Monitoring product integrity of a pharmaceutical product in a syringe using a miniaturized electronic sensor tag

Abstract

The package for a pharmaceutical product includes a syringe and an electronic tag for obtaining information relating to the integrity of the product as assessed from an exposure of said product to physical or environmental conditions during a time span. The tag is attached at or to a constituent of the syringe; or at least a portion of the tag is integrated in a constituent of the syringe. The tag includes an electronics unit having a control unit, a sensor unit having at least one sensor for monitoring the physical or environmental conditions, a display unit having a display for displaying data relating to the integrity referred to as status data and a switch. The control unit is structured and configured for effecting that the display unit displays the status data in reaction to an operation of the switch.

Claims

1. A package for a pharmaceutical product, said package comprising a syringe; an electronic tag for obtaining information relating to the integrity of the product as assessed from an exposure of said product to physical or environmental conditions during a time span; wherein said tag is attached at or to a constituent of said syringe; and said tag comprising a main part comprising an electronics unit comprising a control unit; a sensor unit comprising at least one sensor for monitoring said physical or environmental conditions; a display unit comprising a display for displaying data relating to said integrity referred to as status data; and wherein a foil bonded to said constituent of said syringe holds said main part between itself and said constituent of said syringe.

2. The package according to claim 1, wherein said constituent of said syringe is a plunger top.

3. The package according to claim 1, wherein said constituent of said syringe is a barrel of said syringe.

4. The package according to claim 1, wherein said constituent of said syringe is a constituent of a plunger arrangement of said syringe.

5. The package according to claim 1, wherein said foil is a polymer foil.

6. The package according to claim 1, wherein said main part is sandwiched between said foil and said constituent of said syringe.

7. The package according to claim 1, wherein the package comprises a pressing surface for operating said syringe by pressing against said pressing surface, and wherein said pressing surface is provided by said tag, and wherein said switch is structured and arranged in such a way that it is operated when pressure is exerted against said pressing surface for operating the syringe.

8. The package according to claim 1, wherein said foil is bonded to said constituent of said syringe via a bonding material.

9. The package according to claim 1, wherein said foil is bonded to said constituent of said syringe in an area partially surrounding said main part.

10. The package according to claim 1, wherein said display unit comprises one or more light emitters for emitting light pulses, and wherein said status data is encoded in a sequence of light pulses emitted by said one or more light emitters.

11. A packaged pharmaceutical product, comprising a package according to claim 1 and said pharmaceutical product, wherein said pharmaceutical product is contained in said syringe.

12. A method for manufacturing a package for a pharmaceutical product, the method comprising the steps of A) providing at least one constituent of a syringe for applying said pharmaceutical product; B) providing an electronic tag for obtaining information relating to the integrity of said product as assessed from an exposure of said product to physical or environmental conditions during a time span; the method further comprising the step of C) attaching said tag to said at least one constituent of said syringe; wherein said electronic tag comprises a main part and step C) comprises bonding a foil to said at least one constituent of said syringe to hold said main part between itself and said at least on constituent of said syringe.

13. A method according to claim 12, wherein step C) comprises sandwiching said main part between said foil and said at least one constituent of said syringe.

14. A method for monitoring an integrity of a pharmaceutical product, the method comprising the steps of a) providing a syringe; b) providing an electronic tag attached at or to a constituent of said syringe, said syringe comprising a barrel, said barrel containing said pharmaceutical product; said tag being a tag for obtaining information relating to the integrity of said product as assessed from an exposure of said product to physical or environmental conditions during a time span, the tag comprising a main part comprising an electronics unit comprising a control unit; a sensor unit comprising at least one sensor for monitoring said physical or environmental conditions; a display unit comprising a display for displaying data relating to said integrity referred to as status data; wherein a foil bonded to said constituent of said syringe holds said main part between itself and said constituent of said syringe.

15. The method according to claim 14, wherein said constituent of said syringe is a barrel of said syringe or is a constituent of a plunger arrangement of said syringe.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Below, the invention is described in more detail by means of examples and the included drawings. The figures show schematically:

(2) FIG. 1 a top view onto an electronic tag;

(3) FIG. 2 a cross-sectional view of an attached electronic tag;

(4) FIG. 3 a cross-sectional view of an attached electronic tag;

(5) FIG. 4 a symbolic cross-sectional view of a package;

(6) FIG. 5 an illustration of sequences of light pulses emittable by an electronic tag;

(7) FIG. 6 a top view onto an electronic tag;

(8) FIG. 7 an illustration of method steps;

(9) FIG. 8 an illustration of method steps;

(10) FIG. 9 a strongly schematized illustration of a tag attached at a plunger top by containing the plunger top;

