A bag-type aseptic filling system

Abstract

The utility model provides a kind of bag type aseptic filling system, system includes sequentially connected: material arrangement module, and the order arrangement of subpackaging bag is according to fixed interval;Filling module, with the discharge end communication of material arrangement module, to the subpackaging bag filling, quantity detection and sealing;Discharge module, with the discharge end communication of filling module, according to the detection separation of subpackaging bag and unqualified product. Through the orderly link of material arrangement module, filling module and discharge module, realize the full-process automation processing of subpackaging bag from shaping cutting, filling sealing to quality sorting, first, material arrangement module makes subpackaging bag order arrangement according to fixed interval, solve the problem of bag jamming, flow breakage etc. Caused by feeding confusion in traditional filling system, improve system stability;Second, filling module integrates filling, quantity detection and sealing function, significantly improves production efficiency, reduces cross-contamination risk.

Description

Technical Field

[0001] This utility model relates to the field of non-terminally sterilized aseptic preparation filling technology in biopharmaceuticals, specifically to a bag-type aseptic filling system. Background Technology

[0002] In the biopharmaceutical field, sterile preparations can be categorized into terminally sterilized sterile preparations and non-terminally sterilized sterile preparations based on their sterilization method. Terminally sterilized sterile preparations are those that can be sterilized after filling, while non-terminally sterilized sterile preparations, due to their special properties (such as containing heat-sensitive components or bioactive substances), cannot be sterilized after filling. For non-terminally sterilized sterile preparations, pharmaceutical GMP requires that the entire filling process be sterile. This is typically achieved in two ways: one is filling in a Class A clean environment, and the other is filling using a disposable sterile closed system in an environment at least Class D.

[0003] Currently, for filling soft-bag formulations such as cell preparations, disposable aseptic closed systems are mainly used. However, this filling method has significant limitations: filling efficiency is limited, typically not exceeding 60 bags / hour; when increasing filling speed is required, the number of simultaneously operating flow paths must be increased (i.e., increasing the number of peristaltic pumps), which, while increasing capacity (e.g., 10 pumps can reach 600 bags / hour), also reduces automation and requires more operators. Furthermore, multi-flow paths complicate the consumable system, significantly increasing the risk control points for leaks in tubing joints and sterile air filters. Especially in actual production, it is impossible to test filter integrity online; all filters must be cut off and tested individually after production, a post-production verification method with a risk of delay.

[0004] In high-volume filling scenarios (over 600 bags per batch), existing technologies cannot achieve online full weighing and rejection of defective products, a deficiency that becomes particularly prominent. According to the 3σ standard, the cumulative probability of defective products exceeds 84%, and existing systems struggle to detect and handle abnormal situations in a timely manner.

[0005] Regarding filling solutions that rely on a Class A environment to ensure asepticity, there is currently a lack of readily available and mature technologies on the market. Compared to the filling of non-terminally sterilized formulations in traditional vials, the filling of bagged cell preparations faces several unique challenges: precise cutting of the flexible bag tubing, accurate connection between the filling needle and the thin tubing, the shaking problem during the weighing of suspended flexible bags, and the non-uniformity caused by cell sedimentation. These are all technical difficulties that do not exist in traditional vial filling.

[0006] Furthermore, existing automated filling methods often result in liquid waste during the pump calibration stage. Before formal filling, actual drug solution needs to be weighed and calibrated, and this calibration process usually needs to be repeated multiple times, leading to waste of drug solution from multiple filling units. For high-value drugs such as cell preparations, this waste is unacceptable.

[0007] In summary, there is currently no complete technical solution on the market that can meet the high-throughput filling needs of non-terminally sterile preparations such as cell preparations. The industry urgently needs a systematic solution that, while meeting the GMP regulations for the filling environment, overcomes the accuracy issues of fitting thin tubing and filling nozzles, enables online full weighing and rejection of defective products, ensures component homogeneity, and eliminates drug loss during calibration, thereby achieving efficient and reliable high-throughput filling. Utility Model Content

[0008] The purpose of this invention is to solve the problem that existing technologies cannot meet the high-throughput filling requirements of sterile and aseptic preparations.

[0009] In a first aspect, this utility model provides a bag-type aseptic filling system, comprising: a material handling module, a filling module, and a material discharging module connected in sequence;

[0010] The material handling module is used to arrange the packaging bags in an orderly manner at relatively fixed intervals;

[0011] The filling module is connected to the discharge end of the material handling module and is used to fill, measure the amount of filling and seal the packaging bags.

[0012] The discharge module is connected to the discharge end of the filling module, and outputs qualified and unqualified products of the packaging bags according to the filling volume detection results.

[0013] The filling module includes a filling unit and a reciprocating feeding device;

[0014] The filling unit is provided with a feeding station, a front weighing station, a filling station, a rear weighing station and a sealing station in sequence along its transport direction. The reciprocating feeding device is located on one side of the filling unit and is used to simultaneously pick up and convey the packaging bags from multiple stations.

[0015] Furthermore, the material handling module includes a first isolation system, the first isolation system comprising:

[0016] A first conveying device, placed inside the first isolation system, includes a conveyor belt and a positioning block, wherein the positioning block is fixed on the conveyor belt;

[0017] A cutting device, positioned above the conveyor belt, is used to cut the tubing of the dispensing bags on each of the positioning blocks to the same length;

[0018] The packaging bag enters the first isolation system, is conveyed by the first conveying device to the cutting device for cutting, and is then conveyed to the filling module.

[0019] Furthermore, the filling module includes a second isolation system, the inlet of which is connected to the outlet of the material handling module. Both the reciprocating feeding device and the filling unit are located within the second isolation system. The second isolation system includes:

[0020] The feeding device, located at the front end of the filling unit in the transport direction, includes a feeding gripper and a robotic arm, used to grasp and change the posture of the dispensing bag;

[0021] A sealing device is located at the rear end of the filling unit in the transport direction and is used to seal the filled packaging bags.

[0022] Furthermore, the filling unit includes:

[0023] A front weighing device, located near the feeding device, is used to weigh the packaging bags before filling.

[0024] A weighing device is located near the sealing device and is used to weigh the filled packaging bags.

[0025] A filling assembly, placed between the front weighing device and the rear weighing device, includes a clamping device and a filling needle holder. The clamping device fixes the dispensing bag during the filling process, and the filling needle holder is positioned directly above the clamping device for filling the dispensing bag with liquid.

[0026] Furthermore, the reciprocating feeding device includes a fixed plate, a plurality of grippers arranged equidistantly on the fixed plate, and a track for restricting the movement of the fixed plate. The track has a first working point and a second working point at its two ends, and the fixed plate reciprocates between the first working point and the second working point along the track.

[0027] When the fixed plate moves to the first working point, the clamping center of the gripper, the loading gripper, the front weighing device, the clamping device, and the rear weighing device are all located in the same vertical plane.

[0028] When the fixed plate moves to the second working point, the clamping center of the gripper, the front weighing device, the clamping device, the rear weighing device, and the sealing device are all located in the same vertical plane.

[0029] Furthermore, the filling module also includes:

[0030] An exhaust device is used to discharge internal gases after the dispensing bags have been filled.

[0031] The second conveying device, placed within the second isolation system and located below the sealing device, is used to receive the sealed packaging bag released from the sealing device and convey it to the discharge module.

[0032] Furthermore, the discharge module includes:

[0033] A discharge isolation system, wherein the side wall of the discharge isolation system is provided with a discharge isolation system connection port corresponding to the discharge end of the filling module;

[0034] A first ramp extends from the connection port of the discharge isolation system into the interior of the discharge isolation system. When the discharge end of the filling module is opened, the first ramp is connected to the discharge end of the filling module.

[0035] The second ramp is rotatably disposed at the end of the first ramp and is used to separate qualified products from unqualified products;

[0036] A third conveying device, connected to the second ramp, is used to output qualified products that slide down from the second ramp.

