Time-temperature tracking label

1. A time-temperature tracking and indicator system for a pharmaceutical product having a time-temperature threshold, the system comprising a label, a computing device, and a computer application, wherein:

the time-temperature threshold comprises an upper temperature threshold, an extreme upper temperature threshold, and a lower temperature threshold;

the label is configured to be attached to at least one of the product and packaging for the product, the label including:

a facestock comprising printed indicia, wherein the facestock has a thickness from about 10 to about 100 microns,

a microchip configured to store information associated with the product, the information including at least one of time data and temperature data associated with the product, wherein the microchip is configured to record time only when a temperature threshold is exceeded;

a communication apparatus configured to wirelessly communicate the information stored in the microchip to the computing device,

an indicator configured to display an initial status and a secondary status, and to provide a permanent visual indication as the secondary status for indicating that the time-temperature threshold of the product has been exceeded, wherein the indicator comprises at least one of a liquid crystal display (LCD), thermochromic ink, and electrochromic ink and

a power source for powering the microchip, the indicator, and optionally the communication apparatus; and

the computer application is executable on the computing device and configured to create manipulated information by performing operations on the information communicated to the computing device by the communication apparatus, and to output the manipulated information to indicate if the time-temperature threshold of the product has been exceeded;

wherein the indicator is visible through the facestock.

2. The system of claim 1 , wherein the manipulated information is output to the computing device and is displayed by the computing device.

3. The system of claim 1 , wherein the communication apparatus comprises a radio frequency identification (RFID) tag and the computing device comprises an RFID reader.

4. The system of claim 3 , wherein the RFID tag comprises a passive near field communication (NFC) tag and the computing device comprises an active RFID reader for interrogating the NFC tag in the label.

5. The system of claim 1 , wherein the computing device comprises a hand-held mobile device and the computer application is executable on the hand-held mobile device.

6. The system of claim 1 , wherein the microchip actuates the indicator to provide the permanent visual indication when the time-temperature threshold of the product has been exceeded.

7. The system of claim 1 , wherein the indicator is further configured to provide a visual indication of a current temperature of the product, or of an environment to which the product is exposed.

8. The system of claim 1 , wherein the indicator comprises a liquid crystal display and the liquid crystal display provides the permanent visual indication when the time-temperature threshold of the product has been exceeded.

9. The system of claim 1 , wherein the facestock, the microchip, the communication apparatus, the indicator, and the power source are in contact with an adhesive to form the label.

10. The system of claim 9 , wherein the adhesive comprises a pressure sensitive adhesive (PSA).

11. The system of claim 1 , wherein the label further comprises an adhesive layer for adhering the label to the packaging, wherein the adhesive layer comprises a pressure sensitive adhesive (PSA).

12. The system of claim 11 , wherein the label further includes a release liner removably covering the adhesive layer.

13. The system of claim 1 , wherein the microchip is configured to continuously store and compute the information associated with the product after activation.

14. The system of claim 1 , wherein the indicator is configured such that the secondary status can be selectively reset to the initial status.

15. The system of claim 1 , wherein the indicator comprises an electrochromic display.

16. The system of claim 1 , wherein the indicator is configured to provide an indication when a predetermined time interval has elapsed.

17. The system of claim 1 , wherein:

the label comprises a first label,

the system further comprises a second label, the second label including:

a facestock, and

an indicator attached to the facestock and configured to provide visual indication that the time-temperature threshold of the product has been exceeded; and

the first label is attached to an outer portion of the packaging, and

the second label is attached to an inner portion of the packaging.

18. The system of claim 1 , wherein the computer application is configured to store an elapsed time after a first use of the product.

19. The system of claim 1 , wherein the computer application is configured to provide an alert when at least one of the following is satisfied:

a. the temperature of the product, or the temperature of an environment to which the product is exposed, is not at a recommended temperature or not within a recommended temperature range, and

b. one or more predetermined time intervals have elapsed after the first use of the product.

20. A method of determining if a time-temperature threshold of a perishable pharmaceutical product has been exceeded, the method comprising:

providing a time-temperature tracking and indicator system comprising an activatable label and a computer application, the label comprising a facestock comprising printed indicia, wherein the facestock has a thickness from about 10 to about 100 microns, a microchip, a communication apparatus, an indicator, and a power source for powering the microchip, the indicator, and optionally the communication apparatus, wherein the indicator comprises at least one of a liquid crystal display (LCD), thermochromic ink, and electrochromic ink;

activating the label such that the microchip records information associated with the product only when a temperature of the product, or a temperature to which the product is exposed, is not at recommended temperature or not within a recommended temperature range, the information including at least one of time data and temperature data associated with the product, and the microchip actuates the indicator to provide a permanent visual indication when the time-temperature threshold of the product has been exceeded;

