Production area structure of a solid preparation workshop

Abstract

The present invention relates to a production area structure of a solid preparation workshop, specifically to a production area structure of a solid preparation workshop with a partition design for the clean area corridor. The clean area corridor of the present invention is divided into a clean corridor and a waste corridor in the clean area, and the anteroom and the exit passage of the inner packaging area are optimized. Overall, the flow of people and materials enters each dust-producing functional room from the clean corridor in the clean area and leaves from the waste corridor in the clean area. The production area structure layout of the solid preparation workshop of the present invention is simple, which can effectively reduce cross-contamination and the dust amount in some areas, and is particularly suitable for the production of solid preparations with relatively large toxic and side effects such as anlotinib, imatinib, and dasatinib.

Description

Technical Field

[0001] The present invention relates to a structure of a building, and more particularly to a production area structure of a solid preparation workshop. Background Art

[0002] Solid preparations are an important type of pharmaceutical products in the pharmaceutical field. Common solid dosage forms include powders, granules, tablets, capsules, dripping pills, etc. Among them, tablets, capsules, and granules are the most widely used. The production processes of different solid preparation products have certain similarities. For example, processes such as crushing, sieving, weighing, and total mixing are essential in the production of various solid preparations. The difference in dosage forms mainly lies in the distinction of processes such as tabletting and capsule filling.

[0003] An important feature of a solid preparation workshop is that there are many dust - generating processes and different shifts. In the production workshops of solid preparations, previous production was mostly concentrated in a large flat floor. Raw material powders or tablets and capsules were stored and transported in stainless - steel buckets. In recent years, with the development of solid preparation equipment, a vertical transportation mode relying on the self - gravity of materials has emerged. Corresponding to the typical solid preparation production process, the production facilities in the vertical material transportation process can be distributed on multiple floors. The materials are first sent to the top floor by a freight elevator and then transported down to the lower floors in sequence as much as possible using the self - gravity of the materials along with the production process. In addition, the mode of downstream production of different types of solid preparations in the same production area and then packaging through different packaging lines is becoming increasingly popular.

[0004] The application of new equipment and new concepts continuously brings convenience to the modern production of oral solid preparations. However, the structural layout of the production area in traditional solid preparation workshops still needs to be improved:

[0005] 1. There is only one clean - area corridor in the corridor of the production area of traditional solid preparations. When designing, it is necessary to try to meet the one - way flow of people and materials design and reach each functional room through the simplest and quickest route as much as possible, which often increases the overall layout difficulty of the production area.

[0006] 2. When there are multiple inner packaging areas in the production area of traditional solid preparations, the exit channels between multiple inner packaging areas and the corridor are set unreasonably, and the convenience of passage is often affected due to the existence of packaging linkage lines.

[0007] 3. In the inner packaging area of the production area of traditional solid preparations, multiple inner packaging areas share the same anteroom. The inner packaging area is a dust - generating functional room. The dosage forms, excipients, and active ingredients of the products to be packaged in different inner packaging areas may be different, which is likely to cause cross - contamination. Summary of the Invention

[0008] The object of the present invention is to provide a solid preparation workshop structure with a simple structure and reasonable layout, so as to reduce cross-contamination and facilitate the passage of people and logistics.

[0009] On the one hand, the present invention provides a production area structure of a solid preparation workshop with a cleanliness classification for the clean area corridor.

[0010] The production area structure of the solid preparation workshop includes a clean area corridor and a dust-generating functional room. The clean area corridor is divided into a clean clean corridor and a clean dirt corridor in the clean area. There are personnel and material cleaning channels for leaving the clean area dirt corridor and entering the clean clean corridor between the clean clean corridor and the clean area dirt corridor. There are channels between the dust-generating functional room and both the clean clean corridor and the clean area dirt corridor. The channel between the dust-generating functional room and the clean clean corridor is connected through a pre-chamber, while the channel between the dust-generating functional room and the clean area dirt corridor does not have a pre-chamber. There is a one-way leaving channel for leaving the dust-generating functional room between the dust-generating functional room and the clean area dirt corridor, and neither logistics nor personnel return to the dust-generating functional room from the clean area dirt corridor.

