EP2847082B1 - Closure element for a receptacle - Google Patents
Closure element for a receptacle Download PDFInfo
- Publication number
- EP2847082B1 EP2847082B1 EP13721352.6A EP13721352A EP2847082B1 EP 2847082 B1 EP2847082 B1 EP 2847082B1 EP 13721352 A EP13721352 A EP 13721352A EP 2847082 B1 EP2847082 B1 EP 2847082B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- closure
- label
- capsule
- closure element
- tear strip
- 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.)
- Active
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS 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
- B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
- B65D25/20—External fittings
- B65D25/205—Means for the attachment of labels, cards, coupons or the like
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS 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
- B65D23/00—Details of bottles or jars not otherwise provided for
- B65D23/08—Coverings or external coatings
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS 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
- B65D23/00—Details of bottles or jars not otherwise provided for
- B65D23/08—Coverings or external coatings
- B65D23/0842—Sheets or tubes applied around the bottle with or without subsequent folding operations
- B65D23/085—Sheets or tubes applied around the bottle with or without subsequent folding operations and glued or otherwise sealed to the bottle
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS 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
- B65D41/00—Caps, e.g. crown caps or crown seals, i.e. members having parts arranged for engagement with the external periphery of a neck or wall defining a pouring opening or discharge aperture; Protective cap-like covers for closure members, e.g. decorative covers of metal foil or paper
- B65D41/62—Secondary protective cap-like outer covers for closure members
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS 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
- B65D55/00—Accessories for container closures not otherwise provided for
- B65D55/02—Locking devices; Means for discouraging or indicating unauthorised opening or removal of closure
- B65D55/06—Deformable or tearable wires, strings or strips; Use of seals
- B65D55/08—Annular elements encircling container necks
- B65D55/0818—Destructible or permanently removable bands, e.g. adhesive
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS 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
- B65D2203/00—Decoration means, markings, information elements, contents indicators
- B65D2203/10—Transponders
Definitions
- the present invention relates to a closure element for a vessel with a pharmaceutical content.
- the original packaging has no proof indicating the first opening of the packaging (first opening protection).
- first opening protection the first opening protection
- a buyer of such a subsequently filled original packaging will therefore be unable to recognize that it is not an original product. Only after unpacking or when using the inferior product will he recognize the damage involved. However, as the buyer assumes, based on the original packaging, that it is a product of the original manufacturer, he will also attribute the damage to the original manufacturer.
- Such high-quality original products are for example medical devices such as implants, prostheses, orthoses, autoinjectors, pens for the administration of liquid drugs, pharmaceutical products such.
- medical devices such as implants, prostheses, orthoses, autoinjectors, pens for the administration of liquid drugs, pharmaceutical products such.
- liquid drugs pharmaceutical products
- drugs or pre-filled with liquid drugs syringes but also lipsticks, cigarettes and cigars, cosmetics such.
- perfumes, foods, drinks such.
- a refilled packaging for a pharmaceutical product may contain an ineffective substance.
- a patient would not receive the potentially urgently needed drug. It would be far worse moreover, if instead of the intended drug another, contaminated or even harmful substance was introduced. In this case, the patient would suffer considerable harm.
- the opening of a medicine bottle can be provided with a plastic capsule, as used for example for beverage bottles.
- plastic capsules are usually made of a material that contracts under the influence of heat and thus rests more closely against the bottle opening and the bottleneck. Normally, this plastic capsule must be torn open to open. The capsule is mechanically destroyed and can not be reused.
- a capsule In order to obtain a very close fitting capsule, a capsule is usually used which shrinks under heat, ie contracts under the influence of heat, so that its diameter is reduced.
- pharmaceutical products are usually very sensitive to heat, the content could suffer damage when shrinking such a capsule. Therefore, a sealing of pharmaceutical containers with such shrink films is usually not possible.
- a closure element according to the preamble of claim 1 of the present application is made GB 275 491 A known.
- the closure element has a closure capsule for covering an opening of a vessel, a tear strip with a grip tab for opening the closure capsule and a bottom-adhesive label.
- the label rests completely on the circumference of the vessel and on the areas of the circumference of the vessel covered with the tear strip.
- the closure capsule Spaced apart from the label, the closure capsule is arranged at the top and near the vessel opening. Outside the vessel, the label and the closure capsule are spaced apart and interconnected only by the tear strip. Between the label and the capsule, the peripheral surface of the vessel is largely free; only the tear strip covers there a narrow portion of the peripheral surface.
- the end GB 275 491 A known, provided with the local closure element vessel has insufficient initial opening protection.
- the label of the closure element is removed and then the closure capsule is carefully unscrewed with the tear strip, whereby the contents of the vessel would be accessible. Subsequently, the closure capsule could be screwed back on with the tear strip and the tear strip fastened to the circumference of the vessel with another, imitated label without this manipulative intervention being visible.
- the closure element comprises a closure box, a tear strip and a label.
- the closure capsule has a lateral surface, a closed end and an open end.
- the tear strip comprises a grip tab for opening the closure capsule.
- the label comprises a web-shaped substrate which is provided on an underside with adhesive. The closure capsule covers an opening of a vessel.
- the closure element according to the invention is attached to the vessel in such a way that a first subarea of the label is arranged on the vessel, whereas a second subarea of the label is arranged on the closure capsule and / or the tear strip.
- the label is partially on the peripheral surface of the vessel and partly on the closure capsule and / or the tear strip on.
- the second portion of the label which rests on the closure cap and / or the tear strip, but does not overlap the grip tab of the tear strip; This is therefore free and therefore easy to grasp by hand and wegziehbar.
- closure capsule of the closure element is rotationally symmetrical.
- Such closure capsules are particularly suitable for closing the vessels described above, since these vessels usually also have an approximately round opening area.
- the tear strip can run radially along the lateral surface of the closure capsule, ie (azimuthally) along the circumferential direction of the lateral surface; at upright storage of the vessel so horizontal.
- the closure element can be opened all around.
- the tear strip may also be parallel to a cylinder axis of the rotationally symmetrical closure capsule, i. along an axial direction.
- the closure capsule can be opened from top to bottom or vice versa by pulling on the tear strip.
- the tear strip may also extend axially from the top or bottom to the middle (or to some other height) of the closure capsule and from there continue to run horizontally along the circumferential direction of the envelope surface.
- the tear strip can be designed as a part of the closure capsule. Thus, it is not necessary to produce an additional material element in a separate operation.
- the tear strip can be separated or delimited from the remaining closure capsule by one or more perforations or punches, but otherwise be integrally connected to it.
- the tear strip can also be designed as a separate part. In this case, no previous processing of the cap in a further step is required. In addition, it is possible here to produce the tear strip of a particularly stable and tear-resistant material.
- the label comprises an additional layer of material having a predetermined thickness.
- This thickness of the additional material layer preferably corresponds approximately to the thickness of the lateral surface of the closure capsule. In this way, it is possible to attach the label on the closure element and the vessel so that a wrinkle-free application is possible.
- the closure element comprises a label with security punches.
- Such safety punctures cause the label is particularly easily tears and thus destroyed in a peel attempt of the label. Further use is then no longer possible.
- a closure element described above may be applied to a vessel having a pharmaceutical content. Thus, such a vessel is reliably protected against manipulation, in particular unauthorized re-use, since the first time the vessel is opened, the closure element is destroyed irreversibly.
- Such a vessel may be, for example, a bottle with a bottle neck and a bottle body, the label being attached to the neck of the bottle.
- the label can also be attached to the bottle body.
- the bottleneck is completely enclosed by the closure capsule.
- the pharmaceutical liquid container may have any shape and purpose, and may be, for example, an injection syringe.
- identification means in particular an RFID chip (with antenna) or a visual ID code can be provided; in this regard, reference is made to the description of the figures and the claims.
- FIG. 1 first shows a closure capsule 10 for a first embodiment of a closure element.
- the closure capsule 10 shown here is a cylindrical capsule which is closed at its upper end 11 and at its lower end 12 is open.
- the closed end 11 may be either completely closed, or alternatively, this end 11 may also have a kind of "collar", creating an edge. Due to this edge of this end is then narrowed so much that at least the opening on this page is severely limited.
- the closure capsule 10 is e.g. produced as a film capsule of one or more plastic films, such as one each for the end face (or other head cover) and for the lateral surface.
- the capsule is thus a printed product whose raw material can be guided as a material web over rollers and then punched out, reshaped or otherwise processed and handled.
- the capsule 10 can also be made of a (possibly single) foil-like or solid plastic molded part.
- materials for the plastic capsule 10 for example, polyvinyl chloride (PVC), polyethylene terephthalate (PET) or oriented polystyrene (OPS) possible.
- PVC polyvinyl chloride
- PET polyethylene terephthalate
- OPS oriented polystyrene
- the closure capsule 10 may be designed to be transparent or non-transparent, or in some cases in each case transparent and non-transparent.
- an ID code (whether as an RFID chip with electronic key, as a visual ID code or other marking) arranged on the vessel or its vessel lid itself (such as a vial cap) can be opened until and Removing the cap 10 are hidden and thus initially hidden.
- the closure capsule 10 further comprises a tear strip 20.
- This tear strip 20 can either be integrated into the closure capsule 14 as a separate part.
- the tear strip 20 can be embodied, for example, by a strip-shaped plastic film, a thread or the like.
- the tear strip 20 may be embodied as part of the closure cap 10 itself.
- the tear strip 20, for example by means of Perforation or a similarly shaped stamping of the remaining cap 10 are separated.
- the tear strip 20 has a free end 21.
- This free end 21 can be detached from the closure cap 10 and serves as a grip tab. For later opening of the closure element, a user can thus grip the grip tab 21, pull on it and thus open the closure capsule 10.
- FIG. 2 shows an alternative embodiment of a closure capsule 10 with a tear strip 20. While in the embodiment shown above FIG. 1 the tear strip 20 extends radially along a circumferential line of the cylindrical closure capsule 10, the tear strip 20 runs in this alternative embodiment FIG. 2
- the gripping tab 21 of the tear strip 20 can be located at the lower, open end 12 of the capsule or alternatively be attached to the upper, fully or partially closed end 11 of the capsule.
- the tear strip 20 may be embodied both as a separate element or be a part of the closure capsule 10 cut off by stampings.
- closure capsule 10 can also have one of numerous other forms in addition to the cylindrical arrangement already described above.
- FIG. 3A shows first a conventional, cylindrical capsule.
- a conical shape is shown which has a smaller diameter at the upper, closed end 11 than at the lower, open end 12.
- FIG. 3C further shows a part-cylindrical embodiment. In this case, the upper portion is conical, while the lower portion has a cylindrical shape.
- FIGS. 3B and 3C shown conical or part cylindrical shapes several such capsules 10 can be stacked very well together and require it for transport a relatively small volume.
- capsules as in the Figures 3D and 3E represented also have almost any other shapes that are adapted for example, especially to the opening area of the closing vessel.
- this capsule can be prepared in the desired shape from the beginning and is then available in this form for the closure of the vessel.
- the capsule may also be produced in a thermally deformable or thermally shrinkable material and brought into the desired shape by heat at a later time, as described, for example, in US Pat FIG. 4 is shown.
- the capsule 10 is arranged above a "punch" 100. Thereafter, the capsule 10 is brought into the shape of the punch 100 under the action of heat.
- the shape of the capsule 10 can also be easily varied.
- FIG. 5 shows a cross section through a label 30, as it can be used for a closure element.
- the label 30 comprises a web-shaped substrate 31, for example of a plastic film or of a paper web. On the underside 31 a of the substrate, an adhesive 32 is applied.
