Whole-course closed preparation system and method for high-activity medicine solid tablets
By using a fully enclosed preparation system and modular isolation design, the problem of dust diffusion in highly active drugs was solved, achieving safety and quality control in the drug preparation process and ensuring the health of operators and the purity of the drugs.
Patent Information
- Application Number
- CN202512020835.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-30
- Publication Date
- 2026-02-03
AI Technical Summary
The release of highly active drug dust poses a serious health hazard to operators and is difficult to prevent cross-contamination and control environmental emissions.
Design a fully enclosed preparation system that adopts modular isolation and unidirectional flow design. Utilize equipment such as negative pressure isolators and negative pressure weighing hoods to construct a three-dimensional defense system, achieving fully enclosed material transfer and accurate weighing, and preventing dust diffusion.
It effectively prevents occupational exposure risks to operators from dust, ensures the purity of drug quality and the absence of cross-contamination, and achieves safety and quality control in the drug preparation process.
Smart Images
Figure CN121445618A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to pharmaceutical manufacturing equipment, and more particularly to a fully enclosed preparation system and method for highly active pharmaceutical solid tablets. Background Technology
[0002] The active pharmaceutical ingredients (APIs) of highly active drugs (such as antitumor drugs, hormones, and immunosuppressants) often carry risks of high toxicity, sensitization, or carcinogenicity. Even trace exposure to their dust can pose serious health hazards to operators.
[0003] Highly toxic: Even very low doses can cause serious damage to human organs (such as the liver, kidneys, and bone marrow);
[0004] High allergenicity: Exposure to trace amounts of dust may trigger severe allergic reactions;
[0005] Genotoxicity or carcinogenicity: May damage DNA and pose a potential carcinogenic risk;
[0006] Reproductive toxicity: May affect fertility or harm the fetus.
[0007] Dust generated during processes such as weighing, feeding, mixing, and tableting can escape into the operating environment. Even extremely low doses can cause serious health hazards if inhaled or exposed to the skin over a long period.
[0008] Therefore, maintaining a completely sealed environment is a core engineering technology for ensuring personnel safety, preventing cross-contamination, and controlling environmental emissions during the preparation of highly active drug solid tablets. Simultaneously, to prevent such highly active ingredients from contaminating other pharmaceuticals or the production environment, strict physical isolation is necessary to block dust diffusion pathways. Summary of the Invention
[0009] The purpose of this invention is to provide a fully closed preparation system and method for highly active drug solid tablets.
[0010] The technical solution adopted by this invention to solve its technical problem is as follows:
[0011] A fully closed preparation system for highly active pharmaceutical solid tablets, comprising:
[0012] The material inlet module is connected to the material warehouse through a transfer system. Auxiliary materials and APIs in the material warehouse can be transferred to the material inlet module for de-packaging and de-inventory processing and temporary storage.
[0013] The auxiliary material weighing module is connected to the material inlet module through a transfer system. The auxiliary materials in the material inlet module can enter the auxiliary material weighing module for weighing and temporary storage.
[0014] The API weighing module is connected to the material inlet module through a transfer system. The API in the material inlet module can enter the API weighing module for weighing operations and temporary storage.
[0015] The mixing and screening module is connected to the auxiliary material weighing module and the API weighing module through a transfer system. The auxiliary materials in the auxiliary material weighing module can be transferred to the mixing and screening module for mixing. The mixed auxiliary materials can be transferred to the API weighing module to add API, and then transferred back to the mixing and screening module for mixing and screening.
[0016] The tableting module is connected to the mixing and screening module via a transfer system. The material after mixing and screening in the mixing and screening module can be transferred to the tableting module for tableting to form drug tablets.
[0017] The coating processing module is connected to the tableting processing module via a transfer system. The drug tablets in the tableting processing module can be transferred to the coating processing module for coating operations to form drug-coated tablets.
[0018] The material inlet module includes:
[0019] The primary entry room is connected to the material warehouse via a transfer system, where auxiliary materials and APIs in the material warehouse can be transferred to the primary entry room for de-inspection processing.
