EP1447327A2 - Method for identifying and/or monitoring of medical syringes - Google Patents

Method for identifying and/or monitoring of medical syringes Download PDF

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Publication number
EP1447327A2
EP1447327A2 EP03027587A EP03027587A EP1447327A2 EP 1447327 A2 EP1447327 A2 EP 1447327A2 EP 03027587 A EP03027587 A EP 03027587A EP 03027587 A EP03027587 A EP 03027587A EP 1447327 A2 EP1447327 A2 EP 1447327A2
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European Patent Office
Prior art keywords
syringes
reading
labeling
syringe
batch
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EP03027587A
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German (de)
French (fr)
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EP1447327B1 (en
EP1447327A3 (en
Inventor
Udo J. Vetter
Helmut Hennig
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Apotheker Vetter and Company Arzneimittel GmbH Ravensburg
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Apotheker Vetter and Company Arzneimittel GmbH Ravensburg
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003Filling medical containers such as ampoules, vials, syringes or the like

Definitions

  • the invention relates to a method for identification and / or monitoring medical syringes, especially pre-filled syringes and cartridges, during the production process or for later Assignment to a production batch using a machine-readable labeling. Furthermore, the Invention a device for carrying out the Process.
  • the invention is therefore based on the object to improve such a process so that during the entire manufacturing process, i.e. starting at Cleaning, filling, sterilization and packaging as well then a check when applying the syringe and Verification of belonging to the current one Batch and a clear assignment to the contained Active ingredient and others in this context essential data is possible.
  • This problem is solved by a method in which first preferably the syringe barrel with the Caption is provided, which is a unique Identification regarding product, batch, dosage, Filling and expiry date enabled, and at which then a test reading with subsequent separation of the Syringes with not or only partially readable or one non-batch labeling.
  • the advantage achieved by the invention is essential in that on the syringe machine-readable labeling is applied, which contains all product-specific data, so that on the one hand, such syringe cylinders are recognized and in the Episode can be discarded that - unintentionally or faulty - got into the production process, on the other hand, it is ensured that ultimately at final packaging of the syringe with such exactly the content shown on the packaging is in it.
  • the Labeling using redundant coding whereby a determination of the remaining by the test reading Redundancy is made and depending on that The syringes are discarded. This has the advantage that even some damage to the lettering Scope nevertheless clear identification possible is.
  • Attach the lettering immediately at the beginning of the Production process or to a suitable later Production or assembly step takes place.
  • the Attachment allowed at the beginning of the production process complete monitoring and, if necessary, one Tracing back to previous ones Cleaning processes.
  • the label is visible in daylight or applied invisibly.
  • the selection of im Appropriate labeling depends on the individual case the respective existing specifications, one for example, only legible labeling under UV light a correspondingly higher technical effort.
  • Lettering must be printed.
  • the possibility that the inscription by means of a laser is branded, but basically also more Labeling processes are conceivable.
  • the code can be made Space constraints one or more times during application to be shared. It is then recognized by the system assembled into a code.
  • a further increase in the detection security can be achieved in that the rotational speed the syringes during the reading process in synchronism with the Image recording frequency of the optical recording system is.
  • a device-solving task Device is characterized by a single lane or multi-lane transport device for the syringes, over which are fed to a reading station, the Reading station a rotating device for the syringes as well at least one optical recording system for detecting the has coding applied to the syringes, further through a separator, which the Corresponding syringes in transit the recorded coding and evaluation in a good outlet or hand over a bad outlet.
  • the device is expediently designed to that the transport device and the reading station and the Separating device than in the manufacturing process integrable compact machine module is formed. As a result, it can easily - even afterwards - be inserted into existing manufacturing processes.
  • the device shown in the drawing is used for Identification and / or monitoring of medical Syringes 1 and cartridges, preferably from pre-filled Pre-filled syringes and cartridges, especially during the Production process.
  • the syringes 1 or Carpules in not shown in the drawing Way by means of machine-readable labeling provided, the label in a coded form done, which is a clear identification regarding Product, batch, dosage, filling and expiry date allows.
  • the labeling is done in detail using a redundant coding, being immediately after attachment a test reading can be carried out on the label in order to determine whether there is sufficient redundancy for the the label is read again.
  • the labeling is attached expediently at the beginning of the production process. is however, for example with regard to Cleaning processes initially disruptive, so the Lettering also for a suitable later Production or assembly step take place.
  • the lettering can be more visible in daylight or - insofar as this is annoying - in invisible Way are applied, in the latter case for For purposes of reading, for example, lighting with UV light is to be used.
  • the label can do this for example printed on or also by means of a laser be branded.
  • the syringe by means of a Drive 3 rotated at least once around its longitudinal axis.
  • an optical one in the drawing Recording system 2 provided in the form of a video camera, the on the passing syringes 1 or cartridges aligned and, if necessary, with regard to the Marking locations on the syringe 1 or carpule adjustable is.
  • two or more optical Provide recording systems 2 to a specific Angle with respect to the longitudinal axis of the syringe 1 are offset from each other. This will an increase in redundancy achieved; in particular can also - due to the different point of view - unfavorable lighting conditions, types of lighting, Contrast areas and reflections are balanced.
  • the speed of rotation of syringes 1 or cartridges can also be synchronized with the image recording frequency of the optical recording system 2 can be selected.
  • the separating / transport device and the Reading station and the separation device can Conveniently designed as a compact machine module be so that they can be easily attached to the desired one Can be integrated into the manufacturing process.

