A highly enclosed small-batch integrated pharmaceutical system

Abstract

The present application discloses a highly sealed small-batch integrated pharmaceutical system, comprising a main body shell, and also comprising: a material bin, which is arranged on the main body shell, and is provided with a spray gun for spraying slurry into the interior thereof, and granules are formed through boiling and heating, and a rotatable bottom screen is provided at the bottom of the material bin; a feeding assembly, comprising a powder barrel and a feeding pipe connected to the powder barrel, and the end of the feeding pipe facing away from the powder barrel is connected to the material bin; a filter chamber, which is sealed and connected to the material bin, and is provided with an exhaust fan connected thereto, and the exhaust fan is used to create a negative pressure in the material bin and boil the material in the material bin; a dry granulation assembly, which is sealed and connected to the bottom of the bottom pot, and comprises a granulation screen and a dry granulation knife rotatably arranged above the granulation screen; and a discharging assembly, which is used to receive the material discharged by the dry granulation assembly. The granulation system arranged in the above manner can improve the overall sealing performance, thereby achieving the purpose of closed production throughout the entire process.

Description

Technical Field

[0001] The present application relates to the technical field of pharmaceutical equipment, and in particular to a highly enclosed small-batch integrated pharmaceutical system. Background Art

[0002] With the development and progress of the pharmaceutical industry, the production demand for anti-tumor drugs, highly active drugs, health foods and other drugs that require closed production processes has increased. There are also more and more R&D experiments for these products, and small batches of drugs need to be produced for clinical trials and approval. At the same time, according to the production standards and document requirements of food and drugs such as GMP and FDA, it is necessary to avoid harm to the health of operators due to contact with such drugs. However, the existing R&D laboratory granulation equipment cannot complete the granulation in one step. Multiple transfer processes are required in the middle, which is prone to leakage risks. It is also impossible to achieve the closed feeding, closed production, closed sampling, closed cleaning and closed discharging required in the product production process. The production efficiency is low and it will also endanger the health of the staff.

[0003] Therefore, in view of the shortcomings of the existing technology, how to design a highly enclosed small-batch integrated granulation system with closed production throughout the entire process and without the need for multiple transfers is a technical problem that needs to be solved by those skilled in the art. Summary of the Invention

[0004] The purpose of this application is to provide a highly enclosed small-batch integrated granulation system, which can realize small-batch production with closed feeding, closed production, closed sampling, closed cleaning and closed discharge, without the need for multiple transfer processes and with high production efficiency.

[0005] To achieve the above objectives, the present application provides a highly sealed small-batch integrated pharmaceutical system, comprising a main body housing, and further comprising:

[0006] A material bin is provided on the main body housing, and is provided with a spray gun for spraying slurry into the bin. The slurry is used to mix with the material and form particles after boiling and heating. A rotatable bottom screen is provided at the bottom of the material bin, and the rotated bottom screen is used to discharge the particles;

[0007] A feeding assembly, comprising a powder barrel and a feeding pipe connected to the powder barrel, wherein the end of the feeding pipe facing away from the powder barrel is connected to the material bin;

[0008] a filter chamber located above the material bin and sealed and connected to the material bin; an exhaust fan connected to the filter chamber is provided on the filter chamber, the exhaust fan is used to create a negative pressure in the material bin and boil the material in the material bin; a filter disc is provided in the filter chamber, the filter disc is used to prevent the material in the material bin from entering the filter chamber;

[0009] A bottom pot is sealed and connected to the bottom of the material bin;

[0010] A dry granulation assembly is sealed and connected to the bottom of the pot, and comprises a granulation screen and a dry granulation knife rotatably arranged above the granulation screen;

[0011] The discharge assembly is used to receive the material discharged by the dry monolith assembly.

[0012] Preferably, a feed port is provided on the outer wall of the material bin, a manual valve is provided on the feed port, the manual valve is connected to the feed pipe, a feed valve A is provided at the end of the feed pipe away from the manual valve, a feed valve B is provided at the bottom of the powder barrel, the feed valve A is connected to the feed valve B, and the feed valve A and the feed valve B jointly control the connection and disconnection of the powder barrel and the feed pipe.

