Raw material mixing device for biological pharmacy

Abstract

The invention relates to the technical field of mixing devices, in particular to a raw material mixing device for biological pharmacy. Comprising a machine frame, a motor is installed on the machine frame, an overturning frame driven by the motor is arranged on the machine frame, a swing mechanism driven by the motor is installed on the overturning frame, a material mixing shell swinging by + / -30 degrees on the overturning frame and a rotating center shaft are connected to the swing mechanism, and a rotary seat is fixedly installed on the center shaft and rotationally connected with the material mixing shell. The center shaft is rotationally sleeved with a rotating frame, the rotating frame is rotationally sleeved with a forward rotating sleeve, the forward rotating sleeve is rotationally sleeved with a reverse rotating sleeve, and the rotating frame, the forward rotating sleeve and the reverse rotating sleeve are driven by the center shaft to rotate. The device has the beneficial effects that through three-dimensional linkage of 360-degree axial overturning of the overturning frame and + / -30-degree radial swinging of the mixing shell, a low-shear and dead-corner-free mixing flow field is constructed.

Description

Technical Field

[0001] This invention relates to the field of mixing equipment technology, specifically to a raw material mixing device for biopharmaceuticals. Background Technology

[0002] In the biopharmaceutical field, raw material mixing is one of the core processes for ensuring drug purity, activity, and batch stability. Biopharmaceutical raw materials, such as proteins, enzymes, polysaccharide colloids, and solid-liquid mixtures with significant density differences, have unique physicochemical properties: on the one hand, most active ingredients are sensitive to shear forces, and high-speed mechanical impacts can easily damage their spatial structure, leading to loss of activity; on the other hand, raw material systems often exhibit characteristics such as high viscosity, multiphase nature, or large density differences. Traditional mixing methods are prone to stratification, agglomeration, or mixing dead zones, making it difficult to meet the stringent requirements for mixing uniformity in the Good Manufacturing Practice (GMP) for pharmaceuticals. As the biopharmaceutical industry continues to demand higher product quality and production efficiency, existing raw material mixing equipment is gradually revealing multi-dimensional technical deficiencies, specifically as follows: Existing devices cannot simultaneously resolve the contradiction between protecting the activity of heat-sensitive or shear-sensitive raw materials and achieving high uniformity mixing. Existing biopharmaceutical raw material mixing devices are mainly divided into two categories: one is the mechanical paddle stirring type, which uses a motor to drive the paddles in the tank to rotate at high speed, and uses the shearing and pushing action of the paddles on the raw materials to achieve mixing. In order to solve the problem of mixing uniformity of high viscosity or multiphase raw materials, this type of device usually needs to increase the paddle speed. However, the local shear force generated by high-speed rotation will directly destroy the peptide bonds or spatial conformation of active ingredients such as proteins and enzymes. The other type is the single-dimensional flipping type, which achieves raw material mixing by flipping the tank around a fixed axis 360°. Although it can reduce shear force, the mixing only relies on the axial flow of the raw materials' own gravity and inertia, lacking radial disturbance. Based on this, the present invention provides a raw material mixing device for biopharmaceuticals to solve the problems mentioned in the background art. Summary of the Invention

[0003] This invention addresses the technical problems existing in the prior art by providing a biopharmaceutical raw material mixing device to solve the contradiction between the protection of the activity of heat-sensitive or shear-sensitive raw materials and high uniformity mixing in existing devices.

[0004] The technical solution of this invention to solve the above-mentioned technical problems is as follows: A raw material mixing device for biopharmaceuticals includes a frame on which a motor is mounted. A rotating frame driven by the motor is provided on the frame. A swinging mechanism driven by the motor is installed on the rotating frame. A mixing shell that swings ±30° on the rotating frame and a rotating central shaft are connected to the swinging mechanism. A rotary seat is fixedly mounted on the central shaft and rotatably connected to the mixing shell. A rotating frame is rotatably sleeved on the central shaft. A forward rotating sleeve is rotatably sleeved on the rotating frame. A reverse rotating sleeve is rotatably sleeved on the forward rotating sleeve. The rotating frame, forward rotating sleeve, and reverse rotating sleeve are all driven to rotate by the central shaft. Gear discs are installed on both the forward rotating sleeve and the reverse rotating sleeve. Each gear disc is provided with a transmission meshing section and a... A toothless intermittent section has four arrayed transmission guide shafts rotatably connected to the rotating frame. Each transmission guide shaft is equipped with two reversing gears and one speed-changing gear. The two reversing gears mesh with the transmission meshing sections on the two gear discs, respectively. Four arrayed stirring shafts are rotatably connected to the rotary seat. Each stirring shaft has four external gears installed at its tail. The four external gears mesh with four speed-changing gears, respectively. The transmission ratios of the four speed-changing gears to the corresponding external gears are different. Among them, stirring rods are arrayed on two stirring shafts, and spiral stirring blades are installed on the other two stirring shafts. The spiral directions of the two spiral stirring blades are opposite. Liquid-turning arc plates are arrayed on the surface of the rotary seat, and four filtrate sieve plates are fixedly installed.

