DE102004046003A1 - Pharmaceutical package, as a syringe or vial or capsule, has an integrated microchip and antenna to give a unique and tamper-proof identity - Google Patents

Abstract

The pharmaceutical package is a syringe (1), a vial or capsule, with an identification (23) which is inaccessible or integrated into it at the disk (19) of the finger flange (21) of the syringe body cylinder (3). The identification is a microchip encapsulated within the syringe plastics material, with a separate antenna embedded in conductive plastics as a radio frequency identification (RFID) chip to be accessed by a high frequency scanner.

Description

The The invention relates to pharmaceutical packaging, in particular syringes, Vials or carpules, with an identification means. The invention also concerns a process for the preparation of a pharmaceutical packaging according to the generic term the claims 21 and 22.

packaging with identification means are known. For example, special Labels, imprints or the like used to the packaging to mark. For example, to identify packaging materials Barcodes or other marking fields applied to the packaging. Microchips are also used, for example those which evaluated with a high-frequency reader (HF reader) and / or can be programmed. Such chips are also called radio frequency identification chips (RFID chips) designated. The chips can be integrated into the label.

It has turned out to be the means of identification of the one addressed here Art later changed or removable, without the user of a package this could find out.

task The invention therefore is to provide a pharmaceutical packaging, which does not have this disadvantage.

to solution This task creates a pharmaceutical packaging, having the features mentioned in claim 1. It includes a Identification means incorporated in the packaging or in this is integrated. It is thus no longer accessible and can be visible without damage or destruction of the packaging should not be tampered with or removed.

In order to a tamper evident function is realized and a unique created identifiable packaging.

Further Embodiments of the packaging material will become apparent from the dependent claims.

task the invention is also a process for the preparation of a pharmaceutical packaging created so that manipulation is not possible.

to solution This object is achieved by a method which is the subject of 21 features. It is characterized by the fact that an identification means associated with the packaging means in an injection mold used and then molded with plastic. That's it Identification means only by damage or destruction of the Packaging accessible. Manipulations are therefore excluded.

to solution This task is also proposed a method that the in Claim 22 features. It stands out because of it from that an identification means assigned to the packaging means is housed in a recess in the packaging and this then it is closed. The closure can only be damaged or damaged destruction of the packaging opened again so that manipulations for a user readily recognizable.

Further embodiments the methods emerge from the subclaims.

The The invention will be explained in more detail below with reference to the drawing. It demonstrate:

1 a schematic diagram of a pharmaceutical packaging in side view;

2 a greatly enlarged portion of the packaging according to 1 in partial section and

3 a modified embodiment of the in 2 represented part.

The schematic diagram according to 1 shows a pharmaceutical packaging in side view. In connection with the present invention pharmaceutical packaging is addressed. By this term are meant, for example, primary packaging, in particular syringes, vials and / or cartridges, ie packaging, which come directly into contact with a pharmaceutical substance, for example, include these and are filled in a corresponding manufacturing process with them. Also covered are secondary packaging, ie packaging, which capture or enclose a primary packaging, in particular being so connected to the primary packaging, that a separation only with change, especially damage, the packaging is possible. In the following, the term packaging material also covers tertiary packaging means which, according to what has been said above, include secondary packaging in particular in such a way that removal of the secondary packaging means is possible only with alteration, in particular destruction of the tertiary packaging means or parts thereof. It is essential that secondary, tertiary and other packaging means detect or include tamper-proof packaging.

By way of example, it is assumed below that the packaging material 1 a trained as a syringe primary packaging is. It has a syringe body 3 with an approach 5 on top of which a needle holder 7 with a hypodermic needle 9 is plugged. This is covered by a protective cap 11 covered. Instead of the needle holder may be on the approach 5 also be a tamper evident attached. The embodiment of the packaging shown here 1 is chosen only as an example.

In the syringe body 3 is a plug movable in its longitudinal direction 13 introduced, which has an interior 15 in the syringe body 3 concludes. At the stopper 13 is a piston rod 17 attached, which serves the plug 13 to move in the axial direction and one in the interior 15 existing medium through the injection needle 9 expel.

At that the approach 5 opposite end of the syringe body 3 is a finger rest 19 provided here, for example by means of a cylindrical extension, which also serves as a flange 21 is designated on the syringe body 3 is attached. The piston rod 17 reaches through the finger rest 19 and is insofar freely movable. Preferably, the finger rest 19 designed so that the plug 13 not from the syringe body 3 can be pulled out and thus serves as a so-called back-stop.

At the in 1 illustrated embodiment of the packaging 1 is in the finger pad 19 an identification means 23 integrated.