[0013] Preferably, the bottom screen is arranged along the radial cross-section of the material bin, and the material in the material bin is located above the bottom screen, a rotating shaft is provided on the edge of the bottom screen, the rotating shaft passes through the outer wall of the material bin, and is rotatably provided on the material bin, the end of the rotating shaft away from the bottom screen extends out of the material bin, and is provided with a handle, the handle is provided with a plurality of positioning holes passing through it, and the positioning holes are provided with positioning pins that are engaged with the outer wall of the material bin.

[0014] Preferably, an articulated support is provided on the outer wall of the main body shell, and an articulated shaft is provided on the outer wall of the material bin. The articulated shaft is inserted into the articulated support from top to bottom and is rotatably connected thereto. When the material bin rotates and does not interfere with the filter chamber, the material bin is lifted upward to cause the articulated shaft to detach from the articulated support.

[0015] Preferably, the material bin rotatably arranged by the hinged support and the hinged shaft is less than 5 mm from the filter chamber and less than 5 mm from the bottom pot.

[0016] Preferably, a protruding limiting ring is provided along the circumference of the upper edge of the bottom pot, and the limiting ring is used to limit the rotation of the material bin.

[0017] Preferably, the limiting ring is provided with an in-place sensor, and the in-place sensor is used to detect whether the material bin is rotated into place.

[0018] Preferably, a first sealing ring is provided between the filter disc and the filter chamber, a second sealing ring is provided between the filter chamber and the material bin, a third sealing ring is provided between the material bin and the bottom pot, and a fourth sealing ring is provided between the bottom pot and the dry granulation assembly.

[0019] Preferably, the first sealing ring, the second sealing ring, the third sealing ring and the fourth sealing ring are all inflatable sealing rings, and the inflation signal of the first sealing ring is detected by a first sensor, the inflation signals of the second sealing ring and the third sealing ring are detected by a second sensor, and the inflation signal of the fourth sealing ring is detected by a third sensor.

[0020] Preferably, a control system is provided on the main body housing, and the control system is used to be electrically connected to the first sensor, the second sensor, and the third sensor, and the first sensor, the second sensor, and the third sensor feed back the inflation signal to the control system.

[0021] Preferably, the discharging component includes a temporary storage barrel and a lifting device for adjusting the height of the temporary storage barrel. A discharge valve B is provided on the upper part of the temporary storage barrel, and a discharge valve A is provided at the lower end of the dry granulation component. The discharge valve A and the discharge valve B form a connecting channel, and the material enters the temporary storage barrel under the action of gravity.

[0022] Preferably, a sampling tube is provided on the material bin, and a connected sampling cavity is provided on the sampling tube, and the sampling cavity is located on the lower side of the sampling tube and opens downward. A piston rod is slidably provided in the sampling tube, and the sliding piston rod is used to control the conduction and closure of the sampling tube.

[0023] Preferably, a peristaltic pump is provided on the main body housing, and the peristaltic pump is connected to the spray gun through a slurry tube. The slurry flows through the slurry tube to the spray gun under the squeezing action of the peristaltic pump, and is atomized by compressed air at the spray gun.

[0024] Preferably, the highly enclosed small-batch integrated pharmaceutical system further comprises:

[0025] A cleaning system includes a cleaning water inlet connected to an external water storage device and a cleaning gun connected to the cleaning water inlet, wherein the cleaning gun is used to clean the interior of the filter chamber, the material bin, the bottom pot, and the dry granulation assembly;

[0026] The drainage system is located at the bottom of the discharge assembly and is connected thereto, including a drainage pipe connected to the discharge assembly, the drainage pipe is connected to the discharge assembly through a drainage valve, the ends of the drainage pipe away from the drainage valve are respectively connected to an active drainage pipeline and a sewage drainage pipeline, and an active drainage valve and a sewage valve are respectively provided on the active drainage pipeline and the sewage drainage pipeline.

[0027] Preferably, an exhaust filter box is provided between the exhaust fan and the filter chamber, a primary filter and a secondary filter are provided in the exhaust filter box, and the primary filter and the secondary filter are respectively provided with inspection doors, and bag inlet and outlet interfaces are respectively provided on both sides of the two inspection doors.

[0028] Compared with the above-mentioned background technology, the present application provides a highly enclosed small-batch integrated granulation system, which delivers the material to the material bin through the feeding component, and then the material bin mixes the material with the slurry. After the slurry and the material are fully mixed, they adhere to each other to form fine particles, which boil under the negative pressure generated by the exhaust fan, and are heated to form relatively compact large particles. In addition, the above processes are all completed above the bottom screen. When the material forms large particles, it needs to be discharged through the bottom screen. Specifically, the bottom screen is set to be rotatable. When it rotates, a gap is formed between the bottom screen and the material bin, and the material falls through the gap under the action of its own gravity. Of course, the rotation angle of the bottom screen can be adjusted according to actual conditions to control the falling speed of the material.