[0020] The secondary entrance is connected to the primary entrance via a shielding door and is also connected to the primary entrance via a transfer system. The auxiliary materials and APIs in the primary entrance can be transferred to the secondary entrance for unpacking.
[0021] The material storage room is connected to the secondary entrance through a shielded door and material channel, and is also connected to the secondary entrance through a transfer system. Auxiliary materials and APIs in the secondary entrance can be transferred to the material storage room for temporary storage.
[0022] The auxiliary material weighing module includes:
[0023] The auxiliary material weighing room is connected to the material inlet module through a shielded door and a material channel, and is connected to the material outlet module through a transfer system. The auxiliary materials in the material inlet module can be transferred to the auxiliary material weighing room.
[0024] Auxiliary material weighing device, wherein the auxiliary material weighing device is a negative pressure weighing hood, which is installed in the auxiliary material weighing room, and the auxiliary material weighing hood weighs the auxiliary materials transferred from the material port module;
[0025] The auxiliary material temporary storage room is connected to the auxiliary material weighing room through a shielded door and material channel, and is also connected to the auxiliary material weighing room through a transfer system. The auxiliary materials weighed in the auxiliary material weighing room can be transferred to the auxiliary material temporary storage room for temporary storage.
[0026] The API weighing module includes:
[0027] The API weighing room is connected to the material inlet module via a shielded door and a material channel, and is also connected to the material inlet module via a transfer system. APIs in the material inlet module can be transferred to the API weighing room.
[0028] A negative pressure isolator is installed in the API weighing room. The negative pressure isolator weighs and temporarily stores the API transferred from the material inlet module.
[0029] The mixing and screening module includes:
[0030] The mixing and screening room is connected to the auxiliary material weighing module through a shielding door and a material channel, and is also connected to the auxiliary material weighing module through a transfer system. The auxiliary materials in the auxiliary material weighing module can be transferred to the mixing and screening room.
[0031] The mixing weighing device is equipped with a negative pressure weighing hood, which is installed in the mixing and screening room. The auxiliary materials transferred from the auxiliary material weighing module can be poured into the closed material hopper in the mixing weighing device, and the auxiliary materials in the closed material hopper can be weighed.
[0032] The mixing and screening machine is installed in the mixing and screening chamber. Auxiliary materials can be transferred to the mixing and screening machine through a closed material hopper. The mixing and screening machine premixes the auxiliary materials. The premixed auxiliary materials can be transferred to the API weighing module through the closed material hopper. The API weighing module adds API to the closed material hopper. The auxiliary materials and API can be transferred to the mixing and screening machine through the closed material hopper. The closed material hopper is connected to the mixing and screening machine through a closed valve. The mixing and screening machine mixes and screens the auxiliary materials and API in the closed material hopper.
[0033] The tablet compression processing module includes:
[0034] The tableting operation room is connected to the mixing and screening module through a shielded door and a material channel, and is also connected to the mixing and screening module through a transfer system. The material after screening in the mixing and screening module can be transferred to the tableting operation room.
[0035] The tablet weighing device is equipped with a negative pressure weighing hood and is installed in the tableting operation room. It can weigh the materials transferred from the mixing and screening module inside the tablet weighing device.
[0036] The tablet pressing machine is installed in the tableting operation room. The material weighed by the tablet weighing device can be connected to the sealed valve of the tablet pressing machine through the elevator. The tablet pressing machine performs tableting operation on the material. The resulting drug tablets are temporarily stored in double-layer sealed bags. The dust in the tablet pressing machine is discharged after being removed by the negative pressure dust collection mechanism and the bag inlet and bag outlet filter device.
[0037] The coating processing module includes:
[0038] The coating operation room is connected to the tableting module through a shielded door and a material channel, and is also connected to the tableting module through a transfer system. The drug tablets in the tableting module can be transferred to the coating operation room.
