Intravenous bag inspection apparatus and method

Abstract

An apparatus for inspecting IV bags includes a base with a working surface. A conveyor belt is raised above the working surface by a conveyor belt support and includes multiple bag clamps, each adapted to hold one of the IV bags in an inverted position at one of multiple workstations. A controller moves the conveyor belt such that each bag clamp moves from one workstation to the next at set time intervals. A loading workstation places one of the IV bags into one of the bag clamps. A bubble reduction station agitates the fluid within the IV bag to remove any air bubbles. Two particle agitation stations agitate the fluid and any residual particles. The inspection station includes a backlight, a camera, a display, and a non-conforming chute leading to a disposal container.

Description

[0001] Cross-reference of related applications

[0002] This application claims the rights of U.S. Provisional Patent Application No. 63 / 242,020, filed September 8, 2021, and U.S. Utility Patent Application No. 17 / 902,991, filed September 5, 2022, both of which are incorporated herein by reference.

[0003] Statement on Federally Funded Research and Development

[0004] not applicable. Technical Field

[0005] This invention relates to the testing of medical devices, and more specifically, to an apparatus and method for testing filled intravenous (IV) bags. Background Technology

[0006] Current technology for inspecting IV bags primarily relies on a manual process involving the individual manipulation and inspection of each bag. Around the world, IV bags are manually inspected by qualified inspectors who manually manipulate the bags and attempt to see through various visual obstacles. These obstacles typically include printing on the bag, air bubbles in the liquid, and sometimes the bag is made of EVA or other nearly opaque materials. These visual obstacles do not disappear quickly, thus posing the same challenges to manual, semi-automatic, and fully automated inspection processes.

[0007] The typical manual procedure for inspecting IV bags includes the following steps:

[0008] 1. The inspector picks up and manually manipulates the IV bag to shake it in an attempt to move any particles.

[0009] 2. A few seconds before the inspector positions the IV bag toward a white background illuminated area, visually inspect the IV bag for any dark particles that are difficult to see.

[0010] 3. A few seconds before the inspector reorients the IV bag to a black background lighting area, check the IV bag for any light-colored particles that are difficult to see.

[0011] 4. The inspector places the IV bag in the non-conforming product location / box, or places the IV bag in the "conforming" product location / box.

[0012] Note: USP 790 and USP 1790 regulations require that all manual inspections be performed twice. To meet this requirement, the process should be performed twice (but this is rarely done).

[0013] This existing manual process involves a large amount of repetitive, ergonomic movement (individual IV bags can weigh several pounds each). Furthermore, inspectors must possess exceptional visual acuity and the ability to avoid distractions and focus on the task at hand. The entire process typically takes an inspector approximately 20 seconds per IV bag, and any variability in consistency between inspectors leads to a decrease in inspection quality. Variations in the duration of individual inspection timings also contribute to this quality degradation. In addition, inconsistencies in the shaking, placement, or positioning of IV bags by each inspector can introduce variations in inspection quality. Moreover, current best lighting systems used for so-called "manual inspection benches" control the uniformity of LED lighting to a variation of no more than 5%.

[0014] Therefore, there is a need for an apparatus that produces more consistent inspection due to the consistent positioning and movement of IV bags in front of a human inspector, without requiring the human inspector to directly grasp or otherwise manipulate the IV bags. This desired invention would take less time than prior art inspection methods and result in more consistent inspection with more uniform inspection quality. This desired device would provide backlight uniformity of no more than 0.05% for the inspection of IV bags. The present invention achieves these objectives. Summary of the Invention

[0015] This device is a semi-automatic inspection system for IV bags containing fluid, operated by two or more human inspectors. For example, additional human operators may be included to load or unload the device. The base comprises a generally flat working surface with at least three side edges. This working surface is preferably supported by, for example, multiple table legs.

[0016] The conveyor belt is raised above the work surface by one or more conveyor belt supports. The conveyor belt is preferably a belt with a plurality of bag clamps fixed thereto. Each bag clamp is adapted to hold one of the IV bags in an inverted position above the work surface at one of a plurality of workstations. Each workstation is positioned in front of the conveyor belt and at one side edge of the base. Preferably, each of the bag clamps is spaced apart by a given predetermined distance, the distance corresponding to the distance between the workstations.

[0017] The controller is adapted to move the conveyor belt using an electric motor, causing each bag clip to move from one workstation to the next at set time intervals or under the guidance of a human inspector. The controller and the electric motor are powered by a power source, such as line voltage or the like. The controller further includes at least one user interface, such as soft buttons on a tablet computer, buttons or dials on a control panel, or electromechanical buttons on a remote control interface. The belt may include a timing aperture that allows LED light from an LED emitter to pass through and enter a detector, enabling the controller to determine when each bag clip has moved to the next workstation and to stop the conveyor belt from moving for a predetermined time period, for example, 8 to 10 seconds. The conveyor belt then moves forward until each bag clip has moved to the next workstation, and the process is repeated.