- FIG. 6 shows a plan view of a label 30 described above.
- the label 30 has in this case shown here at its outer edges still additional lines of weakness 35, in particular stampings. These punctures are executed as so-called security punches and cause the label 30 begins to enter these punches very easily, if the glued label 30 would try to replace a substrate.
- stampings These punctures are executed as so-called security punches and cause the label 30 begins to enter these punches very easily, if the glued label 30 would try to replace a substrate.
- T-shapedangoeinstanzonne or lines of weakness 35 differently shaped shapes for the stampings are possible.
- FIG. 7A shows a cross section through a vessel which is filled with a pharmaceutical liquid.
- This vessel 40 has an opening 41 in the upper area, through which the liquid can be filled and removed. In the illustrated figure, the opening 41 is closed by a closure 42.
- a closure capsule 10 is first slipped over the opening 41. Subsequently, a label 30 is wrapped around the neck 43 and adhered so that it is connected in a first region 39 with the capsule 10 and in a second portion 38 with the bottleneck 43. Thus, the closure capsule 10 is connected via the label 30 fixed to the vessel 40 and can not be removed without destroying the label 30.
- FIG. 7B shows an alternative arrangement of a closure element on a vessel 40.
- a closure capsule 10 is placed over the opening 41 so that the capsule 10, the opening and the complete bottleneck 43 covers.
- the lateral surface 13 of the closure capsule 10 projects down to the bottle body 44 of the vessel 40.
- the label 30 is attached to the lower portion 44 of the vessel 40 so that the capsule 10 is fixed.
- a cavity is created between the bottleneck 43 and the capsule 10.
- the vessel 40 in the lower region 44 usually has a larger circumference, a larger label 30 can be attached in this embodiment. Thus, a larger area for the identification of the vessel 40 is available.
- Figure 8A shows a plan view of a first embodiment of a sealed vessel.
- the closure capsule 10 in this case has a radially circumferential tear strip 20.
- the free end 21 of the tear strip was folded over in the direction of the upper end of the closure capsule 10.
- the label 30 is arranged on the closure capsule 10 and the vessel 40, that the label is connected in an upper portion with the closure capsule 10 and is glued to the vessel 40 in a lower portion. Since the grip tab 21 of the tear strip 20 has been folded up, the projecting Grasping tab from the label and can therefore be easily grasped to open the closure at a later date.
- FIG. 8B shows an alternative embodiment of a vessel 40 that has been sealed with a closure element.
- the closure capsule 10 has a radially circumferential tear strip 20.
- the free end 21 of the tear strip 20 is not folded up or down in this case. Rather, the label 30 is arranged in this case positionally accurate so that the free end 21 is not covered by the label 30. In this case, therefore, the free end 21 must not be handled with the grip tab of the tear strip 20. However, this requires a positionally accurate attachment of the label 30 on the vessel 40 with the capsule 10.
- FIG. 8C shows a further alternative embodiment for a closure element.
- the closure capsule 10 comprises a tear strip which runs parallel to the cylinder axis of the capsule.
- the grip tab 21 of the tear strip 20 inevitably protrudes up or down out of the label 30.
- the closure capsule 10 is attached to the label 30 on the bottle neck 43, as shown schematically in FIG FIG. 7A is shown.
- all embodiments described above may also be attached to the bottle body 44 as previously described with reference to FIG FIG. 7B has been described
- FIG. 9 shows the use of a closure element on a syringe 400.
- the closure capsule 10 can be slipped over the area with the injection needle 401. Subsequently, the capsule 10 is fixed by means of label 30 on the syringe body.
- This example shows that the term "vessel for pharmaceutical liquids” is to be understood as meaning not only glass or plastic bottles, but also any other type of containers for pharmaceutical liquids, to which an opening is to be securely sealed.
- Injection syringe 400 may additionally include a needle shield (Needle Shield or Rigid Needle Shield) that encloses injection needle 401 after use and so protects clinic personnel from accidental injury.
- the injection needle 401 may be connected, for example via a Luer-Lock, Luer-Cone or via a simple plug connection with the injection syringe.
- FIG. 10 shows a further embodiment of a closure element on a vessel 40. Shown in this figure, the closure capsule along its lateral surface 13 has a thickness d1. Due to this thickness d1, the outer circumference of the closure capsule increases in comparison to the somewhat smaller outer periphery of the vessel 40.
- a single-layered label 30 is arranged so that it Covering both the larger circumference of the closure capsule 10 and the smaller circumference of the vessel 40, it could lead to a wrinkling of the label 30.
- a further material layer 33 on the bottom 31 a are applied, wherein the material layer 33 has approximately the same thickness d2 as the thickness d1 of the lateral surface 13 of the closure capsule.
- FIG. 11 shows a cross section through such a label 30.
- a further material layer 33 is applied with the thickness d2.
- an adhesive 32 is also applied.
- FIG. 12 shows a further embodiment of a closure capsule 10.
- the lateral surface 13 of the cylindrical capsule comprises a plurality of lines of weakness 15.
- the lines of weakness 15 preferably extend parallel to the cylinder axis of the cylindrical capsule 10. But other courses of the lines of weakness 15 are possible.
- the lines of weakness 15 in the lateral surface 13 all end at an edge line 14 at the lower edge, at which the lateral surface 13 merges with the open end 12 of the closure capsule 10. In this way, form at the intersections between this edge line 14 and the end points of the weakening lines 15th Starting points at which a particularly easy entry of the closure capsule 10 is possible.
- FIG. 13 shows a label 30 for this alternative embodiment of the closure capsule 10.
- the label 30 has an approximately rectangular shape.
- the label 30 is also provided in this case on one side with an adhesive.
- the label can be coated on the entire surface with adhesive either on this page or alternatively only in some areas.
- the label 30 comprises a plurality of lines of weakness 35.
- the lines of weakness 35 terminate in each case at two opposite outer edges of the label 30. In this way, a tear strip 34 forms between the lines of weakness 35.
- the weakening lines 35 may be, for example, perforations. Alternatively, for example, only a partial punching in the label 30 is possible.
- the label 30 may further include a grip tab 31.
- This grip tab 31 can be designed, for example, as a continuation of the label on a portion of an outer edge.
- the grip tab is located, for example, along a region of an outer edge, which is delimited by two lines of weakness 35.
- the grip tab unlike the rest of the label 30 on the underside is not adhesive.
- either no adhesive can be applied to the grip tab.
- a previously applied adhesive may be attenuated or neutralized by applying a suitable substance.
- FIG. 14 shows an alternative embodiment for a label 30.
- the label 30 comprises only one line of weakness 35.
- the grip tab 31 is here arranged between an outer edge and the one weakening line 35.
- a tear strip 34 is formed between this outer edge and the weakening line 35.
- the label 30 In order to be able to remove the capsule 10 and thus reach the closure 42 of the vessel 40, the label 30 must first be opened. This happens because a user grasps and pulls on the grip tab 31. The label 30 first tears along the lines of weakness 35. Thus, the tag 30 is irrevocably destroyed and can not be reused.
- the capsule 10 Since the label 30 is also connected to the capsule 10 at the same time, the capsule 10 will enter along the weakening lines 15 during the opening process when pulling on the grip tab 31. Therefore, the cap 10 will be destroyed irreversibly during the opening process.
- both the capsule 10 and the label 30 are irreversibly destroyed in the opening process, these parts can not be used again to re-close the vessel. Such a destroyed closure element can be easily recognized by a user, so that a fraudulent reuse is excluded.
- closure capsule 10 can be integrated in the closure capsule 10 and / or in the label 30. So a manipulation attempt can be very be detected effectively.
- a hologram can be used as a further security feature.
- Special printing inks that are sensitive to light or heat can also be used as additional security features.
- Other suitable security features are also possible.
- a closure element intended for a vessel which is irreversibly destroyed in a first opening attempt.
- the closure element comprises e.g. a plastic capsule, with which the opening of the vessel is closed, a label, with which the plastic capsule is fixed to the vessel and a tear strip, with the aid of the closure element can be opened, in particular the capsule can be removed to release the opening of the vessel. Since the closure element is irreversibly destroyed when first opened, the closure element can not be reused, for example, to seal a counterfeit product with an original closure element.
- FIGS. 15A to 15G show an embodiment of the closure element, in which the tear strip 20 laterally offset from the label 30, namely in the direction of symmetry (ie in the axial or vertical direction of the closure element or vessel) offset from the label 30 is arranged.
- Figure 15A shows the closure capsule 10, in which the tear strip 20 incorporated, for example, bounded by lines of weakness or perforations.
- the tear strip 20 can also be an independent, separate element, which is arranged on or in the closure capsule 10. However, at least the grip tab 21 is located outside the lateral surface of the (for example cylindrical) closure capsule 10.
- FIG. 15B shows the vessel 40 with attached cap 10, but still without a label. This is only in FIG. 15C (in cross-sectional view) and Figure 15D (in side view) recognizable.
- FIG. 15D shows that the tear strip 20 is disposed above the label 30, ie when tearing not the label, but the capsule severed and destroyed.
- FIG. 15E shows the vessel 40 before placing the cap 10 from Figure 15A.
- FIG. 15F shows the vessel 40 after in Figure 15D the tear strip 20 has been removed and the Closure capsule was removed; only the label 30 and a lower edge of the closure capsule underneath adhere to the outer periphery of the vessel 40.
- the removed closure capsule 10 and the tear strip 20 are in FIG FIG. 15G shown.
- the capsule has been damaged and can no longer be used; As a result, a first opening detection is achieved, which can also be combined with further (serving for example for the identification of the individual vessel) detection, identification or identification means of this application.
- FIGS. 16A to 16F show a similar embodiment, but in which the tear strip 20 is largely covered by the label 30 and therefore the label when tearing (alone or in addition to the cap) is severed.
- the tear strip 20 to be pasted over by the label at its grip tab 21 can be angled or bent so that it points up or down (in the direction of symmetry of the closure capsule 10) to at least at the outermost end in a region which is not through the label is covered to expose.
- the grip tab 21 may be as in Figure 15A run, if it is ensured in another way that the grip tab is still exposed even after pasting with the label 30.
- the label 30 may be formed as a "fast wrap-around label," ie, a label that completely (ie, only partially) orbits the periphery of the closure capsule 10 and / or the vessel 40 less than once. Then lies in the non-over-adhered by the label portion of the outer periphery of the grip tab.
- a recess, indentation or other recess in the vicinity of the grip tab may be formed in the label (cf. Figure 20E or 20F ) so that it is exposed.
- FIG. 16B shows the vessel 40 with attached cap 10, but still without label 30. This is only in FIG. 16C (in cross-sectional view) and Figure 16D (in side view).
- Figure 16D FIG. 11 shows that the turned-up tab 21 is exposed above the label 30, although otherwise the remaining portion of the tear-open strip 20 is covered by the label 30.
- Figures 16E and 16F After opening, a portion of the label 30 remains on the vessel 40 and on the closure capsule 10 with the aid of the tear strip 20; also Here, the cap is destroyed and is not easily reusable.
- identification means which characterize the very specific, individual copy of the vessel and / or the closure element and are arranged for this purpose in a position that they are destroyed when removing the tear strip 20 and made unusable. This prevents, after first opening and removing the closure cap 10 and / or other parts of the closure element from the vessel, their re-use for another vessel that has not been manufactured, filled or otherwise authorized by the original manufacturer or at least one authorized dealer. This in FIG.
- the vessel shown can alternatively have an angular, in particular rectangular lateral surface or formed from other, several partial circumferential surfaces. Likewise other round, approximately oval peripheral surfaces of one or more curved partial circumferential surfaces or other partial surfaces are conceivable.
