A color-patch device for automatic particle detection in parenteral bottles

Abstract

The invention discloses a device (100) for automated detection of particles in parenteral bottles (105), combining alternating black (102) and white (103) stripes with a gray gradient (104) on an acrylic diffuser (101), backlit by Light Emitting Diodes. The device (100) identifies the particles by contrast black particles are visible against white stripes and vice versa. The gray gradient (104) minimizes false positives caused by minor vibrations, interpreted as particle movement at the stripes' boundaries. The Tyndall effect, resulting from light scattering by particles, facilitates the detection of white, transparent and semi-transparent particles. The device streamlines the visual inspection process, merging the capabilities for detecting both black and white particles within bottles of various sizes, into a single station, thereby simplifying the setup and reducing the costs associated with conventional inspection devices.

Description

TITLE OF THE INVENTIONA color-patch device for automatic particle detection in parenteral bottlesDESCRIPTION OF THE INVENTIONTechnical field of the invention

[0001] The present invention relates to a color patch device for use in particle inspection machines within the technical field of pharmaceutical quality control and inspection technology. More specifically, the invention relates to a color patch device for visual inspection of pharmaceutical liquids in containers such as ampules, vials, and bottles wherein the color patch device is made of acrylic material diffuser, features alternating black and white stripes, along with a linear gray gradient between the black and white stripes, and is equipped with a Light Emitting Diode (LED) illumination. The invention discloses the detection of various particles in different types of pharmaceutical liquids in bottles of varying sizes utilizing contrasting particle colors against the striped background.Background of the invention

[0002] In the realm of pharmaceutical manufacturing, particularly for injectable products contained in ampules, vials, and bottles (collectively termed "bottles" in this context), stringent regulatory standards mandate a comprehensive 100% inspection of all filled and sealed bottles. The thorough inspection process is vital for identifying any particulate contamination in the liquid, as the impurities can lead to adverse reactions when administered to patients. To comply with the rigorous standards, manufacturers must properly examine each bottle. The pharmaceutical industry is shifting towards the use of automated inspection machines, due to the high inspection speeds and reliability in detecting particles within the liquid.

[0003] The predominant operating principle of the automatic inspection machines involves spinning the bottle containing the liquid, and then stopping the spin. Whenthe spinning ceases, the liquid inside the bottle continues to move, setting any particles within in motion. Detection instruments such as camera, and software are used to detect the moving particles. The core principle of the software operation is to find the image difference between consecutive frames. Static parts of the frame do not result in any image difference, whereas moving parts, such as particles, create a noticeable difference in the area where the particle moves.

[0004] Particles found in the bottles generally fall into two broad categories: “opaque” or “black” particles, which do not reflect light, and “white” or “glass” particles, which reflect and scatter light. Current automatic inspection machines use separate black and white backgrounds for the visibility of white and black particles respectively. The white backgrounds are for spotting black or opaque particles, while black backgrounds are effective for detecting white and light- scattering particles. The backgrounds, coupled with suitable lighting, are employed at separate inspection stations.

[0005] The existing state-of-the-art in pharmaceutical particle inspection, which involves using separate stations for detecting different types of particles, poses several significant drawbacks. Firstly, the necessity for multiple stations to discern between black and white particles inherently increases the complexity of the machinery, the initial cost of the equipment and impacts the maintenance expenses and operational logistics.

[0006] Additionally, the physical space required for multiple stations can be substantial, posing a challenge in facilities where space optimization is crucial. The process of transferring bottles between these stations for a comprehensive inspection can lead to inefficiencies in the workflow, potentially affecting the throughput and overall productivity of the inspection process.

[0007] Moreover, each station requires individual calibration and maintenance, increasing the operational downtime and the potential for errors. The fragmented approach can also complicate the training and skill requirements for the operating personnel.

[0008] The separate station methodology, while effective in particle detection, introduces a range of logistical, financial, and operational challenges that can impact the efficiency and cost-effectiveness of the pharmaceutical manufacturing process.

[0009] To address the challenges inherent in the existing state-of-the-art particle inspection methods, several inventive solutions have been proposed and developed.