[0018] The first workstation is a loading workstation adapted to receive one of the IV bags into one of the bag clamps. Each bag clamp is adapted to move between an open position in which two opposing clamping parts are separated to receive the IV bag and a closed position in which the two opposing clamping parts are pushed together to hold the IV bag therebetween. When released, a spring or other actuating member pushes the bag clamp to the closed position.

[0019] The second workstation is a bubble reduction station adapted to agitate the fluid within one of the IV bags to expel any air bubbles within the IV bag. Preferably, the bubble reduction station comprises two or more solenoid-actuated impactors adapted to strike the IV bag to expel the air bubbles within the IV bag, each impactor adapted to strike the IV bag at a different location on the IV bag. The bubble reduction station may further include a support surface disposed in front of the IV bag to prevent the IV bag from swinging back and forth when struck by the solenoid-actuated impactors.

[0020] The third and fifth workstations are particle shaking stations, each adapted to shake the fluid within one of the IV bags to facilitate movement of the fluid and any residual particles within the IV bag. Preferably, each particle shaking station includes at least one ultrasonic actuator adapted to press against the IV bag and ultrasonically shake the fluid and any residual particles within the IV bag.

[0021] The fourth workstation is a visual inspection station, which has a backlight device placed behind one of the IV bags and a non-conforming chute passing through the work surface and leading to the disposal container.

[0022] The sixth workstation is an inspection station, which has one of the following: a backlight device located behind one of the IV bags; a camera located in front of the IV bags; a display adjacent to the IV bags and adapted to display an image of the IV bags from the camera; and a non-conforming chute passing through the work surface and leading to a disposal container.

[0023] The visual inspection station and the inspection station itself further include one of a bag clamp release actuator, which engages the bag clamp to release the IV bag when a human inspector has determined that the IV bag has failed the inspection. A remote control interface within each inspection station is adapted to actuate the bag clamp release actuator.

[0024] The seventh workstation is the unloading workstation, where the IV bags are released from the bag holders and placed in containers designated for the inspected IV bags. A human operator may assist with this step if needed or necessary.

[0025] In use, one of the IV bags is loaded onto one of the bag clamps at the loading station and moved by the conveyor belt to the bubble reduction station. Any bubbles in the IV bag move to the bottom of the inverted IV bag by buoyancy. The IV bag is then moved by the conveyor belt to the third station, the particle shaking station, where any residual particles within the IV bag are shaken and moved. The IV bag is then moved by the conveyor belt to the fourth station, the appearance inspection station, where one of the human inspectors directly inspects the IV bag to detect any residual particles or defects. If residual particles or defects are detected, the human inspector releases the IV bag from the bag clamp and releases it into the non-conforming chute. The remaining IV bags are then moved by the conveyor belt to the fifth station, the other of the particle shaking station, and then to the sixth station, the inspection station. Another of the human inspectors examines the image of the IV bag on the display to detect any residual particles or defects in the IV bag. If residual particles or defects are detected, the IV bag is released from the bag clamp and into the non-conforming chute. Thereafter, the IV bags remaining on the conveyor belt are moved by the conveyor belt to the seventh workstation, the unloading workstation, where the IV bags are released from the bag clamp and moved to a container designated for IV bags that have passed inspection.

[0026] Preferably, the working surface of the base has five side edges, wherein the first, second and seventh workstations are along the first side of the working surface, the third and fourth workstations are along the third side of the working surface, and the fifth and sixth workstations are along the fourth side of the working surface.

[0027] The inspection system of this invention is designed to handle IV bags ranging from 50 ml to 1000 ml with minimal changes to parts, and no tools are required to achieve this change in bag size. The system may be able to handle IV bags up to 6 L. The inspection system is typically used in typical pharmaceutical packaging areas.

[0028] All physical handling of IV bags is completed by an automated inspection system (once the IV bags are placed in the loading box). This eliminates any variability in the handling and positioning of IV bags by inspectors during the inspection process and allows inspectors to focus on inspection rather than material handling, resulting in more consistent inspection and improved inspection quality.

[0029] The reduction of air bubbles in IV fluid is achieved by removing air bubbles that act as visual obstructions (almost completely eliminating them from the bulk of the fluid). When the IV bag contains any foreign matter, the particle shaking station causes those particles to move slowly around in the fluid; this makes them easier for inspectors to observe.