(11) FIG. 10 a strongly schematized illustration of a plunger top with integrated tag;

(12) FIG. 11 a strongly schematized illustration of an assembly step inserting a plunger rod into a housing portion of a tag;

(13) FIG. 12 a strongly schematized illustration of a constituent of a plunger assembly including plunger top and plunger rod and integrating a foldable housing for an electronic tag;

(14) FIG. 13 a strongly schematized illustration of a plunger top integrating a foldable housing for an electronic tag;

(15) FIG. 14 a strongly schematized illustration of a plunger top integrating a foldable housing for an electronic tag;

(16) FIG. 15 a perspective view onto an assembly including a plunger top/plunger rod part and a housing of an electronic tag;

(17) FIG. 16 a different perspective view onto the assembly of FIG. 15;

(18) FIG. 17 a perspective view onto an assembly including a plunger top/plunger rod part and an electronic tag;

(19) FIG. 18 a perspective view onto an assembly of a plunger top/plunger rod part and an electronic tag;

(20) FIG. 19 a perspective view onto the assembly of FIG. 18, but with open housing.

(21) FIG. 20 a perspective view onto a portion of the assembly of FIGS. 18 and 19.

DETAILED DESCRIPTION OF THE INVENTION

(22) The described embodiments are meant as examples and shall not limit the invention.

(23) FIG. 1 shows a schematized top view onto an electronic tag 1. Tag 1 includes a temperature sensor or a sensor for some other physical or environmental condition. The tag can monitor that magnitude and decide whether or not certain (prescribed) conditions concerning that magnitude are met, e.g., whether or not a threshold value has been exceeded and possibly also for how long it has been exceeded. Depending on the monitored (sensed or measured) values (of temperature, pressure, humidity, acceleration or others and usually also of the time), one or more types of alarm indications can be provided by the tag, depending on the type of event or failure that occurred. Since such functionalities are known from prior art, we will not go into much detail here concerning this point.

(24) Tag 1 of FIG. 1 includes a main part 2 and a rip strip 3, which are mutually interconnected. The main part 2 typically has a volume of at most 35 mm30 mm12 mm, in particular having a side length of, at most, the specified lengths, and more particularly, it may have a volume of at most 25 mm20 mm10 mm, and in particular a side length of, at most, the specified lengths.

(25) The main part 2 includes an electronics unit including i.a. a user-operable switch 9 (cf. the dotted hand symbol in FIG. 1) and a display 6 substantially consisting of two light emitters 7, 8 such as two LEDs, in particular a red LED and a green LED. The rip strip 3 substantially consists of a printed circuit board (PCB) or of a piece or part thereof and more particularly of PCB base material 4 in and/or on which conductor lines 5 are present. It is particularly suitable to provide, as the rip strip 3, an electrically insulating foil 4 such as a polymer foil provided with conductor lines 5.

(26) In fact, the electronics unit (having reference symbol 40 in further figures) and the rip strip 3 may be considered to share one printed circuit board. And the electronics unit 40 may be considered to be a printed circuit board assembly (PCB assembly or PCBA), i.e. a PCB with components mounted thereon (the components being described above and also below), wherein the PCB forming the rip strip 3 is continuous with the PCB of the PCBA representing the electronics unit 40.

(27) FIG. 2 shows a schematic cross-sectional view of an attached electronic tag 1, and at the same time, FIG. 2 may be interpreted to show a schematized detail of a package 10 including a syringe (the syringe bearing reference numeral 70 in further figures). The tag 1 of FIG. 2 may be identical with the one of FIG. 1.

(28) Tag 1 includes electronics unit 40 in its main part 2 and rip strip 3, each including a portion of one and the same PCB, which may be a flexible PCB.

(29) Tag 1 and, more particularly, main part 2 includes a housing 41 in which electronics unit 40 is present. Electronics unit 40 includes, besides the PCB and mounted thereon, an energy source such as a battery 42, the above-mentioned switch 9, which may be, e.g., an electro-mechanical switch or a capacitive switch, the light emitters of the display (only LED 7 being illustrated in FIG. 2) and an integrated circuit (IC) 44 such as an ASIC (application-specific IC). IC 44 may embody a control unit and a sensor unit, but it is also possible that a separate sensor unit is mounted on the PCB.

(30) It is possible that data sensed by a sensor of the sensing unit are continuously (or quasi-continuously) taken, but usually, measuring or sensing takes place in time intervals of between 30 seconds and 12 hours, more particularly between 1 minute and 30 minutes, so as to save energy.