[0011] In a preferred embodiment of the present invention, the dust-generating functional room can be one or a combination of several groups selected from the following, and can be one or more rooms:

[0012] (1) Capsule filling room;

[0013] (2) Tablet pressing room, coating room;

[0014] (3) Tablet pressing room;

[0015] (4) Inner packaging area;

[0016] The channel between each dust-generating functional room and the clean clean corridor is connected through an independent pre-chamber, and the channel between the dust-generating functional room and the clean clean corridor is a one-way entry channel for people and objects. Optionally, a material entry and / or exit channel can be added. The description of the material channel between the dust-generating functional room and the clean area corridor as "optionally... entry and / or exit channel" is because the upstream products entering the dust-generating functional room and / or the products to be packaged leaving the dust-generating functional room can also be transmitted to this production area structure from the upper floor and / or transmitted from this production area structure to the lower floor through the vertical material transmission method described in the background art.

[0017] In a preferred embodiment of the present invention, an upper floor is further provided above the production area structure. The upper floor can be used for upstream processes such as crushing, sieving, weighing, and total mixing of solid preparations, or only for transporting upstream intermediate products downward to the production area structure described in the present invention. An upper material channel is provided on the upper floor and connected to the capsule filling room and / or tablet pressing room and / or coating room in the lower structure. Further preferably, a lower floor is provided below the production area structure. The production area structure is provided with a lower material channel to transport the solid preparation products to be packaged through the material channel to the lower floor, and the packaging is completed through the inner packaging area and outer packaging area provided on the lower floor.

[0018] In a preferred embodiment of the present invention, the clean corridor in the clean area of the production area structure is provided with access channels for personnel to enter and leave, which are communicated with the outside of the production area structure. The waste corridor in the clean area is provided with waste discharge channels, which are communicated with the outside of the production area structure. The material channels communicated with the outside of the production area structure include one of the following design schemes:

[0019] (1) A material inlet channel is provided on the upper layer of the production area structure and connected to the production area structure.

[0020] (2) The material inlet channel of the production area structure is arranged in the clean corridor of the clean area.

[0021] And one of the following design schemes:

[0022] (1) The material discharge channel of the production area is arranged in the clean corridor of the clean area.

[0023] (2) The material discharge channel of the production area structure is connected to the lower layer of the production area structure.

[0024] (3) When there is an inner packaging area in the production area structure, there is no material discharge channel in the production area, and the packaging is directly carried out in this production area.

[0025] Combination.

[0026] In a preferred embodiment of the present invention, the personnel and material purification channels between the clean corridor and the waste corridor in the clean area are divided into four channels: equipment channel, cleaning tool channel, clothing channel, and personnel channel.

[0027] In a preferred embodiment of the present invention, the relative area pressures described above are set as: clean corridor in the clean area > dust generating room > waste corridor in the clean area.

[0028] On the other hand, the present invention further optimizes the above production area structure and designs a production area structure integrating the production and packaging of tablets and capsules:

[0029] In a preferred embodiment of the present invention, the dust-producing functional rooms in the production area structure include a capsule filling room, a tableting room, a coating room, an inner packaging area, and an outer packaging area. As described above, the capsule filling room, the tableting room, the coating room, and the inner packaging area are dust-producing functional rooms. There are both personnel flow and material flow channels between them and the clean corridor and the waste corridor in the clean area. The channel between them and the clean corridor in the clean area is a one-way entry channel for personnel flow and material flow into the inner packaging area, and the channel between them and the waste corridor in the clean area is a one-way exit channel for personnel flow and material flow leaving the inner packaging area. The channels between the capsule filling room, the tableting room, the coating room, the inner packaging area and the clean corridor in the clean area are connected through an anteroom, while there is no anteroom at the channel between them and the waste corridor in the clean area, and they are directly connected to the waste corridor in the clean area.

[0030] In a preferred embodiment of the present invention, an upper floor is also provided in the production area structure. The upper floor can be used for upstream processes such as crushing, sieving, weighing, and total mixing of solid preparations, or only for transporting upstream intermediate products down to the production area structure described in the present invention. There is a material channel on the upper floor connecting to the capsule filling room and / or the tableting room and / or the coating room in the lower structure. Since the material channel of the upstream product is connected to the upper floor, the channel design of the production area structure communicating with the external non-clean area is as follows: the personnel entry and exit channel communicates with the clean corridor in the clean area, the waste exit channel communicates with the waste corridor in the clean area, and the exit channel of the packaged product communicates with the outer packaging area.

[0031] In a preferred embodiment of the present invention, the production area structure further includes a solid preparation product temporary storage room and / or an inner packaging material temporary storage room. There is a material flow channel for transporting inner packaging materials between the solid preparation product temporary storage room and / or the inner packaging material temporary storage area and the clean corridor in the clean area.

