DE202005014444U1 - Container used as a pharmaceutical preparation has a predetermined breaking point which is completely surrounded by a film - Google Patents
Container used as a pharmaceutical preparation has a predetermined breaking point which is completely surrounded by a film Download PDFInfo
- Publication number
- DE202005014444U1 DE202005014444U1 DE200520014444 DE202005014444U DE202005014444U1 DE 202005014444 U1 DE202005014444 U1 DE 202005014444U1 DE 200520014444 DE200520014444 DE 200520014444 DE 202005014444 U DE202005014444 U DE 202005014444U DE 202005014444 U1 DE202005014444 U1 DE 202005014444U1
- Authority
- DE
- Germany
- Prior art keywords
- film
- container according
- container
- breaking point
- predetermined breaking
- 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.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
- A61J1/065—Rigid ampoules, e.g. glass ampoules
-
- 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
- B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
- B65D1/02—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
- B65D1/0223—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by shape
- B65D1/023—Neck construction
- B65D1/0238—Integral frangible closures
-
- 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
- B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
- B65D1/09—Ampoules
-
- 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
Landscapes
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Health & Medical Sciences (AREA)
- Ceramic Engineering (AREA)
- Hematology (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Description
Die vorliegende Erfindung betrifft einen Behälter mit mindestens einer Sollbruchstelle. Insbesondere betrifft sie einen pharmazeutischen Behälter mit mindestens einer Sollbruchstelle.The The present invention relates to a container with at least one predetermined breaking point. In particular, it relates to a pharmaceutical container with at least one predetermined breaking point.
Derartige Behälter werden im pharmazeutischen Anwendungsbereich üblicherweise dazu verwendet, um vorzugsweise flüssige Arzneimittel wie beispielsweise Injektionsflüssigkeiten luftdicht zu verpacken. Die Sollbruchstelle dient dem definierten Öffnen des Behälters. Üblicherweise werden solche Behälter aus Glas und in Form von Ampullen oder Vials bereitgestellt.such container are commonly used in the pharmaceutical field of application, preferably liquid Packing medicines such as injection fluids airtight. The predetermined breaking point serves for the defined opening of the container. Usually become such containers made of glass and in the form of ampoules or vials.
Wird
ein derartiger Behälter
vom Endverbraucher – im
Klinikbereich vom behandelnden Personal und im Privatgebrauch vom
Patienten selbst – geöffnet, entsteht
an der Sollbruchstelle eine scharte Kante. Diese Kante kann bei
unsachgemäßer oder ungeschickter Öffnung in
Teilbereichen spitz und unregelmäßig sein.
Es ergeben sich eine erhöhte
Verletzungsgefahr für
die Person, die mit dem Behälter umgeht,
und hierdurch verschiedenartige Gefährdungen für Behandelnden und Patient:
Einerseits
können
durch Schnitt- oder Stichverletzungen Keime und Inhaltsstoffe des
Arzneimittels in den Organismus der behandelnden Person gelangen.
Bei hochdosierten und potenziell toxischen Medikamenten stellt dies
eine nicht unerhebliche Gefahr für
die behandelnde Person dar. Andererseits können auch Keime und Blut in
das Medikament gelangen, wodurch sich wiederum Infektionsrisiken
für den
Patienten ergeben.If such a container by the end user - in the clinic by the treating staff and in private use by the patient - opened, created at the breaking point a sharp edge. This edge can be pointed and irregular in case of improper or clumsy opening in some areas. There is an increased risk of injury to the person handling the container and thereby various hazards to the treating and patient:
On the one hand, germs and ingredients of the drug can get into the organism of the treating person by cutting or stab wounds. In high-dose and potentially toxic drugs, this represents a significant risk to the person treating. On the other hand, germs and blood can enter the drug, which in turn result in infection risks for the patient.
Aufgabe dieser Erfindung ist es daher, einen Behälter mit Sollbruchstelle bereitzustellen, dessen Verletzungsgefährlichkeit deutlich reduziert ist. Weiterhin ist es Aufgabe der Erfindung, ein kostengünstiges Produkt bereitzustellen, das diese Anforderungen erfüllt.task of this invention is therefore to provide a container with predetermined breaking point, its injury hazard is significantly reduced. Furthermore, it is an object of the invention a cost-effective To provide a product that meets these requirements.