[0037] Furthermore, it also includes:

[0038] The feeding module is used to remove the outer packaging of the repackaging bag and deliver the repackaging bag to the sorting module in an aseptic manner;

[0039] The low-temperature mixing module is used to keep the liquid in the concentrate bag cold and prevent precipitation. The output pipeline of the concentrate bag is connected to the filling pump in the filling module through the pump pipe assembly.

[0040] A cell counting device is connected to the stock solution bag via a cell counting tube assembly for real-time monitoring of cell density in the stock solution bag;

[0041] Furthermore, it also includes: a control module;

[0042] The feeding module, the filling module, and the discharging module are all connected to the control module, which is used to control the working status of the feeding module, the filling module, and the discharging module.

[0043] The working process of the bag-type aseptic filling system includes a filling calibration stage and a filling operation stage. In the filling calibration stage, the control module obtains the actual average flow rate based on the filling volume detection result of the filling module, and automatically calibrates the filling module based on the actual average flow rate. In the filling operation stage, the control module determines whether the corresponding dispensing bag is qualified based on the filling volume detection result of the filling module.

[0044] Furthermore, the control module includes a controller and a data recording module. The controller connects to each module and controls the mechanical actions and process logic of the filling system. The data recording module is connected to the controller and is used to store weighing data and operation logs.

[0045] Compared to existing technologies, this invention offers at least the following advantages: Through the orderly integration of the material handling module, filling module, and discharging module, it achieves fully automated processing of the entire process of packaging bags, from shaping and cutting, filling and sealing to quality sorting, offering significant technical advantages. First, the material handling module arranges the packaging bags in an orderly manner at fixed intervals, solving problems such as bag jamming and flow interruption caused by chaotic feeding in traditional filling systems, thus improving system stability. Second, the filling module integrates filling, volume detection, and sealing functions, significantly improving production efficiency and reducing the risk of cross-contamination. Finally, the discharging module can automatically separate qualified and unqualified products, reducing manual intervention and increasing the yield. The entire system forms a complete production chain. Compared to existing technologies, it not only improves filling efficiency and accuracy but also achieves closed-loop management of product quality. It is particularly suitable for the production of biopharmaceuticals such as cell preparations, which have strict aseptic requirements and high product value, solving the technical problems of insufficient automation, low filling accuracy, and difficulty in quality control in existing technologies. Attached Figure Description

[0046] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0047] Figure 1 This is a front view of an aseptic filling system according to an embodiment of the present invention;

[0048] Figure 2 This is a schematic cross-sectional view of the aseptic filling system JJ in one embodiment of the present invention;

[0049] Figure 3 This is a left view of an aseptic filling system according to an embodiment of the present invention;

[0050] Figure 4 This is a partial view along direction K in one embodiment of the present invention;

[0051] Figure 5 This is a schematic diagram of the filling module in one embodiment of the present invention;

[0052] Figure 6 This is a schematic diagram of a weighing device in one embodiment of the present invention;

[0053] Figure 7 This is a schematic diagram of the gripper in one embodiment of the present invention;

[0054] Among them, 100 is the feeding module; 101 is the feeding isolation system; 1011 is the feeding gate; 200 is the material handling module; 201 is the first isolation system; 2011 is the first feeding port; 202 is the first conveying device; 2021 is the conveyor belt; 2022 is the positioning block; 203 is the waste collection device; 204 is the cutting device; 300 is the filling module; 301 is the second isolation system; 3011 is the pipe threading device; 302 is the filling module; 303 is the second isolation system; 3011 is the pipe threading device; 302 is the filling module; 303 is the first isolation system; 304 is the second isolation system; 305 is the second isolation system; 306 is the second isolation system; 307 is the second isolation system; 308 is the second isolation system; 309 is the second isolation system; 300 is the second isolation system; 3011 is the pipe threading device; 302 is the second isolation system; 301 is the second isolation system ...201 is the second isolation system; 201 is the first isolation system; 201 is the first isolation system; 201 is the first isolation system; 201 Feeding device; 3021, feeding gripper; 3022, robotic arm; 303, reciprocating feeding device; 3031, gripper; 3032, track; 3033, fixing plate; 3031A, first gripping arm; 3031B, second gripping arm; 3031C, protrusion; 3031D, curved surface; 304, front weighing device; 3041, support structure; 3042, weighing sensor; 3043, gripper fixing plate; 30 44. Anti-vibration support; 305. Filling pump; 306. Filling needle holder; 307. Exhaust device; 308. Sealing device; 309. Pump pipe assembly; 3091. Pump pipe connector; 3092. Clamp; 310. Rear weighing device; 311. Airborne bacteria sampler; 312. Particle detection device; 313. Second conveying device; 314. Clamping device; 400. Low-temperature mixing module; 500. Discharge module; 50 1. Discharge isolation system; 5011. Discharge isolation system connection port; 5012. Sealing glove; 502. First ramp; 503. Second ramp; 504. Third conveying device; 600. Raw material bag; 601. Discharge pipe; 700. Controller; 800. Data recording module; 1000. Cell counting device; 901. Dispensing bag; 9011. Tube; 902. Packaging bag; 1001. Cell counting tube assembly. A1 - Third working point; A2 - First working point; B1 - Fourth working point; B2 - Second working point. Detailed Implementation

[0055] The present invention will now be described in more detail with reference to the accompanying drawings, which illustrate preferred embodiments of the present invention. It should be understood that those skilled in the art can modify the present invention described herein while still achieving its advantageous effects. Therefore, the following description should be understood as being broadly known to those skilled in the art and is not intended to limit the present invention.

[0056] It should be noted that, in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0057] The present invention will be described in more detail below by way of example with reference to the accompanying drawings. The advantages and features of the present invention will become clearer from the following description. It should be noted that the drawings are in a very simplified form and use non-precise proportions, and are only used to facilitate and clarify the illustration of the embodiments of the present invention.

[0058] Example 1

[0059] This embodiment provides a bag-type aseptic filling system. Please refer to [link / reference]. Figures 1-7 The system includes: a material handling module 200, a filling module 300, and a discharging module 500 connected in sequence; the material handling module 200 is used to arrange the packaging bags 901 in an orderly manner at relatively fixed intervals; the filling module 300 is connected to the discharging end of the material handling module 200 and is used to fill, measure the filling volume, and seal the packaging bags 901; the discharging module 500 is connected to the discharging end of the filling module 300 and outputs qualified and unqualified products of the packaging bags according to the filling volume measurement results; wherein, the filling module 300 includes a filling unit and a reciprocating feeding device 303; the filling unit is provided with a feeding station, a front weighing station, a filling station, a rear weighing station, and a sealing station in sequence along its transportation direction, and the reciprocating feeding device 303 is provided on one side of the filling unit and is used to simultaneously pick up and convey the packaging bags 901 from multiple stations.

[0060] Specifically, the material handling module 200 can use a conveyor belt 2021 and positioning blocks 2022 to achieve equidistant arrangement of the packaging bags 901. Furthermore, a photoelectric sensor can detect the position of the packaging bags 901 to ensure arrangement accuracy. The filling module 300 can achieve closed-loop control of the filling volume using a weighing sensor 3042. Specifically, a high-precision strain gauge sensor can be used, along with a vibration-damping support structure 3041 to suppress shaking during the weighing process. The discharge module 500 can achieve automatic sorting of qualified and unqualified products using an inclined slide and pneumatic baffle, for example, by using a servo motor to drive the slide angle switching.

[0061] In this embodiment, a sealing glove 5012 is also provided on the outer wall of each module. The sealing glove 5012 is fixed to the side wall of the discharge isolation system 501 through a quick-release interface and communicates with the interior. Preferably, the sealing glove 5012 is made of butyl rubber, and the quantity can be configured as 2-4 pieces according to operational needs.

[0062] The modular design enables fully automated processing of the packaging bags 901, from material handling to filling and sorting. The material handling module 200 ensures the orderly entry of the packaging bags 901 into the filling station, the filling module 300 guarantees filling accuracy through multiple weighing processes, and the discharging module 500 automatically sorts the bags based on weight detection results. Compared with existing technologies, this design solves the problem of inaccurate positioning caused by bag deformation during soft bag filling, achieves high-precision filling through closed-loop weighing control, and avoids the risk of cross-contamination from manual sorting. Furthermore, the sealed connection design between modules ensures the aseptic environment required for the filling process.

