METHOD AND SYSTEM FOR DETERMINING THE QUALITY OF PHARMACEUTIAL PRODUCTS

• US 20110293166A1
• Filed: 02/04/2010
• Published: 12/01/2011
• Est. Priority Date: 02/05/2009
• Status: Active Grant

• Current Assignee: I Win Technology Company Limited
• Original Assignee: I Win Technology Company Limited
• Inventors: Sinbar, Eran, Weinstein, Yoav
• Granted Patent: US 9,008,408 B2
• Time in Patent Office: Days
• US Class Current: 382/141
• CPC Class Codes: G01N 21/3554 for determining moisture content
• CPC Class Codes: G01N 21/85 Investigating moving fluids or granular solids
• CPC Class Codes: G01N 21/9508 Capsules; Tablets
• CPC Class Codes: G01N 25/72 Investigating presence of flaws
• CPC Class Codes: G01N 33/02 Food
• CPC Class Codes: G01N 33/14 Beverages
• CPC Class Codes: G01N 33/15 Medicinal preparations ; Physical properties thereof, e.g. dissolubility drug screening with animal cells G01N33/5008
• CPC Class Codes: H04N 23/11 for generating image signals from visible and infrared light wavelengths

Abstract

Thermographic imaging is used to monitor quality parameters of pharmaceutical products (108 in a manufacturing process.

Claims

1. A method for determining quality of material obtained in a manufacturing process comprising:

(a) generating an infrared (IR) thermographic image of said material by an IR detector operable to sense, in its field of view, radiation of said material in a mid to very long IR wavelength;

(b) processing the IR thermographic image to generate an output indicative of the quality of said material; and

(c) displaying said output or utilizing said output to alter the manufacturing process or a combination of same.

2. The method of claim 1, wherein said manufacturing process provides a product selected from a therapeutic product, a beverage, cosmetic product, chemical product, a food product or food supplemental, fuel.

6. The method of claim 1, wherein said thermographic image is generated by active thermography and said active thermography comprises applying onto said material a single thermal pulse or a sequence of two or more thermal pulses.

7. The method of claim 6, wherein said thermal pulse is selected from heating said material, cooling said material, cooling followed by heating of said material and heating followed by cooling said material.

11. The method of claim 1, wherein said mid to very long IR wavelength comprises any wavelength from 3 μ

m to about 5 μ

m.

12. The method of claim 1, wherein said IR image is generated by said IR detector in combination with an optical arrangement for focusing said radiation of said material on the IR detector.

15. The method of claim 1, where said IR image is combined with one or more images of said material obtained in the NIR, VIS, UV.

16. The method of claim 1, wherein said output is selected from said IR image or at least one material parameter selected from moisture content, moisture dispersion, density, particle size, polymorphic structures, crystal structure, temperature, temperature distribution, material homogeneity, morphology, texture, coating quality, porosity, authenticity of the material or a combination of image and said at least one material parameter.

17. The method of claim 16, comprising correlating said material parameter with a predetermined threshold parameter for said manufacturing process, the threshold parameter comprises an essentially distinct value or a range of values representing a desired quality of the material prepared in said manufacturing process, and generating from said correlation the said output,

when said material parameter is different from said threshold parameter, said output indicates a defect in said material;

and

when said material parameter is within said threshold parameter, said output indicates that the material has a desired quality.

3-5. -5. (canceled)

8-10. -10. (canceled)

13-14. -14. (canceled)

18-24. -24. (canceled)

25. A system for determining quality of material obtained in a manufacturing process comprising:

(a) an IR image generating device comprising an IR detector operable to sense, in its field of view, radiation of said material in a mid to very long IR wavelength and to generate therefrom a respective IR thermographic image of said material;

(b) a processing utility for processing said IR image to generate an output indicative of the quality of said material;

(c) a control unit configured to display said output or to utilize said output to alter the manufacturing process or a combination thereof.

27. The system of claim 25, wherein said thermographic image is generated by an active thermography and said system comprises a thermal pulse generator operable to apply at least one thermal pulse onto said material, the thermal pulse source is configured to apply onto said material a single thermal pulse or a sequence of two or more thermal pulses.

32. The system of claim 25, wherein said mid to very long IR wavelength comprises any wavelength from 3 μ

m to about 5 μ

m.

36. The system of claim 25, wherein said processing utility is operable to:

generate an output that comprises said IR image or at least one material parameter selected from moisture content, moisture dispersion, density, particle size, polymorphic structure, crystal structure, temperature, temperature distribution, material homogeneity, morphology, texture, coating quality, porosity, authenticity of the material, missing material, material integrity, or a combination of said IR image and said at least one material parameter; and

correlate said material parameter with a predetermined threshold parameter for said manufacturing process, and to generate therefrom said output.

38. The system of claim 25, comprising a memory comprising a database of predetermined threshold parameters of manufacturing processes, each threshold parameter is an essentially distinct value or a range of values representing a desired quality of a material to be obtained in a manufacturing process associated with said predetermined threshold, and said material parameter is correlatable with a threshold parameter from said database.

39. The system of claim 38, wherein said database of predetermined threshold parameters comprises for each threshold parameter an essentially distinct value or a range of values representing a desired quality of a material to be obtained in a manufacturing process associated with said predetermined threshold.

40. The system of claim 25, wherein said control unit is configured to receive said output and display said output, alter said manufacturing process or a combination of same.

43. The system of claim 40, wherein when said output is indicative of a defect in said material, said control unit is operable to alter said manufacturing process by one or more of ceasing the process, repeating the process, directing the material to a different manufacturing process, altering process conditions.

51. The method of claim 25, wherein said reference package is an image of an authentic package.

26. (canceled)

28-31. -31. (canceled)

33-35. -35. (canceled)

37. (canceled)

41-42. -42. (canceled)

44-47. -47. (canceled)

48. A method for determining authenticity of a package or quality of a package comprising:

(a) generating one or more images of said package by a visible (VIS) detector, near IR (NIR) detector, ultraviolet (UV) detector, ultrasound (US) detector, MWIR detector or Terahertz detector operable to detect, in its field of view, said package, wherein when said one or more images is generated by a VIS detector or by the NIR detector, said package is illuminated during image generation and wherein when said one or more images is generated by a VIS detector said illumination is by UV light;

(b) comparing said one or more images of said package with a reference package; and

(c) displaying said comparison or a quantitative value indicative of said comparison, thereby enabling determination of the authenticity of said package.

49-50. -50. (canceled)