Screw racking machine with CIPSIP function

Abstract

The invention belongs to the technical field of sub-packaging, and discloses a screw sub-packaging machine with a CIPSIP function, the screw sub-packaging machine comprises a supporting mechanism, a buffer tank mechanism, a powder feeding mechanism and a sub-packaging mechanism, the front end and the rear end of the powder feeding mechanism are respectively communicated with the buffer tank mechanism and the sub-packaging mechanism to form a powder feeding passage; wherein power shafts of driving components in the buffer tank mechanism, the powder feeding mechanism and the split charging mechanism are all provided with special-shaped sealing rings which can be isolated from a powder feeding channel in a sealed mode, and a tank opening in the top of the buffer tank mechanism and a discharging opening in the bottom of the split charging mechanism are connected with a CIPSIP station through quick couplings respectively. According to the method, only the pipelines need to be connected, the operation is automatically carried out according to a set process, and the CIPSIP operation is simple; all operations included in offline sterilization can be reduced, the time occupied by production is prolonged, and the operation time of cleaning and sterilization is greatly saved.

Description

Technical Field

[0001] The invention belongs to the technical field of packaging, and relates to a screw packaging machine, in particular to a screw packaging machine with a CIPSIP function. Background Art

[0002] As a traditional filling equipment, the screw filling machine has been used to this day due to its irreplaceable advantages (large filling range, low cost, simple structure). The principle of screw filling is to use the intermittent rotation of the screw to quantitatively fill the drug powder into the vial according to the metering requirements by controlling the speed of the screw. Its working process is roughly as follows: sterile powder is loaded into the hopper, the screw in the filling head rotates, and the screw transfers the powder drug inside along the axial direction to the outlet of the filling mechanism, and then falls into the vial under the filling head.

[0003] After the screw filling machine completes a day's work, the filling screw, powder cover, funnel and other parts that are in direct or indirect contact with the powder need to be cleaned and sterilized for the next day's production. Due to current technical deficiencies, this process can only be achieved by manual operation, which is often referred to as offline sterilization and aseptic transfer. Offline sterilization requires manual disassembly of parts for cleaning, and then placing them in a sterilization cabinet for high-temperature sterilization for a period of time. After sterilization, they are aseptically transferred to the equipment and then manually aseptically installed. This offline sterilization process is time-consuming, labor-intensive, and has high risks. Summary of the invention

[0004] The present invention provides a screw filling machine with CIPSIP function to solve the technical problem that traditional filling machines need to be sterilized offline. The novel filling machine realizes online cleaning and online sterilization of parts in contact with medicine powder through an ingenious structure.

[0005] To achieve the above object, the present invention adopts the following technical solutions:

[0006] A screw filling machine with CIPSIP function comprises a supporting mechanism, a buffer tank mechanism, a powder feeding mechanism and a filling mechanism, wherein the front and rear ends of the powder feeding mechanism are respectively connected to the buffer tank mechanism and the filling mechanism to form a powder feeding passage, wherein:

[0007] A special-shaped sealing ring that can be sealed and isolated from the powder feeding passage is installed on the power shaft of each driving component in the buffer tank mechanism, powder feeding mechanism and sub-packaging mechanism, and the top tank port of the buffer tank mechanism and the bottom discharge port of the sub-packaging mechanism are respectively connected to the CIPSIP station through quick-release connectors.

[0008] Preferably, the support mechanism comprises a support shaft seat, a support large plate and a support upper plate, wherein:

[0009] The support shaft seat is a vertically arranged columnar structure, and its upper end is rotatably connected to the middle part of the support large plate through a bearing;

[0010] The supporting plate is a Z-shaped structure, with the buffer tank mechanism and the powder feeding mechanism being obliquely installed at the lower end thereof, and the driving component of the dispensing mechanism being installed at the higher end thereof;

[0011] The supporting upper plate cover is arranged at a higher end of the supporting large plate, and the motor cover of the sub-assembling mechanism is installed at the end thereof.

[0012] Preferably, the buffer tank mechanism comprises a buffer material barrel, a buffer stirring paddle and a buffer driving component, wherein:

[0013] The lower end of the buffer barrel is detachably mounted on the chuck seat of the powder feeding mechanism by using a first clamp, and the buffer stirring paddle is vertically arranged inside the buffer barrel;

[0014] The power shaft of the buffer driving component is sealed and connected to the inner hole of the chuck seat by a first special-shaped sealing ring, and is detachably connected to the lower end of the buffer stirring paddle.

[0015] Preferably, a buffer tank insulation interlayer is provided on the outside of the buffer material barrel, a first liquid discharge joint is provided at the lower end of the buffer tank insulation interlayer, and a first liquid inlet joint is provided at the upper end;

[0016] A powder stirring flange is coaxially sleeved outside the power shaft of the buffer driving component, and the upper and lower ends of the powder stirring flange are detachably connected to the top of the buffer driving component and the bottom of the chuck seat respectively.

