20 to 70 mm, preferably about 30 or 50 mm. The stopper may have any suitable shape but is preferably substantially circular.
  • The stopper according to any embodiment of the invention may comprise a septum for entry of a liquid collection device, such as a needle and syringe. The septum preferably has a diameter of from 5 to 95 mm, such as 15 to 65 mm, preferably 25 to 50 mm. A particularly preferred diameter is from 10 to 15 mm, such as 12 mm.
  • The stopper and/or septum may comprise a material, such as at least one polymer, which is injection moulded, preferably co-moulded. For example, at least one thermoplastic elastomer (such as SEBS) and/or at least one polyolefin (such as polyethylene) as defined herein, may be injection moulded, preferably co-moulded, to form the stopper.
  • In one embodiment of the invention, the term "leak proof" is intended to mean that the stopper of the invention, in combination with a container body, passes the blue crystal dye test as set out in WO 01/15989 A1 , the contents of which are incorporated herein by reference, before and/or after penetration of the stopper with a liquid collection device.
  • In another embodiment of the invention, there is provided a disposable (e.g., one-time use) stopper which has a tight fitting seal, maintains a leak proof seal after sampling with a liquid collection device, such as a needle and syringe, and has an integrated tamper evident feature built into the stopper. For example, the stopper may be adapted for penetration by a liquid collection device, such as a needle and syringe, to form a substantially leak proof seal.
  • In one embodiment, the invention provides an injection-moulded stopper to create a leak proof seal with a container body. Such a stopper may be co-moulded. More than one material, such as a polymer, for example, two different materials, may be co-moulded to form the stopper.
  • The tamper evident feature may comprise an indicator and/or barrier to entry, which, if breached or missing, provides visible evidence to consumers that tampering has occurred. In other words, the tamper evident feature may be intended to provide a visual indication of package integrity when handled in a reasonable manner during manufacture, distribution and retail supply.
  • The visual indication may be accompanied by appropriate precautionary label statements to describe the tamper evident feature(s) to the consumer and to warn that the absence of or damage to such feature(s) at the time of purchase is an indication of possible tampering with the product.
  • The tamper evident feature according to the present invention may prevent the manual removal of the stopper (i.e., by hand) and/or provide a visual indication that the stopper has been removed. The tamper evident feature typically comprises a moulded, preferably plastic, portion of any shape, for example a full or partially annular portion, that is connected to and/or integrated with and/or co-moulded with the stopper body and which can be disconnected under force, such as that in excess of the typical forces experienced during manufacture, packaging and transport of the stopper e.g., by the human hand when attempting to remove the stopper from a container body. The plastic may be a polymer, such as a thermoplastic elastomer or polyolefin, as defined herein for the stopper.
  • It is preferred that the moulded portion is only connected to the stopper by at least one breakable or frangible bridge, preferably at least two, more preferably at least six bridges such as at least 12 bridges (i.e., with no material between them). The bridges may each have a length of, for example, from 1 to 15 mm, such as about 2 to 10 mm, such as about 2 mm. The thickness of each bridge may be about 0.1 to 1 mm, such as about 0.3 mm. The bridges may be distributed symmetrically or asymmetrically around the stopper. In addition, the portion may optionally be connected to the stopper at fixed positions. The moulded portion may optionally comprise an arm portion substantially parallel to the external surface of the stopper. The bridges are breakable or frangible in the sense that when it is attempted to remove the stopper from a container body, they fracture, break or rupture visibly and irreversibly. Accordingly, the fixed positions do not change in the same way as the bridges upon removal of the stopper.
  • In a preferred embodiment of the invention, as defined in any of the aspects herein, the tamper evident feature comprises a lip having an outer rim and the outer rim of the lip comprises an opposing frangible web connected to the stopper.
  • The frangible web may be connected to the stopper at one or more positions, such as at least two, preferably at least six or twelve. The connection may be via bridges or spokes. The web may, for example, comprise at least part of the circumference of a stopper.
  • In one embodiment of the invention, there is provided a stopper assembly including an outer rim of the lip having an opposing frangible web connected to the top of the stopper.
