CA2454546C - Method and apparatus for identification and/or monitoring of medical syringes - Google Patents
Method and apparatus for identification and/or monitoring of medical syringes Download PDFInfo
- Publication number
- CA2454546C CA2454546C CA002454546A CA2454546A CA2454546C CA 2454546 C CA2454546 C CA 2454546C CA 002454546 A CA002454546 A CA 002454546A CA 2454546 A CA2454546 A CA 2454546A CA 2454546 C CA2454546 C CA 2454546C
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- syringes
- station
- syringe
- scanning
- filling station
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
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- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medical Treatment And Welfare Office Work (AREA)
Abstract
The invention provides a method for the identification and/or monitoring of medical syringes, especially pre-filled syringes and cartridges. The method is intended to identify and/or monitor the syringes, during production or subsequent allocation to a production lot using a machine-readable code. In this method, the syringe or cylinder, is first labeled with a code that enables clear identification of the product, lot number, dosage, fill date, and expiry date.
Next, the syringe or cylinder is read or scanned in order to sort out and removes any syringes or cylinders that are unreadable or partially unreadable, or are labeled with a code that does not match a given lot.
Next, the syringe or cylinder is read or scanned in order to sort out and removes any syringes or cylinders that are unreadable or partially unreadable, or are labeled with a code that does not match a given lot.
Description
METHOD AND APPARATUS FOR I~ENTIFTQATION AM,/0R "ITQRIK OF
Technical Field MDICAL S'YRIIJGES
The invention relates to a method that is intended to identify and/or monitor medical (hypodermic) syringes, especially pre-filled syringes and cylinders (cartridges) intended for syringes, during the production process or subsequent allocation to a production lot using a machine-readable code.
Furthermore, the invention relates to a device by means of which this method is carried out.
Background of the Invention During the production or loading of pre-filled syringes, especially those intended for intramuscular or intravenous application, it is essential that the product be clearly identified by active ingredient, dose, lot number, production date and expiry date. This means that it must be possible to monitor and verify every single syringe, not only during the production process, but also after the production process, as well as after use of the syringe, if need be.
Thus, the present invention seeks to improve this type of procedure in such a way that, during the entire production process, from cleaning, to loading, to sterilization, to packing, as well as after the actual use of the syringe, it is possible to monitor and verify every syringe as belonging to a specific lot, and as containing a specific active ingredient, including all information related thereto.
Summary of the Invention This objective is achieved through a method in which the syringe, or a cylinder (cartridge) intended for a syringe, is first labeled with a code that enables clear identification of the product, lot number, dosage, fill date, and expiry date, after which the syringes are scanned in order to sort out any syringes that are unreadable or only partially readable, or are labeled with a code that does not match a given lot.
More particularly, the invention provides a method of making prefilled syringes, the method comprising the steps of: displacing a succession of syringes along a conveyor path from a supply station successively through a marking station, a filling station, and to a downstream packing station; permanently marking the syringes in the marking station with machine-readable data identifying the medicament to be put in the empty syringe at the filling station;
scanning the syringes downstream of the marking station and upstream of the filling station and removing from the conveyor path any syringe whose data is not readable; filling each of the syringes with a predetermined dose of a medicament in the filling station; and scanning the syringes downstream of the filling station and upstream of the packing station and removing from the conveyor path any syringe whose data does not correspond to the medicament filled into the syringe at the filling station.
The present invention preferably provides that each syringe is labeled with a machine-readable code that includes all production-related information, so that, on one hand, such syringes or cylinders, whether they entered the production assembly unintentionally or erroneously, can be identified and consequently removed and, on the other hand, each label is secured in such a way that, when it is packed, each syringe or cylinder bears a label that matches the contents listed on the final packaging.