[0029] In addition, since the particle sizes produced by the above process are inconsistent, the particle size is adjusted by a dry granulation component. Specifically, the dry granulation component includes a dry granulation knife and a granulation screen. The dry granulation knife quickly cuts the particles to obtain a suitable particle size, and then the particles pass through the granulation screen and fall into the discharging component to complete the discharging.

[0030] In addition, the material bin and the filter chamber are sealed, the material bin and the bottom pot are sealed, and the bottom of the pot and the dry granulation component are sealed to ensure that the entire system is in a closed condition and the overall sealing performance of the system is guaranteed, thereby achieving the purpose of closed production throughout the entire process. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are merely embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without any creative work.

[0032] Figure 1 This is a schematic side view of the structure of a highly enclosed small-batch integrated granulation system provided in an embodiment of the present application;

[0033] Figure 2 This is a schematic diagram of the front structure of the highly enclosed small-batch integrated granulation system provided in an embodiment of the present application;

[0034] Figure 3 A top view of a highly enclosed small-batch integrated granulation system provided in an embodiment of the present application;

[0035] Figure 4 A partially enlarged structural diagram of the exhaust filter box of the highly enclosed small-batch integrated granulation system provided in an embodiment of the present application;

[0036] Figure 5 This is a schematic diagram of the bottom screen arrangement structure of the highly enclosed small-batch integrated granulation system provided in an embodiment of the present application;

[0037] Figure 6 This is a schematic diagram of the structure of the junction support and the hinged shaft of the highly enclosed small-batch integrated granulation system provided in an embodiment of the present application;

[0038] Figure 7 A schematic diagram of the positioning hole arrangement structure of the highly enclosed small-batch integrated granulation system provided in an embodiment of the present application;

[0039] Figure 8 This is a schematic diagram of the internal structure of the dry granulation component of the highly enclosed small-batch integrated granulation system provided in an embodiment of the present application.

[0040] In the figure: 1. Powder barrel; 2. Feed valve B; 3. Feed valve A; 4. Feed pipe; 5. Material bin; 6. Bottom pot; 7. Dry granulation assembly; 8. Discharge valve A; 9. Discharge valve B; 10. Temporary storage barrel; 11. Lifting device; 12. Main unit housing; 13. Filter bag; 14. Second sealing ring; 15. Feed hand valve; 16. Sampling tube; 17. Handle; 18. Third sealing ring; 19. Fourth sealing ring; 20. Limiting ring; 21. Peristaltic pump; 22. Hinge support; 23. Hinge shaft; 24. Sampling bottle; 25. Positioning pin; 26. Rotating shaft; 27. Bottom screen; 28. First sealing ring ;29. Filter chamber;30. Spray gun;31. Positioning hole;32. Dry granulation knife;33. Reverse thread nut;34. Granulation screen;35. Filter plate;101. Cleaning water inlet;102. Cleaning diaphragm valve;104. Left filter chamber cleaning nozzle;105. Right filter chamber cleaning nozzle;106. Cleaning gun;108. Drain valve;109. Drain pipe;110. Active drain valve;111. Active drain pipeline;112. Sewage valve;113. Sewage drainage pipeline;201. Primary filter;202. Secondary filter;203. Inspection door;205. Exhaust filter box;206. Exhaust fan. DETAILED DESCRIPTION

[0041] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0042] In order to enable those skilled in the art to better understand the present application, the present application is further described in detail below with reference to the accompanying drawings and specific implementation methods.