- the tear strip is preferably used to tear off a section of the closure capsule during tearing which completely circumscribes the peripheral surface of the vessel and remains thereon. However, the majority of the closure capsule may be peeled off the article or vessel after the tear strip has been peeled or torn open.
- FIGS. 17A to 17H show various embodiments of the closure capsule 10 - either alternatively or in combination with the embodiments of the FIGS. 3A to 3E . 7A to 9 and or 12
- the closure capsule 10 is partially conical, in particular in a central region (between a lower and an upper circular cylindrical region with diameters of different diameters).
- the concrete form can vary as desired; is exemplified here again on the FIGS. 3A to 3E . 7A to 9 and or 12 directed.
- Figure 17A shows a closure capsule with a conical section.
- the (incorporated or separately attached) Tear strip 20 runs as in Figure 15A
- Figure 17B The tear strip runs as in FIG.
- Figure 17C shows a label 19, for example in the form of a print or an impression.
- embossed into the material of the closure capsule 10 label is hardly destructively removable.
- embossed or other labels especially those of the label 30, the simpler representation because not specifically illustrated.
- Figure 17D shows a groove 18 in height between the upper, for example, circular cylindrical portion and the central, such as conical portion of the closure capsule 10.
- a similar capsule with the tear strip shown, but without lettering 19 is in Figure 17E shown.
- this cap 10 as in Figure 17F shown, placed on a vessel 40, the groove 18 can engage below a vascular cap 45 laterally on its circumference and is thus secured against falling and / or peeling.
- the closure capsule 10 with a groove 18 can also be attached to (pre-filled) syringes. Alternatively or additionally, the closure capsule 10 can also be fixed by thermal shrinking.
- Figure 17H shows an alternative embodiment of a closure capsule 10, in which on the outer circumference a corrugation 17 is provided in the form of a plurality of grooves or bulges.
- This has the advantage that the outer circumference (which in this case is, for example, circular cylindrical in its basic form) becomes stronger in connection, ie more stable, with respect to mechanical deformations, for example to protect against glass breakage (in the case of a glass vessel) in the event of impacts from outside.
- FIGS. 18A to 18D show two further developments in which an identification means for electronic encryption of an ID code, security codes or other suitable for the individualization of a single vessel code is provided.
- a closure element in addition to the closure capsule 10 (see Figure 19A .
- FIG. 15B or Figure 16B ) and the label 30 (see Figure 15D or Figure 16D ) further comprises an RFID chip 1.
- an antenna 2 is provided for reading out the RFID chip 1, which can circulate the RFID chip, for example, annularly, spirally or at least in the form of a plurality of loops or turns.
- the RFID chip is preferably a passive RFID chip that is suitable for storing an electronically encrypted ID code (another chip that can not be read out via RFID could also be used in principle).
- the reading is then done externally using a reader or excitation of the chip via the antenna 2.
- any suitable technology such as RFID (Radio Frequency Identification) can be used, for example NFC (Near Field Communication), or alternatively Bluetooth.
- RFID Radio Frequency Identification
- NFC Near Field Communication
- Bluetooth Bluetooth
- RFID is suitable for reading the chip.
- the chip can be an individual consecutive number or other Label to be stored, which is associated with the concrete closure element or vessel or its pharmaceutical content.
- the RFID chip can be read in particular by means of a smartphone or, if applicable, an iPhone, whereby, for example, access to an electronic database can be established on the Internet or elsewhere, for example to check the authenticity of the pharmaceutical product, its container or, in particular, the closure element described here at the original manufacturer ,
- the access authorization of the user or user can also be checked by reading out the RFID code.
- the access authorization of the user or user can be checked before the RFID code is read out by another identification means (such as a visual ID code, see below).
- further elements in particular visual ID codes
- the tear strip 20 runs in such a way that when tearing it removes the RFID chip 1 or at least separates it from its antenna, ie destroys the antenna 2. For example, their turns are severed when tearing.
- the tear strip (which may also be formed as a tear thread or the like) azimuthal around the peripheral surface of the closure element or vessel around or runs, for example, perpendicular or oblique.
- the tear strip can also extend diagonally or spirally on the outer circumference; the particular desired crack guidance and crack stabilization is achieved by the positioning of weakening lines, perforations in the closure capsule 10 and / or the label 30 or simply by the course of a separate tear strip relative to them.
- indentation for controlled crack initiation and then further crack guidance by the label and / or by the closure capsule also ensures that at the first opening of the closure element (by pulling on the Grasping tab 21) the readability of the RFID chip is suppressed for the future.
- a recess or other recess can - as well as the externally visible grip tab 21 itself - be used in the machine and labeling of the vessel as a position mark or control mark, such as the correct rotational orientation of a cylindrical vessel prior to the dispensing of an RFID chip. 1 and / or the label or to print the label in the right place or to provide it with further elements.
- an optional closure seal or tear-open seal can also be applied (as a further indicator that the closure element has been torn or damaged at least in places by the tear strip or in another way), which is also severed when the tear strip 21 is torn open.
- closure element is thus particularly suitable to check before the first opening of the container provided therewith (specifically before tearing open the tear strip 20), whether the data stored in the RFID chip 1 with those of an external database (such as the original manufacturer or an authorized dealer or user, for example doctor) or not.
- an external database such as the original manufacturer or an authorized dealer or user, for example doctor
- counterfeit plagiarism can be distinguished from genuine products, or it can be determined whether the identification number stored in the chip has previously been used elsewhere and a product provided with it has also already been opened.
- the authenticity of the externally intact appearing closure element can be checked, in particular to check whether this was really used for the first time or reused after removal of another vessel unauthorized.
- FIG. 18B shows the severed or destroyed antenna 2 after the tearing of the tear strip after the upper part of the cap 10 has been separated from the vessel 40.
- Figure 18C shows a training opposite Figure 18A , in which case a plurality of antennas 2a, 2b, 2c is connected to the RFID chip 1. At least one antenna 2a is arranged so that they are in the Tearing of the tear strip 20 is destroyed, whereas at least one other antenna 2 c is arranged so that it remains when tearing open the tear strip.
- the antenna 2c can therefore also be used after the closure element has been opened, for example in order to enable a limited communication with the RFID chip even after the closure element has been opened.
- FIG. 18D shows the state after rupture and removal of the closure capsule 10 from the vessel; via the destroyed antennas 2a, 2b communication with the chip is no longer possible.
- FIGS. 19A to 19E show further education to the FIGS. 18A to 18D , According to the FIGS. 19B to 19E
- a shielding element 25 (“shielding") is provided, which initially prevents communication with the RFID chip 1, but is removable from this. This prevents, for example, communication with the chip through unopened outer packaging.
- Figure 19A shows the vessel with attached cap 10.
- the label 30 is additionally shown, which here also carries the shielding element 25 in the form of an over label. This is provided with its own Abziehlasche and should first be withdrawn individually before opening the closure element to immediately thereafter the RFID chip 1 (Fig. Figure 18A or 18C ) read out.
- the RFID chip and its antenna can be arranged on the outside of the label 30, its inside or in its interior (as an inlay) or between the label and the closure capsule 10.
- the chip and the antenna can be arranged on the inside or inside wall of the closure capsule 10 or as an inlay of the closure capsule itself (which can also be a foil capsule), for example about its lateral surface.
- the shielding element 25 initially prevents access to the data content of the RFID chip.
- the shielding element is preferably a conductive, in particular metallic, layer, for example in the form of an aluminum foil or other foil or coating of a conductive material.
- a VOID region 24 may be provided on the label 30 and / or its over label in order to visualize a first, even partial removal of the shielding element 25 and to irreversibly display unauthorized manipulation attempts.
- the label can also be embodied as an overlay label that rotates the closure capsule 10 and the vessel 40 so far that it comes to rest on itself and there is still room in the overlap area for a shielding element 25.
- FIGS. 20A to 20F show various embodiments of a label 30.
- the label according to Figure 20A is a label that only partially encloses the circumference of the container or, as far as it is an overlay label (not to scale), does not itself cover the RFID chip 1 and the antenna 2. Instead, the shielding element 25 is designed as an over label 26, which is provided with its own grip tab and can be removed separately from the RFID chip. In addition, punched holes 34 or other weakening lines 35 are arranged on the label edges in order to make the removal of the label 30 more difficult.
- the label off Figure 20A is suitable for the closure element FIGS. 19B and 19C .
- the label off Figure 20B is suitable in particular for the closure element according to FIGS.
- FIGS. 20C and 20D show labels 30 in which the RFID chip 1 and the antenna 2 are arranged on a separable portion 22 of the label 30.
- the separable portion 22 is delimited by a parting line 23 (weakening line or perforation) of the remaining part of the label 30 and thus torn off.
- the antenna 2 also protrudes into the remaining part of the label 30 and is therefore severed during the tearing off of the section 22 along the dividing line 23, ie destroyed.
- the RFID chip is canceled.
- the antenna 2 is completely in the section 22, that is, it remains when tearing the section 22 is obtained.
- the RFID chip 1 contained on the section 22 with its antenna 2 can thus continue to be used, in particular adhered to another object (for example a medical record).
- Figure 20E shows a label 30 with identification of the course of the tear guide for the tear strip 20 of the closure element.
- a recess 37 or another recess, perforation or line of weakness is provided so that at least the antenna 2 of the RFID chip 1 is severed together with the label.
- Figure 20F shows an embodiment in which instead of the RFID chip 1 a visual ID code 5 (for example, a QR code, a two-dimensional code or a bar code or bar code) is destroyed when torn.
- a visual ID code 5 for example, a QR code, a two-dimensional code or a bar code or bar code
- the embodiments are equally suitable for destroying a visual ID code 5 upon initial opening of the vessel.
- Figure 21A shows a closure capsule 10, in which instead of the lateral surface now on its end face 16 (axial end, top surface, head area, etc.) an identification means is arranged, be it an electronically storing identification means (RFID chip 1 and 2 antenna), be it a visual ID code 5.
- RFID chip 1 and 2 antenna an electronically storing identification means
- another identification means may additionally be provided on the lateral surface or be provided on the label.
- On the end face 16 also other labels 19 may be arranged.
- the respective identification means is not arranged on the outside, but on the inside of the end face 16 of the closure capsule 10. This has the advantage that the respective identification means is visible only after the opening or tearing off of the closure capsule 10, so that the user can read or scan the identification means under the end face 16 only after opening and destroying the closure element.
- FIG 21C shows a third variant in which the further identification means on a vessel cap 45 (plug, cap or other cover) of the vessel 40 is arranged.
- the closure capsule 10 may be at least partially, for example, on its end face intransparent to prevent reading before removing the VerInstitutlements.
- Figure 21D shows a shielding member 25 which may be disposed on the end face 16 of the closure capsule 10 to at least temporarily cover an RFID chip 1 or an antenna 2, a visual ID code 5 or any other means of identification.
- an electrically conductive, ie shielding shielding element 25 may be provided at the same place an opaque cover, for example, any other over label for covering a label or a visual ID code.
- a plurality of identification means or other means for Clearö Stamm Stamm at the same time may be provided, such as an RFID chip 1 in addition to a visual ID code 5 or other visual (or electronic) identification means. It is also possible to provide three or more such identification or identification means, for example one or more of them, in, under or over the lateral surface of the vessel or the label, one on a head side or end face of the vessel and / or another if necessary (surrounded by the closure cap) on the vessel or its cap.
- a separate Ablekapsel or cap (such as metal foil capsule) in addition to a (inner, formed for example from plastic or foil) Be provided closure capsule, whereby a double capsule is formed.