[0032] In the third aspect of the present invention, the packaging area part of the above production area structure is further modified:

[0033] In a preferred embodiment of the present invention, there is more than one inner packaging area. Each inner packaging area is provided with a packaging linkage line for the same product line connecting to the outer packaging area, and the design of each packaging linkage line is basically parallel. There is a clean area waste branch corridor adjacent to each inner packaging area in the clean area waste corridor and there is a channel connecting them. And there is an anteroom connected between each inner packaging area and the clean corridor in the clean area respectively. The connection mode between the clean area waste branch corridor and each inner packaging area is as follows: the clean area waste branch corridor is cross-designed for each inner packaging area, and a channel is set on the wall adjacent to the inner packaging area. At the same time, the packaging linkage line affected after the clean area waste branch corridor is embedded is raised to a height that does not affect personnel passage. The packaging linkage line at the cross part with the clean area waste branch corridor only has a transmission function. Generally, it involves three steps: lifting, translation, and lowering. This operation mode can be realized according to the existing technology and will not be elaborated here.

[0034] Preferably, the dirt branch corridor in the clean area is located at the junction of the inner packaging area and the outer packaging area and is adjacent and connected to each inner packaging area. The dirt branch corridor in the clean area does not necessarily completely separate the inner packaging area and the outer packaging area at the junction of the inner packaging area and the outer packaging area. It only needs to ensure that each inner packaging area has an area adjacent to the dirt branch corridor in the clean area where a passage can be set. More preferably, the packaging linkage line crosses the space where the dirt branch corridor in the clean area is located or above the space, and the height of the crossed part is set higher than the human height. For example, an inverted U-shaped design, usually with a height of more than 1.8 meters, preferably more than 2.0 meters, as long as it does not affect the passage of most personnel.

[0035] In a preferred embodiment of the present invention, the clean corridor and the dirt corridor in the clean area divide each dust-generating functional room in the production area structure into three functional groups: the first functional group includes the solid preparation product temporary storage room and / or the inner packaging material temporary storage area, the second functional group includes the capsule filling room, the tableting room, and the coating room, and the third functional group includes the inner packaging area and the outer packaging area. Each dust-generating functional room between each functional group is not separated by the clean corridor or the dirt corridor in the clean area. Here, the dirt corridor in the clean area does not include the dirt branch corridor in the clean area.

[0036] The fourth aspect of the present invention relates to the use of the production area structure of the above-mentioned solid preparation workshop for preparing solid preparations, especially for preparing solid preparation products with high toxicity, high activity or allergenicity, such as anti-tumor and hormonal drugs.

[0037] The production area structure of the solid preparation workshop of the present invention has the following advantages compared with the prior art:

[0038] 1. The traditional single clean area corridor is subdivided into a clean corridor and a dirt corridor in the clean area. Apparently, the factory building structure becomes more complex, but in fact, it reduces the design difficulty of meeting the conditions such as non-backflow, non-detour, and non-crossing of people flow and material flow in the traditional workshop layout. In addition, it is beneficial to avoid cross-contamination. In addition, a pre-chamber is generally provided at the passage between the traditional dust-generating functional rooms (such as the tableting room and the capsule filling room) and the clean area corridor. In the present invention, only a pre-chamber needs to be set at the passage between the dust-generating functional rooms adjacent to the clean corridor in the clean area, and a pre-chamber does not need to be set at the passage between the dust-generating functional rooms adjacent to the non-clean area corridor of the present invention, saving costs and space;

[0039] 2. Multiple inner packaging areas in the present invention correspond to multiple independent pre-chambers, avoiding cross-contamination caused by the use of the same pre-chamber in different inner packaging areas in the prior art;

[0040] 3. In the present invention, by setting a branch corridor in the corridor to embed the inner packaging area and elevating the corresponding packaging linkage line, the corridor communicates with each inner packaging area in the simplest route, while ensuring the short and smooth packaging process route and the passage for personnel in the inner packaging area (leaving the inner packaging area and entering the clean area corridor), further simplifying the overall layout of the production area.

[0041] Lexical Explanation:

[0042] Passage: In the present invention, the passage described can be either directly connected or indirectly connected. The indirectly connected passage may include equipment or rooms for realizing or facilitating the function of the passage. For example, a cleaning room and a storage room for sanitary ware can be provided in the sanitary ware passage.