[0039] The tablet coating machine is installed in the coating operation room and can coat tablets transferred to the coating operation room. The resulting drug-coated tablets are put into double-layer polyethylene bags and transferred to the finished product packaging module for packaging. The dust in the tablet coating machine is discharged after being removed by a dust collector and a bag inlet and bag outlet filter.
[0040] A fully closed-loop preparation method for highly active drug solid tablets, which utilizes the aforementioned fully closed-loop preparation system for highly active drug solid tablets, includes the following steps:
[0041] S1: Transfer auxiliary materials and APIs from the material warehouse to the material entry module; first, the materials enter the primary entry room for unpacking; then, the materials are transferred to the secondary entry room for unpacking; finally, the materials enter the material temporary storage room for temporary storage.
[0042] S2: Transfer the auxiliary materials in the material storage room to the auxiliary material weighing room, weigh the auxiliary materials in the auxiliary material weighing room using a negative pressure weighing hood, and temporarily store the weighed auxiliary materials in the auxiliary material storage room; at the same time, transfer the API in the material storage room to the API weighing room, weigh the API in the API weighing room using a negative pressure isolator and temporarily store it.
[0043] S3: Transfer the weighed auxiliary materials in the auxiliary material storage room to the mixing and screening room; then, pour the auxiliary materials into a closed material hopper under the negative pressure weighing hood in the mixing and screening room; then, transfer the closed material hopper containing the auxiliary materials to the mixing and screening machine, where it is premixed; after premixing, transfer the closed material hopper containing the premixed auxiliary materials to the API weighing room, where the weighed API is added to the closed material hopper by the negative pressure isolator; then, transfer the closed material hopper containing the auxiliary materials and API back to the mixing and screening room, where the closed material hopper is connected to the mixing and screening machine through a closed valve, where the mixing and screening machine performs mixing and screening operations on the materials.
[0044] S4: The material that has completed the screening operation in the mixing and screening machine is transferred to the tableting operation room through the sealed material hopper; the transferred material is weighed in the negative pressure weighing hood in the tableting operation room; then, the material is connected to the sealed valve of the tablet press through the elevator via the sealed material hopper, and the tablet press performs the tableting operation to form drug tablets; the formed drug tablets are temporarily stored in double-layer sealed bags; during this process, the dust in the tablet press is discharged after being removed by the negative pressure dust collection mechanism and the bag inlet and bag outlet filter device.
[0045] S5: The uncoated tablets in the tableting room are transferred to the coating room along with double-layer sealed bags; the uncoated tablets are coated using a tablet coating machine in the coating room to form drug-coated tablets; the coated drug-coated tablets are packed into double-layer polyethylene bags and transferred to the finished product packaging module for packaging; during this process, the dust in the uncoated tablet coating machine is discharged after being removed by a dust collector and a bag inlet / outlet filter.
[0046] The advantages of this invention are:
[0047] This highly active drug solid preparation system and method constructs a three-dimensional defense system that simultaneously ensures personnel safety and drug quality through an integrated design of modular isolation, complete sealing, and unidirectional flow. In terms of safety, the system places the highest-risk API operations in a negative pressure isolator to achieve absolute separation of humans and drugs, and sets up negative pressure protection equipment at each dust-generating point to form an active dust control network, fundamentally eliminating occupational exposure risks through engineering control. In terms of quality, the system strictly achieves physical isolation and unidirectional transfer between different active materials through independent purification inlets, independent weighing modules, and a closed material flow throughout the process, effectively preventing cross-contamination, and ensuring product content uniformity through closed transfer and precise weighing. Attached Figure Description
[0048] Figure 1 This is a schematic diagram of the fully enclosed preparation system for highly active drug solid tablets proposed in this invention.