[0017] Preferably, the powder feeding mechanism comprises a chuck seat, a powder feeding drive component, a powder feeding flange, a powder feeding pipe and a powder feeding screw, wherein:

[0018] A first mounting hole is vertically opened in the middle of the chuck seat, a second mounting hole is horizontally opened at one side end and arranged obliquely downward toward the sub-packaging mechanism, and a buffer bottom groove is arranged on the top to connect the first mounting hole and the second mounting hole;

[0019] The powder delivery driving component is fixedly mounted on one end of the chuck seat through the powder delivery flange, and a second special-shaped sealing ring is arranged between the powder delivery driving component and the powder delivery flange;

[0020] The powder delivery flange is coaxially sleeved on the outside of the power shaft of the powder delivery drive component, and a first sealing ring is arranged between the powder delivery flange and the chuck seat;

[0021] The powder delivery pipe is arranged obliquely, a second sealing ring is arranged between one end thereof and the outlet of the second mounting hole, a third sealing ring is arranged between the other end thereof and the dispensing mechanism, and a powder delivery heat-insulating interlayer is arranged on the outer peripheral body of the powder delivery pipe;

[0022] The powder feeding screw is arranged in the coaxially arranged second mounting hole and powder feeding tube, the front end shaft of which is connected to the power shaft of the powder feeding driving component, and the rear end extends to the feed port at the upper part of the dispensing mechanism.

[0023] More preferably, the second mounting hole in the chuck seat, the powder feeding pipe and the powder feeding screw are coaxially arranged to be inclined downward, and the inclination angle relative to the horizontal plane is 3-10°.

[0024] More preferably, the bottom of the chuck seat is a plane and the top is an inclined surface, the dispensing mechanism is vertically mounted on the top, and the inclination angle of the top inclined surface is 3-10°.

[0025] Preferably, the sub-packaging mechanism comprises an upper barrel, a middle barrel, a lower barrel, a screw sleeve, a sub-packaging screw and a sub-packaging drive component which are coaxially arranged, wherein:

[0026] The upper barrel, the middle barrel and the lower barrel are detachably connected in sequence from top to bottom, the top end of the upper barrel is fixedly mounted on the bottom of the higher end of the supporting plate on the supporting mechanism, and the side wall thereof is provided with an opening connected to the powder feeding pipe;

[0027] The upper end of the screw sleeve is connected to the power shaft of the sub-packaging drive component installed on the supporting large plate, and the lower end is fixedly connected to the upper end of the sub-packaging screw located in the discharge barrel;

[0028] The subpackaging driving component is downwardly mounted on the bearing seat through a powder delivery flange sleeved on the outside of its power shaft, and the lower end of the bearing seat is fixedly mounted in the through hole at the end of the supporting large plate through a seat sleeve.

[0029] Preferably, the subpackaging mechanism further comprises a subpackaging stirring paddle, a subpackaging stirring shaft, a subpackaging sleeve, a secondary stirring gear, a main stirring gear and a stirring drive component, wherein:

[0030] There is at least one packing stirring paddle, which is located outside the screw sleeve and / or the packing screw and is fixedly connected to the lower end of the packing stirring shaft, and at least one packing stirring paddle extends downward to one side of the packing screw;

[0031] The inner cavity of the sub-packaging stirring shaft is coaxially provided with the screw sleeve, and the inner wall of the lower end thereof is sealedly connected with the screw sleeve via a needle bearing and a third special-shaped sealing ring;

[0032] The lower end of the sub-packaging sleeve is connected to the upper end of the sub-packaging stirring shaft, and the outer wall of the upper end is sealed to the inner wall of the upper end of the loading barrel through a fourth special-shaped sealing ring, and the top end is connected to the auxiliary stirring gear;

[0033] The auxiliary stirring gear is rotatably mounted on the lower end of the bearing seat through a bearing, and is connected to the power shaft of the stirring driving component through the main stirring gear arranged on one side.

[0034] Preferably, the dispensing mechanism further comprises a pressure-balancing hose and a diaphragm valve, wherein:

[0035] The lower end of the pressure balancing hose is connected to the inner cavity of the lower end of the lower barrel through a first quick-release connector, and the upper end is connected to the inner cavity of the upper barrel through a second quick-release connector, and the diaphragm valve is installed on it.