[0043] It should be noted that in the appendix of the manual Figure 1 In the present disclosure, the directions or positions indicated by "upper" and "lower" are based on the directions or positions shown in the accompanying drawings and are intended solely to facilitate the description of this application and simplify the description. They do not indicate or imply that the devices or components referred to must have a specific direction, be constructed, or operate in a specific direction. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," "third," and "fourth" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0044] like Figure 1 and Figure 2 As shown, this embodiment provides a highly enclosed small-batch integrated pharmaceutical system, including a main body shell 12 and a material bin 5 arranged on the main body shell 12. The system delivers the material into the material bin 5 through the feeding component, and then the material bin 5 mixes the material with the slurry. After the slurry and the material are fully mixed, they adhere to each other to form fine particles, which boil under the negative pressure generated by the exhaust fan 206, and are heated to form relatively compact large particles. In addition, the above processes are all completed above the bottom screen 27. When the material forms large particles, it needs to be discharged through the bottom screen 27. Specifically, the bottom screen 27 is set to be rotatable. When it rotates, a gap is formed between the bottom screen 27 and the material bin 5, and the material falls through the gap under the action of its own gravity. Of course, the rotation angle of the bottom screen 27 can be adjusted according to actual conditions to control the falling speed of the material.

[0045] In addition, since the granules produced by the above process are not uniform in size, the granule size is adjusted by the dry granulation assembly 7, such as Figure 8 As shown, specifically, the dry granulation component 7 includes a dry granulation knife 32 and a granulation screen 34. The dry granulation knife 32 quickly cuts the particles to obtain a suitable particle size, and then the particles pass through the granulation screen 34 and fall into the discharging component to complete the discharging.

[0046] Specifically, the dry granulation knife 32 is installed on the upper end of the granulation screen 34, and the dry granulation knife 32 is connected to the granulation power system through the reverse thread nut 33; in the granulation process, the dry granulation knife 32 is first turned on, the appropriate speed is selected, and the handle 17 is manually opened to drive the rotating bottom screen 27, and the particles enter the dry granulation component 7, thereby achieving rapid cutting of the particles; since the particle size of the particles formed during the drying process is inconsistent, the appropriate particle size can be obtained after dry granulation; the size of the granulation screen 34 can be changed according to the material properties and the final particle size, so as to better achieve the later process production goals.

[0047] It should be noted that a feed port is provided on the material bin 5, and a manual valve is provided on the feed port. The manual valve is externally connected to a feed assembly. Specifically, the manual valve is connected to the feed pipe 4, a feed valve B2 is provided at the bottom of the distributor, and a feed valve A3 is provided at the end of the feed pipe 4. The feed valve A3 and the feed valve B2 are used in conjunction with each other; during the feeding process, the feed valve B2 and the feed valve A3 installed at the lower end of the powder barrel 1 are manually docked, and the feed valve B2 and the feed valve A3 are manually opened. A communicating channel is formed inside the feed valve B2 and the feed valve A3, and the material can pass through the feed pipe 4 and enter the pot body under the action of the negative pressure generated by the exhaust fan 206; the feed valve B2 and the feed valve A3 are closed, and the communicating channel is closed by the feed valve B2 and the feed valve A3. The docking of the feed valve B2 and the feed valve A3 is manually disassembled, the powder barrel 1 is removed, and the feed manual valve 15 is closed at the same time to complete the feeding process. The entire feeding process is completely sealed.

[0048] In addition, if Figure 5 and Figure 7 As shown, the bottom screen 27 is arranged along the radial cross-section of the material bin 5, and the material in the material bin 5 is located above the bottom screen 27. A rotating shaft 26 is arranged on the edge of the bottom screen 27. The rotating shaft 26 passes through the outer wall of the material bin 5 and is rotatably arranged on the material bin 5. The end of the rotating shaft 26 away from the bottom screen 27 extends out of the material bin 5 and is provided with a handle 17. The handle 17 is provided with a plurality of positioning holes 31 passing through it, and a positioning pin 25 is provided in the positioning hole 31 to be clamped with the outer wall of the material bin 5.

[0049] Specifically, during the production process, the bottom screen 27 is in a horizontal state, and the material is dried on the upper part of the bottom screen 27 of the material bin 5. After the drying process is completed, the material passes through the bottom pot 6 and enters the dry granulation component 7 for flipping out. The positioning pin 25 is pulled up, and the countersunk head of the positioning pin 25 will come out of the positioning hole 31. The handle 17 is rotated, and the handle 17 drives the rotating shaft 26 to rotate counterclockwise upward. The positioning pin 25 reaches another positioning hole 31, and the bottom screen 27 is at a 45-degree tilt angle, which can ensure that the material moves slowly downward under the action of gravity to prevent clogging of the dry granulation. After unloading for a period of time, continue to rotate the handle 17, and the positioning pin 25 reaches the remaining positioning holes 31. The bottom screen 27 is at a 90-degree tilt angle, which ensures that the material moves quickly downward under the action of gravity, completing the discharge of the material bin 5.