[0049] In the diagram, the following are listed: Primary Inlet Room - 110, Secondary Inlet Room - 120, Material Temporary Storage Room - 130, Auxiliary Material Weighing Room - 210, Auxiliary Material Weigher - 220, Auxiliary Material Temporary Storage Room - 230, API Weighing Room - 310, Negative Pressure Isolator - 320, Mixing and Screening Room - 410, Mixing and Weighing Device - 420, Mixing and Screening Machine - 430, Tableting Operation Room - 510, Tableting Weigher - 520, Plain Tablet Press - 530, Coating Operation Room - 610, Plain Tablet Coating Machine - 620. Detailed Implementation
[0050] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.
[0051] like Figure 1 As shown, the fully enclosed preparation system for highly active drug solid tablets proposed in this invention includes a material inlet module, an excipient weighing module, an API weighing module, a mixing and sieving module, a tableting module, and a coating module. The material inlet module is connected to the material warehouse via a transfer system. Excipients and APIs in the material warehouse can be transferred to the material inlet module for desaturation and decoating treatment before temporary storage. The excipient weighing module is connected to the material inlet module via a transfer system. Excipients in the material inlet module can enter the excipient weighing module for weighing and temporary storage. The API weighing module is connected to the material inlet module via a transfer system. APIs in the material inlet module can enter the API weighing module for weighing and temporary storage. The storage, mixing and screening module is connected to the excipient weighing module and the API weighing module through a transfer system. The excipients in the excipient weighing module can be transferred to the mixing and screening module for mixing. The mixed excipients can be transferred to the API weighing module to add API, and then transferred back to the mixing and screening module for mixing and screening. The tableting module is connected to the mixing and screening module through a transfer system. The mixed and screened materials in the mixing and screening module can be transferred to the tableting module for tableting to form drug tablets. The coating module is connected to the tableting module through a transfer system. The drug tablets in the tableting module can be transferred to the coating module for coating to form drug coated tablets.
[0052] In this embodiment, the material inlet module includes a primary inlet 110, a secondary inlet 120, and a material storage room 130. The primary inlet 110 is connected to the material warehouse 7 via a transfer system. Auxiliary materials and APIs in the material warehouse can be transferred to the primary inlet 110 for depackaging. The secondary inlet 120 is connected to the primary inlet 110 via a shielded door and a transfer system. Auxiliary materials and APIs in the primary inlet 110 can be transferred to the secondary inlet 120 for depackaging. The material storage room 130 is connected to the secondary inlet 120 via a shielded door and a material channel and a transfer system. Auxiliary materials and APIs in the secondary inlet 120 can be transferred to the material storage room 130 for temporary storage.
[0053] The auxiliary material weighing module includes an auxiliary material weighing room 210, an auxiliary material weighing device 220, and an auxiliary material temporary storage room 230. The auxiliary material weighing room 210 is connected to the material temporary storage room 130 of the material inlet module through a shielding door and a material channel, and is also connected to the material temporary storage room 130 of the material inlet module through a transfer system. The auxiliary materials in the material temporary storage room 130 of the material inlet module can be transferred to the auxiliary material weighing room 210. The auxiliary material weighing device 220 is a negative pressure weighing hood, which is installed in the auxiliary material weighing room 210. The auxiliary material weighing hood 220 weighs the auxiliary materials transferred from the material temporary storage room 130 of the material inlet module. The auxiliary material temporary storage room 230 is connected to the auxiliary material weighing room 210 through a shielding door and a material channel, and is also connected to the auxiliary material weighing room 210 through a transfer system. The auxiliary materials weighed in the auxiliary material weighing room 210 can be transferred to the auxiliary material temporary storage room 230 for temporary storage.
[0054] The API weighing module includes an API weighing chamber 310 and a negative pressure isolator 320. The API weighing chamber 310 is connected to the material storage chamber 130 of the material inlet module through a shielded door and a material channel, and is also connected to the material storage chamber 130 of the material inlet module through a transfer system. APIs in the material storage chamber 130 of the material inlet module can be transferred to the API weighing chamber 310. The negative pressure isolator 320 is installed in the API weighing chamber 310 and is used to weigh and temporarily store the APIs transferred from the material storage chamber 130 of the material inlet module.