[0036] The present invention adopts the above technical solution, which has the following technical effects compared with the prior art:

[0037] The screw filling machine with CIPSIP function of the present invention only needs to connect the pipelines and automatically proceed according to the set process. The CIPSIP operation is simple; it can reduce all operations included in the off-line sterilization, increase the time occupied by production, and greatly save the operation time of cleaning and sterilization; and the improved screw filling machine can better implement the aseptic operation process and reduce the risks brought by offline sterilization. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 The three-dimensional structure of a screw filling machine with CIPSIP function of the present invention is shown in FIG. Figure 1 ;

[0039] Figure 2 The three-dimensional structure of a screw filling machine with CIPSIP function of the present invention is shown in FIG. Figure 2 ;

[0040] Figure 3 It is a side structural schematic diagram of a screw filling machine with CIPSIP function of the present invention;

[0041] Figure 4 This is a schematic diagram of the main structure of a screw packaging machine with CIPSIP function according to the present invention;

[0042] Figure 5 It is a schematic diagram of a transverse cross-sectional structure of a screw filling machine with CIPSIP function of the present invention;

[0043] Figure 6 It is a partial enlarged structural schematic diagram of part A of a screw filling machine with CIPSIP function of the present invention;

[0044] Figure 7 It is a partial enlarged structural schematic diagram of part B of a screw filling machine with CIPSIP function of the present invention;

[0045] Figure 8It is a partial enlarged structural schematic diagram of the C part of a screw filling machine with CIPSIP function of the present invention;

[0046] Fig. 9 It is a schematic diagram of the longitudinal cross-sectional structure of the AA position in a screw filling machine with CIPSIP function of the present invention;

[0047] Fig.10 It is a partial enlarged structural schematic diagram of the D part of a screw filling machine with CIPSIP function of the present invention;

[0048] Fig.11 It is a partial side cross-sectional structural schematic diagram of a screw packing with CIPSIP function of the present invention;

[0049] Fig.12 The present invention is a schematic diagram of the process flow of a screw packaging method with CIPSIP function. DETAILED DESCRIPTION

[0050] The present invention is described in detail and specifically by specific examples below to provide a better understanding of the present invention, but the following examples do not limit the scope of the present invention.

[0051] In some embodiments, Figure 1 , Figure 2 , Figure 3 and Figure 4 As shown, a screw filling machine with CIPSIP function is provided, which mainly includes a support mechanism 100 and a buffer tank mechanism 200 installed at the left and right ends of the support mechanism 100, a powder delivery mechanism 300 and a filling mechanism 400, and a matching SIPCIP station 500, and the front and rear ends of the powder delivery mechanism 300 are respectively connected to the buffer tank mechanism 200 and the filling mechanism 400 to form a powder delivery passage. The SIPCIP station 500 is mainly used to realize CIP and SIP functions after being connected to the equipment through a pipeline.

[0052] In order to solve the technical problem that traditional filling machines need to be sterilized offline, the improved screw filling machine realizes the online cleaning and sterilization functions of the parts in contact with the powder through a clever structure. The specific solution is that a special-shaped sealing ring that can be sealed and isolated from the powder feeding passage is installed on the power shaft of each driving component in the buffer tank mechanism 200, the powder feeding mechanism 300 and the filling mechanism 400, and the special-shaped sealing ring is made of modified PTFE.

[0053] During the CIPSIP operation, the top tank port of the buffer tank mechanism 200 and the bottom discharge port of the subpackaging mechanism 400 are manually connected to the CIPSIP station through quick-release connectors, and then cleaned and sterilized. The entire process is strictly carried out in accordance with GMP. After completion, the connecting pipes are removed. The process is carried out under Class A laminar flow protection. The setting of the special-shaped sealing ring can effectively separate the raw material powder from various drive interiors, thereby ensuring the safety and sterility of drug production; at the same time, it can also effectively isolate the cleaning medium and steam from the interior of the drive.

[0054] In some of the embodiments, Figure 1 , Figure 2 , Figure 3 , Figure 4 and Figure 5 As shown, the support mechanism 100 is used as the installation platform of the novel screw filling machine, which is mainly assembled from a support shaft seat 101, a support plate 102 and a support upper plate 103. As required, the support shaft seat 101, the support plate 102 and the support upper plate 103 are made of stainless steel or aluminum alloy.

[0055] Specifically, the support shaft seat 101 is a vertically arranged columnar structure, the upper end of which is rotatably connected to the middle of the support plate 102 through a bearing, and the lower end is detachably mounted on the equipment platform by bolts. The support plate 102 can be flexibly controlled to rotate on the support shaft seat 101 through the bearing, thereby realizing the adjustment of the sub-packaging mechanism 400 in different angles and directions, thereby meeting the purpose of multi-station sub-packaging.

[0056] In order to facilitate the installation of the buffer tank mechanism 200, the powder feeding mechanism 300 and the sub-packaging mechanism 400, a large support plate 102 with an overall Z-shaped structure is adopted. The buffer tank mechanism 200 and the powder feeding mechanism 300 are obliquely installed on the lower end thereof, and the driving components of the sub-packaging mechanism 400 are installed on the higher end. The powder in the buffer tank mechanism 200 is transported from a high position to the sub-packaging mechanism 400 at a low position.