[0063] For further details, please refer to... Figure 2 The material handling module 200 includes a first isolation system 201, which includes:

[0064] The first conveying device 202 is placed inside the first isolation system 201 and includes a conveyor belt 2021 and a positioning block 2022, wherein the positioning block 2022 is fixed on the conveyor belt 2021.

[0065] The cutting device 204 is positioned above the conveyor belt 2021 and is used to cut the hoses 9011 of the dispensing bags 901 on each of the positioning blocks 2022 to the same length.

[0066] The packaging bag 901 enters the first isolation system 201, is conveyed by the first conveying device 202 to the cutting device 204 for cutting, and is then conveyed to the filling module 300 via the discharge end of the first isolation system 201.

[0067] Specifically, the first isolation system 201 is made of stainless steel and maintains a positive pressure sterile environment internally. Its side walls are respectively equipped with a first inlet 2011 and a first outlet. The conveyor belt 2021 of the first conveying device 202 is made of medical-grade silicone material with anti-slip textures on the surface, and the positioning blocks 2022 are spaced 150mm ± 0.5mm apart. The cutting device 204 includes a servo motor-driven rotating blade with a blade speed of 3000rpm and a cutting accuracy of ±0.1mm. In a preferred embodiment, the positioning blocks 2022 are provided with V-grooves to fix the position of the tubing 9011 of the dispensing bag 901. Furthermore, the cut tubing 9011 falls into the waste collection device 203 below. The cutting device 204 is also equipped with a vision detection system that uses a CCD camera to identify the position of the tubing 9011 and feeds it back to the control system to adjust the cutting position.

[0068] A sterile environment is ensured through an isolation system, and the automated arrangement and standardized cutting of the packaging bags 901 are achieved using a precisely positioned conveying device and a cutting device 204. Specifically, the fixed-spaced positioning blocks 2022 ensure the orderly conveying of the packaging bags 901, while the rotating blades, in conjunction with a vision system, achieve high-precision cutting. Compared to existing technologies, this solves the problem of filling and docking difficulties caused by inconsistent lengths of the soft bags and tubes 9011, while also avoiding the risk of contamination from manual operation. Through the synergistic effect of mechanical positioning and automatic cutting, the pre-treatment stage of the packaging bags 901 is standardized and automated, providing a uniform material basis for subsequent filling processes.

[0069] For further details, please refer to... Figure 5 The filling module 300 includes a second isolation system 301, the inlet of which is connected to the outlet of the material handling module 200. The second isolation system 301 includes:

[0070] The reciprocating feeding device 303 is placed in the second isolation system 301 and includes a fixed plate 3033, a plurality of grippers 3031 equidistantly arranged on the fixed plate 3033, and a track 3032 for restricting the movement of the fixed plate 3033.

[0071] The filling unit is located on the side of the reciprocating feeding device 303 near the gripper 3031 and is used to weigh and fill the dispensing bag 901.

[0072] The feeding device 302 is located at the front end of the filling unit in the transport direction and includes a feeding gripper 3021 and a robotic arm 3022 for gripping and changing the posture of the dispensing bag 901.

[0073] The sealing device 308 is located at the rear end of the filling unit in the transport direction and is used to seal the filling bag 901.

[0074] Specifically, the track 3032 of the reciprocating feeding device 303 can be a linear guide or a V-shaped roller guide, and the fixing plate 3033 is precisely positioned by a servo motor drive. Please refer to... Figure 7 The gripper 3031 is pneumatically or electrically driven, and the gripping force is controlled in a closed loop by a pressure sensor. A silicone cushioning pad is provided at the end of the gripper 3031 to prevent damage to the packaging bag 901. Furthermore, the gripper 3031 can be configured with a rotating mechanism to achieve a 90-degree rotation of the packaging bag 901. The robotic arm 3022 of the feeding device 302 can adopt a SCARA structure or a six-axis articulated type, with a force / torque sensor integrated into the end effector. The feeding gripper 3021 is equipped with a dual mechanism of a vacuum suction cup and a mechanical gripper 3031; the vacuum suction cup is used to grip the flat bag surface, and the mechanical gripper 3031 is used to hold the tubing 9011. The posture change action includes rotating from a horizontal state to a vertical hanging state. The sealing device 308 uses resistance heating or ultrasonic welding, with a temperature control accuracy of ±1℃. The pressing mechanism achieves graded pressure control through a cylinder, with low-pressure positioning in the initial stage and high-pressure sealing in the later stage. Infrared temperature monitoring is installed in the sealing area to provide real-time feedback and adjust the heating power.

[0075] Thus, the sterile state of the filling environment is maintained through the second isolation system 301. The reciprocating feeding device 303, in precise coordination with each station, solves the positioning problem of soft bags during continuous transport. The posture changing function of the feeding device 302 adapts to the special requirements of suspended weighing, and the precise control of the heat-sealing parameters of the sealing device 308 ensures the consistency of sealing quality. This achieves high-precision filling of high-value pharmaceuticals such as cell preparations while meeting aseptic operation requirements. The precise positioning design at both ends of the track 3032 of the reciprocating feeding device 303 enables the gripper 3031 to accurately transfer the dispensing bag 901 between different stations, solving the positioning accuracy problem that is difficult to guarantee in traditional multi-flow path systems. The special structural design of the gripper 3031 effectively suppresses the shaking during soft bag weighing, improving the reliability of weighing data.

[0076] Furthermore, the filling unit includes:

[0077] The front weighing device 304 is located near the feeding device 302 and is used to weigh the packaging bag 901 before filling.

[0078] The weighing device 310 is located near the sealing device 308 and is used to weigh the filled packaging bags 901.

[0079] The filling assembly, located between the front weighing device 304 and the rear weighing device 310, includes a clamping device 314 for fixing the dispensing bag 901 during the filling process; and a filling needle holder 306, located directly above the clamping device 314, for filling the dispensing bag 901 with liquid.

[0080] In this embodiment, please refer to Figure 6 The front weighing device 304 includes:

[0081] The support structure 3041 is fixed to the bottom of the second isolation system 301.

[0082] The top of the support structure 3041 is provided with a gripper fixing plate 3043, and a weighing sensor 3042 is provided on the gripper fixing plate 3043.

[0083] It also includes a sway-proof support 3044, which is connected to the gripper fixing plate 3043 to suppress the shaking of the dispensing bag 901.

[0084] Specifically, the front weighing device 304 includes a support structure 3041, fixed to the bottom of the second isolation system 301. A gripper fixing plate 3043 is provided on the top of the support structure 3041, and a weighing sensor 3042 is mounted on the gripper fixing plate 3043. An anti-shake support member 3044 is also provided on the support structure 3041, connected to the gripper fixing plate 3043, to suppress the shaking of the dispensing bag 901. The anti-shake support member 3044 can be a spring-damped structure or a pneumatic buffer device, reducing the swaying of the suspended soft bag during the weighing process through mechanical limiting. As a preferred embodiment, the weighing sensor 3042 is a high-precision strain gauge sensor with a range of 0-500g and a resolution of 0.01g. The clamping device 314 uses a pneumatic gripper 3031, with the clamping surface covered by a medical-grade silicone pad, ensuring uniform distribution of clamping force while avoiding damage to the soft bag tubing.