Abstract

To identify and/or monitor filled medical syringes (1), and cartridges, the syringe cylinders are labeled in advance with the product, charge, dosage, filling and use-by dates using machine-readable labels. For scanning, the syringe is aligned and rotated by a drive (3) at least once around its longitudinal axis, to be viewed by a video camera (2) as they pass by the monitoring station.

Description

Die Erfindung betrifft ein Verfahren zur Identifizierung und/oder Überwachung von medizinischen Spritzen, insbesondere vorgefüllten Fertigspritzen und Karpulen, während des Produktionsablaufes bzw. zur späteren Zuordnung zu einer Produktionscharge mittels einer maschinenlesbaren Beschriftung. Ferner betrifft die Erfindung eine Vorrichtung zur Durchführung des Verfahrens.The invention relates to a method for identification and / or monitoring medical syringes, especially pre-filled syringes and cartridges, during the production process or for later Assignment to a production batch using a machine-readable labeling. Furthermore, the Invention a device for carrying out the Process.

Bei der Fertigung bzw. Abfüllung von Fertigspritzen, insbesondere solchen, die zur intramuskulären oder intravenösen Applikation vorgesehen sind, kommt es entscheidend darauf an, daß das Produkt hinsichtlich Wirkstoff, Dosierung, Charge, Herstellungsdatum und Verfallsdatum eindeutig identifiziert werden kann. Dies bedeutet, daß eine Überprüfung und Überwachung jeder einzelnen Spritze nicht nur während des Produktionsprozesses, sondern auch nachträglich, gegebenenfalls sogar noch nach der Applikation der Spritze, möglich sein muß.When manufacturing or filling pre-filled syringes, especially those for intramuscular or intravenous application are provided, it happens crucial to the fact that the product with regard Active ingredient, dosage, batch, date of manufacture and Expiration date can be clearly identified. This means a review and monitoring everyone single syringe not only during the Production process, but also afterwards, if necessary, even after the application of Syringe, must be possible.

Der Erfindung liegt daher die Aufgabe zugrunde, ein derartiges Verfahren so zu verbessern, daß während des gesamten Herstellungsprozesses, also beginnend bei Reinigung, Befüllung, Sterilisierung und Verpackung sowie danach bei der Applikation der Spritze eine Kontrolle und Überprüfung hinsichtlich Zugehörigkeit zur aktuellen Charge sowie eine eindeutige Zuordnung zum enthaltenen Wirkstoff und den weiteren in diesem Zusammenhang wesentlichen Daten möglich ist.The invention is therefore based on the object to improve such a process so that during the entire manufacturing process, i.e. starting at Cleaning, filling, sterilization and packaging as well then a check when applying the syringe and Verification of belonging to the current one Batch and a clear assignment to the contained Active ingredient and others in this context essential data is possible.

Diese Aufgabe wird durch ein Verfahren gelöst, bei welchem zunächst vorzugsweise der Spritzenzylinder mit der Beschriftung versehen wird, die eine eindeutige Identifizierung hinsichtlich Produkt, Charge, Dosierung, Abfüll- und Verfalldatum ermöglicht, und bei welchem sodann eine Prüflesung mit anschließender Aussonderung der Spritzen mit nicht bzw. unvollständig lesbarer oder einer chargenfremden Beschriftung erfolgt.This problem is solved by a method in which first preferably the syringe barrel with the Caption is provided, which is a unique Identification regarding product, batch, dosage, Filling and expiry date enabled, and at which then a test reading with subsequent separation of the Syringes with not or only partially readable or one non-batch labeling.

