DETECTION AND CHARACTERIZATION OF DEFECTS IN PHARMACEUTICAL CYLINDRICAL CONTAINERS

Abstract

An apparatus for inspecting a pharmaceutical cylindrical container made of a polymer, a specific method for inspecting a pharmaceutical cylindrical container made of a polymer and a specific bundle of pharmaceutical cylindrical containers made of a polymer.

Claims

1. An apparatus for inspecting a pharmaceutical cylindrical container made of a 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 an inspection beam; and a light receiving unit comprising a camera that receives light emitted by the pharmaceutical cylindrical container and acquires an image of the pharmaceutical cylindrical container.

2. The apparatus of claim 1, wherein the support device, the light emitting unit, and the light receiving unit are configured to inspected the pharmaceutical cylindrical container in one second or less.

3. The apparatus of claim 1, wherein the light source emits light comprising a wavelength in a range selected from a group consisting of 10 nm to 1000 nm, 100 nm to 400 nm, and 220 nm to 380 nm.

4. The apparatus of claim 1, wherein the light source is a source selected from a group consisting of an ultraviolet gas-discharge lamp, an ultraviolet light-emitting diode, an ultraviolet laser, an ultraviolet light-emitting diode, an ultraviolet laser, and combinations thereof.

5. The apparatus of claim 1, wherein the light receiving unit is configured to receive light emitted by the pharmaceutical cylindrical container having a wavelength in a range selected from a group consisting of 300 nm to 700 nm, 400 nm to 500 nm, and 430 nm to 460 nm.

6. The apparatus of claim 1, wherein in the support device, the light emitting unit, and the light receiving unit are configured so that X=B−A, wherein B is a wavelength of the light emitted by the pharmaceutical cylindrical container at a maximum, and wherein A is a wavelength emitted by the light source of the light emitting unit at a maximum, and X is in distance in a range selected from a group consisting of 50 nm to 500 nm, 75 nm to 500 nm, and 100 nm to 300 nm.

7. The apparatus of claim 1, wherein the light receiving unit further comprises a lens, wherein the lens is permeable for light having a wavelength in a range selected from a group consisting of 200 nm to 900 nm, 400 nm to 800 nm, 400 nm to 500 nm, and 430 nm to 460 nm.

8. The apparatus of claim 1, wherein the light receiving unit further comprises a filter, wherein the filter blocks light having a wavelength of 600 nm or more and/or a wavelength of 200 nm or less.

9. 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, and wherein the 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.

10. 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, and wherein the 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.

11. 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, and wherein the 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.

12. The apparatus of claim 1, wherein the inspection beam comprises unpolarized light.

13. A method for inspecting a pharmaceutical cylindrical container made of a polymer, comprising: illuminating the pharmaceutical cylindrical container with a light emitting unit; receiving light emitted by the pharmaceutical cylindrical container with a light receiving unit to acquire a first image of the pharmaceutical cylindrical container; and characterizing defects in and/or on the pharmaceutical cylindrical container based on the image.

14. The method of claim 13, further comprising: illuminating the pharmaceutical cylindrical container with the same and/or a further light emitting unit; receiving light scattered by and/or transmitted through the pharmaceutical cylindrical container with the same or a further light receiving unit to acquire a second image of the pharmaceutical cylindrical container; characterizing additional defects in and/or on the pharmaceutical cylindrical container based on the second image.

15. The method of claim 14, wherein the first image and/or second image are analyzed to detect slides in the polymer of the pharmaceutical cylindrical container.

16. The method of claim 14, further comprising controlling a process of manufacturing the pharmaceutical cylindrical container based on the first image and/or second image.

17. The method of claim 14, further comprising disregarding, based on the first image and/or second image, any pharmaceutical cylindrical container exhibiting a value of Y and/or Z of 0.05 to 1.0, wherein Y=A1/B1, wherein A1 is a maximum length in cm of any slide in a cylindrical part of the pharmaceutical cylindrical container, wherein B1 is a length in cm of the cylindrical part of the pharmaceutical cylindrical container, wherein Z=A2/B2, wherein A2 is an area in cm.sup.2 of any slides, and wherein B2 is an area in cm.sup.2 of the cylindrical part.

18. The method of claim 17, wherein the value of Y and/or Z is 0.5 to 1.0.

19. The method of claim 17, wherein the value of Y and/or Z is 0.05 to 1.0.

20. The method of claim 14, wherein the illuminating, receiving, and characterizing defects steps for each pharmaceutical cylindrical container are completed in 1 second or less.