The choice of accommodation is merely exemplary. It is very possible, an identification means 23 in the stopper 13 , the piston rod 17 , in the needle holder 7 , the protective cap 11 and / or to accommodate a further component of such a packaging. However, a prerequisite is that with an identification means 23 provided elements insoluble with the syringe body 3 are connected or can only be removed under damage or destruction of fasteners. This ensures that the means of identification 23 for unambiguous identification of the packaging 1 can be used.

2 shows greatly enlarged part of the packaging 1 namely a part of the finger rest 19 in cross section. This points, as well as out 1 can be seen, a syringe body, not shown here 3 surrounding flange 21 on, concentric to the central axis M of the finger rest 19 runs. This falls with the central axis of the syringe body 3 together.

Perpendicular to the flange 21 runs a the actual finger rest forming area, which extends over the peripheral surface of the syringe body 3 protrudes and serves to be able to hold this while the piston rod 17 in the interior 15 is moved.

In the enlarged view it is clear that in the embodiment shown here, the finger rest 19 an identification means 23 is housed in the actual finger rest and a chip 25 includes. The chip may have, for example, a size of 2 × 2 mm or 3 × 3 mm as a microchip. The size depends among other things on the production method.

The chip 25 may have an integrated antenna to be accessible via a high frequency reader and programmer.

At the in 2 illustrated embodiment, the antenna is not in the chip 25 integrated but as a separate antenna 27 educated. This is the chip 25 so assigned to that from the chip 25 over the antenna 27 Information can be read or vice versa via the antenna 27 Information in the chip 25 can be entered. The following should be noted: In detachably connected to the syringe body elements, protective caps 11 , Needle holder 7 , Finger pads 19 , Piston rod 17 and the like, at least the chip is allowed 25 then not housed, a possibly separate antenna 27 if the actual, the pharmaceutical containing primary packaging, here so the syringe body 3 , a chip 25 should be clearly assigned, and if the assignment is chip 25 - Pharmaceutical should not be changeable to realize a tamper-evident function.

The finger rest 19 surrounds the syringe barrel 3 , It is therefore possible to use the antenna 27 In many ways, it can be in the area of the chip 25 extend radially to the central axis M, it can form a concentric circle to the central axis M in the area forming the actual finger support or extend in a spiral to this. The length of the antenna 27 can thus be easily adapted to the frequencies by which the chip 25 is programmable or can be read from this information.

3 shows a modified embodiment of a finger rest 19 , The same parts are provided with the same reference numerals, so that reference is made to the description of the preceding figures.

This in 3 illustrated embodiment of the finger rest 19 also has a flange 21 on, concentric to the central axis M of the finger rest 19 and thus the syringe body 13 of the packaging 1 runs.

In the perpendicular to the central axis M extending portion of the finger rest 19 is the chip 25 housed, an external, separate antenna 27 having. However, this extends not only in the region perpendicular to the central axis M arranged area of the finger rest, but also in the region of the flange 21 ,

Again, it is possible, for example, the antenna 27 form practically straight, so that this runs quasi L-shaped. This is the antenna 27 partly in the region perpendicular to the central axis M arranged portion of the finger rest 19 and additionally parallel to the central axis M within the flange 21 ,

But it is also possible, the antenna ring-shaped in the cylindrical flange 21 let go, the syringe body 3 of the packaging 1 surrounds. Finally, it is possible for the antenna in the region perpendicular to the central axis M and / or in the flange 21 spiraling. It may also rectilinear, annular and / or spirally extending portions of the antenna 27 both in the 3 illustrated embodiment of the finger rest 19 be provided, as well as in the 2 illustrated embodiment of the finger rest 19 ,

The means of identification 23 can easily in the finger rest 19 installed or realized as an integral part of the same.

So it is on the one hand possible, a recess in the finger rest 19 provided, as in the 2 and 3 represented, for example, in the direction perpendicular to the central axis M extending portion of the finger rest 19 can be provided. In this recess, the chip 25 used. Subsequently, the recess is closed so that the chip 25 virtually inaccessible in the finger rest 19 is housed. This is to say that only under damage or destruction of the closure of the recording of the chip 25 is reachable. If necessary, the entire finger rest must also 19 be destroyed to the chip 25 get hold. Anyway, it is certainly avoided that on the chip 25 Manipulations are so feasible that they remain undetected for the user.

In the finger rest 19 a groove can be inserted to the antenna 27 accommodate, which consists of electrically conductive material. For example, a wire can be inserted into this groove, which is then closed so that the antenna can not be removed unnoticed. This also in this regard manipulations that are not recognizable for a user excluded.

