Tube handling system for GMP applications

Abstract

Disclosed is a tube handling system for GMP applications, and the tube handling system for GMP applications, according to an embodiment of the present application, may comprise: a cap opening / closing unit configured to open and close a cap of a conical tube; a gripper unit for gripping a body of the conical tube; a stirring unit for stirring a substance contained in the conical tube; and a weighing unit for measuring the weight of the conical tube.

Description

Tube handling system for GMP

[0001] This invention relates to a tube handling system for GMP.

[0002] The pharmaceutical manufacturing industry must comply with Good Manufacturing Practice (GMP) to ensure product quality and safety. In a GMP environment, maintaining sterility, preventing cross-contamination, and ensuring process traceability are essential requirements, and to achieve this, the automation of manufacturing processes is gradually expanding.

[0003] In the manufacturing processes of biopharmaceuticals and cell therapies, reagent preparation, mixing, and measurement operations using conical tubes are frequently performed. Conical tubes are laboratory tubes with a conical bottom structure and typically 15 ml or 50 ml in capacity, used to store and process cell culture media, reagents, and biological samples. Operations using these tubes consist of several steps, such as opening the cap, injecting reagents, weighing, mixing (stirring), and sealing the cap, and each step requires precise manipulation.

[0004] In conventional GMP environments, conical tube processing was performed primarily through manual labor or by using separate equipment for each individual step. For example, the tube caps were opened and closed manually, the tubes were transferred to a separate vortexer for mixing, and then weighed on a scale. This method has drawbacks, such as work quality varying depending on the operator's skill level, high fatigue due to repetitive tasks, and prolonged processing times.

[0005] Furthermore, manual processes inevitably involve contact between workers and samples, increasing the risk of cross-contamination and incurring additional management burdens to meet GMP standards. In particular, if tube caps are not completely sealed during the vortexing process, liquid may scatter or aerosols may be generated, potentially contaminating the surrounding environment; this is a major factor that compromises the cleanliness of the GMP environment.

[0006] While equipment has been introduced to automate individual process steps in some automation systems, most of this equipment is designed to perform only a single function, resulting in the inconvenience of having to move tubes between multiple pieces of equipment. Consequently, there are limitations such as increased overall process time, the continued risk of contamination during transfer, and significant burdens regarding installation space and costs.

[0007] Furthermore, existing automated equipment lacks mechanisms to effectively remove foreign substances or contaminants generated during stirring, making it difficult to maintain the cleanliness of the GMP environment. Fine particles or liquid droplets generated during the vortexing process can diffuse into the workspace and contaminate other samples or equipment, requiring the installation of separate hoods or the operation of air purification systems to prevent this.

[0008] Therefore, there is a need to develop an integrated tube handling system capable of automatically performing a series of operations, such as opening and closing conical tube caps, weighing, and stirring, within a single system while maintaining the cleanliness of the GMP environment.

[0009] The technology forming the background of the present invention is disclosed in Korean Published Patent Application No. 10-2021-0127344.

[0010] The present invention aims to solve the problems of the aforementioned conventional technology by providing a GMP tube handling system capable of automatically performing cap opening and closing, gripping, stirring, and weighing operations of a conical tube within a single system.

[0011] However, the technical problems that the embodiments of the present invention aim to solve are not limited to the technical problems described above, and other technical problems may exist.

[0012] As a technical means for achieving the above-mentioned technical problem, a tube handling system for GMP according to one embodiment of the present invention may include a cap opening / closing part provided to open or close the cap of a conical tube, a gripper part for gripping the body of the conical tube, a stirring part for stirring a substance contained in the conical tube, and a weight measuring part for measuring the weight of the conical tube.

[0013] In addition, the weight measuring unit and the stirring unit may be arranged side by side in the horizontal direction.

[0014] In addition, a tube handling system for GMP according to one embodiment of the present invention may include a tube conveying unit that reciprocates in the horizontal direction between the weight measuring unit and the stirring unit while the gripper unit is gripping the conical tube.

[0015] In addition, a tube handling system for GMP according to one embodiment of the present invention may include a tube lifting unit that raises the gripper unit in a vertical direction.

[0016] In addition, the tube lifting unit can lift the gripper unit to avoid interference with the weight measuring unit and the stirring unit when the gripper unit is transferred to the weight measuring unit and the stirring unit while gripping the conical tube.

[0017] In addition, a tube handling system for GMP according to one embodiment of the present invention may include a contaminant discharge unit that discharges foreign substances generated during the stirring operation of the stirring unit downward.

[0018] In addition, the contaminant discharge section can form an air flow path that guides the foreign substance downward.

[0019] In addition, the cap opening / closing part may operate to grip or release the cap of the conical tube through a parallel mechanism, and to rotate open or rotate closed the cap through a rotation mechanism.

[0020] In addition, a tube handling system for GMP according to one embodiment of the present invention may include a cap lifting unit that raises and lowers the cap opening / closing unit in a vertical direction so that the operations of gripping, rotating opening, rotating sealing, and releasing gripping of the cap are performed sequentially.

[0021] In addition, a tube handling system for GMP according to one embodiment of the present invention may include a vision measuring unit configured to measure the layer separation state of the material contained in the conical tube.