  • Preferably, the frangible web may break when the stopper is initially lifted from the container. The tamper evident feature may prevent the stopper from being removed by hand without the use of a tool or through automatic means.
  • In a further embodiment of the invention, the centre of the stopper may comprise an indentation, for example, the stopper may have a small indentation i.e., less than 20%, preferably less than 10% of the surface area of the top surface of the stopper in use.
  • In any of the aspects or embodiments defined herein, a liquid collection device, such as a needle and syringe, may penetrate the stopper to access a sample inside a container.
  • In one embodiment of the invention, the container body comprises a reusable bottle such as of the type manufactured by Bartec GmbH. Preferably, the stopper can be pierced by a liquid collection device and upon removal of the liquid collection device (and any sample therein) reseals or becomes resealed, such that the stopper remains leak proof.
  • In a particularly preferred embodiment of the invention, as defined in any of the above aspects or embodiments, the stopper is disposable i.e., it is designed or adapted to be used once, for example to seal a container body and for one sample to be withdrawn. The stopper is preferably comprised of flexible material or materials such as at least one thermoplastic elastomer as defined herein.
  • In one embodiment, the stopper of the invention is formed from or comprises one material. Alternatively, the stopper comprises at least two different materials. The materials may be polymers, preferably polymers that can be injection moulded. For example, the different polymers may be selected from a thermoplastic elastomer, such as for example, styrenic block copolymers, such as SBS and SEBS, thermoplastic polyolefins, thermoplastic vulcanisates, thermoplastic polyurethanes, thermoplastic copolyesters, thermoplastic polyether block amides, a polyolefin, such as polypropylene or polyalkylene. Preferably the stopper comprises a thermoplastic elastomer and a polyolefin such as polyethylene.
  • In a preferred embodiment, a first material, such as a polymer, forms an inner section of the stopper, for penetration by a liquid collection device, and a second material, such as a polymer, forms an outer section of the stopper, surrounding the inner section. The first and second materials, such as polymers, are different and may be any suitable polymer, such as those indicated above. Preferably the first polymer is a thermoplastic elastomer and the second polymer is different, such as a polyolefin, for example polyethylene. It is preferred that the first polymer comprises a central disc and the second polymer forms a surrounding annular disc.
  • A stopper according to the invention preferably comprises a thermoplastic elastomer, such as SEBS, in an amount of from 10 wt.% to 95 wt.%, preferably from 30 to 90 wt.%, such as from 50 to 85 wt.%, for example, about 80 wt.%, based on the total weight of the stopper, and about 90 wt.% to 5 wt.%, preferably 70 to 10 wt.%, such as from 50 to 15 wt.%, for example about 20 wt.% polyolefin such as polypropylene.
  • In a particularly preferred embodiment of the invention, the stopper may be composed of about 80% SEBS and about 20% polypropylene.
  • In one embodiment of the invention, the base of the stopper may be made from a polyolefin, such as polyethylene, which, if tampered with, would readily show alteration and/or damage to the stopper base. Further, the plug of the stopper of the invention may be made from a flexible thermoplastic elastomer material, which, when pierced by a liquid collection device allows for gathering of a sample from a container.
  • The container body or container may be made from any suitable material, such as plastic or glass. Preferably the container is made or constructed from a plastics material, such as polyolefins, for example polyethylene and/or polyurethane. The container may be adapted for liquid samples and/or the stopper according to the invention. In a preferred embodiment of the invention, the container body is a reusable bottle. The container body and/or the stopper according to the invention are preferably clean (i.e., substantially uncontaminated with, for example, milk or milk fat) and/or sterile before use.
  • The stopper according to the invention typically forms a leak proof seal with the container body.
  • The container body preferably contains a liquid. The volume of liquid containable by the container is typically from 1 ml to 1000 ml, such as from 10 ml to 800 ml, preferably from 50 to 500 ml, for example, 100 ml, 200 ml, or 300 ml. A particularly preferred liquid is milk although other liquids, such as a biological solution, could also be included.
