Acoustic and video imaging system for quality determination of pharmaceutical products

• US 5,422,831 A
• Filed: 02/15/1994
• Issued: 06/06/1995
• Est. Priority Date: 08/03/1992
• Status: Expired due to Fees

• Current Assignee: Iowa State University Research Foundation Incorporated (Iowa State University)
• Original Assignee: Iowa State University Research Foundation Incorporated (Iowa State University)
• Inventors: Misra, Manjit K., Shyy, Yuh-Yuan
• Primary Examiner(s): Cosimano, Edward R.
• Application Number:
  US08/196,844
• Time in Patent Office: 476 Days
• Field of Search: 356/407, 364/552, 382/1, 382/8
• US Class Current: 702/81
• CPC Class Codes: B07C 5/34 Sorting according to other particular properties material testing per se G01N; quality control G07C3/14
• CPC Class Codes: G01N 29/045 by imparting shocks to the workpiece and detecting the vibrations or the acoustic waves caused by the shocks measuring resonant frequency G01H13/00; measuring strength properties by application of mechanical stress G01N3/00
• CPC Class Codes: G01N 33/15 Medicinal preparations ; Physical properties thereof, e.g. dissolubility drug screening with animal cells G01N33/5008
• CPC Class Codes: G06T 2207/30128 Food products
• CPC Class Codes: G06T 7/0004 Industrial image inspection
• CPC Class Codes: G06T 7/13 Edge detection

Abstract

A flexible system for determining the quality of pharmaceutical products based on characteristics such as, for example, mass, shape, hardness, size, color and surface texture is disclosed herein. The quality determination apparatus includes a feeder assembly for sequentially dropping individual product samples upon an impact transducer arrangement. The impact transducer generates transducer signals indicative of the physical characteristics of each product sample. In addition, an imaging device operates to synthesize a digital image representation of each product sample. The transducer signal and digital image representation corresponding to each product are analyzed so as to determine the appropriate degree of quality to be associated therewith.

Claims

1. An apparatus for determining quality of a pharmaceutical product of a predefined type, comprising:

impact transducer means for generating a transducer signal indicative of a set of physical characteristics representative of composition of said product;

imaging means for synthesizing a digital image representation of physical appearance of said product; and

signal processing means for analyzing said transducer signal and said digital image representation in accordance with a transducer impact signal routine and an image analysis routine respectively;

whereby, based on results of said transducer impact signal and image analysis routines, a degree of quality is associated with said pharmaceutical product.

2. The apparatus of claim 1 wherein said predefined type is included within the set consisting of pharmaceutical pills, pharmaceutical tablets, and pharmaceutical capsules.

3. The apparatus of claim 1 wherein said acoustical transducer means further includes a drop tube feeder apparatus for dropping said pharmaceutical product upon said transducer.

4. The apparatus of claim 3 wherein said imaging means includes camera means for providing an image of said pharmaceutical product and for digitizing said image so as to create said digital image representation.

5. The apparatus of claim 1 wherein said physical characteristics include mass and hardness.

6. The apparatus of claim 5 wherein said digital image representation includes information pertaining to shape and boundary roughness of said pharmaceutical product.

7. The apparatus of claim 6 wherein said signal processing means includes means for determining said shape of said pharmaceutical product based on said digital image representation, said shape determining means including means for identifying a portion of said digital image representation as corresponding to an edge of said pharmaceutical product and means for determining a center of said product relative to said edge.

8. The apparatus of claim 7 wherein said signal processing means includes means for determining roughness of said pharmaceutical product by plotting separation between predefined sections of said edge and said center and comparing said plot with a reference plot.

9. The apparatus of claim 5 wherein said acoustical transducer means includes an impact transducer, said transducer signal being generated in response to impact of said pharmaceutical product upon said transducer.

10. The apparatus of claim 9 wherein said signal processing means includes means for performing a time-domain analysis of said transducer signal.

11. The apparatus of claim 10 wherein said time-domain analysis means includes means for detecting a peak region of said transducer signal, wherein magnitude of said transducer signal at said peak region corresponds to said mass of said pharmaceutical product.

12. The apparatus of claim 11 wherein a slope of said peak signal at a predefined magnitude thereof corresponds to said hardness of said pharmaceutical product.

13. A method for determining quality of a pharmaceutical product of a predefined type comprising the steps of:

dropping said product upon an impact transducer, said transducer being disposed to generate a transducer signal indicative of a set of physical characteristics representative of composition of said product;

creating an image of said product;

digitizing said image and creating a digital image representation of said product;

storing said digital image representation in computer memory;

analyzing said transducer signal and digital image representation in accordance with a transducer impact signal routine and an image analysis routine respectively;

whereby, based on results of said transducer impact signal and image analysis routines, a degree of quality is associated with said pharmaceutical product.

14. The method of claim 13 wherein said digital image representation includes information pertaining to at least one characteristic included within the set of product characteristics consisting of surface texture, area and color.

15. The method of claim 13 wherein said step of analyzing includes the step of determining said shape of said pharmaceutical product based on said digital image representation, said shape determining step including the steps of:

identifying a portion of said digital image representation as corresponding to an edge of said pharmaceutical product, and

determining a center of said product relative to said edge.

16. The method of claim 15 wherein said step of analyzing includes the step of determining boundary roughness of said pharmaceutical product by plotting separation between predefined sections of said edge and said center and comparing said plot with a reference plot.

17. The method of claim 16 wherein said predefined type is included within the set consisting of pharmaceutical pills, pharmaceutical tablets and pharmaceutical capsules.

18. The method of claim 13 wherein said physical characteristics include mass and hardness.

19. The method of claim 18 wherein said digital image representation includes information pertaining to shape and boundary roughness of said pharmaceutical product.

20. The method of claim 19 wherein said step of analyzing includes the step of performing a time-domain analysis upon said transducer signal.

21. The method of claim 20 wherein said time-domain analysis step includes the step of detecting a peak region of said transducer signal, wherein magnitude of said transducer signal at said peak region corresponds to said mass of said pharmaceutical product.

22. The method of claim 21 wherein said time-domain analysis step includes the step of determining the slope of said transducer signal at a predefined magnitude thereof wherein said slope corresponds to said hardness of said pharmaceutical product.