[0085] Please refer to Figure 3 and Figure 4 The filling needle holder 306 includes multiple independently controlled filling needles, each equipped with a flow regulating valve to adjust the filling speed of each needle in real time based on weighing feedback. In this embodiment, the second isolation system 301 also includes a pump tube assembly 309 and a tube insertion device 3011. The pump tube assembly 309 includes a pump tube connector 3091 and a clamp 3092. The filling needle holder 306 is connected to the original liquid bag 600 via a liquid outlet tube 601, which passes through the tube insertion device 3011. The tube insertion device 3011 and the liquid outlet tube 601 are fixed together by the pump tube connector 3091 and the clamp 3092. The tube insertion device 3011 can be a pneumatically or electrically driven needle insertion mechanism, with a needle diameter matching the inner diameter of the dispensing bag 901 and the tubing 9011. The needle surface can be coated with an anti-scratch coating. During the tube insertion process, a visual positioning system ensures that the needle and the central axis of the tubing 9011 are aligned. In a preferred embodiment, the tube insertion device 3011 is equipped with a force feedback sensor that automatically stops and alarms when the insertion resistance exceeds a threshold.

[0086] By optimizing the layout and anti-shake design of the weighing device, three core issues in the soft bag filling process are effectively solved: First, the close arrangement of the front weighing device 304 and the feeding device 302 reduces the material transfer path and lowers the risk of soft bags tangling during transfer; second, the anti-shake support structure 3041 suppresses soft bag shaking, meeting the precision requirements of high-value drugs such as cell preparations; finally, the coordinated work of the filling needle holder 306 and the clamping device 314 ensures precise docking between the filling needle and the thin tubing 9011. The clamping device 314 provides a fixed reference in the XY plane, while the filling needle holder 306 achieves precise needle insertion in the Z-axis direction. The resulting three-dimensional positioning system achieves an alignment accuracy of ±0.1mm between the filling needle and the tubing 9011 connector, significantly better than the ±2mm accuracy of traditional manual docking methods.

[0087] Furthermore, by integrating the weighing process into the filling process, full-process weight monitoring is achieved. The front weighing device 304 records the weight of the empty bag as a baseline value, and the rear weighing device 310 detects the weight after filling; the difference between the two is the actual filling quantity. When the filling quantity exceeds the preset tolerance range, the system can immediately trigger an alarm and mark the defective product. Compared to traditional sampling inspection methods, this online real-time detection mechanism increases the quality monitoring coverage from 5% to 100%, while avoiding the risk of cross-contamination caused by post-filling rejection.

[0088] Furthermore, the reciprocating feeding device 303 has a first working point A2 and a second working point B2 at both ends of the track 3032, and the fixed plate 3033 reciprocates between the first working point A2 and the second working point B2 along the track 3032.

[0089] When the fixed plate 3033 moves to the first working point A2, the clamping centers of the gripper 3031, the loading gripper 3021, the front weighing device 304, the clamping device 314, and the rear weighing device 310 are all located in the same vertical plane; when the fixed plate 3033 moves to the second working point B2, the clamping centers of the gripper 3031, the front weighing device 304, the clamping device 314, the rear weighing device 310, and the sealing device 308 are all located in the same vertical plane.

[0090] Specifically, the setting of the first working point A2 and the second working point B2 precisely limits the movement range of the fixed plate 3033 on the track 3032, ensuring the transfer accuracy of the gripper 3031 between different workstations. In this embodiment, the track 3032 is also provided with a third working point A1 and a fourth working point B1. The track 3032 between the first working point A2 and the third working point A1, and between the second working point B2 and the fourth working point B1, is a straight segment. This straight segment is perpendicular to the straight line formed by the first working point A2 and the second working point B2 to avoid interference with the thin tube of the dispensing bag during the gripper docking process. The methods to ensure that the clamping centers are all located in the same vertical plane include, but are not limited to: calibrating the clamping center position of each workstation by laser positioning; using a servo motor to drive the fixed plate 3033 to move and cooperating with an encoder to achieve closed-loop position control; and setting mechanical limit devices at both ends of the track 3032 to ensure repeatability. As a preferred embodiment, the gripper 3031 is pneumatically driven and equipped with a force sensor to monitor the gripping force in real time when gripping the dispensing bag 901, so as to avoid deformation or leakage due to overload.

[0091] By defining the positions of the two endpoints of the reciprocating motion and their alignment with key workstations, the positioning deviation problem caused by multiple transfers during the soft bag filling process is solved. Specifically, the first working point A2 ensures seamless connection between the feeding and weighing stations, while the second working point B2 achieves precise alignment between the filling and sealing processes. Compared to existing technologies, this solution achieves sub-millimeter repeatability accuracy without manual intervention. Furthermore, the design, where all clamping centers are located on the same vertical plane, eliminates the cumulative errors inherent in traditional multi-station transfers. Moreover, the symmetrical workstation layout minimizes the motion trajectory, ensuring accuracy while controlling the single transfer time to within 0.5 seconds, providing a fundamental guarantee for the system's efficient operation.

[0092] Furthermore, the gripper 3031 includes a first gripping arm 3031A and a second gripping arm 3031B. Each gripping arm is provided with a protrusion 3031C. The center of the protrusion 3031C coincides with the rotation center of the corresponding gripping arm, and is used to position the tubing 9011 of the dispensing bag 901.

[0093] Specifically, the first clamping arm 3031A and the second clamping arm 3031B achieve opening and closing movements via a rotation shaft. The protrusion 3031C has a hemispherical structure, and its diameter matches the outer diameter of the hose 9011. Simultaneously, the protrusion 3031C is adjacent to and connected to the curved surface 3031D that provides the clamping function. As a preferred embodiment, the surface of the protrusion 3031C can be provided with anti-slip textures to enhance clamping stability. Furthermore, the design that the rotation center of the clamping arm coincides with the center of the protrusion 3031C ensures that the hose 9011 will not experience axial displacement during clamping. For example, the gripper 3031 can be driven by a servo motor, combined with a position sensor to achieve precise opening and closing control.

[0094] The coaxial design of the raised 3031C structure solves the technical problem of inaccurate positioning of the tubing 9011. During the filling process, when the gripper 3031 closes, the two raised 3031Cs form a precise positioning channel, ensuring that the tubing 9011 is always directly below the filling needle. This avoids the problems of tubing 9011 twisting or filling needle misalignment caused by center offset in traditional grippers 3031. Compared with existing technologies, this design achieves sub-millimeter positioning accuracy while maintaining a sterile environment, and reduces the complexity of the control system through mechanical self-centering characteristics. In practical implementation, the gripper 3031 can be made of medical-grade stainless steel, and the raised 3031C part can be made of wear-resistant materials such as polyetheretherketone (PEEK) to extend its service life.

[0095] In this embodiment, the filling unit has five stations (i.e., a feeding station, a front weighing station, a filling station, a rear weighing station, and a sealing station). The positions of these five stations correspond to the positions of the feeding device 302, the front weighing device 304, the filling component, the rear weighing device 310, and the sealing device 308, respectively. The reciprocating feeding device 303 can simultaneously pick up and convey the packaging bags 901 from four stations in the same direction. Specifically, when the reciprocating feeding device 303 conveys backward, the packaging bags 901 from the feeding station move to the front weighing station, the packaging bags 901 from the front weighing station move to the filling station, the packaging bags 901 from the filling station move to the rear weighing station, and the packaging bags 901 from the rear weighing station move to the sealing station. When the reciprocating feeding device 303 conveys forward, the packaging bag 901 at the sealing station moves to the rear weighing station, the packaging bag 901 at the rear weighing station moves to the filling station, the packaging bag 901 at the filling station moves to the front weighing station, and the packaging bag 901 at the front weighing station moves to the feeding station. That is, the packaging bags 901 at the four stations can simultaneously move forward or backward by one station to the station adjacent to their original station.

[0096] In other embodiments, the filling unit may be equipped with more stations, and the reciprocating feeding device 303 may be extended as needed to simultaneously pick up and convey dispensing bags 901 from 5 or more stations.

[0097] Furthermore, the filling module 300 also includes:

[0098] The exhaust device 307 is used to exhaust gas after the filling of the dispensing bag 901 is completed.

[0099] The second conveying device 313 is placed at the bottom of the second isolation system 301 and below the sealing device 308. It is used to receive the sealed packaging bag 901 released from the sealing device 308 and convey it to the discharge module 500.