[0022] The means for solving the problem described above are merely exemplary and should not be interpreted as intended to limit the present invention. In addition to the exemplary embodiments described above, additional embodiments may exist in the drawings and the detailed description of the invention.

[0023]

[0024] According to the means for solving the problem of the present invention described above, a tube handling system for GMP can be provided that can automatically perform cap opening and closing, gripping, stirring, and weighing operations of a conical tube within a single system.

[0025] According to the solution to the problem of the present invention described above, by automatically performing the opening and closing of the cap, gripping, stirring, and weight measurement of a conical tube within a single integrated system, work efficiency can be improved and the manual burden on the operator can be significantly reduced.

[0026] According to the solution to the problem of the present invention described above, by discharging foreign substances generated during stirring operation downward through airflow, contamination of the working environment can be prevented and a clean environment meeting GMP standards can be maintained.

[0027] According to the solution to the problem of the present invention described above, stable and rapid operation processing is possible without kinematic collisions by transporting the tube through the tube lifting unit while avoiding interference with the weight measuring unit and the stirring unit.

[0028] According to the solution to the problem of the present invention described above, the cap of a conical tube can be precisely gripped, opened, sealed, and released through a cap opening and closing structure that combines a parallel mechanism and a rotational mechanism, thereby contributing to the safe storage of samples and the prevention of cross-contamination.

[0029] However, the effects obtainable from this invention are not limited to those described above, and other effects may exist.

[0030]

[0031] FIG. 1 is a schematic diagram of a tube handling system for GMP according to one embodiment of the present invention.

[0032] FIG. 2 is a side view showing the schematic shape of a tube handling system for GMP according to one embodiment of the present invention.

[0033] FIG. 3 is a perspective view showing the detailed structure of a tube handling system for GMP according to one embodiment of the present invention.

[0034] FIG. 4 is a diagram showing an air flow path formed for a cap opening / closing part and a cap lifting part of a tube handling system for GMP according to one embodiment of the present invention.

[0035] FIG. 5 is a diagram illustrating an airflow-based contaminant discharge process of a tube handling system for GMP according to one embodiment of the present invention.

[0036]

[0037] Embodiments of the present invention are described below with reference to the attached drawings to enable those skilled in the art to easily implement the invention. However, the present invention may be embodied in various different forms and is not limited to the embodiments described herein. Furthermore, in order to clearly explain the present invention in the drawings, parts unrelated to the explanation have been omitted, and similar parts throughout the specification are denoted by similar reference numerals.

[0038] Throughout this specification, when a part is described as being "connected" to another part, this includes not only cases where they are "directly connected," but also cases where they are "electrically connected" or "indirectly connected" with other elements interposed between them.

[0039] Throughout the entire specification, when a component is described as being located "on," "on top," "on top," "under," "on bottom," or "on bottom" of another component, this includes not only cases where the component is in contact with the other component but also cases where another component exists between the two components.

[0040] Throughout this specification, when a part is described as "comprising" a certain component, this means that, unless specifically stated otherwise, it does not exclude other components but may include additional components.

[0041] For reference, terms related to direction or position (horizontal direction, vertical direction, front, rear, rear end, top, upward, downward, width direction, etc.) in the description of the embodiments of the present invention are described based on the arrangement state of each component shown in the drawings. For example, when viewed in FIG. 1, the horizontal direction may be from 4 o'clock to 10 o'clock and the vertical direction may be from 12 o'clock to 6 o'clock. Also, when viewed in FIG. 2, the horizontal direction may be from 2 o'clock to 8 o'clock and the vertical direction may be from 12 o'clock to 6 o'clock.

[0042] However, such direction setting may vary depending on the arrangement of the present invention. For example, if necessary, the present invention may be arranged so that the upward direction relative to FIG. 1 faces the horizontal direction (left and right direction), and as another example, the present invention may be arranged so that the upward direction relative to FIG. 1 faces the oblique inclination direction.

[0043] This invention relates to a tube handling system for GMP.

[0044] FIG. 1 is a schematic diagram of a tube handling system for GMP according to one embodiment of the present invention, and FIG. 2 is a side view showing a schematic shape of a tube handling system for GMP according to one embodiment of the present invention.

[0045] Referring to FIG. 1 and FIG. 2, a tube handling system (10) for GMP according to one embodiment of the present invention (hereinafter referred to as the 'tube handling system (10)') is an integrated system for automatically handling conical tubes in a GMP environment, and can continuously perform cap opening and closing, tube gripping, weight measurement, and stirring operations within a single module.

[0046] As described in detail below, the tube handling system (10) disclosed herein may include a cap opening / closing unit (100) that automatically opens and closes the cap of a conical tube, a gripper unit (200) that grips and fixes the body of a conical tube, a stirring unit (300) that stirs a substance inside the conical tube, a weight measuring unit (400) that measures the weight of the conical tube, a tube conveying unit (500) that moves the gripper unit (200) in a horizontal direction, a tube lifting unit (600) that raises the gripper unit (200) in a vertical direction, and a cap lifting unit (700) that raises the cap opening / closing unit (100) in a vertical direction.

[0047] Additionally, the tube handling system (10) can arrange the weight measuring unit (400) and the stirring unit (300) side by side in a horizontal direction and reciprocate the conical tube held by the gripper unit (200) between the two components through the tube conveying unit (500).

