METHODS FOR QUALITY CONTROL

• US 20070160814A1
• Filed: 12/20/2006
• Published: 07/12/2007
• Est. Priority Date: 06/20/2005
• Status: Active Grant

• Current Assignee: Authentiform Technologies, LLC
• Original Assignee: Authentiform Technologies, LLC
• Inventors: Mercolino, Thomas
• Granted Patent: US 8,247,018 B2
• Time in Patent Office: Days
• US Class Current: 428/195.100
• 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 for quality control of surface coating of a product in a manufacturing process comprising the steps of:

a) associating a population of entities with coating medium of the product, wherein the counts or relative counts of entities correlate with deposition of at least one coating medium on the article;

b) analyzing the product to obtain a measured value of the counts, relative counts, and/or uniformity of deposition of a least one such population of entities;

c) comparing the measured counts, relative counts, and/or uniformity of deposition of entities with a corresponding expected counts, relative count, and/or uniformity of deposition acceptance value; and

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

2. The method of claim 1, wherein the product has multiple surface coatings.

3. The method of claim 1, wherein the entities of any particular surface coating have one or more discretely measurable common properties that are shared by entities within said coating, but not by entities within any other coating of the product.

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 1, wherein the product is a medical device or a consumer product.

16. A method of authenticating a coated product according to claim 1, 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 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 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;

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.

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 18, 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 23, 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 28, wherein the product is a medical device or a consumer product.

31. 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 counts or relative counts of entities per cluster, wherein a signature array that comprises information about the counts or relative counts of entities of the at least two distinct clusters of entities is recorded;

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.

32. The method of claim 31, wherein recorded information about the product is selected from the amount, concentration, or presence or absence of a product component.

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 34, 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 39, 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 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 counts or relative counts of entities per cluster and wherein the 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;

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.

47. The method of claim 46, wherein the environmental stimulus is a maximum acceptable temperature, a minimum acceptable temperature, a maximum acceptable humidity, a minimum acceptable humidity, a maximum acceptable level of electromagnetic radiation

48. 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.

49. The method of claim 46, wherein the one or more discretely measurable common properties are properties of one or more tags associated with the entities.

50. The method of claim 49, 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.

51. 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.

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

53. The method of claim 52, wherein the microparticles are labeled with at least two discretely measurable fluorescent dyes.

54. The method of claim 53, wherein the at least two discretely measurable fluorescent dyes are present on the same microparticle.

55. The method of claim 53, wherein the microparticles are labeled with a fluorescent dye in at least two detectable different intensity levels.

56. 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.

57. The method of claim 46, 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.

58. The method of claim 46, wherein the product is a solid pharmaceutical product.

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

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

61. 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 counts or relative counts of entities per cluster, wherein a signature array that comprises information about the counts or relative counts of entities of the at least two distinct clusters of entities is recorded;

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.

62. The method of claim 61 further comprising the step of performing steps b and c in-line during a manufacturing labeling operation.

63. The method of claim 61, wherein the container also incorporates a signature array for matching with the signature array of the label.

64. The method of claim 61, 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 61, wherein the machine-readable feature is a bar code.

66. The method of claim 61, 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 61, 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 61, 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 61, 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 72, wherein the microparticles are labeled with a fluorescent dye in at least two detectable different intensity levels.

74. The method of claim 61, 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.

76. The method of claim 61, wherein the product is a medical device, a pharmaceutical product or a consumer product.

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

78. The method of claim 61, further comprising the steps of:

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

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

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

79. The method of claim 78 further comprising the step of performing steps b and c in-line during a manufacturing labeling operation.

80. The method of claim 78, wherein the container and or the label further comprises machine-readable features for matching with any or all signature arrays.

81. The method of claim 78, wherein the machine-readable feature is a bar code.

82. The method of claim 78, 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.

83. The method of claim 78, wherein the one or more discretely measurable common properties are properties of one or more tags associated with the entities.

84. The method of claim 78, 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.

85. The method of claim 78, 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.

86. The method of claim 78, wherein the population of entities comprises microparticles.

87. The method of claim 86, wherein the microparticles are labeled with at least two discretely measurable fluorescent dyes.

88. The method of claim 87, wherein the at least two discretely measurable fluorescent dyes are present on the same microparticle.

89. The method of claim 87, wherein the microparticles are labeled with a fluorescent dye in at least two detectable different intensity levels.

90. The method of claim 78, 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.

91. The method of claim 78, wherein the product is a medical device, a pharmaceutical product, or a consumer product.

92. The method of claim 78, wherein the entities are bioabsorbable and non-toxic in amounts used.