[0005] Based on the above technical solution, the present invention can be further improved as follows.

[0006] As a preferred technical solution of the present invention, a central control unit is installed on the frame, an electric heating plate is integrated on the mixing shell, and a material valve is connected to the top and bottom of the mixing shell. The center angle corresponding to the transmission meshing section is 120°, the center angle corresponding to the intermittent toothless section is 240°, and the transmission meshing sections on the two toothed discs are staggered by 180°.

[0007] As a preferred technical solution of the present invention, two symmetrically arranged flipping shafts are installed on the flipping frame. A hollow rotating shaft is rotatably sleeved on one of the flipping shafts. The other flipping shaft and the hollow rotating shaft are rotatably connected to the frame through bearings. Two first synchronous belts are drivenly connected to the output shaft of the motor. The two first synchronous belts are respectively drivenly connected to the hollow rotating shaft and one of the flipping shafts.

[0008] As a preferred embodiment of the present invention, the swing mechanism includes a forward rotating shaft and a reverse rotating shaft rotatably connected to the tilting frame. A driven bevel gear is installed on both the forward rotating shaft and the reverse rotating shaft. A transmission bevel gear is installed on the hollow rotating shaft. Both driven bevel gears are connected to the transmission bevel gear. A transmission missing gear is installed on both the forward rotating shaft and the reverse rotating shaft. Two swing shafts are fixedly installed on the mixing shell. Swing gears are installed on both swing shafts. The positions of the two transmission missing gears correspond to the positions of the two swing gears, and the two transmission missing gears alternately mesh with the swing gears at the corresponding positions. A torsion spring is installed at the bottom end of one swing shaft, and the other end of the torsion spring is fixedly connected to the tilting frame.

[0009] As a preferred technical solution of the present invention, the center angle corresponding to the effective meshing section on the transmission missing gear is 30°, the effective meshing sections on the two transmission missing gears are staggered by 180°, and the two driven bevel gears are respectively disposed on both sides of the transmission bevel gear.

[0010] As a preferred technical solution of the present invention, the swing mechanism further includes a drive shaft rotatably connected to a swing shaft, a second synchronous belt drivingly connecting the drive shaft and the rotating shaft, a first bevel gear mounted on the central shaft and the rotating frame, a drive bevel gear mounted on the drive shaft, both first bevel gears drivingly connected to the drive bevel gear, and the two first bevel gears are respectively arranged on both sides of the drive bevel gear.

[0011] As a preferred embodiment of the present invention, a differential shaft and a synchronous shaft are rotatably connected to the mixing shell. Differential bevel gears are installed on both the rotating frame and the differential shaft, and the two differential bevel gears are orthogonally meshed. Second bevel gears are installed on both the forward rotating sleeve and the differential shaft, and the two second bevel gears are orthogonally meshed. Synchronous bevel gears are installed on the synchronous shaft. Third bevel gears are installed on both the forward rotating sleeve and the reverse rotating sleeve, and the two third bevel gears are drivenly connected to the synchronous bevel gears.

[0012] As a preferred embodiment of the present invention, the two third bevel gears are respectively disposed on both sides of the synchronous bevel gear, and the axes of the synchronous shaft and the differential shaft are perpendicular to the axis of the central shaft.

[0013] As a preferred technical solution of the present invention, a counterweight is installed on the tilting frame, the axis of the swing shaft is perpendicular to the axis of the tilting shaft, and liquid permeable mesh holes are evenly distributed on the spiral stirring blade.

[0014] As a preferred embodiment of the present invention, the four stirring shafts and the four filtrate sieves are alternately arranged on the rotary seat, and a sealing ring is provided at the rotational connection between the rotary seat and the mixing shell.