[0043] Dust-generating functional room: A room that generates dust in the solid preparation production area, usually a room involved in the preparation process. There is usually an anteroom between the dust-generating functional room and the corridor, and the dust-generating functional room is not necessarily limited to one room and can also be a suite.

[0044] Packaging linkage line: An automated or semi-automated production line for product packaging, which is connected by the inner packaging linkage line in the inner packaging area and the outer packaging linkage line in the outer packaging area.

[0045] Material: Refers to the intermediate product for preparing solid preparations or the product that has been made into solid preparations but not yet packaged.

[0046] Object: Refers to non-products, such as tools and equipment.

[0047] Clean area waste branch corridor: A part of the clean area waste corridor, defined for the convenience of referring to this part. Description of the Drawings

[0048] Figure 1 Specific solution of the production area structure of a solid preparation workshop with a graded clean area corridor according to the present invention

[0049] Figure 2 Specific solution of the production area structure of an integrated production and packaging of tablets and capsules according to the present invention

[0050] Figure 3 Another specific solution of the production area structure of an integrated production and packaging of tablets and capsules according to the present invention

[0051] Figure 4 Cross-sectional view of a packaging linkage line design solution according to the present invention Detailed Implementation Modes

[0052] For a clearer understanding of the technical features, objectives, and effects of the present invention, the detailed implementation modes of the present invention are now described with reference to the accompanying drawings.

[0053] Example 1

[0054] Structure of the solid preparation production area in the solid preparation workshop with classified clean area corridors

[0055] As Figure 1 shown, this embodiment provides a specific scheme for the production area structure of a solid preparation workshop with a classified clean area corridor, including a clean area corridor, a capsule filling room, a tabletting room, and a coating room. The clean area corridor is divided into a clean clean corridor and a dirty clean corridor in the clean area.

[0056] Among them, there are personnel and material purification channels for leaving the dirty clean corridor in the clean area and entering the clean clean corridor between the clean clean corridor and the dirty clean corridor in the clean area. Specifically, it includes: an equipment channel, a sanitary ware channel, a clothing channel, and a personnel channel. There are both personnel flow and material flow channels between the capsule filling room, the tabletting room, the coating room and the clean clean corridor and the dirty clean corridor in the clean area. And the channels between the above-mentioned dust-generating functional rooms and the clean clean corridor are one-way entrance channels for personnel and objects entering the dust-generating functional rooms, and the channels between them and the dirty clean corridor in the clean area are one-way exit channels for personnel and objects leaving the dust-generating functional rooms.

[0057] The channel design of this production area structure communicating with the outside is as follows: the entrance and exit channels for personnel communicate with the clean clean corridor in the clean area, and the waste leaving channel communicates with the dirty clean corridor in the clean area. The upper layer of this production area structure serves as an upstream process workshop, and there is a material channel connecting to this production area structure for transporting upper layer materials to this production area structure; the lower layer of this production area structure serves as a packaging workshop, and there is also a material channel connecting to this production area structure for transporting the products to be packaged in this production area structure to the lower layer.

[0058] It can be seen from the production area structure of the above solid preparations that the personnel flow and material flow in the corridors of the production area structure of this embodiment do not flow back, do not detour, and do not cross; due to the separated design of the clean clean corridor and the dirty clean corridor in the clean area, the dirty clean corridor in the clean area can be used as the leaving channel for production area personnel and waste. This channel itself does not have too high requirements for cleanliness, so there is no need to set up an anteroom between the dust-generating functional room and the dirty clean corridor in the clean area.

[0059] Example 2

[0060] Structure of the solid preparation production area with integrated production and packaging of tablets and capsules

[0061] As Figure 2 shown, this embodiment provides a production area structure for the integrated production and packaging of tablets and capsules. This production area structure includes a dust-generating functional room and a clean area corridor. Among them, the dust-generating functional room includes a capsule filling room, a tabletting room, a coating room, a solid preparation product temporary storage room, an inner packaging area, and an outer packaging area. The clean area corridor includes a clean clean corridor and a dirty clean corridor in the clean area.

[0062] Among them, there are personnel flow and material flow channels between the capsule filling room, tablet pressing room, coating room, inner packaging area and the clean corridor and the waste corridor in the clean area of the clean area. The channel between the inner packaging area and the clean corridor in the clean area is a one-way access channel to enter the inner packaging area, and the channel between the inner packaging area and the waste corridor in the clean area is a one-way exit channel to leave the inner packaging area. There is a one-way personnel and material cleaning channel from the waste corridor in the clean area to the clean corridor in the clean area, specifically including: equipment channel, cleaning utensils channel, clothing channel and personnel channel. The channels between the capsule filling room, tablet pressing room, coating room, inner packaging area and the clean corridor in the clean area are connected through the anteroom, while there is no anteroom at the channel between the inner packaging area and the waste corridor in the clean area, and it is directly connected to the waste corridor in the clean area.