  • In order to obtain a liquid sample from a preferably sealed container and stopper assembly according to the invention containing a liquid, a liquid collection device, such as a needle and syringe, can be inserted through the stopper according to the invention and access liquid contained in the container. A sample of the liquid in the container can then be withdrawn into the liquid collection device and the device removed from the stopper. Preferably a leak proof seal is formed after the removal of the liquid collection device from the stopper.
  • The stopper according to the invention can be used to maintain the integrity of a liquid sample in a container. In other words, it may not be possible for a liquid sample to be compromised or tampered with, without this being visible or evident.
  • The following non-limiting examples illustrate the invention and do not limit its scope in any way. In the examples and throughout this specification, all percentages, parts and ratios are by weight unless indicated otherwise. Any steps described herein may be carried out in any desired order (and any desired steps may be added and/or deleted).
  • Referring to Figs. 2 to 7, a tamper evident stopper or lid (1) that fits into a conventional or existing reusable bottle or vial (4) (in this example, a bottle manufactured by Bartec GmbH) is shown. In operation, after filling, the stopper (1) may simply be placed (pressed into) the bottle or vial (4). The stopper may be pierced by a liquid collection device, such as a needle and syringe, for sampling (e.g., milk sampling) and may reseal.
  • In one embodiment, the stopper is pierced by a liquid collection device for milk sampling and must reseal. The stopper may be disposable. The lid is disposable in a preferred embodiment. In one example (which example is intended to be illustrative and not restrictive), the stopper may be composed of about 80% SEBS (a thermoplastic elastomer) and about 20% PP (polypropylene).
  • Referring now to Figs. 8 to 11, a disposable tamper evident stopper according to other embodiments of the present invention is shown.
  • In Figure 8, the central disc portion (8) may comprise or consist of a thermoplastic elastomer, as defined above in the defined amounts. In a preferred embodiment of the invention, the thermoplastic elastomer (TPE), for example SEBS, comprises from about 10 to 95 wt.% based on the weight of the stopper, such as about 80 wt.% (for example, the TPE in the central disc of the stopper may be TPE shore A55 in an amount of 0.1 to 10g, such as 0.2g). The surrounding disc portion (9) may comprise or consist of a different polymer from TPE, such as polyethylene. Preferably (9) comprises the different polymer, such as polyethylene, in an amount of about from about 90 to 5 wt.% of the stopper, such as about 90 wt.% (or 2.0g), for example, the weight ratio of material (9) to material (8) may be from 20:1 to 5:1 such as about 10:1, i.e., about 2.0g (9) (such as polyethylene) when the amount of (8) is 0.2g. The polyethylene may have a base density of g 7.
  • Figure 9 shows suitable dimensions (in mm) for a stopper according to the invention. These dimensions may, separately or in combination, form further embodiments of the invention. In Figure 10, the bridges or connecting portions (10) are shown as being preferably symmetrically distributed around the periphery of the stopper, with spaces (11) in between the bridges. Figure 11 is an expanded view of one of the bridges (10) with an indication of the thickness for a suitable frangible web bridge.
  • Reference will now be made to an example method of producing a stopper according to an embodiment of the present invention (of course, this example is intended to be illustrative and not restrictive).
  • In one embodiment, the stopper according to the invention may be made using a co-moulding or two-shot moulding process, such as two shot injection moulding. Two shot injection moulding processes are known in the art and provide the ability to produce complex mouldings at the same time during one machine cycle. Thus, mouldings with more than one colour or with different materials combined in one moulding can be produced. Therefore, a two-shot mould may allow for the reduction in assembly steps and costs and may eliminate post-moulding assemblies (such as snap-fits, ultrasonic welding, adhesives, screws and/or bolts).
  • Further, the two-shot moulding process may also enhance the tamper evident feature (e.g., such a moulded plastic portion for the tamper evident feature may reduce or eliminate the possibility of unseen tampering; in addition, any desired rubber portion may remain).
  • While a number of embodiments of the present invention have been described, it is understood that these embodiments are illustrative only, and not restrictive, and that many modifications may become apparent to those of ordinary skill in the art.
  • Although the foregoing invention has been described in terms of certain embodiments, other embodiments will become apparent to those of ordinary skill in the art in view of the disclosure herein. Accordingly, the present invention is not intended to be limited by the recitation of preferred embodiments, but is intended to be defined solely by reference to the appended claims.