It is preferably provided that the antenna 27 made of conductive plastic, which in one in the main body of the finger rest 19 introduced groove is housed.

Particularly preferred is an embodiment in which the with an identification means 23 provided part of the packaging 1 , here's the finger pad 19 made of plastic. In this case it is possible to use the means of identification 23 to place in an injection mold and then spray them with plastic. As the means of identification 23 into the main body of the finger rest 19 injected, it remains unattainable for manipulation. The finger rest 19 would have to be at least damaged or destroyed, which would be immediately recognizable to a user.

In this manufacturing process, which is also referred to as insert molding, the chip 25 anywhere on the finger rest 19 be housed, so not only in the perpendicular to the central axis M extending area, but also in the flange 21 ,

Particularly preferred is a finger rest 19 , which is made of plastic and the antenna 27 is realized by an electrically conductive plastic and which is produced by means of a two- or multi-component injection molding process. So that means when making the finger rest 19 becomes an antenna at the same time 27 realized that with the chip 25 directly connected or arranged opposite to this, that signals from the antenna 27 to the chip and vice versa are transferable.

Because the chip 25 It can be miniaturized, it can be practically anywhere in a packaging 1 be provided, so not only in the field of finger rest 19 but also in the protective cap 11 , the needle holder 7 , the stopper 13 and / or the piston rod 17 , Should the syringe body 3 made of plastic, could also be an identification means here 23 realized in the manner addressed here.

Is the syringe body 3 As often provided, made of glass, the antenna can 27 also be realized by a conductive area in the syringe body 3 integrated or applied to this. Antenna and chip 25 must be assigned in such a way that data transmission is possible. If necessary, it still requires a special connection, which can also be realized by conductive plastic. So it is possible, for example, a chip 25 in a first part of the packaging 1 accommodate, for example, in the flange 21 , and the associated antenna in / on the syringe body by 3 , for example by a vapor deposition method. In addition, it is possible to use the chip 25 in the finger pad 19 or in the stopper 13 to accommodate, and the antenna 27 in the piston rod 17 ,

So it is clear that the antenna is in the chip 25 can be integrated, but also a separately trained antenna 27 is feasible, either as based on the 2 and 3 explained in one and the same part of the packaging 1 is housed, as here in the finger rest 19 , But it is also possible, the chip 25 and the antenna 27 in separate parts of the packaging 1 accommodate, for example, the chip in the finger rest 19 or in the piston 13 and the antenna 27 in the syringe body 3 or in the piston rod 17 ,

The pharmaceutical packaging 1 So can in many ways with an identification means 23 be provided. It is therefore possible to realize many different security systems for pharmaceutical packaging and to tailor them to its size.

Preferably, so-called RFID chips are used in the context mentioned here, which are accessible via RF readers. It is thus possible to read information stored in the chips by means of the reader or by means of this device in the chip 25 save.

The identification means 23 can be actively designed, so be equipped with a battery, an accumulator and / or a solar cell or the like, and thus have an internal power source. It is also conceivable, passive chips 25 to realize when reading in and out of information via an integrated antenna or via the separate antenna 27 be powered so that during reading and reading data between the chip and the reader are interchangeable.

In connection with the packaging 1 can use a wide variety of identification means 23 Find use, so chips 25 that carry unchangeable data or include changeable data in addition to unchangeable data, or those that contain only changeable data.

Preference is given to chips 25 that have at least one area of immutable data that is then clearly on the chip 25 and the associated packaging 1 refer. This allows every single packaging 1 be singular and clearly assignable.

The in the chip 25 Recorded data may include information about the filling, for example a batch number, a serial number, the name of the pharmaceutical, its concentration and / or dosage.

The chip 25 can be programmed, for example, directly after filling, during assembly of the finger rest, during packaging of the packaging 1 or during another manufacturing step. Depending on the production stage, additional information can be stored. It is possible in this way to clearly trace the production process and the filling of the packaging.

The packaging 1 can be clearly identified during shipment, retailer, retailer and / or consumer, private person or hospital. In addition, information about the packaging material 1 included pharmaceutical, whose concentration and dosage are read.

It is always possible that to the preferably immutable data in the chip 25 additional information can be stored in this, if necessary.

Will be a packaging 1 with an identification means 23 For example, used in connection with metering devices, this information from the packaging 1 read to capture, for example, the pharmaceutical contained and its concentration. At the same time, such devices may contain information on the identification means 23 save to repeated use of the packaging 1 To be able to determine when the quantity of pharmaceutical contained there has been used up and in order to be able to provide it in time for replacement.