attaching the label to at least one of the product and packaging for the product, wherein the indicator is visible through the facestock;

establishing communication between the communication apparatus and a separate computing device whereby the information recorded in the microchip is wirelessly communicated to the computing device;

executing the computer application on the computing device whereby the computer application creates manipulated information by performing operations on the information communicated to the computing device, the computer application outputs the manipulated information to the computing device, and the computing device displays the manipulated information; and

assessing at least one of the indicator and the manipulated information displayed on the computing device in order to determine if the time-temperature threshold of the product has been exceeded;

wherein the time-temperature threshold comprises an upper temperature threshold, an extreme upper temperature threshold, and a lower temperature threshold.

21. The method of claim 20 , wherein the communication apparatus comprises a passive near field communication (NFC) tag and the computing device comprises an active RFID reader such that the information is wirelessly communicated when the active RFID reader interrogates the NFC tag.

22. The method of claim 20 , wherein the computing device comprises a hand-held mobile device and the computer application is executed on the hand-held mobile device.

23. The method of claim 20 , wherein the indicator is further configured to provide a visual indication of a current temperature of the product, or of an environment to which the product is exposed.

24. The method of claim 20 , wherein the indicator comprises the liquid crystal display and the liquid crystal display provides the permanent visual indication when the time-temperature threshold of the product has been exceeded.

25. The method of claim 20 , wherein the facestock, the microchip, the communication apparatus, the indicator, and the power source are in contact with an adhesive to form the label.

26. The method of claim 25 , wherein the adhesive comprises a pressure sensitive adhesive (PSA).

27. The method of claim 20 , the label comprises an adhesive layer for adhering the label to the packaging, wherein the adhesive layer comprises a pressure sensitive adhesive (PSA).

28. The method of claim 27 , wherein the label includes a release liner removably covering the adhesive layer and wherein the attaching includes adhering the label to the packaging by removing the release liner from the label to expose the adhesive layer and contacting the adhesive layer to the packaging.

29. The method of claim 20 , wherein:

the label is a first label, the first label being attached to an outer portion of the packaging;

the system further comprises a second label, the second label including:

a facestock, and

an indicator attached to the facestock and configured to provide visual indication that the time-temperature threshold of the product has been exceeded; and

the method further comprising attaching the second label to an inner portion of the packaging.

30. The method of claim 20 , wherein the computer application is configured to record an elapsed time after a first use of the product.

31. The method of claim 20 , wherein the microchip is configured to record the elapsed time after the first use of the product, and wherein the indicator is configured to provide a visual indication of the elapsed time after the first use of the product.

32. The method of claim 20 , wherein the computer application is configured to provide an alert on the computing device when at least one of the following is provided:

a. the temperature of the product, or the temperature of an environment to which the product is exposed, is not at the recommended temperature or within the recommended temperature range, and

b. one or more predetermined time intervals after the first use of the product have elapsed.

33. A method of compiling information relating a perishable pharmaceutical product contained in a series of packages and having a time-temperature threshold, the information including at least one of time data and temperature data associated with the perishable product, the method comprising:

providing a time-temperature tracking and indicator system comprising a plurality of labels and a computer application executable on a computing device, the labels each comprising a facestock comprising printed indicia, wherein the facestock has a thickness from about 10 to about 100 microns, a microchip, a communication apparatus, an indicator, and a power source for powering the microchip, the indicator, and optionally the communication apparatus, wherein the indicator comprises at least one of a liquid crystal display (LCD), thermochromic ink, and electrochromic ink;

attaching one of the labels to each package in the series of packages; wherein the indicator is visible through the facestock;

activating the labels such that the microchip records information associated with the product only when a temperature of the product, or a temperature to which the product is exposed, is not at a recommended temperature or within a recommended temperature range, the information including at least one of time data and temperature data associated with the product, and the microchip actuates the indicator to provide a permanent visual indication when the time-temperature threshold of the product has been exceeded;

establishing communication between the computing device and the communication apparatus, whereby the information recorded in the microchip is wirelessly communicated to the computing device; and

executing the computer application on the computing device whereby the information communicated to the computing device is communicated to a database to thereby compile the information relating to the product contained in the series of packages;

wherein the time-temperature threshold comprises an upper temperature threshold, an extreme upper temperature threshold, and a lower temperature threshold; and

further wherein the microchip is configured to record time only when a temperature threshold is exceeded.