[0010] For instance, the Patent No. CN103163152A titled “Light inspection method for semi-automatic ampoule bottle light inspection machine''1discloses a method for inspecting light in semi-automatic ampoule bottles using a specialized machine. The method involves setting up a black or white background, positioning three adjustable white light sources above, below, and directly in front of the bottles at a 45-degree angle. It also includes adjusting the machine's motor speed for optimal liquid rotation in the bottles, applying high-speed disturbance against a white background before entering the inspection zone, and low-speed disturbance within the zone for defect detection, with a consistent transport speed. When using a black background, defects are identified through rapid rotation and abrupt stopping of the bottles in the inspection zone.

[0011] The Patent No. CN113049604A titled “Universal lamp inspection mechanism with background transformation and lamp inspection method" discloses a light inspection mechanism designed for medicine bottle inspection. It features a bottle positioned between a light source system and an image capture assembly. The light source system includes a light source and a background plate with changeable colors, with the light source located above the bottle and the background plate facing it. The image capture assembly consists of a camera focused on the bottle. This setup allows for various lighting modes like backlight, bottom light, and low light backlight combinations, catering to diverse imaging requirements in bottle inspection.

[0012] The Patent No. CN113049605A titled “Foreign matter lamp inspection mechanism based on combined light source and lamp inspection method"" discloses a mechanism and method for detecting foreign matter in medicine bottles, using acombined light source. It includes a bottle positioned between a dual light source system (an upper light source and a backlight source) and an image capture assembly with a camera. This setup reduces interference from liquid levels, enhancing the detection of impurities like hair and white spots, particularly in large- capacity solutions. The method provides defect detection at a single station, and identification of foreign matter in solvents. However, it is primarily suitable for large volume bottles exceeding 100ml, whereas the current invention is applicable to bottles of all sizes. Additionally, the principle of operation of the system is akin to using two distinct stations for inspecting each type of particle, differing only in that it alternates between different light sources. Moreover, the invention necessitates electronic synchronization between the camera and the light source, introducing additional hardware requirements that increase cost and complexity.

[0013] None of the prior arts address the issue of detecting the particles of different kinds within pharmaceutical bottles of all sizes using a single inspection station. Consequently, there exists a discernible demand for a device that streamlines the detection process, reducing the need for multiple stations and thereby minimizing operational complexity and cost.Summary of the invention

[0014] The present invention addresses the limitations of the prior art by disclosing a device for automatic inspection of parenteral bottles that consolidates the detection of different types of particles in bottles of varying sizes, into a single station. The device comprises a pattern of alternating black and white stripes, along with a gray gradient transition between the stripes printed on an acrylic diffuser. The grey gradient reduces false positives commonly caused when slight vibrations of the inspection set up are misinterpreted as particle movement by the inspection instrument (e.g., camera) at the boundary between the contrasting stripes.

[0015] The operating principle of automatic inspection machines involves the spinning the parenteral bottle containing the fluid and then stopping the spin. Upon cessation of spinning, the liquid within the parenteral bottle remains in motion, thereby setting any particles within the parenteral bottle into motion as well.Inspection instrument and software are utilized to detect moving particles within the liquid, with the software's main operation principle being to calculate the difference between consecutive frames. Static parts of the frame will not result in any image difference, whereas moving parts (e.g., particles) will create an image difference in the area where the particles are in motion.

[0016] The primary component of the device is the specially designed acrylic diffuser which is backlit to facilitate the inspection process. The acrylic diffuser, bearing the strategic printed pattern of alternating black and white stripes, along with a gray gradient transition between the stripes, is positioned in front of an LED enclosure to ensure even illumination. During the inspection, the device is positioned behind a parenteral bottle, which is then set into spinning motion. The spinning action causes particles within the parenteral bottle to spin, becoming visible against the contrasting stripes — white and transparent particles through reflection or scattering against the black and gray background, and black particles through absorption of light against the white background. The present invention allows for the efficient identification of particles as they transit across the varied background, utilizing the contrast provided by the black, white, and gray segments to enhance the accuracy of the inspection process.