[0063] The channel design of the production area structure of this embodiment communicating with the external non-clean area is as follows: the personnel entry channel, the personnel exit channel communicate with the clean corridor in the clean area, the waste exit channel communicates with the waste corridor in the clean area, there is a material channel for upstream products on the upper layer of the production area connected to the capsule filling room and the tablet pressing room of the production area structure, and the exit channel for the packaged products is set in the outer packaging area.

[0064] The traditional material entry channel is usually set on this floor and needs to be treated for dust removal before entry. And even after treatment, due to some objective factors, it will still inevitably bring certain pollution during the transportation in the corridor. On the basis of Embodiment 1, the above production area structure changes the material entry channel to a longitudinal design, so that the dust pollution source in the clean corridor of the clean area of the production area structure is further reduced, thus further avoiding cross-contamination between the dust-producing functional rooms.

[0065] At the same time, the packaging area of the production area structure of the solid preparations in this embodiment adds a solid preparation product temporary storage room, an inner packaging material entry channel, an inner packaging area and an outer packaging area compared with Embodiment 1. Under the condition of increasing the complexity of the production area structure, this embodiment follows the design principle of setting a one-way entry channel between the dust-producing functional room and the clean corridor in the clean area and a one-way exit channel between the dust-producing functional room and the waste corridor in the clean area, which not only simplifies the space layout but also meets the requirements of no backflow, no detour and no cross.

[0066] Embodiment 3

[0067] Specific plan for the structure of the production area with integrated production and packaging of tablets and capsules containing multiple packaging linkage lines Plan

[0068] As Figure 3As shown in the figure, this embodiment provides a structure of a solid preparation production area for the integrated production and packaging of tablets and capsules with multiple packaging linkage lines. The production area structure includes a dust-producing functional room and a clean area corridor. The dust-producing functional room includes a capsule filling room, a tableting room, a coating room, a solid preparation product temporary storage room, an inner packaging area, and an outer packaging area. The clean area corridor includes a clean clean corridor and a clean waste corridor in the clean area. The number of inner packaging areas is 3. The layout of the production area structure in this embodiment is basically the same as that in Embodiment 2, which will not be elaborated here one by one. The difference lies only in the number of inner packaging areas.

[0069] As Figure 3 , 4 shown, there are 3 inner packaging areas. A separate packaging linkage line is provided between each inner packaging area and the outer packaging area. The design of each inner packaging area and its packaging linkage line is basically parallel. The clean waste corridor in the clean area is provided with a clean waste branch corridor adjacent to each inner packaging area and connected by a passage. At the same time, a front room is respectively set between each inner packaging area and the clean clean corridor in the clean area. The connection mode between the clean waste branch corridor and each inner packaging area is as follows: The clean waste branch corridor is designed in an embedded manner at the junction of the inner packaging area and the outer packaging area, and an exit passage for the corresponding inner packaging area is set on the wall adjacent to the inner packaging area. At the same time, the packaging linkage line affected after the clean waste branch corridor is embedded is raised to a height that does not affect personnel passage. The linkage line in the embedded part of the branch corridor only has a transmission function, and generally involves three steps of lifting, translation, and lowering. This operation mode can be realized according to the existing technology.

[0070] It can be seen from this that the embedded design scheme of the clean waste branch corridor in the clean area is hardly affected by the number of inner packaging areas. The packaging linkage line affected by the clean waste branch corridor in the clean area is raised to a height of 2.5 meters, which does not affect the passage of personnel leaving the inner packaging area and entering the clean waste corridor through the clean waste branch corridor in the clean area. The layout is compact and simple, and it is convenient for personnel to pass.

[0071] The above description is only the specific implementation manner of the present invention and is not intended to limit the scope of the present invention. Any equivalent changes, modifications, and combinations made by those skilled in the art without departing from the concept and principle of the present invention shall fall within the scope of protection of the present invention.