[0015] The beneficial effects of this invention are: 1. Addressing the technical problems of high-speed shear damage to activity and insufficient radial disturbance leading to stratification in existing mechanical paddle mixers and single-flip mixing, this invention constructs a low-shear and dead-angle-free mixing flow field through three-dimensional linkage of 360° axial flipping of the flipping frame and ±30° radial oscillation of the mixing shell. The flipping frame drives the mixing shell to flip at all angles, driving the material to periodically replace axially, breaking the stratification trend of light and heavy components from the root. The mixing shell simultaneously performs ±30° reciprocating oscillation, forming gentle turbulence in the radial direction. The two work together to avoid local shear hotspots in traditional mixing and eliminate the mixing dead angles of single flipping. This linkage design not only protects the spatial conformation and activity of sensitive raw materials such as proteins and enzymes, but also significantly improves the mixing uniformity compared to existing inventions, solving the problem of being unable to simultaneously achieve activity protection and uniform mixing.

[0016] 2. Unlike existing stirring systems with their unidirectional transmission and single rotation speed, this invention adapts to complex raw material systems through a synergistic design of differentiated stirring shaft speeds, periodic forward and reverse rotation, and synchronous filtration. Four stirring shafts achieve different rotation speeds via variable speed gears, while the reverse spiral blades generate bidirectional convection, breaking up axial material stagnation. The stirring rods break up local agglomerates at high speed, and the 180° staggered meshing of the gear discs enables a composite motion of forward rotation, intermittent rotation, reverse rotation, and intermittent rotation. The intermittent phase provides a buffer for the raw materials, avoiding continuous shear damage, while the reverse rotation further eliminates the risk of agglomeration. At the same time, the stirring shafts and filtrate sieves are alternately set, allowing for simultaneous filtration of impurities during stirring. This process is more efficient than the existing process of mixing first and then filtering, and is especially suitable for difficult-to-mix systems such as powders, colloids, and solid-liquid multiphase systems in biopharmaceuticals. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of a raw material mixing device for biopharmaceutical applications. Figure 2 for Figure 1 A structural diagram from another perspective; Figure 3 This is a schematic diagram of the cross-sectional structure of the rotary seat and the spiral blades; Figure 4 for Figure 3 A magnified schematic diagram of the partial structure at point A in the middle; Figure 5 for Figure 3 A magnified schematic diagram of the local structure at point B; Figure 6 This is a schematic diagram of the structure of the rotary seat and the liquid-turning arc plate; Figure 7 for Figure 6 Another perspective structural diagram; Figure 8 for Figure 7 A magnified schematic diagram of the structure at point C in the middle; Figure 9 This is a schematic diagram of the structure of the agitator shaft and the external gear; Figure 10 This is a schematic diagram of the structure of the speed-changing gear and the torsion spring.

[0018] The attached diagram lists the components represented by each number as follows: 1. Frame; 2. Motor; 3. Tilting frame; 4. Mixing shell; 5. Central shaft; 6. Rotary seat; 7. Rotating frame; 8. Forward rotation sleeve; 9. Reverse rotation sleeve; 10. Gear disc; 11. Transmission meshing section; 12. Transmission guide shaft; 13. Reversing gear; 14. Speed ​​change gear; 15. Stirring shaft; 16. External gear; 17. Stirring rod; 18. Spiral stirring blade; 19. Filtration sieve plate; 20. Central control unit; 21. Heating plate; 22. Material valve; 23. Tilting shaft; 24. Hollow rotating shaft; 25. Forward rotation shaft; 26. Reverse rotation shaft; 27. Transmission missing gear; 28. Swing shaft; 29. ​​Swing gear; 30. Torsion spring; 31. Drive shaft; 32. Differential shaft; 33. Synchronous shaft; 34. Counterweight balance block; 35. Liquid permeable mesh; 36. Tilting arc plate. Detailed Implementation

[0019] The principles and features of the present invention are described below with reference to the accompanying drawings. The examples given are only for explaining the present invention and are not intended to limit the scope of the present invention.