The invention also provides an apparatus for making prefilled syringes, the apparatus comprising: means for displacing a succession of syringes along a conveyor path from a supply station successively through a marking station, a filling station, and to a downstream packing station; means at the filling station for filling each of the syringes with a predetermined dose of a medicament in the filling station; means along the path at the marking station upstream of the filling station for permanently marking the syringes with machine-readable data identifying the medicament to be put in the empty syringe at the filling station;
means along the path downstream of the marking station and upstream of the filling station for scanning the syringes and removing from the conveyor path any syringe whose data is not readable; and means along the path downstream of the filling station and upstream of the packing station for removing from the conveyor path any syringe whose data does not correspond to the medicament filled into the syringe at the filling station.
Brief Description of the Drawings In the following, the invention is described in greater detail, using a working example represented in Fig. 1 of the accompanying drawing.
In the drawing:
Fig. 1 shows an arrangement for the execution of the method of the invention.
2a Detailed Description of Preferred Embodiments In the preferred embodiment of the invention, labeling takes place by means of redundant coding, whereby during the test scan the remaining redundancy is determined, on the basis of which the syringes are then sorted.
This has the advantage that, even when a label is damaged to a certain extent, a clear identification is still possible.
Further, the invention also provides that labels be applied immediately at the start of the production process, or at a suitable subsequent stage of production or manufacturing. When labels are applied at the start of the production process, the syringes can be monitored and, if need be, traced back all the way to the preceding cleaning processes.
Thus, an advantage of the method lies in the fact of reading a label at least one time during and/or at the end of the production process, so that syringes that are unreadable or do not belong to a given lot can be sorted out and removed. At the very least whenever syringes enter a subsequent stage of processing from containers, trays, or the like, such a test should occur.
Moreover, the invention also makes it possible to apply labels in such a way that they are visible or invisible in daylight. Suitable labels can be selected to meet the requirements of a specific situation, whereby, for example, a label that is visible only under UV light would require a higher technical expenditure.
Once the invention has been carried out, labeling can begin. Likewise, it is also possible to etch labels using a laser, which would also fundamentally involve further conceivable labeling processes. Depending on how much space is available, the code can be split once or multiple times during application.
In such cases, the code is reconstituted during system recognition.
A further advantage of the invention has been found in rotating the syringe or cartridge at least once along the longitudinal axis during reading or labeling. This is already made possible by virtue of the arrangement and mounting of the syringe.
In order to attain higher redundancy and reliability during code recognition, it is advisable that scanning take place using two or more optical recognition systems that are staggered across from each other at a certain angle in relation to the longitudinal axis of the syringe. In this way, unwanted optical input can be eliminated.
Recognition reliability also can be further increased by synchronizing the rotation speed of the syringes during scanning and the image capture frequency of the optical recognition system.
For marking the syringes, it is advantageous to use Data Matrix Code ECC 200T"' for labeling.
In terms of equipment, one way to accomplish the task is to use a one-lane or multiple-lane transport apparatus for the syringes, via which the syringes are conveyed to a reading station, whereby the reading station is equipped with a turning device for the syringes and at least one optical recognition system to register the codes located on the syringes, as well as a separating device, which transfers the syringes that pass through the transport apparatus according to whether they are good output or bad output, depending on the code and evaluation that are registered.
For such purposes, the device is structured in such a way that the transport apparatus, as well as the reading station and the separating device is built as a compact machine module that can be integrated into the manufacturing process. In this way, it can easily be inserted into pre-existing manufacturing processes - even after the fact.
The arrangement shown in Fig. 1 is intended for the identification and/or monitoring of medical, or hypodermic syringes 1 and cartridges, preferably pre-filled syringes and cartridges, during the production process. To this end, syringes 1 or cartridges are labeled with a machine-readable code, whereby labeling takes place in a coded form that enables the clear identification of the product, lot, dosage, fill date and expiry date. Then it is possible, at appropriate or required stations within the production process, to conduct a test reading by means of the arrangement represented in the drawing, or a comparable arrangement, after which those syringes or cartridges with unreadable or only partially readable codes, or syringes with labels that do not match the lot being processed, can be sorted out and removed.