[0017] The introduction of the gray gradient reduces the contrast at the boundary of the black and white stripes, preventing the inspection instrument (camera) from falsely detecting changes due to minor vibrations of the inspection set-up. The device simplifies the operational setup by eliminating the need for separate stations dedicated for inspecting different particle types. The present invention also reduces the cost by minimizing the number of stations required for set up and regular cost of maintenance.Brief description of the drawings

[0018] The foregoing and other features of embodiments will become more apparent from the following detailed description of embodiments when read in conjunction with the accompanying drawings. In the drawings, like reference numerals refer to like elements.

[0019] FIG 1 illustrates a front view of a color-patch device for automatic particle detection in parenteral bottles, in accordance with one embodiment of the present invention.

[0020] FIG 2 illustrates an exemplary explanation of the role of the linear gray gradient in preventing false positives, in accordance with one embodiment of the present invention.

[0021] FIG 3 illustrates an exemplary usage of the color-patch device for automatic particle detection in parenteral bottles, in accordance with one embodiment of the present invention.Detailed description of the invention

[0022] In order to more clearly and concisely describe and point out the subject matter of the claimed invention, the following definitions are provided for specific terms, which are used in the following written description.

[0023] The term “Parenteral Botle ” refers to a sterile container designed to contain medications for administration into the body through routes other than the digestive system.

[0024] The term “Particle Detection ” refers to a method for identifying foreign bodies within a solution, crucial for maintaining the purity and safety of injectable medications.

[0025] The term “Color-Patch Background” refers to a specifically designed background pattern consisting of alternating black and white stripes with intervening gray gradients, used to enhance the visibility of particles during inspection in a single station.

[0026] The term “Incident Light” refers to a primary light source directed from the color-patch background onto the parenteral bottle, which is essential for illuminating the particles within the parenteral bottle for detection purposes.

[0027] The term “Scattered Light” refers to the light that has been redirected after encountering particles in the solution, used to highlight and detect particles during the inspection process.

[0028] The term “Inspection Instrument (Camera) ” refers to a device integrated into the inspection process to capture images and detect particles against the colorpatch background.

[0029] The term “Tyndall Effect ” refers to a phenomenon where light is scattered by particles in suspension, which is observable in the inspection of parenteral solutions for quality control.

[0030] The term “False Positive ” refers to an erroneous signal in an inspection mechanism that incorrectly suggest the presence of particles, potentially leading to unnecessary waste or additional inspection.

[0031] The term “Linear Gray Gradient” refers to a smooth transition in shading from black to white, applied to the color-patch background to reduce the impact of minor movements and vibrations on the inspection results.

[0032] The term “Acrylic Diffuser ” refers to a part of the device that evenly spreads light across the color-patch background, ensuring that particles are well-illuminated and discernible by the inspection instrument.

[0033] The present invention discloses a device designed for the automated detection of particles in parenteral bottles using a single inspection station. The device incorporates a combination of alternating black and white stripes with a linear gray gradient on an acrylic diffuser, backlit by LEDs. The black stripes are responsible for the visibility of white particles, whereas the white stripes are optimized for the detection of black particles within the parenteral bottle. The introduction of a linear gray gradient between the black and white stripes plays a vital role in reducing false positives caused by minor vibrations of the inspection set-up, thereby ensuring the reliability of the particle detection. Incident light from the device illuminates the particles within a parenteral bottle to make them visible to the inspection instrument, such as a camera. The invention maximizes theidentification of white, transparent and semi-transparent particles by the Tyndall effect, as indicated by the behavior of scattered light The device merges the detection of various particle types into a single, streamlined operation, showcasing a significant leap forward in the field of particle inspection technology.

[0034] FIG 1 illustrates a front view of a color-patch device for automatic particle detection in parenteral bottles, in accordance with one embodiment of the present invention. The device (100) comprises a plurality of alternate black stripe (102) and white stripes (103), and a linear gray gradient (104) region in between each black (102) and white (103) stripes, each serving a specific function in the particle detection process. The black stripes (102) are configured to detect white particles by presenting a contrasting dark background. The contrast ensures that white particles is highlighted and distinguishable during the inspection process.

