Method and system for determining the quality of pharmaceutical products

• US 9,008,408 B2
• Filed: 02/04/2010
• Issued: 04/14/2015
• Est. Priority Date: 02/05/2009
• Status: Expired due to Fees

• Current Assignee: I Win Technology Company Limited
• Original Assignee: I Win Technology Company Limited
• Inventors: Sinbar, Eran, Weinstein, Yoav
• Primary Examiner(s): CHANG, JON CARLTON
• Application Number:
  US13/147,867
• Publication Number:
  US 20110293166A1
• Time in Patent Office: 1,895 Days
• Field of Search: None
• 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 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) in a spatial domain, processing the IR thermographic image to generate an output indicative of the quality of said material and which comprises at least one material parameter selected from the group consisting of moisture content, moisture dispersion, density, particle size, polymorphic structures, crystal structure, temperature, temperature distribution, material homogeneity, morphology, texture, coating quality, porosity, material integrity, missing material and authenticity of the material; and

(c) correlating said material parameter with a predetermined threshold parameter for said manufacturing process, said 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

(d) utilizing said output to alter the manufacturing process when said material parameter is different from said threshold parameter or is outside the range of values of said threshold parameter,

wherein said manufacturing process provides a product selected from a therapeutic product, a beverage, a cosmetic product, a food product or a food supplemental.

2. 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.

3. The method of claim 2, 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.

4. The method of claim 1, wherein said mid to very long IR wavelength comprises any wavelength in the range selected from the group consisting of from 3 μ

m to 20 μ

m, from 8 μ

m to 12 μ

m, from 7 μ

m to 14 μ

m, from 5 μ

m to 8 μ

m, and from 3 μ

m to about 5 μ

m.

5. 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.

6. 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.

7. 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 in a spatial domain said IR image to generate an output indicative of the quality of said material and which comprises at least one material parameter selected from the group consisting of moisture content, moisture dispersion, density, particle size, polymorphic structures, crystal structure, temperature, temperature distribution, material homogeneity, morphology, texture, coating quality, porosity, material integrity, missing material and authenticity of the material, wherein said processing utility is operable to correlate said material parameter with a predetermined threshold parameter for said manufacturing process, said threshold parameter comprises an essentially distinct value or a range of values representing a desired quality of the material prepared in said manufacturing process;

(c) a control unit configured to utilize said output to alter the manufacturing process when said material parameter is different from said threshold parameter or is outside the range of values of said threshold parameter;

wherein said manufacturing process provides a product selected from a therapeutic product, a beverage, a cosmetic product, a food product or a food supplemental.

8. The system of claim 7, 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.

9. The system of claim 7, wherein said mid to very long IR wavelength comprise any wavelength in the range selected from the group consisting of from 3 μ

m to 20 μ

m, from 8 μ

m to 12 μ

m, from 7 μ

m to 14 μ

m, from 5 μ

m to 8 μ

m, and from 3 μ

m to about 5 μ

m.

10. The system of claim 7, 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.

11. The system of claim 10, 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.

12. The system of claim 7, 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.