[0057] In addition, the support upper plate 103 is detachably covered with a plurality of screws on the higher end of the support large plate 102 to form a power accommodating space between the support large plate 102 and the support upper plate 103, and the main power components of the subassembly mechanism 400 are installed in the power accommodating space.

[0058] In order to avoid the driving components on the top of the dispensing mechanism 400, a mounting hole is opened at the outer end of the supporting upper plate 103, and the motor cover 422 of the dispensing mechanism 400 is installed in the mounting hole to achieve the installation and fixation of the motor cover 422.

[0059] In some of the embodiments, Figure 5 , Fig. 9 and Fig.10 As shown, the buffer tank mechanism 200 mainly includes a buffer barrel 201, a buffer stirring paddle 202 and a buffer driving component 203. The buffer barrel 201 is a hollow cylindrical structure with upper and lower openings, and quick connectors are provided at the upper and lower ends thereof, which are coaxially arranged with the buffer stirring paddle 202 therein.

[0060] The lower end opening of the buffer barrel 201 is in a narrowed shape, and it is detachably mounted on the chuck seat 301 of the powder feeding mechanism 300 by using a first clamp 206, and a sealing ring is provided at the connection between the two, and the buffer stirring paddle 202 vertically arranged in its inner cavity is connected to the power shaft of the buffer driving component 203 below. The buffer driving component 203 adopts a servo motor, and by starting the buffer driving component 203, the buffer stirring paddle 202 can be synchronously driven to rotate, thereby achieving the purpose of stirring and feeding the powder in the buffer barrel 201.

[0061] In order to effectively separate the raw material powder in the buffer barrel 201 from the buffer drive component 203 below, the first special-shaped sealing ring 205 is respectively used at the upper and lower ends of the power shaft of the buffer drive component 203 to seal and connect with the inner hole of the chuck seat 301 and the motor housing to prevent the powder from entering the buffer drive component 203 from the buffer barrel 201, thereby ensuring the safety and sterility of drug production. At the same time, when performing the CIPSIP function, the first special-shaped sealing ring 205 can also effectively isolate the cleaning medium and steam from the inside of the drive.

[0062] As a preferred embodiment, Figure 5 and Fig. 9 As shown, in order to ensure the stability of the high-temperature steam temperature during CIPSIP operation, a buffer tank insulation interlayer 207 is arranged on the outside of the buffer barrel 201, and a first liquid discharge joint 208 is arranged at the lower end of the buffer tank insulation interlayer 207, and a first liquid inlet joint 209 is arranged at the upper end. High-temperature circulating water is passed through the buffer tank insulation interlayer 207 through the first liquid discharge joint 208 and the first liquid inlet joint 209 to prevent heat loss of high-temperature steam.

[0063] In order to achieve the installation and fixation of the buffer driving component 203, a powder stirring flange 204 is coaxially sleeved on the outside of the power shaft of the above-mentioned buffer driving component 203, and the upper and lower ends of the powder stirring flange 204 are detachably connected to the top of the buffer driving component 203 and the bottom of the chuck seat 301 respectively.

[0064] When the buffer tank mechanism 200 is in use, the bagged raw material powder is poured into the buffer material barrel 201 under the protection of Class A laminar flow until the powder reaches the appropriate powder level. The buffer tank mechanism 200 is equipped with a minimum powder level detection sensor 210. When the powder level reaches the minimum position, the control system will prompt the feeding operation. The buffer stirring paddle 202 in the buffer material barrel 201 rotates slowly to assist in powder feeding. The stirring speed can be adjusted according to the characteristics of the powder.

[0065] In some of the embodiments, Figure 5 , Figure 6 , Fig. 9 and Fig.10 As shown, the powder feeding mechanism 300 mainly includes a chuck seat 301, a powder feeding drive component 302, a powder feeding flange 303, a powder feeding tube 304 and a powder feeding screw 305. The powder feeding drive component 302 slowly pushes the raw material powder forward into the powder cup of the filling mechanism 400 through the powder feeding screw 305. Its purpose is to transport the raw material medicine in the buffer tank mechanism 200 to the filling mechanism 400 for filling.

[0066] Specifically, in order to facilitate the installation of the buffer tank mechanism 200 and the powder feeding mechanism 300, a chuck seat 301 with a specific structural design is adopted. A first mounting hole 3011 is vertically opened in the middle of the chuck seat 301 for mounting the power shaft on the buffer tank mechanism 200. A second mounting hole 3032 is horizontally opened on the chuck seat 301 on one side of the first mounting hole 3011 and arranged obliquely downward toward the dispensing mechanism 400 for mounting the power shaft of the powder feeding drive component 302, namely, the powder feeding screw 305.