[0048] In particular, the tube handling system (10) is equipped with a contaminant discharge structure that discharges foreign substances generated during stirring operations downward through airflow, thereby maintaining the cleanliness of the GMP environment, and adopts a parallel processing structure that can process multiple conical tubes simultaneously, thereby maximizing work efficiency.

[0049] In the case of conventional equipment, opening and closing the cap, measuring weight, and stirring operations were performed on separate equipment, and the tube had to be moved between multiple pieces of equipment, but the tube handling system (10) of the present invention can shorten working time and reduce the risk of contamination by automatically processing all operations within a single system.

[0050] FIG. 3 is a perspective view showing the detailed structure of a tube handling system for GMP according to one embodiment of the present invention.

[0051] Referring to FIG. 3, the tube handling system (10) may include a cap opening / closing unit (100), a gripper unit (200), a stirring unit (300), a weight measuring unit (400), a tube conveying unit (500), a tube lifting unit (600), and a cap lifting unit (700).

[0052] The cap opening / closing unit (100) may be a submodule of a tube handling system (10) configured to open or close the cap of a conical tube.

[0053] In this regard, in the description of the embodiments of the present invention, the conical tube is an experimental vessel having a conical bottom structure and can be used to store and process liquid reagents, cell culture media, biological samples, etc. The conical tube is generally equipped with a threaded cap at the top that can be opened or closed by rotating the cap.

[0054] The capacity of such conical tubes may vary, but for example, a 15ml or 50ml specification may be adopted, and in one embodiment of the present invention, a 50ml conical tube may be used, but is not limited thereto. The body of the conical tube is formed of a transparent plastic material so that the amount and condition of the internal material can be checked visually, and a scale indicating the capacity may be marked on the outer wall.

[0055] Furthermore, the cap of a conical tube can provide a sealing function to prevent liquid leakage and block the ingress of external contaminants, and in a GMP environment, the precise opening, closing, and sealing of the cap can be critical. The liquid contained within the conical tube can be various forms of substances, such as reagents, solutions, cell culture media, and buffers, and these substances may undergo processing steps such as stirring, mixing, and centrifugation.

[0056] Specifically, the cap opening / closing part (100) can operate to grip or release the cap of the conical tube through a parallel mechanism, and to rotate open or rotate close the cap through a rotation mechanism.

[0057] In this regard, the parallel mechanism of the cap opening / closing part (100) may refer to a structure in which two or more gripping members move in parallel to grip or ungrip the cap of the conical tube. In the parallel mechanism, the gripping members can simultaneously approach the center of the cap to grip the cap with a uniform force, and conversely, move simultaneously in a direction away from the center of the cap to ungrip it.

[0058] For example, the parallel mechanism may include two gripping jaws driven by an air cylinder or an electric actuator, and each gripping jaw may move parallel along a linear guide. As another example, the parallel mechanism may use a cam structure to convert the rotational motion of a single driving source into parallel linear motion of two gripping members.

[0059] As another example, the parallel mechanism may be configured to employ a linkage mechanism so that the gripping members can open and close while maintaining a precisely parallel trajectory. The parallel mechanism can prevent deformation or damage to the cap by ensuring that no eccentric force is generated when gripping the cap, and can also be controlled so that the cap does not deviate from its original position even when released.

[0060] In contrast to this, the rotation mechanism of the cap opening / closing part (100) is structured to open or close the cap of the conical tube by rotating it, and can rotate the cap held by the parallel mechanism according to the screw thread structure. The rotation mechanism can perform an opening operation to separate the cap from the tube body by rotating the cap counterclockwise, and a closing operation to connect the cap to the tube body by rotating the cap clockwise.

[0061] For example, the rotation mechanism may include a rotation axis connected to a servo motor or a stepping motor, and can precisely control the rotational torque and rotation angle of the rotation axis. As another example, the rotation mechanism may rotate the cap using a pneumatic motor or a hydraulic motor, and can prevent damage to the cap or tube due to excessive rotational force through a torque limiting function.

[0062] This rotation mechanism can determine the number of rotations required for the cap to be fully opened or closed by taking into account the thread pitch and rotation angle of the cap. For example, the cap of a 50ml conical tube can be fully opened or closed by controlling it to a preset number of rotations (e.g., about 2 to 3 rotations). The rotation mechanism may be equipped with a torque sensor or a position sensor to check the sealing state of the cap, and can stop rotation when a set torque value is reached to prevent excessive tightening.

[0063] The gripper part (200) may be a sub-module of the tube handling system (10) configured to grip the body of the conical tube.

[0064] Specifically, the gripper part (200) can stably fix the outer wall of the body of the conical tube by gripping it, and can form a contact surface in accordance with the shape of the tube. In one embodiment, the gripper part (200) may include two or more grip fingers that grip the cylindrical upper part of the conical tube, and each grip finger may have a contact surface having a curvature corresponding to the curved surface of the tube. The grip fingers may be opened and closed by an air gripper or an electric gripper, and when gripping the tube, they may be controlled to apply an appropriate gripping force so that the tube does not slip but is not deformed.