Given the fact that the means of identification 23 a very small chip 25 it is possible to use the identification means 23 at various points of a packaging 1 accommodate and thus the arrangement of, for example, the chip 25 to be chosen so that the data can be read out with the aid of a wide variety of devices. This can be the packaging 1 Test devices and / or metering devices are supplied, it can always be ensured that due to the special arrangement of the identification means 23 the information can be read out or saved trouble-free.

It is essential that in a simple way identification means 23 with packaging 1 are so combinable; that manipulations and / or removal of identification means for a user are readily apparent. This can be a very high security of use of the packaging 1 ge be ensured.

After all, it also shows that the production of the packaging 1 or of its parts is very favorable, especially when using a plastic injection process. It can not just chips 25 used in plastic parts and poured there but also be integrated into this by means of a Einsatzspritzgießverfahrens. It can both chips 25 with built-in antenna as well as chips 25 with separate antenna 27 be used. It is possible to realize the existing of electrically conductive material antenna in the way of a two- or multi-component injection molding in a simple manner.

This manufacturing method also allows the realization of very different forms of antennas 27 , so that on defined areas of parts of the packaging 1 Antennas can be arranged so that they are particularly easy to reach with readers but also for data exchange with metering can be optimally arranged.

Claims (23)

Pharmaceutical packaging, in particular syringe, vial or carpule, having an identification means, characterized in that the identification means ( 23 ) in the packaging ( 1 ) is installed inaccessible or integrated into this. Packaging according to claim 1, characterized in that the identification means ( 23 ) a chip ( 25 ). Packaging according to claim 1 or 2, characterized in that the identification means ( 23 ) comprises an integrated antenna. Packaging according to claim 1 or 2, characterized in that the identification means ( 23 ) a separate antenna ( 27 ). Packaging according to one of the preceding claims, characterized in that the chip ( 25 ) and the antenna ( 27 ) on different parts of the packaging ( 1 ) can be arranged. Packaging according to one of the preceding claims, characterized in that the antenna ( 27 ) has rectilinear, annular and / or spirally extending portions or straight, annular or spiral runs. Packaging according to one of the preceding claims, characterized in that the identification means ( 23 ) in a plastic part of the packaging ( 1 ) is built-in or integrated. Packaging according to one of the preceding claims, characterized in that the identification means ( 23 ) by means of an insert injection molding process in the packaging ( 1 ) can be installed. Packaging according to one of the preceding claims, characterized in that the antenna ( 27 ) comprises at least electrically conductive regions comprising electrically conductive plastic. Packaging according to one of the preceding claims 1 to 9, characterized in that the antenna ( 27 ) or areas thereof by means of a two- or multi-component injection molding process can be produced. Packaging according to one of the preceding claims 1 to 9, characterized in that the antenna ( 27 ) or areas thereof by means of a vapor-deposition technique can be produced. Packaging according to one of the preceding claims, characterized in that the packaging material ( 1 ) is a syringe. Packaging according to one of the preceding claims, characterized in that the chip ( 25 ) and / or the antenna ( 27 ) in a finger rest ( 19 ) the syringe is integrated or installed. Packaging according to one of the preceding claims, characterized in that the chip ( 25 ) and / or the antenna ( 27 ) in a cylindrical flange ( 21 ) of the finger rest ( 19 ) is integrated or installable. Packaging according to one of the preceding claims, characterized characterized in that the chip and / or the antenna in the syringe barrel the syringe can be integrated or installed. Packaging according to one of the preceding claims, characterized in that the chip ( 25 ) and / or the antenna ( 27 ) in the piston ( 17 ) or plug ( 13 ) or in a permanently connected to this piston rod of a syringe can be integrated or installed. Packaging according to one of the preceding claims, characterized in that the chip ( 25 ) has a fixed and / or a variable data set. Packaging according to one of the preceding claims, characterized in that the chip ( 25 ) An energy source is assigned. Packaging according to one of the preceding claims, characterized in that the chip ( 25 ) via the antenna ( 27 ) is supplied with energy. Method for producing a pharmaceutical packaging with an identification means ( 23 ) by means of the following steps: - insertion of the means of identification ( 23 ) in an injection mold, - Injection molding of the identification means with plastic. Process for the preparation of a pharmaceutical packaging ( 1 ) with an identification means ( 23 ) by means of the following steps: - insertion of the identification means ( 23 ) in a recess in the packaging ( 1 ), - closing the recess. Method according to claim 20 or 21, characterized in that the antenna ( 27 ) is produced by a two- or multi-component injection molding process. Method according to claim 20 or 21, characterized that the antenna is produced by means of a vapor deposition method.