[0055] The mixing and screening module includes a mixing and screening chamber 410, a mixing weigher 420, and a mixing and screening machine 430. The mixing and screening chamber 410 is connected to the auxiliary material storage chamber 230 of the auxiliary material weighing module through a shielding door and a material channel, and is also connected to the auxiliary material storage chamber 230 of the auxiliary material weighing module through a transfer system. The auxiliary materials in the auxiliary material storage chamber 230 of the auxiliary material weighing module can be transferred to the mixing and screening chamber 410. The mixing weigher 420 is a negative pressure weighing hood, which is installed inside the mixing and screening chamber 410. The auxiliary materials transferred from the auxiliary material storage chamber 230 of the auxiliary material weighing module can be poured into the sealed material hopper in the mixing weigher 420, and the auxiliary materials in the sealed material hopper can be... Weighing is performed in the mixing and screening machine 430, which is installed in the mixing and screening chamber 410. The auxiliary materials can be transferred to the mixing and screening machine 430 through the closed material hopper. The mixing and screening machine 430 premixes the auxiliary materials. The premixed auxiliary materials can be transferred to the API weighing chamber 310 of the API weighing module through the closed material hopper. The negative pressure isolator 320 of the API weighing module adds API to the closed material hopper. The auxiliary materials and API can be transferred to the mixing and screening machine 430 through the closed material hopper. The closed material hopper is connected to the mixing and screening machine 430 through the closed valve. The mixing and screening machine 430 performs mixing and screening operations on the auxiliary materials and API in the closed material hopper.
[0056] The tableting processing module includes a tableting operation room 510, a tableting weighing device 520, and a tablet pressing machine 530. The tableting operation room 510 is connected to the mixing and screening room 410 of the mixing and screening module via a shielded door and material channel, and is also connected to the mixing and screening room 410 of the mixing and screening module via a transfer system. The material after screening in the mixing and screening machine 430 of the mixing and screening module can be transferred to the tableting operation room 510 via a sealed material hopper. The tableting weighing device 520 is a negative pressure weighing hood, which is installed inside the tableting operation room 510 and can be used for tableting. The tablet weigher 520 weighs the material transported from the mixing and screening machine 430 of the mixing and screening module with the closed material hopper. The tablet press 530 is installed in the tablet pressing operation room 510. The material weighed by the tablet weigher 520 can be connected to the closed valve of the tablet press 530 via the elevator through the closed material hopper. The tablet press 530 performs the tablet pressing operation, and the resulting drug tablets are temporarily stored in double-layer sealed bags. The dust in the tablet press 530 is discharged after being removed by the negative pressure dust collection mechanism and the bag inlet and bag outlet filter device.
[0057] The coating processing module includes a coating operation room 610 and a tablet coating machine 620. The coating operation room 610 is connected to the tableting operation room 510 of the tableting processing module through a shielded door and material channel, and is also connected to the tableting operation room 510 of the tableting processing module through a transfer system. The tablets in the tableting operation room 510 of the tableting processing module can be transferred to the coating operation room 610 with double-layer sealed bags. The tablet coating machine 620 is installed in the coating operation room 610 and can perform coating operations on the tablets transferred to the coating operation room 610. The resulting drug-coated tablets are put into double-layer polyethylene bags and transferred to the finished product packaging module for packaging. The dust in the tablet coating machine 620 is discharged after being removed by a dust collector and a bag inlet and bag outlet filter.
[0058] The fully enclosed preparation method for highly active drug solid tablets proposed in this invention is operated using the aforementioned fully enclosed preparation system for highly active drug solid tablets, and includes the following steps:
[0059] S1: Transfer auxiliary materials and APIs from material warehouse 7 to material entry module; first, the materials enter primary entry room 110 for unpacking; then, the materials are transferred to secondary entry room 120 for unpacking; finally, the materials enter material temporary storage room 130 for temporary storage.