[0020] The present invention provides the following preferred embodiments, such as Figure 1-10 As shown, a raw material mixing device for biopharmaceuticals includes a frame 1 on which a motor 2 is mounted. A tilting frame 3 driven by the motor 2 is provided on the frame 1. A swinging mechanism driven by the motor 2 is installed on the tilting frame 3. A mixing shell 4 that swings ±30° on the tilting frame 3 and a central shaft 5 are connected to the swinging mechanism. A central control unit 20 is installed on the frame 1, an electric heating plate 21 is integrated on the mixing shell 4, and material valves 22 are connected to the top and bottom of the mixing shell 4. A counterweight 34 is installed on the tilting frame 3. The counterweight 34 is made of high-density cast iron and its weight adjustment range is 5-20kg. The central control unit 20 can preset parameters such as mixing temperature, tumbling speed, and oscillation frequency to achieve automated control of the mixing process; The electric heating plate 21 can precisely heat the mixing shell 4 according to instructions, meeting the specific temperature mixing requirements of some heat-sensitive raw materials in biopharmaceuticals; The inner wall of the mixing shell 4 integrates a PT100 temperature sensor, which is linked in a closed loop with the central control unit 20. The top feed valve 22 is used for independent feeding, and the bottom feed valve 22 is used for independent discharge, avoiding raw material residue and cross-contamination caused by traditional single-port feeding and discharging. When the tilting frame 3 is running, the counterweight balance block 34 can adjust its weight according to the total amount of mixed liquid in the mixing shell 4 to balance the torque on both sides of the tilting frame 3. Two symmetrically arranged tilting shafts 23 are installed on the tilting frame 3. A hollow rotating shaft 24 is rotatably sleeved on one tilting shaft 23. The other tilting shaft 23 and the hollow rotating shaft 24 are rotatably connected to the frame 1 through bearings. Two first synchronous belts are driven to the output shaft of the motor 2. The two first synchronous belts are driven to the hollow rotating shaft 24 and the tilting shaft 23 respectively. After the motor 2 starts, its output shaft drives the hollow rotating shaft 24 and one of the flipping shafts 23 to rotate synchronously through two first synchronous belts. Since the two flipping shafts 23 are symmetrically installed on the flipping frame 3, the two work together to drive the flipping frame 3 to achieve a stable 360° rotation around the axis of the flipping shaft 23, thereby driving the mixing shell 4 to rotate synchronously. The swing mechanism includes a forward rotating shaft 25 and a reverse rotating shaft 26 rotatably connected to the tilting frame 3. Both the forward rotating shaft 25 and the reverse rotating shaft 26 are equipped with driven bevel gears. A transmission bevel gear is installed on the hollow rotating shaft 24. Both driven bevel gears are connected to the transmission bevel gear. Both the forward rotating shaft 25 and the reverse rotating shaft 26 are equipped with transmission missing gears 27. Two swing shafts 28 are fixedly installed on the mixing shell 4. The axis of the swing shaft 28 is perpendicular to the axis of the tilting shaft 23. Two swing shafts 28 are each equipped with a swing gear 29. The positions of two transmission missing gears 27 correspond to the positions of the two swing gears 29, and the two transmission missing gears 27 alternately mesh with the swing gears 29 at the corresponding positions. A torsion spring 30 is installed at the bottom of one swing shaft 28, and the other end of the torsion spring 30 is fixedly connected to the flipping frame 3.

