The present invention relates to leak detection apparatus for blister packs, particularly but not exclusively pharmaceutical blister packs.
Currently, there are a number of methods used to detect leaks in the pockets of pharmaceutical blister packs. In one current method, a vacuum is applied across the blister pack being tested, and the rate of decompression when the vacuum is released gives an overall indication of the existence of a leak in one or more of the pockets of the blister pack. However, this method does not identify which pocket is faulty. In a second current method, individual apparatus is contacted with every pocket of a blister pack for individual testing. Whilst this will reveal individual pockets which are leaking, the overall testing procedure is time-consuming, difficult to validate, marks the pack, expensive, and limited in use.
Identification of which pocket or pockets are leaking in a blister pack is particularly desired in order to provide information on any faults or weaknesses in the manufacturing process, e.g. a fault which constantly leads to the same-positioned pocket being damaged.
Our U.S. Pat. No. 6,687,622 relates to an apparatus for detecting a leak in a blister pack using reduced pressure and a particular scanner means.
According to one aspect of the present invention, there is provided apparatus for detecting a leak in one or more blister pockets of one or more blister packs, the apparatus comprising at least:
(I) a plate for receiving the pack or packs;
(ii) a pressure reducer able to change the pressure around the pack or packs so as to seek to cause deflection of at least one side of the or each blister pocket between at least a first pressure and a second pressure;
(iii) an illumination source able to provide a lattice illumination on the or each blister pocket at at least the first pressure and the second pressure;
(iv) an image capture device able to take latticed pictures of the or each blister pocket at at least the first pressure and the second pressure; and
(v) a processor able to compare the latticed pictures at at least the first pressure and the second pressure to detect deflection of that side of the or each blister pocket at the different pressures.
In this way, the apparatus detects the deflection of each blister pocket at two or more different pressures, e.g. at atmospheric pressure, at a vacuum or near-vacuum pressure, and possibly one or more intermediate pressures.
A pressure reducer for creating and releasing a reduced pressure, such as a vacuum, therearound is well known in the art.
The illumination source could be stationary or have movement to range across the packs and/or pockets. In one embodiment, the illumination source is a stationary light able to illuminate all blister pockets, whether stationary or mobile themselves, thereunder. There could be more than one illumination source, e.g. two, one on each side of a blister pocket.
Generally the or each illumination source comprises one or more lights which emit visible illumination in a lattice or grid pattern, usually using one or more screens or masks to create said pattern. The latticing may have any suitable dimensions, shapes or patterning, generally able to provide a latticed image across at least one blister pocket.
Conveniently, the or each illumination source can be located substantially within a vacuum chamber of the apparatus of the apparatus within which the pressure reduction occurs. Alternatively, the or each illumination source can be located substantially external to a vacuum chamber of the apparatus, the or each illumination source gaining access to the vacuum chamber by means of an aperture or apertures.
The image capture device may comprise one or more of any suitable device including but not limited to a charged coupled device (CCD) camera.
Conveniently, the or each image capture device can be located substantially within a vacuum chamber of the apparatus within which the pressure reduction occurs. Alternatively, the or each image capture device can be located substantially external of a vacuum chamber of the apparatus, an aperture enabling the image capture device to gain access to the vacuum chamber.
According to one embodiment of the present invention, the processor analyses first and second pictures of the or each blister pack to produce a comparison picture wherein the comparison picture is used to detect any defects in each blister pocket of greater than a pre-determined dimension and greater than a pre-determined intensity. If any such defects are found, the blister pack could be deemed ‘rejected’ or the like.
Preferably, the apparatus is able to inspect any form of packaged medical products provided in a blister pack, including any from one or more of the group comprising: medical devices and pharmaceutical products. The present invention is useable with many different sizes, shapes and formats of pharmaceutical blister packs in particular, which can comprise blister pockets of up to 40 mm or more diameter, and different pocket depths of up to 10 mm or more, and have in-line, diagonal or asymmetric pocket formats.
The apparatus of the present invention can detect a leak in any format of blister pocket regardless of the shape of the pocket or whether the contents are tablets or capsules.
Advantageously, in accordance with the present invention the blister pack or packs may be arranged randomly on the plate without the requirement to be placed at a particular location or in a defined orientation. Similarly, where two or more packs are provided on the plate they may be placed with any mutual spacing or may partially overlap, for example at the edges of the blister packs. This enables a user of the apparatus to quickly place a blister pack, or to scatter a number of packs, to be tested on the plate thereby obviating the need to carefully position or arrange said pack or packs. Conveniently, this enables each test to be carried out quickly without any detrimental effect to the reliability or accuracy of the test results.
