DETECTION AND CHARACTERIZATION OF DEFECTS IN PHARMACEUTICAL CYLINDRICAL CONTAINERS

Abstract

An apparatus for inspecting a pharmaceutical cylindrical container made of glass or of a polymer is provided. A corresponding method for inspecting the pharmaceutical cylindrical container made of glass or of a polymer and to a bundle of pharmaceutical cylindrical containers made of glass or of a polymer is also provided.

Claims

1. An apparatus for inspecting a pharmaceutical cylindrical container made of glass or polymer, the apparatus comprising: a support device configured to support the pharmaceutical cylindrical container and rotate the cylindrical pharmaceutical container around a longitudinal axis; a light receiving unit comprising a main camera configured to acquire an image of the pharmaceutical cylindrical container; and a light emitting unit comprising, with respect to the main camera, a bright field light source, a radial dark field light source, and an axial dark field light source.

2. The apparatus of claim 1, wherein the support device supports the pharmaceutical cylindrical container so that the longitudinal axis and a horizontal axis perpendicular to the longitudinal axis define a horizontal plane, wherein: the main camera has a centerline that intersects the horizontal plane at an angle in a range selected from a group consisting of 0° or more and 30° or less, 0° or more and 20° or less, and 0° or more and 10° or less, and/or the bright field light source has a centerline that intersects the horizontal plane at an angle in a range selected from a group consisting of 0° or more and 30° or less, 0° or more and 20° or less, and 0° or more and 10° or less, and/or the axial dark field light source has a centerline that intersects the horizontal plane at an angle in a range selected from a group consisting of 0° or more and 30° or less, 0° or more and 20° or less, and 0° or more and 20° or less, and/or the radial dark field light source has a centerline that intersects the horizontal plane at an angle in a range selected from a group consisting of 10° or more and 90° or less, 45° or more and 90° or less, and 70° or more and 90° or less.

3. The apparatus of claim 1, wherein the support device supports the pharmaceutical cylindrical container so that the longitudinal axis and a vertical axis perpendicular to the longitudinal axis define a vertical plane, wherein: the main camera has a centerline that intersects the vertical plane at an angle of 60° or more and 90° or less, 70° or more and 90° or less, and 80° or more and 90° or less, and/or the bright field light source has a centerline that intersects the vertical plane at an angle in a range selected from a group consisting of 60° or more and 90° or less, 70° or more and 90° or less, and 80° or more and 90° or less, and/or the axial dark field light source has a centerline that intersects the vertical plane at an angle in a range selected from a group consisting of 0° or more and 30° or less, 0° or more and 20° or less, and 0° or more and 20° or less, and/or the radial dark field light source has a centerline that intersects the vertical plane at an angle in a range selected from a group consisting of 0° or more and 70° or less, 0° or more and 45° or less, and 0° or more and 20° or less.

4. The apparatus of claim 1, wherein the support device supports the pharmaceutical cylindrical container so that a horizontal axis perpendicular to the longitudinal axis and a vertical axis perpendicular to the longitudinal axis intersect a middle of a cylindrical part of the pharmaceutical cylindrical container at a transversal plane, wherein: the main camera has a centerline that intersects the transversal plane at an angle in a range selected from a group consisting of 0° or more and 30° or less, 0° or more and 20° or less, and 0° or more and 10° or less, and/or the bright field light source has a centerline that intersects the transversal plane at an angle in a range selected from a group consisting of 0° or more and 30° or less, 0° or more and 20° or less, and 0° or more and 10° or less, and/or the axial dark field light source has a centerline that intersects the transversal plane at an angle in a range selected from a group consisting of 60° or more and 90° or less, 70° or more and 90° or less, and 80° or more and 90° or less, and/or the radial dark field light source has a centerline that intersects the transversal plane at an angle in a range selected from a group consisting of 0° or more and 70° or less, 0° or more and 45° or less, and 0° or more and 20° or less.