(31) Housing 41 may be made substantially of a material which is sufficiently transparent for letting light emitted by light emitters 7, 8 of tag 1 pass through such that it is visible from the outside, or may include, as indicated in FIG. 2, a transparent or (particularly) thin portion 49 for that purpose.

(32) In order to attach tag 1 to a tag carrier 11 such as a constituent of a syringe, e.g., a plunger top, a double-faced adhesive tape 15 may be used. An alternative would be to use a different bonding technique such as the application of an initially liquid bonding material such as a glue. A bonding may take place between the housing 41 and the tag carrier 11, and it is possible, as indicated in FIG. 2, to provide that it takes place, in addition, between the battery 42 and the tag carrier 11. In the latter case, the adhesive tape 15 or other bonding material may function as a part of the housing of the tag 1.

(33) An alternative way of attaching tag 1 to a tag carrier 11 is illustrated in FIG. 3. In the embodiment of FIG. 3, the tag may be identical with the one of FIG. 1, and its electronics unit 40 may be identical with the one of FIG. 2. However, the attaching of main part 2 to tag carrier 11 is accomplished in an indirect way. More specifically: A foil 18 such as a polymer foil holds main part 2 between itself and tag carrier 11. In an area partially surrounding main part 2, foil 18 is bonded to tag carrier 11 using a bonding material such as a glue (indicated at 19 in FIG. 3, but not separately drawn). Thus, main part 2 is sandwiched between foil 18 and tag carrier 11.

(34) Suitable tag carriers 11 are constituents of a syringe to be provided with a tag, e.g., the barrel of the syringe or a constituent of the plunger arrangement of the syringe. Below, a plunger top will be described as a possible tag carrier, but also a barrel of a syringe will be described as a possible tag carrier.

(35) A pharmaceutical product (later referenced by reference numeral 24) to be monitored by means of the tag is contained in the syringe, more particularly in a barrel of the syringe. The pharmaceutical product usually will be provided in liquid form, so as to be injectable using the syringe.

(36) FIG. 4 is a symbolic cross-sectional view of a two-level package 10 and of a corresponding packaged pharmaceutical product 24. Pharmaceutical product 24 is contained in a barrel 72 of syringe 70. Syringe 70 includes barrel 72 and needle hub 74 (also referred to as adaptor) and plunger assembly 75. Plunger assembly 75 includes plunger seal 79 and plunger rod 78 and plunger top 77.

(37) Syringe 70 is contained in a blister-type package 22 usually made of a polymer (and possible also paper-type material) which again is contained in a box 12, which typically is a folding carton. Instead of such a two-level package 10, also a single-level package might be used for packaging product 24, e.g., providing box 12 only (and no blister-type bag) and providing a blister-type package 22 only (and no additional box).

(38) Whatever constitutes the outer-most package level (in FIG. 4 it is box 12) intended for the end-user (typically patient or health care professional), it may be provided that therein, no further syringe but one single syringe is present. For example, in a folding carton, one syringe (and not more than one) may be present, however, it is possible that, in addition, one or two or more containers each containing another pharmaceutical product are present inside the folding carton, e.g., one or more vials. This may, in particular, be useful in case that the pharmaceutical products are vaccines (such as different vaccines for a single person/patient).

(39) It is to be noted that it is possible that inside a package, e.g., inside a folding carton or a blister-type package, two or more parts (or constituents) of the syringe are separate, i.e. disassembled. In particular, the plunger top (including the tag) and the plunger rod (or a portion of the plunger rod) may be one part which is separate from another part which establishes the barrel and the plunger seal (and possibly also a portion of the plunger rod). Before use, the syringe then has to be assembled from the separate parts.

(40) Providing a disassembled syringe can allow to package the syringe (including the tag) in a smaller outer package, e.g., a smaller folding carton. And an accidental pressing of the pharmaceutical product out of the barrel may be largely inhibited.

(41) A tag 1, e.g., a tag like described elsewhere in the present patent application, e.g., in FIG. 1 or 2, is attached to syringe 70 and more particularly to plunger top 77. As indicated by dotted lines, it is also possible to provide another tag 1 (which includes a main part 2 and a rip strip 3) at a different constituent of syringe 70, e.g., as illustrated, at barrel 72. In particular, it may be provided that in one folding box (such as folding box 12 in FIG. 4), exactly one syringe is present (and no further syringe).

(42) Bag 22 is a container which usually is at least partially constituted by a polymer foil, in particular by transparent polymer foil.

(43) A tag 1, e.g., one as described above, and, more particularly, the corresponding electronics unit 40 can be structured and configured for detecting an interruption of a conductor line loop of rip strip 3, e.g., by cutting rip strip 3 using a cutting tool or by ripping rip strip 3 by hand. And, moreover, this may result in a termination of the monitoring (and of the measurements and of the sensing) being accomplished (or at least evaluated) by the tag 1.