[0021] The center angle corresponding to the effective meshing section on the transmission missing gear 27 is 30°. The effective meshing sections on the two transmission missing gears 27 are staggered by 180°. The two driven bevel gears are respectively located on both sides of the transmission bevel gear. The hollow rotating shaft 24 drives the transmission bevel gear to rotate. Since the two driven bevel gears are located on both sides of the transmission bevel gear and mesh with each other, they then drive the forward rotating shaft 25 and the reverse rotating shaft 26 to rotate in opposite directions. The forward rotating shaft 25 and the reverse rotating shaft 26 respectively drive the transmission missing gear 27 to rotate. Since the effective meshing section of the transmission missing gear 27 is misaligned by 180°, when the transmission missing gear 27 on the forward rotating shaft 25 meshes with the corresponding swing gear 29, it drives the mixing shell 4 to swing to one side to 30°. At this time, the transmission missing gear 27 of the reverse rotating shaft 26 is in the non-meshing section. After the forward rotating shaft 25 disengages from the drive gear 27, the reverse rotating shaft 26 immediately engages with the drive gear 27, driving the mixing shell 4 to swing to the other side to 30°. The torsion spring 30 stores and releases elastic potential energy during the swing, assisting the mixing shell 4 to reset, and finally realizing the ±30° reciprocating swing of the mixing shell 4. The 360° rotation of the flipping frame 3 drives the material to achieve periodic overall replacement in the axial direction, breaking the trend of light and heavy components separating into layers. The ±30° oscillation of the mixing shell 4 forms the optimal turbulence intensity in the radial direction, which avoids local stagnation and prevents material agglomeration. The two work together to construct a dynamic three-dimensional mixing flow field, which improves the mixing uniformity and effectively eliminates mixing dead angles and segregation phenomena. It is especially suitable for the mixing needs of materials with large density differences or viscous materials. On the other hand, this coordinated motion creates a low-shear mixing environment. The low-speed stable flipping of the flipping frame 3 avoids local shear hotspots, and the oscillation of the mixing shell 4 promotes mass transfer through gentle flow field disturbance, rather than blade impact. The tilting frame 3 rotates at all angles and works in conjunction with the reciprocating swing of the mixing shell 4 to drive the material to flow completely along the inner wall of the shell. A rotary seat 6 is fixedly mounted on the central shaft 5. The rotary seat 6 is rotatably connected to the mixing shell 4. A sealing ring is provided at the rotatable connection between the rotary seat 6 and the mixing shell 4. The sealing ring is made of food-grade silicone. A rotating frame 7 is rotatably mounted on the central shaft 5, a forward rotating sleeve 8 is rotatably mounted on the rotating frame 7, and a reverse rotating sleeve 9 is rotatably mounted on the forward rotating sleeve 8. The rotating frame 7, the forward rotating sleeve 8, and the reverse rotating sleeve 9 are all driven to rotate by the central shaft 5. A differential shaft 32 and a synchronous shaft 33 are rotatably connected to the mixing shell 4. Differential bevel gears are installed on both the rotating frame 7 and the differential shaft 32. The two differential bevel gears mesh orthogonally. A second bevel gear is installed on both the forward rotating sleeve 8 and the differential shaft 32. The two second bevel gears mesh orthogonally. A synchronous bevel gear is installed on the synchronous shaft 33, and a third bevel gear is installed on both the forward rotating sleeve 8 and the reverse rotating sleeve 9. Both third bevel gears are connected to the synchronous bevel gear for transmission. The two third bevel gears are respectively set on both sides of the synchronous bevel gear. The axes of the synchronous shaft 33 and the differential shaft 32 are perpendicular to the axis of the central shaft 5. The swing mechanism also includes a drive shaft 31 rotatably connected to a swing shaft 28. A second synchronous belt is connected between the drive shaft 31 and the rotating shaft 25. A first bevel gear is installed on the central shaft 5 and the rotating frame 7. A drive bevel gear is installed on the drive shaft 31. Both first bevel gears are connected to the drive bevel gear, and the two first bevel gears are respectively located on both sides of the drive bevel gear. The rotating shaft 25 drives the drive shaft 31 to rotate via the second synchronous belt. The drive bevel gear on the drive shaft 31 drives the first bevel gear on the central shaft 5 and the rotating frame 7 to rotate, thereby driving the central shaft 5 and the rotating frame 7 to rotate. The rotating frame 7 drives the differential shaft 32 through the differential bevel gear, and the differential shaft 32 then drives the forward rotating sleeve 8 to rotate through the second bevel gear. The forward rotating sleeve 8 drives the synchronous shaft 33 through the third bevel gear, and the synchronous shaft 33 then drives the reverse rotating sleeve 9 to rotate in the opposite direction through the third bevel gear on the other side, ultimately realizing the differentiated rotation of the rotating frame 7, the forward rotating sleeve 8, and the reverse rotating sleeve 9. Multiple sets of bevel gears cooperate with synchronous shaft 33 and differential shaft 32 to realize the differentiated motion of multiple components driven by a single power source. The structure is compact and energy consumption is low, avoiding the synchronization problem caused by multiple motors 2. The reverse rotation of the reverse sleeve 9 and the forward rotation sleeve 8, and the independent rotation of the rotating frame 7, provide the basis for the speed change transmission of the subsequent transmission guide shaft 12, and create a complex motion trajectory for the raw materials. The sealing ring design between the rotary seat 6 and the mixing shell 4 prevents raw material leakage or the entry of external impurities, meets the sterility requirements of biopharmaceuticals, and ensures the purity of raw materials. Both the forward-rotating sleeve 8 and the reverse-rotating sleeve 9 are equipped with gear discs 10. Each gear disc 10 has a transmission engagement section 11 and an intermittent toothless section. The center angle corresponding to the transmission engagement section 11 is 120°, and the center angle corresponding to the intermittent toothless section is 240°. The transmission engagement sections 11 on the two gear discs 10 are offset by 180°. When the forward-rotating sleeve 8 and the reverse-rotating sleeve 9 rotate in opposite directions, they drive the gear disc 10 to rotate synchronously. Because the two toothed discs 10 are 180° misaligned in the transmission meshing section 11, when the meshing section of the forward rotating sleeve 8 toothed disc 10 meshes with the corresponding reversing gear 13, the reverse rotating sleeve 9 toothed disc 10 is in the non-meshing section. After the forward-rotating sleeve 8 toothed disc 10 disengages, the reversing sleeve 9 toothed disc 10 immediately engages with another reversing gear 13, realizing the forward, intermittent, reverse, and intermittent periodic motion of the reversing gear 13; The ratio of 120° engagement section to 240° toothless section is designed to control engagement and buffering time, and to prevent the reversing gear 13 from being continuously overloaded. The 180° offset design enables the reversing gear 13 to drive alternately, breaking the agglomeration of raw materials. It is especially suitable for powder and colloidal raw materials in biopharmaceuticals, solving the problem of insufficient mixing in traditional unidirectional transmission. The intermittent toothless section provides a buffer for the transmission components, reduces gear meshing impact, extends equipment service life, and improves transmission stability.