[0030] The inspection process is facilitated by a specialized “backlit” LED lighting method, a high-resolution camera, and a large-screen LED monitor. The specialized LED lighting is controlled and monitored to specific formulation-derived intensity, with variations controlled to less than 0.05%. The high-resolution camera and large-screen LED monitor provide 2.5 to 3 times magnification of the bag and any particles within it. These particles are quickly and easily detected because they are larger and moving. While “backlit” methods are commonly used to inspect other hard-walled injection vessels, the use of this advanced lighting technology is both different and new for IV bag inspection. Furthermore, the lightbox equipped with LED lights is specially designed to ensure a uniform beam of light is projected onto the back of the IV bag, making all foreign matter (particles) appear as darker defects while producing little or no glare on the bag. This advanced lighting technology eliminates the need for the darker and brighter backgrounds currently used in manual inspection operations. Each inspector only needs to inspect IV bags against a single colored background (white), minimizing eye strain compared to constantly switching between bright white and dark backgrounds. The inspector's eye strain is further reduced by observing the bag indirectly on a magnified LED monitor, where the backlight (white background) is visible in low-light conditions. This feature reduces inspector eye fatigue and allows for better utilization of the inspector's skills.

[0031] When a defect is detected on the LED monitor, the inspector simply presses the non-conforming item button on the assigned remote controller to automatically remove the IV bag from the inspection machine and place it into the non-conforming item box at the station.

[0032] All IV bags that successfully pass the inspection of two inspectors are automatically popped into the "qualified" box or, optionally, onto a conveyor belt at the end of the inspection cycle for transport to the next packaging process.

[0033] The inspection time value is set in a specific IV bag formulation, which can vary based on the size and shape of the container, the fluid, and the acceptable inspection time determined by the qualification process.

[0034] This system is designed to meet FDA expectations based on USP 790 and USP 1790 requirements for IV bag inspection. Specifically, this device provides the same or better inspection as "standard" manual inspection, while also ensuring a physical observation period of at least 5 seconds for inspection and fully complying with all manual inspections requiring double inspection. This invention is an apparatus that produces more consistent inspection due to the consistent position and movement of IV bags in front of a human inspector, without requiring the human inspector to directly grasp or otherwise manipulate the IV bags. This invention requires less time than prior art inspection methods and results in more consistent inspection with more consistent inspection quality. This device provides backlight uniformity of no more than 0.05% for IV bag inspection. Other features and advantages of the invention will become apparent from the following more detailed description taken in conjunction with the accompanying drawings, which illustrate the principles of the invention by way of example. Attached Figure Description

[0035] Figure 1 This is a perspective view of the present invention;

[0036] Figure 2 This is a top view of the present invention;

[0037] Figure 3 This is a partial perspective view of the loading workstation of the present invention;

[0038] Figure 4 This is a partial perspective view of the bubble reduction station of the present invention;

[0039] Figure 5 This is a partial perspective view of the particle shaking station of the present invention;

[0040] Figure 6A This is a partial perspective view of the backlight device of the testing station of the present invention;

[0041] Figure 6B yes Figure 6A A top-view plan view showing the path of light emitted from the LED of this invention;

[0042] Figure 7 This is a partial perspective view of the testing station of the present invention;

[0043] Figure 8This is a partial perspective view of the inspection station, showing bag IV, which was deemed non-compliant by a human inspector and fell into the non-compliant chute; and

[0044] Figure 9 This is a partial perspective view of the unloading workstation of the present invention. Detailed Implementation

[0045] The following describes illustrative embodiments of the invention. The following explanations provide specific details for a thorough understanding of these embodiments and for a whimsical description. Those skilled in the art will understand that the invention can be practiced without these details. In other examples, well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0046] Unless the context explicitly requires otherwise, throughout the description and claims, the terms "comprise," "comprising," and similar terms shall be interpreted in an inclusive sense, not in an exclusive or exhaustive sense; that is, in the sense of "including but not limited to." The use of singular or plural terms shall also include the plural or singular, respectively. Furthermore, when used in this application, the terms "this," "above," "below," and similar terms shall refer to the entire application, not any particular part thereof. When the claims use the term "or" to refer to a list of two or more items, the term covers all of the following interpretations: any item in the list, all items in the list, and any combination of items in the list. When the term "each" is used to refer to an element previously described as having a quantity of at least one, the term "each" does not necessarily mean multiple elements, but may also mean a single element.

[0047] Figure 1 and 2 This describes a device 10 that allows two or more human inspectors 15 to perform semi-automatic inspection of their respective IV bags 20 containing fluid. Additional human operators (not shown) may be included to load or unload the device 10.