Die Aufgabe wird mit einem Behälter gemäß Anspruch 1 gelöst. Besonders bevorzugte Ausführungsformen finden sich in den Folgeansprüchen.The Task is with a container according to claim 1 solved. Particularly preferred embodiments can be found in the following claims.
Die Lösung der Aufgabe besteht darin, dass die Sollbruchstelle des Behälters mit einer umlaufenden Folie geschützt wird. Vorzugsweise liegt diese Folie direkt am Behälter an und ist aus besonders reiß- und schnittfestem Material ausgebildet.The solution the task is that the breaking point of the container with protected by a rotating film becomes. Preferably, this film is directly on the container and is made of particularly tear- and cut resistant material formed.
Im folgenden werden anhand der Figuren besonders bevorzugte Ausführungsformen der Erfindung näher erläutert. Die Zeichnungen sind nicht maßstabsgetreu und rein schematisch zu verstehen. Es zeigenin the The following will be particularly preferred embodiments with reference to the figures closer to the invention explained. The drawings are not to scale and to understand purely schematically. Show it
In
In
In
Während der
Behälter
in
In
Der
Effekt, den diese Folie bewirkt, ist in
Das Wirkprinzip dieser Erfindung (der Schutz vor Schnitt- und Stichverletzungen durch den offen liegenden Öffnungsrand) kommt unter einigen Voraussetzungen besonders gut zur Geltung: Vorzugsweise ist die Folie möglichst schnitt- und knickfest und weist mindestens eine Dicke von 20 μm auf, vorzugsweise mindestens 40 μm. Als besonders geeignet haben sich Folien aus Polyvinylchlorid (PVC) und Polyethylentherephthalat (PET) erwiesen. Weitere mögliche Materialien sind Polypropylen (PP), (biaxial) orientiertes Polystyrol (OPS) oder Polyethylen (PE).The working principle of this invention (the protection before cutting and stab wounds through the exposed opening edge) is particularly well under some conditions to advantage: Preferably, the film as possible cut and kink resistant and has at least a thickness of 20 microns, preferably at least 40 microns. Particularly suitable films of polyvinyl chloride (PVC) and polyethylene terephthalate (PET) have been found. Other possible materials are polypropylene (PP), (biaxially) oriented polystyrene (OPS) or polyethylene (PE).
Im pharmazeutischen Anwendungsbereich ist weiterhin üblicherweise gefordert, dass von den Verpackungsteilen eines Medikaments keine Verschmutzungsrisiken für das Medikament ausgehen. Daher ist eine besonders bevorzugte Ausführungsform der Folie, dass sie im Bereich der Sollbruchstelle unterseitig nichtklebend ausgeführt ist. Dies kann beispielsweise mit sogenannten Schrumpf-Folien erreicht werden, die als Hülse auf den Behälter aufgeschrumpft werden. Dies kann entweder durch Hitzeschrumpfen erfolgen, d.h. durch Zusammenziehen der Folien unter Einfluß höherer Temperaturen oder durch Kaltschrumpfen. Beim Kaltschrumpfen handelt es sich um ein Verfahren, bei dem eine Folie vor der Applikation gedehnt wird und danach auf den Mantel des Behälters zurückschrumpft. Statt des Einflusses von Hitze sind auch andere Schrumpfungsmethoden, beispielsweise durch Bestrahlung oder chemische Einflüsse, möglich. Im Falle der Anwendung von Schrumpf-Folien ist eine unterseitige Klebstoffbeschichtung grundsätzlich nicht notwendig; sie kann jedoch in Teilbereichen (nicht jedoch im Bereich der Sollbruchstelle) angewandt werden, um eine sichere Fixierung der Folie auf dem Behälter zu gewährleisten. Die Schrumpfeigenschaften der Folie sind so zu wählen, dass beim Schrumpfen auftretende Belastungen des Glaskörpers nicht zu dessen Schwächung führen. Ebenso darf die aufgeschrumpfte Folie den Anwender nicht beim Öffnen des Behälter hindern, etwa weil eine zu starre Folie verwendet wird.in the pharmaceutical field of application is still usually required, that from the packaging parts of a drug no pollution risks for the Drug go out. Therefore, a particularly preferred embodiment the film that they are non-adhesive in the area of the predetermined breaking point underside accomplished is. This can be achieved for example with so-called shrink films be that as a sleeve on the container shrunk. This can be done either by heat shrinking take place, i. by contraction of the films under the influence of higher temperatures or by cold shrinking. Cold shrinkage is about a method in which a film is stretched before application and then shrink back onto the jacket of the container. Instead of the influence of Heat is also other shrinking methods, for example by Irradiation or chemical influences, possible. In the case of the application of shrink films is an underside Adhesive coating in principle unnecessary; however, it may be in subareas (not, however in the area of the predetermined breaking point) to secure fixation the foil on the container to ensure. The shrinkage properties of the film should be selected so that when shrinking occurring loads of the glass body does not lead to its weakening. As well The shrunk-on film must not cause the user to open the film container prevent, for example, because a too rigid film is used.