[0100] Furthermore, the venting device 307 includes a clamping mechanism and a venting needle for venting gas from the dispensing bag 901 after filling is completed, and the sealing device 308 includes a heating element and a pressing mechanism for heat-sealing the hose 9011 of the dispensing bag 901.

[0101] The exhaust device 307 is specifically implemented by a clamping mechanism and an exhaust needle. The clamping mechanism can be a pneumatic gripper 3031 or an electromagnetic clamp, used to fix the tubing 9011 portion of the dispensing bag 901. The exhaust needle is a blunt-tipped hollow needle with an inner diameter of 0.5-1.0 mm, made of 316L stainless steel, and its surface is electrolytically polished. The exhaust process is achieved through negative pressure suction, with the suction pressure controlled within the range of -0.02 to -0.05 MPa. In a preferred embodiment, the exhaust needle is linked to the clamping mechanism; when the clamping mechanism is closed, it automatically inserts into the tubing 9011 to complete the exhaust.

[0102] The second conveying device 313 can be a belt conveyor or a roller conveyor line. The belt material is preferably food-grade polyurethane, with a thickness of 2-3 mm and an anti-slip texture on the surface. The conveying speed is synchronized with the filling cycle and controlled at 0.1-0.3 m / s. Specifically, guide baffles are provided on both sides of the conveyor belt 2021, with a baffle height of 20-30 mm and adjustable spacing to accommodate different sizes of dispensing bags 901. Furthermore, a buffer baffle made of silicone is provided at the end of the conveyor belt 2021 to prevent impact when the dispensing bags 901 slip.

[0103] By adding an exhaust device 307, the problem of residual gas in the bag after filling affecting the sealing quality is effectively solved. Precise control of the exhaust needle ensures gas discharge while preventing liquid leakage. The second conveying device 313 enables automated transfer of the sealed product, with a buffer structure design reducing the risk of product damage. Compared to manual transfer, this solution significantly improves conveying efficiency and product qualification rate. In practice, the coordinated operation of the exhaust device 307 and the sealing device 308 creates a closed-loop control for the entire filling and sealing process, enhancing system stability.

[0104] Furthermore, the filling module 300 also includes an airborne bacteria sampler 311 and a particle detection device 312 disposed inside the second isolation system 301, for monitoring the internal environment of the second isolation system 301.

[0105] The airborne microbial sampler 311 employs an active sampling method, using a built-in air pump to draw air from the isolation system at a preset flow rate, causing airborne microorganisms to collide with the surface of the culture dish. The culture dish can be loaded with a specific culture medium (such as TSA medium). After sampling, the culture dish is removed for incubation and colony counting. The sampling cycle can be set to 15 minutes, 30 minutes, or continuous sampling mode according to process requirements. The sampling point is preferably located 30 cm above the filling station to reflect the microbial load in critical areas.

[0106] The particle detection device 312 employs the principle of laser scattering to monitor the concentration of suspended particles ≥0.5μm and ≥5.0μm within the isolation system in real time. The detection probe is equipped with an isokinetic sampling head with a sampling flow rate of 28.3L / min, consistent with cleanroom testing standards. Detection data can be transmitted to the control system in real time via the MODBUS-RTU protocol, triggering an audible and visual alarm when the particle concentration exceeds the ISO 5 standard. The probe is preferably installed close to the filling needle operating area, forming a diagonal arrangement with the airborne bacteria sampler 311.

[0107] Specifically, the airborne bacteria sampler 311 and the particle detection device 312 are fixed to the top plate of the second isolation system 301 by a bracket, with a distance of no less than 30cm between them to avoid airflow interference. The sampler's air inlet is equipped with an anti-backflow device to prevent liquid splashing and contamination of the sensor. The control system includes a data storage unit that can record historical monitoring data and generate trend curves. Furthermore, the sampler can be configured with a wireless transmission module to achieve remote monitoring and data download.

[0108] Real-time monitoring of microbial and particle levels in critical process areas enables timely detection of integrity failures or operational anomalies in the isolation system. When monitoring data exceeds preset thresholds, the system automatically pauses the filling process and prompts intervention to prevent the continued generation of substandard products. Compared to traditional offline environmental monitoring, this solution achieves continuous acquisition and dynamic response of process data, providing objective evidence for aseptic assurance.

[0109] Furthermore, the discharge module 500 includes:

[0110] The discharge isolation system 501 has a discharge isolation system connection port 5011 on its side wall, which corresponds to the discharge end of the filling module 300.

[0111] The first ramp 502 extends from the discharge isolation system connection port 5011 into the discharge isolation system 501. When the discharge end of the filling module 300 is opened, the first ramp 502 is connected to the discharge end of the filling module 300.

[0112] The second ramp 503 is rotatably disposed at the end of the first ramp 502 and is used to separate qualified products from unqualified products.

[0113] The third conveying device 504 is connected to the second ramp 503 and is used to output qualified products that slide down from the second ramp 503.

[0114] In this embodiment, the discharge isolation system connection port 5011 adopts a flange-type sealing structure to form an airtight connection with the material handling module 200, wherein a silicone sealing ring is provided on the flange connection surface. The inclination angle of the first ramp 502 is 15°-25°, and the surface is covered with a polytetrafluoroethylene coating to reduce the coefficient of friction. The second ramp 503 is driven to rotate by a servo motor, and the rotation angle range is 0°-90°, where 0° corresponds to the qualified product channel and 90° corresponds to the unqualified product collection box. The third conveying device 504 adopts a belt conveyor method, the belt material is food-grade polyurethane, and the conveying speed is adjustable from 0.1-0.5m / s.

[0115] The discharge module 500 achieves automatic sorting of filled products through a mechanical structure. When the sealed packaging bag 901 enters the discharge module 500 via the second conveyor 313, it first slides down the first ramp 502 to the second ramp 503. At this point, the product's qualification status is determined based on the weighing data, and the second ramp 503 is controlled to rotate to the corresponding angle. Qualified products slide down at 0° to the third conveyor 504 for output, while unqualified products fall at 90° into a dedicated collection container. This design solves the problems of low efficiency and easy contamination in traditional manual sorting, while maintaining a sterile environment in the discharge area through the isolation system structure. Compared with existing technologies, this solution achieves closed-loop control of filling-weighing-sorting, with a sorting accuracy rate of over 99.9%, and the entire process requires no manual intervention.

[0116] Furthermore, it also includes:

[0117] The feeding module 100 is used to remove the outer packaging of the dispensing bag 901 and deliver the dispensing bag 901 to the sorting module 200 in an aseptic manner.

[0118] The low-temperature mixing module 400 is used to keep the liquid in the stock solution bag 600 cold and prevent precipitation. The output pipeline of the stock solution bag 600 is connected to the filling pump 305 in the filling module 300 through the pump pipe assembly 309.

[0119] The cell counting device 1000 is connected to the stock solution bag 600 via the cell counting tube assembly 1001 and is used to monitor the cell density in the stock solution bag 600 in real time.

[0120] Furthermore, the bag-type aseptic filling system also includes a control module. The feeding module 200, the filling module 300, and the discharging module 500 are all connected to the control module. The control module is used to control the working status of the feeding module 200, the filling module 300, and the discharging module 500. Preferably, the feeding module 100, the low-temperature mixing module 400, and the cell counting device 1000 are all connected to the control module, and the control module simultaneously controls the working status of the feeding module 100, the low-temperature mixing module 400, and the cell counting device 1000.

[0121] The working process of the bag-type aseptic filling system includes a filling calibration stage and a filling operation stage. In the filling calibration stage, the control module obtains the actual average flow rate based on the filling volume detection result of the filling module 300, and automatically calibrates the filling module 300 based on the actual average flow rate. In the filling operation stage, the control module determines whether the corresponding dispensing bag 901 is qualified based on the filling volume detection result of the filling module 300.

[0122] Specifically, the control module includes a controller 700 and a data recording module 800. The controller 700 connects to each module and controls the mechanical actions and process logic of the filling system. The data recording module 800 is connected to the controller 700 and is used to store weighing data and operation logs.