5. The apparatus of claim 1, wherein the light receiving unit further comprises a plurality of cameras.

6. The apparatus of claim 5, wherein the plurality of the cameras is between 5 to 25 cameras.

7. The apparatus of claim 1, wherein the light emitting unit comprises a property selected from the group consisting of: the bright field light source having a light emitting plane that has a size in a range a range selected from a group consisting of 20 cm.sup.2 to 2000 cm.sup.2, 15 cm.sup.2 to 1000 cm.sup.2, and 25 cm.sup.2 to 600 cm.sup.2; the radial dark field light source having a light emitting plane that has a size in a range a range selected from a group consisting of 0.5 cm.sup.2 to 2000 cm.sup.2, 0.8 cm.sup.2 to 1000 cm.sup.2, and 1 cm.sup.2 to 400 cm.sup.2; the axial dark field light source having a light emitting plane that has a size in a range a range selected from a group consisting of 0.5 cm.sup.2 to 1000 cm.sup.2, 0.8 cm.sup.2 to 200 cm.sup.2, and 1.0 cm.sup.2 to 64 cm.sup.2; and any combinations thereof.

8. The apparatus of claim 1, wherein the bright field light source, the radial dark field light source, and the axial dark field light source each comprise a light emitting plane, wherein: the light emitting planes have a property selected from the group consisting of: a color temperature between 2000 K and 7000 K, a color temperature between 3000 K to 6000 K, a color temperature between 4000 K to 5000 K, and combinations thereof; and/or the light emitting planes of the axial and the radial dark field light sources each have a luminous flux that are higher than a luminous flux of the light emitting plane of the bright field light source; and/or the support device has a distance between each of the light emitting planes that is in a range selected from a group consisting of 5 to 50 cm, 8 to 30 cm, 10 to 20 cm, and combinations thereof.

9. The apparatus of claim 1, wherein the light emitting unit has a first light emitting plane and a second light emitting plane adjoining each other, wherein the first light emitting plane and the second light emitting plane intersect at an angle in a range selected from a group consisting of 10° to 80°, 30° to 60°, and 40° to 50°.

10. The apparatus of claim 1, wherein the support device comprises at least two support wheels and a friction wheel arranged such that the pharmaceutical cylindrical container is on the support wheels and is rotatable around the longitudinal axis by the friction wheel.

11. The apparatus of claim 1, further comprising a control unit configured to control the support device, the light emitting unit, and the light receiving unit to perform a task selected from a group consisting of: measure the pharmaceutical cylindrical container in 0.3 to 10 seconds; rotate the pharmaceutical cylindrical container 360° around the longitudinal axis; rotate the pharmaceutical cylindrical container in increments between 0.5° and 4°; rotate the pharmaceutical cylindrical container in between the image acquisitions; activate/deactivate the main camera based on the speed of a friction wheel; and any combinations thereof.

12. The apparatus of claim 11, wherein the control unit controls to acquire a plurality of images, the plurality of images being selected from a group consisting of: when only the bright field light source is activated; when only the axial dark field light source is activated; when only the radial dark field light source is activated; when both the radial and axial dark field light sources are activated; and any combinations thereof.

13. The apparatus of claim 1, wherein the control unit controls to disregard any container having a defect with a property selected from a group consisting of: a size of 200 μm; a size of 100 μm or more; a size of 80 μm or more; a size of 50 μm or more; a size of 40 μm or more; a size of 20 μm or more; a size of 16 μm or more; a metallic defect on a surface of the pharmaceutical cylindrical container; a non-metallic defect on a surface of the pharmaceutical cylindrical container; a bubble within a wall or on a surface of pharmaceutical cylindrical container; a metallic defect within a wall of pharmaceutical cylindrical container; a non-metallic defect within a wall of the pharmaceutical cylindrical container; and any combinations thereof.

