Methods for quality control

• US 8,247,018 B2
• Filed: 12/20/2006
• Issued: 08/21/2012
• Est. Priority Date: 06/20/2005
• Status: Active Grant

• Current Assignee: Authentiform Technologies, LLC
• Original Assignee: Authentiform Technologies, LLC
• Inventors: Mercolino, Thomas J.
• Primary Examiner(s): Yuan, Dah-Wei
• Assistant Examiner(s): BOWMAN, ANDREW J
• Application Number:
  US11/613,437
• Publication Number:
  US 20070160814A1
• Time in Patent Office: 2,071 Days
• Field of Search: 250/302, 250/556, 250/483.1, 250/492.1, 235/462.01, 235/462.1, 235/462.11, 235/462.16, 235/462.25, 235/375, 215/232, 700/225, 229/3.5, 436/524, 382/115
• US Class Current: 427/2.1
• CPC Class Codes: G01N 2021/8427 Coatings
• CPC Class Codes: G01N 21/643 non-biological material
• CPC Class Codes: G01N 21/8422 Investigating thin films, e.g. matrix isolation method
• CPC Class Codes: G09F 13/20 with luminescent surfaces or parts luminescent compositions C09K11/00; light sources using luminescence F21K2/00
• CPC Class Codes: G09F 3/00 Labels, tag tickets, or similar identification or indication means medals or badges A44C3/00; making labels B31D1/02; sheets temporarily attached together B42F; labelling B65C; labels on record carriers G11B23/38, G11B23/40; Seals; Postage or like stamps
• CPC Class Codes: Y10T 428/24802 Discontinuous or differential coating, impregnation or bond [e.g., artwork, printing, retouched photograph, etc.]

Abstract

The present invention relates to method for quality control of surface coated objects used independently or in conjunction with product authentication; methods for assuring proper product handling; methods for assuring that product contents'"'"' match product'"'"'s label, comprising the use of microparticulate taggants having different detectable physical properties, wherein each combination of properties is used as an encoding bit to create codes.

Claims

1. A method of authenticating a coated product, comprising the steps of:

a) associating a population of entities with the product, wherein the population comprises at least two distinct clusters of entities having detectable absolute counts or relative counts of entities per cluster;

b) assigning a signature array of the population of entities to the product as a product authentication code, wherein the signature array comprises information about the absolute counts or relative counts of entities of at least two distinct clusters of entities within the population;

wherein information about the signature array and the product authentication code is recorded and wherein absolute count is the count or number measured in all or a portion of said coated product and relative count is a ratio between two or more absolute counts;

c) analyzing the product to obtain a measured signature array of the population of entities associated with the product;

d) comparing the measured signature array with that which is expected based on the recorded information; and

e) accepting the product as authenticated when the measured signature array matches that which is expected.

2. The method of claim 1, wherein recorded information about the product is selected from the amount, concentration, or presence or absence of a product component.

3. The method of claim 1, wherein each of the at least two distinct clusters of entities has one or more discretely measurable common properties that are shared by entities within said cluster, but not by entities within any other cluster.

4. The method of claim 3, wherein the one or more discretely measurable common properties are properties of one or more tags associated with the entities.

5. The method of claim 4, wherein the one or more tags associated with the entities is selected from the group consisting of:

colors, fluorescent dyes, ultraviolet radiation dyes, luminescent compositions, microparticles, haptens, nucleotides, polypeptides, scents, and a combination thereof.

6. The method of claim 3, wherein the one or more discretely measurable common properties of the entities are the size of the entities, the style of the entities, or the shape of the entities.

7. The method of claim 1, wherein the population of entities comprises microparticles.

8. The method of claim 7, wherein the microparticles are labeled with at least two discretely measurable fluorescent dyes.

9. The method of claim 8, wherein the at least two discretely measurable fluorescent dyes are present on the same microparticle.

10. The method of claim 8, wherein the microparticles are labeled with a fluorescent dye in at least two detectable different intensity levels.

11. The method of claim 1, wherein the population of entities comprises one or more types of entities selected from the group consisting of microparticles, nucleic acid molecules, peptides, polypeptides, hapten, or a combination thereof.

12. The method of claim 1, wherein during the step of associating a population of entities with the product, the population is associated with the product by incorporation on or in the coating medium of the product.