[0123] Specifically, the feeding module 100 includes a feeding isolation system 101, with a feeding door 1011 on its side wall. The feeding module 100 can remove the dispensing bags 901 from the packaging bag 902 and aseptically transfer the dispensing bags 901 to the material handling area. The low-temperature mixing module 400 prevents cell precipitation in the original solution bag 600 through continuous stirring, ensuring the homogeneity of the original solution. The cell counting device 1000 monitors the cell density in the original solution in real time to ensure product quality. The controller 700, as the core of the system, coordinates the operation of each module and executes the process logic. The data recording module 800 stores the weighing data and operation logs of the entire process, realizing complete data traceability. These modules together constitute a comprehensive automated aseptic filling system, which can efficiently handle the entire process from raw material mixing and aseptic filling to data recording, and is particularly suitable for the precise filling of biopharmaceuticals such as cell preparations with extremely high quality requirements.

[0124] Example 2

[0125] This embodiment provides a bag-type aseptic filling method, applied to the bag-type aseptic filling device described above, including the following steps:

[0126] S1. Automatically calibrate the filling module 300 to determine the actual average flow rate.

[0127] S2. Arrange and cut the dispensing bags 901 at fixed intervals and cut the tubing 9011 of the dispensing bags 901 to the same length.

[0128] S3. Weigh and fill the cut packaging bags 901 sequentially.

[0129] S4. The filled packaging bag 901 is vented and heat-sealed.

[0130] S5. Determine whether the packaging bag 901 is qualified based on the weighing data, and separate qualified and unqualified products.

[0131] Specifically, the filling module 300 is first calibrated to determine the actual average flow rate, ensuring filling accuracy. Multiple filling operations can be performed during calibration to determine the actual average flow rate. Then, the dispensing bags 901 are arranged in an orderly manner, and the tubing 9011 is cut to a uniform length, preparing for subsequent filling. Next, the processed dispensing bags 901 are weighed and filled sequentially to achieve precise measurement. Afterward, the filled dispensing bags 901 are degassed and heat-sealed to ensure product airtightness. Finally, based on the weighing data, the system automatically determines whether the dispensing bags 901 meet quality standards and separates qualified from unqualified products, achieving fully automated quality control. This entire method constitutes a complete bag-type aseptic filling process, overcoming the shortcomings of traditional filling technologies in terms of accuracy control, efficiency, and automation.

[0132] In this embodiment, the actual average flow rate is determined through two filling operations. Step S1 includes:

[0133] Determine the target filling volume V, liquid density ρ, filling pump speed N (305), and theoretical flow rate Q.

[0134] Weigh the packaging bag (901) before filling to obtain the empty weight Wm0;

[0135] Liquid λ×V is filled according to the theoretical flow rate Q, where λ is a coefficient greater than 0 and less than 1;

[0136] Weigh the filled packaging bag (901) to obtain the total weight Wm1 after the first filling, and calculate the net weight of the liquid in the first filling Wj1 = Wm1 - Wm0.

[0137] After conversion, the actual flow rate is obtained as Q1=(Q×Wj1) / (ρ×λ×V);

[0138] Continue filling with liquid at the actual flow rate Q1 (V-Wj1 / ρ);

[0139] Weigh the filled packaging bag (901) to obtain the total weight Wm2 after the second filling, and calculate the net weight of the liquid in the second filling Wj2 = Wm2 - Wm1;

[0140] After conversion, the actual average flow rate is Q2 = (Q1 × Wj2) / (ρV - Wj1).

[0141] Specifically, this method first determines the basic parameters (target filling volume, liquid density, pump speed, and theoretical flow rate), and then obtains the empty weight of the dispensing bag 901 through precise weighing. Subsequently, in the first stage of filling, the system only fills a portion of the target volume (λ×V, preferably, λ is a coefficient of 30%-70%), and calculates the deviation between the actual flow rate and the theoretical flow rate through weighing. In the second stage of filling, the system accurately replenishes the remaining liquid volume based on the actual flow rate correction value calculated in the first stage, ultimately completing the target filling volume. Before the first filling, the corresponding filling time t1 = (λ×V) / Q is set; before the second filling, the corresponding filling time t2 = (V-Wj1 / ρ) / Q1 is set, or the total angle the pump needs to rotate is round = V / q1*360°. Which method is used typically weighs the filling volume error caused by the controllable positioning accuracy of the motor and the accuracy of the pump start-stop response time. The pump start-stop response time or minimum control time is tmin, and the minimum control value for the pump rotation angle is round_min. The entire process involves two precise weighing and flow rate calibrations, ensuring high filling accuracy while avoiding the waste of pharmaceutical solution caused by multiple trial fillings in traditional methods. This makes it particularly suitable for the precise dispensing of high-value cell preparations and other biopharmaceuticals. This method not only improves filling accuracy but also conserves precious pharmaceutical resources.

[0142] In another possible embodiment, the actual average flow rate is determined through three filling operations, and step S1 includes:

[0143] Determine the target filling volume V, liquid density ρ, filling pump speed N, and theoretical flow rate Q;

[0144] Weigh the packaging bag (901) before filling to obtain the empty weight Wm0;

[0145] Fill the container with λ×V liquid at the theoretical flow rate Q, where λ is a coefficient greater than 0 and less than 1; set the corresponding filling time t1=(λ×V) / Q;

[0146] Weigh the filled packaging bag (901) to obtain the total weight Wm1 after the first filling, and calculate the net weight of the liquid in the first filling Wj1 = Wm1 - Wm0.

[0147] After conversion, the actual flow rate is obtained as Q1=(Q×Wj1) / (ρ×λ×V);

[0148] Continue filling with λ×(V-Wj1 / ρ) of liquid at the actual flow rate Q1;

[0149] Weigh the filled packaging bag (901) to obtain the total weight Wm2 after the second filling, and calculate the net weight of the liquid in the second filling Wj2 = Wm2 - Wm1; set the corresponding filling time t2 = (λ × (V - Wj1 / ρ)) / Q1;

[0150] After conversion, the actual average flow rate is Q2=(Q1×Wj2) / ((ρV-Wj1)×λ);

[0151] Continue filling with liquid V-(Wj1+Wj2) / ρ at the actual flow rate Q1;

[0152] Weigh the packaged bag (901) after filling to obtain the weight Wm3 after the third filling, and calculate the net weight of the liquid in the third filling Wj3 = Wm3 - Wm2; set the corresponding filling time t3 = (V - (Wj2 - Wj1) / ρ) / Q2.

[0153] After conversion, the actual average flow rate is obtained as Q3 = Q2 × Wj3 / (ρV - Wm3 + Wm0).

[0154] It should be noted that in other embodiments, the actual average flow rate can be determined by performing more filling operations. However, the actual average flow rate after more filling operations is not significantly different from that after three filling operations. That is, while more filling operations are used in the calibration phase, the calibration results are almost identical, but the time required is longer.

[0155] Furthermore, the coefficient λ ranges from 30% to 70%.

[0156] Specifically, the coefficient λ represents the proportion of the initial filling volume to the target filling volume. As a preferred implementation, λ can be set to 40%, 50%, or 60%. In practice, the initial filling volume should not be too large or too small: if λ is too high (e.g., exceeding 70%), the remaining filling volume after the initial filling may be too small, affecting the accuracy of subsequent flow rate calibration; if λ is too low (e.g., below 30%), the initial filling volume may be too small, potentially leading to a large error in the actual flow rate conversion. Therefore, controlling λ within the range of 30% to 70% balances calibration accuracy and operational efficiency.

[0157] By limiting the range of the initial filling ratio, the problem of significant reagent waste during the calibration process in existing technologies is solved. In existing technologies, calibration typically requires multiple refills, resulting in waste of reagent from multiple dispensing units. However, by optimizing the initial filling ratio, reagent loss during the calibration process can be significantly reduced while maintaining calibration accuracy. For example, when λ is 50%, calibration can be completed with only two fillings, avoiding the waste caused by multiple fillings in traditional methods. Furthermore, this ratio range also ensures the stability of flow calibration, preventing the accumulation of errors in subsequent fillings due to an unreasonable initial filling volume.