Individual labeling takes place by means of redundant coding, whereby immediately after a label has been applied, a test scan can be conducted, in order to determine whether there is sufficient redundancy for repeat reading of the label.
Appropriately, labels are applied at the beginning of the production process. However, if labeling is, for example, disruptive to the cleaning processes, it can occur at a suitable, later stage of production or manufacturing.
After labeling has taken place, there remains nonetheless the fundamental possibility to monitor those syringes or cartridges actually in production, so that especially shortly before loading with often costly pharmaceutical substances, verification can take place.
Labels can be applied such that they are visible by daylight or, if this is undesirable, that they can be invisibie, which latter case would involve, for example, the use of UV-iight for the purposes of reading. Labels can, for example, be printed or etched by a laser.
Technical Field MDICAL S'YRIIJGES
The invention relates to a method that is intended to identify and/or monitor medical (hypodermic) syringes, especially pre-filled syringes and cylinders (cartridges) intended for syringes, during the production process or subsequent allocation to a production lot using a machine-readable code.
Furthermore, the invention relates to a device by means of which this method is carried out.
Background of the Invention During the production or loading of pre-filled syringes, especially those intended for intramuscular or intravenous application, it is essential that the product be clearly identified by active ingredient, dose, lot number, production date and expiry date. This means that it must be possible to monitor and verify every single syringe, not only during the production process, but also after the production process, as well as after use of the syringe, if need be.
Thus, the present invention seeks to improve this type of procedure in such a way that, during the entire production process, from cleaning, to loading, to sterilization, to packing, as well as after the actual use of the syringe, it is possible to monitor and verify every syringe as belonging to a specific lot, and as containing a specific active ingredient, including all information related thereto.
Summary of the Invention This objective is achieved through a method in which the syringe, or a cylinder (cartridge) intended for a syringe, is first labeled with a code that enables clear identification of the product, lot number, dosage, fill date, and expiry date, after which the syringes are scanned in order to sort out any syringes that are unreadable or only partially readable, or are labeled with a code that does not match a given lot.
More particularly, the invention provides a method of making prefilled syringes, the method comprising the steps of: displacing a succession of syringes along a conveyor path from a supply station successively through a marking station, a filling station, and to a downstream packing station; permanently marking the syringes in the marking station with machine-readable data identifying the medicament to be put in the empty syringe at the filling station;
scanning the syringes downstream of the marking station and upstream of the filling station and removing from the conveyor path any syringe whose data is not readable; filling each of the syringes with a predetermined dose of a medicament in the filling station; and scanning the syringes downstream of the filling station and upstream of the packing station and removing from the conveyor path any syringe whose data does not correspond to the medicament filled into the syringe at the filling station.
The present invention preferably provides that each syringe is labeled with a machine-readable code that includes all production-related information, so that, on one hand, such syringes or cylinders, whether they entered the production assembly unintentionally or erroneously, can be identified and consequently removed and, on the other hand, each label is secured in such a way that, when it is packed, each syringe or cylinder bears a label that matches the contents listed on the final packaging.
The invention also provides an apparatus for making prefilled syringes, the apparatus comprising: means for displacing a succession of syringes along a conveyor path from a supply station successively through a marking station, a filling station, and to a downstream packing station; means at the filling station for filling each of the syringes with a predetermined dose of a medicament in the filling station; means along the path at the marking station upstream of the filling station for permanently marking the syringes with machine-readable data identifying the medicament to be put in the empty syringe at the filling station;
means along the path downstream of the marking station and upstream of the filling station for scanning the syringes and removing from the conveyor path any syringe whose data is not readable; and means along the path downstream of the filling station and upstream of the packing station for removing from the conveyor path any syringe whose data does not correspond to the medicament filled into the syringe at the filling station.
Brief Description of the Drawings In the following, the invention is described in greater detail, using a working example represented in Fig. 1 of the accompanying drawing.
In the drawing:
Fig. 1 shows an arrangement for the execution of the method of the invention.