Claims (20)

  1. A stopper for a container body wherein the stopper comprises an integrated tamper evident feature, and the stopper can be penetrated by a liquid collection device to access the container body and can maintain a leak proof seal after removal of the liquid collection device.
  2. A stopper according to Claim 1, wherein the stopper is an injection-moulded stopper capable of forming a leak proof seal with a container body.
  3. A stopper according to Claim 1 or Claim 2, wherein the tamper evident feature comprises a lip having an outer rim and the outer rim of the lip comprises an opposing frangible web connected to the stopper.
  4. A stopper according to Claim 3, wherein the frangible web breaks when the stopper is initially lifted from a container body.
  5. A stopper according to any one of Claims 1 to 4, wherein the tamper evident feature prevents the stopper from being removed by hand without the use of a tool or through automatic means.
  6. A stopper according to any one of Claims 1 to 5, wherein the centre of the stopper comprises an indentation.
  7. A stopper according to any one of Claims 1 to 6, wherein a liquid collection device may penetrate the stopper to access a sample inside a container.
  8. A stopper according to any one of Claims 1 to 7, wherein the container comprises a reusable bottle.
  9. A stopper according to any one of Claims 1 to 8, wherein the stopper can be pierced by a liquid collection device and reseals.
  10. A stopper according to any one of Claims 1 to 9, wherein the stopper is disposable.
  11. A stopper according to any one of Claims 1 to 10, wherein the stopper is formed from two different materials, such as polymers.
  12. A stopper according to Claim 11, wherein a first polymer forms an inner section of the stopper, for penetration by a liquid collection device, and a second polymer forms an outer section of the stopper, surrounding the inner section.
  13. A stopper according to any one of Claims 1 to 12, wherein the stopper comprises about 80 wt.% SEBS and about 20 wt.% polypropylene.
  14. A stopper according to any one of Claims 1 to 13, wherein the tamper evident feature provides a visual indication of package integrity.
  15. A container comprising a container body and a stopper according to any one of Claims 1 to 14.
  16. A container according to Claim 15, wherein the container body is a reusable bottle.
  17. A container according to Claim 15 or Claim 16, wherein the container contains a liquid.
  18. A container according to Claim 17, wherein the liquid is milk.
  19. A method of obtaining a liquid sample from a sealed container comprising removing a liquid sample from a container comprising a stopper according to any one of Claims 1 to 14 using a liquid collection device.
  20. Use of a stopper according to any one of Claims 1 to 14 to maintain the integrity of a liquid sample in a container.
EP07250071A 2006-01-09 2007-01-09 Stopper Withdrawn EP1806294A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US75763506P 2006-01-09 2006-01-09
US79026406P 2006-04-06 2006-04-06

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EP1806294A1 true EP1806294A1 (en) 2007-07-11

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EP07250071A Withdrawn EP1806294A1 (en) 2006-01-09 2007-01-09 Stopper

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2715136A1 (en) * 1994-01-14 1995-07-21 Kerplas Snc Cap used for container containing pharmaceutical products
US20020130100A1 (en) * 1996-07-17 2002-09-19 Smith James C. Closure device for containers
WO2003064044A1 (en) * 2002-01-28 2003-08-07 Abner Levy Self resealing elastomeric closure
JP2004299682A (en) * 2003-03-28 2004-10-28 Japan Crown Cork Co Ltd Plastic cap

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2715136A1 (en) * 1994-01-14 1995-07-21 Kerplas Snc Cap used for container containing pharmaceutical products
US20020130100A1 (en) * 1996-07-17 2002-09-19 Smith James C. Closure device for containers
WO2003064044A1 (en) * 2002-01-28 2003-08-07 Abner Levy Self resealing elastomeric closure
JP2004299682A (en) * 2003-03-28 2004-10-28 Japan Crown Cork Co Ltd Plastic cap

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