(44) Accordingly, it can be provided that monitoring the integrity of a product 24 is carried out from a starting event to an end point. The starting event can be, e.g., when syringe 70 is packaged in an outer package (in particular into a folding box), or when syringe 70 is assembled (with product 24 in barrel 72), or when product 24 is filled into barrel 72. The end point may be indicated by a ripping of rip strip 3. And this ripping can be linked to an accessing of product 24, e.g., by prescribing (to a user such as a patient or a health care specialist) that rip strip 3 has to be ripped when box 12 is opened or when the syringe is about to be used (for giving a shot). This way, it can be ensured to some extent that the monitoring of the integrity of product 24 is terminated when product 24 is accessed. The integrity status of product 24 may, also in reaction to the ripping, be stored in tag 1 such that it can be recalled later (namely by operating switch 9, cf. FIGS. 1-3) and/or may be displayed by the display 6 of tag 1, e.g., by the emission of light pulses.

(45) A beginning of the time span during which the physical or environmental conditions are monitored may be indicted by breaking another loop present on rip strip 3, cf. also FIG. 7 below. For example, dividing the rip strip of FIG. 1 along the dashed line s2 (and thus opening the longer one of the two loops present on rip strip 3) may be detected by electronics unit 40 (and more particularly by a control unit realized therein) by an increase of an ohmic resistance and make the electronics unit 40 start the monitoring. On the other hand, dividing the rip strip of FIG. 1 along the dashed line s1 (and thus opening the shorter one of the two loops present on rip strip 3; the longer one being already open) may be detected by electronics unit 40 (and more particularly by a control unit realized therein) by an increase of an ohmic resistance and make the electronics unit 40 terminate (stop) the monitoring.

(46) Alternatively, the monitoring can be started differently, cf. below at the description of FIG. 8 (initiating switch). In that case, a single conductor line loop may be sufficient, and rip strip 3 may remain unripped at least until after packaging, i.e. at least up to forwarding/shipping the packaged pharmaceutical product 24. Furthermore, rip strip 3 (cf. FIG. 6) might in general be dispensed with. In that case, the tag is substantially identical with its main part.

(47) As is clear from the above, a display 6 of a tag 1 may include (an in particular essentially consist of) one or more light emitters such as LEDs, in particular light emitters of different color, e.g., one emitting red light and another emitting green light. A control unit of tag 1, e.g., an integrated circuit, e.g., the one of FIGS. 2, 3, may control the display 6 to emit light pulses, more particularly sequences of light pulses (wherein already a single light pulse shall be considered a sequence of light pulses). Emitted light pulses in a sequence may differ in at least one of color, duration, intensity. Assuming that color is a parameter which can be varied for displaying integrity status information, generally, the emission of green light may be emitted in order to indicate that the product integrity is still in order, and the emission of red light may be emitted in order to indicate that the product integrity is not in order anymore.

(48) Assuming that in addition, the duration (of a pulse in a sequence) is a parameters which can be varied for displaying integrity status information, it can be provided, e.g., that two or more types of alarm (or types of failures) are indicated by different pulse durations. An example will be illustrated and described by means of FIG. 5.

(49) FIG. 5 is an illustration of sequences of light pulses emittable by an electronic tag 1 such as by an above-described tag 1. The curves a to e illustrate different sequence which may be emitted in 5 different cases, i.e. in five different integrity statuses. The horizontal axis is the time axis, the vertical axis is the light intensity axis, intensities being either zero or a maximum value.

(50) One way of distinguishing three types of failures (one, two or three of which may have occurred and thus may have to be indicated when displaying the integrity status) works as follows:

(51) If a failure of a first type has occurred, a single short red pulse is emitted (cf. curve a).

(52) If a failure of a second type has occurred, a two short red pulses are emitted (cf. curve b).

(53) If failures of both, first and second type, have occurred, a three short red pulses are emitted (cf. curve c).

(54) If a failure of a third type has occurred, a single long red pulse is emitted (cf. curve d).

(55) If, in addition to a failure of the third type, a failure of the first and/or a failure of the second type has occurred, the (partial) sequence for the additional failure(s) is appended to the long red light pulse indicating the third type failure. Curve e indicates the case that a failure of a first type and a failure of a third type have occurred.

(56) A failure of first type may mean, e.g., that an upper temperature limit T(up) has been exceeded.