[0050] like Figure 6 As shown, in this embodiment, a hinged support is provided on the outer wall of the main body shell 12, and a hinged shaft is provided on the outer wall of the material bin 5. The hinged shaft is inserted into the hinged support from top to bottom and is rotatably connected thereto. When the material bin 5 rotates and does not interfere with the filter chamber, the material bin 5 is lifted upward to disengage the hinged shaft from the hinged support.

[0051] To meet the requirements of different experimental batches, the material bin 5 of various sizes can be replaced. During the replacement process, the right handle is gripped and the bin 5 is rotated to the left by a certain angle. When it does not interfere with the filter chamber 29, the bin 5 is pulled upward, causing the hinge shaft 23 to disengage from the hinge support 22. The hinge shaft 23 of the replacement bin 5 is then aligned with the hinge support 22 and guided into the hinge support 22 under the action of gravity. The right handle is gripped and the bin 5 is rotated to the right until it contacts the limit ring 20. The limit ring 20 limits the position of the bin 5, preventing it from rotating too far, and the bin 5 is replaced. Different batches of products can be produced on the same equipment, saving costs.

[0052] In addition, in order to ensure the positioning accuracy of the material bin 5, the filter chamber and the bottom pot 6, in this embodiment, the distance between the material bin 5 and the filter chamber is less than 5 mm, and the distance between the material bin 5 and the bottom pot 6 is less than 5 mm.

[0053] On the basis of the above embodiment, a position sensor is provided on the limiting ring 20 to detect whether the material bin 5 is rotated into position, so as to prevent the material bin 5 from not being in position.

[0054] It should be noted that a filter disc 35 and a filter bag 13 are provided inside the filter chamber. The filter disc 35 is used to prevent the material in the material bin 5 from entering the filter chamber. In addition, a first sealing ring 28 is provided between the filter disc 35 and the filter chamber, a second sealing ring 14 is provided between the filter chamber and the material bin 5, a third sealing ring 18 is provided between the material bin 5 and the bottom pot 6, and a fourth sealing ring 19 is provided between the bottom pot 6 and the dry granulation component 7.

[0055] Among them, the first sealing ring 28, the second sealing ring 14, the third sealing ring 18 and the fourth sealing ring 19 are all inflatable sealing rings. The four inflatable sealing rings fill all the gaps between the filter disc 35, the filter chamber 29, the material bin 5, the bottom pot 6 and the dry whole grain component 7 to achieve a sealing effect. In addition, the first sensor, the second sensor and the third sensor are respectively connected to the control system. The first sensor detects the inflation signal of the filter disc 35 and the filter chamber 29, the second sensor detects the inflation signal of the filter chamber 29 and the material bin 5, the material bin 5 and the bottom pot 6, and the third sensor detects the inflation signal of the bottom pot 6 and the dry whole grain component 7. The sensor feeds the signal back to the control system, and the control system transmits the inflation signal to the staff; when all the inflation states are detected, the next production process can be carried out; if any of the first sensor, the second sensor and the third sensor does not detect the corresponding inflation signal, the staff needs to check and re-inflate the corresponding gas; the setting of the first sensor, the second sensor and the third sensor can detect the inflation state of the corresponding position in real time, further ensuring that the entire production process of the product is in a closed environment.

[0056] In addition, the above-mentioned discharging component specifically includes a temporary storage barrel 10 and a lifting device 11 for adjusting the height of the temporary storage barrel 10. The temporary storage barrel 10 is adjusted to a suitable height by the lifting device 11, and the lifting device 11 is locked; it should be noted that after the discharge valve A8 installed at the lower end of the dry granulation component 7 is docked with the discharge valve B9 installed at the upper end of the temporary storage barrel 10, the discharge valve A8 and the discharge valve B9 are manually opened, and a communicating channel is formed inside the discharge valve B9 and the discharge valve A8. The material enters the temporary storage barrel 10 under the action of gravity, completing the discharging process.

