DETECTION AND CHARACTERIZATION OF DEFECTS IN PHARMACEUTICAL CYLINDRICAL CONTAINERS

Abstract

Apparatuses and methods for inspecting a pharmaceutical cylindrical containers are provided. The apparatus includes a support device, a light emitting unit, and a light receiving unit. The support device supports the pharmaceutical cylindrical container and rotates the cylindrical pharmaceutical container around a longitudinal axis. The light emitting unit has a light source that illuminates the pharmaceutical cylindrical container with a detection beam while the support device rotates the pharmaceutical cylindrical container. The light receiving unit has a camera that acquires polarization information of the detection beam.

Claims

1. An apparatus for inspecting a pharmaceutical cylindrical container made of glass or polymer, comprising: a support device configured to support the pharmaceutical cylindrical container and rotate the cylindrical pharmaceutical container around a longitudinal axis; a light emitting unit comprising a light source configured to illuminate the pharmaceutical cylindrical container with a detection beam while the support device rotates the pharmaceutical cylindrical container; and a light receiving unit comprising a camera that acquires polarization information of the detection beam.

2. The apparatus of claim 1, wherein the light source is a source selected from a group consisting of a gas-discharge lamp, a light-emitting diode, a laser, and any combination thereof.

3. The apparatus of claim 1, further comprising a polarizer selected from a group consisting of a Fresnel reflection polarizer, a birefringent polarizer, a thin film polarizer, and a wire-grid polarizer, wherein the polarizer is arranged between the light source and the pharmaceutical cylindrical container.

4. The apparatus of claim 3, wherein the light emitting unit and/or the light receiving unit comprise the polarizer.

5. The apparatus of claim 1, further comprising a depolarizer selected from a group consisting of a Cornu depolarizer, a Lyot depolarizer, a wedge depolarizer, and a time-variable depolarizer, wherein the depolarizer is arranged between the light source and the pharmaceutical cylindrical container.

6. The apparatus of claim 5, wherein the light emitting unit and/or the light receiving unit comprise the depolarizer.

7. The apparatus of claim 1, further comprising a wave plate selected from a group consisting of a half-wave plate, a quarter-wave plate, full-wave plate, and sensitive-tint plate, wherein the wave plate is arranged between the light source and the pharmaceutical cylindrical container.

8. The apparatus of claim 7, wherein the light emitting unit and/or the light receiving unit comprise the wave plate.

9. The apparatus of claim 1, wherein the light receiving unit is configured to measure a first linear polarized light beam and a second linear polarized light beam, wherein the first linear polarized light beam has a first plane of polarization and the second linear polarized light beam has a second plane of polarization, wherein the first and second planes intersect at an angle in a range selected from a group consisting of 10 to 170°, 90°, and 45°.

10. The apparatus of claim 1, wherein the light receiving unit acquires information of the detection beam other than the polarization information.

11. The apparatus of claim 1, wherein the light receiving unit measures an intensity and/or a wavelength of the detection beam.

12. The apparatus of claim 1, wherein the light emitting unit and/or the light receiving unit are arranged such that light reflected by the pharmaceutical cylindrical container defines the detection beam.

13. The apparatus of claim 1, wherein the light emitting unit and/or the light receiving unit are arranged such that light transmitted through the pharmaceutical cylindrical container defines the detection beam.

14. The apparatus of claim 1, wherein the light emitting unit and/or the light receiving unit are arranged such that α=β=arctan (n), wherein α is an angle between a centerline of the light source and a normal N of a lateral surface of the pharmaceutical cylindrical container, wherein β is a angle between a centerline of the camera and the normal N of the lateral surface, and wherein n is a refractive index of the glass or polymer of the pharmaceutical cylindrical container.

15. A method for inspecting a pharmaceutical cylindrical container made of glass or polymer, comprising: illuminating the pharmaceutical cylindrical container with an inspection beam; receiving at least one detection beam from the pharmaceutical cylindrical container with a light receiving unit; and acquiring polarization information of the detection beam.

16. The method of claim 15, further comprising disregarding, based on the polarization information, any pharmaceutical cylindrical container exhibiting: a defect on an outer surface having a size selected from a group consisting of 40 mm or more, 30 mm or more, 20 mm or more, 10 mm or more, and 2 mm or more, and/or a wall penetrating defect having a size selected from a group consisting of 0.5 mm or more, 0.3 mm or more, 0.1 mm or more, and 0.05 mm or more.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0071] There are several ways how to design and further develop the teaching of the present invention in an advantageous way. To this end, the following explanation of preferred examples of embodiments of the invention, illustrated by the drawing on the other hand. In connection with the explanation of the preferred embodiments of the invention by the aid of the drawing, generally preferred embodiments and further developments of the teaching will be explained in FIGS. 1 to 7.

[0072] FIG. 1 shows a schematic side view of an apparatus according to another embodiment,

[0073] FIG. 2 shows a schematic side view of an apparatus according to another embodiment,

[0074] FIG. 3 shows a schematic side view of an apparatus according to another embodiment,

[0075] FIG. 4 shows a schematic side view of an apparatus according to another embodiment,

[0076] FIG. 5 shows a schematic side view of an apparatus according to another embodiment,

[0077] FIG. 6 shows a schematic side view of an apparatus according to another embodiment,

[0078] FIG. 7 shows a schematic block diagram of a method according to an embodiment.

[0079] In the following description of embodiments, the same reference numeral designate similar components.