[0048] The base 30 includes a generally flat working surface 31 with at least three side edges 32. The working surface 31 is preferably supported by, for example, a plurality of table legs 34.

[0049] The conveyor belt 40 is raised above the work surface 31 by one or more conveyor belt supports 44. The conveyor belt 40 is preferably a belt 42 with a plurality of bag clips 45 attached thereto. Each bag clip 45 is adapted to hold one of the IV bags 20 in an inverted position 29 above the work surface 31 at one of the plurality of workstations 50. Each workstation 50 is positioned in front of the conveyor belt 40 and at one side edge 32 of the base 30. Preferably, each of the bag clips 45 is spaced apart by a given predetermined distance, the distance corresponding to the distance between the workstations 50, for example, 18 inches or similar.

[0050] The controller 60 is adapted to move the conveyor belt using a motor 70, such that each bag clip 45 moves from one workstation 50 to the next at set time intervals or under the guidance of a human inspector 15. The controller 60 and the motor 70 are powered by a power source 80, such as line voltage or the like. The controller 60 further includes at least one user interface 90, such as soft buttons on a tablet computer (not shown but known in the art), buttons or dials on a control panel (not shown but known in the art), or electromechanical buttons 261, 262 on a remote control interface 260. The belt 42 may include a timing hole (not shown) that allows LED light from an LED emitter (not shown) to pass through and enter a detector (not shown), allowing the controller 60 to determine when each bag clip 45 has moved to the next workstation 50, stopping the conveyor belt 40 from moving for a predetermined time period, for example, 8 to 10 seconds. The conveyor belt 40 then moves the belt 42 forward until each bag clip 45 has moved to the next workstation 50, and this process is repeated.

[0051] The first workstation is the loading workstation 51 ( Figure 2 and 3 The loading station 51 is adapted to receive one of the IV bags 20 into one of the bag clamps 45. Preferably, the loading station 51 includes an IV bag loading box adapted to hold one of the IV bags 20 in the inverted position 29. Figure 3The robotic gripper 210 is adapted to move to a lowered position 220 to secure the IV bag 20 in the gripper 240, and then move upward together with the IV bag 20 to a raised position 230 to engage the IV bag 20 with one of the bag clamps 45. Each bag clamp 45 is adapted to move between an open position 241 in which two opposing gripping parts 245 are separated to receive the IV bag 20 and a closed position 242 in which two opposing gripping parts 245 are pushed together to hold the IV bag 20 therebetween. A bag clamp release actuator 250 is adapted to press one of the opposing gripping parts 245 of the bag clamp 45 to open the bag clamp 45 to the open position 241. When released, a spring or other actuating member (not shown) pushes the bag clamp 45 to the closed position 242. The bag clamp release actuator 250 may be driven by a solenoid and activated by a controller 60. If needed or necessary, a human operator can assist in this step by inverting the IV bags and loading them into the IV bag loading bin when it becomes empty. Alternatively, another conveyor belt (not shown) can automatically load the IV bag loading bin.

[0052] The second workstation is the bubble reduction station 52 ( Figure 2 and 4 The air reduction station 52 is adapted to agitate the fluid within one of the IV bags 20 to expel any air bubbles 21 within the IV bag 20. Preferably, the air bubble reduction station 52 includes at least one solenoid-actuated impactor 170 adapted to agitate the IV bag 20 to expel air bubbles 21 within the IV bag 20. Preferably, the at least one solenoid-actuated impactor 170 is two or more solenoid-actuated impactors 170, each impactor 170 adapted to agitate the IV bag 20 at a different location on the IV bag 20. The air bubble reduction station may further include a support surface 180 disposed in front of the IV bag 20 to prevent the IV bag 20 from swinging back and forth when agitated by the solenoid-actuated impactor 170. Each solenoid-actuated impactor 170 is adapted to agitate the IV bag 20 when the IV bag 20 is directly in front of the solenoid-actuated impactor 170, regardless of whether the conveyor belt 40 is moving the IV bag 20. For example, an IV bag detector (not shown) or a hole (not shown) in each bag clamp 45 within the conveyor belt 41 can be used with an LED and a photodetector to actuate the solenoid-actuated impactor 170. Other components known in the art for detecting the appropriate timing of actuating the solenoid-actuated impactor 170 can also be used. This solenoid-actuated impactor 170 is preferably electrically connected to the controller 60, but can be powered and wired independently.