[0060] S2: Transfer the auxiliary materials in the material storage room 130 to the auxiliary material weighing room 210, weigh the auxiliary materials in the auxiliary material weighing room 210 using a negative pressure weighing hood 220, and temporarily store the weighed auxiliary materials in the auxiliary material storage room 230; at the same time, transfer the API in the material storage room 130 to the API weighing room 310, weigh the API in the API weighing room 310 using a negative pressure isolator 320 and temporarily store it.
[0061] S3: The weighed auxiliary materials in the auxiliary material storage room 230 are transferred to the mixing and screening room 410; then, under the negative pressure weighing hood 420 in the mixing and screening room 410, the auxiliary materials are poured into a closed material hopper; then, the closed material hopper containing the auxiliary materials is transferred to the mixing and screening machine 430, where it is premixed; after premixing, the closed material hopper containing the premixed auxiliary materials is transferred to the API weighing room 310, where the weighed API is added to the closed material hopper by the negative pressure isolator 320; then, the closed material hopper containing the auxiliary materials and API is transferred back to the mixing and screening room 410, where the closed material hopper is connected to the mixing and screening machine 430 through a closed valve, where the mixing and screening machine 430 performs mixing and screening operations on the materials.
[0062] S4: The material that has completed the screening operation in the mixing and screening machine 430 is transferred to the tableting operation room 510 through the sealed material hopper; the transferred material is weighed in the negative pressure weighing hood 520 in the tableting operation room 510; then, the material is connected to the sealed valve of the tablet press 530 through the elevator via the sealed material hopper, and the tablet press 530 performs the tableting operation to form drug tablets; the formed drug tablets are temporarily stored in double-layer sealed bags; during this process, the dust in the tablet press 530 is discharged after being removed by the negative pressure dust collection mechanism and the bag inlet and bag outlet filter device.
[0063] S5: The uncoated tablets in the tableting operation room 510 are transferred to the coating operation room 610 along with double-layer sealed bags; the uncoated tablets are coated by the uncoated tablet coating machine 620 in the coating operation room 610 to form drug-coated tablets; the coated drug-coated tablets are put into double-layer polyethylene bags and transferred to the finished product packaging module for packaging; during this process, the dust in the uncoated tablet coating machine 620 is discharged after being removed by a dust collector and a bag inlet / outlet filter.
[0064] In the description of this invention, it should be noted that when terms such as "upper," "lower," "inner," "outer," "left," and "right" appear to indicate orientation or positional relationships, they should be understood as being based on the orientation or positional relationships shown in the accompanying drawings, or the orientation or positional relationships commonly used when the product of this invention is in use, or the orientation or positional relationships commonly understood by those skilled in the art. These terms are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or component referred to must have a specific orientation, or be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the invention. Furthermore, when terms such as "first" and "second" appear, they are only used to distinguish descriptions and should not be construed as indicating or implying relative importance. In the description of this invention, it should also be noted that unless otherwise explicitly specified and limited, terms such as "installation," "setting," and "connection" should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.
Claims
1. A fully closed preparation system for highly active pharmaceutical solid tablets, characterized in that, include: The material inlet module is connected to the material warehouse through a transfer system. Auxiliary materials and APIs in the material warehouse can be transferred to the material inlet module for de-packaging and de-inventory processing and temporary storage. The auxiliary material weighing module is connected to the material inlet module through a transfer system. The auxiliary materials in the material inlet module can enter the auxiliary material weighing module for weighing and temporary storage. The API weighing module is connected to the material inlet module through a transfer system. The API in the material inlet module can enter the API weighing module for weighing operations and temporary storage. The mixing and screening module is connected to the auxiliary material weighing module and the API weighing module through a transfer system. The auxiliary materials in the auxiliary material weighing module can be transferred to the mixing and screening module for mixing. The mixed auxiliary materials can be transferred to the API weighing module to add API, and then transferred back to the mixing and screening module for mixing and screening. The tableting module is connected to the mixing and screening module via a transfer system. The material after mixing and screening in the mixing and screening module can be transferred to the tableting module for tableting to form drug tablets. The coating processing module is connected to the tableting processing module via a transfer system. The drug tablets in the tableting processing module can be transferred to the coating processing module for coating operations to form drug-coated tablets.