14. A bundle of pharmaceutical cylindrical containers made of glass or of a polymer, comprising a plurality of the pharmaceutical cylindrical containers each comprising no defect having a size of 200 μm or more, wherein the plurality of the pharmaceutical cylindrical containers comprises ten or more containers.

15. The bundle of claim 14, wherein the plurality of the pharmaceutical cylindrical containers comprises up to 1000 containers.

16. The bundle of claim 14, wherein each pharmaceutical cylindrical container exhibits no defect having a property selected from a group consisting of: a size of 200 μm; a size of 100 μm or more; a size of 80 μm or more; a size of 50 μm or more; a size of 40 μm or more; a size of 20 μm or more; a size of 16 μm or more; a metallic defect on a surface of the pharmaceutical cylindrical container; a non-metallic defect on a surface of the pharmaceutical cylindrical container; a bubble within a wall or on a surface of pharmaceutical cylindrical container; a metallic defect within a wall of pharmaceutical cylindrical container; a non-metallic defect within a wall of the pharmaceutical cylindrical container; and any combinations thereof.

17. The bundle of claim 14, wherein the plurality of the pharmaceutical cylindrical containers are encased in a wrapping and are sterilized.

18. A method for inspecting a pharmaceutical cylindrical container made of glass or polymer, comprising: arranging the pharmaceutical cylindrical container with a lateral surface on a support device; rotating the pharmaceutical cylindrical container around its longitudinal axis; and activating a light emitting unit and a light receiving unit to acquire at least one image of the pharmaceutical cylindrical container.

19. The method of claim 18, wherein the activating step comprises activating to acquire a plurality of images, the plurality of images being selected from a group consisting of: when only a bright field light source is activated; when only a axial dark field light source is activated; when only a radial dark field light source is activated; when both the radial and axial dark field light sources are activated; and any combinations thereof.

20. The method of claim 19, wherein the bright field image, the axial dark field image, the radial dark field image and/or the combined axial and radial dark field image are each acquired after the pharmaceutical cylindrical container is rotated in an increment between 0.5° and 4°.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0077] There are several ways how to design and further develop the teaching of the present invention in an advantageous way. To this end, preferred examples of embodiments of the invention, illustrated by the figures on the other hand. In connection with the explanation of the preferred embodiments by the aid of the figures, generally preferred embodiments and further developments of the teaching will be explained:

[0078] FIG. 1 shows in a schematic view an embodiment of an apparatus,

[0079] FIG. 2 shows in a schematic top view an embodiment of an apparatus,

[0080] FIG. 3 shows in a schematic side view an embodiment of an apparatus,

[0081] FIG. 4 shows in a schematic front view an embodiment of an apparatus,

[0082] FIG. 5 shows in a further schematic front view an embodiment of an apparatus, and

[0083] FIG. 6 shows a block diagram of an embodiment of the method.

DETAILED DESCRIPTION

[0084] FIG. 1 shows an embodiment of the apparatus. The apparatus comprises a not shown support device for supporting a pharmaceutical cylindrical container 1 on its lateral surface such that the container 1 is rotatable around its longitudinal axis 2. The longitudinal axis 2 of the pharmaceutical cylindrical container 1 and a horizontal axis being perpendicular to the longitudinal axis 2 define a horizontal plane 3. Further, the longitudinal axis 2 of the pharmaceutical cylindrical container 1 and a vertical axis being perpendicular to the longitudinal axis 2 define a vertical plane 4. In addition, a horizontal axis being perpendicular to the longitudinal axis 2 of the pharmaceutical cylindrical container 1 and a vertical axis being perpendicular to the longitudinal axis and intersecting the middle of a cylindrical part of the pharmaceutical cylindrical container 1 define a transversal plane 5. A skilled person will understand FIG. 1 only shows half of the container 1 since the transversal plane 8 covers the other half of the container 1.