(57) A failure of second type may mean, e.g., that a lower temperature limit T(low) has been fallen short of

(58) A failure of third type may mean, e.g., that a threshold temperature limit T(thr) has been exceeded (or fallen short of) for a too long time, more particularly for more than a prescribed threshold time t(thr).

(59) Such a kind of data indicative of prescribed limitations of a product, e.g., T(up), T(low), T(thr) and t(thr), are usually stored in the electronics unit. They may be programmable in a way described further above in the present patent application. If programming pads are provided for programming such values, these may in particular be provided on the rip strip. FIG. 6 illustrates a possible design of a rip strip with contact pads for programming such values.

(60) FIG. 6 shows an illustration of a top view onto an electronic tag 1. This tag 1 can be largely identical with other tags described in the present patent application, such as tag 1 of FIG. 1, but the rip strip 3 is designed to provide two contact pads 60, 66. While conductor lines 5 form two loops L1, L2 which may (as illustrated) partially overlap and are readily interrupted by ripping rip strip 3 along separation lines s1, s2, conductor line 50 provides an electrical connection between pad 60 and the electronics unit of tag 1, and conductor line 55 provides an electrical connection between pad 66 and the electronics unit of tag 1. Via contact pads 60, 66, data indicative of prescribed limitations of a product to be monitored (such as the above-mentioned T(up), T(low), T(thr) and t(thr)) may be programmed before ripping rip strip 3 along s1 or s2.

(61) In the process of packaging pharmaceutical products, a (high) number of such tags 1 may be present, and an arbitrary one of them is selected for the next product, and thenwhen the type of product to be packaged is knownthe data indicative of prescribed limitations of that specific product for the exposure of that specific product to the monitored physical or environmental conditions are programmed (using pads 60 and 66). This way, in a single packaging line, the provision of a single type of tag 1 can be sufficient for packaging (and monitoring) in that packaging line a plurality of different products (with different prescribed limitations). Accordingly, storing various different types of tags, each specifically designed for the different products to be packaged (set to the respective specific prescribed limitations for the exposure of the product to the physical or environmental conditions), may become superfluous this way.

(62) And starting the monitoring by opening loop L2, e.g., by cutting along line s2, will simultaneously make a reprogramming of tag 1 difficult, thus impeding tampering with the tag.

(63) If product integrity is in order, this may be indicated by one or more green light pulses. It is, more specifically, possible to distinguish different types of (still-)in-order statuses. For example, in a first case, a single green pulse is emitted, cf., e.g., curve a or curve e. And in a second case, two green pulses are emitted, cf., e.g., curve b, or more than two pulses are emitted, or green and red pulses are emitted.

(64) The first (still-)in-order status case may be, e.g., that no threshold value has been reached. In case a temperature is monitored, this would be the case, e.g., if the temperature never left the range at which the product may be kept virtually forever or (as more often will be the case) until its expiration date.

(65) The second (still-)in-order status case may be, e.g., that for more than a pre-selected time duration, a threshold value has been exceeded and fallen short of, respectively, (depending on the threshold being an upper and a lower threshold value, respectively). For example, in case a temperature is monitored, this would be the case, e.g., if the temperature of the product may be above an upper threshold of, e.g., 37 C. for at most, e.g., 72 hours, and an alarm is desired as soon as only 24 hours or less are left (24 hours being the pre-selected time duration). If then the temperature has in fact been above 37 C. for already more than 48 hours, such that the product will be in order for only less than 24 hours (provided that its temperature will remain above 37 C.), the second (still-)in-order status shall be indicated.

(66) FIG. 7 illustrates method steps. Reference symbol t denotes the time, dt denotes the time span during which monitoring takes place. In steps 100, 110, the time span during which integrity monitoring shall take place is started by interrupting a first electrical contact, e.g., by opening a conductor line loop, cf. also dashed line s2 in FIG. 1. Operating switch 9 during the subsequent time span (step 120) results in a displaying of the status data (step 130).

(67) Interrupting another electrical contact (cf. step 140) results in terminating the time span and the monitoring (step 150), obtaining the final status data (step 160) and displaying the final status data (step 170). When later on, switch 9 is operated (step 180), the final status data are displayed (step 190).

(68) It is to be noted that usually, the status data will not be permanently displayed, but only when the switch 9 is operated; and optionally also when the time span (and thus the monitoring) is terminated and/or optionally in (regular) time intervals (controlled by the control unit), the time intervals being usually between 1 second and 2 minutes, more particularly between 10 seconds and 1 minute.