- a VOID film or another, preferably non-transparent (colored) cover film can be provided for the complete or partial covering of visual information.
- the Figures 22A to 22E show a development in which the closure element 10 additionally comprises a further closure capsule 50, which is arranged at an opposite end (for example, a bottom end of a spray bottle 300 or another vessel 40) and surrounds this.
- a foam layer 51 or another shock-absorbing layer or a suitable corrugation as in FIG Figure 17H ) be provided;
- Figure 22B shows the arrangement of the spray bottle 300 between two closure capsules 10, 50th
- Figure 22C shows the overall arrangement in which the label 30 connects both closure caps together, thereby securely enclosing the vessel.
- the label 30 may itself contain a shock-absorbing layer.
- the label 30 is preferably adhered to the vessel in a central region between the two closure capsules 10, 20 (not shown for the sake of clarity).
- Figure 22D shows the same arrangement as Figure 22C , but in side view instead of in cross-sectional view.
- Figure 22E shows the arrangement after the opening and tearing of the tear strip 20, whereby an upper part of the closure capsule 10 is separated and removed. As a result, the web of the spray head 310 is exposed to remove the spray bottle 301 and use.
- the embodiments of this application provide effective Siegöschensschutz and copy protection.
- opening the closure element not only the vessel is accessible, but also the closure element, in particular its label and, if necessary, as well as an identification means (such as an RFID chip with antenna and / or a visual ID code, if necessary, also a void area or a closure seal) visibly and irreversibly destroyed and rendered useless.
- an identification means such as an RFID chip with antenna and / or a visual ID code, if necessary, also a void area or a closure seal
- the electronic or otherwise visual coding of the individual vessel or its visual or electronic detection function is destroyed irreversibly.
- the closure element for the vessel does not necessarily have to enclose the largest circumference of the vessel (such as in FIG FIG. 7B or on the figure sheets with the FIGS. 15A to 19E and 21A to 22E shown). Instead, the closure element (in particular that of the embodiments of the FIGS. 15A to 19E and 21A to 22E ) be modified, for example, so that it encloses only a vessel part of smaller circumference. The closure element is then to be attached (by means of its closure label) to this narrower vessel part.
- the closure element can be provided or shaped, for example, for a vessel which narrows upwards and, for example, similar to the one in FIGS FIGS. 7A . 8A to 8C or 10 is designed.
- the vessel may have an opening or head area or neck 43 having a smaller radius and circumference than another (preferably lower) part of the vessel, such as a belly of the vessel (such as bottle body 44) which is wide enough for circumferentially enclosing the actual vessel contents (usually a liquid).
- the head area (or opening area or bottleneck 43) of the vessel may have an outer circumference which is smaller than the outer circumference (and preferably also the inner circumference) of the circumferential outer wall of the vessel belly.
- the diameter and / or circumference (in particular inner circumference) of the closure capsule described in this application can be dimensioned such that they are modeled on the diameter and / or circumference (in particular outer circumference) of the vessel.
- the closure element can then be attached to the head region of the vessel without the vessel belly having to be covered or covered by the closure element; the vessel belly is then exposed after attaching the closure element.
- the closure element may further be adhered to a vessel having a transition region in which the vessel diameter or outer vessel circumference of that of the neck of the vessel rises to that of the vessel belly, be formed.
- the closure label can be designed for attachment, in particular adhesion to the transition region (instead of the head region).
- a lower or outer part of the label surface (alternatively or additionally also a lower part of the closure capsule itself; FIG. 12 ) be provided with lines of weakness 15 or other Sollriss Modellen.
- These predetermined tear structures can be formed in particular on a lower edge of the closure label and / or the closure capsule.
- the closure label of the closure element can be used for adhering to the head region or opening (or neck) (as in FIGS FIGS.
- FIGS. 15A to 19E and 21A to 22E can be modified.
- FIGS. 7A and 7B show that the closure element is selectively attachable to the opening portion or the largest circumference of the vessel, even those embodiments in which the closure element is shown as attached to the opening area, modified to the effect that the closure element designed for attachment to the largest outer circumference, in particular on the vessel belly is.
- the additional material layer 30, which is exemparically based FIG. 10 is explained, as in the embodiments of the FIGS. 15A to 19E and 21A to 22E be provided; and there preferably between the outer periphery of the vessel belly and the inner surface of the closure label.
- the additional material layer 30 can be provided.
- the embodiments of the FIGS. 1 to 3E and 5 to 14 on those of FIGS. 15A to 22E transferable and vice versa.
- the tear strip is a component of the closure capsule, ie it forms part of a one-piece molded part (preferably made of plastic), from which the closure capsule and the tear strip are formed together.
- the tear strip 20 thus forms at least until tearing or tearing a material part which is at least partially connected along the entire or at least predominant portion of the outer periphery with a larger and preferably also more massive part of the closure cap 10.
- the closure element of the embodiments of the application is preferably designed so that with the tearing open of the tear strip the label is severed and destroyed; in particular in such a way that one or more than one, preferably a plurality of different identification means, such as an RFID chip, an antenna for an RFID chip and / or a visual ID code (such as a QR code) cuts, damages or otherwise unusable made and / or changed.
- a plurality of different identification means such as an RFID chip, an antenna for an RFID chip and / or a visual ID code (such as a QR code) cuts, damages or otherwise unusable made and / or changed.
- the tear strip can also be designed as a tear-off strip, ie connected with the remaining part of the closure cap 10 in such a way that it generally tears off completely during stripping.
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Description
Die vorliegende Erfindung betrifft ein Verschlusselement für ein Gefäß mit einem pharmazeutischen Inhalt.The present invention relates to a closure element for a vessel with a pharmaceutical content.
Qualitativ hochwertige Produkte erfordern einen großen Aufwand für Entwicklung und Produktion sowie entsprechend teure Rohstoffe für die Herstellung. Daher sind solche hochwertigen Produkte in der Regel auch sehr teuer.High-quality products require a lot of effort for development and production as well as correspondingly expensive raw materials for the production. Therefore, such high quality products are usually also very expensive.
Aufgrund der hohen Verkaufspreise dieser hochwertigen Produkte, werden neben den relativ aufwändig hergestellten Originalprodukten immer mehr minderwertige Kopien der Originale hergestellt und verkauft. Dabei werden die minderwertigen Kopien jedoch nicht immer als solche gekennzeichnet. Um einen möglichst hohen Gewinn zu erzielen, wird der Eindruck erweckt, es handele sich bei den minderwertigen Kopien um Originalprodukte. Einerseits werden hierzu die minderwertigen Kopien in täuschend ähnlichen Verpackungen angeboten. Andererseits wird versucht, in den Besitz der Originalverpackungen zu gelangen und die minderwertigen Kopien in diesen Originalverpackungen in Verkehr zu bringen.Due to the high sales prices of these high-quality products, more and more inferior copies of the originals are produced and sold in addition to the relatively complex original products. However, the inferior copies are not always marked as such. In order to achieve the highest possible profit, the impression is created that the inferior copies are original products. On the one hand, the inferior copies are offered in deceptively similar packaging. On the other hand, an attempt is made to obtain the original packaging and place the inferior copies in these original packaging on the market.
Oftmals besitzen die Originalverpackungen keinen Nachweis, der ein erstmaliges Öffnen der Verpackung anzeigt (Erstöffnungsschutz). Somit ist es möglich, die Originalverpackung zu öffnen, den ursprünglichen Inhalt zu entnehmen und durch eine minderwertige Kopie zu ersetzen, ohne dass dies für einen späteren Benutzer ersichtlich ist.Often, the original packaging has no proof indicating the first opening of the packaging (first opening protection). Thus, it is possible to open the original packaging, remove the original contents and replace them with an inferior copy, without this being apparent to a later user.
Um in den Besitz der Originalverpackungen zu gelangen, werden dabei auch bereits verwendete weggeworfene Verpackungen ohne wirkungsvollen Erstöffnungsschutz verwendet. Solche Verpackungen stammen ursprünglich aus der Produktion eines Originalherstellers. Ein potentieller Käufer hat daher zunächst wenige Anhaltspunkte um zu erkennen, dass es sich bei der wieder gefüllten Originalverpackung um eine Verpackung mit einem gefälschten Inhalt handelt.In order to gain possession of the original packaging, used discarded packaging without effective first-opening protection is also used. Such packaging originally came from the production of an original manufacturer. Therefore, a potential buyer initially has few indications to recognize that the refilled original packaging is a package with a counterfeit content.
Ein Käufer einer solchen nachträglich befüllten Originalverpackung wird daher nicht erkennen können, dass es sich um kein Originalprodukt handelt. Erst nach dem Auspacken oder bei der Verwendung des minderwertigen Produktes wird er den damit verbundenen Schaden erkennen. Da der Käufer jedoch aufgrund der Originalverpackung annimmt, es handele sich um ein Produkt des Originalherstellers, wird er den damit verbundenen Schaden auch dem Originalhersteller zuschreiben.A buyer of such a subsequently filled original packaging will therefore be unable to recognize that it is not an original product. Only after unpacking or when using the inferior product will he recognize the damage involved. However, as the buyer assumes, based on the original packaging, that it is a product of the original manufacturer, he will also attribute the damage to the original manufacturer.
Darüber hinaus erschwert die Verwendung solcher Originalverpackungen auch für den Hersteller den Nachweis, dass es sich tatsächlich um eine minderwertige Kopie handelt. Sollte einem Benutzer aufgrund der minderwertigen Kopie ein Schaden entstanden sein, könnte daher im ungünstigsten Fall sogar der Originalhersteller zur Verantwortung gezogen werden.In addition, the use of such original packaging also makes it more difficult for the manufacturer to prove that it is indeed an inferior copy. Should a user be damaged due to the inferior copy, even the original manufacturer could be held responsible in the worst case scenario.
Daher sind die Hersteller qualitativ hochwertiger Produkte darauf bedacht, dass ein Käufer möglichst einfach erkennen kann, ob es sich tatsächlich um ein hochwertiges Originalprodukt oder um eine Kopie von minderwertiger Qualität handelt.Therefore, manufacturers of high quality products are keen to make it as easy as possible for a buyer to identify whether it is actually a high quality original product or a low quality copy.
Derartige hochwertige Originalprodukte, wie sie schon eingangs angesprochen wurden, sind beispielsweise medizintechnische Produkte wie Implantate, Prothesen, Orthesen, Autoinjektoren, Pens zur Verabreichung flüssiger Medikamente, pharmazeutische Produkte wie z. B. Medikamente oder bereits mit flüssigen Medikamenten vorgefüllte Spritzen, aber auch Lippenstifte, Zigaretten und Zigarren, Kosmetikartikel wie z. B. Parfums, Lebensmittel, Getränke wie z. B. Champagner oder Whisky oder auch Ersatzteile für Maschinen, für Fahrzeuge oder für Flugzeuge.Such high-quality original products, as they were already mentioned, are for example medical devices such as implants, prostheses, orthoses, autoinjectors, pens for the administration of liquid drugs, pharmaceutical products such. As drugs or pre-filled with liquid drugs syringes, but also lipsticks, cigarettes and cigars, cosmetics such. As perfumes, foods, drinks such. As champagne or whiskey or spare parts for machinery, for vehicles or for aircraft.