2a Detailed Description of Preferred Embodiments In the preferred embodiment of the invention, labeling takes place by means of redundant coding, whereby during the test scan the remaining redundancy is determined, on the basis of which the syringes are then sorted.
This has the advantage that, even when a label is damaged to a certain extent, a clear identification is still possible.
Further, the invention also provides that labels be applied immediately at the start of the production process, or at a suitable subsequent stage of production or manufacturing. When labels are applied at the start of the production process, the syringes can be monitored and, if need be, traced back all the way to the preceding cleaning processes.
Thus, an advantage of the method lies in the fact of reading a label at least one time during and/or at the end of the production process, so that syringes that are unreadable or do not belong to a given lot can be sorted out and removed. At the very least whenever syringes enter a subsequent stage of processing from containers, trays, or the like, such a test should occur.
Moreover, the invention also makes it possible to apply labels in such a way that they are visible or invisible in daylight. Suitable labels can be selected to meet the requirements of a specific situation, whereby, for example, a label that is visible only under UV light would require a higher technical expenditure.
Once the invention has been carried out, labeling can begin. Likewise, it is also possible to etch labels using a laser, which would also fundamentally involve further conceivable labeling processes. Depending on how much space is available, the code can be split once or multiple times during application.
In such cases, the code is reconstituted during system recognition.
A further advantage of the invention has been found in rotating the syringe or cartridge at least once along the longitudinal axis during reading or labeling. This is already made possible by virtue of the arrangement and mounting of the syringe.
In order to attain higher redundancy and reliability during code recognition, it is advisable that scanning take place using two or more optical recognition systems that are staggered across from each other at a certain angle in relation to the longitudinal axis of the syringe. In this way, unwanted optical input can be eliminated.
Recognition reliability also can be further increased by synchronizing the rotation speed of the syringes during scanning and the image capture frequency of the optical recognition system.
For marking the syringes, it is advantageous to use Data Matrix Code ECC 200T"' for labeling.
In terms of equipment, one way to accomplish the task is to use a one-lane or multiple-lane transport apparatus for the syringes, via which the syringes are conveyed to a reading station, whereby the reading station is equipped with a turning device for the syringes and at least one optical recognition system to register the codes located on the syringes, as well as a separating device, which transfers the syringes that pass through the transport apparatus according to whether they are good output or bad output, depending on the code and evaluation that are registered.
For such purposes, the device is structured in such a way that the transport apparatus, as well as the reading station and the separating device is built as a compact machine module that can be integrated into the manufacturing process. In this way, it can easily be inserted into pre-existing manufacturing processes - even after the fact.
The arrangement shown in Fig. 1 is intended for the identification and/or monitoring of medical, or hypodermic syringes 1 and cartridges, preferably pre-filled syringes and cartridges, during the production process. To this end, syringes 1 or cartridges are labeled with a machine-readable code, whereby labeling takes place in a coded form that enables the clear identification of the product, lot, dosage, fill date and expiry date. Then it is possible, at appropriate or required stations within the production process, to conduct a test reading by means of the arrangement represented in the drawing, or a comparable arrangement, after which those syringes or cartridges with unreadable or only partially readable codes, or syringes with labels that do not match the lot being processed, can be sorted out and removed.
Individual labeling takes place by means of redundant coding, whereby immediately after a label has been applied, a test scan can be conducted, in order to determine whether there is sufficient redundancy for repeat reading of the label.
Appropriately, labels are applied at the beginning of the production process. However, if labeling is, for example, disruptive to the cleaning processes, it can occur at a suitable, later stage of production or manufacturing.
After labeling has taken place, there remains nonetheless the fundamental possibility to monitor those syringes or cartridges actually in production, so that especially shortly before loading with often costly pharmaceutical substances, verification can take place.
Labels can be applied such that they are visible by daylight or, if this is undesirable, that they can be invisibie, which latter case would involve, for example, the use of UV-iight for the purposes of reading. Labels can, for example, be printed or etched by a laser.