DETAILED DESCRIPTION

[0080] According to FIG. 1 the apparatus comprises a light emitting unit 7 and a light receiving unit 8. The light emitting unit 7 comprises a light source 9 for illuminating the pharmaceutical cylindrical container 1 with an inspection beam 10. The inspection beam 10 can comprise no polarization. Due to the reflection on the surface, the detection beam 11 will be polarized, if the container 1 comprises no defect. Therefore, the light receiving unit 8 acquires polarization information of the detection beam 11 for detecting a defect on the outer surface of the pharmaceutical cylindrical container 1, for example an air bubble. In this embodiment, the light receiving unit 8 can comprise a polarization camera 12 for acquiring the polarization information of the detection beam 11. The arrangement of the light source and the camera is in such a manner that the illumination and detection takes place in the Brewster's angle. The pharmaceutical cylindrical container 1 is rotatable around 360° during the measurement.

[0081] The apparatus shown in FIG. 2 comprises a light emitting unit 7 and a light receiving unit 8. The light receiving unit 8 comprises a camera 13 and a polarizer 14. The polarizer 14 serves to acquire information about the polarization of the detection beam 11 since only light of a specific polarization can pass through the polarizer 14. Hence, if the pharmaceutical cylindrical container 1 comprises a defect, such that the detection beam 11 is not polarized, the polarizer 14 blocks the not polarized detection beam 11. Since (almost) no light arrives at the camera 13, the camera 13 will detect (almost) no light. The further features of the apparatus shown in FIG. 2 corresponds to the apparatus shown in FIG. 1.

[0082] The apparatus in FIG. 3 comprises a light emitting unit 7 and a light receiving unit 8. In this embodiment, the light that transmits through the pharmaceutical cylindrical container 1 defines the detection beam 11. Further, the apparatus shown in FIG. 3 corresponds to the embodiment shown in FIG. 1.

[0083] FIG. 4 shows an embodiment of an apparatus for inspecting a pharmaceutical cylindrical container 1. As already described with regard to FIG. 2, the light receiving unit 8 comprises a camera 13 and a polarizer 14, whereby the light that transmits through the pharmaceutical cylindrical container 1 defines the detection beam 11.

[0084] FIG. 5 shows another embodiment of an apparatus. In this embodiment, the light receiving unit 8 comprises two polarization cameras 12, 12′. The first polarization camera 12 serves to detect the first detection beam 11, being defined by the light that is reflected by the pharmaceutical cylindrical container 1. The second polarization camera 12′ serves to detect the second detection beam 11′, being defined by the light that transmits through the pharmaceutical cylindrical container 1. A skilled person understands that at least one of the polarization cameras 12, 12′ can be substituted by an arrangement comprising a light sensor and a polarizer as shown in FIGS. 2 and 4. Furthermore, the apparatus can comprise a polarization camera 12 and a camera 12′ which is not a polarization camera but a conventional camera. By comparing the images acquired by the polarization camera and the conventional camera, defects can be detected very easily.

[0085] FIG. 6 shows a schematic cross section of a pharmaceutical cylindrical container 1 made of a polymer and produced by injection molding, wherein the pharmaceutical cylindrical container 1 comprises a defect 6. In this embodiment, the defect 6 is an air bubble, which can typically occur after an injection molding process. Due to the defect 6 the arrangement of the molecules 2 is disrupted such that the electrical field E of the pharmaceutical cylindrical container 1 is at least decreased. As can be seen, the incident light ray 3 is partly reflected, i.e. a reflected light ray 4 occurs, and partly transmits through the pharmaceutical cylindrical container 1, i.e. a transmitted light ray 5 occurs. If the incident light ray 3 comprises a linear polarization, the transmitted light ray 5 will have linear polarization, however the plane of polarization has been changed. Hence, by acquiring polarization information of the light ray 5, it is possible to detect a defect 6, like an air bubble or any other kind of defect, that will decrease or extinguish the electrical field E of the pharmaceutical cylindrical container 1 made of a glass or of a polymer.

[0086] Furthermore it should be noted that in all of the described embodiment of FIGS. 1 to 6 the light emitting unit 7 can comprise several light sources, for example two light sources, such that the pharmaceutical cylindrical container 1 can be illuminated with two inspection beams, preferably comprising different wavelength, for example a first detection beam defined by UV-light and a second detection beam defined by visible light. A skilled person will understand that the light receiving unit 8 will have to be adapted accordingly, to acquire information about the polarization of these at least two different detection beams.

[0087] FIG. 7 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. In a first step 15 the pharmaceutical cylindrical container is illuminated with an inspection beam, for example of unpolarized light. In a second step 16, at least one detection beam from the pharmaceutical cylindrical container is received by a light receiving unit and analyzed with regard to its polarization. In a third step 17, a pharmaceutical cylindrical container can be disregarded from further processing when the detection beam is at least partly unpolarized.

[0088] In a fourth step 18 the remaining containers that are not disregarded are formed into a bundle. During the fourth step 18, 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.

[0089] In a fifth step 19 and a sixth step 20, the bundles are at least partly covered or encased by a plastic foil and sterilized, e.g. steam sterilized or sterilized by gamma rays. In some embodiments, the fifth step 19 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 sixth step 20. In other embodiments, the bundle is first covered or encased in the plastic foil in the fifth step 19, followed by a sterilization process, e.g. sterilized by gamma rays, in the sixth step 20.

[0090] 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

[0091] 1 pharmaceutical cylindrical container [0092] 2 polymer molecules [0093] 3 light ray (incident) [0094] 4 light ray (reflected) [0095] 5 light ray (transmitted) [0096] 6 defect [0097] 7 light emitting unit [0098] 8 light receiving unit [0099] 9 light source [0100] 10 inspection beam [0101] 11, 11′ detection beam [0102] 12, 12′ polarization camera [0103] 13 camera [0104] 14 polarizer [0105] 15 first step [0106] 16 second step [0107] 17 third step [0108] 18 fourth step [0109] 19 fifth step [0110] 20 sixth step