21. A bundle of pharmaceutical cylindrical containers made of a polymer, comprising: ten or more pharmaceutical cylindrical containers; and a value Y and/or a value Z of 0.5 or less, wherein Y=A1/B1, wherein A1 is a maximum length in cm of any slide in a cylindrical part of the pharmaceutical cylindrical container, wherein B1 is a length of the cylindrical part of the pharmaceutical cylindrical container, wherein Z=A2/B2, wherein A2 is an area in cm.sup.2 of any slides in the cylindrical part, and wherein B2 is an area in cm.sup.2 of the cylindrical part.

22. The bundle of claim 21, wherein the pharmaceutical cylindrical containers are made of a polymer selected from a group consisting of a cycloolefin copolymer (COC), a cycloolefin polymer (COP), and a cycloolefin copolymer (COC).

23. The bundle of claim 21, wherein the value of Y and/or Z is 0.2 or less.

24. The bundle of claim 21, wherein the value of Y and/or Z is 0.1 or less.

25. The bundle of claim 21, wherein the value of Y and/or Z is 0.05 or less.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0050] FIG. 1 shows in a schematic cross-sectional view an apparatus according to an embodiment of the present invention,

[0051] FIG. 2 shows in a schematic cross-sectional view an apparatus according to a further embodiment of the present invention,

[0052] FIG. 3 shows in a schematic cross-sectional view an embodiment of a support device of the present invention,

[0053] FIG. 4 shows in a schematic view the horizontal, vertical and transversal plane, and

[0054] FIG. 5 shows a schematic block diagram of a method according to an embodiment of the invention.

DETAILED DESCRIPTION

[0055] In the following description of embodiments, the same reference numeral designate similar components.

[0056] FIG. 1 shows an apparatus according to an embodiment of the present invention. The apparatus comprises a support device 1 for a pharmaceutical cylindrical container 2, a light receiving unit 3 and a light emitting unit 4.

[0057] The light emitting unit 4 comprises a light source 5 for illuminating the pharmaceutical cylindrical container 2 being positioned on the support device 1. The light 6 emitted by the pharmaceutical cylindrical container 2, i.e. the photoluminescence light, for example phosphorescence and fluorescence light, is received by the light receiving unit 3. In this embodiment, the light receiving unit 3 comprises a lens 7 and a camera 8. Hence, an image of at least a part of the pharmaceutical cylindrical container 2 can be acquired by camera 7, whereas defects, for example slides, can be identified on these images. In a preferred embodiment, the light source 5 is an ultraviolet light source, the lens 7 is at least permeable for light having a wavelength of 430 to 460 nm, and the camera 8 is a camera which can detect light in the visible region of the electromagnetic spectrum, e.g. the camera acA1920-155 um from Basler with the sensor IMX174 CMOS from Sony.

[0058] FIG. 2 shows in a schematic cross-sectional view of the apparatus according to a further embodiment of the present invention. The apparatus shown in FIG. 2 corresponds to the apparatus described with FIG. 1, whereas the light receiving unit 3 further comprises a filter 18. In a preferred embodiment, the filter 18 selectively blocks light having a wavelength of 200 nm or less and 600 nm or more, preferably 300 nm or less and 500 nm or more, more preferably 300 nm or less and 460 nm or more, more preferably 300 nm or less and 430 nm or more.

[0059] Except for the filter 18 and the arrangement of the light emitting unit and light receiving unit, the embodiment of FIG. 2 corresponds to the embodiment of FIG. 1. As such, the description of FIG. 1 is referred to here, as it analogously applies to FIG. 2.

[0060] Without being considered limiting with respect to the embodiments shown, FIG. 3 serves to illustrate an embodiment of a support device 1 for an apparatus according to the invention. The support device 1 comprises a first support wheel 9 and a second support wheel 10 as well as a container 2 being supported by the first support wheel 9 and the second support wheel 10. As can be seen, the rotational axis 11 of said first support wheel 9 and the longitudinal axis 12 of the container 2 define a first plane 13. Additionally the rotational axis 14 of the second support wheel 10 and said longitudinal axis 12 of the container 2 define a second plane 15. The first plane 13 and said second plane 15 intersect at an angle 16. According to a preferred embodiment, the angle 16 ranges from 45° to less than 120°, preferably 50° to 90°, more preferably of 60° to 80°, more preferably of 65° to 75°, most preferably at an angle of about 70°. One of ordinary skill in the art will understand, that the position of longitudinal axis 12 depends on the diameter of the container 2. Hence, when the apparatus is used for container 2 with different diameter, the position of the first and second support wheels 9, 10 has to be adapted. Furthermore, above the support device 1 a friction wheel 17 is arranged such that the container 2 can be rotated around its longitudinal axis 12. To illuminate the pharmaceutical cylindrical container, preferably a top-light is used (not shown).