[0065] As another example, the gripper unit (200) may attach a pad made of an elastic material to the contact surface of the grip finger to increase friction with the tube and prevent damage to the tube surface. The gripper unit (200) can move in the horizontal and vertical directions by the tube transport unit (500) and the tube lifting unit (600) while gripping the tube, and can maintain sufficient gripping force so that the tube does not shake or detach during movement. The gripper unit (200) may be equipped with a sensor to detect the position of the tube and can proceed with subsequent operations after confirming that the tube is gripped in the correct position.

[0066] According to one embodiment of the present invention, the gripper unit (200) may operate to adaptively adjust the gripping force based on at least one of the weight of the conical tube, the amount of contents, and the conveying speed. In one embodiment, the gripper unit (200) receives information on the total weight of the tube measured by the weight measuring unit (400), and if the total weight is greater than or equal to a preset first weight reference value, it may increase the gripping force to prevent the heavy tube from slipping or falling during conveying. The first weight reference value may be set, for example, to 150% or 200% of the weight of the empty tube, and the gripping force may be controlled to increase linearly as the amount of contents increases.

[0067] As another example, the gripper unit (200) may further increase the gripping force when the transfer speed of the tube transfer unit (500) exceeds a preset reference speed, which may be to counteract the inertial force generated during high-speed transfer. As yet another example, the gripper unit (200) may adjust the gripping force according to the material or surface condition of the tube, and in the case of a tube with a smooth surface, a greater gripping force may be required due to the low coefficient of friction. The gripper unit (200) may be equipped with a gripping force sensor to monitor the actual applied gripping force in real time, and may re-perform the gripping operation if the deviation between the target gripping force and the actual gripping force exceeds a preset allowable error range.

[0068] The stirring unit (300) may be a submodule of the tube handling system (10) configured to stir a material contained in a conical tube.

[0069] Specifically, the stirring unit (300) can mix the material inside the conical tube uniformly by stirring it in a vortexing manner. Vortexing may be a method of rapidly mixing the material by forming a vortex inside the tube by vibrating or rotating the tube at high speed. In one embodiment, the stirring unit (300) may include an eccentric motor or a vibration motor, and an eccentric mass may be attached to the rotation axis of the motor to generate vibration when rotated.

[0070] Additionally, the stirring unit (300) can transfer the conical tube, which is held by the gripper unit (200), to a stirring position and then place the lower end of the tube on the vibration platform of the stirring unit (300). As another example, the stirring unit (300) may be equipped with a holder that fixes the conical tube, and the holder itself may vibrate to stir the material inside the tube. By controlling the stirring speed and stirring time, the stirring unit (300) can form a uniform solution by ensuring that the material inside the conical tube is sufficiently mixed during the stirring process, and can redisperse any precipitates or separated layers. The stirring unit (300) can perform stirring with the cap completely sealed to prevent splashing of liquid or aerosols that may occur during the stirring operation.

[0071] The weight measuring unit (400) may be a sub-module of the tube handling system (10) configured to measure the weight of the conical tube.

[0072] Specifically, the weight measuring unit (400) can precisely measure the weight of the conical tube using a load cell. A load cell is a sensor that converts an applied load into an electrical signal and can be implemented using various principles such as strain gauge, piezoelectric, and capacitive methods.

[0073] For example, the weight measuring unit (400) can transport the conical tube, which is gripped by the gripper unit (200), to a weight measuring position and then place the lower end of the tube on a measuring platform equipped with a load cell. The load cell can measure the total weight of the tube and calculate the net weight of the material inside the tube by subtracting the weight of the empty tube stored in advance.

[0074] As another example, the weight measuring unit (400) may employ a high-precision load cell to enable precise measurement in units of 0.01g or 0.001g and may be used to verify the accuracy of the reagent injection amount. The weight measuring unit (400) may minimize measurement errors caused by vibration or external shock by providing a measurement stabilization time, and as an example, may operate to acquire a weight value after a predetermined stabilization time (e.g., 2 to 5 seconds, etc.) has elapsed after the tube is seated.

[0075] Additionally, according to one embodiment of the present invention, the weight measuring unit (400) can transmit the measured weight data to a control unit (not shown), and the control unit (not shown) can determine the appropriateness of the reagent injection amount by comparing the target weight with the actual measured value. The weight measurement results can be recorded and stored in accordance with GMP documentation requirements.

[0076] According to one embodiment of the present invention, the weight measuring unit (400) can improve measurement accuracy by compensating for the temperature dependence of the load cell and zero drift over time. In one embodiment, the weight measuring unit (400) can measure the temperature of the load cell in real time through a temperature sensor installed adjacent to the load cell, and if the measured temperature deviates from a preset reference temperature, the weight measurement value can be corrected by applying a temperature compensation coefficient.

[0077] Here, the temperature compensation factor can be determined based on the temperature characteristic curve of the load cell and can be applied in different correction directions when the temperature is higher and lower than the reference temperature, respectively. As another example, the weight measuring unit (400) can perform zero calibration at preset zero calibration cycles or whenever the number of continuous measurements reaches a preset reference number, which may be a process of resetting the measurement value to zero when nothing is placed on the load cell platform.

[0078] As another example, the weight measuring unit (400) may be equipped with an auto-calibration function using standard weights, and may automatically perform calibration at preset calibration cycles or when the repeatability of the measurement value exceeds a preset allowable range. The weight measuring unit (400) may evaluate measurement stability by calculating the standard deviation of continuous measurement values, and may finalize the measurement value when the standard deviation is below a preset stability reference value.