[0035] Conversely, white stripes (103) are intended to provide a high-contrast background against which black particles can be identified by the inspection mechanism. The strategic placement of the contrasting regions within the field of view of the device (100) is essential for achieving a comprehensive particle detection capability, enabling the device (100) to identify particles of varying colors and sizes.

[0036] The inclusion of the linear gray gradient (104) between the black (102) and white (103) stripes introduces a nuanced approach in addressing the challenge of false positives, which can result from minor vibrations or shifts in the inspection set up. By implementing a gradient that transitions smoothly from white to black, the linear gray gradient (104) region serves to dampen the impact of the environmental variables on the detection accuracy. The feature of the linear gray gradient (105) is critical in ensuring that the device (100) maintains high fidelity in particle detection, reducing the likelihood of false detections due to minor background movements. The integration of the three regions into the device's (100) design exemplifies a balanced approach to enhance the visibility of particles, leveraging the principles of contrast, light diffusion and scattering due to Tyndall effect that optimize the detection process.

[0037] FIG 2 Illustrates an exemplary explanation of the role of the linear gray gradient in preventing false positives, in accordance with one embodiment of the present invention. The first row in FIG-2 depicts a range of grayscale values from pure black, representing 0% white, to pure white, representing 100% white, divided into five equal-width regions. The progression is indicative of the background against which particles within the parenteral bottle (105) is identified during an inspection process.

[0038] The second row in FIG. 2 shows the same regions after being shifted to the right, representing the type of background displacement that might result from mechanical vibrations within the inspection set-up. The third row provides a comparative analysis, presenting the percentage change in grayscale value for each region post-shift. Notably, no region exhibits a change exceeding 25%, which is a crucial observation.

[0039] The data displayed in FIG. 2 is instrumental in defining operational parameters for an inspection instrument (109). By establishing a detection threshold for movement that is greater than the maximum observed change of 25%, the inspection set up is calibrated to ignore minor, inconsequential shifts in the background, thereby minimizing the occurrence of false positive detections of particles. The threshold ensures that only substantive changes in the background, likely indicative of actual particles’ movement, will be flagged by the inspection set-up. The feature is vital for maintaining high specificity in particle detection, which is particularly important in the high-stakes production environment of parenteral medications where accuracy is crucial.

[0040] The following example is offered to illustrate the aspect of the present invention. However, the example is provided to explain the subject matter and not a limitation. Various changes and modifications obvious to one skilled in the art to which the invention pertains are deemed to be within the spirit, scope and contemplation of the invention.Example 1: Demonstrative illustration of usage of proposed invention

[0041] FIG 3 illustrates an exemplary application of the color-patch device for automatic particle detection in parenteral bottles, in accordance with one embodiment of the present invention.

[0042] The invention employs an alternating black (102) and white (103) stripes, with a linear gray gradient (104) positioned between the contrasting stripes on an acrylic diffuser (101) and illuminated from behind by LED lights. The set-up is designed to identify particles based on their contrast against the background. The alternating stripes of black (102) and white (103) create a high-contrast environment that aids in the visibility of both white and black particles, respectively. The gray gradient (104) between the stripes is critical for minimizing false positives that could arise from minor vibrations in the inspection setup, ensuring the reliability of particle detection. The invention aims to enhance the visibility of multiple white particles (106) within the parenteral bottle (105), utilizing the principle of light refraction, and the Tyndall effect that uses scattered light (108) to illuminate particles for detection by the inspection instrument (109), likely a camera.