[0053] The third and fifth workstations are particle shaking stations 53 and 55. Figure 1 , 2And 5), each particle shaking station is adapted to shake the fluid within one of the IV bags to facilitate movement of the fluid and any residual particles 22 within the IV bag 20. Preferably, each particle shaking station 53, 55 includes at least one ultrasonic actuator 190 adapted to press against and ultrasonically shake the fluid and any residual particles 22 within the IV bag 20. When the IV bag 20 is detected at shaking station 53, 55, a solenoid (not shown) can be used to position the ultrasonic actuator 190 against the IV bag 20. As previously detailed, any number of components for detecting the presence of the IV bag 20 at shaking stations 53, 55 can be used. Alternatively, for simplicity, the ultrasonic actuator 190 can be actuated when the conveyor belt 40 stops and it is assumed that one of the IV bags 20 is located at shaking station 53, 55, regardless of whether the IV bag 20 is located at shaking station 53, 55.

[0054] The fourth workstation is the appearance inspection station 54. Figure 1 , 2 6A, 6B and 8), which have a backlight device 100 disposed behind one of the IV bags 20 and a non-conforming chute 130 passing through the working surface 31 and leading to the disposal container 140. The backlight device 100 of the appearance inspection station 54 preferably includes a backlight housing 200 having an opening 201, a reflective coating 202 on its inner surface 203 and at least two LEDs 204, the LEDs 204 being positioned such that light from the LEDs 204 is reflected at least once from the reflective coating 202 to exit the opening 201 in the backlight housing 200, the brightness of all such light emitted from the opening 201 being relatively uniform throughout the opening 201.

[0055] The sixth workstation is inspection station 56. Figure 2 , 6A 6B, 7, and 8) have one of the following: a backlight device 100 disposed behind one of the IV bags 20; a camera 110 disposed in front of the IV bag 20; a display 120 adjacent to the IV bag and adapted to display an image 125 of the IV bag 20 from the camera 110; and a non-conforming chute 130 passing through the work surface 31 and leading to the disposal container 140. The backlight device 100 of the inspection station 56 preferably includes a backlight housing 200 having an opening 201, a reflective coating 202 on its inner surface 203, and at least two LEDs 204 positioned such that light from the LEDs 204 is reflected at least once from the reflective coating 202 to exit the opening 201 in the backlight housing 200, and the brightness of all such light emitted from the opening 201 is relatively uniform throughout the opening 201.

[0056] Visual inspection stations 54 and 56 further include one of bag release actuators 250, which engages bag clamps 45 to release IV bags 20 when a human inspector 15 has determined that IV bags 20 have failed inspection. A remote control interface 260 within each visual inspection station 54 and 56 is adapted to actuate the bag release actuator 250. As known in the art, the remote control interface 260 may be wirelessly connected to the controller 60 or connected via an interface cable (not shown). The remote control interface 260 may further include a pause button 261, such that, for example, if the human inspector 15 needs more time to inspect a particular IV bag 20, they can pause the conveyor belt 40. For example, a resume button 262 may be included on the remote control interface 260 to reactivate the conveyor belt 40, or the pause button 261 and the resume button 262 may be the same button that simply toggles the state of the conveyor belt 40 between a paused state and an active state. A non-conforming item button 263 may be included on a remote control interface 260 to cause a bag release actuator 250 to open a bag clamp 245 to release the IV bag 20 into a disposal chute 130. This remote control interface 260 is station-specific, meaning that a remote control interface 260 located near an appearance inspection station 54 will not result in any action being taken at the inspection station 56, or vice versa.

[0057] The seventh workstation is the offloading workstation 57 ( Figure 2 and 9 IV bags 20 are released from bag clamps 45 and placed in containers 150 designated for the inspected IV bags 20. A human operator may assist with this step if needed or necessary. Alternatively, the inspected IV bags 20 may fall onto an alternative conveyor belt (not shown) for subsequent packaging and / or transport to other locations.

[0058] In use, one of the IV bags 20 is loaded onto one of the bag clamps 45 in loading station 51 and moved by conveyor belt 40 to bubble reduction station 52. Any bubbles 21 in the IV bag 20 move to the bottom 160 of the inverted IV bag 20 by buoyancy. The IV bag 20 is then moved by conveyor belt 40 to a third station, particle shaking station 53. Any residual particles 22 within the IV bag 20 are shaken and moved, and then the IV bag 20 is moved by conveyor belt 40 to a fourth station, appearance inspection station 54, where one of the human inspectors 15 inspects the IV bag 20 to detect any residual particles 22 or appearance defects. If residual particles 22 or defects are detected, the human inspector releases the IV bag 20 from the bag clamp 45 and releases it into the non-conforming chute 130. The IV bag 20 is then moved by conveyor belt 40 to the other of the fifth station, particle shaking station 55, and then to the sixth station, inspection station 56. Another human inspector 15 examines the image 125 of the IV bag 20 on the display 120 to detect any residual particles 22 or defects in the IV bag 20. If residual particles 22 or defects are detected, the IV bag 20 is released from the bag clamp 45 and released into the non-conforming chute 130. Thereafter, the IV bag 20 is moved by the conveyor belt 40 to the seventh workstation, the unloading workstation 57, where the IV bag 20 is released from the bag clamp 45 and moved into the container designated for the IV bags that have passed inspection.