34. The method of claim 33 wherein the computing device comprises a plurality of computing devices.

35. The method of claim 33 , wherein the communication apparatus comprises a passive near field communication (NFC) tag and each of the computing devices comprises an active RFID reader such that the information is wirelessly communicated when the active RFID reader interrogates the NFC tag.

36. The method of claim 33 , wherein the computing device comprises a hand-held mobile device and the computer application is executed on the hand-held mobile device.

37. The method of claim 33 , wherein each of the labels includes a release liner removably covering an adhesive layer, and wherein the attaching includes removing the release liner to expose the adhesive layer and bringing the adhesive layer into contact with a package.

38. The method of claim 33 , wherein at least one of the microchip in each of the labels and the computer application is configured to record an elapsed time after a first use of the product.

39. A time-temperature tracking and indicator label for a pharmaceutical product having a time-temperature threshold, the label comprising:

a facestock comprising printed indicia, wherein the facestock has a thickness from about 10 to about 100 microns,

a microchip configured to store information associated with the product including at least one of time data and temperature data associated with the product,

a communication apparatus configured to wirelessly communicate the information stored in the microchip to a computing device,

an indicator configured to provide a permanent visual indication that the time-temperature threshold of the product has been exceeded, wherein the indicator comprises at least one of a liquid crystal display (LCD), thermochromic ink, and electrochromic ink, and

a power source for powering the microchip, the indicator, and optionally the communication apparatus;

wherein the label is configured to be attached to at least one of the product and packaging for the product;

wherein the indicator is visible through the facestock;

wherein the time-temperature threshold comprises an upper temperature threshold, an extreme upper temperature threshold, and a lower temperature threshold; and

wherein the microchip is configured to record time only when a temperature threshold is exceeded.

40. The label of claim 39 , wherein the communication apparatus comprises a radio frequency identification (RFID) tag.

41. The label of claim 39 , wherein the RFID tag comprises a passive near field communication (NFC) tag.

42. The label of claim 39 , wherein the microchip stores the information when a temperature of the product, or a temperature of an environment to which the product is exposed, is not within a recommended temperature range of the product.

43. The label of claim 39 , wherein the microchip actuates the indicator to provide the permanent visual indication when the time-temperature threshold of the product has been exceeded.

44. The label of claim 39 , wherein the indicator is further configured to provide a visual indication of a current temperature of the product, or of an environment to which the product is exposed.

45. The label of claim 39 , wherein the indicator comprises the liquid crystal display and the liquid crystal display provides the permanent visual indication when the time-temperature threshold of the product has been exceeded.

46. The label of claim 39 , wherein the facestock, the microchip, the communication apparatus, the indicator, and the power source are in contact with an adhesive to form the label.

47. The label of claim 46 , wherein the adhesive comprises a pressure sensitive adhesive (PSA).

48. The label of claim 39 , wherein the label further comprises an adhesive layer for adhering the label to the packaging, wherein the adhesive layer comprises a pressure sensitive adhesive (PSA).

49. The label of claim 48 , wherein the label further includes a release liner removably covering the adhesive layer.

50. A time-temperature tracking and indicator system for a pharmaceutical product having a time-temperature threshold, the system comprising a label, and packaging for the product, wherein the label is attached to the packaging, the label including:

a facestock comprising printed indicia, wherein the facestock has a thickness from about 10 to about 100 microns,

a microchip configured to store information associated with the product including at least one of time data and temperature data associated with the product,

a communication apparatus configured to wirelessly communicate the information stored in the microchip to a computing device,

an indicator configured to provide a permanent visual indication that the time-temperature threshold of the product has been exceeded, wherein the indicator comprises at least one of a liquid crystal display (LCD), thermochromic ink, and electrochromic ink, and

a power source for powering the microchip, the indicator, and optionally the communication apparatus;

wherein the indicator is visible through the facestock;

wherein the time-temperature threshold comprises an upper temperature threshold, an extreme upper temperature threshold, and a lower temperature threshold; and

further wherein the microchip is configured to record time only when a temperature threshold is exceeded.

51. The system of claim 50 , wherein the packaging comprises an inner packaging and an outer packaging, wherein the label is attach to at least one of the inner packaging and the outer packaging.

52. The system of claim 50 , wherein the communication apparatus comprises a passive near field communication (NFC) tag.

53. The system of claim 50 , wherein the microchip actuates the indicator to provide the permanent visual indication when the time-temperature threshold of the product has been exceeded.

54. The system of claim 50 , wherein the label comprises a first label, the system further comprising a second label, the second label including:

a facestock, and

an indicator attached to the facestock and configured to provide visual indication that the time-temperature threshold of the product has been exceeded;

wherein the first label is attached to the outer packaging, and

wherein the second label is attached to the inner packaging.