[0057] In this embodiment, if Figure 6 As shown, a sampling tube 16 is provided on the material bin 5, and a connected sampling cavity is provided on the sampling tube 16, and the sampling cavity is located at the lower side of the sampling tube 16, with an opening downward, and a piston rod is slidingly provided in the sampling tube 16, and the sliding piston rod is used to control the conduction and closure of the sampling tube 16; specifically, by pulling the piston rod outward, the upper channel of the sampling cavity is opened, and under the action of gravity, the material flows into the sampling bottle 24 through the sampling cavity. After the sampling is completed, the piston rod moves back to seal the sampling cavity and block the sampling tube 16 at the same time to prevent the material in the material bin 5 from falling into the sampling bottle 24 or the ground at any time, so as to improve the sampling safety.

[0058] It should be noted that the sampling process adopts a bag-in-bag-out interface. The first sampling bag is put on the sampling bottle 24 and is clamped in the sampling cavity by the first O-ring. After the material flows into the sampling bottle 24, the second sampling bag is put on the outside of the first sampling bag. The second sampling bag is also clamped in the sampling cavity with the second O-ring. The first O-ring, the first PE sampling bag and the sampling bottle 24 inside it are pulled to the rear end of the second sampling bag. Two cable ties are used to separate the front and rear ends of the second sampling bag. The second sampling bag is cut open between the two cable ties. There is no dust leakage throughout the process, thereby achieving closed sampling.

[0059] In addition, a peristaltic pump 21 is provided on the main body housing 12. The slurry tube passes through the peristaltic pump 21 and is connected to the interface of the spray gun 30 through a quick-plug interface. The slurry flows through the slurry tube to the spray gun 30 through the extrusion action of the peristaltic pump 21, and is atomized by compressed air at the spray gun 30, enters the material bin 5, and is fully mixed with the material.

[0060] In this embodiment, if Figure 2 and Figure 3 As shown, the highly enclosed small-batch integrated pharmaceutical system also includes a cleaning system and a drainage system. The cleaning system is connected to an external water storage device through a cleaning water inlet 101. The cleaning system includes multiple cleaning diaphragm valves 102 and multiple cleaning guns 106. The multiple cleaning diaphragm valves 102 are used to control the cleaning of different areas. The multiple cleaning guns 106 are respectively installed on the filter chamber 29, the material bin 5, the bottom pot 6, and the dry granulation component 7 to clean the inside of the four. Figure 3As shown, a left filter chamber cleaning nozzle 104 and a right filter chamber cleaning nozzle 105 are provided on both sides of the filter chamber 29, and a cleaning gun 106 is provided on the bottom pot 6. Of course, the specific setting method can be set according to actual needs and is not specifically limited here.

[0061] The drainage system is located at the bottom of the discharge assembly and is connected thereto. In this embodiment, the drain pipe 109 is connected to the bottom of the temporary storage barrel 10 through the drain valve 108. The ends of the drain pipe 109 facing away from the drain valve 105 are respectively connected to the active drainage pipeline 111 and the sewage drainage pipeline 113, and the active drainage valve 110 and the sewage valve 112 are respectively provided on the active drainage pipeline 111 and the sewage drainage pipeline 113.

[0062] When the equipment needs to be cleaned, the cleaning water passes through the cleaning water inlet 101 and is cleaned on different areas through the cleaning diaphragm valve 102 respectively. The cleaning gun 106 on the material bin 5 can realize the cleaning of the material bin 5 body, and the cleaning gun 106 on the dry whole grain can realize the cleaning of the dry whole grain component 7; after the equipment is cleaned, when the cleaning water is discharged, it is necessary to open the drain valve 108 first, and the drain valve 108 is connected to the drain pipe 109. According to the nature of the discharged sewage, the active drain valve 110 or the sewage valve 112 is opened, and the sewage is discharged to the external inactivation device or the external ground drain accordingly to realize closed cleaning and drainage.

[0063] In addition, if Figure 4 As shown, an exhaust filter box 205 is arranged between the exhaust fan 206 and the filter chamber 29, and a primary filter 201 and a secondary filter 202 are arranged in the exhaust filter box 205. The primary filter 201 and the secondary filter 202 are respectively provided with an inspection door 203, and bag inlet and outlet interfaces are respectively provided on both sides of the two inspection doors 203.