Der durch die Erfindung erreichte Vorteil besteht im wesentlichen darin, daß auf der Spritze eine maschinenlesbare Beschriftung aufgebracht wird, die alle produktspezifischen Daten enthält, so daß einerseits solche Spritzenzylinder erkannt und in der Folge ausgesondert werden können, die - unbeabsichtigt oder fehlerhaft - in den Produktionsgang gelangt sind, andererseits sichergestellt wird, daß letztlich bei der abschließenden Verpackung der Spritze eine solche mit genau dem auf der Verpackung ausgewiesenen Inhalt sich darin befindet.The advantage achieved by the invention is essential in that on the syringe machine-readable labeling is applied, which contains all product-specific data, so that on the one hand, such syringe cylinders are recognized and in the Episode can be discarded that - unintentionally or faulty - got into the production process, on the other hand, it is ensured that ultimately at final packaging of the syringe with such exactly the content shown on the packaging is in it.

In bevorzugter Ausführungsform der Erfindung erfolgt die Beschriftung mittels einer redundanten Kodierung, wobei durch die Prüflesung eine Ermittlung der verbleibenden Redundanz vorgenommen wird und hiervon abhängig die Aussonderung der Spritzen erfolgt. Dies hat den Vorteil, daß selbst einer Beschädigung der Beschriftung in gewissem Umfang gleichwohl ein eindeutige Identifizierung möglich ist.In a preferred embodiment of the invention, the Labeling using redundant coding, whereby a determination of the remaining by the test reading Redundancy is made and depending on that The syringes are discarded. This has the advantage that even some damage to the lettering Scope nevertheless clear identification possible is.

Weiter ist im Rahmen der Erfindung vorgesehen, daß die Anbringung der Beschriftung unmittelbar zu Beginn des Produktionsablaufs oder zu einem geeigneten späteren Produktions- oder Konfektionierungsschritt erfolgt. Die Anbringung bereits zu Beginn des Produktionsablauf erlaubt dabei eine lückenlose Überwachung und gegebenenfalls eine Rückverfolgung bis zu den vorangehenden Reinigungsprozessen.It is further provided in the context of the invention that Attach the lettering immediately at the beginning of the Production process or to a suitable later Production or assembly step takes place. The Attachment allowed at the beginning of the production process complete monitoring and, if necessary, one Tracing back to previous ones Cleaning processes.

Wesentlich und somit vorteilhaft ist hierbei weiter, wenn die Beschriftung wenigstens einmal während und/oder am Ende des Produktionsablaufs gelesen wird und nicht lesbare oder nicht zur Charge gehörende Spritzen ausgesondert werden. Zumindest immer dann, wenn die Spritzen aus Behältnissen, Trays oder dergleichen wieder einem maschinellen Weiterverarbeitungsprozess zugeführt werden, sollte eine solche Prüfung vorgenommen werden. It is also essential and therefore advantageous if the lettering at least once during and / or on End of production is read and unreadable or syringes not belonging to the batch become. At least whenever the syringes are out Containers, trays or the like again machine processing process are fed, such a check should be made.

Ferner besteht im Rahmen der Erfindung die Möglichkeit, daß die Beschriftung in bei Tageslicht sichtbarer oder unsichtbarer Weise aufgebracht wird. Die Auswahl der im Einzelfall geeigneten Beschriftung richtet sich dabei nach den jeweils bestehenden Vorgaben, wobei eine beispielsweise nur unter UV-Licht lesbare Beschriftung einen entsprechend höheren technischen Aufwand bedingt.Furthermore, there is the possibility within the scope of the invention that the label is visible in daylight or applied invisibly. The selection of im Appropriate labeling depends on the individual case the respective existing specifications, one for example, only legible labeling under UV light a correspondingly higher technical effort.

Nach einer ersten Ausgestaltung der Erfindung kann die Beschriftung aufgedruckt sein. Ebenso besteht jedoch auch die Möglichkeit, daß die Beschriftung mittels eines Lasers eingebrannt wird, wobei grundsätzlich auch weitere Beschriftungsverfahren denkbar sind. Der Code kann aus Platzgründen ein- oder mehrfach bei der Aufbringung geteilt werden. Er wird dann bei der Erkennung vom System zu einem Code zusammengesetzt.According to a first embodiment of the invention Lettering must be printed. However, it also exists the possibility that the inscription by means of a laser is branded, but basically also more Labeling processes are conceivable. The code can be made Space constraints one or more times during application to be shared. It is then recognized by the system assembled into a code.