Advantageously, the apparatus may be provided with pack retaining means adapted to retain one or more blister packs on the plate.
The pack retaining means may comprise one or separate or integral elements or devices, able to retain and/or support one or more blister packs, said blister packs possibly being of the same, similar or of dissimilar, shapes and sizes. For example, the pack retaining means may be generic, and be able to support blister packs of any shape, size or design, or it may be specifically shaped, or comprise one or more specifically shapes elements, for one or more specific blister pack shapes.
In one embodiment, the pack retaining means comprises an over-mesh or over-net which makes light contact with at least a portion of the blister pack or packs in use, the over-mesh or over-net comprising a mesh of fine wires or strands. Contact of the pack or packs with the over-mesh or over-net is effected by moving the plate towards the over-mesh or vice versa.
In an alternative embodiment, the pack retaining means may comprise a tacky or adhesive surface or covering applied to the plate.
Optionally, the apparatus includes a drawer, preferably moveable between an open position at which the or each blister pack is changeable, and a closed position wherein the or each blister pack is suitably located within the apparatus for one or more changes in pressure to be applied therearound.
Further optionally, the plate comprises the drawer, or a portion of the drawer such as the drawer base, or is locatable in or on the drawer.
The apparatus of the present invention can be of any suitable size, shape and design so as to be able to test one or a number of blister packs simultaneously.
The apparatus may include an inscriber to mark the or each blister pocket and/or pack having a detected leak.
The apparatus of the present invention is capable of detecting holes of low sizes typically down to ten microns with time to allow pressure changes to be affected in a blister pocket.
According to a second aspect of the present invention, there is provided a method of detecting a leak in one or more blister pockets of one or more blister packs, comprising the steps of:
In one embodiment of the present invention, the method further includes measuring the intensities of at least part of the first and second pictures, and/or adjusting illumination levels of the or each source of illumination, as necessary, until the intensities of the parts of the first and second pictures are approximately the same.
Preferably, for the or each picture, pixels of the picture are analysed to determine an intensity value of each pixel, and a thresholding function is then chosen and applied to the picture, such that any pixel having an intensity value equal to or greater than the thresholding function is shown as a first colour such as white on a processed picture of the picture, and any pixel having an intensity value below the thresholding function is shown as a second colour such as black on the processed picture of the picture, or vice versa. The intensity of the pixels could be determined according to an intensity scale comprising 0 to 256.
The image processing could be one or more of the group comprising: thresholding of the or each picture, intensity inversion of the or each picture, particle filtering of the or each picture, and application of regions of interest to the or each picture.
Alternatively and/or additionally, the image processing could comprise processing the first picture to produce a processed first picture in which any defects appear bright and any features common to both the first and second pictures appear bright; processing the second picture to produce a processed second picture in which any defects appear bright and any features common to both the first and second pictures appear dark; and comparing the processed first picture and the processed second picture to produce a comparison picture in which any defects appear bright and any features common to both the first and second picture appear dark. For example, analysing pixels of the first picture to determine an intensity value of each pixel, applying a first thresholding function range to the pixels of the first picture such that any pixel of the first picture having an intensity value within this range has an intensity value in the processed first picture of 256 and any pixel of the first picture having an intensity value outside this range has an intensity value in the processed first picture of 0, or vice versa.
According to another embodiment of the present invention, there is provided a monitor screen wherein a graphical representation of one or more blister packs having one or more blister pockets undergoing a leak detection test is presentable, wherein the or each sealed blister pocket is represented by a first indicia, such as a first colour, and the or each leaking pocket is represented in a second indicia, such as a second colour.
One such indicia is the word “fail”. With colour, preferably the first colour is green and the second colour is red, although any two suitable colours can be selected
The screen presentation provides clear graphic display of test results for a non-skilled operator. Results can also be recorded or transmitted as desired or necessary.