[0079] Referring to FIG. 1, the weight measuring unit (400) and the stirring unit (300) can be arranged side by side in the horizontal direction (from 4 o'clock to 10 o'clock direction based on the illustration in FIG. 1) in the layout arrangement structure of the tube handling system (10).

[0080] The tube transfer unit (500) may be a sub-module of the tube handling system (10) for reciprocating horizontally between the weight measuring unit (400) and the stirring unit (300) arranged parallel along the horizontal direction while the gripper unit (200) is gripping the conical tube.

[0081] For example, the tube conveyor (500) may employ a linear motor, a ball screw drive method, or a belt drive method, and precise position control may be possible. The tube conveyor (500) may include a linear guide rail arranged in the Y-axis direction, and a carriage supporting the gripper unit (200) may move along the rail. As another example, the tube conveyor (500) may be configured by combining a servo motor and a ball screw, and the rotational motion of the servo motor may be converted into linear motion through the ball screw to move the carriage.

[0082] Meanwhile, the tube conveyor (500) can set multiple stopping positions, such as a weight measurement position, a stirring position, and an initial standby position, and can verify whether accurate arrival has been made through a position sensor when moving to each position. For example, the tube conveyor (500) can measure the weight of the conical tube at the weight measurement unit (400), then move the tube horizontally to the stirring unit (300) to perform stirring, and return it to the weight measurement unit (400) after stirring is completed. The tube conveyor (500) can control the movement speed and can set acceleration and deceleration sections to minimize shaking of the material inside the tube.

[0083] According to one embodiment of the present invention, the tube transfer unit (500) can dynamically optimize the transfer path between the weight measuring unit (400) and the stirring unit (300) to reduce transfer time and avoid collisions. In one embodiment, the tube transfer unit (500) can prevent interference between tubes by planning the transfer order and path of each tube when a plurality of conical tubes are processed simultaneously, and the transfer priority can be determined based on the work progress status, waiting time, process urgency, etc. of each tube. As another example, the tube transfer unit (500) can automatically generate an alternative path when an obstacle is detected on the transfer path, and obstacle detection can be performed through a proximity sensor, a laser sensor, or a vision system.

[0084] Additionally, the tube conveying unit (500) can control the conveying speed in sections, accelerate to a preset first acceleration reference value in the acceleration section, maintain a preset first conveying speed reference value in the constant speed section, and decelerate to a preset first deceleration reference value in the deceleration section. As another example, the tube conveying unit (500) can reduce the conveying speed to a preset second conveying speed reference value when the amount of material inside the tube is greater than or equal to a preset second weight reference value, and the second conveying speed reference value is set to a value smaller than the first conveying speed reference value to minimize shaking of the contents and splashing. The tube conveying unit (500) can verify the stopping accuracy at the target position after conveying is completed, and can perform a fine adjustment operation if the position deviation exceeds a preset position tolerance range.

[0085] The tube lifting unit (600) may be a sub-module of the tube handling system (10) for lifting the gripper unit (200) in a vertical direction.

[0086] Specifically, the tube lifting unit (600) can lift the gripper unit (200) to avoid interference with the weight measuring unit (400) and the stirring unit (300) when the gripper unit (200) is transferred to the weight measuring unit (400) and the stirring unit (300) while gripping the conical tube.

[0087] In this regard, according to one embodiment of the present invention, the tube lifting unit (600) can avoid interference with the weight measuring unit (400) and the stirring unit (300) by raising the gripper unit (200) in a vertical direction. In one embodiment, when the gripper unit (200) moves horizontally from the weight measuring position to the stirring position while gripping the conical tube, if there is an obstacle or other component in the intermediate path, the tube lifting unit (600) can raise the gripper unit (200) to avoid interference, complete the movement, and then lower it again.

[0088] Additionally, the tube lifting unit (600) may include a linear actuator, an air cylinder, or a ball screw drive mechanism for Z-axis driving. As another example, the tube lifting unit (600) may be connected to a carriage supporting the gripper unit (200) to raise the entire carriage and move vertically along a linear guide in the Z-axis direction. The tube lifting unit (600) may lower the gripper unit (200) to place the lower end of the tube on the load cell platform during weight measurement, and after the measurement is completed, may raise the tube to switch to a state ready for transport.

[0089] As another example, even during a stirring operation, the tube lifting unit (600) can lower the lower end of the tube to an appropriate height to bring it into contact with the vibration platform of the stirring unit (300). The tube lifting unit (600) can control the speed and position of the rising and falling movements, and can confirm the exact lifting position through a position sensor. The lifting distance of the tube lifting unit (600) can be determined according to the system layout and, for example, may have a lifting stroke in the range of 50 mm to 100 mm, but is not limited thereto.

[0090] The cap lifting unit (700) may be a sub-module of a tube handling system (10) that raises the cap opening / closing unit (100) in a vertical direction so that gripping, rotational opening, rotational closing, and gripping release operations on the cap of the conical tube are performed sequentially.