Insbesondere bei pharmazeutischen Produkten, wie beispielsweise Medikamenten, ist neben dem Imageschaden für den Hersteller oft auch eine große Gefahr für den Patienten verbunden, der ein solches Medikament erhalten soll. Eine wiederbefüllte Verpackung für ein pharmazeutisches Produkt kann beispielsweise eine wirkungslose Substanz enthalten. In diesem Fall würde ein Patient nicht das eventuell dringend benötigte Medikament erhalten. Weitaus schlimmer wäre es darüber hinaus, wenn anstelle des beabsichtigten Medikaments eine andere, verunreinigte oder sogar schädliche Substanz eingeführt würde. In diesem Fall würde der Patient erheblichen Schaden nehmen.In particular, in pharmaceutical products, such as drugs, in addition to the image damage to the manufacturer often associated with a great risk to the patient, who should receive such a drug. For example, a refilled packaging for a pharmaceutical product may contain an ineffective substance. In this case, a patient would not receive the potentially urgently needed drug. It would be far worse moreover, if instead of the intended drug another, contaminated or even harmful substance was introduced. In this case, the patient would suffer considerable harm.
Aus diesem Grund sind ganz besonders die Hersteller von Medikamenten und anderen pharmazeutischen Produkten darauf bedacht, dass man stets erkennen kann, ob die Verpackung das hochwertige Originalprodukt enthält oder ob es sich um eine wiederbefüllte Verpackung handelt.For this reason, especially the manufacturers of medicines and other pharmaceutical products are careful to always be able to see whether the packaging contains the high-quality original product or whether it is a refilled packaging.
Hierzu kann beispielsweise die Öffnung einer Medikamentenflasche mit einer Kunststoffkapsel versehen werden, wie diese beispielsweise auch für Getränkeflaschen verwendet wird. Solche Kunststoffkapseln werden in der Regel aus einem Material hergestellt, das sich unter Hitzeeinwirkung zusammenzieht und so enger an der Flaschenöffnung und dem Flaschenhals anliegt. Zum Öffnen muss daher normalerweise diese Kunststoffkapsel aufgerissen werden. Dabei wird die Kapsel mechanisch zerstört und kann nicht wieder verwendet werden.For this purpose, for example, the opening of a medicine bottle can be provided with a plastic capsule, as used for example for beverage bottles. Such plastic capsules are usually made of a material that contracts under the influence of heat and thus rests more closely against the bottle opening and the bottleneck. Normally, this plastic capsule must be torn open to open. The capsule is mechanically destroyed and can not be reused.
Dieser Ansatz hat jedoch den Nachteil, dass die übrigen Kennzeichnungen auf der Flasche, wie beispielsweise die zusätzlich angebrachten Etiketten, weiterhin unversehrt erhalten bleiben. Ein Fälscher muss daher lediglich in den Besitz neuer Kapseln für den Flaschenhals gelangen. Somit könnte die entleerte Flasche mit einer beliebigen Substanz nachgefüllt werden und würde nach dem Anbringen einer neuen Kapsel dem Original täuschend ähnlich sehen.However, this approach has the disadvantage that the remaining markings on the bottle, such as the additional labels attached, remain intact. Therefore, a counterfeiter only has to get possession of new capsules for the bottleneck. Thus, the deflated bottle could be refilled with any substance and would look deceptively similar to the original after attaching a new capsule.
Darüber hinaus kann es auch in vielen Fällen passieren, dass die Originalkapsel auch zerstörungsfrei von der Öffnung heruntergezogen werden kann. In diesem Fall ist es möglich, die hochwertige Originalsubstanz zu entnehmen, durch eine andere, minderwertige Substanz zu ersetzen und anschließend wieder die ursprüngliche Verschlusskapsel anzubringen.In addition, it can also happen in many cases that the original capsule can be pulled down non-destructively from the opening. In this case, it is possible to remove the high-quality original substance, replace it with another, inferior substance and then re-attach the original capsule.
Um eine sehr eng anliegende Verschlusskapsel zu erhalten, wird normalerweise eine Kapsel verwendet, die unter Hitzeeinwirkung schrumpft, d.h. sich unter Einwirkung von Wärme zusammenzieht, so dass ihr Durchmesser verringert wird. Da pharmazeutische Produkte jedoch in der Regel sehr wärmeempfindlich sind, könnte der Inhalt beim Aufschrumpfen einer solchen Kapsel Schaden leiden. Daher ist eine Versiegelung von pharmazeutischen Gefäßen mit solchen Schrumpffolien in der Regel nicht möglich.In order to obtain a very close fitting capsule, a capsule is usually used which shrinks under heat, ie contracts under the influence of heat, so that its diameter is reduced. There However, pharmaceutical products are usually very sensitive to heat, the content could suffer damage when shrinking such a capsule. Therefore, a sealing of pharmaceutical containers with such shrink films is usually not possible.
Ein Verschlusselement gemäß dem Oberbegriff des Anspruchs 1 der vorliegenden Anmeldung ist aus
Beabstandet von dem Etikett ist oben an und nahe der Gefäßöffnung die Verschlusskapsel angeordnet. Außen an dem Gefäß sind das Etikett und die Verschlusskapsel voneinander beabstandet und nur durch den Aufreißstreifen miteinander verbunden. Zwischen dem Etikett und der Verschlusskapsel liegt die Umfangsfläche des Gefäßes weitestgehend frei; lediglich der Aufreißstreifen überdeckt dort einen schmalen Abschnitt der Umfangsfläche.Spaced apart from the label, the closure capsule is arranged at the top and near the vessel opening. Outside the vessel, the label and the closure capsule are spaced apart and interconnected only by the tear strip. Between the label and the capsule, the peripheral surface of the vessel is largely free; only the tear strip covers there a narrow portion of the peripheral surface.
Das aus
Es ist daher die Aufgabe der Erfindung, ein für ein Gefäß mit einem pharmazeutischen Inhalt geeignetes Verschlusselement bereitzustellen, mit dem das Gefäß so verschließbar ist, dass ein erstmaliges Öffnen des Gefäßes zweifelsfrei erkannt und nachgewiesen werden kann. Nach dem erstmaligen Öffnen soll ein erneutes Verschließen des Gefäßes nicht mehr oder nur mit sichtbaren Spuren, die auf ein erstmaliges Öffnen hindeuten, möglich sein.It is therefore an object of the invention to provide a suitable for a vessel with a pharmaceutical content closure element with which the vessel is closed so that a first-time opening of the vessel can be recognized and proven beyond doubt. After the first opening should be another Closing the vessel is no longer possible or only with visible traces that indicate a first opening, be possible.
Zur Lösung dieser Aufgabe wird ein an einem Gefäß mit einem pharmazeutischen Inhalt befestigtes Verschlusselement gemäß Anspruch 1 vorgeschlagen.To achieve this object, a fastened to a vessel with a pharmaceutical content closure element according to claim 1 is proposed.
Das Verschlusselement umfasst eine Verschlusskasel, einen Aufreißstreifen und ein Etikett. Die Verschlusskapsel besitzt eine Mantelfläche, ein geschlossenes Ende und ein offenes Ende. Der Aufreißstreifen umfasst eine Anfasslasche zum Öffnen der Verschlusskapsel. Das Etikett umfasst ein bahnförmiges Substrat, das auf einer Unterseite mit Klebstoff versehen ist. Die Verschlusskapsel überdeckt eine Öffnung eines Gefäßes.The closure element comprises a closure box, a tear strip and a label. The closure capsule has a lateral surface, a closed end and an open end. The tear strip comprises a grip tab for opening the closure capsule. The label comprises a web-shaped substrate which is provided on an underside with adhesive. The closure capsule covers an opening of a vessel.
Das erfindungsgemäße Verschlusselement ist so an dem Gefäß angebracht, dass ein erster Teilbereich des Etiketts auf dem Gefäß angeordnet ist, wohingegen ein zweiter Teilbereich des Etiketts auf der Verschlusskapsel und/oder dem Aufreißstreifen angeordnet ist. Somit liegt das Etikett teilweise auf der Umfangsfläche des Gefäßes und teilweise auf der Verschlusskapsel und/oder dem Aufreißstreifen auf. Der zweite Teilbereich des Etiketts, der auf der Verschlusskapsel und/oder dem Aufreißstreifen aufliegt, überdeckt jedoch nicht die Anfasslasche des Aufreißstreifens; diese liegt daher frei und ist somit leicht mit der Hand greifbar und wegziehbar.The closure element according to the invention is attached to the vessel in such a way that a first subarea of the label is arranged on the vessel, whereas a second subarea of the label is arranged on the closure capsule and / or the tear strip. Thus, the label is partially on the peripheral surface of the vessel and partly on the closure capsule and / or the tear strip on. The second portion of the label, which rests on the closure cap and / or the tear strip, but does not overlap the grip tab of the tear strip; This is therefore free and therefore easy to grasp by hand and wegziehbar.
In einer besonderen Ausführungsform ist die Verschlusskapsel des Verschlusselements rotationssymmetrisch. Solche Verschlusskapseln eignen sich besonders gut zum Verschließen der oben beschriebenen Gefäße, da diese Gefäße in der Regel ebenfalls einen annähernd runden Öffnungsbereich besitzen.In a particular embodiment, the closure capsule of the closure element is rotationally symmetrical. Such closure capsules are particularly suitable for closing the vessels described above, since these vessels usually also have an approximately round opening area.
Der Aufreißstreifen kann dabei radial entlang der Mantelfläche der Verschlusskapsel verlaufen, d.h. (azimutal) entlang der Umfangsrichtung der Mantelfläche; bei aufrechter Lagerung des Gefäßes also horizontal. Somit kann durch Ziehen an dem Aufreißstreifen das Verschlusselement rundherum geöffnet werden.The tear strip can run radially along the lateral surface of the closure capsule, ie (azimuthally) along the circumferential direction of the lateral surface; at upright storage of the vessel so horizontal. Thus, by pulling on the tear strip, the closure element can be opened all around.
Alternativ kann der Aufreißstreifen auch parallel zu einer Zylinderachse der rotationssymmetrischen Verschlusskapsel, d.h. entlang einer axialen Richtung verlaufen. In diesem Fall kann durch Ziehen an dem Aufreißstreifen die Verschlusskapsel von oben bis unten oder umgekehrt geöffnet werden.Alternatively, the tear strip may also be parallel to a cylinder axis of the rotationally symmetrical closure capsule, i. along an axial direction. In this case, the closure capsule can be opened from top to bottom or vice versa by pulling on the tear strip.
Alternativ kann der Aufreißstreifen auch axial von oben oder unten bis zur Mitte (oder bis zu irgendeiner anderen Höhe) der Verschlusskapsel verlaufen und von dort aus horizontal entlang der Umfangsrichtung der Mantelfläche weiterlaufen.Alternatively, the tear strip may also extend axially from the top or bottom to the middle (or to some other height) of the closure capsule and from there continue to run horizontally along the circumferential direction of the envelope surface.
Der Aufreißstreifen kann als ein Teil der Verschlusskapsel ausgeführt sein. Somit ist es nicht erforderlich, ein zusätzliches Materialelement in einem separaten Arbeitsschritt herzustellen. Beispielsweise kann der Aufreißstreifen durch eine oder mehrere Perforationen oder Einstanzungen von der übrigen Verschlusskapsel abgetrennt bzw. abgegrenzt, ansonsten aber einstückig mit ihr verbunden sein.The tear strip can be designed as a part of the closure capsule. Thus, it is not necessary to produce an additional material element in a separate operation. For example, the tear strip can be separated or delimited from the remaining closure capsule by one or more perforations or punches, but otherwise be integrally connected to it.
Alternativ kann der Aufreißstreifen auch als separates Teil ausgeführt sein. In diesem Fall ist keine vorherige Bearbeitung der Verschlusskapsel in einem weiteren Arbeitsschritt erforderlich. Außerdem besteht die Möglichkeit, hierbei den Aufreißstreifen aus einem besonders stabilen und reißfesten Material herzustellen.Alternatively, the tear strip can also be designed as a separate part. In this case, no previous processing of the cap in a further step is required. In addition, it is possible here to produce the tear strip of a particularly stable and tear-resistant material.