[0067] At the same time, in order to facilitate the installation of the buffer barrel 201, a buffer bottom groove 3013 connecting the first mounting hole 3011 and the second mounting hole 3012 is provided on the top of the chuck seat 301, that is, the first mounting hole 3011 and the second mounting hole 3012 are located at the bottom of the buffer bottom groove 3013, which facilitates the installation of the buffer drive component 203 and the powder feeding screw 305.

[0068] A second special-shaped sealing ring 306 is provided between the powder delivery drive component 302 and the powder delivery flange 303. The second special-shaped sealing ring 306 is made of modified PTFE material and is used to separate the raw material powder in the buffer barrel 201 from the powder delivery drive component 302 on one side, so as to prevent the drug powder from entering the powder delivery drive component 302 from the buffer barrel 201, thereby ensuring the safety and sterility of drug production. At the same time, when performing the CIPSIP function, the second special-shaped sealing ring 306 can also effectively isolate the cleaning medium and steam from the inside of the powder delivery drive component 302, thereby ensuring the stable operation of the powder delivery drive component 302.

[0069] To facilitate quick installation and fixation of the powder delivery driving component 302, the powder delivery driving component 302 is fixedly installed on one end of the chuck seat 301 through the powder delivery flange 303, and the powder delivery flange 303 is coaxially sleeved on the outside of the power shaft of the powder delivery driving component 302, and a first sealing ring 307 is arranged between it and the chuck seat 301, and the first sealing ring 307 is made of modified PTFE material.

[0070] To improve the powder delivery efficiency, the powder delivery tube 304 and the powder delivery screw 305 arranged therein are arranged at an angle, a second sealing ring 308 is arranged between one end of the powder delivery tube 304 and the outlet of the second mounting hole 3012, and a third sealing ring 309 is arranged between the other end of the powder delivery tube 304 and the packaging mechanism 400.

[0071] At the same time, in order to ensure the stability of the high-temperature steam temperature during CIPSIP operation, a powder delivery insulation interlayer 310 is provided on the outer periphery of the powder delivery pipe 304; a second liquid discharge joint 311 is provided at the lower end of the powder delivery insulation interlayer 310, and a second liquid inlet joint 312 is provided at the other higher end thereof, and high-temperature circulating water is passed through the powder delivery insulation interlayer 310 through the second liquid discharge joint 311 and the second liquid inlet joint 312 to prevent the heat loss of the high-temperature steam.

[0072] Depend on Figure 5 and Figure 7 It can be seen that the powder delivery screw 305 is arranged in the coaxially arranged second mounting hole 3032 and powder delivery tube 304, and its front end is connected to the power shaft of the powder delivery drive component 302, and its rear end extends to the feed port at the upper part of the sub-packaging mechanism 400. The powder delivery drive component 302 can synchronously drive the powder delivery screw 305 as the power shaft to rotate, so as to transport the raw material powder in the buffer barrel 201 to the downstream sub-packaging mechanism 400 through the powder delivery tube 304, so as to realize the feeding of the raw material powder.

[0073] In addition, as some preferred embodiments, the second mounting hole 3012, the powder delivery tube 304 and the powder delivery screw 305 in the chuck seat 301 are coaxially arranged to be tilted downward, and the tilt angle relative to the horizontal plane is 3-10°, preferably 4°. Accordingly, the chuck seat 301 adopts an inclined block structure, the bottom of which is a plane and the top is an inclined surface, the dispensing mechanism 400 is vertically mounted on the top, and the tilt angle of the top inclined surface is 3-10°, preferably 4°.

[0074] In some of the embodiments, Figure 2 , Figure 5 , Figure 7 , Figure 8 and Fig.10As shown, the sub-packaging mechanism 400 mainly includes a coaxially arranged upper barrel 401, a middle barrel 402, a lower barrel 403, a screw sleeve 404, a sub-packaging screw 405 and a sub-packaging driving component 414. A powder level sensor 413 is installed on the barrel at the lower part of the sub-packaging mechanism 400. When it is detected that the powder level reaches the lowest level, the control system will rotate the powder feeding screw 305 to realize the function of automatic material replenishment.

[0075] The upper barrel 401, the middle barrel 402, and the lower barrel 403 are detachably connected to form a whole by clamps from top to bottom, and are all made of stainless steel or aluminum alloy. The top of the upper barrel 401 is fixedly mounted on the bottom of the higher end of the supporting plate 102 on the supporting mechanism 100, and its side wall is provided with a side opening connected to the powder delivery pipe 304.