5 In order to read labels using the arrangement represented in the drawing, the syringe is rotated at least one time about the longitudinal axis using a drive 3. For the purpose of reading, the drawing makes reference to an optical recognition system 2 in the form of a video camera, which can be adjusted to the passing syringes I or cartridges and, as the case may be, to the type of marking on the syringe 1 or cartridge. Here it is possible, especially in the manner indicated in the drawing, to include two or more optical recognition systems that are staggered across from each other at a certain angle in relation to the longitudinal axis of the syringe 1. In this way, redundancy can be increased; in particular, through the differing angles, unfavourable lighting conditions, types of lighting, contrast surfaces and reflections can be equalized.
In addition to this, the speed of rotation of the syringes 1 or cartridges can be chosen to synchronize with the image capture frequency of the optical recognition system.
The separating / transport apparatus, as well as the reading station and the sorting apparatus can, accordingly, take the form of a compact machine module, so that it can be integrated without difficulty at a given desired location within the manufacturing process.
In addition to this, the speed of rotation of the syringes 1 or cartridges can be chosen to synchronize with the image capture frequency of the optical recognition system.
The separating / transport apparatus, as well as the reading station and the sorting apparatus can, accordingly, take the form of a compact machine module, so that it can be integrated without difficulty at a given desired location within the manufacturing process.
Claims (13)
1. A method of making prefilled syringes, the method comprising the steps of:
displacing a succession of syringes along a conveyor path from a supply station successively through a marking station, a filling station, and to a downstream packing station;
permanently marking the syringes in the marking station with machine-readable data identifying the medicament to be put in the empty syringe at the filling station;
scanning the syringes downstream of the marking station and upstream of the filling station and removing from the conveyor path any syringe whose data is not readable;
filling each of the syringes with a predetermined dose of a medicament in the filling station; and scanning the syringes downstream of the filling station and upstream of the packing station and removing from the conveyor path any syringe whose data does not correspond to the medicament filled into the syringe at the filling station.
displacing a succession of syringes along a conveyor path from a supply station successively through a marking station, a filling station, and to a downstream packing station;
permanently marking the syringes in the marking station with machine-readable data identifying the medicament to be put in the empty syringe at the filling station;
scanning the syringes downstream of the marking station and upstream of the filling station and removing from the conveyor path any syringe whose data is not readable;
filling each of the syringes with a predetermined dose of a medicament in the filling station; and scanning the syringes downstream of the filling station and upstream of the packing station and removing from the conveyor path any syringe whose data does not correspond to the medicament filled into the syringe at the filling station.
2. The method of making prefilled syringes defined in claim 1 wherein the machine-readable data marked on the syringes is redundant.
3. The method of making prefilled syringes defined in claim 1 wherein the markings are not readable under normal light.
4. The method of making prefilled syringes defined in claim 1 wherein the markings are printed on the syringes.
5. The method of making prefilled syringes defined in claim 1 wherein the markings are laser-inscribed on the syringes.
6. The method of making prefilled syringes defined in claim 1, further comprising the step of rotating the syringes about their axes during scanning of the markings.
7 7. The method of making prefilled syringes defined in claim 6 wherein the scanning is effected from two locations offset angularly with respect to the axis of the syringe being scanned.
8. The method of making prefilled syringes defined in claim 6 wherein the syringes are rotated at an angular speed coordinated with a frame rate of a scanning device effecting the scanning.
9. The method defined in claim 1, further comprising the steps of:
loading the syringes into respective packages carrying contents identification at the packing station; and scanning the syringes downstream of the packing station and removing from the conveyor path any package whose syringe's data does not correspond to the medicament identified on the respective package.
loading the syringes into respective packages carrying contents identification at the packing station; and scanning the syringes downstream of the packing station and removing from the conveyor path any package whose syringe's data does not correspond to the medicament identified on the respective package.