[0091] Specifically, the cap lifting unit (700) can lower the cap opening / closing unit (100) to access the cap of the conical tube, and the parallel mechanism of the cap opening / closing unit (100) can operate to grasp the cap. Next, with the cap grasped, the rotation mechanism of the cap opening / closing unit (100) can operate to rotate the cap counterclockwise to perform a rotational opening operation to separate the cap from the tube body. During this process, the cap lifting unit (700) can further raise the cap opening / closing unit (100) to completely separate the opened cap from the top of the tube. After the reagent injection and weight measurement operations are completed, the cap lifting unit (700) can lower the cap opening / closing unit (100) to reposition the cap to the top of the tube, and the rotation mechanism of the cap opening / closing unit (100) can rotate the cap clockwise to perform a rotational sealing operation to attach it to the tube body.

[0092] Subsequently, when the cap is completely closed, the parallel mechanism of the cap opening / closing unit (100) can be operated to release the grip on the cap, and the cap lifting unit (700) can raise the cap opening / closing unit (100) to return it to its initial position. The cap lifting unit (700) may include a linear actuator, an air cylinder, or a ball screw drive type Z-axis drive mechanism, and as one embodiment, may have a lifting stroke in the range of 50 mm to 100 mm (e.g., 73 mm, etc.).

[0093] Additionally, the cap lifting unit (700) can precisely control the lifting position at each stage and can verify whether the lifting operation is completed through a position sensor. The lifting speed of the cap lifting unit (700) can be appropriately controlled to prevent damage to the cap and ensure precise opening and closing operations.

[0094] Additionally, although not shown in the drawing, the tube handling system (10) may be equipped with a contaminant discharge section (not shown) that discharges foreign substances generated during the stirring operation of the stirring section (300) downward.

[0095] Meanwhile, the tube handling system (10) may have a parallel structure for processing multiple conical tubes simultaneously. In one embodiment, the tube handling system (10) may process three conical tubes simultaneously, and each of the cap opening / closing unit (100), gripper unit (200), stirring unit (300), and weight measuring unit (400) may be composed of three processing units. The cap opening / closing unit (100) may include a first cap opening / closing unit (100a), a second cap opening / closing unit (100b), and a third cap opening / closing unit (100c), and each cap opening / closing unit may independently open / close the cap of each conical tube. The gripper unit (200) may include a first gripper unit (200a), a second gripper unit (200b), and a third gripper unit (200c), and each gripper unit may be spaced apart by a first interval set in the horizontal direction. The first gap can be determined by considering the diameter of the conical tube, the space required for the gripping operation, and the safety margin to avoid interference between tubes, and for example, in the case of a 50ml conical tube, it can be set within the range of 60mm to 100mm, but is not limited thereto.

[0096] As another example, the stirring unit (300) may include a first stirring unit (300a), a second stirring unit (300b), and a third stirring unit (300c), and each stirring unit may include an independent vibration motor or three tube holders placed on a common vibration platform. When using independent vibration motors, the stirring intensity and time of each tube can be controlled individually, and when using a common vibration platform, the three tubes can be stirred simultaneously under the same conditions, thereby simplifying the system structure.

[0097] Additionally, the weight measuring unit (400) may include a first weight measuring unit (400a), a second weight measuring unit (400b), and a third weight measuring unit (400c), and each weight measuring unit may be equipped with an independent load cell and a measuring platform to simultaneously measure the weight of different tubes. The spacing between each weight measuring unit may be set to be the same as or similar to the first spacing so that each gripper unit of the gripper unit (200) can transport the tube to the corresponding weight measuring unit.

[0098] As another example, the tube transfer unit (500) may include a common transfer platform capable of transferring three gripper units simultaneously or sequentially, and the common transfer platform may move the three gripper units together while moving along a linear guide in the Y-axis direction. In this case, efficient simultaneous transfer is possible when the three tubes are in the same work stage, and when the work stages are different, individual transfer can be performed by providing an independent transfer mechanism to each gripper unit.

[0099] Additionally, the tube lifting unit (600) may include a first lifting unit (600a), a second lifting unit (600b), and a third lifting unit (600c) corresponding to three gripper units, and each lifting unit may be controlled independently to perform the lifting operation of each tube individually. The cap lifting unit (700) may include a first cap lifting unit (700a), a second cap lifting unit (700b), and a third cap lifting unit (700c) corresponding to three cap opening / closing units, and each cap lifting unit may independently lift the corresponding cap opening / closing unit.

[0100] In this regard, the tube handling system (10) may have a work scheduler that tracks and coordinates the progress of work for each of the multiple tubes. In one embodiment, the work scheduler may maximize the utilization rate of each component by staggering the work order so that when the first tube is in the cap opening stage, the second tube is in the weighing stage and the third tube is in the stirring stage.

[0101] As another example, the work scheduler of the tube handling system (10) can set the processing priority of each tube and determine the processing order by giving high priority to tubes with high urgency, tubes with long waiting times, or tubes that require connection to the next process. As yet another example, the work scheduler can resolve bottlenecks by adjusting the work speed of other components when the number of tubes waiting in a specific component exceeds a preset number of allowed waiting tubes.

[0102] Additionally, according to one embodiment of the present invention, the tube handling system (10) may be equipped with an identification system for distinguishing and tracking a plurality of conical tubes. In one embodiment, a barcode, a QR code, or an RFID tag may be attached to each conical tube, and the tube handling system (10) may be equipped with a barcode reader, a QR code scanner, or an RFID reader to read the identification information of each tube. As another example, the location and identification information of the tubes may be recognized simultaneously through a vision system, and the recognized information may be stored in a control unit and linked with the work history, measurement data, stirring conditions, etc. of each tube. The identification system can prevent confusion or misplacement of tubes and can satisfy GMP requirements by ensuring complete traceability for each tube.