[0076] In order to realize the transmission connection between the sub-packaging driving component 414 and the sub-packaging screw 405 below, a screw sleeve 404 is arranged between the two. The upper end of the screw sleeve 404 is connected to the power shaft of the sub-packaging driving component 414 installed on the supporting large plate 102, and the lower end thereof is fixedly connected to the upper end of the sub-packaging screw 405 located in the unloading barrel 403. When the sub-packaging driving component 414 is started, the sub-packaging screw 405 below can be synchronously driven to rotate through the screw sleeve 404, thereby realizing the purpose of unloading and sub-packaging.

[0077] In addition, to facilitate the installation and fixation of the sub-packaging drive component 414, the sub-packaging drive component 414 is downwardly installed on the bearing seat 416 through the powder delivery flange 415 sleeved on the outside of its power shaft, and the lower end of the bearing seat 416 is fixedly installed in the through hole at the end of the supporting plate 102 through the seat sleeve 417.

[0078] In some embodiments, to improve the packing efficiency, such as Figure 5 , Figure 7 and Figure 8 As shown, the packing mechanism 400 also includes a stirring and mixing mechanism consisting of a packing stirring paddle 406, a packing stirring shaft 407, a packing sleeve 410, a secondary stirring gear 419, a main stirring gear 420 and a stirring driving component 421. The stirring and mixing mechanism is used to stir the powder during the packing process to speed up the feeding speed.

[0079] There is at least one dispensing stirring paddle 406, which is located outside the screw sleeve 404 and / or the dispensing screw 405 and is fixedly connected to the lower end of the dispensing stirring shaft 407. The dispensing stirring paddle 406 is synchronously driven by the dispensing stirring shaft 407 to stir. Figure 5 and Figure 8 As shown, there are two dispensing stirring paddles 406, which are arranged facing inward and upward respectively.

[0080] As required, one of the packing stirring paddles 406 is extended downward to one side of the packing screw 405 to stir and mix the powder outside the packing screw 405, thereby accelerating the packing efficiency of the packing screw 405. Figure 5 and Figure 8 As shown, the downwardly arranged dispensing stirring paddle 406 adopts a specific structural design, wherein the upper end thereof is a vertically arranged Z-shaped structure, the lower end is provided with a semi-arc spiral paddle plate, and a plurality of spaced stirring bars are provided at the bottom of the paddle plate to increase the feeding rate.

[0081] In addition, the screw sleeve 404 is coaxially arranged in the inner cavity of the sub-packaging stirring shaft 407, and the inner wall of the lower end thereof is sealed and connected with the screw sleeve 404 through a needle bearing 408 and a third special-shaped sealing ring 409. The third special-shaped sealing ring 409 is made of modified PTFE material, and is used to separate the raw material powder in the sub-packaging mechanism 400 from the upper sub-packaging drive component 414, so as to prevent the drug powder from entering the sub-packaging drive component 414 from the sub-packaging drive component 414, thereby ensuring the safety and sterility of drug production. At the same time, when performing the CIPSIP function, the setting of the third special-shaped sealing ring 409 can also effectively isolate the cleaning medium and steam from the inside of the sub-packaging drive component 414, thereby ensuring the stable operation of the sub-packaging drive component 414.

[0082] As above, the lower end of the sub-packaging sleeve 410 is connected to the upper end of the sub-packaging stirring shaft 407, and the outer wall of the upper end is sealed and connected to the inner wall of the upper end of the loading barrel 401 through a fourth special-shaped sealing ring 418. The fourth special-shaped sealing ring 418 is made of modified PTFE material, and is used to separate the raw material powder in the sub-packaging mechanism 400 from the upper sub-packaging drive component 414 and the stirring drive component 421, so as to prevent the powder from entering the sub-packaging drive component 414 and the stirring drive component 421 from the sub-packaging drive component 414, thereby ensuring the safety and sterility of drug production. At the same time, when executing the CIPSIP function, the setting of the fourth special-shaped sealing ring 418 can also effectively isolate the cleaning medium and steam from the inside of the sub-packaging drive component 414, thereby ensuring the stable operation of the sub-packaging drive component 414 and the stirring drive component 421.

[0083] The transmission of the stirring and mixing mechanism is as follows: the auxiliary stirring gear 419 is rotatably mounted on the lower end of the bearing seat 416 through a bearing, and is connected to the power shaft of the stirring driving component 421 through the main stirring gear 420 provided on one side. When the stirring driving component 421 is started, the main stirring gear 420 and the auxiliary stirring gear 419 are meshed, and then the sub-packaging sleeve 410 and the sub-packaging stirring shaft 407 are synchronously driven to stir the sub-packaging stirring paddle 406.

[0084] In some embodiments, because the powder storage space of the lower cavity of the entire dispensing mechanism 400 is sealed, as the amount of powder decreases, the internal pressure will decrease, which will affect the smooth dispensing of the powder. Therefore, to solve this problem, the pressure difference between the cavity where the material is located and the external environment is balanced, such as Figure 1 , Figure 3 , Figure 4 and Fig.11 As shown, a pressure balancing hose 423 is provided on one side of the lower end cavity of the dispensing mechanism 400 as a bypass pipe.