10. An apparatus for making prefilled syringes, the apparatus comprising:
means for displacing a succession of syringes along a conveyor path from a supply station successively through a marking station, a filling station, and to a downstream packing station;
means at the filling station for filling each of the syringes with a predetermined dose of a medicament in the filling station;
means along the path at the marking station upstream of the filling station for permanently marking the syringes with machine-readable data identifying the medicament to be put in the empty syringe at the filling station;
means along the path downstream of the marking station and upstream of the filling station for scanning the syringes and removing from the conveyor path any syringe whose data is not readable; and means along the path downstream of the filling station and upstream of the packing station for removing from the conveyor path any syringe whose data does not correspond to the medicament filled into the syringe at the filling station.
means for displacing a succession of syringes along a conveyor path from a supply station successively through a marking station, a filling station, and to a downstream packing station;
means at the filling station for filling each of the syringes with a predetermined dose of a medicament in the filling station;
means along the path at the marking station upstream of the filling station for permanently marking the syringes with machine-readable data identifying the medicament to be put in the empty syringe at the filling station;
means along the path downstream of the marking station and upstream of the filling station for scanning the syringes and removing from the conveyor path any syringe whose data is not readable; and means along the path downstream of the filling station and upstream of the packing station for removing from the conveyor path any syringe whose data does not correspond to the medicament filled into the syringe at the filling station.
11. The apparatus defined in claim 10 wherein the means for scanning includes means for rotating the syringe about their axes.
12. The apparatus defined in claim 10 wherein the scanning means is formed as a separate removable module.
13. The apparatus defined in claim 10, further comprising:
means for loading the syringes into respective packages carrying contents identification at the packing station; and means downstream of the packing station for scanning the syringes and removing from the conveyor path any package whose syringe's data does not correspond to the medicament identified on the respective package.
means for loading the syringes into respective packages carrying contents identification at the packing station; and means downstream of the packing station for scanning the syringes and removing from the conveyor path any package whose syringe's data does not correspond to the medicament identified on the respective package.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE10306400A DE10306400A1 (en) | 2003-02-15 | 2003-02-15 | Method for identifying and / or monitoring medical syringes, in particular prefilled pre-filled syringes |
| DE10306400.1-44 | 2003-02-15 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2454546A1 CA2454546A1 (en) | 2004-08-15 |
| CA2454546C true CA2454546C (en) | 2007-10-02 |
Family
ID=32668077
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002454546A Expired - Fee Related CA2454546C (en) | 2003-02-15 | 2003-12-30 | Method and apparatus for identification and/or monitoring of medical syringes |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US7036288B2 (en) |
| EP (1) | EP1447327B1 (en) |
| JP (1) | JP4409978B2 (en) |
| CA (1) | CA2454546C (en) |
| DE (1) | DE10306400A1 (en) |
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| CN104338693A (en) * | 2013-08-06 | 2015-02-11 | 江门市力泰科技有限公司 | Cartridge case detection device |
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2003
- 2003-02-15 DE DE10306400A patent/DE10306400A1/en not_active Withdrawn
- 2003-12-02 EP EP03027587A patent/EP1447327B1/en not_active Expired - Lifetime
- 2003-12-30 CA CA002454546A patent/CA2454546C/en not_active Expired - Fee Related
-
2004
- 2004-02-06 JP JP2004031126A patent/JP4409978B2/en not_active Expired - Fee Related
- 2004-02-12 US US10/779,527 patent/US7036288B2/en not_active Expired - Fee Related
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104338693A (en) * | 2013-08-06 | 2015-02-11 | 江门市力泰科技有限公司 | Cartridge case detection device |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2004243118A (en) | 2004-09-02 |
| EP1447327A3 (en) | 2006-02-01 |
| US7036288B2 (en) | 2006-05-02 |
| EP1447327B1 (en) | 2012-07-18 |
| JP4409978B2 (en) | 2010-02-03 |
| US20040182475A1 (en) | 2004-09-23 |
| DE10306400A1 (en) | 2004-09-02 |
| CA2454546A1 (en) | 2004-08-15 |
| EP1447327A2 (en) | 2004-08-18 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |
Effective date: 20131231 |