2. The fully enclosed preparation system for highly active drug solid tablets according to claim 1, characterized in that, The material inlet module includes: Primary entrance room (110), which is connected to the material warehouse through a transfer system, where auxiliary materials and APIs in the material warehouse can be transferred to the primary entrance room (110) for de-insurance processing; The secondary entrance room (120) is connected to the primary entrance room (110) through a shielding door and is connected to the primary entrance room (110) through a transfer system. The auxiliary materials and APIs in the primary entrance room (110) can be transferred to the secondary entrance room (120) for unpacking. Material storage room (130) is connected to secondary entrance room (120) through shielding door and material channel, and is connected to secondary entrance room (120) through transfer system. Auxiliary materials and API in secondary entrance room (120) can be transferred to material storage room (130) for temporary storage.
3. The fully enclosed preparation system for highly active drug solid tablets according to claim 1, characterized in that, The auxiliary material weighing module includes: The auxiliary material weighing room (210) is connected to the material inlet module through a shielding door and a material channel, and is connected to the material outlet module through a transfer system. The auxiliary materials in the material inlet module can be transferred to the auxiliary material weighing room (210). Auxiliary material weighing device (220), wherein the auxiliary material weighing device (220) is a negative pressure weighing hood, which is installed in the auxiliary material weighing room (210) and weighs the auxiliary materials transferred from the material port module by the auxiliary material weighing hood; The auxiliary material temporary storage room (230) is connected to the auxiliary material weighing room (210) through a shielding door and a material channel, and is connected to the auxiliary material weighing room (210) through a transfer system. The auxiliary materials weighed in the auxiliary material weighing room (210) can be transferred to the auxiliary material temporary storage room (230) for temporary storage.
4. The fully enclosed preparation system for highly active drug solid tablets according to claim 1, characterized in that, The API weighing module includes: API weighing room (310), the API weighing room (310) is connected to the material inlet module through a shielded door and material channel, and is connected to the material inlet module through a transfer system, the API in the material inlet module can be transferred to the API weighing room (310). Negative pressure isolator (320), which is installed in the API weighing room (310), weighs and temporarily stores the API transferred from the material inlet module by the negative pressure isolator (320).
5. The fully enclosed preparation system for highly active drug solid tablets according to claim 1, characterized in that, The mixing and screening module includes: Mixing and screening room (410), the mixing and screening room (410) is connected to the auxiliary material weighing module through a shielding door and material channel, and is connected to the auxiliary material weighing module through a transfer system. The auxiliary materials in the auxiliary material weighing module can be transferred to the mixing and screening room (410). Mixing weigher (420), the mixing weigher (420) is a negative pressure weighing hood, which is installed in the mixing screening room (410). The auxiliary materials transferred from the auxiliary material weighing module can be poured into the closed material hopper in the mixing weigher (420), and the auxiliary materials in the closed material hopper can be weighed. Mixing and screening machine (430), the mixing and screening machine (430) is installed in the mixing and screening room (410). Auxiliary materials can be transferred to the mixing and screening machine (430) along with the closed material hopper. The mixing and screening machine (430) premixes the auxiliary materials. The premixed auxiliary materials can be transferred to the API weighing module along with the closed material hopper. The API weighing module adds API to the closed material hopper. The auxiliary materials and API can be transferred to the mixing and screening machine (430) along with the closed material hopper. The closed material hopper is connected to the mixing and screening machine (430) through the closed valve. The mixing and screening machine (430) mixes and screens the auxiliary materials and API in the closed material hopper.