[0064] The design of the exhaust filter box 205 can prevent dust from being discharged into the external environment and causing personal injury. When the exhaust filter box 205 is used for a long time, the primary filter 201 and the secondary filter 202 need to be cleaned or replaced. The cleaning or replacement process needs to be carried out in a closed environment. During the cleaning and replacement process, a PE bag is first put on the bag inlet and outlet interface, and the PE bag is fixed to the bag inlet and outlet interface with existing fasteners. The inspection door 203 is opened, and the primary filter 201 or the secondary filter 202 is taken out and sent to the corresponding location for cleaning. After cleaning, the primary filter 201 or the secondary filter 202 is put back into the exhaust filter box 205 in the same way, the inspection door 203 is closed, and the PE bag is removed. The entire process is carried out in a closed environment, meeting the requirements for closed replacement of the primary filter 201 and the secondary filter 202, and avoiding harm to the operator.

[0065] In summary, during the use of the granulation system of the present application, the material bin 5 is first rotated into place, the first sealing ring 28, the second sealing ring 14, the third sealing ring 18 and the fourth sealing ring 19 are inflated respectively, the feed valve A3 and the feed hand valve 15 are opened respectively, and the exhaust fan 206 is turned on. Then, the material can pass through the feed pipe 4 and enter the interior of the material bin 5 under the action of negative pressure; after heating, one-step granulation, drying, dry granulation and other processes, the material enters the discharge assembly, and the material passes through the discharge valve A8 and the discharge valve B9 connected to the bottom of the dry granulation assembly 7 and enters the temporary storage barrel 10; when the material is sealed and sampled, the sampling tube 16 is pressed, so that the material enters the sampling bottle 24 under the action of gravity, and the material and the sampling bottle 24 are taken out by bag-in-bag-out; during the entire production process, the highly active medicinal API is always inside the sealed cavity and will not leak out, which can ensure the sealing requirements in the food and drug production process and realize the production of highly sealed small-batch integrated granulation.

[0066] It should be noted that, in this specification, relational terms such as first and second are merely used to distinguish one entity from other entities, but do not necessarily require or imply any actual relationship or order between these entities.

[0067] This document uses specific examples to illustrate the principles and implementation methods of this application. The description of the above examples is only intended to help understand the method and core ideas of this application. It should be noted that for those skilled in the art, without departing from the principles of this application, various improvements and modifications can be made to this application, and such improvements and modifications also fall within the scope of protection of the claims of this application.

Claims

1. A highly enclosed small-batch integrated pharmaceutical system, comprising a main body housing, characterized in that: Also includes: A material bin is provided on the main body housing, and is provided with a spray gun for spraying slurry into the bin. The slurry is used to mix with the material and form particles after boiling and heating. A rotatable bottom screen is provided at the bottom of the material bin, and the rotated bottom screen is used to discharge the particles; A feeding assembly, comprising a powder barrel and a feeding pipe connected to the powder barrel, wherein the end of the feeding pipe facing away from the powder barrel is connected to the material bin; a filter chamber located above the material bin and sealed and connected to the material bin; an exhaust fan connected to the filter chamber is provided on the filter chamber, the exhaust fan is used to create a negative pressure in the material bin and boil the material in the material bin; a filter disc is provided in the filter chamber, the filter disc is used to prevent the material in the material bin from entering the filter chamber; A bottom pot is sealed and connected to the bottom of the material bin; A dry granulation assembly is sealed and connected to the bottom of the pot, and comprises a granulation screen and a dry granulation knife rotatably arranged above the granulation screen; A discharging assembly, used for receiving the material discharged from the dry granulation assembly; The bottom screen is arranged along the radial cross-section of the material bin, and the material in the material bin is located above the bottom screen. A rotating shaft is arranged at the edge of the bottom screen, and the rotating shaft passes through the outer wall of the material bin and is rotatably arranged on the material bin. The end of the rotating shaft away from the bottom screen extends out of the material bin and is provided with a handle. The handle is provided with a plurality of positioning holes passing through it, and the positioning holes are provided with positioning pins that are engaged with the outer wall of the material bin.

2. The highly enclosed small-batch integrated pharmaceutical system according to claim 1, characterized in that: A feed port is provided on the outer wall of the material bin, a manual valve is provided on the feed port, the manual valve is connected to the feed pipe, a feed valve A is provided at the end of the feed pipe away from the manual valve, a feed valve B is provided at the bottom of the powder barrel, the feed valve A is connected to the feed valve B, and the feed valve A and the feed valve B jointly control the connection and disconnection of the powder barrel and the feed pipe.