(69) FIG. 8 is another illustration of method steps, similar to the one of FIG. 7. It illustrates an example for the case that no switch is required for displaying the status data. Instead, the status data are displayed periodically, before and after terminating the monitoring, cf. steps 230 and 290. And FIG. 8 also illustrates an example for the case that monitoring is started without needing a rip strip for that purpose. Instead, the monitoring is started in reaction to the operation of a switch, referred to as initiating switch, cf. step 200. It can be referred to FIG. 2 for illustrating a corresponding electronic tag 1, wherein the item referenced 9 in this case is interpreted as such an initiating switch, i.e. as a switch, when operated, effecting that the monitoring starts. Such a switch may be an electro-mechanical switch, a capacitive switch, a magnetic switch or an inductive switch. Note that it is possible to nevertheless provide in this case a rip stripin particular for the purpose of terminating the monitoring. But alternatives thereto are possible, e.g., a switch (e.g., the before-mentioned initiating switch) may be provided for that purpose.

(70) Otherwise, the method and the corresponding package and tag may be as described elsewhere herein.

(71) Note that the initiating switch may in particular be a magnetic or inductive switch. For example, the manufacturing of the retail package or retail unit may include moving the same along a path along which a suitable magnet (permanent or electromagnet) and a suitable coil, respectively, is suitably positioned, e.g., along a path described by a conveyor transporting the retail package or retail unit. Then, while passing along the respective magnetic or electric field, the initiating switch is operated (without mechanically contacting the tag), and the monitoring starts. However, the initiating switch might also be an electro-mechanical or a capacitive switch, the latter also allowing a contact-free operation.

(72) Of course, it is also possible to provide in the embodiment of FIG. 8 the before-described switch by means of which a displaying of the status data can be initiated (display switch). This switch (sufficiently described above) may be identical with the initiating switch or be an additional switch. In case the switches are identical, it may be provided that different effects may be provoked by differently operating the switch. For example, a brief operation of the switch (e.g., for at most 1.5 seconds) provokes a displaying of the status data, whereas a longer operation (e.g., for at least 3 seconds) can effect that the monitoring starts. Moreover, the function of the rip strip (for terminating the monitoring) may also be assumed by the switch, e.g., termination of monitoring is in that case effected in reaction to operating the switch for an even longer time (e.g., for at least 8 seconds). In this case, the rip strip may be dispensed with.

(73) Instead of bonding the tag 1 to a part of the syringe 70, tag 1 can be attached thereto in a different manner or even be integrated, at least in part, therein. The following examples basically refer to the plunger top as a syringe constituent to or at which the tag is attached or in which a part of the tag, such as in particular a housing of the tag, is integrated. But other constituents of the syringe may also be used for attaching or integrating the tag.

(74) FIG. 9 illustrates in a strongly schematized manner a tag 1 attached at a plunger top 77 by containing the plunger top 77. The tag can be a tag as described elsewhere herein, e.g., in FIG. 1 or 2. The housing 41, symbolized by thick lines, has an opening through or into which plunger rod 78 extends.

(75) PCB 34 of tag 1 is present between battery 42 and the electronic components of tag 1.

(76) In order to be able to insert electronics unit 40 into housing 41, the latter may be dividable into two (or possibly more) parts, e.g., along the dotted line in FIG. 9.

(77) Plunger rod 78 may be fixed to plunger top 77, e.g., by a threading (not illustrated in FIG. 9).

(78) However, plunger rod 78 may alternatively be integrally formed with plunger top 77, e.g., the two being a single injection molded part. In this case, for assembling housing 41 and the plunger top/plunge rod part, the lower half of housing 41 (which has the above-mentioned hole) may be pushed over the plunger rod, with the hole, from the free end of plunger rod 78. With the two housing halves still separate, electronics unit 40 can be inserted into housing 41, and then, housing 41 can be closed, which in addition attaches tag 1 to plunger top 77.

(79) FIG. 10 is a strongly schematized illustration of a plunger top 77 with integrated tag 1. In this case, plunger top 77 constitutes a housing 41 for at least a portion of tag 1, in particular for electronics unit 40. If a rip strip is comprised in a tag, the rip strip will usually not be housed by a housing 41. A part illustrated in FIG. 10 fulfills the functions of both, being the plunger top for or of a syringe, and being a housing for at least a portion of an electronic tag.

(80) The housing 41 of FIG. 10 may be dividable into two (or possibly more) parts, e.g., along the dotted line in FIG. 10.

(81) The housing in FIG. 9 and also the housing 41 in FIG. 10 may be integrally formed, e.g., being a single molded part.