[0059] Preferably, the working surface 31 of the base 30 has five side edges 32, wherein the first, second, and seventh workstations are along the first side 33 of the working surface 31, the third and fourth workstations are along the third side 34 of the working surface 31, and the fifth and sixth workstations are along the fourth side 35 of the working surface 31. Figure 2 It may include a cover of 270 ( ). Figure 1 To protect human inspectors 15 from injury by the moving conveyor belt 40 and other moving parts.

[0060] While specific forms of the invention have been described and illustrated, it will be apparent that various modifications may be made without departing from the spirit and scope of the invention. For example, the appearance inspection station 54 and the first particle shaking station 53 may be omitted in a single inspection device. Therefore, the invention is not intended to be limited except as described in the appended claims.

[0061] Certain terms used in describing certain features or aspects of the invention should not be construed as implying that such terms are redefined herein as limited to any particular characteristic, feature, or aspect of the invention associated with the term. In general, the terms used in the following claims should not be construed as limiting the invention to the specific embodiments disclosed in the specification, unless such terms are expressly defined in the preceding detailed description section. Therefore, the actual scope of the invention covers not only the disclosed embodiments but also all equivalent ways of practicing or implementing the invention.

[0062] The detailed description of the embodiments of the present invention above is not intended to be exhaustive or to limit the invention to the precise forms disclosed above or the specific fields of use mentioned in this disclosure. As those skilled in the art will recognize, while specific embodiments and examples of the invention have been described above for illustrative purposes, various equivalent modifications are possible within the scope of the invention. Furthermore, the teachings of the invention provided herein can be applied to other systems, not necessarily those described above. Elements and actions of the various embodiments described above can be combined to provide other embodiments.

[0063] All the patents and applications mentioned above, as well as other references (including any that may be listed in the appended applications), are incorporated herein by reference. If necessary, aspects of the invention may be modified to incorporate the systems, functions, and concepts described above to provide further embodiments of the invention.

[0064] Modifications to the invention may be made in light of the foregoing “Detailed Description”. While certain embodiments of the invention have been described in detail above, and the best mode considered has been described, the invention can be practiced in many ways, however detailed it may appear in the text. Therefore, the implementation details may vary considerably, while still being covered by the invention disclosed herein. As mentioned above, specific terms used when describing certain features or aspects of the invention should not be construed as implying that such terms are redefined herein to be limited to any particular characteristic, feature, or aspect of the invention associated with those terms.

[0065] While certain aspects of the invention are presented hereinafter in certain claims, the inventors consider all aspects of the invention in any number of claims. Therefore, the inventors reserve the right to add additional claims after filing the application to pursue other aspects of the invention in such additional claim forms.

Claims

1. A device for semi-automatic inspection of IV bags containing fluid by two or more human inspectors, comprising: The base has a generally flat working surface with at least three side edges; A conveyor belt, which is lifted above the work surface by one or more conveyor belt supports; Multiple bag clamps, each bag clamp secured by the conveyor belt, and used to hold one of the IV bags in an inverted position above the work surface at one of a plurality of workstations, each workstation being located in front of the conveyor belt and at one of the side edges of the base. A controller for moving the conveyor belt by a motor, such that each bag clamp moves from one workstation to the next workstation at set time intervals, the controller and the motor being powered by a power source, the controller further including at least one user interface; The first workstation is a loading workstation, which is used to receive one of the IV bags into one of the bag clamps; The second workstation is a bubble reduction station, which is used to shake the fluid in one of the IV bags to remove any bubbles in the IV bag. The third and fifth workstations are particle shaking stations, each used to shake the fluid in one of the IV bags to facilitate the movement of the fluid and any residual particles in the IV bag. The fourth workstation is a visual inspection station, which has a backlight device placed behind one of the IV bags and a non-conforming chute passing through the work surface and leading to the disposal container. The sixth workstation is an inspection station, which has one of the following: a backlight device located behind one of the IV bags; a camera located in front of the IV bags; a display adjacent to the IV bags for displaying images of the IV bags from the camera; and a non-conforming chute passing through the work surface and leading to a disposal container. The seventh workstation is an unloading workstation, in which the IV bags are released from the bag clamps to be stored in a container designated for the IV bags that have passed inspection; In the first workstation, an IV bag is loaded onto one of the bag clamps and moved by the conveyor belt to the second workstation, where any air bubbles are reduced towards the bottom of the inverted IV bag. The IV bag is then moved by the conveyor belt to the third workstation, where any residual particles within the IV bag are agitated and moved. The IV bag is then moved by the conveyor belt to the fourth workstation, where one of the human inspectors examines the image of the IV bag on the display to detect any residual particles or appearance defects in the IV bag. If residual particles or defects are detected, the human inspector releases the IV bag from the bag clamp and releases it to the non-conforming category. In the non-conforming chute, the IV bag is then moved by the conveyor belt to the fifth workstation, where any residual particles within the IV bag are shaken and moved. The IV bag is then moved by the conveyor belt to the sixth workstation, where one of the human inspectors examines the image of the IV bag on the display to detect any residual particles or defects in the IV bag. If residual particles or defects are detected, the human inspector releases the IV bag from the bag clamp and releases it into the non-conforming chute. The IV bag is then moved by the conveyor belt to the seventh workstation, where the IV bag is released from the bag clamp and moved into the container designated for the IV bag that has passed inspection.