[0022] Four arrayed transmission guide shafts 12 are rotatably connected to the rotating frame 7. Each transmission guide shaft 12 is equipped with two reversing gears 13 and one speed-changing gear 14. The two reversing gears 13 mesh with the transmission meshing sections 11 on the two gear discs 10 respectively. The four speed-changing gears 14 have different radii and numbers of teeth. Four arrayed stirring shafts 15 are rotatably connected to the rotary seat 6. Each stirring shaft 15 has four external gears 16 installed at its tail. The four external gears 16 mesh with the four speed-changing gears 14 respectively. The transmission ratios of the four speed-changing gears 14 to the corresponding external gears 16 are different. Among them, stirring rods 17 are arrayed on two stirring shafts 15, and spiral stirring blades 18 are installed on the other two stirring shafts 15. Liquid permeable mesh holes 35 are evenly distributed on the spiral stirring blades 18, and the spiral directions of the two spiral stirring blades 18 are opposite. Liquid-turning arc plates 36 are arrayed on the surface of the rotary seat 6 and four filtrate sieve plates 19 are fixedly installed. The spiral blade 18 is made of food-grade stainless steel 304; Four stirring shafts 15 and four filtrate sieve plates 19 are alternately arranged on the rotary seat 6; The curved surface of the liquid-turning arc plate 36 can guide the fluid to form a composite circulation flow in the axial and radial directions, which can lift and push the dense solid raw materials or easily settled high-concentration slurries from the bottom of the tank to the middle and upper layers. At the same time, the streamlined edge design forms a micro vortex to flush the sediment on the bottom of the tank, which can reduce the settling rate for heavy auxiliary materials and light pharmaceutical systems. The transmission guide shaft 12 obtains periodic power through the alternating meshing of the reversing gear 13, which drives the speed change gear 14 to rotate. Because the four speed-changing gears 14 have different transmission ratios with the external gear 16, they drive the four agitator shafts 15 to rotate at different speeds. Two stirring shafts 15 with stirring rods 17 shear and disperse the raw material at high speed, and two stirring shafts 15 with reverse spiral stirring blades 18 convey the raw material to form an upward and downward convection. At the same time, the rotary seat 6 drives the stirring shaft 15 and the filtrate sieve plate 19 to rotate, and the filtrate sieve plate 19 filters impurities synchronously. The stirring shaft 15 and the filtrate sieve plate 19 are alternately arranged to avoid raw material residue. The device achieves a periodic compound motion of forward rotation, intermittent rotation, reverse rotation, and intermittent rotation through four stirring shafts 15 driven by the alternating meshing of the reversing gear 13 and the toothed disc 10. The rotation speed of each stirring shaft 15 changes alternately during the revolution, forming a dynamic stirring mode with multiple speeds, multiple directions, and intermittent operation. The periodic forward and reverse rotation and speed variation of the agitator 15 can efficiently break up agglomerates, promote three-dimensional convection, and prevent stratification caused by differences in density or viscosity. It can also achieve gentle shearing through intermittent buffering and speed regulation, effectively protecting the activity of heat-sensitive and shear-sensitive raw materials such as proteins and enzymes.

[0023] The two spiral blades 18 and the two sets of stirring rods 17 continuously change their relative positions and areas of action during the stirring process. The reverse spiral blades 18 form strong bidirectional convection in the differential rotation, while the stirring rods 17 perform local shearing and dispersing in the high-speed stage and switch to gentle diffusion in the low-speed stage. The two work together in alternation and time, which not only realizes the full-domain circulation and replacement of materials in the axial and radial directions, but also avoids the following phenomenon commonly found in traditional agitators, thereby significantly improving the mixing uniformity and dispersion efficiency of high-viscosity, multiphase system raw materials.