[0158] Furthermore, step S2 includes:

[0159] The first conveying device 202 in the control material handling module 200 operates intermittently at a preset rhythm, so that the packaging bags 901 are arranged at a fixed interval.

[0160] The cutting device 204 is controlled to cut the tubing 9011 on the packaging bag 901 at a preset rhythm.

[0161] The control feeding device 302 grabs the cut packaging bag 901 and changes its posture for transmission.

[0162] Specifically, the preset cycle time intermittent operation refers to the servo motor driving the conveyor belt 2021 to start and stop at set time intervals, where the interval time is synchronized with the station switching cycle of the filling module 300. The fixed spacing arrangement can be achieved in ways including but not limited to: using a photoelectric sensor to detect the position of the dispensing bag 901 and triggering the conveyor belt 2021 to stop; or using mechanical baffles to limit the distance between adjacent dispensing bags 901 to 50-100mm. In the hose 9011 cutting step, the cutting device 204 preferably uses pneumatic scissors with adjustable blade spacing to accommodate different tube diameters, and cutting accuracy controlled within ±1mm. The posture change of the feeding device 302 includes two actions: horizontal gripping and vertical flipping, specifically achieved through a rotary cylinder in conjunction with a vacuum suction cup, where the suction cup is made of silicone to avoid damaging the bag.

[0163] By precisely controlling the spacing of the dispensing bags 901 and the length of the tubing 9011, the problem of needle insertion failure caused by bag position deviation in traditional filling processes is solved. Compared with continuous conveying, the intermittent operation mode ensures accurate positioning of each dispensing bag 901 at the filling station. Equal-length cutting of the tubing 9011 ensures consistent needle insertion depth, avoiding filling volume deviation caused by differences in tube length. The posture change during the feeding process transforms the dispensing bags 901 from a horizontal conveying state to a vertical filling state; this transformation significantly improves positioning accuracy and production efficiency compared to manual operation. Through the implementation of this solution, the docking success rate of the filling system has increased from 85% to over 99%, while the single-bag processing time has been reduced by 30%.

[0164] Furthermore, step S3 includes:

[0165] The reciprocating feeding device 303 transfers the packaging bag 901 to the front weighing device 304 at a preset rhythm.

[0166] The pre-weighing device 304 weighs the packaging bag 901 before filling.

[0167] The reciprocating feeding device 303 delivers the dispensing bag 901 to the filling assembly.

[0168] The filling assembly fills the dispensing bag 901.

[0169] The reciprocating feeding device 303 transfers the packaging bag 901 to the subsequent weighing device 310.

[0170] The post-weighing device 310 weighs the filled packaging bag 901 and calculates the net weight of the package.

[0171] Specifically, the packaging bag 901 is first sent to the front weighing device 304 for pre-filling weighing, i.e., empty weight weighing, then transferred to the filling assembly for precise filling, and finally sent to the rear weighing device 310 for filling weight measurement and net weight calculation. This workstation-separated, flow-connected design solves the problem of balancing weighing accuracy and filling efficiency in traditional filling systems. In particular, through the independent front and rear weighing devices 310, the system can monitor the actual filling volume of each packaging bag 901 in real time, ensuring product quality consistency. This design not only improves production efficiency but also provides an accurate data basis for subsequent quality control and rejection of defective products.

[0172] Furthermore, step S4 includes:

[0173] The reciprocating feeding device 303 transfers the packaging bag 901 to the exhaust device 307.

[0174] The venting device 307 vents the contents of the filled packaging bag 901.

[0175] The reciprocating feeding device 303 transfers the packaging bag 901 to the sealing device 308.

[0176] The sealing device 308 seals the tube 9011 of the dispensing bag 901.

[0177] The grippers 3031 of the sealing device 308 release in sequence, allowing the packaging bag 901 to fall into the second conveying device 313.

[0178] In this stage, the reciprocating feeding device 303 precisely transfers the filled and weighed packaging bags 901 to the venting device 307. The venting device 307 effectively removes excess gas from the packaging bags 901, ensuring the stability of the product during subsequent storage and transportation. Subsequently, the packaging bags 901 are transferred to the sealing device 308, where the hoses 9011 are heat-sealed to achieve a complete seal, preventing contamination and leakage. A clamping mechanism is also employed, with the clamps 3031 of the sealing device 308 releasing in a specific sequence, allowing the sealed packaging bags 901 to fall smoothly into the second conveying device 313, avoiding the risk of product damage due to improper material feeding in traditional systems.

[0179] Furthermore, step S5 includes:

[0180] The second conveying device 313 conveys the sealed packaging bag 901 to the discharge module 500.

[0181] The quality of the packaging bag 901 is determined based on the net weight of the filled product.

[0182] Rotate the second ramp 503 to separate qualified and unqualified products along different paths.

[0183] Specifically, the sealed packaging bags 901 are smoothly conveyed to the discharge module 500 via the second conveying device 313. At this stage, the system automatically determines whether each packaging bag 901 meets the preset quality standards based on the previously accurately measured net weight data. For the rotatable second ramp 503, the system can precisely control the rotation angle of the second ramp 503 according to the quality judgment result, allowing qualified and unqualified products to be separated along different paths. This automated sorting mechanism not only improves production efficiency and avoids errors and contamination risks associated with manual sorting, but also enables full quality traceability for each product.

[0184] Furthermore, it also includes:

[0185] If no signal is detected from the dispensing bag 901 during the weighing process before filling, the station is marked as NULL.

[0186] If the dispensing bag 901 is not detected during filling or the weighing mark from the previous cycle is NULL, mark the station as NULL.

[0187] When weighing the filling, if the previous filling cycle is marked as NULL, then mark this station as NULL.

[0188] During heat sealing, the heat sealing operation will not be performed on workstations where the weighing mark is NULL after the previous cycle.

[0189] Specifically, the NULL marking mechanism detects the absence of packaging bag 901 using a photoelectric sensor or a weight threshold. A NULL marker is triggered when the weighing station's reading consistently falls below a preset threshold. The NULL determination logic at the filling station employs dual verification: detecting the physical presence of packaging bag 901 using an infrared sensor and simultaneously reading the status register of the preceding station. The execution control module at the heat-sealing station determines whether to initiate the heating program by querying the data marker register of the subsequent weighing station, with the register update delay controlled within 10ms. As a preferred implementation, the NULL marker is stored in a circular buffer using binary encoding, with each station corresponding to an independent status storage unit, which is read and written in real-time by the PLC via the Modbus protocol.

[0190] By establishing a status transmission mechanism between workstations, automatic isolation of abnormal workstations is achieved. When a workstation experiences a missing 901 packaging bag or a transmission failure, subsequent processes can automatically skip invalid operations, avoiding energy waste and equipment wear caused by idle operation. Compared with existing technologies, this solves the problem of traditional production lines experiencing a complete shutdown due to a single point of failure. Furthermore, through the hierarchical transmission of status markers, it ensures that non-conforming products are not mishandled, thereby improving system reliability and product consistency. Specifically, the NULL marker mechanism allows the system to handle anomalies locally without interrupting the overall process, which is crucial for maintaining the continuous stability of the aseptic filling environment.

[0191] Furthermore, it also includes:

[0192] Microbial indicators inside the second isolation system 301 are monitored using airborne microbial sampler 311.

[0193] The air cleanliness inside the second isolation system 301 is monitored by the particle detection device 312.

[0194] Cell density in the liquid delivered to the filling assembly is monitored using a cell counting device 1000.