2. The device of claim 1, wherein the working surface has five side edges, wherein the first, second and seventh workstations are along a first side of the working surface, the third and fourth workstations are along a third side of the working surface, and the fifth and sixth workstations are along a fourth side of the working surface.

3. The device of claim 1, wherein the bubble reduction station comprises at least one solenoid-actuated impactor for impacting the IV bag to expel the bubbles within the IV bag, the bubble reduction station further comprising a support surface disposed in front of the IV bag to prevent the IV bag from swinging back and forth when impacted by the solenoid-actuated impactor.

4. The apparatus of claim 3, wherein the bubble reduction station comprises three solenoid-actuated impactors, each impactor being used to impact the IV bag at a different location on the IV bag.

5. The apparatus of claim 4, wherein when the IV bag is directly in front of the solenoid-actuated impactor, each solenoid-actuated impactor is used to impact the IV bag, regardless of whether the conveyor belt is moving the IV bag.

6. The apparatus of claim 1, wherein each particle shaking station comprises at least one ultrasonic actuator for pressing against the IV bag and ultrasonically shaking the fluid and any residual particles within the IV bag.

7. The device of claim 1, wherein the appearance inspection station and the backlighting device of both the inspection station comprise a backlight housing having an opening, a plurality of mirrors on an inner surface, and at least two LEDs, the LEDs being positioned such that light from the LEDs is reflected at least once from one of the mirrors to exit relatively uniformly from the opening in the backlight housing.

8. The apparatus of claim 1, wherein the loading workstation comprises: a IV bag loading box for holding one of the IV bags in the inverted position; and a robotic gripper for moving to a lowered position to secure the IV bag in a clamp, and then moving upward to a raised position to engage the IV bag with one of the bag clamps.

9. The device of claim 1, wherein each bag clamp is movable between an open position in which two opposing clamping components are separated and a closed position in which the two opposing clamping components are pressed together to hold the IV bag therebetween.

10. The device of claim 1, wherein the appearance inspection station and the inspection station each further comprise: a bag clamp release actuator that engages the bag clamp to release the IV bag when the human inspector has determined that the IV bag has failed the inspection; and a remote control interface adapted to be close to the human inspector for actuating the bag clamp release actuator.

11. The apparatus of claim 1, wherein the unloading workstation further comprises a bag clamp release actuator that engages the bag clamp to release the IV bag when the IV bag arrives at the unloading workstation.

12. The device of claim 10, wherein the remote control interface further includes a pause button and a restart button, the remote control interface being used to communicate with the controller to pause the controller from using the motor to advance the conveyor belt.