[0085] Specifically, the lower end of the pressure balancing hose 423 is connected to the lower end inner cavity of the lower barrel 403 through the first quick-release connector 424, and the upper end is connected to the inner cavity of the upper barrel 401 through the second quick-release connector 425, and the diaphragm valve 426 is installed on it to balance the pressure inside and outside the cavity.

[0086] The screw filling machine has the functions of online cleaning and online sterilization. The power shafts of the buffer tank component drive, filling drive and powder delivery drive are equipped with modified PTFE sealing rings, which can effectively separate the raw material powder from the internal parts of various drives, thereby ensuring the safety and sterility of drug production. During CIPSIP operation, the sealing ring can also effectively isolate the cleaning medium and steam from the internal parts of the drive.

[0087] When executing the CIPSIP function, the pipeline of the CIPSIP station 500 is manually connected to the quick-release connectors at the buffer tank mechanism 200 and the sub-packaging mechanism 400, and then cleaned and sterilized. The entire process is strictly carried out in accordance with GMP. After completion, the connecting pipeline is removed. The process is carried out under Class A laminar flow protection.

[0088] Specifically, Fig.12 As shown in the figure, the process flow of online cleaning and online sterilization of the screw filling machine with CIPSIP function is as follows: after the production is completed, all parts in contact with the materials are not disassembled. The pipeline of the CIPSIP station 500 is manually connected to the quick-release connectors at the buffer tank mechanism 200 and the filling mechanism 400, and then the online cleaning and online sterilization procedures are carried out. The whole process is strictly carried out in accordance with GMP. After the completion, the connecting pipeline is removed. The process is carried out under Class A laminar flow protection.

[0089] The quick-release connector with spray cleaning function connected to the L1 pipeline is compatible with the L2 steam pipeline. The L6 pipeline is used to discharge waste liquid and waste gas generated during CIPSIP. When performing CIP, in order to make the cleaning more thorough, each drive motor runs synchronously to make the cleaning medium form turbulence, clean every corner of the interior, and avoid the generation of cleaning dead corners. During SIP, the L1 pipeline is closed and L2 is opened. At the same time, in order to ensure the stability of the high-temperature steam temperature of 121 degrees Celsius, high-temperature circulating water is passed through each insulation layer to prevent the heat loss of high-temperature steam.

[0090] The specific embodiments of the present invention are described in detail above, but they are only examples, and the present invention is not limited to the specific embodiments described above. For those skilled in the art, any equivalent modifications and substitutions made to the present invention are also within the scope of the present invention. Therefore, the equalization changes and modifications made without departing from the spirit and scope of the present invention should be included in the scope of the present invention.

Claims

1. A screw filling machine with CIPSIP function, characterized in that: It includes a supporting mechanism, a buffer tank mechanism, a powder feeding mechanism and a sub-packaging mechanism, wherein the front and rear ends of the powder feeding mechanism are respectively connected to the buffer tank mechanism and the sub-packaging mechanism to form a powder feeding passage, wherein: A special-shaped sealing ring that can be sealed and isolated from the powder feeding passage is installed on the power shaft of each driving component in the buffer tank mechanism, powder feeding mechanism and sub-packaging mechanism, and the top tank port of the buffer tank mechanism and the bottom discharge port of the sub-packaging mechanism are respectively connected to the CIPSIP station through quick-release connectors.

2. The screw filling machine with CIPSIP function according to claim 1, characterized in that: The support mechanism includes a support shaft seat, a support large plate and a support upper plate, wherein: The support shaft seat is a vertically arranged columnar structure, and its upper end is rotatably connected to the middle part of the support large plate through a bearing; The supporting plate is a Z-shaped structure, with the buffer tank mechanism and the powder feeding mechanism being obliquely installed at the lower end thereof, and the driving component of the dispensing mechanism being installed at the higher end thereof; The supporting upper plate cover is arranged at a higher end of the supporting large plate, and the motor cover of the sub-assembling mechanism is installed at the end thereof.

3. The screw filling machine with CIPSIP function according to claim 1, characterized in that: The buffer tank mechanism includes a buffer barrel, a buffer stirring paddle and a buffer driving component, wherein: The lower end of the buffer barrel is detachably mounted on the chuck seat of the powder feeding mechanism by using a first clamp, and the buffer stirring paddle is vertically arranged inside the buffer barrel; The power shaft of the buffer driving component is sealed and connected to the inner hole of the chuck seat by a first special-shaped sealing ring, and is detachably connected to the lower end of the buffer stirring paddle.

