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

• US 9,750,868 B2
• Filed: 07/02/2014
• Issued: 09/05/2017
• Est. Priority Date: 07/03/2013
• Status: Active Grant

• Current Assignee: Berlinger & Co. AG
• Original Assignee: Q-Tag, AG
• Inventors: Tobescu, Corneliu
• Primary Examiner(s): Alunkal, Thomas
• Application Number:
  US14/901,742
• Publication Number:
  US 20160151558A1
• Time in Patent Office: 1,161 Days
• CPC Class Codes: A61J 1/18 Arrangements for indicating condition of container contents, e.g. sterile condition
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3327 Measuring
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6027 Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: G06K 19/0717 the sensor being capable of sensing environmental conditions such as temperature history or pressure
• CPC Class Codes: G06K 19/07345 by activating or deactivating at least a part of the circuit on the record carrier, e.g. ON/OFF switches
• CPC Class Codes: G06K 19/07705 the visual interface being a single light or small number of lights capable of being switched on or off, e.g. a series of LEDs
• CPC Class Codes: G06K 19/07711 the interface being an audio interface
• CPC Class Codes: G06K 19/07798 part of the antenna or the integrated circuit being adapted for rupturing or breaking, e.g. record carriers functioning as sealing devices for detecting not-authenticated opening of containers electronic seals G09F3/03
• CPC Class Codes: G09F 3/02 Forms or constructions layered products B32B

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

I) said tag is attached at or to a constituent of said syringe;

or

II) at least a portion of said tag is integrated in a constituent of said syringe;

and wherein said tag comprises 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;

a switch;

wherein said control unit is structured and configured for effecting that said display unit displays said status data in reaction to an operation of said switch.

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 a housing of said tag is integrated in said constituent of said syringe.

4. The package according to claim 1, wherein the tag is attached to or at said constituent of the syringe, and wherein at least a portion of said constituent of the syringe is contained in the tag or in a constituent of the tag, more specifically in a housing of the tag.

5. The package according to claim 3, wherein and said housing and said constituent of said syringe are integrally formed.

6. The package according to claim 4, wherein said constituent of said syringe is a plunger top, the syringe comprising a plunger rod, wherein a constituent of the tag has an opening, said plunger rod extending into or through said opening.

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 the tag comprises a housing comprising a first and a second housing portion which are mutually attachable by establishing a snap fit with one another.

9. The package according to claim 1, wherein the tag comprises a rip strip comprising a breakable electrical connection operationally connected to said control unit.

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.

17. The package according to claim 9, wherein a breaking of said breakable electrical connection indicates the end of said time span or the beginning of said time span.

18. The package according to claim 1, wherein said data is encoded in one or more of

the color of the light pulses;

a duration of the light pulses;

the number of the light pulses in the sequence.

12. A device, comprising

a plunger top for use in or with a syringe for applying a pharmaceutical product;

and

an electronic tag for obtaining information relating to the integrity of a product as assessed from an exposure of said product to physical or environmental conditions during a time span;

wherein

I) said tag is attached at or to said plunger top;

or

II) at least a portion of said tag is integrated in said plunger top; and

wherein said tag comprises 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;

a switch;

wherein said control unit is structured and configured for effecting that said display unit displays said status data in reaction to an operation of said switch.

13. A device, comprising a plunger top for use in or with a syringe for applying a pharmaceutical product, wherein said plunger top establishes a housing suitable for receiving at least a portion of an electronic tag for obtaining information relating to the integrity of a product as assessed from an exposure of said product to physical or environmental conditions during a time span;

and wherein said tag comprises 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;

a switch;

wherein said control unit is structured and configured for effecting that said display unit displays said status data in reaction to an operation of said switch.

14. 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

CI) attaching said tag to said at least one constituent of said syringe;

or the step of

CII) integrating at least a portion of said tag in a constituent of said syringe;

and wherein said tag comprises 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;

a switch;

wherein said control unit is structured and configured for effecting that said display unit displays said status data in reaction to an operation of said switch.

15. A method according to claim 14, comprising the step of manufacturing a unitary or an integrally formed part which establishes said constituent of the syringe and an openable housing for at least a part of the tag.

16. A method for monitoring an integrity of a pharmaceutical product, the method comprising the steps of

a) providing a syringe;

b) providing

I) an electronic tag attached at or to a constituent of said syringe;

or

II) an electronic tag at least a portion of which is integrated in 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 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;

a switch;

wherein said control unit is structured and configured for effecting that said display unit displays said status data in reaction to an operation of said switch.