Als vorteilhaft im Rahmen der Erfindung hat es sich weiter erwiesen, wenn die Spritze oder Karpule zum Lesen der Beschriftung wenigstens einmal um ihre Längsachse gedreht wird. Dies bietet sich schon im Hinblick auf die Anordnung und Halterung der Spritze an.It has also proven advantageous in the context of the invention proven if the syringe or cartridge for reading the Lettering rotated at least once around its longitudinal axis becomes. This already lends itself to the arrangement and holder of the syringe.

Um eine höhere Redundanz und Sicherheit bei der Erkennung der Kodierung zu erreichen, ist es zweckmäßig, wenn das Lesen durch zwei oder mehrere optische Aufnahmesysteme erfolgt, die um einen bestimmten Winkel bezüglich der Längsachse der Spritze gegeneinander versetzt angeordnet sind. Dadurch lassen sich gegebenenfalls auch ungünstige optische Einflüsse eliminieren. For higher redundancy and security in the detection to achieve the coding, it is useful if that Reading through two or more optical recording systems takes place at a certain angle with respect to the Longitudinal axis of the syringe offset from one another are. This may also result in unfavorable conditions Eliminate optical influences.

Eine weitere Erhöhung der Erkennungssicherheit kann dadurch erreicht werden, daß die Rotationsgeschwindigkeit der Spritzen während des Lesevorgangs synchron zur Bildaufnahmefrequenz des optischen Aufnahmesystems ist.A further increase in the detection security can can be achieved in that the rotational speed the syringes during the reading process in synchronism with the Image recording frequency of the optical recording system is.

Für die Kennzeichnung der Spritzen ist es vorteilhaft, wenn zur Beschriftung der Data Matrix Code ECC 200 verwendet wird.For the identification of the syringes, it is advantageous if to label the Data Matrix Code ECC 200 is used.

Eine die Aufgabe in vorrichtungsmäßiger Hinsicht lösende Vorrichtung ist gekennzeichnet durch eine einbahnige oder mehrbahnige Transporteinrichtung für die Spritzen, über die diese einer Lesestation zugeführt werden, wobei die Lesestation eine Dreheinrichtung für die Spritzen sowie wenigstens ein optisches Aufnahmesystem zur Erfassung der auf den Spritzen aufgebrachten Kodierung aufweist, ferner durch eine Trenneinrichtung, welche die die Transporteinrichtung durchlaufenden Spritzen entsprechend der erfassten Kodierung und Bewertung in einen Gutauslauf oder einen Schlechtauslauf überstellen.A device-solving task Device is characterized by a single lane or multi-lane transport device for the syringes, over which are fed to a reading station, the Reading station a rotating device for the syringes as well at least one optical recording system for detecting the has coding applied to the syringes, further through a separator, which the Corresponding syringes in transit the recorded coding and evaluation in a good outlet or hand over a bad outlet.

Zweckmäßigerweise ist die Vorrichtung dazu so gestaltet, daß die Transporteinrichtung sowie die Lesestation und die Trenneinrichtung als in den Fertigungsprozeß integrierbares kompaktes Maschinenmodul ausgebildet ist. Dadurch kann sie auf einfache Weise - auch nachträglich - in bestehende Fertigungsprozesse eingefügt werden.The device is expediently designed to that the transport device and the reading station and the Separating device than in the manufacturing process integrable compact machine module is formed. As a result, it can easily - even afterwards - be inserted into existing manufacturing processes.

Im folgenden wird die Erfindung anhand eines in der Zeichnung dargestellten Ausführungsbeispiels näher erläutert; die einzige Figur zeigt eine Vorrichtung zur Durchführung des erfindungsgemäßen Verfahrens. In the following the invention is based on one in the Drawing shown embodiment closer explains; the only figure shows a device for Implementation of the method according to the invention.