[0085] Further, the apparatus comprises a light receiving unit with a main camera 6 and a light transmitting unit with a bright field light source 7, a radial dark field light source 8 and a not shown axial dark field light source 9. Furthermore, FIG. 1 shows the centerline 10 of the main camera 6, the centerline 11 of the bright field light source 7, the centerline 12 of the radial dark field light source 8 and the centerline 13 of the not shown axial dark field light source 9. The centerline 13 of the axial dark field light source 9 corresponds in this embodiment to the longitudinal axis 2 of the container 1.

[0086] FIGS. 2 to 4 show different views of the apparatus according to FIG. 1. Especially the axial dark field light source 8 is shown. Since the embodiment of FIGS. 2 to 4 corresponds to the embodiment of FIG. 1 the description of FIG. 1 is referred to here, as it analogously applies to FIGS. 2 to 4.

[0087] FIG. 5 shows another embodiment of an apparatus. In this embodiment the support device is shown in detail. The support device comprises a first support wheel 14 and a second support wheel 15. The first support wheel 14 and the second support wheel 15 support the container 1 on its lateral surface. Furthermore, a friction wheel 16 is arranged such that the container 2 can be rotated around its longitudinal axis 12. In addition, the apparatus comprises a main camera 6, a bright field light source 7, a radial dark field light source 8 and an axial field light source 9.

[0088] Except for the support and the positioning of the radial dark field light source 8, the embodiment of FIG. 5 corresponds to the embodiment of FIGS. 1 to 4. As such, the description of FIGS. 1 to 4 is referred to here, as it analogously applies to FIG. 5.

[0089] FIG. 6 shows a block diagram of an embodiment of the method. The method serves to inspecting a pharmaceutical cylindrical container made of a glass or of a polymer.

[0090] In a first step 17 the pharmaceutical cylindrical container is arranged with its lateral surface on the support device. In a second step 18 the pharmaceutical cylindrical container is rotated around its longitudinal axis, wherein the rotation is preferably performed in increments. In a third step 19, the light emitting unit and the light receiving unit are activated for acquiring at least one image of the pharmaceutical cylindrical container.

[0091] In a fourth step 20, pharmaceutical cylindrical containers having defects as set forth herein are disregarded, while in a fifth step 21 the remaining containers are formed into a bundle. During the fifth step 21, bundles can be separated by a spacer, for example a plastic or paper sheet or can be positioned in a holding device, for example a nest, tub or tray, so that they are not in contact with each other during transport.

[0092] In a sixth step 22 and seventh step 23, the bundles are at least partly covered or encased by a plastic foil and are sterilized. In some embodiments, the sixth step 22 is a sterilization process, e.g. steam sterilized or sterilized by gamma rays, with the sterilized bundle being then covered or encased in the plastic foil in the seventh step 23. In other embodiments, the bundle is first covered or encased in the plastic foil in the sixth step 22, followed by a sterilization process, e.g. sterilized by gamma rays, in the seventh step 23.

[0093] Many modifications and other embodiments of the invention set forth herein will come to mind to the one skilled in the art to which the invention pertains having the benefit of the teachings presented in the foregoing description and the associated drawings. Therefore, it is to be understood that the invention is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

LIST OF REFERENCE SIGNS

[0094] 1 container

[0095] 2 longitudinal axis (container)

[0096] 3 horizontal plane

[0097] 4 vertical plane

[0098] 5 transversal plane

[0099] 6 main camera

[0100] 7 bright field light source

[0101] 8 radial dark field light source

[0102] 9 axial field light source

[0103] 10 centerline main camera

[0104] 11 centerline bright field light source

[0105] 12 centerline radial dark field light source

[0106] 13 centerline axial dark field light source

[0107] 14 first support wheel

[0108] 15 second support wheel

[0109] 16 friction wheel

[0110] 17 first step

[0111] 18 second step

[0112] 19 third step

[0113] 20 fourth step

[0114] 21 fifth step

[0115] 22 sixth step

[0116] 23 seventh step