13. A device for semi-automatic inspection of IV bags containing fluid by two or more human inspectors, comprising: The base has a generally flat working surface with five side edges; A conveyor belt, which is lifted above the work surface by one or more conveyor belt supports; Multiple bag clamps, each bag clamp secured by the conveyor belt, and used to hold one of the IV bags in an inverted position above the work surface at one of a plurality of workstations, each workstation being located in front of the conveyor belt and at one of the side edges of the base. A controller for moving the conveyor belt by a motor, such that each bag clamp moves from one workstation to the next workstation at set time intervals, the controller and the motor being powered by a power source, the controller further including at least one user interface; The first workstation is a loading workstation for receiving one of the IV bags into one of the bag clamps. The loading workstation includes: an IV bag loading box for holding one of the IV bags in the inverted position; and a robotic gripper for moving to a lowered position to secure the IV bag in the clamp, and then moving upward to a raised position to engage the IV bag with one of the bag clamps. The clamp releases the IV bag after it has been secured by the bag clamp. Each bag clamp is movable between an open position in which two opposing clamping parts are separated from each other and a closed position in which two opposing clamping parts are pressed together to hold the IV bag therebetween. The second workstation is a bubble reduction station for agitating the fluid within one of the IV bags to expel any bubbles within the IV bag, and includes three solenoid-actuated impactors for impacting the IV bag to expel the bubbles within the IV bag. Each solenoid-actuated impactor impacts the IV bag at a different location on the IV bag. The bubble reduction station further includes a support surface positioned in front of the IV bag to prevent the IV bag from swaying back and forth when impacted by one of the solenoid-actuated impactors. Each solenoid-actuated impactor impacts the IV bag when it is directly in front of the solenoid-actuated impactor, regardless of whether the conveyor belt is moving the IV bag. The third and fifth workstations are particle shaking stations. Each particle shaking station is used to shake the fluid in one of the IV bags to promote the movement of the fluid and any residual particles in the IV bag. Each particle shaking station includes at least one ultrasonic actuator for pressing against the IV bag and ultrasonically shaking the fluid and any residual particles in the IV bag. The fourth workstation is a visual inspection station, which has a backlight device disposed behind one of the IV bags and a non-conforming chute passing through the work surface and leading to a disposal container. The backlight device includes a backlight housing having an opening, a plurality of mirrors on an inner surface, and at least two LEDs. The LEDs are positioned such that light from the LEDs is reflected at least once from one of the mirrors to exit the opening in the backlight housing relatively evenly. The visual inspection station further includes a bag clamp release actuator that engages the bag clamp to release the IV bag when a human inspector has determined that the IV bag has failed the inspection. A remote control interface, which is adapted to be close to the human inspector, for actuating the bag release actuator; The sixth workstation is an inspection station, comprising one of the backlighting devices disposed behind one of the IV bags, a camera disposed in front of the IV bag, a display adjacent to the IV bag for displaying an image of the IV bag from the camera, and the non-conforming chute passing through the work surface and leading to a disposal container. The backlighting device of the inspection station includes a backlight housing having the opening, the plurality of mirrors on the inner surface, and at least two of the LEDs, the LEDs being positioned such that light from the LEDs is reflected at least once from one of the mirrors to exit the opening in the backlight housing relatively uniformly. The appearance inspection station and the inspection station further include: a bag clamp release actuator that engages the bag clamp to release the IV bag when a human inspector has determined that the IV bag has failed the inspection. The remote control interface is adapted to be close to the human inspector for actuating the bag release actuator. The seventh workstation is an unloading workstation, wherein the IV bag is released from the bag clamp to be placed in a container designated for the IV bag that has passed inspection, and the unloading workstation further includes a bag clamp release actuator that engages the bag clamp to release the IV bag when the IV bag arrives at the unloading workstation. The first, second, and seventh workstations are along the first side of the working surface, the third and fourth workstations are along the third side of the working surface, and the fifth and sixth workstations are along the fourth side of the working surface. The visual inspection station and the inspection station further include: a bag clamp release actuator that engages the bag clamp to release the IV bag when the human inspector has determined that the IV bag has failed the inspection; and a remote control interface adapted to be close to the human inspector for actuating the bag clamp release actuator. and The remote control interface further includes a pause button and a restart button, and the remote control interface is used to communicate with the controller to pause the controller from using the motor to move the conveyor belt forward; In the first workstation, an IV bag is loaded onto one of the bag clamps and moved by the conveyor belt to the second workstation, where any air bubbles are reduced towards the bottom of the inverted IV bag. The IV bag is then moved by the conveyor belt to the third workstation, where any residual particles within the IV bag are agitated and moved. The IV bag is then moved by the conveyor belt to the fourth workstation, where one of the human inspectors examines the image of the IV bag on the display to detect any residual particles or defects in the IV bag. If residual particles or defects are detected, the human inspector releases the IV bag from the bag clamp and releases it to the nonconforming product. In the chute, the IV bag is then moved by the conveyor belt to the fifth workstation, where any residual particles within the IV bag are shaken and moved. The IV bag is then moved by the conveyor belt to the sixth workstation, where one of the human inspectors examines the image of the IV bag on the display to detect any residual particles or defects in the IV bag. If residual particles or defects are detected, the human inspector releases the IV bag from the bag clamp and releases it into the non-conforming chute. The IV bag is then moved by the conveyor belt to the seventh workstation, where the IV bag is released from the bag clamp and moved into the container designated for the IV bag that has passed inspection.

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