[0103] Below, the contaminant discharge function of the tube handling system (10) will be described in detail with reference to FIGS. 4 and FIGS. 5.

[0104] FIG. 4 is a diagram showing an air flow path formed for a cap opening / closing part and a cap lifting part of a tube handling system for GMP according to one embodiment of the present invention.

[0105] Referring to FIG. 4, the tube handling system (10) is equipped with an air flow forming structure on the side of the cap opening / closing part (100) and the tube lifting part (600) or the cap lifting part (700) to effectively discharge foreign substances generated during operation. The cap opening / closing part (100) may have an air inlet formed at the top to collect fine particles or dust that may be generated during the opening / closing operation of the cap, and the incoming air may be guided downward along a vertical conduit formed inside the tube lifting part (600) or the cap lifting part (700). The tube lifting part (600) or the cap lifting part (700) may be equipped with a lifting mechanism having a predetermined stroke, and for this purpose, a conduit for air flow may be formed inside or outside the lifting shaft.

[0106] The airflow formed through these vertical pipes starts in the upper region of the cap opening / closing section (100), moves downward along the lifting axis of the tube lifting section (600) or the cap lifting section (700), and can finally be discharged to the outside through an outlet installed at the bottom of the system. This airflow structure can prevent foreign substances generated during the cap opening / closing operation from spreading into the workspace and contribute to maintaining the cleanliness of the GMP environment.

[0107] For example, the airflow of the contaminant discharge section (not shown) can be formed by a fan or a blower, and the air velocity can be controlled so as not to interfere with the operation while effectively capturing foreign substances.

[0108] FIG. 5 is a diagram illustrating an airflow-based contaminant discharge process of a tube handling system for GMP according to one embodiment of the present invention.

[0109] Referring to FIG. 5, the contaminant discharge section (not shown) can form an air flow path that guides contaminants, including foreign substances generated during the stirring operation of the stirring section (300), downward.

[0110] As illustrated in FIG. 5, the air flow path of the tube handling system (10) can be broadly divided into two paths. The first air flow path (A) is a path for collecting foreign substances generated from the cap opening / closing part (100), through which air is introduced through an air inlet formed on the upper or side of the cap opening / closing part (100) and guided downward along a vertical conduit formed on the lifting axis of the cap lifting part (700). The first air flow path (A) can effectively collect microplastic particles or dust that may be generated during the rotational opening and rotational closing operations of the cap.

[0111] In addition to this, the second air flow path (B) is a path for collecting foreign substances generated in the areas of the gripper section (200) and the tube transport section (500). Air is introduced through an air inlet formed around the gripper section (200) and can join the vertical conduit of the tube lifting section (600) via a connecting conduit formed inside or below the tube transport section (500). The second air flow path (B) can collect foreign substances that may occur during the gripping and releasing operations of the gripper section (200) and contaminants that may fall off the outer wall of the tube during tube transport.

[0112] Meanwhile, the first air flow path (A) and the second air flow path (B) can be combined in the vertical conduit of the tube lifting section (600) and then discharged to the outside through a common outlet located at the bottom of the system. The air flow paths can be designed to have appropriate conduit diameters and curvatures to minimize flow resistance and ensure smooth air movement.

[0113] In this regard, according to one embodiment of the present invention, a contaminant discharge unit (not shown) can perform the function of sucking in foreign substances generated during the stirring operation of the stirring unit (300) through a fan and discharging them downward. During the stirring operation, as the material inside the conical tube is stirred at high speed, liquid droplets or aerosols may be generated through fine gaps in the tube cap, and such foreign substances may contaminate the GMP environment.

[0114] To this end, the contaminant discharge unit may include a suction fan positioned on the upper or side of the stirring unit (300), and the suction fan may continuously draw in air around the stirring position to collect foreign substances. In one embodiment, the contaminant discharge unit may form a hood structure surrounding the stirring unit (300), and the air inside the hood may be guided downward by the suction fan. As another example, the contaminant discharge unit may be equipped with a HEPA filter (High Efficiency Particulate Air Filter) or an activated carbon filter to remove fine particles or volatile substances from the inhaled air before discharge. The air flow path of the contaminant discharge unit may start from the stirring unit (300) and be connected to the outside along a discharge duct formed at the bottom of the system, and the discharged air may be processed in conjunction with the building's exhaust system.

[0115] In addition, the contaminant discharge unit (not shown) can operate continuously during the stirring process and maintain operation for a certain period after stirring is completed to completely remove residual foreign substances. The suction airflow of the contaminant discharge unit (not shown) can be adjusted so as not to affect the stirring process while effectively capturing foreign substances. The contaminant discharge unit may be equipped with a sensor that monitors the operating status of the fan, and can trigger an alarm to induce maintenance if a fan failure or filter blockage is detected.

[0116] Additionally, although not shown in the drawing, the tube handling system (10) may be equipped with a vision measuring unit (not shown) configured to measure the layer separation state of a material contained in a conical tube.