Die in der Zeichnung dargestellte Vorrichtung dient zur Identifizierung und/oder Überwachung von medizinischen Spritzen 1 und Karpulen, vorzugsweise von vorbefüllten Fertigspritzen und Karpulen insbesondere während des Produktionsablaufes. Dazu werden die Spritzen 1 oder Karpulen in in der Zeichnung nicht näher dargestellter Weise mittels einer maschinenlesbaren Beschriftung versehen, wobei die Beschriftung in einer codierten Form erfolgt, die eine eindeutige Identifizierung hinsichtlich Produkt, Charge, Dosierung, Abfüll- und Verfalldatum ermöglicht. Sodann besteht die Möglichkeit, an den jeweils zweckmäßigen bzw. erforderlichen Stationen des Produktionsablaufes eine Prüflesung mit der in der Zeichnung dargestellten oder in vergleichbarer Anordnung vorzunehmen, worauf anschließend eine Aussonderung derjenigen Spritzen oder Karpulen erfolgen kann, deren Codierung nicht bzw. nur unvollständig lesbar ist oder die eine Beschriftung aufweisen, die nicht der in Bearbeitung befindlichen Charge entspricht.The device shown in the drawing is used for Identification and / or monitoring of medical Syringes 1 and cartridges, preferably from pre-filled Pre-filled syringes and cartridges, especially during the Production process. For this, the syringes 1 or Carpules in not shown in the drawing Way by means of machine-readable labeling provided, the label in a coded form done, which is a clear identification regarding Product, batch, dosage, filling and expiry date allows. Then there is the possibility of each appropriate or required stations of the Production process a test reading with that in the Drawing shown or in a comparable arrangement carry out, after which a separation syringes or cartridges can be made whose Coding is not or only partially readable or the have a label that is not in progress located batch corresponds.

Die Beschriftung erfolgt dabei im einzelnen mittels einer redundanten Codierung, wobei gleich nach der Anbringung der Beschriftung eine Prüflesung erfolgen kann, um festzustellen, ob eine ausreichende Redundanz für das erneute Lesen der Beschriftung vorhanden ist.The labeling is done in detail using a redundant coding, being immediately after attachment a test reading can be carried out on the label in order to determine whether there is sufficient redundancy for the the label is read again.

Die Anbringung der Beschriftung erfolgt dabei zweckmäßigerweise zu Beginn des Produktionsablaufes. Ist sie jedoch beispielsweise im Hinblick auf Reinigungsprozesse zunächst störend, so kann die Beschriftung auch zu einem geeigneten späteren Produktions- oder Konfektionierungsschritt erfolgen. Nach erfolgter Beschriftung besteht jedenfalls grundsätzlich die Möglichkeit einer Überprüfung der im Produktionsablauf befindlichen Spritzen oder Karpulen, so daß insbesondere auch kurz vor der Befüllung mit häufig teurer pharmazeutischer Substanz eine Überprüfung erfolgen kann.The labeling is attached expediently at the beginning of the production process. is however, for example with regard to Cleaning processes initially disruptive, so the Lettering also for a suitable later Production or assembly step take place. To In any case, there is always a label the possibility of checking the in the production process located syringes or cartridges, so that in particular also shortly before filling with often more expensive pharmaceutical substance can be checked.

Die Beschriftung kann dabei in bei Tageslicht sichtbarer oder auch - soweit dies störend ist - in unsichtbarer Weise aufgebracht werden, wobei im letzteren Fall zum Zwecke des Lesens beispielsweise eine Beleuchtung mit UV-Licht einzusetzen ist. Dazu kann die Beschriftung beispielsweise aufgedruckt oder auch mittels eines Lasers eingebrannt werden.The lettering can be more visible in daylight or - insofar as this is annoying - in invisible Way are applied, in the latter case for For purposes of reading, for example, lighting with UV light is to be used. The label can do this for example printed on or also by means of a laser be branded.