[0043] FIG 3 illustrates the mechanism of detection of white particles (106) present within the parenteral bottle (105) against the grey (104) or black (102) background regions in the device (100). In figure, the larger circle represents the boundary of the parenteral bottle (105). The smaller circle within the larger circle represents a white particle (106) within the liquid in the parenteral bottle (105). An incident light (107) that falls normally on the parenteral bottle (105), enter and passes through the central axis of the parenteral bottle (105). Some parts of light that are incident slantly on the side walls of the parenteral bottle (105) are directed towards the center of the parenteral bottle (105) due to refraction, and illuminates white particles (106) present within the liquid in the parenteral bottle (105). When the incident light hits the particles, light scattering occurs due to the Tyndall effect, that makes the white particle (106) visible against the black (102) background. Transparent particles are also made visible as the irregularly shaped transparent particle scatter the lightincident on them, resulting them becoming visible. The white (106), transparent and semi-transparent particles are thereby detected by the inspection instrument (109) when they pass in front of the black stripes (102).

[0044] Using the black (102) and white (103) stripes for inspection of particles results in a high chance of false positives due to minor vibrations in the machine setup. This is because any movement at the border of the black (102) and white(103) stripe is detected as a change in background color. A linear gray gradient(104) is used between the black (102) and white (103) stripes to ensure that any minor movement is not registered as a change in background because the change in background between the grey and black / white region is less when compared to the change in background between white and black regions.

[0045] The device addresses the challenge of the risk of false positives due to machine vibrations, by incorporating a linear gray gradient (104) between the black (102) and white (103) stripes. The linear gray gradient (104) ensures that minor movements of the inspection set up do not trigger false detections, as the change in background contrast is minimized. The linear nature of the gray gradient (104), transitioning from 100% white to 100% black, i.e., the intensity of the gray color is directly proportional to the distance from the white or black region, further refines the detection process, allowing for a precise and reliable identification of particles within the parenteral bottles (105).

[0046] While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist.

[0047] The invention offers significant advancements in the cost-effectiveness of particles’ inspection in parenteral bottles. By integrating both black and white particle inspection mechanisms into a single station, the invention substantially reduces setup cost, operational expenses and decreases regular maintenance costs.

[0048] Additionally, the use of a linear gray gradient (104) used in the device (100) enhance detection accuracy, minimizing false positives and improving particlevisibility. The advancements expedite the inspection process and also reduce the need for extensive manual oversight, further cutting down labor costs and increasing efficiency in quality control operations.Reference numbers:

Claims

ClaimsI claim:

1. A color-patch device for automatic particle detection in parenteral bottle, the device (100) comprising: a. an acrylic diffuser (101) with plurality of an alternating black (102) and a white (103) stripes configured to provide a contrasting background for the detection of multiple particles within a parenteral bottle (105) based on the color contrast; and b. a linear gray gradient (104) positioned between each of the alternating black (102) and white (103) stripes; wherein the linear gray gradient (104) facilitates a linear gradual change in background contrast from each of the black stripe (102) to the white (103) stripe and vice versa.

2. The device (100) as claimed in claim 1, wherein the linear gray gradient (104) is designed to reduce the false positive detection of particles within the parenteral bottle (105).

3. The device (100) as claimed in claim 1, wherein the device (100) comprising the acrylic diffuser (101) is positioned in front of an illumination source, ensuring uniform illumination across the device (100) for detection of particles within the parenteral bottle (105).

4. The device (100) as claimed in claim 3, wherein the illumination source includes a plurality of Light Emitting Diodes (LEDs) configured to uniformly backlight the acrylic diffuser (101).

5. The device (100) as claimed in claim 4, wherein the plurality of LEDs comprises white LEDs, Ultra-Violet (UV) LEDs, and infrared LEDs, accommodating various inspection requirements for detecting particles inparenteral bottle (105), based on the fluid types contained within the said parenteral bottle (105).

6. The device (100) as claimed in claim 1, wherein the intensity of the illumination source is adjustable based on the type of fluid contents within the parenteral bottle (105) to optimize particle detection.

7. The device (100) as claimed in claim 1, wherein the detection of the particles within the parenteral bottle (105) is facilitated by an external inspection instrument (109).

8. The device (100) as claimed in claim 1, wherein the dimensions of the alternating black (102) and white (103) stripes and the width of the linear gray gradient (104) are specifically calibrated to maximize contrast and visibility of a wide range of particle sizes and types, including both opaque and transparent particles within the parenteral bottle (105) of various volumes.

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