In
Durch
die gleichzeitige Verwendung der Folie als Kennzeichnungs- oder Informationsetikett
lassen sich in der Regel zwei Herstellungsprozesse verbinden: Die
ohnehin notwendige Kennzeichnung wird mit Hilfe einer bedruckten
schützenden
Folie erreicht, anstatt dass zunächst
etikettiert und danach die Schutzfolie appliziert wird. Dies bedeutet,
dass die Herstellungskosten für
den Behälter
gemäß
Claims (19)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE200520014444 DE202005014444U1 (en) | 2005-09-13 | 2005-09-13 | Container used as a pharmaceutical preparation has a predetermined breaking point which is completely surrounded by a film |
PCT/EP2006/066238 WO2007031495A1 (en) | 2005-09-13 | 2006-09-11 | Protected container having a predetermined breaking point |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE200520014444 DE202005014444U1 (en) | 2005-09-13 | 2005-09-13 | Container used as a pharmaceutical preparation has a predetermined breaking point which is completely surrounded by a film |
Publications (1)
Publication Number | Publication Date |
---|---|
DE202005014444U1 true DE202005014444U1 (en) | 2005-11-17 |
Family
ID=35433734
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE200520014444 Expired - Lifetime DE202005014444U1 (en) | 2005-09-13 | 2005-09-13 | Container used as a pharmaceutical preparation has a predetermined breaking point which is completely surrounded by a film |
Country Status (2)
Country | Link |
---|---|
DE (1) | DE202005014444U1 (en) |
WO (1) | WO2007031495A1 (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102007056462B4 (en) * | 2007-11-23 | 2011-10-27 | Pari Pharma Gmbh | Disposable ampoule for a device for generating aerosols |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4826025A (en) * | 1986-11-21 | 1989-05-02 | Toppan Printing Co., Ltd. & Mect Corp. | Ampoule package |
US5076613A (en) * | 1990-04-04 | 1991-12-31 | Kovacs George W | Label or package construction incorporating hidden indicia game |
FR2687066A1 (en) * | 1992-02-06 | 1993-08-13 | Oreal | Auto-breakable ampoule |
JPH1017018A (en) * | 1996-07-01 | 1998-01-20 | Toppan Printing Co Ltd | Composite container having handle |
WO1998025834A1 (en) * | 1996-12-10 | 1998-06-18 | Sleever International Company | Sleeve-type envelope of heat-shrinkable plastic material for packaging at least one item |
DE19843561A1 (en) * | 1998-09-23 | 2000-03-30 | Weimar Pharma Gmbh | Glass ampoule surrounded by electrostatically charged plastic film casing with intentional break points near constriction, reduces probability of injury, prevents leakage of contents and immobilizes glass splinters at source |
-
2005
- 2005-09-13 DE DE200520014444 patent/DE202005014444U1/en not_active Expired - Lifetime
-
2006
- 2006-09-11 WO PCT/EP2006/066238 patent/WO2007031495A1/en active Application Filing
Also Published As
Publication number | Publication date |
---|---|
WO2007031495A1 (en) | 2007-03-22 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
R207 | Utility model specification |
Effective date: 20051222 |
|
R150 | Term of protection extended to 6 years |
Effective date: 20081103 |
|
R151 | Term of protection extended to 8 years | ||
R151 | Term of protection extended to 8 years |
Effective date: 20110921 |
|
R152 | Term of protection extended to 10 years |
Effective date: 20130918 |
|
R071 | Expiry of right |