[0061] FIG. 4 shows a pharmaceutical cylindrical container 2 and its longitudinal axis 12. The longitudinal axis 12 and a horizontal axis being perpendicular define a horizontal plane 18. Further, the longitudinal axis 12 of the pharmaceutical cylindrical container 2 and a vertical axis being perpendicular to the longitudinal axis define a vertical plane 19. In addition, a horizontal axis being perpendicular to the longitudinal axis 12 of the pharmaceutical cylindrical container 2 and a vertical axis being perpendicular to the longitudinal axis and intersecting the middle of a cylindrical part of the pharmaceutical cylindrical container define a transversal plane 20.

[0062] FIG. 5 shows a block diagram of an embodiment of the method. The method serves for inspecting a pharmaceutical cylindrical container 2 made of a polymer. In a first step 21 the pharmaceutical cylindrical container 2 is illuminated with a light emitting unit 4. In a second step 22, the light 6 emitted by the pharmaceutical cylindrical container 2 is received by a light receiving unit 3 for acquiring an image of the pharmaceutical cylindrical container 2. In a third step 23 defects in and/or on the pharmaceutical cylindrical container 2 are characterized based on the obtained image.

[0063] In a fourth step 24, the image(s) is/are analyzed in order to detect slides in the pharmaceutical cylindrical container 2, and/or the image is analyzed to optimize and/or control the process of manufacturing the pharmaceutical cylindrical container 2, and/or the pharmaceutical cylindrical container 2 is disregarded from further processing when a slide having at least a predetermined length is detected. Further steps can be, illuminating the pharmaceutical cylindrical container with a, preferably a further, light emitting unit, then receiving light scattered by and/or transmitted through the pharmaceutical cylindrical container with a, preferably further, light receiving unit for acquiring an image of the pharmaceutical cylindrical container, and then characterizing defects in and/or on the pharmaceutical cylindrical container based on the obtained images.

[0064] In a fifth step 25, any defective pharmaceutical cylindrical containers are disregarded and the remaining containers are formed into a bundle of inspected pharmaceutical cylindrical containers 26. The bundle includes 10 or more, preferably 10 to 1000, more preferably 20 to 500, most preferably 40 to 250, pharmaceutical cylindrical containers, and wherein the pharmaceutical cylindrical containers exhibit a value Y in the following equation of about 0.5 or less, preferably 0.4 or less, more preferably 0.3 or less, more preferably 0.2 or less, more preferably 0.1 or less, more preferably 0.05 or less, more preferably 0.01 or less: Y=A/B. A is the maximum length in cm of any slide in the cylindrical part of the pharmaceutical cylindrical container, and B is the length in cm of the cylindrical part of the pharmaceutical cylindrical container; and/or wherein the pharmaceutical cylindrical containers in the bundle exhibit a value Z in the following equation of about 0.5 or less, preferably 0.4 or less, more preferably 0.3 or less, more preferably 0.2 or less, more preferably 0.1 or less, more preferably 0.05 or less, more preferably 0.01 or less: Z=A/B; wherein A is the area in cm.sup.2 of the slide(s) in the cylindrical part of the pharmaceutical cylindrical container, and wherein B is the area in cm.sup.2 of the cylindrical part of the pharmaceutical cylindrical container.

[0065] 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

[0066] 1 support device [0067] 2 Container [0068] 3 light receiving unit [0069] 4 light emitting unit [0070] 5 light source [0071] 6 emitted light [0072] 7 Lens [0073] 8 Camera [0074] 9 first support wheel [0075] 10 second support wheel [0076] 11 rotational axis (first support wheel) [0077] 12 longitudinal axis (container) [0078] 13 first plane [0079] 14 rotational axis (second support wheel) [0080] 15 second plane [0081] 16 angle [0082] 17 friction wheel [0083] 18 horizontal plane [0084] 19 vertical plane [0085] 20 transversal plane [0086] 21 first step [0087] 22 second step [0088] 23 third step [0089] 24 fourth step [0090] 25 fifth step [0091] 26 bundle