Zum Lesen der Beschriftung mittels der in der Zeichnung dargestellten Vorrichtung wird die Spritze mittels eines Antriebs 3 wenigstens einmal um Ihre Längsachse gedreht. Für den Lesevorgang ist in der Zeichnung ein optisches Aufnahmesystem 2 in Form einer Videokamera vorgesehen, das auf die vorbeilaufenden Spritzen 1 oder Karpulen ausgerichtet und gegebenenfalls hinsichtlich des Markierungsorts auf der Spritze 1 oder Karpule justierbar ist. Hierbei ist es insbesondere auch in in der Zeichnung angedeuteter Weise möglich, zwei oder mehrere optische Aufnahmesysteme 2 vorzusehen, die um einen bestimmten Winkel bezüglich der Längsachse der Spritze 1 gegeneinander versetzt angeordnet sind. Hierdurch wird eine Erhöhung der Redundanz erreicht; insbesondere können auch - durch den unterschiedlichen Blickwinkel - ungünstige Lichtverhältnisse, Beleuchtungsarten, Kontrastflächen und Reflektionen ausgeglichen werden. To read the label using the in the drawing shown device is the syringe by means of a Drive 3 rotated at least once around its longitudinal axis. For the reading process there is an optical one in the drawing Recording system 2 provided in the form of a video camera, the on the passing syringes 1 or cartridges aligned and, if necessary, with regard to the Marking locations on the syringe 1 or carpule adjustable is. Here it is particularly in the drawing indicated way possible two or more optical Provide recording systems 2 to a specific Angle with respect to the longitudinal axis of the syringe 1 are offset from each other. This will an increase in redundancy achieved; in particular can also - due to the different point of view - unfavorable lighting conditions, types of lighting, Contrast areas and reflections are balanced.

Die Rotationsgeschwindigkeit der Spritzen 1 oder Karpulen kann hierzu zusätzlich synchron zur Bildaufnahmefrequenz des optischen Aufnahmesystems 2 gewählt werden.The speed of rotation of syringes 1 or cartridges can also be synchronized with the image recording frequency of the optical recording system 2 can be selected.

Die Vereinzelungs-/Transporteinrichtung sowie die Lesestation und die Trenneinrichtung können zweckmäßigerweise als kompaktes Maschinenmodul ausgebildet sein, so daß sie problemlos an der jeweils gewünschten Stelle in den Fertigungsprozeß integriert werden können.The separating / transport device and the Reading station and the separation device can Conveniently designed as a compact machine module be so that they can be easily attached to the desired one Can be integrated into the manufacturing process.

Claims (13)