13. The method of claim 1, wherein the product is a solid pharmaceutical product.

14. The method of claim 1, wherein the entities are bioabsorbable and non-toxic in amounts used.

15. The method of claim 13, wherein the product is a medical device or a consumer product.

16. A method for quality control and release of products from a manufacturing process, comprising the steps of:

a) associating a population of entities with a product during the manufacturing process, wherein the population of entities comprises at least two distinct clusters of entities having detectable absolute counts or relative counts of entities per cluster, wherein a signature array that comprises information about the absolute counts or relative counts of entities of the at least two distinct clusters of entities is recorded and wherein absolute count is the count or number measured in all or a portion of said product thereof and relative count is a ratio between two or more absolute counts;

b) analyzing the product to obtain a measured signature array of the population of entities associated with the product;

c) comparing the measured signature array with that which is expected based on the recorded information; and

d) releasing products manufactured by the manufacturing process when the measured signature array matches that which is expected.

17. The method of claim 16, wherein recorded information about the product is selected from the amount, concentration, or presence or absence of a product component.

18. The method of claim 16, wherein each of the at least two distinct clusters of entities has one or more discretely measurable common properties that are shared by entities within said cluster, but not by entities within any other cluster.

19. The method of claim 16, wherein the one or more discretely measurable common properties are properties of one or more tags associated with the entities.

20. The method of claim 19, wherein the one or more tags associated with the entities is selected from the group consisting of:

colors, fluorescent dyes, ultraviolet radiation dyes, luminescent compositions, microparticles, haptens, nucleotides, polypeptides, scents, and a combination thereof.

21. The method of claim 16, wherein the one or more discretely measurable common properties of the entities are the size of the entities, the style of the entities, or the shape of the entities.

22. The method of claim 16, wherein the population of entities comprises microparticles.

23. The method of claim 22, wherein the microparticles are labeled with at least two discretely measurable fluorescent dyes.

24. The method of claim 23, wherein the at least two discretely measurable fluorescent dyes are present on the same microparticle.

25. The method of claim 24, wherein the microparticles are labeled with a fluorescent dye in at least two detectable different intensity levels.

26. The method of claim 16, wherein the population of entities comprises one or more types of entities selected from the group consisting of microparticles, nucleic acid molecules, peptides, polypeptides, hapten, or a combination thereof.

27. The method of claim 16, wherein during the step of associating a population of entities with the product, the population is associated with the product by incorporation on or in the coating medium of the product.

28. The method of claim 16, wherein the product is a solid pharmaceutical product.

29. The method of claim 16, wherein the entities are bioabsorbable and non-toxic in amounts used.

30. The method of claim 16, wherein the product is a medical device or a consumer product.

31. A method for assuring the proper handling of a product comprising the steps of:

a) associating a population of entities with a product during a manufacturing process, wherein the population of entities comprises at least two distinct clusters of entities having detectable absolute counts or relative counts of entities per cluster and wherein the absolute counts or relative counts of entities within at least one of said clusters changes in response to exposure of the product to an environmental stimulus and wherein absolute count is the count or number measured in all or portion of said product and relative count is a ratio between two or more absolute counts;

b) analyzing the product to obtain a measured value of the counts of said cluster(s) that change(s) in response to exposure of the product to an environmental stimulus;

c) comparing the measured counts with a corresponding expected counts acceptance value; and

d) releasing products manufactured by the manufacturing process when the measured value is within an acceptable range of the expected value.

32. The method of claim 31, wherein the environmental stimulus is a maximum acceptable temperature, a minimum acceptable temperature, a maximum acceptable humidity, a minimum acceptable humidity, or a maximum acceptable level of electromagnetic radiation.

33. The method of claim 31, wherein each of the at least two distinct clusters of entities has one or more discretely measurable common properties that are shared by entities within said cluster, but not by entities within any other cluster.

34. The method of claim 31, wherein the one or more discretely measurable common properties are properties of one or more tags associated with the entities.

35. The method of claim 31, wherein the one or more tags associated with the entities is selected from the group consisting of:

colors, fluorescent dyes, ultraviolet radiation dyes, luminescent compositions, microparticles, haptens, nucleotides, polypeptides, scents, and a combination thereof.

36. The method of claim 31, wherein the one or more discretely measurable common properties of the entities are the size of the entities, the style of the entities, or the shape of the entities.

37. The method of claim 31, wherein the population of entities comprises microparticles.

38. The method of claim 37, wherein the microparticles are labeled with at least two discretely measurable fluorescent dyes.

39. The method of claim 38, wherein the at least two discretely measurable fluorescent dyes are present on the same microparticle.

40. The method of claim 38, wherein the microparticles are labeled with a fluorescent dye in at least two detectable different intensity levels.

41. The method of claim 31, wherein the population of entities comprises one or more types of entities selected from the group consisting of microparticles, nucleic acid molecules, peptides, polypeptides, hapten, or a combination thereof.

42. The method of claim 31, wherein during the step of associating a population of entities with the product, the population is associated with the product by incorporation on or in the coating medium of the product.