[0117] Specifically, a vision measurement unit (not shown) can perform the function of measuring layer separation of a material within a conical tube. In the biopharmaceutical manufacturing process, layers may separate after centrifuging or standing a solution mixed with cell culture medium, serum, buffer, etc., and it may be important to measure the location and thickness of the interface of each layer. The vision measurement unit may include a camera that photographs the side of the conical tube, and the camera may be a visible light camera, an infrared camera, or a high-resolution industrial camera, but is not limited thereto.

[0118] According to one embodiment of the present invention, a vision measurement unit (not shown) can photograph a conical tube at a weight measurement position or a stirring position, and can improve the contrast of the layer boundary surface by placing illumination on the background of the tube. As another example, the vision measurement unit can determine the three-dimensional distribution of the material inside the tube by placing a plurality of cameras at different angles. The vision measurement unit can analyze the captured image through an image processing algorithm and can detect the position of the layer boundary surface in pixel units and convert it into an actual height.

[0119] As another example, the vision measurement unit can automatically recognize complex layer structures or unclear boundaries by utilizing image analysis models based on machine learning or deep learning. The vision measurement unit can transmit measured layer separation information to the control unit, which can determine the suitability of the process by evaluating factors such as layer thickness ratios and the clarity of boundaries. The measurement results from the vision measurement unit can be stored as quality control data to meet GMP documentation requirements, and if abnormalities are detected, notifications can be provided to operators to prompt rework or additional inspection.

[0120] A method for operating a tube handling system for GMP according to one embodiment of the present invention may be implemented in the form of program instructions that can be executed through various computer means and recorded on a computer-readable medium. The computer-readable medium may include program instructions, data files, data structures, etc., either alone or in combination. The program instructions recorded on the medium may be those specifically designed and configured for the present invention, or those known and available to those skilled in the art of computer software. Examples of computer-readable recording media include magnetic media such as hard disks, floppy disks, and magnetic tapes; optical recording media such as CD-ROMs and DVDs; magneto-optical media such as floptical disks; and hardware devices specifically configured to store and execute program instructions, such as ROM, RAM, and flash memory. Examples of program instructions include machine code, such as that generated by a compiler, as well as high-level language code that can be executed by a computer using an interpreter, etc. The hardware devices described above may be configured to operate as one or more software modules to perform the operation of the present invention, and vice versa.

[0121] In addition, the driving method of the aforementioned GMP tube handling system can also be implemented in the form of a computer program or application executed by a computer stored on a recording medium.

[0122] The foregoing description of the present invention is for illustrative purposes only, and those skilled in the art will understand that other specific forms can be easily modified without altering the technical concept or essential features of the present invention. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive. For example, each component described as a single unit may be implemented in a distributed manner, and components described as distributed may likewise be implemented in a combined form.

[0123] The scope of the present invention is defined by the claims set forth below rather than by the detailed description above, and all modifications or variations derived from the meaning and scope of the claims and the concept of equivalents thereof should be interpreted as being included within the scope of the present invention.

[0124] [Explanation of the symbol]

[0125] 10: Tube Handling System for GMP

[0126] 100: Cap opening / closing part

[0127] 200: Gripper section

[0128] 300: Stirring section

[0129] 400: Weight measuring unit

[0130] 500: Tube transfer unit

[0131] 600: Tube lifting section

[0132] 700: Cab lifting unit

Claims

1. In a tube handling system for GMP, A cap opening / closing part provided to open or close the cap of a conical tube; A gripper part that grips the body of the above conical tube; A stirring unit for stirring a material contained in the conical tube; and A weight measuring unit for measuring the weight of the above conical tube, A tube handling system for GMP including 2. In Paragraph 1, The above-mentioned weight measuring unit and the above-mentioned stirring unit are arranged side by side in the horizontal direction, and A tube conveyor that reciprocates in the horizontal direction between the weight measuring unit and the stirring unit while the gripper unit holds the conical tube, A tube handling system for GMP that further includes 3. In Paragraph 2, A tube lifting unit that raises the above gripper unit in a vertical direction, A tube handling system for GMP that further includes 4. In Paragraph 3, The above tube lifting unit is, A tube handling system for GMP, wherein the gripper part is raised and lowered to avoid interference with the weight measuring part and the stirring part when the gripper part is transferred to the weight measuring part and the stirring part while gripping the conical tube.

5. In Paragraph 1, A contaminant discharge unit that discharges foreign substances generated during the stirring operation of the above stirring unit downwards, A tube handling system for GMP that further includes 6. In Paragraph 5, The above-mentioned pollutant discharge section is, A tube handling system for GMP characterized by forming an air flow path that guides the above foreign substances downward.

7. In Paragraph 1, The above cap opening / closing part is, A tube handling system for GMP that operates to grip or release the cap of the conical tube through a parallel mechanism and to rotate open or rotate close the cap through a rotation mechanism.

8. In Paragraph 7, A cap lifting unit that raises and lowers the cap opening / closing unit in a vertical direction so that the gripping, rotational opening, rotational closing, and gripping release operations of the cap are performed sequentially. A tube handling system for GMP that further includes 9. In Paragraph 1, A vision measuring unit configured to measure the layer separation state of the material contained in the conical tube, A tube handling system for GMP that further includes

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