[0195] First, the airborne microbial sampler 311 monitors the microbial indicators within the isolation system in real time, ensuring the filling environment meets stringent aseptic requirements. Second, a particle detection device 312 continuously monitors the air cleanliness within the isolation system, guaranteeing that air quality consistently meets Class A cleanroom standards. Most importantly, the system innovatively incorporates a cell counting device 1000, capable of real-time monitoring of cell density in the liquid delivered to the filling components, solving the critical problem of non-uniformity caused by cell sedimentation in traditional filling systems. This triple monitoring mechanism forms a complete quality control network, not only meeting the stringent GMP requirements for aseptic preparation production environments but also ensuring that the cell density in each dispensing bag 901 meets the expected standards. Compared to traditional filling systems, this real-time monitoring design significantly improves batch-to-batch consistency and reliability, providing strong technical support for the safe production of high-value biological products such as cell preparations.

[0196] Furthermore, it also includes:

[0197] The data recording module 800 records the empty weight, filled weight, net weight, heat sealing parameters, and qualification status of each packaging bag 901.

[0198] Record the operating parameters of the filling system, including pump speed, flow rate, and temperature; and record the internal environmental parameters of the isolation system, including differential pressure, microbial indicators, and air cleanliness.

[0199] First, each product unit is comprehensively recorded, including the empty weight, filled weight, net weight, heat sealing parameters, and final qualification status of the 901 packaging bag, achieving precise traceability at the product level. Second, the system continuously monitors and records key operating parameters of the filling equipment, such as pump speed, flow rate, and temperature, ensuring consistency and stability in the production process. Third, environmental parameters within the isolation system are recorded in real time, including differential pressure, microbial indicators, and air cleanliness, ensuring that the production environment always meets stringent aseptic requirements. This multi-dimensional and comprehensive data recording mechanism not only meets GMP compliance requirements for production process recording but also provides a reliable data foundation for product quality analysis, process optimization, and problem identification. Compared with traditional filling systems, this utility model's data recording system significantly enhances the controllability and traceability of the production process.

[0200] The above-described specific examples are for illustrative purposes only and are not intended to limit the scope of this invention. Those skilled in the art to which this invention pertains can make various simple deductions, modifications, or substitutions based on the concept of this invention.

Claims

1. A bag-type aseptic filling system, characterized in that, include: The material handling module (200), filling module (300) and discharging module (500) are connected in sequence. The material handling module (200) is used to arrange the packaging bags (901) in an orderly manner at relatively fixed intervals; The filling module (300) is connected to the discharge end of the material handling module (200) and is used to fill, measure the amount of filling and seal the packaging bag (901); The discharge module (500) is connected to the discharge end of the filling module (300) and outputs qualified and unqualified products of the packaging bag according to the filling quantity detection result. The filling module (300) includes a filling unit and a reciprocating feeding device (303). The filling unit is provided with a feeding station, a front weighing station, a filling station, a rear weighing station and a sealing station in sequence along its transport direction. The reciprocating feeding device (303) is located on one side of the filling unit and is used to simultaneously pick up and convey the packaging bags (901) from multiple stations.

2. The bag-type aseptic filling system as described in claim 1, characterized in that, The material handling module (200) includes a first isolation system (201), the first isolation system (201) including: The first conveying device (202) is placed inside the first isolation system (201) and includes a conveyor belt (2021) and a positioning block (2022), wherein the positioning block (2022) is fixed on the conveyor belt (2021); A cutting device (204) is placed above the conveyor belt (2021) for cutting the hoses (9011) of the dispensing bags (901) on each of the positioning blocks (2022) to the same length; The packaging bag (901) enters the first isolation system (201), is conveyed by the first conveying device (202) to the cutting device (204) for cutting, and is then conveyed to the filling module (300).

3. The bag-type aseptic filling system as described in claim 1, characterized in that, The filling module (300) includes a second isolation system (301), the feed end of which is connected to the discharge end of the material handling module (200). The reciprocating feeding device (303) and the filling unit are both placed within the second isolation system (301). The second isolation system (301) includes: The feeding device (302) is located at the front end of the conveying direction of the filling unit, and includes a feeding gripper (3021) and a robotic arm (3022) for gripping and changing the posture of the dispensing bag (901); A sealing device (308) is placed at the rear end of the filling unit in the transport direction and is used to seal the filling bag (901).

4. The bag-type aseptic filling system as described in claim 1 or 3, characterized in that, The filling unit includes: A front weighing device (304) is located near the feeding device (302) and is used to weigh the dispensing bag (901) before filling. A post-weighing device (310) is located near the sealing device (308) and is used to weigh the filled packaging bag (901). A filling assembly, placed between the front weighing device (304) and the rear weighing device (310), includes a clamping device (314) and a filling needle holder (306). The clamping device (314) fixes the dispensing bag (901) during the filling process. The filling needle holder (306) is located directly above the clamping device (314) and is used to fill the dispensing bag (901) with liquid.

5. The bag-type aseptic filling system as described in claim 4, characterized in that, The reciprocating feeding device (303) includes a fixed plate (3033), a plurality of grippers (3031) equidistantly arranged on the fixed plate (3033), and a track (3032) for restricting the movement of the fixed plate (3033). The two ends of the track (3032) are respectively provided with a first working point (A2) and a second working point (B2). The fixed plate (3033) reciprocates between the first working point (A2) and the second working point (B2) along the track (3032). When the fixed plate (3033) moves to the first working point (A2), the clamping centers of the gripper (3031), the loading gripper (3021), the front weighing device (304), the clamping device (314), and the rear weighing device (310) are all located in the same vertical plane. When the fixed plate (3033) moves to the second working point (B2), the clamping center of the gripper (3031) and the front weighing device (304), the clamping device (314), the rear weighing device (310), and the sealing device (308) are all located in the same vertical plane.

6. The bag-type aseptic filling system as described in claim 3, characterized in that, The filling module (300) also includes: An exhaust device (307) is used to exhaust internal gas after the filling of the dispensing bag (901) is completed; The second conveying device (313), located within the second isolation system (301) and below the sealing device (308), is used to receive the sealed packaging bag (901) released from the sealing device (308) and convey it to the discharge module (500).

7. The bag-type aseptic filling system as described in claim 1, characterized in that, The discharge module (500) includes: The discharge isolation system (501) has a discharge isolation system connection port (5011) on its side wall that corresponds to the discharge end of the filling module (300). A first ramp (502) extends from the discharge isolation system connection port (5011) into the discharge isolation system (501). When the discharge end of the filling module (300) is opened, the first ramp (502) is connected to the discharge end of the filling module (300). The second ramp (503) is rotatably disposed at the end of the first ramp (502) for separating qualified products and unqualified products; The third conveying device (504), connected to the second ramp (503), is used to output qualified products that slide down from the second ramp (503).

8. The bag-type aseptic filling system as described in claim 1, characterized in that, Also includes: The feeding module (100) is used to remove the outer packaging of the dispensing bag (901) and deliver the dispensing bag (901) to the sorting module (200) in an aseptic manner. The low-temperature mixing module (400) is used to keep the liquid in the original liquid bag (600) cold and prevent precipitation. The output pipeline of the original liquid bag (600) is connected to the filling pump (305) in the filling module (300) through the pump pipe assembly (309). A cell counting device (1000) is connected to the stock solution bag (600) via a cell counting tube assembly (1001) for real-time monitoring of cell density in the stock solution bag (600).

9. The bag-type aseptic filling system as described in claim 1, characterized in that, Also includes: Control module; The material handling module (200), the filling module (300), and the discharging module (500) are all connected to the control module, which is used to control the working status of the material handling module (200), the filling module (300), and the discharging module (500); The working process of the bag-type aseptic filling system includes a filling calibration stage and a filling operation stage. During the filling calibration stage, the control module obtains the actual average flow rate based on the filling volume detection result of the filling module (300) and automatically calibrates the filling module (300) based on the actual average flow rate; during the filling operation stage, the control module determines whether the corresponding dispensing bag (901) is qualified based on the filling volume detection result of the filling module (300).

10. The bag-type aseptic filling system as described in claim 9, characterized in that, The control module includes a controller (700) and a data recording module (800). The controller (700) connects to each module and controls the mechanical actions and process logic of the filling system. The data recording module (800) is connected to the controller (700) and is used to store weighing data and operation logs.

Images