4. The screw filling machine with CIPSIP function according to claim 3, characterized in that: A buffer tank insulation interlayer is arranged outside the buffer material barrel, a first liquid discharge joint is arranged at the lower end of the buffer tank insulation interlayer, and a first liquid inlet joint is arranged at the upper end; A powder stirring flange is coaxially sleeved outside the power shaft of the buffer driving component, and the upper and lower ends of the powder stirring flange are detachably connected to the top of the buffer driving component and the bottom of the chuck seat respectively.

5. The screw filling machine with CIPSIP function according to claim 1, characterized in that: The powder feeding mechanism includes a chuck seat, a powder feeding drive component, a powder feeding flange, a powder feeding pipe and a powder feeding screw, wherein: A first mounting hole is vertically opened in the middle of the chuck seat, a second mounting hole is horizontally opened at one side end and arranged obliquely downward toward the sub-packaging mechanism, and a buffer bottom groove is arranged on the top to connect the first mounting hole and the second mounting hole; The powder delivery driving component is fixedly mounted on one end of the chuck seat through the powder delivery flange, and a second special-shaped sealing ring is arranged between the powder delivery driving component and the powder delivery flange; The powder delivery flange is coaxially sleeved on the outside of the power shaft of the powder delivery drive component, and a first sealing ring is arranged between the powder delivery flange and the chuck seat; The powder delivery pipe is arranged obliquely, a second sealing ring is arranged between one end thereof and the outlet of the second mounting hole, a third sealing ring is arranged between the other end thereof and the dispensing mechanism, and a powder delivery heat-insulating interlayer is arranged on the outer peripheral body of the powder delivery pipe; The powder feeding screw is arranged in the coaxially arranged second mounting hole and powder feeding tube, the front end shaft of which is connected to the power shaft of the powder feeding driving component, and the rear end extends to the feed port at the upper part of the dispensing mechanism.

6. The screw filling machine with CIPSIP function according to claim 5, characterized in that: The second mounting hole in the chuck seat, the powder feeding pipe and the powder feeding screw are coaxially arranged to be inclined downward, and the inclination angle relative to the horizontal plane is 3-10°.

7. The screw filling machine with CIPSIP function according to claim 5, characterized in that: The bottom of the chuck seat is a plane and the top is an inclined surface. The dispensing mechanism is vertically installed on the top, and the inclination angle of the top inclined surface is 3-10 degrees.

8. The screw filling machine with CIPSIP function according to claim 1, characterized in that: The sub-packaging mechanism comprises an upper barrel, a middle barrel, a lower barrel, a screw sleeve, a sub-packaging screw and a sub-packaging drive component which are coaxially arranged, wherein: The upper barrel, the middle barrel and the lower barrel are detachably connected in sequence from top to bottom, the top end of the upper barrel is fixedly mounted on the bottom of the higher end of the supporting plate on the supporting mechanism, and the side wall thereof is provided with an opening connected to the powder feeding pipe; The upper end of the screw sleeve is connected to the power shaft of the sub-packaging drive component installed on the supporting large plate, and the lower end is fixedly connected to the upper end of the sub-packaging screw located in the discharge barrel; The subpackaging driving component is downwardly mounted on the bearing seat through a powder delivery flange sleeved on the outside of its power shaft, and the lower end of the bearing seat is fixedly mounted in the through hole at the end of the supporting large plate through a seat sleeve.

9. The screw filling machine with CIPSIP function according to claim 8, characterized in that: The subpackaging mechanism also includes a subpackaging stirring paddle, a subpackaging stirring shaft, a subpackaging sleeve, a secondary stirring gear, a main stirring gear and a stirring driving component, wherein: There is at least one packing stirring paddle, which is located outside the screw sleeve and / or the packing screw and is fixedly connected to the lower end of the packing stirring shaft, and at least one packing stirring paddle extends downward to one side of the packing screw; The inner cavity of the sub-packaging stirring shaft is coaxially provided with the screw sleeve, and the inner wall of the lower end thereof is sealedly connected with the screw sleeve via a needle bearing and a third special-shaped sealing ring; The lower end of the sub-packaging sleeve is connected to the upper end of the sub-packaging stirring shaft, and the outer wall of the upper end is sealed to the inner wall of the upper end of the loading barrel through a fourth special-shaped sealing ring, and the top end is connected to the auxiliary stirring gear; The auxiliary stirring gear is rotatably mounted on the lower end of the bearing seat through a bearing, and is connected to the power shaft of the stirring driving component through the main stirring gear arranged on one side.

10. The screw filling machine with CIPSIP function according to claim 1, characterized in that: The dispensing mechanism further comprises a pressure-balancing hose and a diaphragm valve, wherein: The lower end of the pressure balancing hose is connected to the inner cavity of the lower end of the lower barrel through a first quick-release connector, and the upper end is connected to the inner cavity of the upper barrel through a second quick-release connector, and the diaphragm valve is installed on it.

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