[0024] The specific steps for using this invention are as follows: Before operation, the mixing shell 4 is fed in a horizontal position. Then, the motor 2 is started. After the motor 2 is started, it drives the tilting frame 3 to rotate continuously in 360° through two sets of first synchronous belts, while driving the hollow rotating shaft 24 to rotate. The hollow rotating shaft 24 drives the forward rotating shaft 25 and the reverse rotating shaft 26 to rotate in opposite directions through the transmission bevel gear. The two 180° misaligned transmission gears 27 on it alternately mesh with the swing gear 29 on the mixing shell 4. Combined with the reset action of the torsion spring 30, the mixing shell 4 is driven to swing back and forth on the tilting frame 3 by ±30°, thereby constructing a three-dimensional dynamic mixing flow field with axial tilting and radial swinging in coordination. During this process, the positive rotation shaft 25 drives the drive shaft 31 to rotate via the second synchronous belt, and the drive bevel gear on the drive shaft 31 simultaneously drives the central shaft 5 and the rotating frame 7 to rotate. The central shaft 5 drives the rotating seat 6, which is fixed on it, to rotate as a whole, while the rotating frame 7 drives the forward rotating sleeve 8 to rotate through the differential bevel gear, the differential shaft 32 and the second bevel gear. The forward rotating sleeve 8 then drives the reverse rotating sleeve 9 to rotate in the opposite direction through the third bevel gear and the synchronous shaft 33, thereby realizing the differentiated rotation of the rotating frame 7, the forward rotating sleeve 8 and the reverse rotating sleeve 9. The two 180° misaligned gear discs 10 on the forward rotating sleeve 8 and the reverse rotating sleeve 9 rotate accordingly and alternately mesh with the reversing gears 13 of the four transmission guide shafts 12 on the rotating frame 7, so that each transmission guide shaft 12 and its speed change gear 14 periodically perform a compound motion of forward rotation, intermittent rotation, reverse rotation, and intermittent rotation. Four speed-changing gears 14 of different sizes and numbers of teeth respectively mesh with the corresponding external gears 16 at the tail of the four stirring shafts 15 on the rotary seat 6, driving the four stirring shafts 15 to rotate differentially at different speeds; Two of the agitator shafts 15 with agitator rods 17 perform high-speed shearing, while the other two agitator shafts 15 with reverse spiral blades 18 generate bidirectional convection. At the same time, the rotary seat 6 drives the four stirring shafts 15 and the four filtrate sieve plates 19 fixed on the surface to revolve together, so as to realize the simultaneous stirring and filtration. The temperature, tumbling and oscillation parameters of the entire mixing process can be preset and automatically controlled by the central control unit 20, and finally discharged through the material valve 22.

[0025] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A raw material mixing device for biopharmaceuticals, comprising a frame (1) on which a motor (2) is mounted, characterized in that, The frame (1) is provided with a tilting frame (3) driven by a motor (2). The tilting frame (3) is equipped with a swinging mechanism driven by a motor (2). The swinging mechanism is connected to a mixing shell (4) that swings ±30° on the tilting frame (3) and a rotating central shaft (5). A rotary seat (6) is fixed on the central shaft (5). The rotary seat (6) is rotatably connected to the mixing shell (4). A rotating frame (7) is rotatably mounted on the central shaft (5). A forward rotating sleeve (8) is rotatably mounted on the rotating frame (7). A reverse rotating sleeve (9) is rotatably mounted on the forward rotating sleeve (8). The rotating frame (7), the forward rotating sleeve (8), and the reverse rotating sleeve (9) are all driven to rotate by the central shaft (5). A gear plate (10) is mounted on both the forward rotating sleeve (8) and the reverse rotating sleeve (9). Each of the two gear plates (10) has a transmission meshing section (11) and an intermittent toothless section. Four arrayed transmissions are rotatably connected to the rotating frame (7). The guide shaft (12) has two reversing gears (13) and one speed change gear (14) installed on each transmission guide shaft (12). The two reversing gears (13) mesh with the transmission meshing sections (11) on the two gear discs (10) respectively. The rotary seat (6) is rotatably connected to four arrayed stirring shafts (15). Each stirring shaft (15) has four external gears (16) installed at its tail. The four external gears (16) mesh with the four speed change gears (14) respectively. The transmission ratios of the four speed change gears (14) to the corresponding external gears (16) are different. Among them, two stirring shafts (15) are equipped with stirring rods (17) in an array, and the other two stirring shafts (15) are equipped with spiral stirring blades (18). The spiral directions of the two spiral stirring blades (18) are opposite. The surface of the rotary seat (6) is equipped with an array of liquid-turning arc plates (36) and four filtrate sieve plates (19) are fixedly installed.