Embodiments of the present invention will now be described by way of example only and with reference to the accompanying diagrammatic drawings in which:
a is a schematic view of internal parts of an apparatus according to the present invention;
In
a to 4d are cross-sectional side views of a blister pocket at different pressure levels and points of the leak detection process;
Referring to the drawings,
Over-mesh (or over-net) 4 provides a retaining means adapted to retain one or more blister packs 2 on plate 6, the over-mesh comprising a mesh of fine wires or strands which make light contact with at least a portion of the blister pack or packs 2 in use. Contact of the blister pack or packs 2 with the over-mesh may be effected by moving plate 6 towards over-mesh 4 or vice-versa.
Over-net 4 is just one example of a suitable blister pack retaining means adapted to prevent motion of a pack or packs when reduced pressure is applied as described below.
In an alternative embodiment, the blister pack retaining means may comprise a tacky or adhesive surface or covering applied to plate 6 and upon which a pack releasably adheres.
Other suitable pack retaining means may comprise one or separate or integral elements or devices, able to retain and/or support one or more blister packs, said blister packs possibly being of the same, similar or of dissimilar, shapes and sizes. For example, the pack retainer may be generic, and be able to support blister packs of any shape, size or design, or it may be specifically shaped, or comprise one or more specifically shapes elements, for one or more specific blister pack shapes.
The apparatus 8 also includes a suitable air inlet and outlet (not shown), and a monitor screen 12.
a figuratively shows a vacuum chamber 14 in the apparatus 8 having three blister packs 2 suitably located below an illumination source, comprising two light projectors 16. The illumination provided by the light projectors 16 is a lattice illumination 17. That is, either the arrangement of the source or sources of illumination in the light projectors 16, and/or the use of one or more screens, masks, grids, etc. in front of the light projectors 16, is able to project the illumination so that it is seen in a lattice or grid-like form or pattern on the top side of the blister packs 2 facing the light projectors 16.
In this way, the view or image of the regular spacing or other geometric arrangement of the laths/lines/bars, etc. of the lattice pattern or patterning projected onto each pocket of the blister packs 2 will change (relative to the same picture-taking position) if the shape (i.e. the ‘height’) of the top side of the blister pockets 20 of the blister packs 2 changes in relation to the rest of the blister pack 2, following a change in ambient pressure. One or more of such changes in the arrangement of the lattice at different pressures can then be compared.
b figuratively shows an alternative arrangement where the camera 18 and light projectors 16 are located substantially outside vacuum chamber 14, apertures provided in the wall of the chamber enabling the camera and projectors to gain access to the vacuum chamber 14.
a shows a cross-sectional view of one blister pocket 20 in a blister pack 2, with a tablet 22 therein.
In use, the blister pack 2 is located in the pack retainer and drawer 9, and the drawer 9 is located in the apparatus 8. Optionally, a first latticed picture is taken by the camera 18 (
After any such first picture taking, a reduced pressure is applied within the apparatus 8. The reduced pressure can be wholly or substantially a vacuum. The reduction in pressure should force at least the flat side 24 of each blister pocket 20 to deflect outwardly in view of the normal pressure within the blister pocket 20. This is shown in
Thereafter, a partial increase in pressure (or a partial decrease in the vacuum) could be applied within the apparatus 8 and a third latticed picture taken of the blister pack 2 once time has allowed settling of the new pressure. This could reduce the deflection in the flat side 24 of each blister pocket 20 as shown in
Thereafter, pressure in the apparatus 8 is returned to the atmosphere, such that the drawer 9 is openable and the blister packs 2 removable.
On the screen 12 of the apparatus 8 can be projected an image of the blister pack 2 such as that shown in
If desired, a histogram of the first comparison picture in
Again,
Finally, those blister pockets 20 being another shade/colour (labelled “I”) could be ignored, as they were not sufficiently represented in original
The present invention provides a fast and convenient way to inspect a number of blisters pockets and/or packs to detect different types or forms of leaks therein, and to present the information in a suitable form for a user to understand.
In particular, the present invention provides an easy-to-use and operate testing apparatus and method able to test multiple numbers of blister packs simultaneously and in a non-destructive manner, for leaks in individual blisters from a projected grid image.
Various modifications and variations to the described embodiments of the invention will be apparent within the art without the parting of the scope of the invention testifying herein. Although the invention has been described in connection with specific preferred embodiments it should be understood that the invention as defined herein should not be unduly limited to such specific embodiment.
Number | Date | Country | Kind |
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1002294.5 | Feb 2010 | GB | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/GB11/50207 | 2/7/2011 | WO | 00 | 8/10/2012 |