Verfahren zur Identifizierung und/oder Überwachung von medizinischen Spritzen, insbesondere vorgefüllten Fertigspritzen und Karpulen, während des Produktionsablaufes bzw. zur späteren Zuordnung zu einer Produktionscharge mittels einer maschinenlesbaren Beschriftung, bei welchem zunächst vorzugsweise der Spritzenzylinder mit der Beschriftung versehen wird, die eine eindeutige Identifizierung hinsichtlich Produkt, Charge, Dosierung, Abfüll- und Verfalldatum ermöglicht, und bei welchem sodann eine Prüflesung mit anschließender Aussonderung der Spritzen (1) mit nicht bzw. unvollständig lesbarer oder einer chargenfremden Beschriftung erfolgt.Methods for identifying and / or monitoring medical syringes, especially prefilled Pre-filled syringes and cartridges during the Production process or for later assignment to a production batch by means of a machine-readable lettering, with which initially preferably the syringe barrel with the label is provided, the unique identification in terms of product, batch, dosage, filling and Expiration date enabled, and then at which a Test reading with subsequent separation of the Syringes (1) with not or only partially readable or non-batch labeling. Verfahren nach Anspruch 1, dadurch gekennzeichnet, daß die Beschriftung mittels einer redundanten Kodierung erfolgt, wobei durch die Prüflesung eine Ermittlung der verbleibenden Redundanz erfolgt und hiervon abhängig die Aussonderung der Spritzen (1) erfolgt.Method according to Claim 1, characterized in that the labeling is carried out by means of a redundant coding, the test redundancy being used to determine the remaining redundancy and, depending on this, the syringes (1) being sorted out. Verfahren nach Anspruch 1 oder 2, dadurch gekennzeichnet, daß die Anbringung der Beschriftung unmittelbar zu Beginn des Produktionsablaufs oder zu einem geeigneten späteren Produktions- oder Konfektionierungsschritt erfolgt.Method according to claim 1 or 2, characterized in that the labeling is applied directly at the beginning of the production process or at a suitable later production or packaging step. Verfahren nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, daß die Beschriftung wenigstens einmal während und/oder am Ende des Produktionsablaufs gelesen wird und nicht lesbare oder nicht zur Charge gehörende Spritzen (1) ausgesondert werden.Method according to one of claims 1 to 3, characterized in that the labeling is read at least once during and / or at the end of the production process and syringes (1) which are not readable or which do not belong to the batch are discarded. Verfahren nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, daß die Beschriftung in bei Tageslicht sichtbarer oder unsichtbarer Weise aufgebracht wird.Method according to one of claims 1 to 4, characterized in that the inscription is applied in a way which is visible or invisible in daylight. Verfahren nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß die Beschriftung aufgedruckt wird.Method according to one of claims 1 to 5, characterized in that the inscription is printed on. Verfahren nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß die Beschriftung mittels eines Lasers eingebrannt wird.Method according to one of claims 1 to 5, characterized in that the inscription is burned in by means of a laser. Verfahren nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, daß die Spritze (1) zum Lesen der Beschriftung wenigstens einmal um ihre Längsachse gedreht wird.Method according to one of claims 1 to 7, characterized in that the syringe (1) is rotated at least once around its longitudinal axis for reading the inscription. Verfahren nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, daß das Lesen durch zwei oder mehrere optische Aufnahmesysteme (2) erfolgt, die um einen bestimmten Winkel bezüglich der Längsachse der Spritze gegeneinander versetzt angeordnet sind.Method according to one of claims 1 to 8, characterized in that the reading is carried out by two or more optical recording systems (2) which are arranged offset from one another by a certain angle with respect to the longitudinal axis of the syringe. Verfahren nach einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, daß die Rotationsgeschwindigkeit der Spritzen (1) während des Lesevorgangs synchron zur Bildaufnahmefrequenz des optischen Aufnahmesystems (2) ist.Method according to one of Claims 1 to 9, characterized in that the rotational speed of the syringes (1) during the reading process is synchronous with the image recording frequency of the optical recording system (2). Verfahren nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, daß zur Beschriftung der Data Matrix Code ECC 200 verwendet wird. Method according to one of claims 1 to 10, characterized in that the data matrix code ECC 200 is used for labeling. Vorrichtung zur Durchführung des Verfahrens nach den Ansprüchen 1 bis 11, gekennzeichnet durch eine einbahnige oder mehrbahnige Transporteinrichtung für die Spritzen (1) oder Karpulen, über die diese einer Lesestation zugeführt werden, wobei die Lesestation eine Dreheinrichtung für die Spritzen (1) oder Karpulen sowie wenigstens ein optisches Aufnahmesystem (2) zur Erfassung der auf den Spritzen (1) aufgebrachten Kodierung aufweist, ferner durch eine Trenneinrichtung, welche die die Transporteinrichtung durchlaufenden Spritzen (1) entsprechend der erfassten Kodierung und Bewertung in einen Gutauslauf oder einen Schlechtauslauf überstellen.Device for carrying out the method according to claims 1 to 11, characterized by a single-lane or multi-lane transport device for the syringes (1) or carpules, via which they are fed to a reading station, the reading station being a rotating device for the syringes (1) or carpules and Has at least one optical recording system (2) for detecting the coding applied to the syringes (1), further by a separating device which transfers the syringes (1) passing through the transport device into a good discharge or a bad discharge according to the detected coding and evaluation. Vorrichtung nach Anspruch 12, dadurch gekennzeichnet, daß die Transporteinrichtung sowie die Lesestation und die Trenneinrichtung als in den Fertigungsprozeß integrierbares kompaktes Maschinenmodul ausgebildet ist.Apparatus according to claim 12, characterized in that the transport device as well as the reading station and the separating device is designed as a compact machine module which can be integrated into the manufacturing process.
EP03027587A 2003-02-15 2003-12-02 Method for identifying and/or monitoring of medical syringes Expired - Lifetime EP1447327B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10306400 2003-02-15
DE10306400A DE10306400A1 (en) 2003-02-15 2003-02-15 Method for identifying and / or monitoring medical syringes, in particular prefilled pre-filled syringes

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EP1447327A2 true EP1447327A2 (en) 2004-08-18
EP1447327A3 EP1447327A3 (en) 2006-02-01
EP1447327B1 EP1447327B1 (en) 2012-07-18

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US (1) US7036288B2 (en)
EP (1) EP1447327B1 (en)
JP (1) JP4409978B2 (en)
CA (1) CA2454546C (en)
DE (1) DE10306400A1 (en)

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Also Published As

Publication number Publication date
EP1447327B1 (en) 2012-07-18
US7036288B2 (en) 2006-05-02
JP4409978B2 (en) 2010-02-03
CA2454546A1 (en) 2004-08-15
CA2454546C (en) 2007-10-02
DE10306400A1 (en) 2004-09-02
JP2004243118A (en) 2004-09-02
EP1447327A3 (en) 2006-02-01
US20040182475A1 (en) 2004-09-23

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