In einer besonderen Ausführungsform umfasst das Etikett eine zusätzliche Materiallage mit einer vorbestimmten Dicke. Diese Dicke der zusätzlichen Materiallage entspricht dabei vorzugsweise in etwa der Dicke der Mantelfläche der Verschlusskapsel. Auf diese Weise ist es möglich, das Etikett so auf dem Verschlusselement und dem Gefäß anzubringen, dass eine faltenfreie Applikation ermöglicht wird.In a particular embodiment, the label comprises an additional layer of material having a predetermined thickness. This thickness of the additional material layer preferably corresponds approximately to the thickness of the lateral surface of the closure capsule. In this way, it is possible to attach the label on the closure element and the vessel so that a wrinkle-free application is possible.
In einer speziellen Ausführungsform umfasst das Verschlusselement ein Etikett mit Sicherheitseinstanzungen. Solche Sicherheitseinstanzungen führen dazu, dass bei einem Ablöseversuch des Etiketts das Etikett besonders leicht einreißt und somit zerstört wird. Eine Weiterverwendung ist danach nicht mehr möglich. Ein oben beschriebenes Verschlusselement kann auf ein Gefäß mit einem pharmazeutischen Inhalt aufgebracht werden. Somit ist ein solches Gefäß zuverlässig vor einer Manipulation, insbesondere einer nicht autorisierten Weiterverwendung geschützt, da bei dem erstmaligen Öffnen des Gefäßes das Verschlusselement irreversibel zerstört wird.In a specific embodiment, the closure element comprises a label with security punches. Such safety punctures cause the label is particularly easily tears and thus destroyed in a peel attempt of the label. Further use is then no longer possible. A closure element described above may be applied to a vessel having a pharmaceutical content. Thus, such a vessel is reliably protected against manipulation, in particular unauthorized re-use, since the first time the vessel is opened, the closure element is destroyed irreversibly.
Bei einem solchen Gefäß kann es sich beispielsweise um eine Flasche mit einem Flaschenhals und einem Flaschenkörper handeln, wobei das Etikett an dem Flaschenhals angebracht ist. Alternativ kann das Etikett auch am Flaschenkörper angebracht werden. Dabei ist dann der Flaschenhals vollständig von der Verschlusskapsel umschlossen. Das Gefäß mit bzw. für eine pharmazeutische Flüssigkeit kann jede beliebige Form und Verwendungszweck besitzen und insbesondere beispielsweise eine Injektionsspritze sein.Such a vessel may be, for example, a bottle with a bottle neck and a bottle body, the label being attached to the neck of the bottle. Alternatively, the label can also be attached to the bottle body. In this case, then the bottleneck is completely enclosed by the closure capsule. The pharmaceutical liquid container may have any shape and purpose, and may be, for example, an injection syringe.
Bei allen Ausführungsformen dieser Anmeldung können Identifikationsmittel, insbesondere ein RFID-Chip (mit Antenne) oder ein visueller ID-Code vorgesehen sein; insoweit wird auf die Figurenbeschreibung und die Patentansprüche verwiesen.In all embodiments of this application, identification means, in particular an RFID chip (with antenna) or a visual ID code can be provided; in this regard, reference is made to the description of the figures and the claims.
Zur Erläuterung werden einige Ausführungsformen der Anmeldung exemplarisch anhand der beigefügten Figuren erläutert. Die Figuren sind nur schematisch und die Größenverhältnisse, Abmessungen und/oder Relationen zwischen ihnen nicht zwingend maßstabgetreu. Es zeigen:
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Figur 1 : eine Seitenansicht auf eine Verschlusskapsel für ein Verschlusselement; -
Figur 2 : eine Seitenansicht auf eine alternative Ausführungsform einer Verschlusskapsel; - die
Figuren 3A bis 3E : Ausführungsformen hinsichtlich der Geometrie der Verschlusskapsel in Schrägansicht; - die
Figur 4 : eine weitere Ausführungsform hinsichtlich der Geometrie der Verschlusskapsel in Querschnittsansicht; -
Figur 5 : eine Querschnittsansicht eines Etiketts des Verschlusselements oder seiner Verschlusskapsel; -
Figur 6 : eine Draufsicht einer Ausführungsform eines Etiketts mit Sicherheitseinstanzungen; -
Figur 7A : einen Querschnitt durch ein Gefäß, das mit einem Verschlusselement versiegelt ist; -
Figur 7B : eine Querschnitt durch ein Gefäß, das mit einer alternativen Ausführungsform eines Verschlusselements versiegelt ist; -
Figur 8A : eine Draufsicht auf ein Gefäß, das mit einem Verschlusselement versiegelt ist; -
Figur 8B : eine Draufsicht auf ein Gefäß, das mit einer alternativen Ausführungsform eines Verschlusselements versiegelt ist; -
Figur 8C : eine Draufsicht auf ein Gefäß, das mit einer alternativen Ausführungsform eines Verschlusselements versiegelt ist; -
Figur 9 : einen Querschnitt durch eine Injektionsspritze, die mit einer Ausführungsform eines Verschlusselements versiegelt ist; -
Figur 10 : einen Querschnitt durch ein Gefäß, das mit einer speziellen Ausführungsform eines Verschlusselements versiegelt ist; -
Figur 11 : eine Querschnittsansicht eines Etiketts für die Ausführungsform einer Verschlusskapsel nachFig. 10 ; -
Figur 12 : eine Schrägansicht auf eine weitere alternative Ausführungsform einer Verschlusskapsel für ein Verschlusselement; -
Figur 13 : eine Draufsicht auf eine spezielle Ausführungsform eines Etiketts für ein Verschlusselement mit einer Kapsel gemäßFig. 12 ; -
Figur 14 : eine Draufsicht auf eine zuFigur 13 alternative Ausführungsform eines Etiketts für ein Verschlusselement für eine Kapsel gemäßFig. 12 ; - die
Figuren 15A bis 15G : eine Ausführungsform eines Verschlusselements mit einem zum Etikett seitlich versetzten Aufreißstreifen, - die
Figuren 16A bis 16F : eine Ausführungsform mit durch das Etikett abgedecktem Aufreißstreifen, - die
Figuren 17A bis 17H : verschiedene Ausführungsformen der Verschlusskapsel, - die
Figuren 18A bis 18D : zwei lediglich exemplarische Ausführungsformen mit einem RFID-Chip, - die
Figuren 19A bis 19E : zwei Ausführungsformen mit einem Abschirmelement über einem RFID-Chip, - die
Figuren 20A bis 20F : verschiedene Ausführungsformen eines Etiketts für das Verschlusselement, - die
D: verschiedene Ausführungsformen einer Verschlusskapsel mit ID-Code auf ihrer Stirnfläche undFiguren 21A bis 21 - die
Figuren 22A bis 22E : verschiedene Ausführungsformen eines als Sprühflasche ausgebildeten Gefäßes mit einem Verschlusselement.
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FIG. 1 a side view of a closure cap for a closure element; -
FIG. 2 a side view of an alternative embodiment of a closure capsule; - the
FIGS. 3A to 3E Embodiments relating to the geometry of the closure capsule in an oblique view; - the
FIG. 4 a further embodiment in terms of the geometry of the closure capsule in cross-sectional view; -
FIG. 5 a cross-sectional view of a label of the closure element or its closure capsule; -
FIG. 6 a plan view of an embodiment of a label with security punches; -
FIG. 7A a cross-section through a vessel sealed with a closure element; -
FIG. 7B Fig. 3 is a cross-section through a vessel sealed with an alternative embodiment of a closure element; -
Figure 8A Fig. 10 is a plan view of a vessel sealed with a closure member; -
FIG. 8B Fig. 5 is a plan view of a vessel sealed with an alternative embodiment of a closure element; -
FIG. 8C Fig. 5 is a plan view of a vessel sealed with an alternative embodiment of a closure element; -
FIG. 9 Fig. 3 is a cross-sectional view of a hypodermic syringe sealed with an embodiment of a closure member; -
FIG. 10 a cross-section through a vessel sealed with a particular embodiment of a closure element; -
FIG. 11 : A cross-sectional view of a label for the embodiment of a closure cap according toFig. 10 ; -
FIG. 12 a perspective view of a further alternative embodiment of a closure capsule for a closure element; -
FIG. 13 FIG. 2: a plan view of a special embodiment of a label for a closure element with a capsule according to FIGFig. 12 ; -
FIG. 14 : a top view of a toFIG. 13 alternative embodiment of a label for a closure element for a capsule according toFig. 12 ; - the
FIGS. 15A to 15G an embodiment of a closure element with a tear strip laterally offset from the label, - the
FIGS. 16A to 16F an embodiment with a tear strip covered by the label, - the
FIGS. 17A to 17H : different embodiments of the closure capsule, - the
FIGS. 18A to 18D FIG. 2 shows two exemplary embodiments with an RFID chip, FIG. - the
FIGS. 19A to 19E FIG. 2 shows two embodiments with a shielding element over an RFID chip, FIG. - the
FIGS. 20A to 20F : various embodiments of a label for the closure element, - the
FIGS. 21A to 21 D: various embodiments of a closure capsule with ID code on its face and - the
Figures 22A to 22E : Various embodiments of a container designed as a spray bottle with a closure element.