2. The biopharmaceutical raw material mixing device according to claim 1, characterized in that, A central control unit (20) is installed on the frame (1), and an electric heating plate (21) is integrated on the mixing shell (4). The top and bottom of the mixing shell (4) are connected to a material valve (22). The center angle corresponding to the transmission meshing section (11) is 120°, and the center angle corresponding to the intermittent toothless section is 240°. The transmission meshing sections (11) on the two toothed discs (10) are staggered by 180°.

3. The biopharmaceutical raw material mixing device according to claim 1, characterized in that, The flipping frame (3) is equipped with two symmetrically arranged flipping shafts (23). A hollow rotating shaft (24) is rotatably sleeved on one of the flipping shafts (23). The other flipping shaft (23) and the hollow rotating shaft (24) are rotatably connected to the frame (1) through bearings. Two first synchronous belts are driven on the output shaft of the motor (2). The two first synchronous belts are driven to the hollow rotating shaft (24) and the flipping shaft (23) respectively.

4. The biopharmaceutical raw material mixing device according to claim 3, characterized in that, The swing mechanism includes a forward rotating shaft (25) and a reverse rotating shaft (26) rotatably connected to the tilting frame (3). Both the forward rotating shaft (25) and the reverse rotating shaft (26) are equipped with driven bevel gears. The hollow rotating shaft (24) is equipped with a transmission bevel gear. Both driven bevel gears are connected to the transmission bevel gears. Both the forward rotating shaft (25) and the reverse rotating shaft (26) are equipped with transmission missing gears (27). Two swing shafts (28) are fixedly installed on the mixing shell (4). Both swing shafts (28) are equipped with swing gears (29). The positions of the two transmission missing gears (27) correspond to the positions of the two swing gears (29), and the two transmission missing gears (27) are alternately meshed with the swing gears (29) at the corresponding positions. A torsion spring (30) is installed at the bottom end of one swing shaft (28), and the other end of the torsion spring (30) is fixedly connected to the tilting frame (3).

5. A biopharmaceutical raw material mixing device according to claim 4, characterized in that, The center angle corresponding to the effective meshing section on the transmission missing gear (27) is 30°, and the effective meshing sections on the two transmission missing gears (27) are staggered by 180°. The two driven bevel gears are respectively located on both sides of the transmission bevel gear.

6. A biopharmaceutical raw material mixing device according to claim 5, characterized in that, The swing mechanism also includes a drive shaft (31) rotatably connected to a swing shaft (28). The drive shaft (31) is connected to the rotating shaft (25) by a second synchronous belt. The central shaft (5) and the rotating frame (7) are both equipped with first bevel gears. The drive shaft (31) is equipped with a drive bevel gear. Both first bevel gears are connected to the drive bevel gear, and the two first bevel gears are respectively located on both sides of the drive bevel gear.

7. A biopharmaceutical raw material mixing device according to claim 6, characterized in that, The mixing shell (4) is rotatably connected to a differential shaft (32) and a synchronous shaft (33). Differential bevel gears are installed on both the rotating frame (7) and the differential shaft (32). The two differential bevel gears mesh orthogonally. A second bevel gear is installed on both the forward rotating sleeve (8) and the differential shaft (32). The two second bevel gears mesh orthogonally. A synchronous bevel gear is installed on the synchronous shaft (33). A third bevel gear is installed on both the forward rotating sleeve (8) and the reverse rotating sleeve (9). The two third bevel gears are connected to the synchronous bevel gears for transmission.

8. A biopharmaceutical raw material mixing device according to claim 7, characterized in that, The two third bevel gears are respectively disposed on both sides of the synchronous bevel gear, and the axes of the synchronous shaft (33) and the differential shaft (32) are perpendicular to the axis of the central shaft (5).

9. A biopharmaceutical raw material mixing device according to claim 4, characterized in that, The tilting frame (3) is equipped with a counterweight (34), the axis of the swing shaft (28) is perpendicular to the axis of the tilting shaft (23), and the spiral stirring blade (18) is evenly distributed with liquid permeable mesh holes (35).

10. A biopharmaceutical raw material mixing device according to claim 1, characterized in that, The four stirring shafts (15) and the four filtrate sieves (19) are arranged alternately on the rotary seat (6), and a sealing ring is provided at the rotational connection between the rotary seat (6) and the mixing shell (4).

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