(82) FIG. 11 is a strongly schematized illustration of an assembly step inserting a plunger rod 78 into a housing portion 46 of a tag 1. FIG. 11 can be seen in conjunction with FIG. 9, since in both cases, a plunger rod 78 may have to be inserted into an opening of a housing part (referenced 46 in FIG. 11), so as to provide that a plunger top 77 is present inside a housing 41 of a tag 1, whereas a plunger rod 78 extends out of the housing 41. With the opening being designed as sketched in FIG. 11, plunger rod 78 can be entered sideways. This can be useful in particular if a plunger seal is present at an end of the plunger rod 78 which cannot be removed, e.g., the plunger assembly already being assembled with the barrel of the syringe.

(83) FIGS. 12 to 14 can be seen in conjunction with FIG. 10, since they concern the configuration in which a part of the tag is integrated in a part of the plunger assembly, more particularly in the plunger top 77. In FIGS. 12 to 14, the housing 41 includes a first housing portion 45 and a second housing portion 46 which are interconnected by a folding portion 47. All these parts may be integrally formed. They may, e.g., be a single injection molded part.

(84) FIG. 12 is a strongly schematized illustration of a constituent of a plunger assembly including plunger top 77 and plunger rod 78 and integrating a foldable housing 41 for an electronic tag 1. In this case, housing 41, plunger top 77 and plunger top 78 are integrally formed. Plunger rod 78 may have, as illustrated in FIG. 12, an outer threading 48 for connecting it to a plunger seal. Other ways of establishing the connection may be provided, e.g., bonding, and a plunger seal may also be integrated.

(85) FIG. 13 is a strongly schematized illustration of a plunger top 77 integrating a foldable housing 41 for an electronic tag 1. In this case, plunger top 77 includes an outer threading 48 for attaching a plunger rod. Also here, other ways of establishing the desired connection may be applied, e.g., bonding.

(86) FIG. 14 is a strongly schematized illustration of a plunger top 77 integrating a foldable housing 41 for an electronic tag 1, wherein in this case, plunger top 77 includes an inner threading 43 for attaching a plunger rod. Also here, other ways of establishing the desired connection may be applied, e.g., bonding.

(87) FIG. 15 is a perspective view onto an assembly of a plunger top 77/plunger rod 78 part (which in particular may be integrally formed, cf. also the description concerning FIGS. 9 and 11) and a housing 41 of an electronic tag 1. Plunger rod 78 is pushed through the opening in a second portion 46 of housing 41. The second portion 46 is foldable onto a first portion 45 of housing 41. The two housing portions are interconnected by a folding portion 47 of housing 41, which may be resilient due to its (reduced) thickness, or the material of which housing 41 is made is (generally) sufficiently resilient.

(88) First housing portion 45 provides two transparent portions which may be windows (in particular be having a reduced thickness) or openings (not drawn in FIG. 16). LEDs of a display unit of an electronics unit to be inserted into housing 41 are better visible this way.

(89) In addition, housing 41 provides a flexible portion 38 which is defined by a slit in housing 41. A switch of an electronics unit to be inserted into housing 41 can be more easily approached this way. Pushing the flexible portion 38 from outside housing 41 can allow to readily operate a switch positioned below the flexible portion 38.

(90) The two housing portions 45, 46 can be designed to establish a snap fit. This way, housing 41 can be readily closed (after inserting the electronics unit), and a well-defined alignment of the housing parts can be achieved this way.

(91) FIG. 16 is a different perspective view onto the assembly of FIG. 14. In this view, the inside of housing 41 can be seen. Plunger top 77 is present inside housing 41.

(92) Housing 41 includes another opening, referenced 37, through which a rip strip (if present in the tag) may extend out of housing 41.

(93) Furthermore, housing 41 provides a holder or fixture for a constituent of the tag, in particular for a battery of the tag. For establishing this, e.g., protrusions 39 like illustrated in FIG. 16, e.g., ribs, may be provided.

(94) FIG. 17 is a perspective view onto an assembly of a plunger top 77/plunger rod 78 part and an electronic tag 1. FIG. 17 may be understood as the assembly of FIGS. 15 and 16, but including the tag 1. Housing 41 is closed, portions 45 and 46 are snapped into each other, and the electronics unit 40 is inserted. A rip strip 3 of tag is extends out of housing 41.

(95) FIG. 18 is a perspective view onto an assembly of a plunger top 77/plunger rod 78 part and an electronic tag 1. A first way of interpreting FIG. 18 is to understand it as another view of the assembly of FIG. 17.

(96) However, the assembly of FIG. 18 can also be understood, in a second interpretation, as illustrating an example for an integrated tag. In this case, housing 41 establishes plunger top 77 or, vice versa, plunger top 77 establishes housing 41 of the tag 1. Thus, a single integrally formed part may include housing 41 (including all its parts) and plunger top 77 and, optionally also plunger rod 78. FIGS. 12 to 14 schematically various possible variations.