Das geschlossene Ende 11 kann dabei entweder vollständig geschlossen sein, oder aber alternativ kann dieses Ende 11 auch eine Art "Kragen "besitzen, wodurch ein Rand entsteht. Aufgrund dieses Randes ist dieses Ende dann soweit eingeengt, dass zumindest die Öffnung auf dieser Seite stark eingeschränkt ist.The
Die Verschlusskapsel 10 ist z.B. als Folienkapsel aus einer oder mehreren Kunststofffolien hergestellt, etwa je einer für die Stirnfläche (oder sonstigem Kopfdeckel) und für die Mantelfläche. Die Kapsel ist somit ein Druckerzeugnis, dessen Rohmatieral als Materialbahn über Rollen geführt und dann ausgestanzt, umgeformt oder sonstwie bearbeitet und gehandhabt werden kann. Alternativ kann die Kapsel 10 auch aus einem (ggfs. einzigen) folienartigen oder massiven Kunststoff-Formteil hergestellt sein. Als Materialien für die Kunststoffkapsel 10 beispielsweise Polyvinylchlorid (PVC), Polyethylenterephthalat (PET) oder orientiertes Polystyrol (OPS) möglich. Die Verschlusskapsel 10 kann transparent oder intransparent gestaltet sein oder bereichsweise jeweils transparent und intransparent. Soweit sie intransparent ist, kann eine auf dem Gefäß oder seinem Gefäßdeckel selbst (etwa einer Vial-Kappe) angeordneter ID-Code (sei es als RFID-Chip mit elektronischem Schlüssel, als visueller ID-Code oder als sonstige Markierung) bis zum Öffnen und Entfernen der Verschlusskapsel 10 verdeckt werden und dadurch zunächst verborgen bleiben.The
Die Verschlusskapsel 10 umfasst weiterhin einen Aufreißstreifen 20. Dieser Aufreißstreifen 20 kann entweder als separates Teil in die Verschlusskapsel 14 integriert werden. In diesem Fall kann der Aufreißstreifen 20 beispielsweise durch eine streifenförmige Kunststofffolie, einen Faden oder Ähnliches ausgeführt sein.The
Alternativ kann der Aufreißstreifen 20 als ein Teil der Verschlusskapsel 10 selbst ausgeführt sein. In diesem Fall kann der Aufreißstreifen 20 beispielsweise mittels Perforation oder einer ähnlich gestalteten Einstanzung von der übrigen Verschlusskapsel 10 abgetrennt werden.Alternatively, the
In jedem Fall besitzt der Aufreißstreifen 20 ein freies Ende 21. Dieses freie Ende 21 kann von der Verschlusskapsel 10 abgelöst werden und dient als Anfasslasche. Zum späteren Öffnen des Verschlusselements kann ein Benutzer somit die Anfasslasche 21 greifen, daran ziehen und so die Verschlusskapsel 10 öffnen.In any case, the
Unabhängig von der Anordnung des Aufreißstreifens 20 an der Verschlusskapsel 10, kann die Verschlusskapsel 10 neben der oben bereits beschriebenen zylinderförmigen Anordnung auch eine von zahlreichen anderen Formen besitzen.Regardless of the arrangement of the
Die
Darüber hinaus können die Kapseln wie in den
Zur Herstellung in der gewünschten Form für die Kapsel 10 kann diese Kapsel bereits von Beginn an in der gewünschten Form hergestellt werden und steht dann in dieser Form auch für den Verschluss des Gefäßes zur Verfügung. Alternativ kann die Kapsel jedoch auch in einem thermisch verformbaren oder thermisch schrumpfbaren Material hergestellt werden und erst zu einem späteren Zeitpunkt durch Wärmeeinwirkung in die gewünschte Form gebracht werden, wie dies beispielsweise in
Zum Versiegeln des Gefäßes 40 wird zunächst eine Verschlusskapsel 10 über die Öffnung 41 gestülpt. Anschließend wird ein Etikett 30 so um den Flaschenhals 43 herumgewickelt und aufgeklebt, dass es in einem ersten Bereich 39 mit der Kapsel 10 und in einem zweiten Teilbereich 38 mit dem Flaschenhals 43 verbunden ist. Somit ist die Verschlusskapsel 10 über das Etikett 30 fest mit dem Gefäß 40 verbunden und kann nicht mehr abgenommen werden, ohne das Etikett 30 zu zerstören.To seal the
Da das Gefäß 40 im unteren Bereich 44 in der Regel einen größeren Umfang besitz, kann bei dieser Ausführungsform auch ein größeres Etikett 30 angebracht werden. Somit steht auch eine größere Fläche für die Kennzeichnung des Gefäßes 40 zur Verfügung.Since the
Bei den in Zusammenhang mit den
sowohl den größeren Umfang der Verschlusskapsel 10 als auch den kleineren Umfang des Gefäßes 40 überdeckt, könnte es zu einer Faltenbildung des Etiketts 30 kommen.
Covering both the larger circumference of the
Um dieser Faltenbildung entgegenzuwirken, kann in dem unteren Bereich 36 des Etiketts 30 eine weitere Materiallage 33 auf der Unterseite 31 a aufgebracht werden, wobei die Materiallage 33 annähernd die gleiche Dicke d2 hat wie die Dicke d1 der Mantelfläche 13 der Verschlusskapsel.To counteract this wrinkling, in the
Die Schwächungslinien 15 in der Mantelfläche 13 enden alle an einer Randlinie 14 am unteren Rand, an dem die Mantelfläche 13 an das offene Ende 12 der Verschlusskapsel 10 übergeht. Auf diese Weise bilden sich an den Schnittpunkten zwischen dieser Randlinie 14 und den Endpunkten der Schwächungslinien 15 Startpunkte, an denen ein besonders leichtes Einreisen der Verschlusskapsel 10 möglich ist.The lines of
Als Schwächungslinien 15 sind beispielsweise Perforationen möglich. Alternativ ist auch eine partielle Einstanzung, d.h. eine Einstanzung, die das Folienmaterial der Verschlusskapsel 10 nur teilweise durchdringt, möglich.As lines of
Das Etikett 30 ist auch in diesem Fall auf einer Seite mit einem Klebstoff versehen. Dabei kann das Etikett entweder auf dieser Seite vollflächig mit Klebstoff beschichtet sein oder alternativ auch nur in Teilbereichen.The
Weiterhin umfasst das Etikett 30 mehrere Schwächungslinien 35. Die Schwächungslinien 35 enden dabei jeweils an zwei sich gegenüberliegenden Außenkanten des Etiketts 30. Auf diese Weise bildet sich zwischen den Schwächungslinien 35 ein Aufreißstreifen 34.Furthermore, the
Bei den Schwächungslinien 35 kann es sich beispielsweise um Perforationen handeln. Alternativ ist auch beispielsweise eine nur partielle Einstanzungen in das Etikett 30 möglich.The weakening lines 35 may be, for example, perforations. Alternatively, for example, only a partial punching in the
Das Etikett 30 kann ferner eine Anfasslasche 31 umfassen. Diese Anfasslasche 31 kann beispielsweise als Fortsetzung des Etiketts an einem Teilbereich einer Außenkante ausgeführt sein. Die Anfasslasche befindet sich dabei beispielsweise entlang eines Bereiches einer Außenkante, der von zwei Schwächungslinien 35 begrenzt wird.The
Um diese Anfasslasche 31 besser greifen zu können, ist die Anfasslasche im Gegensatz zu dem übrigen Etikett 30 auf der Unterseite nicht klebend ausgeführt. Hierzu kann entweder erst gar kein Klebstoff an der Anfasslasche aufgebracht werden. Alternativ kann ein zuvor aufgetragene Klebstoff durch Auftragen einer geeigneten Substanz abgeschwächt oder neutralisiert werden.In order to better grip this
Wird nun eine zuvor beschriebene Verschlusskapsel 10 mit Schwächungslinien 15 auf einem Gefäß angebracht und dieses dann mit einem Etikett 30 verklebt, das ebenfalls die oben beschriebenen Schwächungslinien 35 aufweist, so verlaufen bei dieser Anordnung die Schwächungslinien 15 der Kapsel 10 als auch die Schwächungslinien 35 des Etiketts 30 annähernd parallel zu der in den
Um die Kapsel 10 abnehmen zu können und so an den Verschluss 42 des Gefäßes 40 zu gelangen, muss zuvor das Etikett 30 geöffnet werden. Dies geschieht dadurch, dass ein Benutzer die Anfasslasche 31 greift und daran zieht. Dabei reißt das Etikett 30 zunächst entlang der Schwächungslinien 35 ein. Somit wird das Etikett 30 unwiderruflich zerstört und kann nicht erneut verwendet werden.In order to be able to remove the
Da das Etikett 30 auch gleichzeitig mit der Kapsel 10 verbunden ist, wird während des Öffnungsvorgangs beim Ziehen an der Anfasslasche 31 auch die Kapsel 10 entlang der Schwächungslinien 15 einreisen. Daher wird auch die Verschlusskapsel 10 während des Eröffnungsvorgangs irreversibel zerstört werden.Since the
Da bei allen Ausführungsformen sowohl die Kapsel 10 als auch das Etikett 30 bei dem Öffnungsvorgang irreversibel zerstört werden, können diese Teile kein weiteres Mal verwendet werden, um das Gefäß erneut zu verschließen. Ein so zerstörtes Verschlusselement kann von einem Benutzer leicht erkannt werden, so dass eine betrügerische Wiederverwendung ausgeschlossen ist.Since in all embodiments both the
Weiterhin können in der Verschlusskapsel 10 und/oder in dem Etikett 30 weitere Sicherheitsmerkmale integriert werden. So kann ein Manipulationsversuch sehr wirkungsvoll nachgewiesen werden. Beispielsweise kann als weiteres Sicherheitsmerkmal ein Hologramm eingesetzt werden. Auch spezielle Druckfarben, die sensitiv auf Lichteinfall oder Wärme reagieren, können als zusätzliche Sicherheitsmerkmale eingesetzt werden. Weitere geeignete Sicherheitsmerkmale sind ebenso möglich.Furthermore, 30 further security features can be integrated in the
Zusammenfassend wird ein für ein Gefäß bestimmtes Verschlusselement bereitgestellt, das bei einem ersten Öffnungsversuch irreversibel zerstört wird. Das Verschlusselement umfasst z.B. eine Kunststoffkapsel, mit der die Öffnung des Gefäßes verschlossen wird, ein Etikett, mit dem die Kunststoffkapsel an dem Gefäß fixiert wird sowie einen Aufreißstreifen, mit dessen Hilfe das Verschlusselement geöffnet, insbesondere die Kapsel entfernt werden kann, um die Öffnung des Gefäßes freizugeben. Da das Verschlusselement beim erstmaligen Öffnen irreversibel zerstört wird, kann das Verschlusselement nicht wieder verwendet werden, um beispielsweise ein gefälschtes Produkt mit einem Originalverschlusselement zu versiegeln.In summary, a closure element intended for a vessel is provided, which is irreversibly destroyed in a first opening attempt. The closure element comprises e.g. a plastic capsule, with which the opening of the vessel is closed, a label, with which the plastic capsule is fixed to the vessel and a tear strip, with the aid of the closure element can be opened, in particular the capsule can be removed to release the opening of the vessel. Since the closure element is irreversibly destroyed when first opened, the closure element can not be reused, for example, to seal a counterfeit product with an original closure element.
Die
Die
Die
Die Verschlusskapsel 10 mit einer Nut 18 kann auch an (vorgefüllte) Spritzen angebracht werden. Alternativ oder ergänzend kann die Verschlusskapsel 10 auch durch thermisches Aufschrumpfen fixiert werden.The
Die
Gemäß
Das in
Die
Die
Die
Die Ausführungsbeispiele dieser Anmeldung bieten einen wirksamen Erstöffnungsschutz und Kopierschutz. Beim Öffnen des Verschlusselements wird nicht nur das Gefäß zugänglich, sondern auch das Verschlusselement, insbesondere dessen Etikett und ggfs. ebenso ein Identifikationsmittel (etwa ein RFID-Chip mit Antenne und/oder ein visueller ID-Code; ggfs. auch ein Void-Bereich oder ein Verschlusssiegel) sichtbar und irreversibel zerstört und unbrauchbar gemacht. Ferner wird die elektronische oder ansonsten visuelle Codierung des individuellen Gefäßes bzw. seine visuelle oder elektronische Erkennungsfunktion irreversibel zerstört.The embodiments of this application provide effective Erstöffnungsschutz and copy protection. When opening the closure element not only the vessel is accessible, but also the closure element, in particular its label and, if necessary, as well as an identification means (such as an RFID chip with antenna and / or a visual ID code, if necessary, also a void area or a closure seal) visibly and irreversibly destroyed and rendered useless. Further the electronic or otherwise visual coding of the individual vessel or its visual or electronic detection function is destroyed irreversibly.
Das Verschlusselement für das Gefäß braucht nicht notwendigerweise den größten Umfang des Gefäßes zu umschließen (wie etwa in
Das Verschlusselement kann beispielsweise für ein Gefäß vorgesehen bzw. geformt sein, welches sich nach oben hin verengt und beispielsweise ähnlich wie in den
Das Verschlusselement kann weiterhin zum Aufkleben auf ein Gefäß mit einem Übergangsbereich, in dem der Gefäßdurchmesser bzw. äußere Gefäßumfang von demjenigen des Gefäßhalses auf denjenigen des Gefäßbauchs ansteigt, ausgebildet sein. Insbesondere kann das Verschlussetikett zum Anbringen, insbesondere Ankleben an den Übergangsbereich (statt des Kopfbereichs) gestaltet sein. In diesem Fall kann ein unterer bzw. äußerer Teil der Etikettenfläche (alternativ oder zusätzlich auch ein unterer Teil der Verschlusskapsel selbst; vgl.