6. The fully enclosed preparation system for highly active drug solid tablets according to claim 1, characterized in that, The tablet compression processing module includes: The tableting operation room (510) is connected to the mixing and screening module through a shielding door and a material channel, and is connected to the mixing and screening module through a transfer system. The material after screening in the mixing and screening module can be transferred to the tableting operation room (510). The tablet weighing device (520) is a negative pressure weighing hood installed in the tablet operating room (510). It can weigh the materials transferred from the mixing and screening module in the tablet weighing device (520). The tablet press (530) is installed in the tableting operation room (510). The material weighed by the tablet weigher (520) can be connected to the sealed valve of the tablet press (530) through the elevator. The tablet press (530) performs tableting operation on the material. The resulting drug tablets are temporarily stored in double-layer sealed bags. The dust in the tablet press (530) is discharged after being removed by the negative pressure dust collection mechanism and the bag inlet and bag outlet filter.
7. The fully enclosed preparation system for highly active drug solid tablets according to claim 1, characterized in that, The coating processing module includes: The coating operation room (610) is connected to the tableting module through a shielding door and a material channel, and is also connected to the tableting module through a transfer system. The drug tablets in the tableting module can be transferred to the coating operation room (610). The uncoated tablet coating machine (620) is installed in the coating operation room (610) and can coat the uncoated tablets transferred to the coating operation room (610). The formed drug-coated tablets are put into double-layer polyethylene bags and transferred to the finished product packaging module for packaging. The dust in the uncoated tablet coating machine (620) is discharged after being removed by a dust collector and a bag inlet and bag outlet filter.
8. A fully enclosed preparation method for highly active pharmaceutical solid tablets, characterized in that, The operation using the fully closed preparation system for highly active drug solid tablets according to any one of claims 1 to 7 includes the following steps: S1: Transfer auxiliary materials and APIs from the material warehouse to the material entry module; first, the materials enter the primary entry room (110) for unpacking; then, the materials are transferred to the secondary entry room (120) for unpacking; finally, the materials enter the material temporary storage room (130) for temporary storage; S2: Transfer the auxiliary materials in the material storage room (130) to the auxiliary material weighing room (210), weigh the auxiliary materials in the auxiliary material weighing room (210) using a negative pressure weighing hood (220), and temporarily store the weighed auxiliary materials in the auxiliary material storage room (230); at the same time, transfer the API in the material storage room (130) to the API weighing room (310), weigh the API in the API weighing room (310) using a negative pressure isolator (320) and temporarily store it; S3: The weighed auxiliary materials in the auxiliary material storage room (230) are transferred to the mixing and screening room (410); then, the auxiliary materials are poured into a closed material hopper under the negative pressure weighing hood (420) in the mixing and screening room (410); then, the closed material hopper containing the auxiliary materials is transferred to the mixing and screening machine (430) for premixing; after the premixing is completed, the closed material hopper containing the premixed auxiliary materials is transferred to the API weighing room (310), and the weighed API is added to the closed material hopper by the negative pressure isolator (320) in the API weighing room (310); then, the closed material hopper containing the auxiliary materials and API is transferred back to the mixing and screening room (410), so that the closed material hopper is connected to the mixing and screening machine (430) through the closed valve, and the mixing and screening machine (430) performs mixing and screening operations on the materials therein; S4: The material that has completed the screening operation in the mixing and screening machine (430) is transferred to the tableting operation room (510) through the closed material hopper; the transferred material is weighed in the negative pressure weighing hood (520) in the tableting operation room (510); then, the material is connected to the closed valve of the tablet press (530) through the elevator via the closed material hopper, and the tablet press (530) performs tableting operation on the material to form drug tablets; the formed drug tablets are temporarily stored in double-layer sealed bags; during this process, the dust in the tablet press (530) is discharged after being removed by the negative pressure dust collection mechanism and the bag inlet and bag outlet filter device; S5: The uncoated tablets in the tableting operation room (510) are transferred to the coating operation room (610) along with double-layer sealed bags; the uncoated tablets are coated by the uncoated tablet coating machine (620) in the coating operation room (610) to form drug-coated tablets; the coated drug-coated tablets are put into double-layer polyethylene bags and transferred to the finished product packaging module for packaging; during this process, the dust in the uncoated tablet coating machine (620) is discharged after being removed by the dust collector and the bag inlet and bag outlet filter.