(97) FIG. 19 is a perspective view onto an assembly of FIG. 18, but with housing 41 open. It may be interpreted in the same two ways as FIG. 18 can be interpreted.

(98) Electronics unit 40 and its constituents are well visible in FIG. 19. Battery 42 is connected to PCB 34 via two contacts 35. Battery contact leads may be bonded to battery 42 which lead to the contacts 35.

(99) At flexible portion 38, a protrusion 38a may be provided which facilitates operating switch 9 (with housing 41 closed).

(100) FIG. 20 is a perspective view onto a portion of the assembly of FIGS. 18 and 19. In FIG. 20, housing portion 46 is not drawn, but housing portion 45 is. The electronics unit 40 is inserted in housing portion 45. Since, in the embodiments of FIGS. 16, 19 and 20, battery clamping takes place in housing portion 45, insertion of electronics unit 40 is accomplished rather in the way suggested by in FIG. 20 than in FIGS. 16 and 19.

(101) A battery contact lead 33 contacting battery 42 is visible in FIG. 20.

(102) Described arrangements of the tag and the switch at the plunger top allow to make sure that a person about to use (operate) the syringe will, practically inevitably, effect a display of the integrity status. Pressing against the plunger top or a portion of the tag present there for pressing some of the pharmaceutical product or air present in the syringe out of the syringe can result in operating the switch (display switch), such that the integrity status is displayed. In case the display indicates that the pharmaceutical product has been exposed to detrimental conditions, an injection of (probably) perished medication can be avoided.

(103) The tag, the package and the packaged pharmaceutical product described in the present patent application are easy to use and operable by untrained personnel, i.e. by people not specifically instructed on how to use the tag, the package, the packaged pharmaceutical product, as far as the integrity monitoring is concerned. Patients and health care specialists who apply or use the pharmaceutical product can, without additional measures and without the need of additional tools, check the integrity of the product to be applied or used. And this can be accomplished (at least approximately) at the time when the product is applied or used. Suitably positioning the tag and in particular the (display) switch can make a display of status data (practically) unavoidable at the time the syringe (and the pharmaceutical product) is about to be used, cf. above.

(104) It can happen that pharmaceutical products are returned from the acquirer or user (e.g., patient or health care specialist) to the manufacturer or the distributor without having been used. This sometimes is the case, e.g., in case of particularly valuable products.

(105) If the product is returned to the manufacturer or distributor, the manufacturer or distributor can check the integrity status of the product by using the tag. Based thereon, it can, e.g., be decided whether or not to forward the product to another acquirer or user.

(106) Independently of having checked the integrity status or not, it may be provided that the manufacturer or distributor forwards the product to another acquirer or user. That other acquirer or user can then (e.g., when the product is about to be applied) check the integrity status of the product using the herein described tag and the package, respectively.

(107) It shall be noted that the tag, the package and the packaged pharmaceutical product provide standalone solutions which do not require further equipment, at least not for having the integrity status of the product displayed. And the attaching of the tag to the syringe can be accomplished by the manufacturer or by the packaging company packaging the product in a box.

(108) The tag may consist of merely:

(109) an electronics unit; and

(110) a PCB (typically a flexible PCB) forming, if present, the rip strip, and the PCB on which the components of the electronics unit are mounted; wherein the electronics unit may consist merely of:

(111) a switch (and possibly also a second switchnamely, e.g., for starting the monitoring);

(112) one or more, typically two, light emitters, typically LEDs;

(113) an integrated circuit (embodying at least the control unit); and

(114) an energy source such as a battery;

(115) wherein, if the one or more sensors are not integrated in the integrated circuit, at least one sensor is, in addition, comprised, too, in the electronics unit, and

(116) wherein optionally up to four capacitors and/or up to four resistors may be comprised, too, in the electronics unit. And typically, all components comprised in the electronics unit are mounted on the PCB, more precisely on one and the same PCB.

(117) Note that the PCB can be sufficient for electrically contacting the energy source (battery), cf. FIGS. 2, 3, such that no separate battery holder or battery holder leads needs to be provided. However, the battery may be contacted by one or more (typically two) contact leadswhich again are operationally (and usually galvanically) connected to the PCB, cf. FIGS. 19, 20.

(118) And note furthermore, that it is possible that the rip strip is dispensed with (at least in its function as providing a means for starting the monitoring) and/or the switch may be dispensed with (at least in its function as a means for requesting a displaying of the status data, and this at least for times not coinciding with the time of terminating the monitoring).

(119) A display of an above-described kind can be particularly small and cost-efficient. There is no need for a liquid crystal display or the like.