43. The method of claim 31, wherein the product is a solid pharmaceutical product.

44. The method of claim 31, wherein the entities are bioabsorbable and non-toxic in amounts used.

45. The method of claim 31, wherein the product is a medical device or a consumer product.

46. A method for minimizing the occurrence of packaging mismatch errors comprising the steps of:

a) associating a population of entities with a product label to be applied to a container during a manufacturing process, wherein the population of entities comprises at least two distinct clusters of entities having detectable absolute counts or relative counts of entities per cluster, wherein a signature array that comprises information about the absolute counts or relative counts of entities of the at least two distinct clusters of entities is recorded and wherein absolute count is the count or number measured in all or portion of said product and relative count is a ratio between two or more absolute counts;

b) determining that the signature array is consistent with proper match between the label and the container; and

c) rejecting labeled containers that are determined to be mismatched.

47. The method of claim 46 further comprising the step of performing steps b and c in-line during a manufacturing labeling operation.

48. The method of claim 46, wherein the container also incorporates a signature array for matching with the signature array of the label.

49. The method of claim 46, wherein the container and or the label further comprises machine-readable features for matching with any or all signature arrays.

50. The method of claim 49, wherein the machine-readable feature is a bar code.

51. The method of claim 46, wherein each of the at least two distinct clusters of entities has one or more discretely measurable common properties that are shared by entities within said cluster, but not by entities within any other cluster.

52. The method of claim 51, wherein the one or more discretely measurable common properties are properties of one or more tags associated with the entities.

53. The method of claim 52, wherein the one or more tags associated with the entities is selected from the group consisting of:

colors, fluorescent dyes, ultraviolet radiation dyes, luminescent compositions, microparticles, haptens, nucleotides, polypeptides, scents, and a combination thereof.

54. The method of claim 46, wherein the one or more discretely measurable common properties of the entities are the size of the entities, the style of the entities, or the shape of the entities.

55. The method of claim 46, wherein the population of entities comprises microparticles.

56. The method of claim 55, wherein the microparticles are labeled with at least two discretely measurable fluorescent dyes.

57. The method of claim 56, wherein the at least two discretely measurable fluorescent dyes are present on the same microparticle.

58. The method of claim 57, wherein the microparticles are labeled with a fluorescent dye in at least two detectable different intensity levels.

59. The method of claim 46, wherein the population of entities comprises one or more types of entities selected from the group consisting of microparticles, nucleic acid molecules, peptides, polypeptides, hapten, or a combination thereof.

60. The method of claim 46, wherein the product is a medical device, a pharmaceutical product or a consumer product.

61. The method of claim 46, wherein the entities are bioabsorbable and non-toxic in amounts used.

62. The method of claim 46, further comprising the steps of:

a) associating the signature array with the bulk of a product prior to filling the labeled containers;

b) determining whether or not the signature array is consistent with proper match between the product bulk and the container; and

c) rejecting filled containers for which the signature array is determined not to be consistent with proper match between the label and the container.

63. The method of claim 62 further comprising the step of performing steps b and c in-line during a manufacturing labeling operation.

64. The method of claim 62, wherein the container and or the label further comprises machine-readable features for matching with any or all signature arrays.

65. The method of claim 62, wherein the machine-readable feature is a bar code.

66. The method of claim 62, wherein each of the at least two distinct clusters of entities has one or more discretely measurable common properties that are shared by entities within said cluster, but not by entities within any other cluster.

67. The method of claim 66, wherein the one or more discretely measurable common properties are properties of one or more tags associated with the entities.

68. The method of claim 67, wherein the one or more tags associated with the entities is selected from the group consisting of:

colors, fluorescent dyes, ultraviolet radiation dyes, luminescent compositions, microparticles, haptens, nucleotides, polypeptides, scents, and a combination thereof.

69. The method of claim 66, wherein the one or more discretely measurable common properties of the entities are the size of the entities, the style of the entities, or the shape of the entities.

70. The method of claim 62, wherein the population of entities comprises microparticles.

71. The method of claim 70, wherein the microparticles are labeled with at least two discretely measurable fluorescent dyes.

72. The method of claim 71, wherein the at least two discretely measurable fluorescent dyes are present on the same microparticle.

73. The method of claim 71, wherein the microparticles are labeled with a fluorescent dye in at least two detectable different intensity levels.

74. The method of claim 62, wherein the population of entities comprises one or more types of entities selected from the group consisting of microparticles, nucleic acid molecules, peptides, polypeptides, hapten, or a combination thereof.

75. The method of claim 62, wherein the product is a medical device, a pharmaceutical product, or a consumer product.

76. The method of claim 62, wherein the entities are bioabsorbable and non-toxic in amounts used.