Claims

1. The production area structure of a solid preparation workshop, comprising a clean area corridor and a dust-generating functional room, is characterized in that The clean area corridor is divided into a clean corridor and a waste corridor in the clean area. There are personnel and material purification channels for leaving the waste corridor in the clean area and entering the clean corridor in the clean area. There are channels between the dust-generating functional rooms and both the clean corridor and the waste corridor in the clean area. The channel between the dust-generating functional room and the clean corridor in the clean area is connected through a pre-chamber, while the channel between the dust-generating functional room and the waste corridor in the clean area does not have a pre-chamber; Among them, the personnel and material purification channels between the clean corridor and the waste corridor in the clean area are divided into four channels: equipment channel, cleaning utensils channel, clothing channel, and personnel channel; Among them, the clean corridor in the clean area is connected to the personnel entry channel and the personnel exit channel, and the waste corridor in the clean area is connected to the waste exit channel; Among them, the dust-generating functional room includes an inner packaging area. There is more than one inner packaging area. The inner packaging area is equipped with a packaging production line in series, and the channel between each inner packaging area and the clean corridor in the clean area is connected through an independent pre-chamber; There is also a waste branch corridor in the clean area waste corridor adjacent to all inner packaging areas and intersecting with some or all of the packaging production lines in series. Each inner packaging area has an exit channel in the clean area waste corridor or the clean area waste branch corridor; The part of the packaging production line in series intersecting with the clean area waste branch corridor is designed to be relatively elevated; The dust-generating functional room and the clean corridor in the clean area are provided with a one-way entry channel, and a one-way exit channel is provided between the dust-generating functional room and the waste corridor in the clean area.

2. The production area structure according to claim 1, characterized in that The types of the dust-generating functional rooms are a combination of one or more of the following groups, and each type of dust-generating functional room has one or more rooms: (1) capsule filling room; (2) tableting room, coating room; (3) tableting room; (4) inner packaging area.

3. The production area structure according to claim 1, characterized in that It includes a capsule filling room, a tableting room, a coating room, an inner packaging area, an outer packaging area, and a solid preparation product temporary storage room. The solid preparation product temporary storage room is connected to the clean corridor in the clean area and not connected to the waste corridor in the clean area; the outer packaging area is not connected to either the clean corridor or the waste corridor in the clean area.

4. The production area structure according to claim 3, wherein The clean corridor and the waste corridor in the clean area divide each functional room in the production area structure into three functional groups: the first functional group includes the OSD product temporary storage room, the second functional group includes the capsule filling room, the tableting room, and the coating room, and the third functional group includes the inner packaging area and the outer packaging area.

5. The production area structure according to any one of claims 1-4, characterized in that The channels between the production area structure and the outside include: the material channel between the upper layer of the production area structure and the tableting room and the capsule filling room in the production area structure; the inner packaging material entry channel, the personnel entry channel, and the personnel exit channel between the clean corridor in the clean area and the outside of the production area structure, and the waste exit channel between the waste corridor in the clean area and the outside of the production area structure.

6. The production area structure according to any one of claims 1-4, characterized in that The channel between the dust-generating functional room and the clean corridor in the clean area is an entry channel for personnel and objects. Optionally, the following changes can also be made: (1) adding an entry and / or exit channel for materials; (2) the personnel entry channel also serves as an entry and / or exit channel for materials, and there is an exit channel for leaving the dust-generating functional room between the dust-generating functional room and the waste corridor in the clean area.

7. The production area structure according to any one of claims 1-4, characterized in that The clean corridor in the clean area of the production area structure is provided with access channels for personnel to enter and leave, which communicate with the outside of the production area structure. The waste corridor in the clean area is provided with a waste leaving channel that communicates with the outside of the production area structure. The material and product channel that communicates with the outside of the production area structure includes one of the following design schemes: (1) There is a material entering channel on the upper layer of the production area structure, which is connected to the production area structure; (2) The material entering channel of the production area structure is arranged in the clean corridor of the clean area; And one of the following design schemes: (1) The material leaving channel of the production area structure is arranged in the clean corridor of the clean area; (2) The material leaving channel of the production area structure is connected to the lower layer of the production area structure; (3) When there is an inner packaging area in the production area structure, there is no material leaving channel in the production area structure; Combination.

8. The production area structure according to any one of claims 1 to 4, characterized in that The relative pressure of each area is: clean corridor in the clean area > dust generating room > waste corridor in the clean area.

9. Use of the production area structure according to any one of claims 1-4 for producing toxic, active or sensitizing drugs.

10. Use of the production area structure according to claim 9 for producing anti-tumor drugs.

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