3. The highly enclosed small-batch integrated pharmaceutical system according to claim 1 is characterized in that: An articulated support is provided on the outer wall of the main body shell, and an articulated shaft is provided on the outer wall of the material bin. The articulated shaft is inserted into the articulated support from top to bottom and is rotatably connected thereto. When the material bin rotates and does not interfere with the filter chamber, the material bin is lifted upward to disengage the articulated shaft from the articulated support.

4. The highly enclosed small-batch integrated pharmaceutical system according to claim 3 is characterized in that: The material bin is rotatably arranged by the hinged support and the hinged shaft, and the distance between the material bin and the filter chamber is less than 5 mm, and the distance between the material bin and the bottom pot is less than 5 mm.

5. The highly enclosed small-batch integrated pharmaceutical system according to claim 4 is characterized in that: A protruding limiting ring is provided along the circumference of the upper edge of the bottom pot, and the limiting ring is used to limit the rotation of the material bin.

6. The highly enclosed small-batch integrated pharmaceutical system according to claim 5, characterized in that: The limiting ring is provided with an in-place sensor, and the in-place sensor is used to detect whether the material bin is rotated into place.

7. The highly enclosed small-batch integrated pharmaceutical system according to claim 1, characterized in that: A first sealing ring is provided between the filter disc and the filter chamber, a second sealing ring is provided between the filter chamber and the material bin, a third sealing ring is provided between the material bin and the bottom pot, and a fourth sealing ring is provided between the bottom pot and the dry granulation assembly.

8. The highly enclosed small-batch integrated pharmaceutical system according to claim 7, characterized in that: The first sealing ring, the second sealing ring, the third sealing ring and the fourth sealing ring are all inflatable sealing rings, and the inflation signal of the first sealing ring is detected by the first sensor, the inflation signals of the second sealing ring and the third sealing ring are detected by the second sensor, and the inflation signal of the fourth sealing ring is detected by the third sensor.

9. The highly enclosed small-batch integrated pharmaceutical system according to claim 8, characterized in that: The host housing is provided with a control system, which is used to be electrically connected to the first sensor, the second sensor and the third sensor, and the first sensor, the second sensor and the third sensor feed back inflation signals to the control system.

10. The highly enclosed small-batch integrated pharmaceutical system according to claim 1, characterized in that: The discharging assembly includes a temporary storage barrel and a lifting device for adjusting the height of the temporary storage barrel. A discharge valve B is provided on the upper part of the temporary storage barrel, and a discharge valve A is provided at the lower end of the dry granulation assembly. The discharge valve A and the discharge valve B form a connecting channel, and the material enters the temporary storage barrel under the action of gravity.

11. The highly enclosed small-batch integrated pharmaceutical system according to claim 1, characterized in that: A sampling tube is provided on the material bin, and a connected sampling cavity is provided on the sampling tube. The sampling cavity is located on the lower side of the sampling tube and opens downward. A piston rod is slidably provided in the sampling tube, and the sliding piston rod is used to control the conduction and closure of the sampling tube.

12. The highly enclosed small-batch integrated pharmaceutical system according to claim 1, characterized in that: A peristaltic pump is provided on the main body housing, and the peristaltic pump is connected to the spray gun through a slurry pipe. The slurry flows through the slurry pipe to the spray gun under the squeezing action of the peristaltic pump, and is atomized by compressed air at the spray gun.

13. The highly enclosed small-batch integrated pharmaceutical system according to claim 1, characterized in that: Also includes: A cleaning system includes a cleaning water inlet connected to an external water storage device and a cleaning gun connected to the cleaning water inlet, wherein the cleaning gun is used to clean the interior of the filter chamber, the material bin, the bottom pot, and the dry granulation assembly; The drainage system is located at the bottom of the discharge assembly and is connected thereto, including a drainage pipe connected to the discharge assembly, the drainage pipe is connected to the discharge assembly through a drainage valve, the ends of the drainage pipe away from the drainage valve are respectively connected to an active drainage pipeline and a sewage drainage pipeline, and an active drainage valve and a sewage valve are respectively provided on the active drainage pipeline and the sewage drainage pipeline.

14. The highly enclosed small-batch integrated pharmaceutical system according to claim 1, characterized in that: An exhaust filter box is provided between the exhaust fan and the filter chamber, and a primary filter and a secondary filter are provided in the exhaust filter box. The primary filter and the secondary filter are respectively provided with inspection doors, and bag inlet and outlet interfaces are respectively provided on both sides of the two inspection doors.

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