So wie die
Vorzugsweise ist der Aufreißstreifen ein Bestandteil der Verschlusskapsel, d.h. er bildet einen Teil eines einstückigen Formteils (vorzugsweise aus Kunststoff), aus welchem die Verschlusskapsel und der Aufreißstreifens gemeinsam geformt sind.Preferably, the tear strip is a component of the closure capsule, ie it forms part of a one-piece molded part (preferably made of plastic), from which the closure capsule and the tear strip are formed together.
Der Aufreißstreifen 20 bildet damit zumindest bis zum Aufreißen oder Abreißen einen Materialteil, der entlang des gesamten oder jedenfalls überwiegenden Abschnitts des Außenumfangs mit einem größeren und vorzugsweise auch massiveren Teil der Verschlusskapsel 10 zumindest abschnittsweise verbunden ist.The
Weiterhin ist das Verschlusselement der Ausführungsbeispiele der Anmeldung vorzugsweise so ausgebildet, dass mit dem Aufreißen des Aufreißstreifens das Etikett durchtrennt und zerstört wird; insbesondere in der Weise, dass ein oder gleich mehrere, vorzugsweise mehrere unterschiedliche Identifikationsmittel, etwa ein RFID-Chip, eine Antenne für einen RFID-Chip und/oder ein visueller ID-Code (etwa ein QR-Code) durchtrennt, beschädigt oder anderweitig unbrauchbar gemacht und/oder verändert werden. Somit wird beim Aufreißen des Aufreißstreifens zumindest auch das Verschlussetikett zerstört oder zumindest soweit irreversibel beschädigt, dass der Versuch einer Wiederherstellung oder eine unbefugte Wiederverwendung leicht erkennbar ist.Furthermore, the closure element of the embodiments of the application is preferably designed so that with the tearing open of the tear strip the label is severed and destroyed; in particular in such a way that one or more than one, preferably a plurality of different identification means, such as an RFID chip, an antenna for an RFID chip and / or a visual ID code (such as a QR code) cuts, damages or otherwise unusable made and / or changed. Thus, when tearing open the tear strip, at least the closure label is destroyed or at least so far irreversibly damaged that the attempt to restore or unauthorized reuse is easily recognizable.
Der Aufreißstreifen kann schließlich bei allen Ausführungsformen auch als Abreißstreifen ausgebildet sein, d.h. mit dem übrigen Teil der Verschlusskapsel 10 so zusammenhängen, dass er beim Abziehen in der Regel vollständig abreißt.Finally, in all embodiments, the tear strip can also be designed as a tear-off strip, ie connected with the remaining part of the
- 11
- RFID-ChipRFID chip
- 2; 2a, 2b, 2c2; 2a, 2b, 2c
- Antenneantenna
- 33
- Umfangsflächeperipheral surface
- 55
- visueller ID-Codevisual ID code
- 1010
- VerschlusskapselA closure cap
- 1111
- oberes Endetop end
- 1212
- unteres Endelower end
- 1313
- Mantelflächelateral surface
- 1414
- Randlinieboundary line
- 1515
- Schwächungslinieweakening line
- 1616
- Stirnflächeface
- 1717
- Riffelungknurl
- 1818
- Nutgroove
- 1919
- Beschriftunglabeling
- 2020
- Aufreißstreifentear
- 2121
- Anfasslaschegrip tab
- 2222
- Teilabschnittpart Of
- 2323
- Trennlinieparting line
- 2424
- VOID-BereichVOID area
- 2525
- Abschirmelementshielding
- 2626
- ÜberetikettAbout label
- 3030
- Etikettlabel
- 3131
- Substratsubstratum
- 31a31a
- Unterseitebottom
- 3232
- Klebstoffadhesive
- 3333
- Materiallagematerial layer
- 3434
- Einstanzunginlaying
- 3535
- Schwächungslinieweakening line
- 3636
- unterer Bereichlower area
- 3737
- Einbuchtungindentation
- 3838
- erster Teilbereichfirst subarea
- 3939
- zweiter Teilbereichsecond subarea
- 4040
- Gefäßvessel
- 4141
- Öffnungopening
- 4242
- Verschlussshutter
- 4343
- Flaschenhalsbottleneck
- 4444
- Flaschenkörperbottle body
- 4545
- Gefäßkappevessel cap
- 5050
- weitere Verschlusskapseladditional capsule
- 5151
- Schaumschichtfoam layer
- 100100
- Stempelstamp
- 300300
- Sprühflaschespray bottle
- 301301
- Sprühkopfspray nozzle
- 400400
- Injektionsspritzesyringe
- 401401
- Injektionsnadelinjection needle
- d1, d2d1, d2
- Dickethickness
Claims (17)
- A closure element on a container comprising a pharmaceutical content, the closure element comprising:- a closure capsule (10) covering an opening of the container,
the closure capsule (10) comprising a lateral surface (13), a closed end (11) and an open end (12),- a tear strip (20) comprising a grip tab (21) for opening the closure capsule (10) and- a label (30) of the closure, comprising a web-shaped substrate (31) which has its underside (31a) provided with an adhesive (32),characterized in that
the closure element is attached to the container such that a first partial area (38) of the label (30) is arranged on the container and a second partial area (39) of the label (30) is arranged on the closure capsule (10) and the tear strip (20) such that the grip tab (21) of the tear strip (20) is not covered by the label (30). - The closure element according to claim 1, wherein the closure capsule (10) is rotationally symmetrical, preferably cylindrical and in particular circularly cylindrical.
- The closure element according to claim 1 or 2, wherein the tear strip (20) extends in the circumferential direction along the lateral surface (13) of the closure capsule (10).
- The closure element according to claim 1 or 2, wherein the tear strip (20) extends so as to be parallel to a symmetry axis of the closure capsule (10).
- The closure element according to any of claims 1 to 4, wherein the tear strip (20) is implemented as a part of the closure capsule (10) or of the label (30), for instance as an inlay of the label (30).
- The closure element according to any of claims 1 to 5, wherein the tear strip (20) is realized as a separate part which is preferably arranged between the label (30) and the closure capsule (10).
- The closure element according to any of claims 1 to 6, wherein the label (30) comprises weakening lines (35), for instance in the form of notches, punchings (34) or perforations, at least some of the weakening lines (35) ensuring an exact crack formation through the label (30) when the tear strip (20) is torn open.
- The closure element according to any of claims 1 to 7, wherein the grip tab (21) of the tear strip (20) is exposed in the area of an indentation (37) or other kind of recess of the label (30).
- The closure element according to any of claims 1 to 8,
wherein the grip tab (21) of the tear strip (20) is folded or angled in other way and thereby extends along a symmetry axis of the closure capsule (10) so as to be exposed, whereas a major part of the tear strip (20) extends azimuthally along the lateral surface (13) the closure capsule (10). - The closure element according to any of claims 1 to 9, wherein the closure element comprises an RFID chip (1), in particular a passive RFID chip (1) for storing an electronically encrypted ID code.
- The closure element according to any of claims 1 to 10,
wherein the closure capsule (10) is made from a plastic foil. - The closure element according to any of claims 1 to 11,
wherein the closure element comprises a further closure capsule (50) which is connected to the label (30). - The closure element according to claim 12,
wherein at least one of the two closure capsules (10; 50) comprises a shock-absorbing plastic layer, in particular a foam layer (51), on a bottom surface or end surface. - A container (40) comprising a pharmaceutical content,
characterized in that the container (40) is provided with a closure element according to any of claims 1 to 13, which closes the container (40). - The container according to claim 14, wherein the container (40) comprises a bottleneck (43) and a bottle body (44), the label (30) being attached to the bottle body.
- The container according to claim 14, wherein the container (40) is a spray bottle (300) or an injection syringe (400), wherein the closure capsule (10) surrounds in axial direction, in particular in the discharge direction of the pharmaceutical content, and secures a spray head (301) of the spray bottle (300) and its protective cap or, respectively, an injection needle (401) of the injection syringe (400) and its protective cap.
- The container according to claim 14 or 15, wherein the container (40) is a vial or an ampoule, a reservoir bottle, a tablet bottle or any other bottle comprising or being provided for a pharmaceutical content, in particular comprising or being provided for a pharmaceutical liquid.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE201210104062 DE102012104062A1 (en) | 2012-05-09 | 2012-05-09 | Closure element for vessel filled with pharmaceutical content, has tear strip that is arranged so that the grip tab of tear strip from label is not covered |
| DE201210112297 DE102012112297A1 (en) | 2012-12-14 | 2012-12-14 | Closure element for e.g. syringe with medicament, has label including partial region arranged on vessel, and another partial region arranged on closure capsule and tear-open strip so that grip lug is not covered by label |
| PCT/EP2013/059669 WO2013167701A1 (en) | 2012-05-09 | 2013-05-08 | Closure element for a receptacle |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP2847082A1 EP2847082A1 (en) | 2015-03-18 |
| EP2847082B1 true EP2847082B1 (en) | 2016-09-14 |
Family
ID=48326318
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP13721352.6A Active EP2847082B1 (en) | 2012-05-09 | 2013-05-08 | Closure element for a receptacle |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US10035624B2 (en) |
| EP (1) | EP2847082B1 (en) |
| CN (2) | CN104395197A (en) |
| BR (1) | BR112014027704B1 (en) |
| CA (1) | CA2872759C (en) |
| RU (1) | RU2622806C2 (en) |
| WO (1) | WO2013167701A1 (en) |
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| WO2020200706A1 (en) * | 2019-03-29 | 2020-10-08 | Schreiner Group Gmbh & Co. Kg | Identification kit for identifying a pharmaceutical vessel, and pharmaceutical packaging unit |
| WO2024160624A1 (en) * | 2023-01-30 | 2024-08-08 | Schreiner Group Gmbh & Co. Kg | Label, system and method for applying a label to a multi-part container |
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- 2013-05-08 CA CA2872759A patent/CA2872759C/en active Active
- 2013-05-08 US US14/399,583 patent/US10035624B2/en active Active
- 2013-05-08 CN CN201910132717.4A patent/CN109941568B/en active Active
- 2013-05-08 BR BR112014027704-4A patent/BR112014027704B1/en not_active IP Right Cessation
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2020200706A1 (en) * | 2019-03-29 | 2020-10-08 | Schreiner Group Gmbh & Co. Kg | Identification kit for identifying a pharmaceutical vessel, and pharmaceutical packaging unit |
| US12153981B2 (en) | 2019-03-29 | 2024-11-26 | Schreiner Group Gmbh & Co. Kg | Labeling set for marking a pharmaceutical vessel and pharmaceutical packaging unit |
| WO2024160624A1 (en) * | 2023-01-30 | 2024-08-08 | Schreiner Group Gmbh & Co. Kg | Label, system and method for applying a label to a multi-part container |
Also Published As
| Publication number | Publication date |
|---|---|
| BR112014027704B1 (en) | 2021-04-27 |
| CN109941568B (en) | 2021-12-07 |
| CN104395197A (en) | 2015-03-04 |
| US20150090625A1 (en) | 2015-04-02 |
| US10035624B2 (en) | 2018-07-31 |
| RU2622806C2 (en) | 2017-06-20 |
| EP2847082A1 (en) | 2015-03-18 |
| BR112014027704A2 (en) | 2017-06-27 |
| RU2014149346A (en) | 2016-06-27 |
| WO2013167701A1 (en) | 2013-11-14 |
| CA2872759A1 (en) | 2013-11-14 |
| CN109941568A (en) | 2019-06-28 |
| CA2872759C (en) | 2020-04-21 |
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